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Quarter 2015 Financial Results and Update

Monday, November 9, 2015 3 min read
Key Takeaway: Quarter 2015 Financial Results and Update Ziona, Israel, November 9, 2015 - BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV, TASE: BVXV), a clinical stage biopharmaceutical company focused on developing and commercializing immunomodulation therapies for infectious diseases, today

Full Press Release Details

Quarter 2015 Financial Results and Update
Ziona, Israel, November 9, 2015 - BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV, TASE: BVXV), a clinical
stage biopharmaceutical company focused on developing and commercializing immunomodulation therapies for infectious diseases,
today announced its financial results for the third quarter of 2015 and provided a business update.
Quarter 2015 Financial Summary
are in New Israel Shekels (NIS) and a translation to US$ is provided, using the exchange rate of 3.923 as at September 30, 2015.
Total operating expenses were NIS 2.21m ($563,000) compared with NIS 1.96m in the third quarter of last year;
R&D expenses amounted to NIS 1.25m ($319,000) compared with NIS 1.40m in the third quarter of last year;
Cash, cash equivalents and short and long-term marketable securities at the end of the quarter were NIS 40.94m ($10.41m) compared with NIS 13.68m as of December 31, 2014;
On October 1, 2015, BiondVax designatged Cytovance Biologics Inc., a Contract Manufacturing Organization (CMO), for the production of clinical batches of BiondVax's Universal Flu Vaccine (M-001) in order to be ready for phase 3 clinical trials in the 2017/2018 timeframe;
At the end of September, 2015, a phase 2b clinical trial was initiated in Europe in collaboration with the UNISEC European Consortium. The trial will examine BiondVax's Universal Flu Vaccine (M-001) as a primer for an Avian (H5N1) flu pandemic outbreak;
On September 2, 2015, BiondVax announced its intention to launch a phase 2 trial in the United States in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), a part of the U.S. National Institutes of Health (NIH), which is expected to take place in 2016;
Results are expected from both these phase 2b trials in the second half of 2016;
In August 2015, BiondVax reported that sera samples from elderly participants in the BVX-005 trial in 2012, contained significantly more protective antibodies against the current epidemic flu strain, H3N2, which did not exist in 2012;
The company and its management are actively engaging an investor relations program including monthly non-deal roadshows and investor conference appearences with US and international investors;
Ron Babecoff, CEO of BiondVax Commented: "The third quarter of 2015 was a very eventful one for BiondVax, and we made
significant progress towards our interim goal of reaching phase 3 trials in the 2017/2018 timeframe. We are very excited to be
working together with a European consortium in a phase 2b trial in Europe, where in the past few weeks we admitted and successfully
vaccinated the first patients with our Universal Flu Vaccine. Following FDA acceptance of our IND application earlier this year,
we are also excited that the NIAID/NIH agreed to collaborate and fund an upcoming trial in the United States, which we look forward
to starting in early 2016."
Mr. Babecoff, "In the next few weeks, I plan to meet with investors and analysts in New York, Boston, Chicago, Toronto
and Los Angeles in order to raise our profile amongst the investor community. This is a particularly timely visit, as the 2015/2016
flu season is now unfortunately well underway in North America."
is typical every year, millions of people will contract flu - including many who have taken the currently available trivalent
vaccine. Hence, at this time of year, we see the increased importance in our mission and what we are working so hard for. We are
encouraged because we are nearing the finishing line when we expect our vaccine will become commercially available for people
who need it in the US and worldwide," concluded Dr. Babecoff.
is an innovative biopharmaceutical company developing a universal flu vaccine, designed to provide multi-season and multi-strain
protection against most human influenza virus strains, including both seasonal and pandemic flu strains.
technology utilizes a unique, proprietary combination of conserved and common peptides from influenza virus proteins to activate
both arms of the immune system for a cross-protecting and long-lasting effect.
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 contempalted Phase 2 & 3 trials,
the impact of the global economic environment on the Company customer target base, the adequacy of available csah resoure 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 Prospectus which was declared effective on May 11,
2015. BiondVax Pharmaceuticals Ltd. undertakes no obligation to update or revise any forward-looking statements.
Convenience translation (Note 2)
December 31, September 30, September 30,
2014 2014 2015 2015
Unaudited Unaudited
N I S U.S. dollars
(In thousands except share and per share data)
CURRENT ASSETS:
Cash and cash equivalents 9,612 12,411 36,294 9,252
Marketable securities 2,016 2,014 2,016 514
Short term deposits - - 578 147
Other receivables 1,081 266 1,594 406
12,709 14,691 40,482 10,319
LONG-TERM ASSETS:
Marketable securities 2,049 2,047 2,047 522
Property, plant and equipment 2,638 2,793 2,191 559
Other long term assets 1,066 288 24 6
5,753 5,128 4,262 1,087
18,462 19,819 44,744 11,406
CURRENT LIABILITIES:
Trade payables 524 299 571 146
Other payables 1,289 1,155 758 194
1,813 1,454 1,329 340
LONG-TERM LIABILITIES:
Options - - 6,863 1,749
Severance pay liability, net 62 61 67 17
62 61 6,930 1,766
SHAREHOLDERS' EQUITY (DEFICIT):
Ordinary shares of NIS 0.0000001 par value:
Authorized: 391,000,000 shares as of September 30, 2015, 2014 (unaudited) and December 31, 2014; Issued and Outstanding: 135,097,367, 54,284,367 and 54,297,367 shares respectively *) *) *) *)
Share premium 83,517 83,459 110,352 28,129
Options 2,536 2,536 2,536 646
Other comprehensive income 17 18 12 3
Accumulated deficit (69,483 ) (67,709 ) (76,415 ) (19,478 )
16,587 18,304 36,485 9,300
18,462 19,819 44,744 11,406
*) Represents an amount lower than NIS 1.
STATEMENTS OF COMPREHENSIVE
Convenience translation (Note 2)
Year ended December 31, Three months ended September 30, Nine months ended September 30, Nine months ended September 30,
2014 2014 2015 2014 2015 2015
Unaudited Unaudited
N I S U.S. dollars
(In thousands, except per share data)
Operating expenses:
Research and development, net of participations 5,492 1,399 1,247 4,474 5,032 1,283
Marketing, general and administrative 2,650 561 966 1,688 2,216 564
Total operating expenses 8,142 1,960 2,213 6,162 7,248 1,847
Operating loss (8,142 ) (1,960 ) (2,213 ) (6,162 ) (7,248 ) (1,847 )
Financial income (394 ) (166 ) (1,540 ) (184 ) (651 ) (166 )
Financial expense 16 6 5 12 20 5
Financial expenses due to issuance of warrants - - (812 ) - 315 80
Total finance expense (income), net (378 ) (160 ) (2,347 ) (172 ) (316 ) (81 )
Net loss (income) 7,764 1,800 (134 ) 5,990 6,932 1,766
Other comprehensive loss (income):
Items to be reclassified to profit or loss in subsequent periods:
Loss (gain) from available-for-sale financial assets 4 - 2 3 5 2
Total comprehensive loss (income) 7,768 1,800 (132 ) 5,993 6,937 1,768
Basic and Diluted net loss (gain) per share (NIS) 0.14 0.03 (0.00 ) 0.11 0.07 0.02
Weighted average number of shares outstanding used to compute basic and diluted loss per share 54,286,227 54,284,367 135,097,367 54,284,367 95,519,426 95,519,426
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Last updated: Nov 9, 2015