Biodexa Enters Into Exclusive License to eRapa, a Phase 3 Ready Asset for the Treatment of Familial Adenomatous Polyposis (FAP)

April 26, 2024

Biodexa Pharmaceuticals PLC
(“Biodexa” or the “Company”)

Biodexa Enters Into Exclusive License to eRapa, a Phase 3 Ready Asset for the
Treatment of Familial Adenomatous Polyposis (FAP)

Worldwide rights come with $17 million in non-dilutive grant funding for Pivotal Phase 3 trial in FAP

An estimated 100,000 in U.S. and Europe are afflicted with FAP, precancerous polyps that typically lead to surgical removal of the colon and/or rectum

In FAP, eRapa holds the potential of delaying or preventing surgical intervention

Multiple opportunities seen in other indications, including bladder and prostate cancers

• FAP is a substantially genetic orphan disease for which there are no approved therapeutic options; the current standard of care is surveillance and surgery
• Phase 3 FAP program is supported by a $17 million grant awarded from the Cancer Prevention and Research Institute of Texas (“CPRIT”) in a competitive process
• Phase 2 results in FAP to be presented at two leading scientific conferences in Q2 ‘24
• Ongoing Phase 2 study in Non-muscle Invasive Bladder Cancer expected to read-out in Q2 ‘25
• Phase 2 study in NMI Bladder Cancer supported by $3 million grant from National Cancer Institute, part of the National Institutes of Health
  
  

Biodexa Pharmaceuticals PLC, (Nasdaq: BDRX), an acquisition-focused clinical stage biopharmaceutical company developing a pipeline of innovative products for the treatment of diseases with unmet medical needs, announced it entered into a definitive agreement with Rapamycin Holdings Inc. (d/b/a Emtora Biosciences) (“Emtora”) for the rights to eRapa under an exclusive, worldwide license (with the ability to grant sublicenses) to develop, manufacture, commercialize and otherwise advance the clinical potential of eRapa.      

Stephen Stamp, CEO and CFO of Biodexa said, “Acquiring a Phase 3 ready asset, particularly one supported by $17 million of non-dilutive grant funding, significantly advances Biodexa’s oncology pipeline and adds numerous valuation catalysts for our stakeholders. We are delighted to be working with the Emtora team which has excelled in bringing eRapa close to the end of Phase 2 in Non-muscle Invasive Bladder Cancer and to the beginning of a Phase 3 trial in FAP, a devastating disease for which there is currently no approved pharmacological agent for altering its progression. Left untreated, it almost always leads to incredibly invasive surgery and a major deterioration in the quality of life.”