LONDON - Biodexa Pharmaceuticals PLC (NASDAQ:BDRX), a clinical-stage biopharmaceutical company, announced today that it has entered into an exclusive worldwide licensing agreement with Emtora Biosciences for eRapa, a drug candidate poised to enter Phase 3 trials for the treatment of Familial Adenomatous Polyposis (FAP). This move could potentially offer a pharmacological option for the estimated 100,000 individuals affected by FAP in the U.S. and Europe.
FAP is a hereditary condition characterized by the development of precancerous polyps in the colon and rectum, which often necessitates invasive surgery. eRapa, an oral tablet formulation of rapamycin, is expected to delay or prevent the need for surgical interventions in FAP patients by targeting the mTOR pathway, a key player in cell growth and proliferation.
The upcoming Phase 3 trial for eRapa in FAP is bolstered by a $17 million grant from the Cancer Prevention and Research Institute of Texas (CPRIT), awarded through a competitive process. The trial aims to enroll around 140 patients across numerous sites, focusing on progression-free survival as a primary endpoint.
Besides FAP, eRapa is also being investigated in a Phase 2 study for Non-muscle Invasive Bladder Cancer (NMIBC), with results anticipated in the second quarter of 2025. This study is supported by a $3 million grant from the National Cancer Institute.
As part of the licensing transaction, Emtora will receive 378,163 of Biodexa's American Depository Shares, and Biodexa may pay up to $41.5 million in sales milestones post-commercialization, along with tiered royalties on net sales.
Stephen Stamp, CEO and CFO of Biodexa, expressed optimism about the acquisition of eRapa, highlighting its potential to enrich the company's oncology pipeline and provide value to stakeholders. Stephen Dufilho, Executive Chairman of Emtora, reflected on the decade-long effort to bring eRapa to this critical phase and looked forward to the collaboration with Biodexa.
This article is based on a press release statement from Biodexa Pharmaceuticals PLC.
InvestingPro Insights
As Biodexa Pharmaceuticals PLC (NASDAQ:BDRX) gears up for pivotal trials with its drug candidate eRapa, investors are closely monitoring the company's financial health and market performance. According to the latest InvestingPro data, Biodexa holds a market capitalization of $3.18 million, reflecting the company's current valuation in the market. Despite the promising developments in its pipeline, Biodexa's revenue over the last twelve months as of Q4 2023 was reported at $0.49 million, with a notable decline in revenue growth of -45.49%. This contraction highlights the challenges faced in generating sales and may raise concerns about the company's short-term financial sustainability.
InvestingPro Tips reveal a complex picture for Biodexa. On one hand, the company holds more cash than debt, which is a positive sign of financial stability. However, the company is also quickly burning through its cash reserves, which may necessitate further financing to continue its operations and clinical trials. Additionally, Biodexa's stock has been characterized by high price volatility, which could indicate a higher risk profile for investors. In fact, the stock is trading near its 52-week low, and analysts do not anticipate the company to be profitable this year.
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