Press Releases
First Participant Enrolled in BiondVax’s Universal Flu Vaccine Pivotal Phase 3 Clinical Trial
M-001 vaccine designed to protect against current, future, seasonal, and pandemic influenza strains
Ness Ziona, Israel – August 8, 2018BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV) reported today the first participant’s initial visit in a pivotal clinical efficacy Phase 3 trial of the M-001 universal flu vaccine candidate. The primary endpoints of the trial are to demonstrate protection from influenza and safety of M-001. A secondary endpoint will assess reduction in flu illness severity among those receiving M-001 versus placebo.In six completed clinical trials in Israel and Europe (two Phase 1/2 and four Phase 2), M-001 has been shown to be safe, well-tolerated, and immunogenic to a broad range of influenza strains. An additional Phase 2 trial in the USA, sponsored and conducted by the US National Institutes of Health (NIH), is ongoing.
Dr. Ron Babecoff, BiondVax’s Founder and CEO, commented, “We are very excited to reach this milestone for our M-001 universal flu vaccine candidate. I wish to thank our many partners who have supported us, and the BiondVax team, as we reach this pivotal moment. Our goal has remained consistent from the beginning - to reduce the human burden of influenza. I hope this major step brings us closer to providing improved worldwide protection from the flu.”Dr. Tamar Ben-Yedidia, BiondVax’s Chief Scientific Officer and co-inventor of M-001, explained, “Following six clinical trials that showed M-001 is safe and induces T-cell and enhances B-cell immune responses, this new Phase 3 trial will also assess the extent to which M-001 reduces flu illness incidence and severity between the trial’s experimental and control arms. This is an exciting moment for me and Professor Ruth Arnon with whom I developed our universal flu vaccine beginning at the Weizmann Institute of Science and then at BiondVax.” The study, titled “A Pivotal Multi-center, Randomized, Modified Double-blind, Placebo-controlled Phase 3 Trial to Assess the Safety and Clinical Efficacy of M-001 Influenza Vaccine Administered Intramuscularly Twice in Older Adults and Elderly (≥50 Years)”, plans to enroll 9,630 participants from several eastern European countries over two flu seasons. Participants will be aged 50 years and over, with at least half aged 65 years and over. The study design includes a flexible enrollment regimen to adjust for variability in seasonal flu incidence, meaning the total number of participants may be more than 9,630 if flu incidence is lower than expected.Participants will receive either two doses of M-001 or two doses of placebo approximately 21 days apart. Cohort One of the study, consisting of 4,333 participants, will be enrolled by November 2018. These participants will receive the vaccine or placebo regimen once and be monitored for two flu seasons. Cohort Two, with 5,297 participants, will be enrolled prior to the 2019/20 flu season. These participants will be monitored for one flu season. Participants will only receive M-001 or placebo, without any other flu vaccines, in order to assess M-001’s clinical efficacy as a standalone universal flu vaccine.Participants will be contacted twice weekly throughout the flu season to monitor for influenza-like illness (ILI). When an ILI is reported, nasal and throat swabs will be collected by specially trained medical personnel. Swab samples will be sent to a central laboratory to confirm presence of influenza virus.Following guidance provided by the European Medicines Agency (EMA), following the first flu season BiondVax is permitted to assess the total number of laboratory confirmed influenza cases, in order to adjust, if necessary, the number of Cohort 2 participants. Final study results are expected by Q4 2020.As previously reported, the 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 Pharmaceuticals LtdBiondVax is an advanced 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; 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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Corporate Biotech Executive Mark Germain Joins BiondVax’s Board of Directors
NESS ZIONA, Israel, June 28, 2018 -- BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), developer of M‑001, a clinical phase Universal Influenza Vaccine candidate, announced today the appointment of Mr. Mark Germain as Vice Chairman of its Board of Directors.Based in New York, and having served as founder, director, chairman of the board, and/or investor in over twenty biotech companies, and with experience assisting in arranging corporate partnerships, acquiring technology, entering mergers and acquisitions, and executing financings, Mr. Germain is well suited to help guide BiondVax’s ongoing corporate development. Among his current positions, Mr. Germain is a Managing Director at The Aentib Group, a boutique merchant bank, and serves as a director on the board of the Israeli company Pluristem Therapeutics Inc. (Nasdaq: PSTI).Mr. Mark Germain commented, “I am pleased and excited to join the BiondVax board at this important time in the development of the company. It is about to commence a Phase 3 pivotal trial for its universal flu vaccine, an innovative multi-strain, multi-season product with the potential to protect against pandemic strains as well. We have a strong shareholder base, with €20 million additional non-dilutive funding from the European Investment Bank, and are poised to build a successful company. I’m looking forward to working with our CEO Ron Babecoff, the rest of the board, and shareholders.”Dr. Ron Babecoff, BiondVax’s President and CEO, remarked, “On behalf of BiondVax’s Board of Directors, I warmly welcome Mark’s appointment. I am confident that his biotech and corporate experience and track record will contribute significantly to BiondVax’s upcoming activities.”“This year we plan to launch our universal flu vaccine’s first pivotal, clincal efficacy, Phase 3 trial, and are constructing our mid-size commercial scale manufacturing facility. Mark’s advice and guidance, along with that of the rest of our Board, will be valuable to BiondVax’s future,” continued Babecoff.About BiondVax BiondVax (Nasdaq: BVXV) is an advanced 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.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 risk that drug development involves a lengthy and expensive process with uncertain outcomes, the successful completion of our planned manufacturing facility, the results of the ongoing Phase 2 trial and the pivotal Phase 3 trial, delays or obstacles in launching and/or successfully completing our clinical trials, the impact of the global economic environment on the Company customer target base, 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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BiondVax receives its first €6M tranche disbursement from the European Investment Bank (EIB)
NESS ZIONA, Israel, June 19, 2018 -- BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), developer of M‑001, a clinical phase Universal Influenza Vaccine candidate, announced today the receipt of a €6 million disbursement from the European Investment Bank (EIB). These funds are the first tranche of the previously announced €20 million co-financing agreement signed in June 2017.Dr. Ron Babecoff, BiondVax’s President and CEO, commented, “We plan to begin our first pivotal, clinical efficacy, Phase 3 trial later this year, while the construction of our mid-size commercial manufacturing facility is well underway. Our collaboration with the EIB has helped enable this late stage progress towards bringing a universal flu vaccine to the European and international markets.”“We are grateful for the excellent ongoing collaboration and relationship with the EIB towards the development of our universal flu vaccine,” continued Babecoff.Mr. Uri Ben-Or, BiondVax’s CFO, noted, “Our collaboration with the EIB and their innovative co-funding mechanism has enabled BiondVax to proceed confidently into late stage clinical trials and construction of a manufacturing facility. We plan to call for the additional tranches in the near future as needed.”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 an advanced 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.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 risk that drug development involves a lengthy and expensive process with uncertain outcomes, the successful completion of our planned manufacturing facility, the results of Phase 2 & 3 trials, delays or obstacles in launching and/or successfully completing our clinical trials, the impact of the global economic environment on the Company customer target base, 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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BiondVax Announces First Quarter 2018 Financial Results
NESS ZIONA, Israel, May 29, 2018 - BiondVax 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, 2018.First Quarter 2018 Financial SummaryResults are in New Israel Shekels (NIS) and convenience translation to $US is provided using the exchange rate of 3.514 (NIS/$US) as at March 29, 2018
- First quarter operating expenses were NIS 12.6m ($3.6m) compared with NIS 2.97m for the first quarter of 2017;
- First quarter R&D expenses amounted to NIS 11.7m ($3.3m) compared with NIS 1.87m for the first quarter of 2017;
As of March 31, 2018, BiondVax had cash and cash equivalents of NIS 55.7 million ($15.8 million) as compared to NIS 71.3 million as of December 31, 2017. The decrease is attributable to execution of planned ongoing operations related to launch of the 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.
** Tables to Follow **
About BiondVaxBiondVax (Nasdaq: BVXV) is an advanced 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.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 risk that drug development involves a lengthy and expensive process with uncertain outcome, the results of Phase 2 & 3 trials, delays or obstacles in launching and/or successfully completing our clinical trials, the impact of the global economic environment on the Company customer target base, 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.
BALANCE SHEETS |
|||||||||
In thousands, except per share data |
|||||||||
*) Represents an amount lower than NIS 1. |
|||||||||
Conveniencetranslation |
|||||||||
December 31, |
March 31, |
March 31, |
|||||||
2017 |
2017 |
2018 |
2018 |
||||||
Audited |
Unaudited |
Unaudited |
|||||||
N I S |
U.S. dollars |
||||||||
CURRENT ASSETS: |
|||||||||
Cash and cash equivalents |
71,382 |
24,020 |
55,675 |
15,844 |
|||||
Marketable securities |
- |
4,068 |
- |
||||||
Short-term deposits |
- |
6,751 |
- |
- |
|||||
Other receivables |
3,923 |
4,979 |
2,975 |
847 |
|||||
75,305 |
39,818 |
58,650 |
16,691 |
||||||
LONG‑TERM ASSETS: |
|||||||||
Property, plant and equipment |
5,510 |
1,297 |
12,537 |
3,568 |
|||||
Other long term assets |
880 |
478 |
880 |
250 |
|||||
6,390 |
1,775 |
13,417 |
3,818 |
||||||
81,695 |
41,593 |
72,067 |
20,509 |
||||||
CURRENT LIABILITIES: |
|||||||||
Trade payables |
6,223 |
752 |
8,526 |
2,426 |
|||||
Other payables |
660 |
526 |
768 |
219 |
|||||
6,883 |
1,278 |
9,294 |
2,645 |
||||||
LONG‑TERM LIABILITIES: |
|||||||||
Liability in respect of government grants |
10,300 |
11,252 |
3,202 |
||||||
Warrants |
8,177 |
10,848 |
9,315 |
2,651 |
|||||
Severance pay liability, net |
83 |
76 |
78 |
22 |
|||||
18,560 |
10,924 |
20,645 |
5,875 |
||||||
SHAREHOLDERS' EQUITY: |
|||||||||
Ordinary shares of NIS 0.0000001 par value: |
|||||||||
Authorized: 391,000,000 shares as of March31, 2018, 2017 (unaudited) andDecember 31, 2016; Issued andOutstanding: 261,419,599 , 162,481,153and 261,419,599 shares respectively |
*) - |
*) - |
*) - |
*) - |
|||||
Share premium |
179,669 |
129,550 |
179,747 |
51,152 |
|||||
Options |
- |
533 |
- |
- |
|||||
Other comprehensive income |
- |
6 |
- |
||||||
Accumulated deficit |
(123,417) |
(100,698) |
(137,619) |
(39,163) |
|||||
56,252 |
29,391 |
42,128 |
11,989 |
||||||
81,695 |
41,593 |
72,067 |
20,509 |
STATEMENTS OF COMPREHENSIVE INCOME |
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In thousands, except per share data |
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Convenience |
|||||||||||||||||
translation |
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Three months |
|||||||||||||||||
Year ended |
Three months ended |
ended |
|||||||||||||||
December 31, |
March 31, |
March 31, |
|||||||||||||||
2017 |
2017 |
2018 |
2018 |
||||||||||||||
Audited |
Unaudited |
Unaudited |
|||||||||||||||
NIS |
U.S. dollars |
||||||||||||||||
Operating expenses: |
|||||||||||||||||
Research and development, net ofparticipations |
18,777 |
1,874 |
11,745 |
3,342 |
|||||||||||||
Marketing, general and administrative |
4,879 |
1,094 |
884 |
251 |
|||||||||||||
Total operating expenses |
23,656 |
2,968 |
12,629 |
3,593 |
|||||||||||||
Operating loss |
(23,656) |
(2,968) |
(12,629) |
(3,593) |
|||||||||||||
Financial income |
18 |
8 |
- |
- |
|||||||||||||
Financial expense |
(10,913) |
(8,872) |
(1,573) |
(448) |
|||||||||||||
Net loss |
(34,551) |
(11,832) |
(14,202) |
(4,041) |
|||||||||||||
Other comprehensive loss: |
|||||||||||||||||
Loss from available-for-sale marketable securities |
(6) |
- |
- |
- |
|||||||||||||
Total comprehensive loss |
(34,557) |
(11,832) |
(14,202) |
(4,041) |
|||||||||||||
Basic and Diluted net loss per share |
(0.17) |
(0.07) |
(0.05) |
(0.02) |
|||||||||||||
Weighted average number of sharesoutstanding used to compute basic anddiluted loss per share |
201,030,768 |
162,481,153 |
261,419,599 |
261,419,599 |
|||||||||||||
BiondVax in the News
In case you missed it, we thought we'd share some recent press about BiondVax and our universal flu vaccine candidate M-001:
A New Push for a Universal Flu Vaccine

A Checkup for the Flu Vaccine
BiondVax’s M-001 vaccine similarly elicits T cell responses to conserved viral epitopes from influenza A and B strains and is in trials as a standalone vaccine and as a priming step before administration of the seasonal flu vaccine...
NIAID-Sponsored Trial of a Universal Influenza Vaccine Begins
“The 2017-2018 influenza season in the United States was among the worst of the last decade and serves as a reminder of the urgent need for a more effective and broadly protective influenza vaccine,” said NIAID Director Anthony S. Fauci, M.D. “An effective universal influenza vaccine would lessen the public health burden of influenza, alleviate suffering and save lives.”
BiondVax Announces Fourth Quarter and Full Year 2017 Financial Results and Update
NESS ZIONA, Israel, April 30, 2018 -- BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), a clinical stage biopharmaceutical company focused on developing and commercializing M-001, a universal flu vaccine candidate, today announced its fourth quarter and full year financial results for the year ended December 31, 2017 and provided a business update.Fourth Quarter 2017 Financial SummaryResults are in New Israel Shekels (NIS) and convenience translation to $US is provided using the exchange rate of 3.467(NIS/$US) as at December 29, 2017.
- Fourth quarter operating expenses were NIS 14.9 million (approximately $4.3 million) compared with NIS 3.12 million for the fourth quarter of 2016;
- Fourth quarter R&D expenses amounted to NIS 13.7 million ($3.95 million) compared with NIS 1.83 million for the fourth quarter of 2016;
Full Year 2017 Financial Summary
- Total operating expenses, net, were NIS 23.66 million ($6.82 million) compared with NIS 11.90 million in 2016;
- R&D expenses, net, amounted to NIS 18.78 million ($5.42 million) compared with NIS 7.79 million in 2016;
As of December 31, 2017, BiondVax had cash and cash equivalents and short-term investments of NIS 71.38 million ($20.59m) as compared to NIS 27.4 million as of December 31, 2016.2017 Highlights and Recent Corporate Update
- Pivotal clinical efficacy Phase 3 trial: The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) allowed BiondVax to proceed with the pivotal Phase 3 clinical trial plan for M-001, BiondVax’s universal flu vaccine candidate. The CHMP wrote that a successful pivotal efficacy trial could suffice for approval of the vaccine. BiondVax signed a Master Service Agreement with a contract research organization (CRO) in March, 2018, and the Phase 3 trial is planned to begin later this year, prior to the 2018/19 Northern Hemisphere flu season. 9,630 participants aged 50 years and over will be enrolled across four to six countries in eastern Europe. The pivotal trial is expected to follow participants for up to two flu seasons.
- Mid-size commercial manufacturing facility: The Israeli Ministry of Economy granted BiondVax 20% of a NIS 20 million budget towards construction. The company secured a lease for an entire floor (approximately 20,000 square feet or 1850m2) in the Jerusalem Bio Park, a biotech hub on the Hadassah Ein Kerem campus, and construction began in January, 2018. BiondVax intends to produce a batch in the new facility for the upcoming Phase 3 clinical trial’s second participant group.
- €20 million non-dilutive co-funding: In June 2017, the European Investment Bank (EIB) signed an agreement to support M-001’s commercial scale production and Phase 3.
- NIH-sponsored Phase 2 clinical trial: Earlier this month (April, 2018), the first participant was enrolled in the United States in a Phase 2 clinical trial of the BiondVax’s universal flu vaccine candidate, M-001. The trial is sponsored by the US National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). Conducted under an FDA Investigational New Drug (IND), the trial marks M-001’s clinical debut in the United States.
- EU-sponsored Phase 2b clinical trial: M-001 successfully met the UNISEC consortium’s Phase 2b clinical trial primary The universal flu vaccine candidate showed statistically significant elevated T-cell immune responses, a good safety profile and was well-tolerated.
- Nasdaq consolidation: BiondVax consolidated trading on Nasdaq by voluntarily delisting from the Tel Aviv Stock Exchange on January 22, 2018.
Complete financial results are available in the Company’s annual report on Form 20-F for the year ended December 31, 2017, which was filed with the Securities and Exchange Commission on April 30, 2018.
~
About BiondVax BiondVax (Nasdaq: BVXV) is an advanced 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.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 risk that drug development involves a lengthy and expensive process with uncertain outcome, the results of Phase 2 & 3 trials, delays or obstacles in launching and/or successfully completing our clinical trials, the impact of the global economic environment on the Company customer target base, 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. * Tables to Follow *
BALANCE SHEETS |
||||||
Convenience |
||||||
translation |
||||||
December 31, |
December 31, |
|||||
2016 |
2017 |
2017 |
||||
N I S |
U.S. dollars |
|||||
CURRENT ASSETS: |
||||||
Cash and cash equivalents |
15,705 |
71,382 |
20,589 |
|||
Marketable securities |
2,017 |
- |
- |
|||
Short-term deposits |
7,602 |
- |
- |
|||
Other receivables |
815 |
3,923 |
1,131 |
|||
26,139 |
75,305 |
21,720 |
||||
LONG‑TERM ASSETS: |
||||||
Marketable securities |
2,050 |
- |
- |
|||
Property, plant and equipment |
1,443 |
5,510 |
1,589 |
|||
Other long term assets |
478 |
880 |
254 |
|||
3,971 |
6,390 |
1,843 |
||||
30,110 |
81,695 |
23,563 |
||||
CURRENT LIABILITIES: |
||||||
Trade payables |
686 |
6,223 |
1,795 |
|||
Other payables |
689 |
660 |
190 |
|||
1,375 |
6,883 |
1,985 |
||||
LONG‑TERM LIABILITIES: |
||||||
Liability in respect of government grants |
- |
10,300 |
2,971 |
|||
Warrants |
3,043 |
8,177 |
2,358 |
|||
Severance pay liability, net |
76 |
83 |
24 |
|||
3,119 |
18,560 |
5,353 |
||||
SHAREHOLDERS' EQUITY :- |
||||||
Ordinary shares of NIS 0.0000001 par value: |
||||||
Authorized: 391,000,000 shares as of December 31, 2017;Issued and Outstanding: 261,419,599, 135,097,367, sharesas of December 31 2017 and December 31, 2016, respectively |
*) - |
*) - |
*) - |
|||
Share premium |
113,041 |
179,669 |
51,823 |
|||
Options |
1,435 |
- |
- |
|||
Other comprehensive income |
6 |
- |
- |
|||
Accumulated deficit |
(88,866) |
(123,417) |
(35,598) |
|||
25,616 |
56,252 |
16,225 |
||||
30,110 |
81,695 |
23,563 |
||||
*) Represents an amount lower than NIS 1. |
STATEMENTS OF COMPREHENSIVE INCOME |
|||||||||||
In thousands, except per share data |
|||||||||||
Convenience translation
|
|||||||||||
Year ended December 31, |
Year ended December 31, |
||||||||||
2015 |
2016 |
2017 |
2017 |
||||||||
N I S |
U.S. dollars |
||||||||||
Operating expenses: |
|||||||||||
Research and development, net of participations |
7,906
|
7,794
|
18,777 |
5,416 |
|||||||
Marketing, general and administrative |
3,397 |
4,106 |
4,879 |
1,407 |
|||||||
Total operating expenses |
11,303 |
11,900 |
23,656 |
6,823 |
|||||||
Operating loss |
(11,303) |
(11,900) |
(23,656) |
(6,823) |
|||||||
Financial income |
1,128 |
3,019 |
18 |
5 |
|||||||
Financial expense |
(24) |
(303) |
(10,913) |
(3,148) |
|||||||
Loss |
(10,199) |
(9,184) |
(34,551) |
(9,966) |
|||||||
Other comprehensive income (loss): |
|||||||||||
Items to be reclassified to profit or loss in subsequent periods: |
|||||||||||
Gain (loss) from available-for-sale marketable securities |
(5) |
(6) |
(6) |
(2) |
|||||||
Total comprehensive loss |
(10,204) |
(9,190) |
(34,557) |
(9,968) |
|||||||
Basic and diluted loss per share |
(0.10) |
(0.07) |
(0.17) |
(0.05) |
|||||||
Weighted average number of shares outstanding used to compute basic and diluted loss per share |
105,522,642 |
135,097,367 |
201,030,768 |
201,030,768 |
|||||||
BiondVax to Present at Universal Influenza Vaccines Conference
Ness Ziona, Israel – April 12, 2018 - BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), developer of the universal flu vaccine candidate M-001, reported today it will present at the Universal Influenza Vaccines 2018 Conference. The conference is being held on April 16-18 at the University of Lausanne in Switzerland.Dr. Tamar Ben-Yedidia, BiondVax’s Chief Science Officer (CSO), will provide an overview of the Company’s clinical development achievements and plans, with a focus on:
- Results of a Phase 2b trial conducted in collaboration with the EU-sponsored UNISEC* consortium
- Update of an ongoing United States NIH-sponsored Phase 2 trial
- Plans for the pivotal, clinical efficacy Phase 3 trial, expected to begin in 2018
Details of Dr. Ben-Yedidia’s talk:Getting closer to the market: M-001 universal flu vaccine starting pivotal Phase 3 TrialDate: Monday, April 16, 2018Time: 4:00pm (GMT+2)Location: CHUV, University of Lausanne, Lausanne, SwitzerlandDr. Ron Babecoff, CEO, and Dr. Ben-Yedidia are serving on the conference’s Scientific Advisory Panel and will be available for meetings.* Research supporting UNISEC activities received funding from the European Union Seventh Framework Programme (FP7/2007-2013) under grant agreement n°602012.About BiondVax Pharmaceuticals LtdBiondVax is an advanced 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+972-8-930-2529j.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 Phase 2 and Phase 3 trials, 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, 2016 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.
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BiondVax Begins NIH-Sponsored Phase 2 Clinical Trial of its Universal Flu Vaccine in the United States
Ness Ziona, Israel - April 11, 2018 - BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), reported today the first participant enrollment in the United States in a Phase 2 clinical trial of the company’s universal flu vaccine candidate, M-001. The trial is sponsored by the US National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). Conducted under an FDA Investigational New Drug (IND), the trial marks M-001’s clinical debut in the United States.Initially developed in Professor Ruth Arnon’s lab at the Weizmann Institute of Science in Israel, M-001 is comprised of nine epitopes common to influenza virus strains including both influenza Type A and B. In six completed clinical trials in Israel and Europe (two Phase 1/2 and four Phase 2), BiondVax’s universal flu vaccine candidate has been shown to be safe, well-tolerated, and immunogenic to a broad range of influenza strains.As previously announced, a pivotal clinical efficacy Phase 3 trial is planned in Europe later this year. Co-funded by the European Union’s European Investment Bank (EIB), the trial will enroll 9,630 participants aged 50 years and older across four to six countries over a period of two flu seasons.Dr. Ron Babecoff, BiondVax’s CEO, commented, “We are honored to be merging the world-renowned clinical and biomedical expertise of NIAID-supported researchers with BiondVax’s universal flu vaccine development efforts. We are pleased to participate in NIAID’s focus on development of novel flu vaccines to improve protection against current strains and protect against emerging seasonal and pandemic threats.”The NIAID-sponsored study, titled “A Phase II, Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial to Assess the Safety, Reactogenicity and Immunogenicity of Two Doses of Multimeric-001 (M-001) Followed by Seasonal Quadrivalent Influenza Vaccine” is being conducted at three sites (University of Iowa, Cincinnati Children's Hospital Medical Center in Ohio, and Baylor College of Medicine in Houston, Texas), with laboratory support by St. Louis University in St. Louis, Missouri. These sites are part of the NIAID-funded network of Vaccine and Treatment Evaluation Units (VTEUs).A total of 120 participants aged 18 to 49 years will be randomly assigned to receive either two doses of M-001 or two doses of a placebo, with the doses spaced several weeks apart. A few months following the second injection, all participants will receive a currently marketed unadjuvanted quadrivalent seasonal influenza vaccine. Safety and immunogenicity will be assessed and compared between the groups receiving M-001 and placebo.Additional information regarding both the NIAID-sponsored Phase 2 trial and the pivotal clinical efficacy Phase 3 trial are published on the clinicaltrials.gov website at www.clinicaltrials.gov/ct2/show/NCT03058692 and www.clinicaltrials.gov/ct2/show/NCT03450915, respectively.
Contact: Joshua Phillipson | t: +972 8 930 2529 | e: 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 Phase 2 and Phase 3 trials, 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, 2016 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.
BiondVax Appoints CRO to Conduct Pivotal Clinical Efficacy Phase 3 Trial of its Novel Universal Flu Vaccine Candidate
Ness Ziona, Israel – March 13, 2018BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), developer of the Universal Flu Vaccine candidate M-001, announced today the signing of a Master Service Agreement (MSA) with a contract research organization (CRO) to conduct the first pivotal, clinical efficacy, Phase 3 trial of M-001.Originally conceived in the lab of Professor Ruth Arnon at the Weizmann Institute of Science in Israel, M-001 is comprised of nine epitopes common to the vast majority of influenza virus strains including both influenza Type A and B. In M-001’s six successful completed clinical trials (two Phase 1/2 and four Phase 2) to-date, it has been shown to be safe, well-tolerated, and immunogenic to a broad range of influenza strains.BiondVax’s pivotal, clinical efficacy, Phase 3 trial is planned to begin later this year, prior to the 2018/19 Northern Hemisphere flu season. 9,630 participants aged over 50 years will be enrolled across four to six countries in eastern Europe. The trial is expected to follow participants for up to two flu seasons. The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) previously reviewed BiondVax’s Phase 3 trial plan, and accepts the entire approach in general and the study design in particular, thus enabling the Company to proceed. The CHMP stated that “a single pivotal efficacy trial that provides a robust demonstration of efficacy against laboratory-proven influenza like illness (ILI) could suffice for an approval.”1Dr. Tamar Ben-Yedidia, BiondVax’s Chief Science Officer (CSO), commented, “Having worked on our universal flu vaccine since the very beginning and ushering it through many years of R&D and clinical trials, I am particularly proud to reach this exciting milestone. As far as we know, this is the world’s most clinically advanced universal flu vaccine. This winter’s flu season shows us once again the urgent need for an improved flu vaccine. I hope our vaccine will contribute to significant reduction of the economic and social burden of influenza.”Additional information regarding the pivotal, clinical efficacy Phase 3 trial is published on clinicaltrials.gov website: www.clinicaltrials.gov/ct2/show/NCT03450915. About BiondVax Pharmaceuticals LtdBiondVax is an advanced 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: BiondVaxJosha Phillipson+972-8-930-2529 x5105j.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 Phase 3 trials, 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, 2016 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.
###
BiondVax and European UNISEC Consortium to Host Universal Flu Vaccine Conference
Ness Ziona, Israel – February 8, 2018BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), developer of a Universal Flu Vaccine candidate currently in preparation for a Phase 3 clinical trial, and the European UNISEC consortium announced today they will co-host the Annual UNISEC Consortium Meeting, which will take place next week in Jerusalem, Israel. Attendees representing the consortium’s partners from academia, government, and industry will discuss achievements towards development of a universal influenza vaccine, including the recent successful results of the Phase 2b clinical trial on BiondVax’s universal flu vaccine candidate M-001. Also expected to attend will be representatives from the U.S. Department of Health and Human Services (HHS).Dr. Ed Schmidt, Executive Manager of the UNISEC consortium, commented, “UNISEC is pleased to see the significant advancements we have enabled towards improved influenza vaccines. We are grateful to the EU FP7 for their financial support of UNISEC and previous consortia towards this important goal. I also wish to thank the consortium partners for their remarkable collaborative spirit and intensive work.”Dr. Ron Babecoff, BiondVax’s CEO, noted, “The UNISEC consortium collaboration has been a significant factor in propelling BiondVax’s universal flu vaccine towards our upcoming pivotal Phase 3 trial. We are proud to be part of the UNISEC consortium and honored to host this meeting in Jerusalem.”Babecoff continued, “Experts report that we are currently experiencing the worst flu season since the 2009 pandemic. There is wide consensus for the urgent need to develop a broadly protective and effective influenza vaccine. BiondVax continues to lead the global effort and hopes to be the first to bring to the world a multi-strain multi-season universal flu vaccine, as our pivotal clinical efficacy Phase 3 trial is starting later this year.”Research supporting UNISEC activities received funding from the European Union Seventh Framework Programme (FP7/2007-2013) under grant agreement n°602012.----About BiondVax Pharmaceuticals LtdBiondVax is an advanced 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.About UNISECInformation regarding the UNISEC Consortium is available at www.unisecconsortium.eu.For further information, please contact: BiondVax Joshua Phillipson+972-8-930-2529 x5105j.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 risk that drug development involves a lengthy and expensive process with uncertain outcome; the outcome of the Phase 3 trials; 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, 2016 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.
###
BiondVax Universal Flu Vaccine Patent Granted in India
Ness Ziona, Israel – January 2, 2018BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV, TASE: BVXV), developer of M-001, the Universal Flu Vaccine candidate currently in preparation for a Phase 3 clinical trial, announced today that one of its key patents titled "A Synthetic or Recombinant Influenza Multi-Epitope Polypeptide" has been granted in India. The patent belongs to BiondVax’s portfolio family titled “Multimeric Multi-Epitope Influenza Vaccines” and has now been granted in over 30 countries.With a population of over 1.3 billion people, and high population density in some of the major cities, India is an important potential market for BiondVax and a universal flu vaccine may significantly improve public health.Dr. Tamar Ben-Yedidia, CSO of BiondVax, commented, “We are pleased and thankful that the Government of India’s Patent Office accepted the uniqueness of our universal flu vaccine solution and approved this main patent of BiondVax. Authorities worldwide recognize that currently marketed influenza vaccines fall short. I am proud that M-001, which is designed to cover current, future, seasonal and pandemic flu strains, is preparing to enter Phase 3 trials later in 2018.”There is a general recommendation for seasonal influenza vaccination in India for healthcare workers, pregnant women, and people with some chronic illnesses. However, Northern and Southern Hemisphere flu strains dominate at different times and in different regions of the Indian subcontinent. A universal flu vaccine, designed to cover all flu strains, would provide consistent coverage, and be appropriate for vaccination throughout the year.The patent describes influenza vaccines comprised of multiple copies of several epitopes, such as M-001 which contains nine common and conserved influenza virus epitopes.About BiondVax Pharmaceuticals LtdBiondVax is an advanced 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 and TASE: BVXV. Please visit www.biondvax.com.For further information, please contact: BiondVax Joshua Phillipson+972-8-930-2529 x5105j.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 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, 2016 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.
###
BiondVax plans Phase 3 Clinical Trial following receipt of Scientific Advice from the European Medicines Agency (EMA)
Ness Ziona, Israel – December 27, 2017 -BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV, TASE: BVXV) announced today that the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) reviewed BiondVax’s Phase 3 trial plan, provided advice, and allowed the Company to proceed with the Phase 3 clinical trial plan for M-001, BiondVax’s universal flu vaccine candidate. The CHMP advice will facilitate procedures in the countries where the Phase 3 study will take place.The CHMP response states that, “It is agreed that a single pivotal efficacy trial that provides a robust demonstration of efficacy against laboratory-proven influenza like illness (ILI) could suffice for an approval.”
Dr. Tamar Ben Yedidia, BiondVax’s Chief Science Officer noted, “According to our expert European advisors, the CHMP accepts the entire approach in general and the study design in particular. This means BiondVax can proceed to Phase 3 as planned.”Dr. Ron Babecoff, CEO of BiondVax, commented, “I wish to thank the EMA’s CHMP for their thoughtful and informative advice which we are incorporating into BiondVax’s pivotal Phase 3 trial plan.”Babecoff continued, “There is a clear need to improve upon current flu vaccine technologies, as noted in the recent New England Journal of Medicine article titled Chasing Seasonal Influenza — The Need for a Universal Influenza Vaccine. BiondVax’s Universal Flu Vaccine candidate is designed to address challenges of current flu vaccines such as mismatches, mutations, and long production lag. With six completed successful human clinical trials, we are excited to proceed to a pivotal clinical efficacy Phase 3 trial with M-001 as a universal flu vaccine.”The placebo-controlled pivotal clinical efficacy Phase 3 trial plans to enrol a total of 7,700 participants over two years. Since assessment of clinical efficacy of influenza vaccines largely depends on the attack rates of circulating influenza strains, the study features flexible enrollement to adjust the required number of participants in year 2. The participants will be aged 50 years and older, with at least half over 65 years of age.The trial is expected to take place in Eastern Europe and begin prior to the 2018/19 flu season.
[1] Paules, CI, et al “Chasing Seasonal Influenza - The Need for a Universal Influenza Vaccine,” The New England Journal of Medicine. November 29, 2017, http://www.nejm.org/doi/full/10.1056/NEJMp1714916 (accessed December 27, 2017).
About BiondVax Pharmaceuticals LtdBiondVax is an advanced 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 partipants, the vaccine has been shown to be safe, well-tolerated, and immunogenic. BiondVax is traded on NASDAQ: BVXV and TASE: BVXV. Please visit www.biondvax.com.For further information, please contact:BiondVaxJoshua Phillipson+972-8-930-2529 x5105j.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 risk that drug development involves a lengthy and expensive process with uncertain outcome, whether preliminary or interim results from a clinical trial will be predictive of the final results of the trial; whether results obtained in clinical trials such as the results referenced in this release will be indicative of results that will be generated in future clinical trials; 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, 2016 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.
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BiondVax’s CEO Issues Letter to Shareholders
Ness Ziona, Israel – December 5, 2017 –BiondVax Pharmaceuticals Ltd. (NASDAQ: BVXV, TASE: BVXV) today released a Letter from the CEO regarding recent activities and plans.“BiondVax has enjoyed a remarkably encouraging 2017, with promising Phase 2b clinical trial results and a significantly strengthened financial position. The combination of events has led us to proceed towards a pivotal clinical efficacy Phase 3 trial. Indeed, we anticipate enrolling the first participants by Q4 2018. I’m happy to take this opportunity to answer some of your questions about our plans. As well, I would like to thank my BiondVax team, our partners at the Weizmann Institute, and our other stakeholders for their contributions.Together, we are accomplishing great things and I look forward to continued success in the coming year.”Kind regards,Dr. Ron BabecoffPresident & CEO
2017 Highlights and 2018 Plans:
January 2017: Marius Nacht’s aMoon Partners fund invests in BiondVax, becoming our largest shareholder. Nacht is co-founder and Chairman of Check Point Software Technologies Ltd. (Nasdaq: CHKP). aMoon is a new Israeli healthcare fund.March: Israel Ministry of Economy grant towards construction of mid-size commercial manufacturing facility in Jerusalem. Planned production of batch for Phase 3 trial’s second participant group. In July, we secured a lease for an entire floor (approximately 20,000 square feet or 1800m2) in the Jerusalem Bio Park building.June: The European Investment Bank (EIB) entered into a €20m (approximately $23m) non-dilutive funding agreement to support the Phase 3 trial and complete the set up of our manufacturing facility.
July: Statistically significant results from our European Union UNISEC consortium Phase2b clinical trial: M-001 is deemed safe and induces significant cellular immunity. Our UNISEC colleagues are in the process of submitting an article for publication in a peer-reviewed science journal.September: Raised $10m in secondary offering. Following the placement, BiondVax has 3 large strategic investors holding a total of over 30%, with Marius Nacht’s aMoon Partners fund remaining our largest current shareholder.
October: Began regulatory procedures with the European EMA (akin to the American FDA) regarding Phase 3 trial plans.November: Signed clinical trial agreement (CTA) for a Phase 2 trial conducted by the U.S. NIH. The NIH-funded trial will include 120 participants with sites in Texas, Ohio, Missouri, and Iowa. This, our first trial in the US under an FDA IND, is planned for Q2 2018, and is in addition to our planned Phase 3 trial in Europe.January 2018: Trading will be consolidated on Nasdaq following our voluntary delisting from the Tel Aviv Stock Exchange effective January 22. Final day of trading on TASE will be January 18. Shareholder FAQ in Hebrew at http://bit.ly/BVXV-TASE.
Keep in touch: Join our mailing list from www.biondvax.com or email j.phillipson@biondvax.com
About BiondVax Pharmaceuticals LtdBiondVax is a clinical phase biopharmaceutical company developing a universal flu vaccine. The vaccine candidate is designed to provide multi-season protection against most seasonal and pandemic human influenza virus strains. BiondVax’s proprietary technology utilizes a unique combination of conserved and common peptides from influenza virus proteins, activating both arms of the immune system for a cross-protecting and long-lasting effect. BiondVax is traded on NASDAQ: BVXV and TASE: BVXV. Please visit www.biondvax.com.For further information, please contact:BiondVaxJoshua Phillipson+972-8-930-2529 x5105j.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 risk that drug development involves a lengthy and expensive process with uncertain outcome, the results of the contemplated Phase 2 & 3 trials, delays or obstacles in launching and/or successfully completing our clinical trials, the impact of the global economic environment on the Company customer target base, 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, 2016 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.
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BiondVax Provides Third Quarter 2017 Financial Results and Update
NESS ZIONA, Israel, November 28, 2017 -- BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV, TASE: 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 September 30, 2017 and provided a business update.Dr. Ron Babecoff, BiondVax’s CEO, commented, “I am pleased that, once again we are meeting our objectives, increased our financial resources, and are moving towards executing our late stage universal flu vaccine development program.”Third Quarter 2017 Financial SummaryResults are in New Israel Shekels (NIS) and convenience translation to $US is provided using the exchange rate of 3.529 (NIS/$US) as at September 30, 2017.
- Third quarter operating expenses were NIS 3.21m ($910,000) compared with NIS 3.47m for the third quarter of 2016;
- Third quarter R&D expenses amounted to NIS 1.17m ($333,000) compared with NIS 2.42m for the third quarter of 2016;
As of September 30, 2017, BiondVax had cash and cash equivalents, short-term investments and marketable securities of NIS 78.09m ($22.13m) as compared to NIS 36.6m as of June 30, 2017. Recent Corporate Update
- The Israel Innovation Authority (IIA) agreed to fund up to 40% of a NIS 2.7 million (approximately US$750,000) budget towards ongoing development of M-001. http://www.biondvax.com/2017/08/biondvax-receives-additional-grant-funding/
- BiondVax to consolidate trading on NASDAQ by voluntarily delisting from the Tel Aviv Stock Exchange on January 22, 2018. Last day of trading on TASE will be January 18, 2018. Shareholders with questions are invited to refer to our FAQ (in Hebrew) at http://bit.ly/BVXV-TASE.
- In September, BiondVax closed a public offering of ADSs on Nasdaq, with gross proceeds of $10 million. http://www.biondvax.com/2017/09/biondvax-announces-closing-of-10-million-public-offering-of-american-depositary-shares-and-exercise-of-over-allotment-option/
- BiondVax and the U.S. NIH signed a clincal trial agreement (CTA) for an NIH-funded Phase 2 trial with M-001, the company’s universal flu vaccine candidate. http://www.biondvax.com/2017/11/biondvax-and-nih-sign-clinical-trial-agreement-for-a-phase-2-trial-in-the-u-s-with-biondvaxs-universal-flu-vaccine/
About BiondVax BiondVax is a biopharmaceutical company developing a universal flu vaccine. The vaccine is designed to provide multi-season protection against most seasonal and pandemic human influenza virus strains. BiondVax’s proprietary technology utilizes a unique combination of conserved and common peptides from influenza virus proteins, activating both arms of the immune system for a cross-protecting and long-lasting effect. BiondVax is traded on NASDAQ: BVXV and TASE: BVXV. For more information, please visit www.biondvax.com.Contact DetailsJoshua Phillipson+972 8 930 2529j.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 risk that drug development involves a lengthy and expensive process with uncertain outcome, the results of the contemplated Phase 2 & 3 trials, delays or obstacles in launching and/or successfully completing our clinical trials, the impact of the global economic environment on the Company customer target base, 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, 2016 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.** Tables to Follow **
BALANCE SHEETS |
|||||||||
In thousands, except per share data |
|||||||||
Convenience |
|||||||||
December 31, |
September 30, |
September 30, |
|||||||
2016 |
2016 |
2017 |
2017 |
||||||
Audited |
Unaudited |
Unaudited |
|||||||
N I S |
U.S. dollars |
||||||||
CURRENT ASSETS: |
|||||||||
Cash and cash equivalents |
15,705 |
15,091 |
76,892 |
21,789 |
|||||
Marketable securities |
2,017 |
2,017 |
- |
- |
|||||
Short-term deposits |
7,602 |
10,510 |
1,200 |
340 |
|||||
Other receivables |
815 |
727 |
3,779 |
1,071 |
|||||
26,139 |
28,345 |
81,871 |
23,200 |
||||||
LONG‑TERM ASSETS: |
|||||||||
Marketable securities |
2,050 |
2,050 |
- |
- |
|||||
Property, plant and equipment |
1,443 |
1,592 |
1,308 |
371 |
|||||
Other long term assets |
478 |
370 |
515 |
146 |
|||||
3,971 |
4,012 |
1,823 |
517 |
||||||
30,110 |
32,357 |
83,694 |
23,717 |
||||||
CURRENT LIABILITIES: |
|||||||||
Trade payables |
686 |
477 |
792 |
225 |
|||||
Other payables |
689 |
466 |
2,344 |
665 |
|||||
1,375 |
943 |
3,136 |
890 |
||||||
LONG‑TERM LIABILITIES: |
|||||||||
Options |
3,043 |
3,528 |
11,829 |
3,352 |
|||||
Severance pay liability, net |
76 |
74 |
81 |
23 |
|||||
3,119 |
3,602 |
11,910 |
3,375 |
||||||
SHAREHOLDERS' EQUITY (DEFICIT): |
|||||||||
Ordinary shares of NIS 0.0000001 par value: |
|||||||||
Authorized: 391,000,000 shares as of September 30, 2017, |
*) - |
*) - |
*) - |
*) - |
|||||
Share premium |
113,041 |
111,697 |
179,182 |
50,774 |
|||||
Options |
1,435 |
2,536 |
533 |
151 |
|||||
Other comprehensive income |
6 |
8 |
- |
- |
|||||
Accumulated deficit |
(88,866) |
(86,429) |
(111,067) |
(31,473) |
|||||
25,616 |
27,812 |
68,648 |
19,452 |
||||||
30,110 |
32,357 |
83,694 |
23,717 |
||||||
*) 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 September 30, |
Nine months ended September 30, |
Nine months ended September 30, |
||||||||||||||||
2016 |
2016 |
2017 |
2016 |
2017 |
2017 |
||||||||||||||
Audited |
Unaudited |
Unaudited |
|||||||||||||||||
N I S |
U.S. dollars |
||||||||||||||||||
(In thousands, except per share data) |
|||||||||||||||||||
Operating expenses: |
|||||||||||||||||||
Research and development, net of participations |
7,794 |
2,421 |
1,174 |
5,962 |
5,070 |
1,437 |
|||||||||||||
Marketing, general and administrative |
4,106 |
1,049 |
2,036 |
2,819 |
3,699 |
1,048 |
|||||||||||||
Total operating expenses |
11,900 |
3,470 |
3,210 |
8,781 |
8,769 |
2,485 |
|||||||||||||
Operating loss |
11,900 |
3,470 |
3,210 |
8,781 |
8,769 |
2,485 |
|||||||||||||
Financial income |
75 |
10 |
217 |
59 |
17 |
5 |
|||||||||||||
Financial expense |
(303) |
(291) |
(45) |
(491) |
(1,829) |
(518) |
|||||||||||||
Financial income (expenses) due to revaluation of options |
2,944 |
1,395 |
4,341 |
2,466 |
(11,620) |
(3,293) |
|||||||||||||
Total finance (expense) income, net |
2,716 |
1,114 |
4,513 |
2,034 |
(13,432) |
(3,806) |
|||||||||||||
Net income (loss) |
(9,184) |
(2,356) |
1,303 |
(6,747) |
(22,201) |
(6,291) |
|||||||||||||
Other comprehensive income (loss): |
|||||||||||||||||||
Items to be reclassified to profit or loss in subsequent periods: |
|||||||||||||||||||
Gain (loss) from available-for-sale financial assets |
(6) |
1 |
(2) |
(4) |
(6) |
(2) |
|||||||||||||
Total comprehensive income ( loss ) |
(9,190) |
(2,355) |
1,301 |
(6,751) |
(22,207) |
(6,293) |
|||||||||||||
Earnings (loss) per share |
|||||||||||||||||||
Basic |
(0.07) |
(0.02) |
0.01 |
(0.05) |
(0.12) |
(0.03) |
|||||||||||||
Diluted |
(0.07) |
(0.02) |
(0.01) |
(0.05) |
(0.12) |
(0.03) |
|||||||||||||
Weighted average number of shares used in computing earnings (loss) per share |
|||||||||||||||||||
Basic |
135,097,367 |
135,097,367 |
191,521,484 |
135,097,367 |
180,680,089 |
180,680,089 |
|||||||||||||
Diluted |
135,097,367 |
135,097,367 |
210,302,584 |
135,097,367 |
180,680,089 |
180,680,089 |
BiondVax and NIH sign Clinical Trial Agreement for a Phase 2 trial in the U.S. with BiondVax’s Universal Flu Vaccine
Ness Ziona, Israel – November 20, 2017 –BiondVax Pharmaceuticals Ltd. (NASDAQ: BVXV, TASE: BVXV) today announced the signing of the clinical trial agreement (CTA) for a Phase 2 clinical trial with the National Institute of Allergy and Infectious Diseases (NIAID) of the U.S. National Institutes of Health (NIH).The study is titled “A Phase II, Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial to Assess the Safety, Reactogenicity and Immunogenicity of Two Doses of Multimeric-001 (M-001) Followed by Seasonal Trivalent Influenza Vaccine.” It is designed to evaluate the cell mediated immunity directly induced by BiondVax’s universal flu vaccine candidate M-001, as well as M-001’s priming effect to enhance the immunogenicity of current seasonal influenza vaccines.Dr. Ron Babecoff, BiondVax’s CEO, commented, “We are honored to work with the American NIH in their effort to improve protection from the flu, one of the world’s most common infectious diseases. We hope that this important strategic collaboration will lead to additional partnerships with other leading institutions.”BiondVax’s Chief Science Officer Dr. Tamar Ben-Yedidia explained, “Along with our successful European Union Phase 2b clinical trial results, this current study will further explore the science behind M-001, our innovative universal flu vaccine candidate. As part of the protocol team, it has been an exciting experience working alongside the field’s leading experts from the NIAID. We are looking forward to the day M-001 will be approved as a key component of influenza prevention.”The NIAID-funded trial will include 120 young adults (aged 18 to 45 years) randomly assigned to one of two groups receiving either placebo or M-001. Later, all participants will receive a currently marketed unadjuvanted trivalent seasonal influenza vaccine. Four trial sites from the NIAID-supported Vaccine and Treatment Evaluation Units contracts are participating, namely Baylor College of Medicine in Texas, Cincinnati Children’s Hospital Medical Center in Ohio, and the University of Iowa, with laboratory support provided by St. Louis University in Missouri1. The NIAID is submitting the Investigational New Drug (IND) to the U.S. Food and Drug Administration (FDA), and participant recruitment is anticipated to begin after the end of the 2017/18 flu season.
1. Contract numbers HHSN272201300015I, HHSN272201300016I, HHSN272201300020I, and HHSN272201300021I, respectively.
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BiondVax Announces Closing of $10 Million Public Offering of American Depositary Shares and Exercise of Over-Allotment Option
NESS ZIONA, Israel, September 18, 2017 –BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV, TASE: BVXV), a clinical stage biopharmaceutical company focused on developing and commercializing M-001, a universal flu vaccine candidate, announced today that it has closed an underwritten public offering of 1,500,000 American Depositary Shares ("ADS"), each ADS representing forty (40) of its ordinary shares which are listed on the Tel Aviv Stock Exchange (at NIS 0.0000001 par value each), at a price to the public of $6.00 per ADS. In connection with the public offering, the underwriters exercised in full their over-allotment option to purchase an additional 166,667 shares of common stock at the public offering price, less the underwriting discount. As a result, the total public offering size was 1,666,667 shares, and the gross proceeds from the public offering were $10 million, before deducting underwriting discounts and offering expenses.Dr. Ron Babecoff, BiondVax’s CEO, commented, “I’d like to thank our investors for their confidence and continued support. We also welcome the new US-based healthcare focused investors. This financing, together with the recent €20 million EIB funding, the Israeli Government support, and our other existing resources, enables us to launch our Phase 3 program including a mid-size manufacturing facility.”Joseph Gunnar & Co., LLC acted as the sole book-running manager for the offering.A registration statement relating to these securities was declared effective by the U.S. Securities and Exchange Commission (SEC). This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.The final prospectus related to the offering was filed with the SEC and may be accessed on the SEC’s website located at http://www.sec.gov. Copies of the final prospectus may also be obtained from Joseph Gunnar & Co, LLC, Prospectus Department, 30 Broad Street, 11th Floor, New York, NY 10004, telephone 212-440-9600, email: prospectus@jgunnar.com. About BiondVax BiondVax is a biopharmaceutical company developing the universal flu vaccine candidate M-001, which is undergoing preparations for a phase 3 clinical trial. The vaccine is designed to provide multi-season protection against most seasonal and pandemic human influenza virus strains. BiondVax’s proprietary technology utilizes a unique combination of conserved and common peptides from influenza virus proteins, activating both arms of the immune system for a cross-protecting and long-lasting effect. BiondVax is traded on NASDAQ: BVXV and TASE: BVXV. For more information, please visit www.biondvax.com.Contact DetailsJoshua PhillipsonBusiness Development+972 8 930 2529j.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 risk that drug development involves a lengthy and expensive process with uncertain outcome, the results of the contemplated Phase 2 & 3 trials, delays or obstacles in launching and/or successfully completing our clinical trials, the impact of the global economic environment on the Company customer target base, 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, 2016 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.
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BiondVax Announces Pricing of Public Offering of American Depositary Shares
NESS ZIONA, Israel, September 14, 2017 -- BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV, TASE: BVXV), a clinical stage biopharmaceutical company focused on developing and commercializing M-001, a universal flu vaccine candidate, announced today that it has priced an underwritten public offering of 1,500,000 American Depositary Shares ("ADS"), each ADS representing forty (40) of its ordinary shares which are listed on the Tel Aviv Stock Exchange (at NIS 0.0000001 par value each), at a price to the public of $6.00 per ADS.BiondVax Pharmaceuticals has granted the underwriter a 45-day option to purchase up to 166,667 additional ADS. The offering is expected to close on or about September 18, 2017, subject to satisfaction of customary closing conditions.Dr. Ron Babecoff, BiondVax’s CEO, commented, “This financing, together with the €20 million EIB funding, the Israeli Government support, and our other existing resources enables us to launch our Phase 3 program including a mid-size manufacturing facility.”Joseph Gunnar & Co., LLC is acting as the sole book-running manager for the offering.The ADSs described above will be issued pursuant to a registration statement on Form F-3 previously filed with and subsequently declared effective by the Securities and Exchange Commission (SEC) on December 15, 2016. The securities may be offered only by means of a prospectus and related prospectus supplement. A preliminary prospectus supplement and accompanying prospectus relating to the offering has been filed with the SEC and will be available on the SEC’s website at http://www.sec.gov.Before buying any of BiondVax’s ADSs in the offering, investors should carefully read the preliminary prospectus supplement and the accompanying prospectus, together with the information incorporated by reference therein. These documents contain important information that investors should consider when making their investment decisions. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to these ADSs may be obtained by contacting Joseph Gunnar & Co., LLC, Prospectus Department, 30 Broad Street, 11th Floor, New York, NY 10004, telephone 212-440-9600, email: prospectus@jgunnar.com.This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. About BiondVax BiondVax is a biopharmaceutical company developing M-001, a universal flu vaccine candidate approaching Phase 3 clinical trials. The vaccine is designed to provide multi-season protection against most seasonal and pandemic human influenza virus strains. BiondVax’s proprietary technology utilizes a unique combination of conserved and common peptides from influenza virus proteins, activating both arms of the immune system for a cross-protecting and long-lasting effect. BiondVax is traded on NASDAQ: BVXV and TASE: BVXV. For more information, please visit www.biondvax.com.Contact DetailsJoshua PhillipsonBusiness Development+972 8 930 2529j.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 risk that drug development involves a lengthy and expensive process with uncertain outcome, the results of the contemplated Phase 2 & 3 trials, delays or obstacles in launching and/or successfully completing our clinical trials, the impact of the global economic environment on the Company customer target base, 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, 2016 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.
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BiondVax Announces Public Offering of American Depositary Shares
NESS ZIONA, Israel, September 13, 2017 -- BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV, TASE: BVXV), a clinical stage biopharmaceutical company focused on developing and commercializing M-001, a universal flu vaccine candidate, today announced that it intends to offer for sale its American Depositary Shares ("ADS"), each representing forty (40) of its ordinary shares which are listed on the Tel Aviv Stock Exchange (at NIS 0.0000001 par value each).All of the ADSs in the offering are being offered by BiondVax. The offering is subject to market conditions and there can be no assurance as to whether the offering may be completed, or as to the actual size or terms of the offering.Joseph Gunnar & Co., LLC is acting as the sole book-running manager for the offering.The ADSs described above will be issued pursuant to a registration statement on Form F-3 previously filed with and subsequently declared effective by the Securities and Exchange Commission (SEC) on December 15, 2016. The securities may be offered only by means of a prospectus and related prospectus supplement. A preliminary prospectus supplement and accompanying prospectus relating to the offering has been filed with the SEC and will be available on the SEC’s website at http://www.sec.gov.Before buying any of BiondVax’s ADSs in the offering, investors should carefully read the preliminary prospectus supplement and the accompanying prospectus, together with the information incorporated by reference therein. These documents contain important information that investors should consider when making their investment decisions. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to these ADSs may be obtained by contacting Joseph Gunnar & Co., LLC, Prospectus Department, 30 Broad Street, 11th Floor, New York, NY 10004, telephone 212-440-9600, email: prospectus@jgunnar.com.This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. About BiondVax BiondVax is a biopharmaceutical company developing M-001, a universal flu vaccine candidate. The vaccine is designed to provide multi-season protection against most seasonal and pandemic human influenza virus strains. BiondVax’s proprietary technology utilizes a unique combination of conserved and common peptides from influenza virus proteins, activating both arms of the immune system for a cross-protecting and long-lasting effect. BiondVax is traded on NASDAQ: BVXV and TASE: BVXV. For more information, please visit www.biondvax.com. Contact DetailsJoshua PhillipsonBusiness Development+972 8 930 2529j.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 risk that drug development involves a lengthy and expensive process with uncertain outcome, the results of the contemplated Phase 2 & 3 trials, delays or obstacles in launching and/or successfully completing our clinical trials, the impact of the global economic environment on the Company customer target base, 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, 2016 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.
BiondVax Provides Second Quarter 2017 Financial Results and Update
NESS ZIONA, Israel, August 31, 2017 -- BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV, TASE: 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 June 30, 2017 and provided a business update.Dr. Ron Babecoff, BiondVax’s CEO, commented, “This quarter’s significant achievements including the €20 million EIB funding and positive Phase 2b clinical trial results enable us continue towards launching our Phase 3 program and constructing our mid-size manufacturing facility towards commercialization.”Second Quarter 2017 Financial SummaryResults are in New Israel Shekels (NIS) and convenience translation to $US is provided using the exchange rate of 3.496 (NIS/$US) as at June 30, 2017.
- Second quarter operating expenses were NIS 2.59m ($742,000) compared with NIS 2.47m for the second quarter of 2016;
- Second quarter R&D expenses amounted to NIS 2.02m ($579,000) compared with NIS 1.48m for the second quarter of 2016;
As of June 30, 2017, BiondVax had cash and cash equivalents, short-term investments and marketable securities of NIS 36.6m ($10.5m) as compared to NIS 34.8m as of March 31, 2017. In the first half of 2017, the Company issued to investors approximately 6.7 million ordinary shares which is equivalent to 167 thousand NASDAQ listed ADSs, raising approximately $1.23 million. Recent Corporate Update
- BiondVax reported statistically significant positive results from the European Phase 2b clinical trial of M-001. Both endpoints, safety and influenza-specific cellular immune responses were achieved. Details: http://www.biondvax.com/2017/07/biondvax-reports-positive-phase-2b-clinical-trial-results-for-its-universal-flu-vaccine/.
- BiondVax signed a significant €20 million (approximately $US 22 million) non-dilutive funding agreement with the European Investment Bank (EIB). Details: http://www.biondvax.com/2017/06/european-investment-bank-eib-supports-late-stage-development-and-production-of-biondvaxs-universal-flu-vaccine-candidate-under-horizon-2020-initiative/.
- Planning for construction of a mid-sized facility, planned to have capacity to annually produce tens of millions of doses of M-001 either in single-dose syringe or in bulk, is ongoing. A lease agreement was recently signed. Details: http://www.biondvax.com/2017/07/biondvax-signs-lease-agreement-for-mid-size-commercial-facility-to-manufacture-universal-flu-vaccine/.
- The Israel Innovation Authority (IIA), formerly known as the Office of the Chief Scientist, agreed to fund up to 40% of a NIS 2.7 million (approximately US$ 750,000) budget towards ongoing development of M-001. Details: http://www.biondvax.com/2017/08/biondvax-receives-additional-grant-funding/.
** Tables to Follow **About BiondVax BiondVax is a biopharmaceutical company developing a universal flu vaccine. The vaccine is designed to provide multi-season protection against most seasonal and pandemic human influenza virus strains. BiondVax’s proprietary technology utilizes a unique combination of conserved and common peptides from influenza virus proteins, activating both arms of the immune system for a cross-protecting and long-lasting effect. BiondVax is traded on NASDAQ: BVXV and TASE: BVXV. For more information, please visit www.biondvax.com.Contact DetailsJoshua PhillipsonBusiness Development+972 8 930 2529j.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 risk that drug development involves a lengthy and expensive process with uncertain outcome, the results of the contemplated Phase 2 & 3 trials, delays or obstacles in launching and/or successfully completing our clinical trials, the impact of the global economic environment on the Company customer target base, 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, 2016 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.
BALANCE SHEETS |
|||||||||
In thousands, except per share data |
|||||||||
Conveniencetranslation |
|||||||||
December 31, |
June 30, |
June 30, |
|||||||
2016 |
2016 |
2017 |
2017 |
||||||
Audited |
Unaudited |
Unaudited |
|||||||
N I S |
U.S. dollars |
||||||||
CURRENT ASSETS: |
|||||||||
Cash and cash equivalents |
15,705 |
15,084 |
31,334 |
8,963 |
|||||
Marketable securities |
2,017 |
2,017 |
4,067 |
1,163 |
|||||
Short-term deposits |
7,602 |
11,503 |
1,200 |
343 |
|||||
Other receivables |
815 |
3,188 |
2,812 |
804 |
|||||
26,139 |
31,792 |
39,413 |
11,273 |
||||||
LONG‑TERM ASSETS: |
|||||||||
Marketable securities |
2,050 |
2,049 |
- |
- |
|||||
Property, plant and equipment |
1,443 |
1,746 |
1,233 |
353 |
|||||
Other long term assets |
478 |
490 |
505 |
144 |
|||||
3,971 |
4,285 |
1,738 |
497 |
||||||
30,110 |
36,077 |
41,151 |
11,770 |
||||||
CURRENT LIABILITIES: |
|||||||||
Trade payables |
686 |
457 |
1,188 |
340 |
|||||
Other payables |
689 |
697 |
664 |
190 |
|||||
1,375 |
1,154 |
1,852 |
530 |
||||||
LONG‑TERM LIABILITIES: |
|||||||||
Options |
3,043 |
4,923 |
18,231 |
5,215 |
|||||
Severance pay liability, net |
76 |
72 |
79 |
22 |
|||||
3,119 |
4,995 |
18,310 |
5,237 |
||||||
SHAREHOLDERS' EQUITY (DEFICIT): |
|||||||||
Ordinary shares of NIS 0.0000001 par value: |
|||||||||
Authorized: 391,000,000 shares as ofJune 30, 2017, 2016 (unaudited) andDecember 31, 2016; Issued andOutstanding: 179,595,199, 135,097,367and 135,097,367 shares respectively |
*) - |
*) - |
*) - |
*) - |
|||||
Share premium |
113,041 |
111,458 |
132,824 |
37,993 |
|||||
Options |
1,435 |
2,536 |
533 |
152 |
|||||
Other comprehensive income |
6 |
7 |
2 |
*) - |
|||||
Accumulated deficit |
(88,866) |
(84,073) |
(112,370) |
(32,142) |
|||||
25,616 |
29,928 |
20,989 |
6,003 |
||||||
30,110 |
36,077 |
41,151 |
11,770 |
||||||
*) Represents an amount lower than NIS 1. |
STATEMENTS OF COMPREHENSIVE INCOME |
|||||||||||||||||||
In thousands, except per share data |
|||||||||||||||||||
Convenience |
|||||||||||||||||||
translation |
|||||||||||||||||||
(Note 2) |
|||||||||||||||||||
Year ended |
Three months ended |
Six months ended |
Six months ended |
||||||||||||||||
December 31, |
June 30 |
June 30 |
June 30 |
||||||||||||||||
2016 |
2016 |
2017 |
2016 |
2017 |
2017 |
||||||||||||||
Unaudited |
Unaudited |
||||||||||||||||||
N I S |
U.S. dollars |
||||||||||||||||||
(In thousands, except per share data) |
|||||||||||||||||||
Operating expenses: |
|||||||||||||||||||
Research and development, net of participations |
7,794 |
1,478 |
2,022 |
3,541 |
3,896 |
1,114 |
|||||||||||||
Marketing, general and administrative |
4,106 |
999 |
569 |
1,770 |
1,663 |
476 |
|||||||||||||
Total operating expenses |
11,900 |
2,477 |
2,591 |
5,311 |
5,559 |
1,590 |
|||||||||||||
Operating loss |
(11,900) |
(2,477) |
(2,591) |
(5,311) |
(5,559) |
(1,590) |
|||||||||||||
Financial income |
75 |
252 |
5 |
49 |
13 |
4 |
|||||||||||||
Financial expense |
(303) |
(6) |
(930) |
(200) |
(1,997) |
(571) |
|||||||||||||
Financial income (expenses) due to revaluation of options |
2,944 |
(383) |
(8,156) |
1,071 |
(15,961) |
(4,566) |
|||||||||||||
Total finance (expense) income, net |
2,716 |
(138) |
(9,081) |
920 |
(17,945) |
(5,133) |
|||||||||||||
Net loss |
(9,184) |
(2,615) |
(11,672) |
(4,39(1 |
(23,504) |
(6,723) |
|||||||||||||
Other comprehensive income (loss): |
|||||||||||||||||||
Items to be reclassified to profit or loss in subsequent periods: |
|||||||||||||||||||
Gain (loss) from available-for-sale financial assets |
(6) |
(7) |
(4) |
(5) |
(4) |
(1) |
|||||||||||||
Total comprehensive loss |
(9,190) |
(2,622) |
(11,676) |
(4,396) |
(23,508) |
(6,724) |
|||||||||||||
Basic and diluted net loss per share (NIS) |
(0.07) |
(0.02) |
(0.07) |
(0.03) |
(0.14) |
(0.04) |
|||||||||||||
Weighted average number of sharesoutstanding used to compute basicand diluted loss per share |
135,097,367 |
135,097,367 |
175,809,413 |
135,097,367 |
169,182,101 |
169,182,101 |
|||||||||||||
###
Dual-Listed BiondVax to Voluntarily Delist from Tel Aviv Stock Exchange
Company also begins search for new Chair of the Board
NESS ZIONA, Israel, August 31, 2017 -- BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV, TASE: BVXV), developer of the universal flu vaccine candidate M-001, today announced that its Board of Directors has decided to voluntarily delist from the Tel Aviv Stock Exchange (TASE), while maintaining a continued listing on NASDAQ.Following the European Investment Bank (EIB)’s significant €20 million funding agreement, and as BiondVax progresses towards Phase 3 clinical trials and construction of its commercial mid-size manufacturing facility, the Board of Directors decided that BiondVax will focus its efforts on the international scene. In that regard, it was decided to (1) consolidate trading of the Company’s securities on the NASDAQ and delist from the TASE; and (2) identify a new Chairman of the Board with relevant global experience to guide the Company through the anticipated upcoming international Phase 3 trials and global commercialization.The delisting process of BiondVax’s shares from trading on the TASE will take place by the end of 2017. An announcement regarding the delisting procedure and timeline will follow. During the interim period, BiondVax’s shares will continue to be traded on the TASE. All shareholders will retain their pro-rated holdings, as trading will migrate to the NASDAQ.Dr. Ron Babecoff, BiondVax’s CEO, commented, “BiondVax is proud to be an Israeli company. Our technology was born in Israel, and we are building our new manufacturing facility in Israel. Nevertheless, a universal flu vaccine is a global product, which demands a global presence. The decision to consolidate trading on NASDAQ and to internationalize our board is an important step towards achieving our goals.”The Company has formed a committee to identify a new Chair of the Board who will play an important role in enhancing its international profile. Professor Avner Rotman will continue to serve as Chairman until a suitable replacement is identified. BiondVax and its Board of Directors thank Professor Rotman for his years of guidance and contributions to the Company, and wish him continued success in all his endeavors.“I wish to personally thank Avner for his friendship and mentorship over the many years we have worked together,” added Babecoff.About BiondVaxBiondVax is a biopharmaceutical company developing a universal flu vaccine. The vaccine is designed to provide multi-season protection against most seasonal and pandemic human influenza virus strains. BiondVax’s proprietary technology utilizes a unique combination of conserved and common peptides from influenza virus proteins, activating both arms of the immune system for a cross-protecting and long-lasting effect. BiondVax is traded on NASDAQ: BVXV and TASE: BVXV. For more information, please visit www.biondvax.com. Contact DetailsJoshua PhillipsonBusiness Development+972 8 930 2529j.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 long term attractive investment opportunity represented by Biondvax, the risk that drug development involves a lengthy and expensive process with uncertain outcome, the results of the contemplated Phase 2 & 3 trials, delays or obstacles in launching and/or successfully completing our clinical trials, the impact of the global economic environment on the Company customer target base, 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, 2016 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.###