Biodexa Pharmaceuticals plc Stock Price, News & Analysis

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).

Biodexa Pharmaceuticals PLC announced positive results from a Phase 1 study of MTX110 in treating Diffuse Midline Glioma (DMG), a pediatric brain cancer. Presented at ISPNO 2024, the study showed a median overall survival of 16.5 months across all patients, compared to 10.0 months in a historical cohort.

The study, conducted by Columbia University Irving Medical Center, involved nine patients receiving two 48-hour infusions of MTX110 via convection enhanced delivery (CED) at escalating doses. The treatment was generally well-tolerated with some adverse events related to the infusion process. The study's primary endpoint was to assess safety and maximum tolerated dose, with secondary endpoints including progression-free survival (PFS) and overall survival (OS).

Results highlight the potential of MTX110 in extending survival in DMG patients, setting a favorable comparison to historical data. Further studies are anticipated to confirm these findings and optimize treatment protocols.

Biodexa Pharmaceuticals announced positive 12-month results from its Phase 2 clinical trial of eRapa™ for treating Familial Adenomatous Polyposis (FAP). The study revealed a 75% non-progression rate, with a median 17% reduction in overall polyp burden among participants. Cohort 2, comprising patients on a 0.5mg daily dosage every other week, showed the highest efficacy with an 81% non-progression rate and a 29% reduction in polyp burden. These results were presented at the 2024 InSIGHT meeting in Barcelona. The trial, which involved 30 adult participants across seven U.S. centers, was partially funded by a $3 million grant from the Cancer Prevention and Research Institute of Texas (CPRIT). A Phase 3 study, supported by a $17 million CPRIT grant, is planned to further evaluate eRapa's potential in reducing the need for surgical intervention in FAP patients.

Biodexa Pharmaceuticals (NASDAQ: BDRX) announced that all resolutions proposed at its Annual General Meeting on June 13, 2024, were approved by shareholders. This includes key decisions relating to business strategy, governance, and financial operations. Stakeholders can access the full details of these resolutions on the company's website.

Biodexa Pharmaceuticals announced that they will present 12-month data from a Phase 2 clinical trial of eRapa for Familial Adenomatous Polyposis (FAP) at the InSIGHT 2024 meeting in Barcelona on June 22, 2024.

The trial showed promising results, with significant reductions in polyp burden and high non-progression rates. The six-month data was previously presented at the Digestive Disease Weekly meeting in Washington D.C.

eRapa, an mTOR inhibitor, has received Orphan Designation in the US and plans to seek the same in Europe. The trial demonstrated eRapa to be safe and well-tolerated, with only two Grade 3 Serious Adverse Events reported.