Protara Therapeutics Announces Third Quarter 2021 Financial Results and Business Overview - TARA-002 Confirmatory Large-Scale GMP Comparability Complete - - U.S. FDA Cleared the Company's IND Application for TARA-002 in

Therapeutics Announces Third Quarter 2021 Financial Results and Business Overview

TARA-002 Confirmatory Large-Scale GMP Comparability Complete -

U.S. FDA Cleared the Company's IND Application for TARA-002 in NMIBC; Company Plans to Initiate Phase 1 Clinical Trial by Year-End

Strong Cash, Cash Equivalents, and Marketable Debt Securities of $138.4M as of September 30, 2021 -

YORK, November 4, 2021 -- 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 third quarter ended September 30,

2021 and provided a business update.

have made significant progress advancing our TARA-002 clinical programs in the third quarter, most notably the completion of our confirmatory

large-scale GMP comparability work and the clearance of our Investigational New Drug (IND) application by the U.S. Food and Drug Administration

(FDA) for our non-muscle invasive bladder cancer (NMIBC) clinical development program. NMIBC is one of the most recurrent and difficult

to treat cancers with limited treatment options, and we look forward to initiating our Phase 1 clinical trial of TARA-002 in adults with

high-grade NMIBC by the end of the year," said Jesse Shefferman, Chief Executive Officer of Protara Therapeutics. "We are

also working to align with the FDA 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."

Highlights and Upcoming Milestones

Choline Chloride in Intestinal Failure Associated Liver Disease (IFALD)

Quarter 2021 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-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.

Non-Muscle Invasive Bladder Cancer

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

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 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,

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.

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 anticipated 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; 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; 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.

CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

thousands, except share and per share data)

Protara Therapeutics