Recent Updates
Recently added Catalysts
TARA

Protara Therapeutics Announces Fourth Quarter and Full Year 2021 Financial Results and Business Overview - Phase 1 Study of TARA-002 in Patients with Non-Muscle Invasive Bladder Cancer Under Way - - Strong Cash Position

Key Takeaway: Protara Therapeutics Announces Fourth Quarter and Full Year 2021 Financial Results and Business Overview - Phase 1 Study of TARA-002 in Patients with Non-Muscle Invasive Bladder Cancer Under Way - - Strong Cash Position of $130.7M as of December 31, 2021 Expected to Fund Ope

Full Press Release Details

Protara Therapeutics Announces Fourth
Quarter and Full Year 2021 Financial Results and Business Overview
- Phase 1 Study of TARA-002 in Patients
with Non-Muscle Invasive Bladder Cancer Under Way -
- Strong Cash Position of $130.7M as of
December 31, 2021 Expected to Fund Operations into Mid-2024 -
NEW YORK, Mar 9, 2022 - Protara
Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage company developing transformative therapies for the treatment of cancer and rare
diseases, today announced financial results for the fourth quarter and year ended December 31, 2021 and provided a business update.
"Following a productive 2021, we are well poised
to advance our pipeline in 2022, in particular, we are excited to have commenced our Phase 1 study of TARA-002 in non-muscle invasive
bladder cancer (NMIBC), a significant step forward in our mission to bring a new immunotherapy to this patient population," said
Jesse Shefferman, Chief Executive Officer of Protara Therapeutics. "Discussions with the U.S. Food and Drug Administration (FDA)
remain ongoing on the design of a clinical trial of TARA-002 in patients with lymphatic malformations (LMs), a rare pediatric indication
for which there are currently no U.S. FDA-approved therapies. In addition, we continue to assess potential future indications and combinations
Mr. Shefferman added, "Supported by a strong
balance sheet, which includes ample runway to support our planned operations into mid-2024, we remain steadfast in our commitment to bringing
meaningful new therapeutic options to pressing areas of high unmet need."
IV Choline Chloride in Intestinal Failure Associated
Liver Disease (IFALD)
Fourth Quarter and Full Year 2021 Financial Results
TARA-002 is an investigational cell therapy in development
for the treatment of NMIBC and 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 and Taiwan by Chugai Pharmaceutical Co., Ltd. Protara has successfully demonstrated 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 strong immune cascade. Neutrophils, monocytes
and lymphocytes infiltrate the abnormal cells and various cytokines, including interleukins IL-6, IL-8, IL-12, interferon (IFN)-gamma,
tumor necrosis factor (TNF)-alpha, and vascular endothelial growth factor (VEGF) are secreted by immune cells to induce a strong local
inflammatory reaction and destroy the abnormal cells.
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 3 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 and Intestinal Failure-associated
Liver Disease (IFALD)
IV Choline Chloride is an investigational, intravenous
(IV) phospholipid substrate replacement therapy initially in development for patients receiving parenteral nutrition (PN) who have IFALD.
Choline is a known important substrate for phospholipids that are critical for healthy liver function. Because PN patients cannot sufficiently
absorb adequate levels of choline and no available PN formulations contain sufficient amounts of choline to correct this deficiency, PN
patients often experience a prolonged progression to hepatic failure and death, with the only known intervention being a dual small bowel/liver
transplant. If approved, IV Choline Chloride would be the first approved therapy for IFALD. It has been granted Orphan Drug Designations
(ODDs) by the FDA for the treatment of IFALD and the prevention of choline deficiency in PN patients.
About Protara Therapeutics, Inc.
Protara is committed to identifying and advancing
transformative therapies for people with cancer and rare diseases with limited treatment options. Protara's portfolio includes its
lead program, TARA-002, an investigational cell-based therapy being developed for the treatment of non-muscle invasive bladder cancer
and lymphatic malformations, and IV Choline Chloride, an investigational phospholipid substrate replacement therapy for the treatment
of intestinal failure-associated liver disease. For more information, visit www.protaratx.com.
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, including potential alignment with the FDA on clinical trial design
for TARA-002 in pediatric LM patients; Protara's financial footing; 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; the impact of the COVID-19
pandemic on Protara's business and the global economy as well as the impact on Protara's contract research organizations,
study sites or other clinical partners; 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; the loss of key members
of management; the impact of general U.S. and foreign, economic, industry, market, regulatory or political 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
PROTARA THERAPEUTICS, INC.
CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share data)
As of
December 31, 2021 December 31, 2020
Assets
Current assets:
Cash and cash equivalents $ 35,724 $ 168,598
Restricted cash - 50
Marketable debt securities 55,505 -
Prepaid expenses and other current assets 1,883 787
Total current assets 93,112 169,435
Restricted cash, non-current 745 745
Marketable debt securities, non-current 39,467 -
Property and equipment, net 1,719 1,240
Operating lease right-of-use asset 7,171 1,060
Goodwill 29,517 29,517
Other assets 865 1,160
Total assets $ 172,596 $ 203,157
Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable $ 954 $ 914
Accrued expenses 2,489 1,913
Operating lease liability, current 855 88
Total current liabilities 4,298 2,915
Operating lease liability, non-current 6,384 999
Total liabilities 10,682 3,914
Commitments and Contingencies (Note 11)
Stockholders' Equity
Preferred stock, $0.001 par value, authorized 10,000,000 shares:
Series 1 convertible preferred stock, 8,028 shares authorized at December 31, 2021 and 2020, respectively 8,027 shares issued and outstanding as of December 31, 2021 and 2020, respectively. - -
Common stock, $0.001 par value, authorized 100,000,000 shares:
Common stock, 11,235,731 and 11,211,840 shares issued and outstanding as of December 31, 2021 and 2020, respectively. 11 11
Additional paid in capital 256,126 245,992
Accumulated deficit (94,012 ) (46,760 )
Accumulated other comprehensive income (loss) (211 ) -
Total stockholders' equity 161,914 199,243
Total Liabilities and Stockholders' Equity $ 172,596 $ 203,157
PROTARA THERAPEUTICS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(in thousands, except share and per share data)
For the Years Ended December 31,
2021 2020
Operating expenses:
Research and development $ 21,088 $ 11,982
General and administrative 26,401 22,462
Total operating expenses 47,489 34,444
Loss from operations (47,489 ) (34,444 )
Other income (expense), net
Interest and investment income 237 500
Interest expense - (34 )
Other income (expense), net 237 466
Net loss (47,252 ) (33,978 )
Net loss per share attributable to common stockholders, basic and diluted $ (4.21 ) $ (4.70 )
Weighted average shares outstanding, basic and diluted 11,232,576 7,233,913
Other comprehensive income (loss):
Net unrealized (loss) gain on marketable debt securities (211 ) -
Other comprehensive income (loss) (211 ) -
Comprehensive Loss $ (47,463 ) $ (33,978 )
Protara Therapeutics
Last updated: Mar 9, 2022