Executive Summary

HIV
OyaGen will soon complete IND-enabling studies and engage the FDA in preIND discussions for Irino-L, a patent-protected, first-in-class antagonist of the HIV-1 Vif protein that protects the APOBEC innate immune system and blocks HIV replication through gene editing. Formulation for oral dosing is the Company’s priority. OyaGen has developed Irino-L through grants and contract research with NIAID and has a series of follow on 2 Vif antagonists in development. Irino-L not only has therapeutic potential but holds the potential to reduce viral reservoir formation as part of a strategy for a cure and prevention.

Irino-L and Vif antagonist will have significant market pentation because there remains a significant health care unmet need due to new infections and 30+ million HIV/AIDS patents worldwide. The drug market is expected to continue to show sustained growth despite advances in controlling the progress of the disease (Cowen & Company). The incidence of HIV continues to grow at a double-digit rate in developed markets according to the U.S. Center for Disease Control. Patient treatment remains low. Approximately 30% of UScitizens infected with HIV are unaware they are HIV positive While treated patients have longer survival, the failure rates for current frontline therapies are 10% and ultimately the virus’s ability to mutate continues to demand new drugs. Each first-in-class HIV drug has achieved blockbuster annual sales (Cowen & Co.). In recent years the Pharma pipeline for new class of HIV therapeutics have dried up largely due to reduction in R&D expenditure. OyaGen preclinical development for a first-in-class treatment is unique in the global effort has significant potential for treatment, prevention and cure.

OyaGen has in late-stage preclinical development a unique therapeutic lead for HIV/AIDS that is 14-16 months from a pre-IND meeting with the FDA. Despite several FDA approved treatments, HIV remains a significant health care issue with >60 million people worldwide affected. The emergence of drug resistant HIV strains, enhanced by inconsistent access to a continuum of care continues to promote the spread HIV globally. The incidence of HIV continues to grow at a double-digit rate according to the U.S. Center for Disease Control. Approximately 30% of US citizens infected with HIV are unaware they are HIV positive. While treated patients have longer survival, the failure rate for current frontline therapies is 10% and ultimately the virus’s ability to mutate continues to demand new drugs. Consequently, the international drug market is expected to continue to show sustained growth despite advances in controlling the virus for those patients with access to treatment (Cowen & Co.). Our current preclinical efforts have shown our leads to be broadly neutralizing of all strains of HIV and additive in efficacy with all commercial highly active anti-HIV therapeutics. We have developed the chemical path with CROs for producing pure compounds and are developing oral formulations that will enable sustained blood levels for once-a-day dosing.

Each first-in-class HIV drug has achieved blockbuster annual sales (Cowen & Co.). In recent years the Pharma pipeline for new classes of HIV therapeutics has dried up largely due to reduction in R&D expenditure. PimStrategus Professional Valuation Services research suggested that while OyaGen’s lead compound has great potential in HIV therapeutics and will be effective against new strains of HIV that may be resistant to current treatments, it has high potential for a block-buster status in the areas of HIV prevention (PrEP) and HIV cure. In that regard, OyaGen has initiated in vitro studies in reservoir cells assessing the potency to neutralize viremia associated with reservoir cell reactivation as proof-of-concept that OyaGen’s lead compound could be part of a functional cure strategy.