Full Press Release Details
Therapeutics Announces Second Quarter 2022 Financial Results and Business Overview
Enrollment Progressing in Phase 1 ADVANCED-1 Study of TARA-002 for the Treatment of Non-Muscle Invasive Bladder Cancer
Strong Cash, Cash Equivalents and Investments Position of $112.8M as of June 30, 2022 Expected to Fund Operations into Mid-2024 -
YORK, August 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 second quarter ended June 30, 2022
and provided a business update.
are pleased with the continued progress of the ADVANCED-1 study of TARA-002 in non-muscle invasive bladder cancer (NMIBC)," said
Jesse Shefferman, Chief Executive Officer of Protara Therapeutics. "We remain committed to unlocking the full potential of TARA-002
in this underserved patient population, and look forward to sharing our progress in the coming quarters. In parallel, we are keenly focused
on finalizing the design of a clinical trial of TARA-002 in patients with lymphatic malformations (LMs), a rare pediatric indication
for which we believe TARA-002 has the potential to serve as a much-needed intervention."
Choline Chloride in Intestinal Failure Associated Liver Disease (IFALD)
Quarter 2022 Financial Results
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.
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-2, IL-6, IL-8, IL-10, IL-12, interferon (IFN)-gamma, tumor necrosis factor (TNF)-alpha, granulocyte colony-stimulating factor, and
granulocyte-macrophage colony-stimulating factor are secreted by immune cells to induce a strong local inflammatory reaction and destroy
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 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.
IV Choline Chloride and Intestinal Failure-associated Liver Disease (IFALD)
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
Protara Therapeutics, Inc.
is committed to identifying and advancing transformative therapies for people with cancer and rare diseases. 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.
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 law.
Condensed Consolidated Balance Sheets
thousands, except share and per share data)
| As of | ||||||||
| June 30, 2022 | December 31, 2021 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 33,815 | $ | 35,724 | ||||
| Marketable debt securities | 64,643 | 55,505 | ||||||
| Prepaid expenses and other current assets | 2,633 | 1,883 | ||||||
| Total current assets | 101,091 | 93,112 | ||||||
| Restricted cash, non-current | 745 | 745 | ||||||
| Marketable debt securities, non-current | 14,349 | 39,467 | ||||||
| Property and equipment, net | 1,640 | 1,719 | ||||||
| Operating lease right-of-use asset | 6,731 | 7,171 | ||||||
| Goodwill | 29,517 | 29,517 | ||||||
| Other assets | 811 | 865 | ||||||
| Total assets | $ | 154,884 | $ | 172,596 | ||||
| Liabilities and Stockholders' Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 392 | $ | 954 | ||||
| Accrued expenses | 2,216 | 2,489 | ||||||
| Operating lease liability | 885 | 855 | ||||||
| Total current liabilities | 3,493 | 4,298 | ||||||
| Operating lease liability, non-current | 5,933 | 6,384 | ||||||
| Total liabilities | 9,426 | 10,682 | ||||||
| Commitments and contingencies (Note 8) | ||||||||
| 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, 2022 and December 31, 2021, 8,027 shares issued and outstanding as of June 30, 2022 and December 31, 2021. | - | - | ||||||
| Common stock, $0.001 par value, authorized 100,000,000 shares: Common stock, 11,257,177 and 11,235,731 shares issued and outstanding as of June 30, 2022 and December 31, 2021, respectively. | 11 | 11 | ||||||
| Additional paid-in capital | 259,875 | 256,126 | ||||||
| Accumulated deficit | (113,306 | ) | (94,012 | ) | ||||
| Accumulated other comprehensive income (loss) | (1,122 | ) | (211 | ) | ||||
| Total stockholders' equity | 145,458 | 161,914 | ||||||
| Total liabilities and stockholders' equity | $ | 154,884 | $ | 172,596 |
PROTARA THERAPEUTICS, INC.
Condensed Consolidated Statements of Operations and Comprehensive Loss
thousands, except share and per share data)
| For the Three months Ended June 30, | For the Six months Ended June 30, | |||||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 3,084 | $ | 5,887 | $ | 8,353 | $ | 12,927 | ||||||||
| General and administrative | 5,621 | 6,905 | 11,226 | 13,445 | ||||||||||||
| Total operating expenses | 8,705 | 12,792 | 19,579 | 26,372 | ||||||||||||
| Loss from operations | (8,705 | ) | (12,792 | ) | (19,579 | ) | (26,372 | ) | ||||||||
| Other income (expense), net: | ||||||||||||||||
| Interest and investment income | 166 | 10 | 285 | 125 | ||||||||||||
| Other income (expense), net | 166 | 10 | 285 | 125 | ||||||||||||
| Net loss | (8,539 | ) | (12,782 | ) | (19,294 | ) | (26,247 | ) | ||||||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.80 | ) | $ | (1.14 | ) | $ | (1.71 | ) | $ | (2.34 | ) | ||||
| Weighted-average shares outstanding, basic and diluted | 11,255,215 | 11,232,010 | 11,252,686 | 11,229,484 | ||||||||||||
| Other comprehensive income (loss): | ||||||||||||||||
| Net unrealized (loss) gain on marketable debt securities | (180 | ) | 63 | (911 | ) | (101 | ) | |||||||||
| Other comprehensive income (loss) | (180 | ) | 63 | (911 | ) | (101 | ) | |||||||||
| Comprehensive Loss | $ | (8,719 | ) | $ | (12,719 | ) | $ | (20,205 | ) | $ | (26,348 | ) |
Protara Therapeutics