Full Press Release Details
Therapeutics Announces Second Quarter 2023 Financial Results and Business Update
YORK, August 3, 2023 - 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, 2023
and provided a business update.
the positive preliminary data from the dose escalation portion of the ADVANCED-1 trial of TARA-002 in patients with high-grade non-muscle
invasive bladder cancer (NMIBC), we have seen rapid enrollment in the expansion portion of the trial and anticipate sharing preliminary
results in the first half of 2024," said Jesse Shefferman, Chief Executive Officer of Protara Therapeutics. "We are building
on this momentum, and plan to initiate two additional trials for TARA-002 later this year while continuing to maintain a disciplined
approach to investments. We are in a solid financial position with cash runway into 2025."
in Lymphatic Malformations (LMs)
Choline Chloride Program
Quarter 2023 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 and approved in Taiwan
by Chugai Pharmaceutical Co., Ltd. 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 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, and tumor necrosis factor (TNF)-alpha are secreted by immune cells to induce
a strong inflammatory reaction and destroy the abnormal cells.
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.
Choline Chloride is an investigational, intravenous (IV) phospholipid substrate replacement therapy initially in development for patients
receiving parenteral nutrition (PN). 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. IV Choline Chloride has been granted Orphan Drug Designation by the FDA
for the prevention of choline deficiency in PN patients.
Protara Therapeutics, Inc.
is committed to 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 for patients dependent on parenteral
nutrition. 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; the loss of key members of management; 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
Consolidated Balance Sheets
thousands, except share and per share data)
| As of | ||||||||
| June 30, 2023 | December 31, 2022 | |||||||
| (unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 33,978 | $ | 24,127 | ||||
| Marketable debt securities | 46,382 | 60,243 | ||||||
| Prepaid expenses and other current assets | 3,905 | 1,776 | ||||||
| Total current assets | 84,265 | 86,146 | ||||||
| Restricted cash, non-current | 745 | 745 | ||||||
| Marketable debt securities, non-current | - | 17,886 | ||||||
| Property and equipment, net | 1,443 | 1,592 | ||||||
| Operating lease right-of-use asset | 5,807 | 6,277 | ||||||
| Other assets | 2,881 | 644 | ||||||
| Total assets | $ | 95,141 | $ | 113,290 | ||||
| Liabilities and Stockholders' Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 1,852 | $ | 1,586 | ||||
| Accrued expenses | 2,131 | 3,237 | ||||||
| Operating lease liability | 949 | 917 | ||||||
| Total current liabilities | 4,932 | 5,740 | ||||||
| Operating lease liability, non-current | 4,984 | 5,467 | ||||||
| Total liabilities | 9,916 | 11,207 | ||||||
| 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, 2023 and December 31, 2022, 8,027 shares issued and outstanding as of June 30, 2023 and December 31, 2022. | - | - | ||||||
| Common stock, $0.001 par value, authorized 100,000,000 shares: Common stock, 11,307,962 and 11,267,389 shares issued and outstanding as of June 30, 2023 and December 31, 2022, respectively. | 11 | 11 | ||||||
| Additional paid-in capital | 265,853 | 262,724 | ||||||
| Accumulated deficit | (180,303 | ) | (159,964 | ) | ||||
| Accumulated other comprehensive income (loss) | (336 | ) | (688 | ) | ||||
| Total stockholders' equity | 85,225 | 102,083 | ||||||
| Total liabilities and stockholders' equity | $ | 95,141 | $ | 113,290 |
THERAPEUTICS, INC. AND SUBSIDIARIES
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, | |||||||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 7,247 | $ | 3,084 | $ | 12,390 | $ | 8,353 | ||||||||
| General and administrative | 4,893 | 5,621 | 9,482 | 11,226 | ||||||||||||
| Total operating expenses | 12,140 | 8,705 | 21,872 | 19,579 | ||||||||||||
| Loss from operations | (12,140 | ) | (8,705 | ) | (21,872 | ) | (19,579 | ) | ||||||||
| Other income (expense), net: | ||||||||||||||||
| Interest and investment income | 846 | 166 | 1,533 | 285 | ||||||||||||
| Other income (expense), net | 846 | 166 | 1,533 | 285 | ||||||||||||
| Net loss | $ | (11,294 | ) | $ | (8,539 | ) | $ | (20,339 | ) | $ | (19,294 | ) | ||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (1.00 | ) | $ | (0.76 | ) | $ | (1.80 | ) | $ | (1.71 | ) | ||||
| Weighted-average shares outstanding, basic and diluted | 11,307,842 | 11,255,215 | 11,305,867 | 11,252,686 | ||||||||||||
| Other comprehensive income (loss): | ||||||||||||||||
| Net unrealized (loss) gain on marketable debt securities | 133 | (180 | ) | 352 | (911 | ) | ||||||||||
| Other comprehensive income (loss) | 133 | (180 | ) | 352 | (911 | ) | ||||||||||
| Comprehensive Loss | $ | (11,161 | ) | $ | (8,719 | ) | $ | (19,987 | ) | $ | (20,205 | ) |
Protara Therapeutics