BiondVax CEO says set the stage in 2022 for ‘highly successful’ 2023

BiondVax Pharmaceuticals published a letter from its CEO, Amir Reichman, addressing 2022 accomplishments, preclinical trial results of the inhaled COVID-19 NanoAb therapy as well as recent financing activities to support 2023 objectives. The letter reads in part: "Today, I am thrilled to share even more compelling results from the preclinical trial. New data from the same study shows that the inhaled NanoAb eliminated viral loads in the lungs: Hamsters treated with BiondVax’s NanoAb had over 30 times lower SARS-COV-2 viral titers in their lungs, six days after infection compared to the placebo group. ..Looking forward to 2023: The collaboration with MPI and UMG has been more successful than we originally contemplated with a number of new potential NanoAb candidates for indications beyond COVID-19 identified well ahead of schedule, in particular, anti-IL-17 NanoAbs for the treatment of psoriasis as well as other disorders. The highly favorable results from our COVID-19 hamster study and the identification of the IL-17 NanoAbs furthered our confidence to move both programs forward aggressively. Rather than slow down progress, in Q4 we determined to raise the capital to fast-track these programs. This was a difficult decision given overall market conditions. After careful consideration and with no certainty that market conditions would soon improve and realizing that delaying financing would impede progress and heighten the risk that funding would be increasingly difficult to obtain, we concluded that now presented the best opportunity to secure capital. With funding in place to continue development, our plans include executing several steps required to bring our inhaled COVID-19 NanoAb therapy into a first-in-human Phase 1/2a clinical trial by the end of 2023. These steps include toxicology studies and GMP manufacturing of the NanoAb. We also intend to exercise our option to obtain an exclusive license at pre-agreed financial terms to anti-IL-17 NanoAbs from our partners in Germany, scale up in-house NanoAb manufacturing, conduct an in vitro proof-of-concept study and potentially also a preclinical trial of the IL-17 NanoAb as a therapy for psoriasis. Bringing innovative pharmaceutical products through manufacturing, clinical trials and regulatory approvals requires substantial resources and entail a high degree of risk. Our biobetter NanoAb approach is specifically designed to mitigate the cost and risk ordinarily incurred in drug development, and we aim to aggressively pursue partnerships with big pharma that can bring in upfront and milestone payments, royalties, and funding for development activities, thereby further reducing our own funding needs and risk. A NanoAb pipeline may provide us with multiple partnering opportunities as well as flexibility in structuring relationships so as to preserve our upside. We also intend to pursue sources of non-dilutive funding, including grants from NGOs and from Israeli and European governmental organizations and have several grant applications in process. Securing meaningful partnerships with large pharma companies requires generating compelling data from pre-clinical and early clinical trials, which is exactly what we intend to pursue with the funds recently raised and with any grant money we are able to secure in the near future. I believe we have set the stage in 2022 for a highly successful 2023."