Press Releases
BiondVax Announces Appointment of Amir Reichman as New CEO
Pharma Industry Veteran in Vaccines will Assume Role Full Time March 2, 2021 with Focus on Developing Product Pipeline in Infectious Diseases
Amir Reichman CEO
Jerusalem, Israel – January 21, 2021 – BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), a biopharmaceutical company focused on development and manufacturing of products for the prevention and treatment of infectious diseases, today announced the appointment of Amir Reichman as its new CEO. Mr. Reichman and Ron Babecoff, BiondVax’s founder and current CEO, will share duties during a transition period while Mr. Reichman completes his work obligations at GlaxoSmithKline (GSK), a global pharmaceutical company. Effective March 2, 2021, Mr. Reichman will assume the CEO position full time and Mr. Babecoff will continue as Senior Advisor to the Company.
Born and educated in Israel, Mr. Reichman currently serves as Head of Global Vaccines Engineering Core Technologies and Asset Management at GSK Vaccines headquarters in Belgium. Prior to his current role in global vaccines engineering, he served as Senior Director Global GSK Vaccines Supply Chain. Mr. Reichman joined GSK in 2015 after its acquisition of Novartis Vaccines. At Novartis Vaccines, he held various leadership roles of increasing responsibility in its Global Vaccines Supply Chain Management organization located in Holly Springs, NC, USA. In 2003, Mr. Reichman’s academic work at Ben-Gurion University of the Negev contributed to the founding of NeuroDerm Ltd., an Israeli company focused on transdermal drug delivery systems that was acquired by Mitsubishi Tanabe Pharma in 2017 for $1.1B. He was NeuroDerm’s first employee and served as the company’s Chief Engineer and Senior Scientist until his departure in 2009. Mr. Reichman earned an M.Sc. in Biotechnology Engineering from the Ben-Gurion University of the Negev in Israel, and an MBA in Finance and Health Care Management from the Wharton School of the University of Pennsylvania, USA.
Mr. Mark Germain, BiondVax’s Chairman of the Board, commented, “The Board of Directors is extremely pleased that Amir has accepted the opportunity to lead BiondVax. After many years abroad, in which he gained pharmaceutical industry senior leadership experience at Novartis and GSK, his return to Israel comes at an auspicious time for BiondVax. Amir’s capabilities align closely with our vision of growing BiondVax into a multi-asset biopharmaceutical company with a focus on infectious diseases. Together, we are already working diligently to expand our pipeline in the infectious diseases space by leveraging our assets, including our vaccine manufacturing facility, IP, people and extensive drug development experience.”
Germain continued, “On behalf of the Board, I wish to thank and commend Ron for his unyielding dedication in founding BiondVax and leading it through preclinical development to eight clinical trials, construction of our state-of-the-art GMP vaccine manufacturing facility, as well as TASE and Nasdaq listings. A number of Ron’s accomplishments were unprecedented for an Israeli company and I think would compare favorably with the best in breed biotech companies anywhere, including the 12,400 participant, 105 site, seven country Phase 3 clinical trial that was conducted on time and on budget in the face of the growing threat of COVID-19, and the €24m European Investment Bank (EIB) non-dilutive financing agreement which was the first such EIB agreement with a non-EU country. Ron’s experience, knowledge and contribution as Senior Advisor will provide ongoing significant value to the Company and I look forward to continuing a strong, productive and beneficial working relationship.”
Mr. Amir Reichman noted, “I am extremely excited and thrilled to assume the role of BiondVax’s CEO. Thanks to the strong foundations built by Ron and his team, as well as the experience and ongoing support of our Board of Directors, BiondVax has tremendous potential to grow into a leading pharmaceutical company. Our mission at BiondVax is to create a healthier world by preventing and curing infectious diseases. To do that, I envision BiondVax becoming a world player; a trusted and preferred bio-pharma company known for its highly innovative products, fast product development, and reliable supply of high-quality and effective medicinal products. While results of the M-001 vaccine candidate’s Phase 3 trial were disappointing, our team has gained many strengths and experience in innovative product research, preclinical and clinical development, and GMP manufacturing in our state-of-the-art facility in Jerusalem. These organizational capabilities are key for a successful turnaround. We continue to believe there is a compelling need and demand for vaccines and therapeutics for infectious diseases, and we are currently exploring various potential paths forward including collaborations and other opportunities to build a new product pipeline that will help us achieve our mission. I wish to thank the board for their trust, and Ron for his support as I transition into the CEO role.”
Dr. Ron Babecoff commented, “After dedicating eighteen years towards the project of developing a universal flu vaccine, including fifteen as BiondVax’s President and CEO, I feel it is the right time to hand over leadership of the Company to Amir, who I believe has the right personality and experience to lead BiondVax to its next phase. I am proud of our accomplishments over the many years of intensive R&D activities from preclinical through a Phase 3 clinical trial, international collaborations such as with the NIH and the EIB, as well as construction of a new state-of-the-art vaccine manufacturing facility in Jerusalem. I would like to express my deep gratitude to my devoted team with whom we achieved so much over the years. I also wish to thank BiondVax’s board members and scientific advisory board, both current and previous, as well as our shareholders, and our many other stakeholders for their continuous support. Finally, I look forward to seeing BiondVax reach its new ambitious goals for the sake of improving global health.”
About BiondVax
BiondVax Pharmaceuticals Ltd. (NASDAQ: BVXV) is a biopharmaceutical company focused on development and manufacturing of products for the prevention of infectious diseases. 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 growing BiondVax into a leading multi-asset pharmaceutical company known for its highly innovative products, fast product development speed and reliable supply of high-quality and effective medicinal products. 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, risks relating to the COVID-19 (coronavirus) pandemic; our ability to acquire rights to additional product opportunities; our ability to enter into collaborations on terms acceptable to us 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 the Company 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 the Company is contained under the heading “Risk Factors” in our 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 Topline Results from Phase 3 Clinical Trial of the M-001 Universal Influenza Vaccine Candidate
Jerusalem, Israel – October 23, 2020 – BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), a pioneer in the development of a universal flu vaccine designed to provide protection against current, future, seasonal and pandemic influenza, today announced topline data from the Company’s pivotal, phase 3 clinical trial of M-001 as a standalone universal flu vaccine candidate.
Results did not demonstrate a statistically significant difference between the vaccinated and placebo groups in reduction of flu illness and severity, and therefore failed to meet both the primary and secondary efficacy endpoints. The study’s primary safety endpoint was met.
“We are disappointed with these results, and I wish to thank the BiondVax team for their efforts, dedication, and passion over the past 15 years. Together we have endeavored to develop an innovative approach to a persistent global problem. I am especially grateful to each of the clinical trial participants, as well as the investigators in all our trials for their efforts, and to our stakeholders for their support,” said Dr. Ron Babecoff, Founder, President, and Chief Executive Officer. “The significant need for better, more proactive flu protection is well-understood by clinicians and public health experts around the world, and we have devoted many years in pursuit of this worthy goal. Unfortunately, this study did not have the efficacy outcomes that we anticipated for M-001 on a standalone basis. We have observed in seven previous studies that M-001 safely provoked an immune response to a broad range of flu strains, but ultimately this was not sufficient on a standalone basis to show protection.”
Dr. Babecoff continued, “We have developed expertise and IP in pursuit of our goals, and we retain a state-of-the-art manufacturing facility. Going forward, we will examine options to maximize the value of these assets.”
About the pivotal Phase 3 trial: The randomized, modified double-blind, placebo-controlled, pivotal Phase 3 trial assessed safety and efficacy of the M‑001 vaccine candidate alone in reducing flu illness and severity in 12,463 adults aged 50 years and older, including 6,291 (50.5%) aged 65 and older. 4,042 participants were enrolled and randomized in the trial’s first cohort prior to the 2018/19 flu season, and an additional 8,421 participants were enrolled across seven Eastern European countries in the trial’s second cohort (2019/20 flu season). Each participant was monitored for one flu season.
The trial commenced in 2018, after the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) reviewed the trial design and provided feedback. The CHMP response included comments regarding various aspects of the trial design, and also stated that, “It is agreed that a single pivotal efficacy trial that provides a robust demonstration of efficacy against laboratory-proven influenza like illness (ILI) could suffice for an approval.”
About BiondVax: BiondVax (NASDAQ: BVXV) is a biopharmaceutical company that has been developing M-001, a novel flu vaccine candidate. The vaccine candidate was designed to provide multi-strain and multi-season protection against current and future, seasonal and pandemic influenza. An NIH/NIAID Phase 2 study completed in 2020 showed a significant increase in polyfunctional CD4+ cells in the M-001 group. In a total of seven previously completed Phase 1/2 and Phase 2 clinical trials, the M-001 vaccine candidate was well-tolerated and immunogenic. For more information, please visit www.biondvax.com.
Company Contact: Joshua E. Phillipson | +972 8 930 2529 | j.phillipson@biondvax.com
Investor Relations: Joseph Green | +1 646 653 7030 | jgreen@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. 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, risks relating to the COVID-19 (coronavirus) pandemic; timing of receipt of regulatory approval of our manufacturing facility in Jerusalem; ability to demonstrate the efficacy and safety of the vaccine; the risk that drug development involves a lengthy and expensive process with uncertain outcome; the ability of the Company to maintain, preserve and defend its intellectual property and patents granted; whether our vaccine candidate will successfully advance through the clinical trial process on a timely basis, or at all, and receive approval from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies; the adequacy of available cash resources and the ability to raise additional capital when needed. More detailed information about the risks and uncertainties affecting the Company is contained under the heading “Risk Factors” in our prospectus filed today and our 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 At-The-Market (ATM) Equity Offering Program
Jerusalem, Israel – October 2, 2020 – BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), developer of the Phase 3 clinical trial M‑001 universal influenza vaccine candidate (“BiondVax” or the “Company”), today announced it has entered into an agreement with BofA Securities as lead sales agent, and Citigroup and Credit Suisse as participating sales agents (collectively, the “Agents”), related to a $100 million At-The-Market (the “ATM Program”) equity offering program pursuant to a prospectus supplement filed today with the Securities and Exchange Commission (the “SEC”).
BiondVax is not obligated to sell any American Depositary Shares (“ADSs”) under the ATM Program. The timing of any sales will depend on a variety of factors to be determined by BiondVax. The Company currently intends to use the net proceeds from the ATM Program, if any, for general corporate purposes, which may include working capital, research and development activities, regulatory matters, capital investment or other related purposes, and pre-commercialization and commercialization activities. We may also use a portion of any net proceeds to in-license, invest in or acquire businesses, assets or technologies that we believe are complementary to our own, although we have no current plans, commitments or agreements with respect to any in-license, investment or acquisition.
The BiondVax ADSs will be offered and sold through the Agents. Sales of ADSs may be made by any method permitted by law deemed to be an “at-the-market offering” as defined in Rule 415 of the Securities Act of 1933, as amended. Sales may be made at market prices prevailing at the time of the sale, at prices related to prevailing market prices or at negotiated prices and, as a result, sales prices may vary.
Under the terms of the Agreement, BiondVax may also sell ADSs directly to any of the Agents, as principal for its own account, at a price agreed upon at the time of sale. If the Company agrees to sell shares to any Agent as principal, it will enter into a separate terms agreement with such Agent.
A shelf registration statement was previously filed with the SEC and declared effective by the SEC on August 10, 2020. A prospectus supplement adds to, updates or otherwise changes information contained in the accompanying prospectus and has been filed with the SEC and is available on the SEC’s website located at www.sec.gov. Prospective investors should read the prospectus, the prospectus supplement and other documents the Company has filed with the SEC (some of which are incorporated by reference into the prospectus and prospectus supplement) for more complete information about the Company, the ATM Program and the risks the Company currently is facing. You may obtain copies of the prospectus supplement and accompanying prospectus relating to the offering without charge by visiting the SEC’s website at www.sec.gov. Alternatively, the issuer, any sales agent or any dealer participating in the offering will arrange to send you the prospectus and the prospectus supplement if you request them by writing to BofA Securities at NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte NC 28255-0001, Attn: Prospectus Department or emailing dg.prospectus_requests@bofa.com, calling Citigroup at 1-800-831-9146 or calling Credit Suisse at 1-800-221-1037 or emailing usa.prospectus@credit-suisse.com.
This press release is for informational purposes only and is not an offer to sell or the solicitation of an offer to buy any ADSs of the Company, which is made only by means of a prospectus supplement and related prospectus. There will be no sale of ADSs in any jurisdiction in which the offer, solicitation of an offer to buy or sale would be unlawful.
About BiondVax BiondVax (NASDAQ: BVXV) is a Phase 3 clinical stage biopharmaceutical company developing a universal flu vaccine. The vaccine candidate, called M-001, is designed to provide multi-strain and multi-season protection against current and future, seasonal and pandemic influenza. BiondVax’s proprietary technology utilizes a unique combination of conserved and common influenza virus peptides intended to stimulate both arms of the immune system for a cross-protecting and long-lasting effect. In a total of seven completed Phase 1/2 and Phase 2 clinical trials enrolling 818 participants, the vaccine has been shown to be safe, well-tolerated, and immunogenic. The ongoing pivotal Phase 3 clinical trial, which enrolled more than 12,400 participants over two flu seasons in 83 sites across seven countries, aims to assess safety and effectiveness of M-001 in reducing flu illness and severity.
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. 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, risks relating to the COVID-19 (coronavirus) pandemic, the prosecution, timing and results of the ongoing Phase 2 and Phase 3 trials and any subsequent trials; timing of receipt of regulatory approval of our manufacturing facility in Jerusalem; ability to demonstrate the efficacy and safety of the vaccine; the timing of clinical trials and marketing approvals; the risk that drug development involves a lengthy and expensive process with uncertain outcome; the ability of the Company to maintain, preserve and defend its intellectual property and patents granted; whether our vaccine candidate will successfully advance through the clinical trial process on a timely basis, or at all, and receive approval from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies; the adequacy of available cash resources and the ability to raise additional capital when needed. More detailed information about the risks and uncertainties affecting the Company is contained under the heading “Risk Factors” in our prospectus filed today and our Annual Report on Form 20-F for the year ended December 31, 2019 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.
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BiondVax Announces Second Quarter 2020 Financial Results
Jerusalem, Israel - Aug. 20, 2020 - BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), a clinical stage biopharmaceutical company focused on developing and commercializing M-001, a universal influenza vaccine candidate, today announced its second quarter financial results for the quarter ended June 30, 2020.
Second Quarter 2020 Financial Summary
Results are in New Israel Shekels (NIS) and convenience translation to $US is provided using the exchange rate of 3.466 (NIS/$US) as at June 30, 2020.
Total operating expenses for the second quarter were NIS 16.0 million (approximately $4.61 million) compared with NIS 19.7 million for the second quarter of 2019.
R&D expenses for the second quarter amounted to NIS 11.9 million (approximately $3.4 million) compared with NIS 15.2 million for the second quarter of 2019.
Net loss for the second quarter was NIS 42 million (approximately $12.1 million) compared to net loss of NIS 47.4 million for the second quarter of 2019.
The decrease in total operating expenses compared to the second quarter of 2019 was primarily due to fewer costs associated with the nearly complete pivotal Phase 3 trial and completion of construction of the manufacturing facility. As of June 30, 2020, BiondVax had cash and cash equivalents of NIS 38.7 million (approximately $11.2 million) compared to NIS 72.4 million as of December 31, 2019.
About BiondVax
BiondVax (NASDAQ: BVXV) is a Phase 3 clinical stage biopharmaceutical company developing a universal flu vaccine. The vaccine candidate, called M-001, is designed to provide multi-strain and multi-season protection against current and future, seasonal and pandemic influenza. BiondVax's proprietary technology utilizes a unique combination of conserved and common influenza virus peptides intended to stimulate both arms of the immune system for a cross-protecting and long-lasting effect. In a total of seven completed Phase 1/2 and Phase 2 clinical trials enrolling 818 participants, the vaccine has been shown to be safe, well-tolerated, and immunogenic. The ongoing pivotal Phase 3 clinical trial aims to assess safety and effectiveness of M-001 in reducing flu illness and severity. For more information, please visit www.biondvax.com.
Contact DetailsJoshua E. Phillipson | +972 8 930 2529 | j.phillipson@biondvax.com
Forward Looking StatementsThis 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. 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, risks relating to the COVID-19 (coronavirus) pandemic, the prosecution, timing and results of the ongoing Phase 2 and Phase 3 trials and any subsequent trials; timing of receipt of regulatory approval of our manufacturing facility in Jerusalem; ability to demonstrate the efficacy and safety of the vaccine; the timing of clinical trials and marketing approvals; the risk that drug development involves a lengthy and expensive process with uncertain outcome; the ability of the Company to maintain, preserve and defend its intellectual property and patents granted; whether our vaccine candidate will successfully advance through the clinical trial process on a timely basis, or at all, and receive approval from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies; the adequacy of available cash resources and the ability to raise additional capital when needed. More detailed information about the risks and uncertainties affecting the Company is contained under the heading "Risk Factors" in our Annual Report on Form 20-F for the year ended December 31, 2019 filed with the U.S. Securities and Exchange Commission, or SEC, which is available on the SEC's website, www.sec.gov. We undertake no obligation to revise or update any forward-looking statement for any reason.
BiondVax Announces Notice of Annual General Meeting of Shareholders and Provides a Clinical Trial Update
Jerusalem, Israel – August 13, 2020 – BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), developer of the Phase 3 clinical trial M‑001 universal influenza vaccine candidate, today announced that the Annual General Meeting of Shareholders of the Company will be held on September 2, 2020 in Tel Aviv, Israel. Details, including a link to the Proxy Statement and voting card, are available on the SEC website at https://www.sec.gov/Archives/edgar/data/1611747/000121390020020357/ea125062-6k_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.
Clinical trial update: BiondVax currently anticipates announcing results from the pivotal Phase 3 clinical trial in late September to the end of October this year based on the schedule of current operational activities. However, there are no assurances that this timetable will be met in the event that we encounter any delays.
About BiondVax
BiondVax (NASDAQ: BVXV) is a Phase 3 clinical stage biopharmaceutical company developing a universal flu vaccine. The vaccine candidate, called M-001, is designed to provide multi-strain and multi-season protection against current and future, seasonal and pandemic influenza. BiondVax’s proprietary technology utilizes a unique combination of conserved and common influenza virus peptides intended to stimulate both arms of the immune system for a cross-protecting and long-lasting effect. In a total of seven completed Phase 1/2 and Phase 2 clinical trials enrolling 818 participants, the vaccine has been shown to be safe, well-tolerated, and immunogenic. The ongoing pivotal Phase 3 clinical trial aims to assess safety and effectiveness of M-001 in reducing flu illness and severity. 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. 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, risks relating to the COVID-19 (coronavirus) pandemic, including a risk of delay in the availability of the top line results from our pivotal clinical efficacy Phase 3 trial for M-001, the prosecution, timing and results of the ongoing Phase 2 and Phase 3 trials and any subsequent trials; timing of receipt of regulatory approval of our manufacturing facility in Jerusalem; ability to demonstrate the efficacy and safety of the vaccine; the timing of clinical trials and marketing approvals; the risk that drug development involves a lengthy and expensive process with uncertain outcome; the ability of the Company to maintain, preserve and defend its intellectual property and patents granted; whether our vaccine candidate will successfully advance through the clinical trial process on a timely basis, or at all, and receive approval from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies; the adequacy of available cash resources and the ability to raise additional capital when needed. More detailed information about the risks and uncertainties affecting the Company is contained under the heading “Risk Factors” in our Annual Report on Form 20-F for the year ended December 31, 2019 filed with the U.S. Securities and Exchange Commission, or SEC, which is available on the SEC’s website, www.sec.gov. We undertake no obligation to revise or update any forward-looking statement for any reason.
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Last of 12,400 Participants Completes Final Visit in BiondVax’s M-001 Universal Flu Vaccine Pivotal Phase 3 Clinical Trial
Jerusalem, Israel – July 1, 2020 – BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV) today announced that all participants in the placebo-controlled, blinded, pivotal, clinical efficacy, Phase 3 trial of BiondVax’s M‑001 universal influenza vaccine candidate have now completed their site visits. In total, over 12,400 volunteers aged 50+ (with half aged 65+) were enrolled in the trial over the past two flu seasons in 83 sites across seven European countries. The purpose of the study is to assess M-001’s ability as a standalone non-adjuvanted vaccine to provide clinical protection from circulating influenza strains as measured by reduction of influenza illness rate (as a primary endpoint) and severity (as a secondary endpoint), as well as to assess M-001’s safety.Seasonal influenza annually infects approximately 10-20% of the world’s population resulting in up to about five million cases of severe illness and 650,000 deaths. In addition, pandemic influenza, such as the H1N1 Swine Flu pandemic of 2009, is a constant global threat. However, current influenza vaccines, which target frequently mutating parts of the flu virus and therefore must be updated annually in the hope they will match the next flu season’s circulating strains, achieve on average only about 40% vaccine effectiveness in the general population and as low as 12% in older adults.BiondVax’s M-001 is a single recombinant protein of highly conserved influenza epitopes. Consequently:
M-001 does not need to be updated and therefore can be manufactured and distributed year-round.
M-001 is designed to provide protection to both existing and future seasonal A and B strains, as well as emerging pandemic strains.
Dr. Tamar Ben-Yedida, BiondVax’s Chief Scientist, commented, “We are pleased that despite the ongoing COVID-19 pandemic, and the challenge of conducting the trial across 83 sites and seven countries, thanks to all the people involved – including the CRO, investigators, and thousands of participants – we have maintained the planned timelines of our pivotal Phase 3 trial. In light of the ongoing COVID-19 pandemic, the need for improved influenza vaccines has arguably never been clearer. To better protect lives and economies, influenza vaccines must be more effective in reducing illness rates and severity. Needless to say, we are eagerly anticipating results of our trial by the end of this year.”Participants in the trial’s second cohort were enrolled prior to the 2019/20 flu season and monitored for influenza-like illness (ILI) symptoms throughout the flu season. Swabs samples were collected from those participants with ILI, and influenza confirmation is currently being conducted by a qualified laboratory. Analysis will continue in the coming months, and results are expected by the end of 2020.As part of this Phase 3 study, cell-mediated immunogenicity markers of M-001 will be evaluated in a subset of participants. The recently completed clinical study report (CSR) of a U.S. National Institute of Allergy and Infectious Diseases (NIAID) supported Phase 2 clinical trial of M-001 concluded that, “M-001 induced significant polyfunctional T cell responses.”In addition to the ongoing pivotal, clinical efficacy, Phase 3 trial, equipment installation and manufacturing process scale-up in BiondVax’s pilot facility in Jerusalem are in progress. The facility has planned annual capacity of up to between 10 and 20 million doses in bulk.
About BiondVax BiondVax (NASDAQ: BVXV) is a Phase 3 clinical stage biopharmaceutical company developing a universal flu vaccine. The vaccine candidate, called M-001, is designed to provide multi-strain and multi-season protection against current and future, seasonal and pandemic influenza. BiondVax’s proprietary technology utilizes a unique combination of conserved and common influenza virus peptides intended to stimulate both arms of the immune system for a cross-protecting and long-lasting effect. In a total of seven completed Phase 1/2 and Phase 2 clinical trials enrolling 818 participants, the vaccine has been shown to be safe, well-tolerated, and immunogenic. The ongoing pivotal Phase 3 clinical trial aims to assess safety and effectiveness of M-001 in reducing flu illness and severity. For more information, please visit www.biondvax.com.
Contact DetailsJoshua 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. 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, risks relating to the COVID-19 (coronavirus) pandemic, including a risk of delay in the availability of the top line results from our pivotal clinical efficacy Phase 3 trial for M-001, the prosecution, timing and results of the ongoing Phase 2 and Phase 3 trials and any subsequent trials; timing of receipt of regulatory approval of our manufacturing facility in Jerusalem; ability to demonstrate the efficacy and safety of the vaccine; the timing of clinical trials and marketing approvals; the risk that drug development involves a lengthy and expensive process with uncertain outcome; the ability of the Company to maintain, preserve and defend its intellectual property and patents granted; whether our vaccine candidate will successfully advance through the clinical trial process on a timely basis, or at all, and receive approval from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies; the adequacy of available cash resources and the ability to raise additional capital when needed. More detailed information about the risks and uncertainties affecting the Company is contained under the heading “Risk Factors” in our Annual Report on Form 20-F for the year ended December 31, 2019 filed with the U.S. Securities and Exchange Commission, or SEC, which is available on the SEC’s website, www.sec.gov. We undertake no obligation to revise or update any forward-looking statement for any reason.
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BiondVax Announces First Quarter 2020 Financial Results
Jerusalem, Israel – June 30, 2020 – BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), a clinical stage biopharmaceutical company focused on developing and commercializing M-001, a universal influenza vaccine candidate, today announced its first quarter financial results for the quarter ended March 31, 2020.
First Quarter 2020 Financial Summary
Results are in New Israel Shekels (NIS) and convenience translation to $US is provided using the exchange rate of 3.57(NIS/$US) as at March 31, 2020.
Total operating expenses for the first quarter were NIS 20.0 million (approximately $5.6 million) compared with NIS 7.1 million for the first quarter of 2019.
R&D expenses for the first quarter amounted to NIS 19 million (approximately $5.3 million) compared with NIS 5.7 million for the first quarter of 2019.
Net loss for the first quarter was NIS 3.7 million (approximately $1.0 million) compared to net income of NIS 566 thousand for the first quarter of 2019.
The increase in total operating expenses compared to the first quarter of 2019 was primarily due to expenses related to the ongoing Phase 3 trial and scale-up at our manufacturing facility. As of March 31, 2020, BiondVax had cash and cash equivalents of NIS 42.5 million (approximately $11.9 million) compared to NIS 72.4 million as of December 31, 2019.
About BiondVax BiondVax (NASDAQ: BVXV) is a Phase 3 clinical stage biopharmaceutical company developing a universal flu vaccine. The vaccine candidate, called M-001, is designed to provide multi-strain and multi-season protection against current and future, seasonal and pandemic influenza. BiondVax’s proprietary technology utilizes a unique combination of conserved and common influenza virus peptides intended to stimulate both arms of the immune system for a cross-protecting and long-lasting effect. In a total of seven completed Phase 1/2 and Phase 2 clinical trials enrolling 818 participants, the vaccine has been shown to be safe, well-tolerated, and immunogenic. The ongoing pivotal Phase 3 clinical trial aims to assess safety and effectiveness of M-001 in reducing flu illness and severity. 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. 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, risks relating to the COVID-19 (coronavirus) pandemic, the prosecution, timing and results of the ongoing Phase 2 and Phase 3 trials and any subsequent trials; timing of receipt of regulatory approval of our manufacturing facility in Jerusalem; ability to demonstrate the efficacy and safety of the vaccine; the timing of clinical trials and marketing approvals; the risk that drug development involves a lengthy and expensive process with uncertain outcome; the ability of the Company to maintain, preserve and defend its intellectual property and patents granted; whether our vaccine candidate will successfully advance through the clinical trial process on a timely basis, or at all, and receive approval from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies; the adequacy of available cash resources and the ability to raise additional capital when needed. More detailed information about the risks and uncertainties affecting the Company is contained under the heading “Risk Factors” in our Annual Report on Form 20-F for the year ended December 31, 2019 filed with the U.S. Securities and Exchange Commission, or SEC, which is available on the SEC’s website, www.sec.gov. We undertake no obligation to revise or update any forward-looking statement for any reason.
BiondVax Announces Fourth Quarter and Full Year 2019 Financial Results and Provides Business Update
Jerusalem, Israel – June 12, 2020 – BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), a clinical stage biopharmaceutical company focused on developing and commercializing M-001, a universal influenza vaccine candidate, today announced its fourth quarter and full year financial results for the year ended December 31, 2019 and provided a business update.
Fourth Quarter 2019 Financial Summary
Results are in New Israel Shekels (NIS) and convenience translation to $US is provided using the exchange rate of 3.456 (NIS/$US) as at December 31, 2019.
Total operating expenses were NIS 32.5 million (approximately $9.4 million) compared with NIS 27.9 million for the fourth quarter of 2018.
R&D expenses for the fourth quarter amounted to NIS 31.6 million ($9.1 million) compared with NIS 26.6 million for the fourth quarter of 2018.
Full Year 2019 Financial Summary
Total operating expenses for 2019 were NIS 78.3 million ($22.6 million) compared with NIS 77 million in 2018.
R&D expenses for 2019 amounted to NIS 68.6 million ($19.8 million) compared with NIS 71.9 million in 2018.
As of December 31, 2019, BiondVax had cash and cash equivalents of NIS 72.4 million ($20.9 million) compared to NIS 75.8 million as of December 31, 2018. Complete financial results are available in the Company’s annual report on Form 20-F for the year ended December 31, 2019, which is being filed with the Securities and Exchange Commission today.
*Tables to follow*
2019 Highlights and Recent Corporate Update
Pivotal clinical efficacy Phase 3 trial: The pivotal Phase 3 clinical trial aims to compare the safety and clinical efficacy of M-001 versus a placebo in preventing flu illness (as primary endpoints), and in reducing flu illness severity (as a secondary endpoint) from circulating influenza strains. Prior to both the 2018/19 and 2019/20 flu seasons, a total of over 12,400 adult volunteers aged 50+ (with half aged 65+) in seven European countries were enrolled. To date, no serious treatment related adverse events have been identified. Monitoring of the trial’s second cohort (enrolled for the 2019/20 flu season) is nearly complete, and the Phase 3 clinical trial results are expected by the end of 2020.
NIH-supported Phase 2 clinical trial: The clinical study report (CSR) of the NIH-supported Phase 2 clinical trial was completed earlier this week. The CSR concludes that “M-001 was safe in this study” and that “M-001 induced significant polyfunctional T cell responses,” indicating that both primary endpoints of the trial were achieved. The trial in 120 adult volunteers, supported by the U.S. National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), was conducted by several of NIAID’s Vaccine Treatment and Evaluation Units (VTEUs) in the U.S.
Pilot manufacturing facility: Equipment installation and scale-up in BiondVax’s pilot manufacturing facility in Jerusalem are in progress. The facility has planned annual capacity of up to between 10 and 20 million doses in bulk.
€24 million non-dilutive co-funding: The European Investment Bank (EIB) extended the 2017 co-financing agreement from €20 million to €24 million to support construction of BiondVax’s pilot manufacturing facility in Israel and Phase 3 trial. BiondVax was honored to host Mr. Ambroise Fayolle, EIB Vice-President, during his visit to BiondVax in June 2019 for a signature event celebrating the extension of the financing agreement.
$20 million rights offering: In June and July 2019, BiondVax raised approximately US$20 million in a rights offering to existing shareholders.
Warrant expiration: BiondVax received proceeds of approximately $4.2 million through exercises of BiondVax warrants between January 1, 2020 and expiration of the warrants in May 2020.
New Board members: In September 2019, Mr. Mark Germain was appointed Chairman of the Board of Directors. In March 2020, Mr. Samuel Moed, Dr. Yael Margolin, and Mr. Adi Raviv were elected to the board. Mr. Moed recently served as Senior Vice President, Corporate Strategy at Bristol Myers Squibb (NYSE: BMY).
About BiondVax BiondVax (NASDAQ: BVXV) is a Phase 3 clinical stage biopharmaceutical company developing a universal flu vaccine. The vaccine candidate, called M-001, is designed to provide multi-strain and multi-season protection against current and future, seasonal and pandemic influenza. BiondVax’s proprietary technology utilizes a unique combination of conserved and common influenza virus peptides intended to stimulate both arms of the immune system for a cross-protecting and long-lasting effect. In a total of seven completed Phase 1/2 and Phase 2 clinical trials enrolling 818 participants, the vaccine has been shown to be safe, well-tolerated, and immunogenic. The ongoing pivotal Phase 3 clinical trial aims to assess safety and effectiveness of M-001 in reducing flu illness and severity. 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. 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, risks relating to the COVID-19 (coronavirus) pandemic, the prosecution, timing and results of the ongoing Phase 2 and Phase 3 trials and any subsequent trials; timing of receipt of regulatory approval of our manufacturing facility in Jerusalem; ability to demonstrate the efficacy and safety of the vaccine; the timing of clinical trials and marketing approvals; the risk that drug development involves a lengthy and expensive process with uncertain outcome; the ability of the Company to maintain, preserve and defend its intellectual property and patents granted; whether our vaccine candidate will successfully advance through the clinical trial process on a timely basis, or at all, and receive approval from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies; the adequacy of available cash resources and the ability to raise additional capital when needed. More detailed information about the risks and uncertainties affecting the Company is contained under the heading “Risk Factors” in our Annual Report on Form 20-F for the year ended December 31, 2019 filed with the U.S. Securities and Exchange Commission, or SEC, which is available on the SEC’s website, www.sec.gov. We undertake 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, |
||||||
|
2018 |
2019 |
2019 |
|||||
|
N I S |
U.S. dollars |
||||||
|
CURRENT ASSETS: |
|||||||
|
Cash and cash equivalents |
75,883 |
72,467 |
20,968 |
||||
|
Other receivables |
965 |
656 |
190 |
||||
|
76,848 |
73,123 |
21,158 |
|||||
|
LONG–TERM ASSETS: |
|||||||
|
Property, plant and equipment |
28,249 |
34,981 |
10,122 |
||||
|
Right-of-use assets |
– |
7,136 |
2,065 |
||||
|
Other long-term assets |
740 |
510 |
148 |
||||
|
28,989 |
42,627 |
12,335 |
|||||
|
105,837 |
115,750 |
33,493 |
|||||
|
CURRENT LIABILITIES: |
|||||||
|
Trade payables |
20,723 |
17,062 |
4,937 |
||||
|
Current maturities of lease liabilities |
– |
694 |
201 |
||||
|
Other payables |
1,076 |
1,203 |
348 |
||||
|
21,799 |
18,959 |
5,486 |
|||||
|
LONG–TERM LIABILITIES: |
|||||||
|
Liability in respect of government grants |
14,643 |
14,812 |
4,286 |
||||
|
Lease Liabilities |
– |
6,809 |
1,970 |
||||
|
Loan from others |
94,360 |
123,780 |
35,816 |
||||
|
Warrants |
6,168 |
16,354 |
4,732 |
||||
|
Severance pay liability, net |
82 |
89 |
26 |
||||
|
115,253 |
161,844 |
46,830 |
|||||
|
SHAREHOLDERS’ EQUITY: |
|||||||
|
Ordinary shares of NIS 0.0000001 par value: Authorized: |
*) – |
*) – |
*) – |
||||
|
Share premium |
179,929 |
255,285 |
73,867 |
||||
|
Accumulated deficit |
(211,144) |
(320,338) |
(92,690) |
||||
|
(31,215) |
(65,053) |
(18,823) |
|||||
|
105,837 |
115,750 |
33,493 |
|||||
|
STATEMENTS OF COMPREHENSIVE LOSS |
|||||||||
|
In thousands, except share and per share data |
|||||||||
|
Convenience translation |
|||||||||
|
Year ended December 31, |
Year ended December 31, |
||||||||
|
2017 |
2018 |
2019 |
2019 |
||||||
|
N I S |
U.S. dollars |
||||||||
|
Operating expenses: |
|||||||||
|
Research and development, net of participations |
18,777 |
71,913 |
68,645 |
19,863 |
|||||
|
Marketing, general and administrative |
4,879 |
5,154 |
9,706 |
2,808 |
|||||
|
Total operating expenses |
23,656 |
77,067 |
78,351 |
22,671 |
|||||
|
Operating loss |
(23,656) |
(77,067) |
(78,351) |
(22,671) |
|||||
|
Financial income |
18 |
2,936 |
4 |
1 |
|||||
|
Financial expense |
(10,913) |
(13,596) |
(30,847) |
(8,926) |
|||||
|
Loss |
(34,551) |
(87,727) |
(109,194) |
(31,596) |
|||||
|
Other comprehensive loss: |
|||||||||
|
Items to be reclassified to profit or loss in subsequent periods: |
|||||||||
|
Loss from available-for-sale marketable |
(6) |
– |
– |
– |
|||||
|
Total comprehensive loss |
(34,557) |
(87,727) |
(109,194) |
(31,596) |
|||||
|
Basic and diluted loss per share |
(0.17) |
(0.34) |
(0.33) |
(0.09) |
|||||
|
Weighted average number of shares outstanding used to compute basic and diluted loss per share |
201,030,768 |
261,419,599 |
326,651,721 |
326,651,721 |
|||||
NIH Report on Phase 2 Clinical Trial of BiondVax’s M-001 Universal Influenza Vaccine Candidate Concludes Both Primary Endpoints Achieved
Jerusalem, Israel – June 10, 2020 – BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV) today announced the completion of the clinical study report (CSR) of a Phase 2 clinical trial of the Company’s M-001 universal influenza vaccine candidate. The trial in 120 adult volunteers was supported by the U.S. National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).
As indicated when the preliminary trial data was published earlier this year, both primary objectives of the trial, to assess the safety and T cell immune responses to M‑001, were achieved. The CSR concludes that “M-001 was safe in this study” and that “M-001 induced significant polyfunctional T cell responses.”
Dr. Tamar Ben-Yedidia, BiondVax’s Chief Scientific Officer, commented, “We are grateful for the opportunity to collaborate with NIAID and thank them for their professionalism and partnership. We also are grateful to the investigators and their teams, and to the 120 volunteers who participated in this trial. It is exciting that data from this Phase 2 trial conducted in the U.S. confirm safety and cellular immune response results, as have six previously completed clinical trials of M-001.”
The NIAID-supported Phase 2 trial was conducted under an FDA Investigational New Drug application (IND), and NIAID’s Division of Microbiology and Infectious Diseases (DMID) has submitted the final CSR to the FDA. NIAID has communicated to BiondVax that the study’s lead investigator may prepare a manuscript for publication sometime in the future.
The published data are available at https://clinicaltrials.gov/ct2/show/NCT03058692. The trial was supported through NIAID awards #HHSN272201300016I, HHSN272201300015I, HHSN272201300020I, and HHSN272201300021I.
In parallel, BiondVax’s pivotal, clinical efficacy, Phase 3 trial in Europe is ongoing. The trial, which is assessing M-001’s ability to provide clinical protection from circulating influenza strains, is being conducted in more than 12,400 volunteers aged 50+ (with half aged 65+) over two flu seasons in seven countries. Results of the pivotal Phase 3 trial are expected by the end of 2020.
About BiondVax BiondVax (NASDAQ: BVXV) is a Phase 3 clinical stage biopharmaceutical company developing a universal flu vaccine. The vaccine candidate, called M-001, is designed to provide multi-strain and multi-season protection against current and future, seasonal and pandemic influenza. BiondVax’s proprietary technology utilizes a unique combination of conserved and common influenza virus peptides intended to stimulate both arms of the immune system for a cross-protecting and long-lasting effect. In a total of seven completed Phase 1/2 and Phase 2 clinical trials enrolling 818 participants, the vaccine has been shown to be safe, well-tolerated, and immunogenic. The ongoing pivotal Phase 3 clinical trial aims to assess safety and effectiveness of M-001 in reducing flu illness and severity. 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. 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, risks relating to the COVID-19 (coronavirus) pandemic, including a risk of delay in the availability of the top line results from our pivotal clinical efficacy Phase 3 trial for M-001, the prosecution, timing and results of the ongoing Phase 2 and Phase 3 trials and any subsequent trials; timing of receipt of regulatory approval of our manufacturing facility in Jerusalem; ability to demonstrate the efficacy and safety of the vaccine; the timing of clinical trials and marketing approvals; the risk that drug development involves a lengthy and expensive process with uncertain outcome; the ability of the Company to maintain, preserve and defend its intellectual property and patents granted; whether our vaccine candidate will successfully advance through the clinical trial process on a timely basis, or at all, and receive approval from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies; the adequacy of available cash resources and the ability to raise additional capital when needed. More detailed information about the risks and uncertainties affecting the Company is contained under the heading “Risk Factors” in our Annual Report on Form 20-F for the year ended December 31, 2018 filed with the U.S. Securities and Exchange Commission, or SEC, which is available on the SEC’s website, www.sec.gov. We undertake no obligation to revise or update any forward-looking statement for any reason.
###
BiondVax Announces Receipt of $4.2 million through Exercise of Warrants
Jerusalem, Israel – May 20, 2020 – BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), developer of the M‑001 universal influenza vaccine candidate, today announced receipt of proceeds of approximately $4.2 million since January 1, 2020 through exercises of BiondVax warrants. The publicly traded warrants, which were issued to investors in connection with BiondVax’s initial public offering on Nasdaq in 2015, had an exercise price of $6.25, traded on Nasdaq under the symbol BVXVW, and expired May 15, 2020. Warrants issued to underwriters in connection with the initial public offering expired May 11, 2020.
As announced in January 2020, holders of outstanding warrants were permitted to exercise their warrants on either a cash or cashless basis. Following the warrants’ exercise and expiry, there are currently 11,353,634 outstanding BiondVax American Depositary Shares (“ADSs”). BiondVax ADSs are traded on Nasdaq under the symbol BVXV.
As filed in a 6-K with the SEC on April 30, 2020, BiondVax expects to file its Annual Report on Form 20-F for the year ended December 31, 2019 no later than June 14, 2020.BiondVax’s pivotal, clinical efficacy, Phase 3 trial in Europe is ongoing. The trial, which is assessing M‑001’s ability to provide clinical protection from any circulating influenza strain, is being conducted with 12,463 volunteers aged 50+ (with half aged 65+) over two flu seasons in 7 countries. Results of the Phase 3 trial continue to be expected by the end of 2020.
About BiondVax BiondVax (NASDAQ: BVXV) is a Phase 3 clinical stage biopharmaceutical company developing a universal flu vaccine. The vaccine candidate, called M-001, is designed to provide multi-strain and multi-season protection against current and future, seasonal and pandemic influenza. BiondVax’s proprietary technology utilizes a unique combination of conserved and common influenza virus peptides intended to stimulate both arms of the immune system for a cross-protecting and long-lasting effect. In a total of 7 completed Phase 1/2 and Phase 2 clinical trials enrolling 818 participants, the vaccine has been shown to be safe, well-tolerated, and immunogenic. The ongoing pivotal Phase 3 clinical trial aims to assess safety and effectiveness of M-001 in reducing flu illness and severity. 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. 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, risks relating to the COVID-19 (coronavirus) pandemic, including a risk of delay in the availability of the top line results from our pivotal clinical efficacy Phase 3 trial for M-001, the prosecution, timing and results of the ongoing Phase 2 and Phase 3 trials and any subsequent trials; timing of receipt of regulatory approval of our manufacturing facility in Jerusalem; ability to demonstrate the efficacy and safety of the vaccine; the timing of clinical trials and marketing approvals; the risk that drug development involves a lengthy and expensive process with uncertain outcome; the ability of the Company to maintain, preserve and defend its intellectual property and patents granted; whether our vaccine candidate will successfully advance through the clinical trial process on a timely basis, or at all, and receive approval from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies; the adequacy of available cash resources and the ability to raise additional capital when needed. More detailed information about the risks and uncertainties affecting the Company is contained under the heading “Risk Factors” in our Annual Report on Form 20-F for the year ended December 31, 2018 filed with the U.S. Securities and Exchange Commission, or SEC, which is available on the SEC’s website, www.sec.gov. We undertake no obligation to revise or update any forward-looking statement for any reason.
BiondVax Announces Upcoming Expiration of Public Warrants
Jerusalem, Israel – May 4, 2020 – BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), developer of the universal influenza vaccine candidate M-001, today published a reminder that its publicly traded warrants (traded on Nasdaq under the symbol BVXVW) will expire, according to their terms, on May 15, 2020. Warrants issued to underwriters in connection with our initial public offering in the United States will expire on May 11, 2020.As previously announced by the Company, holders of warrants may exercise their warrants on a cash or cashless exercise basis.In order to exercise the warrants, brokers must deliver, on or before 5:00 PM (ET) on May 15, 2020 (or May 11, 2020 for holders of warrants issued to underwriters), the completed Warrant Exercise Form to the Company's transfer agent, Computershare. For warrants being exercised on a cash basis, holders must also deliver payment of the exercise price of $6.25 per ADS for the number of public warrants being exercised plus applicable issuance fees. For warrants being exercised on a cashless basis, holders must note on the Warrant Exercise Form that the warrants are being exercised on a cashless basis and deliver payment of applicable issuance fees.
For additional information and copies of the exercise forms, please contact:
CorporateActionsUS@computershare.com
Computershare
Voluntary Corporate Actions
150 Royall Street, Suite VCanton, MA 02021
About BiondVax BiondVax (NASDAQ: BVXV) is a Phase 3 clinical stage biopharmaceutical company developing a universal flu vaccine. The vaccine candidate, called M-001, is designed to provide multi-strain and multi-season protection against current and future, seasonal and pandemic influenza. BiondVax’s proprietary technology utilizes a unique combination of conserved and common influenza virus peptides intended to stimulate both arms of the immune system for a cross-protecting and long-lasting effect. In a total of 7 completed Phase 1/2 and Phase 2 clinical trials enrolling 818 participants, the vaccine has been shown to be safe, well-tolerated, and immunogenic. The ongoing pivotal Phase 3 clinical trial aims to assess safety and effectiveness of M-001 in reducing flu illness and severity. 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. 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, risks relating to the COVID-19 (coronavirus) pandemic, including a risk of delay in the availability of the top line results from our pivotal clinical efficacy Phase 3 trial for M-001, the prosecution, timing and results of the ongoing Phase 2 and Phase 3 trials and any subsequent trials; timing of receipt of regulatory approval of our manufacturing facility in Jerusalem; ability to demonstrate the efficacy and safety of the vaccine; the timing of clinical trials and marketing approvals; the risk that drug development involves a lengthy and expensive process with uncertain outcome; the ability of the Company to maintain, preserve and defend its intellectual property and patents granted; whether our vaccine candidate will successfully advance through the clinical trial process on a timely basis, or at all, and receive approval from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies; the adequacy of available cash resources and the ability to raise additional capital when needed. More detailed information about the risks and uncertainties affecting the Company is contained under the heading “Risk Factors” in our Annual Report on Form 20-F for the year ended December 31, 2018 filed with the U.S. Securities and Exchange Commission, or SEC, which is available on the SEC’s website, www.sec.gov. We undertake no obligation to revise or update any forward-looking statement for any reason.
###
New Directors Elected to BiondVax’s Board of Directors
Jerusalem, Israel – March 24, 2020 – BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), developer of the universal influenza vaccine candidate M-001, announced that all proposed resolutions were approved at the Company’s Annual General Meeting held today, including the election of three new directors to the Company’s Board of Directors, namely, Dr. Yael Margolin, Mr. Adi Raviv, and Mr. Samuel Moed.
Mr. Samuel Moed currently serves as Senior Vice President, Corporate Strategy at Bristol Myers Squibb (BMS; NYSE: BMY), a global biopharma company focused on innovative therapeutics, where for the past six years he has led the strategic direction of the company with close linkage to all of its major businesses, functions and geographies. Previously, Mr. Moed oversaw strategy for BMS’s Worldwide Pharmaceuticals Group, encompassing a range of global strategic initiatives, and managed a global portfolio of strategic alliances. He also led a number of businesses including as President of U.S. Pharmaceuticals and as President of Worldwide Consumer Healthcare. Mr. Moed received a BA in history from Columbia University in New York City.
Dr. Yael Margolin has more than 35 years of experience as senior manager, CEO and board member in venture capital and in the pharmaceutical and biotech industries, leading strategic and business planning, financing, team building, product development and corporate partnerships. From 2005 to 2019, Dr. Margolin served as President, Chief Executive Officer and director of Gamida Cell Ltd. (Nasdaq: GMDA), a clinical stage biopharmaceutical company, leading the company from preclinical development through phase 3 international registration studies. Prior to that, Dr. Margolin was Vice President of Denali Ventures LLC, a venture capital firm focused on healthcare, and a program manager at Teva Pharmaceuticals. Dr. Margolin holds a BSc in biology and a MSc Cum Laude from the department of microbiology, both from Tel Aviv University in Israel, a Ph.D. from the department of membrane research at the Weizmann Institute of Science in Rehovot, Israel and was a post-doctoral associate at the Yale University School of Medicine.
Mr. Adi Raviv is a senior financial executive with a career spanning over 30 years. Since April 2016, Mr. Raviv has been a Principal at Capacity Funding LLC, a company providing working capital solutions to small businesses. Prior to that, Mr. Raviv served in a chief financial officer position in two other companies that provide similar types of funding alternatives – New Era Lending from May 2015 to March 2016, and Kapitus (formerly, Strategic Funding Source) from 2009 to 2014. Mr. Raviv has extensive capital markets, cash management, corporate finance, investor relations, restructuring, tax and treasury, and transactional experience along with knowledge of the private equity and venture capital arenas. Mr. Raviv co-founded THCG, Inc., a publicly traded technology merchant banking and consulting company (where he was also CFO), and has been involved with companies in challenging startup, growth, and turnaround environments. Mr. Raviv has served on the boards of directors of many private and several public companies, as well as various non-profit entities. He received a bachelor’s degree in International Relations with honors from the Hebrew University of Jerusalem and an MBA, with honors, from Columbia University in New York City.Concurrently, Ms. Michal Marom Brikman has resigned her position from the Board of Directors.
Mr. Mark Germain, Chairman of the Board of Directors, commented, “On behalf of BiondVax’s Board of Directors, I am pleased to welcome Sam, Yael, and Adi. Together they bring a wealth of pharma industry leadership and capital markets experience, traits that should prove valuable as the Company proceeds towards results from the ongoing pivotal Phase 3 trial.”Continuing, Mr. Germain noted, “Michal has been a valued member of BiondVax’s Board of Directors, and we thank her for her contributions including as chairperson of the audit committee. We wish her well in her future endeavors.”
Dr. Ron Babecoff, BiondVax’s President and CEO, noted, “BiondVax has significantly progressed from its days as a startup, and I believe the experience and skill sets of the new Board members is what the Company needs going forward. We wish all our stakeholders and friends around the world good health as we strive to advance the ongoing pivotal, clinical efficacy, Phase 3 trial of the M-001 universal influenza vaccine candidate. At the same time, I would like to personally thank Michal Marom Brikman for her many years of significant contributions to BiondVax.”
About BiondVax BiondVax (NASDAQ: BVXV) is a Phase 3 clinical stage biopharmaceutical company developing a universal flu vaccine. The vaccine candidate, called M-001, is designed to provide multi-strain and multi-season protection against current and future, seasonal and pandemic influenza. BiondVax’s proprietary technology utilizes a unique combination of conserved and common influenza virus peptides intended to stimulate both arms of the immune system for a cross-protecting and long-lasting effect. In a total of 7 completed Phase 1/2 and Phase 2 clinical trials enrolling 818 participants, the vaccine has been shown to be safe, well-tolerated, and immunogenic. The ongoing pivotal Phase 3 clinical trial aims to assess safety and effectiveness of M-001 in reducing flu illness and severity. 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. 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, risks relating to the COVID-19 (coronavirus) pandemic, the prosecution, timing and results of the ongoing Phase 2 and Phase 3 trials and any subsequent trials; timing of receipt of regulatory approval of our manufacturing facility in Jerusalem; ability to demonstrate the efficacy and safety of the vaccine; the timing of clinical trials and marketing approvals; the risk that drug development involves a lengthy and expensive process with uncertain outcome; the ability of the Company to maintain, preserve and defend its intellectual property and patents granted; whether our vaccine candidate will successfully advance through the clinical trial process on a timely basis, or at all, and receive approval from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies; the adequacy of available cash resources and the ability to raise additional capital when needed. More detailed information about the risks and uncertainties affecting the Company is contained under the heading “Risk Factors” in our Annual Report on Form 20-F for the year ended December 31, 2018 filed with the U.S. Securities and Exchange Commission, or SEC, which is available on the SEC’s website, www.sec.gov. We undertake no obligation to revise or update any forward-looking statement for any reason.
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BiondVax’s CEO Comments on Impact of COVID-19 Pandemic on the Company’s Ongoing Phase 3 Clinical Trial
Jerusalem, Israel – March 19, 2020 – BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV) today issued an update regarding the impact of the COVID-19 pandemic on the ongoing pivotal, clinical efficacy, Phase 3 trial in Europe of the Company’s M-001 universal influenza vaccine candidate.
Dr. Ron Babecoff, BiondVax’s President and CEO, commented, “While to date the coronavirus pandemic has not significantly impacted our Phase 3 clinical trial, we continue to monitor the situation closely taking into account the best interests of our employees, trial participants, health care professionals, CRO staff and others involved in our trial. The flu season in Europe is declining as expected for this time of year, and most of the swab samples we expected to obtain from participants exhibiting flu like symptoms have already been collected. Nevertheless, we are continuing to collect swab samples while adhering to restrictions imposed by local authorities. As long as the pandemic situation does not further significantly deteriorate, our CRO and statistician currently expect us to reach the targeted number of swab samples. We will continue to take all appropriate and feasible steps to enable us to publish results by the end of this year.”
Dr. Babecoff continued, “We wish all our stakeholders and friends around the world good health as we strive to advance our ongoing pivotal, clinical efficacy, Phase 3 trial of the M-001 universal influenza vaccine candidate.”
About BiondVax BiondVax (NASDAQ: BVXV) is a Phase 3 clinical stage biopharmaceutical company developing a universal flu vaccine. The vaccine candidate, called M-001, is designed to provide multi-strain and multi-season protection against current and future, seasonal and pandemic influenza. BiondVax’s proprietary technology utilizes a unique combination of conserved and common influenza virus peptides intended to stimulate both arms of the immune system for a cross-protecting and long-lasting effect. In a total of 7 completed Phase 1/2 and Phase 2 clinical trials enrolling 818 participants, the vaccine has been shown to be safe, well-tolerated, and immunogenic. The ongoing pivotal Phase 3 clinical trial aims to assess safety and effectiveness of M-001 in reducing flu illness and severity. 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. 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, risks relating to the COVID-19 pandemic, the prosecution, timing and results of the ongoing Phase 2 and Phase 3 trials and any subsequent trials; timing of receipt of regulatory approval of our manufacturing facility in Jerusalem; ability to demonstrate the efficacy and safety of the vaccine; the timing of clinical trials and marketing approvals; the risk that drug development involves a lengthy and expensive process with uncertain outcome; the ability of the Company to maintain, preserve and defend its intellectual property and patents granted; whether our vaccine candidate will successfully advance through the clinical trial process on a timely basis, or at all, and receive approval from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies; the adequacy of available cash resources and the ability to raise additional capital when needed. More detailed information about the risks and uncertainties affecting the Company is contained under the heading “Risk Factors” in our Annual Report on Form 20-F for the year ended December 31, 2018 filed with the U.S. Securities and Exchange Commission, or SEC, which is available on the SEC’s website, www.sec.gov. We undertake no obligation to revise or update any forward-looking statement for any reason.
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Preliminary Data from NIH/NIAID-sponsored Phase 2 Clinical Trial of BiondVax’s M-001 Universal Influenza Vaccine Candidate Validates Results of Previous Clinical Trials
Data published on Clinicaltrials.gov
Jerusalem, Israel – February 5, 2020 – BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV) announced today that preliminary data from the Phase 2 clinical trial of BiondVax’s M-001 universal influenza vaccine candidate have been published. The trial was supported by the U.S. National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). The primary objectives of the trial were to assess safety and T-cell responses to M-001. The data, which are consistent with results of previous clinical trials of M-001, indicate that both primary objectives were achieved. Analysis of the data is ongoing, and the clinical study report (CSR) is expected in Q2 2020.
Dr. Tamar Ben-Yedidia, BiondVax’s Chief Scientific Officer, commented, “We are grateful for the opportunity to collaborate with NIAID and thank them for their professionalism and partnership. This was M-001’s first clinical trial in the US under the FDA’s Investigational New Drug program (IND). Data from this Phase 2 trial confirm results from six previously completed clinical trials of M-001. BiondVax’s universal flu vaccine candidate was found to be safe, well tolerated and induce statistically significant cellular immune responses.”
The Phase 2 clinical trial was conducted by NIAID-funded Vaccine and Treatment Evaluation Units (VTEUs). The trial enrolled 120 participants aged 18 to 49 years at the following VTEU sites: Baylor College of Medicine in Houston, Texas; the University of Iowa in Iowa City, Iowa; and Cincinnati Children’s Hospital Medical Center in Cincinnati, Ohio. Individuals were randomly assigned to receive either two doses of M-001 or two doses of a placebo, with the doses spaced three weeks apart. Later, near the beginning of the 2018/19 flu season, all participants were immunized with a currently marketed quadrivalent seasonal influenza vaccine. Laboratory analyses of vaccine immunogenicity were performed at the Baylor College of Medicine and Saint Louis University (St. Louis, Missouri) VTEU sites and at BiondVax Pharmaceuticals.
The published data are available at https://clinicaltrials.gov/ct2/show/NCT03058692. The trial was supported through NIAID awards #HHSN272201300016I, HHSN272201300015I, HHSN272201300020I, and HHSN272201300021I.
In parallel, BiondVax’s pivotal, clinical efficacy, Phase 3 trial in Europe, involving 12,463 older adults, is ongoing. Results of that trial are expected by the end of 2020.
About BiondVax BiondVax (NASDAQ: BVXV) is a Phase 3 clinical stage biopharmaceutical company developing a universal flu vaccine. The vaccine candidate, called M-001, is designed to provide multi-strain and multi-season protection against current and future, seasonal and pandemic influenza. BiondVax’s proprietary technology utilizes a unique combination of conserved and common influenza virus peptides intended to stimulate both arms of the immune system for a cross-protecting and long-lasting effect. In a total of 7 completed Phase 1/2 and Phase 2 clinical trials enrolling 818 participants, the vaccine has been shown to be safe, well-tolerated, and immunogenic. The ongoing pivotal Phase 3 clinical trial aims to assess safety and effectiveness of M-001 in reducing flu illness and severity. 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. 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, the prosecution, timing and results of the ongoing Phase 2 and Phase 3 trials and any subsequent trials; timing of receipt of regulatory approval of our manufacturing facility in Jerusalem; ability to demonstrate the efficacy and safety of the vaccine; the timing of clinical trials and marketing approvals; the risk that drug development involves a lengthy and expensive process with uncertain outcome; the ability of the Company to maintain, preserve and defend its intellectual property and patents granted; whether our vaccine candidate will successfully advance through the clinical trial process on a timely basis, or at all, and receive approval from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies; the adequacy of available cash resources and the ability to raise additional capital when needed. More detailed information about the risks and uncertainties affecting the Company is contained under the heading “Risk Factors” in our Annual Report on Form 20-F for the year ended December 31, 2018 filed with the U.S. Securities and Exchange Commission, or SEC, which is available on the SEC’s website, www.sec.gov. We undertake no obligation to revise or update any forward-looking statement for any reason.
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BiondVax Announces Warrant Agreement Amendment to Permit Holders of Warrants to Exercise both on a Cash and Cashless Basis
Jerusalem, Israel – January 16, 2020 — BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), a Phase 3 clinical stage biopharmaceutical company focused on developing and commercializing M-001, a universal flu vaccine candidate, announced that effective January 16, 2020, the Company will permit holders of all outstanding warrants of the Company ("Warrants") issued to investors in connection with its initial public offering on Nasdaq (the "Warrant holders") to exercise their warrants on a cashless exercise basis. Warrant holders will continue to be able to exercise their Warrants on a cash basis as well. No other terms of the Warrants are being amended.
The cashless exercise right being offered to Warrant holders allows them to capture the value between the current price of BiondVax’s American Depositary Shares (“ADSs”) and the exercise price of the warrants without the need to provide cash on exercise. At the same time, it results in fewer ADSs being issued to them.
Cashless exercise would enable Warrant holders to exercise their Warrants without paying cash but rather paying the exercise price from the value of the ADSs of BiondVax that would otherwise be issued to the Warrant holder were the Warrants exercised on a cash basis. The Warrant holders exercising on a cashless basis would receive a number of ADSs equal in value to the market value of one ADS at the time of exercise (calculated according to a formula in the amendment to warrant agreement) less the exercise price of the warrants multiplied by the number of Warrants being exercised. This description of the manner for determining the number of shares issuable to a Warrant holder that exercises on a cashless basis is qualified in its entirety by the amendment to the warrant agreement to be submitted to the Securities and Exchange Commission today on Form 6-K.
About BiondVax BiondVax (NASDAQ: BVXV) is a Phase 3 clinical stage biopharmaceutical company developing a universal flu vaccine. The vaccine candidate, called M-001, is designed to provide multi-strain and multi-season protection against current and future, seasonal and pandemic influenza. BiondVax’s proprietary technology utilizes a unique combination of conserved and common influenza virus peptides intended to stimulate both arms of the immune system for a cross-protecting and long-lasting effect. In a total of 6 completed Phase 1/2 and Phase 2 clinical trials, covering 698 participants, the vaccine has been shown to be safe, well-tolerated, and immunogenic. The ongoing pivotal Phase 3 clinical trial aims to assess safety and effectiveness of M-001 in reducing flu illness and severity. 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. 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, the prosecution and outcome of the ongoing Phase 2 and Phase 3 trials and any subsequent trials; timing of publication by NIAID of the results of the NIH/NIAID conducted Phase 2 clinical trial in the USA; timing of receipt of regulatory approval of the new manufacturing facility; ability to demonstrate the efficacy and safety of the vaccine; the timing of clinical trials and marketing approvals; the risk that drug development involves a lengthy and expensive process with uncertain outcome; the ability of the Company to maintain, preserve and defend its intellectual property and patents granted; whether our vaccine candidate will successfully advance through the clinical trial process on a timely basis, or at all, and receive approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies; the adequacy of available cash resources and the ability to raise capital when needed. More detailed information about the risks and uncertainties affecting the Company is contained under the heading “Risk Factors” in our Annual Report on Form 20-F for the year ended December 31, 2018 filed with the U.S. Securities and Exchange Commission, or SEC, which is available on the SEC’s website, www.sec.gov, and in the Company’s periodic filings with the SEC. We undertake no obligation to revise or update any forward-looking statement for any reason.
BiondVax Announces Third Quarter 2019 Financial Results and Business Update
Jerusalem, Israel – November 26, 2019 — BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), a Phase 3 clinical stage biopharmaceutical company focused on developing and commercializing M-001, a universal flu vaccine candidate, today announced its financial results for the quarter ended September 30, 2019.
Third Quarter 2019 Financial Summary
Results are in New Israel Shekels (NIS) and convenience translation to $US is provided using the exchange rate of 3.482 (NIS/$US) as at September 30, 2019.
Third quarter operating expenses were NIS 18.9m ($5.4m) compared with NIS 5.8m for the third quarter of 2018;
Third quarter R&D expenses amounted to NIS 16.1m ($4.6m) compared with NIS 4.3m for the third quarter of 2018;
Expenses were related to execution of planned ongoing operations, including the ongoing pivotal, clinical efficacy, Phase 3 trial of the Company’s M-001 Universal Flu Vaccine candidate and construction of a mid-size pilot manufacturing facility.As of September 30, 2019, BiondVax had cash and cash equivalents of NIS 75.2 million ($21.6 million) as compared to NIS 33.9 million as of June 30, 2019.
Recent Business highlights:
$20 million was raised in a shareholder rights offering that concluded in July 2019. As a consequence of the offering and an associated option to purchase ordinary shares that were not purchased by other shareholders in the offering, Angels Investments in High Tech Ltd., wholly owned by Marius Nacht, lead investor of the aMoon Fund, held approximately 42% of outstanding BiondVax shares.
Mark Germain was appointed Chairman of BiondVax’s Board of Directors, effective September 30, 2019.
In October 2019, BiondVax received €4 million from the European Investment Bank (EIB). These funds are the final tranche of the previously announced co-financing agreement signed in June 2017 and extended in April 2019 from €20 million to €24 million.
Laboratory work for the primary and secondary outcome measures in the NIAID-sponsored Phase 2 clinical trial in the USA is now complete and the analysis is ongoing. Results are expected in Q2 2020.
Enrollment and randomization of 12,463 participants was successfully completed in the pivotal, clinical efficacy, Phase 3 trial of BiondVax’s M-001 Universal Influenza Vaccine candidate.
About BiondVax BiondVax (NASDAQ: BVXV) is a Phase 3 clinical stage biopharmaceutical company developing a universal flu vaccine. The vaccine candidate, called M-001, is designed to provide multi-strain and multi-season protection against current and future, seasonal and pandemic influenza. BiondVax’s proprietary technology utilizes a unique combination of conserved and common influenza virus peptides intended to stimulate both arms of the immune system for a cross-protecting and long-lasting effect. In a total of 6 completed Phase 1/2 and Phase 2 clinical trials, covering 698 participants, the vaccine has been shown to be safe, well-tolerated, and immunogenic. The ongoing pivotal Phase 3 clinical trial aims to assess safety and effectiveness of M-001 in reducing flu illness and severity. 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. 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, the prosecution and outcome of the ongoing Phase 2 and Phase 3 trials and any subsequent trials; timing of publication by NIAID of the results of the NIH/NIAID conducted Phase 2 clinical trial in the USA; timing of receipt of regulatory approval of the new manufacturing facility; ability to demonstrate the efficacy and safety of the vaccine; the timing of clinical trials and marketing approvals; the risk that drug development involves a lengthy and expensive process with uncertain outcome; the ability of the Company to maintain, preserve and defend its intellectual property and patents granted; whether our vaccine candidate will successfully advance through the clinical trial process on a timely basis, or at all, and receive approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies; the adequacy of available cash resources and the ability to raise capital when needed. More detailed information about the risks and uncertainties affecting the Company is contained under the heading “Risk Factors” in our Annual Report on Form 20-F for the year ended December 31, 2018 filed with the U.S. Securities and Exchange Commission, or SEC, which is available on the SEC’s website, www.sec.gov, and in the Company’s periodic filings with the SEC. We undertake no obligation to revise or update any forward-looking statement for any reason.
Enrollment and randomization of 12,463 participants complete in BiondVax’s pivotal, clinical efficacy, Phase 3 Universal Flu Vaccine trial
Results expected by end of 2020
Jerusalem, Israel – November 18, 2019 – BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV) announced today that enrollment and randomization of 12,463 participants in the pivotal, clinical efficacy, Phase 3 trial of the M-001 universal influenza vaccine candidate is complete.
BiondVax’s M-001 universal flu vaccine candidate is designed as a common denominator to influenza A and B viruses. Results from six completed human clinical trials indicate that M‑001 is safe, well-tolerated, and induces an immune response to a broad range of influenza strains. M‑001’s single formulation is intended to enable year‑round production, vaccination, and stockpiling.
Dr. Tamar Ben-Yedidia, BiondVax’s Chief Scientific Officer, commented, “The pivotal Phase 3 trial of our universal flu vaccine is being conducted for two flu seasons over a broad geographic area in 12,463 older adults, which is the group most urgently in need of improved protection from the flu. The study will assess how well M-001 protects the participants against flu illness when they are exposed to any circulating flu strain. We are grateful and impressed with the CRO for the tremendous administrative and logistic achievement enabling the recruitment and randomization of 12,463 people. We are excited about the potential for M-001 to reduce illness and death among older and elderly adults as well as reduce influenza-associated health care costs.”
The placebo-controlled, blinded, pivotal, clinical efficacy Phase 3 trial will assess safety and effectiveness of the M-001 vaccine alone in reducing flu illness and severity in 12,463 adults aged 50 years and older, including 6,291 (50.5%) aged 65 and older. 4,042 people were enrolled and randomized in the trial’s first cohort prior to the 2018/19 flu season, and an additional 8,421 people were enrolled in the trial’s second cohort (2019/20 flu season). 83 clinical trial sites in seven eastern European countries enrolled participants. To assess the trial’s primary endpoint of safety and reduction of illness rates, the second cohort’s participants will be monitored for influenza-like illness (ILI) symptoms throughout the upcoming flu season. Swabs will be collected from those with ILI, and influenza confirmation will be conducted by a qualified laboratory. As part of this Phase 3 study, cell-mediated immunogenicity markers of M-001 will be evaluated in a subset of participants. Results are expected by the end of 2020.As previously reported, the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) reviewed the trial design and allowed BiondVax to proceed. Regulatory authorities in the seven countries in which the trial is being conducted have also allowed the trial to proceed. Participants are volunteers and have provided informed consent.
About BiondVax BiondVax (NASDAQ: BVXV) is a Phase 3 clinical stage biopharmaceutical company developing a universal flu vaccine. The vaccine candidate, called M-001, is designed to provide multi-strain and multi-season protection against current and future, seasonal and pandemic influenza. BiondVax’s proprietary technology utilizes a unique combination of conserved and common influenza virus peptides intended to stimulate both arms of the immune system for a cross-protecting and long-lasting effect. In a total of 6 completed Phase 1/2 and Phase 2 clinical trials covering 698 participants, the vaccine has been shown to be safe, well-tolerated, and immunogenic. The ongoing pivotal Phase 3 clinical trial aims to assess safety and effectiveness of M-001 in reducing flu illness and severity. 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. 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, the prosecution, timing and results of the ongoing Phase 2 and Phase 3 trials and any subsequent trials; timing of receipt of regulatory approval of our manufacturing facility in Jerusalem; ability to demonstrate the efficacy and safety of the vaccine; the timing of clinical trials and marketing approvals; the risk that drug development involves a lengthy and expensive process with uncertain outcome; the ability of the Company to maintain, preserve and defend its intellectual property and patents granted; whether our vaccine candidate will successfully advance through the clinical trial process on a timely basis, or at all, and receive approval from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies; the adequacy of available cash resources and the ability to raise additional capital when needed. More detailed information about the risks and uncertainties affecting the Company is contained under the heading “Risk Factors” in our Annual Report on Form 20-F for the year ended December 31, 2018 filed with the U.S. Securities and Exchange Commission, or SEC, which is available on the SEC’s website, www.sec.gov. We undertake no obligation to revise or update any forward-looking statement for any reason.
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BiondVax receives €4M from the European Investment Bank (EIB) in support of ongoing Universal Influenza Vaccine Pivotal Phase 3 trial
Jerusalem, Israel - October 7, 2019 - BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), a phase 3 clinical stage biopharmaceutical company focused on developing and commercializing the M-001 clinical Phase 3 Universal Influenza Vaccine candidate, announced today the receipt of €4 million from the European Investment Bank (EIB). These funds are the final tranche of the previously announced co-financing agreement signed in June 2017 and extended in April 2019 from €20 million to €24 million.
Dr. Ron Babecoff, BiondVax’s President and CEO, commented, “This past June we were honored to welcome EIB Vice-President Mr. Ambroise Fayolle to our manufacturing facility in Jerusalem for a signature event celebrating the extension of the EIB-BiondVax financing agreement to €24 million. I am grateful to the EIB for their ongoing support of our efforts to introduce an effective universal influenza vaccine to the world.”
The €24 million financing has been provided by the EIB in support of construction of BiondVax’s pilot manufacturing facility in Israel and the ongoing pivotal, clinical efficacy, Phase 3 trial of BiondVax’s M-001 Universal Flu Vaccine candidate in Europe. Together with the $20m raised in the July 2019 rights offering to shareholders, BiondVax expects its existing cash resources will enable funding of operational and capital expenditure requirements to the end of the Phase 3 trial.
The pivotal, clinical efficacy, Phase 3 trial aims to assess safety and effectiveness of the M-001 vaccine alone in reducing flu illness and severity in approximately 12,000 adults aged 50 years and older, with at least half aged 65 and older. An aggregate of 4,094 people was enrolled in the trial’s first cohort prior to the 2018/19 flu season, and approximately 8,000 participants are being enrolled in the trial’s second cohort (2019/20 flu season) in 85 sites in seven countries in eastern Europe. Results are expected by the end of 2020.
About BiondVax BiondVax (NASDAQ: BVXV) is a Phase 3 clinical stage biopharmaceutical company developing a universal flu vaccine. The vaccine candidate, called M-001, is designed to provide multi-strain and multi-season protection against current and future, seasonal and pandemic influenza. BiondVax’s proprietary technology utilizes a unique combination of conserved and common influenza virus peptides intended to stimulate both arms of the immune system for a cross-protecting and long-lasting effect. In a total of 6 completed Phase 1/2 and Phase 2 clinical trials covering 698 participants, the vaccine has been shown to be safe, well-tolerated, and immunogenic. The ongoing pivotal Phase 3 clinical trial aims to assess safety and effectiveness of M-001 in reducing flu illness and severity. 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. 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, the prosecution, timing and results of the ongoing Phase 2 and Phase 3 trials and any subsequent trials; timing of receipt of regulatory approval of our manufacturing facility in Jerusalem; ability to demonstrate the efficacy and safety of the vaccine; the timing of clinical trials and marketing approvals; the risk that drug development involves a lengthy and expensive process with uncertain outcome; the ability of the Company to maintain, preserve and defend its intellectual property and patents granted; whether our vaccine candidate will successfully advance through the clinical trial process on a timely basis, or at all, and receive approval from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies; the adequacy of available cash resources and the ability to raise additional capital when needed. More detailed information about the risks and uncertainties affecting the Company is contained under the heading “Risk Factors” in our Annual Report on Form 20-F for the year ended December 31, 2018 filed with the U.S. Securities and Exchange Commission, or SEC, which is available on the SEC’s website, www.sec.gov. We undertake no obligation to revise or update any forward-looking statement for any reason.
BiondVax Welcomes New Chairman of the Board and Announces Second Quarter 2019 Financial Results
Mark Germain, Chairman of the Board, BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV)
Jerusalem, Israel - August 28, 2019 -- BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), a Phase 3 clinical stage biopharmaceutical company focused on developing and commercializing M-001, a universal flu vaccine candidate, today announced the appointment of a new Chairman of the Board of Directors and financial results for the quarter ended June 30, 2019.
Mr. Mark Germain, who has served as BiondVax’s Vice Chairman of the Board of Directors since June 2018, has been appointed Chairman, effective September 30, 2019. Based in New York, and having served as founder, director, chairman of the board, and/or investor in over twenty biotech companies, and with experience assisting in arranging corporate partnerships, acquiring technology, entering mergers and acquisitions, and executing financings, Mr. Germain is well suited to help guide BiondVax’s ongoing corporate development. Among his current positions, Mr. Germain is a Managing Director at The Aentib Group, a boutique merchant bank, and serves as a director on the board of the Israeli company Pluristem Therapeutics Inc. (Nasdaq: PSTI). Professor Avner Rotman, who has served as BiondVax’s Chairman since 2005, will continue to serve as a Director.
Mr. Mark Germain commented: “It has been a great pleasure to work with Ron and his team this past year, and the rest of the board, and I’m honored to be elected Chairman at this exciting time for the company. Recent events have positioned BiondVax to become a successful manufacturer and marketer of its M-001 universal flu vaccine candidate. In July we closed on a financing of US$20M predominantly supported by our largest shareholder, Marius Nacht, bringing his ownership in the company to approximately 42%. This financing, the 24 million Euros made available by the European Investment Bank, and other resources now provide us with the means to complete our Phase 3 pivotal trial (with a total of approximately 12,000 participants), scale up manufacturing and begin preparation for commercialization.”
Dr. Ron Babecoff, BiondVax’s President and CEO, commented, “I have had the pleasure of working closely with Mark Germain since he joined our Board of Directors last year. I am confident that his experience and knowledge of the pharmaceutical ecosystem, in addition to his relevant international connections, will prove beneficial as we progress through our ongoing pivotal clinical efficacy Phase 3 trial, and upscale production capacity in our manufacturing facility.”
Continuing, Babecoff noted, “Over Professor Rotman’s term as Chairman, BiondVax has grown from a preclinical company to a Nasdaq-listed company. On a personal note, I wish to thank Avner for his leadership, guidance, and support that helped me and the company navigate through the many challenges we encountered over the years.”
Second Quarter 2019 Financial Summary
Results are in New Israel Shekels (NIS) and convenience translation to $US is provided using the exchange rate of 3.566 (NIS/$US) as at June 30, 2019.
Second quarter operating expenses were NIS 19.7m ($5.5m) compared with NIS 30.7m for the second quarter of 2018;
Second quarter R&D expenses amounted to NIS 15.2m ($4.3m) compared with NIS 29.2m for the second quarter of 2018;
As of June 30, 2019, BiondVax had cash and cash equivalents of NIS 33.9 million ($9.5 million) as compared to NIS 75.9m as of December 31, 2018. Expenses are related to execution of planned ongoing operations including the ongoing pivotal, clinical efficacy, Phase 3 trial of the Company’s M-001 Universal Flu Vaccine candidate, and construction of a mid-size commercial manufacturing facility. These figures do not include the $20 million raised in a rights offering that concluded near the beginning of Q3 in July 2019.
About BiondVax BiondVax (NASDAQ: BVXV) is a Phase 3 clinical stage biopharmaceutical company developing a universal flu vaccine. The vaccine candidate, called M-001, is designed to provide multi-strain and multi-season protection against current and future, seasonal and pandemic influenza. BiondVax’s proprietary technology utilizes a unique combination of conserved and common influenza virus peptides intended to stimulate both arms of the immune system for a cross-protecting and long-lasting effect. In a total of 6 completed Phase 1/2 and Phase 2 clinical trials, covering 698 participants, the vaccine has been shown to be safe, well-tolerated, and immunogenic. The ongoing pivotal Phase 3 clinical trial aims to assess safety and effectiveness of M-001 in reducing flu illness and severity. 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. 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, the prosecution and outcome of the ongoing Phase 2 and Phase 3 trials and any subsequent trials; timing of receipt of regulatory approval of the new manufacturing facility; ability to demonstrate the efficacy and safety of the vaccine; the timing of clinical trials and marketing approvals; the risk that drug development involves a lengthy and expensive process with uncertain outcome; the ability of the Company to maintain, preserve and defend its intellectual property and patents granted; whether our vaccine candidate will successfully advance through the clinical trial process on a timely basis, or at all, and receive approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies; the adequacy of available cash resources and the ability to raise capital when needed. More detailed information about the risks and uncertainties affecting the Company is contained under the heading “Risk Factors” in our Annual Report on Form 20-F for the year ended December 31, 2018 filed with the U.S. Securities and Exchange Commission, or SEC, which is available on the SEC’s website, www.sec.gov, and in the Company’s periodic filings with the SEC. We undertake no obligation to revise or update any forward-looking statement for any reason.
BiondVax Announces Rights Offering Fully Subscribed at US$20 Million
Funds to complete ongoing pivotal, clinical efficacy, Phase 3 trial of the M-001 Universal Flu Vaccine candidate and scale-up manufacturing
Jerusalem, Israel – July 16, 2019 –BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV) is proud to announce today the results of its previously announced rights offering. The Company has received subscriptions from existing shareholders for all the offered American Depositary Shares (“ADSs”) and ordinary shares, being a total of 3,057,466 ADSs and 18,298,898 ordinary shares, raising total gross proceeds of US$20 Million.Mr. Marius Nacht has fully subscribed for the entire allotment available to him in the rights offering through his wholly owned entity Angels Investments in High Tech Ltd. (“AIHT”). He also exercised his option to purchase, under the same terms of the rights offering, 2,203,640 ADSs and 141,538 ordinary shares offered in the rights offering that were not purchased by other shareholders. In total, Mr. Nacht’s investment through AIHT in this offering was US$16.67 Million, making Mr. Nacht a Controlling Shareholder (as defined under the Israeli Companies Law) with a holding of about 42% in BiondVax.
Dr. Ron Babecoff, BiondVax’s President and CEO, commented, “The $20 Million raised in this rights offering, together with the recent additional European Investment Bank financing of €4 Million, for a total of €24 Million of non-dilutive funding committed by the EIB, will fund our operations through to the end of our ongoing pivotal, clinical efficacy, Phase 3 trial. I would like to personally thank, on my behalf and on behalf of the entire BiondVax team, our shareholders and in particular Marius Nacht, Yair Schindel, Isaac Devash, and their partners and colleagues at aMoon 1 for their strong, ongoing support and belief in our mission to bring our universal flu vaccine to the market. I am optimistic that together we are closer than ever to bringing our revolutionary ‘one-for-all’ universal influenza vaccine to the world.”
The Company expects that the new ADSs and ordinary shares will be delivered to subscribers by the end of July 2019.The funds will be used to support operations through the end of 2020, including scale-up of manufacturing and completion of the ongoing pivotal, clinical efficacy, Phase 3 trial of BiondVax’s M-001 universal flu vaccine candidate. Approximately 8,000 participants are currently being enrolled in the trial’s second cohort, following 4,094 who were recruited in the first cohort prior to the 2018/19 flu season. Results are expected by the end of 2020.
About BiondVax BiondVax (NASDAQ: BVXV) is a Phase 3 clinical stage biopharmaceutical company developing a universal flu vaccine. The vaccine candidate, called M-001, is designed to provide multi-strain and multi-season protection against current and future, seasonal and pandemic influenza. BiondVax’s proprietary technology utilizes a unique combination of conserved and common influenza virus peptides intended to stimulate both arms of the immune system for a cross-protecting and long-lasting effect. In a total of 6 completed Phase 1/2 and Phase 2 clinical trials, covering 698 participants, the vaccine has been shown to be safe, well-tolerated, and immunogenic. The ongoing pivotal Phase 3 clinical trial aims to assess safety and effectiveness of M-001 in reducing flu illness and severity. 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. 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, the prosecution and outcome of the ongoing Phase 2 and Phase 3 trials and any subsequent trials; timing of receipt of regulatory approval of the new manufacturing facility; ability to demonstrate the efficacy and safety of the vaccine; the timing of clinical trials and marketing approvals; the risk that drug development involves a lengthy and expensive process with uncertain outcome; the ability of the Company to maintain, preserve and defend its intellectual property and patents granted; whether our vaccine candidate will successfully advance through the clinical trial process on a timely basis, or at all, and receive approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies; the adequacy of available cash resources and the ability to raise capital when needed. More detailed information about the risks and uncertainties affecting the Company is contained under the heading “Risk Factors” in our Annual Report on Form 20-F for the year ended December 31, 2018 filed with the U.S. Securities and Exchange Commission, or SEC, which is available on the SEC’s website, www.sec.gov, and in the Company’s periodic filings with the SEC. We undertake no obligation to revise or update any forward-looking statement for any reason.