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TEXAS - Biodexa Pharmaceuticals PLC (NASDAQ:BDRX), a biopharmaceutical company focused on developing treatments for diseases with unmet medical needs, announced today that its collaboration partner, Emtora Biosciences, has been awarded an additional $3 million grant from the Cancer Prevention & Research Institute of Texas (CPRIT). The grant will support the Phase 3 program of eRapa, a drug candidate for familial adenomatous polyposis (FAP), a condition characterized by the growth of numerous polyps that can lead to colon cancer if untreated.
The latest funding increases CPRIT’s total contribution to the eRapa Phase 3 program to $20 million. The study, nearing its final implementation stage, is a double-blind placebo-controlled trial involving 168 patients across approximately 30 clinical sites in the United States and Europe. While analysts maintain a strong buy recommendation with an $18.17 price target, InvestingPro analysis reveals the company is currently burning through cash rapidly, with negative free cash flow of $15.36 million in the last twelve months. The U.S. part of the trial will be managed by LumaBridge in San Antonio, Texas, and the European component will be overseen by Precision for Medicine LLC.
Stephen Stamp, CEO and CFO of Biodexa, expressed gratitude to both Emtora for their efforts in securing the grant and to CPRIT for the additional funding. He highlighted that the grant would help expedite recruitment and potentially bring eRapa to patients sooner, offering an alternative to surgical resection of the gastrointestinal tract, currently the standard care for FAP patients.
eRapa, a proprietary oral tablet formulation of rapamycin, has shown promise in Phase 2 studies, demonstrating safety and tolerability, with a median 17% reduction in total polyp burden at 12 months. The upcoming Phase 3 study will use the dosage regimen that yielded an 89% non-progression rate in the second cohort of the previous phase.
The addressable market for eRapa in FAP, based on the lowest prevalence estimates, is valued at approximately $7.3 billion, considering the adult populations in the U.S. and Europe and the median annual cost of approved non-biologic orphan drugs in the U.S. With a current ratio of 1.75 and minimal debt-to-equity of 0.09, the company appears positioned to maintain operations while pursuing this market opportunity. Investors seeking deeper insights into Biodexa’s financial health and growth prospects can access over 10 additional exclusive ProTips and comprehensive financial metrics through InvestingPro.
CPRIT, since its inception, has awarded $2.9 billion in grants to Texas research institutions and organizations and has been instrumental in cancer prevention and early detection services across the state. Texas voters approved an additional $3 billion for CPRIT in 2019, reflecting the state’s commitment to cancer research and prevention.
This news is based on a press release statement from Biodexa Pharmaceuticals PLC.
In other recent news, Biodexa Pharmaceuticals PLC announced that it has adjusted the exercise price of its outstanding warrants to $0.31 per share, leading to the exercise of 200,433 warrants and the issuance of the same number of American depositary shares. This transaction is expected to close around May 19, 2025, with anticipated proceeds of approximately $62,000 before expenses. Additionally, Biodexa received Orphan Drug Designation from the European Commission for its drug eRapa, aimed at treating familial adenomatous polyposis (FAP), a condition with no current approved drug treatments. The company is preparing to launch a Phase 3 trial for eRapa, supported by a $17 million grant from the Cancer Prevention Research Institute of Texas and an $8.5 million company match. The trial will involve 168 patients across 30 clinical sites in the U.S. and Europe, with LumaBridge and Precision for Medicine overseeing the U.S. and European components, respectively. Biodexa also received Fast Track designation from the FDA for eRapa, which is designed to inhibit the mTOR pathway involved in cell growth. The company has engaged Precision for Medicine to manage the European segment of the trial, emphasizing its focus on advancing treatments for diseases with significant unmet medical needs.
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