CARDIFF, UK - Biodexa Pharmaceuticals PLC (NASDAQ:BDRX), a clinical stage biopharmaceutical company, has completed its final match payment, unlocking the remaining funds from a $17 million grant awarded by the Cancer Prevention and Research Institute of Texas (CPRIT). The funds will support the Phase 3 study of Biodexa's drug eRapa for Familial Adenomatous Polyposis (FAP), a condition with no approved treatment options.
FAP is a hereditary disease characterized by the development of numerous precancerous polyps in the gastrointestinal tract, significantly increasing the risk of colon cancer. The current standard of care involves frequent monitoring and surgical interventions. Biodexa's eRapa, an oral tablet formulation of rapamycin, has shown promise in a 12-month Phase 2 clinical trial, where it achieved a median decrease in polyp burden by 17% and a non-progression rate of 75%.
The Phase 3 registrational trial for eRapa is slated to begin enrollment early next year, aiming to address the needs of approximately 100,000 FAP patients in the U.S. and Europe.
CPRIT, established by the Texas Legislature and supported by voters in 2007 and 2019, is dedicated to funding cancer research and prevention in Texas. To date, it has awarded over $3 billion in grants, contributed to the recruitment of distinguished researchers, and facilitated the provision of cancer prevention services to millions of Texans.
Biodexa focuses on developing treatments for diseases with unmet medical needs. Besides eRapa, its pipeline includes drugs for Non-Muscle Invasive Bladder Cancer, type 1 diabetes, and rare/orphan brain cancers. The company's proprietary drug delivery technologies aim to improve the bio-delivery and bio-distribution of medicines.
This advancement in Biodexa's clinical development is based on a press release statement, and it marks a significant step in the company's efforts to bring new therapeutic options to patients with FAP.
In other recent news, Biodexa Pharmaceuticals announced a $5.0 million registered direct offering and concurrent private placement. The funds are intended to support the company's development programs, including a Phase 3 clinical trial for eRapa in Familial Adenomatous Polyposis (FAP), and to match a $17 million grant from the Cancer Prevention Research Institute of Texas. The offering is expected to close around July 22, 2024, pending customary closing conditions.
Biodexa also revealed positive results from a Phase 2 clinical trial for eRapa, its investigational drug for FAP. The study showed a significant reduction in polyp burden among FAP patients, suggesting that eRapa could potentially reduce the need for surgical interventions and improve patients' quality of life. The Phase 3 trial is expected to involve approximately 140 high-risk FAP patients.
These developments are a part of the company's recent activities. Ladenburg Thalmann & Co. Inc. served as the sole placement agent for the offering, and Biodexa has agreed to amend the exercise price of existing Series E, G, and H warrants held by investors participating in the offering to $1.00 per share upon the offering's closing.
InvestingPro Insights
In light of Biodexa Pharmaceuticals PLC's (NASDAQ:BDRX) recent progress in their clinical trials, an analysis of the company's financial health and market performance provides additional context for investors. According to InvestingPro data, Biodexa has a market capitalization of $5.98 million, which reflects its size within the biopharmaceutical sector. The company's Price to Book ratio, as of the last twelve months ending Q4 2023, stands at 0.97, suggesting that the stock may be valued near its net asset value by the market.
However, Biodexa faces financial challenges, with a reported revenue decline of 45.49% over the last twelve months ending Q4 2023. This contraction aligns with one of the InvestingPro Tips indicating that analysts anticipate a sales decline in the current year. Additionally, the company's operating income margin for the same period was deeply negative at -1733.33%, reflecting substantial operating losses relative to its revenue.
InvestingPro Tips further reveal that Biodexa is quickly burning through cash and is not expected to be profitable this year, corroborated by a negative Price/Earnings (P/E) ratio of -0.78, indicating that the company has been earning negative profits. For investors considering the stock's recent performance, Biodexa's share price has experienced a significant downturn, with a one-year total return of -93.33% as of the last data point.
While Biodexa's advancements in drug development for conditions like FAP are promising from a medical standpoint, the financial metrics and InvestingPro Tips suggest caution. For those seeking comprehensive investment analysis, InvestingPro offers a wide array of additional tips—there are 14 more tips available on Biodexa that can provide deeper insights into the company's financial health and market outlook.
For further details and expert analyses, investors can explore these tips and more at InvestingPro: https://www.investing.com/pro/BDRX.
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