Protara Therapeutics Provides Regulatory Update for TARA-002 for the Treatment of Lymphatic Malformations Company to conduct additional clinical study to support submission of a Biologics License Application for TARA-002

Protara Therapeutics Provides Regulatory Update

for TARA-002 for the Treatment of Lymphatic Malformations

Company to conduct additional clinical study

to support submission of a Biologics License Application for TARA-002 in Lymphatic Malformations

NEW YORK, April 23, 2021 -- Protara Therapeutics, Inc. (Nasdaq:

TARA), a clinical stage company developing transformative therapies for the treatment of cancer and rare diseases with significant unmet

needs, today announced a path forward related to TARA-002 for the treatment of Lymphatic Malformations (LMs), which are rare malformations

of the lymphatic vasculature for which there is no U.S. Food and Drug Administration (FDA)-approved treatment. Based on feedback from

the FDA, the Company intends to complete confirmatory, large-scale, GMP manufacturing comparability in the second half of 2021 and subsequently

initiate a clinical study in pediatric LM patients pending alignment with FDA on study design.

"With the benefit of the recent FDA feedback, we will

work with the agency to align on a clinical study in pediatric LM patients, which, we believe, combined with the existing dataset for

OK-432 (the originator compound for TARA-002), which demonstrated treatment effect and support for strong safety profile in over 500 LM

patients, should provide a robust data package for this rare disease," said Jesse Shefferman, Chief Executive Officer of Protara

Therapeutics. "We have already begun preparation to initiate a clinical study in LMs and we look forward to continued collaboration

with FDA to achieve our goal of delivering the first approved medication for LMs to these patients and their physicians."

TARA-002 is derived from the same cell bank as OK-432, a broad

immunopotentiator approved in Japan and Taiwan for the treatment of LMs, where it is currently the standard of care. In 2020, Protara

successfully demonstrated initial manufacturing comparability between TARA-002 and the originator compound OK-432, which has been studied

in more than 500 patients in one of the largest Phase 2 trials ever conducted in LMs. TARA- 002 has been granted Rare Pediatric Disease

designation by the FDA for the treatment of LMs.

About Lymphatic Malformations

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

About Protara Therapeutics

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

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"continue," "designed," "estimates," "anticipates," "expects," "plans,"

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for its product candidates and related interactions with the FDA. Because such statements are subject to risks and uncertainties, actual

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nature of the forward-looking statements include 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

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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; 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

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Protara Therapeutics