Genprex, Inc. a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes announced its intention to transfer the Company’s diabetes clinical development program and its diabetes gene therapy assets into a new, wholly-owned subsidiary (“NewCo”). NewCo would focus on developing and commercializing GPX-002, a diabetes gene therapy drug candidate for the treatment of Type 1 (T1D) and Type 2 diabetes (T2D).
“Genprex’s diabetes program has received the attention of several potential investors, partners, collaborators and pharmaceutical companies, and we believe separating it from our oncology programs could help increase interest, expedite clinical development and unlock the value of our novel diabetes program,” said Ryan Confer, President and Chief Executive Officer at Genprex. “The new subsidiary would be positioned to be a pure-play diabetes-focused biopharmaceutical company, while Genprex would be a pure-play oncology-focused biopharmaceutical company. This contemplated separation of entities could enable potential direct investment and strategic collaboration into the advancement of the diabetes program. Diabetic patients are in need of advanced therapies, and we believe GPX-002 holds the potential for disease modification for long-term effectiveness, which could directly impact the global diabetes epidemic.”
The planned spin-out transaction would allow both Genprex and NewCo to enhance each company’s focus on meeting the needs of their respective markets, patients and stakeholders. The spin-out, if completed as presently contemplated, would result in NewCo focusing on developing GPX-002, while Genprex would retain its oncology clinical development programs and other oncology pipeline assets. The decision to pursue the reorganization demonstrates Genprex’s strong ongoing commitment to the Company’s streamlined, focused strategies and ongoing research and development prioritization initiative. The potential formation and transfer of the clinical development program into the wholly-owned subsidiary is currently anticipated to occur by the end of 2024, subject to adequate financing, the satisfaction of customary conditions and final approval from the Genprex management and Board of Directors.
The Company’s goal for separating the diabetes clinical development program from its oncology program follows closely behind Genprex’s recent announcement to re-focus its oncology clinical development program for streamlined, expeditious regulatory submission of its lead oncology drug candidate, Reqorsa® Gene Therapy. As previously announced, the Company continues to evaluate ways to optimize its clinical and research programs and operational strategies. Additionally, the Company is considering various strategic alternatives and opportunities to enhance stockholder value.
GPX-002, which has been exclusively licensed from the University of Pittsburgh, is being developed using the same construct for the treatment of both T1D and T2D. The same general novel approach is used in each of T1D and T2D whereby an adeno-associated virus (AAV) vector containing the Pdx1 and MafA genes is administered directly into the pancreatic duct. In humans, this can be done with a routine endoscopy procedure. The diabetes product candidates are currently being evaluated and optimized in preclinical studies at the University of Pittsburgh.
“With the potential to address the entire diabetes market, we believe our gene therapy approach would position NewCo as an innovator in emerging diabetes therapies,” continued Confer. “The most significant advancement in the treatment of diabetes happened more than 100 years ago when insulin was first introduced to treat T1D patients. We believe our treatment has the potential to disrupt the diabetes market by replacing the daily burden of blood glucose monitoring and insulin replacement therapy, as well as the need for GLP-1 treatments in T2D.”
