GeneVentiv's AAV8.FVa gene therapy is the first universal gene therapy for all hemophilias and the first to treat inhibitor patients.
Currently hemophilia A patients must either infuse Factor VIII (FVIII) clotting factor 2-3 times per week or take weekly injections. 30% of hemophilia A patients develop inhibitors (neutralizing antibodies) to their missing clotting factor. FVIII gene therapies that were in development or Roctavian, which was recently approved are not durable, meaning they fail to deliver the promised single infusion treatment for hemophilia. Worse still, patients with inhibitors were ineligible for these gene therapies. As a result, the Roctavian launch was unsuccessful and in December 2024 the other two major hemophilia A gene therapy programs were cancelled by Roche and Pfizer. Our AAV8.FVa gene therapy is not subject to the mechanism that limits the durability of the FVIII gene therapies and can also treat the inhibitor population. We have ongoing discussions with hemophilia gene therapy companies and they have provided input into our study designs. The sweet spot for an exit by acquisition is upon completion of a Phase I/II clinical trial.
Damon Race is the CEO and has 30 years of commercial pharmaceutical and investing experience, all of which is in startups. He holds an MBA from Duke's Fuqua School of Business, is a Certified Licensing Professional and a Chartered Market Technician. Dr. Paris Margaritis, has 30 years of hemophilia gene therapy experience and extensive experience designing pre-clinical studies necessary for us to reach our canine study milestone which is the catalyst for our Series A raise.
We have relationships with both hemophilia gene therapy companies and plasma derived products companies with a gene therapy foothold. Given that their hemophilia A gene therapies are not durable and they could never treat 30% of the population with inhibitors to begin with, we are a very attractive acquisition and complimentary to their portfolios. Based on our discussions, their preferred path to acquisition is familiar and utilizes venture capital funding through our combined Phase I/II human clinical trial. Acquisition negotiations typically begin during the interim clinical trial readout and the transaction concludes on successful completion of the trial. The acquirer is then responsible for the Phase III trial, obtaining approval and marketing the product.
Return for our investors comes at exit. The acquirer will commercialize our gene therapy.
We are raising a $750K convertible note to provide the company with a comfortable runway to pitch data from our canine study to VC and raise a $30M Series A on favorable terms from a venture capital fund that we have good chemistry with. We don't want to arrive at the canine data milestone with limited runway and have less leverage in the conversation. We are offering an 8% interest rate, a 20% discount and a $55M valuation cap subject to market conditions. Efforts to raise the Series A are estimated to begin in September 2025 with the availability of the data from the canine study.
We have very robust pre-clinical data in mice showing that we are able to stop bleeding after severe injuries such as the equivalent of a human limb amputation and a carotid artery injury. We also have safety data. Our SBIR grant funds a study of efficacy and safety in hemophilic canines beginning in Q2 2025. We have a robust network of venture capital funds following our progress and they view replication of our results in canines as the catalyst for investing in our Series A. The Series A funds our last IND-Enabling study in non-human primates through our first in human Phase I/II clinical trial. Based on our discussions with the hemophilia gene therapy companies there is interest in acquiring at the successful conclusion of Phase I/II in 2027.
We have very robust pre-clinical data in mice showing that we are able to stop bleeding after severe injuries such as the equivalent of a human limb amputation and a carotid artery injury. We also have safety data. Our SBIR grant funds a study of efficacy and safety in hemophilic canines beginning in Q2 2025. We have a robust network of venture capital funds following our progress and they view replication of our results in canines as the catalyst for investing in our Series A. The Series A funds our last IND-Enabling study in non-human primates through our first in human Phase I/II clinical trial. Based on our discussions with the hemophilia gene therapy companies there is interest in acquiring at the successful conclusion of Phase I/II in 2027.
