Near Term IPO Potential & Additional Summary Timeline
Eight months following completion of funding, we plan to submit to the US FDA our Investigational New Drug (IND) to initiate additional clinical trials. Immediately after, we may be able to IPO. Discussions are ongoing with potential strategic corporations.
An additional 8 months will allow Geneius to generate data on 9 patients from our planned clinical trial. A further 6 months will allow us to collect data on the total of 20 patients.
As a potential comparable, CAR-T received FDA approval on clinical trial results from 100 patients. Based upon approvals of CAR-T therapies, we believe that replication of results from the earlier academic study of natural EBV reactive T cells (50% CR, 70% ORR, low toxicity in a 21 patient study; Bollard et al.) will be a sufficient basis for applying to FDA for approval from a 70 patient aggregated patient population, enabling an approval in 5 years or less.