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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the
Securities
Exchange Act of 1934
Date
of Report (Date of earliest event reported): May 30, 2024
Celcuity
Inc.
(Exact
name of Registrant as Specified in its Charter)
Delaware |
|
001-38207 |
|
82-2863566 |
(State
or Other Jurisdiction
of
Incorporation) |
|
(Commission
File
Number) |
|
(IRS
Employer
Identification
No.) |
16305
36th Avenue North; Suite 100
Minneapolis,
Minnesota 55446
(Address
of Principal Executive Offices and Zip Code)
(763)
392-0767
(Registrant’s
telephone number, including area code)
Not
Applicable
(Former
Name or Former Address, if Changed Since Last Report)
Check
the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under
any of the following provisions:
☐ |
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|
|
☐ |
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
|
|
☐ |
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
|
|
☐ |
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class |
|
Trading
Symbol(s) |
|
Name
of each exchange on which registered |
Common
Stock, $0.001 par value per share |
|
CELC |
|
The
Nasdaq Stock Market LLC |
Indicate
by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405
of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
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. ☐
Item
1.01 |
Entry into a Material Definitive Agreement. |
On
May 30, 2024, Celcuity Inc. (the “Company”) entered into an underwriting agreement (the “Underwriting Agreement”)
with Leerink Partners LLC, TD Securities (USA) LLC and Stifel, Nicolaus & Company, Incorporated as representatives (the “Representatives”)
of the several underwriters named in Schedule A to the Underwriting Agreement (collectively, the “Underwriters”), relating
to the issuance and sale of 3,871,000 shares of common stock, at a price to the public of $15.50 (the “Offering”). The Offering
closed on May 31, 2024.
The
net proceeds to the Company from the Offering were approximately $56.2 million
after deducting underwriting discounts and other offering expenses payable by the Company. The Company intends to use the net proceeds
from the Offering for working capital and general corporate purposes, which may include capital expenditures, research and development
expenditures, clinical trial expenditures, expansion of business development activities and other general corporate purposes. Clinical
trial expenditures may include a previously announced Phase 3 clinical trial that the Company plans to initiate to evaluate gedatolisib
plus a CDK4/6 inhibitor and fulvestrant as first-line treatment for patients with HR+/HER2- advanced breast cancer.
The
Underwriting Agreement contains customary representations, warranties, covenants and agreements of the Company, indemnification obligations
of the Company and the Underwriters, including liabilities under the Securities Act of 1933, as amended (the “Securities Act”),
other obligations of the parties and termination provisions. The representations, warranties and covenants contained in the Underwriting
Agreement were made only for purposes of such agreement and as of specific dates, were only for the benefit of the parties to such agreement
and may be subject to limitations agreed upon by the contracting parties. The description of the Underwriting Agreement does not purport
to be complete and is qualified in its entirety by the complete text of the Underwriting Agreement attached as Exhibit 1.1 hereto and
incorporated herein by reference.
The
Offering was made pursuant to an effective registration statement on Form S-3 (Reg. No. 333-261155), previously filed with the Securities
and Exchange Commission, and the related prospectus supplement thereunder.
A
copy of the opinion of Fredrikson & Byron, P.A. relating to the legality of the issuance and sale of the shares in the Offering is
attached as Exhibit 5.1 hereto.
On
May 30, 2024, the Company issued a press release announcing the pricing of the Offering. The press release is attached as Exhibit 99.1
and is incorporated herein by reference.
Item 9.01 |
Financial Statements and Exhibits. |
(d)
Exhibits
1.1 |
Underwriting Agreement, dated May 30, 2024, by and among Celcuity Inc., Leerink Partners LLC, TD Securities (USA) LLC and Stifel, Nicolaus & Company, Incorporated. |
5.1 |
Opinion of Fredrikson & Byron, P.A. |
23.1 |
Consent of Fredrikson & Byron, P.A. (included in Exhibit 5.1). |
99.1 |
Press Release, dated May 30, 2024. |
104 |
Cover
Page Interactive Data File (embedded within the Inline XBRL document) |
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 hereunto duly authorized.
Date:
May 31, 2024
|
CELCUITY
INC. |
|
|
|
By |
/s/
Brian F. Sullivan |
|
|
Brian
F. Sullivan |
|
|
Chief
Executive Officer |
Exhibit
1.1
CELCUITY
INC.
(a
Delaware corporation)
3,871,000
Shares of Common Stock
UNDERWRITING
AGREEMENT
May
30, 2024
Leerink
Partners LLC
TD
Securities (USA) LLC
Stifel,
Nicolaus & Company, Incorporated
as
Representatives of the several Underwriters
c/o
Leerink Partners LLC
53
State Street, 40th Floor
Boston,
Massachusetts 02109
c/o
TD Securities (USA) LLC
1
Vanderbilt Avenue
New
York, New York 10017
c/o
Stifel, Nicolaus & Company, Incorporated
787
7th Avenue, 11th Floor
New
York, New York 10019
Ladies
and Gentlemen:
Celcuity
Inc., a Delaware corporation (the “Company”), confirms its agreement with Leerink Partners LLC (“Leerink
Partners”), TD Securities (USA) LLC (“TD Cowen”), Stifel, Nicolaus & Company, Incorporated (“Stifel”)
and each of the other Underwriters named in Schedule A hereto (collectively, the “Underwriters,” which term
shall also include any underwriter substituted as hereinafter provided in Section 10 hereof), for which Leerink Partners, TD Cowen and
Stifel are acting as representatives (in such capacity, the “Representatives”), with respect to the sale by the Company
and the purchase by the Underwriters, acting severally and not jointly, of the respective numbers of shares of common stock, par value
$0.001 per share, of the Company (“Common Stock”) set forth in Schedule A hereto (the “Securities”).
The
Company understands that the Underwriters propose to make a public offering of the Securities as soon as the Representatives deem advisable
after this Underwriting Agreement (this “Agreement”) has been executed and delivered.
The
Company has filed with the Securities and Exchange Commission (the “Commission”) a shelf registration statement on
Form S-3 (No. 333-261155), covering the public offering and sale of certain securities, including the Securities, under the Securities
Act of 1933, as amended (the “1933 Act”) and the rules and regulations of the Commission promulgated thereunder (the
“1933 Act Regulations”), which shelf registration statement was declared effective on November 26, 2021. Such registration
statement, as of any time, means such registration statement as amended by any post-effective amendments thereto to such time, including
the exhibits and any schedules thereto at such time, the documents incorporated or deemed to be incorporated by reference therein at
such time pursuant to Item 12 of Form S-3 under the 1933 Act and the documents otherwise deemed to be a part thereof as of such time
pursuant to Rule 430B under the 1933 Act Regulations (“Rule 430B”), is referred to herein as the “Registration
Statement;” provided, however, that the “Registration Statement” without reference to a time means such registration
statement as amended by any post-effective amendments thereto as of the time of the first contract of sale for the Securities, which
time shall be considered the “new effective date” of such registration statement with respect to the Securities within the
meaning of paragraph (f)(2) of Rule 430B, including the exhibits and schedules thereto as of such time, the documents incorporated or
deemed incorporated by reference therein at such time pursuant to Item 12 of Form S-3 under the 1933 Act and the documents otherwise
deemed to be a part thereof as of such time pursuant to the Rule 430B. Any registration statement filed pursuant to Rule 462(b) of the
1933 Act Regulations is herein called the “Rule 462(b) Registration Statement” and, after such filing, the term “Registration
Statement” shall include the Rule 462(b) Registration Statement. Each preliminary prospectus used in connection with the offering
of the Securities, including the documents incorporated or deemed to be incorporated by reference therein pursuant to Item 12 of Form
S-3 under the 1933 Act, are collectively referred to herein as a “preliminary prospectus.” Where no preliminary prospectus
supplement is filed and distributed to investors in connection with the offering, the “preliminary prospectus” shall be deemed
to be the prospectus included in the Registration Statement (including any documents incorporated therein by reference) as such has been
filed with the Commission at the Applicable Time. Promptly after execution and delivery of this Agreement, the Company will prepare and
file a final prospectus relating to the Securities in accordance with the provisions of Rule 424(b) under the 1933 Act Regulations (“Rule
424(b)”). The final prospectus, in the form first furnished or made available to the Underwriters for use in connection with
the offering of the Securities, including the documents incorporated or deemed to be incorporated by reference therein pursuant to Item
12 of Form S-3 under the 1933 Act, are collectively referred to herein as the “Prospectus.” For purposes of this Agreement,
all references to the Registration Statement, any preliminary prospectus, the Prospectus or any amendment or supplement to any of the
foregoing shall be deemed to include the copy filed with the Commission pursuant to its Electronic Data Gathering, Analysis and Retrieval
system (or any successor system) (“EDGAR”).
As
used in this Agreement:
“Applicable
Time” means 7:30 A.M., New York City time, on May 30, 2024 or such other time as agreed by the Company and the Representatives.
“General
Disclosure Package” means any Issuer General Use Free Writing Prospectuses issued at or prior to the Applicable Time, the most
recent preliminary prospectus (including any documents incorporated therein by reference) that is distributed to investors prior to the
Applicable Time and the information included on Schedule B-1 hereto, all considered together.
“Issuer
Free Writing Prospectus” means any “issuer free writing prospectus,” as defined in Rule 433 of the 1933 Act Regulations
(“Rule 433”), including without limitation any “free writing prospectus” (as defined in Rule 405 of the
1933 Act Regulations (“Rule 405”)) relating to the Securities that is (i) required to be filed with the Commission
by the Company, (ii) a “road show for an offering that is a written communication” within the meaning of Rule 433(d)(8)(i),
whether or not required to be filed with the Commission, or (iii) exempt from filing with the Commission pursuant to Rule 433(d)(5)(i)
because it contains a description of the Securities or of the offering that does not reflect the final terms, in each case in the form
filed or required to be filed with the Commission or, if not required to be filed, in the form retained in the Company’s records
pursuant to Rule 433(g).
“Issuer
General Use Free Writing Prospectus” means any Issuer Free Writing Prospectus that is intended for general distribution to prospective
investors (other than a “bona fide electronic road show,” as defined in Rule 433 (a “Bona Fide Electronic
Road Show”)), as evidenced by its being specified in Schedule B-2 hereto.
“Issuer
Limited Use Free Writing Prospectus” means any Issuer Free Writing Prospectus that is not an Issuer General Use Free Writing Prospectus.
“Testing-the-Waters
Communication” means any oral or written communication with potential investors undertaken in reliance on Section 5(d) of the 1933
Act.
“Written
Testing-the-Waters Communication” means any Testing-the-Waters Communication that is a written communication within the meaning
of Rule 405 under the 1933 Act.
All
references in this Agreement to financial statements and schedules and other information which is “contained,” “included”
or “stated” (or other references of like import) in the Registration Statement, any preliminary prospectus or the Prospectus
shall be deemed to include all such financial statements and schedules and other information incorporated or deemed incorporated by reference
in the Registration Statement, any preliminary prospectus or the Prospectus, as the case may be, prior to the execution and delivery
of this Agreement; and all references in this Agreement to amendments or supplements to the Registration Statement, any preliminary prospectus
or the Prospectus shall be deemed to include the filing of any document under the Securities Exchange Act of 1934, as amended, and the
rules and regulations promulgated thereunder (collectively, the “1934 Act”), incorporated or deemed to be incorporated
by reference in the Registration Statement, such preliminary prospectus or the Prospectus, as the case may be, at or after the execution
and delivery of this Agreement.
SECTION
1. Representations and Warranties.
(a)
Representations and Warranties by the Company. The Company represents and warrants to each Underwriter as of the date hereof,
the Applicable Time, the Closing Time (as defined below), and agrees with each Underwriter, as follows:
(i)
Registration Statement and Prospectuses. The Company meets the requirements for use of Form S-3 under the 1933 Act. Each of the
Registration Statement and any amendment thereto has become effective under the 1933 Act. No stop order suspending the effectiveness
of the Registration Statement or any post-effective amendment thereto has been issued by the Commission under the 1933 Act, no order
preventing or suspending the use of any preliminary prospectus or the Prospectus has been issued by the Commission and no proceedings
for any of those purposes have been instituted by the Commission or are pending or, to the Company’s knowledge, contemplated by
the Commission. The Company has complied with each request (if any) from the Commission for additional information.
Each
of the Registration Statement and any post-effective amendment thereto, at the time of its effectiveness and at each deemed effective
date with respect to the Underwriters pursuant to Rule 430B(f)(2) under the 1933 Act Regulations, complied in all material respects with
the requirements of the 1933 Act and the 1933 Act Regulations. Each preliminary prospectus, the Prospectus and any amendment or supplement
thereto, at the time each was filed with the Commission, complied in all material respects with the requirements of the 1933 Act and
the 1933 Act Regulations. Each preliminary prospectus delivered to the Underwriters for use in connection with the offering and the Prospectus
was or will be identical to the electronically transmitted copies thereof filed with the Commission pursuant to EDGAR, except to the
extent permitted by Regulation S-T.
The
documents incorporated or deemed to be incorporated by reference in the Registration Statement and the Prospectus, when they became effective
or at the time they were or hereafter are filed with the Commission, complied and will comply in all material respects with the requirements
of the 1934 Act and the rules and regulations of the Commission under the 1934 Act (the “1934 Act Regulations”).
The
Registration Statement, any preliminary prospectus and the Prospectus, and the filing of the Registration Statement, any preliminary
prospectus and the Prospectus with the Commission have been duly authorized by and on behalf of the Company, and the Registration Statement
has been duly executed pursuant to such authorization.
(ii)
Accurate Disclosure. Neither the Registration Statement nor any amendment thereto, at its effective time, at the Closing Time,
contained, contains or will contain an untrue statement of a material fact or omitted, omits or will omit to state a material fact required
to be stated therein or necessary to make the statements therein not misleading. As of the Applicable Time, none of (A) the General Disclosure
Package, (B) any individual Issuer Limited Use Free Writing Prospectus, when considered together with the General Disclosure Package,
nor (C) any individual Written Testing-the-Waters Communication, when considered together with the General Disclosure Package, included,
includes or will include an untrue statement of a material fact or omitted, omits or will omit to state a material fact necessary in
order to make the statements therein, in the light of the circumstances under which they were made, not misleading. Neither the Prospectus
nor any amendment or supplement thereto (including any prospectus wrapper), as of its issue date, at the time of any filing with the
Commission pursuant to Rule 424(b), at the Closing Time, included, includes or will include an untrue statement of a material fact or
omitted, omits or will omit to state a material fact necessary in order to make the statements therein, in the light of the circumstances
under which they were made, not misleading. The documents incorporated or deemed to be incorporated by reference in the Registration
Statement, the General Disclosure Package and the Prospectus, at the time the Registration Statement became effective or when such documents
incorporated by reference were filed with the Commission, as the case may be, when read together with the other information in the Registration
Statement, the General Disclosure Package or the Prospectus, as the case may be, did not and will not include an untrue statement of
a material fact or omit to state a material fact required to be stated therein or necessary to make the statements therein not misleading.
The
representations and warranties in this subsection shall not apply to statements in or omissions from the Registration Statement (or any
amendment thereto), the General Disclosure Package or the Prospectus (or any amendment or supplement thereto, including any prospectus
wrapper) made in reliance upon and in conformity with written information furnished to the Company by any Underwriter through the Representatives
expressly for use therein. For purposes of this Agreement, the only information so furnished shall be the information in (i) the sentences
and figure relating to selling concession appearing in the first paragraph under the heading “Underwriting—Discounts and
Commissions” and (ii) the statements concerning the Underwriters contained in the second and third paragraphs under the heading
“Underwriting—Price Stabilization, Short Positions and Penalty Bids, in each case contained in the Prospectus (collectively,
the “Underwriter Information”).
(iii)
Issuer Free Writing Prospectuses. No Issuer Free Writing Prospectus conflicts or will conflict with the information contained
in the Registration Statement or the Prospectus, including any document incorporated by reference therein, and any preliminary or other
prospectus deemed to be a part thereof that has not been superseded or modified. No filing of any “road show” (as defined
in Rule 433(h)) is required in connection with the offering of the Securities. Any Issuer Free Writing Prospectus that the Company is
required to file pursuant to Rule 433(d) under the 1933 Act has been, or will be, filed with the Commission in accordance with the requirements
of the 1933 Act and the 1933 Act Regulations. Each Issuer Free Writing Prospectus that the Company has filed, or is required to file,
pursuant to Rule 433(d) under the 1933 Act or that was prepared by or behalf of or used or referred to by the Company complies or will
comply in all material respects with the requirements of the 1933 Act and the 1933 Act Regulations. Except for the Issuer Free Writing
Prospectuses, if any, identified in Schedule B-2 hereto, and electronic road shows, if any, each furnished to the Representatives
before first use, the Company has not prepared, used or referred to, and will not, without the prior consent of the Representatives,
prepare, use or refer to, any issuer free writing prospectus.
(iv)
Testing-the-Waters Materials. The Company (A) has not engaged in any Testing-the-Waters Communication other than Testing-the-Waters
Communications with the consent of the Representatives with entities that are qualified institutional buyers within the meaning of Rule
144A under the 1933 Act or institutions that are accredited investors within the meaning of Rule 501 under the 1933 Act and (B) has not
authorized anyone other than the Representatives to engage in Testing-the-Waters Communications. The Company reconfirms that the Representatives
have been authorized to act on its behalf in undertaking Testing-the-Waters Communications. The Company has not distributed any Written
Testing-the-Waters Communications other than those listed on Schedule B-3 hereto.
(v)
Company Not Ineligible Issuer. At the time of filing the Registration Statement and any post-effective amendment thereto, at the
earliest time thereafter that the Company or another offering participant made a bona fide offer (within the meaning of Rule 164(h)(2)
of the 1933 Act Regulations) of the Securities and at the date hereof, the Company was not and is not an “ineligible issuer,”
as defined in Rule 405, without taking account of any determination by the Commission pursuant to Rule 405 that it is not necessary that
the Company be considered an ineligible issuer.
(vi)
Authorization and Description of Securities. The Securities to be purchased by the Underwriters from the Company have been duly
authorized for issuance and sale to the Underwriters pursuant to this Agreement and, when issued and delivered by the Company pursuant
to this Agreement against payment of the consideration set forth herein, will be validly issued and fully paid and non-assessable; and
the issuance of the Securities is not subject to the preemptive or other similar rights of any securityholder of the Company. The Common
Stock conforms to all statements relating thereto contained in the Registration Statement, the General Disclosure Package and the Prospectus
and such description conforms to the rights set forth in the instruments defining the same. No holder of Securities will be subject to
personal liability by reason of being such a holder.
(vii)
No Applicable Registration or Other Similar Rights. There are no persons with registration or other similar rights to have any
equity or debt securities registered for sale under the Registration Statement, the General Disclosure Package and the Prospectus or
included in the offering contemplated by this Agreement, except for such rights as have been duly waived.
(viii)
No Material Adverse Change. Except as otherwise disclosed in the Registration Statement, the General Disclosure Package and the
Prospectus, subsequent to the respective dates as of which information is given in the Registration Statement, the General Disclosure
Package and the Prospectus: (i) there has been no material adverse change, or any development that would be expected to result in a material
adverse change, in (A) the condition, financial or otherwise, or in the earnings, business, properties, operations, operating results,
assets, liabilities or prospects, whether or not arising from transactions in the ordinary course of business, of the Company or (B)
the ability of the Company to consummate the transactions contemplated by this Agreement or perform its obligations hereunder (any such
change being referred to herein as a “Material Adverse Change”); (ii) the Company has not incurred any material liability
or obligation, indirect, direct or contingent, including without limitation any losses or interference with their business from fire,
explosion, flood, earthquakes, accident or other calamity, whether or not covered by insurance, or from any strike, labor dispute or
court or governmental action, order or decree, that are material, individually or in the aggregate, to the Company, and have not entered
into any transactions not in the ordinary course of business; and (iii) there has not been any material decrease in the capital stock
or any material increase in any short-term or long-term indebtedness of the Company and there has been no dividend or distribution of
any kind declared, paid or made by the Company, or any repurchase or redemption by the Company of any class of capital stock.
(ix)
Independent Accountants. Boulay PLLP, which has expressed its opinion with respect to the financial statements (which term as
used in this Agreement includes the related notes thereto) filed with the Commission as a part of the Registration Statement, the General
Disclosure Package and the Prospectus, is (i) an independent registered public accounting firm as required by the 1933 Act, the Exchange
Act, and the rules of the Public Company Accounting Oversight Board (“PCAOB”), (ii) in compliance with the applicable
requirements relating to the qualification of accountants under Rule 2-01 of Regulation S-X under the 1933 Act and (iii) a registered
public accounting firm as defined by the PCAOB whose registration has not been suspended or revoked and who has not requested such registration
to be withdrawn.
(x)
Financial Statements. The financial statements of the Company included or incorporated by reference in the Registration Statement,
the General Disclosure Package and the Prospectus, together with the related notes and schedules, present fairly the consolidated financial
position of the Company as of the dates indicated and the results of their operations, changes in stockholders’ equity and cash
flows for the periods specified. Such financial statements have been prepared in compliance with the requirements of the 1933 Act and
the Exchange Act and in conformity with generally accepted accounting principles (“GAAP”) applied on a consistent
basis throughout the periods involved, except as may be expressly stated in the related notes thereto. The supporting schedules, if any,
present fairly, in all material respects, in accordance with GAAP the information required to be stated therein. The selected financial
data and the summary financial information included in the Registration Statement, the General Disclosure Package and the Prospectus
present fairly, in all material respects, the information shown therein and have been compiled on a basis consistent with that of the
audited financial statements included therein. The pro forma financial statements and the related notes thereto included in the Registration
Statement, the General Disclosure Package and the Prospectus present fairly the information shown therein, have been prepared in accordance
with the Commission’s rules and guidelines with respect to pro forma financial statements and have been properly compiled on the
bases described therein, and the assumptions used in the preparation thereof are reasonable and the adjustments used therein are appropriate
to give effect to the transactions and circumstances referred to therein. The interactive data in eXtensible Business Reporting Language
included or incorporated by reference in the Registration Statement fairly presents the information called for in all material respects
and has been prepared in accordance with the Commission’s rules and guidelines applicable thereto. No other historical or pro forma
financial statements or supporting schedules are required to be included in the Registration Statement, the General Disclosure Package
or the Prospectus. The financial data set forth in or incorporated by reference in each of the Registration Statement, the General Disclosure
Package and the Prospectus present the information set forth therein on a basis consistent with that of the audited financial statements
contained in the Registration Statement, the General Disclosure Package and the Prospectus. All disclosures contained in the Registration
Statement, the General Disclosure Package and the Prospectus that constitute non-GAAP financial measures (as defined by the rules and
regulations under the 1933 Act and the Exchange Act) comply with Regulation G under the Exchange Act and Item 10 of Regulation S-K under
the 1933 Act, as applicable. To the Company’s knowledge, no person who has been suspended or barred from being associated with
a registered public accounting firm, or who has failed to comply with any sanction pursuant to Rule 5300 promulgated by the PCAOB, has
participated in or otherwise aided the preparation of, or audited, the financial statements, supporting schedules or other financial
data filed with the Commission as a part of the Registration Statement, the General Disclosure Package and the Prospectus.
(xi)
Company’s Accounting System. The Company makes and keeps accurate books and records and maintain a system of internal accounting
controls sufficient to provide reasonable assurance that: (i) transactions are executed in accordance with management’s general
or specific authorization; (ii) transactions are recorded as necessary to permit preparation of financial statements in conformity with
generally accepted accounting principles as applied in the United States and to maintain accountability for assets; (iii) access to assets
is permitted only in accordance with management’s general or specific authorization; (iv) the recorded accountability for assets
is compared with existing assets at reasonable intervals and appropriate action is taken with respect to any differences; and (v) the
interactive data in eXtensible Business Reporting Language included or incorporated by reference in the Registration Statement, the General
Disclosure Package and the Prospectus fairly presents the information called for in all material respects and is prepared in accordance
with the Commission’s rules and guidelines applicable thereto.
(xii)
Disclosure Controls and Procedures; Deficiencies in or Changes to Internal Control Over Financial Reporting. The Company has established
and maintains disclosure controls and procedures (as defined in Rules 13a-15 and 15d-15 under the Exchange Act), which (i) are designed
to ensure that material information relating to the Company is made known to the Company’s principal executive officer and its
principal financial officer by others within those entities, particularly during the periods in which the periodic reports required under
the Exchange Act are being prepared; (ii) have been evaluated by management of the Company for effectiveness as of the end of the Company’s
most recent fiscal quarter; and (iii) are effective in all material respects to perform the functions for which they were established.
Since the end of the Company’s most recent audited fiscal year, there have been no significant deficiencies or material weaknesses
in the Company’s internal control over financial reporting (whether or not remediated) and no change in the Company’s internal
control over financial reporting that has materially affected, or is reasonably likely to materially affect, the Company’s internal
control over financial reporting. The Company is not aware of any change in its internal control over financial reporting that has occurred
during its most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, the Company’s
internal control over financial reporting.
(xiii)
Incorporation and Good Standing of the Company. The Company has been duly incorporated and is validly existing as a corporation
in good standing under the laws of the State of Delaware and has the corporate power and authority to own, lease and operate its properties
and to conduct its business as described in the Registration Statement, the General Disclosure Package and the Prospectus and to enter
into and perform its obligations under this Agreement. The Company is duly qualified as a foreign corporation to transact business and
is in good standing in the State of Minnesota and each other jurisdiction in which such qualification is required, whether by reason
of the ownership or leasing of property or the conduct of business.
(xiv)
Subsidiaries. The Company does not own or control, directly or indirectly, any corporation, association or other entity.
(xv)
Capitalization and Other Capital Stock Matters. The authorized, issued and outstanding capital stock of the Company is as set
forth in the Registration Statement, the General Disclosure Package and the Prospectus (other than for subsequent issuances, if any,
pursuant to employee benefit plans, or upon the exercise of outstanding options, warrants or convertible securities, in each case described
in the Registration Statement, the General Disclosure Package and the Prospectus). The Securities conform in all material respects to
the description thereof contained in the Prospectus. All of the issued and outstanding shares of Common Stock have been duly authorized
and validly issued, are fully paid and nonassessable and have been issued in compliance with all federal and state securities laws. None
of the outstanding shares of Common Stock was issued in violation of any preemptive rights, rights of first refusal or other similar
rights to subscribe for or purchase securities of the Company. There are no authorized or outstanding options, warrants, preemptive rights,
rights of first refusal or other rights to purchase, or equity or debt securities convertible into or exchangeable or exercisable for,
any capital stock of the Company other than those described in the Registration Statement, the General Disclosure Package and the Prospectus.
The descriptions of the Company’s stock option, stock bonus and other stock plans or any other arrangements, and the options or
other rights granted thereunder, set forth in the Registration Statement, the General Disclosure Package and the Prospectus accurately
and fairly presents the information required to be shown with respect to such plans, arrangements, options and rights.
(xvi)
Stock Exchange Listing. The shares of Common Stock are registered pursuant to Section 12(b) or 12(g) of the Exchange Act and are
listed on the Nasdaq Capital Market, and the Company has taken no action designed to, or likely to have the effect of, terminating the
registration of the shares of Common Stock under the Exchange Act or delisting the shares of Common Stock from the Nasdaq Capital Market,
nor has the Company received any notification that the Commission or the Nasdaq Capital Market is contemplating terminating such registration
or listing. The Company is in compliance with all applicable listing requirements of the Nasdaq Capital Market.
(xvii)
Authorization of Agreement. This Agreement has been duly authorized, executed and delivered by the Company.
(xviii)
Non-Contravention of Existing Instruments; No Further Authorizations or Approvals Required. The Company is not in violation of
its charter or by-laws or is in default (or, with the giving of notice or lapse of time, would be in default) (“Default”)
under any indenture, loan, credit agreement, note, lease, license agreement, contract, franchise or other instrument (including, without
limitation, any pledge agreement, security agreement, mortgage or other instrument or agreement evidencing, guaranteeing, securing or
relating to indebtedness) to which the Company is a party or by which it or any of them may be bound, or to which any of their respective
properties or assets are subject (each, an “Existing Instrument”), except for such Defaults as would not be expected,
individually or in the aggregate, to result in a Material Adverse Change. The Company’s execution, delivery and performance of
this Agreement, consummation of the transactions contemplated hereby and by the Registration Statement, the General Disclosure Package
and the Prospectus and the issuance and sale of the Securities (including the use of proceeds from the sale of the Securities as described
in the Registration Statement, the General Disclosure Package and the Prospectus under the caption “Use of Proceeds”) (i)
have been duly authorized by all necessary corporate action and will not result in any violation of the provisions of the charter or
by-laws of the Company, (ii) will not conflict with or constitute a breach of, or Default or a Debt Repayment Triggering Event (as defined
below) under, or result in the creation or imposition of any lien, charge or encumbrance upon any property or assets of the Company pursuant
to, or require the consent of any other party to, any Existing Instrument and (iii) will not result in any violation of any law, administrative
regulation or administrative or court decree applicable to the Company. No consent, approval, authorization or other order of, or registration
or filing with, any court or other governmental or regulatory authority or agency, is required for the Company’s execution, delivery
and performance of this Agreement and consummation of the transactions contemplated hereby and by the Registration Statement, the General
Disclosure Package and the Prospectus, except such as have been obtained or made by the Company and are in full force and effect under
the 1933 Act and such as may be required under applicable state securities or blue sky laws or FINRA (as defined below). As used herein,
a “Debt Repayment Triggering Event” means any event or condition which gives, or with the giving of notice or lapse
of time would give, the holder of any note, debenture or other evidence of indebtedness (or any person acting on such holder’s
behalf) the right to require the repurchase, redemption or repayment of all or a portion of such indebtedness by the Company.
(xix)
Compliance with Laws. The Company has been and is in compliance with all applicable laws, rules and regulations, except where
failure to be so in compliance would not be expected, individually or in the aggregate, to result in a Material Adverse Change.
(xx)
No Material Actions or Proceedings. There is no action, suit, proceeding, inquiry or investigation brought by or before any legal
or governmental entity now pending or, to the knowledge of the Company, threatened, against or affecting the Company, which would be
expected, individually or in the aggregate, to result in a Material Adverse Change. No material labor dispute with the employees of the
Company, or with the employees of any principal supplier, manufacturer, customer or contractor of the Company, exists or, to the knowledge
of the Company, is threatened or imminent.
(xxi)
Listing. The Securities have been approved for listing on the Nasdaq Capital Market, subject to notice of issuance.
(xxii)
Intellectual Property Rights. The Company owns, or has obtained valid and enforceable licenses for, the inventions, patent applications,
patents, trademarks, trade names, service names, copyrights, trade secrets and other intellectual property described in the Registration
Statement, the General Disclosure Package and the Prospectus as being owned or licensed by them or which are necessary for the conduct
of their respective businesses as currently conducted or as currently proposed to be conducted (collectively, “Intellectual
Property”), and the conduct of their respective businesses does not and will not infringe, misappropriate or otherwise conflict
in any material respect with any such rights of others. The Intellectual Property of the Company has not been adjudged by a court of
competent jurisdiction to be invalid or unenforceable, in whole or in part, and the Company is unaware of any facts which would form
a reasonable basis for any such adjudication. To the Company’s knowledge: (i) there are no third parties who have rights to any
Intellectual Property, except for customary reversionary rights of third-party licensors with respect to Intellectual Property that is
disclosed in the Registration Statement, the General Disclosure Package and the Prospectus as licensed to the Company; and (ii) there
is no infringement by third parties of any Intellectual Property. There is no pending or, to the Company’s knowledge, threatened
action, suit, proceeding or claim by others: (A) challenging the Company’s rights in or to any Intellectual Property, and the Company
is unaware of any facts which would form a reasonable basis for any such action, suit, proceeding or claim; (B) challenging the validity,
enforceability or scope of any Intellectual Property, and the Company is unaware of any facts which would form a reasonable basis for
any such action, suit, proceeding or claim; or (C) asserting that the Company infringes or otherwise violates, or would, upon the commercialization
of any product or service described in the Registration Statement, the General Disclosure Package and the Prospectus as under development,
infringe or violate, any patent, trademark, trade name, service name, copyright, trade secret or other proprietary rights of others,
and the Company is unaware of any facts which would form a reasonable basis for any such action, suit, proceeding or claim. The Company
has complied with the terms of each agreement pursuant to which Intellectual Property has been licensed to the Company, and all such
agreements are in full force and effect. To the Company’s knowledge, there are no material defects in any of the patents or patent
applications included in the Intellectual Property. The Company has taken all reasonable steps to protect, maintain and safeguard their
Intellectual Property, including the execution of appropriate nondisclosure, confidentiality agreements and invention assignment agreements
and invention assignments with their employees, and no employee of the Company is in or has been in violation of any term of any employment
contract, patent disclosure agreement, invention assignment agreement, non-competition agreement, non-solicitation agreement, nondisclosure
agreement, or any restrictive covenant to or with a former employer where the basis of such violation relates to such employee’s
employment with the Company. The duty of candor and good faith as required by the United States Patent and Trademark Office during the
prosecution of the United States patents and patent applications included in the Intellectual Property have been complied with; and in
all foreign offices having similar requirements, all such requirements have been complied with. None of the Company owned Intellectual
Property or technology (including information technology and outsourced arrangements) employed by the Company has been obtained or is
being used by the Company in violation of any contractual obligation binding on the Company or its officers, directors or employees or
otherwise in violation of the rights of any persons. The product candidates described in the Registration Statement, the General Disclosure
Package and the Prospectus as under development by the Company fall within the scope of the claims of one or more patents owned by, or
exclusively licensed to, the Company.
(xxiii)
All Necessary Permits, etc. The Company possesses such valid and current certificates, authorizations or permits required by state,
federal or foreign regulatory agencies or bodies to conduct their respective businesses as currently conducted and as described in the
Registration Statement, the General Disclosure Package and the Prospectus (“Permits”). The Company is not in violation
of, or in default under, any of the Permits or has it received any notice of proceedings relating to the revocation or modification of,
or non-compliance with, any such certificate, authorization or permit.
(xxiv)
Title to Properties. The Company has good and marketable title to all of the real and personal property and other assets reflected
as owned in the financial statements referred to in SECTION 1(a)(ix) above (or elsewhere in the Registration Statement, the
General Disclosure Package and the Prospectus), in each case free and clear of any security interests, mortgages, liens, encumbrances,
equities, adverse claims and other defects. The real property, improvements, equipment and personal property held under lease by the
Company are held under valid and enforceable leases, with such exceptions as are not material and do not materially interfere with the
use made or proposed to be made of such real property, improvements, equipment or personal property by the Company.
(xxv)
Tax Law Compliance. The Company has filed all necessary federal, state and foreign income and franchise tax returns or have properly
requested extensions thereof and have paid all taxes required to be paid by any of them and, if due and payable, any related or similar
assessment, fine or penalty levied against any of them except as may be being contested in good faith and by appropriate proceedings.
The Company has made adequate charges, accruals and reserves in the applicable financial statements referred to in SECTION 1(a)(ix)
above in respect of all federal, state and foreign income and franchise taxes for all periods as to which the tax liability of the Company
has not been finally determined.
(xxvi)
Insurance. The Company is insured by recognized, financially sound and reputable institutions with policies in such amounts and
with such deductibles and covering such risks as are generally deemed adequate and customary for their businesses including, but not
limited to, policies covering real and personal property owned or leased by the Company against theft, damage, destruction, acts of vandalism
and earthquakes and policies covering the Company for product liability claims and clinical trial liability claims. The Company has no
reason to believe that it will not be able (i) to renew its existing insurance coverage as and when such policies expire or (ii) to obtain
comparable coverage from similar institutions as may be necessary or appropriate to conduct its business as now conducted and at a cost
that would not be expected to result in a Material Adverse Change. The Company has not been denied any insurance coverage which it has
sought or for which it has applied.
(xxvii)
Compliance with Environmental Laws. Except as would not be expected, individually or in the aggregate, to result in a Material
Adverse Change: (i) the Company is not in violation of any federal, state, local or foreign statute, law, rule, regulation, ordinance,
code, policy or rule of common law or any judicial or administrative interpretation thereof, including any judicial or administrative
order, consent, decree or judgment, relating to pollution or protection of human health, the environment (including, without limitation,
ambient air, surface water, groundwater, land surface or subsurface strata) or wildlife, including, without limitation, laws and regulations
relating to the release or threatened release of chemicals, pollutants, contaminants, wastes, toxic substances, hazardous substances,
petroleum or petroleum products (collectively, “Hazardous Materials”) or to the manufacture, processing, distribution,
use, treatment, storage, disposal, transport or handling of Hazardous Materials (collectively, “Environmental Laws”);
(ii) the Company has all permits, authorizations and approvals required under any applicable Environmental Laws and are each in compliance
with their requirements; (iii) there are no pending or, to the knowledge of the Company, threatened administrative, regulatory or judicial
actions, suits, demands, demand letters, claims, liens, notices of noncompliance or violation, investigation or proceedings relating
to any Environmental Law against the Company and (iv) there are no events or circumstances that might reasonably be expected to form
the basis of an order for clean-up or remediation, or an action, suit or proceeding by any private party or governmental body or agency,
against or affecting the Company relating to Hazardous Materials or any Environmental Laws.
(xxviii)
ERISA Compliance. The Company and any “employee benefit plan” (as defined under the Employee Retirement Income Security
Act of 1974, as amended, and the regulations and published interpretations thereunder (collectively, “ERISA”)) established
or maintained by the Company or its “ERISA Affiliates” (as defined below) are in compliance in all material respects with
ERISA. “ERISA Affiliate” means, with respect to the Company, any member of any group of organizations described in
Sections 414(b), (c), (m) or (o) of the Internal Revenue Code of 1986, as amended, and the regulations and published interpretations
thereunder (the “Code”) of which the Company is a member. No “reportable event” (as defined under ERISA)
has occurred or is reasonably expected to occur with respect to any “employee benefit plan” established or maintained by
the Company or any of their ERISA Affiliates. No “employee benefit plan” established or maintained by the Company or its
ERISA Affiliates, if such “employee benefit plan” were terminated, would have any “amount of unfunded benefit liabilities”
(as defined under ERISA). Neither the Company or its ERISA Affiliates has incurred or reasonably expects to incur any liability under
(i) Title IV of ERISA with respect to termination of, or withdrawal from, any “employee benefit plan” or (ii) Sections 412,
4971, 4975 or 4980B of the Code. Each “employee benefit plan” established or maintained by the Company or any of its ERISA
Affiliates that is intended to be qualified under Section 401(a) of the Code is so qualified and nothing has occurred, whether by action
or failure to act, which would cause the loss of such qualification.
(xxix)
Company Not an “Investment Company.” The Company is not, and will not be, either after receipt of payment for the
Securities or after the application of the proceeds therefrom as described under “Use of Proceeds” in the Registration Statement,
the General Disclosure Package and the Prospectus, required to register as an “investment company” under the Investment Company
Act of 1940, as amended (the “Investment Company Act”).
(xxx)
No Price Stabilization or Manipulation; Compliance with Regulation M. The Company has not taken, directly or indirectly, any action
designed to or that might cause or result in stabilization or manipulation of the price of the shares of Common Stock or of any “reference
security” (as defined in Rule 100 of Regulation M under the Exchange Act (“Regulation M”)) with respect to the
Securities, whether to facilitate the sale or resale of the Securities or otherwise, and has taken no action which would directly or
indirectly violate Regulation M.
(xxxi)
Related Party Transactions. There are no business relationships or related-party transactions involving the Company or any other
person required to be described in the Registration Statement or the Prospectus which have not been described as required.
(xxxii)
FINRA Matters. All of the information provided to the Underwriters or to counsel for the Underwriters by the Company, its counsel,
its officers and directors and the holders of any securities (debt or equity) or options to acquire any securities of the Company in
connection with the offering of the Securities is true, complete, correct and compliant with Financial Industry Regulatory Authority,
Inc.’s (“FINRA”) rules and any letters, filings or other supplemental information provided to FINRA pursuant
to FINRA Rules or NASD Conduct Rules is true, complete and correct. The Company meets the definition of the term “experienced issuer”
specified in FINRA Rule 5110(j)(6).
(xxxiii)
Statistical and Market-Related Data. All statistical, demographic and market-related data included in the Registration Statement,
the General Disclosure Package and the Prospectus are based on or derived from sources that the Company believes, after reasonable inquiry,
to be reliable and accurate. To the extent required, the Company has obtained the written consent for the use of such data from such
sources.
(xxxiv)
Sarbanes-Oxley Act. There is, and has been, no failure on the part of the Company or any of the Company’s directors or officers,
in their capacities as such, to comply with any applicable provision of the Sarbanes-Oxley Act of 2002, as amended and the rules and
regulations promulgated in connection therewith, including Section 402 related to loans and Sections 302 and 906 related to certifications.
(xxxv)
No Unlawful Contributions or Other Payments. Neither the Company nor, to the Company’s knowledge, any employee or agent
of the Company, has made any contribution or other payment to any official of, or candidate for, any federal, state or foreign office
in violation of any law or of the character required to be disclosed in the Registration Statement, the General Disclosure Package and
the Prospectus.
(xxxvi)
Anti-Corruption and Anti-Bribery Laws. Neither the Company nor any director, officer, or employee of the Company, nor to the knowledge
of the Company, any agent, affiliate or other person acting on behalf of the Company has, in the course of its actions for, or on behalf
of, the Company (i) used any corporate funds for any unlawful contribution, gift, entertainment or other unlawful expenses relating to
political activity; (ii) made or taken any act in furtherance of an offer, promise, or authorization of any direct or indirect unlawful
payment or benefit to any foreign or domestic government official or employee, including of any government-owned or controlled entity
or public international organization, or any political party, party official, or candidate for political office; (iii) violated or is
in violation of any provision of the U.S. Foreign Corrupt Practices Act of 1977, as amended (the “FCPA”), the UK Bribery
Act 2010, or any other applicable anti-bribery or anti-corruption law; or (iv) made, offered, authorized, requested, or taken an act
in furtherance of any unlawful bribe, rebate, payoff, influence payment, kickback or other unlawful payment or benefit. The Company and,
to the knowledge of the Company, the Company’s affiliates have conducted their respective businesses in compliance with the FCPA
and have instituted and maintain policies and procedures designed to ensure, and which are reasonably expected to continue to ensure,
continued compliance therewith.
(xxxvii)
Money Laundering Laws. The operations of the Company are, and have been conducted at all times, in compliance with applicable
financial recordkeeping and reporting requirements of the Currency and Foreign Transactions Reporting Act of 1970, as amended, the money
laundering statutes of all applicable jurisdictions, the rules and regulations thereunder and any related or similar applicable rules,
regulations or guidelines, issued, administered or enforced by any governmental agency (collectively, the “Money Laundering
Laws”) and no action, suit or proceeding by or before any court or governmental agency, authority or body or any arbitrator
involving the Company with respect to the Money Laundering Laws is pending or, to the knowledge of the Company, threatened.
(xxxviii)
Sanctions. Neither the Company nor any of its directors, officers, or employees, nor, to the knowledge of the Company, any agent,
affiliate or other person acting on behalf of the Company is currently the subject or the target of any U.S. sanctions administered by
the Office of Foreign Assets Control of the U.S. Department of the Treasury (“OFAC”) or the U.S. Department of State,
the United Nations Security Council, the European Union, His Majesty’s Treasury of the United Kingdom, or other relevant sanctions
authority (collectively, “Sanctions”); nor is the Company located, organized or resident in a country or territory
that is the subject or the target of Sanctions, including, without limitation, Crimea, Cuba, Iran, North Korea, Syria, the so-called
Luhansk People’s Republic, the so-called Donetsk People’s Republic and the non-government controlled areas of Zaporizhzhia
and Kherson regions of Ukraine (each, a “Sanctioned Country”); and the Company will not directly or indirectly use
the proceeds of this offering, or lend, contribute or otherwise make available such proceeds to any joint venture partner or other person
or entity, for the purpose of financing the activities of or business with any person, or in any country or territory, that at the time
of such financing, is the subject or the target of Sanctions or in any other manner that will result in a violation by any person (including
any person participating in the transaction whether as underwriter, advisor, investor or otherwise) of applicable Sanctions. For the
past five years, the Company has not knowingly engaged in and are not now knowingly engaged in any dealings or transactions with any
person that at the time of the dealing or transaction is or was the subject or the target of Sanctions or with any Sanctioned Country.
(xxxix)
Brokers. Except pursuant to this Agreement, there is no broker, finder or other party that is entitled to receive from the Company
any brokerage or finder’s fee or other fee or commission as a result of any transactions contemplated by this Agreement.
(xl)
Forward-Looking Statements. Each financial or operational projection or other “forward-looking statement” (as defined
by Section 27A of the 1933 Act or Section 21E of the Exchange Act) contained in the Registration Statement or the Prospectus (i) was
so included by the Company in good faith and with reasonable basis after due consideration by the Company of the underlying assumptions,
estimates and other applicable facts and circumstances and (ii) is accompanied by meaningful cautionary statements identifying those
factors that could cause actual results to differ materially from those in such forward-looking statement. No such statement was made
with the knowledge of an executive officer or director of the Company that it was false or misleading.
(xli)
No Outstanding Loans or Other Extensions of Credit. The Company does not have any outstanding extension of credit, in the form
of a personal loan, to or for any director or executive officer (or equivalent thereof) of the Company except for such extensions of
credit as are expressly permitted by Section 13(k) of the Exchange Act.
(xlii)
Cybersecurity. The Company’s information technology assets and equipment, computers, systems, networks, hardware, software,
websites, applications, and databases (collectively, “IT Systems”) are adequate for, and operate and perform in all
material respects as required in connection with the operation of the business of the Company as currently conducted, free and clear
of all material bugs, errors, defects, Trojan horses, time bombs, malware and other corruptants. The Company has implemented and maintained
commercially reasonable physical, technical and administrative controls, policies, procedures, and safeguards to maintain and protect
their material confidential information and the integrity, continuous operation, redundancy and security of all IT Systems and data,
including “Personal Data,” used in connection with their businesses. “Personal Data” means (i) a natural
person’s name, street address, telephone number, e-mail address, photograph, social security number or tax identification number,
driver’s license number, passport number, credit card number, bank information, or customer or account number; (ii) any information
which would qualify as “personally identifying information” under the Federal Trade Commission Act, as amended; (iii) “personal
data” as defined by GDPR (as defined below); (iv) any information which would qualify as “protected health information”
under the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”); and (v) any other piece of information
that allows the identification of such natural person, or his or her family, or permits the collection or analysis of any data related
to an identified person’s health or sexual orientation. There have been no breaches, violations, outages or unauthorized uses of
or accesses to same, except for those that have been remedied without material cost or liability or the duty to notify any other person,
nor any incidents under internal review or investigations relating to the same. The Company is presently in material compliance with
all applicable laws or statutes and all judgments, orders, rules and regulations of any court or arbitrator or governmental or regulatory
authority, internal policies and contractual obligations relating to the privacy and security of IT Systems and Personal Data and to
the protection of such IT Systems and Personal Data from unauthorized use, access, misappropriation or modification.
(xliii)
Compliance with Data Privacy Laws. The Company is, and at all prior times has been, in compliance in all material respects with
all applicable state and federal data privacy and security laws and regulations, including without limitation HIPAA, and the Company
has taken commercially reasonable actions to prepare to comply with, and since May 25, 2018, have been and currently are in compliance
with, the European Union General Data Protection Regulation (“GDPR”) (EU 2016/679) (collectively, the “Privacy
Laws”). To ensure compliance with the Privacy Laws, the Company has in place, complies with, and takes appropriate steps reasonably
designed to ensure compliance in all material respects with its policies and procedures relating to data privacy and security and the
collection, storage, use, disclosure, handling, and analysis of Personal Data (the “Policies”). The Company has at
all times made all disclosures to users or customers required by applicable laws and regulatory rules or requirements, and none of such
disclosures made or contained in any Policy have, to the knowledge of the Company, been inaccurate or in violation of any applicable
laws and regulatory rules or requirements in any material respect. The Company further certifies that it: (i) has not received notice
of any actual or potential liability under or relating to, or actual or potential violation of, any of the Privacy Laws, and has no knowledge
of any event or condition that would reasonably be expected to result in any such notice; (ii) is not currently conducting or paying
for, in whole or in part, any investigation, remediation, or other corrective action pursuant to any Privacy Law; or (iii) is not a party
to any order, decree, or agreement that imposes any obligation or liability under any Privacy Law.
(xliv)
Clinical Data and Regulatory Compliance. The preclinical tests and clinical trials, and other studies (collectively, “studies”)
that are described in, or the results of which are referred to in, the Registration Statement, the General Disclosure Package or the
Prospectus were and, if still pending, are being conducted in all material respects in accordance with the protocols, procedures and
controls designed and approved for such studies and with standard medical and scientific research procedures; each description of the
results of such studies is accurate and complete in all material respects and fairly presents the data derived from such studies, and
the Company has no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results
described or referred to in the Registration Statement or the Prospectus; the Company has no knowledge of any research misconduct or
data fraud in any studies or clinical trials, the results of which the Company intends to include or reference in any regulatory submission
for any product; the Company has made all such filings and obtained all such approvals as may be required by the Food and Drug Administration
of the U.S. Department of Health and Human Services or any committee thereof or from any other U.S. or foreign government or drug or
medical device regulatory agency, or health care facility Institutional Review Board (collectively, the “Regulatory Agencies”);
the Company has not received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or modification
of any clinical trials that are described or referred to in the Registration Statement, the General Disclosure Package or the Prospectus;
and the Company has operated and currently is in compliance in all material respects with all applicable rules, regulations and policies
of the Regulatory Agencies.
(xlv)
Compliance with Health Care Laws. The Company is, and at all times has been, in compliance in all material respects with all Health
Care Laws. For purposes of this Agreement, “Health Care Laws” means: (i) the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. Section 301 et seq.), the Public Health Service Act (42 U.S.C. Section 201 et seq.), and the regulations promulgated thereunder;
(ii) all applicable federal, state, local and foreign health care fraud and abuse laws, including, without limitation, the Anti-Kickback
Statute (42 U.S.C. Section 1320a-7b(b)), the Civil False Claims Act (31 U.S.C. Section 3729 et seq.), the criminal false statements law
(42 U.S.C. Section 1320a-7b(a)), 18 U.S.C. Sections 286 and 287, the health care fraud criminal provisions under HIPAA (42 U.S.C. Section
1320d et seq.), the Stark Law (42 U.S.C. Section 1395nn), the civil monetary penalties law (42 U.S.C. Section 1320a-7a), the exclusion
law (42 U.S.C. Section 1320a-7), the Physician Payments Sunshine Act (42 U.S.C. Section 1320-7h), and applicable laws governing government
funded or sponsored healthcare programs; (iii) HIPAA, as amended by the Health Information Technology for Economic and Clinical Health
Act (42 U.S.C. Section 17921 et seq.); (iv) the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and
Education Reconciliation Act of 2010; (v) the Clinical Laboratories Improvement Act of 1967, as amended); (vi) licensure, quality, safety
and accreditation requirements under applicable federal, state, local or foreign laws or regulatory bodies; and (vii) all other local,
state, federal, national, supranational and foreign laws, relating to the regulation of the Company, and (viii) the directives and regulations
promulgated pursuant to such statutes and any state or non-U.S. counterpart thereof. The Company has not received written notice of any
claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any court or arbitrator or governmental
or regulatory authority or third party alleging that any product operation or activity is in violation of any Health Care Laws nor, to
the Company’s knowledge, is any such claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other
action threatened. The Company has filed, maintained or submitted all material reports, documents, forms, notices, applications, records,
claims, submissions and supplements or amendments as required by any Health Care Laws, and all such reports, documents, forms, notices,
applications, records, claims, submissions and supplements or amendments were complete and accurate on the date filed in all material
respects (or were corrected or supplemented by a subsequent submission). The Company is not a party to any corporate integrity agreements,
monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any governmental or regulatory authority.
Additionally, neither the Company nor any of its respective employees, officers, directors, or agents has been excluded, suspended or
debarred from participation in any U.S. federal health care program or human clinical research or, to the knowledge of the Company, is
subject to a governmental inquiry, investigation, proceeding, or other similar action that would reasonably be expected to result in
debarment, suspension, or exclusion.
(xlvi)
No Contract Terminations. The Company has not sent or received any communication regarding termination of, or intent not to renew,
any of the contracts or agreements referred to or described in the General Disclosure Package and the Prospectus, or referred to or described
in, or filed as an exhibit to, the Registration Statement, and no such termination or non-renewal has been threatened by the Company
or, to the Company’s knowledge, any other party to any such contract or agreement, which threat of termination or non-renewal has
not been rescinded as of the date hereof.
(xlvii)
Duties, Transfer Taxes, Etc. No stamp or other issuance or transfer taxes or duties and no capital gains, income, withholding
or other taxes are payable by the Underwriters in the United States or any political subdivision or taxing authority thereof or therein
in connection with the execution, delivery or performance of this Agreement by the Company or the sale and delivery by the Company of
the Securities.
(xlviii)
Lending Relationship. Except as disclosed in the Registration Statement, the General Disclosure Package and the Prospectus,
the Company (i) does not have any material lending or other relationship with any banking or lending affiliate of any Underwriter and
(ii) does not intend to use any of the proceeds from the sale of the Securities to repay any outstanding debt owed to any affiliate of
any Underwriter.
(xlix)
Maintenance of Rating. The Company has no debt securities or preferred stock that is rated by any “nationally recognized
statistical rating organization” (as that term is defined by the Commission for purposes of Rule 436(g)(2) under the 1933 Act).
(b)
Officer’s Certificates. Any certificate signed by any officer of the Company delivered to the Representatives or to counsel
for the Underwriters shall be deemed a representation and warranty by the Company to each Underwriter as to the matters covered thereby.
SECTION
2. Sale and Delivery to Underwriters; Closing.
(a)
Securities. On the basis of the representations and warranties herein contained and subject to the terms and conditions herein
set forth, the Company agrees to sell to each Underwriter, severally and not jointly, and each Underwriter, severally and not jointly,
agrees to purchase from the Company, at the price per share set forth in Schedule A, that number of Securities set forth in Schedule
A opposite the name of such Underwriter, plus any additional number of Securities which such Underwriter may become obligated to
purchase pursuant to the provisions of Section 10 hereof, subject, in each case, to such adjustments among the Underwriters as the Representatives
in their sole discretion shall make to eliminate any sales or purchases of fractional shares.
(b)
[Reserved.]
(c)
Payment. Payment of the purchase price for, and delivery of certificates or security entitlements for, the Securities shall be
made at the offices of Cooley LLP, or at such other place as shall be agreed upon by the Representatives and the Company, at 10:00 A.M.
(New York City time), on the first (second, if the pricing occurs after 4:30 P.M. (New York City time) on any given day) business day
after the date hereof (unless postponed in accordance with the provisions of Section 10), or such other time not later than ten business
days after such date as shall be agreed upon by the Representatives and the Company (such time and date of payment and delivery being
herein called “Closing Time”). Delivery of the Securities at the Closing Time shall be made through the facilities
of The Depository Trust Company unless the Representatives shall otherwise instruct.
Payment
shall be made to the Company by wire transfer of immediately available funds to a bank account designated by the Company, against delivery
to the Representatives for the respective accounts of the Underwriters of certificates or security entitlements for the Securities to
be purchased by them. It is understood that each Underwriter has authorized the Representatives, for their accounts, to accept delivery
of, receipt for, and make payment of the purchase price for the Securities which it has agreed to purchase. Each of Leerink Partners,
TD Cowen and Stifel, individually and not as representatives of the Underwriters, may (but shall not be obligated to) make payment of
the purchase price for the Securities, if any, to be purchased by any Underwriter whose funds have not been received by the Closing Time,
but such payment shall not relieve such Underwriter from its obligations hereunder.
SECTION
3. Covenants of the Company. The Company covenants with each Underwriter as follows:
(a)
Compliance with Securities Regulations and Commission Requests. The Company, subject to Section 3(b), will comply with the requirements
of Rule 430B, and will notify the Representatives as soon as practicable, and confirm the notice in writing, (i) when any post-effective
amendment to the Registration Statement shall become effective or any amendment or supplement to the Prospectus shall have been filed,
(ii) of the receipt of any comments from the Commission, (iii) of any request by the Commission for any amendment to the Registration
Statement or any amendment or supplement to the Prospectus (including any document incorporated by reference therein) or for additional
information, (iv) of the issuance by the Commission of any stop order suspending the effectiveness of the Registration Statement or any
post-effective amendment or of any order preventing or suspending the use of any preliminary prospectus or the Prospectus, or of the
suspension of the qualification of the Securities for offering or sale in any jurisdiction, or of the initiation or threatening of any
proceedings for any of such purposes or of any examination pursuant to Section 8(d) or 8(e) of the 1933 Act concerning the Registration
Statement and (v) if the Company becomes the subject of a proceeding under Section 8A of the 1933 Act in connection with the offering
of the Securities. The Company will effect all filings required under Rule 424(b), in the manner and within the time period required
by Rule 424(b) (without reliance on Rule 424(b)(8)), and will take such steps as it deems necessary to ascertain promptly whether the
form of prospectus transmitted for filing under Rule 424(b) was received for filing by the Commission and, in the event that it was not,
it will promptly file such prospectus. The Company will make every reasonable effort to prevent the issuance of any stop order, prevention
or suspension and, if any such order is issued, to obtain the lifting thereof at the earliest possible moment.
(b)
Continued Compliance with Securities Laws. The Company will comply with the 1933 Act, the 1933 Act Regulations, the 1934 Act and
the 1934 Act Regulations so as to permit the completion of the distribution of the Securities as contemplated in this Agreement and in
the Registration Statement, the General Disclosure Package and the Prospectus. If at any time when a prospectus relating to the Securities
is (or, but for the exception afforded by Rule 172 of the 1933 Act Regulations (“Rule 172”), would be) required by
the 1933 Act to be delivered in connection with sales of the Securities, any event shall occur or condition shall exist as a result of
which it is necessary, in the opinion of counsel for the Underwriters or for the Company, to (i) amend the Registration Statement in
order that the Registration Statement will not include an untrue statement of a material fact or omit to state a material fact required
to be stated therein or necessary to make the statements therein not misleading, (ii) amend or supplement the General Disclosure Package
or the Prospectus in order that the General Disclosure Package or the Prospectus, as the case may be, will not include any untrue statement
of a material fact or omit to state a material fact necessary in order to make the statements therein not misleading in the light of
the circumstances existing at the time it is delivered to a purchaser or (iii) amend the Registration Statement or amend or supplement
the General Disclosure Package or the Prospectus, as the case may be, in order to comply with the requirements of the 1933 Act or the
1933 Act Regulations, the Company will promptly (A) give the Representatives notice of such event, (B) prepare any amendment or supplement
as may be necessary to correct such statement or omission or to make the Registration Statement, the General Disclosure Package or the
Prospectus comply with such requirements and, a reasonable amount of time prior to any proposed filing or use, furnish the Representatives
with copies of any such amendment or supplement and (C) file with the Commission any such amendment or supplement; provided that the
Company shall not file or use any such amendment or supplement to which the Representatives or counsel for the Underwriters shall object.
The Company will furnish to the Underwriters such number of copies of such amendment or supplement as the Underwriters may reasonably
request. The Company has given the Representatives notice of any filings made pursuant to the 1934 Act or the 1934 Act Regulations within
48 hours prior to the Applicable Time; the Company will give the Representatives notice of its intention to make any such filing from
the Applicable Time to the Closing Time and will furnish the Representatives with copies of any such documents a reasonable amount of
time prior to such proposed filing, as the case may be, and will not file or use any such document to which the Representatives or counsel
for the Underwriters shall reasonably object.
(c)
Delivery of Registration Statements. The Company has furnished or will deliver to the Representatives and counsel for the Underwriters,
without charge, signed copies of the Registration Statement as originally filed and each amendment thereto (including exhibits filed
therewith or incorporated by reference therein and documents incorporated or deemed incorporated by reference therein) and signed copies
of all consents and certificates of experts, and will also deliver to the Representatives, without charge, a conformed copy of the Registration
Statement as originally filed and each amendment thereto (without exhibits) for each of the Underwriters. The copies of the Registration
Statement and each amendment thereto furnished to the Underwriters will be identical to the electronically transmitted copies thereof
filed with the Commission pursuant to EDGAR, except to the extent permitted by Regulation S-T.
(d)
Delivery of Prospectuses. The Company has delivered to each Underwriter, without charge, as many copies of each preliminary prospectus
as such Underwriter reasonably requested, and the Company hereby consents to the use of such copies for purposes permitted by the 1933
Act. The Company will furnish to each Underwriter, without charge, during the period when a prospectus relating to the Securities is
(or, but for the exception afforded by Rule 172, would be) required to be delivered under the 1933 Act, such number of copies of the
Prospectus (as amended or supplemented) as such Underwriter may reasonably request. The Prospectus and any amendments or supplements
thereto furnished to the Underwriters will be identical to the electronically transmitted copies thereof filed with the Commission pursuant
to EDGAR, except to the extent permitted by Regulation S-T.
(e)
Blue Sky Qualifications. The Company will use its best efforts, in cooperation with the Underwriters, to qualify the Securities
for offering and sale under the applicable securities laws of such states and other jurisdictions (domestic or foreign) as the Representatives
may designate and to maintain such qualifications in effect so long as required to complete the distribution of the Securities; provided,
however, that the Company shall not be obligated to file any general consent to service of process or to qualify as a foreign corporation
or as a dealer in securities in any jurisdiction in which it is not so qualified or to subject itself to taxation in respect of doing
business in any jurisdiction in which it is not otherwise so subject.
(f)
Rule 158. The Company will timely file such reports pursuant to the 1934 Act as are necessary in order to make generally available
to its securityholders as soon as practicable an earning statement for the purposes of, and to provide to the Underwriters the benefits
contemplated by, the last paragraph of Section 11(a) of the 1933 Act.
(g)
Use of Proceeds. The Company will use the net proceeds received by it from the sale of the Securities in all material respects
in the manner specified in the Registration Statement, the General Disclosure Package and the Prospectus under the heading “Use
of Proceeds.”
(h)
Listing. The Company will use its best efforts to effect and maintain the listing of the Common Stock (including the Securities)
on the Nasdaq Capital Market.
(i)
Restriction on Sale of Securities. During a period of 90 days from the date of the Prospectus, the Company will not, without the
prior written consent of Leerink Partners and TD Cowen, (i) directly or indirectly, offer, pledge, sell, contract to sell, sell any option
or contract to purchase, purchase any option or contract to sell, grant any option, right or warrant to purchase or otherwise transfer
or dispose of any shares of Common Stock or any securities convertible into or exercisable or exchangeable for Common Stock or file or
confidentially submit any registration statement under the 1933 Act with respect to any of the foregoing, (ii) enter into any swap or
any other agreement or any transaction that transfers, in whole or in part, directly or indirectly, the economic consequence of ownership
of the Common Stock, whether any such swap or transaction described in clause (i) or (ii) above is to be settled by delivery of Common
Stock or such other securities, in cash or otherwise or (iii) publicly announce an intention to effect any such swap, agreement or other
transaction described in clauses (i) and (ii). The foregoing sentence shall not apply to (A) the Securities to be sold hereunder; (B)
any shares of Common Stock issued by the Company upon the exercise of an option or warrant or the conversion of a convertible security
outstanding on the date hereof and referred to in the Registration Statement, the General Disclosure Package and the Prospectus; (C)
any shares of Common Stock issued or options to purchase Common Stock granted pursuant to existing employee benefit plans of the Company
referred to in the Registration Statement, the General Disclosure Package and the Prospectus; (D) any shares of Common Stock issued pursuant
to any existing non-employee director stock plan or dividend reinvestment plan referred to in the Registration Statement, the General
Disclosure Package and the Prospectus; or (E) the filing by the Company of any registration statement on Form S-8 or a successor form
thereto.
(j)
Reporting Requirements. The Company, during the period when a Prospectus relating to the Securities is (or, but for the exception
afforded by Rule 172, would be) required to be delivered under the 1933 Act, will file all documents required to be filed with the Commission
pursuant to the 1934 Act within the time periods required by the 1934 Act and 1934 Act Regulations. Additionally, the Company shall report
the use of proceeds from the issuance of the Securities as may be required under Rule 463 under the 1933 Act.
(k)
Issuer Free Writing Prospectuses. The Company agrees that, unless it obtains the prior written consent of the Representatives,
it will not make any offer relating to the Securities that would constitute an Issuer Free Writing Prospectus or that would otherwise
constitute a “free writing prospectus,” or a portion thereof, required to be filed by the Company with the Commission or
retained by the Company under Rule 433; provided that the Representatives will be deemed to have consented to the Issuer Free Writing
Prospectuses listed on Schedule B-2 hereto and any “road show that is a written communication” within the meaning
of Rule 433(d)(8)(i) that has been reviewed by the Representatives. The Company represents that it has treated or agrees that it will
treat each such free writing prospectus consented to, or deemed consented to, by the Representatives as an “issuer free writing
prospectus,” as defined in Rule 433, and that it has complied and will comply with the applicable requirements of Rule 433 with
respect thereto, including timely filing with the Commission where required, legending and record keeping. If at any time following issuance
of an Issuer Free Writing Prospectus there occurred or occurs an event or development as a result of which such Issuer Free Writing Prospectus
conflicted or would conflict with the information contained in the Registration Statement, any preliminary prospectus or the Prospectus
or included or would include an untrue statement of a material fact or omitted or would omit to state a material fact necessary in order
to make the statements therein, in the light of the circumstances existing at that subsequent time, not misleading, the Company will
promptly notify the Representatives and will promptly amend or supplement, at its own expense, such Issuer Free Writing Prospectus to
eliminate or correct such conflict, untrue statement or omission.
(l)
Testing-the-Waters Materials. If at any time following the distribution of any Written Testing-the-Waters Communication there
occurred or occurs an event or development as a result of which such Written Testing-the-Waters Communication included or would include
an untrue statement of a material fact or omitted or would omit to state a material fact necessary in order to make the statements therein,
in the light of the circumstances existing at that subsequent time, not misleading, the Company will promptly notify the Representatives
and will promptly amend or supplement, at its own expense, such Written Testing-the-Waters Communication to eliminate or correct such
untrue statement or omission.
SECTION
4. Payment of Expenses.
(a)
Expenses. The Company will pay or cause to be paid all expenses incident to the performance of its obligations under this Agreement,
including (i) the preparation, printing and filing of the Registration Statement (including financial statements and exhibits) as originally
filed and each amendment thereto, (ii) the preparation, printing and delivery to the Underwriters of copies of each preliminary prospectus,
each Issuer Free Writing Prospectus and the Prospectus and any amendments or supplements thereto and any costs associated with electronic
delivery of any of the foregoing by the Underwriters to investors, (iii) the preparation, issuance and delivery of the certificates or
security entitlements for the Securities to the Underwriters, including any stock or other transfer taxes and any stamp or other duties
payable upon the sale, issuance or delivery of the Securities to the Underwriters, (iv) the fees and disbursements of the Company’s
counsel, accountants and other advisors, (v) the qualification of the Securities under securities laws in accordance with the provisions
of Section 3(e) hereof, including filing fees and the reasonable fees and disbursements of counsel for the Underwriters in connection
therewith and in connection with the preparation of a “Blue Sky Survey” and any supplement thereto, (vi) the fees and expenses
of any transfer agent or registrar for the Securities, (vii) the costs and expenses of the Company relating to investor presentations
on any “road show” undertaken in connection with the marketing of the Securities, including without limitation, expenses
associated with the production of road show slides and graphics, fees and expenses of any consultants engaged in connection with the
road show presentations, travel and lodging expenses of the representatives and officers of the Company and any such consultants, and
the cost of aircraft and other transportation chartered in connection with the road show, (viii) the filing fees incident to, and the
reasonable fees and disbursements of counsel to the Underwriters in connection with, the review by FINRA of the terms of the sale of
the Securities, (ix) the fees and expenses incurred in connection with the listing of the Securities on the Nasdaq Capital Market, and
(x) the costs and expenses (including, without limitation, any damages or other amounts payable in connection with legal or contractual
liability) associated with the reforming of any contracts for sale of the Securities made by the Underwriters caused by a breach of the
representation contained in the third sentence of Section 1(a)(ii).
(b)
Termination of Agreement. If this Agreement is terminated by the Representatives in accordance with the provisions of Section
5, Section 9(a)(i), Section 9(a)(iii) or Section 10 hereof, the Company shall reimburse the Underwriters for all of their reasonably
documented out-of-pocket expenses, including the reasonable fees and disbursements of counsel for the Underwriters.
SECTION
5. Conditions of Underwriters’ Obligations. The obligations of the several Underwriters hereunder are subject to the
accuracy of the representations and warranties of the Company contained herein or in certificates of any officer of the Company delivered
pursuant to the provisions hereof, to the performance by the Company of its covenants and other obligations hereunder, and to the following
further conditions:
(a)
Effectiveness of Registration Statement. The Registration Statement, including any Rule 462(b) Registration Statement, has become
effective and, at the Closing Time, no stop order suspending the effectiveness of the Registration Statement or any post-effective amendment
thereto has been issued under the 1933 Act, no order preventing or suspending the use of any preliminary prospectus or the Prospectus
has been issued and no proceedings for any of those purposes have been instituted or are pending or, to the Company’s knowledge,
contemplated; and the Company has complied with each request (if any) from the Commission for additional information to the reasonable
satisfaction of counsel to the Underwriters.
(b)
Opinions of Counsel for Company. At the Closing Time, the Representatives shall have received (i) the opinion and the negative
assurance letter, each dated the Closing Time, of Fredrikson & Byron P.A., counsel for the Company, (ii) the opinion of Nelson Mullins
Riley & Scarborough LLP, special counsel for the Company with respect to intellectual property matters, and (iii) the opinion of
Gardner Law, PLLC, special counsel for the Company with respect to regulatory matters, each in form and substance satisfactory to counsel
for the Underwriters.
(c)
Opinion of Counsel for Underwriters. At the Closing Time, the Representatives shall have received the opinion, and negative assurance
letter, each dated the Closing Time, of Cooley LLP, counsel for the Underwriters, together with signed or reproduced copies of such letters
for each of the other Underwriters in form and substance satisfactory to the Representatives. In giving such opinion such counsel may
rely, as to all matters governed by the laws of jurisdictions other than the law of the State of New York, the General Corporation Law
of the State of Delaware and the federal securities laws of the United States, upon the opinions of counsel satisfactory to the Representatives.
Such counsel may also state that, insofar as such opinion involves factual matters, they have relied, to the extent they deem proper,
upon certificates of officers and other representatives of the Company and certificates of public officials.
(d)
Officers’ Certificate. At the Closing Time, there shall not have been, since the date hereof or since the respective dates
as of which information is given in the Registration Statement, the General Disclosure Package or the Prospectus, any material adverse
change in the condition, financial or otherwise, or in the earnings, business affairs or business prospects of the Company, whether or
not arising in the ordinary course of business, and the Representatives shall have received a certificate of the principal executive
officer of the Company and of the principal financial officer of the Company, dated the Closing Time, to the effect that (i) there has
been no such material adverse change, (ii) the representations and warranties of the Company in this Agreement are true and correct with
the same force and effect as though expressly made at and as of the Closing Time, (iii) the Company has complied with all agreements
and satisfied all conditions on its part to be performed or satisfied at or prior to the Closing Time, and (iv) no stop order suspending
the effectiveness of the Registration Statement under the 1933 Act has been issued, no order preventing or suspending the use of any
preliminary prospectus or the Prospectus has been issued and no proceedings for any of those purposes have been instituted or are pending
or, to their knowledge, contemplated.
(e)
Accountant’s Comfort Letter. At the time of the execution of this Agreement, the Representatives shall have received from
Boulay PLLP a letter, dated such date, in form and substance satisfactory to the Representatives, together with signed or reproduced
copies of such letter for each of the other Underwriters containing statements and information of the type ordinarily included in accountants’
“comfort letters” to underwriters with respect to the financial statements and certain financial information contained in
the Registration Statement, the General Disclosure Package and the Prospectus.
(f)
Bring-down Comfort Letter. At the Closing Time, the Representatives shall have received from Boulay PLLP a letter, dated as of
the Closing Time, to the effect that they reaffirm the statements made in the letter furnished pursuant to subsection (e) of this Section,
except that the specified date referred to shall be a date not more than three business days prior to the Closing Time.
(g)
Approval of Listing. At the Closing Time, the Securities shall have been approved for listing on the Nasdaq Capital Market, subject
only to official notice of issuance.
(h)
No Objection. FINRA has confirmed that it has not raised any objection with respect to the fairness and reasonableness of the
underwriting terms and arrangements relating to the offering of the Securities.
(i)
Lock-up Agreements. At the date of this Agreement, the Representatives shall have received an agreement substantially in the form
of Exhibit A hereto signed by all of the Company’s directors, officers and affiliated securityholders.
(j)
Maintenance of Rating. The Company does not have any debt securities or preferred stock that are rated by any “nationally
recognized statistical rating agency” (as defined in Section 3(a)(62) of the 1934 Act).
(k)
[Reserved.]
(l)
Additional Documents. At the Closing Time, counsel for the Underwriters shall have been furnished with such other documents and
opinions as they may reasonably require for the purpose of enabling them to pass upon the issuance and sale of the Securities as herein
contemplated, or in order to evidence the accuracy of any of the representations or warranties, or the fulfillment of any of the conditions,
herein contained; and all proceedings taken by the Company in connection with the issuance and sale of the Securities as herein contemplated
shall be reasonably satisfactory in form and substance to the Representatives and counsel for the Underwriters.
(m)
Termination of Agreement. If any condition specified in this Section shall not have been fulfilled when and as required to be
fulfilled, this Agreement may be terminated by the Representatives by notice to the Company at any time at or prior to Closing Time,
as the case may be, and such termination shall be without liability of any party to any other party except as provided in Section 4 and
except that Sections 1, 4, 6, 7, 8, 14, 15 and 16 shall survive any such termination and remain in full force and effect.
SECTION
6. Indemnification.
(a)
Indemnification of Underwriters. The Company agrees to indemnify and hold harmless each Underwriter, its affiliates (as such term
is defined in Rule 501(b) under the 1933 Act (each, an “Affiliate”)), its selling agents and each person, if any,
who controls any Underwriter within the meaning of Section 15 of the 1933 Act or Section 20 of the 1934 Act as follows:
(i)
against any and all loss, liability, claim, damage and expense whatsoever, as incurred, arising out of any untrue statement or alleged
untrue statement of a material fact contained in the Registration Statement (or any amendment thereto), including any information deemed
to be a part thereof pursuant to Rule 430B, or the omission or alleged omission therefrom of a material fact required to be stated therein
or necessary to make the statements therein not misleading or arising out of any untrue statement or alleged untrue statement of a material
fact included (A) in any preliminary prospectus, any Issuer Free Writing Prospectus, any Written Testing-the-Waters Communication, the
General Disclosure Package or the Prospectus (or any amendment or supplement thereto), or (B) in any materials or information provided
to investors by, or with the approval of, the Company in connection with the marketing of the offering of the Securities (“Marketing
Materials”), including any roadshow or investor presentations made to investors by the Company (whether in person or electronically),
or the omission or alleged omission in any preliminary prospectus, any Issuer Free Writing Prospectus, any Written Testing-the-Waters
Communication, the General Disclosure Package, the Prospectus (or any amendment or supplement thereto) or in any Marketing Materials
of a material fact necessary in order to make the statements therein, in the light of the circumstances under which they were made, not
misleading;
(ii)
against any and all loss, liability, claim, damage and expense whatsoever, as incurred, to the extent of the aggregate amount paid in
settlement of any litigation, or any investigation or proceeding by any governmental agency or body, commenced or threatened, or of any
claim whatsoever based upon any such untrue statement or omission, or any such alleged untrue statement or omission; provided that (subject
to Section 6(d) below) any such settlement is effected with the written consent of the Company;
(iii)
against any and all expense whatsoever, as incurred (including the fees and disbursements of counsel chosen by the Representatives),
reasonably incurred in investigating, preparing or defending against any litigation, or any investigation or proceeding by any governmental
agency or body, commenced or threatened, or any claim whatsoever based upon any such untrue statement or omission, or any such alleged
untrue statement or omission, to the extent that any such expense is not paid under (i) or (ii) above;
provided,
however, that this indemnity agreement shall not apply to any loss, liability, claim, damage or expense to the extent arising out of
any untrue statement or omission or alleged untrue statement or omission made in the Registration Statement (or any amendment thereto),
including any information deemed to be a part thereof pursuant to Rule 430B, the General Disclosure Package or the Prospectus (or any
amendment or supplement thereto) in reliance upon and in conformity with the Underwriter Information.
(b)
Indemnification of Company, Directors and Officers. Each Underwriter severally agrees to indemnify and hold harmless the Company,
its directors, each of its officers who signed the Registration Statement, and each person, if any, who controls the Company within the
meaning of Section 15 of the 1933 Act or Section 20 of the 1934 Act, against any and all loss, liability, claim, damage and expense described
in the indemnity contained in subsection (a) of this Section, as incurred, but only with respect to untrue statements or omissions, or
alleged untrue statements or omissions, made in the Registration Statement (or any amendment thereto), including any information deemed
to be a part thereof pursuant to Rule 430B, the General Disclosure Package or the Prospectus (or any amendment or supplement thereto)
in reliance upon and in conformity with the Underwriter Information.
(c)
Actions against Parties; Notification. Each indemnified party shall give notice as promptly as reasonably practicable to each
indemnifying party of any action commenced against it in respect of which indemnity may be sought hereunder, but failure to so notify
an indemnifying party shall not relieve such indemnifying party from any liability hereunder to the extent it is not materially prejudiced
as a result thereof and in any event shall not relieve it from any liability which it may have otherwise than on account of this indemnity
agreement. In the case of parties indemnified pursuant to Section 6(a) above, counsel to the indemnified parties shall be selected by
the Representatives, and, in the case of parties indemnified pursuant to Section 6(b) above, counsel to the indemnified parties shall
be selected by the Company. An indemnifying party may participate at its own expense in the defense of any such action; provided, however,
that counsel to the indemnifying party shall not (except with the consent of the indemnified party) also be counsel to the indemnified
party. In no event shall the indemnifying parties be liable for the reasonable fees and expenses of more than one counsel (in addition
to any local counsel) separate from their own counsel for all indemnified parties in connection with any one action or separate but similar
or related actions in the same jurisdiction arising out of the same general allegations or circumstances. No indemnifying party shall,
without the prior written consent of the indemnified parties, settle or compromise or consent to the entry of any judgment with respect
to any litigation, or any investigation or proceeding by any governmental agency or body, commenced or threatened, or any claim whatsoever
in respect of which indemnification or contribution could be sought under this Section 6 or Section 7 hereof (whether or not the indemnified
parties are actual or potential parties thereto), unless such settlement, compromise or consent (i) includes an unconditional release
of each indemnified party from all liability arising out of such litigation, investigation, proceeding or claim and (ii) does not include
a statement as to or an admission of fault, culpability or a failure to act by or on behalf of any indemnified party.
(d)
Settlement without Consent if Failure to Reimburse. If at any time an indemnified party shall have requested an indemnifying party
to reimburse the indemnified party for fees and expenses of counsel, such indemnifying party agrees that it shall be liable for any settlement
of the nature contemplated by Section 6(a)(ii) effected without its written consent if (i) such settlement is entered into more than
45 days after receipt by such indemnifying party of the aforesaid request, (ii) such indemnifying party shall have received notice of
the terms of such settlement at least 30 days prior to such settlement being entered into and (iii) such indemnifying party shall not
have reimbursed such indemnified party in accordance with such request prior to the date of such settlement.
SECTION
7. Contribution. If the indemnification provided for in Section 6 hereof is for any reason unavailable to or insufficient to
hold harmless an indemnified party in respect of any losses, liabilities, claims, damages or expenses referred to therein, then each
indemnifying party shall contribute to the aggregate amount of such losses, liabilities, claims, damages and expenses incurred by such
indemnified party, as incurred, (i) in such proportion as is appropriate to reflect the relative benefits received by the Company, on
the one hand, and the Underwriters, on the other hand, from the offering of the Securities pursuant to this Agreement or (ii) if the
allocation provided by clause (i) is not permitted by applicable law, in such proportion as is appropriate to reflect not only the relative
benefits referred to in clause (i) above but also the relative fault of the Company, on the one hand, and of the Underwriters, on the
other hand, in connection with the statements or omissions which resulted in such losses, liabilities, claims, damages or expenses, as
well as any other relevant equitable considerations.
The
relative benefits received by the Company, on the one hand, and the Underwriters, on the other hand, in connection with the offering
of the Securities pursuant to this Agreement shall be deemed to be in the same respective proportions as the total net proceeds from
the offering of the Securities pursuant to this Agreement (before deducting expenses) received by the Company, on the one hand, and the
total underwriting discount received by the Underwriters, on the other hand, in each case as set forth on the cover of the Prospectus,
bear to the aggregate initial public offering price of the Securities as set forth on the cover of the Prospectus.
The
relative fault of the Company, on the one hand, and the Underwriters, on the other hand, shall be determined by reference to, among other
things, whether any such untrue or alleged untrue statement of a material fact or omission or alleged omission to state a material fact
relates to information supplied by the Company or by the Underwriters and the parties’ relative intent, knowledge, access to information
and opportunity to correct or prevent such statement or omission.
The
Company and the Underwriters agree that it would not be just and equitable if contribution pursuant to this Section 7 were determined
by pro rata allocation (even if the Underwriters were treated as one entity for such purpose) or by any other method of allocation which
does not take account of the equitable considerations referred to above in this Section 7. The aggregate amount of losses, liabilities,
claims, damages and expenses incurred by an indemnified party and referred to above in this Section 7 shall be deemed to include any
legal or other expenses reasonably incurred by such indemnified party in investigating, preparing or defending against any litigation,
or any investigation or proceeding by any governmental agency or body, commenced or threatened, or any claim whatsoever based upon any
such untrue or alleged untrue statement or omission or alleged omission.
Notwithstanding
the provisions of this Section 7, no Underwriter shall be required to contribute any amount in excess of the underwriting discounts and
commissions received by such Underwriter in connection with the Securities underwritten by it and distributed to the public.
No
person guilty of fraudulent misrepresentation (within the meaning of Section 11(f) of the 1933 Act) shall be entitled to contribution
from any person who was not guilty of such fraudulent misrepresentation.
For
purposes of this Section 7, each person, if any, who controls an Underwriter within the meaning of Section 15 of the 1933 Act or Section
20 of the 1934 Act and each Underwriter’s Affiliates and selling agents shall have the same rights to contribution as such Underwriter,
and each director of the Company, each officer of the Company who signed the Registration Statement, and each person, if any, who controls
the Company within the meaning of Section 15 of the 1933 Act or Section 20 of the 1934 Act shall have the same rights to contribution
as the Company. The Underwriters’ respective obligations to contribute pursuant to this Section 7 are several in proportion to
the number of Securities set forth opposite their respective names in Schedule A hereto and not joint.
SECTION
8. Representations, Warranties and Agreements to Survive. All representations, warranties and agreements contained in this
Agreement or in certificates of officers of the Company submitted pursuant hereto, shall remain operative and in full force and
effect regardless of (i) any investigation made by or on behalf of any Underwriter or its Affiliates or selling agents, any person
controlling any Underwriter, its officers or directors or any person controlling the Company and (ii) delivery of and payment for
the Securities.
SECTION
9. Termination of Agreement.
(a)
Termination. The Representatives may terminate this Agreement, by notice to the Company, at any time at or prior to the Closing
Time (i) if there has been, in the judgment of the Representatives, since the time of execution of this Agreement or since the respective
dates as of which information is given in the Registration Statement, the General Disclosure Package or the Prospectus, any material
adverse change in the condition, financial or otherwise, or in the earnings, business affairs or business prospects of the Company, whether
or not arising in the ordinary course of business, or (ii) if there has occurred any material adverse change in the financial markets
in the United States or the international financial markets, any outbreak of hostilities or escalation thereof or other calamity or crisis
or any change or development involving a prospective change in U.S. or international political, financial or economic conditions, in
each case the effect of which is such as to make it, in the judgment of the Representatives, impracticable or inadvisable to proceed
with the completion of the offering or to enforce contracts for the sale of the Securities, or (iii) if trading in any securities of
the Company has been suspended or materially limited by the Commission or the Nasdaq Capital Market, or (iv) if trading generally on
the NYSE MKT or the New York Stock Exchange or in the Nasdaq Global Market has been suspended or materially limited, or minimum or maximum
prices for trading have been fixed, or maximum ranges for prices have been required, by any of said exchanges or by order of the Commission,
FINRA or any other governmental authority, or (v) a material disruption has occurred in commercial banking or securities settlement or
clearance services in the United States or with respect to Clearstream or Euroclear systems in Europe, or (vi) if a banking moratorium
has been declared by either Federal or New York authorities.
(b)
Liabilities. If this Agreement is terminated pursuant to this Section, such termination shall be without liability of any party
to any other party except as provided in Section 4 hereof, and provided further that Sections 1, 4, 6, 7, 8, 15, 16 and 17 shall survive
such termination and remain in full force and effect.
SECTION
10. Default by One or More of the Underwriters. If one or more of the Underwriters shall fail at the Closing Time to purchase
the Securities which it or they are obligated to purchase under this Agreement (the “Defaulted Securities”), the
Representatives shall have the right, within 24 hours thereafter, to make arrangements for one or more of the non-defaulting
Underwriters, or any other underwriters, to purchase all, but not less than all, of the Defaulted Securities in such amounts as may
be agreed upon and upon the terms herein set forth; if, however, the Representatives shall not have completed such arrangements
within such 24-hour period, then:
(i)
if the number of Defaulted Securities does not exceed 10% of the number of Securities to be purchased on such date, each of the non-defaulting
Underwriters shall be obligated, severally and not jointly, to purchase the full amount thereof in the proportions that their respective
underwriting obligations hereunder bear to the underwriting obligations of all non-defaulting Underwriters, or
(ii)
if the number of Defaulted Securities exceeds 10% of the number of Securities to be purchased on such date, this Agreement shall terminate
without liability on the part of any non-defaulting Underwriter.
No
action taken pursuant to this Section shall relieve any defaulting Underwriter from liability in respect of its default.
In
the event of any such default which does not result in a termination of this Agreement, either the (i) Representatives or (ii) the Company
shall have the right to postpone Closing Time for a period not exceeding seven days in order to effect any required changes in the Registration
Statement, the General Disclosure Package or the Prospectus or in any other documents or arrangements. As used herein, the term “Underwriter”
includes any person substituted for an Underwriter under this Section 10.
SECTION
11. Notices. All notices and other communications hereunder shall be in writing and shall be deemed to have been duly given
if mailed or transmitted by any standard form of telecommunication. Notices to the Company shall be directed to Celcuity Inc., 16305
36th Avenue North, Suite 100, Minneapolis, MN, Attention: Chief Executive Officer. Notices to the Underwriters shall be directed
to Leerink Partners at 1301 Avenue of the Americas, 12th Floor, New York, New York, 10019, attention of Stuart R. Nayman;
to TD Securities (USA) LLC, 1 Vanderbilt Avenue, New York, New York 10017, Attention: Head of Equity Capital Markets, with a copy to
the General Counsel; and to Stifel, Nicolaus & Company, Incorporated, 787 7th Avenue, 11th Floor, New York, New York 10019, Attention:
Equity Capital Markets.
SECTION
12. No Advisory or Fiduciary Relationship. The Company acknowledges and agrees that (a) the purchase and sale of the
Securities pursuant to this Agreement, including the determination of the initial public offering price of the Securities and any
related discounts and commissions, is an arm’s-length commercial transaction between the Company, on the one hand, and the
several Underwriters, on the other hand, (b) in connection with the offering of the Securities and the process leading thereto, each
Underwriter is and has been acting solely as a principal and is not the agent or fiduciary of the Company or its stockholders,
creditors, employees or any other party, (c) no Underwriter has assumed or will assume an advisory or fiduciary responsibility in
favor of the Company with respect to the offering of the Securities or the process leading thereto (irrespective of whether such
Underwriter has advised or is currently advising the Company or on other matters) and no Underwriter has any obligation to the
Company with respect to the offering of the Securities except the obligations expressly set forth in this Agreement, (d) the
Underwriters and their respective affiliates may be engaged in a broad range of transactions that involve interests that differ from
those of the Company and (e) the Underwriters have not provided any legal, accounting, regulatory or tax advice with respect to the
offering of the Securities and the Company has consulted its own respective legal, accounting, regulatory and tax advisors to the
extent it deemed appropriate.
SECTION
13. Recognition of the U.S. Special Resolution Regimes. In the event that any Underwriter that is a Covered Entity becomes
subject to a proceeding under a U.S. Special Resolution Regime, the transfer from such Underwriter of this Agreement, and any interest
and obligation in or under this Agreement, will be effective to the same extent as the transfer would be effective under the U.S. Special
Resolution Regime if this Agreement, and any such interest and obligation, were governed by the laws of the United States or a state
of the United States.
In
the event that any Underwriter that is a Covered Entity or a BHC Act Affiliate of such Underwriter becomes subject to a proceeding under
a U.S. Special Resolution Regime, Default Rights under this Agreement that may be exercised against such Underwriter are permitted to
be exercised to no greater extent than such Default Rights could be exercised under the U.S. Special Resolution Regime if this Agreement
were governed by the laws of the United States or a state of the United States.
For
purposes of this Agreement, (A) “BHC Act Affiliate” has the meaning assigned to the term “affiliate” in, and
shall be interpreted in accordance with, 12 U.S.C. § 1841(k); (B) “Covered Entity” means any of the following: (i) a
“covered entity” as that term is defined in, and interpreted in accordance with, 12 C.F.R. § 252.82(b); (ii) a “covered
bank” as that term is defined in, and interpreted in accordance with, 12 C.F.R. § 47.3(b); or (iii) a “covered FSI”
as that term is defined in, and interpreted in accordance with, 12 C.F.R. § 382.2(b); (C) “Default Right” has the meaning
assigned to that term in, and shall be interpreted in accordance with, 12 C.F.R. §§ 252.81, 47.2 or 382.1, as applicable; and
(D) “U.S. Special Resolution Regime” means each of (i) the Federal Deposit Insurance Act and the regulations promulgated
thereunder and (ii) Title II of the Dodd-Frank Wall Street Reform and Consumer Protection Act and the regulations promulgated thereunder.
SECTION
14. Parties. This Agreement shall each inure to the benefit of and be binding upon the Underwriters and the Company and their
respective successors. Nothing expressed or mentioned in this Agreement is intended or shall be construed to give any person, firm or
corporation, other than the Underwriters and the Company and their respective successors and the controlling persons and officers and
directors referred to in Sections 6 and 7 and their heirs and legal representatives, any legal or equitable right, remedy or claim under
or in respect of this Agreement or any provision herein contained. This Agreement and all conditions and provisions hereof are intended
to be for the sole and exclusive benefit of the Underwriters and the Company and their respective successors, and said controlling persons
and officers and directors and their heirs and legal representatives, and for the benefit of no other person, firm or corporation. No
purchaser of Securities from any Underwriter shall be deemed to be a successor by reason merely of such purchase.
SECTION
15. Waiver of Trial by Jury. The Company (on its behalf and, to the extent permitted by applicable law, on behalf of its
stockholders and affiliates) and each of the Underwriters hereby irrevocably waives, to the fullest extent permitted by applicable
law, any and all right to trial by jury in any legal proceeding arising out of or relating to this Agreement or the transactions
contemplated hereby.
SECTION
16. GOVERNING LAW. THIS AGREEMENT AND ANY CLAIM, CONTROVERSY OR DISPUTE ARISING UNDER OR RELATED TO THIS AGREEMENT SHALL BE
GOVERNED BY, AND CONSTRUED IN ACCORDANCE WITH THE LAWS OF, THE STATE OF NEW YORK WITHOUT REGARD TO ITS CHOICE OF LAW PROVISIONS.
SECTION
17. Consent to Jurisdiction; Waiver of Immunity. Any legal suit, action or proceeding arising out of or based upon this
Agreement or the transactions contemplated hereby shall be instituted in (i) the federal courts of the United States of America
located in the City and County of New York, Borough of Manhattan or (ii) the courts of the State of New York located in the City and
County of New York, Borough of Manhattan (collectively, the “Specified Courts”), and each party irrevocably
submits to the exclusive jurisdiction (except for proceedings instituted in regard to the enforcement of a judgment of any such
court, as to which such jurisdiction is non-exclusive) of such courts in any such suit, action or proceeding. Service of any
process, summons, notice or document by mail to such party’s address set forth above shall be effective service of process for
any suit, action or other proceeding brought in any such court. The parties irrevocably and unconditionally waive any objection to
the laying of venue of any suit, action or other proceeding in the Specified Courts and irrevocably and unconditionally waive and
agree not to plead or claim in any such court that any such suit, action or other proceeding brought in any such court has been
brought in an inconvenient forum.
SECTION
18. TIME. TIME SHALL BE OF THE ESSENCE OF THIS AGREEMENT. EXCEPT AS OTHERWISE SET FORTH HEREIN, SPECIFIED TIMES OF DAY REFER
TO NEW YORK CITY TIME.
SECTION
19. Partial Unenforceability. The invalidity or unenforceability of any Section, paragraph or provision of this Agreement
shall not affect the validity or enforceability of any other Section, paragraph or provision hereof. If any Section, paragraph or
provision of this Agreement is for any reason determined to be invalid or unenforceable, there shall be deemed to be made such minor
changes (and only such minor changes) as are necessary to make it valid and enforceable.
SECTION
20. Counterparts. This Agreement may be executed in any number of counterparts (which may include counterparts delivered by
any standard form of telecommunication), each of which shall be deemed to be an original, but all such counterparts shall together
constitute one and the same agreement. Counterparts may be delivered via facsimile, electronic mail (including any electronic
signature covered by the U.S. federal ESIGN Act of 2000, Uniform Electronic Transactions Act, the Electronic Signatures and Records
Act or other applicable law, e.g., www.docusign.com) or other transmission method and any counterpart so delivered shall be deemed
to have been duly and validly delivered and be valid and effective for all purposes.
SECTION
21. Effect of Headings. The Section headings herein are for convenience only and shall not affect the construction
hereof.
SECTION
22. Entire Agreement. This Agreement supersedes all prior agreements and understandings (whether written or oral) between the
Company and the Underwriters, or any of them, with respect to the subject matter hereof.
[SIGNATURE
PAGES FOLLOW]
If
the foregoing is in accordance with your understanding of our agreement, please sign and return to the Company a counterpart hereof,
whereupon this instrument, along with all counterparts, will become a binding agreement among the Underwriters and the Company in accordance
with its terms.
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Very truly yours, |
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Celcuity Inc. |
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By: |
/s/
Brian Sullivan |
|
|
Name:
|
Brian F. Sullivan |
|
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Title: |
Chief Executive Officer |
CONFIRMED
AND ACCEPTED |
|
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As
of the date first above written: |
|
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LEERINK
PARTNERS LLC |
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By: |
/s/
Sean Pitt |
|
|
Name: |
Sean
Pitt |
|
|
Title: |
Senior
Managing Director |
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TD
SECURITIES (USA) LLC |
|
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By: |
/s/
Bill Follis |
|
|
Name: |
Bill
Follis |
|
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Title: |
Managing
Director |
|
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STIFEL,
NICOLAUS & COMPANY, INCORPORATED |
|
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By: |
/s/
Kenneth Clausman |
|
|
Name:
|
Kenneth Clausman |
|
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Title: |
Managing
Director |
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For
themselves and as Representatives of the other Underwriters named in Schedule A hereto.
[Signature
Page To Underwriting Agreement]
SCHEDULE
A
The
initial public offering price per share for the Securities shall be $15.50.
The
purchase price per share for the Securities to be paid by the several Underwriters shall be $14.57, being an amount equal to the initial
public offering price set forth above less $0.93 per share, subject to adjustment in accordance with Section 2(b) for dividends or distributions
declared by the Company and payable on the Securities.
Name of Underwriter | |
Number of Securities | |
| |
| |
Leerink Partners LLC | |
| 1,548,400 | |
TD Securities (USA) LLC | |
| 1,548,400 | |
Stifel, Nicolaus & Company, Incorporated | |
| 774,200 | |
| |
| | |
Total | |
| 3,871,000 | |
SCHEDULE
B-1
1.
The Company is selling 3,871,000 shares of Common Stock.
2.
The initial public offering price per share for the Securities shall be $15.50.
3.
The Company’s existing cash, cash equivalents, short-term investments and available borrowings under its amended and restated loan
and security agreement, together with the net proceeds from the offering of the Securities, will be sufficient to fund the Company’s
operating expenses and capital expenditure requirements through at least the second half of 2026.
SCHEDULE
B-2
Free
Writing Prospectuses
None
SCHEDULE
B-3
List
of Written Testing-the-Waters Communications
None
Exhibit
A
FORM
OF LOCK-UP AGREEMENT
Leerink
Partners LLC
TD
Securities (USA) LLC
Stifel,
Nicolaus & Company, Incorporated
As
Representatives of the several Underwriters
c/o
Leerink Partners LLC
1301 Avenue of the Americas, 12th Floor
New York, New York 10019
c/o
TD Securities (USA) LLC
1
Vanderbilt Avenue
New
York, New York 10017
c/o
Stifel, Nicolaus & Company, Incorporated
787
7th Avenue, 11th Floor
New
York, New York 10019
RE:
Celcuity Inc., (the “Company”)
Ladies
and Gentlemen:
The
undersigned is an owner of shares of common stock, par value $0.001 per share, of the Company (“Shares”) or of securities
convertible into or exchangeable or exercisable for Shares. The Company proposes to conduct a public offering of Shares (the “Offering”)
for which Leerink Partners LLC (“Leerink Partners”), TD Securities (USA) LLC (“TD Cowen”) and Stifel,
Nicolaus & Company, Incorporated will act as the representatives of the underwriters. The undersigned recognizes that the Offering
will benefit each of the Company and the undersigned. The undersigned acknowledges that the underwriters are relying on the representations
and agreements of the undersigned contained in this letter agreement in conducting the Offering and, at a subsequent date, in entering
into an underwriting agreement (the “Underwriting Agreement”) and other underwriting arrangements with the Company
with respect to the Offering.
Annex
A sets forth definitions for capitalized terms used in this letter agreement that are not defined in the body of this letter agreement.
Those definitions are a part of this letter agreement.
In
consideration of the foregoing, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged,
the undersigned hereby agrees that, during the Lock-up Period, the undersigned will not (and will cause any Family Member not to), without
the prior written consent of Leerink Partners and TD Cowen, which may withhold their consent in their sole discretion:
|
● |
sell
or Offer to Sell any Shares or Related Securities currently or hereafter owned either of record or beneficially (as defined in Rule
13d-3 under the Exchange Act) by the undersigned or such Family Member, |
|
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|
|
● |
enter
into any Swap, |
|
● |
make
any demand for, or exercise any right with respect to, the registration under the Securities Act of the offer and sale of any Shares
or Related Securities, or cause to be filed a registration statement, prospectus or prospectus supplement (or an amendment or supplement
thereto) with respect to any such registration, or |
|
|
|
|
● |
publicly
announce any intention to do any of the foregoing. |
The
foregoing restrictions will not apply to the registration of the offer and sale of the Shares, and the sale of the Shares to the underwriters,
in each case as contemplated by the Underwriting Agreement. In addition, the foregoing restrictions shall not apply to the transfer of
Shares or Related Securities (i) by gift, (ii) by will or intestate succession, (iii) to a trust whose beneficiaries consist exclusively
of one or more of the undersigned and/or a Family Member, (iv) if the undersigned is a corporation, partnership, limited liability company,
trust or other business entity, (A) to another corporation, partnership, limited liability company, trust or other business entity that
is a direct or indirect affiliate (as defined in Rule 405 promulgated under the Securities Act of 1933, as amended) of the undersigned
or (B) as distributions of Shares or Related Securities to limited partners, limited liability company members or stockholders of the
undersigned, or (v) if the undersigned is a trust, to the beneficiary of such trust; provided, however, that in in each case set forth
in (i) through (v) above, it shall be a condition to such transfer that:
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● |
each
transferee executes and delivers to Leerink Partners and TD Cowen an agreement in form and substance satisfactory to Leerink Partners
and TD Cowen stating that such transferee is receiving and holding such Shares and/or Related Securities subject to the provisions
of this letter agreement and agrees not to Sell or Offer to Sell such Shares and/or Related Securities, engage in any Swap or engage
in any other activities restricted under this letter agreement except in accordance with this letter agreement (as if such transferee
had been an original signatory hereto), and |
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|
● |
prior
to the expiration of the Lock-up Period, no public disclosure or filing under the Exchange Act by any party to the transfer (donor,
donee, transferor or transferee) shall be required, or made voluntarily, reporting a reduction in beneficial ownership of Shares
in connection with such transfer. |
In
addition, the foregoing will not apply to (i) the exercise of stock options granted pursuant to the Company’s equity incentive
plans disclosed in the Company’s public filings; provided that such restrictions shall apply to any Shares issued upon such exercise,
(ii) the establishment of any contract, instruction or plan (a “Plan”) that satisfies all of the requirements of Rule
10b5-1(c)(1)(i)(B) under the Exchange Act; provided that no sales of Shares or Related Securities will be made pursuant to such a Plan
prior to the expiration of the Lock-up Period, and such a Plan may only be established if no public announcement of the establishment
or existence thereof and no filing with the Securities and Exchange Commission or other regulatory authority in respect thereof or transactions
thereunder or contemplated thereby, by the undersigned, the Company or any other person, shall be required, and no such announcement
or filing is made voluntarily, by the undersigned, the Company or any other person, prior to the expiration of the Lock-up Period or
(iii) sales or transfers made pursuant to any Plan for the transfer of Shares or Related Securities entered into by the undersigned prior
to the date of this letter agreement and such Plan has been provided to Leerink Partners and TD Cowen prior to the date hereof; provided
that, to the extent a public announcement or filing under the Exchange Act, if any, is required or voluntarily made by or on behalf of
the undersigned or the Company regarding any such sales or transfers, such announcement or filing shall include a statement to the effect
that the sale or transfer was made pursuant to a trading plan established pursuant to Rule 10b5-1.
The
undersigned also agrees and consents to the entry of stop transfer instructions with the Company’s transfer agent and registrar
against the transfer of Shares or Related Securities held by the undersigned and the undersigned’s Family Members, if any, except
in compliance with the foregoing restrictions.
With
respect to the Offering only, the undersigned waives any registration rights relating to registration under the Securities Act of the
offer and sale of any Shares and/or any Related Securities owned either of record or beneficially by the undersigned, including any rights
to receive notice of the Offering. The Company shall be a beneficiary of, and entitled to rely upon, the foregoing waiver for all purposes.
The
undersigned confirms that the undersigned has not, and has no knowledge that any Family Member has, directly or indirectly, taken any
action designed to or that might reasonably be expected to cause or result in the stabilization or manipulation of the price of any security
of the Company to facilitate the sale of the Shares. The undersigned will not, and will cause any Family Member not to take, directly
or indirectly, any such action.
The
undersigned acknowledges and agrees that the underwriters have not provided any recommendation or investment advice nor have the underwriters
solicited any action from the undersigned with respect to the Offering and the undersigned has consulted their own legal, accounting,
financial, regulatory and tax advisors to the extent deemed appropriate.
Whether
or not the Offering occurs as currently contemplated or at all depends on market conditions and other factors. The Offering will only
be made pursuant to the Underwriting Agreement, the terms of which are subject to negotiation between the Company and the underwriters.
Notwithstanding
anything to the contrary contained herein, this letter agreement will automatically terminate and the undersigned will be released from
all obligations hereunder upon the earliest to occur, if any, of (i) the Company advises the Representatives in writing, prior to the
execution of the Underwriting Agreement, that it has determined not to proceed with the Offering, (ii) the Underwriting Agreement is
executed but is terminated (other than the provisions thereof which survive termination) prior to payment for and delivery of the Shares
to be sold thereunder, or (iii) the Underwriting Agreement is not executed on or before June 28, 2024.
The
undersigned hereby represents and warrants that the undersigned has full power, capacity, and authority to enter into this letter agreement.
This letter agreement is irrevocable and will be binding on the undersigned and the successors, heirs, personal representatives and assigns
of the undersigned. This letter agreement may be delivered via facsimile, electronic mail (including pdf or any electronic signature
complying with the U.S. federal ESIGN Act of 2000, e.g., www.docusign.com or www.echosign.com) or other transmission method and any counterpart
so delivered shall be deemed to have been duly and validly delivered and be valid and effective for all purposes.
This
letter agreement shall be governed by, and construed in accordance with, the laws of the State of New York.
|
Very
truly yours, |
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(Signature) |
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(Name) |
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|
(Indicate
capacity of person signing if signing as custodian or trustee, or on behalf of an entity) |
[Signature
page to Lock-Up Letter]
Annex
A
Certain
Defined Terms Used in Letter Agreement
For
purposes of the letter agreement to which this Annex A is attached and of which it is made a part:
| ● | “Call
Equivalent Position” shall have the meaning set forth in Rule 16a-1(b) under the
Exchange Act. |
| ● | “Exchange
Act” shall mean the Securities Exchange Act of 1934, as amended. |
| ● | “Family
Member” shall mean the spouse of the undersigned, an immediate family member of
the undersigned or an immediate family member of the undersigned’s spouse, in each
case living in the undersigned’s household or whose principal residence is the undersigned’s
household (regardless of whether such spouse or family member may at the time be living elsewhere
due to educational activities, health care treatment, military service, temporary internship
or employment or otherwise). “Immediate family member” as used above shall
have the meaning set forth in Rule 16a-1(e) under the Exchange Act. |
| ● | “Lock-up
Period” shall mean the period beginning on the date hereof and continuing through
the close of trading on the date that is 90 days after the date of the Prospectus (as defined
in the Underwriting Agreement). |
| ● | “Put
Equivalent Position” shall have the meaning set forth in Rule 16a-1(h) under the
Exchange Act. |
| ● | “Related
Securities” shall mean any options or warrants or other rights to acquire Shares
or any securities exchangeable or exercisable for or convertible into Shares, or to acquire
other securities or rights ultimately exchangeable or exercisable for or convertible into
Shares. |
| ● | “Securities
Act” shall mean the Securities Act of 1933, as amended. |
| ● | “Sell
or Offer to Sell” shall mean to: |
| ○ | sell,
offer to sell, contract to sell or lend, |
| ○ | effect
any short sale or establish or increase a Put Equivalent Position or liquidate or decrease
any Call Equivalent Position |
| ○ | pledge,
hypothecate or grant any security interest in, or |
| ○ | in
any other way transfer or dispose of |
in
each case whether effected directly or indirectly.
| ● | “Swap”
shall mean any swap, hedge or similar arrangement or agreement that transfers, in whole or
in part, the economic risk of ownership of Shares or Related Securities, regardless of whether
any such transaction is to be settled in securities, in cash or otherwise. |
Capitalized
terms not defined in this Annex A shall have the meanings given to them in the body of this letter agreement.
Exhibit
5.1
May
30, 2024
Celcuity
Inc.
16305
36th Avenue N., Suite 100
Minneapolis,
MN 55446
RE: |
Celcuity
Inc. Underwritten Offering of Common Stock |
Ladies
and Gentlemen:
We
have acted as counsel to Celcuity Inc., a Delaware corporation (the “Company”), in connection with the preparation
and filing by the Company of a prospectus supplement dated May 30, 2024 (the “Prospectus Supplement”), which supplements
a Registration Statement on Form S-3 (Registration No. 333-261155) (the “Registration Statement”), filed with the
Securities and Exchange Commission (the “Commission”) under the Securities Act of 1933, as amended (the “Securities
Act”), and effective November 26, 2021 and the prospectus included therein (the “Base Prospectus”), and
the Prospectus Supplement (together with the Base Prospectus, the “Prospectus”). The Registration Statement and the
Prospectus relate to the offer and sale by the Company of 3,871,000 shares of common stock, par value $0.001 per share (the “Shares”).
We
understand the Shares are to be issued pursuant to the Prospectus and the Underwriting Agreement (the “Underwriting Agreement”),
dated May 30, 2024, by and between the Company and Leerink Partners LLC, TD Securities (USA) LLC and Stifel, Nicolaus & Company,
Incorporated (the “Representatives”), as Representatives of the several underwriters named in Schedule A to the Underwriting
Agreement.
In
connection with the foregoing, we have relied upon, among other things, our examination of such documents, records of the Company and
certificates of public officials as we deemed necessary for purposes of the opinions expressed below. In addition, as to certain factual
matters relevant to the opinions expressed below, we have relied upon a certificate of officers of the Company. In our examination, we
have assumed the genuineness of all signatures, the authenticity of all documents submitted to us as originals and the conformity with
the original of all documents submitted to us as copies thereof.
Based
upon the foregoing and upon the representations and information provided by the Company, we are of the opinion that the issuance of the
Shares has been duly authorized and, when and to the extent the Shares are issued against payment therefor in accordance with the Prospectus
and the Underwriting Agreement, such Shares will be validly issued, fully paid and non-assessable.
This
opinion is limited to the Delaware General Corporation Law. We hereby consent to the filing of this opinion with the Commission as Exhibit
5.1 to the Current Report on Form 8-K filed by the Company on or about the date hereof and the reference to our firm under the heading
“Legal Matters” in the Registration Statement and Prospectus. In giving this consent, we do not admit that we are within
the category of persons whose consent is required by Section 7 of the Securities Act or the rules and regulations promulgated thereunder
by the Commission.
Very
truly yours, |
|
|
|
Fredrikson
& Byron, P.A. |
|
|
|
By:
|
/s/
Jeffrey Steinle |
|
Its:
|
Vice
President |
|
Exhibit
99.1
![](https://www.sec.gov/Archives/edgar/data/1603454/000149315224022227/ex99-1_001.jpg)
Celcuity
Announces Pricing of Underwritten Common Stock Offering
MINNEAPOLIS,
May 30, 2024 — Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies
for oncology, today announced the pricing of an underwritten offering of 3,871,000 shares of its common stock at an offering price of
$15.50 per share. All of the securities are to be sold by Celcuity. Investors who have agreed to purchase shares in the offering include
BVF Partners L.P., a U.S.-based healthcare focused investor, Vivo Capital, Eventide Asset Management, Samlyn Capital, Driehaus Capital
Management and Blue Owl Healthcare Opportunities. The offering is expected to close on or about May 31, 2024, subject to satisfaction
of customary closing conditions.
Gross
proceeds to Celcuity from the offering are expected to be $60.0 million, before deducting underwriting discounts and commissions and
offering expenses. Celcuity intends to use the net proceeds from the offering for working capital and general corporate purposes, which
may include capital expenditures, research and development expenditures, clinical trial expenditures, expansion of business development
activities and other general corporate purposes. Clinical trial expenditures may include a Phase 3 clinical trial that Celcuity plans
to initiate to evaluate gedatolisib plus a CDK4/6 inhibitor and fulvestrant as first-line treatment for patients with HR+/HER2- advanced
breast cancer. Celcuity expects that its existing cash, cash equivalents and short-term investments and available borrowings under its
recently announced amended and restated loan and security agreement, together with the net proceeds from this offering, will be sufficient
to fund Celcuity’s operating expenses and capital expenditure requirements through at least the second half of 2026.
Leerink
Partners, TD Cowen and Stifel acted as joint bookrunning managers for the offering.
The
shares are being offered by Celcuity pursuant to a Registration Statement on Form S-3 previously filed with, and declared effective by,
the U.S. Securities and Exchange Commission (SEC). A prospectus supplement and accompanying prospectus relating to the offering will
also be filed with the SEC. These documents can be accessed for free through the SEC’s website at www.sec.gov.
When
available, copies of the prospectus supplement and the accompanying prospectus relating to this offering may also be obtained from: Leerink
Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at (800) 808-7525, ext. 6105
or by email at syndicate@leerink.com; or TD Securities (USA) LLC, 1 Vanderbilt Avenue, New York, NY 10017, by telephone at (855) 495-9846
or by email at TD.ECM_Prospectus@tdsecurities; or Stifel, Nicolaus & Company, Incorporated, Attention: Prospectus Department, One
Montgomery Street, Suite 3700, San Francisco, CA 94104, by telephone at (415) 364-2720 or by email at syndprospectus@stifel.com.
This
press release does not constitute an offer to sell or a solicitation of an offer to buy, nor will there be any sale of these securities
in any state or other jurisdiction in which such offer, solicitation, or sale would be unlawful before registration or qualification
under the securities laws of that state or jurisdiction.
About
Celcuity
Celcuity
is a clinical-stage biotechnology company focused on development of targeted therapies for treatment of multiple solid tumor indications.
The company’s lead therapeutic candidate is gedatolisib, a potent, pan-PI3K and mTOR inhibitor. Its mechanism of action and pharmacokinetic
properties are highly differentiated from other currently approved and investigational therapies that target PI3K or mTOR alone or together.
A Phase 3 clinical trial, VIKTORIA-1, evaluating gedatolisib in combination with fulvestrant with or without palbociclib in patients
with HR+/HER2- advanced breast cancer is currently enrolling patients. A Phase 1b/2 clinical trial, CELC-G-201, evaluating gedatolisib
in combination with darolutamide in patients with metastatic castration resistant prostate cancer, is currently enrolling patients. A
Phase 3 clinical trial, VIKTORIA-2, evaluating gedatolisib plus a CDK4/6 inhibitor and fulvestrant as first-line treatment for patients
with HR+/HER2- advanced breast cancer is expected to begin enrolling patients in the second quarter of 2025. The company’s CELsignia
companion diagnostic platform is uniquely able to analyze live patient tumor cells to identify new groups of cancer patients likely to
benefit from already approved targeted therapies. Celcuity is headquartered in Minneapolis.
Cautionary
Note Regarding Forward-Looking Statements
This
press release contains statements that constitute “forward-looking statements.” In some cases, you can identify forward-looking
statements by terminology such as “may,” “should,” “expects,” “plans,” “anticipates,”
“believes,” “estimates,” “predicts,” “potential,” “intends” or “continue,”
and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or
other comparable terminology. Celcuity may not actually achieve the plans, intentions or expectations disclosed in these forward-looking
statements, and you should not place undue reliance on these forward-looking statements. Forward-looking statements are subject to numerous
risks, uncertainties, and conditions, many of which are beyond the control of Celcuity, which include, but are not limited to, risks
and uncertainties related to market conditions and satisfaction of customary closing conditions related to the proposed offering, as
well as those other risks set forth in the Risk Factors section in Celcuity’s Annual Report on Form 10-K for the year ended December
31, 2023 filed with the Securities and Exchange Commission on March 27, 2024, Celcuity’s most recent Form 10-Q and in subsequent
filings Celcuity may make with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements, which
speak only as of the date hereof. Celcuity undertakes no obligation to update these statements for revisions or changes after the date
of this press release, except as required by law.
Contacts:
Celcuity
Inc.
Brian
Sullivan, bsullivan@celcuity.com
Vicky
Hahne, vhahne@celcuity.com
763-392-0123
ICR
Westwicke
Maria
Yonkoski, maria.yonkoski@westwicke.com
(619)
228-5886
SOURCE:
Celcuity Inc.
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