Biodexa Pharmaceuticals plc Stock Price, News & Analysis

Biodexa Pharmaceuticals PLC (Nasdaq: BDRX) has provided an update on its Phase 1 study of MTX110 in recurrent glioblastoma (rGBM). The study, known as MAGIC-G1, involves intermittent infusions of MTX110 administered by convection enhanced delivery (CED) via implanted refillable pump and catheter.

In Cohort A of the study:

• Two patients have deceased with overall survival (OS) of 12 and 13 months
• One patient had progression-free survival (PFS) of 6 months and current OS of 13 months
• One patient has not yet progressed, with current PFS and OS of 12 months

These results compare favorably with typical median PFS of 1.5–6.0 months and median OS of 2.0–9.0 months for rGBM. The data builds on previous promising results from two Phase 1 studies of MTX110 in Diffuse Midline Glioma (DMG), which showed median OS of 16.5 and 26.1 months, compared to a typical median OS of 10.0 months.

Biodexa Pharmaceuticals PLC (Nasdaq: BDRX) released its unaudited interim results for the six months ended June 30, 2024. Key highlights include:

1. Exclusive worldwide licensing of eRapa™, a Phase 3 ready asset for Familial Adenomatous Polyposis (FAP), with access to a $17 million grant.

2. Positive 6-month and 12-month data for eRapa in FAP, showing high non-progression rates and significant reductions in polyp burden.

3. Promising survival data from MTX110 studies in recurrent Glioblastoma and Diffuse Midline Glioma.

4. Financial updates: R&D costs decreased to £2.19 million, administrative costs reduced to £2.03 million, and cash balance at June 30, 2024 was £5.06 million.

5. Post-period developments include approval for a Phase 2a study of tolimidone in Type 1 diabetes and receipt of $5.0 million from a Registered Direct Offering.

Biodexa Pharmaceuticals PLC (Nasdaq: BDRX) announces a ratio change on its American Depositary Receipts (ADR) effective October 4, 2024. The new ratio will be 1 ADR representing 10,000 ordinary shares, changed from 1 ADR representing 400 ordinary shares.

ADR holders will be required to exchange their existing ADRs, receiving 1 new ADR for every 25 old ADRs. This change will have the same effect as a 1-for-25 reverse ADR split. The company's ordinary shares will not be affected by this change.

The ratio change aims to bring Biodexa's ADR price into compliance with Nasdaq's $1.00 minimum bid price requirement, although the company cannot guarantee its effectiveness in achieving this goal.

Biodexa Pharmaceuticals PLC (Nasdaq: BDRX) has made the final match payment for a $17 million grant from the Cancer Prevention Research Institute of Texas (CPRIT). This payment enables access to the remaining grant funds, which will be used to finance the upcoming Phase 3 registrational study of eRapa for Familial Adenomatous Polyposis (FAP). FAP is an inherited disease causing precancerous polyps in the GI tract, affecting approximately 100,000 patients in the U.S. and Europe. A previous 12-month Phase 2 trial of eRapa showed promising results, with a 17% median decrease in overall polyp burden and a 75% non-progression rate. The Phase 3 trial is expected to begin enrollment in early 2025.

Biodexa Pharmaceuticals PLC (Nasdaq: BDRX) received a delisting determination from Nasdaq on August 27, 2024, due to its stock closing below $1.00 for 30 consecutive business days. This violates Nasdaq Listing Rule 5550(a)(2). The company is not eligible for the usual 180-day compliance period because it has effected reverse stock splits with a cumulative ratio of 250:1 or more over the past two years.

Biodexa plans to appeal the decision by requesting a hearing before the Nasdaq Hearings Panel. This request will automatically stay any suspension or delisting action pending the hearing and any additional extension period granted by the Panel. The company remains focused on developing innovative products for diseases with unmet medical needs.

Biodexa Pharmaceuticals PLC (Nasdaq: BDRX) has closed a $5.0 million registered direct offering and concurrent private placement. The company raised approximately $4.2 million in net proceeds after expenses. The offering included:

1. 5,050,808 American Depositary Shares (ADS) and 278,975 pre-funded warrants at $0.94 per ADS
2. Unregistered Series J and K warrants to purchase up to 5,329,783 ADSs each
3. Amendment of existing warrants' exercise price to $1.00 per share

Funds will be used for development programs, including a $17 million CPRIT grant match and initiating a Phase 3 trial of eRapa for FAP. Ladenburg Thalmann & Co. Inc. acted as the sole placement agent.

Biodexa Pharmaceuticals PLC (Nasdaq: BDRX) has announced a $5.0 million registered direct offering and concurrent private placement. The company will sell 5,050,808 American Depositary Shares and 278,975 pre-funded warrants at $0.94 per share. Additionally, Biodexa will issue unregistered Series J and K warrants in a private placement. The proceeds will fund development programs, including a final match payment for a $17 million CPRIT grant and initiation of a Phase 3 clinical trial of eRapa in Familial Adenomatous Polyposis (FAP). The offering is expected to close around July 22, 2024. Ladenburg Thalmann & Co. Inc. acted as the sole placement agent.

Biodexa Pharmaceuticals PLC (Nasdaq: BDRX) has received approval from Health Canada for a Phase 2a study of tolimidone in Type 1 diabetes (T1D). This Investigator Initiated Trial, to be conducted by the University of Alberta, will measure C-peptide levels and HbA1c after three months compared to baseline, as well as the number of hyperglycemic events. The study will initially involve 12 patients across three dose groups, with potential for expansion. Enrollment of the first patient is expected in the current quarter. This clinical program builds on existing tolimidone data from Pfizer, Melior, and Bukwang.

Biodexa Pharmaceuticals PLC (NASDAQ:BDRX) has announced positive 12-month data from its Phase 2 clinical trial of eRapa™ for the treatment of Familial Adenomatous Polyposis (FAP), a condition that significantly increases the risk of colorectal cancer. Presented at the 2024 InSIGHT biannual meeting, results indicate a 17% median reduction in polyp burden and a non-progression rate of 75%. Notably, 89% of patients in Cohort 2 (treated daily on alternate weeks) were deemed non-progressors, with a 29% median reduction in polyp burden.

FAP patients currently undergo continuous surveillance and surgeries, often resulting in complete resection of the colon or rectum. Biodexa aims for eRapa to be the first therapeutic alternative, potentially reducing the need for surgical interventions and improving patients' quality of life. The Phase 3 trial, planned to start soon, will involve 140 high-risk FAP patients and be double-blind placebo-controlled. This trial is partially funded by a $17 million grant from the Cancer Prevention and Research Institute of Texas (CPRIT).