BiondVax Announces Third Quarter 2019 Financial Results and Business Update

JERUSALEM, Nov. 26, 2019 /PRNewswire/ -- BiondVax Pharmaceuticals Ltd. BVXV, a Phase 3 clinical stage biopharmaceutical company focused on developing and commercializing M-001, a universal flu vaccine candidate, today announced its financial results for the quarter ended September 30, 2019.

BiondVax Pharmaceuticals Logo (PRNewsfoto/Biondvax Pharmaceuticals Ltd)

Third Quarter 2019 Financial Summary

Results are in New Israel Shekels (NIS) and convenience translation to $US is provided using the exchange rate of 3.482 (NIS/$US) as at September 30, 2019.

  • Third quarter operating expenses were NIS 18.9m ($5.4m) compared with NIS 5.8m for the third quarter of 2018;
  • Third quarter R&D expenses amounted to NIS 16.1m ($4.6m) compared with NIS 4.3m for the third quarter of 2018;

Expenses were related to execution of planned ongoing operations, including the ongoing pivotal, clinical efficacy, Phase 3 trial of the Company's M-001 Universal Flu Vaccine candidate and construction of a mid-size pilot manufacturing facility.

As of September 30, 2019, BiondVax had cash and cash equivalents of NIS 75.2 million ($21.6 million) as compared to NIS 33.9 million as of June 30, 2019.

Recent Business highlights:

  • $20 million was raised in a shareholder rights offering that concluded in July 2019. As a consequence of the offering and an associated option to purchase ordinary shares that were not purchased by other shareholders in the offering, Angels Investments in High Tech Ltd., wholly owned by Marius Nacht, lead investor of the aMoon Fund, held approximately 42% of outstanding BiondVax shares.
  • Mr. Mark Germain was appointed Chairman of BiondVax's Board of Directors, effective September 30, 2019.
  • In October 2019, BiondVax received €4 million from the European Investment Bank (EIB). These funds are the final tranche of the previously announced co-financing agreement signed in June 2017 and extended in April 2019 from €20 million to €24 million.
  • Laboratory work for the primary and secondary outcome measures in the NIAID-sponsored Phase 2 clinical trial in the USA is now complete and the analysis is ongoing. Results are expected in Q2 2020.
  • Enrollment and randomization of 12,463 participants was successfully completed in the pivotal, clinical efficacy, Phase 3 trial of BiondVax's M-001 Universal Influenza Vaccine candidate.

 ** Tables to Follow **

About BiondVax

BiondVax BVXV is a Phase 3 clinical stage biopharmaceutical company developing a universal flu vaccine. The vaccine candidate, called M-001, is designed to provide multi-strain and multi-season protection against current and future, seasonal and pandemic influenza. BiondVax's proprietary technology utilizes a unique combination of conserved and common influenza virus peptides intended to stimulate both arms of the immune system for a cross-protecting and long-lasting effect. In a total of 6 completed Phase 1/2 and Phase 2 clinical trials, covering 698 participants, the vaccine has been shown to be safe, well-tolerated, and immunogenic. The ongoing pivotal Phase 3 clinical trial aims to assess safety and effectiveness of M-001 in reducing flu illness and severity. Please visit www.biondvax.com.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Litigation Reform Act of 1995. Words such as "expect," "believe," "intend," "plan," "continue," "may," "will," "anticipate," and similar expressions are intended to identify forward-looking statements. These forward-looking statements reflect the management's current views with respect to certain current and future events and are subject to various risks, uncertainties and assumptions that could cause the results to differ materially from those expected by the management of BiondVax Pharmaceuticals Ltd. Risks and uncertainties include, but are not limited to, the prosecution and outcome of the ongoing Phase 2 and Phase 3 trials and any subsequent trials; timing of publication by NIAID of the results of  the NIH/NIAID conducted Phase 2 clinical trial in the USA; timing of receipt of regulatory approval of the new manufacturing facility; ability to demonstrate the efficacy and safety of the vaccine; the timing of clinical trials and marketing approvals; the risk that drug development involves a lengthy and expensive process with uncertain outcome; the ability of the Company to maintain, preserve and defend its intellectual property and patents granted; whether our  vaccine candidate will successfully advance through the clinical trial process on a timely basis, or at all, and receive approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies; the adequacy of available cash resources and the ability to raise capital when needed. More detailed information about the risks and uncertainties affecting the Company is contained under the heading "Risk Factors" in our Annual Report on Form 20-F for the year ended December 31, 2018 filed with the U.S. Securities and Exchange Commission, or SEC, which is available on the SEC's website, www.sec.gov, and in the Company's periodic filings with the SEC. We undertake no obligation to revise or update any forward-looking statement for any reason.

BALANCE SHEETS

In thousands, except share and per share data













Convenience

translation





December 31,



September 30,



September 30,





2018



2018



2019



2019





Audited



Unaudited



Unaudited





N I S



U.S. dollars

CURRENT ASSETS:

















Cash and cash equivalents



75,883



52,985



75,247



21,610

Other receivables



965



2,716



1,887



542























76,848



55,701



77,134



22,152

LONG‑TERM ASSETS:

















Property, plant and equipment



28,249



24,175



34,324



9,857

Right-of-use assets



-



-



7,371



2,117

Other long term assets



740



888



507



146























28,989



25,063



42,202



12,120























105,837



80,764



119,336



34,272



















CURRENT LIABILITIES:

















Trade payables



20,723



1,732



1,552



446

Operating lease liability



-



-



697



200

Other payables



1,076



981



820



235























21,799



2,713



3,069



881

LONG‑TERM LIABILITIES:

















Liability in respect of government grants



14,643



12,930



14,454



4,151

Operating lease liability



-



-



6,898



1,981

Loan from others



94,360



42,770



108,353



31,118

Warrants



6,168



7,759



6,908



1,984

Accrued severance pay, net



82



81



87



25























115,253



63,540



136,700



39,259

SHAREHOLDERS' EQUITY:

















Ordinary shares of NIS 0.0000001 par value:

















Authorized: 600,000,000 shares at September 30, 2019, 2018

(unaudited) and December 31, 2018; Issued and outstanding:

402,351,657, 261,419,599 and 261,41,599 shares at

September 30, 2019, 2018 (unaudited) and December 31, 2018,

respectively



*)   -



*)   -



*)   -



*)   -

Share premium



179,929



179,871



256,889



73,776

Accumulated deficit



(211,144)



(165,360)



(277,322)



(79,644)























(31,215)



14,511



(20,433)



(5,868)























105,837



80,764



119,336



34,272

*) Represents an amount lower than NIS 1.

STATEMENTS OF COMPREHENSIVE LOSS

In thousands, except share and per share data

















Convenience

translation





Year ended

December 31,



Three months ended

September 30,



Nine months ended

September 30,



Nine months

ended

September 30,





2018



2018



2019



2018



2019



2019





Audited



Unaudited



Unaudited





N I S



U.S. dollars

Operating expenses:



















































Research and development, net of 

   participations



71,913



4,347



16,133



45,297



37,037



10,637

Marketing, general and administrative



5,154



1,475



2,790



3,804



8,741



2,510



























Total operating expenses



77,067



5,822



18,923



49,101



45,778



13,147



























Operating loss



(77,067)



(5,822)



(18,923)



(49,101)



(45,778)



(13,147)



























Financial income



2,936



3,729



169



9,817



193



55

Financial expense



(13,596)



(157)



(601)



(2,659)



(20,593)



(5,914)



























Total financial income (expense), net



(10,660)



3,572



(432)



7,158



(20,400)



(5,859)



























Loss and total comprehensive loss



(87,727)



(2,250)



(19,355)



(41,943)



(66,178)



(19,006)



























Basic and diluted net loss per share (in 

   NIS)



(0.34)



(0.01)



(0.05)



(0.16)



(0.23)



(0.07)



























Weighted average number of shares 

   outstanding used to compute basic 

   and diluted loss per share



261,419,599



261,419,599



377,899,911



261,419,599



290,794,601



290,794,601

 

Contact Details:

Joshua E. Phillipson

+972-8-930-2529 

j.phillipson@biondvax.com 

 

Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/biondvax-announces-third-quarter-2019-financial-results-and-business-update-300965320.html

SOURCE BiondVax Pharmaceuticals Ltd.

Market News and Data brought to you by Benzinga APIs
Comments
Loading...
Posted In: EarningsSmall CapPress ReleasesAccounting newsissues
Benzinga simplifies the market for smarter investing

Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.

Join Now: Free!