- BiondVax Pharmaceuticals was recently featured in a research report by Zacks Small-Cap Research
- The report highlighted BiondVax’s recent achievements, the most notable of which is the proof-of-concept animal trial that delivered positive results suggesting that the company’s anti-COVID-19 NanoAb candidate resulted in milder and shorter illness
- The company also received support and advice from the Paul Ehrlich Institute (“PEI”), which are viewed as key toward approval for a Phase 1/2a first-in-human clinical trial
- The report estimates that BiondVax is fully funded for the next 12 months; subsequent to the report’s publication, BiondVax raised an additional $7.3 million net in an underwritten public offering
- Accounting for a ratio change in the company’s ADS and based on a probability-adjusted discounted cash flow (“DCF”) model, Zacks valued the company at $57.00 per share
Calendar year 2022 has been eventful for BiondVax Pharmaceuticals (NASDAQ: BVXV), a biotechnology company focused on developing, manufacturing, and commercializing innovative immunotherapeutic products primarily for the treatment of infectious diseases and autoimmune diseases. Recently, the company was covered in a recent research report by Zacks Small-Cap Research (https://nnw.fm/JPc5L). The report valued the company at $57.00 per American depositary share (“ADS”) against a share price of $9.87 (as of December 8) and highlighted BiondVax’s recent key milestones, starting with highly statistically significant positive results from a preclinical in-vivo proof-of-concept study of its inhaled anti-COVID-19 nanosized antibodies (“NanoAbs”).
Derived from alpacas, a species native to South America, the NanoAbs exhibit superior therapeutic potential for a wide range of diseases, according to BiondVax. Its lead NanoAb candidate, designed to treat COVID-19, has exhibited significant competitive advantages over existing oral therapies and monoclonal antibodies (“mAbs”) (https://nnw.fm/bxH1z). BiondVax intends to further develop NanoAbs as drug candidates for the potential treatment of psoriasis, psoriatic arthritis, and other autoimmune diseases.
In the aforementioned study, whose initial results were announced on November 29, BiondVax found that COVID-19-infected Syrian hamsters treated with its inhaled anti-COVID-19 NanoAb candidate had an average weight loss of 3.80% compared to 12.01% for the control group of animals treated with placebo (https://nnw.fm/F6E0H). In addition to the weight, researchers also tracked eight additional parameters, including but not limited to social behaviors and heart rate, which suggested that the inhaled NanoAb therapy resulted in milder and shorter illness.
BiondVax anticipates this preclinical proof-of-concept trial will continue in January 2023 and will incorporate additional arms that will test lower therapeutic doses, and a protective prophylactic dose of the inhaled NanoAb, with the resulting data guiding dose selection level for the planned first-in-human trial. The company expects to initiate this Phase 1/2a human clinical trial of the inhaled anti-COVID-19 therapy in the fourth quarter of 2023.
Spurring efforts even further, BiondVax announced in the summer that it received scientific advice from the Paul Ehrlich Institute (“PEI”), a part of the German national medicines agency, that addressed preclinical, clinical, and manufacturing development plans for the COVID-19 NanoAb therapy. PEI also indicated support for a combined Phase 1/2a clinical trial among patients with confirmed COVID-19 infection (https://nnw.fm/jRVw9). PEI’s advice is generally considered a first key step towards regulatory approval by the European Medicines Agency (“EMA”), the European parallel of the US Food and Drug Administration (“FDA”).
PEI’s advice, the reports notes, would help avoid the need to provide standard-of-care (“SOC”) medicines before the clinical trial participants receive the NanoAb candidate. This would allow BiondVax to assess the safety and efficacy in one small-sized trial instead of two sequential trials that would typically include a large Phase 2 study.
The Zacks report also touched on BiondVax’s financial results for the third quarter ending September 30, 2022. Though the company did not report any revenues, it had approximately NIS (New Israel Shekels) 29.4 million (approximately $8.3 million at the exchange rate of 3.543 NIS/US$) in cash and cash equivalents. “With a current burn rate of approximately $1 million per month, we estimate the company has sufficient capital to fund operations for the next 12 months,” David Bautz, Ph.D., the author of the research report, writes. Subsequent to the Zacks report, BiondVax raised an additional $7.3 million net in an underwritten public offering, thereby enabling the company to not only proceed apace with the COVID-19 NanoAb development but also to pursue plans to add a number of new potential NanoAb candidates for indications such as anti-IL-17 NanoAbs for the treatment of psoriasis.
Meanwhile, in November, BiondVax effected a ratio change of its ADSs from 1 ADS representing 40 ordinary shares to 1 ADS representing 400 ordinary shares, akin to a reverse stock split of 1 new ADS for every 10 old ADSs. Zacks’ valuation took this ratio change into account.
Put together, these factors influenced a valuation of $57.00 per ADS, which is “based on [Zacks’] probability-adjusted DCF [discounted cash flow] model that takes into account potential revenues from the NanoAb platform.” The model is highly dependent on the clinical success of the NanoAb candidates and will be adjusted accordingly based on emerging data.
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://nnw.fm/BVXV
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