BiondVax provides plan to address Nasdaq compliance

Rhea-AI Summary

BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV) announced it received two non-compliance letters from Nasdaq regarding minimum bid price and stockholders' equity. The first letter, dated October 27, 2022, indicated non-compliance with the $1.00 minimum bid price requirement, with a 180-day window to regain compliance. The second letter, from September 28, 2022, addressed the need for at least $2,500,000 in stockholders' equity. BiondVax has submitted plans to address these issues and is optimistic about future compliance and revenue generation through its innovative therapies.

Positive

• BiondVax submitted a plan to regain compliance with Nasdaq's stockholders' equity requirement of $2.5 million.
• The company is optimistic about regaining compliance with the minimum bid price of $1.00 for its ADSs within the specified 180-day period.
• Potential upcoming data from a preclinical COVID-19 NanoAb study may positively influence investor sentiment.
• BiondVax's GMP-ready biologics manufacturing facility could generate additional cash through CDMO services.

Negative

• BiondVax's shareholders' equity reported at $1,277,000, significantly below the required $2.5 million for Nasdaq listing.
• The company faces the risk of being delisted if it fails to meet Nasdaq's compliance requirements within the allotted time.

JERUSALEM, Nov. 2, 2022 /PRNewswire/ -- BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV) ("BiondVax"), a biotechnology company focused on developing, manufacturing, and commercializing innovative products for the prevention and treatment of infectious diseases and other illnesses, announced updates regarding two non-compliance letters received from the Nasdaq Stock Market ("Nasdaq"), including one dated October 27, 2022 regarding non-compliance with the requirement to maintain a minimum bid price of $1.00 per share. The company previously disclosed in a press release dated September 30, 2022, receipt of a first letter related to minimum shareholders' equity.

The Nasdaq letters are only notifications of deficiency and have no immediate effect on the listing or trading of the Company's American Depository Shares ("ADSs").

In response to the first notification letter from Nasdaq dated September 28, 2022, the company has submitted a plan to Nasdaq regarding actions by which it may regain compliance with Listing Rule 5550(b)(1) requiring listed Nasdaq companies to maintain a minimum of $2,500,000 in stockholders' equity for continued listing. The notification letter related to non-compliance was triggered by BiondVax's Form 6-K/A, dated August 29, 2022, disclosing financial information for the period ended June 30, 2022, which reported shareholders' equity of $1,277,000. BiondVax's executive leadership and board of directors believe the plan will enable the Company to regain compliance with the rule and sustain such compliance in the long term.

In addition, on October 27, 2022, the company received a second letter from Nasdaq indicating that, based on the closing bid price of the Company's ADSs for the last thirty consecutive business days, the company does not meet the requirement to maintain a minimum bid price of $1.00 per share for continued listing on Nasdaq under Nasdaq Listing Rule 5550(a)(2). In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company has been provided an initial period of 180 calendar days to regain compliance. The letter states that the Nasdaq staff will provide written confirmation that the Company has achieved compliance with Rule 5550(a)(2) if at any time before the 180-day period ends on April 25, 2023 the closing bid price of the Company's ADSs closes at $1.00 per share or more for a minimum of ten consecutive business days. BiondVax intends to monitor the closing bid price of its ADSs and may, if appropriate, consider implementing available options to regain compliance with the Minimum Bid Price Requirement.

Amir Reichman, BiondVax's CEO, explained, "We are optimistic that BiondVax's ADSs will regain compliance with Nasdaq listing rules for several reasons. To begin, as previously announced, we soon anticipate initial data from a preclinical proof-of-concept study of our inhaled COVID-19 NanoAb therapy. This will be the first scientific data readout of our nascent NanoAb pipeline. As well, exciting recent progress by our scientific collaborators at the Max Planck Institute for Multidisciplinary Sciences (MPG), and the University Medical Center Göttingen (UMG) may advance development of additional NanoAbs for the treatment of diseases such as psoriasis, asthma, psoriatic arthritis and macular degeneration. Further, we have several mechanisms available for generating cash including potential revenue by providing CDMO services leveraging our GMP-ready biologics manufacturing facility and team, applications for several non-dilutive research grants from governments and NGOs in addition to participation in research consortiums. Moreover, we filed an F1 with the SEC last month to maintain flexibility with respect to funding options of our R&D programs. While the stock market remains unfavorable for capital raising transactions, particularly for small cap companies, we believe aggressively advancing our scientific programs is the best path to create shareholder value to be reflected when the market regains some stability."

About BiondVax

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, BiondVax 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.

Contact Details

Company: Joshua E. Phillipson | +972 8 930 2529 | j.phillipson@biondvax.com

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Litigation Reform Act of 1995. Words such as "expect," "believe," "intend," "plan," "continue," "may," "will," "anticipate," and similar expressions are intended to identify forward-looking statements. All statements, other than statements of historical facts, included in this communication regarding strategy, future operations, future financings, future financial position, future revenue, projected expenses, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, the therapeutic and commercial potential of nanosized antibodies (NanoAbs); and the timing of NanoAb proof-of-concept studies and clinical trials. These forward-looking statements reflect management's current views with respect to certain current and future events and are subject to various risks, uncertainties and assumptions that could cause the results to differ materially from those expected by the management of BiondVax Pharmaceuticals Ltd. Risks and uncertainties include, but are not limited to, the risk that the company may not raise capital on acceptable terms or at all, the risk that the company will not submit a compliance plan acceptable to Nasdaq, the risk that the therapeutic and commercial potential of NanoAbs will not be met; the risk of a delay in the preclinical and clinical data for NanoAbs, if any; the risk that BiondVax may not be able to secure additional capital on attractive terms, if at all; risks relating to the COVID-19 (coronavirus) pandemic; BiondVax's ability to acquire rights to additional product opportunities; BiondVax's ability to enter into collaborations on terms acceptable to BiondVax or at all; timing of receipt of regulatory approval of BiondVax's manufacturing facility in Jerusalem, if at all or when required; the risk that the manufacturing facility will not be able to be used for a wide variety of applications and other vaccine and treatment technologies, and the risk that drug development involves a lengthy and expensive process with uncertain outcomes. More detailed information about the risks and uncertainties affecting the Company is contained under the heading "Risk Factors" in the Company's Annual Report on Form 20-F filed with the Securities and Exchange Commission on March 28, 2022. BiondVax undertakes no obligation to revise or update any forward-looking statement for any reason.

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SOURCE BiondVax Pharmaceuticals Ltd.

FAQ

What non-compliance issues did BiondVax Pharmaceuticals face with Nasdaq?

BiondVax received letters for non-compliance with the minimum bid price of $1.00 and stockholders' equity of $2.5 million.

What is BiondVax's plan to regain Nasdaq compliance?

BiondVax has submitted a plan to Nasdaq to address its stockholders' equity deficiency and aims to monitor its ADS bid price for compliance.

What is the deadline for BiondVax to meet Nasdaq's compliance requirements?

BiondVax has a 180-day period to regain compliance, ending on April 25, 2023.

What impact does the Nasdaq letter have on BiondVax's stock?

The letters are notifications of deficiency but do not have immediate effects on the trading of BiondVax's ADSs.

What future developments is BiondVax anticipating?

BiondVax expects initial data from a preclinical proof-of-concept study for its inhaled COVID-19 NanoAb therapy.