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NEW YORK - Protara Therapeutics, Inc. (NASDAQ:TARA), a clinical-stage biotechnology company valued at approximately $138 million, will present new data from its Phase 2 ADVANCED-2 trial of TARA-002, an investigational cell therapy for patients with non-muscle invasive bladder cancer (NMIBC), at the American Urological Association (AUA) 2025 Annual Meeting in Las Vegas from April 26 to April 29. According to InvestingPro data, the company maintains a strong balance sheet with more cash than debt, though it's currently experiencing rapid cash burn as it advances its clinical programs.
The presentations will include updated safety and efficacy data from the trial, specifically for patients who have reached the 12-month evaluation timepoint. TARA-002 is being assessed in about 130 NMIBC patients, including a cohort unresponsive to Bacillus Calmette-Guérin (BCG) treatment, designed to be registrational following the U.S. Food and Drug Administration's draft guidance for the industry on BCG-unresponsive NMIBC. With the company's next earnings report due on May 1, investors following InvestingPro analysis note that two analysts have recently revised their earnings expectations upward for the upcoming period.
The interim analysis abstract is now available on the AUA website and will be discussed during an interactive poster session on Saturday, April 26. Additional details will be shared in a clinical trials session on Monday, April 28.
TARA-002, derived from the same master cell bank as OK-432 (Picibanil®), is hypothesized to activate immune cells, leading to a pro-inflammatory response and direct tumor cell killing. The therapy has been granted Rare Pediatric Disease Designation by the FDA for the treatment of lymphatic malformations (LMs).
NMIBC is the 6th most common cancer in the United States, with approximately 65,000 patients diagnosed annually. TARA-002 aims to provide a new treatment option for those unresponsive or naïve to BCG.
The company is also developing IV Choline Chloride for patients on parenteral nutrition who cannot meet choline needs orally or enterally.
This news is based on a press release statement from Protara Therapeutics.
In other recent news, Protara Therapeutics reported a narrower-than-expected loss for the fourth quarter of 2024, with an adjusted loss of $0.48 per share, surpassing analyst expectations of a $0.59 per share loss. The company, still in the clinical development stage, did not report any revenue for the quarter. Research and development expenses increased to $9.5 million, reflecting ongoing clinical trials for its lead programs, TARA-002 and IV Choline Chloride. Protara ended the year with a solid cash reserve of $170.3 million, supported by a $100 million public offering in December, which is expected to fund operations into 2027.
Additionally, Cantor Fitzgerald initiated coverage of Protara with an Overweight rating, highlighting the potential of its pipeline, particularly IV Choline, which could achieve $400-500 million in peak sales. H.C. Wainwright maintained its Buy rating with a $23 target, emphasizing the promising results of TARA-002 in non-muscle invasive bladder cancer trials. Protara plans to begin its pivotal THRIVE-3 trial for IV Choline Chloride in 2025, aiming to address choline deficiency in patients dependent on parenteral support. These developments underscore Protara's commitment to advancing its clinical programs and delivering transformative therapies.
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