BiondVax Pharmaceuticals Ltd. (Form: 6-K, Received: 08/24/2020 06:10:35)

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 August 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 August 20, 2020, BiondVax Pharmaceuticals Ltd. issued a press release announcing second quarter 2020 financial results.

Exhibit Index

Exhibit No.		Description

99.1		Press Release dated August 20, 2020

This Report on Form 6-K is hereby incorporated by reference into the Company’s Registration Statement on Form F-3 (Registration No. 333-240189) and its Registration Statement on Form S-8 (Registration No. 333-239344).

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: August 23, 2020	By:	/s/ Ron Babecoff
		Ron Babecoff
		Chief Executive Officer

Exhibit 99.1

BiondVax Announces Second Quarter 2020 Financial Results

Jerusalem, Israel – August 20, 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 second quarter financial results for the quarter ended June 30, 2020.

Second Quarter 2020 Financial Summary

Results are in New Israel Shekels (NIS) and convenience translation to $US is provided using the exchange rate of3.466 (NIS/$US) as at June 30, 2020.

Total operating expenses for the second quarter were NIS 16.0 million (approximately $4.61 million) compared with NIS 19.7 million for the second quarter of 2019.

●

R&D expenses for the second quarter amounted to NIS 11.9 million (approximately $3.4 million) compared with NIS 15.2 million for the second quarter of 2019.

●

Net loss for the second quarter was NIS 42 million (approximately $12.1 million) compared to net loss of NIS 47.4 million for the second quarter of 2019.

The decrease in total operating expenses compared to the second quarter of 2019 was primarily due to fewer costs associated with the nearly complete pivotal Phase 3 trial and completion of construction of the manufacturing facility.

As of June 30, 2020, BiondVax had cash and cash equivalents of NIS 38.7 million (approximately $11.2 million) compared to NIS 72.4 million as of December 31, 2019.

*Tables to follow*

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

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, risks relating to the COVID-19 (coronavirus) pandemic, the prosecution, timing and results of the ongoing Phase 2 and Phase 3 trials and any subsequent trials; timing of receipt of regulatory approval of our manufacturing facility in Jerusalem; 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 U.S. Food and Drug Administration or equivalent foreign regulatory agencies; the adequacy of available cash resources and the ability to raise additional 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, 2019 filed with the U.S. Securities and Exchange Commission, or SEC, which is available on the SEC’s website, www.sec.gov. We undertake no obligation to revise or update any forward-looking statement for any reason.

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BALANCE SHEETS

In thousands, except share and per share data

										Convenience
										Translation
	December 31			June 30,						June 30,
	2019			2019			2020			2020
	Audited			Unaudited						Unaudited
	N I S									U.S. dollars
CURRENT ASSETS:
Cash and cash equivalents		72,467			33,916			38,752			11,181
Other receivables		656			1,258			2,467			712

		73,123			35,174			41,219			11,893
LONG-TERM ASSETS:
Property, plant and equipment		34,981			32,475			36,937			10,658
Right-of-use assets		7,136			7,610			6,662			1,922
Other long-term assets		510			510			891			257

		42,627			40,595			44,490			12,837
											-
		115,750			75,769			85,709			24,730

CURRENT LIABILITIES:
Trade payables		17,062			7,977			4,070			1,174
Operating lease liabilities		694			686			676			195
Other payables		1,203			1,348			1,609			464

		18,959			10,011			6,355			1,835
LONG-TERM LIABILITIES:
Liability in respect of government grants		14,812			14,621			12,686			3,660
Operating lease liabilities		6,809			7,076			6,457			1,863
Loan from others		123,780			110,971			122,041			35,211
Warrants		16,354			5,517			-			-
Severance pay liability, net		89			86			92			26

		161,844			138,271			141,276			40,760
SHAREHOLDERS’ EQUITY:
Ordinary shares of no par value: Authorized: 600,000,000, 391,000,000 and 600,000,000 shares at June 30, 2020 and 2019 (unaudited) and December 31, 2019, respectively; Issued and outstanding: 460,822,640, 261,419,599 and 402,351,657 shares at June 30, 2020 and 2019 (unaudited) and December 31, 2019, respectively		*)-			*)-			*)-			*)-
Share premium		255,285			185,454			304,089			87,735
Accumulated deficit		(320,338	)		(257,967	)		(366,011	)		(105,600	)

		(65,053	)		(72,513	)		(61,922	)		(17,865	)

		115,750			75,769			85,709			24,730

*)	Represents less than NIS\USD 1.

STATEMENTS OF COMPREHENSIVE INCOME (LOSS)

In thousands, except share and per share data

																Convenience translation
	Year ended December 31,			Three months ended June 30,						Six months ended June 30,						Six months ended June 30,
	2019			2019			2020			2019			2020			2020
	Audited			Unaudited												Unaudited
	N I S															U.S. dollars
	(In thousands, except per share data)
Operating expenses:
Research and development, net of participations		68,645			15,172			11,948			20,904			31,016			8,949
Marketing, general and administrative		9,706			4,518			4,139			5,951			5,120			1,477

Total operating expenses		78,351			19,690			16,087			26,855			36,136			10,426
																	-
Operating loss		(78,351	)		(19,690	)		(16,087	)		(26,855	)		(36,136	)		(10,426	)
Financial income		4			-			(11,291	)		24			5,211			1,503
Financial expense		(30,847	)		(27,699	)		(14,600	)		(19,992	)		(14,748	)		(4,255	)

Net loss		(109,194	)		(47,389	)		(41,978	)		(46,823	)		(46,673	)		(13,177	)

Basic and diluted net loss per share (NIS)		(0.33	)		(0.18	)		(0.10	)		(0.18	)		(0.11	)		(0.03	)

Weighted average number of shares outstanding used to compute basic and diluted loss per share		326,651,721			261,482,786			433,498,227			261,435,179			431,485,801			431,485,801