Ness Ziona, Israel, August 18, 2016 – BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV, TASE: BVXV), a clinical stage biopharmaceutical company focused on developing and commercializing a vaccine against current and future seasonal and pandemic influenza strains, today announced its second quarter 2016 financial results ended June 30, 2016 and provided a business update.

Second Quarter 2016 Financial Summary

Results are in New Israel Shekels (NIS) and convenience translation to US$ is provided using the exchange rate of 3.846 as at June 30, 2016.

  • Second quarter operating expenses were NIS 2.47m ($644,000) compared with NIS 3.21m in the second quarter of last year;
  • Second quarter R&D expenses amounted to NIS 1.48m ($385,000) compared with NIS 2.61m in the second quarter of last year;
  • Cash, cash equivalents and short and long-term marketable securities at the end of the quarter were NIS 30.65m ($7.97m) compared with NIS 37.53m as of December 31, 2015;                                                                                                                                                                    

Recent Corporate Update

  • Clinical trials are progressing. The EU UNISEC sponsored Phase 2b clinical trial completed enrolment and results are being analyzed. The US NIH Phase 2 trial preparations are well into advanced stages. Furthermore, US-based Cytovance is beginning to scale-up production of BiondVax’s universal flu vaccine candidate M-001 for Phase 3 clinical trials, which is expected to be ready by H1 2017.
  • In August, a video feature on BiondVax was published by a leading Israeli portal. The video can be viewed at https://www.youtube.com/watch?v=iqzZd4hsvSw. In addition, BiondVax launched a newsletter. The most recent edition can be viewed at http://us12.campaign-archive2.com/?u=37c158f4953dfecaabf88a035&id=763a628862. To receive BiondVax updates directly to your inbox please email j.phillipson@biondvax.com.

Dr. Ron Babecoff, CEO of BiondVax commented: “Our progress continued into the second quarter according to plans. The work with our partners in our different collaborations is also moving forward at a good pace. As each quarter passes, we are coming closer towards our goal of bringing a universal flu vaccine to market.”

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 Details

 

Joshua Phillipson
Business Development Manager
+972 8 930 2529
j.phillipson@biondvax.com
Kenny Green
Investor Relations
+1 646 201 9246
kenny@biondvax.com

 

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Litigation Reform Act of 1995. Words such as “expect,” “believe,” “intend,” “plan,” “continue,” “may,” “will,” “anticipate,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements involve certain risks and uncertainties reflect the management’s current views with respect to certain current and future events and are subject to various risks, uncertainties and assumptions that could cause the results to differ materially from those expected by the management of BiondVax Pharmaceuticals Ltd. Risks and uncertainties include, but are not limited to, the risk that drug development involves a lengthy and expensive process with uncertain outcome, the results of the contemplated  Phase 2 & 3 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. The risks, uncertainties and assumptions referred to above are discussed in detail in our reports filed with the Securities and Exchange Commission, including our annual report for the year ended December 31, 2015 on Form 20-F filed with the Securities and Exchange Commission on April 27, 2016. BiondVax Pharmaceuticals Ltd. undertakes no obligation to update or revise any forward-looking statements.

 

** Tables to Follow **

 

BALANCE SHEETS

 

              Convenience translation
  December 31,   June 30,   June 30,
  2015   2015   2016   2016
  Audited   Unaudited   Unaudited
  N I S   U.S. dollars
  (In thousands except share and per share data)
CURRENT ASSETS:
Cash and cash equivalents 33,470 37,955 15,084 3,922
Short term deposit 11,503 2,991
Marketable securities 2,016 2,016 2,017 524
Other receivables 1,442 763 3,188 829
36,928 40,734 31,792 8,266
LONG‑TERM ASSETS:
    Marketable securities 2,048 2,047 2,049 533
Property, plant and equipment 2,044 2,355 1,746 454
Other long term assets 287 286 490 127
4,379 4,688 4,285 1,114
41,307 45,422 36,077 9,380
CURRENT LIABILITIES:
Trade payables 931 635 457 119
Other payables 768 828 697 181
1,699 1,463 1,154 300
LONG‑TERM LIABILITIES:
Options 5,994 7,958 4,923 1,280
Severance pay liability, net 69 66 72 19
6,063 8,024 4,995 1,299
SHAREHOLDERS’ EQUITY (DEFICIT):
Ordinary shares of NIS 0.0000001 par value:
 Authorized: 391,000,000 shares as of June 30, 2016, 2015 (unaudited) and December 31, 2015; Issued and Outstanding: 135,097,367, shares as of June 30, 2016, 2015 (unaudited) and December 31, 2015. *) – *)   – *)   – *)   –
Share premium 110,679 109,934 111,458 28,980
Options 2,536 2,536 2,536 659
 Other comprehensive income 12 14 7 2
Accumulated deficit (79,682) (76,549) (84,073) (21,860)
33,545 35,935 29,928 7,782
41,307 45,422 36,077 9,380

*)            Represents an amount lower than NIS 1.


 

STATEMENTS OF COMPREHENSIVE INCOME

 

 

 

Convenience translation

(Note 2)

Year ended

December 31,

Three months ended

June 30,

Six months ended

June 30,

Six months

ended

June 30,

2015 2015   2016 2015   2016 2016
  Unaudited Unaudited
N I S U.S. dollars
(In thousands, except per share data)
Operating expenses:
Research and development, net of participations 7,906 2,613 1,478 3,785 3,541 921
Marketing, general and administrative 3,397 600 999 1,250 1,770 460
Total operating expenses 11,303 3,213 2,474 5,035 5,311 1,381
Operating loss 11,303 3,213 2,474 5,035 5,311 1,381
Financial income 1,128 3 252 8 49 13
Financial expense (24) (865) (6) (912) (200) (52)
Financial income (expenses) due to issuance of options (1,127) (383)  

(1,127)

1,071 278
Total finance (expense) income, net 1,104 (1,989) (138) (2,031) 920 239
Net loss 10,199 5,202 2,615 7,066 4,391 1,142
Other comprehensive income (loss):
Items to be reclassified to profit or loss in subsequent periods:
Gain (loss) from available-for-sale financial assets (5) (2) (7) (3) (5) (1)
Total comprehensive loss (10,204) (5,204) (2,622) (7,069) (4,396) (1,143)
Basic and Diluted net loss per share (NIS) (0.10) (0.05) (0.02) (0.09) (0.03) (0.008)
Weighted average number of shares outstanding used to compute basic and diluted loss per share 105,522,642 96,284,034 135,097,367 75,290,700 135,097,367 135,097,367