Biodexa Pharmaceuticals plc Stock Price, News & Analysis

Biodexa Pharmaceuticals (NASDAQ:BDRX) reported interim results for H1 2025, highlighting significant progress in its clinical pipeline. The company's lead candidate eRapa entered Phase 3 trials for FAP with first patient enrollment in Puerto Rico, while securing Orphan Drug Designation in Europe. The company also initiated a Phase 2a study of tolimidone in Type 1 Diabetes.

Financial highlights include a $35 million Equity Line of Credit with C/M Capital Master Fund LP, and a $3 million grant awarded to collaboration partner Emtora Biosciences. R&D costs decreased to £1.67 million (from £2.19M in 1H24), while cash balance stood at £4.04 million as of June 30, 2025.

Biodexa Pharmaceuticals (NASDAQ:BDRX) has initiated its Phase 3 trial for eRapa, a proprietary encapsulated rapamycin treatment for familial adenomatous polyposis (FAP). The company received an additional $3 million grant from the Cancer Prevention & Research Institute of Texas, bringing total non-dilutive funding to $20 million for the Phase 3 trial.

The Phase 2 trial showed promising results with a 29% median decrease in polyp burden and 89% non-progression rate at 12 months in cohort 2. The Phase 3 study will involve 168 patients across approximately 30 clinical sites in the U.S. and Europe. With Fast Track status and Orphan Drug designation, Biodexa is positioned to be first-to-market in an estimated $7.3 billion addressable market with no current therapeutic options.

Biodexa Pharmaceuticals (NASDAQ:BDRX) has announced the enrollment of its first two patients in the pivotal Phase 3 Serenta trial for eRapa, targeting Familial Adenomatous Polyposis (FAP). The trial will be conducted across 30 sites (20 in US, 10 in Europe) and will evaluate 168 patients in a 2:1 drug/placebo randomized study.

The company aims to develop the first non-surgical treatment for FAP, a hereditary condition that typically leads to colorectal cancer if untreated. The program has received $20 million in grant funding from CPRIT and targets a $7.3 billion addressable market. The trial follows promising Phase 2 results and represents a potential breakthrough in FAP treatment, where currently only surgical resection is available.

Biodexa Pharmaceuticals (NASDAQ: BDRX) has implemented its previously announced American Depositary Receipts (ADR) ratio change effective July 31, 2025. The new ratio changes from 1 ADR representing 10,000 ordinary shares to 1 ADR representing 100,000 ordinary shares.

The ratio change functions similarly to a 1-for-10 reverse ADR split, with the exchange occurring automatically through depositary bank JPMorgan Chase Bank. Following the change, the company has 619,523 ADRs outstanding, while the total number of issued ordinary shares remains unchanged at 61,952,308,922.

Biodexa Pharmaceuticals (NASDAQ:BDRX) is advancing its Phase 3 program for eRapa, an oral tablet formulation of rapamycin, to treat Familial Adenomatous Polyposis (FAP). The company has achieved significant regulatory milestones, including FDA Fast Track status and Orphan Drug designation in both US and Europe.

eRapa demonstrated impressive Phase 2 results with an 89% non-progression rate and 29% median reduction in polyp burden at 12 months. The company has initiated its 'Serenta' trial (NCT06950385) in the US and filed a Clinical Trial Application in Europe, targeting a $7 billion addressable market.

With 30 clinical sites identified across the US and Europe, secured funding including a $20 million grant, and potential first-mover advantage, Biodexa is positioned ahead of competitors Recursion Pharmaceuticals (RXRX) and Tempest Therapeutics (TPST) in the race to develop the first approved therapeutic option for FAP.

Biodexa Pharmaceuticals (NASDAQ: BDRX) has announced a significant change in its American Depositary Receipts (ADR) ratio. The company will modify its ADR ratio from 1:10,000 (1 ADR representing 10,000 ordinary shares) to 1:100,000 (1 ADR representing 100,000 ordinary shares), effective July 31, 2025.

ADR holders will be required to exchange their existing ADRs at a ratio of 10:1, with JP Morgan Chase Bank managing the exchange process. This change will effectively function as a 1-for-10 reverse ADR split, though the company's ordinary shares will remain unaffected. The primary goal is to achieve compliance with Nasdaq's minimum bid price requirement of $1.00 per share.

Biodexa Pharmaceuticals (NASDAQ:BDRX) has filed a Clinical Trial Application (CTA) with the European Medicines Agency for its Phase 3 Serenta trial investigating eRapa in Familial Adenomatous Polyposis (FAP). The trial will initially cover clinical sites in Denmark, Germany, Netherlands, and Spain, with Italy to be added later.

The company has achieved several milestones for its eRapa program, including FDA Fast Track Designation, European Orphan Drug designation, and initiation of its first US clinical site. The program is supported by a $20 million grant from CPRIT. The Serenta trial (NCT06950385) is designed as a randomized, double-blind, placebo-controlled Phase 3 study, with European sites expected to begin enrollment in Q4 2025.

Biodexa Pharmaceuticals (NASDAQ: BDRX), a clinical stage biopharmaceutical company, announced that all resolutions proposed at its Annual General Meeting held on June 26, 2025, were successfully passed by shareholders. The company, which focuses on developing innovative treatments for diseases with unmet medical needs, has made the full text of the passed resolutions available on its corporate website under the investor relations section.

Biodexa Pharmaceuticals (NASDAQ:BDRX) has announced the activation of its first clinical study site for the Phase 3 Serenta trial, evaluating eRapa in patients with familial adenomatous polyposis (FAP). The trial (NCT06950385) is designed as a randomized, double-blind, placebo-controlled study and is now actively enrolling participants.

The program has received significant support, including $20 million in grant funding from CPRIT, Fast Track Designation, and a positive Type C Meeting. The company has also launched a dedicated website for patient information at serentatrial.com.