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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 202

Key Takeaway: Therapeutics Announces Second Quarter 2024 Financial Results and Provides a Business Update 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 provi

Full Press Release Details

Therapeutics Announces Second Quarter 2024 Financial Results and
Provides a Business Update
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.
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."
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."
Progress and Highlights
Choline Chloride for Patients on PN
Quarter 2024 Financial Results
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.
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.
Non-Muscle Invasive Bladder Cancer (NMIBC)
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.
Lymphatic Malformations (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.
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.
Protara Therapeutics, Inc.
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 na ve to treatment with Bacillus Calmette-Gu rin (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.
Klinische Einheit, or KE, is a German term indicating a specified weight of dried cells in a vial.
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.
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
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 )
Protara Therapeutics
Last updated: Aug 6, 2024