BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), a biopharmaceutical company focused on developing, manufacturing and commercializing a pipeline of innovative NanoAbs for the prevention and treatment of infectious diseases and other illnesses, received support from a recent Scientific Advice meeting with the Paul Ehrlich Institute (PEI) in Germany. The Scientific Advice addressed preclinical, clinical, and manufacturing development plans for the COVID-19 NanoAb therapy that BiondVax is developing based on an exclusive license from Max-Planck-Innovation GmbH and an accompanying research collaboration with the Max Planck Institute for Multidisciplinary Sciences and University Medical Center Göttingen.
PEI is a part of the German national medicines agency; its experts are also involved in European Medicines Agency (EMA) committees. As PEI Scientific Advice is generally considered a first key step towards regulatory approval, the encouraging feedback is an important milestone towards BiondVax’s successful development of the COVID-19 NanoAb.
PEI also informs Germany’s pharmaceutical regulatory authority of new pharmaceutical product developments. While alignment with PEI advice is not a guarantee for marketing approval, it provides important advice regarding the scientific and regulatory principles for the development of the COVID-19 NanoAb. Therefore, a company’s alignment with PEI advice is widely considered a key drug development milestone.
PEI supports BiondVax’s plan for a first-in-human clinical trial to be conducted in patients as a combined Phase 1/2a, testing both safety and efficacy, thereby shortening BiondVax‘s clinical development timelines for its first NanoAb product, a COVID-19 therapeutic. Based on PEI ’s feedback and following proof-of-concept animal studies anticipated later this year to demonstrate efficacy via the inhalation route of administration, BiondVax plans to initiate a first-in-human Phase 1/2a clinical trial in 2023.
The Scientific Advice Meeting minutes sent by PEI state, “Generally, the PEI concurs with the proposed proof-of-concept study…and the overall nonclinical strategy that is required to support further clinical development as well as potential regulatory approval.”
Notably, PEI indicated support for conducting a combined Phase 1/2a first-in-human clinical trial that would include patients with confirmed COVID-19 infection. This would allow BiondVax to assess safety and efficacy in a single trial rather than the typical two trials, and therefore significantly accelerate its development timeline. This combined Phase 1/2a trial would follow preclinical proof-of-concept and toxicology, with a target start date in 2023.
Dr. Tamar Ben-Yedidia, BiondVax’s Chief Scientific Officer, who oversees BiondVax’s clinical development commented, “We thank the experts at the Paul Ehrlich Institute for their helpful and informative advice. BiondVax intends to align our development plans to PEI s advice, and I am pleased we have a clear path through preclinical and into clinical testing of the COVID-19 NanoAb therapy. As COVID 19 is expected to continue circulating for many years, its high infectivity rate poses a real challenge to vaccination campaigns due to the high costs to health care systems combined with the observed continuously declining immunity. Having a safe and effective therapeutic product, which is also convenient to use, since it may be self-administered directly to the infection site via inhalation, would offer tremendous value both for patients and to our health care systems.”
BiondVax’s COVID-19 NanoAb is being developed as a patient-friendly primary care product that may be self-administered through inhalation directly to the site of infection. Other valuable competitive advantages over existing therapies, demonstrated to date in lab tests, including stability at higher temperatures, superior binding affinity, and more efficient production. With the expectation that COVID-19 will continue to circulate while public interest in repetitive vaccinations wanes, BiondVax believes that these attributes position a successfully developed product to capture significant market share.
Furthermore, the European Investment Bank (the “EIB”) has successfully concluded negotiations and given formal approval of new terms of its outstanding €24 million loans (the “Loan”) to BiondVax.
BiondVax previously announced on March 14, 2022, that general terms of the restructuring had been agreed upon in principle.
The new terms include:
- Loan extension: An extension of the maturity dates from 2023 (€20 million) and 2024 (€4 million) until December 2027.
- Interest accrual: Although the Loan has been outstanding since 2018, interest on the Loan will only begin to accrue starting January 1, 2022, at an annual rate of 7%. The interest payments will be deferred until the new maturity date and will be added to the principal balance at the end of each year during the Loan period.
- Principal repayment: $900,000 will be paid by BiondVax shortly after the execution of the relevant amendment letter with the EIB. This amount will be applied to reduce the outstanding Loan. Going forward 10% of any capital raises until maturity will be used to further repay the Loan principal including any outstanding accrued interest.
- Variable remuneration to the EIB: Once BiondVax‘s commercial sales exceed €5 million, 3% of BiondVax‘s topline revenues will be paid to the EIB as royalties until the EIB receives (from the Loan repayment, inter alia the interest and the royalties) the higher of (i) a total of 2.8 times the original €24 million principal (as provided in the original Loan agreement) and (ii) 20% IRR on the principal calculated from January 1, 2022.
- Prepayment indemnity: In case BiondVax decides to discharge all liabilities under the Finance Contract inter alia payments of the variable remuneration BiondVax would need to repay to the EIB an indemnity amount in addition to the Loan principle and the accrued interest. The indemnity will be calculated such that the EIB receives an additional payment equal to the greater of (i) the prepayment amount (i.e. twice the prepayment amount in the aggregate) and (ii) the amount required to realize 20% IRR on the prepayment amount at the time of prepayment.
Amir Reichman, CEO of BiondVax, commented, “I am extremely pleased to announce the achievement of another major milestone in the relaunch of BiondVax; another ‘promise made, promise kept’. With the cooperation and support of the EIB, we have signed an amendment to our loan facility extending the maturity to December 2027 and clearing the path for us to aggressively pursue the development of a nanosized antibody (NanoAb) pipeline under an exclusive license and related collaboration agreements with the Max Planck Institute for Multidisciplinary Science and University Medical Center Gottingen, Germany. Since the March 2022 announcement of an agreement in principle to restructure the loan, all parties have worked diligently and in good faith to finalize documentation consistent with the announced terms, and we are grateful to our counterparties at the EIB for their efforts in this regard and support of our strategy and our team. We can now devote even more attention to the successful development of NanoAbs that address significant unmet medical needs in a patient-friendly, efficacious, and cost-efficient manner.”
BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV) is a biopharmaceutical company focused on developing, manufacturing and commercializing innovative products for the prevention and treatment of infectious diseases and other illnesses. Since its inception, the company has executed eight clinical trials including a seven-country, 12,400 participant Phase 3 trial of its vaccine candidate and has built a state-of-the-art manufacturing facility for biopharmaceutical products. With highly experienced pharmaceutical industry leadership, BiondVax is aiming to develop a pipeline of diversified and commercially viable products and platforms beginning with an innovative nanosized antibody (NanoAb) pipeline. www.biondvax.com.
Company: Joshua E. Phillipson | +972 8 930 2529 | j.phillipson AT biondvax.com
Investor Relations: Kenny Green | +1 212 378 8040 | kgreen AT edisongroup.com
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