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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):
August 6, 2024
Protara Therapeutics, Inc.
(Exact name of registrant as specified in its
charter)
Delaware |
|
001-36694 |
|
20-4580525 |
(State or other jurisdiction
of incorporation) |
|
(Commission
File No.) |
|
(IRS Employer
Identification No.) |
345 Park Avenue South
Third Floor
New York, NY |
|
10010 |
(Address of principal executive offices) |
|
(Zip Code) |
Registrant’s telephone number, including
area code: (646) 844-0337
N/A
(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, par value $0.001 per share |
|
TARA |
|
The Nasdaq Capital Market |
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 2.02. Results of Operations and Financial
Condition.
On August 6, 2024, Protara Therapeutics, Inc. (the
“Company”) announced its financial results for the quarter ended June 30, 2024 in the press release attached hereto as Exhibit
99.1 and incorporated herein by reference.
The information in this Item 2.02, including the
attached Exhibit 99.1, is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities
Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, nor shall
it be deemed incorporated by reference in any filing made by the Company under the Securities Act of 1933, as amended, or the Exchange
Act, except as shall be expressly set forth by specific reference in such a filing regardless of any general incorporation language.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
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.
|
PROTARA THERAPEUTICS, INC. |
|
|
|
Date: August 6, 2024 |
By: |
/s/ Patrick Fabbio |
|
|
Patrick Fabbio |
|
|
Chief Financial Officer |
2
Exhibit 99.1
Protara
Therapeutics Announces Second Quarter 2024 Financial Results and
Provides a Business Update
| ● | On
track to report preliminary data from six-month evaluable patients in ADVANCED-2 trial of
TARA-002 in NMIBC in Q4 2024 |
| ● | Expect
to dose first patient in pivotal trial for IV Choline Chloride in Q1 2025 |
| ● | Current
cash resources are approximately $90 million, including net proceeds from April 2024 private
placement, expected to fund operations into 2026 |
NEW
YORK, August 6, 2024 – Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage company developing transformative
therapies for the treatment of cancer and rare diseases, today provided a business update and announced financial results for the second
quarter ended June 30, 2024.
“The
first half of the year has been marked by significant progress as we advance our mission to deliver transformative therapies to patients
with cancer and rare diseases,” said Jesse Shefferman, Chief Executive Officer of Protara Therapeutics. “Notably,
we were pleased with our recent announcement of positive three-month data from our TARA-002 program in patients with non-muscle invasive
bladder cancer (NMIBC). We believe our growing clinical dataset continues to support the potential of TARA-002 to serve as a meaningful
addition to the NMIBC treatment landscape and look forward to sharing interim data from our ADVANCED-2 trial in the fourth quarter of
this year. We also continue to focus on identifying the best agent for combination as we believe TARA-002’s mechanism of action
and safety profile give it strong potential for use in combination therapy in NMIBC.”
Mr.
Shefferman continued, “Beyond the NMIBC program, we announced alignment with the FDA on a path forward for intravenous (IV) Choline
Chloride for patients on long-term parenteral nutrition (PN), and we expect to start dosing patients in our pivotal trial in the first
quarter of 2025. Finally, enrollment continues in our Phase 2 STARBORN-1 trial of TARA-002 in pediatric patients with lymphatic malformations
(LMs), an underserved population with no U.S. Food and Drug Administration (FDA)-approved therapies.”
Recent
Progress and Highlights
TARA-002
in NMIBC
| ● | The
Company expects to share preliminary results from a pre-planned risk-benefit analysis from
approximately ten 6-month evaluable patients in the ongoing Phase 2 open-label ADVANCED-2
trial in the fourth quarter of 2024. The ADVANCED-2 trial is assessing intravesical TARA-002
in NMIBC patients with carcinoma in situ or CIS (± Ta/T1) who are Bacillus Calmette-Guérin
(BCG)-unresponsive (n≈100) and BCG-Naïve (n=27). The BCG-Unresponsive cohort has
been designed to be registrational aligned with the FDA’s 2018 BCG-Unresponsive Non-muscle
Invasive Bladder Cancer: Developing Drugs and Biologics for Treatment Guidance for Industry.
|
| ● | In
addition to the ADVANCED-2 trial, the Company is assessing higher dosing at an 80KE1 dose
and has completed enrollment of a three-patient exploratory dosing cohort with data expected
by the end of this year. To date, no differences in safety profile have been observed between
the 40KE and the 80KE doses. |
| ● | The
Company continues to explore systemic priming dosing prior to initiation of intravesical
administration, as well as combination therapy with TARA-002 in NMIBC patients with CIS.
Given TARA-002’s mechanism of action and safety profile, the Company believes it has
strong potential for use in combination therapy and is working to determine the best possible
options for the clinical program. |
IV
Choline Chloride for Patients on PN
| ● | In April
2024, the Company announced alignment with the FDA on a registrational path forward for IV
Choline Chloride in patients dependent on PN who are or may become unable to synthesize choline
from oral or enteral nutrition sources. The Company expects to begin dosing patients in a
pivotal trial in the first quarter of 2025. |
TARA-002
in LMs
| ● | Dosing
continues to progress in the ongoing STARBORN-1 trial. The Company has completed enrollment
of the first safety cohort and will soon begin enrolling patients in the second safety cohort.
STARBORN-1 is a Phase 2 clinical trial of TARA-002 in pediatric patients with macrocystic
and mixedcystic LMs. Including an age de-escalation safety lead-in, the trial will enroll
approximately 30 patients who will receive up to four injections of TARA-002 spaced approximately
six weeks apart. The primary endpoint of the trial is the proportion of participants with
macrocystic and mixed cystic LMs who demonstrate clinical success, defined as having either
a complete response (90% to 100% reduction from baseline in total LM volume) or substantial
response (60% to less than 90% reduction in total LM volume) as measured by axial imaging.
|
| ● | In
addition to LMs, the Company believes that TARA-002 has the potential to be used to treat
other maxillofacial cysts. While completing the STARBORN-1 trial in LMs remains a priority,
there may be potential in the future to explore the use of TARA-002 to treat different types
of maxillofacial cysts based on the historical literature from the TARA-002 predecessor, OK-432,
as well as data in a pediatric patient with a maxillofacial cyst called a Ranula, which resolved
nearly 100% after a single 1KE dose of TARA-002. |
Corporate
Update
| ● | In
June 2024, the Company appointed Lisa Schlesinger as Vice President, Head of New Product
Development and Market Access. |
Second
Quarter 2024 Financial Results
| ● | As
of June 30, 2024, cash, cash equivalents and investments in marketable debt securities totaled approximately
$89.6 million, which includes approximately $42.0 million in net proceeds from
the April 2024 private placement. The Company expects its cash, cash equivalents,
and investments in marketable debt securities will be sufficient to fund its planned operations
and data milestones into 2026. |
| ● | Research
and development expenses for the second quarter of 2024 decreased to $6.4 million from $7.2
million for the prior year period. This decrease was primarily due to a decrease in non-clinical
and clinical trial expenses related to TARA-002. |
| ● | General
and administrative expenses for the second quarter of 2024 decreased to $4.3 million from
$4.9 million for the prior year period. This decrease was primarily due to a reduction in
personnel-related expenses associated with stock-based compensation as well as a decrease
in market development activities. |
| ● | For
the second quarter of 2024, Protara incurred a net loss of $9.5 million, or $0.45 per
share, compared with a net loss of $11.3 million, or $1.00 per share, for
the same period in 2023. Net loss for the second quarter of 2024 included approximately $1.1
million of stock-based compensation expenses. |
About
TARA-002
TARA-002
is an investigational cell therapy in development for the treatment of NMIBC and of LMs, for which it has been granted Rare Pediatric
Disease Designation by the U.S. Food and Drug Administration. TARA-002 was developed from the same master cell bank of genetically distinct
group A Streptococcus pyogenes as OK-432, a broad immunopotentiator marketed as Picibanil® in Japan by Chugai Pharmaceutical Co.,
Ltd and also approved in Taiwan. Protara has successfully shown manufacturing comparability between TARA-002 and OK-432.
When
TARA-002 is administered, it is hypothesized that innate and adaptive immune cells within the cyst or tumor are activated and produce
a pro-inflammatory response with release of cytokines such as tumor necrosis factor (TNF)-alpha, interferon (IFN)-gamma IL-6, IL-10,
IL-12. TARA-002 also directly kills tumor cells and triggers a host immune response by inducing immunogenic cell death, which further
enhances the antitumor immune response.
About
Non-Muscle Invasive Bladder Cancer (NMIBC)
Bladder
cancer is the 6th most common cancer in the United States, with NMIBC representing approximately 80% of bladder cancer diagnoses. Approximately
65,000 patients are diagnosed with NMIBC in the United States each year. NMIBC is cancer found in the tissue that lines the inner surface
of the bladder that has not spread into the bladder muscle.
About
Lymphatic Malformations (LMs)
LMs
are rare, congenital malformations of lymphatic vessels resulting in the failure of these structures to connect or drain into the venous
system. Most LMs are present in the head and neck region and are diagnosed in early childhood during the period of active lymphatic growth,
with more than 50% detected at birth and 90% diagnosed before the age of three years. The most common morbidities and serious manifestations
of the disease include compression of the upper aerodigestive tract, including airway obstruction requiring intubation and possible tracheostomy
dependence; intralesional bleeding; impingement on critical structures, including nerves, vessels, lymphatics; recurrent infection, and
cosmetic and other functional disabilities.
About
IV Choline Chloride
IV
Choline Chloride is an investigational, intravenous phospholipid substrate replacement therapy initially in development for patients
receiving parenteral nutrition. Choline is a known important substrate for phospholipids that are critical for healthy liver function
and also plays an important role in modulating gene expression, cell membrane signaling, brain development and neurotransmission, muscle
function, and bone health. PN patients are unable to synthesize choline from enteral nutrition sources, and there are currently no available
PN formulations containing choline. Approximately 80 percent of PN-dependent patients are choline-deficient and have some degree of liver
damage, which can lead to hepatic failure. There are currently no available PN formulations containing choline. In the U.S. alone,
there are approximately 40,000 patients on long-term parenteral nutrition who would benefit from an IV formulation of choline. IV Choline
Chloride has the potential to become the first FDA approved IV choline formulation for PN patients. IV Choline Chloride has been granted
Orphan Drug Designation by the FDA for the prevention of choline deficiency in PN patients. The Company was issued a U.S. patent
claiming a choline composition with a term expiring in 2041.
About
Protara Therapeutics, Inc.
Protara
is a clinical-stage biotechnology company committed to advancing transformative therapies for people with cancer and rare diseases. Protara’s
portfolio includes its lead candidate, TARA-002, an investigational cell-based therapy in development for the treatment of non-muscle
invasive bladder cancer (NMIBC) and lymphatic malformations (LMs). The Company is evaluating TARA-002 in an ongoing Phase 2 trial in
NMIBC patients with carcinoma in situ (CIS) who are unresponsive or naïve to treatment with Bacillus Calmette-Guérin (BCG),
as well as a Phase 2 trial in pediatric patients with LMs. Additionally, Protara is developing IV Choline Chloride, an investigational
phospholipid substrate replacement for patients on parenteral nutrition who are otherwise unable to meet their choline needs via oral
or enteral routes. For more information, visit www.protaratx.com.
References
1.
Klinische Einheit, or KE, is a German term indicating a specified weight of dried cells in a vial.
Forward-Looking
Statements
Statements
contained in this press release regarding matters that are not historical facts are “forward looking statements” within the
meaning of the Private Securities Litigation Reform Act of 1995. Protara may, in some cases, use terms such as “predicts,”
“believes,” “potential,” “proposed,” “continue,” “designed,” “estimates,”
“anticipates,” “expects,” “plans,” “intends,” “may,” “could,”
“might,” “will,” “should” or other words or expressions referencing future events, conditions or
circumstances that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such forward-looking
statements include but are not limited to, statements regarding Protara’s intentions, beliefs, projections, outlook, analyses or
current expectations concerning, among other things: Protara’s business strategy, including its development plans for its product
candidates and plans regarding the timing or outcome of existing or future clinical trials; statements related to expectations regarding
interactions with the FDA; Protara’s financial position; statements regarding the anticipated safety or efficacy of Protara’s
product candidates; and Protara’s outlook for the remainder of the year. Because such statements are subject to risks and uncertainties,
actual results may differ materially from those expressed or implied by such forward-looking statements. Factors that contribute to the
uncertain nature of the forward-looking statements include: risks that Protara’s financial guidance may not be as expected, as
well as risks and uncertainties associated with: Protara’s development programs, including the initiation and completion of non-clinical
studies and clinical trials and the timing of required filings with the FDA and other regulatory agencies; general market conditions;
changes in the competitive landscape; changes in Protara’s strategic and commercial plans; Protara’s ability to obtain sufficient
financing to fund its strategic plans and commercialization efforts; having to use cash in ways or on timing other than expected; the
impact of market volatility on cash reserves; failure to attract and retain management and key personnel; the impact of general U.S.
and foreign, economic, industry, market, regulatory, political or public health conditions; and the risks and uncertainties associated
with Protara’s business and financial condition in general, including the risks and uncertainties described more fully under the
caption “Risk Factors” and elsewhere in Protara’s filings and reports with the United States Securities and Exchange Commission.
All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s
assumptions and estimates as of such date. Protara undertakes no obligation to update any forward-looking statements, whether as a result
of the receipt of new information, the occurrence of future events or otherwise, except as required by law.
PROTARA
THERAPEUTICS, INC. AND SUBSIDIARIES
Unaudited Condensed Consolidated Balance Sheets
(in thousands, except share and per share data)
| |
As of | |
| |
June 30, 2024 | | |
December 31, 2023 | |
Assets | |
| | |
| |
Current assets: | |
| | |
| |
Cash and cash equivalents | |
$ | 89,581 | | |
$ | 39,586 | |
Marketable debt securities | |
| - | | |
| 25,994 | |
Prepaid expenses and other current assets | |
| 2,633 | | |
| 3,125 | |
Total current assets | |
| 92,214 | | |
| 68,705 | |
Restricted cash, non-current | |
| 745 | | |
| 745 | |
Property and equipment, net | |
| 1,185 | | |
| 1,296 | |
Operating lease right-of-use asset | |
| 4,768 | | |
| 5,264 | |
Other assets | |
| 2,735 | | |
| 2,944 | |
Total assets | |
$ | 101,647 | | |
$ | 78,954 | |
| |
| | | |
| | |
Liabilities and Stockholders’ Equity | |
| | | |
| | |
Current liabilities: | |
| | | |
| | |
Accounts payable | |
$ | 1,385 | | |
$ | 2,434 | |
Accrued expenses and other current liabilities | |
| 3,228 | | |
| 2,732 | |
Operating lease liability | |
| 1,035 | | |
| 983 | |
Total current liabilities | |
| 5,648 | | |
| 6,149 | |
Operating lease liability, non-current | |
| 3,949 | | |
| 4,484 | |
Total liabilities | |
| 9,597 | | |
| 10,633 | |
Commitments and contingencies (Note 9) | |
| | | |
| | |
Stockholders’ Equity: | |
| | | |
| | |
Preferred stock, $0.001 par value, authorized 10,000,000 shares: Series 1 Convertible Preferred Stock, 8,028 shares authorized at June 30, 2024 and December 31, 2023, 7,991 shares issued and outstanding as of June 30, 2024 and December 31, 2023. | |
| - | | |
| - | |
Common stock, $0.001 par value, authorized 100,000,000 shares: Common stock, 20,629,772 and 11,364,903 shares issued and outstanding as of June 30, 2024 and December 31, 2023, respectively. | |
| 21 | | |
| 11 | |
Additional paid-in capital | |
| 313,021 | | |
| 268,725 | |
Accumulated deficit | |
| (220,992 | ) | |
| (200,384 | ) |
Accumulated other comprehensive income (loss) | |
| - | | |
| (31 | ) |
Total stockholders’ equity | |
| 92,050 | | |
| 68,321 | |
Total liabilities and stockholders’ equity | |
$ | 101,647 | | |
$ | 78,954 | |
PROTARA
THERAPEUTICS, INC. AND SUBSIDIARIES
Unaudited Condensed Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except share and per share data)
| |
For the Three Months Ended June
30, | | |
For the Six Months Ended June 30, | |
| |
2024 | | |
2023 | | |
2024 | | |
2023 | |
| |
| | |
| | |
| | |
| |
Operating expenses: | |
| | |
| | |
| | |
| |
Research and development | |
$ | 6,387 | | |
$ | 7,247 | | |
$ | 14,135 | | |
$ | 12,390 | |
General and administrative | |
| 4,274 | | |
| 4,893 | | |
| 8,377 | | |
| 9,482 | |
Total operating expenses | |
| 10,661 | | |
| 12,140 | | |
| 22,512 | | |
| 21,872 | |
Loss from operations | |
| (10,661 | ) | |
| (12,140 | ) | |
| (22,512 | ) | |
| (21,872 | ) |
Other income (expense), net: | |
| | | |
| | | |
| | | |
| | |
Interest and investment income | |
| 1,148 | | |
| 846 | | |
| 1,904 | | |
| 1,533 | |
Other income (expense), net | |
| 1,148 | | |
| 846 | | |
| 1,904 | | |
| 1,533 | |
Net income (loss) | |
$ | (9,513 | ) | |
$ | (11,294 | ) | |
$ | (20,608 | ) | |
$ | (20,339 | ) |
| |
| | | |
| | | |
| | | |
| | |
Net income (loss) per share attributable to
common stockholders, basic and diluted | |
$ | (0.45 | ) | |
$ | (1.00 | ) | |
$ | (1.26 | ) | |
$ | (1.80 | ) |
Weighted-average shares outstanding, basic and diluted | |
| 21,233,163 | | |
| 11,307,842 | | |
| 16,327,056 | | |
| 11,305,867 | |
Other comprehensive income (loss): | |
| | | |
| | | |
| | | |
| | |
Net unrealized gain (loss) on marketable debt securities | |
| 1 | | |
| 133 | | |
| 31 | | |
| 352 | |
Other comprehensive income (loss) | |
| 1 | | |
| 133 | | |
| 31 | | |
| 352 | |
Comprehensive loss | |
$ | (9,512 | ) | |
$ | (11,161 | ) | |
$ | (20,577 | ) | |
$ | (19,987 | ) |
Company
Contact:
Justine
O’Malley
Protara Therapeutics
Justine.OMalley@protaratx.com
646-817-2836
8
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Protara Therapeutics (NASDAQ:TARA)
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Protara Therapeutics (NASDAQ:TARA)
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