Protara Therapeutics to Present Updated, Interim 12-Month Data from the Phase 2 ADVANCED-2 Trial of TARA-002 in BCG-Naïve NMIBC Patients at the American Urological Association Annual Meeting

NEW YORK, April 27, 2026 (GLOBE NEWSWIRE) -- Protara Therapeutics, Inc.(Nasdaq: TARA), a clinical-stage biotechnology company developing transformative therapies for the treatment of cancer and rare diseases, today announced that updated, interim data from Cohort A of the ongoing Phase 2 open-label ADVANCED-2 trial evaluating TARA-002 in patients with BCG-Naïve non-muscle invasive bladder cancer (NMIBC) will be featured during a poster session at the upcoming American Urological Association (AUA) 2026 Annual Meeting taking place from May 15, 2026 to May 18, 2026 in Washington, DC.

The presentation will include data from the abstract published on theAUA website, as well as updated safety and efficacy data as of an April 5, 2026 data cutoff from 31 enrolled BCG-Naïve patients. A second poster presentation will feature previously reported data from the ADVANCED-2 trial cohort of BCG-Unresponsive patients that was originally presented at the ASCO Genitourinary Cancers Symposium in February 2026.

ADVANCED-2 (NCT05951179) is a Phase 2 open-label trial assessing intravesical TARA-002 in NMIBC patients with carcinoma in situ or CIS (± Ta/T1) who are Bacillus Calmette-Guérin (BCG)-Unresponsive or BCG-Naïve. Trial subjects received an induction course, with or without a reinduction, of six weekly intravesical instillations of TARA-002, followed by a maintenance course of three weekly instillations every three months.

• Title:ADVANCED-2 (Cohort A): Preliminary Efficacy and Safety Data In BCG-Naïve Participants with High-Grade Non-Muscle Invasive Bladder Cancer

• Session:Bladder Cancer: Non-invasive I

• Presenter:Mark Tyson, M.D., MPH, Vice Chair for Research and a Professor in the Department of Urology with the Mayo Clinic in Phoenix, Arizona

• Session Date and Time:Friday, May 15, 2026, at 7:00 a.m. – 9:00 a.m.

• Title:ADVANCED-2 (Cohort B): Interim Efficacy and Safety Data in BCG-Unresponsive Participants with High-Grade Non-Muscle Invasive Bladder Cancer

• Session:Bladder Cancer: Non-invasive II

• Presenter:Timothy Clinton, M.D., Associate Surgeon with the Brigham and Women’s Hospital in Boston, Massachusetts

• Session Date and Time:Friday, May 15, 2026, at 3:30 p.m. – 5:30 p.m.

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, Breakthrough 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 AStreptococcus pyogenesas OK-432, a broad immunopotentiator marketed as Picibanil® in Japan by Chugai Pharmaceutical Co., Ltd. Protara has successfully shown manufacturing comparability between TARA-002 and OK-432.

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.

Protara is a clinical-stage biotechnology company committed to advancing transformative therapies for people with cancer and rare diseases. Protara’s portfolio includes its lead candidate, TARA-002, an investigational cell-based therapy in development for the treatment of non-muscle invasive bladder cancer (NMIBC) and lymphatic malformations (LMs). The Company is evaluating TARA-002 in an ongoing Phase 2 trial in NMIBC patients with carcinoma in situ (CIS) who are unresponsive or naïve to treatment with Bacillus Calmette-Guérin, as well as a Phase 2 trial in pediatric patients with LMs. Additionally, Protara is developing IV Choline Chloride, an investigational phospholipid substrate replacement for patients on parenteral support who are otherwise unable to meet their choline needs via oral or enteral routes. For more information, visitwww.protaratx.com.

Justine O'MalleyProtara TherapeuticsJustine.OMalley@protaratx.com646-817-2836