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LONDON - Biodexa Pharmaceuticals PLC (NASDAQ:BDRX), a micro-cap biotech currently valued at $2.5 million, announced Monday it has filed a Clinical Trial Application (CTA) with the European Medicines Agency for its Phase 3 Serenta trial in patients with familial adenomatous polyposis (FAP). According to InvestingPro data, the company maintains a healthy balance sheet with more cash than debt, though it faces significant cash burn challenges.
The application, if approved, would allow the company to conduct the trial at clinical sites in Denmark, Germany, Netherlands and Spain, with Italy expected to be added later. The CTA approval process has a 106-day timeline, with European sites expected to begin enrolling patients in the fourth quarter of 2025. With a current ratio of 1.75, the company appears positioned to meet its near-term obligations, though InvestingPro analysis indicates rapid cash consumption that could affect long-term trial funding.
FAP is a rare inherited disorder characterized by the development of hundreds to thousands of colorectal polyps and a near-100% lifetime risk of colorectal cancer if left untreated. Current treatment options are limited to surgical resection of the colon and/or rectum.
The Serenta trial is a randomized, double-blind, placebo-controlled Phase 3 study designed to evaluate the safety and efficacy of eRapa, a proprietary oral formulation of rapamycin (sirolimus), in FAP patients. The first U.S. site is already open and screening participants.
The company’s eRapa program previously received Fast Track Designation from the FDA and Orphan Drug designation in Europe. The Cancer Prevention and Research Institute of Texas has provided $20 million in grant funding to support the program.
According to information provided in the press release statement, FAP has a reported prevalence of one in 5,000 to 10,000 in the U.S. and one in 11,300 to 37,600 in Europe. While the stock has experienced significant volatility, trading 97% below its 52-week high, InvestingPro analysis suggests the company may be undervalued at current levels. Subscribers can access 11 additional ProTips and comprehensive financial metrics to better evaluate the investment opportunity.
In other recent news, Biodexa Pharmaceuticals has enrolled the first patient in a Phase 2a clinical trial for its type 1 diabetes drug, Tolimidone. This trial, conducted by the University of Alberta, aims to assess the drug’s impact on C-peptide levels and HbA1c over three months. Meanwhile, Biodexa has announced a change in the nominal value of its ordinary shares, reducing it from £0.00005 to £0.000001 per share, following shareholder approval. Additionally, shareholders have approved all resolutions at a recent general meeting, including the authority for directors to allot ordinary shares on a non-pre-emptive basis.
In another development, Biodexa has secured an additional $3 million grant from the Cancer Prevention & Research Institute of Texas for its eRapa drug trial. This funding will aid the Phase 3 program for familial adenomatous polyposis, bringing CPRIT’s total contribution to $20 million. Furthermore, Biodexa has adjusted the exercise price of certain outstanding warrants to $0.31 per share, resulting in the issuance of 200,433 American depositary shares. The company has clarified that no new warrants will be issued to replace the existing ones.
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