Announces Payment of $3.0MM Final Match Payment Enabling Access to Remainder of $17.0MM CPRIT Grant

Rhea-AI Summary

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.

Positive

• Secured access to remainder of $17 million CPRIT grant
• Funding secured for Phase 3 registrational study of eRapa
• Positive Phase 2 results: 17% median decrease in polyp burden
• 75% non-progression rate in Phase 2 trial
• Targeting an orphan indication with 100,000 patients in U.S. and Europe
• No approved therapeutic options for FAP, indicating potential market opportunity

Negative

• Required to make match payments to access grant funds
• Phase 3 trial enrollment not starting until early 2025

Financial Analyst

The $3.0 million final match payment by Biodexa Pharmaceuticals is a significant financial milestone. It unlocks access to the remaining funds from a substantial $17 million grant from CPRIT. This infusion of capital is important for the company's upcoming Phase 3 study of eRapa, potentially reducing the need for dilutive financing. The focus on Familial Adenomatous Polyposis (FAP), an orphan indication, could lead to market exclusivity and premium pricing if successful. However, investors should note that clinical trials, especially Phase 3, are costly and risky. The company's financial health and burn rate will be critical factors to monitor.

Medical Research Analyst

The progress of eRapa into Phase 3 for FAP is noteworthy. The Phase 2 results showing a 17% median decrease in polyp burden and 75% non-progression rate are promising, especially given the lack of approved therapeutics for FAP. This addresses a significant unmet medical need for approximately 100,000 patients in the U.S. and Europe. The potential to delay or prevent surgical interventions could be game-changing for patient care. However, the transition from Phase 2 to Phase 3 is often challenging and investors should be cautious about extrapolating early results to larger populations.

Market Research Analyst

Biodexa's focus on an orphan indication like FAP is a smart strategic move. The orphan drug market is projected to grow significantly, driven by premium pricing and extended market exclusivity. If eRapa proves successful, it could capture a niche but lucrative market. The lack of approved therapeutics for FAP presents a first-mover advantage. However, the small patient population (100,000 in U.S. and Europe) may limit the overall market size. Investors should consider the potential for off-label use in other polyp-related conditions as a possible upside. The company's ability to navigate regulatory pathways and secure reimbursement will be important for commercial success.

09/16/2024 - 08:30 AM

September 16, 2024

Biodexa Pharmaceuticals PLC

Announces Payment of $3.0MM Final Match Payment Enabling Access to Remainder of
$17.0MM CPRIT Grant

Funds to Advance Development of Phase 3 Asset

Biodexa Pharmaceuticals PLC (“Biodexa” or the “Company”) (Nasdaq: BDRX), an acquisition-focused clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs, today announces it made the final match payment with respect to a $17 million grant from the Cancer Prevention Research Institute of Texas (CPRIT).

Commenting, Stephen Stamp, CEO and CFO of Biodexa said “Having made the second and final match payment, we now have access to the remainder of the $17 million CPRIT grant which will be used to fund our upcoming Phase 3 registrational study of eRapa in the orphan indication of Familial Adenomatous Polyposis.”

Familial Adenomatous Polyposis (FAP) is an inherited disease that causes the growth of hundreds or thousands of precancerous polyps throughout the GI tract, putting those afflicted at great risk of developing colon cancer. There is no approved therapeutic option for treating the approximately 100,000 FAP patients in the U.S. and Europe. The current standard of care is active surveillance and surgical resection of the colon and/or rectum.

Results of a 12cmonth Phase 2 clinical trial of eRapa in FAP demonstrated a 17 per cent median decrease in overall polyp burden and an overall non-progression rate of 75 per cent. A Phase 3 registrational trial is expected to begin enrollment early next year.

About the Cancer Prevention and Research Institute of Texas

CPRIT was created by the Texas Legislature and approved by a statewide vote in 2007 to lead the Lone Star State’s fight against cancer. In 2019, Texas voters again voted overwhelmingly to continue CPRIT with an additional $3 billion for a total $6 billion investment in cancer research and prevention. To date, CPRIT has awarded over $3 billion in grants to Texas research institutions and organizations through its academic research, prevention and product development research programs. CPRIT has also recruited more than 281 distinguished researchers to Texas, supported the establishment, expansion or relocation of 51 companies to Texas and generated over $7.66 billion in additional public and private investment. CPRIT funding has advanced scientific and clinical knowledge and provided over 8.1 million life-saving cancer prevention and early detection services to Texans in all 254 counties. Learn more at https://cprit.texas.gov.

About Biodexa Pharmaceuticals PLC

Biodexa Pharmaceuticals PLC (listed on NASDAQ: BDRX) is a clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs. The Company’s lead development programs include eRapa, under development for Familial Adenomatous Polyposis and Non-Muscle Invasive Blader Cancer: tolimidone, under development for the treatment of type 1 diabetes; and MTX110, which is being studied in aggressive rare/orphan brain cancer indications.

eRapa is a proprietary oral tablet formulation of rapamycin, also known as sirolimus. Rapamycin is an mTOR (mammalian Target Of Rapamycin) inhibitor. mTOR has been shown to have a significant role in the signaling pathway that regulates cellular metabolism, growth and proliferation and is activated during tumorgenesis.

Tolimidone is an orally delivered, potent and selective inhibitor of Lyn kinase. Lyn is a member of the Src family of protein tyrosine kinases, which is mainly expressed in hematopoietic cells, in neural tissues, liver, and adipose tissue. Tolimidone demonstrates glycemic control via insulin sensitization in animal models of diabetes and has the potential to become a first in class blood glucose modulating agent.

MTX110 is a solubilised formulation of the histone deacetylase (HDAC) inhibitor, panobinostat. This proprietary formulation enables delivery of the product via convection-enhanced delivery (CED) at chemotherapeutic doses directly to the site of the tumor, by-passing the blood-brain barrier and potentially avoiding systemic toxicity.

Biodexa is supported by three proprietary drug delivery technologies focused on improving the bio-delivery and bio-distribution of medicines. Biodexa’s headquarters and R&D facility is in Cardiff, UK. For more information visit www.biodexapharma.com.

Forward-Looking Statements
Certain statements in this announcement may constitute “forward-looking statements” within the meaning of legislation in the United Kingdom and/or United States. Such statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and are based on management’s belief or interpretation. All statements contained in this announcement that do not relate to matters of historical fact should be considered forward-looking statements including, but not limited to, the anticipated net proceeds, and the anticipated use of proceeds therefrom, and projected cash runway. In certain cases, forward-looking statements can be identified by the use of words such as “plans”, “expects” or “does not anticipate”, or “believes”, or variations of such words and phrases or statements that certain actions, events or results “may”, “could”, “would”, “might” or “will be taken”, “occur” or “be achieved.” Forward-looking statements and information are subject to various known and unknown risks and uncertainties, many of which are beyond the ability of the Company to control or predict, that may cause their actual results, performance or achievements to be materially different from those expressed or implied thereby, and are developed based on assumptions about such risks, uncertainties and other factors set out herein.

Reference should be made to those documents that Biodexa shall file from time to time or announcements that may be made by Biodexa in accordance with the rules and regulations promulgated by the SEC, which contain and identify other important factors that could cause actual results to differ materially from those contained in any projections or forward-looking statements. These forward-looking statements speak only as of the date of this announcement. All subsequent written and oral forward-looking statements by or concerning Biodexa are expressly qualified in their entirety by the cautionary statements above. Except as may be required under relevant laws in the United States, Biodexa does not undertake any obligation to publicly update or revise any forward-looking statements because of new information, future events or events otherwise arising.

For more information, please contact:

Biodexa Pharmaceuticals PLC

Stephen Stamp, CEO, CFO Tel: +44 (0)29 20480 180 www.biodexapharma.com

FAQ

What is the total amount of the CPRIT grant received by Biodexa Pharmaceuticals (BDRX)?

Biodexa Pharmaceuticals (BDRX) received a total grant of $17 million from the Cancer Prevention Research Institute of Texas (CPRIT).

What is the purpose of the CPRIT grant for Biodexa Pharmaceuticals (BDRX)?

The CPRIT grant will be used to fund Biodexa's upcoming Phase 3 registrational study of eRapa for the treatment of Familial Adenomatous Polyposis (FAP).

When is Biodexa Pharmaceuticals (BDRX) expected to begin enrollment for the Phase 3 trial of eRapa?

Biodexa Pharmaceuticals (BDRX) is expected to begin enrollment for the Phase 3 trial of eRapa in early 2025.

What were the key results from the Phase 2 clinical trial of eRapa conducted by Biodexa Pharmaceuticals (BDRX)?

The 12-month Phase 2 clinical trial of eRapa showed a 17% median decrease in overall polyp burden and an overall non-progression rate of 75%.