• BiondVax is developing a pipeline of nanosized antibody (“NanoAb”) therapies addressing diseases with large underserved medical needs and attractive commercial opportunities
• BiondVax recently announced results from a preclinical in vivo proof-of-concept study indicating its innovative inhaled NanoAb COVID-19 therapy virtually eliminates viral presence in the lungs and leads to significantly shorter and milder illness
• BiondVax CEO Amir Reichman presented at the Biotech Showcase Conference, where he discussed recent successful results from the preclinical in vivo study, additional pipeline plans for other NanoAb therapeutics, and the company’s derisked R&D strategy

Mainland China is experiencing a fresh wave of COVID-19 infections sweeping some of its most populous provinces. The SARS-CoV-2 virus, which causes COVID-19, has been spreading fast since the Chinese government in early December lifted restrictions that were aimed at containing infections (https://ibn.fm/SzDKu).

Results of the policy have been dire. Early this year, officials reported the Omicron variant had already infected 89% of the Henan province’s 100 million residents. This comes after late December reports that the industrial province of Zhejiang was battling around 1 million new daily COVID-19 infections, a number that was expected to double in the days ahead (https://ibn.fm/oPJGX). “High levels of SARS-CoV-2 infections and increased pressure on healthcare services in China are expected in the coming weeks due to low population immunity and the relaxation of non-pharmaceutical intervention,” stated a January 3 article by the European Center for Disease Prevention and Control (“ECDC”) (https://ibn.fm/O1JfL).

For Amir Reichman, the CEO of biotechnology company BiondVax Pharmaceuticals (NASDAQ: BVXV), the ongoing outbreak in China and frequent emerging variants have reinforced an undeniable fact: “that continuous development of innovative and safe therapeutics for COVID-19 is the most effective and economical way to control this disease.” Coupled with the fact that there uptake of COVID-19 vaccinations and boosters is waning, there is a significant unmet need that BiondVax intends to solve with its inhaled nanosized antibody (“NanoAb”) COVID-19 therapy.

Developed as part of a strategic research collaboration with the Max Planck Institute for Multidisciplinary Sciences and the University Medical Center Göttingen, the alpaca-derived NanoAb therapies are designed to address diseases with large underserved medical needs and attractive commercial opportunities, including COVID-19, asthma, psoriasis, psoriatic arthritis, and other large market disorders. As part of the development process, BiondVax is conducting a preclinical in vivo proof-of-concept study of its inhaled NanoAb COVID-19 therapy, with the results expected to inform the design of the first-in-human clinical trial of the inhaled COVID-19 therapeutic planned for Q4 2023.

In a recent news release announcing the latest results from the preclinical study, BiondVax reported that the presence of the SARS-CoV-2 virus in the lungs of hamsters treated with the inhaled NanoAb was below detectable levels and significantly (p<0.0005) less than the amount of virus detected in the control group. The study showed that six days after infection, hamsters treated with the inhaled NanoAb had over 30x lower SARS-CoV-2 viral titers in their lungs than the placebo group as measured by median tissue culture infectious dose (TCID50). This highly significant data suggests that BiondVax’s NanoAbs may have the breakthrough potential to dramatically reduce the risk of transmission. According to the announcement, these results were corroborated by PCR testing (https://ibn.fm/KLXl4).

“These lung viral titer results indicate that our inhaled NanoAbs essentially eliminated viral presence in the lungs and led to a shorter and milder illness,” commented Dr. Tamar Ben-Yedidia, BiondVax’s Chief Science Officer (“CSO”). “This data is unequivocal and exciting. We’re looking forward to continuing this study this month by testing additional dose levels of the inhaled NanoAb therapy and as a prophylactic (preventive) treatment.”

The most recent announcement builds on results from the same study reported November 29, 2022. These earlier results showed that the control group’s weight post-infection declined by 12.01% on average compared to the pre-infection weight. In contrast, the weight of hamsters that received the inhaled NanoAb therapeutic declined by only 3.80% on average, a highly statistically significant result (p<0.001) (https://ibn.fm/93ykQ). Weight loss in hamsters is a commonly accepted indicator of COVID illness severity, and was also used as a proxy in earlier studies for Regeneron’s (NASDAQ: REGN) REGEN‑COV COVID antibody cocktail treatment and Pfizer’s (NYSE: PFE) blockbuster COVID treatment Paxlovid.

According to BiondVax, the preclinical study is set to continue in January 2023 and will test lower therapeutic doses and a prophylactic dose of the NanoAb, in addition to evaluating safety parameters. Moreover, the company will this year also conduct a preclinical toxicity study to evaluate safety. BiondVax also intends to scale up its manufacturing processes to produce the NanoAbs in their in-house GMP facility in preparation for the planned Q4 2023 first-in-human Phase 1/2a clinical trial.

Meanwhile, Mr. Reichman recently presented at the Biotech Showcase Conference held between January 9-11, 2023. The presentation focused on the recent successful preclinical in vivo trial results, additional pipeline plans for the other NanoAb therapeutics, and BiondVax’s derisked R&D strategy (https://ibn.fm/HDady).

BiondVax is focused on developing, manufacturing, and commercializing innovative large market immunotherapeutic products primarily for the treatment of infectious and autoimmune diseases.

For more information, visit the company’s website at www.BiondVax.com.

NOTE TO INVESTORS: The latest news and updates relating to BVXV are available in the company’s newsroom at https://ibn.fm/BVXV

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