Biodexa Pharmaceuticals plc Stock Price, News & Analysis

Biodexa Pharmaceuticals (NASDAQ: BDRX) has initiated a Phase 2 study of tolimidone for Type 1 Diabetes treatment, with the first patient now recruited. The Investigator Initiated Trial, conducted at the University of Alberta Diabetes Institute, will evaluate 12 patients across three dose groups. The study will measure C-peptide levels (insulin marker) and HbA1c (blood glucose marker) after three months compared to baseline, along with monitoring hyperglycemic events. Preclinical studies at the University of Alberta have shown promising results, identifying Lyn kinase as crucial for beta cell survival and proliferation. Notably, tolimidone demonstrated the ability to induce proliferation in beta cells from human cadavers, suggesting potential therapeutic applications.

Biodexa Pharmaceuticals (NASDAQ: BDRX) provided a shareholder update detailing its financial position and Phase 3 eRapa program progress. The company has $5.7M in cash, $4.4M in escrow for eRapa Phase 3, and access to $11.9M in undrawn CPRIT grants, with minimal debt of $0.5M. The eRapa Phase 3 program for FAP treatment is substantially funded and entering final implementation stages. The study will involve 168 patients in a 2:1 drug/placebo ratio across 30 US and European clinical sites. With 50.5B ordinary shares outstanding (equivalent to 5.05M ADSs) and a $1.06 ADS price, BDRX's market cap stands at $5.4M. The company projects sufficient working capital through Q1 2026.

Biodexa Pharmaceuticals PLC (NASDAQ: BDRX) has announced a General Meeting scheduled for June 11, 2025, at their Cardiff offices. The company is proposing four key resolutions: (1) subdivision of each issued ordinary share of £0.001 into one ordinary share of £0.00005 and 19 C deferred shares of £0.00005, (2) authorization for Directors to allot shares up to £476,954.10 nominal value until 2028 AGM, (3) empowerment of Directors to allot equity securities for cash without pre-emption rights, and (4) adoption of new articles of association.

The primary purpose of these resolutions is to lower the par value of ordinary shares and enable the company to issue shares above par value. Importantly, the company states that these changes will not affect the number of outstanding ordinary shares or American Depositary Shares.

Biodexa Pharmaceuticals (NASDAQ: BDRX) has announced that its partner Emtora Biosciences received an additional $3.0 million grant from the Cancer Prevention & Research Institute of Texas (CPRIT) to support their Phase 3 program of eRapa in familial adenomatous polyposis (FAP). This brings the total CPRIT funding to $20.0 million for the program. The Phase 3 study will be a double-blind placebo-controlled trial involving 168 patients, randomized 2:1 drug/placebo, across approximately 30 clinical sites in the US and Europe. The study is in its final implementation stages, with recruitment expected to begin in the coming weeks. The US component will be conducted by LumaBridge, while Precision for Medicine LLC will handle the European component.

Biodexa Pharmaceuticals (NASDAQ: BDRX) has received European Commission Orphan Drug Designation for eRapa in treating familial adenomatous polyposis (FAP), a rare inherited precancerous colon disease. This follows the FDA's Orphan Drug Designation granted in 2019. The EU designation provides 10 years of marketing exclusivity and special incentives if approved. The company is preparing for a Phase 3 registrational study targeting a $7.3Bn addressable market. The study will involve 168 patients across approximately 30 clinical sites in the US and Europe, with a 2:1 drug/placebo randomization. The trial is supported by a $17.0 million CPRIT grant and an $8.5 million company match already in escrow.

Biodexa Pharmaceuticals (Nasdaq: BDRX) held a General Meeting on May 2, 2025, where two ordinary resolutions received majority votes of 62% and 61%. However, a crucial special resolution (Resolution 3) failed to pass, receiving 71% of votes when it needed 75%. Since Resolution 1 was dependent on Resolution 3's approval, it also failed despite its majority vote. The failed Resolution 3 was aimed at reducing the nominal value of shares to provide more flexibility in future fundraising efforts. The company's Chairman, Dr. Stephen Parker, indicated that alternative proposals will be presented in the future.

Biodexa Pharmaceuticals (Nasdaq: BDRX) has announced a General Meeting scheduled for May 2, 2025, at 13:00 BST at their Cardiff offices. The meeting will address three key resolutions:

1. Subdivision of each issued ordinary share (£0.00005) into one ordinary share (£0.000001) and 49 D deferred shares (£0.000001)
2. Approval of directors' remuneration policy
3. Adoption of new articles of association

The primary objective of these resolutions is to reduce the par value of ordinary shares, enabling the company to issue shares above par value. The company emphasizes that these changes will not affect the number of outstanding ordinary shares or American Depositary Shares.

Biodexa Pharmaceuticals PLC (Nasdaq: BDRX) has released its audited preliminary financial results for the fiscal year ending December 31, 2024. The company, which positions itself as an acquisition-focused clinical stage biopharmaceutical company, is developing a pipeline of innovative products targeting diseases with unmet medical needs.

Biodexa Pharmaceuticals (NASDAQ:BDRX) is advancing towards initiating a Phase 3 trial for eRapa, its proprietary encapsulated rapamycin formulation for treating familial adenomatous polyposis (FAP). The company recently achieved key milestones including FDA Fast Track designation and a successful Type C meeting.

The Phase 3 study will be a double-blind placebo-controlled trial involving approximately 168 high-risk FAP patients across 30 clinical sites in the U.S. and Europe. The trial is substantially funded with a $17 million grant from the Cancer Prevention Research Institute of Texas, matched by $8.5 million from Biodexa.

The company's Phase 2 trial demonstrated promising results, with cohort 2 showing an 89% non-progression rate and 29% median reduction in polyp burden at 12 months. Biodexa has appointed LumaBridge and Precision for Medicine as CROs for the U.S. and European components respectively.