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Protara Q3 Loss Widens; Completes THRIVE-3 Dosing Cohort, Buys TARA-002 Manufacturing Assets

Protara’s third-quarter 2026 net loss widened to $21.7 million as research and development expenses rose to $16.8 million. Cash, cash equivalents and investments were about $143 million as of September 30, 2026, which the company said should fund planned operations into 2028.

Protara Therapeutics, Inc. (TARA) reported a third-quarter 2026 net loss of $21.7 million, compared with $13.3 million a year earlier, as research and development expenses rose to $16.8 million from $9.6 million. The company, a clinical-stage biotechnology company developing therapies for cancer and rare diseases, completed enrollment of the Phase 2b dosing cohort of THRIVE-3, a registrational trial of IV Choline Chloride in patients dependent on long-term parenteral support, and said it remains on track to report interim results by year-end 2026.

The company also entered into an asset purchase agreement with Novex Innovations, LLC for TARA-002 manufacturing-related assets for an aggregate purchase price of $8.75 million. The deal, dated November 4, 2026, after the third-quarter close, was intended to bring manufacturing in-house and secure dedicated capacity ahead of a potential commercial launch. The transaction included an assembled workforce, inventory, intellectual property, contracts, equipment, permits and regulatory documentation, along with a transition services agreement and a lease for a research and manufacturing facility.

Unrestricted cash, cash equivalents and marketable debt securities totaled $143.1 million as of September 30, 2026, down from about $162 million as of June 30, 2026. Protara said the balance is expected to be sufficient to fund planned operations and milestones into 2028.

For the third quarter of 2026, Protara incurred a net loss of $21.7 million, or $0.35 a share, compared with a net loss of $13.3 million, or $0.31 a share, a year earlier. Research and development expenses rose to $16.8 million from $9.6 million in the prior-year period. The company attributed the increase primarily to higher direct costs associated with ongoing clinical trials of $4.4 million, personnel-related expenses of $2.0 million and non-program-specific research and development expenses, primarily related to TARA-002 chemistry, manufacturing and controls, of $0.8 million. General and administrative expenses increased to $6.3 million from $5.2 million, primarily due to personnel-related expenses of $0.6 million and other general and administrative expenses of $0.6 million.

TARA-002 is an investigational cell therapy in development for non-muscle invasive bladder cancer (NMIBC) and lymphatic malformations (LMs). The company expects to complete enrollment of the BCG-Unresponsive registrational cohort of the ADVANCED-2 trial in NMIBC by year-end 2026. During the third quarter it announced its intent to redesign the ongoing ADVANCED-3 trial as a multi-cohort, open-label study of intravesical TARA-002 in BCG-Naïve and BCG-Exposed CIS (± Ta/T1) and high-grade, high-risk papillary (Ta/T1) patients across BCG exposures. Protara said the design is intended to generate a broad body of clinical evidence across HG-HR NMIBC patients and that it believes the approach positions TARA-002 to benefit from a recent FDA approach to expand the label of a previously approved product for BCG-Unresponsive CIS NMIBC to include HG-HR BCG-Unresponsive papillary disease based on a single-arm trial.

In lymphatic malformations, the company now expects to complete enrollment of the registrational STARBORN-1 trial early in the first quarter of 2027, later than the prior expectation of an update and completion of enrollment in the fourth quarter of 2026. Based on engagement with the FDA under Breakthrough Therapy designation, Protara expects to initiate a rolling Biologics License Application submission for TARA-002 in the second half of 2027.

THRIVE-3 (NCT06910943) is a registrational Phase 2b/3 trial evaluating IV Choline Chloride in adolescent and adult patients with intestinal failure who are dependent on parenteral support and have choline deficiency. The Phase 2b portion is an open-label dose confirmation that enrolled 24 patients.

Chief Executive Officer Jesse Shefferman said Protara continues to deliver across its late-stage portfolio and that the company is on track to complete enrollment of the BCG-Unresponsive registrational cohort by year-end, a key step toward bringing TARA-002 to patients. He said the company is excited to bring manufacturing capability in-house as it advances late-stage clinical trials and prepares to launch TARA-002 in LMs and NMIBC.

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