Press Releases
BiondVax to Present at Edison Group’s Open House Conference
Jerusalem, Israel – January 26, 2022 – BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), a biopharmaceutical company focused on developing, manufacturing and commercializing innovative products for the prevention and treatment of infectious diseases and other illnesses, today announced that it is presenting at the Edison Open House: Global Healthcare 2022 conference.
BiondVax’s presentation is currently available on-demand via the conference portal at https://www.edisongroup.com/edison-open-house-global-healthcare-2022.
BiondVax’s management will also be meeting with investors in a virtual 1-1 setting in relation to this conference. If you wish to set up a meeting with management, please do so via the conference portal or speak directly with investor relations at BiondVax.
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, 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. For more information, please visit www.biondvax.com.
Contact Details: Company: Joshua E. Phillipson | +972 8 930 2529 | j.phillipson@biondvax.com; Investor Relations: Kenny Green | +1 212 378 8040 | kgreen@edisongroup.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 press release regarding strategy, future operations, 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, statements regarding management’s participation in investor conferences. 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 BiondVax will not execute an additional agreement with the Max Planck Society and the University Medical Center Göttingen or that it will be delayed; 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 and EIB will not reach agreement with respect to the restructuring of the loan from European Investment Bank; the risk that BiondVax may not be able to secure additional capital on attractive terms, if at all; the risk that the European Investment Bank may accelerate the loans under its finance contract with BiondVax; 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 prospectus supplement filed with the Securities and Exchange Commission on December 28, 2021. BiondVax undertakes no obligation to revise or update any forward-looking statement for any reason.
BiondVax to Present at H.C. Wainwright Bioconnect Virtual Conference
Jerusalem, Israel – January 10, 2022 – BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), a biopharmaceutical company focused on developing, manufacturing and commercializing innovative products for the prevention and treatment of infectious diseases and other illnesses, today announced that it will present a company overview at the H.C. Wainwright Bioconnect Virtual Conference.
BiondVax’s presentation will be available on-demand from January 10 to 13, 2022 to attendees registering via H.C. Wainwright at https://hcwevents.com/bioconnect/. The slide deck will also be made available on BiondVax’s website at https://www.biondvax.com/investors.
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, 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. For more information, please visit www.biondvax.com.
Contact Details: Company: Joshua E. Phillipson | +972 8 930 2529 | j.phillipson@biondvax.com; Investor Relations: Kenny Green | +1 212 378 8040 | kgreen@edisongroup.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 press release regarding strategy, future operations, 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, statements regarding management’s participation in investor conferences. 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 BiondVax will not execute an additional agreement with the Max Planck Society and the University Medical Center Göttingen or that it will be delayed; 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 and EIB will not reach agreement with respect to the restructuring of the loan from European Investment Bank; the risk that BiondVax may not be able to secure additional capital on attractive terms, if at all; the risk that the European Investment Bank may accelerate the loans under its finance contract with BiondVax; 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 prospectus supplement filed with the Securities and Exchange Commission on December 28, 2021. BiondVax undertakes no obligation to revise or update any forward-looking statement for any reason.
BiondVax Announces Successful Closing of $9.8 million Follow-on Underwritten Offering of ADSs Including Exercise of the Over-Allotment
Jerusalem, Israel – December 29, 2021 – BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), a biopharmaceutical company focused on developing, manufacturing and commercializing innovative products for the prevention and treatment of infectious diseases and other illnesses, today announced the closing of an underwritten public offering of 4,144,068 American Depositary Shares ("ADSs") at a public offering price of $2.36 per ADS for gross proceeds to the Company of approximately $9.8 million in the aggregate, inclusive of the successful execution of the full over-allotment, before deducting underwriting discounts and other offering expenses. Each ADS represents 40 ordinary shares of BiondVax.
Amir Reichman, CEO of BiondVax, commented, “This successful offering is an important event for BiondVax as it provides us with increased capital to fund our recently announced nanosized antibody (NanoAb) program being conducted in collaboration with the world-renowned Max Planck Institute. Development of an innovative COVID-19 NanoAb therapy that exhibits significant potential competitive advantages over existing therapies has already begun, and next month we expect to sign a broader collaboration for the development of additional NanoAbs addressing diseases with large unmet medical needs and attractive commercial opportunities. I would like to thank all those who have supported our recent successes and I warmly welcome the new investors to our story.”
BiondVax intends to use the net proceeds from this offering for the advancement of its recently announced nanosized antibody (NanoAb) development program as well as for general corporate purposes, including, but not limited to, working capital, research and development activities, regulatory matters, capital investment or other related purposes. It may also use a portion of any net proceeds to in-license, invest in or acquire businesses, assets or technologies that it believes are complementary to its business focus, although it has no current commitments or agreements in those regards.
Aegis Capital Corp. acted as the sole book-running manager for the offering.
The ADS described above are being offered by the Company pursuant to a "shelf" registration statement on Form F-3 (333-240189) filed with the Securities and Exchange Commission (the "SEC") and declared effective by the SEC on August 10, 2020. A final prospectus supplement relating to, and describing the terms of, the offering has been filed with the SEC and is available on the SEC's website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may also be obtained from Aegis Capital Corp., Attention: Syndicate Department, 810 7th Avenue, 18th Floor, New York, NY 10019, by email at syndicate@aegiscap.com, or by telephone at (212) 813-1010.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy the securities described herein, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.
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, 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. For more information, please visit www.biondvax.com.
Contact Details: Company: Joshua E. Phillipson | +972 8 930 2529 | j.phillipson@biondvax.com; Investor Relations: Kenny Green | +1 212 378 8040 | kgreen@edisongroup.com
Forward Looking Statements: The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by us or on our behalf. This press release contains statements which constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, including but not limited to statements regarding BiondVax's ability to complete the offering, expected gross proceeds, expected closing date of the offering and the expected use of the proceeds from the offering. Any statement that is not historical in nature is a forward-looking statement and may be identified by the use of words and phrases such as "expects," "anticipates," "believes," "will," "will likely result," "will continue," "plans to," "potential," "promising," and similar expressions. These statements are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including the risk factors described under the heading "Risk Factors" set forth in the Company's reports filed with the SEC from time to time. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. BiondVax undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Readers are cautioned that it is not possible to predict or identify all the risks, uncertainties and other factors that may affect future results and that the risks described herein should not be considered a complete list.
Former CFO of GSK’s Global Vaccines Business Mr. Jay Green Joins BiondVax’s Board of Directors
Mr. Jay Green joins BiondVax’s Board of Directors. Mr. Green recently completed a six-year term as Senior Vice President Finance and CFO of GlaxoSmithKline plc’s (NYSE: GSK) global vaccines business. Since 2020, Mr. Green has served in an advisory role to Gavi for COVAX, an international initiative to support equitable distribution of COVID-19 vaccines.
Jay Green, new member of BiondVax’s Board of Directors
Jerusalem, Israel – December 27, 2021 – BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), a biopharmaceutical company focused on developing, manufacturing and commercializing innovative products for the prevention and treatment of infectious diseases and other illnesses, today announced that all proposed resolutions were approved at today’s Annual General Meeting of Shareholders, including the election of Mr. Jay Green to the Company’s Board of Directors. Mr. Green recently completed a six-year term as Senior Vice President Finance and CFO of GlaxoSmithKline plc’s (NYSE: GSK) global vaccines business. Concurrently, Mr. Isaac Devash retired from the Board of Directors.
Mark Germain, BiondVax’s Chairman of the Board of Directors, stated, “We’re very excited to have Jay join our board of directors, particularly as we relaunch the company’s R&D efforts around the unique nanosized antibody (NanoAb) program in collaboration with the Max Planck Institute. Jay’s experience serving as GSK Vaccine’s SVP Finance/CFO and his current involvement in the global COVID‑19 response as an advisor to Gavi for COVAX is highly relevant and adds a significant dimension to our Board. We aim to leverage his broad knowledge and deep connections as we progress in developing our NanoAbs program, beginning with a highly promising COVID-19 therapy.”
Continued Mr. Germain, “On a personal note, I wish to thank Isaac Devash for his many years of valued service to BiondVax. Isaac has been a dedicated leader on the board and instrumental and highly supportive in our efforts to relaunch the company. He remains a friend to the company and through our successful turnaround we intend to make him proud of the time and effort he has devoted.”
Jay Green commented, “I am pleased to join BiondVax as we begin work on the nanosized antibody (NanoAb) pipeline towards new and improved therapies for multiple diseases with substantial commercial potential. BiondVax is a company with significant opportunity, at a new and exciting inflection point, and I look forward to helping them deliver value to both patients and investors in the near and long term.”
About Jay Green: Mr. Jay Green, CPA, CA, MAcc, recently completed a 19-year career with GSK across several progressive leadership positions in GSK’s three businesses of consumer healthcare, pharmaceuticals, and vaccines, as well as corporate development. He also led GSK’s global enterprise resource planning (ERP) program, one of the largest IT-enabled business transformation programs in the company’s history. Mr. Green most recently served from 2014 to 2020 as Senior Vice President, Finance and CFO of GSK’s global vaccines business. Since 2020, Mr. Green has served in an advisory role to Gavi for COVAX, an international initiative to support equitable distribution of COVID-19 vaccines. He is a Chartered Professional Accountant who holds a Master of Accounting from the University of Waterloo, Ontario, Canada.
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, 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 pipeline. For more information, please visit www.biondvax.com.
Contact Details: Company: Joshua E. Phillipson | +972 8 930 2529 | j.phillipson@biondvax.com; Investor Relations: Kenny Green | +1 212 378 8040 | kgreen@edisongroup.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 press release regarding strategy, future operations, 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, statements regarding execution of an additional agreement with the Max Planck Society and the University Medical Center Göttingen; the therapeutic and commercial potential of NanoAbs; the company’s NanoAb program, the potential for NanoAbs to safely and effectively target COVID-19, and the timing of preclinical and clinical data for NanoAbs and the timing of future clinical trial data. 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 BiondVax will not execute an additional agreement with the Max Planck Society and the University Medical Center Göttingen or that it will be delayed; 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 and EIB will not reach agreement with respect to the restructuring of the loan from EIB; the risk that BiondVax may not be able to secure additional capital on attractive terms, if at all; the risk that the European Investment Bank may accelerate the loans under its finance contract with BiondVax; the risk that BiondVax may not execute a strategic alternative to M-001 or implement a strategy that will diversify BiondVax’s risk, and, if executed, may not be successful; 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 May 13, 2021. BiondVax undertakes no obligation to revise or update any forward-looking statement for any reason.
BiondVax Announces Pricing of $9.0 million Follow-on Underwritten Offering of American Depositary Shares
Jerusalem, Israel - December 27, 2021 - BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), a biopharmaceutical company focused on developing, manufacturing and commercializing innovative products for the prevention and treatment of infectious diseases and other illnesses, today announced the pricing of an underwritten public offering of 3,813,560 American Depositary Shares ("ADSs") at a public offering price of $2.36 per ADS for gross proceeds to the Company of approximately $9.0 million, before deducting underwriting discounts and other offering expenses. Each ADS represents 40 ordinary shares of BiondVax.
BiondVax intends to use the net proceeds from this offering for the advancement of its recently announced nanosized antibody (NanoAb) development program as well as for general corporate purposes, including, but not limited to, working capital, research and development activities, regulatory matters, capital investment or other related purposes. It may also use a portion of any net proceeds to in-license, invest in or acquire businesses, assets or technologies that it believes are complementary to its business focus, although it has no current commitments or agreements in those regards.
The offering is expected to close on or about December 29, 2021, subject to customary closing conditions. In connection with the offering, the Company has also granted the underwriters a 45-day option to purchase additional ADSs offered to the public at the public offering price, less underwriting discount, for covering over-allotments, if any. If the over-allotment option is exercised in full it would increase the total gross proceeds of the offering to approximately $9.8 million.
Aegis Capital Corp. is acting as the sole book-running manager for the offering.
The ADS described above are being offered by the Company pursuant to a "shelf" registration statement on Form F-3 (333-240189) filed with the Securities and Exchange Commission (the "SEC") and declared effective by the SEC on August 10, 2020. An electronic preliminary prospectus supplement and the accompanying prospectus relating to the offering has been filed with the SEC and is available on the SEC's website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering may also be obtained from Aegis Capital Corp., Attention: Syndicate Department, 810 7th Avenue, 18th Floor, New York, NY 10019, by email at syndicate@aegiscap.com, or by telephone at (212) 813-1010. A final prospectus supplement and accompanying base prospectus describing the final terms of the offering will be filed with the SEC and, when available, may be obtained by accessing the SEC's website or by contacting Aegis Capital Corp. at the phone number and email address listed in the previous sentence.
Before buying any of the BiondVax ADSs, investors should read the preliminary prospectus supplement and accompanying prospectus and other documents incorporated by reference therein, available on the SEC's website, for more complete information about the Company and this offering.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy the securities described herein, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.
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, 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. For more information, please visit www.biondvax.com.
Contact Details: Company: Joshua E. Phillipson | +972 8 930 2529 | j.phillipson@biondvax.com; Investor Relations: Kenny Green | +1 212 378 8040 | kgreen@edisongroup.com
Forward Looking Statements: The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by us or on our behalf. This press release contains statements which constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, including but not limited to statements regarding BiondVax's ability to complete the offering, expected gross proceeds, expected closing date of the offering and the expected use of the proceeds from the offering. Any statement that is not historical in nature is a forward-looking statement and may be identified by the use of words and phrases such as "expects," "anticipates," "believes," "will," "will likely result," "will continue," "plans to," "potential," "promising," and similar expressions. These statements are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including the risk factors described under the heading "Risk Factors" set forth in the Company's reports filed with the SEC from time to time. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. BiondVax undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Readers are cautioned that it is not possible to predict or identify all the risks, uncertainties and other factors that may affect future results and that the risks described herein should not be considered a complete list.
BiondVax Announces Proposed Underwritten Public Offering of American Depositary Shares
Jerusalem, Israel - December 23, 2021 - BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), a biopharmaceutical company focused on developing, manufacturing and commercializing innovative products for the prevention and treatment of infectious diseases and other illnesses, today announced that it intends to offer its American Depositary Shares (“ADSs”) in an underwritten public offering.
As announced yesterday (Dec 22, 2021), BiondVax has signed definitive agreements with the Max Planck Society (MPG), the parent organization of the Max Planck Institute of Biophysical Chemistry, and the University Medical Center Göttingen (UMG), both in Germany, to enter into a strategic collaboration for the development and commercialization of innovative COVID-19 nanosized antibodies (NanoAbs). These NanoAbs exhibited in-vitro neutralization of all COVID-19 variants of concern including Delta, and based on in-silico studies, Omicron, at significantly lower dose levels than existing antibody treatments. These agreements are part of a broader collaboration, expected to be signed in January 2022, covering development and commercialization of NanoAbs for several other disease indications with large market sizes that leverage their unique binding affinity, stability at high temperatures, and potential for more effective and convenient routes of administration.
The Company intends to use the net proceeds from this offering for the advancement of its NanoAbs development program as well as general corporate purposes, including, but not limited to, working capital, research and development activities, regulatory matters, capital investment or other related purposes. It may also use a portion of any net proceeds to in-license, invest in or acquire businesses, assets or technologies that it believes are complementary to its business focus, although it has no current commitments or agreements in those regards. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.
Aegis Capital Corp. is acting as the sole book-running manager for the offering.
This offering is being made pursuant to an effective shelf registration statement on Form F-3 (No. 333-240189) previously filed with the U.S. Securities and Exchange Commission (the "SEC") and declared effective by the SEC on August 10, 2020. A preliminary prospectus supplement and accompanying prospectus describing the terms of the proposed offering will be filed with the SEC and will be available on the SEC's website located at http://www.sec.gov. Electronic copies of the preliminary prospectus supplement and the accompanying prospectus may be obtained, when available, by contacting Aegis Capital Corp., Attention: Syndicate Department, 810 7th Avenue, 18th floor, New York, NY 10019, by email at syndicate@aegiscap.com, or by telephone at (212) 813-1010. Before investing in this offering, interested parties should read in their entirety the prospectus supplement and the accompanying prospectus and the other documents that the Company has filed with the SEC that are incorporated by reference in such prospectus supplement and the accompanying prospectus, which provide more information about the Company and such offering.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
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, 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. For more information, please visit www.biondvax.com.
Contact Details: Company: Joshua E. Phillipson | +972 8 930 2529 | j.phillipson@biondvax.com; Investor Relations: Kenny Green | +1 212 378 8040 | kgreen@edisongroup.com
Forward Looking Statements: The Private Securities Litigation Reform Act of 1995 provides a safe harbor for forward-looking statements made by us or on our behalf. This press release contains statements which constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, including but not limited to statements regarding BiondVax’s intention to conduct an offering and sale of securities, ability to complete the offering and the expected use of the proceeds from the offering. Any statement that is not historical in nature is a forward-looking statement and may be identified by the use of words and phrases such as “expects,” “anticipates,” “believes,” “will,” “will likely result,” “will continue,” “plans to,” “potential,” “promising,” and similar expressions. These statements are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including the risk factors described under the heading “Risk Factors” set forth in the Company’s reports filed with the SEC from time to time. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. BiondVax undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Readers are cautioned that it is not possible to predict or identify all the risks, uncertainties and other factors that may affect future results and that the risks described herein should not be considered a complete list.
BiondVax signs definitive agreements for development and commercialization of innovative nanosized COVID-19 antibody therapy
Max Planck Institute of Biophysical Chemistry, a world leading research institute, together with University Medical Center Göttingen have developed unique nanosized antibodies (NanoAbs*) for the treatment of COVID-19 that exhibit significant competitive advantages over existing therapies;
BiondVax to lead development and commercialization with exclusive worldwide license; initial human clinical trials results expected in 2023;
In-vitro data shows neutralization of all COVID-19 variants of concern including Delta, and based on in-silico studies, Omicron, at significantly lower dose levels than existing antibody treatments; These NanoAbs are also stable at very high temperatures and will be developed for convenient inhalation administration targeting the virus directly in the lungs and airways;
Broader collaboration for the development of additional NanoAbs addressing diseases with large unmet medical needs and attractive commercial opportunities expected to be signed in January 2022.
Jerusalem, Israel – December 22, 2021 – BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), a biopharmaceutical company focused on developing, manufacturing and commercializing innovative products for the prevention and treatment of infectious diseases and other illnesses, today announced the signing of definitive agreements with the Max Planck Society (MPG), the parent organization of the Max Planck Institute of Biophysical Chemistry, and the University Medical Center Göttingen (UMG), both in Germany, to enter into a strategic collaboration for the development and commercialization of innovative COVID-19 nanosized antibodies (NanoAbs*). These agreements are part of a broader collaboration, expected to be signed in January 2022, covering development and commercialization of NanoAbs for several other disease indications with large market sizes that leverage their unique binding affinity, stability at high temperatures, and potential for more effective and convenient routes of administration.
The lead NanoAb candidates for the COVID-19 program, developed by Professor Dirk Görlich, Director at the Max Planck Institute of Biophysical Chemistry, and Professor Matthias Dobbelstein, Professor of Molecular Oncology at the UMG, exhibit a strong competitive edge over existing COVID-19 therapies. For example, the NanoAbs exhibit superior affinity to the target, neutralizing the SARS-COV-2 virus, in-vitro, at drug concentrations about 100-times lower than those required by currently commercially available monoclonal antibodies. This may lead to increased efficacy, reduced side effects, and allow production at a lower cost. In addition, the NanoAbs’ small size and hyper-thermostability at 95°C (200°F) potentially enables administration through inhalation and longer shelf life, and potentially avoids the need for enhanced cold chain storage and transport. Together, these attributes are designed to create significant competitive advantages.
The NanoAbs have demonstrated strong neutralization at very low concentrations of major Variants of Concern (VoCs) including Alpha, Beta, Gamma and Delta in in-vitro studies in Görlich’s and Dobbelstein’s laboratories and based on in-silico studies, are expected to neutralize Omicron. Given the potential of additional emerging VoCs, the BiondVax-MPG-UMG collaboration covers development of new NanoAbs as needed during the evolution of COVID-19. The methodologies employed by the Görlich and Dobbelstein labs enable generation of new NanoAb candidates within weeks of acquiring the sequence for any emerging variant, and thereby positions BiondVax to stay at the forefront of COVID-19 preparedness.
In addition to the COVID-19 NanoAb collaboration and as previously announced, BiondVax, MPG and UMG have signed a term-sheet for development of NanoAbs towards other indications with major opportunities in key therapeutic areas of psoriasis, asthma, macular degeneration, and psoriatic arthritis. These are all diseases with known and validated antibody drug targets (thereby shortening development timelines and lowering risk), and where the NanoAb advantages have the potential to capture significant market share. BiondVax anticipates finalizing the collaboration agreements for these additional NanoAbs in January 2022.
BiondVax is planning a rapid development path that leverages the company’s expertise and capabilities in biological drug development and manufacturing. In particular, NanoAbs can be mass-produced through recombinant protein manufacturing in sites such as BiondVax’s GMP biologics manufacturing facility in Jerusalem. BiondVax anticipates conducting COVID-19 NanoAb preclinical studies in 2022 with initial human clinical trials results in 2023.
Mr. Amir Reichman, BiondVax’s CEO, commented, “As Omicron’s recent and rapid emergence makes clear, improved therapeutics are needed to bring COVID-19 under control. The innovative COVID-19 NanoAb candidates offer the potential for a superior therapeutic platform. Overall, the NanoAb platform is an incredible opportunity for BiondVax. It will serve as a basis for an exciting new pipeline of commercially attractive products to address unmet therapeutic needs of diseases such as psoriasis, psoriatic arthritis, asthma, and macular degeneration. The technology is a great fit to our manufacturing site in Jerusalem and our experience and expertise in biological drug development. I wish to thank Professors Görlich and Dobbelstein for their enthusiasm for this project, and Max Planck Innovation’s technology transfer team including Dr. Dieter Link for their assistance in developing this innovative collaboration. BiondVax is in the process of a transformative turnaround, and I am highly confident that these NanoAb therapies present compelling commercial potential and will address important healthcare needs.”
Professor Dirk Görlich, Director at the Max Planck Institute for Biophysical Chemistry, commented, “We believe that the innovative platform developed at the Max Planck Institute for Biophysical Chemistry and the University Medical Center of Göttingen has great potential to provide patients with superior therapies. We are particularly pleased to team with BiondVax to use their drug development and manufacturing capabilities and expertise to advance the COVID-19 nanosized antibodies through additional development towards marketing approvals.”
The collaboration has been facilitated by kENUP, a civic society organization promoting innovative industries in Europe.
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, 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 pipeline. For more information, please visit www.biondvax.com.
* About NanoAbs: NanoAbs are novel nanosized antibodies also known as VHH-antibodies or nanobodies. Nanobody is a trademark registered by ABLYNX N.V., a wholly owned subsidiary of Sanofi. BiondVax has no affiliation with and is not endorsed by Sanofi. The NanoAbs created by Professors Görlich and Dobbelstein exhibit potential to serve as highly attractive therapies for COVID-19, as described in their paper titled “Neutralization of SARS-CoV-2 by highly potent, hyperthermostable, and mutation-tolerant nanobodies” published in The EMBO Journal and available at https://doi.org/10.15252/embj.2021107985. Subsequent to publication of the paper earlier this year, Professors Görlich and Dobbelstein have generated a newer generation of nanoAbs that have been specifically selected for potent neutralization of Alpha, Beta, Gamma, and Delta variants. Based on in-silico studies, they are also expected to neutralize Omicron. These NanoAbs are also included in the collaboration and exclusive licensing agreement with BiondVax.
Contact Details
Company: Joshua E. Phillipson | +972 8 930 2529 | j.phillipson@biondvax.com
Investor Relations: Kenny Green | +1 212 378 8040 | kgreen@edisongroup.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 press release regarding strategy, future operations, 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, statements regarding execution of an additional agreement with the Max Planck Society and the University Medical Center Göttingen; the therapeutic and commercial potential of NanoAb antibodies, the company’s NanoAb program, the potential for NanoAbs to safely and effectively target COVID-19, the timing of preclinical and clinical data for NanoAbs and the timing of future clinical trial data. 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 BiondVax will not execute additional agreements with the Max Planck Society and the University Medical Center Göttingen or that it will be delayed; the risk that the therapeutic and commercial potential of NanoAb antibodies will not be met; the risk of a delay in the preclinical and clinical data for NanoAbs, if any; the risk that BiondVax and EIB will not reach agreement with respect to the restructuring of the loan from EIB; the risk that BiondVax may not be able to secure additional capital on attractive terms, if at all; the risk that the European Investment Bank may accelerate the loans under its finance contract with BiondVax; the risk that BiondVax may not execute a strategic alternative to M-001 or implement a strategy that will diversify BiondVax’s risk, and, if executed, may not be successful; 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 May 13, 2021. BiondVax undertakes no obligation to revise or update any forward-looking statement for any reason.
BiondVax announces Third Quarter 2021 Financial Results and Provides Business Update
Jerusalem, Israel – November 30, 2021 – BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), which focuses on developing, manufacturing and commercializing innovative products for the prevention and treatment of infectious diseases and other illnesses, today published its third quarter financial results for the quarter ended September 30, 2021 and provided a business update.
Business Update
As recently announced, BiondVax signed a term sheet with the world-renowned Max Planck Society (MPG) and the University Medical Center Göttingen (UMG), Germany, for a broad strategic collaboration for the creation of an innovative VHH-antibody (VHH-Ab) pipeline.
VHH antibodies exhibit distinct advantages over monoclonal antibodies for a number of disease conditions. The collaboration with MPG and UMG would focus on large addressable markets, with known and validated drug targets (thereby shortening development timelines and lowering risk), and where the VHH-Ab advantages have the potential to capture significant market share. Scientists at MPG and UMG are among the leaders worldwide in designing VHH-Abs with superior specificity and binding affinity, traits which can increase efficacy, reduce side effects, and at a lower cost than currently available monoclonal antibodies. In addition, the small size and thermostability of VHH‑Abs allows treatment through inhalation, intradermal and other favorable routes of administration and without the need for enhanced cold chain storage and transport. Together, these attributes have the potential to create significant competitive advantages.
Manufacturing preparations underway: To accelerate development timelines, BiondVax has initiated preparations for the manufacturing of VHH-Abs at the Company’s GMP biologics manufacturing facility in Jerusalem. Furthermore, BiondVax’s current and 2022 planned activities, such as setting-up equipment, developing analytical methods, and training staff, will be oriented toward all VHH-antibody production arising out of the collaboration.
COVID-19 variants of concern: Max Planck’s currently developed VHH-Ab has demonstrated superior neutralization of all major Variants of Concern (VoC), including Delta. The COVID-19 license agreement between BiondVax and Max Planck will also include an accompanying research collaboration agreement that provides BiondVax with exclusive access to ongoing life-cycle improvements of the COVID-19 VHH-Abs for emerging VoCs including Omicron.
The European Investment Bank (EIB) has indicated that it supports BiondVax’s new strategic turnaround plans. The parties are currently in discussions to renegotiate the terms of the EIB’s €24 million loan to BiondVax in a manner that would serve both parties’ long-term interests. BiondVax will update its shareholders regarding terms of such negotiations if and once the parties reach an agreement.
The Annual General Meeting (AGM) of Shareholders of the Company will be held on December 27, 2021. Resolutions to be voted upon at the AGM include the election to the Company’s Board of Directors of Jay Green, former Senior Vice President Finance and CFO of GlaxoSmithKline plc (NYSE: GSK) global vaccine business. Further information about the AGM, including a link to the Proxy Statement and voting card, are available on the SEC website at https://www.sec.gov/Archives/edgar/data/0001611747/000121390021060974/ea151013-6k_biondvaxpharma.htm. Shareholders are invited to contact their broker for voting procedures.
Amir Reichman, BiondVax’s CEO, stated, “The innovative VHH-antibody platform, combined with our agile manufacturing capabilities and planned ongoing collaboration with Max Planck, will enable us to respond quickly to new COVID variants of concern, including Omicron. By preparing now to manufacture batches in-house for preclinical studies, we are streamlining manufacturing for clinical and commercial batches of therapies for known and emerging COVID-19 variants, as well as for the anticipated psoriasis, asthma, macular degeneration, and psoriatic arthritis VHH-antibody therapies. BiondVax is in the process of a transformative turnaround, and we are working with urgency to bring VHH-antibody therapies with compelling commercial potential that address important healthcare needs to the market.”
Financial Summary
Results are in New Israel Shekels (NIS) and convenience translation to $US is provided using the exchange rate of 3.229 (NIS/$US), the rate as of the close of business on September 30, 2021.
R&D expenses for the three months ended September 30, 2021 decreased to NIS 2.0 million ($0.6 million) from NIS 12.6 million for the three months ended September 30, 2020. This decrease was primarily attributable to expenses related to a Phase 3 clinical trial and related operations at our biologics manufacturing facility that took place during Q3 2020. As previously reported, the trial concluded in Q4 2020.
Marketing, general and administrative expenses for the three months ended September 30, 2021 decreased to NIS 6.2 million ($1.9 million) from NIS 7.3 million for the three months ended September 30, 2020. This decrease of NIS 1.1 million ($0.34 million) was primarily due to a decrease of NIS 0.4 million in salary and salary related expenses, decrease of NIS 1.6 million in share-based payments expenses offset with increased professional expenses of NIS 0.7 million.
Operating expenses for the three months ended September 30, 2021 were NIS 8.2 million ($2.5 million) compared with NIS 20.0 million for the three months ended September 30, 2020.
As of September 30, 2021, BiondVax had cash and cash equivalents of NIS 34.6 million ($10.7 million) as compared to NIS 39.9 million as of June 30, 2021.
Unaudited Q3 financial results will be submitted to the Securities and Exchange Commission. A summary is included in the tables below.
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, 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. www.biondvax.com.
Contact Details
Company: Joshua E. Phillipson | +972 8 930 2529 | j.phillipson@biondvax.com
Investor Relations: Kenny Green | +1 212 378 8040 | kgreen@edisongroup.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 press release regarding strategy, future operations, 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, statements regarding execution of a definitive agreement with the Max Planck Society and the University Medical Center Göttingen; the therapeutic and commercial potential of VHH antibodies and agreement with EIB regarding the restructuring of the loan from EIB. 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 BiondVax will not execute a definitive agreement with the Max Planck Society and the University Medical Center Göttingen; the risk that the therapeutic and commercial potential of VHH antibodies will not be met; the risk that BiondVax and EIB will not reach agreement with respect to the restructuring of the loan from EIB; the risk that BiondVax may not be able to secure additional capital on attractive terms, if at all; the risk that the European Investment Bank may accelerate the loans under its finance contract with BiondVax; the risk that BiondVax may not execute a strategic alternative to M-001 or implement a strategy that will diversify BiondVax’s risk, and, if executed, may not be successful; 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 May 13, 2021. BiondVax undertakes no obligation to revise or update any forward-looking statement for any reason.
BALANCE SHEETS | |||||||||
In thousands, except share and per share data | |||||||||
Convenience | |||||||||
Translation | |||||||||
December 31, | September 30, | September 30, | |||||||
2020 | 2020 | 2021 | 2021 | ||||||
Audited | Unaudited | Unaudited | |||||||
N I S | U.S. dollars | ||||||||
CURRENT ASSETS: | |||||||||
Cash and cash equivalents | 9,421 | 24,774 | 34,672 | 10,738 | |||||
Other receivables | 1,204 | 2,930 | 1,426 | 442 | |||||
10,625 | 27,704 | 36,098 | 11,180 | ||||||
LONG–TERM ASSETS: | |||||||||
Property, plant and equipment | 39,607 | 39,889 | 38,607 | 11,956 | |||||
Right-of-use assets | 6,206 | 6,433 | 5,874 | 1,819 | |||||
Other long-term assets | 473 | 891 | 446 | 138 | |||||
46,286 | 47,213 | 44,927 | 13,913 | ||||||
56,911 | 74,917 | 81,025 | 25,093 | ||||||
CURRENT LIABILITIES: | |||||||||
Trade payables | 1,868 | 8,213 | 3,313 | 1,026 | |||||
Operating lease liabilities | 654 | 653 | 777 | 241 | |||||
Loan from others | 60,421 | - | 64,488 | 19,972 | |||||
Other payables | 1,246 | 2,289 | 1,693 | 524 | |||||
64,189 | 11,155 | 70,271 | 21,763 | ||||||
LONG–TERM LIABILITIES: | |||||||||
Operating lease liabilities | 6,088 | 6,268 | 5,905 | 1,829 | |||||
Loan from others | - | 59,242 | - | - | |||||
Other payables | 1,135 | - | 568 | 176 | |||||
Severance pay liability, net | 95 | 93 | 95 | 29 | |||||
7,318 | 65,603 | 6,568 | 2,034 | ||||||
SHAREHOLDERS' EQUITY: | |||||||||
Ordinary shares of no par value: Authorized: 1,800,000,000 | *) - | *) - | *) - | *) - | |||||
Share premium | 310,197 | 308,855 | 358,204 | 110,933 | |||||
Accumulated deficit | (324,793) | (310,696) | (354,018) | (109,637) | |||||
(14,596) | (1,841) | 4,186 | 1,296 | ||||||
56,911 | 74,917 | 81,025 | 25,093 | ||||||
*) Represents less than NIS\USD 1. | |||||||||
STATEMENTS OF COMPREHENSIVE LOSS | |||||||||||||||||||
In thousands, except share and per share data | |||||||||||||||||||
Convenience translation | |||||||||||||||||||
Year ended December 31, | Three months ended September 30, | Nine months ended September 30, | Nine months ended September 30, | ||||||||||||||||
2020 | 2020 | 2021 | 2020 | 2021 | 2021 | ||||||||||||||
Audited | Unaudited | Unaudited | |||||||||||||||||
N I S | U.S. dollars | ||||||||||||||||||
(In thousands, except per share data) | |||||||||||||||||||
Operating expenses: | |||||||||||||||||||
Research and development, net of participations | 51,463 | 12,579 | 2,024 | 43,595 | 6,677 | 2,068 | |||||||||||||
Marketing, general and administrative | 16,687 | 7,303 | 6,201 | 12,423 | 17,208 | 5,329 | |||||||||||||
Other income | (75,484) | (75,485) | - | (75,485) | - | - | |||||||||||||
Total operating expenses (income) | (7,334) | (55,603) | 8,225 | (19,467) | 23,885 | 7,397 | |||||||||||||
Operating income (loss) | 7,334 | 55,603 | (8,225) | 19,467 | (23,885) | (7,397) | |||||||||||||
Financial income | 3,843 | - | 1,980 | 5,034 | 2,802 | 868 | |||||||||||||
Financial expense | (15,632) | (288) | (2,801) | (14,859) | (8,142) | (2,522) | |||||||||||||
Net Income (loss) | (4,455) | 55,315 | (9,046) | 9,642 | (29,225) | (9,051) | |||||||||||||
Basic net income (loss) per share (NIS) | (0.01) | 0.12 | (0.02) | 0.02 | (0.05) | (0.02) | |||||||||||||
Diluted net income (loss) per share (NIS) | (0.01) | 0.10 | (0.02) | 0.02 | (0.05) | (0.02) | |||||||||||||
Weighted average number of shares outstanding used to compute basic and diluted loss per share | 443,260,878 | 461,046,640 | 573,205,607 | 437,381,202 | 559,239,052 | 559,239,052 | |||||||||||||
Weighted average number of shares outstanding used to compute diluted income (loss) per share | 443,260,878 | 538,495,403 | 573,205,607 | 497,489,765 | 559,239,052 | 559,239,052 | |||||||||||||
The notes in the Company's quarterly report are an integral part of the financial statements. The complete financial results are available in the Form 6-K to be filed with the Securities and Exchange Commission. | |||||||||||||||||||
BiondVax Announces Notice of Annual General Meeting of Shareholders and Provides a Business Update
Jerusalem, Israel – November 24, 2021 – BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), which focuses on developing, manufacturing and commercializing innovative products for the prevention and treatment of infectious diseases and other illnesses, reports that the Annual General Meeting (AGM) of Shareholders of the Company will be held on December 27, 2021 in Tel Aviv, Israel.
Jay Green, former GSK Vaccines CFO
Resolutions to be voted upon at the AGM include the election of Mr. Jay Green to the Company’s Board of Directors. Mr. Green recently completed a six-year term as Senior Vice President Finance and CFO of GlaxoSmithKline plc (NYSE: GSK)’s global vaccines business, at a time when GSK was the world’s largest vaccines manufacturer.
Business Update:
Last month BiondVax signed a term sheet with the world-renowned Max Planck Institute in Göttingen, Germany for a broad strategic collaboration for creation of an innovative VHH-antibody (nanobody [1] ) pipeline. Upon execution of the final agreements, anticipated by this coming January, BiondVax will:
Exclusively license the COVID-19 VHH-antibody described by Max Planck professors in their paper titled ‘Neutralization of SARS-CoV-2 by highly potent, hyper-thermostable, and mutation-tolerant nanobodies’ and published earlier this year. [2]
Initiate a five-year collaboration to create additional VHH-antibody candidates for treatment of other diseases including psoriasis, asthma, macular degeneration, and psoriatic arthritis. BiondVax would have an exclusive option to receive exclusive worldwide licenses for the VHH-antibody candidates to lead their development to commercialization.
In anticipation of the execution of the definitive agreement with Max Planck, BiondVax has initiated preparations for the manufacturing of VHH-antibodies in the Company’s state-of-the-art GMP biologics manufacturing facility in Jerusalem.
Amir Reichman, BiondVax’s CEO, noted, “BiondVax is on the cusp of a transformative turnaround. The anticipated collaboration with the Max Planck Society will enable us to build a pipeline of innovative VHH-antibody therapies for a range of diseases. I am pleased that Jay Green, who served for many years as GSK Vaccine’s CFO, has agreed to join our board of directors. I am also grateful to our shareholders for their ongoing support and encourage them to participate in the upcoming AGM.”
In addition to approving the election of Jay Green to the Board, shareholders will be asked at the AGM to approve the appointment of EY as the Company’s auditor and in accordance with Israeli law, adoption of the Company Compensation Policy. The compensation policy provides a framework for officers’ and directors’ compensation, and is required by law to be updated at least once every three years. BiondVax’s proposed new policy does not grant new compensation to officers or directors. Further information about the AGM, including a link to the Proxy Statement and voting card, are available on the SEC website https://www.sec.gov/Archives/edgar/data/0001611747/000121390021060974/ea151013-6k_biondvaxpharma.htm. Shareholders are invited to contact their broker for voting procedures. Note that votes must be received prior to the deadline noted on the proxy.
[1] Nanobody is a trademark registered by ABLYNX N.V., a wholly owned subsidiary of Sanofi. BiondVax has no affiliation with and is not endorsed by Sanofi.
[2] Güttler T, Aksu M, Dickmanns A, Stegmann KM, Gregor K, Rees R, Taxer W, Rymarenko O, Schünemann J, Dienemann C, Gunkel P, Mussil B, Krull J, Teichmann U, Groß U, Cordes VC, Dobbelstein M, Görlich D. Neutralization of SARS-CoV-2 by highly potent, hyperthermostable, and mutation-tolerant nanobodies. EMBO J (2021). https://doi.org/10.15252/embj.2021107985
About Jay Green
Mr. Jay Green, CPA, CA, MAcc, recently completed a 19-year career with GSK across several progressive leadership positions in GSK’s three businesses of consumer healthcare, pharmaceuticals, and vaccines, as well as corporate development. He also led GSK’s global enterprise resource planning (ERP) program, one of the largest IT-enabled business transformation programs in the company’s history. Mr. Green most recently served from 2014 to 2020 as Senior Vice President, Finance and CFO of GSK’s global vaccines business. Since 2020, Mr. Green has served in an advisory role to Gavi for COVAX, an international initiative to support equitable distribution of COVID-19 vaccines. He is a Chartered Professional Accountant who holds a Master of Accounting from the University of Waterloo, Ontario, Canada.
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, 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. www.biondvax.com.
Contact Details
Company: Joshua E. Phillipson | +972 8 930 2529 | j.phillipson@biondvax.com
Investor Relations: Kenny Green | +1 212 378 8040 | kgreen@edisongroup.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 press release regarding strategy, future operations, 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, statements regarding execution of a definitive agreement with the Max Planck Society and the University Medical Center Göttingen; the therapeutic and commercial potential of VHH antibodies; and the timing of proof-of-concept studies and clinical trials in VHH antibodies. 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 BiondVax will not execute a definitive agreement with the Max Planck Society and the University Medical Center Göttingen; the risk that the therapeutic and commercial potential of VHH antibodies will not be met; the risk that proof-of-concept studies and clinical trials in VHH antibodies will not occur, will be delayed or not be successful; the risk that BiondVax may not be able to secure additional capital on attractive terms, if at all; the risk that the European Investment Bank may accelerate the loans under its finance contract with BiondVax; the risk that BiondVax may not execute a strategic alternative to M-001 or implement a strategy that will diversify BiondVax’s risk, and, if executed, may not be successful; 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 May 13, 2021. BiondVax undertakes no obligation to revise or update any forward-looking statement for any reason
BiondVax to present at H.C. Wainwright 7th Annual Israel Conference
Jerusalem, Israel – November 15, 2021 – BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), which focuses on developing, manufacturing and commercializing innovative products for the prevention and treatment of infectious diseases and other illnesses, announced today that Chief Executive Officer Amir Reichman will present a company overview at the H.C. Wainwright 7th Annual Israel Virtual Conference today at 10:30 am ET.
Investors that wish to attend should register with H.C. Wainwright at https://hcwevents.com/israel/.
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, 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. www.biondvax.com.
Contact Details
Company: Joshua E. Phillipson | +972 8 930 2529 | j.phillipson@biondvax.com
Investor Relations: Kenny Green | +1 212 378 8040 | kgreen@edisongroup.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 press release regarding strategy, future operations, 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, statements regarding management’s participation in investor conferences. 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 BiondVax will not execute a definitive agreement with the Max Planck Society and the University Medical Center Göttingen; the risk that the therapeutic and commercial potential of VHH antibodies will not be met; the risk that proof-of-concept studies and clinical trials in VHH antibodies will not occur, will be delayed or not be successful; the risk that BiondVax may not be able to secure additional capital on attractive terms, if at all; the risk that the European Investment Bank may accelerate the loans under its finance contract with BiondVax; the risk that BiondVax may not execute a strategic alternative to M-001 or implement a strategy that will diversify BiondVax’s risk, and, if executed, may not be successful; 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 May 13, 2021. BiondVax undertakes no obligation to revise or update any forward-looking statement for any reason.
BiondVax advances its growth strategy towards a new pipeline based on innovative VHH antibodies
Signs term sheet for a broad-based strategic collaboration with Max Planck Society and University Medical Center Göttingen, Germany
Max Planck Society (MPG), one of the world’s leading research organizations, together with University Medical Center Göttingen (UMG) have developed unique VHH antibodies (frequently referred to as nanobodies*) that exhibit key advantages over human monoclonal antibodies (mAbs) and are highly promising therapy candidates for many target diseases;
Collaboration to begin immediately upon execution of definitive agreements with licensing to BiondVax of hyperthermostable COVID-19 VHH antibody candidates shown in MPG and UMG labs to neutralize all known major variants of concern at picomolar concentrations and potentially be suitable for inhalation;
MPG, UMG and BiondVax research collaboration to identify additional VHH antibody candidates for other diseases; BiondVax would have exclusive option to receive exclusive worldwide license for the identified VHH antibody candidates to lead their development to commercialization;
BiondVax to host an analyst and investors webinar event this Thursday, October 21, at 9am Eastern Time. Registration details at the end of the press release.
Jerusalem, Israel – October 19, 2021 – BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), which focuses on developing, manufacturing and commercializing innovative products for the prevention and treatment of infectious diseases and other illnesses, today announced the signing of a term sheet that includes binding financial terms of contemplated definitive agreements with the Max Planck Society and the University Medical Center Göttingen in Germany. The parties intend to enter into a 5-year strategic research collaboration including an option for BiondVax to license innovative VHH antibodies. Frequently referred to as nanobodies*, VHH antibodies have the potential to serve as therapeutics and diagnostics for many diseases. The transaction is subject to execution of definitive agreements.
VHH antibodies developed by Professor Dirk Görlich, Director at the Max Planck Institute for Biophysical Chemistry and Professor Matthias Dobbelstein, Professor of Molecular Oncology at the University Medical Center Göttingen, exhibit key advantages over current industry standard human monoclonal antibodies (mAbs). These include: the ability to bind to smaller target sites; significantly higher affinity to the target; higher stability which supports novel routes of administration such as inhalation; ease and lower cost of manufacturing; and potential for improved patient safety.
Upon execution of definitive agreements based on the term sheet signed today, the collaboration will begin with BiondVax’s exclusive worldwide licensing of novel COVID-19 VHH antibody candidates shown in Görlich and Dobbelstein’s labs to neutralize all known major COVID-19 variants of concern at around 100-times lower drug concentrations than current COVID-19 mAbs and all other reported COVID-19 VHH antibodies. BiondVax anticipates completing preclinical proof-of-concept inhalation studies in 2022 and initiating human clinical trials in 2023.
Görlich and Dobbelstein will also conduct research on additional molecular targets for which the parties believe VHH antibodies have clear advantages over existing drugs used against various diseases. These targets are the basis for validated and currently marketed mAbs including for autoimmune conditions such as psoriasis, asthma, macular degeneration, and psoriatic arthritis. BiondVax will have an exclusive option for an exclusive worldwide license to advance these additional VHH antibodies through preclinical and clinical development, manufacturing, and commercialization. Notably, these VHH antibodies can be mass-produced through recombinant protein manufacturing in sites such as BiondVax’s state-of-the-art facility in Jerusalem.
Mr. Amir Reichman, BiondVax’s CEO, commented, “We are thrilled to embark on this new direction for BiondVax. The VHH antibody platform will serve as a basis for a new pipeline of commercially attractive products. We see enormous potential for the COVID-19 VHH antibodies and we’re ready to hit the ground running to bring them into the clinic. In addition, this collaboration aims to address unmet therapeutic needs of many common diseases such as psoriasis, psoriatic arthritis, asthma and macular degeneration. The technology is a great fit to our manufacturing site in Jerusalem and our experience and expertise in drug development. I wish to thank Professors Görlich and Dobbelstein for their enthusiasm for this project, and Max Planck Innovation’s technology transfer team including Dr. Dieter Link for their assistance in developing this innovative collaboration.”
Professor Dirk Görlich, Director at the Max Planck Institute for Biophysical Chemistry, commented, “We believe that the innovative platform developed at the Max Planck Institute for Biophysical Chemistry has great potential. In this respect, we are looking forward to a final agreement with BiondVax that will leverage their CMC, manufacturing, regulatory and clinical development expertise to advance this technology into clinical applications.”
Mr. Mark Germain, Chairman of BiondVax, stated, “This collaboration is the start of an exciting new era for BiondVax, with multiple opportunities to create significant shareholder value. Professors Görlich and Dobbelstein are world class scientists with a unique talent to develop highly differentiated VHH antibodies, and it’s been a pleasure working with them and their colleagues at Max Planck and the University Medical Center Göttingen. Since coming on board in March 2021, Amir has worked tirelessly to help identify the right opportunity around which to relaunch BiondVax and to negotiate the transaction being announced today. He and the BiondVax team have done an outstanding job researching the value proposition represented by the collaboration and the development path forward. On behalf of the entire Board of Directors, kudos and appreciation to all involved in making this happen.”
Binding terms of the term sheet, which would be included in the definitive agreements, include upfront, milestone and royalty-based cash and stock payments by BiondVax to MPG and UMG. The parties aim to complete definitive agreements within 90 days, although there is no guarantee if and when the parties will execute the definitive agreements.
The collaboration has been facilitated by kENUP, a civic society organization promoting innovative industries in Europe.
* Nanobody is a trademark registered by ABLYNX N.V., a wholly owned subsidiary of Sanofi. BiondVax has no affiliation with and is not endorsed by Sanofi.
Analyst event information: BiondVax will host a Zoom webinar this Thursday, October 21st at 9am Eastern Time (ET) to discuss the VHH antibody MPG-UMG-BiondVax collaboration and provide a forum to answer investor and analyst questions. Investors and analysts are invited to submit questions by tomorrow, Wednesday 5pm ET, to investor relations at ir@biondvax.com. To attend the webinar, please register your attendance from either a link at BiondVax’s investor relations website or via the following Zoom link:
https://us06web.zoom.us/webinar/register/9516341082202/WN_Xg-NP1f4TKudDPD9DzQDdQ
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, 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. www.biondvax.com.
Contact Details
Company: Joshua E. Phillipson | +972 8 930 2529 | j.phillipson@biondvax.com
Investor Relations: Kenny Green | +1 212 378 8040 | kgreen@edisongroup.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 press release regarding strategy, future operations, 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, statements regarding execution of a definitive agreement with the Max Planck Society and the University Medical Center Göttingen; the therapeutic and commercial potential of VHH antibodies; and the timing of proof-of-concept studies and clinical trials in VHH antibodies. 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 BiondVax will not execute a definitive agreement with the Max Planck Society and the University Medical Center Göttingen; the risk that the therapeutic and commercial potential of VHH antibodies will not be met; the risk that proof-of-concept studies and clinical trials in VHH antibodies will not occur, will be delayed or not be successful; the risk that BiondVax may not be able to secure additional capital on attractive terms, if at all; the risk that the European Investment Bank may accelerate the loans under its finance contract with BiondVax; the risk that BiondVax may not execute a strategic alternative to M-001 or implement a strategy that will diversify BiondVax’s risk, and, if executed, may not be successful; 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 May 13, 2021. BiondVax undertakes no obligation to revise or update any forward-looking statement for any reason.
BiondVax announces Second Quarter 2021 financial results and provides business update
Jerusalem, Israel – August 26, 2021 – BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), a biopharmaceutical company focused on developing, manufacturing and ultimately commercializing products for the prevention and treatment of infectious diseases and related illnesses, today published its second quarter financial results for the quarter ended June 30, 2021.
Financial Summary
Results are in New Israel Shekels (NIS) and convenience translation to $US is provided using the exchange rate of 3.26 (NIS/$US), the rate as of the close of business on June 30, 2021.
R&D expenses for the three months ended June 30, 2021 decreased to NIS 1.9 million ($0.6 million) from NIS 11.9 million for the three months ended June 30, 2020. This decrease was primarily attributable to expenses related to a Phase 3 clinical trial and related operations at our manufacturing facility. As previously reported, the trial concluded in Q4 2020.
Marketing, general and administrative expenses for the three months ended June 30, 2021 increased to NIS 7 million ($2.1 million) from NIS 4.1 million for the three months ended June 30, 2020. This increase of NIS 2.9 million ($0.6 million) was primarily due to salary and salary related expenses related to the former CEO’s termination, an increase in Board of Directors expenses, the new CEO’s salary, share based compensation expenses, and an increase in professional services.
Operating expenses for the three months ended June 30, 2021 were NIS 8.9 million ($2.7 million) compared with NIS 16.0 million for the three months ended June 30, 2020.
Financial expenses for the three months ended June 30, 2021 were NIS 3.1 million ($0.95 million) compared with NIS 25.9 million for the three months ended June 30, 2020. This reduction was attributable primarily due to a decrease in financial expenses as a result of a $21 million warrants revaluation charge during the three months ended June 30, 2020 compared to none in the three months ended June 30, 2021.
As of June 30, 2021, BiondVax had cash and cash equivalents of NIS 39.9 million ($12.2 million) as compared to NIS 48.6 million as of March 31, 2021.
Unaudited Q2 financial results will be submitted to the Securities and Exchange Commission. A summary is included in the tables below.
CEO Statement
Chief Executive Officer of BiondVax Mr. Amir Reichman commented, “Since joining the Company earlier this year, my team and I, with the support of the Board of Directors, have been identifying and are assessing a number of promising technologies and potential partners with the goal of building a diversified pipeline of biological products and platforms for therapeutic use through in licensing, co-developing, acquiring or partnering. Our potential partners include top tier researchers, institutes and/or companies that possess relevant Intellectual Property that may fit with BiondVax’s strategic aspirations, experience and capabilities. We are currently engaged in deep-dive evaluations of some particularly intriguing opportunities. In collaboration with these potential partners and relevant experts we are assessing these potential avenues from several perspectives, including scientific merit, complementary synergies with our manufacturing infrastructure and product development expertise, as well as their potential for commercial market success.”
Reichman continued, “Last week, I relocated with my family to Israel from Belgium where I had been serving in a senior leadership role at GSK Vaccines headquarters. I am pleased to now be working face-to-face with the highly experienced, motivated and talented BiondVax team, and I am increasingly optimistic with regard to our potential to rebuild BiondVax to become a successful biopharmaceutical company excelling in identifying, developing, manufacturing and ultimately commercializing biological therapeutics and vaccines.”
About BiondVax
BiondVax Pharmaceuticals Ltd. (NASDAQ: BVXV) is a biopharmaceutical company focused on developing, manufacturing and ultimately commercializing products for the prevention and treatment of infectious diseases and related illnesses. The Company had been developing M‑001, a novel influenza vaccine candidate that was designed to provide multi-strain and multi-season protection against current and future seasonal and pandemic influenza. In seven Phase 1/2 and Phase 2 clinical trials designed to test for immunogenicity, the Company was able to demonstrate M-001 was effective in stimulating an immune response to a broad range of influenza virus strains. In October 2020, the Company completed a Phase 3 clinical trial of M‑001 which did not meet the trial’s primary and secondary efficacy endpoints. The Company is now pursuing the goal of developing a pipeline of diversified and commercially viable products and platforms.
Contact Details
Company: Joshua E. Phillipson | +972 8 930 2529 | j.phillipson@biondvax.com
Investor Relations: Kenny Green (Israel) | +1 646 201 9246 | kgreen@edisongroup.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, including statements regarding future business strategies that BiondVax may explore. 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 BiondVax may not be able to secure additional capital on attractive terms, if at all; the risk that the European Investment Bank may accelerate the loans under its finance contract with BiondVax; the risk that BiondVax may not execute a strategic alternative to M-001 or implement a strategy that will diversify BiondVax’s risk, and, if executed, may not be successful; 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 May 13, 2021. BiondVax undertakes no obligation to revise or update any forward-looking statement for any reason.
BALANCE SHEETS | ||||||||
In thousands, except share and per share data | ||||||||
Convenience | ||||||||
December 31, | June 30, | June 30, | ||||||
2020 | 2020 | 2021 | 2021 | |||||
Audited | Unaudited | Unaudited | ||||||
N I S | U.S. dollars | |||||||
CURRENT ASSETS: | ||||||||
Cash and cash equivalents | 9,421 | 38,752 | 39,883 | 12,234 | ||||
Other receivables | 1,204 | 2,467 | 2,641 | 810 | ||||
10,625 | 41,219 | 42,524 | 13,044 | |||||
LONG–TERM ASSETS: | ||||||||
Property, plant and equipment | 39,607 | 36,937 | 38,979 | 11,957 | ||||
Right-of-use assets | 6,206 | 6,662 | 6,109 | 1,874 | ||||
Other long-term assets | 473 | 891 | 437 | 134 | ||||
46,286 | 44,490 | 45,525 | 13,965 | |||||
56,911 | 85,709 | 88,049 | 27,009 | |||||
CURRENT LIABILITIES: | ||||||||
Trade payables | 1,868 | 4,070 | 2,635 | 808 | ||||
Operating lease liabilities | 654 | 676 | 764 | 234 | ||||
Loan from others | 60,421 | - | 64,248 | 19,708 | ||||
Other payables | 1,246 | 1,609 | 1,739 | 534 | ||||
64,189 | 6,355 | 69,386 | 21,284 | |||||
LONG–TERM LIABILITIES: | ||||||||
Liability in respect of government grants | - | 12,686 | - | - | ||||
Operating lease liabilities | 6,088 | 6,457 | 6,047 | 1,855 | ||||
Loan from others | - | 122,041 | - | - | ||||
Other payables | 1,135 | - | 1,135 | 348 | ||||
Severance pay liability, net | 95 | 92 | 95 | 29 | ||||
7,318 | 141,276 | 7,277 | 2,232 | |||||
SHAREHOLDERS' EQUITY: | ||||||||
Ordinary shares of no par value: Authorized: | *) - | *) - | *) - | *) - | ||||
Share premium | 310,197 | 304,089 | 356,358 | 109,313 | ||||
Accumulated deficit | (324,793) | (366,011) | (344,972) | (105,820) | ||||
(14,596) | (61,922) | 11,386 | 3,493 | |||||
56,911 | 85,709 | 88,049 | 27,009 | |||||
*) Represents less than 1 NIS\USD | ||||||||
STATEMENTS OF COMPREHENSIVE LOSS | |||||||||||||||||||
In thousands, except share and per share data | |||||||||||||||||||
Convenience translation | |||||||||||||||||||
Year ended December 31, | Three months ended June 30, | Six months ended June 30, | Six months ended June 30, | ||||||||||||||||
2020 | 2020 | 2021 | 2020 | 2021 | 2020 | ||||||||||||||
Audited | Unaudited | Unaudited | |||||||||||||||||
N I S | U.S. dollars | ||||||||||||||||||
(In thousands, except per share data) | |||||||||||||||||||
Operating expenses: | |||||||||||||||||||
Research and development, net of participations | 51,463 | 11,948 | 1,900 | 31,016 | 4,653 | 1,427 | |||||||||||||
Marketing, general and administrative | 16,687 | 4,139 | 7,002 | 5,120 | 11,007 | 3,376 | |||||||||||||
Other income | (75,484) | - | - | - | - | - | |||||||||||||
Total operating expenses (income) | (7,334) | 16,087 | 8,902 | 36,136 | 15,660 | 4,803 | |||||||||||||
Operating income (loss) | 7,334 | (16,087) | (8,902) | (36,136) | (15,660) | (4,803) | |||||||||||||
Financial income | 3,843 | (11,291) | (360) | 5,211 | 822 | 252 | |||||||||||||
Financial expense | (15,632) | (14,600) | (2,731) | (14,748) | (5,341) | (1,638) | |||||||||||||
Net loss and total comprehensive loss | (4,455) | (41,978) | (11,993) | (46,673) | (20,179) | (6,189) | |||||||||||||
Basic and diluted net loss per share | (0.01) | (0.10) | (0.03) | (0.11) | (0.04) | (0.01) | |||||||||||||
Weighted average number of shares outstanding used to compute basic and diluted loss per share | 443,260,878 | 433,498,227 | 573,205,607 | 431,485,801 | 552,140,030 | 552,140,030 | |||||||||||||
The notes in the Company's quarterly report are an integral part of the financial statements. The complete financial results are available in the Form 6-K to be filed with the Securities and Exchange Commission. | |||||||||||||||||||
BiondVax Announces First Quarter 2021 Financial Results and Provides Business Update
Jerusalem, Israel – June 23, 2021 – BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), a biopharmaceutical company focused on developing, manufacturing and ultimately commercializing products for the prevention and treatment of infectious diseases and related illnesses, today published its first quarter financial results for the quarter ended March 31, 2021. A summary is included in the tables below.
First Quarter 2021 Financial Summary
Results are in New Israel Shekels (NIS) and convenience translation to $US is provided using the exchange rate of 3.334 (NIS/$US), the rate as of the close of business on March 31, 2020.
Total operating expenses were NIS 6.7 million ($2.0 million) compared with NIS 20.0 million for the first quarter of 2020
Out of the operating expenses, first quarter R&D expenses amounted to NIS 2.75 million ($0.83 million) compared with NIS 19.0 million for the first quarter of 2020
The decrease in total operating expenses, including the R&D expenses, compared to the first quarter of 2020 was primarily attributable to expenses related to a Phase 3 clinical trial and related operations at our manufacturing facility. As previously reported, the trial concluded in Q4 2020. As of March 31, 2021, BiondVax had cash and cash equivalents of NIS 48.6 million ($14.6 million) as compared to NIS 9.4 million as of December 31, 2020. The increase was primarily attributable to a follow-on offering on Nasdaq conducted by the Company in February 2021, providing net proceeds of approximately $12.8 million after fees and underwriter discounts. As previously reported, as of May 12, 2021, the Company had cash and cash equivalents of NIS 46 million (approximately $14 million).
Q1 Business Highlights
New CEO appointed: Mr. Amir Reichman, a GSK veteran, began serving as BiondVax’s CEO
BiondVax’s new mission announced: To develop, manufacture and ultimately commercialize products for the prevention and treatment of infectious diseases and related illnesses
Reviewing opportunities: Continuing to analyze potential opportunities towards the creation of a diversified pipeline of products and platforms
Successful financing: Follow-on offering on Nasdaq providing net proceeds of approximately $12.8 million after fees and underwriter discounts
Investor Relations: Engaged Edison Group to support our upcoming global investor relations outreach activities
About BiondVax
BiondVax Pharmaceuticals Ltd. (NASDAQ: BVXV) is a biopharmaceutical company focused on developing, manufacturing and ultimately commercializing products for the prevention and treatment of infectious diseases and related illnesses. The Company had been developing M‑001, a novel influenza vaccine candidate that was designed to provide multi-strain and multi-season protection against current and future seasonal and pandemic influenza. In seven Phase 1/2 and Phase 2 clinical trials designed to test for immunogenicity, the Company was able to demonstrate M-001 was effective in stimulating an immune response to a broad range of influenza virus strains. In October 2020, the Company completed a Phase 3 clinical trial of M‑001 which failed to meet the trial’s primary and secondary efficacy endpoints. The Company is now pursuing opportunities in the infectious disease space towards development of a pipeline of diversified products and platforms.
Contact Details
Company: Joshua E. Phillipson | +972 8 930 2529 | j.phillipson@biondvax.com
Investor Relations: Kenny Green | +1 646 201 9246 | kgreen@edisongroup.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, including statements regarding future business strategies that BiondVax may explore. 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 BiondVax may not be able to secure additional capital on attractive terms, if at all; the risk that the European Investment Bank may accelerate the loans under its finance contract with BiondVax; the risk that BiondVax may not execute a strategic alternative to M-001 or implement a strategy that will diversify BiondVax’s risk, and, if executed, may not be successful; 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 May 13, 2021. BiondVax undertakes no obligation to revise or update any forward-looking statement for any reason.
BALANCE SHEETS | ||||||||
In thousands, except share and per share data | ||||||||
Convenience | ||||||||
Translation | ||||||||
December 31, | March 31, | March | ||||||
2020 | 2020 | 2021 | 2021 | |||||
Audited | Unaudited | Unaudited | ||||||
N I S | U.S. dollars | |||||||
CURRENT ASSETS: | ||||||||
Cash and cash equivalents | 9,421 | 42,505 | 48,577 | 14,570 | ||||
Other receivables | 1,204 | 1,540 | 481 | 144 | ||||
10,625 | 44,045 | 49,058 | 14,714 | |||||
LONG–TERM ASSETS: | ||||||||
Property, plant and equipment | 39,607 | 35,989 | 39,252 | 11,773 | ||||
Right-of-use assets | 6,206 | 6,899 | 5,978 | 1,793 | ||||
Other long-term assets | 473 | 899 | 436 | 131 | ||||
46,286 | 43,787 | 45,666 | 13,697 | |||||
56,911 | 87,832 | 94,724 | 28,411 | |||||
CURRENT LIABILITIES: | ||||||||
Trade payables | 1,868 | 3,278 | 2,085 | 625 | ||||
Operating lease liabilities | 654 | 684 | 641 | 192 | ||||
Loan from others | 60,421 | - | 62,346 | 18,700 | ||||
Other payables | 1,246 | 807 | 1,640 | 492 | ||||
64,189 | 4,769 | 66,712 | 20,009 | |||||
LONG–TERM LIABILITIES: | ||||||||
Liability in respect of government grants | - | 12,991 | - | - | ||||
Operating lease liabilities | 6,088 | 6,641 | 5,978 | 1,793 | ||||
Loan from others | - | 117,784 | - | - | ||||
Warrants | - | 6,861 | - | - | ||||
Other payables | 1,135 | - | 1,135 | 340 | ||||
Severance pay liability, net | 95 | 90 | 95 | 29 | ||||
7,318 | 144,367 | 7,208 | 2,162 | |||||
SHAREHOLDERS' EQUITY: | ||||||||
Ordinary shares of no par value: Authorized: | *) - | *) - | *) - | *) - | ||||
Share premium | 310,197 | 262,729 | 353,783 | 106,114 | ||||
Accumulated deficit | (324,793) | (324,033) | (332,979) | (99,874) | ||||
(14,596) | (61,304) | 20,804 | 6,240 | |||||
56,911 | 87,832 | 94,724 | 28,411 | |||||
*) Represents less than 1 NIS\USD | ||||||||
STATEMENTS OF COMPREHENSIVE LOSS | |||||||||||||
In thousands, except share and per share data | |||||||||||||
Convenience translation | |||||||||||||
| Year ended December 31, | Three months ended March 31, | Three months ended March 31, | |||||||||||
2020 | 2020 | 2021 | 2021 | ||||||||||
Audited | Unaudited | Unaudited | |||||||||||
NIS | U.S. dollars | ||||||||||||
Operating expenses: | |||||||||||||
Research and development, net of participations | 51,463 | 19,068 | 2,750 | 825 | |||||||||
Marketing, general and administrative | 16,687 | 981 | 4,005 | 1,201 | |||||||||
Other income | (75,484) | - | - | - | |||||||||
Total operating expenses (income) | (7,334) | 20,049 | 6,755 | 2,026 | |||||||||
- | |||||||||||||
Operating income (loss) | 7,334 | (20,049) | (6,755) | (2,026) | |||||||||
Financial income | 3,843 | 16,502 | 1,182 | 354 | |||||||||
Financial expense | (15,632) | (148) | (2,613) | (784) | |||||||||
Net loss and total comprehensive loss | (4,455) | (3,695) | (8,186) | (2,456) | |||||||||
Basic and Diluted net loss per share | (0.01) | (0.01) | (0.02) | (0.005) | |||||||||
Weighted average number of shares outstanding used to compute basic and diluted loss per share | 443,260,878 | 408,596,752 | 530,840,391 | 530,840,391 | |||||||||
BiondVax Announces Fourth Quarter and Full Year 2020 Financial Results and Provides Business Update
Jerusalem, Israel – May 13, 2021 – BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), a biopharmaceutical company focused on developing, manufacturing and ultimately commercializing products for the prevention and treatment of infectious diseases and related illnesses, today published its fourth quarter and full year financial results for the year ended December 31, 2020 and provided a business update.
Fourth Quarter 2020 Financial Summary
Results are in New Israel Shekels (NIS) and convenience translation to US$ is provided using the exchange rate of 3.215 (NIS/US$), the rate as of the close of business on December 31, 2020.
Total operating expenses for the quarter were NIS 12.3 million ($3.2 million) compared with NIS 45.7 million for the fourth quarter of 2019.
R&D expenses for the quarter amounted to NIS 7.8 million ($2.4 million) compared with NIS 37.6 million for the fourth quarter of 2019.
Full Year 2020 Financial Summary
Total operating expenses for the year were NIS 68.2 million ($21.2 million) offset by other income of NIS 75.8 million ($23.4 million) due to the revaluation of the EIB loan compared with NIS 78.3 million in 2019.
R&D expenses for the year amounted to NIS 51.4 million ($16 million) compared with NIS 68.6 million in 2019.
As of December 31, 2020, BiondVax had cash and cash equivalents of NIS 9.4 million ($2.9 million) compared to NIS 72.4 million as of December 31, 2019. Following the balance sheet date, in February 2021, the Company completed a follow-on offering on Nasdaq, providing total gross proceeds of approximately $13.8 million and net proceeds after fees and discounts of approximately $12.8 million. As of May 12, 2021, the Company had cash and cash equivalents of NIS 46 million (approximately $14 million).
The complete financial results are available in the Company’s annual report on Form 20-F for the year ended December 31, 2020, to be filed with the Securities and Exchange Commission. A summary is included in the tables below.
Recent Corporate Update
Following the October 23, 2020 announcement that the Phase 3 trial of M‑001, our universal influenza vaccine candidate, did not meet its efficacy endpoints, BiondVax implemented the following actions:
Appointed a new CEO: Mr. Amir Reichman began serving as BiondVax’s CEO on a full-time basis on March 2, 2021, taking over from Dr. Ron Babecoff, who has continued to serve BiondVax as a senior advisor to ensure a smooth transition. Most recently, Reichman held senior leadership positions at the GSK Vaccine headquarters in Belgium, including Head of Global Vaccines Engineering Core Technologies and Asset Management, and Senior Director Global GSK Vaccines Supply Chain.
New Mission: As described in his March 23, 2021 CEO Letter to Shareholders, Reichman explained that while previously BiondVax had been a one product company, going forward the Company is implementing a strategy to diversify its pipeline of products towards a new mission: To help build a healthier and happier world by developing, manufacturing and ultimately commercializing products for the prevention and treatment of infectious diseases and related illnesses.
Financing: In February 2021, BiondVax completed a follow-on offering on Nasdaq with total gross proceeds of approximately $13.8 million to strengthen the Company’s balance sheet. These additional funds will be used to support ongoing operating expenses and implementation of the new corporate mission and strategy. BiondVax continues to remain in close contact with its main creditor, the European Investment Bank (EIB), to whom the Company has a €24 million outstanding debt. The EIB is supportive of the Company’s ongoing efforts to reposition itself and to date has not indicated an intent to recall the loan.
Assets: The Company’s highly advanced GMP vaccine manufacturing facility in Jerusalem is being maintained by its highly experienced staff as it seeks to expand its product asset pipeline in the coming quarters.
Management Comment
Mr. Amir Reichman, BiondVax’s CEO, commented,
“My team and the Board are actively engaged in pursuing opportunities to diversify our pipeline of assets in light of our new mission. BiondVax’s vaccine development, manufacturing, and clinical trial experience, combined with our people’s deep industry experience and our highly advanced GMP vaccine manufacturing facility, provide us with an incredible untapped potential that I aim to realize over the coming years. I look forward to leading BiondVax to the next level.”
Reichman continued,
“I would like to extend my personal appreciation and gratitude to our shareholders for their support and belief in our new mission, vision and strategy. Together with our employees, management, board and others, I believe we have the capability to successfully grow BiondVax even stronger financially while creating a diversified portfolio of assets to both improve our offering to future customers while reducing specific, single product risks.”
About BiondVax
BiondVax Pharmaceuticals Ltd. (NASDAQ: BVXV) is a biopharmaceutical company focused on developing, manufacturing and ultimately commercializing products for the prevention and treatment of infectious diseases and related illnesses. The Company had been developing M‑001, a novel influenza vaccine candidate that was designed to provide multi-strain and multi-season protection against current and future seasonal and pandemic influenza. In seven Phase 1/2 and Phase 2 clinical trials designed to test for immunogenicity, the Company was able to demonstrate M-001 was effective in stimulating an immune response to a broad range of influenza virus strains. In October 2020, the Company completed a Phase 3 clinical trial of M‑001 which failed to meet the trial’s primary and secondary efficacy endpoints. The Company is now pursuing opportunities in the infectious disease space towards development of a pipeline of diversified products and platforms.
Contact Details
Company: Joshua E. Phillipson | +972 8 930 2529 | j.phillipson@biondvax.com
Investor Relations: Kenny Green (Israel) | +1 646 201 9246 | kgreen@edisongroup.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, including statements regarding future business strategies that BiondVax may explore. 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 BiondVax may not be able to secure additional capital on attractive terms, if at all; the risk that the European Investment Bank may accelerate the loans under its finance contract with BiondVax; the risk that BiondVax may not execute a strategic alternative to M-001 or implement a strategy that will diversify BiondVax’s risk, and, if executed, may not be successful; 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 to be filed with the Securities and Exchange Commission on March 13, 2021. BiondVax undertakes no obligation to revise or update any forward-looking statement for any reason.
BALANCE SHEETS | ||||||||
In thousands, except share and per share data | ||||||||
Convenience | ||||||||
Translation | ||||||||
December 31, | December 31, | |||||||
2019 | 2020 | 2020 | ||||||
N I S | U.S. dollars | |||||||
CURRENT ASSETS: | ||||||||
Cash and cash equivalents | 72,467 | 9,421 | 2,930 | |||||
Other receivables | 656 | 1,204 | 375 | |||||
73,123 | 10,625 | 3,305 | ||||||
LONG–TERM ASSETS: | ||||||||
Property, plant and equipment | 34,981 | 39,607 | 12,319 | |||||
Right-of-use assets | 7,136 | 6,206 | 1,930 | |||||
Other long-term assets | 510 | 473 | 147 | |||||
42,627 | 46,286 | 14,396 | ||||||
115,750 | 56,911 | 17,701 | ||||||
CURRENT LIABILITIES: | ||||||||
Trade payables | 17,062 | 1,868 | 581 | |||||
Current maturities of lease liabilities | 694 | 654 | 203 | |||||
Loan from others | - | 60,421 | 18,793 | |||||
Other payables | 1,203 | 1,246 | 388 | |||||
18,959 | 64,189 | 19,965 | ||||||
LONG–TERM LIABILITIES: | ||||||||
Liability in respect of Government grants | 14,812 | - | - | |||||
Lease Liabilities | 6,809 | 6,088 | 1,894 | |||||
Loan from others | 123,780 | - | - | |||||
Warrants | 16,354 | - | - | |||||
Other payables | - | 1,135 | 353 | |||||
Severance pay liability, net | 89 | 95 | 29 | |||||
161,844 | 7,318 | 2,276 | ||||||
SHAREHOLDERS' EQUITY: | ||||||||
Ordinary shares of no par value: Authorized: 600,000,000 | *) - | *) - | *) - | |||||
Share premium | 255,285 | 310,197 | 96,484 | |||||
Accumulated deficit | (320,338) | (324,793) | (101,024) | |||||
(65,053) | (14,596) | (4,540) | ||||||
115,750 | 56,911 | 17,701 | ||||||
*) Represents less than 1 NIS\USD | ||||||||
STATEMENTS OF COMPREHENSIVE LOSS | ||||||||||
In thousands, except share and per share data | ||||||||||
Convenience
| ||||||||||
Year ended December 31, | Year ended December 31, | |||||||||
2018 | 2019 | 2020 | 2020 | |||||||
N I S | U.S. dollars | |||||||||
Operating expenses: | ||||||||||
Research and development, net of | 71,913 | 68,645 | 51,463 | 16,007 | ||||||
Marketing, general and administrative | 5,154 | 9,706 | 16,687 | 5,190 | ||||||
Other income | - | - | (75,484) | (23,479) | ||||||
Total operating expenses (income) | 77,067 | 78,351 | (7,334) | (2,282) | ||||||
Operating income (loss) | (77,067) | (78,351) | 7,334 | 2,282 | ||||||
Financial income | 2,936 | 4 | 3,843 | 1,195 | ||||||
Financial expense | (13,596) | (30,847) | (15,632) | (4,863) | ||||||
Loss | (87,727) | (109,194) | (4,455) | (1,386) | ||||||
Total comprehensive loss | (87,727) | (109,194) | (4,455) | (1,386) | ||||||
Basic and diluted loss per share | (0.34) | (0.33) | (0.01) | (0.003) | ||||||
Weighted average number of shares | 261,419,599 | 326,651,721 | 443,260,878 | 443,260,878 | ||||||
The notes in the Company’s annual report on Form 20-F are an integral part of the financial statements. The complete financial results are available in the 20-F to be filed with the Securities and Exchange Commission.
Letter from BiondVax’s New CEO to Shareholders
March 23, 2021
Dear Shareholders,
After many years of pharmaceutical leadership positions in the US and Europe, I jumped at the opportunity to return to my roots in Israel to take over the reins as BiondVax’s CEO. Since my appointment was announced in January, I had been wrapping up my role as Head of Global Vaccines Engineering, Core Technologies, and Asset Management at GSK Vaccines headquarters in Belgium. I started as BiondVax’s full time CEO on March 2nd and intend to relocate to Israel this coming summer. In the meantime, I will be traveling between Belgium and Israel.
The first thing I have done as the new CEO, together with our Board of Directors, was to define a new mission and vision for BiondVax. Our new mission reflects an aspiration to focus on infectious diseases, which leverages BiondVax’s core competencies, while ensuring diversification of our corporate risks through the establishment of a new, broad product and platform pipeline.
BiondVax’s mission is to help build a healthier and happier world by developing, manufacturing and ultimately commercializing products for the prevention and treatment of infectious diseases and related illnesses.
In the past, BiondVax was a one product company, solely focused on developing the M-001 universal influenza vaccine. Going forward, my intent in rejuvenating BiondVax is to implement a strategy that will diversify the risk along several axes:
Build a pipeline of products not only for prevention (through vaccines) but also for treatment of infectious diseases and related illnesses
Build a pipeline that would present various routes of drug delivery (e.g., intra-muscular, nasal, oral, etc.)
Build a pipeline that would rely on various platforms (different types of molecules and manufacturing platforms)
Build a pipeline of products at different stages of clinical development
If successfully implemented, this strategy would provide BiondVax with a robust and diverse multi-dimensional pipeline. Over these past few months, we have been actively engaged in identifying and evaluating many opportunities. These include in-licensing, acquisitions, and joint ventures, with industry, academia, and governments. Indeed, we are currently engaged in due diligence and negotiations on a number of exciting potential opportunities.
I would like to share with you what attracted me to BiondVax. I believe that BiondVax presents a unique set of strong capabilities along the three most important pillars of business management: People, Process and Technology. In my view, these capabilities, if managed correctly, could prove to be a serious competitive advantage versus other bio-pharma companies of comparable size and value, and serve as a jumping board for a revitalized and rebuilt company.
People: Our leadership team has deep and highly relevant biotech and pharmaceutical industry experience, including our Chairman Mark Germain (Alexion, Neurocrine, Pluristem and others), Board director Samuel Moed (Bristol Myers Squibb), and COO Elad Mark (Novartis). As CEO, I bring a background of extensive vaccines R&D, supply chain, manufacturing, and engineering at a global level from Novartis in the USA and GSK in Europe. Furthermore, our Chief Science Officer, Dr. Tamar Ben-Yedidia, ushered a novel influenza vaccine candidate from R&D at the Weizmann Institute through eight clinical trials culminating in a 12,400 participant, seven country, two season pivotal Phase 3 clinical trial. Dr. Ben-Yedidia conducted her preliminary research in the 1990’s under the guidance of Professor Ruth Arnon, co-inventor of Teva Pharmaceutical’s blockbuster Copaxone drug; Professor Arnon continues to serve as head of BiondVax’s Scientific Advisory Board.
Process: Thanks to 18 years of experience, BiondVax has developed a mature set of business processes including pre-clinical and clinical development, regulatory, quality, GMP manufacturing processes and more. We are still under a master services agreement with our CRO, with whom we partnered for our recent Phase 3 clinical trial, and through which we retain access to over 90 medical centers in their investigational site network which can rapidly be re-activated should we in-license a clinical stage asset. These processes can help us accelerate time to market for future in-licensed assets and hence provide us with a competitive value proposition versus other companies our size.
Technology: Our existing and highly advanced GMP vaccine manufacturing facility in Jerusalem uses an agile and modular ‘Single Use’ infrastructure that can be used for a wide variety of applications and technologies, such as the production of recombinant proteins, RNA, monoclonal antibodies, and other vaccines and treatments. In addition, we have advanced automation, data management and IT systems necessary for regulatory compliant clinical development, clinical supplies and commercial supplies.
Looking back over 2020, the results of the Phase 3 clinical trial of our M-001 universal influenza vaccine candidate were deeply disappointing for our management, employees, shareholders, and all our other stakeholders. While clinical effectiveness of M-001 versus a placebo was not observed in the trial, there was evidence of robust immune responses in the seven previous clinical trials. Thus, we believe our vaccine still has potential and under different trial settings it is possible that clinical effectiveness would be observed. For this reason, we have not discarded M-001 but rather placed it on the shelf for the time being, in the hope that we may revisit it in the future.
While the Phase 3 trial of M-001 did not meet its clinical endpoints, a common occurrence in the industry, the employees and Board of Directors devoted a tremendous amount of time and effort to ensure that the trial was properly managed, completed on time and on budget despite the looming threat of the COVID-19 pandemic. This by itself was a major achievement for any company in the industry, much less a relatively small biotech firm.
On April 6, BiondVax will host an extraordinary meeting of shareholders to approve my terms of office as CEO of BiondVax, approve compensation packages, and expand our authorized share capital to provide flexibility in raising additional capital in the future. While we will seek to fund our growth in a manner that enhances long-term shareholder value, equity remains an important component in the financing strategy of building the prospective diverse portfolio of products, drug delivery technologies and platforms that I described earlier.
You, our shareholders, have an important say in these measures which we believe are essential steps towards realizing BiondVax’s new mission and vision. On behalf of Management and the Board, we would be grateful for your continued support by voting in line with our recommendations on the proxy. Details are available on the SEC website, and we urge you to contact your broker to exercise your right to vote. You may also contact my investor relations team at any time for any query you may have or information you require.
Under my new leadership, I believe BiondVax is well positioned to become a globally trusted and preferred bio-pharmaceutical company known for fast and efficient product development of highly innovative products, offering a reliable supply of high-quality and effective prophylactic and therapeutic products targeting infectious diseases and related illnesses.
I pledge to keep you updated as we progress towards our important and exciting goals.
Sincerely,
Amir Reichman
CEO
BiondVax Pharmaceutical Ltd.
About BiondVax
BiondVax Pharmaceuticals Ltd. (NASDAQ: BVXV) is a biopharmaceutical company focused on developing, manufacturing and ultimately commercializing products for the prevention and treatment of infectious diseases and related illnesses. The Company had been developing M‑001, a novel influenza vaccine candidate that was designed to provide multi-strain and multi-season protection against current and future seasonal and pandemic influenza. In seven Phase 1/2 and Phase 2 clinical trials designed to test for immunogenicity, the Company was able to demonstrate M-001 was effective in stimulating an immune response to a broad range of influenza virus strains. In October 2020, the Company completed a Phase 3 clinical trial of M‑001 which failed to meet the trial’s primary and secondary efficacy endpoints. The Company is now pursuing opportunities in the infectious disease space towards development of a pipeline of diversified products and platforms.
Contact Details
Company: Joshua E. Phillipson | +972 8 930 2529 | j.phillipson@biondvax.com
Investor Relations: Megan Paul (USA) | +1 646 653 7034 | mpaul@edisongroup.com // Kenny Green (Israel) | +1 646 201 9246 | kgreen@edisongroup.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, including statements regarding future business strategies that BiondVax may explore. 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 BiondVax may not be able to secure additional capital on attractive terms, if at all; the risk that the European Investment Bank may accelerate the loans under its finance contract with BiondVax; the risk that BiondVax may not execute a strategic alternative to M-001 or implement a strategy that will diversify BiondVax’s risk, and, if executed, may not be successful; 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 our prospectus supplement, which is available on the SEC’s website, www.sec.gov. BiondVax undertakes no obligation to revise or update any forward-looking statement for any reason.
BiondVax Announces Exercise in Full of Underwriter’s Over-Allotment Option in Follow-on Offering
Total Gross Proceeds of Underwritten Offering Approximately $13.8 million
Jerusalem, Israel – February 10, 2021 – BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), a biopharmaceutical company focused on developing, manufacturing and ultimately commercializing products for the prevention and treatment of infectious diseases and related illnesses, today announced that the underwriter of its recent follow-on underwritten offering fully exercised its over-allotment option to purchase 365,217 of BiondVax’s American Depositary Shares (“ADS”). The option was granted in connection with the follow-on offering of 2,434,783 ADSs at a public offering price of $4.95 per ADS which closed on February 2, 2020.
The exercise of the over-allotment option brings the total gross proceeds of the offering to approximately $13.8 million.
Aegis Capital Corp. acted as sole bookrunning manager for the offering.
The ADSs described above were offered by the Company pursuant to a registration statement that was previously filed with the Securities and Exchange Commission (the “SEC”) and declared effective by the SEC on August 10, 2020. A prospectus supplement and accompanying base prospectus relating to and describing the final terms of the offering are available on the SEC’s website located at www.sec.gov or from Aegis Capital Corp., Attention: Syndicate Department, 810 7th Avenue, 18th Floor, New York, NY 10019, by email at syndicate@aegiscap.com, or by telephone at (212) 813-1010.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy the securities described herein, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.
About BiondVax
BiondVax Pharmaceuticals Ltd. (NASDAQ: BVXV) is a biopharmaceutical company focused on developing, manufacturing and ultimately commercializing products for the prevention and treatment of infectious diseases and related illnesses. The Company had been developing M‑001, a novel influenza vaccine candidate that was designed to provide multi-strain and multi-season protection against current and future seasonal and pandemic influenza. In seven Phase 1/2 and Phase 2 clinical trials designed to test for immunogenicity, the Company was able to demonstrate M-001 was effective in stimulating an immune response to a broad range of influenza virus strains. In October 2020, the Company completed a Phase 3 clinical trial of M‑001 which failed to meet the trial’s primary and secondary efficacy endpoints. The Company is now pursuing opportunities in the infectious disease space, including exploring several alternatives for development of a pipeline of assets.
Contact Details
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, including statements regarding future business strategies that BiondVax may explore. 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 BiondVax may not be able to secure additional capital on attractive terms, if at all; the risk that the European Investment Bank may accelerate the loans under its finance contract with BiondVax; the risk that BiondVax may not execute a strategic alternative to M-001 and, if executed, may not be successful; 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; 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 our prospectus supplement, which is available on the SEC’s website, www.sec.gov. BiondVax undertakes no obligation to revise or update any forward-looking statement for any reason.
BiondVax Announces Closing of $12.1 Million Follow-on Underwritten Offering
Jerusalem, Israel – February 2, 2021 – BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), a biopharmaceutical company focused on developing, manufacturing and ultimately commercializing products for the prevention and treatment of infectious diseases and related illnesses, today announced the closing of its previously announced underwritten offering. The total number of American Depositary Shares (“ADS”) sold by the Company was 2,434,783, each ADS representing forty (40) of its ordinary shares, at a public offering price of $4.95 per ADS, for gross proceeds to the Company of approximately $12.1 million, before deducting underwriting discounts and other offering expenses.
In connection with the offering, the Company has also granted the underwriters a 30-day option to purchase up to an additional 15% of the number of ADSs offered to the public at the public offering price, less underwriting discount, for covering over-allotments, if any. If the over-allotment option is exercised in full it would increase the total gross proceeds of the offering to approximately $13.8 million.
Aegis Capital Corp. acted as sole bookrunning manager for the offering.
BiondVax intends to use the net proceeds from the offering, together with its existing cash and cash equivalents, for general corporate purposes, which may include working capital, research and development activities, regulatory matters, capital investment or other related purposes. The Company may also use a portion of the net proceeds to in-license, invest in or acquire businesses, assets or technologies that BiondVax believes are complementary to its business focus, although BiondVax has no current commitments or agreements in those regards.
The ADSs described above were offered by the Company pursuant to a registration statement that was previously filed with the Securities and Exchange Commission (the “SEC”) and declared effective by the SEC on August 10, 2020. A prospectus supplement and accompanying base prospectus relating to and describing the final terms of the offering are available on the SEC’s website located at www.sec.gov or from Aegis Capital Corp., Attention: Syndicate Department, 810 7th Avenue, 18th Floor, New York, NY 10019, by email at syndicate@aegiscap.com, or by telephone at (212) 813-1010.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy the securities described herein, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.
About BiondVax
BiondVax Pharmaceuticals Ltd. (NASDAQ: BVXV) is a biopharmaceutical company focused on developing, manufacturing and ultimately commercializing products for the prevention and treatment of infectious diseases and related illnesses. The Company had been developing M‑001, a novel influenza vaccine candidate that was designed to provide multi-strain and multi-season protection against current and future, seasonal and pandemic influenza. In seven Phase 1/2 and Phase 2 clinical trials designed to test for immunogenicity, the Company was able to demonstrate M-001 was effective in stimulating an immune response to a broad range of influenza virus strains. In October 2020, the Company completed a Phase 3 clinical trial of M‑001 which failed to meet the trial’s primary and secondary efficacy endpoints. The Company is now pursuing opportunities in the infectious disease space, including exploring several alternatives for development of a pipeline of assets.
Contact Details
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, including statements regarding future business strategies that BiondVax may explore. 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 BiondVax may not be able to secure capital on attractive terms, if at all; the risk that BiondVax is currently exploring new business strategies after its M-001 universal influenza vaccine candidate failed to meet the trial’s primary and secondary efficacy endpoints; the risk that the European Investment Bank may accelerate the loans under its finance contract with BiondVax; the risk that BiondVax may not execute a strategic alternative to M-001; 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; 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 our prospectus supplement, which is available on the SEC’s website, www.sec.gov. BiondVax undertakes no obligation to revise or update any forward-looking statement for any reason.
BiondVax Announces Pricing of $12.1 Million Follow-on Underwritten Offering of American Depositary Shares
Jerusalem, Israel – January 29, 2021 – BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), a biopharmaceutical company focused on developing, manufacturing and ultimately commercializing products for the prevention and treatment of infectious diseases and related illnesses, today announced the pricing of an underwritten public offering of 2,434,783 American Depositary Shares (“ADSs”), each representing forty ordinary shares, at a public offering price of $4.95 per ADS, for gross proceeds to the Company of approximately $12.1 million, before deducting underwriting discounts and other offering expenses.
BiondVax intends to use the net proceeds from the offering, together with its existing cash and cash equivalents, for general corporate purposes, which may include working capital, research and development activities, regulatory matters, capital investment or other related purposes. The Company may also use a portion of any net proceeds to in-license, invest in or acquire businesses, assets or technologies that BiondVax believes are complementary to its business focus, although BiondVax has no current commitments or agreements in those regards.
The offering is expected to close on or about February 2, 2021, subject to customary closing conditions. In connection with the offering, the Company has also granted the underwriters a 30-day option to purchase up to an additional 15% of the number of ADSs offered to the public at the public offering price, less underwriting discount, for covering over-allotments, if any. If the over-allotment option is exercised in full it would increase the total gross proceeds of the offering to approximately $13.8 million.
Aegis Capital Corp. is acting as the sole book-running manager for the offering.
The ADSs described above are being offered by the Company pursuant to a “shelf” registration statement on Form F-3 (333-240189) filed with the Securities and Exchange Commission (the “SEC”) and declared effective by the SEC on August 10, 2020. A prospectus supplement and accompanying base prospectus relating to and describing the terms of the offering may be obtained, when available, from the SEC’s website located at www.sec.gov or from Aegis Capital Corp., Attention: Syndicate Department, 810 7th Avenue, 18th Floor, New York, NY 10019, by email at syndicate@aegiscap.com, or by telephone at (212) 813-1010.
Before buying any of the BiondVax ADSs, investors should read the preliminary prospectus supplement and accompanying prospectus and other documents incorporated by reference therein, available on the SEC’s website, for more complete information about the Company and this offering.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy the securities described herein, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.
About BiondVax
BiondVax Pharmaceuticals Ltd. (NASDAQ: BVXV) is a biopharmaceutical company focused on developing, manufacturing and ultimately commercializing products for the prevention of infectious diseases and related illnesses. The Company had been developing M‑001, a novel influenza vaccine candidate that was designed to provide multi-strain and multi-season protection against current and future, seasonal and pandemic influenza. In seven Phase 1/2 and Phase 2 clinical trials designed to test for immunogenicity, the Company was able to demonstrate M-001 was effective in stimulating an immune response to a broad range of influenza strains. In October 2020, the Company completed a Phase 3 clinical trial of M‑001 which failed to meet the trial’s primary and secondary efficacy endpoints. The company is now pursuing opportunities in the infectious disease space, including exploring several alternatives for development of a pipeline of assets.
Contact Details
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, including statements regarding future business strategies that BiondVax may explore. 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, that BiondVax does not have sufficient cash to operate its business for the next 12 months, which raises substantial doubt about its ability to continue as a going concern; the risk that BiondVax may not be able to secure capital on attractive terms, if at all; the risk that BiondVax is currently exploring new business strategies after its M-001 universal influenza vaccine candidate failed to meet the trial’s primary and secondary efficacy endpoints; the risk that the European Investment Bank may accelerate the loans under its finance contract with BiondVax; the risk that BiondVax may not execute a strategic alternative to M-001; 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; 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 our preliminary prospectus supplement, which is available on the SEC’s website, www.sec.gov. BiondVax undertakes no obligation to revise or update any forward-looking statement for any reason.
BiondVax Announces Launch of Proposed Underwritten Follow-on Offering of American Depositary Shares
Jerusalem, Israel – January 28, 2021 – BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), a biopharmaceutical company focused on developing, manufacturing and ultimately commercializing products for the prevention and treatment of infectious diseases and related illnesses, today announced its intention to offer its American Depositary Shares (“ADSs”) in an underwritten public offering. In connection with the offering, BiondVax expects to grant the underwriter a 30-day option to purchase up to an additional 15% of the ADSs to be sold in the offering to cover over-allotments, if any. The ADSs are being offered by BiondVax pursuant to an effective shelf registration statement on file with the Securities and Exchange Commission (the “SEC”).
BiondVax intends to use the net proceeds from the offering, together with its existing cash and cash equivalents, for general corporate purposes, which may include working capital, research and development activities, regulatory matters, capital investment or other related purposes. The Company may also use a portion of any net proceeds to in-license, invest in or acquire businesses, assets or technologies that BiondVax believes are complementary to its business focus, although BiondVax has no current commitments or agreements in those regards.
Aegis Capital Corp. is acting as the sole book-running manager for the offering.
The offering is subject to market conditions and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.
The ADSs described above are being offered by the Company pursuant to a registration statement that was previously filed with the SEC and declared effective by the SEC on August 10, 2020. A prospectus supplement and accompanying base prospectus relating to and describing the final terms of the offering will be made available on the SEC’s website located at www.sec.gov or from Aegis Capital Corp., Attention: Syndicate Department, 810 7th Avenue, 18th Floor, New York, NY 10019, by email at syndicate@aegiscap.com, or by telephone at (212) 813-1010.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy the securities described herein, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.
About BiondVax
BiondVax Pharmaceuticals Ltd. (NASDAQ: BVXV) is a biopharmaceutical company focused on developing, manufacturing and ultimately commercializing products for the prevention of infectious diseases and related illnesses. The Company had been developing M‑001, a novel flu vaccine candidate that was designed to provide multi-strain and multi-season protection against current and future, seasonal and pandemic influenza. In seven Phase 1/2 and Phase 2 clinical trials designed to test for immunogenicity, the Company was able to demonstrate M-001 was effective in stimulating an immune response to a broad range of flu strains. In October 2020, the Company completed a Phase 3 clinical trial of M‑001 which failed to meet the trial’s primary and secondary efficacy endpoints. The company is now pursuing opportunities in the infectious disease space, including exploring several alternatives for development of a pipeline of assets. For more information, please visit www.biondvax.com.
Contact Details
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, including statements regarding future business strategies that BiondVax may explore. These forward-looking statements reflect the 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, that BiondVax does not have sufficient cash to operate its business for the next 12 months, which raises substantial doubt about its ability to continue as a going concern; the risk that BiondVax may not be able to secure capital on attractive terms, if at all; the risk that BiondVax is currently exploring new business strategies after its M‑001 universal flu vaccine candidate failed to meet the trial’s primary and secondary efficacy endpoints; the risk that the European Investment Bank may accelerate the loans under its finance contract with BiondVax; the risk that BiondVax may not execute a strategic alternative to M-001; 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 our manufacturing facility in Jerusalem; the risk that drug development involves a lengthy and expensive process with uncertain outcome; the ability of BiondVax to maintain, preserve and defend its intellectual property and patents granted; the adequacy of available cash resources and the ability to raise additional capital when needed. More detailed information about the risks and uncertainties affecting BiondVax is contained under the heading “Risk Factors” in BiondVax’s Annual Report on Form 20-F for the year ended December 31, 2019 and other filings filed with the U.S. Securities and Exchange Commission, or SEC, which is available on the SEC’s website, www.sec.gov. The Company undertakes no obligation to revise or update any forward-looking statement for any reason.
BiondVax Announces Third Quarter 2020 Financial Results & Business Update
Jerusalem, Israel – January 28, 2021 – BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), a biopharmaceutical company focused on developing, manufacturing and ultimately commercializing products for the prevention and treatment of infectious diseases and related illnesses, today announced its third quarter financial results for the quarter ended September 30, 2020.
Third Quarter 2020 Financial Summary
Total operating income for the third quarter was NIS 55.6 million (approximately $16.1 million) compared with a total operating loss of NIS 19.0 million for the third quarter of 2019.
R&D expenses, net of participations, for the third quarter amounted to NIS 12.6 million (approximately $ 3.7 million) compared with NIS 16.1 million for the third quarter of 2019.
Net profit for the third quarter was NIS 55.3 million (approximately $ 16.1 million) compared to a net loss of NIS 19.4 million for the third quarter of 2019.
As of September 30, 2020, BiondVax had cash and cash equivalents of NIS 24.8 million (approximately $7.2 million) compared to NIS 72.5 million as of December 31, 2019. At the currently anticipated burn rate going forward, BiondVax has sufficient funds to continue operations through the end of Q2 2021.
Recent Business Updates:
On October 23, 2020, BiondVax announced that the Phase 3 clinical trial of the Company’s M–001 universal flu vaccine candidate failed to meet the trial’s primary and secondary efficacy endpoints.
On January 21, 2021, BiondVax announced the appointment of Amir Reichman as its new CEO. Reichman currently serves as Head of Global Vaccines Engineering Core Technologies and Asset Management at GSK Vaccines headquarters in Belgium.
In light of the Phase 3 clinical trial results, Company’s management estimates that there will be no future revenues from the M-001. Therefore, most likely, there will be no future royalty payments to the Israel Innovation Authority (IIA) & European Investment Bank (EIB). The operating income and net profit noted in these Q3 2020 financial results are attributable primarily to the revaluation of the liabilities to the IIA and EIB on the Company’s balance sheet in accordance with applicable IFRS standards, offset by R&D, Marketing, and G&A expenses.
BiondVax is currently pursuing collaborations and other opportunities in the infectious disease space, including exploring several alternatives for development of a new product pipeline.
About BiondVax
BiondVax Pharmaceuticals Ltd. (NASDAQ: BVXV) is a biopharmaceutical company focused on developing, manufacturing and ultimately commercializing products for the prevention of infectious diseases and related illnesses. The Company had been developing M‑001, a novel flu vaccine candidate that was designed to provide multi-strain and multi-season protection against current and future, seasonal and pandemic influenza. In seven Phase 1/2 and Phase 2 clinical trials designed to test for immunogenicity, the Company was able to demonstrate M-001 was effective in stimulating an immune response to a broad range of flu strains. In October 2020, the Company completed a Phase 3 clinical trial of M‑001 which failed to meet the trial’s primary and secondary efficacy endpoints. The company is now pursuing opportunities in the infectious disease space, including exploring several alternatives for development of a pipeline of assets. For more information, please visit www.biondvax.com.
Contact Details
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, including statements regarding future business strategies that BiondVax may explore. These forward-looking statements reflect the 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, that BiondVax does not have sufficient cash to operate its business for the next 12 months, which raises substantial doubt about its ability to continue as a going concern; the risk that BiondVax may not be able to secure capital on attractive terms, if at all; the risk that BiondVax is currently exploring new business strategies after its M-001 universal flu vaccine candidate failed to meet the Phase 3 trial’s primary and secondary efficacy endpoints; the risk that the European Investment Bank may accelerate the loans under its finance contract with BiondVax; the risk that BiondVax may not execute a strategic alternative to M-001; 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 us or at all; receipt, if and when provided, of regulatory approval of BiondVax’s manufacturing facility in Jerusalem; the risk that drug development involves a lengthy and expensive process with uncertain outcomes; and the ability of the Company to maintain, preserve and defend its intellectual property and patents granted. 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 for the year ended December 31, 2019 and other filings filed with the U.S. Securities and Exchange Commission, or SEC, which is available on the SEC’s website, www.sec.gov. The Company undertakes no obligation to revise or update any forward-looking statement for any reason.