Scinai Immunotherapeutics Ltd (SCNI) 6-K, filed Jun 12, 2020

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 June 2020

Commission File Number: 001-37353

BIONDVAX PHARMACEUTICALS LTD.

(Translation of registrant’s name into English)

Jerusalem BioPark, 2nd Floor

Hadassah Ein Kerem Campus

Jeusalem, Israel

(Address of principal executive office)

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 ☒ 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): ____

On June 12, 2020, BiondVax Pharmaceuticals Ltd. issued a press release announcing fourth quarter and full year 2019 financial results and providing business update.

Exhibit Index

Exhibit No.	Description
99.1	Press Release dated June 12, 2020

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: June 12, 2020	By:	/s/ Ron Babecoff
		Ron Babecoff
		Chief Executive Officer

Exhibit 99.1

BiondVax Announces Fourth Quarter andFull Year 2019 Financial Results and Provides Business Update

Jerusalem, Israel – June 12, 2020 – BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), a clinical stage biopharmaceutical company focused on developing and commercializing M-001, a universal influenza vaccine candidate, today announced its fourth quarter and full year financial results for the year ended December 31, 2019 and provided a business update.

Fourth Quarter 2019 Financial Summary

Results are in New Israel Shekels (NIS)and convenience translation to $US is provided using the exchange rate of 3.456 (NIS/$US) as at December 31, 2019.

●	Total operating expenses were NIS 32.5<br>million (approximately $9.4 million) compared with NIS 27.9 million for the fourth quarter of 2018.
●	R&D expenses for the fourth quarter<br>amounted to NIS 31.6 million ($9.1 million) compared with NIS 26.6 million for the fourth quarter of 2018.
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Full Year 2019 Financial Summary

●	Total operating expenses for 2019 were<br>NIS 78.3 million ($22.6 million) compared with NIS 77 million in 2018.
●	R&D expenses for 2019 amounted to<br>NIS 68.6 million ($19.8 million) compared with NIS 71.9 million in 2018.
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As of December 31, 2019, BiondVax had cash and cash equivalents of NIS 72.4 million ($20.9 million) compared to NIS 75.8 million as of December 31, 2018. Complete financial results are available in the Company’s annual report on Form 20-F for the year ended December 31, 2019, which is being filed with the Securities and Exchange Commission today.

*Tables to follow*

2019 Highlights and Recent CorporateUpdate

●	Pivotal clinical efficacy Phase 3 trial:<br>The pivotal Phase 3 clinical trial aims to compare the safety and clinical efficacy of M-001 versus a placebo in preventing flu<br>illness (as primary endpoints), and in reducing flu illness severity (as a secondary endpoint) from<br>circulating influenza strains. Prior to both the 2018/19 and 2019/20 flu seasons, a total of over 12,400 adult volunteers<br>aged 50+ (with half aged 65+) in seven European countries were enrolled. To date, no serious treatment related adverse events have<br>been identified. Monitoring of the trial’s second cohort (enrolled for the 2019/20 flu season) is nearly complete, and the<br>Phase 3 clinical trial results are expected by the end of 2020.
●	NIH-supported Phase 2 clinical trial:<br>The clinical study report (CSR) of the NIH-supported Phase 2 clinical trial was completed earlier this week. The CSR concludes<br>that “M-001 was safe in this study” and that “M-001 induced significant polyfunctional T cell responses,”<br>indicating that both primary endpoints of the trial were achieved. The trial in 120 adult volunteers, supported by the U.S. National<br>Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), was conducted by several<br>of NIAID’s Vaccine Treatment and Evaluation Units (VTEUs) in the U.S.
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●	Pilot manufacturing facility: Equipment<br>installation and scale-up in BiondVax’s pilot manufacturing facility in Jerusalem are in progress. The facility has planned<br>annual capacity of up to between 10 and 20 million doses in bulk.
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●	€24 million non-dilutive co-funding:<br>The European Investment Bank (EIB) extended the 2017 co-financing agreement from €20 million to €24 million to support<br>construction of BiondVax’s pilot manufacturing facility in Israel and Phase 3 trial. BiondVax was honored to host Mr. Ambroise<br>Fayolle, EIB Vice-President, during his visit to BiondVax in June 2019 for a signature event celebrating the extension of the financing<br>agreement.
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●	$20 million rights offering: In<br>June and July 2019, BiondVax raised approximately US$20 million in a rights offering to existing shareholders.
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●	Warrant expiration: BiondVax received<br>proceeds of approximately $4.2 million through exercises of BiondVax warrants between January 1, 2020 and expiration of the warrants<br>in May 2020.
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●	New Board members: In September<br>2019, Mr. Mark Germain was appointed Chairman of the Board of Directors. In March 2020, Mr. Samuel Moed, Dr. Yael Margolin, and<br>Mr. Adi Raviv were elected to the board. Mr. Moed recently served as Senior Vice President, Corporate Strategy at Bristol Myers<br>Squibb (NYSE: BMY).
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About BiondVax

BiondVax (NASDAQ: 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 seven completed Phase 1/2 and Phase 2 clinical trials enrolling 818 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. For more information, please visit www.biondvax.com.

Contact Details

Joshua E. Phillipson | +972 8 930 2529 | j.phillipson@biondvax.com

Forward Looking Statements

Thispress 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. Theseforward-looking statements reflect the management’s current views with respect to certain current and future events and aresubject to various risks, uncertainties and assumptions that could cause the results to differ materially from those expected bythe management of BiondVax Pharmaceuticals Ltd. Risks and uncertainties include, but are not limited to, risks relating to theCOVID-19 (coronavirus) pandemic, the prosecution, timing and results of the ongoing Phase 2 and Phase 3 trials and any subsequenttrials; timing of receipt of regulatory approval of our manufacturing facility in Jerusalem; ability to demonstrate the efficacyand safety of the vaccine; the timing of clinical trials and marketing approvals; the risk that drug development involves a lengthyand expensive process with uncertain outcome; the ability of the Company to maintain, preserve and defend its intellectual propertyand 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 U.S. Food and Drug Administration or equivalent foreign regulatory agencies; the adequacyof available cash resources and the ability to raise additional capital when needed. More detailed information about the risksand uncertainties affecting the Company is contained under the heading “Risk Factors” in our Annual Report on Form20-F for the year ended December 31, 2019 filed with the U.S. Securities and Exchange Commission, or SEC, which is available onthe SEC’s website, www.sec.gov. 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,						December 31,
	2018			2019			2019
	N I S						U.S. dollars
CURRENT ASSETS:
Cash and cash equivalents		75,883			72,467			20,968
Other receivables		965			656			190
		76,848			73,123			21,158
LONG-TERM ASSETS:
Property, plant and equipment		28,249			34,981			10,122
Right-of-use assets		-			7,136			2,065
Other long-term assets		740			510			148
		28,989			42,627			12,335
		105,837			115,750			33,493
CURRENT LIABILITIES:
Trade payables		20,723			17,062			4,937
Current maturities of lease liabilities		-			694			201
Other payables		1,076			1,203			348
		21,799			18,959			5,486
LONG-TERM LIABILITIES:
Liability in respect of government grants		14,643			14,812			4,286
Lease Liabilities		-			6,809			1,970
Loan from others		94,360			123,780			35,816
Warrants		6,168			16,354			4,732
Severance pay liability, net		82			89			26
		115,253			161,844			46,830
SHAREHOLDERS’ EQUITY:
Ordinary shares of NIS 0.0000001 par value: Authorized: 391,000,000 shares at December 31, 2019 and 2018; Issued and outstanding: 402,351,657 and 261,419,599, shares at of December 31, 2019 and 2018, respectively		*) -			*) -			*) -
Share premium		179,929			255,285			73,867
Accumulated deficit		(211,144	)		(320,338	)		(92,690	)
		(31,215	)		(65,053	)		(18,823	)
		105,837			115,750			33,493
*)	Represents amounts less than NIS\USD 1.
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STATEMENTS OF COMPREHENSIVELOSS

In thousands, exceptshare and per share data

										Convenience translation
	Year ended<br> <br>December 31,									Year ended<br> <br>December 31,
	2017			2018			2019			2019
	N I S									U.S. dollars
Operating expenses:
Research and development, net of participations	18,777			71,913			68,645			19,863
Marketing, general and administrative		4,879			5,154			9,706			2,808
Total operating expenses		23,656			77,067			78,351			22,671
Operating loss		(23,656	)		(77,067	)		(78,351	)		(22,671	)
Financial income		18			2,936			4			1
Financial expense		(10,913	)		(13,596	)		(30,847	)		(8,926	)
Loss		(34,551	)		(87,727	)		(109,194	)		(31,596	)
Other comprehensive loss:
Items to be reclassified to profit or loss in subsequent periods:
Loss from available-for-sale marketable securities		(6	)		-			-			-
Total comprehensive loss		(34,557	)		(87,727	)		(109,194	)		(31,596	)
Basic and diluted loss per share		(0.17	)		(0.34	)		(0.33	)		(0.09	)
Weighted average number of shares outstanding used to compute basic and diluted loss per share		201,030,768			261,419,599			326,651,721			326,651,721

Scinai Immunotherapeutics Ltd 6-K, filed Jun 12, 2020

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