BiondVax Pharmaceuticals Ltd. (BVXV), which focuses on developing, manufacturing and commercializing innovative products for the prevention and treatment of infectious diseases and other illnesses, today published its financial results for the quarter ended June 30, 2022 and provided a business update.
Business Update
- Development of the NanoAb program is proceeding according to plan. A pilot quantity of the lead NanoAb, a COVID-19 therapy, was manufactured in-house then sent for preclinical inhalation device evaluation and selection of an inhaler for human use.
- In September 2022, BiondVax plans to initiate an inhalation proof of concept study with its anti-SARS-COV-2 NanoAbs in COVID-19 infected animals with readout expected in November 2022.
- BiondVax currently holds several anti-SARS-COV-2 NanoAb candidates, generated and initially characterized by Max Planck Institute for Multidisciplinary Sciences in Göttingen together with University Medical Center Göttingen and exclusively licensed from Max-Planck-Innovation GmbH, which demonstrated high affinity to and strong neutralization of COVID-19 VoCs including Omicron BA1&2 and will be testing them in the coming months for neutralization of BA2.75 and BA5.
- BiondVax received supportive Scientific Advice from the Paul Ehrlich Institute (PEI) for its COVID-19 NanoAb development plans. PEI supported BiondVax's plan for first-in-human clinical trial to be conducted directly in sick patients as a combined Phase 1/2a, testing both safety and efficacy, thereby shortening BiondVax's clinical development timelines.
- As part of their broader research collaboration with BiondVax, the researchers at Max Planck Institute for Multidisciplinary Sciences in Göttingen and University Medical Center Gottingen have been able to successfully isolate new NanoAbs targeting IL-17A/F and other cytokines, which can be used for treatment of other diseases such as psoriasis, psoriatic arthritis, asthma, and macular degeneration. BiondVax has an exclusive option for an exclusive license to further develop and commercialize these drug candidates.
Second Quarter 2022 Financial Summary
Results are in New Israel Shekels (NIS) and convenience translation to $US is provided using the exchange rate of 3.5 (NIS/$US), the rate as of the close of business on June 30, 2022.
- R&D expenses for the three months ended June 30, 2022 were NIS 6.5 million ($1.85 million) compared to NIS 1.9 million for the three months ended June 30, 2021. Total R&D expenses for the six months ended June 30, 2022 were NIS 10.1 million ($2.9 million) compared to NIS 4.6 million for the six months ended June 30, 2021. These increases were primarily due to drug development activities related to the new COVID-19 NanoAb program licensed from Max-Planck-Innovation GmbH in December 2021.
- Marketing, general and administrative expenses for the three months ended June 30, 2022 were NIS 4.3 million ($1.2 million) compared to NIS 7.0 million for the three months ended June 30, 2021. Total marketing, general and administrative expenses for the six months ended June 30, 2022 were NIS 8.9 million ($2.5 million) compared to NIS 11 million for the six months ended June 30, 2021. These decreases were primarily due to salaries and related expenses of NIS 1.2 million and share based payment of NIS 1 million.
- Financial expenses for the three months ended June 30, 2022 were NIS 2.1 million ($0.6 million) compared to NIS 3.0 million for the three months ended June 30, 2021. Financial expenses for the six months ended June 30, 2022 were NIS 3.2 million ($1 million) compared to NIS 4.5 million for the six months ended June 30, 2021. These decreases were primarily due to currency exchange differences and EIB loan financial expenses.
- Total operating expenses for the three months ended June 30, 2022 were NIS 10.8 million ($3.1 million) compared to NIS 8.9 million for the three months ended June 30, 2021. Total operating expenses for the six months ended June 30, 2022 were NIS 19 million ($5.5 million) compared to NIS 15.6 million for the six months ended June 30, 2021.
- Net loss for the for the three months ended June 30, 2022 was NIS 12.9 million ($3.7 million) compared to NIS 12.0 million for the three months ended June 30, 2021. Net loss for the six months ended June 30, 2022 was NIS 22.3 million ($6.4 million) compared to NIS 20.2 million for the six months ended June 30, 2021. These increases were primarily due to an increase in R&D expenses, offset by a decrease in marketing, general and administrative expenses as described above.
As of June 30, 2022, BiondVax had cash and cash equivalents of NIS 39.5 million ($11.3 million) compared to NIS 54.0 million as of December 31, 2021.
Unaudited second quarter financial results will be submitted to the Securities and Exchange Commission. A summary is included in the tables below.