Board Change • May 20
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 9 experienced directors. No highly experienced directors. Independent Director Jane Huang was the last director to join the board, commencing their role in 2021. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Announcement • May 15
Protara Therapeutics, Inc. Announces Positive Updated 12-Month Data Demonstrating Durable Responses in the Fully Enrolled BCG-Naïve Cohort of the Ongoing Phase 2 Advanced-2 Trial of TARA-002 in NMIBC Protara Therapeutics, Inc. announced positive updated 12-month data from Cohort A of the ongoing Phase 2 open-label ADVANCED-2 trial of TARA-002 in patients with carcinoma in situ or CIS (± Ta/T1) non-muscle invasive bladder cancer (NMIBC). These results in Bacillus Calmette-Guérin (BCG)-Naïve NMIBC patients will be featured during a poster session at the American Urological Association (AUA) 2026 Annual Meeting in Washington, D.C.
The BCG-Naïve dataset includes a total of 31 patients of whom 29 were evaluable for efficacy, with 27 patients evaluable at six months and 20 patients evaluable at 12 months, as of an April 5, 2026 data cutoff. The CR rate at any time in BCG-Naïve patients was 72.4% (21 of 29). The CR rate in BCG-Naïve patients was 66.7% (18 of 27) at six months and 55.0% (11 of 20) at 12 months. Among responders: The Kaplan-Meier estimated probability of maintaining a CR for six months was 73.1% (95% CI: 52.9, 93.4). 91.7% (11 of 12) maintained their CR from nine to 12 months. 66.7% (4 of 6) of re-induced patients converted to a CR at six months. The majority of treatment-related adverse events (TRAEs) were Grade 1 and transient, with no Grade 3 or greater TRAEs reported, as assessed by study investigators. No patients discontinued treatment due to TRAEs. The most commonly reported TRAEs were dysuria, fatigue, and hematuria. About ADVANCED-2: 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. Protara has completed enrollment of the BCG-Naïve cohort and expects to complete enrollment of the BCG-Unresponsive cohort in the second half of 2026. 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. 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. Announcement • Apr 29
Protara Therapeutics, Inc. 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 Protara Therapeutics, Inc. 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 the AUA 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. 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 A Streptococcus pyogenes as 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. 
