On November 6, 2026 Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage biotechnology company developing transformative therapies for the treatment of cancer and rare diseases, reported financial results for the third quarter ended September 30, 2026 and provided a business update.

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"Protara continues to deliver across our late-stage portfolio, advancing each of our programs toward its next key clinical and regulatory milestone. This steady progress positions us to close out the year with strong momentum and sets the stage for an impactful 2027," said Jesse Shefferman, Chief Executive Officer at Protara Therapeutics. "TARA-002 has the potential to be a preferred treatment option for patients with non-muscle invasive bladder cancer (NMIBC), and we are on track to complete enrollment of the BCG-Unresponsive registrational cohort by year-end, a key step toward bringing this therapy to patients. Following quarter end, we also entered into a purchase agreement for TARA-002 manufacturing-related assets from Novex Innovations, LLC, our clinical supply partner since 2019. We are excited to bring this manufacturing capability in-house as we advance our late-stage clinical trials and prepare to launch TARA-002 in lymphatic malformations (LMs) and NMIBC."

Mr. Shefferman added, "Turning to our rare disease pipeline, we now expect to complete enrollment of the registrational STARBORN-1 trial of TARA-002 in LMs early in the first quarter of 2027. Supported by the program’s Breakthrough Therapy designation, we remain on track to initiate our rolling Biologics License Application (BLA) submission in the second half of 2027. We also completed enrollment of the Phase 2b portion of the THRIVE-3 trial of IV Choline Chloride and look forward to reporting interim results by the end of this year."

Recent Progress and Highlights

TARA-002 in NMIBC

● The Company expects to complete enrollment of the BCG-Unresponsive cohort of the ADVANCED-2 trial in the fourth quarter of 2026.

● During the third quarter of 2026, the Company announced its intent to redesign the ongoing ADVANCED-3 trial. The redesigned ADVANCED-3 trial is expected to be a multi-cohort, open-label trial evaluating the efficacy and safety of intravesical TARA-002 in BCG-Naïve and BCG-Exposed CIS (± Ta/T1) and high-grade, high-risk (HG-HR) papillary (Ta/T1) patients across BCG exposures. The trial is intended to generate a broad body of clinical evidence across HG-HR NMIBC patients. The Company believes this positions TARA-002 to benefit from the recent approach from the U.S. Food and Drug Administration (FDA) 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.

TARA-002 in LMs

● The Company now expects to complete enrollment in the STARBORN-1 trial early in the first quarter of 2027.

● Based on engagement with the FDA under the Breakthrough Therapy designation, the Company expects to initiate a rolling BLA submission for TARA-002 in the second half of 2027.

IV Choline Chloride for Patients on Parenteral Support (PS)

● Protara completed enrollment of the Phase 2b portion of the THRIVE-3 trial evaluating IV Choline Chloride in patients on PS. THRIVE-3 (NCT06910943) is a registrational Phase 2b/3 clinical trial evaluating the efficacy and safety of IV Choline Chloride in adolescent and adult patients with intestinal failure who are dependent on PS and have choline deficiency. The Phase 2b portion of the THRIVE-3 trial is an open-label dose confirmation, which enrolled 24 patients.

● The Company remains on track to report interim results from the Phase 2b portion of THRIVE-3 in the fourth quarter of 2026.

Corporate Update

● On November 4, 2026, Protara 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. Novex has manufactured TARA-002 for Protara since 2019 under a Manufacturing Services Agreement. The Company completed the acquisition to bring manufacturing in-house and secure dedicated manufacturing capacity ahead of a potential commercial launch. The transaction included an assembled workforce, inventory, intellectual property, contracts, equipment, permits, regulatory documentation and records. The Company also entered into certain ancillary agreements, including a transition services agreement, and a lease for a research and manufacturing facility.

Third Quarter 2026 Financial Results

● As of September 30, 2026, unrestricted cash and cash equivalents and marketable debt securities totaled $143.1 million. The Company expects its cash and cash equivalents and marketable debt securities will be sufficient to fund its planned operations and milestones into 2028.

● Research and development expenses for the third quarter of 2026 increased to $16.8 million from $9.6 million for the prior year period. This increase was primarily due 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 for the third quarter of 2026 increased to $6.3 million from $5.2 million for the prior-year period. The increase was primarily due to personnel-related expenses of $0.6 million and other general and administrative expenses of $0.6 million.

● For the third quarter of 2026, Protara incurred a net loss of $21.7 million, or $0.35 per share, compared with a net loss of $13.3 million, or $0.31 per share, for the prior-year period.

About TARA-002

TARA-002 is an investigational cell therapy in development for the treatment of NMIBC and of LMs, for which it has been granted Rare Pediatric Disease, Orphan Drug, Breakthrough Therapy and Fast Track designations by the FDA. TARA-002 is a first-in-class TLR2/NOD2 agonist and novel immunopotentiator derived from inactivated Streptococcus pyogenes with a mechanism of action that includes the activation of innate and adaptive immune pathways within the bladder wall. When TARA-002 is administered, it is hypothesized that innate and adaptive immune cells within the cyst or tumor are activated and produce a pro-inflammatory response with the release of cytokines such as tumor necrosis factor (TNF)-alpha, interferon (IFN)-gamma, IL-6, IL-10 and IL-12. TARA-002 also directly kills tumor cells and triggers a host immune response by inducing immunogenic cell death, which further enhances the antitumor immune response.

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 by Chugai Pharmaceutical Co., Ltd

About Non-Muscle Invasive Bladder Cancer

Bladder cancer is the sixth most common cancer in the United States, with non-muscle invasive bladder cancer (NMIBC) representing approximately 80% of bladder cancer diagnoses, or approximately 65,000 patients in the U.S. 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. Patients suffering from high-grade, high-risk NMIBC face high rates of disease recurrence and are potentially subject to full removal of the bladder (cystectomy).

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. Protara’s focus is on macrocystic and mixed cystic LMs, for which there are no currently approved therapies. More than 50% of LMs are detected at birth and 90% are diagnosed before the age of three 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 and lymphatics; recurrent infection; and cosmetic and other functional disabilities. TARA-002 has been granted Rare Pediatric Disease, Orphan Drug, Breakthrough Therapy and Fast Track designations by the FDA for the treatment of LMs.

About IV Choline Chloride for Patients on Parenteral Support

IV Choline Chloride is an investigational, intravenous phospholipid substrate replacement therapy in development for patients receiving parenteral support (PS). Choline is an important substrate for phospholipids that are critical for healthy liver function and play an important role in modulating gene expression, cell membrane signaling, brain development and neurotransmission, muscle function and bone health. There are currently no available PS formulations containing choline. IV Choline Chloride has the potential to become the first FDA approved IV choline formulation for PS patients. It has been granted Orphan Drug designation by the FDA for the prevention and/or treatment of choline deficiency in patients on long-term parenteral nutrition and has been granted Fast Track designation as a source of choline when oral or enteral nutrition is not possible, insufficient or contraindicated. The U.S. Patent and Trademark Office has issued Protara a U.S. patent claiming a choline composition and a U.S. patent claiming a method of treating choline deficiency with a choline composition, each with a term expiring in 2041.

(Press release, Protara Therapeutics, NOV 6, 2026, View Source [SID1234674396])