Protara Therapeutics, Inc. announced additional encouraging data from the Phase 1a dose-escalation component of its ongoing ADVANCED-1 clinical trial of TARA-002, the Company's investigational cell-based therapy, for the treatment of patients with high-grade non-muscle invasive bladder cancer (NMIBC). In addition, the study design for its ADVANCED-2 trial will be presented. The data will be featured during a poster session at the 24th Annual Meeting of the Society of Urologic Oncology (SUO) being held in Washington, D.C. from November 28, 2023 through December 1, 2023.

Study Results: TARA-002 was generally well tolerated at all three dose levels evaluated in the trial, and no dose limiting toxicities were observed. While a maximum tolerated dose was not determined, the Company has selected the 40KE1 dose for use in subsequent clinical trials. The majority of reported adverse events were Grades 1 and 2 across all dose levels, and treatment-related adverse events, as assessed by study investigators, were in line with typical responses to bacterial immunopotentiation, and included fatigue, headache, fever, and chills.

Approximately 65,000 patients are diagnosed with NMIBC in the U.S. each year. 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 Designation by the U.S. Food and Drug Administration. 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 and approved in Taiwan by Chugai Pharmaceutical Co. Ltd. Protara has successfully shown manufacturing comparability between TARA-002 and OK-432. Protara may, in some cases, use terms such as "predicts," "bel believes," "pot potential," "continue," "designed," "estimates," "ant anticipates," " plans," " plans," " plans, plans regarding the timing or outcome of existing or future clinical trials; statements related to expectations regarding interactions with the FDA; Protara's financial position; statements regarding the anticipated safety or efficacy of Protara's product candidates; and Protara's outlook for the remainder of the year.