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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
(Mark
One)
☒ |
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For
the quarterly period ended June 30, 2024
or
☐ |
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For
the transition period from ___________ to __________
Commission
file number: 001-36199
PULMATRIX,
INC.
(Exact
name of registrant as specified in its charter)
Delaware |
|
46-1821392 |
(State
or other jurisdiction of
incorporation
or organization) |
|
(I.R.S.
Employer
Identification
No.) |
|
|
|
945
Concord Street, Suite 1217
Framingham,
MA |
|
01701 |
(Address
of principal executive offices) |
|
(Zip
Code) |
(888)
355-4440
Registrant’s
telephone number, including area code
36
Crosby Drive, Suite 100
Bedford,
MA 01730
Former
name, former address and former fiscal year, if changed since last report
Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)
has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Yes ☒ No ☐
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting
company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer”,
“smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act. (Check one):
Large
accelerated filer |
☐ |
Accelerated
filer |
☐ |
|
|
|
|
Non-accelerated
filer |
☒ |
Smaller
reporting company |
☒ |
|
|
|
|
|
|
Emerging
growth company |
☐ |
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
Securities
registered pursuant to Section 12(b) of the Exchange Act:
Title
of each Class |
|
Trading
Symbol(s) |
|
Name
of each exchange on which registered |
Common
Stock, par value $0.0001 per share |
|
PULM |
|
The
NASDAQ Stock Market LLC |
As
of August 8, 2024, the registrant had 3,652,285 shares of common stock outstanding.
PULMATRIX,
INC.
FORM
10-Q
FOR
THE QUARTERLY PERIOD ENDED JUNE 30, 2024
TABLE
OF CONTENTS
PART
I—FINANCIAL INFORMATION
Item
1. Condensed Consolidated Financial Statements.
PULMATRIX,
INC.
Consolidated
Balance Sheets
(in
thousands, except share and per share data)
| |
June 30, 2024 | | |
December 31, 2023 | |
| |
(unaudited) | | |
| |
Assets | |
| | | |
| | |
Current assets: | |
| | | |
| | |
Cash and cash equivalents | |
$ | 12,379 | | |
$ | 19,173 | |
Restricted cash | |
| 1,421 | | |
| - | |
Accounts receivable | |
| 635 | | |
| 928 | |
Prepaid expenses and other current assets | |
| 1,201 | | |
| 742 | |
Total current assets | |
| 15,636 | | |
| 20,843 | |
Property and equipment, net | |
| - | | |
| 1,158 | |
Operating lease right-of-use asset | |
| - | | |
| 10,309 | |
Long-term restricted cash | |
| 51 | | |
| 1,472 | |
Other long-term assets | |
| 93 | | |
| 176 | |
Total assets | |
$ | 15,780 | | |
$ | 33,958 | |
Liabilities and stockholders’ equity | |
| | | |
| | |
Current liabilities: | |
| | | |
| | |
Accounts payable | |
$ | 393 | | |
$ | 1,915 | |
Accrued expenses and other current liabilities | |
| 1,783 | | |
| 947 | |
Operating lease liability | |
| 24 | | |
| 429 | |
Deferred revenue | |
| 270 | | |
| 618 | |
Total current liabilities | |
| 2,470 | | |
| 3,909 | |
Deferred revenue, net of current portion | |
| - | | |
| 3,727 | |
Operating lease liability, net of current portion | |
| - | | |
| 8,327 | |
Total liabilities | |
| 2,470 | | |
| 15,963 | |
Commitments and contingencies (Note 10) | |
| - | | |
| - | |
Stockholders’ equity: | |
| | | |
| | |
Preferred Stock, $0.0001 par value — 500,000 shares authorized; 6,746 shares designated Series A convertible preferred stock; no shares issued and outstanding at June 30, 2024 and December 31, 2023 | |
| - | | |
| - | |
Common stock, $0.0001 par value — 200,000,000 shares authorized; 3,652,285 shares issued and outstanding at June 30, 2024 and December 31, 2023 | |
| - | | |
| - | |
Additional paid-in capital | |
| 305,893 | | |
| 305,592 | |
Accumulated deficit | |
| (292,583 | ) | |
| (287,597 | ) |
Total stockholders’ equity | |
| 13,310 | | |
| 17,995 | |
Total liabilities and stockholders’ equity | |
$ | 15,780 | | |
$ | 33,958 | |
The
accompanying footnotes are an integral part of these condensed consolidated financial statements.
PULMATRIX,
INC.
Consolidated
Statements of Operations
(in
thousands, except share and per share data)
(unaudited)
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Revenues | |
$ | 1,552 | | |
$ | 1,844 | | |
$ | 7,437 | | |
$ | 3,343 | |
| |
| | | |
| | | |
| | | |
| | |
Operating expenses: | |
| | | |
| | | |
| | | |
| | |
Research and development | |
| 2,834 | | |
| 4,165 | | |
| 6,346 | | |
| 8,039 | |
General and administrative | |
| 2,001 | | |
| 1,670 | | |
| 3,627 | | |
| 3,880 | |
Loss on disposal group held for sale | |
| 2,618 | | |
| - | | |
| 2,618 | | |
| - | |
Total operating expenses | |
| 7,453 | | |
| 5,835 | | |
| 12,591 | | |
| 11,919 | |
Loss from operations | |
| (5,901 | ) | |
| (3,991 | ) | |
| (5,154 | ) | |
| (8,576 | ) |
Other income (expense): | |
| | | |
| | | |
| | | |
| | |
Interest income | |
| 133 | | |
| 236 | | |
| 293 | | |
| 458 | |
Other expense, net | |
| (43 | ) | |
| (61 | ) | |
| (125 | ) | |
| (146 | ) |
Total other income, net | |
| 90 | | |
| 175 | | |
| 168 | | |
| 312 | |
Net loss | |
$ | (5,811 | ) | |
$ | (3,816 | ) | |
$ | (4,986 | ) | |
$ | (8,264 | ) |
Net loss per share attributable to common stockholders – basic and diluted | |
$ | (1.59 | ) | |
$ | (1.04 | ) | |
$ | (1.37 | ) | |
$ | (2.26 | ) |
Weighted average common shares outstanding – basic and diluted | |
| 3,652,285 | | |
| 3,652,285 | | |
| 3,652,285 | | |
| 3,651,531 | |
The
accompanying footnotes are an integral part of these condensed consolidated financial statements.
PULMATRIX,
INC.
Consolidated
Statements of Stockholders’ Equity
(in
thousands, except share data)
(unaudited)
| |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Equity | |
| |
Preferred Stock | | |
Common Stock | | |
Additional Paid-in | | |
Accumulated | | |
Total Stockholders’ | |
| |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Equity | |
Balance — January 1, 2024 | |
| - | | |
$ | - | | |
| 3,652,285 | | |
$ | - | | |
$ | 305,592 | | |
$ | (287,597 | ) | |
$ | 17,995 | |
Stock-based compensation | |
| - | | |
| - | | |
| - | | |
| - | | |
| 198 | | |
| - | | |
| 198 | |
Net income | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| 825 | | |
| 825 | |
Balance — March 31, 2024 | |
| - | | |
$ | - | | |
| 3,652,285 | | |
$ | - | | |
$ | 305,790 | | |
$ | (286,772 | ) | |
$ | 19,018 | |
Balance | |
| - | | |
$ | - | | |
| 3,652,285 | | |
$ | - | | |
$ | 305,790 | | |
$ | (286,772 | ) | |
$ | 19,018 | |
Stock-based compensation | |
| - | | |
| - | | |
| - | | |
| - | | |
| 103 | | |
| - | | |
| 103 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (5,811 | ) | |
| (5,811 | ) |
Balance — June 30, 2024 | |
| - | | |
$ | - | | |
| 3,652,285 | | |
$ | - | | |
$ | 305,893 | | |
$ | (292,583 | ) | |
$ | 13,310 | |
Balance | |
| - | | |
$ | - | | |
| 3,652,285 | | |
$ | - | | |
$ | 305,893 | | |
$ | (292,583 | ) | |
$ | 13,310 | |
| |
Preferred Stock | | |
Common Stock | | |
Additional Paid-in | | |
Accumulated | | |
Total Stockholders’ | |
| |
Shares | | |
Amount | | |
Shares | | |
Amount | | |
Capital | | |
Deficit | | |
Equity | |
Balance — January 1, 2023 | |
| - | | |
$ | - | | |
| 3,639,185 | | |
$ | - | | |
$ | 304,585 | | |
$ | (273,476 | ) | |
$ | 31,109 | |
Issuance of common stock, net of issuance costs | |
| - | | |
| - | | |
| 13,100 | | |
| - | | |
| 53 | | |
| - | | |
| 53 | |
Stock-based compensation | |
| - | | |
| - | | |
| - | | |
| - | | |
| 296 | | |
| - | | |
| 296 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (4,448 | ) | |
| (4,448 | ) |
Balance — March 31, 2023 | |
| - | | |
$ | - | | |
| 3,652,285 | | |
$ | - | | |
$ | 304,934 | | |
$ | (277,924 | ) | |
$ | 27,010 | |
Balance | |
| - | | |
$ | - | | |
| 3,652,285 | | |
$ | - | | |
$ | 304,934 | | |
$ | (277,924 | ) | |
$ | 27,010 | |
Stock-based compensation | |
| - | | |
| - | | |
| - | | |
| - | | |
| 255 | | |
| - | | |
| 255 | |
Net loss | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (3,816 | ) | |
| (3,816 | ) |
Net income (loss) | |
| - | | |
| - | | |
| - | | |
| - | | |
| - | | |
| (3,816 | ) | |
| (3,816 | ) |
Balance — June 30, 2023 | |
| - | | |
$ | - | | |
| 3,652,285 | | |
$ | - | | |
$ | 305,189 | | |
$ | (281,740 | ) | |
$ | 23,449 | |
Balance | |
| - | | |
$ | - | | |
| 3,652,285 | | |
$ | - | | |
$ | 305,189 | | |
$ | (281,740 | ) | |
$ | 23,449 | |
The
accompanying footnotes are an integral part of these condensed consolidated financial statements.
PULMATRIX,
INC.
Consolidated
Statements of Cash Flows
(in
thousands)
(unaudited)
| |
2024 | | |
2023 | |
| |
Six Months Ended June 30, | |
| |
2024 | | |
2023 | |
Cash flows from operating activities: | |
| | | |
| | |
Net loss | |
$ | (4,986 | ) | |
$ | (8,264 | ) |
Adjustments to reconcile net loss to net cash used in operating activities: | |
| | | |
| | |
Depreciation and amortization | |
| 106 | | |
| 64 | |
Amortization of operating lease right-of-use asset | |
| 329 | | |
| 777 | |
Stock-based compensation | |
| 301 | | |
| 551 | |
Loss on disposal group held for sale | |
| 2,618 | | |
| - | |
Changes in operating assets and liabilities: | |
| | | |
| | |
Accounts receivable | |
| 293 | | |
| 880 | |
Prepaid expenses and other current assets | |
| (459 | ) | |
| 49 | |
Other long-term assets | |
| 83 | | |
| (1,595 | ) |
Accounts payable | |
| (1,522 | ) | |
| (309 | ) |
Accrued expenses and other current liabilities | |
| 1,225 | | |
| (437 | ) |
Operating lease liability | |
| (309 | ) | |
| (843 | ) |
Deferred revenue | |
| (4,075 | ) | |
| (705 | ) |
Net cash used in operating activities | |
| (6,396 | ) | |
| (9,832 | ) |
Cash flows from investing activities: | |
| | | |
| | |
Purchases of property and equipment | |
| (398 | ) | |
| (58 | ) |
Net cash used in investing activities | |
| (398 | ) | |
| (58 | ) |
Cash flows from financing activities: | |
| | | |
| | |
Proceeds from issuance of common stock, net of issuance costs | |
| - | | |
| 53 | |
Net cash provided by financing activities | |
| - | | |
| 53 | |
Net decrease in cash, cash equivalents and restricted cash | |
| (6,794 | ) | |
| (9,837 | ) |
Cash, cash equivalents and restricted cash — beginning of period | |
| 20,645 | | |
| 37,253 | |
Cash, cash equivalents and restricted cash — end of period | |
$ | 13,851 | | |
$ | 27,416 | |
| |
| | | |
| | |
Reconciliation of cash, cash equivalents and restricted cash to the consolidated balance sheets: | |
| | | |
| | |
Cash and cash equivalents | |
$ | 12,379 | | |
$ | 25,791 | |
Restricted cash | |
| 1,421 | | |
| 153 | |
Long-term restricted cash | |
| 51 | | |
| 1,472 | |
Total cash, cash equivalents and restricted cash | |
$ | 13,851 | | |
$ | 27,416 | |
| |
| | | |
| | |
Supplemental disclosures of non-cash investing and financing information: | |
| | | |
| | |
Reduction of operating lease right-of-use asset and lease liability upon lease modification | |
$ | 8,423 | | |
$ | - | |
Purchases of property and equipment not yet paid | |
$ | - | | |
$ | 50 | |
Operating lease right-of-use asset obtained in exchange for operating lease obligation | |
$ | - | | |
$ | 344 | |
The
accompanying footnotes are an integral part of these condensed consolidated financial statements.
PULMATRIX,
INC.
Notes
to Condensed Consolidated Financial Statements (Unaudited)
(in
thousands, except share and per share data)
1.
Organization
Pulmatrix,
Inc. (the “Company”) was incorporated in 2013 as a Delaware corporation. The Company is a clinical-stage biopharmaceutical
company focused on the development of a novel class of inhaled therapeutic products. The Company’s proprietary dry powder delivery
platform, iSPERSE™, is engineered to deliver small, dense particles with highly efficient dispersibility and
delivery to the airways, which can be used with an array of dry powder inhaler technologies and can be formulated with a variety of drug
substances. The Company has developed a pipeline of iSPERSE™-based therapeutic candidates targeted at prevention
and treatment of a range of central nervous system, respiratory and other diseases with important unmet medical needs.
2.
Summary of Significant Accounting Policies and Recent Accounting Standards
Basis
of Presentation
The
condensed consolidated financial statements of the Company included herein have been prepared pursuant to the rules and regulations of
the Securities and Exchange Commission (the “SEC”). Certain information and footnote disclosures normally included in financial
statements prepared in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”)
have been condensed or omitted from this report, as is permitted by such rules and regulations. Accordingly, these condensed consolidated
financial statements should be read in conjunction with the consolidated financial statements and notes thereto included in the Company’s
Annual Report on Form 10-K for the fiscal year ended December 31, 2023, filed with the SEC on March 28, 2024 (the “Annual Report”).
The
financial information as of June 30, 2024, and for the three and six months ended June 30, 2024 and 2023, is unaudited. In the opinion
of management, all adjustments (including those which are normal and recurring) considered necessary for a fair presentation of the interim
financial information have been included. The balance sheet data as of December 31, 2023 was derived from audited consolidated financial
statements. The results of the Company’s operations for any interim periods are not necessarily indicative of the results that
may be expected for any other interim period or for a full fiscal year.
Based
on its current operating plan, the Company believes that its cash and cash equivalents as of June 30, 2024, will be adequate to fund
its currently anticipated operating expenses for at least twelve months from the date these condensed consolidated financial statements
are issued. The Company will need to secure additional funding in the future, from one or more equity or debt financings, collaborations,
or other sources, in order to carry out all of the Company’s planned research and development activities and regulatory activities;
commercialize product candidates; or conduct any substantial, additional development requirements requested by the FDA. Additional funding
may not be available to the Company on acceptable terms, or at all. If the Company is unable to secure additional capital, it will be
required to significantly decrease the amount of planned expenditures and may be required to cease operations. In addition, any disruption
in the capital markets could make any financing more challenging, and there can be no assurance that Pulmatrix will be able to obtain
such financing on commercially reasonable terms or at all. Curtailment of operations would cause significant delays in the Company’s
efforts to develop and introduce its products to market, which is critical to the realization of its business plan and the future operations
of the Company.
Use
of Estimates
In
preparing the condensed consolidated financial statements in conformity with U.S. GAAP, management is required to make estimates and
assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date
of the condensed consolidated financial statements, as well as the reported amounts of expenses during the reporting period. Due to inherent
uncertainty involved in making estimates, actual results may differ from these estimates. On an ongoing basis, the Company evaluates
its estimates and assumptions. The most significant estimates and assumptions in the Company’s condensed consolidated financial
statements include, but are not limited to, estimates of future expected costs in order to derive
and recognize revenue and estimates related to clinical trial accruals and upfront deposits.
Concentrations
of Credit Risk
Cash
is a financial instrument that potentially subjects the Company to concentrations of credit risk. For all periods presented, substantially
all of the Company’s cash was deposited in accounts at a single financial institution that management believes is creditworthy,
and the Company has not incurred any losses to date. The Company is exposed to credit risk in the event of default by this financial
institution for amounts in excess of the Federal Deposit Insurance Corporation insured limits.
For
the three and six months ended June 30, 2024, revenue from one customer accounted for 61% and 89%, respectively, of revenue recognized
in the accompanying condensed consolidated financial statements. For the three and six months ended June 30, 2023, revenue from one customer
accounted for 100% of revenue recognized in the accompanying condensed consolidated financial statements. As of June 30, 2024, two customers
accounted for 100% of accounts receivable. As of December 31, 2023, one customer accounted for 100% of accounts receivable.
Summary
of Significant Accounting Policies
The
Company’s significant accounting policies are described in Note 2, Summary of Significant Accounting Policies and Recent Accounting
Standards, in the Annual Report. During the six months ended June 30, 2024, the Company did not make any changes to its significant
accounting policies.
Recent
Accounting Pronouncements
From
time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”) or other standard
setting bodies that are adopted by the Company as of the specified effective date. The Company did not adopt any new accounting pronouncements
during the six months ended June 30, 2024 that had a material effect on its condensed consolidated financial statements.
In
December 2023, the FASB issued Accounting Standard Update 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures
(“ASU 2023-09”). The guidance in ASU 2023-09 improves the transparency of income tax disclosures by greater disaggregation
of information in the rate reconciliation and income taxes paid disaggregated by jurisdiction. The standard becomes effective for the
annual period beginning on January 1, 2025, with early adoption permitted. The Company is currently evaluating the impact that the adoption
of ASU 2023-09 may have on its consolidated financial statements.
As
of June 30, 2024, there are no other new, or existing recently issued, accounting pronouncements that are of significance, or potential
significance, that impact the Company’s condensed consolidated financial statements.
3.
Prepaid Expenses and Other Current Assets
Prepaid
expenses and other current assets consisted of the following:
Schedule
of Prepaid Expenses and Other Current Assets
| |
June 30, 2024 | | |
December 31, 2023 | |
Clinical and consulting | |
$ | 457 | | |
$ | 30 | |
Insurance | |
| 438 | | |
| 232 | |
Software and hosting costs | |
| 86 | | |
| 108 | |
Other | |
| 220 | | |
| 372 | |
Total prepaid expenses and other current assets | |
$ | 1,201 | | |
$ | 742 | |
4.
Property and Equipment, Net
The
Company’s Property and equipment, net, were included in the disposal group as part of the MannKind Transaction (as defined in Note
6, Significant Agreements. Refer to that note for further details and accounting discussion). The Company recorded a full write-down
of its net property and equipment balance as of June 30, 2024:
Schedule of Property and Equipment
| |
June 30, 2024 | | |
December 31, 2023 | |
Laboratory equipment | |
$ | - | | |
$ | 1,656 | |
Leasehold improvements | |
| - | | |
| - | |
Office furniture and equipment | |
| - | | |
| 401 | |
Computer equipment | |
| - | | |
| 237 | |
Capital in progress | |
| - | | |
| 600 | |
Total property and equipment | |
| - | | |
| 2,894 | |
Less accumulated depreciation and amortization | |
| - | | |
| (1,736 | ) |
Property and equipment, net | |
$ | - | | |
$ | 1,158 | |
Depreciation
and amortization expense for the six months ended June 30, 2024 and 2023 was $106 and $64, respectively.
5.
Accrued Expenses and Other Current Liabilities
Accrued
expenses and other current liabilities consisted of the following:
Schedule of Accrued Expenses and Other Current Liabilities
| |
June 30, 2024 | | |
December 31, 2023 | |
Wages and incentives | |
$ | 1,221 | | |
$ | 70 | |
Clinical and consulting | |
| 296 | | |
| 347 | |
Legal and patents | |
| 223 | | |
| 42 | |
Accrued purchases of property and equipment | |
| - | | |
| 389 | |
Other | |
| 43 | | |
| 99 | |
Total accrued expenses and other current liabilities | |
$ | 1,783 | | |
$ | 947 | |
6.
Significant Agreements
Development
and Commercialization Agreement with Cipla Technologies LLC (“Cipla”)
On
April 15, 2019, the Company entered into a Development and Commercialization Agreement (the “Cipla Agreement”) with Cipla
for the co-development and commercialization, on a worldwide exclusive basis, of PUR1900, the Company’s inhaled iSPERSE™
drug delivery system (the “Product”) enabled formulation of the antifungal drug itraconazole, which is only available
as an oral drug, for the treatment of all pulmonary indications, including allergic bronchopulmonary aspergillosis (“ABPA”)
in patients with asthma. The Company entered into an amendment to the Cipla Agreement on November 8, 2021 (the “Second Amendment”)
and a subsequent amendment on January 6, 2024 (the “Third Amendment”). All references to the Cipla Agreement herein refer
to the Cipla Agreement, as amended.
The
Company received a non-refundable upfront payment of $22.0 million (the “Upfront Payment”) under the Cipla Agreement. Upon
receipt of the Upfront Payment, the Company irrevocably assigned to Cipla the following assets, solely to the extent that each covers
the Product in connection with any treatment, prevention, and/or diagnosis of diseases of the pulmonary system (“Pulmonary Indications”):
all existing and future technologies, current and future drug master files, dossiers, third-party contracts, regulatory filings, regulatory
materials and regulatory approvals, patents, and intellectual property rights, as well as any other associated rights and assets directly
related to the Product, specifically in relation to Pulmonary Indications (collectively, the “Assigned Assets”), excluding
most specifically the Company’s iSPERSE™ technology. A portion of the Upfront Payment was deposited by
the Company into a bank account, along with an equal amount from the Company, and was dedicated to the development of the Product (the
“Initial Development Funding”). The Initial Development Funding was depleted during the year ended December 31, 2021, at
which point the Company and Cipla each became responsible for a portion of the development costs actually incurred as described below
(the “Co-Development Phase”).
Pursuant
to the Second Amendment, the Company and Cipla were each responsible for 60% and 40%, respectively, of the Company’s overhead costs
and the time spent by the Company’s employees and consultants on development of the Product (“Direct Costs”). The Company
will share all other development costs with Cipla that are not Direct Costs, such as the cost of clinical research organizations, manufacturing
costs and other third-party costs, on a 50/50 basis.
Pursuant
to the Third Amendment, the Company and Cipla agreed that, during the period commencing on January 6, 2024 and ending July 30, 2024 (the
“Wind Down Period”), the Company will complete all Phase 2b activities, assign or license all patents to Cipla and their
registration with the appropriate authorities in regions other than the United States, complete a physical and demonstrable technology
transfer and secure all data from the Phase 2b study for inclusion in the safety database. The Company will share costs with Cipla during
the Wind Down Period in the same proportions in effect with the Second Amendment discussed above, but subject to a maximum reimbursement
amount by Cipla as approved by the joint steering committee.
Accounting
Treatment
The
Company concluded that because both it and Cipla are active participants in the arrangement and are exposed to the significant risks
and rewards of the collaboration, the Company’s collaboration with Cipla is within the scope of Accounting Standards Codification
(“ASC”) 808, Collaborative Arrangements (“ASC 808”). The Company concluded that Cipla is a customer since
they contracted with the Company to obtain research and development services and a license to the Assigned Assets, each of which is an
output of the Company’s ordinary activities, in exchange for consideration. Therefore, the Company has applied the guidance in
ASC 606, Revenue from Contracts with Customers (“ASC 606”) to account for the research and development services and
a license within the contract. The Company determined that the research and development services and license to the Assigned Assets are
considered highly interdependent and highly interrelated and therefore are considered a single combined performance obligation because
Cipla cannot benefit from the license without the performance by the Company of the research and development services. Such research
and development services are highly specialized and proprietary to the Company and therefore not available to Cipla from any other third
party.
The
Company initially determined the total transaction price to be $22.0 million – comprised of $12.0 million for research and development
services for the Product and $10.0 million for the irrevocable license to the Assigned Assets. Any consideration related to the Co-Development
Phase was not initially included in the transaction price as such amounts are subject to the variable consideration constraint. Additionally,
upon commercialization, Cipla and the Company will share equally, both positive and negative total free cash-flows earned by Cipla in
respect of the Product. However, the Company has not included such free cash-flows in the transaction price as these milestones are constrained.
Revenue
is recognized for the Cipla Agreement as the research and development services are provided using an input method, according to the ratio
of costs incurred to the total costs expected to be incurred in the future to satisfy the Company’s obligations. In management’s
judgment, this input method is the best measure of the transfer of control of the combined performance obligation. The amounts received
that have not yet been recognized as revenue are recorded in deferred revenue on the Company’s consolidated balance sheets, with
amounts expected to be recognized in the next 12 months recorded as current.
The
Company concluded that the Third Amendment is a contract modification that should be accounted for as part of the existing contract.
During the three and six months ended June 30, 2024, the Company recognized $0.9 million and $6.6 million, respectively, in revenue related
to the research and development services and irrevocable license to the Assigned Assets in the Company’s consolidated statements
of operations, as compared to $1.8 million and $3.3 million, respectively, recognized during the three and six months ended June 30,
2023. The revenue recognized during the six months ended June 30, 2024 was primarily associated with the cumulative catch-up recorded
in the three months ended March 31, 2024, from the contract modification, that had been included in deferred revenue at the beginning of the period.
As of June 30, 2024, the aggregate transaction price related to the Company’s unsatisfied obligations was $0.3 million and was
recorded in deferred revenue, all of which was current.
Agreements
with MannKind Corporation (“MannKind”)
On
May 28, 2024, the Company executed certain agreements with MannKind and the Company’s landlord (collectively,
the “MannKind Transaction”), all of which closed during July 2024. The agreements with MannKind included a Bill of Sale and
Assignment Agreement (the “Bill of Sale”) with respect to the assignment of the Company’s rental facility at 36 Crosby
Drive, Bedford, Massachusetts (the “Bedford Facility”) to MannKind along with the transfer of all leasehold improvements,
laboratory equipment and other related personal property. In connection with the assignment of the Bedford Facility, the Company, MannKind
and Cobalt Propco 2020, LLC (the “Landlord”) entered into an Amendment to Lease and Consent to Assignment of Lease (the “Lease
Assignment Agreement”) pursuant to that certain Lease Agreement, dated as of January 7, 2022 (the “Lease Agreement”),
by and between the Company and the Landlord. Pursuant to the Lease Assignment Agreement, MannKind assumed all of the Company’s
obligations under the Lease Agreement, including all rent and other payments.
In
connection with the transactions contemplated by the Bill of Sale and Lease Assignment Agreement, the Company and MannKind entered into
an Intellectual Property Cross License Agreement (the “Cross License Agreement”). Pursuant to the Cross License Agreement,
the Company granted to MannKind (i) an exclusive license to develop, use, manufacture, market, offer and sell iSPERSE formulations of
Clofazimine, (ii) an exclusive license to develop, use, manufacture, market, offer and sell formulations of iSPERSE with one more active
pharmaceutical ingredients for the treatment of nontuberculous mycobacteria lung disease in humans, (iii) an exclusive license to develop,
use, manufacture, market, offer and sell iSPERSE formulations of insulin, (iv) a non-exclusive license to develop, use, manufacture,
market, offer and sell formulations of iSPERSE with one more active pharmaceutical ingredients for the treatment of endocrine disease
in humans, and (v) a non-exclusive license to develop, use, manufacture, market, offer and sell formulations of iSPERSE with one more
active pharmaceutical ingredients for the treatment of interstitial lung diseases (including IPF, PPF and other related lung diseases)
in humans (collectively, the “Out-License”).
Additionally,
pursuant to the Cross License Agreement, MannKind granted to the Company (i) the exclusive right to develop, use, manufacture, market,
offer and sell its single-use disposable dry powder inhaler (including all modifications or improvement thereto made by or on behalf
of the Company, the “Cricket Device”) for the inhaled delivery of dihydroergotamine in any formulation whatsoever, including
the Company’s PUR3100 treatment of acute migraine and (ii) a non-exclusive license to develop, use, manufacture, market, offer
and sell the Cricket Device for the inhaled delivery of one more active pharmaceutical ingredients formulated with iSPERSE for the treatment
of neurological disease in humans (collectively, the “In-License”).
Additionally,
pursuant to the Master Services Agreement, by and between the Company and MannKind, MannKind shall provide certain development services
to the Company, including but not limited to, activities to develop a dry powder formulation of the active pharmaceutical ingredient
that the Company provides to MannKind for oral inhalation using iSPERSE.
To
maintain continuity of iSPERSE platform knowledge, MannKind hired certain members of the Company’s research and development staff
in July 2024.
Accounting
Treatment
The
Company determined that the MannKind Transaction represents a combined agreement for accounting purposes, as the individual components
have the same overall commercial objectives and the consideration under each component is dependent on the other components.
The
consideration due to the Company in the MannKind Transaction consists solely of the non-cash consideration in the form of the In-License.
The fair value of the non-cash consideration received should be allocated to the other components of the MannKind Transaction to determine
the consideration received for the other components. The Company determined that the fair value of the In-License is immaterial given
that adequate alternative inhaler devices are already available on the market (and indeed, the Company has already established use of
another third-party inhalation device in their PUR3100 Phase 1 trial that performed well as a DHE delivery device as reported in a peer-reviewed
publication), and considering optional purchases of Cricket Devices are at market prices. Accordingly, the consideration allocated to
other components of the MannKind Transaction was immaterial.
The
Company accounted for the Lease Assignment Agreement upon execution as a lease modification that reduced the lease term to the assignment
date in July 2024. Accordingly, the Company remeasured its operating lease liability as of the modification date to reflect the decrease
in fixed lease payments, with the amount of the remeasurement, $8.4 million, adjusted by a corresponding reduction to the right-of-use
asset. Refer to Note 11, Leases, for further details.
The
Company concluded that the Out-License component of the MannKind Transaction was within the scope of ASC 606, as the monetization of
its core technology represents an output of the Company’s ordinary activities. The Company transferred control of the combined
licenses of iSPERSE to MannKind at a point in time in July 2024 upon closing of the MannKind Transaction; however, no revenue was recognized
because the consideration allocated to the Out-License component was immaterial.
The
Company determined that its operating lease right-of-use asset and property and equipment subject to the Bill of Sale represented a disposal
group that became held for sale during the second quarter of 2024 and remained classified as held for sale as of June 30, 2024, which
should be measured at the lower of its carrying value or fair value less costs to sell. Since the fair value of the disposal group was
considered immaterial, the Company recorded a full write-down of the disposal group’s carrying value as of June 30, 2024, in the
amount of $2.6 million.
Concurrent
with the closing of the MannKind Transaction, the Company terminated and MannKind hired the majority of the Company’s research
and development employees, representing approximately two-thirds of the Company’s workforce. During the quarter ended June 30,
2024, the Company agreed to provide termination benefits to these employees, which has been included in the balance of accrued expenses
and other current liabilities on the consolidated balance sheet as of June 30, 2024, and was paid to the employees in July 2024.
7.
Common Stock
In
May 2021, the Company entered into an At-The-Market Sales Agreement (the “Sales Agreement”) with H.C. Wainwright and Co.,
LLC (“HCW”) to act as the Company’s sales agent with respect to the issuance and sale of up to $20.0 million of the
Company’s shares of common stock, from time to time in an at-the-market public offering (the “ATM Offering”). Upon
filing of the Annual Report, the Company continued to be subject to General Instruction I.B.6 of Form S-3, pursuant to which in no event
will the Company sell its common stock in a registered primary offering using Form S-3 with a value exceeding more than one-third of
its public float in any 12 calendar month period so long as its public float remains below $75,000,000. Therefore, the amount that may
be able to be raised using the ATM Offering will be significantly less than $20,000,000, until such time as the Company’s public
float held by non-affiliates exceeds $75,000,000.
Sales
of common stock under the Sales Agreement are made pursuant to an effective shelf registration statement on Form S-3, which was filed
with the SEC on May 17, 2024, and subsequently declared effective on May 30, 2024 (File No. 333-279491), and a related prospectus. HCW
acts as the Company’s sales agent on a commercially reasonable efforts basis, consistent with its normal trading and sales practices
and applicable state and federal laws, rules and regulations and the rules of The Nasdaq Capital Market (“Nasdaq”). If expressly
authorized by the Company, HCW may also sell the Company’s common stock in privately negotiated transactions. There is no specific
date on which the ATM Offering will end, there are no minimum sale requirements and there are no arrangements to place any of the proceeds
of the ATM Offering in an escrow, trust or similar account. HCW is entitled to compensation at a fixed commission rate of 3.0% of the
gross proceeds from the sale of the Company’s common stock pursuant to the Sales Agreement.
During
the six months ended June 30, 2024, no shares of the Company’s common stock were sold under the Sales Agreement.
8.
Warrants
There
were no warrants issued or exercised during the six months ended June 30, 2024. During the six months ended June 30, 2024, warrants to
purchase up to 160,445 shares of common stock at a weighted average exercise price of $44.12 per share expired. Subsequent to June 30,
2024, but before the date these condensed consolidated financial statements were issued, warrants to purchase up to 66,675 shares of
common stock at a weighted average exercise price of $26.79 per share expired. The following represents a summary of the warrants outstanding
and exercisable at June 30, 2024, all of which are equity-classified:
Schedule
of Warrants Outstanding
| |
Adjusted | | |
| |
Number of Shares Underlying Warrants | |
Issue Date | |
Exercise Price | | |
Expiration Date | |
Outstanding | | |
Exercisable | |
December 17, 2021 | |
$ | 14.99 | | |
December 15, 2026 | |
| 36,538 | | |
| 36,538 | |
December 17, 2021 | |
$ | 13.99 | | |
December 17, 2026 | |
| 281,047 | | |
| 281,047 | |
February 16, 2021 | |
$ | 49.99 | | |
February 11, 2026 | |
| 65,003 | | |
| 65,003 | |
August 7, 2020 | |
$ | 35.99 | | |
July 14, 2025 | |
| 90,743 | | |
| 90,743 | |
August 7, 2020 | |
$ | 44.99 | | |
July 14, 2025 | |
| 10,939 | | |
| 10,939 | |
July 23, 2020 | |
$ | 35.99 | | |
July 14, 2025 | |
| 77,502 | | |
| 77,502 | |
July 13, 2020 | |
$ | 44.99 | | |
July 14, 2025 | |
| 21,846 | | |
| 21,846 | |
July 13, 2020 | |
$ | 35.99 | | |
July 14, 2025 | |
| 334,800 | | |
| 334,800 | |
February 12, 2019 | |
$ | 26.79 | | |
August 12, 2024 | |
| 66,675 | | |
| 66,675 | |
June 15, 2015 | |
$ | 1,509.99 | | |
Five years after milestone achievement | |
| 15,955 | | |
| - | |
Total | |
| | | |
| |
| 1,001,048 | | |
| 985,093 | |
9.
Stock-based Compensation
The
Company sponsors the Pulmatrix, Inc. Amended and Restated 2013 Employee, Director and Consultant Equity Incentive Plan (the “Incentive
Plan”). As of June 30, 2024, the Incentive Plan provided for the grant of up to 818,936 shares of the Company’s common stock,
of which 503,669 shares remained available for future grant. In addition, the Company sponsors two legacy plans under which no additional
awards may be granted. As of June 30, 2024, the two legacy plans have a total of 8 options outstanding, all of which are fully vested
and for which common stock will be issued upon exercise.
The
following table summarizes stock option activity during the six months ended June 30, 2024:
Schedule
of Stock Option Activity
| |
Number of Options | | |
Weighted- Average Exercise Price | | |
Weighted- Average Remaining Contractual Term (Years) | | |
Aggregate Intrinsic Value | |
Outstanding — January 1, 2024 | |
| 344,306 | | |
$ | 20.92 | | |
| 7.54 | | |
$ | - | |
Forfeited or expired | |
| (32,869 | ) | |
$ | 5.18 | | |
| | | |
| | |
Outstanding — June 30, 2024 | |
| 311,437 | | |
$ | 22.58 | | |
| 6.95 | | |
$ | - | |
Exercisable — June 30, 2024 | |
| 221,578 | | |
$ | 29.07 | | |
| 6.46 | | |
$ | - | |
No
stock options were granted during the six months ended June 30, 2024. The Company records stock-based compensation expense related to
stock options based on their grant-date fair value. As of June 30, 2024, there was $0.5 million of unrecognized stock-based compensation
expense related to unvested stock options granted under the Company’s stock award plans. This expense is expected to be recognized
over a weighted-average period of approximately 1.6 years.
The
following table presents total stock-based compensation expense for the three and six months ended June 30, 2024 and 2023:
Schedule
of Stock-based Compensation Expenses
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Research and development | |
$ | 29 | | |
$ | 59 | | |
$ | 145 | | |
$ | 131 | |
General and administrative | |
| 74 | | |
| 196 | | |
| 156 | | |
| 420 | |
Total stock-based compensation expense | |
$ | 103 | | |
$ | 255 | | |
$ | 301 | | |
$ | 551 | |
10.
Commitments and Contingencies
Research
and Development Activities
The
Company contracts with various other organizations to conduct research and development activities, including clinical trials. The scope
of the services under contracts for research and development activities may be modified and the contracts, subject to certain conditions,
may generally be cancelled by the Company upon written notice. In some instances, the contracts, subject to certain conditions, may be
cancelled by the third party. As of June 30, 2024, the Company had no material noncancellable commitments not expected to be reimbursed
under the Cipla Agreement.
Legal
Proceedings
In
the ordinary course of its business, the Company may be involved in various legal proceedings involving contractual and employment relationships,
patent or other intellectual property rights, and a variety of other matters. The Company is not aware of any pending legal proceedings
that would reasonably be expected to have a material impact on the Company’s financial position or results of operations.
11.
Leases
The
Company has limited leasing activities as a lessee which are primarily related to its corporate headquarters, which were relocated during
the third quarter of 2023 and again during the third quarter of 2024.
On
January 7, 2022, the Company executed the Lease Agreement with the Landlord for its corporate headquarters at 36 Crosby Drive, Bedford,
Massachusetts. The leased premises comprise approximately 20,000 square feet of office and lab space, and the lease provides for base
rent of $0.1 million per month, payment of which began in March 2024. The Company is responsible for real estate taxes, maintenance,
and other operating expenses applicable to the leased premises.
On
May 28, 2024, as part of the MannKind Transaction (see further discussion in Note 6, Significant Agreements), the Company and
the Landlord executed the Lease Assignment Agreement to assign the Lease Agreement to MannKind in July 2024. The Company accounted for
the Lease Assignment Agreement as a lease modification that reduced the lease term to the assignment date in July 2024. Accordingly,
the Company remeasured its lease liability as of the modification date to reflect the decrease in fixed lease payments, with the amount
of the remeasurement, $8.4 million, adjusted by a corresponding reduction to the right-of-use asset.
As of June 30, 2024, the
Company had $1.4 million of restricted cash held in a depository account at a financial institution to collateralize a conditional stand-by
letter of credit related to the Lease Agreement, which was presented within current assets on the consolidated balance sheet. Following the closing of the MannKind Transaction, this collateral was released in August 2024, providing additional cash available for operations.
In
June 2024, the Company entered into a short-term lease agreement for its new headquarters at 945 Concord Street, Framingham, Massachusetts.
No lease liability or right-of-use asset has been recorded for this short-term lease.
The
components of lease expense for the Company for the three and six months ended June 30, 2024 and 2023 were as follows:
Schedule
of Components of Lease Expenses
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Lease cost | |
| | | |
| | | |
| | | |
| | |
Fixed lease cost | |
$ | 271 | | |
$ | 418 | | |
$ | 678 | | |
$ | 796 | |
Variable lease cost | |
| 104 | | |
| 168 | | |
| 206 | | |
| 281 | |
Total lease cost | |
$ | 375 | | |
$ | 586 | | |
$ | 884 | | |
$ | 1,077 | |
| |
| | | |
| | | |
| | | |
| | |
Other information | |
| | | |
| | | |
| | | |
| | |
Cash paid for amounts included in the measurement of lease liabilities | |
$ | 322 | | |
$ | 432 | | |
$ | 657 | | |
$ | 863 | |
Weighted-average remaining lease term | |
| | | |
| | | |
| 7 days | | |
| 0.2 years | |
Weighted-average discount rate | |
| | | |
| | | |
| - | | |
| 8.40 | % |
Maturities
of lease liabilities due under these lease agreements as of June 30, 2024 are as follows:
Schedule of Maturities of Lease Liabilities
| |
Operating Leases | |
Maturity of lease liabilities | |
| | |
2024 (7 days) | |
$ | 24 | |
Total lease payments | |
| 24 | |
Less: interest | |
| - | |
Total lease liabilities | |
$ | 24 | |
| |
| | |
Reported as of June 30, 2024 | |
| | |
Lease liabilities — short term | |
$ | 24 | |
Lease liabilities — long term | |
| - | |
Total lease liabilities | |
$ | 24 | |
12.
Income Taxes
The
Company had no income tax expense due to operating losses incurred for the three and six months ended June 30, 2024 and 2023.
Management
of the Company evaluated the positive and negative evidence bearing upon the realizability of its deferred tax assets and determined
that it is more likely than not that the Company will not recognize the benefits of the deferred tax assets. As a result, a full valuation
allowance was recorded as of June 30, 2024 and December 31, 2023.
The
Company applies ASC 740, Income Taxes, for the financial statement recognition, measurement, presentation, and disclosure of uncertain
tax positions taken or expected to be taken in income tax returns. Unrecognized tax benefits represent tax positions for which reserves
have been established. A full valuation allowance has been provided against the Company’s deferred tax assets, so that the effect
of the unrecognized tax benefits is to reduce the gross amount of the deferred tax asset and the corresponding valuation allowance. The
Company has no material uncertain tax positions as of June 30, 2024 and December 31, 2023.
13.
Net Loss Per Share
Basic
net loss per share is calculated by dividing net loss by the weighted-average number of common shares outstanding during the period.
Diluted net loss per share is calculated by dividing the weighted-average number common shares outstanding during the period, after taking
into consideration any potentially dilutive effects from outstanding stock options or warrants.
Basic
and diluted net loss per share were the same for the three and six months ended June 30, 2024 and 2023, as the effect of potentially
dilutive securities would have been anti-dilutive.
The
following potentially dilutive securities outstanding have been excluded from the computation of diluted weighted-average shares outstanding,
because such securities had an anti-dilutive impact:
Schedule
of Computation of Anti-Dilutive Weighted-Average Shares Outstanding
| |
Three and Six Months Ended June 30, | |
| |
2024 | | |
2023 | |
Options to purchase common stock | |
| 311,437 | | |
| 393,254 | |
Warrants to purchase common stock | |
| 1,001,048 | | |
| 1,161,493 | |
Total options and warrants to purchase common stock | |
| 1,312,485 | | |
| 1,554,747 | |
14.
Subsequent Events
Departure
of Chief Executive Officer
On
July 15, 2024, the Board of Directors (the “Board”) of the Company approved a General Release and Severance Agreement (the
“Raad Severance Agreement”), by and between the Company and Teofilo Raad, dated as of July 19, 2024, and effective as of
the same date (the “Separation Date”). Effective as of the Separation Date, Mr. Raad’s employment with the Company
ceased and Mr. Raad relinquished all positions, offices, and authority with the Company and any affiliates, including as a member of
the Board and all committees thereto, and the Amended and Restated Employment Agreement by and between the Company and Mr. Raad, dated
as of June 28, 2019, was terminated.
Pursuant
to the terms of the Raad Severance Agreement, the Company will provide to Mr. Raad certain termination-related payments totaling approximately
$1.0 million, less all lawful and authorized withholdings and deductions. Any outstanding equity awards granted to Mr. Raad under the
Company’s equity compensation plans and that would have vested during the 12-month period following the Separation Date became
fully vested as of the Separation Date.
Appointment
of Interim Chief Executive Officer
On
July 15, 2024, the Board approved the appointment of Peter Ludlum as the Interim Chief Executive Officer (the “Interim
CEO”), effective as of July 20, 2024 (“Ludlum Effective Date”), pursuant to an amendment to the consulting
agreement, by and between the Company and Danforth Advisors, LLC, dated as of November 29, 2021, and
amended on April 8, 2022, and October 20, 2022.
The
Company has completed an evaluation of all other subsequent events after the balance sheet date of June 30, 2024 through the date the
condensed consolidated financial statements were issued to ensure that the condensed consolidated financial statements include appropriate
disclosure of events both recognized in the condensed consolidated financial statements as of June 30, 2024, and events which occurred
subsequently but were not recognized in the condensed consolidated financial statements. The Company has concluded that no subsequent
events have occurred that require disclosure, except as disclosed within the condensed consolidated financial statements.
Item
2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
Management’s
Discussion and Analysis of Financial Condition and Results of Operations is intended to provide a reader of our financial statements
with a narrative from the perspective of our management on our financial condition, results of operations, liquidity, and certain other
factors that may affect our future results. The information set forth below should be read in conjunction with the condensed consolidated
financial statements and the notes thereto included elsewhere in this Quarterly Report on Form 10-Q as well as the audited consolidated
financial statements and the notes thereto contained in our Annual Report on Form 10-K filed with the SEC on March 28, 2024. Unless stated
otherwise, references in this Quarterly Report on Form 10-Q to “us,” “we,” “our,” or our “Company”
and similar terms refer to Pulmatrix, Inc., a Delaware corporation and its subsidiaries.
Forward-Looking
Statements
This
Quarterly Report on Form 10-Q contains forward-looking statements. All statements other than statements of historical fact contained
herein, including statements regarding our business plans or strategies, projected or anticipated benefits or other consequences of our
plans or strategies, projected or anticipated benefits from acquisitions to be made by us, or projections involving anticipated revenues,
earnings, or other aspects of our operating results, are forward-looking statements. Words such as “anticipates,” “assumes,”
“believes,” “can,” “could,” “estimates,” “expects,” “forecasts,”
“guides,” “intends,” “is confident that,” “may,” “plans,” “seeks,”
“projects,” “targets,” and “would,” and their opposites and similar expressions, as well as statements
in future tense, are intended to identify forward-looking statements. Forward-looking statements should not be read as a guarantee of
future performance or results and may not be accurate indications of when such performance or results will actually be achieved. Forward-looking
statements are based on information we have when those statements are made or our management’s good faith belief as of that time
with respect to future events and are subject to risks and uncertainties that could cause actual performance or results to differ materially
from those expressed in or suggested by the forward-looking statements. Important factors that could cause such differences include,
but are not limited to:
|
● |
our
history of recurring losses and negative cash flows from operating activities, significant future commitments and the uncertainty
regarding the adequacy of our liquidity to pursue or complete our business objectives; |
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● |
our
inability to carry out research, development and commercialization plans; |
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● |
our
inability to manufacture our product candidates on a commercial scale on our own or in collaborations with third parties; |
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● |
our
inability to complete preclinical testing and clinical trials as anticipated; |
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● |
our
collaborators’ inability to successfully carry out their contractual duties; |
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● |
termination
of certain license agreements; |
|
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|
● |
our
ability to adequately protect and enforce rights to intellectual property, or defend against claims of infringement by others; |
|
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|
● |
difficulties
in obtaining financing on commercially reasonable terms, or at all; |
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● |
intense
competition in our industry, with competitors having substantially greater financial, technological, research and development, regulatory
and clinical, manufacturing, marketing and sales, distribution, personnel and resources than we do; |
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entry
of new competitors and products and potential technological obsolescence of our products; |
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adverse
market and economic conditions; |
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|
● |
our
ability to maintain compliance with Nasdaq’s listing standards; |
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● |
loss
of one or more key executives or scientists; and |
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● |
difficulties
in securing regulatory approval to market our product candidates. |
For
a more detailed discussion of these and other risks that may affect our business and that could cause our actual results to differ from
those projected in these forward-looking statements, see the risk factors and uncertainties described under the heading “Risk Factors”
in Part II, Item 1A of this Quarterly Report on Form 10-Q and in Part I, Item 1A of our Annual Report on Form 10-K. The forward-looking
statements contained in this Quarterly Report on Form 10-Q are expressly qualified in their entirety by this cautionary statement. We
do not undertake any obligation to update any forward-looking statement to reflect events or circumstances after the date on which any
such statement is made or to reflect the occurrence of unanticipated events, except as required by law.
“iSPERSE™”
is one of our trademarks used in this Quarterly Report on Form 10-Q. Other trademarks appearing in this report are the property of their
respective holders. Solely for convenience, these and other trademarks, trade names and service marks referred to in this report appear
without the ®, TM and SM symbols, but those references are not intended to indicate, in any way, we or the owners of such
trademarks will not assert, to the fullest extent under applicable law, their rights to these trademarks and trade names.
Overview
Business
We
are a clinical-stage biopharmaceutical company focused on the development of novel inhaled therapeutic products intended to prevent and
treat respiratory and other diseases with important unmet medical needs using our patented iSPERSE™ technology. Our
proprietary product pipeline includes treatments for central nervous system (“CNS”) disorders such as acute migraine and
serious lung diseases such as Chronic Obstructive Pulmonary Disease (“COPD”) and allergic bronchopulmonary aspergillosis
(“ABPA”). Our product candidates are based on our proprietary engineered dry powder delivery platform, iSPERSE™,
which seeks to improve therapeutic delivery to the lungs by optimizing pharmacokinetics and reducing systemic side effects to improve
patient outcomes.
We
design and develop inhaled therapeutic products based on our proprietary dry powder delivery technology, iSPERSE™, which
enables delivery of small or large molecule drugs to the lungs by inhalation for local or systemic applications. The iSPERSE™
powders are engineered to be small, dense particles with highly efficient dispersibility and delivery to airways. iSPERSE™
powders can be used with an array of dry powder inhaler technologies and can be formulated with a broad range of drug substances
including small molecules and biologics. We believe the iSPERSE™ dry powder technology offers enhanced drug loading
and delivery efficiency that outperforms traditional lactose-blend inhaled dry powder therapies.
Our
goal is to develop breakthrough therapeutic products that are safe, convenient, and more effective than the existing therapeutic products
for respiratory and other diseases where iSPERSE™ properties are advantageous.
Our
current pipeline of clinical assets is aligned to this goal as we develop iSPERSE™-based therapeutic candidates
which target the prevention and treatment of a range of diseases, including CNS disorders and pulmonary diseases. These therapeutic
candidates include PUR3100 for the treatment of acute migraine, PUR1800 for the treatment of acute exacerbations of chronic
obstructive pulmonary disease (“AECOPD”), and PUR1900 for the treatment of ABPA in patients with asthma and in patients
with cystic fibrosis (“CF”). Each program is enabled by its unique iSPERSE™ formulation designed to
achieve specific therapeutic objectives.
Contingent on securing additional funding, we
intend to capitalize on our iSPERSE™ technology platform and our expertise in inhaled therapeutics to identify new product
candidates for the prevention and treatment of diseases, including those with considerable unmet medical needs, and to build our product
pipeline beyond our existing candidates. In order to advance clinical trials for our therapeutic candidates and leverage the iSPERSE™
platform to enable delivery of partnered compounds, we intend to form strategic alliances with third parties, including pharmaceutical
and biotechnology companies or academic or private research institutes.
Contingent on securing additional funding, we
expect to continue to incur substantial expenses and operating losses for at least the next several years based on our drug development
plans and in connection with our ongoing activities, as we:
|
● |
Pursue
further clinical studies for PUR3100, an orally inhaled dihydroergotamine (“DHE”) including a Phase 2 clinical study
for the treatment of acute migraine, contingent on securing financing or partnership arrangements. We received Food and Drug Administration
(“FDA”) acceptance of our Investigational New Drug Application (“IND”) and a “study may proceed”
letter in September 2023, positioning PUR3100 as Phase 2-ready for potential financing or partnership discussions. |
|
|
We
developed PUR3100, an iSPERSE™ formulation of DHE in 2020. We completed good laboratory practice (“GLP”)
toxicology studies in 2021 and 2022. In 2022, we completed a Phase 1 study designed as a double-blinded trial to assess the safety,
tolerability, and pharmacokinetics of three dose levels of single doses of inhaled PUR3100 with intravenous (“IV”) placebo,
as compared to IV DHE (DHE mesylate injection) with inhaled placebo. |
|
|
On
January 4, 2023, we announced the Phase 1 topline results, indicating that PUR3100 was safe and tolerated with fewer gastrointestinal
side effects in all doses compared to IV DHE. PUR3100 showed a five-minute Tmax and Cmax within the targeted
therapeutic range for all three doses tested. The Phase 1 study data was presented at the American Headache Society 65th
Annual Meeting in June 2023. In May 2024, we announced a peer-reviewed publication of Phase 1 clinical results in the publication
Headache: The Journal of Head and Face Pain.
In
September 2023, we announced the FDA’s acceptance of an IND application for PUR3100 and receipt of a “study may proceed”
letter for a Phase 2 study. The IND includes a Phase 2 clinical protocol where safety and preliminary efficacy of PUR3100 will be
investigated in patients with acute migraine.
Based
on the rapid systemic exposure in the therapeutic range and the improved side effect profile relative to IV dosing, we believe the
PUR3100 formulation of DHE may differentiate from approved DHE products or those in development. If effectiveness is demonstrated,
PUR3100 may offer the convenience of being self-administered with a pharmacokinetic profile that may potentially provide rapid onset
of action. |
|
|
|
|
● |
Pursue
partnership or other alternatives to monetize or advance PUR1800, focusing on the development of an orally inhaled kinase inhibitor
for treatment of AECOPD. |
|
|
|
|
|
We
completed preclinical safety studies for PUR1800, our iSPERSE™ formulation of RV1162, in 2018 and advanced
our formulation and process development efforts to support clinical testing in stable moderate-severe COPD patients. We completed
a Phase 1b safety, tolerability, and pharmacokinetics clinical study of PUR1800 for subjects with stable moderate-severe COPD and
received topline data from the Phase 1b clinical study in the first quarter of 2022. We analyzed data from the completed Phase 1b
clinical study of PUR1800 for AECOPD and presented study results at the American Academy of Allergy, Asthma & Immunology (AAAAI)
conference in the first quarter of 2023. The results indicated PUR1800 was safe and well tolerated with no observed safety signals.
The topline data, along with the results from chronic toxicology studies, support the continued development of PUR1800 for the treatment
of AECOPD and other inflammatory respiratory diseases. |
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|
● |
Terminate
the PUR1900 Phase 2b study and seek to monetize PUR1900 in the United States. |
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|
In
agreement with our partner Cipla, we stopped patient enrollment for in the Phase 2b study of PUR1900. The decision to stop the study
was unrelated to any safety concerns. This study had been ongoing since the first quarter of 2023. We remain on track to complete
all Phase 2b wind down activities within the third quarter of 2024.
After
the study wind down, Pulmatrix will bear no further financial responsibility for the commercialization and development activities
as related to PUR1900 outside the United States and will receive 2% royalties on any potential future net sales by Cipla outside
the United States. Within the United States, we and Cipla will seek to monetize PUR1900, our inhaled iSPERSE™ formulation
of the antifungal drug itraconazole for indications where an orally inhaled antifungal may provide a therapeutic benefit or fulfill
an unmet medical need. |
|
● |
Capitalize
on our proprietary iSPERSE™ technology and our expertise in inhaled therapeutics and particle engineering to identify
new product candidates for prevention and treatment of diseases, including those with important unmet medical needs. |
|
|
|
|
|
To
add additional inhaled therapeutics to our development pipeline and facilitate additional collaborations, we are leveraging our iSPERSE™
technology and our expertise in inhaled therapeutics and particle engineering to identify potential product
candidates. |
|
|
|
|
● |
Invest
in protecting and expanding our intellectual property portfolio and file for additional patents to strengthen our intellectual property
rights. |
|
|
|
|
|
The
status of our patent portfolio changes frequently in the ordinary course of patent prosecution. As of June 30, 2024, our patent portfolio
related to iSPERSE™ included approximately 144 granted patents, 18 of which are granted US patents, with
expiration dates from 2024 to 2037, and approximately 52 additional pending patent applications in the US and other jurisdictions.
Our in-licensed portfolio related to kinase inhibitors included approximately 278 granted patents, 33 of which are granted US patents,
with expiration dates from 2029 to 2035, and approximately 19 additional pending patent applications in the US and other jurisdictions.
We have national phase applications pending in Australia, Brazil, Canada, China, Europe, Israel, India, Japan, Korea, Mexico, New
Zealand, Russia, and the United States that cover certain formulations and methods of use relevant to our PUR3100 program. |
|
● |
Seek
partnerships and license agreements to support the product development and commercialization of our product candidates. |
|
|
|
|
|
In
order to advance our clinical programs, we may seek partners or licensees in areas of pharmaceutical and clinical development. |
|
● |
Position
the Company to be able to consider strategic alternatives. |
|
|
|
|
|
Continue
our cost saving measures which have included the wind down of the Phase 2b study for PUR1900 and the assignment of our long-term
lease of our Bedford facility pursuant to those certain agreements by and between us, MannKind Corporation (“MannKind”) and Cobalt
Propco 2020, LLC (the “MannKind Transaction”) to conserve our cash resources as we consider strategic alternatives for the
Company. |
Therapeutic
Candidates
PUR3100
In
2020, we developed PUR3100, the iSPERSE™ formulation of DHE, for the treatment of acute migraine. Currently DHE is only
available as subcutaneous, intravenous infusion or intranasal delivery. If approved for commercialization, PUR3100 has the opportunity
to be the first orally inhaled DHE treatment for acute migraine and be an alternative to other acute therapies. Given the oral inhaled
route of delivery, PUR3100 is anticipated to provide relief from the rapid onset of migraine symptoms and provide a favorable tolerability
profile.
A
total of three 14-day GLP toxicology studies have been completed with PUR3100 to support single-dose clinical studies. We are planning
to conduct a chronic toxicology study to support long-term dosing. Based on discussions with the FDA, this would complete the non-clinical
requirements to support a new drug application (“NDA”).
Our
interactions with the FDA have indicated that, in addition to the planned Phase 2 and Phase 3 studies, long-term safety should be assessed
in a minimum of one hundred patients for six months of dosing and fifty patients for twelve months of dosing. The FDA also confirmed
that it will be necessary to perform a safety study administering PUR3100 to otherwise healthy patients with asthma before an NDA is
submitted.
On
September 26, 2022, we announced the completion of patient dosing in a Phase 1 clinical study, performed in Australia. The study design
was a double-dummy, double-blinded trial to assess the safety, tolerability, and pharmacokinetics of three dose levels of single doses
of inhaled PUR3100 with IV placebo, as compared to IV DHE (DHE mesylate injection) with inhaled placebo. This study may also provide
preliminary comparative bioavailability data to support the use of the 505(b)(2) pathway for marketing authorization. Twenty-six healthy
subjects were enrolled and each of the four groups contained at least six subjects.
On
January 4, 2023, we announced topline results. We presented the Phase 1 study data at the American Headache Society 65th Annual
Meeting in June 2023. The study showed that PUR3100 achieved peak exposures in the targeted therapeutic range and time to maximum concentration
occurred at five minutes after dosing at all dosing levels. The PUR3100 dose groups also showed a lower incidence of nausea and no vomiting
compared to observations of nausea and vomiting in the IV administered DHE dose group.
Based
on the rapid systemic exposure in the therapeutic range and the improved side effect profile relative to IV dosing, we believe the PUR3100
formulation of DHE may differentiate from approved DHE products or those known to be in development. If effectiveness is demonstrated,
PUR3100 may offer the convenience of being self-administered with a pharmacokinetic profile that may potentially provide rapid onset
of action.
In
September 2023, we announced that the FDA accepted the PUR3100 IND and the receipt of a “study may proceed” letter for the
clinical study: “A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Single Event Study to Evaluate the Safety,
Tolerability, and Efficacy of PUR3100 (Dihydroergotamine Mesylate Inhalation Powder) in the Acute Treatment of Migraine”. We anticipate
that this Phase 2 clinical study will initiate once financing or partnership arrangements have been made.
PUR1800
Reduced
responsiveness to corticosteroids represents an important barrier to effective treatment of COPD and AECOPD and provides a clear rationale
to seek novel medicines to treat these respiratory diseases. In addition, current treatments generally fail to treat the underlying source
of the AECOPD, in particular when a viral or bacterial infection is the cause, which occurs in approximately 80% of exacerbations. RV1162,
the active ingredient of PUR1800, is a novel, potent anti-inflammatory that inhibits the phosphorylation of a narrow spectrum of kinases.
In pre-clinical studies, RV1162 demonstrated direct anti-inflammatory activity in a model of viral induced respiratory inflammation.
RV1162 also demonstrated a reduction in corticosteroid-resistant inflammatory responses in a model of cigarette smoke induced inflammation.
These findings suggested that RV1162 has the potential to deliver effective anti-inflammatory outcomes in corticosteroid-resistant patients
while also reducing the underlying source of inflammation in an exacerbation, such as a viral and/or bacterial respiratory infection.
Clinical
studies conducted by RespiVert/Janssen with RV1162 formulated as a lactose blend for inhalation demonstrated that the molecule was well
tolerated for up to 14 days of dosing in patients with COPD. Analysis of sputum collected from patients with COPD treated with RV1162
showed reduced levels of p38 phosphorylation in sputum cells and decreases in the number of neutrophils recovered in sputum after 12
days of dosing. These findings suggest that inhalation of RV1162 may confer anti-inflammatory benefits after a short dosing regimen.
Long-term toxicology studies with RV1162 as a lactose blend suggested that this formulation was not suitable for chronic dosing.
Based
upon the clinical results generated by RespiVert/Janssen for RV1162 and the anticipated benefits of an iSPERSE™
formulation of RV1162, we entered into a License, Development and Commercialization Agreement with RespiVert Ltd. (“RespiVert”),
a wholly owned subsidiary of Janssen Biotech, Inc. on June 9, 2017. RespiVert granted us an exclusive, royalty-bearing license in a portfolio
of narrow spectrum kinase inhibitor compounds (“NSKI”). We subsequently formulated RV1162 into PUR1800 for development as
a potential therapy for AECOPD.
We
completed a Phase 1b safety, tolerability, and pharmacokinetics of PUR1800 for patients with stable moderate-severe COPD. Topline data
was delivered in the first quarter of 2022 and presented at the American Academy of Allergy, Asthma and Immunology conference in the
first quarter of 2023.
The
clinical study, performed at the Medicines Evaluation Unit in Manchester, UK, was a randomized, three-way crossover double-blind study
with 14 days of daily dosing, which included placebo and one of two doses of PUR1800, and included a 28-day follow-up period after each
treatment period. A total of 18 adults with stable COPD were enrolled. Safety and tolerability, as well as systemic pharmacokinetics
(“PK”) were evaluated.
PUR1800
was well tolerated and there were no observed safety signals. The PK data indicate that PUR1800 results in low and consistent systemic
exposure when administered via oral inhalation. The topline data, along with the results from chronic toxicology studies, support the
continued development of PUR1800 for the treatment of AECOPD and other inflammatory respiratory diseases. These data will inform the
design of a potential Phase 2 study in the treatment of AECOPD.
PUR1900
PUR1900
is our iSPERSE™ inhaled formulation of itraconazole, an antifungal drug commercially available as an oral drug. We developed
PUR1900 for the prevention and treatment of fungal infections and allergic/hypersensitivity reactions to fungus in patients with severe
lung disease, including those with asthma and CF.
On
April 15, 2019, we entered into the Cipla Agreement with Cipla for the co-development and commercialization, on a worldwide, except for
the Cipla Territory defined below, exclusive basis, of PUR1900, our inhaled iSPERSE™ enabled formulation of the
antifungal drug itraconazole, which is only available as an oral drug, for the treatment of all pulmonary indications, including ABPA
in patients with asthma. We entered into the Second Amendment to the Cipla Agreement on November 8, 2021 and the Third Amendment on January
6, 2024. All references to the Cipla Agreement herein refer to the Cipla Agreement, as amended. The Cipla Agreement will remain in effect
in perpetuity, unless otherwise earlier terminated in accordance with its terms.
Pursuant
to the Third Amendment, all development and commercialization activities with respect to the Product in all markets other than the United
States (the “Cipla Territory”) will be conducted exclusively by Cipla at Cipla’s sole cost and expense, and Cipla shall
be entitled to all profits from the sale of the Product in the Cipla Territory, except that we will receive 2% royalties on any potential
future net sales by Cipla outside the United States.
Pursuant
to the Third Amendment, we and Cipla stopped patient enrollment for the ongoing Phase 2b clinical study. During the Wind Down Period,
we will complete all Phase 2b activities, assign or license all patents to Cipla and their registration with the appropriate authorities
in the Cipla Territory, complete a physical and demonstrable technology transfer and secure all data from the Phase 2b study for inclusion
in the safety database for the Cipla Territory.
For
the duration of the Wind Down Period, we and Cipla are each responsible for 60% and 40%, respectively, of our Direct Costs. We will share
all other development costs with Cipla that are not Direct Costs, such as the cost of clinical research organizations, manufacturing
costs and other third-party costs, on a 50/50 basis. Reimbursements from Cipla to us for these costs are subject to a maximum reimbursement
amount as approved by the joint steering committee.
We
remain on track to complete all Phase 2b wind down activities within the third quarter of 2024. After the conclusion of the Wind Down
Period, Pulmatrix will bear no further financial responsibility for the commercialization and development with respect to the Product
in the Cipla Territory, with such commercialization and development expenses of the Product in the Cipla Territory to be borne at Cipla’s
sole cost and expense after January 6, 2024. We will receive 2% royalties on any potential future net sales by Cipla outside the United
States.
Financial
Overview
Revenues
To
date, we have not generated any product sales. The revenues for the three and six months ended June 30, 2024 and 2023 were primarily
generated from the Cipla Agreement as related to our PUR1900 program, which is currently in the process of winding down as previously
discussed.
For
more discussion on the Cipla Agreement, please see Note 6, Significant Agreements, to our condensed consolidated financial statements
included in this Quarterly Report on Form 10-Q.
Research
and Development Expenses
Research
and development expenses consist primarily of costs incurred for the research and development of our preclinical and clinical candidates,
and include:
|
● |
employee-related
expenses, including salaries, benefits and stock-based compensation expense; |
|
|
|
|
● |
expenses
incurred under agreements with contract research organizations (“CROs”) or contract manufacturing organizations (“CMOs”),
and consultants that conduct our clinical trials and preclinical activities; |
|
|
|
|
● |
the
cost of acquiring, developing and manufacturing clinical trial materials and lab supplies; |
|
● |
facility,
depreciation and other expenses, which include direct and allocated expenses for rent, maintenance of our facility, insurance and
other supplies; |
|
● |
costs
associated with preclinical activities and clinical regulatory operations; and |
|
|
|
|
● |
consulting
and professional fees associated with research and development activities |
We
expense research and development costs to operations as incurred. We recognize costs for certain development activities, such as clinical
trials, based on an evaluation of the progress to completion of specific tasks using data such as patient enrollment, clinical site activations
or information provided to us by our vendors.
Research
and development activities are central to our business model. We have utilized a combination of internal and external efforts to
advance product development from early-stage work to clinical trial manufacturing and clinical trial support. External efforts have
included work with consultants and substantial work at CROs and CMOs. We have historically supported an internal research and
development team and facility for our pipeline and other potential development programs, however following the closing of the
MannKind Transaction in the third quarter of 2024, in which the majority of our research and development employees were terminated
and our facility lease was assigned to MannKind, we expect to utilize external resources for further development. To continue
development of existing programs or opportunities identified for iSPERSE™ in any new indications, we will
need to secure additional funding and anticipate additional development costs would be incurred. Because of the numerous risks and
uncertainties associated with product development, however, we cannot determine with certainty the duration and completion costs of
these or other current or future preclinical studies and clinical trials. The duration, costs and timing of our future clinical
trials and development of our product candidates will depend on a variety of factors, including the selected development path and
uncertainties associated with clinical and preclinical studies, clinical trial enrollment rates and changing government
regulation. In addition, the probability of success for each product candidate will depend on numerous factors, including
competition, manufacturing capability and commercial viability.
General
and Administrative Expenses
General
and administrative expenses consist principally of salaries, benefits and related costs such as stock-based compensation for personnel
and consultants in executive, finance, business development, corporate communications and human resource functions, facility costs not
otherwise included in research and development expenses, patent filing fees and legal fees. Other general and administrative expenses
include travel expenses, expenses related to being a publicly traded company and professional fees for consulting, auditing and tax services.
Following
the closing of the MannKind Transaction in the third quarter of 2024, we anticipate that our general and administrative expenses will
decrease in the future as they relate to audit, legal, regulatory, and tax-related services associated with maintaining compliance with
exchange listing and SEC requirements, director and officer liability insurance, investor relations costs and other costs associated
with being a public company. Additionally, if and when we believe a regulatory approval of a product candidate appears likely, we anticipate
an increase in staffing and related expenses as a result of our preparation for commercial operations, especially as it relates to the
sales and marketing of our product candidates.
Critical
Accounting Estimates
This
management’s discussion and analysis of our financial condition and results of operations is based on our condensed consolidated
financial statements, which have been prepared in accordance with U.S. GAAP. The preparation of these condensed consolidated financial
statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses
and the disclosure of contingent assets and liabilities in our condensed consolidated financial statements. We base our estimates on
historical experience, known trends and events, and other assumptions that we believe are reasonable under the circumstances, and we
evaluate these estimates on an ongoing basis. Actual results may differ from these estimates under different assumptions or conditions.
There
were no changes to our critical accounting estimates during the six months ended June 30, 2024 as compared to those described in Management’s
Discussion and Analysis of Financial Condition and Results of Operations included in our Annual Report. It is important that the discussion of our operating results that follow
be read in conjunction with the critical accounting estimates disclosed in our Annual Report.
Results
of Operations
Comparison
of the Three Months Ended June 30, 2024 and 2023
The
following table sets forth our results of operations for each of the periods set forth below (in thousands):
| |
Three Months Ended June 30, | | |
| |
| |
2024 | | |
2023 | | |
Change | |
Revenues | |
$ | 1,552 | | |
| 1,844 | | |
$ | (292 | ) |
| |
| | | |
| | | |
| | |
Operating expenses: | |
| | | |
| | | |
| | |
Research and development | |
| 2,834 | | |
| 4,165 | | |
| (1,331 | ) |
General and administrative | |
| 2,001 | | |
| 1,670 | | |
| 331 | |
Loss on disposal group held for sale | |
| 2,618 | | |
| - | | |
| 2,618 | |
Total operating expenses | |
| 7,453 | | |
| 5,835 | | |
| 1,618 | |
Loss from operations | |
| (5,901 | ) | |
| (3,991 | ) | |
| (1,910 | ) |
Other income (expense): | |
| | | |
| | | |
| | |
Interest income | |
| 133 | | |
| 236 | | |
| (103 | ) |
Other expense, net | |
| (43 | ) | |
| (61 | ) | |
| 18 | |
Net loss | |
$ | (5,811 | ) | |
| (3,816 | ) | |
$ | (1,995 | ) |
Revenues
— Revenues were $1.6 million for the three months ended June 30, 2024, as compared to $1.8 million for the three months
ended June 30, 2023, a decrease of $0.3 million. The decrease is primarily related to the continued winding down of the PUR1900 Phase
2b clinical trial, for which the Company incurred fewer expenses eligible for reimbursement under the Cipla Agreement as compared to
the corresponding period in the previous year.
Research
and development expenses — Research and development expenses were $2.8 million for the three months ended June 30, 2024,
as compared to $4.2 million for the three months ended June 30, 2023, a decrease of approximately $1.3 million. The decrease was primarily
due to winding down the PUR1900 Phase 2b clinical trial.
General
and administrative expenses — General and administrative expenses were $2.0 million for the three months ended June 30,
2024, as compared to $1.7 million for the three months ended June 30, 2023, an increase of approximately $0.3 million. The increase was
primarily due to an increase in incurred legal costs.
Loss
on disposal group held for sale — Loss on disposal group held for sale was $2.6 million on certain assets held for sale
as of June 30, 2024, in connection with the MannKind Transaction, as compared to no loss on disposal group held for sale for the three months ended June 30, 2023.
Comparison
of the Six Months Ended June 30, 2024 and 2023
The
following table sets forth our results of operations for each of the periods set forth below (in thousands):
| |
Six Months Ended June 30, | | |
| |
| |
2024 | | |
2023 | | |
Change | |
Revenues | |
$ | 7,437 | | |
| 3,343 | | |
$ | 4,094 | |
| |
| | | |
| | | |
| | |
Operating expenses: | |
| | | |
| | | |
| | |
Research and development | |
| 6,346 | | |
| 8,039 | | |
| (1,693 | ) |
General and administrative | |
| 3,627 | | |
| 3,880 | | |
| (253 | ) |
Loss on disposal group held for sale | |
| 2,618 | | |
| - | | |
| 2,618 | |
Total operating expenses | |
| 12,591 | | |
| 11,919 | | |
| 672 | |
Loss from operations | |
| (5,154 | ) | |
| (8,576 | ) | |
| 3,422 | |
Other income (expense): | |
| | | |
| | | |
| | |
Interest income | |
| 293 | | |
| 458 | | |
| (165 | ) |
Other expense, net | |
| (125 | ) | |
| (146 | ) | |
| 21 | |
Net loss | |
$ | (4,986 | ) | |
| (8,264 | ) | |
$ | 3,278 | |
Revenues
— Revenues were $7.4 million for the six months ended June 30, 2024, as compared to $3.3 million for the six months ended
June 30, 2023, an increase of $4.1 million. The increase is primarily related to a contract modification of the Cipla Agreement which
resulted in a cumulative catch-up adjustment recorded during the three months ended March 31, 2024. The amount of the cumulative catch-up
had been included in deferred revenue at the beginning of the period.
Research
and development expenses — Research and development expenses were $6.3 million for the six months ended June 30, 2024,
as compared to $8.0 million for the six months ended June 30, 2023, a decrease of approximately $1.7 million. The decrease was primarily
due to winding down the PUR1900 Phase 2b clinical trial.
General
and administrative expenses — General and administrative expenses were $3.6 million for the six months ended June 30, 2024,
as compared to $3.9 million for the six months ended June 30, 2023, a decrease of approximately $0.3 million. The decrease was primarily
due to decreased employment and facilities costs, partially offset by an increase in incurred legal costs.
Loss
on disposal group held for sale — Loss on disposal group held for sale was $2.6 million on certain assets held for sale
as of June 30, 2024, in connection with the MannKind Transaction, as compared with no loss on disposal group held for sale for the six months ended June 30, 2023.
Liquidity
and Capital Resources
Through
June 30, 2024, we incurred an accumulated deficit of $292.6 million, primarily as a result of expenses incurred through a combination
of research and development activities related to our various product candidates and general and administrative expenses supporting those
activities. We have financed our operations since inception primarily through the sale of preferred and common stock, the issuance of
convertible promissory notes, term loans, and collaboration and license agreements. Our total cash and cash equivalents balance as of
June 30, 2024 was $12.4 million, and additionally $1.4 million in short-term restricted cash became available for operations
in August 2024.
We
anticipate that we will continue to incur losses over the next several years due to development costs associated with our iSPERSE™
pipeline programs, contingent on obtaining financing or partnership to continue such development. We may raise capital through
a combination of equity offerings, debt financings, other third-party funding and other collaborations and strategic alliances. We are
currently exploring financing or partnership arrangements to develop and initiate a potential Phase 2 clinical study for PUR3100.
We
expect that our existing cash and cash equivalents as of June
30, 2024 will enable us to fund our corporate operating expenses for at least the next 12 months
following the date of this Quarterly Report on Form 10-Q. We have based our projections of
operating capital requirements on assumptions that may prove to be incorrect, and we may use all of our available capital resources sooner
than we expect. Because of the numerous risks and uncertainties associated with research, development, achievement of contingent milestones
and commercialization of pharmaceutical products, we are unable to estimate the exact amount of our operating capital requirements.
We
have no material off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on our financial
condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources
that is material to investors.
The
following table sets forth the major sources and uses of cash for each of the periods set forth below (in thousands):
| |
Six Months Ended June 30, | |
| |
2024 | | |
2023 | |
Net cash used in operating activities | |
$ | (6,396 | ) | |
$ | (9,832 | ) |
Net cash used in investing activities | |
| (398 | ) | |
| (58 | ) |
Net cash provided by financing activities | |
| - | | |
| 53 | |
Net decrease in cash, cash equivalents, and restricted cash | |
$ | (6,794 | ) | |
$ | (9,837 | ) |
Net
cash used in operating activities
Net
cash used in operating activities for the six months ended June 30, 2024 was $6.4 million, which was primarily the result of $5.0 million
of net loss and $4.8 million in cash outflows associated with changes in operating assets and liabilities, partially offset by $3.4 million
of net non-cash adjustments.
Net
cash used in operating activities for the six months ended June 30, 2023 was $9.8 million, which was primarily the result of a net loss
of $8.3 million and $3.0 million in cash outflows associated with changes in operating assets and liabilities, partially offset by $1.4
million of net non-cash adjustments.
Net
cash used in investing activities
Net
cash used in investing activities for the six months ended June 30, 2024 and 2023 was $0.4 million and $0.1 million, respectively,
which was due to purchases of property and equipment.
Net
cash provided by financing activities
No
cash was provided by financing activities for the six months ended June 30, 2024. Net cash provided by financing activities for the six
months ended June 30, 2023 resulted from proceeds from the issuance of common stock, net of issuance costs.
Financings
In
May 2021, we entered into the Sales Agreement with HCW to act as our sales agent with respect to the issuance and sale of up to $20,000,000
of our shares of common stock, from time to time in an ATM Offering. Upon filing of the Annual Report, we continued to be subject to
General Instruction I.B.6 of Form S-3, pursuant to which in no event will we sell our common stock in a registered primary offering using
Form S-3 with a value exceeding more than one-third of our public float in any 12 calendar month period so long as our public float remains
below $75,000,000. Therefore, the amount we may be able to raise using the ATM Offering will be significantly less than $20,000,000,
until such time as our public float held by non-affiliates exceeds $75,000,000.
Sales
of common stock under the Sales Agreement are made pursuant to an effective shelf registration statement on Form S-3, which was filed
with the SEC on May 17, 2024, and subsequently declared effective on May 30, 2024 (File No. 333-279491), and a related prospectus. HCW
acts as our sales agent on a commercially reasonable efforts basis, consistent with its normal trading and sales practices and applicable
state and federal laws, rules and regulations and the rules of Nasdaq. If expressly authorized by us, HCW may also sell our common stock
in privately negotiated transactions. There is no specific date on which the ATM Offering will end, there are no minimum sale requirements
and there are no arrangements to place any of the proceeds of the ATM Offering in an escrow, trust or similar account. HCW is entitled
to compensation at a fixed commission rate of 3.0% of the gross proceeds from the sale of our common stock pursuant to the Sales Agreement.
During
the six months ended June 30, 2024, no shares of our common stock were sold under the Sales Agreement.
Known
Trends, Events and Uncertainties
In
May 2023, the World Health Organization determined that COVID-19 no longer fit the definition of a public health emergency and the U.S.
government announced its plan to let the declaration of a public health emergency associated with COVID-19 expire on May 11, 2023. In
addition, the ongoing conflict between Russia and Ukraine and the ongoing conflict between Israel and Hamas, including related sanctions
and countermeasures, are difficult to predict, and could adversely impact geopolitical and macroeconomic conditions, the global economy,
and contribute to increased market volatility, which may in turn adversely affect our business and operations. We may not be able
to raise sufficient additional capital and may tailor our drug candidate development program based on the amount of funding we are able
to raise in the future. Nevertheless, there is no assurance that these initiatives will be successful.
Other
than as discussed above and elsewhere in this report, we are not aware of any trends, events or uncertainties that are likely to have
a material effect on our financial condition.
Item
3. Quantitative and Qualitative Disclosures About Market Risk.
Not
applicable.
Item
4. Controls and Procedures.
Disclosure
Controls and Procedures
Our
Principal Executive Officer and Principal Financial Officer, after evaluating the effectiveness of our disclosure controls and procedures
(as defined in Rules 13a-15(e) and 15d-15(e) promulgated under the Securities Exchange Act of 1934, as amended (the “Exchange Act”))
as of the end of the period covered by this Quarterly Report on Form 10-Q, have concluded that, based on such evaluation, our disclosure
controls and procedures were effective to ensure that information required to be disclosed by us in the reports that we file or submit
under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and
forms, and is accumulated and communicated to our management, including our Principal Executive Officer and Principal Financial Officer
as appropriate to allow timely decisions regarding required disclosure.
In
designing and evaluating our disclosure controls and procedures, our management recognizes that any controls and procedures, no matter
how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and our management
necessarily is required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures.
Changes
in Internal Controls over Financial Reporting
There
were no changes in our internal control over financial reporting that occurred during the quarter ended June 30, 2024 that have materially
affected, or are reasonably likely to materially affect, our internal control over financial reporting.
PART
II—OTHER INFORMATION
Item
1. Legal Proceedings.
From
time to time, we may be involved in litigation that arises through the normal course of business. As of the date of this filing, we are
not aware of any material legal proceedings to which we or any of our subsidiaries is a party or to which any of our property is subject,
nor are we aware of any such threatened or pending litigation or any such proceedings known to be contemplated by governmental authorities.
We
are not aware of any material proceedings in which any of our directors, officers, or affiliates or any registered or beneficial stockholder
of more than 5% of our common stock, or any associate of any of the foregoing, is a party adverse to or has a material interest adverse
to, us or any of our subsidiaries.
Item
1A. Risk Factors.
Investing
in our common stock involves a high degree of risk. You should carefully consider the risks and uncertainties described in Part I, Item
1A under the heading “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2023, in addition to
the other information included in this Quarterly Report on Form 10-Q before making an investment decision regarding our common stock.
If any of these risks actually occur, our business, financial condition, or operating results would likely suffer, possibly materially,
the trading price of our common stock could decline, and you could lose part or all of your investment.
Item
2. Unregistered Sales of Equity Securities and Use of Proceeds.
|
(a) |
Unregistered
Sales of Equity Securities |
None.
|
(b) |
Issuer
Purchases of Equity Securities. |
None.
Item
3. Defaults Upon Senior Securities.
None.
Item
4. Mine Safety Disclosures.
Not
applicable.
Item
5. Other Information.
None.
Item
6. Exhibits.
See
“Index to Exhibits” following the signature page to this Form 10-Q for a list of exhibits filed or furnished with this Quarterly
Report on Form 10-Q.
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned, thereunto duly authorized.
|
PULMATRIX,
INC. |
|
|
|
Date:
August 13, 2024 |
By: |
/s/
Peter Ludlum |
|
|
Peter
Ludlum |
|
|
Interim
Chief Executive Officer and Interim Chief Financial Officer |
|
|
(Principal
Executive, Financial and Accounting Officer) |
INDEX
TO EXHIBITS
Exhibit
Number |
|
Exhibit
Description |
|
|
|
10.1# |
|
General Release and Severance Agreement, dated as of July 19, 2024, by and between Pulmatrix, Inc. and Teofilo Raad (incorporated by reference to Exhibit 10.1 of Pulmatrix, Inc.’s Current Report on Form 8-K, filed with the SEC on June 19, 2024). |
|
|
|
10.2# |
|
Amendment No. 3 to Consulting Agreement, dated as of July 15, 2024, by and between Pulmatrix, Inc. and Danforth Advisors, LLC (incorporated by reference to Exhibit 10.2 of Pulmatrix, Inc.’s Current Report on Form 8-K, filed with the SEC on June 19, 2024). |
|
|
|
10.3# |
|
Letter Agreement, dated as of July 15, 2024, by and between Pulmatrix, Inc. and Peter Ludlum (incorporated by reference to Exhibit 10.3 of Pulmatrix, Inc.’s Current Report on Form 8-K, filed with the SEC on June 19, 2024). |
|
|
|
10.4* |
|
Bill of Sale and Assignment Agreement, dated as of May 28, 2024, by and between Pulmatrix, Inc. and MannKind Corporation. |
|
|
|
10.5* |
|
Intellectual Property Cross License Agreement, dated as of May 28, 2024, by and between Pulmatrix, Inc. and MannKind Corporation. |
|
|
|
10.6* |
|
Master Services Agreement, dated as of May 28, 2024, by and between Pulmatrix, Inc. and MannKind Corporation. |
|
|
|
31.1* |
|
Certification of the Principal Executive Officer and Principal Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 |
|
|
|
32.1** |
|
Certification of Principal Executive Officer and Principal Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
|
|
|
101.
INS* |
|
Inline
XBRL Instance Document |
|
|
|
101.SCH* |
|
Inline
XBRL Taxonomy Extension Schema Document |
|
|
|
101.CAL* |
|
Inline
XBRL Taxonomy Extension Calculation Linkbase Document |
|
|
|
101.DEF* |
|
Inline
XBRL Taxonomy Extension Definition Linkbase Document |
|
|
|
101.LAB* |
|
Inline
XBRL Taxonomy Extension Labels Linkbase Document |
|
|
|
101.PRE* |
|
Inline
XBRL Taxonomy Extension Presentation Linkbase Document |
|
|
|
104* |
|
Cover
Page Interactive Data File (formatted as inline XBRL and contained in Exhibit 101) |
|
|
|
* |
|
Filed
herewith. |
** |
|
Furnished
herewith. |
# |
|
These
exhibits are management contracts or compensatory plans or arrangements. |
Exhibit
10.4
BILL
OF SALE AND ASSIGNMENT AGREEMENT
THIS
BILL OF SALE AND ASSIGNMENT AGREEMENT (this “Agreement”), dated May 28, 2024 is entered into by and among Pulmatrix,
Inc., a Delaware corporation (the “Seller”), and MannKind Corporation, a Delaware corporation (“Purchaser”).
Seller and Purchaser are sometimes referred to collectively herein as the “Parties” and each individually a
“Party.”
RECITALS:
WHEREAS,
Seller has agreed to sell and Purchaser has agreed to purchase from Seller, Seller’s Premises (as defined below) and the Lab Assets
(as defined below);
WHEREAS,
Seller has agreed to assign, and Purchaser has agreed to assume from Seller, the Lab Contracts (as defined below) on the terms and conditions
of this Agreement;
WHEREAS,
in connection with the sale of the Lab Assets and the Assignment of the Lab Contracts, Seller and Purchaser have agreed to execute and
deliver this Agreement; and
WHEREAS,
simultaneously with the entry of this Agreement, the Parties have entered into that certain Intellectual Property Cross-License Agreement;
(ii) Amendment to Lease and Consent to Assignment of Lease relating to that certain Lease Agreement dated as of January 7, 2022 (the
“Lease”) pursuant to which Seller leases certain premises consisting of approximately 19,603 rentable square
feet (the “Premises”) on the first floor of the building located at 36 Crosby Drive, Bedford, Massachusetts
; (iii) Assignment and Assumption of Lease; and (iv) the Master Service Agreement, each of which will become effective as of the closing
of this transaction on July 8, 2024 (the “Effective Date”).
NOW,
THEREFORE, for good and valuable consideration, the receipt, adequacy and legal sufficiency of which are expressly confessed and acknowledged,
and intending to be legally bound hereby, the Parties agree as follows:
AGREEMENTS:
1. Sale
of Lab Assets and Assignment of Lab Contracts. Effective upon the Effective Date, for and in consideration of the Parties
simultaneously entering into that certain: (i) Intellectual Property Cross-License Agreement; (ii) Amendment to Lease and Consent to
Assignment of Lease; (iii) Assignment and Assumption of Lease; and (iv) the Master Service Agreement, and other good and valuable
consideration, the receipt and sufficiency of which is hereby acknowledged, Seller hereby: (A) grants, bargains, sells, transfers,
and conveys to Purchaser, and Purchaser hereby purchases, acquires and accepts from Seller, on an “AS IS, WHERE IS”
basis and without any representation or warranty on the part of Seller of any kind, including without limitation, as to fitness,
merchantability or otherwise, all right, title and interest of Seller as of the Effective Date in and to the assets as set forth on Exhibit
A, including all manufacturer’s warranties, rights, or claims against third parties relating to such assets (collectively,
the “Lab Assets”), free and clear of all liens or encumbrances of any kind, including security interests
and (B) sell, convey, transfer and assign to Purchaser all of the contracts as set forth on Exhibit B (the “Lab
Contracts”), free and clear of all liens and encumbrances of any kind, including security interests effective as of
the Effective Date. Prior to the Effective Date, Seller shall provide to Purchaser a UCC-3 termination statement and other evidence
of the release of all security interests, liens or other encumbrances on the Lease, Lab Assets or Lab Contracts.
2.
Assumption of Liabilities. Effective as of the Effective Date (a) Purchaser hereby accepts the assignment of the Lab Contracts and
assumes and agrees to perform all of Seller’s obligations under the Lab Contracts arising from and after the Effective Date provided
that, to the extent a request for payment covers provision of services or supply of goods during a period starting prior to the
Effective Date and ending on or after the Effective Date, (i) in the case of provision of services, such Liabilities shall be
allocated between Purchaser and Seller on a pro rata basis based on the number of days when the service was performed before or
after the Effective Date or (ii) in the case of supply of goods, such Liabilities shall be allocated to the party receiving the
goods; provided further, that such Liabilities shall exclude any (x) Liabilities resulting from any breach of or non-compliance with
any such Lab Contract by Seller or any of its Affiliates or (y) Seller tax Liabilities (the “Assumed
Liabilities”). If the vendor under the Lab Contract does not pro rate the amounts payable under the Lab Contract
between the parties, the party who pays the invoice shall invoice the other party for its pro rata share of such invoice, which will
be payable within 30 days. For purposes of this Agreement, “Liability” or
“Liabilities” means, with respect to any Person, any debt, liability or obligation of any kind (whether
known or unknown, direct or indirect, contingent, accrued, due or to become due, secured or unsecured, matured or otherwise),
including accounts payable, trade payables, royalties payable, accrued bonuses and commissions, accrued vacation and any other form
of leave, termination payment obligations, employee expense obligations.
3. Nonassignable
Assets. Nothing in this Agreement nor the consummation of the transactions contemplated hereby shall be construed as an attempt
or agreement to assign or transfer any Lab Contracts to Purchaser (i) which by its terms or by requirement of law is not assignable
or transferable without a consent or is cancellable by a third party in the event of an assignment or transfer and (ii) for which
such consent has not been obtained or such requirement of law has not been satisfied as of the Effective Date, unless and until such
consent shall have been obtained or such requirement of law satisfied (as applicable) (such Lab Contracts, the
“Nonassignable Contract”). Both parties shall as promptly as practicable use their respective reasonable
best efforts to obtain any consent that may be required and satisfy any requirement of law necessary to the assignment or transfer
of a Nonassignable Contract to Purchaser; provided that neither Purchaser nor Seller shall be obligated to make any payments
to any such third parties in order to obtain any such consent. Until a consent to assignment of a Nonassignable Contract is
obtained, Seller shall use reasonable best efforts to provide Purchaser the use of or economic benefits of the Nonassignable
Contract.
4.
Excluded Liabilities. The Parties acknowledge and agree that Purchaser will not, and in no event will Purchaser assume, be required
to pay, perform, or discharge any Liabilities other than the Assumed Liabilities, and that, as between the Parties, Seller shall
remain responsible for all Excluded Liabilities. For purposes of this Agreement, “Excluded Liabilities”
means all Liabilities of Seller and its Affiliates not expressly included in the definition of Assumed Liabilities,
including:
(a)
any Liabilities arising from Seller’s ownership or use of the Lab Assets or Lab or the conduct of its business at or prior to
Effective Date;
(b)
any Liabilities arising out of Seller’s business, including any assets other than the Lab Assets or Lab Contracts or
Seller’s ongoing operations, including those arising after the Effective Date;
(c)
all federal, state, municipal, local, foreign and other taxes of Seller or its Affiliates, or for which the Seller or any of its
Affiliates is or are liable (including as a transferee or successor, pursuant to Treasury Regulations Section 1.1502-6, by contract
or otherwise), for any taxable period (including any Tax of Seller or any of its Affiliates that becomes a Liability of Purchaser
under transferee or successor liability or otherwise by operation of contract or law);
(d)
all Liabilities incurred under any Lab Contract (i) whereby provision of services or supply of goods arose on or prior to Effective
Date or (ii) resulting from any breach of or non-compliance with any such Lab Contract by Seller or any of its Affiliates at or
prior to Effective Date;
(e)
all Liabilities arising from Seller’s lease occupancy of the Premises at or prior to the Effective Date or arising under the
Lease on or prior to the Effective Date;
(f)
all accounts payable or other trade payables due or owed by Seller or any of its Affiliates to any third party;
(g)
any Liabilities relating to or in any way arising out of any present and past employees, officers, directors, temporary employees,
independent contractors or consultants of Seller or its Affiliates or who have provided services to Seller or its Affiliates and/or
the employment or service (and any termination thereof) of any such person, including any Liability relating to: (i) payroll or any
accrued wages, salaries or fees; (ii) any employee benefit plan and any contract or insurance policy or other funding medium with
respect thereto; (iii) workers’ compensation for injuries and (iv) any obligations or Liability arising from Seller or its
Affiliates’ failure to comply with applicable law;
(h)
any Liabilities related to the provision of notice or payment in lieu of notice and any applicable penalties under the WARN Act and
any comparable state or local Law for which the initial provision of notice occurs on or prior to the Effective Date, including any
required due to the sale of the Premises;
(i)
all Liabilities relating to, resulting from, or arising out of or in connection with a failure to comply with any applicable bulk
sale or bulk transfer laws with respect to the sale and purchase of the Lab Assets and Lab Contracts pursuant to this Agreement;
and
(j)
any Liabilities arising from Seller or its Affiliates’ non-compliance with applicable law.
5.
Indemnification. Seller shall indemnify and hold harmless Purchaser, Purchaser’s affiliates, and their respective officers, directors,
managers, employees, agents, successors, and permitted assigns (collectively, the “Purchaser Indemnified Parties”)
against and in respect of any Losses suffered or incurred by any Purchaser Indemnified Party resulting from or arising out of any Excluded
Liabilities. “Losses” means any actual debts, demands, damages, losses, expenses, costs, settlement payments,
judgments, fines or penalties, including reasonable attorneys’ fees and taxes.
6.
Payment of Transfer Taxes and Fees. Effective upon the Effective Date, Purchaser hereby assumes and agrees to be responsible for:
(i) the preparation, completion and filing of any and all documents related to the transfer of the Lab Assets from Seller to
Purchaser and (ii) performance or discharge, when payment or performance is due or required, of all transfer, documentary, sales,
use, stamp, registration and other such taxes and fees incurred in connection with the transfer of the Lab Assets from Seller to
Purchaser. Title to all Lab Assets is conveyed by delivery of the Lab Assets at the Premises.
7. General
Provisions.
(a)
Governing Law. This Agreement shall be governed by and construed and enforced in accordance with the Laws of the State of Delaware
without regard to the conflicts of laws provisions thereof.
(b)
Waiver of Trial by Jury. EACH OF THE PARTIES HEREBY IRREVOCABLY WAIVES, TO THE FULLEST EXTENT PERMITTED BY LAW, ANY AND ALL RIGHT TO
TRIAL BY JURY IN ANY LEGAL ACTION OR PROCEEDING ARISING OUT OF OR RELATING TO THIS AGREEMENT OR ANY OF THE TRANSACTIONS CONTEMPLATED
HEREBY.
(c)
Further Assurances. From time to time following the Effective Date, Seller and Purchaser shall, and shall cause their respective
affiliates to, execute, acknowledge and deliver all such further conveyances, notices, licensure and permit filings, assumptions,
releases and acquaintances and such other instruments, and shall take such further actions, as may be reasonably necessary or
appropriate to assure fully to Purchaser and its successors or assigns, all of the properties, rights, titles, interests, estates,
remedies, powers and privileges intended to be conveyed to Purchaser under this Agreement, and to otherwise make effective the
transactions contemplated hereby and thereby.
(d)
Amendments. No amendment of any provision of this Agreement shall be valid unless the same shall be in writing and duly executed by
Purchaser and Seller.
(e) Non-Waiver.
No waiver by any Party of any default, misrepresentation, or breach of warranty or covenant hereunder, whether intentional or not,
shall be deemed to extend to any prior or subsequent default, misrepresentation, or breach of warranty or covenant hereunder or
affect in any way any rights arising by virtue of any prior or subsequent such occurrence.
(f) Severability.
Any term or provision of this Agreement that is invalid or unenforceable in any situation in any jurisdiction shall not affect the
validity or enforceability of the remaining terms and provisions hereof or the validity or enforceability of the offending term or
provision in any other situation or in any other jurisdiction.
(g)
Successors and Assigns. This Agreement shall be binding upon and inure to the benefit of the Parties named herein and their
respective successors and permitted assigns. Seller may not assign this Agreement or any of their rights, interests or obligations
hereunder without the prior written consent of the Purchaser.
(h) Rights
of Third Parties. This Agreement shall not confer any rights or remedies upon any Person other than the Parties and their
respective successors and permitted assigns.
(i) Entire
Agreement. This Agreement (together with the Exhibits hereto) between Seller and Purchaser, supersede all prior discussions and
agreements between the Parties with respect to the subject matter hereof and thereof, and contain the sole and entire agreement
between the Parties with respect to the subject matter hereof and thereof, and there are no agreements, understandings,
representations or warranties between the Parties other than those set forth herein or therein. No oral statements or prior written
material not specifically incorporated in this Agreement shall be of any force and effect. The Parties represent and acknowledge
that in executing this Agreement, the Parties did not rely, and have not relied, on any communications, promises, statements,
inducements, or representation(s), oral or written, by any other Party, except as expressly contained in this Agreement.
(j)
Counterparts. This Agreement may be executed in any number of counterparts, each of which shall be deemed an original, but
all of which together shall constitute one and the same instrument. Any facsimile or other electronic copies hereof or signature
hereon shall, for all purposes, be deemed originals.
[Signatures
appear on the following page]
IN
WITNESS WHEREOF, Seller and Purchaser have duly executed and delivered this Agreement to be effective as of the Effective Date.
SELLER: |
|
|
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PULMATRIX,
INC. |
|
|
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By: |
/s/
Teofilo Raad |
|
Name: |
Teofilo
Raad |
|
Title: |
Chief
Executive Officer |
|
PURCHASER: |
|
|
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MANNKIND
CORPORATION |
|
|
|
By: |
/s/
Michael Castagna |
|
Name: |
Michael
Castagna |
|
Title: |
Chief
Executive Officer |
|
EXHIBIT
A
(LAB
ASSETS)
EXHIBIT
B
Cobalt
JV 2020 LLC |
|
Lease
Agreement between Cobalt Propco 2020, LLC and Pulmatrix, Inc. dated January 7, 2022. |
Reliable
Building Solutions, Inc. |
|
Janitorial
Cleaning Specifications contract between Reliable Building Solutions and Pulmatrix, Inc. dated July 19, 2023. |
Airgas
Inc |
|
Product
Sale Agreement between Airgas USA, LLC and Pulmatrix, Inc. dated March 16, 2023. |
TA
Instruments |
|
Service
Agreement between TA Instruments - Waters L.L.C. and Pulmatrix, Inc. dated April 25, 2023. |
TA
Instruments |
|
Service
Agreement between TA Instruments - Waters L.L.C. and Pulmatrix, Inc. dated December 13, 2022. |
Brinkmann
Instruments / Metrohm |
|
Service
Agreement between Metrohm USA, Inc. and Pulmatrix, Inc. dated April 6, 2023. |
Bostonbean
Coffee Co Inc |
|
Equipment
Rental and Supplies Agreement between BonstonBean Coffee Company and Pulmatrix, Inc. dated April 6, 2023. |
Bostonbean
Coffee Co Inc |
|
Equipment
Rental and Supplies Agreement between BonstonBean Coffee Company and Pulmatrix, Inc. dated April 24, 2023. |
American
Alarm & Communications, Inc. |
|
Professional
Services Agreement between American Alarm and Communications, Inc. and Pulmatrix, Inc. dated July 19, 2023. |
Vestis
(f/k/a Aramark) |
|
Service
Agreement between Aramark Uniform Services and Pulmatrix, Inc. dated June 8, 2020. |
Macquarie
Equipment Capital Inc |
|
Lease
Agreement between Macquarie Equipment Capital Inc. and Pulmatrix, Inc. dated August 1, 2023. |
Boston
Document Systems |
|
Customer
Service Maintenance Agreement between Boston Document Systems, Inc. and Pulmatrix, Inc. dated June 15, 2023. |
Comcast
(Internet) |
|
Business
Internet Service Order Agreement between Comcast Cable Communications Management, LLC and Pulmatrix, Inc. dated June 1, 2023. |
Comcast
Business (Telephone) |
|
Business
VoiceEdge Service Order Agreement between Comcast Cable Communications Management, LLC and Pulmatrix, Inc. dated June 1, 2023. |
Exhibit 10.5
INTELLECTUAL
PROPERTY CROSS-LICENSE AGREEMENT
This
INTELLECTUAL PROPERTY CROSS-LICENSE AGREEMENT (this “Agreement”), dated as of July 8, 2024 is made between
MANNKIND CORPORATION, a Delaware corporation company (“MannKind”) and PULMATRIX, INC., a Delaware
corporation (“Pulmatrix”). MannKind and Pulmatrix are each referred to individually as a “Party”
and collectively as the “Parties”.
WHEREAS,
MannKind owns or has valid rights in certain intellectual property and technology (the “MannKind Technology”)
relating to its “Cricket” single-use disposable dry powder inhaler (including any modifications or improvements thereto made
by or on behalf of MannKind, the “Cricket Device”);
WHEREAS,
Pulmatrix has developed an inhaled formulation of dihydroergotamine (“DHE”) for the treatment of acute
migraine known as PUR3100 (“PUR3100”);
WHEREAS,
Pulmatrix owns certain intellectual property and technology for its dry powder delivery technology, iSPERSE (inhaled Small Particles
Easily Respirable and Emitted), which enables delivery of small or large molecule drugs to the lungs by inhalation for local or systemic
applications (including any modifications or improvements thereto made by or on behalf of Pulmatrix, “iSPERSE”);
WHEREAS,
the parties wish to enter into a technology exchange as set forth herein;
WHEREAS,
MannKind desires to grant Pulmatrix the exclusive right to develop, use, manufacture, market, offer and sell the Cricket Device for
the inhaled delivery of DHE in any formulation whatsoever, including PUR31000;
WHEREAS,
MannKind desires to grant Pulmatrix a non-exclusive license to develop, use, manufacture, market, offer and sell the Cricket Device
for the inhaled delivery of one more active pharmaceutical ingredients formulated with iSPERSE for the treatment of neurological disease
in humans (“Neurological Disease”);
WHEREAS,
Pulmatrix desires to grant to MannKind an exclusive license to develop, use, manufacture, market, offer and sell iSPERSE formulations
of Clofazimine;
WHEREAS,
Pulmatrix desires to grant to MannKind an exclusive license to develop, use, manufacture, market, offer and sell formulations of
iSPERSE with one more active pharmaceutical ingredients for the treatment of nontuberculous mycobacteria lung disease in humans (“NTM”);
WHEREAS,
Pulmatrix desires to grant to MannKind an exclusive license to develop, use, manufacture, market, offer and sell iSPERSE formulations
of insulin;
WHEREAS,
Pulmatrix desires to grant to MannKind a non-exclusive license to develop, use, manufacture, market, offer and sell formulations
of iSPERSE with one more active pharmaceutical ingredients for the treatment of endocrine disease in humans (“Endocrine Disease”);
WHEREAS,
Pulmatrix desires to grant to MannKind a non-exclusive license to develop, use, manufacture, market, offer and sell formulations
of iSPERSE with one more active pharmaceutical ingredients for the treatment of interstitial lung diseases (including IPF, PPF and other
related lung diseases) in humans (“ILD”);
WHEREAS,
Pulmatrix has provided to MannKind certain development services related to the development of an iSPERSE formulation of Clofazimine as
specified in a master services agreement dated March 1, 2024 (the “Pulmatrix Services Agreement”); and
WHEREAS,
concurrent with the execution of this Agreement, the Parties are executing (i) that certain Lease Assignment and Assumption Agreement
pursuant to which Pulmatrix will assign to MannKind a specified lease agreement and certain assets related thereto as specified therein
(the “Lease Assignment”) and (ii) that certain Master Services Agreement pursuant to which MannKind will provide
specified development services for Pulmatrix as specified therein (the “MannKind Services Agreement”).
NOW
THEREFORE, in consideration of the ongoing financial and other support provided by the Parties to each other and other good and valuable
consideration, the receipt and sufficiency of which is hereby acknowledged, MannKind and Pulmatrix hereby agree as follows:
ARTICLE
1 DEFINITIONS
In
addition to terms defined elsewhere in this Agreement, the following terms shall have the following meanings:
“Affiliate”
means, with respect to a Party, any Person that controls, is controlled by, or is under common control with such Party, where
“control” (including, with correlative meaning, the terms “controlled by” or “under common control with”)
means the possession, directly or indirectly, through one or more intermediaries, of the power to direct or cause the direction of the
management or policies of a Person, whether through ownership of more than fifty percent (50%) of voting securities, controlling interests
or similar arrangement.
“Change
of Control” shall mean, with respect to an Entity (including a Party): (a) the sale or disposition of all or substantially
all of the assets of such Entity or its direct or indirect controlling Affiliate to another Entity, other than to an Entity of which
more than fifty percent (50%) of the voting capital stock are owned after such sale or disposition by shareholders of such Entity or
its direct or indirect controlling Affiliate (in either case, whether directly or indirectly through any parent Entity) or (b) (i) the
acquisition by another Entity, alone or together with any of its Affiliates, other than an employee benefit plan (or related trust) sponsored
or maintained by such Entity or any of its Affiliates, of more than fifty percent (50%) of the outstanding shares of voting capital stock
of such Entity or its direct or indirect controlling Affiliate, or (ii) the acquisition, merger or consolidation of such Entity or its
direct or indirect controlling Affiliate with or into another Entity, other than, in the case of subclause (i) or (ii), an acquisition
or a merger or consolidation of such Entity or its controlling Affiliate in which the holders of shares of voting capital stock of such
Entity or its controlling Affiliate, as the case may be, immediately prior to such acquisition, merger or consolidation will beneficially
own, directly or indirectly, at least fifty percent (50%) of the shares of voting capital stock of the acquiring Entity or the surviving
corporation in such acquisition, merger or consolidation, as the case may be, immediately after such acquisition, merger or consolidation;
and, in each case ((a) or (b)), whether through a single transaction or a series of related transactions but excluding any and all bona
fide financing transactions.
“Control”
means with respect to any material, Know-How, or intellectual property right, that a Party or its Affiliate (a) owns or (b) has
a license (other than a license granted to such Party under this Agreement) to such material, Know-How, or intellectual property right
and, in each case, has the ability to grant to the other Party access, a license, or a sublicense (as applicable) to the foregoing on
the terms and conditions set forth in this Agreement without violating the terms of any then-existing agreement or other legally enforceable
arrangement with any Third Party. In the event of a Change of Control of a Party, any Know-How, Patents, or other intellectual property
rights that are owned or controlled by a Third Party that becomes an Affiliate of such Party as a result of such Change of Control will
not be deemed to be Controlled by such Party or its Affiliates for purposes of this Agreement.
“Cover”
means, with respect to a claim of a Patent and a product, that such claim would be infringed, absent a license, by the manufacture,
use, offer for sale, sale or importation of such product (considering claims of patent applications to be issued as then pending).
“Effective
Date” means the date that the “Closing” (as defined in the Lease Assignment) has occurred under the Lease Assignment
and the Lease Assignment has gone into effect.
“Entity”
means an individual, corporation, partnership, joint venture, limited liability company, governmental authority, unincorporated
organization, trust, association or other entity.
“Exploit”
means to make, have made, import, use, sell or offer for sale, including to research, develop, commercialize, register, manufacture,
have manufactured, hold or keep (whether for disposal or otherwise), have used, export, transport, distribute, promote, market, sell,
have sold, dispose of, copy, distribute, create derivative works of, publicly perform or publicly display.
“Governmental
Body” means any federal, national, state, provincial, or local government, or political subdivision thereof, or any multinational
organization, or any authority, agency, regulatory body, or commission entitled to exercise any administrative, executive, judicial,
legislative, police, regulatory, or taxing authority or power, or any court or tribunal (or any department, bureau or division of any
of the foregoing, or any governmental arbitrator or arbitral body).
“Know-How”
means any data, results, technology, business or financial information or information of any type whatsoever, in any tangible
or intangible form, including know-how, trade secrets, practices, techniques, methods, processes, designs, manuals, guidelines, inventions,
developments, specifications, formulations, formulae, software, algorithms, marketing reports, expertise, technology, test data (including
pharmacological, biological and chemical, biochemical, clinical test data and data resulting from non-clinical studies), CMC information,
stability data and other study data and procedures.
“Licensed
Technology” means the MannKind Technology and/or the Pulmatrix Technology, as the context may require.
“Licensee”
means the Party receiving rights under a license grant pursuant to this Agreement. Depending on the context, Licensee may mean
either or both of MannKind and Pulmatrix.
“Licensor”
means the Party granting rights under a license grant pursuant to this Agreement. Depending on the context, Licensor may mean
either or both of MannKind and Pulmatrix.
“MannKind
Know-How” means Know-How Controlled by MannKind as of the Effective Date or during the Term that is necessary or reasonably
useful to Exploit the Cricket Device.
“MannKind
Patents” means all Patents Controlled by MannKind as of the Effective Date or during the Term to the extent that such Patents
Cover the Cricket Device. The MannKind Patents existing as of the Effective Date are listed in Schedule 2 attached hereto.
“MannKind
Regulatory Approvals” means all Regulatory Approvals owned by MannKind specifically relating to the Cricket Device.
“MannKind
Technology” means the MannKind Know-How, the MannKind Patents, the MannKind Trademarks and all MannKind Regulatory Approvals.
“MannKind
Trademarks” means any Trademarks used by MannKind to designate the Cricket Device. For clarity, MannKind Trademarks does
not include any Trademarks used to designate MannKind’s or any of its Affiliates’ corporate name(s).
“Patent
Owner” means, with respect to each Patent within the Licensed Technology, the Party that Controls such Patent. In the event
any Patent is owned by both MannKind and Pulmatrix, then for purposes of this Agreement MannKind shall be deemed the Patent Owner of
such Patent.
“Product”
means, (a) with respect to a product Exploited by MannKind, any pharmaceutical product or medical device that incorporates any Pulmatrix
Technology whether alone or in combination with any other active ingredient and (b) with respect to a product Exploited by Pulmatrix,
any pharmaceutical product or medical device that incorporates any MannKind Technology whether alone or in combination with any other
active ingredient.
“Prosecute
and Maintain” means with regard to a Patent, the preparing, filing, prosecuting and maintenance of such Patent, as well
as handling re-examinations and reissues with respect to such Patent, together with the conduct of interferences, the defense of oppositions
and other similar proceedings with respect to the particular Patent. For clarification, Prosecute and Maintain does not include any other
enforcement actions taken with respect to a Patent.
“Pulmatrix
Know-How” means Know-How Controlled by Pulmatrix as of the Effective Date or during the Term that is necessary or reasonably
useful to Exploit iSPERSE.
“Pulmatrix
Patents” means all Patents Controlled by Pulmatrix as of the Effective Date or during the Term that Cover iSPERSE. The
Pulmatrix Patents existing as of the Effective Date are listed in Schedule 1 attached hereto.
“Pulmatrix
Regulatory Approvals” means all Regulatory Approvals owned by Pulmatrix specifically relating to iSPERSE.
“Pulmatrix
Technology” means the Pulmatrix Know-How, the Pulmatrix Patents, the Pulmatrix Trademarks and all Pulmatrix Regulatory
Approvals.
“Pulmatrix
Trademarks” means any Trademark used by Pulmatrix to designate iSPERSE. For clarity, Pulmatrix Trademarks does not include
any Trademarks used to designate Pulmatrix’s or any of its Affiliates’ corporate name(s).
“Regulatory
Approvals” means the technical, medical and scientific licenses, registrations, authorizations and approvals issued by
or under the jurisdiction of a Governmental Body, as necessary for the distribution, marketing, promotion, offer for sale, supply, use,
import, export or sale of a pharmaceutical product or medical device in a regulatory jurisdiction.
“Third
Party” means any entity other than Pulmatrix or MannKind or an Affiliate of either of them.
“Trademark”
means any word, name, symbol, color, shape, designation or device or any combination thereof, including any trademark, service mark,
trade name, trade dress, brand name, product configuration, domain name, logo, design or business symbol, that functions as an identifier
of source, origin or membership, whether or not registered, and all statutory and common law rights therein, and all registrations and
applications therefor, together with all goodwill associated with, or symbolized by, any of the foregoing.
“Valid
Claim” means (a) a claim of an issued, unexpired Patent that has not been revoked, disclaimed, abandoned or held invalid
or unenforceable by a court or other body of competent jurisdiction in an unappealed or unappealable decision and (b) a claim of any
patent application which has not been abandoned or finally disallowed without the possibility of appeal or re-filing of the application.
ARTICLE
2 LICENSE GRANTS
Section
2.1: MannKind Exclusive License Grant to Pulmatrix.
Subject
to the terms and conditions of this Agreement, MannKind hereby grants to Pulmatrix, and Pulmatrix hereby accepts, a worldwide, fully
paid up, royalty-free, exclusive, sub-licensable (through multiple tiers) license to the MannKind Technology in order for Pulmatrix to
Exploit the Cricket Device for the inhaled delivery of DHE in any formulation whatsoever, including PUR31000, for the treatment or prevention
of any disease or condition in humans.
Section
2.2: MannKind Non-Exclusive License Grant to Pulmatrix.
Subject
to the terms and conditions of this Agreement, MannKind hereby grants to Pulmatrix, and Pulmatrix hereby accepts, a worldwide, fully
paid up, royalty-free, non-exclusive, sub-licensable (through multiple tiers) license to the MannKind Technology in order for Pulmatrix
to Exploit the Cricket Device for the inhaled delivery of any dry powder formulation of one more active pharmaceutical ingredients formulated
for the treatment or prevention of Neurological Disease.
Section
2.3: Pulmatrix Exclusive License Grants to MannKind.
(a)
Subject to the terms and conditions of this Agreement, Pulmatrix hereby grants to MannKind, and MannKind hereby accepts, a worldwide,
fully paid up, royalty-free, exclusive, sub-licensable (through multiple tiers) license to the Pulmatrix Technology in order for MannKind
to Exploit formulations of iSPERSE formulation with Clofazimine for inhalation by humans for the treatment or prevention of infection.
(b)
Subject to the terms and conditions of this Agreement, Pulmatrix hereby grants to MannKind, and MannKind hereby accepts, a worldwide,
fully paid up, royalty-free, exclusive, sub-licensable (through multiple tiers) license to the Pulmatrix Technology in order for MannKind
to Exploit formulations of iSPERSE with one more active pharmaceutical ingredients for inhalation for the treatment or prevention of
NTM.
(c)
Subject to the terms and conditions of this Agreement, Pulmatrix hereby grants to MannKind, and MannKind hereby accepts, a worldwide,
fully paid up, royalty-free, exclusive, sub-licensable (through multiple tiers) license to the Pulmatrix Technology in order for MannKind
to Exploit formulations of iSPERSE with insulin for inhalation by humans for the treatment or prevention of diabetes.
Section
2.4: Pulmatrix Non-Exclusive License Grants to MannKind.
(a)
Subject to the terms and conditions of this Agreement, Pulmatrix hereby grants to MannKind, and MannKind hereby accepts, a worldwide,
fully paid up, royalty-free, non-exclusive, sub-licensable (through multiple tiers) license to the Pulmatrix Technology in order for
MannKind to Exploit formulations of iSPERSE with one or more active pharmaceutical ingredients for inhalation for the treatment or prevention
of Endocrine Disease.
(b)
Subject to the terms and conditions of this Agreement, Pulmatrix hereby grants to MannKind, and MannKind hereby accepts, a worldwide,
fully paid up, royalty-free, non-exclusive, sub-licensable (through multiple tiers) license to the Pulmatrix Technology in order for
MannKind to Exploit formulations of iSPERSE with one or more active pharmaceutical ingredients for inhalation for the treatment or prevention
of ILD.
Section
2.5: No Implied Licenses; Negative Covenant.
Except
as otherwise specifically set forth herein, only the licenses granted pursuant to the express terms of this Agreement shall be of any
legal force and effect. No license or other intellectual property rights shall be created by implication in any Patents, technology and/or
proprietary information owned by a Party, even if such Patents, technology, or proprietary information is necessary to exploit the Licensed
Technology. Neither Party shall, and neither Party shall permit any of its Affiliates or sublicensees to, practice any Licensed Technology
licensed to it by the other Party outside the scope of the licenses granted to it under this Agreement.
Section
2.6: Scope
(a)
For the avoidance of doubt, the foregoing licenses set forth in this Article 2 are royalty free and not limited by territory.
(b)
The licenses set forth in this Article 2 to Pulmatrix do not include the right for Pulmatrix to manufacture or have manufactured
the Cricket Device.
(c)
The licenses set forth in this Article 2 to Pulmatrix do not include rights to any Know-How, Patents or other rights covering
any active ingredient, formulation technology or other proprietary product other than the Cricket Device itself.
(d)
The licenses set forth in this Article 2 shall not include rights to any Know-How, Patents or other intellectual property rights
in-licensed or acquired by Licensor from a Third Party after the Effective Date unless the applicable Licensee agrees in writing (i)
to be bound by the terms and conditions of any applicable Third Party agreement granting Licensor Control of such Know-How, Patents or
other intellectual property rights and (ii) to pay all payments owed to such Third Party that are attributable to Licensee’s use
of such Know-How, Patents or other intellectual property rights under this Agreement.
Section
2.7 Sublicenses.
Subject
to the terms and conditions of this Agreement, each Party may grant sublicenses through multiple tiers, under any or all of the rights
granted in Section 2.1, Section 2.2, Section 2.3 and Section 2.4, as applicable, to its Affiliates and to
Third Parties (each such Affiliate or Third Party, a “Sublicensee” and each such agreement, a “Sublicense”).
Each Sublicense shall be consistent with the terms and conditions of this Agreement applicable to the scope of the sublicense granted
to such Sublicensee. Each Party shall promptly notify the other Party in writing of any Sublicense granted to a Third Party (other than
non-exclusive Sublicenses granted to Third Party service providers or vendors providing services on such Party’s behalf) and shall
provide the other Party with a copy of such Sublicense; provided, that such Party may redact any confidential or financial information
contained therein that is unnecessary for the other Party to confirm compliance with this Agreement.
Section
2.8 Trademarks.
(a)
MannKind Trademarks. The licenses set forth in this Article 2 to Pulmatrix include the right for Pulmatrix to use the MannKind
Trademarks solely in connection with the Exploitation of Products within the scope of the licenses granted to Pulmatrix under this Article
2. Pulmatrix shall, and shall ensure that its Affiliates and Sublicensees will not, adapt or make any use of any Trademark that is confusingly
similar to any MannKind Trademark or any Trademark that MannKind or its Affiliates use to designate its corporate name. All use of the
MannKind Trademarks shall be consistent with the MannKind Trademark style and usage provisions as identified by MannKind to Pulmatrix
in writing. All goodwill generated from the use of the MannKind Trademarks shall inure to the benefit of and is hereby assigned to MannKind.
MannKind shall have the sole right to prosecute, enforce and defend the MannKind Trademarks.
(b)
Pulmatrix Trademarks. The licenses set forth in this Article 2 to MannKind include the right for MannKind to use the Pulmatrix
Trademarks solely in connection with the Exploitation of Products within the scope of the licenses granted to MannKind under this Article
2. MannKind shall, and shall ensure that its Affiliates and Sublicensees will not, adapt or make any use of any Trademark that is confusingly
similar to any Pulmatrix Trademark or any Trademark that Pulmatrix or its Affiliates use to designate its corporate name. All use of
the Pulmatrix Trademarks shall be consistent with the Pulmatrix Trademark style and usage provisions as identified by Pulmatrix to MannKind
in writing. All goodwill generated from the use of the Pulmatrix Trademarks shall inure to the benefit of and is hereby assigned to Pulmatrix.
Pulmatrix shall have the sole right to prosecute, enforce and defend the Pulmatrix Trademarks.
Section
2.9 Technology Transfer.
(a)
Transfer to MannKind. Within thirty (30) days after the Effective Date, Pulmatrix shall provide MannKind with the Pulmatrix Know-How
and all regulatory materials (including Regulatory Approvals) specifically relating to iSPERSE. On an ongoing basis thereafter, at the
reasonable request of MannKind, Pulmatrix shall provide MannKind with copies of any Pulmatrix Know-How generated since the last such
transfer under this Section 2.8.
(b)
Transfer to Pulmatrix. Within thirty (30) days after the Effective Date, MannKind shall provide Pulmatrix with the MannKind Know-How
and all regulatory materials (including Regulatory Approvals) specifically relating to the Cricket Device. On an ongoing basis thereafter,
at the reasonable request of Pulmatrix, MannKind shall provide Pulmatrix with copies of any MannKind Know-How generated since the last
such transfer under this Section 2.8.
ARTICLE
3 PATENT PROSECUTION AND MAINTENANCE; PATENT ENFORCEMENT
Section
3.1: Patent Prosecution and Maintenance.
Each
Party, as Patent Owner, shall have the first right to Prosecute and Maintain any and all Patents Controlled by such Party that are included
in such Party’s Licensed Technology, at its own cost. If a Patent Owner decides not to: (i) prosecute certain patent applications
within the Licensed Technology to issuance or (ii) maintain any United States or foreign issued Patent within the Licensed Technology,
the Patent Owner shall timely notify the Licensee of such Patent in writing thereof and solely to the extent the Patent Owner owns such
Patent, upon written request by the Licensee, the Parties shall cooperate to transfer the ownership of such Patent to the Licensee, provided,
that the Patent Owner shall retain a worldwide, irrevocable, perpetual, fully paid up, royalty-free, exclusive, transferable, sublicensable
(through multiple tiers) license to and under the transferred Patent in any field of use. The preceding sentence shall not apply to any
patent applications within the Licensed Technology that will be abandoned for the pursuit of a utility application in the case of a provisional
application, a divisional or continuation application in the case of any utility application, any national stage applications in the
case of a Patent Cooperation Treaty (PCT) application, or countries not validated in the case of a European or other regional patent
application. Before any Party makes a filing or extension on any Patent included in such Party’s Licensed Technology, the Patent
Owner shall consider in good faith any reasonable comments thereto provided by the other Party in connection with the prosecution of
such Patents. Pulmatrix shall promptly provide MannKind with copies of all material communications from any patent authority regarding
the Pulmatrix Patents, and shall provide MannKind, for its review and comment, with drafts of any material filings or responses to be
made to such patent authorities in a reasonable amount of time in advance of submitting such filings or responses.
Section
3.2: Infringement Procedures.
During
the term of this Agreement, each Party shall promptly inform the other of any suspected infringement, misuse, misappropriation, theft
or breach of confidence of other proprietary rights in the Licensed Technology by a Third Party in the other Party’s exclusive
field of use as provided in Article 2 (collectively “Third Party Activities”), and with respect to such activities
as are suspected. MannKind shall have the sole right, but not the obligation, to institute an action or proceeding against Third Party
Activities related to the MannKind Patents and to defend any declaratory judgment action relating to the MannKind Patents. For Third
Party Activities involving the Pulmatrix Patents in MannKind’s exclusive field of use as provided in Article 2, MannKind shall
have the sole right, but not the obligation, to institute an action or proceeding against Third Party Activities and defend any declaratory
judgment action relating thereto and Pulmatrix shall have the right, but not the obligation, to join any such suit, legal action or proceeding
that is initiated by MannKind with respect to the Pulmatrix Patents, at MannKind’s cost. Pulmatrix shall, where necessary, furnish
a power of attorney solely for such purpose, or be named as a necessary party, to such action, at MannKind’s cost. Pulmatrix will
reasonably cooperate with MannKind in such action. In addition, notwithstanding anything to the contrary contained herein, if Pulmatrix
cooperates in such action, such cooperation shall be at MannKind’s sole expense. All recoveries, whether by judgment, award, decree
or settlement, from infringement or misuse of Licensed Technology under this Section 3.2 shall be apportioned as follows: (a)
MannKind shall recover an amount equal the costs and expenses incurred by MannKind directly related to the prosecution of such action
or proceeding and Pulmatrix shall recover any unreimbursed costs and expenses incurred by Pulmatrix, if any, directly related to its
cooperation in the prosecution of such action or proceeding (which amounts shall be allocated pro rata if insufficient to cover the totality
of such costs and expenses) and (b) the remainder shall be allocated to the Party bringing the action.
Section
3.3: Consent to Settle.
A
settlement, consent judgment or other voluntary final disposition of an action covered by an action covered by Section 3.2 may
be entered into by the party instituting such action without the consent of the non-enforcing Party; provided, however, that any such
settlement, consent judgment or other disposition shall not, without the prior written consent of the non-enforcing Party, (a) impose
any liability or obligation on the non-enforcing Party or any of its Affiliates, or (b) admit the invalidity or unenforceability of,
or otherwise impair or materially adversely affect the scope of, any Patent owned or controlled by the non-enforcing Party, such consent
to not be unreasonably withheld, conditioned or delayed.
Section
3.4: Defense of Infringement Claims.
If
any Third Party asserts a claim, demand, action, suit or proceeding against a Licensee (or any of its sublicensees), alleging that the
use or practice of the Licensed Technology, infringes, misappropriates or violates the intellectual property rights of any Person (any
such claim, demand, action, suit or proceeding being referred to as an “Infringement Claim”), the Licensee
shall promptly notify the Patent Owner in writing specifying the facts, to the extent known, in reasonable detail. In the case of any
such Infringement Claim, the Licensee shall assume control of the defense and shall have the exclusive right to settle any Infringement
Claim against the Licensee without the consent of the Patent Owner; provided, however, if such settlement requires any payment from the
Patent Owner, imposes any obligation or liability on the Patent Owner or decreases the Patent Owner’s rights or interests under
this Agreement, the Licensee shall be required to obtain the Patent Owner’s consent, which consent will not be unreasonably withheld.
ARTICLE
4 TERM; TERMINATION
Section
4.1: Term. This Agreement shall commence upon the Effective Date and, unless earlier terminated pursuant to this Article 4,
shall expire, on a country-by-country basis, on the date of expiration of the last Valid Claim of the Patents in the Licensed Technology.
Upon the expiration of the Term for a particular country, the licenses granted under Section 2.1 with respect to such country
shall become perpetual and irrevocable. If the Effective Date has not occurred by July 31, 2024, then this Agreement shall be void ab
initio as if it was never executed by the parties.
Section
4.2: Termination for Breach. If either Party believes that the other is in breach of its material obligations hereunder, then the
non-breaching Party may deliver notice of such breach to the other Party. For all breaches other than a failure to make a payment as
set forth in this Agreement, the allegedly breaching Party shall have sixty (60) days from such notice to dispute or cure such breach.
If the Party receiving notice of breach fails to cure, or fails to dispute, that breach within the applicable period set forth above,
then the Party originally delivering the notice of breach may terminate this Agreement effective on written notice of termination to
the other Party.
Section
4.3: Termination for Bankruptcy. Either Party may terminate this Agreement in its entirety upon written notice to the other Party
in the event that (a) a case is commenced by or against such other Party under applicable bankruptcy, insolvency or similar laws, which
case, if commenced against (not by) such other Party, is not dismissed within ninety (90) days of the commencement thereof, (b) such
other Party files for bankruptcy, reorganization, liquidation, receivership or similar proceedings, (c) such other Party assigns all
or a substantial portion of its assets for the benefit of creditors, (d) a receiver or custodian is appointed for such other Party’s
business, (e) a substantial portion of such other Party’s business is subject to attachment or similar process or (f) anything
analogous to any of the events described in the foregoing clauses (a) through (f) occurs under the laws of any applicable jurisdiction.
Section
4.4: Effects of Termination.
(a)
Termination by MannKind. Upon termination of this Agreement by MannKind pursuant to Section 4.2 or Section 4.3:
(i) all rights and licenses granted by MannKind to Pulmatrix under this Agreement shall terminate and revert to MannKind, (ii) all rights
and licenses granted by Pulmatrix to MannKind under this Agreement shall survive and become perpetual and irrevocable, and (iii) at the
request of MannKind, Pulmatrix shall return, or at the election of MannKind, destroy, and thereafter provide MannKind with written certification
evidencing such destruction, all data, files, records and other materials in its or its Affiliates’ or Sublicensees’, possession
or control containing or comprising MannKind’s Confidential Information; provided, that Pulmatrix shall be entitled to retain one
(1) copy MannKind’s Confidential Information solely for litigation or archival purposes and Pulmatrix shall not be required to
delete any of MannKind’s Confidential Information that is stored automatically, such as through server backup processes.
(b)
Termination by Pulmatrix. Upon termination of this Agreement by Pulmatrix pursuant to Section 4.2 or Section 4.3:
(i) all rights and licenses granted by Pulmatrix to MannKind under this Agreement shall terminate and revert to Pulmatrix, (ii) all rights
and licenses granted by MannKind to Pulmatrix under this Agreement shall survive and become perpetual and irrevocable, and (iii) at the
request of Pulmatrix, MannKind shall return, or at the election of Pulmatrix, destroy, and thereafter provide Pulmatrix with written
certification evidencing such destruction, all data, files, records and other materials in its or its Affiliates’ or Sublicensees’,
possession or control containing or comprising Pulmatrix’s Confidential Information; provided, that MannKind shall be entitled
to retain one (1) copy Pulmatrix’s Confidential Information solely for litigation or archival purposes and MannKind shall not be
required to delete any of Pulmatrix’s Confidential Information that is stored automatically, such as through server backup processes.
ARTICLE
5 INDEMNIFICATION
Section
5.1: Pulmatrix Indemnity.
Pulmatrix
shall indemnify, defend, and hold harmless MannKind and its Affiliates and their respective officers, shareholders, members, managers,
directors, employees, personnel and agents (the “MannKind Indemnitees”) from and against all damages or other
amounts payable to a Third Party claimant (including liabilities, costs, expenses, reasonable attorneys’ fees, damages and losses
resulting from the foregoing) (collectively, “Losses”) resulting from any claims, actions, causes of action
or demands, brought by or on behalf of a Third Party (collectively, “Claims”) arising out of or in connection
with: (a) any breach of any of Pulmatrix’s representations, warranties, covenants, and obligations under this Agreement, (b) any
violation of applicable law by Pulmatrix, its Affiliates or its sublicensees; (c) infringement of intellectual property rights of a Third
Party arising from Pulmatrix’s use of the MannKind Technology; (d) the development, commercialization, marketing or sale of any
Product by Pulmatrix, its Affiliates and Sublicensees, and (e) Pulmatrix’s, its Affiliates’ or its Sublicensees’ gross
negligence, willful misconduct or fraudulent conduct. Pulmatrix shall not be responsible to, nor shall it indemnify, defend or hold harmless
MannKind for any Claims to the extent arising from any negligent act or omission or willful misconduct of any MannKind Indemnitee or
a Claim for which MannKind would be required to indemnify Pulmatrix under this Agreement. This Section 5.1 shall survive any termination
or expiration of this Agreement.
Section
5.2: MannKind Indemnity.
MannKind
shall indemnify, defend, and hold harmless Pulmatrix and its Affiliates and their respective officers, shareholders, members, managers,
directors, employees, personnel and agents (the “Pulmatrix Indemnitees”) from and against all Losses resulting
from any Third Party Claims arising out of or in connection with: (a) any breach of any of MannKind’s representations, warranties,
covenants, and obligations under this Agreement, (b) any violation of applicable law by MannKind, its Affiliates or its sublicensees;
(c) any Third Party claim of infringement of intellectual property rights of such Third Party arising from MannKind’s use of the
Pulmatrix Technology; (d) the development, commercialization, marketing or sale of any Product by or on behalf of MannKind, its Affiliates
or Sublicensees; and (e) MannKind’s, its Affiliates or its Sublicensees gross negligence, willful misconduct or fraudulent conduct.
MannKind shall not be responsible to, nor shall it indemnify, defend or hold harmless Pulmatrix for any Claims to the extent arising
from any negligent act or omission or willful misconduct of any Pulmatrix Indemnitee or a Claim for which Pulmatrix would be required
to indemnify MannKind under this Agreement. This Section 5.2 shall survive any termination or expiration of this Agreement.
Section
5.3: Procedure.
The
indemnified Party shall promptly notify the indemnifying Party in writing of any Claim for which it believes it is entitled to indemnification
hereunder. Failure or delay in providing such notice shall not relieve the indemnifying Party of its indemnification obligations, except
to the extent the indemnifying Party demonstrates that the defense or settlement of the Claim has been prejudiced thereby. Subject to
the provisions below in this Section 5.3, the indemnifying Party shall have the right to control the defense and settlement of
any Claim, or may at any time tender control of the defense or settlement of such Claim to the indemnified Party. The indemnified Party
may, at its own cost, elect to participate in the defense or settlement of any Claim with counsel of its choice. No compromise or settlement
may be committed to by the indemnifying Party without the indemnified Party’s prior written approval (which shall not be unreasonably
withheld, conditioned or delayed).
ARTICLE
6 LIMITATION OF LIABILITY
Section
6.1: WAIVER OF CONSEQUENTIAL DAMAGES.
EXCEPT
FOR BREACHES OF ARTICLE 7, IN NO EVENT SHALL EITHER PARTY, ITS DIRECT OR INDIRECT SUBSIDIARIES, AFFILIATES, DIRECTORS, OFFICERS, AGENTS,
EMPLOYEES OR REPRESENTATIVES BE LIABLE FOR ANY INDIRECT, INCIDENTAL, SPECIAL, PUNITIVE, EXEMPLARY OR CONSEQUENTIAL DAMAGES OF ANY KIND,
NOR FOR ANY LOST PROFITS OR REVENUES, IN CONNECTION WITH OR ARISING OUT OF THIS AGREEMENT, EXCEPT TO THE EXTENT THAT A PARTY IS LIABLE
TO A THIRD PARTY FOR THE SAME IN CONNECTION WITH A CLAIM FOR WHICH SUCH PARTY IS ENTITLED TO INDEMNIFICATION UNDER ARTICLE 5.
Section
6.2: LIMITATION OF LIABILITY.
EXCEPT
FOR BREACHES OF ARTICLE 7 OR DAMAGES AVAILABLE TO A THIRD PARTY IN CONNECTION WITH A CLAIM FOR WHICH SUCH PARTY IS ENTITLED TO INDEMNIFICATION
UNDER ARTICLE 5, THE MAXIMUM AGGREGATE LIABILITY OF EITHER PARTY TO THE OTHER, FOR ANY REASON AND UPON ANY CAUSE OF ACTION ARISING OUT
OF OR RELATING TO THIS AGREEMENT SHALL BE LIMITED TO AN AMOUNT NOT TO EXCEED $1,000,000, EVEN IF A PARTY HAS BEEN ADVISED OF THE POSSIBILITY
OF SUCH DAMAGES OR SUCH DAMAGES ARE REASONABLY FORESEEABLE. THE FOREGOING LIMITATIONS SHALL APPLY REGARDLESS OF THE CAUSE OR FORM OF
ACTION, WHETHER BASED IN CONTRACT, TORT, NEGLIGENCE, STRICT LIABILITY, WARRANTY OR OTHERWISE AND SHALL NEVER BE DEEMED TO FAIL IN THEIR
ESSENTIAL PURPOSE.
Section
6.3: Insurance.
Each
Party shall procure and maintain insurance, including product liability insurance, with respect to its activities hereunder that is consistent
with normal business practices of prudent companies similarly situated at all times during which any product subject to a license granted
to such Party under this Agreement is being clinically tested in human subjects or commercially distributed or sold. Each Party shall
provide the other Party with evidence of such insurance upon request and shall provide the other Party with written notice at least sixty
(60) days prior to the cancellation, non-renewal or material decrease in such insurance. Such insurance shall not be construed to create
a limit of either Party’s liability with respect to its indemnification obligations under Article 5.
ARTICLE
7 CONFIDENTIALITY
Section
7.1: Definition of Confidentiality.
For
purposes of this Agreement, “Confidential Information” of a Party means any non-public information or materials
belonging to, concerning or in the possession or control of such Party or its Affiliates (the “Disclosing Party”) that
is furnished, disclosed or otherwise made available (directly or indirectly) to the other Party (or Persons acting on such other Party’s
behalf) (the “Receiving Party”) in connection with this Agreement and which is either marked or identified
as confidential or proprietary or is of a type that a reasonable person would recognize it to be confidential or proprietary.
Section
7.2: Confidentiality Obligations.
The
Receiving Party shall: (a) hold the Confidential Information in strict confidence and avoid the disclosure thereof to any Third Party
by using the same degree of care as it uses to avoid the unauthorized use or disclosure of its own Confidential Information of a similar
nature, but not less than reasonable care; and (b) not use the Confidential Information for any purpose except as contemplated under
this Agreement. Should a Party become possessed of a trade secret of a Disclosing Party under the terms of this Agreement, the Receiving
Party shall not, during the term and thereafter, disclose such trade secret to a Third Party. The Receiving Party shall restrict the
possession and use of Confidential Information to its employees, agents, consultants, contractors, personnel, Affiliates and Sublicensees
who have a need to know and are bound by confidentiality obligations no less stringent than those contained herein. The Receiving Party
may disclose Confidential Information as required by applicable law, provided the Receiving Party discloses only such information as
is required by applicable law and, if permitted by applicable law, uses reasonable efforts to notify the Disclosing Party of such disclosure
and provides reasonable assistance to the Disclosing Party in seeking a protective order or similar confidential treatment at Disclosing
Party’s expense. The Receiving Party shall promptly notify the Disclosing Party of any facts known to the Receiving Party regarding
any unauthorized disclosure or use of Confidential Information. Each Party acknowledges that its breach of the obligations set forth
in this Section 7.2 may cause irreparable harm for which the other Party shall be entitled to seek injunctive or other equitable
relief. All Confidential Information shall remain the exclusive property of the Disclosing Party.
Section
7.3: Limitations.
Confidential
Information shall not include any information to the extent that such information: (a) was demonstrably known by the Receiving Party
before disclosure by the Disclosing Party, (b) becomes generally publicly known other than through any act or omission of the receiving
Party in breach of this Agreement, (c) was disclosed to the Receiving Party free of any obligation of confidentiality by a Third Party
who has a legal right to make such disclosure; or (d) is independently developed by the Receiving Party by persons without access to
such information.
Section
7.4: Residual Rights.
Each
Party acknowledges and agrees that the other Party, its Affiliates and their respective employees and agents shall be free to use and
employ their general skills, ideas, concepts, know-how and expertise, and to use, disclose, and employ any generalized ideas, concepts,
know-how, methods, techniques or skills gained or learned during the course of any activities performed hereunder, subject to its obligations
respecting the other Party’s Confidential Information pursuant to this Article 7. Each Party acknowledges and agrees that
to the extent any former employee of one Party becomes an employee of the other Party, such employee shall be free to use Confidential
Information of such Party that was its former employer within the scope of the licenses granted under this Agreement to the Party that
it is current employer.
Section
7.5: Terms of the Agreement.
(a)
The Parties agree that the material terms of this Agreement are the Confidential Information of both Parties, subject to the special
authorized disclosure provisions set forth in this Section 7.5 or Section 7.2. In addition, a Party may disclose such terms
to the extent reasonably necessary to be disclosed to any bona fide potential or actual investor, acquiror, licensee or merger partner
for the sole purpose of evaluating an actual or potential investment, acquisition, license or merger; provided that in connection with
such disclosure, such Party shall inform each disclosee of the confidential nature of such Confidential Information and ensure that each
such disclosee is contractually obligated to treat such Confidential Information as confidential.
(b)
The Parties acknowledge that either or both Parties may be obligated to file under applicable laws a copy of this Agreement with the
U.S. Securities and Exchange Commission or other Governmental Body. Each Party shall be entitled to make such a required filing, provided
that it requests confidential treatment of the commercial terms and sensitive technical terms hereof and thereof to the extent such confidential
treatment is reasonably available to such Party. In the event of any such filing, each Party will provide the other Party with a copy
of this Agreement marked to show provisions for which such Party intends to seek confidential treatment and shall reasonably consider
and incorporate the other Party’s reasonable comments thereon to the extent consistent with the legal requirements, with respect
to the filing Party, governing disclosure of material agreements and material information that must be publicly filed. Each Party shall
have the right to repeat disclosure any information that has already been publicly disclosed by such Party in accordance with this Section
7.5 without the obligation to repeat this process under this Section 7.5, provided such information remains accurate as of
such time of repeated disclosure.
ARTICLE
8 REPRESENTATIONS AND WARRANTIES AND OTHER AGREEMENTS
Section
8.1: Mutual Representations and Warranties.
Each
Party represents and warrants to the other Party as of the Effective Date that such first Party has: (a) all requisite legal and corporate
power to execute and deliver this Agreement; (b) taken all corporate action necessary for the authorization, execution and delivery of
this Agreement; (c) no agreement or understanding with any Third Party that interferes with or will interfere with the performance of
their respective obligations under this Agreement; (d) obtained and shall maintain all rights, approvals and consents necessary to perform
their respective obligations under this Agreement; (e) taken all action required or necessary to make such agreements legal, valid and
binding obligations upon them; and (f) it has the right to grant the licenses to the other which are granted in this Agreement and it
has not granted any license, option, right or interest in, to or under its Licensed Technology to any Third Party that is inconsistent
with the license granted to the other Party under this Agreement. Each Party further represents and warrants to the other Party as of
the Effective Date that, to its knowledge, none of its Licensed Technology infringes on the rights of any Third Party. MannKind further
represents and warrants to Pulmatrix as of the Effective Date that (x) all of the Patents and Know-How controlled by MannKind that are
necessary or reasonably useful to Exploit the Cricket Device in the fields of use licensed to Pulmatrix under Article 2 are owned by
MannKind and not in-licensed from a Third Party and (y) all of the Patents owned by MannKind that are necessary or reasonably useful
to Exploit the Cricket Device in the fields of use licensed to Pulmatrix under Article 2 are set forth on Schedule 2. Pulmatrix
further represents and warrants to MannKind as of the Effective Date that (1) all of the Patents and Know-How controlled by Pulmatrix
that are necessary or reasonably useful to Exploit iSPERSE in the fields of use licensed to MannKind under Article 2 are owned by Pulmatrix
and not in-licensed from a Third Party and (2) all of the Patents owned by Pulmatrix that are necessary or reasonably useful to Exploit
iSPERSE in the fields of use licensed to MannKind pursuant to Article 2 are set forth on Schedule 1.
Section
8.2: Disclaimer.
NEITHER
PARTY MAKES ANY REPRESENTATION OR WARRANTY OF ANY KIND, WHETHER EXPRESS OR IMPLIED, EXCEPT FOR THE REPRESENTATIONS AND WARRANTIES EXPRESSLY
SET FORTH IN SECTION 8.1, AND EACH PARTY EXPRESSLY DISCLAIMS ANY IMPLIED OR STATUTORY WARRANTIES OF MERCHANTABILITY, FITNESS FOR
A PARTICULAR PURPOSE, QUALITY, TITLE OR ANY REPRESENTATION OR WARRANTY ARISING FROM COURSE OF PERFORMANCE, COURSE OF DEALING OR USAGE
OF TRADE.
Section
8.3 Other Agreements.
(a)
Regulatory Assistance.
(i)
Pulmatrix shall, at MannKind’s request and expense, provide reasonable assistance with respect to regulatory matters concerning
the Exploitation of iSPERSE by or on behalf of MannKind or its Sublicensees within the scope of MannKind’s licenses under this
Agreement, including (x) assistance with respect to regulatory filings required to obtain or maintain Regulatory Approval for MannKind’s
or its Sublicensees’ Products and (y) providing MannKind with regulatory materials in its possession or control that are necessary
or reasonably useful for MannKind to obtain or maintain Regulatory Approval for MannKind’s or its Sublicensees’ Products.
(ii)
MannKind shall, at Pulmatrix’s request and expense, provide reasonable assistance with respect to regulatory matters concerning
the Exploitation of the Cricket Device by or on behalf of Pulmatrix or its Sublicensees within the scope of Pulmatrix’s licenses
under this Agreement, including (x) assistance with respect to regulatory filings required to obtain or maintain Regulatory Approval
for Pulmatrix’s or its Sublicensees’ Products and (y) providing Pulmatrix with regulatory materials in its Control that are
necessary or reasonably useful for Pulmatrix to obtain or maintain Regulatory Approval for Pulmatrix’s or its Sublicensees’
Products.
(b)
Remedial Actions. Each Party will notify the other Party immediately, and promptly confirm such notice in writing, if it obtains
information indicating that any Product being Exploited by such Party may be subject to any recall, market withdrawal, clinical hold,
or any other similar corrective or other regulatory action with respect to such Product taken by virtue of applicable law (a “Remedial
Action”). The Parties will reasonably assist each other in gathering and evaluating such information as is necessary to determine
the necessity of conducting a Remedial Action and preparing and maintaining corresponding documentation, as well as, if necessary, making
any required submissions to the applicable Governmental Body. The Party Exploiting such Product subject to the Remedial Action shall
be solely responsible for all costs and expenses associated with such Remedial Action.
(c)
Regulatory Approvals. Each Party shall have the right to apply for and maintain, at its own cost and expense, all regulatory approvals
of the Products being developed by such Party. Subject to Section 8.3(a), each Party shall be responsible for and have sole discretion
over the preparation of all regulatory materials and all communications and interactions with the applicable regulatory authorities or
other Governmental Bodies with respect to the Products being developed by such Party, both prior to and subsequent to Regulatory Approval.
(d)
Manufacture and Supply.
(i)
At the request of Pulmatrix, the Parties agree to promptly negotiate in good faith and enter into supply agreements for the clinical
and commercial supply of the Cricket Device to Pulmatrix.
(ii)
Without limiting the generality of Section 2.9, at the request of MannKind, Pulmatrix will (x) transfer to MannKind all Know-How
and materials related to manufacturing using iSPERSE (including all CMC related information) as necessary or reasonably useful to enable
MannKind or its Third Party contract manufacturer to manufacture using iSPERSE and (y) provide MannKind with reasonable technical assistance
and support at MannKind’s reasonable cost and expense with respect to manufacturing using iSPERSE.
(e)
Pulmatrix Licensed Technology Transaction Notice. If, during the Term, Pulmatrix or any of its Affiliates determines to initiate
or otherwise engages in discussions with a Third Party (other than Teva Pharmaceutical Industries Ltd) regarding the assignment, transfer
or sale of Pulmatrix’s or its Affiliate’s right, title and interest in and to all or substantially all of the Pulmatrix Licensed
Technology, then Pulmatrix shall provide notice thereof to MannKind. At the request of MannKind after receipt of any such notice, (i)
Pulmatrix will, on a non-exclusive basis (unless otherwise agreed to by the Parties), engage in good faith negotiations with MannKind
regarding such potential assignment, transfer or sale and (ii) Pulmatrix will provide MannKind with a high-level summary of data, results,
and other material information that is relevant to the Pulmatrix Licensed Technology.
(f)
Ownership of Inventions. As between the Parties, each Party shall own all right, title and interest in and to all inventions and
intellectual property rights made solely by or on behalf of its or its Affiliates’ employees, agents, or independent contractors
in exercising its rights under this Agreement.
(g)
Project Technology. Notwithstanding anything to the contrary under the Pulmatrix Services Agreement, Pulmatrix hereby assigns
and transfers to MannKind all of its right, title and interest in and to Project Technology (as such term is defined in the Pulmatrix
Services Agreement) generated by or on behalf of Pulmatrix in performance of the services under the Pulmatrix Services Agreement and
Pulmatrix agrees to take, and to cause its employees, agents, and consultants to take, all further acts reasonably required to evidence
such assignment and transfer to MannKind, at MannKind’s reasonable expense.
ARTICLE
9 ADDITIONAL PROVISIONS
Section
9.1: Further Assurances.
Each
Party covenants and agrees to execute and deliver or cause to be executed and delivered to the other Party such instruments or further
assurances as may, in the reasonable opinion of such other Party, be necessary or desirable to give effect to the provisions of this
Agreement.
Section
9.2: Notices.
All
notices required or permitted under this Agreement shall be in writing and delivered via overnight mail or overnight courier service,
signature proof of receipt required. Notices shall be directed to the addresses set forth below and shall be deemed effective upon receipt.
Either Party may change its address for notices from time to time by providing written notice to the other Party.
If
to MannKind:
MannKind
Corporation
Attn:
General Counsel
30930
Russell Ranch Road, Suite 300
Westlake
Village, CA 91362
Email:
legal@mannkindcorp.com
If
to Pulmatrix:
Pulmatrix,
Inc.
Attn:
Ted Raad, CEO
945
Concord Street
Framingham
MA 01701
Email:
traad@pulmatrix.com
Section
9.3: Assignment.
The
Agreement shall be binding on the Parties and their successors and permitted assigns. Neither Party shall assign, transfer or delegate
any of its rights, duties or obligations under this Agreement, or any part thereof, whether by operation of law or otherwise, without
the prior written consent of the other Party, provided that either Party shall be entitled to assign or transfer this Agreement in connection
with the sale or acquisition of all or substantially all of its business to which this Agreement relates, whether by merger, sale of
stock, sale of assets or otherwise. Any assignment in violation of this paragraph shall be void ab initio.
Section
9.4: Publicity; Press Releases.
Except
as permitted pursuant to Section 7.4 or as otherwise required by applicable law, (a) neither Party shall, without the prior written
consent of the other Party which shall not be unreasonably withheld, issue any press releases or make any public statements concerning
the existence of or activities under this Agreement and (b) the Parties will mutually agree upon the content and timing of any press
release announcing the execution of this Agreement or otherwise relating to the terms of this Agreement.
Section
9.5: Modifications; Waiver.
This
Agreement may be modified only pursuant to a writing executed by authorized representatives of both Parties. The Parties expressly disclaim
the right to claim the enforceability of any oral modifications to this Agreement or any amendments based on course of dealing, waiver,
reliance, estoppel or other similar legal theory. No delay or omission by either Party to exercise any right occurring upon any non-compliance
or default of the other Party with respect to any of the terms of this Agreement shall impair any such right or be construed to be a
waiver thereof.
Section
9.6: No Third Party Beneficiaries.
This
Agreement is for the sole benefit of the Parties and their successors and permitted assigns and nothing herein, express or implied, shall
give or be construed to give any Person other than the Parties any legal or equitable rights hereunder.
Section
9.7: Severability.
In
the event any provision of this Agreement is determined by a court of competent jurisdiction to be invalid or unenforceable under applicable
law, such provision shall be amended and interpreted to accomplish the objectives of such provision to the greatest extent possible under
applicable law, and the remaining provisions of this Agreement shall continue in full force and effect.
Section
9.8: Governing Law.
This
Agreement shall be governed by and construed in accordance with the laws of Delaware, without reference to the principles of conflicts
of law that would apply the substantive laws of another jurisdiction. Notwithstanding the foregoing, nothing herein shall prevent either
Party from commencing an action for the purpose of seeking immediate injunctive relief in the appropriate jurisdiction.
Section
9.9: Survival.
Termination
or expiration of this Agreement shall not affect any rights or obligations of the Parties under this Agreement that have accrued prior
to the date of termination or expiration. Any provision of this Agreement that contemplates performance or observance subsequent to any
expiration or termination of this Agreement, or which is otherwise necessary to interpret the respective rights and obligations of the
Parties hereunder, shall survive any expiration or termination of this Agreement and continue in full force and effect, including without
limitation Section 4.1 (Term), Section 4.4 (Effects of Termination), Article 5 (Indemnification), Article 6
(Limitation of Liability), Article 7 (Confidentiality), and Article 9 (Additional Provisions).
Section
9.10: Headings; Construction.
The
headings of the various sections in this Agreement are for convenience of reference only and shall not affect the construction or interpretation
of this Agreement. The Parties acknowledge and agree that any principle of construction or rule of law that provides that an agreement
shall be construed against the drafter of the agreement in the event of any inconsistency or ambiguity in such agreement shall not apply
to the terms and conditions of this Agreement.
Section
9.11: Entire Agreement.
This
Agreement, together with the Schedules attached hereto, sets forth the entire and exclusive agreement between the Parties as to the subject
matter hereof and supersedes all prior and contemporaneous understandings, negotiations and agreements, written or oral, between the
Parties.
Section
9.12: Rights in Bankruptcy
(a)
The Parties intend to take advantage of the protections of Section 365(n) (or any successor provision) of the U.S. Bankruptcy Code or
any analogous provisions in any other country or jurisdiction to the maximum extent permitted by applicable law. All rights and licenses
granted under or pursuant to this Agreement, but only to the extent they constitute licenses of a right to “intellectual property”
as defined in Section 101 of the U.S. Bankruptcy Code or in any analogous provisions in any other country or jurisdiction (as the case
may be) shall be deemed to be “intellectual property” for the purposes of Section 365(n) or any analogous provisions in any
other country or jurisdiction (as the case may be). The Parties shall retain and may fully exercise all of their rights and elections
under the U.S. Bankruptcy Code or any analogous provisions in any other country or jurisdiction, including the right to obtain the intellectual
property from another entity.
(b)
During the Term, Licensor shall create and maintain current copies to the extent practicable of all such intellectual property. In the
event of the commencement of a bankruptcy proceeding by or against either Party under the U.S. Bankruptcy Code or any analogous provisions
in any other country or jurisdiction, the Party that is not subject to such proceeding shall be entitled to a complete duplicate of (or
complete access to, as appropriate) all such intellectual property (including all embodiments of such intellectual property), which,
if not already in the non-subject Party’s possession, shall be promptly delivered to it upon the non-subject Party’s written
request (a) after commencement of a bankruptcy proceeding, unless the Party subject to such proceeding continues to perform all of its
obligations under this Agreement, or (b) if not delivered pursuant to clause (a) above because the subject Party continues to perform,
upon the rejection of this Agreement by or on behalf of the subject Party.
(c)
All rights of the Parties under this Section 9.12 and under the U.S. Bankruptcy Code or any analogous provisions in any other
country or jurisdiction (as the case may be) are in addition to and not in substitution of any and all other rights, powers, and remedies
that each Party may have under this Agreement and any other applicable laws. If a case under the U.S. Bankruptcy Code or any analogous
provisions in any other country or jurisdiction (as the case may be) is commenced by or against Licensor, Licensee shall have the right
to perform the obligations of Licensor hereunder with respect to such intellectual property, but neither such provision nor such performance
by Licensee shall release Licensor from any such obligation or liability for failing to perform it.
(b)
The Parties agree that they intend the foregoing Licensee rights to extend to the maximum extent permitted by law and any provisions
of applicable contracts with Third Parties, including for purposes of the U.S. Bankruptcy Code or any analogous provisions in any other
country or jurisdiction (as the case may be), (i) the right of access to any intellectual property (including all embodiments thereof)
of Licensor or any Third Party with whom Licensor contracts to perform an obligation of Licensor under this Agreement, and, in the case
of the Third Party, which is necessary for the Exploitation of a product within the scope of the licenses granted to Licensee under this
Agreement and (ii) the right to contract directly with any Third Party described in (i) in this sentence to complete the contracted work.
Section
9.13: Counterparts.
This
Agreement may be executed in several counterparts, including by e-mail and with electronic signatures, each of which will be deemed an
original, and all of which taken together shall constitute one single agreement between the Parties with the same effect as if all the
signatures were upon the same instrument. An electronic signature shall be as legally effective as an original signature.
[SIGNATURE
PAGE FOLLOWS]
IN
WITNESS WHEREOF, the Parties have duly executed and delivered this Agreement as of the Effective Date.
MANNKIND
CORPORATION |
|
|
|
|
By: |
/s/
Michael Castagna |
|
Name: |
Michael
Castagna |
|
Title: |
Chief
Executive Officer |
|
|
|
|
PULMATRIX,
INC. |
|
|
|
|
By: |
/s/
Teofilo Raad |
|
Name: |
Teofilo
Raad |
|
Title: |
Chief
Executive Officer |
|
Schedule
1
Pulmatrix
Licensed Technology
Family
ID |
|
Patent
Application Title |
|
Country |
|
Application
Number |
|
Grant
Date |
|
Patent
No. |
PUL109 |
|
DRY
POWDER FORMULATIONS AND METHODS FOR TREATING PULMONARY DISEASES |
|
United
States of America |
|
61/267747 |
|
|
|
|
PUL109 |
|
DRY
POWDER FORMULATIONS AND METHODS FOR TREATING PULMONARY DISEASES |
|
Patent
Cooperation Treaty |
|
PCT/US2010/028961 |
|
|
|
|
PUL115 |
|
MONOVALENT
METAL CATION DRY POWDERS |
|
United
States of America |
|
61/387883 |
|
|
|
|
PUL117 |
|
DRY
POWDER FORMULATIONS AND METHODS FOR TREATING PULMONARY DISEASES |
|
United
States of America |
|
61/387925 |
|
|
|
|
PUL117 |
|
DRY
POWDER FORMULATIONS AND METHODS FOR TREATING PULMONARY DISEASES |
|
United
States of America |
|
61/431242 |
|
|
|
|
PUL115 |
|
MONOVALENT
METAL CATION DRY POWDERS |
|
United
States of America |
|
61/481879 |
|
|
|
|
PUL109 |
|
DRY
POWDER FORMULATIONS AND METHODS FOR TREATING PULMONARY DISEASES |
|
European
Patent |
|
10713283.9 |
|
15-Mar-2017 |
|
2410981 |
PUL109 |
|
DRY
POWDER FORMULATIONS AND METHODS FOR TREATING PULMONARY DISEASES |
|
European
Patent |
|
10713283.9_OPP |
|
15-Mar-2017 |
|
2410981 |
PUL117 |
|
DRY
POWDER FORMULATIONS AND METHODS FOR TREATING PULMONARY DISEASES |
|
Patent
Cooperation Treaty |
|
PCT/US2011/049435 |
|
|
|
|
PUL109 |
|
DRY
POWDER FORMULATIONS AND METHODS FOR TREATING PULMONARY DISEASES |
|
Australia |
|
2010229668 |
|
08-Sep-2016 |
|
2010229668 |
PUL109 |
|
DRY
POWDER FORMULATIONS AND METHODS FOR TREATING PULMONARY DISEASES |
|
Brazil |
|
PI1011721-0 |
|
16-Nov-2021 |
|
PI1011721-0 |
PUL109 |
|
DRY
POWDER FORMULATIONS AND METHODS FOR TREATING PULMONARY DISEASES |
|
Canada |
|
2754691 |
|
30-Jul-2019 |
|
2754691 |
PUL109 |
|
DRY
POWDER FORMULATIONS AND METHODS FOR TREATING PULMONARY DISEASES |
|
China |
|
201080023554.3 |
|
23-Mar-2018 |
|
ZL201080023554.3 |
PUL109 |
|
DRY
POWDER FORMULATIONS AND METHODS FOR TREATING PULMONARY DISEASES |
|
Russian
Federation |
|
2011137960 |
|
16-Feb-2016 |
|
2577698 |
PUL109 |
|
DRY
POWDER FORMULATIONS AND METHODS FOR TREATING PULMONARY DISEASES |
|
India |
|
7373/DELNP/2011 |
|
08-Sep-2021 |
|
376685 |
PUL109 |
|
DRY
POWDER FORMULATIONS AND METHODS FOR TREATING PULMONARY DISEASES |
|
Israel |
|
215276 |
|
01-Dec-2016 |
|
215276 |
PUL109 |
|
DRY
POWDER FORMULATIONS AND METHODS FOR TREATING PULMONARY DISEASES |
|
Japan |
|
2012-502314 |
|
26-Dec-2014 |
|
5671001 |
PUL109 |
|
DRY
POWDER FORMULATIONS AND METHODS FOR TREATING PULMONARY DISEASES |
|
Korea,
Republic of (KR) |
|
10-2011-7024843 |
|
06-Jul-2016 |
|
10-1639098 |
PUL109 |
|
DRY
POWDER FORMULATIONS AND METHODS FOR TREATING PULMONARY DISEASES |
|
Mexico |
|
MX/a/2011/009957 |
|
22-Mar-2018 |
|
354829 |
PUL109 |
|
DRY
POWDER FORMULATIONS AND METHODS FOR TREATING PULMONARY DISEASES |
|
New
Zealand |
|
595281 |
|
|
|
|
PUL109 |
|
DRY
POWDER FORMULATIONS AND METHODS FOR TREATING PULMONARY DISEASES |
|
United
States of America |
|
13/259635 |
|
|
|
|
PUL115 |
|
MONOVALENT
METAL CATION DRY POWDERS FOR INHALATION |
|
Patent
Cooperation Treaty |
|
PCT/US2011/053829 |
|
|
|
|
PUL121 |
|
PROCESSABLE
DRY POWDERS |
|
United
States of America |
|
61/605083 |
|
|
|
|
PUL121 |
|
PROCESSABLE
DRY POWDERS |
|
United
States of America |
|
61/607928 |
|
|
|
|
PUL121 |
|
PROCESSABLE
DRY POWDERS |
|
United
States of America |
|
61/645927 |
|
|
|
|
PUL121 |
|
PROCESSABLE
DRY POWDERS |
|
United
States of America |
|
61/648506 |
|
|
|
|
PUL109 |
|
DRY
POWDER FORMULATIONS AND METHODS FOR TREATING PULMONARY DISEASES |
|
Hong
Kong |
|
12106373.0 |
|
05-Jan-2018 |
|
1165709 |
PUL121 |
|
PROCESSABLE
DRY POWDERS |
|
United
States of America |
|
61/707071 |
|
|
|
|
PUL117 |
|
DRY
POWDER FORMULATIONS AND METHODS FOR TREATING PULMONARY DISEASES |
|
Australia |
|
2011296343 |
|
23-Mar-2016 |
|
2011296343 |
PUL117 |
|
DRY
POWDER FORMULATIONS AND METHODS FOR TREATING PULMONARY DISEASES |
|
Canada |
|
2809666 |
|
22-Sep-2020 |
|
2809666 |
PUL117 |
|
DRY
POWDER FORMULATIONS AND METHODS FOR TREATING PULMONARY DISEASES |
|
China |
|
201180052479.8 |
|
31-Jul-2018 |
|
ZL201180052479.8 |
PUL117 |
|
DRY
POWDER FORMULATIONS AND METHODS FOR TREATING PULMONARY DISEASES |
|
European
Patent |
|
11751775.5 |
|
01-Apr-2020 |
|
2611438 |
PUL117 |
|
DRY
POWDER FORMULATIONS AND METHODS FOR TREATING PULMONARY DISEASES |
|
Israel |
|
224916 |
|
|
|
|
PUL117 |
|
DRY
POWDER FORMULATIONS AND METHODS FOR TREATING PULMONARY DISEASES |
|
Japan |
|
2013-527146 |
|
29-Jan-2016 |
|
5877201 |
PUL117 |
|
DRY
POWDER FORMULATIONS AND METHODS FOR TREATING PULMONARY DISEASES |
|
New
Zealand |
|
607749 |
|
|
|
|
PUL117 |
|
DRY
POWDER FORMULATIONS AND METHODS FOR TREATING PULMONARY DISEASES |
|
United
States of America |
|
13/817963 |
|
23-Jun-2015 |
|
9061352 |
PUL115 |
|
MONOVALENT
METAL CATION DRY POWDERS FOR INHALATION |
|
Australia |
|
2011308865 |
|
20-Apr-2017 |
|
2011308865 |
PUL115 |
|
MONOVALENT
METAL CATION DRY POWDERS |
|
Brazil |
|
BR112013007304-7 |
|
14-Dec-2021 |
|
BR112013007304-7 |
PUL115 |
|
MONOVALENT
METAL CATION DRY POWDERS FOR INHALATION |
|
Canada |
|
2812414 |
|
22-Sep-2020 |
|
2812414 |
PUL115 |
|
MONOVALENT
METAL CATION DRY POWDERS FOR INHALATION |
|
China |
|
201180057314.X |
|
05-Apr-2017 |
|
ZL201180057314.X |
PUL115 |
|
MONOVALENT
METAL CATION DRY POWDERS FOR INHALATION |
|
European
Patent |
|
11770941.0 |
|
|
|
|
PUL115 |
|
MONOVALENT
METAL CATION DRY POWDERS FOR INHALATION |
|
Israel |
|
225398 |
|
01-Apr-2018 |
|
225398 |
PUL115 |
|
MONOVALENT
METAL CATION DRY POWDERS FOR INHALATION |
|
India |
|
2755/DELNP/2013 |
|
24-Sep-2019 |
|
321221 |
PUL115 |
|
MONOVALENT
METAL CATION DRY POWDERS FOR INHALATION |
|
Japan |
|
2013-531826 |
|
29-Jan-2016 |
|
5877204 |
PUL115 |
|
MONOVALENT
METAL CATION DRY POWDERS FOR INHALATION |
|
Korea,
Republic of (KR) |
|
10-2013-7010157 |
|
30-Oct-2018 |
|
101915241 |
PUL115 |
|
MONOVALENT
METAL CATION DRY POWDERS FOR INHALATION |
|
Mexico |
|
MX/a/2013/003478 |
|
22-Mar-2018 |
|
354828 |
PUL115 |
|
MONOVALENT
METAL CATION DRY POWDERS FOR INHALATION |
|
New
Zealand |
|
608834 |
|
|
|
|
PUL115 |
|
MONOVALENT
METAL CATION DRY POWDERS FOR INHALATION |
|
Russian
Federation |
|
2013118453 |
|
12-Jan-2018 |
|
2640921 |
PUL115 |
|
MONOVALENT
METAL CATION DRY POWDERS FOR INHALATION |
|
United
States of America |
|
13/876312 |
|
09-May-2017 |
|
9642798 |
PUL121 |
|
INHALABLE
DRY POWDERS |
|
Patent
Cooperation Treaty |
|
PCT/US2013/028261 |
|
|
|
|
PUL109 |
|
DRY
POWDER FORMULATIONS AND METHODS FOR TREATING PULMONARY DISEASES |
|
New
Zealand |
|
621065 |
|
03-Nov-2015 |
|
621065 |
PUL117 |
|
DRY
POWDER FORMULATIONS AND METHODS FOR TREATING PULMONARY DISEASES |
|
Hong
Kong |
|
13114302.9 |
|
|
|
|
PUL115 |
|
MONOVALENT
METAL CATION DRY POWDERS FOR INHALATION |
|
Hong
Kong |
|
14100210.8 |
|
|
|
|
PUL109 |
|
DRY
POWDER FORMULATIONS AND METHODS FOR TREATING PULMONARY DISEASES |
|
United
States of America |
|
14/456445 |
|
|
|
|
PUL121 |
|
INHALABLE
DRY POWDERS |
|
United
States of America |
|
14/378453 |
|
|
|
|
PUL121 |
|
INHALABLE
DRY POWDERS |
|
European
Patent |
|
13709666.5 |
|
|
|
|
PUL121 |
|
PROCESSABLE
DRY POWDERS |
|
Japan |
|
2014-560032 |
|
|
|
|
PUL121 |
|
INHALABLE
DRY POWDERS |
|
China |
|
201380020063.7 |
|
|
|
|
PUL121 |
|
INHALABLE
DRY POWDERS |
|
Australia |
|
2013225982 |
|
15-Mar-2018 |
|
2013225982 |
PUL121 |
|
INHALABLE
DRY POWDERS |
|
Canada |
|
2865972 |
|
04-Jan-2022 |
|
2865972 |
PUL121 |
|
INHALABLE
DRY POWDERS |
|
Israel |
|
234153 |
|
|
|
|
PUL121 |
|
INHALABLE
DRY POWDERS |
|
India |
|
6933/DELNP/2014 |
|
04-Dec-2020 |
|
353032 |
PUL121 |
|
INHALABLE
DRY POWDERS |
|
New
Zealand |
|
629722 |
|
04-Jul-2017 |
|
629722 |
PUL115 |
|
MONOVALENT
METAL CATION DRY POWDERS FOR INHALATION |
|
New
Zealand |
|
705080 |
|
01-Nov-2016 |
|
705080 |
PUL117 |
|
DRY
POWDER FORMULATIONS AND METHODS FOR TREATING PULMONARY DISEASES |
|
New
Zealand |
|
703804 |
|
30-Aug-2016 |
|
703804 |
PUL109 |
|
DRY
POWDER FORMULATIONS AND METHODS FOR TREATING PULMONARY DISEASES |
|
Japan |
|
2014-256325 |
|
08-Jul-2016 |
|
5964939 |
PUL115 |
|
MONOVALENT
METAL CATION DRY POWDERS FOR INHALATION |
|
United
States of America |
|
14/666959 |
|
|
|
|
PUL109 |
|
DRY
POWDER FORMULATIONS AND METHODS FOR TREATING PULMONARY DISEASES |
|
United
States of America |
|
14/667857 |
|
01-Sep-2015 |
|
9119778 |
PUL117 |
|
DRY
POWDER FORMULATIONS AND METHODS FOR TREATING PULMONARY DISEASES |
|
United
States of America |
|
14/717243 |
|
12-Jan-2016 |
|
9233158 |
PUL121 |
|
INHALABLE
DRY POWDERS |
|
Hong
Kong |
|
15105912.7 |
|
|
|
|
PUL109 |
|
DRY
POWDER FORMULATIONS AND METHODS FOR TREATING PULMONARY DISEASES |
|
United
States of America |
|
14/804940 |
|
19-Jan-2016 |
|
9238005 |
PUL109 |
|
DRY
POWDER FORMULATIONS AND METHODS FOR TREATING PULMONARY DISEASES |
|
United
States of America |
|
14/960695 |
|
|
|
|
PUL117 |
|
DRY
POWDER FORMULATIONS AND METHODS FOR TREATING PULMONARY DISEASES |
|
United
States of America |
|
14/954128 |
|
|
|
|
PUL117 |
|
DRY
POWDER FORMULATIONS AND METHODS FOR TREATING PULMONARY DISEASES |
|
China |
|
201610054941.2 |
|
16-Aug-2019 |
|
ZL201610054941.2 |
PUL115 |
|
MONOVALENT
METAL CATION DRY POWDERS FOR INHALATION |
|
Japan |
|
2016-011411 |
|
04-Aug-2017 |
|
6186458 |
PUL117 |
|
DRY
POWDER FORMULATIONS AND METHODS FOR TREATING PULMONARY DISEASES |
|
United
States of America |
|
15/095586 |
|
|
|
|
PUL109 |
|
DRY
POWDER FORMULATIONS AND METHODS FOR TREATING PULMONARY DISEASES |
|
Israel |
|
|
|
|
|
|
PUL109 |
|
DRY
POWDER FORMULATIONS AND METHODS FOR TREATING PULMONARY DISEASES |
|
United
States of America |
|
15/095319 |
|
|
|
|
PUL109 |
|
DRY
POWDER FORMULATIONS AND METHODS FOR TREATING PULMONARY DISEASES |
|
European
Patent |
|
17000124.2 |
|
|
|
|
PUL109 |
|
DRY
POWDER FORMULATIONS AND METHODS FOR TREATING PULMONARY DISEASES |
|
United
States of America |
|
15/245656 |
|
|
|
|
PUL117 |
|
DRY
POWDER FORMULATIONS AND METHODS FOR TREATING PULMONARY DISEASES |
|
United
States of America |
|
15/247040 |
|
|
|
|
PUL115 |
|
MONOVALENT
METAL CATION DRY POWDERS FOR INHALATION |
|
United
States of America |
|
15/277062 |
|
13-Aug-2019 |
|
10376465 |
PUL115 |
|
MONOVALENT
METAL CATION DRY POWDERS FOR INHALATION |
|
Australia |
|
2016269398 |
|
17-Jan-2019 |
|
2016269398 |
PUL109 |
|
DRY
POWDER FORMULATIONS AND METHODS FOR TREATING PULMONARY DISEASES |
|
United
States of America |
|
15/401215 |
|
|
|
|
PUL117 |
|
DRY
POWDER FORMULATIONS AND METHODS FOR TREATING PULMONARY DISEASES |
|
United
States of America |
|
15/401303 |
|
|
|
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PUL115 |
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MONOVALENT
METAL CATION DRY POWDERS FOR INHALATION |
|
China |
|
201710140007.7 |
|
15-Jul-2022 |
|
ZL201710140007.7 |
PUL121 |
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METHODS
FOR PRODUCING RESPIRABLE DRY POWDERS |
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United
States of America |
|
15/495450 |
|
17-Mar-2020 |
|
10589039 |
PUL109 |
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DRY
POWDER FORMULATIONS AND METHODS FOR TREATING PULMONARY DISEASES |
|
United
States of America |
|
15/601669 |
|
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PUL117 |
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DRY
POWDER FORMULATIONS AND METHODS FOR TREATING PULMONARY DISEASES |
|
United
States of America |
|
15/602724 |
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PUL121 |
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PROCESSABLE
DRY POWDERS |
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Japan |
|
2017-104816 |
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PUL121 |
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INHALABLE
DRY POWDERS |
|
China |
|
201710695234.6 |
|
23-Apr-2021 |
|
ZL201710695234.6 |
PUL115 |
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MONOVALENT
METAL CATION DRY POWDERS FOR INHALATION |
|
Japan |
|
2017-148309 |
|
31-Aug-2018 |
|
6392422 |
PUL109 |
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DRY
POWDER FORMULATIONS AND METHODS FOR TREATING PULMONARY DISEASES |
|
United
States of America |
|
15/720690 |
|
|
|
|
PUL117 |
|
DRY
POWDER FORMULATIONS AND METHODS FOR TREATING PULMONARY DISEASES |
|
United
States of America |
|
15/720445 |
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PUL115 |
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MONOVALENT
METAL CATION DRY POWDERS FOR INHALATION |
|
Israel |
|
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|
01-Jul-2020 |
|
256360 |
PUL109 |
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DRY
POWDER FORMULATIONS AND METHODS FOR TREATING PULMONARY DISEASES |
|
Hong
Kong |
|
17113613.1 |
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PUL115 |
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MONOVALENT
METAL CATION DRY POWDERS FOR INHALATION |
|
Russian
Federation |
|
2017144619 |
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PUL109 |
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DRY
POWDER FORMULATIONS AND METHODS FOR TREATING PULMONARY DISEASES |
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China |
|
201810147094.3 |
|
19-Nov-2021 |
|
ZL201810147094.3 |
PUL109 |
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DRY
POWDER FORMULATIONS AND METHODS FOR TREATING PULMONARY DISEASES |
|
United
States of America |
|
15/897274 |
|
|
|
|
PUL117 |
|
DRY
POWDER FORMULATIONS AND METHODS FOR TREATING PULMONARY DISEASES |
|
United
States of America |
|
15/897345 |
|
|
|
|
PUL115 |
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MONOVALENT
METAL CATION DRY POWDERS FOR INHALATION |
|
Mexico |
|
MX/a/2018/002638 |
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PUL109 |
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DRY
POWDER FORMULATIONS AND METHODS FOR TREATING PULMONARY DISEASES |
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Belgium |
|
10713283.9 |
|
15-Mar-2017 |
|
2410981 |
PUL109 |
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DRY
POWDER FORMULATIONS AND METHODS FOR TREATING PULMONARY DISEASES |
|
Switzerland |
|
10713283.9 |
|
15-Mar-2017 |
|
2410981 |
PUL109 |
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DRY
POWDER FORMULATIONS AND METHODS FOR TREATING PULMONARY DISEASES |
|
Germany
(Federal Republic of) |
|
10713283.9 |
|
15-Mar-2017 |
|
602010040750.0 |
PUL109 |
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DRY
POWDER FORMULATIONS AND METHODS FOR TREATING PULMONARY DISEASES |
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Denmark |
|
10713283.9 |
|
15-Mar-2017 |
|
2410981 |
PUL109 |
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DRY
POWDER FORMULATIONS AND METHODS FOR TREATING PULMONARY DISEASES |
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Spain |
|
10713283.9 |
|
15-Mar-2017 |
|
2410981 |
PUL109 |
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DRY
POWDER FORMULATIONS AND METHODS FOR TREATING PULMONARY DISEASES |
|
United
Kingdom |
|
10713283.9 |
|
15-Mar-2017 |
|
2410981 |
PUL109 |
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DRY
POWDER FORMULATIONS AND METHODS FOR TREATING PULMONARY DISEASES |
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Ireland
(Republic of) |
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10713283.9 |
|
15-Mar-2017 |
|
2410981 |
PUL109 |
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DRY
POWDER FORMULATIONS AND METHODS FOR TREATING PULMONARY DISEASES |
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Netherlands |
|
10713283.9 |
|
15-Mar-2017 |
|
2410981 |
PUL109 |
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DRY
POWDER FORMULATIONS AND METHODS FOR TREATING PULMONARY DISEASES |
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Norway |
|
10713283.9 |
|
15-Mar-2017 |
|
2410981 |
PUL109 |
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DRY
POWDER FORMULATIONS AND METHODS FOR TREATING PULMONARY DISEASES |
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Portugal |
|
10713283.9 |
|
15-Mar-2017 |
|
2410981 |
PUL109 |
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DRY
POWDER FORMULATIONS AND METHODS FOR TREATING PULMONARY DISEASES |
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Sweden |
|
10713283.9 |
|
15-Mar-2017 |
|
2410981 |
PUL109 |
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DRY
POWDER FORMULATIONS AND METHODS FOR TREATING PULMONARY DISEASES |
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France |
|
10713283.9 |
|
15-Mar-2017 |
|
2410981 |
PUL109 |
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DRY
POWDER FORMULATIONS AND METHODS FOR TREATING PULMONARY DISEASES |
|
United
States of America |
|
16/039547 |
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PUL117 |
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DRY
POWDER FORMULATIONS AND METHODS FOR TREATING PULMONARY DISEASES |
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United
States of America |
|
16/036226 |
|
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PUL115 |
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MONOVALENT
METAL CATION DRY POWDERS FOR INHALATION |
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Korea,
Republic of (KR) |
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10-2018-7031481 |
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PUL117 |
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DRY
POWDER FORMULATIONS AND METHODS FOR TREATING PULMONARY DISEASES |
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United
States of America |
|
16/202422 |
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PUL109 |
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DRY
POWDER FORMULATIONS AND METHODS FOR TREATING PULMONARY DISEASES |
|
United
States of America |
|
16/202457 |
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PUL121 |
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INHALABLE
DRY POWDERS |
|
China |
|
201910141714.7 |
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PUL117 |
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DRY
POWDER FORMULATIONS AND METHODS FOR TREATING PULMONARY DISEASES |
|
United
States of America |
|
16/389178 |
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|
|
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PUL109 |
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DRY
POWDER FORMULATIONS AND METHODS FOR TREATING PULMONARY DISEASES |
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United
States of America |
|
16/389065 |
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|
|
|
PUL115 |
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MONOVALENT
METAL CATION DRY POWDERS |
|
United
States of America |
|
16/456990 |
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|
|
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PUL121 |
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PROCESSABLE
DRY POWDERS |
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Japan |
|
2019-128556 |
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PUL109 |
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DRY
POWDER FORMULATIONS AND METHODS FOR TREATING PULMONARY DISEASES |
|
United
States of America |
|
16/559096 |
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|
|
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PUL117 |
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DRY
POWDER FORMULATIONS AND METHODS FOR TREATING PULMONARY DISEASES |
|
United
States of America |
|
16/562027 |
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|
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PUL115 |
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A
RESPIRABLE DRY POWDER |
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India |
|
201918037611 |
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PUL115 |
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A
RESPIRABLE DRY POWDER COMPRISING RESPIRABLE DRY PARTICLES |
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India |
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201918037610 |
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MONOVALENT
METAL CATION DRY POWDERS FOR INHALATION |
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Israel |
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PUL121 |
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INHALABLE
DRY POWDERS |
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United
States of America |
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16/752841 |
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20-Oct-2020 |
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PUL109 |
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DRY
POWDER FORMULATIONS AND METHODS FOR TREATING PULMONARY DISEASES |
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United
States of America |
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16/781744 |
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|
|
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PUL117 |
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DRY
POWDER FORMULATIONS AND METHODS FOR TREATING PULMONARY DISEASES |
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United
States of America |
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16/781704 |
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PUL117 |
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DRY
POWDER FORMULATIONS AND METHODS FOR TREATING PULMONARY DISEASES |
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United
Kingdom |
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|
01-Apr-2020 |
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DRY
POWDER FORMULATIONS AND METHODS FOR TREATING PULMONARY DISEASES |
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Germany
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01-Apr-2020 |
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PUL117 |
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DRY
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France |
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01-Apr-2020 |
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MONOVALENT
METAL CATION DRY POWDERS FOR INHALATION |
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Canada |
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DRY
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United
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PUL117 |
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DRY
POWDER FORMULATIONS AND METHODS FOR TREATING PULMONARY DISEASES |
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United
States of America |
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PUL121 |
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INHALABLE
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United
States of America |
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01-Feb-2022 |
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United
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PUL117 |
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DRY
POWDER FORMULATIONS AND METHODS FOR TREATING PULMONARY DISEASES |
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United
States of America |
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17/097018 |
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PUL155 |
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DIHYDROERGOTAMINE
DRY POWDER FORMULATIONS AND METHODS OF USE |
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United
States of America |
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PUL115 |
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MONOVALENT
METAL CATION DRY POWDER FOR INHALATION |
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United
States of America |
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16-Nov-2021 |
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METAL CATION DRY POWDERS FOR INHALATION |
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Canada |
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POWDER FORMULATIONS AND METHODS FOR TREATING PULMONARY DISEASES |
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United
States of America |
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PUL117 |
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DRY
POWDER FORMULATIONS AND METHODS FOR TREATING PULMONARY DISEASES |
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United
States of America |
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PUL109 |
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DRY
POWDER FORMULATIONS AND METHODS FOR TREATING PULMONARY DISEASES |
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United
States of America |
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PUL117 |
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DRY
POWDER FORMULATIONS AND METHODS FOR TREATING PULMONARY DISEASES |
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United
States of America |
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17/402147 |
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PUL115 |
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MONOVALENT
METAL CATION DRY POWDERS FOR INHALATION |
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United
States of America |
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17/494241 |
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PUL117 |
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DRY
POWDER FORMULATIONS AND METHODS FOR TREATING PULMONARY DISEASES |
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United
States of America |
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DIHYDROERGOTAMINE
DRY POWDER FORMULATIONS AND METHODS OF USE |
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Israel |
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METAL CATION DRY POWDERS FOR INHALATION |
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United
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PUL115 |
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MONOVALENT
METAL CATION DRY POWDERS FOR INHALATION |
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United
States of America |
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17/848610 |
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United
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United
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United
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PUL109 |
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DRY
POWDER FORMULATIONS AND METHODS FOR TREATING PULMONARY DISEASES |
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United
States of America |
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PUL115 |
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MONOVALENT
METAL CATION DRY POWDERS FOR INHALATION |
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United
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18/050584 |
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PUL121 |
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INHALABLE
DRY POWDERS |
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United
States of America |
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PUL117 |
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DRY
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United
States of America |
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18/160011 |
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PUL109 |
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DRY
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United
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INHALABLE
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United
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DRY
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United
States of America |
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18/342136 |
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PUL117 |
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DRY
POWDER FORMULATIONS AND METHODS FOR TREATING PULMONARY DISEASES |
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United
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PUL115 |
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MONOVALENT
METAL CATION DRY POWDERS FOR INHALATION |
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United
States of America |
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PUL109 |
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DRY
POWDER FORMULATIONS AND METHODS FOR TREATING PULMONARY DISEASES |
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United
States of America |
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18/348265 |
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PUL115 |
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MONOVALENT
METAL CATION DRY POWDERS FOR INHALATION |
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United
States of America |
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PUL115 |
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MONOVALENT
METAL CATION DRY POWDERS FOR INHALATION |
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United
States of America |
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18/400030 |
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PUL115 |
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MONOVALENT
METAL CATION DRY POWDERS FOR INHALATION |
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United
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18/663609 |
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Mexico |
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PUL121 |
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INHALABLE
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United
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INHALABLE
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United
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METHODS
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Patent
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PUL109 |
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DRY
POWDER FORMULATIONS AND METHODS FOR TREATING PULMONARY DISEASES |
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United
States of America |
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18/515615 |
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PUL109 |
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DRY
POWDER FORMULATIONS AND METHODS FOR TREATING PULMONARY DISEASES |
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United
States of America |
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18/626633 |
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DIHYDROERGOTAMINE
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Australia |
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Brazil |
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Japan |
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DRY POWDER FORMULATIONS AND METHODS OF USE |
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DIHYDROERGOTAMINE
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Mexico |
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DRY POWDER FORMULATIONS AND METHODS OF USE |
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New
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DRY POWDER FORMULATIONS AND METHODS OF USE |
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Russian
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DIHYDROERGOTAMINE
DRY POWDER FORMULATIONS AND METHODS OF USE |
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DRY POWDER COMPRISING CALCIUM LACTATE, SODIUM CHLORIDE AND LEUCINE |
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United
States of America |
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13/504284 |
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RESPIRABLY
DRY POWDER COMPRISING CALCIUM LACTATE, SODIUM CHLORIDE AND LEUCINE |
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Hong
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Switzerland |
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PUL114 |
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RESPIRABLY
DRY POWDER COMPRISING CALCIUM LACTATE, SODIUM CHLORIDE AND LEUCINE |
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Germany |
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|
RESPIRABLY
DRY POWDER COMPRISING CALCIUM LACTATE, SODIUM CHLORIDE AND LEUCINE |
|
Sweden |
|
11757713.0 |
|
|
|
2448571 |
PUL114 |
|
RESPIRABLY
DRY POWDER COMPRISING CALCIUM LACTATE, SODIUM CHLORIDE AND LEUCINE |
|
United
Kingdom |
|
11757713.0 |
|
|
|
2448571 |
PUL114 |
|
RESPIRABLY
DRY POWDER COMPRISING CALCIUM LACTATE, SODIUM CHLORIDE AND LEUCINE |
|
United
States of America |
|
14/284880 |
|
|
|
8992983 |
PUL114 |
|
RESPIRABLY
DRY POWDER COMPRISING CALCIUM LACTATE, SODIUM CHLORIDE AND LEUCINE |
|
United
States of America |
|
14/633432 |
|
|
|
|
PUL116 |
|
CATIONIC
DRY POWDERS |
|
United
States of America |
|
61/387855 |
|
|
|
|
PUL116 |
|
CATIONIC
DRY POWDERS |
|
Patent
Cooperation Treaty |
|
PCT/US2011/053833 |
|
|
|
|
PUL116 |
|
CATIONIC
DRY POWDERS |
|
Australia |
|
2011314007 |
|
04-May-2017 |
|
2011314007 |
PUL116 |
|
CATIONIC
DRY POWDERS |
|
Canada |
|
2812417 |
|
22-Oct-2019 |
|
2812417 |
PUL116 |
|
CATIONIC
DRY POWDERS |
|
European
Patent |
|
11767877.1 |
|
07-Nov-2018 |
|
2621488 |
PUL116 |
|
CATIONIC
DRY POWDERS |
|
Israel |
|
225399 |
|
28-May-2020 |
|
225399 |
PUL116 |
|
CATIONIC
DRY POWDERS |
|
New
Zealand |
|
608838 |
|
|
|
|
PUL116 |
|
CATIONIC
DRY POWDERS |
|
United
States of America |
|
13/876315 |
|
06-Sep-2016 |
|
9433576 |
PUL116 |
|
CATIONIC
DRY POWDERS |
|
United
States of America |
|
15/220732 |
|
29-Aug-2017 |
|
9744130 |
PUL116 |
|
CATIONIC
DRY POWDERS |
|
United
States of America |
|
15/650255 |
|
|
|
|
PUL116 |
|
CATIONIC
DRY POWDERS |
|
United
States of America |
|
15/819749 |
|
|
|
|
PUL116 |
|
CATIONIC
DRY POWDERS |
|
United
States of America |
|
15/958101 |
|
|
|
|
PUL116 |
|
CATIONIC
DRY POWDERS |
|
United
States of America |
|
16/129278 |
|
|
|
|
PUL116 |
|
CATIONIC
DRY POWDERS |
|
Belgium |
|
11767877.1 |
|
07-Nov-2018 |
|
2621488 |
PUL116 |
|
CATIONIC
DRY POWDERS |
|
Switzerland |
|
11767877.1 |
|
07-Nov-2018 |
|
2621488 |
PUL116 |
|
CATIONIC
DRY POWDERS |
|
Germany |
|
11767877.1 |
|
07-Nov-2018 |
|
602011053653.2 |
PUL116 |
|
CATIONIC
DRY POWDERS |
|
Denmark |
|
11767877.1 |
|
07-Nov-2018 |
|
|
PUL116 |
|
CATIONIC
DRY POWDERS |
|
France |
|
11767877.1 |
|
07-Nov-2018 |
|
|
PUL116 |
|
CATIONIC
DRY POWDERS |
|
United
Kingdom |
|
11767877.1 |
|
07-Nov-2018 |
|
|
PUL116 |
|
CATIONIC
DRY POWDERS |
|
Ireland |
|
11767877.1 |
|
07-Nov-2018 |
|
|
PUL116 |
|
CATIONIC
DRY POWDERS |
|
Netherlands |
|
11767877.1 |
|
07-Nov-2018 |
|
|
PUL116 |
|
CATIONIC
DRY POWDERS |
|
Norway |
|
11767877.1 |
|
07-Nov-2018 |
|
|
PUL116 |
|
CATIONIC
DRY POWDERS |
|
Sweden |
|
11767877.1 |
|
07-Nov-2018 |
|
|
PUL116 |
|
CATIONIC
DRY POWDERS |
|
Spain |
|
11767877.1 |
|
07-Nov-2018 |
|
|
PUL116 |
|
CATIONIC
DRY POWDERS |
|
Portugal |
|
11767877.1 |
|
07-Nov-2018 |
|
|
PUL116 |
|
CATIONIC
DRY POWDERS |
|
United
States of America |
|
16/272045 |
|
|
|
|
PUL116 |
|
CATIONIC
DRY POWDERS |
|
United
States of America |
|
16/455350 |
|
|
|
|
PUL116 |
|
CATIONIC
DRY POWDERS |
|
United
States of America |
|
16/675956 |
|
|
|
|
PUL116 |
|
CATIONIC
DRY POWDERS |
|
United
States of America |
|
16/837541 |
|
|
|
|
PUL116 |
|
CATIONIC
DRY POWDERS |
|
United
States of America |
|
17/003172 |
|
|
|
|
PUL116 |
|
CATIONIC
DRY POWDERS |
|
United
States of America |
|
17/140602 |
|
|
|
|
PUL116 |
|
CATIONIC
DRY POWDERS |
|
United
States of America |
|
17/349449 |
|
|
|
|
PUL116 |
|
CATIONIC
DRY POWDERS |
|
United
States of America |
|
17/513289 |
|
|
|
|
PUL116 |
|
CATIONIC
DRY POWDERS |
|
United
States of America |
|
17/693336 |
|
|
|
|
PUL116 |
|
CATIONIC
DRY POWDERS |
|
United
States of America |
|
17/866848 |
|
|
|
|
PUL116 |
|
CATIONIC
DRY POWDERS |
|
United
States of America |
|
18/061214 |
|
|
|
|
PUL116 |
|
CATIONIC
DRY POWDERS |
|
United
States of America |
|
18/303612 |
|
|
|
|
PUL116 |
|
CATIONIC
DRY POWDERS |
|
United
States of America |
|
18/464491 |
|
|
|
|
PUL116 |
|
CATIONIC
DRY POWDERS |
|
United
States of America |
|
18/413779 |
|
|
|
|
Schedule
2
MannKind
Licensed Technology
MANNKIND REF. |
|
ATTORNEY
Ref. |
|
Country |
|
Serial
# |
|
File
Date |
|
Patent
# |
|
Issue Date |
|
Status |
|
Exp.
Date |
A
DRY POWDER INHALER AND SYSTEM FOR DRUG DELIVERY |
51300-00074-AR |
|
51300-00074-AR |
|
ARGENTINA |
|
P-090102125 |
|
6/12/2009 |
|
AR072114B1 |
|
9/15/2016 |
|
ISSUED |
|
6/12/2029 |
51300-00074-AR-1 |
|
51300-00074.1AR |
|
ARGENTINA |
|
20160100755 |
|
3/21/2016 |
|
AR104034B2 |
|
7/29/2021 |
|
ISSUED |
|
6/12/2029 |
51300-00074-AR-2 |
|
51300-00074.2 |
|
ARGENTINA |
|
20160100756 |
|
3/21/2016 |
|
AR104035B2 |
|
9/29/2023 |
|
ISSUED |
|
6/12/2029 |
51300-00074-AU |
|
51300-00074-AU |
|
AUSTRALIA |
|
2009257311 |
|
6/12/2009 |
|
2009257311 |
|
3/19/2015 |
|
ISSUED |
|
6/12/2029 |
51300-00074-AU-1 |
|
51300-00074.1-
AU |
|
AUSTRALIA |
|
2014200952 |
|
2/24/2014 |
|
2014200952 |
|
3/26/2015 |
|
ISSUED |
|
6/12/2029 |
51300-00074-AU-2 |
|
51300-00074.2-AU |
|
AUSTRALIA |
|
2014200982 |
|
2/24/2014 |
|
2014200982 |
|
1/14/2016 |
|
ISSUED |
|
6/12/2029 |
51300-00074-AU-3 |
|
51300-00074.3-AU |
|
AUSTRALIA |
|
2014200975 |
|
2/24/2014 |
|
2014200975 |
|
5/21/2015 |
|
ISSUED |
|
6/12/2029 |
51300-00074-AU-4 |
|
51300-00074.4-AU |
|
AUSTRALIA |
|
2015200947 |
|
6/12/2009 |
|
2015200947 |
|
8/24/2017 |
|
ISSUED |
|
6/12/2029 |
51300-00074-BR |
|
51300-00074-BR |
|
BRAZIL |
|
PI0914998-8 |
|
6/12/2009 |
|
PI09149988 |
|
8/3/2021 |
|
ISSUED |
|
6/12/2029 |
51300-00074-CA |
|
51300-00074-CA |
|
CANADA |
|
2728230 |
|
6/12/2009 |
|
2728230 |
|
10/17/2017 |
|
ISSUED |
|
6/12/2029 |
51300-00074-CA-1 |
|
51300.00325
CA DIV |
|
CANADA |
|
2982550 |
|
6/12/2009 |
|
2982550 |
|
8/25/2020 |
|
ISSUED |
|
6/12/2029 |
51300-00074-CA-2 |
|
51300.00424
CA |
|
CANADA |
|
3086027 |
|
6/12/2009 |
|
3086027 |
|
5/17/2022 |
|
ISSUED |
|
6/12/2029 |
51300-00074-CA-3 |
|
51300.00466 |
|
CANADA |
|
3153292 |
|
6/12/2009 |
|
|
|
|
|
PENDING |
|
6/12/2029 |
51300-00074-CN-1 |
|
51300.00074.1
CN |
|
CHINA |
|
200980000440.4 |
|
6/12/2009 |
|
CN101827626B |
|
3/18/2015 |
|
ISSUED |
|
6/12/2029 |
51300-00074-CN-3 |
|
51300-000175-CN |
|
CHINA |
|
201410612764.6 |
|
6/12/2009 |
|
104491962 |
|
10/23/2018 |
|
ISSUED |
|
6/12/2029 |
51300-00074-CN-4 |
|
51300.00074.3
CN |
|
CHINA |
|
201510084945.0 |
|
6/12/2009 |
|
104689432 |
|
7/6/2018 |
|
ISSUED |
|
6/12/2029 |
51300-00074-EP-1 |
|
51300-00074-EPDIV1 |
|
EUROPE |
|
12170549.5
(EP 2570147) |
|
6/1/2012 |
|
2570147 |
|
10/18/2017 |
|
VALIDATED |
|
6/12/2029 |
51300-00074-BE-1 |
|
51300-00074-BE-1 |
|
BELGIUM |
|
12170549.5 |
|
6/1/2012 |
|
2570147 |
|
10/18/2017 |
|
ISSUED |
|
6/12/2029 |
51300-00074-DE-1 |
|
51300-00074-DE-1 |
|
GERMANY |
|
12170549.5 |
|
6/1/2012 |
|
2570147 |
|
10/18/2017 |
|
ISSUED |
|
6/12/2029 |
51300-00074-DK-1 |
|
51300-00074-DK-1 |
|
DENMARK |
|
12170549.5 |
|
6/1/2012 |
|
2570147 |
|
10/18/2017 |
|
ISSUED |
|
6/12/2029 |
51300-00074-ES-1 |
|
51300-00074-ES-1 |
|
SPAIN |
|
12170549.5 |
|
6/1/2012 |
|
2570147 |
|
10/18/2017 |
|
ISSUED |
|
6/12/2029 |
51300-00074-FR-1 |
|
51300-00074-FR-1 |
|
FRANCE |
|
12170549.5 |
|
6/1/2012 |
|
2570147 |
|
10/18/2017 |
|
ISSUED |
|
6/12/2029 |
51300-00074-GB-1 |
|
51300-00074-GB-1 |
|
UNITED
KINGDOM |
|
12170549.5 |
|
6/1/2012 |
|
2570147 |
|
10/18/2017 |
|
ISSUED |
|
6/12/2029 |
51300-00074-IE-1 |
|
51300-00074-IE-1 |
|
IRELAND |
|
12170549.5 |
|
6/1/2012 |
|
2570147 |
|
10/18/2017 |
|
ISSUED |
|
6/12/2029 |
51300-00074-IT-1 |
|
51300-00074-IT-1 |
|
ITALY |
|
12170549.5 |
|
6/1/2012 |
|
2570147 |
|
10/18/2017 |
|
ISSUED |
|
6/12/2029 |
51300-00074-LI-1 |
|
51300-00074-LI-1 |
|
LIECHTENSTEIN |
|
12170549.5 |
|
6/1/2012 |
|
2570147 |
|
10/18/2017 |
|
ISSUED |
|
6/12/2029 |
51300-00074-LU-1 |
|
51300-00074-LU-1 |
|
LUXEMBOURG |
|
12170549.5 |
|
6/1/2012 |
|
2570147 |
|
10/18/2017 |
|
ISSUED |
|
6/12/2029 |
51300-00074-NL-1 |
|
51300-00074-NL-1 |
|
NETHERLANDS |
|
12170549.5 |
|
6/1/2012 |
|
2570147 |
|
10/18/2017 |
|
ISSUED |
|
6/12/2029 |
51300-00074-CH-1 |
|
51300-00074-CH-1 |
|
SWITZERLAND |
|
12170549.5 |
|
6/1/2012 |
|
2570147 |
|
10/18/2017 |
|
ISSUED |
|
6/12/2029 |
51300-00074-SE-1 |
|
51300-00074-SE-1 |
|
SWEDEN |
|
12170549.5 |
|
6/1/2012 |
|
2570147 |
|
10/18/2017 |
|
ISSUED |
|
6/12/2029 |
51300-00074-EP-2 |
|
51300-00074-EPDIV2 |
|
EUROPE |
|
EP12170583.4 |
|
6/1/2012 |
|
2567723 |
|
1/20/2021 |
|
VALIDATED |
|
6/12/2029 |
51300-00074-DE-2 |
|
51300-00074-DE-2 |
|
GERMANY |
|
EP12170583.4 |
|
6/1/2012 |
|
2567723 |
|
1/20/2021 |
|
ISSUED |
|
6/12/2029 |
51300-00074-FR-2 |
|
51300-00074-FR-2 |
|
FRANCE |
|
EP12170583.4 |
|
6/1/2012 |
|
2567723 |
|
1/20/2021 |
|
ISSUED |
|
6/12/2029 |
51300-00074-GB-2 |
|
51300-00074-GB-2 |
|
UNITED
KINGDOM |
|
EP12170583.4 |
|
6/1/2012 |
|
2567723 |
|
1/20/2021 |
|
ISSUED |
|
6/12/2029 |
51300-00074-EP-3 |
|
1951300.00323EPDIV |
|
EUROPE |
|
17191023.5 |
|
9/14/2017 |
|
3281663 |
|
8/17/2022 |
|
ISSUED |
|
6/12/2029 |
51300-00074-DE-3 |
|
1951300.00323DEDIV |
|
GERMANY |
|
17191023.5 |
|
9/14/2017 |
|
3281663 |
|
8/17/2022 |
|
ISSUED |
|
6/12/2029 |
51300-00074-FR-3 |
|
1951300.00323FRDIV |
|
FRANCE |
|
17191023.5 |
|
9/14/2017 |
|
3281663 |
|
8/17/2022 |
|
ISSUED |
|
6/12/2029 |
51300-00074-ES-3 |
|
1951300.00323ESDIV |
|
SPAIN |
|
17191023.5 |
|
9/14/2017 |
|
3281663 |
|
8/17/2022 |
|
ISSUED |
|
6/12/2029 |
51300-00074-IT-3 |
|
1951300.00323ITDIV |
|
ITALY |
|
17191023.5 |
|
9/14/2017 |
|
3281663 |
|
8/17/2022 |
|
ISSUED |
|
6/12/2029 |
51300-00074-CH-3 |
|
1951300.00323CHDIV |
|
SWITZERLAND |
|
17191023.5 |
|
9/14/2017 |
|
3281663 |
|
8/17/2022 |
|
ISSUED |
|
6/12/2029 |
51300-00074-NL-3 |
|
1951300.00323NLDIV |
|
NETHERLANDS |
|
17191023.5 |
|
9/14/2017 |
|
3281663 |
|
8/17/2022 |
|
ISSUED |
|
6/12/2029 |
51300-00074-GB-3 |
|
1951300.00323GBDIV |
|
UNITED
KINGDOM |
|
17191023.5 |
|
9/14/2017 |
|
3281663 |
|
8/17/2022 |
|
ISSUED |
|
6/12/2029 |
51300-00074-HK-3-EP2 |
|
51300-00074.2HK |
|
HONG
KONG |
|
13110557.9 |
|
6/12/2009 |
|
HK1183251 |
|
5/7/2021 |
|
ISSUED |
|
6/12/2029 |
51300-00074-HK-CN1 |
|
51300-00074-1-HK |
|
Hong
Kong |
|
11101802.3 |
|
2/24/2011 |
|
HK1147706 |
|
1/13/2017 |
|
ISSUED |
|
6/12/2029 |
51300-00074-HK-4-CN3 |
|
51300-00175-HK |
|
HONG
KONG |
|
15109097.6 |
|
10/27/2015 |
|
HK1209665 |
|
7/12/2019 |
|
ISSUED |
|
6/12/2029 |
51300-00074-HK-4-CN4 |
|
51300-00074.3HK |
|
HONG
KONG |
|
15110536.3 |
|
9/17/2015 |
|
HK1208389 |
|
10/4/2019 |
|
ISSUED |
|
6/12/2029 |
51300-00074-HK-6-EP3 |
|
51300.00370
HK |
|
HONG
KONG |
|
18108979.8 |
|
6/12/2009 |
|
HK1249463 |
|
12/30/2022 |
|
ISSUED |
|
6/12/2029 |
51300-00074-ID |
|
51300-00074-ID |
|
INDONESIA |
|
W00201100149 |
|
6/12/2009 |
|
ID
P 0034130 |
|
7/12/2013 |
|
ISSUED |
|
6/12/2029 |
51300-00074-IL |
|
51300-00074-IL |
|
ISRAEL |
|
209956 |
|
6/12/2009 |
|
209956 |
|
12/31/2014 |
|
ISSUED |
|
6/12/2029 |
51300-00074-IL-1 |
|
51300-00074.1-IL |
|
ISRAEL |
|
227046 |
|
6/12/2009 |
|
227046 |
|
11/1/2016 |
|
ISSUED |
|
6/12/2029 |
51300-00074-IL-2 |
|
51300-000152IL |
|
ISRAEL |
|
234322 |
|
6/12/2009 |
|
234322 |
|
8/30/2017 |
|
ISSUED |
|
6/12/2029 |
51300-00074-IL-3 |
|
5130000074.2IL |
|
ISRAEL |
|
246442 |
|
6/12/2009 |
|
246442 |
|
6/30/2018 |
|
ISSUED |
|
6/12/2029 |
51300-00074-IL-6 |
|
51300.00495-IL |
|
ISRAEL |
|
303019 |
|
5/18/2023 |
|
|
|
|
|
PENDING |
|
6/12/2029 |
51300-00074-IN |
|
51300-00074-IN |
|
INDIA |
|
252/DELNP/2011 |
|
6/12/2009 |
|
280564 |
|
2/22/2017 |
|
ISSUED |
|
6/12/2029 |
51300-00074-IN-1 |
|
51300-00074.1-IN |
|
INDIA |
|
201618038349 |
|
6/12/2009 |
|
422785 |
|
2/22/2023 |
|
ISSUED |
|
6/12/2029 |
51300-00074-JP-1 |
|
51300-00074.1-JP |
|
JAPAN |
|
2013-241130 |
|
11/28/2013 |
|
5839732 |
|
11/20/2015 |
|
ISSUED |
|
6/12/2029 |
51300-00074-JP-2 |
|
51300-00074.2-JP |
|
JAPAN |
|
2015-038046 |
|
2/27/2015 |
|
|
|
|
|
PENDING |
|
6/12/2029 |
51300-00074-KR |
|
51300-00074-KR |
|
SOUTH
KOREA |
|
10-2011-7000330 |
|
6/12/2009 |
|
1558026 |
|
9/30/2015 |
|
ISSUED |
|
6/12/2029 |
51300-00074-KR-1 |
|
51300-00153-KR.2 |
|
SOUTH
KOREA |
|
10-2014-7026936 |
|
9/25/2014 |
|
1548092 |
|
8/21/2015 |
|
ISSUED |
|
6/12/2029 |
51300-00074-KR-2 |
|
51300-00154-KR.3 |
|
SOUTH
KOREA |
|
10-2014-7026937 |
|
9/25/2014 |
|
1591621 |
|
1/28/2016 |
|
ISSUED |
|
6/12/2029 |
51300-00074-KR-3 |
|
51300-00153KR.1 |
|
SOUTH
KOREA |
|
10-2015-7007318 |
|
3/23/2015 |
|
1655053 |
|
8/31/2016 |
|
ISSUED |
|
6/12/2029 |
51300-00074-KR-4 |
|
51300.00074.1KR |
|
SOUTH
KOREA |
|
10-2015-0077234 |
|
6/1/2015 |
|
1618515 |
|
4/28/2016 |
|
ISSUED |
|
6/12/2029 |
51300-00074-KR-5 |
|
51300-00154.1KR |
|
SOUTH
KOREA |
|
10-2015-0077266 |
|
6/1/2015 |
|
1655032 |
|
8/31/2016 |
|
ISSUED |
|
6/12/2029 |
51300-00074-MX |
|
51300-00074-MX |
|
MEXICO |
|
MX/a/2010/013590 |
|
6/12/2009 |
|
333045 |
|
9/8/2015 |
|
ISSUED |
|
6/12/2029 |
51300-00074-MX-1 |
|
51300-00074-MX-DIV |
|
MEXICO |
|
MX/a/2015/011834 |
|
9/7/2015 |
|
395141 |
|
8/29/2022 |
|
ISSUED |
|
6/12/2029 |
51300-00074-MY |
|
51300-00074-MY |
|
MALAYSIA |
|
2010005946 |
|
6/12/2009 |
|
MY
1555524-A |
|
10/30/2015 |
|
ISSUED |
|
6/12/2029 |
51300-00074-MY-1 |
|
51300-00074.1
MY |
|
MALAYSIA |
|
PI2014002366 |
|
8/14/2014 |
|
MY
172371-A |
|
11/21/2019 |
|
ISSUED |
|
6/12/2029 |
51300-00074-MY-2 |
|
51300-00074.2
MY |
|
MALAYSIA |
|
PI2014002367 |
|
8/14/2014 |
|
MY-176697-A |
|
08/19/2020 |
|
ISSUED |
|
6/12/2029 |
51300-00074-RU |
|
51300-00074-RU |
|
RUSSIA |
|
2011100779 |
|
6/12/2009 |
|
2468832 |
|
12/10/2012 |
|
ISSUED |
|
6/12/2029 |
51300-00074-RU-1 |
|
51300-00074-RU1 |
|
RUSSIA |
|
2012136220 |
|
6/12/2009 |
|
2608439 |
|
1/18/2017 |
|
ISSUED |
|
6/12/2029 |
51300-00074-RU-2 |
|
51300-00074DIV2 |
|
RUSSIA |
|
2016147947 |
|
12/7/2016 |
|
2731107 |
|
8/28/2020 |
|
ISSUED |
|
6/12/2029 |
51300-00074-SG |
|
51300-00074-SG |
|
SINGAPORE |
|
2010092534.0 |
|
6/12/2009 |
|
167365 |
|
9/4/2015 |
|
ISSUED |
|
6/12/2029 |
51300-00074-SG-1 |
|
51300-00074-SG
DIV1 |
|
SINGAPORE |
|
10201507036T |
|
6/12/2009 |
|
10201507036T |
|
6/17/2021 |
|
ISSUED |
|
6/12/2029 |
51300-00074-SG-2 |
|
51300-00074-SG
DIV2 |
|
SINGAPORE |
|
10201507038V |
|
6/12/2009 |
|
10201507038V |
|
6/17/2021 |
|
ISSUED |
|
6/12/2029 |
51300-00074-TW |
|
51300-00074-TW |
|
TAIWAN |
|
98119686 |
|
6/12/2009 |
|
I592178 |
|
7/21/2017 |
|
ISSUED |
|
6/12/2029 |
51300-00074-TW-1 |
|
51300-00074.1TW |
|
TAIWAN |
|
104124899 |
|
6/12/2009 |
|
I611818 |
|
1/21/2018 |
|
ISSUED |
|
6/12/2029 |
51300-00074-US-8 |
|
51300.00458
US |
|
UNITED
STATES |
|
17/512,529 |
|
10/27/2021 |
|
|
|
|
|
PENDING |
|
|
51300-00074-WO |
|
51300-00074-WO |
|
WIPO |
|
PCT/US2009/047281 |
|
6/12/2009 |
|
WO
09/152477 |
|
12/17/2009 |
|
NAT
PHASE |
|
____ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
A
DRY POWDER INHALER AND SYSTEM FOR DRUG DELIVERY |
51300-00103-US |
|
51300.00103-US |
|
UNITED
STATES |
|
12/484,125 |
|
6/12/2009 |
|
8,499,757 |
|
8/6/2013 |
|
ISSUED |
|
2/19/2032 |
51300-00103-US-5 |
|
51300.00459 |
|
UNITED
STATES |
|
TBA |
|
|
|
|
|
|
|
PENDING |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
A
DRY POWDER INHALER AND SYSTEM FOR DRUG DELIVERY |
51300-00106-US |
|
51300.00106-US |
|
UNITED
STATES |
|
12/484,129 |
|
6/12/2009 |
|
8,636,001 |
|
1/28/2014 |
|
ISSUED |
|
7/12/2032 |
51300-00106-US-4 |
|
51300-00106.3-US |
|
UNITED
STATES |
|
14/092,810 |
|
11/27/2013 |
|
9,511,198 |
|
12/6/2016 |
|
ISSUED |
|
2/16/2030 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
DRY
POWDER DELIVERY SYSTEM AND METHODS |
51300-00124-AU |
|
51300.00124AU |
|
AUSTRALIA |
|
2011271097 |
|
6/21/2011 |
|
2011271097.0 |
|
3/12/2015 |
|
ISSUED |
|
6/21/2031 |
51300.00124-AU-1 |
|
51300.00124.1AU |
|
AUSTRALIA |
|
2015200705 |
|
6/21/2011 |
|
2015200705 |
|
9/29/2016 |
|
ISSUED |
|
6/21/2031 |
51300-00124-AU-2 |
|
51300.00124.2AU |
|
AUSTRALIA |
|
2016222336 |
|
8/30/2016 |
|
2016222336 |
|
1/3/2019 |
|
ISSUED |
|
6/21/2031 |
51300-00124-CA |
|
51300.00124CA |
|
CANADA |
|
2801936 |
|
6/21/2011 |
|
2801936 |
|
6/1/2021 |
|
ISSUED |
|
6/21/2031 |
51300-00124-IL |
|
51300.00124IL |
|
ISRAEL |
|
223742 |
|
6/21/2011 |
|
223742 |
|
10/1/2016 |
|
ISSUED |
|
6/21/2031 |
51300-00124-IN |
|
51300.00124IN |
|
INDIA |
|
10855/DELNP/2012 |
|
6/21/2011 |
|
313526 |
|
5/31/2019 |
|
ISSUED |
|
6/21/2031 |
51300-00124-JP |
|
51300.00124JP |
|
JAPAN |
|
2013516701 |
|
6/21/2011 |
|
6385673 |
|
8/17/2018 |
|
ISSUED |
|
6/21/2031 |
51300-00124-MX |
|
51300.00124MX |
|
MEXICO |
|
MX/a/2012/015093 |
|
6/21/2011 |
|
359281 |
|
9/21/2018 |
|
ISSUED |
|
6/21/2031 |
51300-00124-RU |
|
51300.00124RU |
|
RUSSIA |
|
2013102529 |
|
6/21/2011 |
|
2531455 |
|
10/20/2014 |
|
ISSUED |
|
6/21/2031 |
51300-00124-RU-1 |
|
51300.00124-1
RU |
|
RUSSIA |
|
2014133362 |
|
6/21/2011 |
|
2571331 |
|
12/20/2015 |
|
ISSUED |
|
6/21/2031 |
51300-00124-US-3 |
|
51300.00249-2
(124) |
|
UNITED
STATES |
|
15/144,651 |
|
5/2/2016 |
|
9,662,461 |
|
5/30/2017 |
|
ISSUED |
|
6/12/2029 |
51300-00124-WO |
|
51300.00124WO |
|
WIPO |
|
PCT/US2011/041303 |
|
6/21/2011 |
|
WO
11/163272 |
|
12/29/2011 |
|
NAT
PHASE |
|
____ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
DRY
POWDER INHALER |
51300-00136-AR |
|
51300.00136AR |
|
ARGENTINA |
|
83811 |
|
4/20/2012 |
|
83811 |
|
4/20/2012 |
|
ISSUED |
|
4/20/2027 |
51300-00136-BR |
|
51300.00136BR |
|
BRAZIL |
|
BR3020120019982 |
|
4/20/2012 |
|
BR3020120019982 |
|
2/13/2013 |
|
ISSUED |
|
4/20/2037 |
51300-00136-EM |
|
51300.00136EM |
|
EUROPE
(CTM) |
|
002030130-0001 |
|
4/20/2012 |
|
002030130-0001 |
|
7/4/2012 |
|
ISSUED |
|
4/20/2037 |
51300-00136-GB |
|
51300.00136GB |
|
UNITED
KINGDOM |
|
9002030130-0001 |
|
4/20/2012 |
|
9002030130-0001 |
|
7/4/2012 |
|
ISSUED |
|
4/20/2037 |
51300-00136-IN |
|
51300.00136IN |
|
INDIA |
|
244714 |
|
4/20/2012 |
|
244714 |
|
8/23/2012 |
|
ISSUED |
|
10/20/2026 |
51300-00136-JP |
|
51300.00136JP |
|
JAPAN |
|
2012-009290 |
|
4/20/2012 |
|
1450065 |
|
8/3/2012 |
|
ISSUED |
|
8/3/2032 |
51300-00136-KR |
|
51300.00136KR |
|
SOUTH
KOREA |
|
30-2012-0018808 |
|
4/20/2012 |
|
30-0709561 |
|
9/13/2013 |
|
ISSUED |
|
9/13/2028 |
51300-00136-MX |
|
51300.00136MX |
|
MEXICO |
|
MX/f/2012/001228 |
|
4/20/2012 |
|
38664 |
|
5/10/2013 |
|
ISSUED |
|
4/20/2027 |
51300-00136-RU |
|
51300.00136RU |
|
RUSSIA |
|
2012501242 |
|
4/20/2012 |
|
84747 |
|
3/16/2013 |
|
ISSUED |
|
4/20/2037 |
51300-00136-TW |
|
51300.00136TW |
|
TAIWAN |
|
101302196 |
|
4/20/2012 |
|
D152925 |
|
4/11/2013 |
|
ISSUED |
|
4/20/2024 |
51300-00136-TW-1 |
|
51300.00136.1TW |
|
TAIWAN |
|
102300650 |
|
1/24/2013 |
|
D160905 |
|
6/1/2014 |
|
ISSUED |
|
4/20/2024 |
51300-00136-US |
|
51300.00136.US |
|
UNITED
STATES |
|
29/404,464 |
|
10/20/2011 |
|
D674,893 |
|
1/22/2013 |
|
ISSUED |
|
1/22/2027 |
Exhibit
10.6
MASTER
SERVICES AGREEMENT
This
Master Services Agreement (the “Agreement”),
dated as of July 8, 2024 (the “Effective Date”), is made and entered into by and between MannKind Corporation
having its offices at 1 Casper St, Danbury, Connecticut 06810 (“MANNKIND”) and Pulmatrix, Inc., a Delaware
corporation having an address at 945 Concord Street, Framingham MA 01701 (“PULMATRIX”). PULMATRIX
and MANNKIND may be referred to herein individually as a “Party” or collectively as the “Parties.”
PULMATRIX
owns, manufactures, develops, or has rights to certain pharmaceutical or biotechnology products. MANNKIND employs personnel with certain
expertise and experience regarding pharmaceutical formulation. PULMATRIX desires to retain the services of MANNKIND to perform certain
formulation development, process development and/or analytical method development activities for advancement of PULMATRIX’s products.
For
good and valuable consideration contained herein, the exchange, receipt and sufficiency of which are acknowledged, the Parties agree
as follows:
1.
Definitions.
1.1 “Active
Material” shall mean the active pharmaceutical ingredient that PULMATRIX provides to MANNKIND for performance of the Services.
1.2 “Bulk
Drug Product” shall mean any formulations, either in a bulk state or as finished dosage forms, developed by MANNKIND for PULMATRIX
as part of the rendered services.
1.3 “Raw
Material” shall mean any material, other than the Active Material or Bulk Drug Product, used by MANNKIND for provision of the
services.
1.4 “Affiliate”
shall mean any individual, corporation, limited liability company, partnership, joint venture, association or other legal entity
(“Person”) who, directly or indirectly through one or more intermediaries, Controls, is Controlled by, or is
under common Control with any other Person. “Control” means (a) the direct or indirect legal or beneficial ownership of more
than twenty percent (20%) of (i) the ownership interests in a Person or (ii) the outstanding voting rights in a Person, or (b) the power
to otherwise direct the business activities of a Person.
1.5 “Applicable
Laws” shall mean all treaties, laws, statutes, rules, regulations, guidance, judicial opinions or administrative findings or
orders applicable to the Services.
1.6 “Claim
or Proceeding” shall mean any third-party claim, action, suit, proceeding or arbitration, including any governmental authority
action or investigation.
1.7 “Deliverable”
shall mean the tangible deliverables specified in a Scope of Work.
Master Services Agreement Page 1 |
1.8 “Intellectual
Property Rights” means any and all rights, title and interest (including a composition of matter, formula, process, method
of use, invention, improvement, business name, domain name or database right to the extent any of the foregoing is protected in a utility
model, trademark, trade name, service mark, service name, copyright, registered design, design right, patent, patent registration, know-how,
trade secret, rights in or to confidential information (including Confidential Information as defined in Section 7.1) and any other proprietary
right of any nature whatsoever arising or enforceable under any United States federal or state law, rule or regulation, non-United States
law, rule or regulation or international treaty throughout the world (whether registered or unregistered and including all applications
and rights to apply for the same) in any technology, system, invention medium or content and documentation.
1.9 “Losses”
shall mean any and all losses, fines, fees, settlements, payments, obligations, penalties, deficiencies, liabilities, damages, and
all related costs and expenses (including reasonable attorneys’ fees and disbursements and costs of investigation, litigation,
settlement, judgment, interest and penalties).
1.10 “Material”
shall mean any or all of the Active Material, Raw Material and/or Bulk Drug Product.
1.11 “Inventions”
means any and all discoveries, concepts, ideas, products, Technical Information, developments, specifications, methods, drawings,
designs, flow charts, diagrams, models, formulae, procedures, processes, schematics, specifications, algorithms, apparatus, inventions,
ideas, know how, materials, techniques, methodologies, modifications, improvements, works of authorship and data (whether or not protectable
under patent, copyright, trade secrecy or similar laws and whether or not reduced to practice), know-how, materials, methods, models,
procedures, processes, schematics, specifications, techniques, tools, and any other forms of technology.
1.12 “Project
Technology” means all Inventions that are conceived, created, discovered, developed, generated, made or reduced to practice
or tangible medium of expression during the performance of this Agreement, whether solely by one or more employees or consultants of
PULMATRIX, solely by one or more employees or consultants of MANNKIND, or jointly by one or more employees or consultants of PULMATRIX
and one or more employees or consultants of MANNKIND, in each case relating to the Services, together with all Intellectual Property
Rights in or to such Inventions.
1.13 “iSPERSE”
shall mean the collective application of PULMATRIX’s dry powder technology platform which includes processes, materials and
equipment and affiliated patents, knowhow and trade secrets.
1.14 “Services”
shall mean activities to develop a dry powder formulation of the Active Material for oral inhalation using the iSPERSE engineered
particle technology platform, including but not limited to a description of the specific services to be provided, Deliverables, and target
completion dates as outlined in one or more “Scopes of Work”, a sample of which is attached hereto as Exhibit A.
Master Services Agreement Page 2 |
2.
Services.
2.1 Services
to be Provided. MANNKIND hereby agrees to use commercially reasonable efforts to allocate up to four full-time equivalent employees
to perform Services for PULMATRIX from time to time as detailed in uniquely numbered Scopes of Work. MANNKIND shall perform the Services
in a timely, professional, and workmanlike manner using personnel of required skill, experience, and qualifications, and in compliance
with (i) the terms and conditions of this Agreement, (ii) generally recognized industry standards, and (iii) all Applicable Laws.
2.2 Forms
and Inconsistencies. Any term or condition of any correspondence between the Parties that is different from, inconsistent with or
contrary to the terms and conditions of this Agreement shall be void. All Scopes of Work shall be deemed to incorporate and be subject
to the terms and conditions of this Agreement.
2.3 Subcontractors.
MANNKIND may subcontract Services only with PULMATRIX’s prior written consent. Any agreement entered into by MANNKIND with a third-party
subcontractor shall, at a minimum, provide for ownership and allocation of intellectual property rights and for obligations of confidentiality
of information, record-keeping, access, and rights to data that are consistent with the intent and are as restrictive as the terms of
this Agreement. MANNKIND shall remain fully responsible for the performance of any of its obligations hereunder that it delegates to
a subcontractor as if it had performed such obligations itself.
3.
Materials and Data.
3.1 Safety
Information. PULMATRIX shall provide certain Materials to MANNKIND as are necessary for the performance of the Services at PULMATRIX’s
cost. MANNKIND shall use the Materials solely for the purpose of performing the Services. MANNKIND shall not supply the Materials, or
any portion thereof, to any third party unless directed to do so by PULMATRIX in writing. PULMATRIX will provide a Safety and Data Sheet
(“SDS”) with all Materials provided to MANNKIND in a form agreed to by the Parties, which shall include appropriate
storage and handling conditions for each Active Material, and any other compliance statements agreed to by the Parties. New SDS information
will be shared promptly by PULMATRIX if it is known by PULMATRIX to have a material impact on the production process and employee safety
at MANNKIND.
3.2 Active
and Raw Materials. MANNKIND and PULMATRIX shall mutually determine the amounts of Materials that MANNKIND will need to make the Deliverables,
which amounts shall be approved by PULMATRIX prior to MANNKIND beginning work on the Services. The Parties shall mutually agree in writing
in a Scope of Work which Materials will be supplied by each respective Party.
3.3 Excess
Material. At the conclusion of the term of this Agreement, MANNKIND may provide notice to PULMATRIX of any excess Material (the “Excess
Material”) requiring disposal. If PULMATRIX does not respond to MANNKIND stating that it agrees to accept receipt of or
otherwise dispose of the Excess Material within sixty (60) days of receipt of such notice, then MANNKIND shall again provide notice to
PULMATRIX providing an additional thirty (30) days’ notice. If PULMATRIX does not respond to MANNKIND stating that it agrees to
accept receipt of or otherwise dispose of the Excess Material within such thirty (30) day notice period MANNKIND may dispose of the Excess
Material without any further liability or obligation to PULMATRIX. The Party ultimately responsible for the disposal of the Excess Materials
shall handle, store and dispose of such Excess Materials in compliance with all Applicable Laws.
Master Services Agreement Page 3 |
3.4 Data.
MANNKIND shall keep complete, accurate and authentic accounts, notes, data and records of the work performed under this Agreement adequate
to comply with all Applicable Laws. MANNKIND shall maintain complete and adequate records pertaining to the methods and facilities used
by it for the provision of Services. MANNKIND shall promptly disclose in writing to PULMATRIX any Project Technology developed by MANNKIND
during the course of this Agreement. At the completion of the Services by MANNKIND (or termination of the Services by either Party),
all raw data relating to the Services, including paper data, computer tapes and other materials as appropriate, will, at PULMATRIX’s
option, be transferred to PULMATRIX or retained in the archive of MANNKIND subject to a reasonable annual fee.
4. Deliverables.
4.1 Regarding
the Deliverables. MANNKIND represents and warrants to PULMATRIX that, as of the date of delivery to PULMATRIX, each Deliverable furnished
by MANNKIND to PULMATRIX has been manufactured or, otherwise, prepared (as applicable) in conformity with this Agreement and in accordance
with Applicable Laws.
5. Compensation.
5.1 Payment
Terms.
(a) Compensation for Services. The Parties shall specify the compensation for the Services in a Scope of Work.
(b) Timing. MANNKIND will invoice PULMATRIX monthly.
(c) Invoices. Electronic submission is the preferred method. Invoices must be sent to finance@pulmatrix.com.
(d) Payment. Undisputed payments are due within thirty (30) days of receipt of MANNKIND’s invoice. Unless agreed to by the Parties in writing, all payments to MANNKIND under this Agreement shall be made as set forth in the applicable invoice.
If
PULMATRIX elects to submit payment via wire transfer or other electronic means, PULMATRIX will be solely responsible for all additional
reasonable costs incurred in connection with such electronic payment transmission.
(e) Setoff Permitted. Notwithstanding anything to the contrary in this Agreement, and without prejudice to any other right or remedy it has or may have, PULMATRIX may set off or recoup any liability it owes to MANNKIND against any liability for which MANNKIND is liable to PULMATRIX or its Affiliates, whether either liability is matured or unmatured, is liquidated or unliquidated, or arises under this Agreement. Notwithstanding anything to the contrary in this Agreement, and without prejudice to any other right or remedy it has or may have, MANNKIND may set off or recoup any liability it owes to PULMATRIX against any liability for which PULMATRIX is liable to MANNKIND or its Affiliates, whether either liability is matured or unmatured, is liquidated or unliquidated, or arises under this Agreement.
Master Services Agreement Page 4 |
5.2 Payment
after Termination. Upon termination of this Agreement pursuant to Section 14, PULMATRIX shall pay MANNKIND all fees for all Services
performed through to the termination date. In addition, PULMATRIX shall reimburse MANNKIND for all reasonably incurred future obligations
to third parties that cannot be reasonably avoided or mitigated and that were approved by PULMATRIX in writing and in advance.
6. Ownership
of Intellectual Property.
6.1 This
Agreement shall not change, modify or otherwise affect any rights to any Confidential Information, inventions, patents, patent applications
or other Intellectual Property Rights owned or developed by either Party before the Effective Date (“Background IP”).
This Agreement shall not confer on either Party any rights in and/or to any Background IP of the other Party. Unless otherwise expressly
set forth in this Agreement, this Agreement shall not be construed as conveying any rights to a Party’s Intellectual Property Rights.
6.2 The
following provisions shall apply to intellectual property developed under this Agreement:
(a) PULMATRIX shall have sole ownership of all rights, title and interest in any inventions that claim or cover PULMATRIX’s Background IP, Active Material, Bulk Drug Product or any improvements thereto and that do not claim or cover MANNKIND’s Background IP (the “PULMATRIX Inventions”). MANNKIND shall assign any and all rights, title and interest in such PULMATRIX Inventions to PULMATRIX.
(b) MANNKIND shall have sole ownership of all rights, title and interest in any inventions that claim or cover MANNKIND’s Background IP and that do not claim or cover PULMATRIX’s Background IP, Active Material, Bulk Drug Product or any improvement thereto (the “MANNKIND Inventions”). PULMATRIX shall assign any and all rights, title and interest in such MANNKIND Inventions to MANNKIND.
6.3 PULMATRIX
acknowledges that it shall be solely and fully responsible for doing any and all freedom to operate assessments regarding possible infringement
of third party Intellectual Property Rights for any and all products and processes for any Deliverables which it makes, has made, uses,
sells, offers for sale or imports.
7. Confidentiality.
7.1 “Confidential
Information” means all confidential or proprietary information disclosed or made available by either Party to the other
Party, including information about its business affairs, goods and services, forecasts, Background IP, trade secrets, third-party confidential
information, and other sensitive or proprietary information, as well as the terms of this Agreement, whether orally or in written, electronic,
or other form or media, and whether or not marked, designated, or otherwise identified as “confidential.” The chemical structure
of any Active Material and Bulk Drug Product shall also be considered Confidential Information of PULMATRIX.
Master Services Agreement Page 5 |
7.2 Use
of Confidential Information. Each Party shall use the other’s Confidential Information solely for the purposes contemplated
by this Agreement and for no other purpose without the prior written consent of the other Party. Neither Party shall publish, disseminate
or otherwise disclose Confidential Information of the other to any third party without first obtaining the written consent of such other
Party. Each Party shall restrict the dissemination of the other’s Confidential Information to only those directors, officers, employees,
agents, representatives and advisors (collectively, “Agents”) and to those subcontractors approved in writing
in accordance with this Agreement who have a need to know. Each Party shall ensure that all of its Agents and subcontractors are bound
by confidentiality obligations no less stringent than those stated herein. The receiving Party shall be liable for any failure of any
of its Agents to (a) maintain the confidentiality of the disclosing Party’s Confidential Information, or (b) otherwise comply with
the terms of this Section 7 to the same extent as the receiving Party is obligated to do so.
7.3 Exceptions
to Confidential Information. The above provisions of confidentiality shall not apply to that part of the disclosing Party’s
Confidential Information that the receiving Party is able to demonstrate by documentary evidence:
|
(a) |
was
in the receiving Party’s possession prior to receipt from the disclosing Party; |
|
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|
|
(b) |
was
in the public domain at the time of receipt from the disclosing Party; |
|
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|
|
(c) |
subsequently
becomes a part of the public domain through no fault of the receiving Party or its Agents; |
|
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(d) |
is lawfully
received by the receiving Party from a third party who is not and was not prohibited from disclosing such Confidential Information;
and/or |
|
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|
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(e) |
is independently
developed by or for the receiving Party without reference to or use of the disclosing Party’s Confidential Information. |
Notwithstanding
the fact that individual components of information are in the public domain, but a particular compilation or integration of such components
is not in the public domain, the fact that such individual components are in the public domain does not relieve the receiving Party of
its obligations of confidentiality under this Section 7 with regard to the compilation or integration of such components.
The
above provisions of confidentiality (including the obligations of non-disclosure and non-use) shall not apply to any Confidential Information
solely to the extent that such Confidential Information is (a) disclosed to legal counsel solely for the purpose of seeking legal advice
and provided it is not further used or disclosed; and/or (b) disclosed or used to prove compliance with this Agreement in a legal action
between the Parties provided that adequate protections are sought to prevent further use or disclosure.
Master Services Agreement Page 6 |
7.4 Disclosure
Required by Law. The Parties’ non-disclosure obligations pursuant to this Agreement shall not apply to Confidential Information
that a receiving Party is required to disclose pursuant to any Applicable Law, subpoena, judicial action, order of the court or other
governmental agency; provided, however, that the receiving Party shall make all reasonable efforts to notify the disclosing Party prior
to the disclosure of Confidential Information and cooperate with and allow the disclosing Party the opportunity to contest and avoid
such disclosure at its own cost and expense, and further provided that the receiving Party shall disclose only that portion of such Confidential
Information that it is legally required to disclose.
7.5 Disclosure
Required by Business Need. A Party may disclose the text and terms of this Agreement if required in regulatory filings, or in confidential
disclosures to investors, partners, potential investors, potential partners and its auditors and attorneys so long as such persons are
bound to confidentiality obligations with respect to such text and terms substantially similar to those contained herein.
7.6 Return
of Confidential Information. Upon termination or expiration of this Agreement or at the disclosing Party’s earlier written
request, the receiving Party shall return, and shall cause its Agents to return, all documentary, electronic or other tangible forms
of Confidential Information (that are still subject to confidentiality obligations hereunder) of the disclosing Party, including any
and all extracts, summaries or abstracts thereof, and any and all copies of any of the foregoing, or, at the disclosing Party’s
request, destroy all or such parts of the disclosing Party’s Confidential Information as the disclosing Party shall direct. Notwithstanding
the foregoing, the receiving Party may retain copies of the disclosing Party’s Confidential Information as is reasonably necessary
for regulatory purposes or electronic files containing Confidential Information that are made in the ordinary course of its business
information back-up procedures pursuant to its electronic record retention and destruction practices that apply to its own general electronic
files and information, subject to the ongoing obligation to maintain the confidentiality of such information.
7.7 Remedy.
Each Party agrees that its obligations hereunder are necessary and reasonable in order to protect the other Party and the other Party’s
business, and expressly agrees that monetary damages would be inadequate to compensate the other Party for any breach of the terms of
this Agreement. Accordingly, each Party agrees and acknowledges that any such violation or threatened violation will cause irreparable
injury to the other Party, and that, in addition to any other remedies that may be available, the other Party shall be entitled to seek
injunctive relief against the threatened breach of this Agreement or the continuation of any such breach, without the necessity of proving
actual damages.
7.8 Term
of Non-Disclosure. All obligations of confidentiality under this Section 7 will terminate ten (10) years after the expiration or
termination of this Agreement; provided however that the obligations of confidentiality for Confidential Information that is a trade
secret will survive indefinitely until such trade secret information no longer qualifies as a trade secret.
7.9 Publication.
Except as otherwise provided in this Section 7, MANNKIND shall not publish any articles or make any presentations relating to the Services
provided to PULMATRIX under this Agreement, or referring to Materials, PULMATRIX’s Confidential Information, Project Technology
or any data, information or materials generated as part of the Services (excluding MANNKIND’s Confidential Information, MANNKIND’S
Background IP and MANNKIND Inventions), in whole or in part, without the prior written consent of PULMATRIX. Notwithstanding the forgoing,
PULMATRIX shall be permitted to publicly disclose that it has entered into a collaboration with MANNKIND in a press release or other
public statement and the general nature of the collaboration, provided, however, that any such disclosure does not include any financial
terms or Confidential Information of MANNKIND.
Master Services Agreement Page 7 |
8.
Indemnification.
8.1 Indemnification
of PULMATRIX. MANNKIND shall indemnify, defend and hold PULMATRIX, its Affiliates and their respective officers, directors, employees
and agents (each, a “PULMATRIX Indemnified Party”) harmless from and against any and all Losses suffered, incurred
or sustained by any PULMATRIX Indemnified Party, by reason of any Claim or Proceeding to the extent arising out of or resulting from
MANNKIND’S: (i) breach of this Agreement; (ii) negligence or willful misconduct in connection with this Agreement; or (iii) failure
to meet specifications with regard to any Deliverable; provided however, that MANNKIND shall have no obligation of indemnity hereunder
with respect to any Losses to the extent caused by the negligence or willful misconduct on the part of PULMATRIX.
8.2 Indemnification
of MANNKIND.
(a) PULMATRIX
shall indemnify, defend and hold MANNKIND, its Affiliates and their respective officers, directors, employees and agents (each, a “MANNKIND
Indemnified Party”) harmless from and against any and all Losses suffered, incurred or sustained by any MANNKIND Indemnified
Party, by reason of any Claim or Proceeding to the extent arising out of or resulting from PULMATRIX’s (i) breach of this Agreement;
or (ii) negligence or willful misconduct in connection with this Agreement; or (iii) resulting from death or bodily injury directly caused
by the Bulk Drug Product used in accordance with this Agreement and the SDS; provided however, that PULMATRIX shall have no obligation
of indemnity hereunder with respect to any Losses to the extent caused by the negligence or willful misconduct on the part of MANNKIND.
(b) PULMATRIX
shall also defend, indemnify, and hold harmless MANNKIND, its Affiliates and their respective officers, directors, employees and agents
from and against any and all Losses arising out of or resulting from a Claim or Proceeding alleging that a Deliverable, or any part thereof,
infringes, misappropriates, or otherwise violates a patent, copyright, trade secret, trademark or other Intellectual Property Right of
any third party, except and to the extent that the inclusion of the third party’s Intellectual Property Right in a Deliverable
was the result of (i) MANNKIND’s action in violation of the provisions of this Agreement, (ii) MANNKIND’s negligence or willful
misconduct, (iii) MANNKIND’s Background IP, or (iv) any products, materials, process, or equipment supplied or used by MANNKIND
or an authorized subcontract.
Master Services Agreement Page 8 |
8.3 Indemnification
Procedures. In the event that any Claim or Proceeding is asserted or imposed against any Party, and such Claim or Proceeding involves
a matter which is subject to a claim for indemnification under this Section 8, then such Party (an “Indemnified Party”)
shall promptly give written notice to the other Party (the “Indemnifying Party”) of such Claim or Proceeding.
The Indemnifying Party shall assume, at its cost and expense, the defense of such Claim or Proceeding through its legal counsel selected
and reasonably acceptable to the Indemnified Party, except that the Indemnified Party may, at its option and expense, select and be represented
by separate counsel. The Indemnifying Party shall have control over the Claim or Proceeding, including the right to settle; provided,
however, that the Indemnifying Party shall not, absent the prior written consent of the Indemnified Party, consent to the entry of any
judgment or enter into any settlement that (1) provides for any relief other than the payment of monetary damages for which the Indemnifying
Party shall be solely liable and (2) where the claimant or plaintiff does not release the Indemnified Party, its Affiliates and their
respective directors, officers, employees, agents and representatives, as the case may be, from all liability in respect thereof. In
no event shall the Indemnified Party be liable for any claims that are compromised or settled in violation of this Section 8.
9.
Compliance with Laws.
9.1 Each
Party shall comply with all Applicable Laws, rules, regulations, codes, and standards of all federal, state, local and municipal government
agencies that affect their respective performance and activities under this Agreement.
9.2 MANNKIND
represents, warrants, and certifies that neither it nor any of its officers, directors, owners, principals or employees has been debarred
under Section 306 of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. §335a(a) or (b), or similar local law. MANNKIND shall not
use in any capacity the services of any individual, corporation, partnership, or association which has been debarred. In the event that
any such party becomes debarred, MANNKIND shall notify PULMATRIX in writing immediately.
9.3 Except
to the extent resulting from any breach of this Agreement by MANNKIND, it is PULMATRIX’s responsibility to ensure that any pharmaceutical
product that PULMATRIX distributes based on or resulting from the Services will take the form described in any documents used for all
governmental approvals and will comply with all governmental applications, submissions, and approvals filed by PULMATRIX, or given to
PULMATRIX, by any regulatory agency in any other jurisdiction.
10. Independent
Contractor. The relationship of MANNKIND to PULMATRIX in the performance of this Agreement shall be that of independent
contractor. Nothing in this Agreement creates any agency, joint venture, partnership, or other form of joint enterprise, employment or
fiduciary relationship between the Parties. Neither Party has any express or implied right or authority to assume or create any obligations
on behalf of or in the name of the other Party or to bind the other Party to any contract, agreement, or undertaking with any third party.
11.
Term and Termination.
11.1 Term.
The term of this Agreement shall commence on the Effective Date and shall continue for a term of twelve months, unless extended by the
Parties’ mutual written agreement, including a Scope of Work.
Master Services Agreement Page 9 |
11.2 Termination
by PULMATRIX. This Agreement may be terminated without cause by PULMATRIX on thirty (30) days’ prior written notice to MANNKIND.
11.3 Termination
for Breach. Either Party may terminate this Agreement for material breach upon thirty (30) days’ written notice specifying
the nature of the breach if such breach is not cured within the 30-day notice period. During such 30-day cure period, each Party will
continue to perform its obligations under this Agreement. In the event of termination by PULMATRIX for breach by MANNKIND, PULMATRIX
shall not be required to pay MANNKIND for any fees directly relating to the breach. In the event of a breach by MANNKIND, at PULMATRIX’s
option, MANNKIND shall either re-perform the Services related directly to the breach or refund to PULMATRIX any fees paid by PULMATRIX
which relate directly to the breach.
11.4 Survival
of Obligations Following Termination. The termination of this Agreement for any reason shall not relieve either Party of its obligation
to the other for those obligations set forth in Sections 6 (Ownership of Intellectual Property), 7 (Confidentiality), 8 (Indemnification)
and 16 (Miscellaneous).
12.
Risk of Loss.
12.1 Risk
of Loss. MANNKIND shall be responsible for risk of loss (including damage, theft, or other loss) of PULMATRIX’s Materials or
property that are stored on MANNKIND’s premises.
13.
Miscellaneous.
13.1 Assignment;
No Third Party Beneficiaries. This Agreement may not be assigned by either Party without the prior written consent of the other Party;
provided, however, that without the prior consent of the other Party, a Party may assign this Agreement hereunder to (a) a successor-in-interest
by reason of any merger, acquisition, partnership, or license agreement, or (b) a purchaser of all or substantially all of a Party’s
assets to which this Agreement relates. Nothing in this Agreement express or implied, is intended to confer on any person or entity other
than the Parties hereto or their respective successors and permitted assigns, any benefits, rights or remedies.
13.2 Waiver
of Default. A waiver by either Party of any violation of or default in any provision of this Agreement shall not constitute a waiver
of (i) any subsequent violation of or default in the same provision, or (ii) any violation of or default in any other provision of this
Agreement.
13.3 Void
and Severable Provisions. If any arbitrator or court of competent jurisdiction determines that any provision of this Agreement is
void, the remainder of this Agreement shall continue to be binding on and inure to the benefit of both Parties.
13.4 Notices.
Any notice shall be in writing and deemed sufficiently given when received by the party notified at the address given below, or when
mailed, if mailed by registered or certified mail, return receipt requested, and postage paid.
Master Services Agreement Page 10 |
To
PULMATRIX:
Pulmatrix,
Inc.
945
Concord Street
Framingham
MA 01701
ATTN:
Ted Raad
traad@pulmatrix.com
To
MANNKIND:
MannKind
Corporation
1
Casper St.
Danbury,
Connecticut 06810
ATTN:
General Counsel
WITH
COPIES VIA EMAIL TO:
traad@pulmatrix.com;
mcastagna@mannkindcorp.com;
legal@mannkindcorp.com
13.5 Entire
Agreement. This Agreement, including all Scopes of Work, supersedes any previous agreement or arrangement between the Parties in
relation to the Services and represents the entire agreement between the Parties with respect to the subject matter hereof, and it may
not be varied except as provided by an instrument in writing by persons legally authorized by each of the Parties.
13.6 Dispute
Resolution. Any dispute, controversy, or claim arising out of or relating to this Agreement, or the breach, termination, or invalidity
hereof (each, a “Dispute”), shall be submitted for negotiation and resolution to the Chief Financial Officer
of PULMATRIX (or to such other person of equivalent or superior position designated by PULMATRIX in a written notice to MANNKIND) and
the Chief Financial Officer of MANNKIND (or to such other person of equivalent or superior position designated by MANNKIND in a written
notice to PULMATRIX), by delivery of written notice (each, a “Dispute Notice”) from either Party to the other
Party. Such persons shall negotiate in good faith to resolve the Dispute. If the Parties cannot resolve the Dispute within thirty (30)
days after delivery of the applicable Dispute Notice, either Party may file suit in a court of competent jurisdiction in accordance with
the provisions of Section 16.11.
13.7 Force
Majeure. Neither Party shall be liable for delays in performance or nonperformance in whole or in part, and neither Party shall be
deemed to be in breach of its obligations, if such failure or delay is due to any causes that are beyond its reasonable control and not
due to its acts or omissions, such as acts of God; flood; volcanic eruption; epidemic; fire; war; terrorism; strike; industrial dispute;
equipment or machinery breakdown; unavailable or nonconforming vendor-supplied raw materials; embargo; acts of government or other similar
causes. In such event, the Party delayed shall promptly give notice to the other Party. The Party affected by the other’s delay
may elect to suspend performance and extend the time for performance for the duration of the event or to cancel or terminate all or any
part of the unperformed part of this Agreement without penalty.
Master Services Agreement Page 11 |
13.8 Governing
Law. This Agreement, including any exhibits, schedules, attachments, and appendices attached to this Agreement and thereto, and all
matters arising out of or relating to this Agreement, are governed by, and construed in accordance with, the laws of the Commonwealth
of Massachusetts without regard to the conflict of laws provisions thereof to the extent such principles or rules would require or permit
the application of the laws of any jurisdiction other than those of the Commonwealth of Massachusetts. The Parties acknowledge and agree
that the United Nations Convention on Contracts for the International Sale of Goods does not apply to this Agreement.
13.9 Amendments.
No amendment, change or modification to this Agreement shall be effective unless in writing and executed by MANNKIND and PULMATRIX.
13.10 Jurisdiction.
Each Party irrevocably and unconditionally agrees that it will not commence any action, litigation, or proceeding of any kind whatsoever
against the other Party in any way arising from or relating to this Agreement, including any exhibits, schedules, attachments, and appendices
attached to this Agreement and thereto, and all contemplated transactions, including contract, equity, tort, fraud, and statutory claims,
in any forum other than the courts of the Commonwealth of Massachusetts, and any appellate court from any thereof. Each Party irrevocably
and unconditionally submits to the exclusive jurisdiction of such courts and agrees to bring any such action, litigation, or proceeding
only in the courts of the Commonwealth of Massachusetts. Each Party agrees that a final judgment in any such action, litigation, or proceeding
is conclusive and may be enforced in other jurisdictions by suit on the judgment or in any other manner provided by Applicable Law.
13.11
Further Assurances.
(a) Each
Party shall cooperate fully with the other Party and to execute such further instruments, documents and agreements, and to give further
written assurances as may reasonably be requested by the other Party to evidence and reflect the transactions described herein, and to
carry into effect the intents and purposes of this Agreement.
(b) MANNKIND
shall execute, acknowledge and deliver all documents, including all instruments of assignment, patent and copyright applications and
supporting documents, and to perform all acts, that PULMATRIX may reasonably request to perfect, secure, defend and maintain its Intellectual
Property Rights to the Deliverables and to carry out the intent of this Agreement. MANNKIND shall assist PULMATRIX, at PULMATRIX’s
expense, to obtain for PULMATRIX, in any and all countries, patents, trademarks, copyrights or other legal protection for all Intellectual
Property Rights in the Deliverables provided hereunder. PULMATRIX shall reimburse MANNKIND for its reasonable fees, costs and expenses
incurred in the foregoing.
13.12 Rules
of Construction. References in this Agreement to “Sections” refer to Sections of this Agreement, unless the context expressly
indicates otherwise. References to “provisions” of this Agreement refer to the terms, conditions, restrictions and promises
contained in this Agreement. References in this Agreement to laws and regulations refer to such laws and regulations as in effect on
this date and to the corresponding provisions, if any, of any successor law or regulation. At each place in this Agreement where the
context so requires, the masculine, feminine or neuter gender includes the others and the singular or plural number includes the other.
Forms of the verb “including” mean “including without limitation.” The introductory headings at the beginning
of Sections of this Agreement (other than definitions) are solely for the convenience of the Parties and do not affect any provision
of this Agreement.
13.13 Third
Party Rights: Except as specifically provided in this Agreement, no person who is not a party to this Agreement has any right under
the Contracts (Rights of Third Parties) Act 1999 to enforce any of its terms.
Master Services Agreement Page 12 |
IN
WITNESS WHEREOF the Parties have signed their names as of the Effective Date.
MANNKIND
CORPORATION |
|
PULMATRIX,
INC. |
|
|
|
|
|
By:
|
/s/ Michael
Castagna |
|
By: |
/s/ Teofilo
Raad |
Name:
|
Michael
Castagna |
|
Name:
|
Teofilo
Raad |
Title:
|
Chief
Executive Officer |
|
Title:
|
Chief
Executive Officer |
Master Services Agreement Page 13 |
Exhibit
A
Scope
of Work
THIS
SCOPE OF WORK NO. ___(the “SOP”) is made and entered into by and between MannKind Corporation having its offices at 1 Casper
St, Danbury, Connecticut 06810 (“MANNKIND”) and Pulmatrix, Inc., a Delaware corporation, having an address at 945 Concord
Street, Framingham MA 01701 (“PULMATRIX”) and upon execution shall be incorporated into the Master Services Agreement between
MANNKIND and PULMATRIX dated March 1, 2024 (the “Agreement”).
PULMATRIX
hereby engages MANNKIND to provide Services as follows:
1. Services.
[Insert detailed description of specific Services, milestones, Deliverables, and target completion dates.]
2. Compensation
and Expenses. [Insert if applicable.]
3. Project
Contacts (MANNKIND and PULMATRIX): [Insert contact details.]
4. Term.
This SOP shall commence on the date last signed below and, unless earlier terminated in accordance with the Agreement, shall expire upon
completion of the Services and obligations hereunder.
5. Except
as modified by this SOP, all other terms and conditions of the Agreement shall remain in effect.
AGREED
TO AND ACCEPTED BY:
MANNKIND
CORPORATION |
|
PULMATRIX,
INC. |
|
|
|
|
|
By: |
/s/ Michael
Castagna |
|
By: |
/s/ Teofilo
Raad |
Name:
|
Michael
Castagna |
|
Name:
|
Teofilo
Raad |
Title:
|
Chief
Executive Officer |
|
Title:
|
Chief
Executive Officer |
Date:
|
|
|
Date: |
|
Master Services Agreement Page 14 |
Exhibit 31.1
CERTIFICATIONS UNDER SECTION 302
I, Peter Ludlum, certify that:
1. |
I have reviewed this Quarterly Report on Form 10-Q of Pulmatrix, Inc.; |
|
|
|
2. |
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
|
|
|
3. |
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
|
|
|
4. |
The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
|
|
|
|
a) |
designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
|
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b) |
designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
|
|
|
|
c) |
evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
|
|
|
|
d) |
disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
|
|
|
5. |
The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): |
|
|
|
|
a) |
all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and |
|
|
|
|
b) |
any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
Date: August 13, 2024 |
|
|
|
/s/ Peter Ludlum |
|
Peter Ludlum |
|
Interim Chief Executive Officer and Interim Chief Financial Officer |
|
(Principal Executive, Financial and Accounting Officer)
|
|
Exhibit 32.1
CERTIFICATIONS UNDER SECTION 906
Pursuant to section 906 of the Sarbanes-Oxley Act
of 2002 (subsections (a) and (b) of section 1350, chapter 63 of title 18, United States Code), each of the undersigned officers of Pulmatrix,
Inc., a Delaware corporation (the “Company”), does hereby certify, to such officer’s knowledge and in the capacity of
an officer, that:
The Quarterly Report for the quarter ended June 30,
2024 (the “Form 10-Q”) of the Company fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange
Act of 1934, and the information contained in the Form 10-Q fairly presents, in all material respects, the financial condition and results
of operations of the Company as of, and for, the periods presented in the Form 10-Q.
Date: August 13, 2024 |
By: |
/s/ Peter Ludlum |
|
|
Peter Ludlum |
|
|
Interim Chief Executive Officer and Interim Chief Financial Officer
(Principal Executive, Financial and Accounting Officer) |
v3.24.2.u1
Cover - shares
|
6 Months Ended |
|
Jun. 30, 2024 |
Aug. 08, 2024 |
Entity Addresses [Line Items] |
|
|
Document Type |
10-Q
|
|
Amendment Flag |
false
|
|
Document Quarterly Report |
true
|
|
Document Transition Report |
false
|
|
Document Period End Date |
Jun. 30, 2024
|
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Document Fiscal Period Focus |
Q2
|
|
Document Fiscal Year Focus |
2024
|
|
Current Fiscal Year End Date |
--12-31
|
|
Entity File Number |
001-36199
|
|
Entity Registrant Name |
PULMATRIX,
INC.
|
|
Entity Central Index Key |
0001574235
|
|
Entity Tax Identification Number |
46-1821392
|
|
Entity Incorporation, State or Country Code |
DE
|
|
Entity Address, Address Line One |
945
Concord Street
|
|
Entity Address, Address Line Two |
Suite 1217
|
|
Entity Address, City or Town |
Framingham
|
|
Entity Address, State or Province |
MA
|
|
Entity Address, Postal Zip Code |
01701
|
|
City Area Code |
(888)
|
|
Local Phone Number |
355-4440
|
|
Title of 12(b) Security |
Common
Stock, par value $0.0001 per share
|
|
Trading Symbol |
PULM
|
|
Security Exchange Name |
NASDAQ
|
|
Entity Current Reporting Status |
Yes
|
|
Entity Interactive Data Current |
Yes
|
|
Entity Filer Category |
Non-accelerated Filer
|
|
Entity Small Business |
true
|
|
Entity Emerging Growth Company |
false
|
|
Entity Shell Company |
false
|
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Entity Common Stock, Shares Outstanding |
|
3,652,285
|
Former Address [Member] |
|
|
Entity Addresses [Line Items] |
|
|
Entity Address, Address Line One |
36
Crosby Drive
|
|
Entity Address, Address Line Two |
Suite 100
|
|
Entity Address, City or Town |
Bedford
|
|
Entity Address, State or Province |
MA
|
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Entity Address, Postal Zip Code |
01730
|
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v3.24.2.u1
Consolidated Balance Sheets - USD ($) $ in Thousands |
Jun. 30, 2024 |
Dec. 31, 2023 |
Current assets: |
|
|
Cash and cash equivalents |
$ 12,379
|
$ 19,173
|
Restricted cash |
1,421
|
|
Accounts receivable |
635
|
928
|
Prepaid expenses and other current assets |
1,201
|
742
|
Total current assets |
15,636
|
20,843
|
Property and equipment, net |
|
1,158
|
Operating lease right-of-use asset |
|
10,309
|
Long-term restricted cash |
51
|
1,472
|
Other long-term assets |
93
|
176
|
Total assets |
15,780
|
33,958
|
Current liabilities: |
|
|
Accounts payable |
393
|
1,915
|
Accrued expenses and other current liabilities |
1,783
|
947
|
Operating lease liability |
24
|
429
|
Deferred revenue |
270
|
618
|
Total current liabilities |
2,470
|
3,909
|
Deferred revenue, net of current portion |
|
3,727
|
Operating lease liability, net of current portion |
|
8,327
|
Total liabilities |
2,470
|
15,963
|
Commitments and contingencies (Note 10) |
|
|
Stockholders’ equity: |
|
|
Preferred Stock, $0.0001 par value — 500,000 shares authorized; 6,746 shares designated Series A convertible preferred stock; no shares issued and outstanding at June 30, 2024 and December 31, 2023 |
|
|
Common stock, $0.0001 par value — 200,000,000 shares authorized; 3,652,285 shares issued and outstanding at June 30, 2024 and December 31, 2023 |
|
|
Additional paid-in capital |
305,893
|
305,592
|
Accumulated deficit |
(292,583)
|
(287,597)
|
Total stockholders’ equity |
13,310
|
17,995
|
Total liabilities and stockholders’ equity |
$ 15,780
|
$ 33,958
|
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v3.24.2.u1
Consolidated Balance Sheets (Parenthetical) - $ / shares
|
Jun. 30, 2024 |
Dec. 31, 2023 |
Preferred stock, par value |
$ 0.0001
|
$ 0.0001
|
Preferred stock, shares authorized |
500,000
|
500,000
|
Common stock, par value |
$ 0.0001
|
$ 0.0001
|
Common stock, shares authorized |
200,000,000
|
200,000,000
|
Common stock, shares issued |
3,652,285
|
3,652,285
|
Common stock, shares outstanding |
3,652,285
|
3,652,285
|
Series A Convertible Preferred Stock [Member] |
|
|
Preferred stock, shares authorized |
6,746
|
6,746
|
Preferred stock, shares issued |
0
|
0
|
Preferred stock, shares outstanding |
0
|
0
|
X |
- DefinitionFace amount or stated value per share of common stock.
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v3.24.2.u1
Consolidated Statements of Operations (Unaudited) - USD ($) $ in Thousands |
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Income Statement [Abstract] |
|
|
|
|
Revenues |
$ 1,552
|
$ 1,844
|
$ 7,437
|
$ 3,343
|
Operating expenses: |
|
|
|
|
Research and development |
2,834
|
4,165
|
6,346
|
8,039
|
General and administrative |
2,001
|
1,670
|
3,627
|
3,880
|
Loss on disposal group held for sale |
2,618
|
|
2,618
|
|
Total operating expenses |
7,453
|
5,835
|
12,591
|
11,919
|
Loss from operations |
(5,901)
|
(3,991)
|
(5,154)
|
(8,576)
|
Other income (expense): |
|
|
|
|
Interest income |
133
|
236
|
293
|
458
|
Other expense, net |
(43)
|
(61)
|
(125)
|
(146)
|
Total other income, net |
90
|
175
|
168
|
312
|
Net loss |
$ (5,811)
|
$ (3,816)
|
$ (4,986)
|
$ (8,264)
|
Net loss per share attributable to common stockholders - basic |
$ (1.59)
|
$ (1.04)
|
$ (1.37)
|
$ (2.26)
|
Net loss per share attributable to common stockholders - diluted |
$ (1.59)
|
$ (1.04)
|
$ (1.37)
|
$ (2.26)
|
Weighted average common shares outstanding - basic |
3,652,285
|
3,652,285
|
3,652,285
|
3,651,531
|
Weighted average common shares outstanding - diluted |
3,652,285
|
3,652,285
|
3,652,285
|
3,651,531
|
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v3.24.2.u1
Consolidated Statements of Stockholders' Equity (Unaudited) - USD ($) $ in Thousands |
Preferred Stock [Member] |
Common Stock [Member] |
Additional Paid-in Capital [Member] |
Retained Earnings [Member] |
Total |
Balance at Dec. 31, 2022 |
|
|
$ 304,585
|
$ (273,476)
|
$ 31,109
|
Balance, shares at Dec. 31, 2022 |
|
3,639,185
|
|
|
|
Stock-based compensation |
|
|
296
|
|
296
|
Net income (loss) |
|
|
|
(4,448)
|
(4,448)
|
Issuance of common stock, net of issuance costs |
|
|
53
|
|
53
|
Issuance of common stock, net of issuance costs, shares |
|
13,100
|
|
|
|
Balance at Mar. 31, 2023 |
|
|
304,934
|
(277,924)
|
27,010
|
Balance, shares at Mar. 31, 2023 |
|
3,652,285
|
|
|
|
Balance at Dec. 31, 2022 |
|
|
304,585
|
(273,476)
|
31,109
|
Balance, shares at Dec. 31, 2022 |
|
3,639,185
|
|
|
|
Net income (loss) |
|
|
|
|
(8,264)
|
Balance at Jun. 30, 2023 |
|
|
305,189
|
(281,740)
|
23,449
|
Balance, shares at Jun. 30, 2023 |
|
3,652,285
|
|
|
|
Balance at Mar. 31, 2023 |
|
|
304,934
|
(277,924)
|
27,010
|
Balance, shares at Mar. 31, 2023 |
|
3,652,285
|
|
|
|
Stock-based compensation |
|
|
255
|
|
255
|
Net income (loss) |
|
|
|
(3,816)
|
(3,816)
|
Balance at Jun. 30, 2023 |
|
|
305,189
|
(281,740)
|
23,449
|
Balance, shares at Jun. 30, 2023 |
|
3,652,285
|
|
|
|
Balance at Dec. 31, 2023 |
|
|
305,592
|
(287,597)
|
17,995
|
Balance, shares at Dec. 31, 2023 |
|
3,652,285
|
|
|
|
Stock-based compensation |
|
|
198
|
|
198
|
Net income (loss) |
|
|
|
825
|
825
|
Balance at Mar. 31, 2024 |
|
|
305,790
|
(286,772)
|
19,018
|
Balance, shares at Mar. 31, 2024 |
|
3,652,285
|
|
|
|
Balance at Dec. 31, 2023 |
|
|
305,592
|
(287,597)
|
17,995
|
Balance, shares at Dec. 31, 2023 |
|
3,652,285
|
|
|
|
Net income (loss) |
|
|
|
|
(4,986)
|
Balance at Jun. 30, 2024 |
|
|
305,893
|
(292,583)
|
13,310
|
Balance, shares at Jun. 30, 2024 |
|
3,652,285
|
|
|
|
Balance at Mar. 31, 2024 |
|
|
305,790
|
(286,772)
|
19,018
|
Balance, shares at Mar. 31, 2024 |
|
3,652,285
|
|
|
|
Stock-based compensation |
|
|
103
|
|
103
|
Net income (loss) |
|
|
|
(5,811)
|
(5,811)
|
Balance at Jun. 30, 2024 |
|
|
$ 305,893
|
$ (292,583)
|
$ 13,310
|
Balance, shares at Jun. 30, 2024 |
|
3,652,285
|
|
|
|
X |
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v3.24.2.u1
Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands |
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Cash flows from operating activities: |
|
|
|
|
Net loss |
$ (5,811)
|
$ (3,816)
|
$ (4,986)
|
$ (8,264)
|
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
|
|
Depreciation and amortization |
|
|
106
|
64
|
Amortization of operating lease right-of-use asset |
|
|
329
|
777
|
Stock-based compensation |
|
|
301
|
551
|
Loss on disposal group held for sale |
2,618
|
|
2,618
|
|
Changes in operating assets and liabilities: |
|
|
|
|
Accounts receivable |
|
|
293
|
880
|
Prepaid expenses and other current assets |
|
|
(459)
|
49
|
Other long-term assets |
|
|
83
|
(1,595)
|
Accounts payable |
|
|
(1,522)
|
(309)
|
Accrued expenses and other current liabilities |
|
|
1,225
|
(437)
|
Operating lease liability |
|
|
(309)
|
(843)
|
Deferred revenue |
|
|
(4,075)
|
(705)
|
Net cash used in operating activities |
|
|
(6,396)
|
(9,832)
|
Cash flows from investing activities: |
|
|
|
|
Purchases of property and equipment |
|
|
(398)
|
(58)
|
Net cash used in investing activities |
|
|
(398)
|
(58)
|
Cash flows from financing activities: |
|
|
|
|
Proceeds from issuance of common stock, net of issuance costs |
|
|
|
53
|
Net cash provided by financing activities |
|
|
|
53
|
Net decrease in cash, cash equivalents and restricted cash |
|
|
(6,794)
|
(9,837)
|
Cash, cash equivalents and restricted cash — beginning of period |
|
|
20,645
|
37,253
|
Total cash, cash equivalents and restricted cash |
13,851
|
27,416
|
13,851
|
27,416
|
Reconciliation of cash, cash equivalents and restricted cash to the consolidated balance sheets: |
|
|
|
|
Cash and cash equivalents |
12,379
|
25,791
|
12,379
|
25,791
|
Restricted cash |
1,421
|
153
|
1,421
|
153
|
Long-term restricted cash |
$ 51
|
$ 1,472
|
51
|
1,472
|
Supplemental disclosures of non-cash investing and financing information: |
|
|
|
|
Reduction of operating lease right-of-use asset and lease liability upon lease modification |
|
|
8,423
|
|
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v3.24.2.u1
Organization
|
6 Months Ended |
Jun. 30, 2024 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
|
Organization |
1.
Organization
Pulmatrix,
Inc. (the “Company”) was incorporated in 2013 as a Delaware corporation. The Company is a clinical-stage biopharmaceutical
company focused on the development of a novel class of inhaled therapeutic products. The Company’s proprietary dry powder delivery
platform, iSPERSE™, is engineered to deliver small, dense particles with highly efficient dispersibility and
delivery to the airways, which can be used with an array of dry powder inhaler technologies and can be formulated with a variety of drug
substances. The Company has developed a pipeline of iSPERSE™-based therapeutic candidates targeted at prevention
and treatment of a range of central nervous system, respiratory and other diseases with important unmet medical needs.
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v3.24.2.u1
Summary of Significant Accounting Policies and Recent Accounting Standards
|
6 Months Ended |
Jun. 30, 2024 |
Accounting Policies [Abstract] |
|
Summary of Significant Accounting Policies and Recent Accounting Standards |
2.
Summary of Significant Accounting Policies and Recent Accounting Standards
Basis
of Presentation
The
condensed consolidated financial statements of the Company included herein have been prepared pursuant to the rules and regulations of
the Securities and Exchange Commission (the “SEC”). Certain information and footnote disclosures normally included in financial
statements prepared in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”)
have been condensed or omitted from this report, as is permitted by such rules and regulations. Accordingly, these condensed consolidated
financial statements should be read in conjunction with the consolidated financial statements and notes thereto included in the Company’s
Annual Report on Form 10-K for the fiscal year ended December 31, 2023, filed with the SEC on March 28, 2024 (the “Annual Report”).
The
financial information as of June 30, 2024, and for the three and six months ended June 30, 2024 and 2023, is unaudited. In the opinion
of management, all adjustments (including those which are normal and recurring) considered necessary for a fair presentation of the interim
financial information have been included. The balance sheet data as of December 31, 2023 was derived from audited consolidated financial
statements. The results of the Company’s operations for any interim periods are not necessarily indicative of the results that
may be expected for any other interim period or for a full fiscal year.
Based
on its current operating plan, the Company believes that its cash and cash equivalents as of June 30, 2024, will be adequate to fund
its currently anticipated operating expenses for at least twelve months from the date these condensed consolidated financial statements
are issued. The Company will need to secure additional funding in the future, from one or more equity or debt financings, collaborations,
or other sources, in order to carry out all of the Company’s planned research and development activities and regulatory activities;
commercialize product candidates; or conduct any substantial, additional development requirements requested by the FDA. Additional funding
may not be available to the Company on acceptable terms, or at all. If the Company is unable to secure additional capital, it will be
required to significantly decrease the amount of planned expenditures and may be required to cease operations. In addition, any disruption
in the capital markets could make any financing more challenging, and there can be no assurance that Pulmatrix will be able to obtain
such financing on commercially reasonable terms or at all. Curtailment of operations would cause significant delays in the Company’s
efforts to develop and introduce its products to market, which is critical to the realization of its business plan and the future operations
of the Company.
Use
of Estimates
In
preparing the condensed consolidated financial statements in conformity with U.S. GAAP, management is required to make estimates and
assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date
of the condensed consolidated financial statements, as well as the reported amounts of expenses during the reporting period. Due to inherent
uncertainty involved in making estimates, actual results may differ from these estimates. On an ongoing basis, the Company evaluates
its estimates and assumptions. The most significant estimates and assumptions in the Company’s condensed consolidated financial
statements include, but are not limited to, estimates of future expected costs in order to derive
and recognize revenue and estimates related to clinical trial accruals and upfront deposits.
Concentrations
of Credit Risk
Cash
is a financial instrument that potentially subjects the Company to concentrations of credit risk. For all periods presented, substantially
all of the Company’s cash was deposited in accounts at a single financial institution that management believes is creditworthy,
and the Company has not incurred any losses to date. The Company is exposed to credit risk in the event of default by this financial
institution for amounts in excess of the Federal Deposit Insurance Corporation insured limits.
For
the three and six months ended June 30, 2024, revenue from one customer accounted for 61% and 89%, respectively, of revenue recognized
in the accompanying condensed consolidated financial statements. For the three and six months ended June 30, 2023, revenue from one customer
accounted for 100% of revenue recognized in the accompanying condensed consolidated financial statements. As of June 30, 2024, two customers
accounted for 100% of accounts receivable. As of December 31, 2023, one customer accounted for 100% of accounts receivable.
Summary
of Significant Accounting Policies
The
Company’s significant accounting policies are described in Note 2, Summary of Significant Accounting Policies and Recent Accounting
Standards, in the Annual Report. During the six months ended June 30, 2024, the Company did not make any changes to its significant
accounting policies.
Recent
Accounting Pronouncements
From
time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”) or other standard
setting bodies that are adopted by the Company as of the specified effective date. The Company did not adopt any new accounting pronouncements
during the six months ended June 30, 2024 that had a material effect on its condensed consolidated financial statements.
In
December 2023, the FASB issued Accounting Standard Update 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures
(“ASU 2023-09”). The guidance in ASU 2023-09 improves the transparency of income tax disclosures by greater disaggregation
of information in the rate reconciliation and income taxes paid disaggregated by jurisdiction. The standard becomes effective for the
annual period beginning on January 1, 2025, with early adoption permitted. The Company is currently evaluating the impact that the adoption
of ASU 2023-09 may have on its consolidated financial statements.
As
of June 30, 2024, there are no other new, or existing recently issued, accounting pronouncements that are of significance, or potential
significance, that impact the Company’s condensed consolidated financial statements.
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v3.24.2.u1
Prepaid Expenses and Other Current Assets
|
6 Months Ended |
Jun. 30, 2024 |
Prepaid Expenses And Other Current Assets |
|
Prepaid Expenses and Other Current Assets |
3.
Prepaid Expenses and Other Current Assets
Prepaid
expenses and other current assets consisted of the following:
Schedule
of Prepaid Expenses and Other Current Assets
| |
June 30, 2024 | | |
December 31, 2023 | |
Clinical and consulting | |
$ | 457 | | |
$ | 30 | |
Insurance | |
| 438 | | |
| 232 | |
Software and hosting costs | |
| 86 | | |
| 108 | |
Other | |
| 220 | | |
| 372 | |
Total prepaid expenses and other current assets | |
$ | 1,201 | | |
$ | 742 | |
|
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- DefinitionDisclosure of prepaid expenses and other current assets [Text Block]
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v3.24.2.u1
Property and Equipment, Net
|
6 Months Ended |
Jun. 30, 2024 |
Property, Plant and Equipment [Abstract] |
|
Property and Equipment, Net |
4.
Property and Equipment, Net
The
Company’s Property and equipment, net, were included in the disposal group as part of the MannKind Transaction (as defined in Note
6, Significant Agreements. Refer to that note for further details and accounting discussion). The Company recorded a full write-down
of its net property and equipment balance as of June 30, 2024:
Schedule of Property and Equipment
| |
June 30, 2024 | | |
December 31, 2023 | |
Laboratory equipment | |
$ | - | | |
$ | 1,656 | |
Leasehold improvements | |
| - | | |
| - | |
Office furniture and equipment | |
| - | | |
| 401 | |
Computer equipment | |
| - | | |
| 237 | |
Capital in progress | |
| - | | |
| 600 | |
Total property and equipment | |
| - | | |
| 2,894 | |
Less accumulated depreciation and amortization | |
| - | | |
| (1,736 | ) |
Property and equipment, net | |
$ | - | | |
$ | 1,158 | |
Depreciation
and amortization expense for the six months ended June 30, 2024 and 2023 was $106 and $64, respectively.
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v3.24.2.u1
Accrued Expenses and Other Current Liabilities
|
6 Months Ended |
Jun. 30, 2024 |
Payables and Accruals [Abstract] |
|
Accrued Expenses and Other Current Liabilities |
5.
Accrued Expenses and Other Current Liabilities
Accrued
expenses and other current liabilities consisted of the following:
Schedule of Accrued Expenses and Other Current Liabilities
| |
June 30, 2024 | | |
December 31, 2023 | |
Wages and incentives | |
$ | 1,221 | | |
$ | 70 | |
Clinical and consulting | |
| 296 | | |
| 347 | |
Legal and patents | |
| 223 | | |
| 42 | |
Accrued purchases of property and equipment | |
| - | | |
| 389 | |
Other | |
| 43 | | |
| 99 | |
Total accrued expenses and other current liabilities | |
$ | 1,783 | | |
$ | 947 | |
|
X |
- DefinitionThe entire disclosure for accounts payable and accrued liabilities at the end of the reporting period.
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v3.24.2.u1
Significant Agreements
|
6 Months Ended |
Jun. 30, 2024 |
Commitments and Contingencies Disclosure [Abstract] |
|
Significant Agreements |
6.
Significant Agreements
Development
and Commercialization Agreement with Cipla Technologies LLC (“Cipla”)
On
April 15, 2019, the Company entered into a Development and Commercialization Agreement (the “Cipla Agreement”) with Cipla
for the co-development and commercialization, on a worldwide exclusive basis, of PUR1900, the Company’s inhaled iSPERSE™
drug delivery system (the “Product”) enabled formulation of the antifungal drug itraconazole, which is only available
as an oral drug, for the treatment of all pulmonary indications, including allergic bronchopulmonary aspergillosis (“ABPA”)
in patients with asthma. The Company entered into an amendment to the Cipla Agreement on November 8, 2021 (the “Second Amendment”)
and a subsequent amendment on January 6, 2024 (the “Third Amendment”). All references to the Cipla Agreement herein refer
to the Cipla Agreement, as amended.
The
Company received a non-refundable upfront payment of $22.0 million (the “Upfront Payment”) under the Cipla Agreement. Upon
receipt of the Upfront Payment, the Company irrevocably assigned to Cipla the following assets, solely to the extent that each covers
the Product in connection with any treatment, prevention, and/or diagnosis of diseases of the pulmonary system (“Pulmonary Indications”):
all existing and future technologies, current and future drug master files, dossiers, third-party contracts, regulatory filings, regulatory
materials and regulatory approvals, patents, and intellectual property rights, as well as any other associated rights and assets directly
related to the Product, specifically in relation to Pulmonary Indications (collectively, the “Assigned Assets”), excluding
most specifically the Company’s iSPERSE™ technology. A portion of the Upfront Payment was deposited by
the Company into a bank account, along with an equal amount from the Company, and was dedicated to the development of the Product (the
“Initial Development Funding”). The Initial Development Funding was depleted during the year ended December 31, 2021, at
which point the Company and Cipla each became responsible for a portion of the development costs actually incurred as described below
(the “Co-Development Phase”).
Pursuant
to the Second Amendment, the Company and Cipla were each responsible for 60% and 40%, respectively, of the Company’s overhead costs
and the time spent by the Company’s employees and consultants on development of the Product (“Direct Costs”). The Company
will share all other development costs with Cipla that are not Direct Costs, such as the cost of clinical research organizations, manufacturing
costs and other third-party costs, on a 50/50 basis.
Pursuant
to the Third Amendment, the Company and Cipla agreed that, during the period commencing on January 6, 2024 and ending July 30, 2024 (the
“Wind Down Period”), the Company will complete all Phase 2b activities, assign or license all patents to Cipla and their
registration with the appropriate authorities in regions other than the United States, complete a physical and demonstrable technology
transfer and secure all data from the Phase 2b study for inclusion in the safety database. The Company will share costs with Cipla during
the Wind Down Period in the same proportions in effect with the Second Amendment discussed above, but subject to a maximum reimbursement
amount by Cipla as approved by the joint steering committee.
Accounting
Treatment
The
Company concluded that because both it and Cipla are active participants in the arrangement and are exposed to the significant risks
and rewards of the collaboration, the Company’s collaboration with Cipla is within the scope of Accounting Standards Codification
(“ASC”) 808, Collaborative Arrangements (“ASC 808”). The Company concluded that Cipla is a customer since
they contracted with the Company to obtain research and development services and a license to the Assigned Assets, each of which is an
output of the Company’s ordinary activities, in exchange for consideration. Therefore, the Company has applied the guidance in
ASC 606, Revenue from Contracts with Customers (“ASC 606”) to account for the research and development services and
a license within the contract. The Company determined that the research and development services and license to the Assigned Assets are
considered highly interdependent and highly interrelated and therefore are considered a single combined performance obligation because
Cipla cannot benefit from the license without the performance by the Company of the research and development services. Such research
and development services are highly specialized and proprietary to the Company and therefore not available to Cipla from any other third
party.
The
Company initially determined the total transaction price to be $22.0 million – comprised of $12.0 million for research and development
services for the Product and $10.0 million for the irrevocable license to the Assigned Assets. Any consideration related to the Co-Development
Phase was not initially included in the transaction price as such amounts are subject to the variable consideration constraint. Additionally,
upon commercialization, Cipla and the Company will share equally, both positive and negative total free cash-flows earned by Cipla in
respect of the Product. However, the Company has not included such free cash-flows in the transaction price as these milestones are constrained.
Revenue
is recognized for the Cipla Agreement as the research and development services are provided using an input method, according to the ratio
of costs incurred to the total costs expected to be incurred in the future to satisfy the Company’s obligations. In management’s
judgment, this input method is the best measure of the transfer of control of the combined performance obligation. The amounts received
that have not yet been recognized as revenue are recorded in deferred revenue on the Company’s consolidated balance sheets, with
amounts expected to be recognized in the next 12 months recorded as current.
The
Company concluded that the Third Amendment is a contract modification that should be accounted for as part of the existing contract.
During the three and six months ended June 30, 2024, the Company recognized $0.9 million and $6.6 million, respectively, in revenue related
to the research and development services and irrevocable license to the Assigned Assets in the Company’s consolidated statements
of operations, as compared to $1.8 million and $3.3 million, respectively, recognized during the three and six months ended June 30,
2023. The revenue recognized during the six months ended June 30, 2024 was primarily associated with the cumulative catch-up recorded
in the three months ended March 31, 2024, from the contract modification, that had been included in deferred revenue at the beginning of the period.
As of June 30, 2024, the aggregate transaction price related to the Company’s unsatisfied obligations was $0.3 million and was
recorded in deferred revenue, all of which was current.
Agreements
with MannKind Corporation (“MannKind”)
On
May 28, 2024, the Company executed certain agreements with MannKind and the Company’s landlord (collectively,
the “MannKind Transaction”), all of which closed during July 2024. The agreements with MannKind included a Bill of Sale and
Assignment Agreement (the “Bill of Sale”) with respect to the assignment of the Company’s rental facility at 36 Crosby
Drive, Bedford, Massachusetts (the “Bedford Facility”) to MannKind along with the transfer of all leasehold improvements,
laboratory equipment and other related personal property. In connection with the assignment of the Bedford Facility, the Company, MannKind
and Cobalt Propco 2020, LLC (the “Landlord”) entered into an Amendment to Lease and Consent to Assignment of Lease (the “Lease
Assignment Agreement”) pursuant to that certain Lease Agreement, dated as of January 7, 2022 (the “Lease Agreement”),
by and between the Company and the Landlord. Pursuant to the Lease Assignment Agreement, MannKind assumed all of the Company’s
obligations under the Lease Agreement, including all rent and other payments.
In
connection with the transactions contemplated by the Bill of Sale and Lease Assignment Agreement, the Company and MannKind entered into
an Intellectual Property Cross License Agreement (the “Cross License Agreement”). Pursuant to the Cross License Agreement,
the Company granted to MannKind (i) an exclusive license to develop, use, manufacture, market, offer and sell iSPERSE formulations of
Clofazimine, (ii) an exclusive license to develop, use, manufacture, market, offer and sell formulations of iSPERSE with one more active
pharmaceutical ingredients for the treatment of nontuberculous mycobacteria lung disease in humans, (iii) an exclusive license to develop,
use, manufacture, market, offer and sell iSPERSE formulations of insulin, (iv) a non-exclusive license to develop, use, manufacture,
market, offer and sell formulations of iSPERSE with one more active pharmaceutical ingredients for the treatment of endocrine disease
in humans, and (v) a non-exclusive license to develop, use, manufacture, market, offer and sell formulations of iSPERSE with one more
active pharmaceutical ingredients for the treatment of interstitial lung diseases (including IPF, PPF and other related lung diseases)
in humans (collectively, the “Out-License”).
Additionally,
pursuant to the Cross License Agreement, MannKind granted to the Company (i) the exclusive right to develop, use, manufacture, market,
offer and sell its single-use disposable dry powder inhaler (including all modifications or improvement thereto made by or on behalf
of the Company, the “Cricket Device”) for the inhaled delivery of dihydroergotamine in any formulation whatsoever, including
the Company’s PUR3100 treatment of acute migraine and (ii) a non-exclusive license to develop, use, manufacture, market, offer
and sell the Cricket Device for the inhaled delivery of one more active pharmaceutical ingredients formulated with iSPERSE for the treatment
of neurological disease in humans (collectively, the “In-License”).
Additionally,
pursuant to the Master Services Agreement, by and between the Company and MannKind, MannKind shall provide certain development services
to the Company, including but not limited to, activities to develop a dry powder formulation of the active pharmaceutical ingredient
that the Company provides to MannKind for oral inhalation using iSPERSE.
To
maintain continuity of iSPERSE platform knowledge, MannKind hired certain members of the Company’s research and development staff
in July 2024.
Accounting
Treatment
The
Company determined that the MannKind Transaction represents a combined agreement for accounting purposes, as the individual components
have the same overall commercial objectives and the consideration under each component is dependent on the other components.
The
consideration due to the Company in the MannKind Transaction consists solely of the non-cash consideration in the form of the In-License.
The fair value of the non-cash consideration received should be allocated to the other components of the MannKind Transaction to determine
the consideration received for the other components. The Company determined that the fair value of the In-License is immaterial given
that adequate alternative inhaler devices are already available on the market (and indeed, the Company has already established use of
another third-party inhalation device in their PUR3100 Phase 1 trial that performed well as a DHE delivery device as reported in a peer-reviewed
publication), and considering optional purchases of Cricket Devices are at market prices. Accordingly, the consideration allocated to
other components of the MannKind Transaction was immaterial.
The
Company accounted for the Lease Assignment Agreement upon execution as a lease modification that reduced the lease term to the assignment
date in July 2024. Accordingly, the Company remeasured its operating lease liability as of the modification date to reflect the decrease
in fixed lease payments, with the amount of the remeasurement, $8.4 million, adjusted by a corresponding reduction to the right-of-use
asset. Refer to Note 11, Leases, for further details.
The
Company concluded that the Out-License component of the MannKind Transaction was within the scope of ASC 606, as the monetization of
its core technology represents an output of the Company’s ordinary activities. The Company transferred control of the combined
licenses of iSPERSE to MannKind at a point in time in July 2024 upon closing of the MannKind Transaction; however, no revenue was recognized
because the consideration allocated to the Out-License component was immaterial.
The
Company determined that its operating lease right-of-use asset and property and equipment subject to the Bill of Sale represented a disposal
group that became held for sale during the second quarter of 2024 and remained classified as held for sale as of June 30, 2024, which
should be measured at the lower of its carrying value or fair value less costs to sell. Since the fair value of the disposal group was
considered immaterial, the Company recorded a full write-down of the disposal group’s carrying value as of June 30, 2024, in the
amount of $2.6 million.
Concurrent
with the closing of the MannKind Transaction, the Company terminated and MannKind hired the majority of the Company’s research
and development employees, representing approximately two-thirds of the Company’s workforce. During the quarter ended June 30,
2024, the Company agreed to provide termination benefits to these employees, which has been included in the balance of accrued expenses
and other current liabilities on the consolidated balance sheet as of June 30, 2024, and was paid to the employees in July 2024.
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v3.24.2.u1
Common Stock
|
6 Months Ended |
Jun. 30, 2024 |
Equity [Abstract] |
|
Common Stock |
7.
Common Stock
In
May 2021, the Company entered into an At-The-Market Sales Agreement (the “Sales Agreement”) with H.C. Wainwright and Co.,
LLC (“HCW”) to act as the Company’s sales agent with respect to the issuance and sale of up to $20.0 million of the
Company’s shares of common stock, from time to time in an at-the-market public offering (the “ATM Offering”). Upon
filing of the Annual Report, the Company continued to be subject to General Instruction I.B.6 of Form S-3, pursuant to which in no event
will the Company sell its common stock in a registered primary offering using Form S-3 with a value exceeding more than one-third of
its public float in any 12 calendar month period so long as its public float remains below $75,000,000. Therefore, the amount that may
be able to be raised using the ATM Offering will be significantly less than $20,000,000, until such time as the Company’s public
float held by non-affiliates exceeds $75,000,000.
Sales
of common stock under the Sales Agreement are made pursuant to an effective shelf registration statement on Form S-3, which was filed
with the SEC on May 17, 2024, and subsequently declared effective on May 30, 2024 (File No. 333-279491), and a related prospectus. HCW
acts as the Company’s sales agent on a commercially reasonable efforts basis, consistent with its normal trading and sales practices
and applicable state and federal laws, rules and regulations and the rules of The Nasdaq Capital Market (“Nasdaq”). If expressly
authorized by the Company, HCW may also sell the Company’s common stock in privately negotiated transactions. There is no specific
date on which the ATM Offering will end, there are no minimum sale requirements and there are no arrangements to place any of the proceeds
of the ATM Offering in an escrow, trust or similar account. HCW is entitled to compensation at a fixed commission rate of 3.0% of the
gross proceeds from the sale of the Company’s common stock pursuant to the Sales Agreement.
During
the six months ended June 30, 2024, no shares of the Company’s common stock were sold under the Sales Agreement.
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v3.24.2.u1
Warrants
|
6 Months Ended |
Jun. 30, 2024 |
Warrants |
|
Warrants |
8.
Warrants
There
were no warrants issued or exercised during the six months ended June 30, 2024. During the six months ended June 30, 2024, warrants to
purchase up to 160,445 shares of common stock at a weighted average exercise price of $44.12 per share expired. Subsequent to June 30,
2024, but before the date these condensed consolidated financial statements were issued, warrants to purchase up to 66,675 shares of
common stock at a weighted average exercise price of $26.79 per share expired. The following represents a summary of the warrants outstanding
and exercisable at June 30, 2024, all of which are equity-classified:
Schedule
of Warrants Outstanding
| |
Adjusted | | |
| |
Number of Shares Underlying Warrants | |
Issue Date | |
Exercise Price | | |
Expiration Date | |
Outstanding | | |
Exercisable | |
December 17, 2021 | |
$ | 14.99 | | |
December 15, 2026 | |
| 36,538 | | |
| 36,538 | |
December 17, 2021 | |
$ | 13.99 | | |
December 17, 2026 | |
| 281,047 | | |
| 281,047 | |
February 16, 2021 | |
$ | 49.99 | | |
February 11, 2026 | |
| 65,003 | | |
| 65,003 | |
August 7, 2020 | |
$ | 35.99 | | |
July 14, 2025 | |
| 90,743 | | |
| 90,743 | |
August 7, 2020 | |
$ | 44.99 | | |
July 14, 2025 | |
| 10,939 | | |
| 10,939 | |
July 23, 2020 | |
$ | 35.99 | | |
July 14, 2025 | |
| 77,502 | | |
| 77,502 | |
July 13, 2020 | |
$ | 44.99 | | |
July 14, 2025 | |
| 21,846 | | |
| 21,846 | |
July 13, 2020 | |
$ | 35.99 | | |
July 14, 2025 | |
| 334,800 | | |
| 334,800 | |
February 12, 2019 | |
$ | 26.79 | | |
August 12, 2024 | |
| 66,675 | | |
| 66,675 | |
June 15, 2015 | |
$ | 1,509.99 | | |
Five years after milestone achievement | |
| 15,955 | | |
| - | |
Total | |
| | | |
| |
| 1,001,048 | | |
| 985,093 | |
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v3.24.2.u1
Stock-based Compensation
|
6 Months Ended |
Jun. 30, 2024 |
Share-Based Payment Arrangement [Abstract] |
|
Stock-based Compensation |
9.
Stock-based Compensation
The
Company sponsors the Pulmatrix, Inc. Amended and Restated 2013 Employee, Director and Consultant Equity Incentive Plan (the “Incentive
Plan”). As of June 30, 2024, the Incentive Plan provided for the grant of up to 818,936 shares of the Company’s common stock,
of which 503,669 shares remained available for future grant. In addition, the Company sponsors two legacy plans under which no additional
awards may be granted. As of June 30, 2024, the two legacy plans have a total of 8 options outstanding, all of which are fully vested
and for which common stock will be issued upon exercise.
The
following table summarizes stock option activity during the six months ended June 30, 2024:
Schedule
of Stock Option Activity
| |
Number of Options | | |
Weighted- Average Exercise Price | | |
Weighted- Average Remaining Contractual Term (Years) | | |
Aggregate Intrinsic Value | |
Outstanding — January 1, 2024 | |
| 344,306 | | |
$ | 20.92 | | |
| 7.54 | | |
$ | - | |
Forfeited or expired | |
| (32,869 | ) | |
$ | 5.18 | | |
| | | |
| | |
Outstanding — June 30, 2024 | |
| 311,437 | | |
$ | 22.58 | | |
| 6.95 | | |
$ | - | |
Exercisable — June 30, 2024 | |
| 221,578 | | |
$ | 29.07 | | |
| 6.46 | | |
$ | - | |
No
stock options were granted during the six months ended June 30, 2024. The Company records stock-based compensation expense related to
stock options based on their grant-date fair value. As of June 30, 2024, there was $0.5 million of unrecognized stock-based compensation
expense related to unvested stock options granted under the Company’s stock award plans. This expense is expected to be recognized
over a weighted-average period of approximately 1.6 years.
The
following table presents total stock-based compensation expense for the three and six months ended June 30, 2024 and 2023:
Schedule
of Stock-based Compensation Expenses
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Research and development | |
$ | 29 | | |
$ | 59 | | |
$ | 145 | | |
$ | 131 | |
General and administrative | |
| 74 | | |
| 196 | | |
| 156 | | |
| 420 | |
Total stock-based compensation expense | |
$ | 103 | | |
$ | 255 | | |
$ | 301 | | |
$ | 551 | |
|
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Commitments and Contingencies
|
6 Months Ended |
Jun. 30, 2024 |
Commitments and Contingencies Disclosure [Abstract] |
|
Commitments and Contingencies |
10.
Commitments and Contingencies
Research
and Development Activities
The
Company contracts with various other organizations to conduct research and development activities, including clinical trials. The scope
of the services under contracts for research and development activities may be modified and the contracts, subject to certain conditions,
may generally be cancelled by the Company upon written notice. In some instances, the contracts, subject to certain conditions, may be
cancelled by the third party. As of June 30, 2024, the Company had no material noncancellable commitments not expected to be reimbursed
under the Cipla Agreement.
Legal
Proceedings
In
the ordinary course of its business, the Company may be involved in various legal proceedings involving contractual and employment relationships,
patent or other intellectual property rights, and a variety of other matters. The Company is not aware of any pending legal proceedings
that would reasonably be expected to have a material impact on the Company’s financial position or results of operations.
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|
v3.24.2.u1
Leases
|
6 Months Ended |
Jun. 30, 2024 |
Leases |
|
Leases |
11.
Leases
The
Company has limited leasing activities as a lessee which are primarily related to its corporate headquarters, which were relocated during
the third quarter of 2023 and again during the third quarter of 2024.
On
January 7, 2022, the Company executed the Lease Agreement with the Landlord for its corporate headquarters at 36 Crosby Drive, Bedford,
Massachusetts. The leased premises comprise approximately 20,000 square feet of office and lab space, and the lease provides for base
rent of $0.1 million per month, payment of which began in March 2024. The Company is responsible for real estate taxes, maintenance,
and other operating expenses applicable to the leased premises.
On
May 28, 2024, as part of the MannKind Transaction (see further discussion in Note 6, Significant Agreements), the Company and
the Landlord executed the Lease Assignment Agreement to assign the Lease Agreement to MannKind in July 2024. The Company accounted for
the Lease Assignment Agreement as a lease modification that reduced the lease term to the assignment date in July 2024. Accordingly,
the Company remeasured its lease liability as of the modification date to reflect the decrease in fixed lease payments, with the amount
of the remeasurement, $8.4 million, adjusted by a corresponding reduction to the right-of-use asset.
As of June 30, 2024, the
Company had $1.4 million of restricted cash held in a depository account at a financial institution to collateralize a conditional stand-by
letter of credit related to the Lease Agreement, which was presented within current assets on the consolidated balance sheet. Following the closing of the MannKind Transaction, this collateral was released in August 2024, providing additional cash available for operations.
In
June 2024, the Company entered into a short-term lease agreement for its new headquarters at 945 Concord Street, Framingham, Massachusetts.
No lease liability or right-of-use asset has been recorded for this short-term lease.
The
components of lease expense for the Company for the three and six months ended June 30, 2024 and 2023 were as follows:
Schedule
of Components of Lease Expenses
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Lease cost | |
| | | |
| | | |
| | | |
| | |
Fixed lease cost | |
$ | 271 | | |
$ | 418 | | |
$ | 678 | | |
$ | 796 | |
Variable lease cost | |
| 104 | | |
| 168 | | |
| 206 | | |
| 281 | |
Total lease cost | |
$ | 375 | | |
$ | 586 | | |
$ | 884 | | |
$ | 1,077 | |
| |
| | | |
| | | |
| | | |
| | |
Other information | |
| | | |
| | | |
| | | |
| | |
Cash paid for amounts included in the measurement of lease liabilities | |
$ | 322 | | |
$ | 432 | | |
$ | 657 | | |
$ | 863 | |
Weighted-average remaining lease term | |
| | | |
| | | |
| 7 days | | |
| 0.2 years | |
Weighted-average discount rate | |
| | | |
| | | |
| - | | |
| 8.40 | % |
Maturities
of lease liabilities due under these lease agreements as of June 30, 2024 are as follows:
Schedule of Maturities of Lease Liabilities
| |
Operating Leases | |
Maturity of lease liabilities | |
| | |
2024 (7 days) | |
$ | 24 | |
Total lease payments | |
| 24 | |
Less: interest | |
| - | |
Total lease liabilities | |
$ | 24 | |
| |
| | |
Reported as of June 30, 2024 | |
| | |
Lease liabilities — short term | |
$ | 24 | |
Lease liabilities — long term | |
| - | |
Total lease liabilities | |
$ | 24 | |
|
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v3.24.2.u1
Income Taxes
|
6 Months Ended |
Jun. 30, 2024 |
Income Tax Disclosure [Abstract] |
|
Income Taxes |
12.
Income Taxes
The
Company had no income tax expense due to operating losses incurred for the three and six months ended June 30, 2024 and 2023.
Management
of the Company evaluated the positive and negative evidence bearing upon the realizability of its deferred tax assets and determined
that it is more likely than not that the Company will not recognize the benefits of the deferred tax assets. As a result, a full valuation
allowance was recorded as of June 30, 2024 and December 31, 2023.
The
Company applies ASC 740, Income Taxes, for the financial statement recognition, measurement, presentation, and disclosure of uncertain
tax positions taken or expected to be taken in income tax returns. Unrecognized tax benefits represent tax positions for which reserves
have been established. A full valuation allowance has been provided against the Company’s deferred tax assets, so that the effect
of the unrecognized tax benefits is to reduce the gross amount of the deferred tax asset and the corresponding valuation allowance. The
Company has no material uncertain tax positions as of June 30, 2024 and December 31, 2023.
|
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v3.24.2.u1
Net Loss Per Share
|
6 Months Ended |
Jun. 30, 2024 |
Earnings Per Share [Abstract] |
|
Net Loss Per Share |
13.
Net Loss Per Share
Basic
net loss per share is calculated by dividing net loss by the weighted-average number of common shares outstanding during the period.
Diluted net loss per share is calculated by dividing the weighted-average number common shares outstanding during the period, after taking
into consideration any potentially dilutive effects from outstanding stock options or warrants.
Basic
and diluted net loss per share were the same for the three and six months ended June 30, 2024 and 2023, as the effect of potentially
dilutive securities would have been anti-dilutive.
The
following potentially dilutive securities outstanding have been excluded from the computation of diluted weighted-average shares outstanding,
because such securities had an anti-dilutive impact:
Schedule
of Computation of Anti-Dilutive Weighted-Average Shares Outstanding
| |
Three and Six Months Ended June 30, | |
| |
2024 | | |
2023 | |
Options to purchase common stock | |
| 311,437 | | |
| 393,254 | |
Warrants to purchase common stock | |
| 1,001,048 | | |
| 1,161,493 | |
Total options and warrants to purchase common stock | |
| 1,312,485 | | |
| 1,554,747 | |
|
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Subsequent Events
|
6 Months Ended |
Jun. 30, 2024 |
Subsequent Events [Abstract] |
|
Subsequent Events |
14.
Subsequent Events
Departure
of Chief Executive Officer
On
July 15, 2024, the Board of Directors (the “Board”) of the Company approved a General Release and Severance Agreement (the
“Raad Severance Agreement”), by and between the Company and Teofilo Raad, dated as of July 19, 2024, and effective as of
the same date (the “Separation Date”). Effective as of the Separation Date, Mr. Raad’s employment with the Company
ceased and Mr. Raad relinquished all positions, offices, and authority with the Company and any affiliates, including as a member of
the Board and all committees thereto, and the Amended and Restated Employment Agreement by and between the Company and Mr. Raad, dated
as of June 28, 2019, was terminated.
Pursuant
to the terms of the Raad Severance Agreement, the Company will provide to Mr. Raad certain termination-related payments totaling approximately
$1.0 million, less all lawful and authorized withholdings and deductions. Any outstanding equity awards granted to Mr. Raad under the
Company’s equity compensation plans and that would have vested during the 12-month period following the Separation Date became
fully vested as of the Separation Date.
Appointment
of Interim Chief Executive Officer
On
July 15, 2024, the Board approved the appointment of Peter Ludlum as the Interim Chief Executive Officer (the “Interim
CEO”), effective as of July 20, 2024 (“Ludlum Effective Date”), pursuant to an amendment to the consulting
agreement, by and between the Company and Danforth Advisors, LLC, dated as of November 29, 2021, and
amended on April 8, 2022, and October 20, 2022.
The
Company has completed an evaluation of all other subsequent events after the balance sheet date of June 30, 2024 through the date the
condensed consolidated financial statements were issued to ensure that the condensed consolidated financial statements include appropriate
disclosure of events both recognized in the condensed consolidated financial statements as of June 30, 2024, and events which occurred
subsequently but were not recognized in the condensed consolidated financial statements. The Company has concluded that no subsequent
events have occurred that require disclosure, except as disclosed within the condensed consolidated financial statements.
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v3.24.2.u1
Summary of Significant Accounting Policies and Recent Accounting Standards (Policies)
|
6 Months Ended |
Jun. 30, 2024 |
Accounting Policies [Abstract] |
|
Basis of Presentation |
Basis
of Presentation
The
condensed consolidated financial statements of the Company included herein have been prepared pursuant to the rules and regulations of
the Securities and Exchange Commission (the “SEC”). Certain information and footnote disclosures normally included in financial
statements prepared in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”)
have been condensed or omitted from this report, as is permitted by such rules and regulations. Accordingly, these condensed consolidated
financial statements should be read in conjunction with the consolidated financial statements and notes thereto included in the Company’s
Annual Report on Form 10-K for the fiscal year ended December 31, 2023, filed with the SEC on March 28, 2024 (the “Annual Report”).
The
financial information as of June 30, 2024, and for the three and six months ended June 30, 2024 and 2023, is unaudited. In the opinion
of management, all adjustments (including those which are normal and recurring) considered necessary for a fair presentation of the interim
financial information have been included. The balance sheet data as of December 31, 2023 was derived from audited consolidated financial
statements. The results of the Company’s operations for any interim periods are not necessarily indicative of the results that
may be expected for any other interim period or for a full fiscal year.
Based
on its current operating plan, the Company believes that its cash and cash equivalents as of June 30, 2024, will be adequate to fund
its currently anticipated operating expenses for at least twelve months from the date these condensed consolidated financial statements
are issued. The Company will need to secure additional funding in the future, from one or more equity or debt financings, collaborations,
or other sources, in order to carry out all of the Company’s planned research and development activities and regulatory activities;
commercialize product candidates; or conduct any substantial, additional development requirements requested by the FDA. Additional funding
may not be available to the Company on acceptable terms, or at all. If the Company is unable to secure additional capital, it will be
required to significantly decrease the amount of planned expenditures and may be required to cease operations. In addition, any disruption
in the capital markets could make any financing more challenging, and there can be no assurance that Pulmatrix will be able to obtain
such financing on commercially reasonable terms or at all. Curtailment of operations would cause significant delays in the Company’s
efforts to develop and introduce its products to market, which is critical to the realization of its business plan and the future operations
of the Company.
|
Use of Estimates |
Use
of Estimates
In
preparing the condensed consolidated financial statements in conformity with U.S. GAAP, management is required to make estimates and
assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date
of the condensed consolidated financial statements, as well as the reported amounts of expenses during the reporting period. Due to inherent
uncertainty involved in making estimates, actual results may differ from these estimates. On an ongoing basis, the Company evaluates
its estimates and assumptions. The most significant estimates and assumptions in the Company’s condensed consolidated financial
statements include, but are not limited to, estimates of future expected costs in order to derive
and recognize revenue and estimates related to clinical trial accruals and upfront deposits.
|
Concentrations of Credit Risk |
Concentrations
of Credit Risk
Cash
is a financial instrument that potentially subjects the Company to concentrations of credit risk. For all periods presented, substantially
all of the Company’s cash was deposited in accounts at a single financial institution that management believes is creditworthy,
and the Company has not incurred any losses to date. The Company is exposed to credit risk in the event of default by this financial
institution for amounts in excess of the Federal Deposit Insurance Corporation insured limits.
For
the three and six months ended June 30, 2024, revenue from one customer accounted for 61% and 89%, respectively, of revenue recognized
in the accompanying condensed consolidated financial statements. For the three and six months ended June 30, 2023, revenue from one customer
accounted for 100% of revenue recognized in the accompanying condensed consolidated financial statements. As of June 30, 2024, two customers
accounted for 100% of accounts receivable. As of December 31, 2023, one customer accounted for 100% of accounts receivable.
|
Summary of Significant Accounting Policies |
Summary
of Significant Accounting Policies
The
Company’s significant accounting policies are described in Note 2, Summary of Significant Accounting Policies and Recent Accounting
Standards, in the Annual Report. During the six months ended June 30, 2024, the Company did not make any changes to its significant
accounting policies.
|
Recent Accounting Pronouncements |
Recent
Accounting Pronouncements
From
time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”) or other standard
setting bodies that are adopted by the Company as of the specified effective date. The Company did not adopt any new accounting pronouncements
during the six months ended June 30, 2024 that had a material effect on its condensed consolidated financial statements.
In
December 2023, the FASB issued Accounting Standard Update 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures
(“ASU 2023-09”). The guidance in ASU 2023-09 improves the transparency of income tax disclosures by greater disaggregation
of information in the rate reconciliation and income taxes paid disaggregated by jurisdiction. The standard becomes effective for the
annual period beginning on January 1, 2025, with early adoption permitted. The Company is currently evaluating the impact that the adoption
of ASU 2023-09 may have on its consolidated financial statements.
As
of June 30, 2024, there are no other new, or existing recently issued, accounting pronouncements that are of significance, or potential
significance, that impact the Company’s condensed consolidated financial statements.
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v3.24.2.u1
Prepaid Expenses and Other Current Assets (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Prepaid Expenses And Other Current Assets |
|
Schedule of Prepaid Expenses and Other Current Assets |
Prepaid
expenses and other current assets consisted of the following:
Schedule
of Prepaid Expenses and Other Current Assets
| |
June 30, 2024 | | |
December 31, 2023 | |
Clinical and consulting | |
$ | 457 | | |
$ | 30 | |
Insurance | |
| 438 | | |
| 232 | |
Software and hosting costs | |
| 86 | | |
| 108 | |
Other | |
| 220 | | |
| 372 | |
Total prepaid expenses and other current assets | |
$ | 1,201 | | |
$ | 742 | |
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Property and Equipment, Net (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Property, Plant and Equipment [Abstract] |
|
Schedule of Property and Equipment |
Schedule of Property and Equipment
| |
June 30, 2024 | | |
December 31, 2023 | |
Laboratory equipment | |
$ | - | | |
$ | 1,656 | |
Leasehold improvements | |
| - | | |
| - | |
Office furniture and equipment | |
| - | | |
| 401 | |
Computer equipment | |
| - | | |
| 237 | |
Capital in progress | |
| - | | |
| 600 | |
Total property and equipment | |
| - | | |
| 2,894 | |
Less accumulated depreciation and amortization | |
| - | | |
| (1,736 | ) |
Property and equipment, net | |
$ | - | | |
$ | 1,158 | |
|
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v3.24.2.u1
Accrued Expenses and Other Current Liabilities (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Payables and Accruals [Abstract] |
|
Schedule of Accrued Expenses and Other Current Liabilities |
Accrued
expenses and other current liabilities consisted of the following:
Schedule of Accrued Expenses and Other Current Liabilities
| |
June 30, 2024 | | |
December 31, 2023 | |
Wages and incentives | |
$ | 1,221 | | |
$ | 70 | |
Clinical and consulting | |
| 296 | | |
| 347 | |
Legal and patents | |
| 223 | | |
| 42 | |
Accrued purchases of property and equipment | |
| - | | |
| 389 | |
Other | |
| 43 | | |
| 99 | |
Total accrued expenses and other current liabilities | |
$ | 1,783 | | |
$ | 947 | |
|
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v3.24.2.u1
Warrants (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Warrants |
|
Schedule of Warrants Outstanding |
Schedule
of Warrants Outstanding
| |
Adjusted | | |
| |
Number of Shares Underlying Warrants | |
Issue Date | |
Exercise Price | | |
Expiration Date | |
Outstanding | | |
Exercisable | |
December 17, 2021 | |
$ | 14.99 | | |
December 15, 2026 | |
| 36,538 | | |
| 36,538 | |
December 17, 2021 | |
$ | 13.99 | | |
December 17, 2026 | |
| 281,047 | | |
| 281,047 | |
February 16, 2021 | |
$ | 49.99 | | |
February 11, 2026 | |
| 65,003 | | |
| 65,003 | |
August 7, 2020 | |
$ | 35.99 | | |
July 14, 2025 | |
| 90,743 | | |
| 90,743 | |
August 7, 2020 | |
$ | 44.99 | | |
July 14, 2025 | |
| 10,939 | | |
| 10,939 | |
July 23, 2020 | |
$ | 35.99 | | |
July 14, 2025 | |
| 77,502 | | |
| 77,502 | |
July 13, 2020 | |
$ | 44.99 | | |
July 14, 2025 | |
| 21,846 | | |
| 21,846 | |
July 13, 2020 | |
$ | 35.99 | | |
July 14, 2025 | |
| 334,800 | | |
| 334,800 | |
February 12, 2019 | |
$ | 26.79 | | |
August 12, 2024 | |
| 66,675 | | |
| 66,675 | |
June 15, 2015 | |
$ | 1,509.99 | | |
Five years after milestone achievement | |
| 15,955 | | |
| - | |
Total | |
| | | |
| |
| 1,001,048 | | |
| 985,093 | |
|
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v3.24.2.u1
Stock-based Compensation (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Share-Based Payment Arrangement [Abstract] |
|
Schedule of Stock Option Activity |
The
following table summarizes stock option activity during the six months ended June 30, 2024:
Schedule
of Stock Option Activity
| |
Number of Options | | |
Weighted- Average Exercise Price | | |
Weighted- Average Remaining Contractual Term (Years) | | |
Aggregate Intrinsic Value | |
Outstanding — January 1, 2024 | |
| 344,306 | | |
$ | 20.92 | | |
| 7.54 | | |
$ | - | |
Forfeited or expired | |
| (32,869 | ) | |
$ | 5.18 | | |
| | | |
| | |
Outstanding — June 30, 2024 | |
| 311,437 | | |
$ | 22.58 | | |
| 6.95 | | |
$ | - | |
Exercisable — June 30, 2024 | |
| 221,578 | | |
$ | 29.07 | | |
| 6.46 | | |
$ | - | |
|
Schedule of Stock-based Compensation Expenses |
The
following table presents total stock-based compensation expense for the three and six months ended June 30, 2024 and 2023:
Schedule
of Stock-based Compensation Expenses
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Research and development | |
$ | 29 | | |
$ | 59 | | |
$ | 145 | | |
$ | 131 | |
General and administrative | |
| 74 | | |
| 196 | | |
| 156 | | |
| 420 | |
Total stock-based compensation expense | |
$ | 103 | | |
$ | 255 | | |
$ | 301 | | |
$ | 551 | |
|
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v3.24.2.u1
Leases (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Leases |
|
Schedule of Components of Lease Expenses |
The
components of lease expense for the Company for the three and six months ended June 30, 2024 and 2023 were as follows:
Schedule
of Components of Lease Expenses
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
Three Months Ended June 30, | | |
Six Months Ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
Lease cost | |
| | | |
| | | |
| | | |
| | |
Fixed lease cost | |
$ | 271 | | |
$ | 418 | | |
$ | 678 | | |
$ | 796 | |
Variable lease cost | |
| 104 | | |
| 168 | | |
| 206 | | |
| 281 | |
Total lease cost | |
$ | 375 | | |
$ | 586 | | |
$ | 884 | | |
$ | 1,077 | |
| |
| | | |
| | | |
| | | |
| | |
Other information | |
| | | |
| | | |
| | | |
| | |
Cash paid for amounts included in the measurement of lease liabilities | |
$ | 322 | | |
$ | 432 | | |
$ | 657 | | |
$ | 863 | |
Weighted-average remaining lease term | |
| | | |
| | | |
| 7 days | | |
| 0.2 years | |
Weighted-average discount rate | |
| | | |
| | | |
| - | | |
| 8.40 | % |
|
Schedule of Maturities of Lease Liabilities |
Maturities
of lease liabilities due under these lease agreements as of June 30, 2024 are as follows:
Schedule of Maturities of Lease Liabilities
| |
Operating Leases | |
Maturity of lease liabilities | |
| | |
2024 (7 days) | |
$ | 24 | |
Total lease payments | |
| 24 | |
Less: interest | |
| - | |
Total lease liabilities | |
$ | 24 | |
| |
| | |
Reported as of June 30, 2024 | |
| | |
Lease liabilities — short term | |
$ | 24 | |
Lease liabilities — long term | |
| - | |
Total lease liabilities | |
$ | 24 | |
|
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v3.24.2.u1
Net Loss Per Share (Tables)
|
6 Months Ended |
Jun. 30, 2024 |
Earnings Per Share [Abstract] |
|
Schedule of Computation of Anti-Dilutive Weighted-Average Shares Outstanding |
The
following potentially dilutive securities outstanding have been excluded from the computation of diluted weighted-average shares outstanding,
because such securities had an anti-dilutive impact:
Schedule
of Computation of Anti-Dilutive Weighted-Average Shares Outstanding
| |
Three and Six Months Ended June 30, | |
| |
2024 | | |
2023 | |
Options to purchase common stock | |
| 311,437 | | |
| 393,254 | |
Warrants to purchase common stock | |
| 1,001,048 | | |
| 1,161,493 | |
Total options and warrants to purchase common stock | |
| 1,312,485 | | |
| 1,554,747 | |
|
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v3.24.2.u1
Schedule of Property and Equipment (Details) - USD ($) $ in Thousands |
Jun. 30, 2024 |
Dec. 31, 2023 |
Property, Plant and Equipment [Line Items] |
|
|
Total property and equipment |
|
$ 2,894
|
Less accumulated depreciation and amortization |
|
(1,736)
|
Property and equipment, net |
|
1,158
|
Laboratory Equipment [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Total property and equipment |
|
1,656
|
Leasehold Improvements [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Total property and equipment |
|
|
Office Furniture and Equipment [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Total property and equipment |
|
401
|
Computer Equipment [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Total property and equipment |
|
237
|
Capital in Progress [Member] |
|
|
Property, Plant and Equipment [Line Items] |
|
|
Total property and equipment |
|
$ 600
|
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v3.24.2.u1
Significant Agreements (Details Narrative) - USD ($) $ in Thousands |
|
3 Months Ended |
6 Months Ended |
May 28, 2024 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Product Liability Contingency [Line Items] |
|
|
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Agreement description |
|
|
|
Pursuant
to the Second Amendment, the Company and Cipla were each responsible for 60% and 40%, respectively, of the Company’s overhead costs
and the time spent by the Company’s employees and consultants on development of the Product (“Direct Costs”). The Company
will share all other development costs with Cipla that are not Direct Costs, such as the cost of clinical research organizations, manufacturing
costs and other third-party costs, on a 50/50 basis.
|
|
Transaction cost |
|
$ 22,000
|
|
$ 22,000
|
|
Revenue |
|
1,552
|
$ 1,844
|
7,437
|
$ 3,343
|
Disposal of carrying value |
|
|
|
2,600
|
|
Cipla Agreement [Member] | Cipla Technologies LLC [Member] |
|
|
|
|
|
Product Liability Contingency [Line Items] |
|
|
|
|
|
Proceeds from related party debt |
|
|
|
22,000
|
|
Deferred revenue |
|
300
|
|
300
|
|
Cipla Agreement [Member] | Cipla Technologies LLC [Member] | Research and Development Service [Member] |
|
|
|
|
|
Product Liability Contingency [Line Items] |
|
|
|
|
|
Transaction cost |
|
12,000
|
|
12,000
|
|
Revenue |
|
900
|
$ 1,800
|
6,600
|
$ 3,300
|
Cipla Agreement [Member] | Cipla Technologies LLC [Member] | Irrevocable License [Member] |
|
|
|
|
|
Product Liability Contingency [Line Items] |
|
|
|
|
|
Transaction cost |
|
$ 10,000
|
|
$ 10,000
|
|
Lease Assignment Agreement [Member] |
|
|
|
|
|
Product Liability Contingency [Line Items] |
|
|
|
|
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Decrease in right-of-use asset |
$ 8,400
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v3.24.2.u1
Common Stock (Details Narrative) - H.C.Wainwright and Co., LLC [Member] - Sale Agreement [Member] - USD ($)
|
1 Months Ended |
6 Months Ended |
May 31, 2021 |
Jun. 30, 2024 |
Subsidiary, Sale of Stock [Line Items] |
|
|
Sale of stock, consideration received on transaction |
$ 20,000,000.0
|
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3.00%
|
|
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0
|
Minimum [Member] |
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|
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|
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$ 75,000,000
|
|
Minimum [Member] | ATM Offering [Member] |
|
|
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|
|
Sale of stock, consideration received on transaction |
$ 20,000,000
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v3.24.2.u1
Schedule of Warrants Outstanding (Details)
|
6 Months Ended |
Jun. 30, 2024
$ / shares
shares
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
Number of Shares Underlying Warrants, Outstanding Total |
160,445
|
Warrant One [Member] |
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
Warrants, Issue Date |
Dec. 17, 2021
|
Warrants, Exercise Price | $ / shares |
$ 14.99
|
Warrants, Expiration Date |
Dec. 15, 2026
|
Number of Shares Underlying Warrants, Outstanding Total |
36,538
|
Number of Shares Underlying Warrants, Exercisable Total |
36,538
|
Warrant Two [Member] |
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
Warrants, Issue Date |
Dec. 17, 2021
|
Warrants, Exercise Price | $ / shares |
$ 13.99
|
Warrants, Expiration Date |
Dec. 17, 2026
|
Number of Shares Underlying Warrants, Outstanding Total |
281,047
|
Number of Shares Underlying Warrants, Exercisable Total |
281,047
|
Warrant Three [Member] |
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
Warrants, Issue Date |
Feb. 16, 2021
|
Warrants, Exercise Price | $ / shares |
$ 49.99
|
Warrants, Expiration Date |
Feb. 11, 2026
|
Number of Shares Underlying Warrants, Outstanding Total |
65,003
|
Number of Shares Underlying Warrants, Exercisable Total |
65,003
|
Warrant Four [Member] |
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
Warrants, Issue Date |
Aug. 07, 2020
|
Warrants, Exercise Price | $ / shares |
$ 35.99
|
Warrants, Expiration Date |
Jul. 14, 2025
|
Number of Shares Underlying Warrants, Outstanding Total |
90,743
|
Number of Shares Underlying Warrants, Exercisable Total |
90,743
|
Warrant Five [Member] |
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
Warrants, Issue Date |
Aug. 07, 2020
|
Warrants, Exercise Price | $ / shares |
$ 44.99
|
Warrants, Expiration Date |
Jul. 14, 2025
|
Number of Shares Underlying Warrants, Outstanding Total |
10,939
|
Number of Shares Underlying Warrants, Exercisable Total |
10,939
|
Warrant Six [Member] |
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
Warrants, Issue Date |
Jul. 23, 2020
|
Warrants, Exercise Price | $ / shares |
$ 35.99
|
Warrants, Expiration Date |
Jul. 14, 2025
|
Number of Shares Underlying Warrants, Outstanding Total |
77,502
|
Number of Shares Underlying Warrants, Exercisable Total |
77,502
|
Warrant Seven [Member] |
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
Warrants, Issue Date |
Jul. 13, 2020
|
Warrants, Exercise Price | $ / shares |
$ 44.99
|
Warrants, Expiration Date |
Jul. 14, 2025
|
Number of Shares Underlying Warrants, Outstanding Total |
21,846
|
Number of Shares Underlying Warrants, Exercisable Total |
21,846
|
Warrant Eight [Member] |
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
Warrants, Issue Date |
Jul. 13, 2020
|
Warrants, Exercise Price | $ / shares |
$ 35.99
|
Warrants, Expiration Date |
Jul. 14, 2025
|
Number of Shares Underlying Warrants, Outstanding Total |
334,800
|
Number of Shares Underlying Warrants, Exercisable Total |
334,800
|
Warrant Nine [Member] |
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
Warrants, Issue Date |
Feb. 12, 2019
|
Warrants, Exercise Price | $ / shares |
$ 26.79
|
Warrants, Expiration Date |
Aug. 12, 2024
|
Number of Shares Underlying Warrants, Outstanding Total |
66,675
|
Number of Shares Underlying Warrants, Exercisable Total |
66,675
|
Warrant Ten [Member] |
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
Warrants, Issue Date |
Jun. 15, 2015
|
Warrants, Exercise Price | $ / shares |
$ 1,509.99
|
Number of Shares Underlying Warrants, Outstanding Total |
15,955
|
Number of Shares Underlying Warrants, Exercisable Total |
|
Warrants, Expiration Date, Description |
Five years after milestone achievement
|
Warrant [Member] |
|
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] |
|
Number of Shares Underlying Warrants, Outstanding Total |
1,001,048
|
Number of Shares Underlying Warrants, Exercisable Total |
985,093
|
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Schedule of Stock Option Activity (Details) - USD ($)
|
6 Months Ended |
12 Months Ended |
Jun. 30, 2024 |
Dec. 31, 2023 |
Offsetting Assets [Line Items] |
|
|
Weighted Average Exercise Price, Outstanding, Balance |
$ 44.12
|
|
Equity Option [Member] |
|
|
Offsetting Assets [Line Items] |
|
|
Number of Options, Outstanding, Balance |
344,306
|
|
Weighted Average Exercise Price, Outstanding, Balance |
$ 20.92
|
|
Weighted Average Remaining Contractual Term (Years), Outstanding |
6 years 11 months 12 days
|
7 years 6 months 14 days
|
Aggregate Intrinsic Value, Balance |
|
|
Number of Options, Forfeited or expired |
(32,869)
|
|
Weighted Average Exercise Price, Forfeited or expired |
$ 5.18
|
|
Number of Options, Outstanding, Balance |
311,437
|
344,306
|
Weighted Average Exercise Price, Outstanding, Balance |
$ 22.58
|
$ 20.92
|
Aggregate Intrinsic Value, Balance |
|
|
Number of Options, Exercisable |
221,578
|
|
Weighted Average Exercise Price, Outstanding, Exercisable |
$ 29.07
|
|
Weighted Average Remaining Contractual Term (Years), Exercisable |
6 years 5 months 15 days
|
|
Aggregate Intrinsic Value, Exercisable |
|
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Schedule of Stock-based Compensation Expenses (Details) - USD ($) $ in Thousands |
3 Months Ended |
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Jun. 30, 2024 |
Jun. 30, 2023 |
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] |
|
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$ 103
|
$ 255
|
$ 301
|
$ 551
|
Research and Development Expense [Member] |
|
|
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29
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59
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145
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131
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General and Administrative Expense [Member] |
|
|
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|
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] |
|
|
|
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$ 74
|
$ 196
|
$ 156
|
$ 420
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v3.24.2.u1
Leases (Details Narrative) $ in Millions |
|
|
1 Months Ended |
|
May 28, 2024
USD ($)
|
Jan. 07, 2022
ft²
|
Mar. 31, 2024
USD ($)
|
Jun. 30, 2024
USD ($)
|
Lease Agreement [Member] |
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
Restricted cash |
|
|
|
$ 1.4
|
Lease Agreement [Member] | Cobalt Propco [Member] |
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
Area of land | ft² |
|
20,000
|
|
|
Lessee, operating lease, description |
|
lease provides for base
rent of $0.1 million per month, payment of which began in March 2024. The Company is responsible for real estate taxes, maintenance,
and other operating expenses applicable to the leased premises.
|
|
|
Payments for rent |
|
|
$ 0.1
|
|
Lease Assignment Agreement [Member] |
|
|
|
|
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] |
|
|
|
|
Decrease in right-of-use asset |
$ 8.4
|
|
|
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- DefinitionIncrease decrease in right of use asset.
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v3.24.2.u1
v3.24.2.u1
Schedule of Computation of Anti-Dilutive Weighted-Average Shares Outstanding (Details) - shares
|
6 Months Ended |
Jun. 30, 2024 |
Jun. 30, 2023 |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Total options and warrants to purchase common stock |
1,312,485
|
1,554,747
|
Options to Purchase Common Stock [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Total options and warrants to purchase common stock |
311,437
|
393,254
|
Warrants to Purchase Common Stock [Member] |
|
|
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] |
|
|
Total options and warrants to purchase common stock |
1,001,048
|
1,161,493
|
X |
- DefinitionSecurities (including those issuable pursuant to contingent stock agreements) that could potentially dilute basic earnings per share (EPS) or earnings per unit (EPU) in the future that were not included in the computation of diluted EPS or EPU because to do so would increase EPS or EPU amounts or decrease loss per share or unit amounts for the period presented.
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Pulmatrix (NASDAQ:PULM)
Gráfica de Acción Histórica
De Nov 2024 a Dic 2024
Pulmatrix (NASDAQ:PULM)
Gráfica de Acción Histórica
De Dic 2023 a Dic 2024