Press Releases
First Participant Enrolled in Second Cohort of BiondVax’s Pivotal, Clinical Efficacy, Phase 3 Universal Flu Vaccine Trial
Jerusalem, Israel – July 8, 2019 –BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV) announced today that the first participants in the second cohort of the pivotal, clinical efficacy, Phase 3 trial of the M-001 universal flu vaccine candidate have been successfully enrolled.
Influenza viruses mutate frequently and unpredictably, and the strains that dominate often vary in time and place. For example, according to the CDC, the first part of the 2018/19 flu season was dominated by H1 strains throughout most of the continental USA, while the south-east USA was dominated by an H3 strain. In the latter part of the flu season, a drifted H3 strain that was not included in the season’s flu vaccine circulated across the country, resulting in overall flu vaccine effectiveness of only about 29%. Meanwhile, Australia’s 2019 flu season has started about three months earlier than usual.
BiondVax’s M-001 universal flu vaccine candidate is designed to improve upon currently marketed strain-specific vaccines in several ways. Designed as a common denominator to influenza viruses, results from six completed clinical trials indicate M-001 induces an immune response to a broad range of influenza strains. As well, M-001’s single formulation enables year-round production, vaccination, and stockpiling.
Dr. Tamar Ben-Yedidia, BiondVax’s Chief Science Officer, commented, “Different flu strains circulate with varying frequency across seasons and countries. The Phase 3 trial of our universal flu vaccine is being conducted for two flu seasons over a broad geographic area, and vaccination began this year in July, well before the usual onset of flu season. The current study aims to demonstrate how well M-001 protects the participants against flu illness when they are exposed to any circulating flu strain.”
The placebo-controlled, pivotal, clinical efficacy, Phase 3 trial will 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. 4,094 people were enrolled in the trial’s first cohort prior to the 2018/19 flu season, and upon review of the safety profile the Data Safety Monitoring Board (DSMB) allowed the company to proceed with the trial’s second cohort. About 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. 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.
European Investment Bank VP attends Signature Event at BiondVax Extending Financing Agreement with BiondVax to €24 million
Jerusalem, Israel – June 26, 2019 –The Board of Directors and Management of BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), was honored to host Mr. Ambroise Fayolle, Vice-President of the European Investment Bank (EIB), during his visit to BiondVax’s new mid-size commercial scale manufacturing facility in Israel. During his visit, Mr. Fayolle, together with Dr. Ron Babecoff, BiondVax’s President and CEO, signed the previously announced financing agreement extension through which the EIB has supported both construction of BiondVax’s new facility and the ongoing pivotal, clinical efficacy, Phase 3 trial of M-001, BiondVax’s universal flu vaccine candidate.
Dr. Babecoff noted, “I am grateful for the EIB’s innovative financing support of BiondVax’s universal flu vaccine development. The EIB’s support has enabled us to conduct a large pivotal, clinical efficacy, Phase 3 trial in Europe, and construct a mid-size commercial scale manufacturing facility in Jerusalem. It is an honor to host Mr. Fayolle and his colleagues.”
The transaction between EIB and BiondVax was initiated and is supported by kENUP Foundation.
BiondVax is currently conducting a pivotal, clinical efficacy, Phase 3 trial of M-001 in Europe. 4,094 participants were recruited prior to the 2018/19 flu season, and preparations are proceeding as planned towards the trial’s second season of 2019/20, in which about 8,000 participants are expected to be enrolled. The placebo-controlled trial will assess safety and effectiveness of M-001 alone in reducing flu illness and severity in adults aged 50 years and older, with at least half aged 65 and older. Results are expected by the end of 2020.In parallel, the NIAID/NIH is conducting a Phase 2 clinical trial of M-001 in the USA, with results anticipated by the end of 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.
Patent Covering Manufacturing Process of BiondVax’s M-001 Universal Flu Vaccine Allowed in USA and Japan
Pivotal Clinical Efficacy Phase 3 Clinical Trial Results Expected in 2020
Jerusalem, Israel – June 18, 2019 –BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), announced today that a patent covering production processes of the Company’s M-001 universal influenza vaccine candidate was allowed in the USA and Japan.
Titled “Compositions of multimeric-multiepitope influenza polypeptides and their production” the patent, which is pending in Europe, covers the unique composition and manufacturing processes of M-001. Designed to provide multi-strain and multi-season protection against current and future, seasonal and pandemic influenza, the vaccine has been shown to be safe, well-tolerated, and immunogenic to a broad range of flu strains in clinical trials.
Dr. Tamar Ben-Yedidia, BiondVax’s Chief Science Officer, commented, “The USA and Japan, together with Europe, are among the largest influenza vaccine markets. We are pleased our universal flu vaccine’s patent protected composition and manufacturing process is progressing as planned through its pivotal Phase 3 clinical trial. We look forward to bringing the vaccine to the people of Japan, USA, Europe, and the rest of the world in the coming years.”
BiondVax is currently conducting a pivotal, clinical efficacy, Phase 3 trial of M-001 in Europe. 4,094 participants were recruited prior to the 2018/19 flu season, and preparations are proceeding as planned towards the trial’s second season of 2019/20, in which about 8,000 participants are expected to be enrolled. The placebo-controlled trial will assess safety and effectiveness of M-001 alone in reducing flu illness and severity in adults aged 50 years and older, with at least half aged 65 and older. Results are expected by the end of 2020.In parallel, the NIAID/NIH is conducting a Phase 2 clinical trial in the USA, with results anticipated by the end of 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 in Support of Ongoing Pivotal, Clinical Efficacy Phase 3 Trial of the M-001 Universal Flu Vaccine and Scale Up of Manufacturing Process
Jerusalem, Israel – June 10, 2019
BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), a clinical stage biopharmaceutical company focused on developing and commercializing M-001, a universal flu vaccine candidate, today announced a rights offering to holders of the Company’s American Depositary Shares (“ADSs”).Proceeds from the rights offering will be used to fund operations including completion of the ongoing pivotal, clinical efficacy Phase 3 trial of BiondVax’s M-001 universal flu vaccine candidate, and scale up of the M-001 production process in BiondVax’s newly constructed mid-size manufacturing facility. The Company anticipates results of the Phase 3 trial will be announced by the end of 2020.
ADS holders shall receive 0.537823255 ADS rights for each ADS owned of record at 5:00 p.m., New York City time, on June 9, 2019 (which effectively is all settled positions as of close of business on Friday June 7, 2019). One ADS right entitles an ADS holder to subscribe for and purchase one new ADS. The rights offering will begin on June 10, 2019 and end on July 12, 2019 at 5:00 p.m., New York City time.
ADS holders who are interested in exercising their rights in this rights offering are encouraged to contact their bank or broker for further information. Alternatively, they may contact MacKenzie Partners, Inc., the information agent, at +1-(212)-929-5500 or toll free at +1-800-322-2885, or by email at rightsoffer@mackenziepartners.com. ADS holders may also direct questions to BiondVax’s lawyer Mr. Mark Hamilton at mhamilton@pearlcohen.com or by phone at +972-(0)3-303-9063 at Pearl Cohen Zedek Latzer Baratz in Tel Aviv, Israel.
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 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, 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 First Quarter 2019 Financial Results
Jerusalem, Israel – May 30, 2019BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), a 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 March 31, 2019.First Quarter 2019 Financial SummaryResults are in New Israel Shekels (NIS) and convenience translation to $US is provided using the exchange rate of 3.63 (NIS/$US) as at March 31, 2019.
- First quarter operating expenses were NIS 7.1m ($1.97m) compared with NIS 12.6m for the first quarter of 2018;
- First quarter R&D expenses amounted to NIS 5.7m ($1.58m) compared with NIS 11.7m for the first quarter of 2018;
As of March 31, 2019, BiondVax had cash and cash equivalents of NIS 57.5 million ($15.8 million) as compared to NIS 75.8 million as of December 31, 2018. The decrease is attributable to execution of planned ongoing operations related to the ongoing pivotal, clinical efficacy, Phase 3 trial of the Company’s M-001 Universal Flu Vaccine candidate.** Tables to Follow **About BiondVaxBiondVax (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 DetailsJoshua E. Phillipson | +972 8 930 2529 | j.phillipson@biondvax.comForward 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, 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.
BALANCE SHEETS |
|||||||||
In thousands, except share and per share data |
|||||||||
Conveniencetranslation |
|||||||||
December 31, |
March 31, |
March 31, |
|||||||
2018 |
2018 |
2019 |
2019 |
||||||
Audited |
Unaudited |
Unaudited |
|||||||
N I S |
U.S. dollars |
||||||||
CURRENT ASSETS: |
|||||||||
Cash and cash equivalents |
75,883 |
55,675 |
57,532 |
15,840 |
|||||
Other receivables |
965 |
2,975 |
1,854 |
511 |
|||||
76,848 |
58,650 |
59,386 |
16,351 |
||||||
LONG‑TERM ASSETS: |
|||||||||
Property, plant and equipment |
28,249 |
12,537 |
31,417 |
8,650 |
|||||
Right-of-use assets |
- |
- |
7,845 |
2,160 |
|||||
Other long term assets |
740 |
880 |
711 |
196 |
|||||
28,989 |
13,417 |
39,973 |
11,006 |
||||||
105,837 |
72,067 |
99,359 |
27,357 |
||||||
CURRENT LIABILITIES: |
|||||||||
Trade payables |
20,723 |
8,526 |
15,249 |
4,199 |
|||||
Operating lease liability |
- |
- |
676 |
186 |
|||||
Other payables |
1,076 |
768 |
1,275 |
351 |
|||||
21,799 |
9,294 |
17,200 |
4,736 |
||||||
LONG‑TERM LIABILITIES: |
|||||||||
Liability in respect of government grants |
14,643 |
11,252 |
14,568 |
4,011 |
|||||
Operating lease liabilities |
- |
- |
7,247 |
1,995 |
|||||
Loan from others |
94,360 |
- |
88,792 |
24,447 |
|||||
Warrants |
6,168 |
9,315 |
2,059 |
567 |
|||||
Severance pay liability, net |
82 |
78 |
84 |
23 |
|||||
115,253 |
20,645 |
112,750 |
31,044 |
||||||
SHAREHOLDERS' EQUITY: |
|||||||||
Ordinary shares of NIS 0.0000001 par value: |
|||||||||
Authorized: 391,000,000 shares as of March 31, 2019,2018 (unaudited) and December 31, 2018; Issued andOutstanding: 261,419,599 shares as of March 31, 2019,2018 (unaudited) and December 31, 2018 |
*) - |
*) - |
*) - |
*) - |
|||||
Share premium |
179,929 |
179,747 |
179,987 |
49,556 |
|||||
Accumulated deficit |
(211,144) |
(137,619) |
(210,578) |
(57,979) |
|||||
(31,215) |
42,128 |
(30,591) |
(8,423) |
||||||
105,837 |
72,067 |
99,359 |
27,357 |
||||||
STATEMENTS OF COMPREHENSIVE INCOME (LOSS) |
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In thousands, except share and per share data |
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Convenience translation |
|||||||||||||||||
Year ended December 31, |
Three months ended March 31, |
Three months ended March 31, |
|||||||||||||||
2018 |
2018 |
2019 |
2019 |
||||||||||||||
Audited |
Unaudited |
Unaudited |
|||||||||||||||
NIS |
U.S. dollars |
||||||||||||||||
Operating expenses: |
|||||||||||||||||
Research and development, net of participations |
71,913 |
11,745 |
5,732 |
1,578 |
|||||||||||||
Marketing, general and administrative |
5,154 |
884 |
1,433 |
395 |
|||||||||||||
Total operating expenses |
77,067 |
12,629 |
7,165 |
1,973 |
|||||||||||||
Operating loss |
(77,067) |
(12,629) |
(7,165) |
(1,973) |
|||||||||||||
Financial income |
2,936 |
- |
9,754 |
2,685 |
|||||||||||||
Financial expense |
(13,596) |
(1,573) |
(2,023) |
(557) |
|||||||||||||
Net income (loss) |
(87,727) |
(14,202) |
566 |
156 |
|||||||||||||
Basic and Diluted net income (loss) per share |
(0.34) |
(0.05) |
0.002 |
0.001 |
|||||||||||||
Weighted average number of shares outstandingused to compute basic and diluted income (loss)per share |
261,419,599 |
261,419,599 |
261,419,599 |
261,419,599 |
|||||||||||||
BiondVax to provide update of M-001 Universal Flu Vaccine pivotal Phase 3 clinical trial at 18th MIXiii-BIOMED Conference
Jerusalem, Israel – May 13, 2019 –BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), developer of the M-001 universal influenza vaccine candidate, reported today it will present this week at the 18th MIXiii-BIOMED Conference and Exhibition in Tel Aviv, Israel.Dr. Tamar Ben-Yedidia, BiondVax’s Chief Scientific Officer, will provide an overview of the Company’s achievements and plans, including the ongoing pivotal, clinical efficacy, Phase 3 trial.Details of Dr. Ben-Yedidia’s presentation:Update of the Pivotal, Clinical Efficacy, Phase 3 trial of BiondVax’s M-001 Universal Influenza VaccineDate: Wednesday, May 15, 2019Time: 16:40 - 16:55Location: Hall B, David InterContinental Hotel, Tel Aviv, Israel About BiondVaxBiondVax (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 DetailsJoshua E. Phillipson | +972 8 930 2529 | j.phillipson@biondvax.comForward 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, 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.
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BiondVax Announces Fourth Quarter and Full Year 2018 Financial Results and Update
Jerusalem, Israel – April 30, 2019 – BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), a biopharmaceutical company focused on developing and commercializing M-001, a universal flu vaccine candidate currently undergoing a pivotal clinical efficacy Phase 3 trial, today announced its fourth quarter and full year financial results for the year ended December 31, 2018 and provided a business update.Fourth Quarter 2018 Financial SummaryResults are in New Israel Shekels (NIS) and convenience translation to $US is provided using the exchange rate of 3.748(NIS/$US) as at December 31, 2018.
- Fourth quarter operating expenses were NIS 27.9 million (approximately $7.5 million) compared with NIS 14.9 million for the fourth quarter of 2017;
- Fourth quarter R&D expenses amounted to NIS 26.6 million ($7.1 million) compared with NIS 13.7 million for the fourth quarter of 2017;
Full Year 2018 Financial Summary
- Total operating expenses, net, were NIS 77.06 million ($20.5 million) compared with NIS 23.66 million in 2017;
- R&D expenses, net, amounted to NIS 71.9 million ($19.18 million) compared with NIS 18.78 million in 2017;
As of December 31, 2018, BiondVax had cash and cash equivalents and short-term investments of NIS 75.8 million ($20.24m) as compared to NIS 71.38 million as of December 31, 2017.2018 Highlights and Recent Corporate Update
- Pivotal clinical efficacy Phase 3 trial: In the first cohort of BiondVax’s ongoing pivotal, clinical efficacy, Phase 3 trial of M-001, 4,094 participants were recruited prior to the 2018/19 flu season. Approximately 8,000 additional participants are expected to be recruited in the trial’s second cohort beginning in Q3 2019. The placebo-controlled trial will assess safety and effectiveness of M-001 alone in reducing flu illness and severity in adults aged 50 years and older. Results are expected by the end of 2020.
- Mid-size commercial manufacturing facility: In August 2018, BiondVax relocated to a newly constructed mid-size commercial scale manufacturing facility in Jerusalem, Israel. Based in the Jerusalem Bio Park, a biotech hub on the Hadassah Medical Center Hebrew University Ein Kerem campus, the new approximately 20,000 square foot (1850m2) facility includes offices, laboratories, and GMP manufacturing suites with planned annual capacity of 20 million doses of M-001 in bulk with up to 10 million single dose syringes.
- €24 million non-dilutive co-funding: In April 2019, the Management Committee of the European Investment Bank (EIB) agreed to extend the €20 million EIB-BiondVax non-dilutive co-financing agreement, signed in 2017, by an additional €4 million. The funds will be used in support of the ongoing pivotal, clinical efficacy, Phase 3 trial of BiondVax’s M-001 Universal Flu Vaccine candidate in Europe.
- NIH-sponsored Phase 2 clinical trial: All participants have completed their final visit in a Phase 2 clinical trial of BiondVax’s M-001 universal flu vaccine, conducted by several Vaccine Treatment and Evaluation Units (VTEUs) sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. Department of Health & Human Services (HHS)’s National Institutes of Health (NIH).
Complete financial results are available in the Company’s annual report on Form 20-F for the year ended December 31, 2018, which was filed with the Securities and Exchange Commission on April 30, 2019. About BiondVax BiondVax (NASDAQ: BVXV) is a Phase 3 clinical stage biopharmaceutical company developing a universal flu vaccine. The proprietary technology of the vaccine candidate, called M-001, utilizes a unique combination of conserved and common influenza virus peptides designed to provide multi-season and multi-strain protection against current and future, seasonal and pandemic influenza. 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. An additional Phase 2 trial is being conducted by the NIH/NIAID is the US. As well, BiondVax is currently conducting a large pivotal clinical efficacy Phase 3 trial in Europe. Please visit www.biondvax.com.Contact DetailsJoshua E. Phillipson | +972 8 930 2529 | j.phillipson@biondvax.com* Tables to Follow *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, 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.
BALANCE SHEETS |
||||||
In thousands, except share and per share data |
||||||
Convenience |
||||||
Translation |
||||||
December 31, |
December 31, |
|||||
2017 |
2018 |
2018 |
||||
N I S |
U.S. dollars |
|||||
CURRENT ASSETS: |
||||||
Cash and cash equivalents |
71,382 |
75,883 |
20,246 |
|||
Other receivables |
3,923 |
965 |
258 |
|||
75,305 |
76,848 |
20,504 |
||||
LONG‑TERM ASSETS: |
||||||
Property, plant and equipment |
5,510 |
28,249 |
7,537 |
|||
Other long term assets |
880 |
740 |
197 |
|||
6,390 |
28,989 |
7,734 |
||||
81,695 |
105,837 |
28,238 |
||||
CURRENT LIABILITIES: |
||||||
Trade payables |
6,223 |
20,723 |
5,529 |
|||
Other payables |
660 |
1,076 |
287 |
|||
6,883 |
21,799 |
5,816 |
||||
LONG‑TERM LIABILITIES: |
||||||
Liability in respect of government grants |
10,300 |
14,643 |
3,907 |
|||
Loan from others |
- |
94,360 |
25,176 |
|||
Warrants |
8,177 |
6,168 |
1,645 |
|||
Severance pay liability, net |
83 |
82 |
22 |
|||
18,560 |
115,253 |
30,750 |
||||
SHAREHOLDERS' EQUITY: |
||||||
Ordinary shares of NIS 0.0000001 parvalue: |
||||||
Authorized: 391,000,000 shares as ofDecember 31, 2018 and 2017; Issued andOutstanding: 261,419,599, shares as ofDecember 31, 2018 and 2017 |
*) - |
*) - |
*) - |
|||
Share premium |
179,669 |
179,929 |
48,007 |
|||
Accumulated deficit |
(123,417) |
(211,144) |
(56,335) |
|||
56,252 |
(31,215) |
(8,328) |
||||
81,695 |
105,837 |
28,238 |
||||
*) Represents an amount lower than NIS 1.
|
STATEMENTS OF COMPREHENSIVE INCOME |
|||||||||
In thousands, except per share data |
|||||||||
Conveniencetranslation |
|||||||||
Year ended December 31, |
Year ended December 31, |
||||||||
2016 |
2017 |
2018 |
2018 |
||||||
N I S |
U.S. dollars |
||||||||
Operating expenses: |
|||||||||
Research and development, net ofparticipations |
7,794 |
18,777 |
71,913 |
19,187 |
|||||
Marketing, general andadministrative |
4,106 |
4,879 |
5,154 |
1,375 |
|||||
Total operating expenses |
11,900 |
23,656 |
77,067 |
20,562 |
|||||
Operating loss |
(11,900) |
(23,656) |
(77,067) |
(20,562) |
|||||
Financial income |
3,019 |
18 |
2,936 |
783 |
|||||
Financial expense |
(303) |
(10,913) |
(13,596) |
(3,628) |
|||||
Loss |
(9,184) |
(34,551) |
(87,727) |
(23,407) |
|||||
Other comprehensive loss: |
|||||||||
Items to be reclassified to profit orloss in subsequent periods: |
|||||||||
Loss from available-for-salemarketable securities |
(6) |
(6) |
- |
- |
|||||
Total comprehensive loss |
(9,190) |
(34,557) |
(87,727) |
(23,407) |
|||||
Basic and diluted loss per share |
(0.07) |
(0.17) |
(0.34) |
(0.09) |
|||||
Weighted average number of sharesoutstanding used to compute basicand diluted loss per share |
135,097,367 |
201,030,768 |
261,419,599 |
261,419,599 |
|||||
European Investment Bank (EIB) extends financing agreement to €24 million total in support of BiondVax’s universal flu vaccine ongoing pivotal Phase 3 clinical trial
€4 million extension to 2017 financing agreement
Jerusalem, Israel – April 22, 2018 –BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), announced today that the Management Committee of the European Investment Bank (EIB) agreed to extend the 2017 financing agreement with BiondVax by an additional €4 million. The funds will be used in support of the ongoing pivotal, clinical efficacy, Phase 3 trial of BiondVax’s M-001 Universal Flu Vaccine candidate in Europe.The original €20 million EIB-BiondVax non-dilutive co-financing agreement was signed in June 2017 to support both construction of BiondVax’s new mid-size commercial-scale manufacturing facility in Israel and the pivotal, clinical efficacy, Phase 3 trial in Europe. The funds, which were advanced over the course of 2018, are structured as a zero-percent fixed interest loan repayable five years after drawdown, with a variable remuneration based on royalties of net sales of M-001 following commercialization. The additional €4m, representing 20% of the original loan, will be disbursed upon enrollment of the first participant in the clinical trial’s second season and with agreed matching funds provided by BiondVax. Other terms in the new agreement including BiondVax’s option to repay the loan and repurchase the royalties at any time carry over from the 2017 agreement.BiondVax is currently conducting a pivotal, clinical efficacy, Phase 3 trial of M-001. 4,094 participants were recruited prior to the 2018/19 flu season. With the additional funds, the trial’s second cohort is expected to increase up to 8,000 participants, bringing the planned total size of the trial to approximately 12,000 participants. The increase in the number of participants is intended to compensate for the relatively mild 2018/19 flu season in Europe, as reported by the ECDC. The placebo-controlled trial will assess safety and effectiveness of M-001 alone in reducing flu illness and severity in adults aged 50 years and older. Results are expected by the end of 2020.Dr. Ron Babecoff, BiondVax’s CEO, commented, “I am grateful to the EIB and the people of Europe for their long-term support of BiondVax’s efforts to bring our universal flu vaccine candidate to the world. The World Health Organization (WHO) recently stated that global influenza pandemic is one of the top threats to global health. The extension of the EIB agreement attests that we have continued to meet our milestones towards the important goal of developing a vaccine that provides multi-season and multi-strain protection against seasonal and pandemic influenza illness.”About BiondVax BiondVax (NASDAQ: BVXV) is a Phase 3 clinical stage biopharmaceutical company developing a universal flu vaccine. The proprietary technology of the vaccine candidate, called M-001, utilizes a unique combination of conserved and common influenza virus peptides designed to provide multi-season and multi-strain protection against current and future, seasonal and pandemic influenza. 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. An additional Phase 2 trial is being conducted by the NIH/NIAID is the US. As well, BiondVax is currently conducting a large pivotal clinical efficacy Phase 3 trial in Europe. Please visit www.biondvax.com.Contact DetailsJoshua E. Phillipson | +972 8 930 2529 | j.phillipson@biondvax.comForward 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 involve certain risks and uncertainties 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 its products; 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, 2017 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 Universal Flu Vaccine Patent Application Accepted in Australia
Jerusalem, Israel – April 15, 2018 –BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), announced today that a patent application covering formulation and production processes of the M-001 universal influenza vaccine candidate was accepted in Australia. Titled “Compositions of multimeric-multiepitope influenza polypeptides and their production” the patent application has been filed in eight other jurisdictions, and is under examination in Europe, China, Japan, and the USA.Dr. Tamar Ben-Yedidia, BiondVax’s Chief Science Officer, commented, “Our five patent families cover multimeric-multiepitope polypeptides as well as composition, use, formulation and production aspects of M-001, BiondVax’s Phase 3 universal flu vaccine candidate. We are pleased the Australian authorities have accepted this patent, which widens and strengthens our international IP portfolio.”BiondVax is currently conducting a pivotal, clinical efficacy, Phase 3 trial of M-001 in Europe. 4,094 participants were recruited prior to the 2018/19 flu season, and preparations are proceeding as planned towards the trial’s second season of 2019/20, in which at least 6,000 participants are expected to be enrolled. The placebo-controlled trial will assess safety and effectiveness of M-001 alone in reducing flu illness and severity in adults aged 50 years and older. 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 DetailsJoshua E. Phillipson | +972 8 930 2529 | j.phillipson@biondvax.comForward 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 involve certain risks and uncertainties 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 its products; 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, 2017 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 to provide update of M-001 Universal Flu Vaccine pivotal Phase 3 clinical trial at IVW2019 conference
Jerusalem, Israel – March 28, 2018 –BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), developer of the M-001 universal influenza vaccine candidate, reported today it will present next week at the Influenza Vaccines for the World conference in Edinburgh, Scotland, UK.Joshua Phillipson, BiondVax’s Head of Business Development, will provide an overview of the Company’s achievements and plans, including the ongoing pivotal, clinical efficacy, Phase 3 trial.Details of Mr. Phillipson’s presentation:Getting Closer to the Market: BiondVax's Universal Flu Vaccine Pivotal Phase 3 TrialDate: Tuesday, April 2, 2019Location: Royal College of Physicians of Edinburgh, Edinburgh, Scotland, UKThose interested in meeting with Mr. Phillipson are invited to contact him at j.phillipson@biondvax.com.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 DetailsJoshua E. Phillipson | +972 8 930 2529 | j.phillipson@biondvax.comForward 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 involve certain risks and uncertainties 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 its products; 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, 2017 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.
Last participant out in USA Phase 2 clinical trial of BiondVax’s M-001 Universal Influenza Vaccine candidate
Jerusalem, Israel – March 21, 2019 – BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), developer of the M-001 universal influenza vaccine candidate, reported today that all participants have completed their final visit in a Phase 2 clinical trial conducted by several Vaccine Treatment and Evaluation Units (VTEUs) sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. Department of Health & Human Services (HHS)’s National Institutes of Health (NIH).120 participants aged 18 to 49 years were enrolled at VTEUs at 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. Safety and immunogenicity will be assessed and compared between the groups receiving M-001 and placebo. Laboratory analyses of vaccine immunogenicity will be performed at VTEUs at Baylor College of Medicine and St Louis University (St. Louis, Missouri) and at BiondVax Pharmaceuticals. Results are anticipated by the end of 2019.Dr. Tamar Ben-Yedidia, BiondVax’s Chief Scientific Officer, commented, “We are pleased with the progress of this Phase 2 trial, and grateful for the opportunity to collaborate with NIAID and their researchers.”In parallel, BiondVax’s pivotal, clinical efficacy, Phase 3 trial in Europe, which recruited 4,094 participants prior to the 2018/19 flu season, is proceeding towards its second season of 2019/20. The M-001 batch for the Phase 3 trial’s second cohort is being filled in single-use syringes in BiondVax’s new mid-size commercial scale manufacturing facility in Israel. The placebo-controlled trial will assess safety and effectiveness of M-001 alone in reducing flu illness and severity in adults aged 50 years and older. 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 DetailsJoshua E. Phillipson | +972 8 930 2529 | j.phillipson@biondvax.comForward 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 involve certain risks and uncertainties 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 its products; 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, 2017 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 CEO to Present at “World Vaccine Congress 2018 San Diego” about BiondVax’s Phase 3 Universal Flu Vaccine Candidate
Jerusalem, Israel – November 26, 2018 –BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), developer of the M-001 universal influenza vaccine candidate, reported today it will present this week at the World Vaccine & Immunotherapy Congress West Coast 2018 in San Diego.Dr. Ron Babecoff, BiondVax’s Founder and CEO, will participate in a panel discussion and provide an overview of the Company’s achievements and plans, including the ongoing pivotal, clinical efficacy, Phase 3 trial.Details of Dr. Babecoff's presentations:(1) Panel: How will we integrate knowledge gained from the UIVI and other research into the development of a Universal Influenza Vaccine?Date: Wednesday, November 28, 2018Time: 12:35pm(2) Getting Closer to the Market: BiondVax's Universal Flu Vaccine Pivotal Phase 3 TrialDate: Wednesday, November 28, 2018Time: 3:50pmThose interested in meeting with Dr. Babecoff are invited to contact Joshua Phillipson at j.phillipson@biondvax.com. About BiondVaxBiondVax (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-season protection against current and future, seasonal and pandemic influenza virus strains. BiondVax’s proprietary technology utilizes a unique combination of conserved and common influenza virus peptides, activating 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 human clinical trials, covering 698 participants, the vaccine has been shown to be safe, well-tolerated, and immunogenic. Please visit www.biondvax.com.Contact DetailsJoshua E. Phillipson | +972 8 930 2529 | j.phillipson@biondvax.comForward 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 involve certain risks and uncertainties 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 its products; 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, 2017 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 Issues Clarification Regarding Third Quarter 2018 Financial Results
Jerusalem, Israel - November 19, 2018 -- 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 issued a clarification regarding information published on November 13, 2018 in connection with the third quarter financial results.
As correctly indicated in the financial tables filed on November 14, 2018 in a 6-K with the United States Securities And Exchange Commission (SEC), third quarter operating expenses were NIS 5.8m (US$1.6m), while cumulative operating expenses for the nine months ending September 30, 2018 were NIS 49.1m (US$13.5m). As well, third quarter R&D expenses amounted to NIS 4.3m (US$1.2m), while cumulative R&D expenses for the nine months ending September 30, 2018 were NIS 45.3m (US$12.5m).
Note that results are in New Israel Shekels (NIS) and the convenience translation to $US is provided using the exchange rate of 3.627 (NIS/$US) as at September 30, 2018.
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-season protection against current and future, seasonal and pandemic influenza virus strains. BiondVax’s proprietary technology utilizes a unique combination of conserved and common influenza virus peptides, activating 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 human clinical trials, covering 698 participants, the vaccine has been shown to be safe, well-tolerated, and immunogenic. 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 involve certain risks and uncertainties 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 its products; 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, 2017 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 2018 Financial Results
Jerusalem, Israel - November 13, 2018 -- 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, 2018.
Third Quarter 2018 Financial Summary
Results are in New Israel Shekels (NIS) and convenience translation to $US is provided using the exchange rate of 3.627 (NIS/$US) as at September 30, 2018.
Third quarter operating expenses were NIS 49.1m ($13.5m) compared with NIS 3.21m for the third quarter of 2017;
Third quarter R&D expenses amounted to NIS 45.3m ($12.5m) compared with NIS 1.17m for the third quarter of 2017;
As of September 30, 2018, BiondVax had cash and cash equivalents of NIS 53.0 million ($14.6 million) as compared to NIS 37.1 million as of June 30, 2018. Expenses are related to execution of planned ongoing operations including the launch of a 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. Of note, during this third quarter a €6 million tranche was received by the Company as part of the previously announced €20 million co-financing agreement with the European Investment Bank (EIB). On October 21, 2018, after this third quarter reporting period, an additional €8 million representing the third and final tranche of the EIB agreement was received by BiondVax, and will be included in the Company’s fourth quarter financial results.
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-season protection against current and future, seasonal and pandemic influenza virus strains. BiondVax’s proprietary technology utilizes a unique combination of conserved and common influenza virus peptides, activating 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 human clinical trials, covering 698 participants, the vaccine has been shown to be safe, well-tolerated, and immunogenic. 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 involve certain risks and uncertainties 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 its products; 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, 2017 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’s Universal Flu Vaccine Phase 3 Clinical Trial Completes First Season’s Enrollment of 4,098 Participants
JERUSALEM, Israel, October 24, 2018 -- BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV) announced today the successful enrollment of the last participant in the first season of a pivotal, clinical efficacy, Phase 3 trial of the M-001 universal flu vaccine candidate.The 4,098 participants enrolled in this year’s cohort will be monitored for two flu seasons. A second cohort of approximately 6,000 participants will be enrolled prior to the 2019/2020 flu season. Participants, aged 50 years and older, with half aged 65 plus, are randomly divided into two equal groups, one receiving M-001 and the other receiving a placebo. Safety, as well as laboratory confirmed influenza incidence will be assessed, with results expected in the second half of 2020.Dr. Tamar Ben-Yedidia, BiondVax’s Chief Science Officer and co-inventor of M-001, commented, “We are pleased with the progress of our universal flu vaccine’s pivotal Phase 3 trial. Our partners are doing a wonderful job conducting this challenging study. The trial aims to show the extent to which M-001 protects people against influenza illness, regardless of flu strain.”To date, participants were recruited in 55 clinical trial sites in four European countries. Some additional European countries and sites are expected to participate in the Phase 3 trial’s second season.In 6 completed clinical trials in 698 young adult to elderly participants, M-001 has been shown to be safe, well-tolerated, and immunogenic to a broad range of influenza strains. A recombinant protein consisting of nine common and conserved influenza virus epitopes, M-001 is a single, unchanging vaccine formulation. It is designed to induce T-cell immune responses and to serve as a common denominator to current, future, seasonal, and pandemic influenza.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 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-season protection against current and future, seasonal and pandemic influenza virus strains. BiondVax’s proprietary technology utilizes a unique combination of conserved and common influenza virus peptides, activating 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 human clinical trials, covering 698 participants, the vaccine has been shown to be safe, well-tolerated, and immunogenic. Please visit www.biondvax.com.Contact DetailsJoshua E. Phillipson | +972 8 930 2529 | j.phillipson@biondvax.comForward 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 involve certain risks and uncertainties 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 and its products; 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 resource 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, 2017 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 and the Tel-Aviv Stock Exchange. We undertake no obligation to revise or update any forward-looking statement for any reason.
###
BiondVax receives €8M from the European Investment Bank (EIB) in support of manufacturing facility and ongoing Phase 3 clinical trial
JERUSALEM, Israel, October 22, 2018 -- BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), developer of M‑001, a clinical phase 3 Universal Influenza Vaccine candidate, announced today the receipt of an €8 million disbursement from the European Investment Bank (EIB). These funds are the third and final tranche of the previously announced €20 million co-financing agreement signed in June 2017. The first two tranches totaling €12 million were received by BiondVax earlier this year.Dr. Ron Babecoff, BiondVax’s CEO, stated, “I am grateful to the EIB for their ongoing support, which has helped BiondVax launch our pivotal, clinical efficacy Phase 3 trial, and construct our new mid-size commercial manufacturing facility for M-001, our universal flu vaccine candidate.”The EIB-BiondVax non-dilutive co-financing agreement, signed in June 2017, is structured as a zero-percent fixed interest loan, with a variable remuneration based on royalties of net sales of M-001 following commercialization. Funds were advanced in three tranches, whose disbursement was dependent on achievement of certain specified milestones. The tranches are repayable five years after each drawdown. BiondVax retains the option to repay the loan and repurchase the royalties at any time.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-season protection against current and future, seasonal and pandemic influenza virus strains. BiondVax’s proprietary technology utilizes a unique combination of conserved and common influenza virus peptides, activating 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 human clinical trials, covering 698 participants, the vaccine has been shown to be safe, well-tolerated, and immunogenic. Please visit www.biondvax.com.Contact DetailsJoshua 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 involve certain risks and uncertainties 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 and its products; 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 resource 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, 2017 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 and the Tel-Aviv Stock Exchange. We undertake no obligation to revise or update any forward-looking statement for any reason.
###
BiondVax to Present at Influenza 2018 Oxford Conference
Jerusalem, Israel – September 4, 2018 –BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), developer of the M-001 universal influenza vaccine candidate, reported today it will present at the Influenza 2018 Oxford conference at the University of Oxford.Joshua Phillipson, BiondVax’s Business Development Manager, will provide an overview of the Company’s clinical development achievements and plans, including the recently launched pivotal, clinical efficacy, Phase 3 trial.Details of Mr. Phillipson’s talk:Getting Closer to the Market: M-001 Universal Flu Vaccine Starting Pivotal Phase 3 TrialDate: Wednesday, September 5, 2018Time: 10:40amLocation: Vernon Harcourt Room, South Building, St Hilda’s College, University of Oxford, UK.About BiondVaxBiondVax (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-season protection against current and future, seasonal and pandemic influenza virus strains. BiondVax’s proprietary technology utilizes a unique combination of conserved and common influenza virus peptides, activating 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 human clinical trials, covering 698 participants, the vaccine has been shown to be safe, well-tolerated, and immunogenic. Please visit www.biondvax.com.
BiondVax Announces Second Quarter 2018 Financial Results
Jerusalem, Israel - August 22, 2018 -- 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 June 30, 2018.Second Quarter 2018 Financial SummaryResults are in New Israel Shekels (NIS) and convenience translation to $US is provided using the exchange rate of 3.65 (NIS/$US) as at June 30, 2018.
- Second quarter operating expenses were NIS 30.6m ($8.4m) compared with NIS 2.59m for the second quarter of 2017;
- Second quarter R&D expenses amounted to NIS 29.2m ($8m) compared with NIS 2m for the second quarter of 2017;
As of June 30, 2018, BiondVax had cash and cash equivalents of NIS 37.1 million ($10.1 million) as compared to NIS 36.6m as of March 30, 2018. Expenses are related to execution of planned ongoing operations including the launch of a 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.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-season protection against current and future, seasonal and pandemic influenza virus strains. BiondVax’s proprietary technology utilizes a unique combination of conserved and common influenza virus peptides, activating 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 human clinical trials, covering 698 participants, the vaccine has been shown to be safe, well-tolerated, and immunogenic. Please visit www.biondvax.com.Contact Details: Joshua E. Phillipson | +972 8 930 2529 | j.phillipson@biondvax.comForward 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 involve certain risks and uncertainties 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 its products; 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, 2017 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 and the Tel-Aviv Stock Exchange. We undertake no obligation to revise or update any forward-looking statement for any reason.
** Tables to Follow **
BALANCE SHEETS |
|||||||||
In thousands, except per share data |
|||||||||
Conveniencetranslation |
|||||||||
December 31, |
June 30, |
June 30, |
|||||||
2017 |
2017 |
2018 |
2018 |
||||||
Audited |
Unaudited |
Unaudited |
|||||||
N I S |
U.S. dollars |
||||||||
CURRENT ASSETS: |
|||||||||
Cash and cash equivalents |
71,382 |
31,334 |
37,128 |
10,172 |
|||||
Marketable securities |
- |
4,067 |
- |
||||||
Short-term deposits |
- |
1,200 |
- |
- |
|||||
Other receivables |
3,923 |
2,812 |
4,067 |
1,114 |
|||||
75,305 |
39,413 |
41,195 |
11,286 |
||||||
LONG‑TERM ASSETS: |
|||||||||
Property, plant and equipment |
5,510 |
1,233 |
18,793 |
5,149 |
|||||
Other long term assets |
880 |
505 |
880 |
241 |
|||||
6,390 |
1,738 |
19,673 |
5,390 |
||||||
81,695 |
41,151 |
60,868 |
16,676 |
||||||
CURRENT LIABILITIES: |
|||||||||
Trade payables |
6,223 |
1,188 |
1,323 |
363 |
|||||
Other payables |
660 |
664 |
780 |
214 |
|||||
6,883 |
1,852 |
2,103 |
577 |
||||||
LONG‑TERM LIABILITIES: |
|||||||||
Liability in respect of government grants |
10,300 |
- |
12,790 |
3,504 |
|||||
Loan from others |
- |
- |
20,710 |
5,674 |
|||||
Warrants |
8,177 |
18,231 |
8,475 |
2,322 |
|||||
Severance pay liability, net |
83 |
79 |
79 |
22 |
|||||
18,560 |
18,310 |
42,054 |
11,522 |
||||||
SHAREHOLDERS' EQUITY: |
|||||||||
Ordinary shares of NIS 0.0000001 par value: |
|||||||||
Authorized: 391,000,000 shares as of June 30,2018, 2017 (unaudited) and December 31,2017; Issued and Outstanding: 261,419,599,179,595,199 and 261,419,599 shares respectively |
*) - |
*) - |
*) - |
*) - |
|||||
Share premium |
179,669 |
132,824 |
179,821 |
49,265 |
|||||
Options |
- |
533 |
- |
- |
|||||
Other comprehensive income |
- |
2 |
- |
- |
|||||
Accumulated deficit |
(123,417) |
(112,370) |
(163,110) |
(44,688) |
|||||
56,252 |
20,989 |
16,711 |
4,577 |
||||||
81,695 |
41,151 |
60,868 |
16,676 |
||||||
*) Represents an amount lower than NIS 1.
|
STATEMENTS OF COMPREHENSIVE INCOME |
|||||||||||||||||||
In thousands, except per share data |
|||||||||||||||||||
Convenience translation |
|||||||||||||||||||
Year ended December 31, |
Three months ended June 30, |
Six months ended June 30, |
Six months ended June 30, |
||||||||||||||||
2017 |
2017 |
2018 |
2017 |
2018 |
2018 |
||||||||||||||
Unaudited |
Unaudited |
||||||||||||||||||
N I S |
U.S. dollars |
||||||||||||||||||
(In thousands, except per share data) |
|||||||||||||||||||
Operating expenses: |
|||||||||||||||||||
Research and development, net of participations |
18,777 |
2,022 |
29,205 |
3,896 |
40,950 |
11,219 |
|||||||||||||
Marketing, general and administrative |
4879 |
569 |
1,445 |
1,663 |
2,329 |
638 |
|||||||||||||
Total operating expenses |
23,656 |
2,591 |
30,650 |
5,559 |
43,279 |
11,857 |
|||||||||||||
Operating loss |
(23,656) |
(2,591) |
(30,650) |
(5,559) |
(43,279) |
(11,857) |
|||||||||||||
Financial income |
18 |
5 |
6,386 |
13 |
6,386 |
1,255 |
|||||||||||||
Financial expense |
(10,913) |
(9,086) |
(1,227) |
(17,958) |
(2,800) |
(273) |
|||||||||||||
0 |
|||||||||||||||||||
Total finance (expense) income, net |
(10,895) |
(9,081) |
5,159 |
(17,945) |
3,586 |
982 |
|||||||||||||
Net loss |
(34,551) |
(11,672) |
(25,491) |
(23,504) |
(39,693) |
(10,875) |
|||||||||||||
Other comprehensive loss: |
|||||||||||||||||||
Items to be reclassified to profit or loss in subsequent periods: |
|||||||||||||||||||
Loss from available-for-sale financial assets |
(6) |
(4) |
- |
(4) |
- |
- |
|||||||||||||
Total comprehensive loss |
(34,557) |
(11,676) |
(25,491) |
(23,508) |
(39,693) |
(10,875) |
|||||||||||||
Basic and diluted net loss per share (NIS) |
(0.17) |
(0.07) |
(0.10) |
(0.14) |
(0.15) |
(0.04) |
|||||||||||||
Weighted average number of shares outstanding used to compute basic anddiluted loss per share |
201,030,768 |
175,809,413 |
261,419,599 |
169,182,101 |
261,419,599 |
261,419,599 |
BiondVax Moves to New Universal Flu Vaccine Manufacturing Facility
State-of-the-art facility designed for annual capacity of 40 million doses in bulk with up to 20 million single dose syringesJerusalem, Israel – August 20, 2018BiondVax Pharmaceuticals Ltd. (NASDAQ: BVXV), developer of the M-001 universal influenza vaccine candidate, reported today the company’s relocation to a newly constructed mid-size commercial scale manufacturing facility in Jerusalem, Israel.Dr. Shimon Hassin, BiondVax’s COO, commented, “BiondVax’s new facility is custom-built for GMP manufacturing of our innovative flu vaccine candidate, which can be produced year-round and is designed to provide broad protection against influenza. As BiondVax moves into this next exciting stage, I would like to thank our partners at Biopharmax for the design and construction of our new facility.”Based in the Jerusalem Bio Park, a biotech hub on the Hadassah Medical Center Hebrew University Ein Kerem campus, the new approximately 20,000 square foot (1850m2) facility includes offices, laboratories, and GMP manufacturing suites with potential annual capacity of 40 million doses of M-001 in bulk with up to 20 million single dose syringes.BiondVax’s contact information, including telephone, fax, email, and mailing address currently remains the same as it was prior to the move.About BiondVax Pharmaceuticals Ltd.BiondVax is a Phase 3 clinical stage biopharmaceutical company developing a universal flu vaccine. The vaccine candidate, called M-001, is designed to provide multi-season protection against current and future, seasonal and pandemic influenza virus strains. BiondVax’s proprietary technology utilizes a unique combination of conserved and common influenza virus peptides, activating 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 human clinical trials, covering 698 participants, the vaccine has been shown to be safe, well-tolerated, and immunogenic. BiondVax is traded on NASDAQ: BVXV. Please visit www.biondvax.com.For further information, please contact:BiondVax: Joshua Phillipson | +972-8-930-2529 | j.phillipson@biondvax.comForward 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 involve certain risks and uncertainties 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 its products; ability 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 resource 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, 2017 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 and the Tel-Aviv Stock Exchange. We undertake no obligation to revise or update any forward-looking statement for any reason.
BiondVax receives second €6M tranche disbursement from the European Investment Bank (EIB)
NESS ZIONA, Israel, August 14, 2018 -- BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), developer of M‑001, a clinical phase 3 Universal Influenza Vaccine candidate, announced today the receipt of a €6 million disbursement from the European Investment Bank (EIB). These funds are the second tranche of the previously announced €20 million co-financing agreement signed in June 2017. The first tranche of €6 million was received by BiondVax in June 2018.Dr. Ron Babecoff, BiondVax’s CEO, stated, “I am grateful to the EIB for their ongoing support, which has helped us reach our targets including the recent launch of our pivotal Phase 3 trial and the construction of a new mid-size commercial manufacturing facility for M-001, our universal flu vaccine candidate.”The EIB-BiondVax non-dilutive co-financing agreement, signed in June 2017, is structured as a zero-percent fixed interest loan, available for up to 36 months from the date of signing with a variable remuneration based on royalties of net sales of M-001 following commercialization. Funds will be advanced in three tranches. The tranches are available up to 12, 24, and 36 months following the date of the agreement, and are dependent on achievement of certain specified milestones. The tranches are repayable five years after each drawdown. BiondVax retains the option to repay the loan and repurchase the royalties at any time.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-season protection against current and future, seasonal and pandemic influenza virus strains. BiondVax’s proprietary technology utilizes a unique combination of conserved and common influenza virus peptides, activating 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 human clinical trials, covering 698 participants, the vaccine has been shown to be safe, well-tolerated, and immunogenic. Please visit www.biondvax.com. Contact: Joshua 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 involve certain risks and uncertainties 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 and its products; 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 resource 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, 2017 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 and the Tel-Aviv Stock Exchange. We undertake no obligation to revise or update any forward-looking statement for any reason.
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