Form 6-K BiondVax Pharmaceuticals For: Nov 09

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 6-K

 

Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16

Under the Securities Exchange Act of 1934

 

For the Month of November 2015

 

001-37353

(Commission File Number)

 

BIONDVAX PHARMACEUTICALS LTD.

(Exact name of Registrant as specified in its charter)

 

14 Einstein St.

Nes Ziona

Israel 74036

(Address of principal executive offices)

 

Indicate by check mark whether the registrant files or will file annual reports under cover

Form 20-F or Form 40-F.

 

Form 20-F  þ    Form 40-F  ☐

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by

Regulation S-T Rule 101(b)(1): ____

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by

Regulation S-T Rule 101(b)(7): ____

 

Indicate by check mark whether by furnishing the information contained in this Form, the registrant is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.

Yes  ☐    No  þ

 

If "Yes" is marked, indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b): 82-N/A

 

 

 

On November 9, 2015, BiondVax Pharmaceuticals Ltd. issued a press release announcing its financial results for the quarter ended September 30, 2015. A copy of the press release with the interim unaudited financial statements for the three and nine month periods ended September 30, 2015 is attached hereto as Exhibit 99.1, and is incorporated herein by reference.

 

Exhibit Index

 

Exhibit No.		Description
99.1		Press Release, dated November 9, 2015

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

	BiondVax Pharmaceuticals Ltd.
Date: November 9, 2015	By:	/s/ Ron Babecoff
		Ron Babecoff
		Chief Executive Officer

 

 

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Exhibit 99.1

 

 

 

BiondVax Announces

Third Quarter 2015 Financial Results and Update

 

Nes 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.

 

Third Quarter 2015 Financial Summary

Results 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;

 

Recent Corporate Update

●	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;

 

 

Dr. 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.”

 

Continued 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.”

 

“As 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.

 

About BiondVax

BiondVax 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.

 

BiondVax’s 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.

 

Contact Details

 

Company Contact Limor Chen, Director of BD [email protected]

Investor Relations Contact GK Investor Relations Kenny Green, Partner +1 646 201 9246 [email protected]

 

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 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.

 

** Tables to Follow **

 

 

BALANCE SHEETS

  

														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 INCOME

 

																						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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