6-K

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, 2019

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 November 26, 2019, BiondVax Pharmaceuticals Ltd. issued a press release announcing its financial results for the period ended September 30, 2019. A copy of this press release and interim unaudited financial statements for the period ended September 30, 2019 are attached hereto as Exhibit 99.1 and Exhibit 99.2, respectively, and are incorporated herein by reference.

Exhibit Index

Exhibit No.	Description
99.1	Press Release dated November 26, 2019.
99.2	BiondVax Pharmaceuticals Ltd. unaudited financial statements for the period ending September 30, 2019

1

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 26, 2019	By:	/s/ Ron Babecoff
		Ron Babecoff
		Chief Executive Officer

2

EX-99.1

Exhibit 99.1

 

BiondVax Announces Third Quarter 2019 Financial Results and Business Update

Jerusalem, Israel – November 26, 2019 — BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), a Phase 3 clinical stage biopharmaceutical company focused on developing and commercializing M-001, a universal flu vaccine candidate, today announced its financial results for the quarter ended September 30, 2019.

Third Quarter 2019 Financial Summary

Results are in New Israel Shekels (NIS) and convenience translation to $US is provided using the exchange rate of 3.482 (NIS/$US) as at September 30, 2019.

● Third quarter operating expenses were NIS 18.9m ($5.4m) compared with NIS 5.8m for the third quarter of 2018;

● Third quarter R&D expenses amounted to NIS 16.1m ($4.6m) compared with NIS 4.3m for the third quarter of 2018;

Expenses were related to execution of planned ongoing operations, including the ongoing pivotal, clinical efficacy, Phase 3 trial of the Company’s M-001 Universal Flu Vaccine candidate and construction of a mid-size pilot manufacturing facility.

As of September 30, 2019, BiondVax had cash and cash equivalents of NIS 75.2 million ($21.6 million) as compared to NIS 33.9 million as of June 30, 2019.

Recent Business highlights:

● $20 million was raised in a shareholder rights offering that concluded in July 2019. As a consequence of the offering and an associated option to purchase ordinary shares that were not purchased by other shareholders in the offering, Angels Investments in High Tech Ltd., wholly owned by Marius Nacht, lead investor of the aMoon Fund, held approximately 42% of outstanding BiondVax shares.

● Mr. Mark Germain was appointed Chairman of BiondVax’s Board of Directors, effective September 30, 2019.

● In October 2019, BiondVax received €4 million from the European Investment Bank (EIB). These funds are the final tranche of the previously announced co-financing agreement signed in June 2017 and extended in April 2019 from €20 million to €24 million.

● Laboratory work for the primary and secondary outcome measures in the NIAID-sponsored Phase 2 clinical trial in the USA is now complete and the analysis is ongoing. Results are expected by Q2 2020.

● Enrollment and randomization of 12,463 participants was successfully completed in the pivotal, clinical efficacy, Phase 3 trial of BiondVax’s M-001 Universal Influenza Vaccine candidate.

 ** 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 6 completed Phase 1/2 and Phase 2 clinical trials, covering 698 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. 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, the prosecution and outcome of the ongoing Phase 2 and Phase 3 trials and any subsequent trials; timing of publication by NIAID of the results of the NIH/NIAID conducted Phase 2 clinical trial in the USA; timing of receipt of regulatory approval of the new manufacturing facility; 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 United States Food and Drug Administration or equivalent foreign regulatory agencies; the adequacy of available cash resources and the ability to raise 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, 2018 filed with the U.S. Securities and Exchange Commission, or SEC, which is available on the SEC’s website, www.sec.gov, and in the Company’s periodic filings with the SEC. We undertake no obligation to revise or update any forward-looking statement for any reason.

2 

BALANCE SHEETS

In thousands, except share and per share data

										Convenience translation
	December 31,			September 30,						September 30,
	2018			2018			2019			2019
	Audited			Unaudited						Unaudited
	N I S									U.S. dollars
CURRENT ASSETS:
Cash and cash equivalents		75,883			52,985			75,247			21,610
Other receivables		965			2,716			1,887			542
		76,848			55,701			77,134			22,152
LONG-TERM ASSETS:
Property, plant and equipment		28,249			24,175			34,324			9,857
Right-of-se assets		-			-			7,371			2,117
Other long term assets		740			888			507			146
		28,989			25,063			42,202			12,120
		105,837			80,764			119,336			34,272
CURRENT LIABILITIES:
Trade payables		20,723			1,732			1,552			446
Operating lease liability		-			-			697			200
Other payables		1,076			981			820			235
		21,799			2,713			3,069			881
LONG-TERM LIABILITIES:
Liability in respect of government grants		14,643			12,930			14,454			4,151
Operating lease liability		-			-			6,898			1,981
Loan from others		94,360			42,770			108,353			31,118
Warrants		6,168			7,759			6,908			1,984
Accrued severance pay, net		82			81			87			25
		115,253			63,540			136,700			39,259
SHAREHOLDERS' EQUITY:
Ordinary shares of NIS 0.0000001 par value:
Authorized: 600,000,000 shares at September 30, 2019, 2018 (unaudited) and December 31, 2018; Issued and outstanding: 402,351,657, 261,419,599 and 261,41,599 shares at September 30, 2019, 2018 (unaudited) and December 31, 2018, respectively		*)-			*)-			*)-			*)-
Share premium		179,929			179,871			256,889			73,776
Accumulated deficit		(211,144	)		(165,360	)		(277,322	)		(79,644	)
		(31,215	)		14,511			(20,433	)		(5,868	)
		105,837			80,764			119,336			34,272

*) Represents an amount lower than NIS 1.

3 

STATEMENTS OF COMPREHENSIVE LOSS

In thousands, except share and per share data

																Convenience translation
	Year ended December 31,			Three months ended September 30,						Nine months ended September 30,						Nine months ended September 30,
	2018			2018			2019			2018			2019			2019
	Audited			Unaudited												Unaudited
	N I S															U.S. dollars
Operating expenses:
Research and development, net of participations		71,913			4,347			16,133			45,297			37,037			10,637
Marketing, general and administrative		5,154			1,475			2,790			3,804			8,741			2,510
Total operating expenses		77,067			5,822			18,923			49,101			45,778			13,147
Operating loss		(77,067	)		(5,822	)		(18,923	)		(49,101	)		(45,778	)		(13,147	)
Financial income		2,936			3,729			169			9,817			193			55
Financial expense		(13,596	)		(157	)		(601	)		(2,659	)		(20,593	)		(5,914	)
Total financial income (expense), net		(10,660	)		3,572			(432	)		7,158			(20,400	)		(5,859	)
Loss and total comprehensive loss		(87,727	)		(2,250	)		(19,355	)		(41,943	)		(66,178	)		(19,006	)
Basic and diluted net loss per share (in NIS)		(0.34	)		(0.01	)		(0.05	)		(0.16	)		(0.23	)		(0.07	)
Weighted average number of shares outstanding used to compute basic and diluted loss per share		261,419,599			261,419,599			377,899,911			261,419,599			290,794,601			290,794,601

4

EX-99.2

Exhibit 99.2

BIONDVAX PHARMACEUTICALS LTD.

INTERIM FINANCIAL STATEMENTS

AS OF SEPTEMBER 30, 2019

NIS IN THOUSANDS

UNAUDITED

INDEX

	Page
Balance Sheets	2
Statements of Comprehensive Loss	3
Statements of Changes in Shareholders’ Equity (Deficiency)	4 – 5
Statements of Cash Flows	6 – 7
Notes to Financial Statements	8 – 16

- - - - - - - - - - - - -

1 

BIONDVAX PHARMACEUTICALS LTD.

BALANCE SHEETS

In thousands, except share and per share data

										Convenience translation (Note 2)
	December 31,			September 30,						September 30,
	2018			2018			2019			2019
	Audited			Unaudited						Unaudited
	N I S									U.S. dollars
CURRENT ASSETS:
Cash and cash equivalents		75,883			52,985			75,247			21,610
Other receivables		965			2,716			1,887			542
		76,848			55,701			77,134			22,152
LONG-TERM ASSETS:
Property, plant and equipment		28,249			24,175			34,324			9,857
Right-of-se assets		-			-			7,371			2,117
Other long term assets		740			888			507			146
		28,989			25,063			42,202			12,120
		105,837			80,764			119,336			34,272
CURRENT LIABILITIES:
Trade payables		20,723			1,732			1,552			446
Operaitng lease liability		-			-			697			200
Other payables		1,076			981			820			235
		21,799			2,713			3,069			881
LONG-TERM LIABILITIES:
Liability in respect of government grants		14,643			12,930			14,454			4,151
Operaitng lease liability		-			-			6,898			1,981
Loan from others		94,360			42,770			108,353			31,118
Warrants		6,168			7,759			6,908			1,984
Accrued severance pay, net		82			81			87			25
		115,253			63,540			136,700			39,259
SHAREHOLDERS’ EQUITY:
Ordinary shares of NIS 0.0000001 par value:
Authorized: 600,000,000 shares at September 30, 2019, 2018 (unaudited) and December 31, 2018; Issued and outstanding: 402,351,657, 261,419,599 and 261,41,599 shares at September 30, 2019, 2018 (unaudited)  and December 31, 2018, respectively		*)-			*)-			*)-			*)-
Share premium		179,929			179,871			256,889			73,776
Accumulated deficit		(211,144	)		(165,360	)		(277,322	)		(79,644	)
		(31,215	)		14,511			(20,433	)		(5,868	)
		105,837			80,764			119,336			34,272

*) Represents an amount lower than NIS 1.

The accompanying notes are an integral part of the financial statements.

November 20, 2019
Date of approval of the	Mark Germain	Ron Babecoff	Uri Ben-Or
financial statements	Chairman of the Board	Chief Executive officer	Chief Financial officer

2 

BIONDVAX PHARMACEUTICALS LTD.

STATEMENTS OF COMPREHENSIVE LOSS

In thousands, except share and per share data

																Convenience translation (Note 2)
	Year ended December 31,			Three months ended September 30,						Nine months ended September 30,						Nine months ended September 30,
	2018			2018			2019			2018			2019			2019
	Audited			Unaudited												Unaudited
	N I S															U.S. dollars
Operating expenses:
Research and development, net of participations		71,913			4,347			16,133			45,297			37,037			10,637
Marketing, general and administrative		5,154			1,475			2,790			3,804			8,741			2,510
Total operating expenses		77,067			5,822			18,923			49,101			45,778			13,147
Operating loss		(77,067	)		(5,822	)		(18,923	)		(49,101	)		(45,778	)		(13,147	)
Financial income		2,936			3,729			169			9,817			193			55
Financial expense		(13,596	)		(157	)		(601	)		(2,659	)		(20,593	)		(5,914	)
Total financial income (expense), net		(10,660	)		3,572			(432	)		7,158			(20,400	)		(5,859	)
Loss and total comprehensive loss		(87,727	)		(2,250	)		(19,355	)		(41,943	)		(66,178	)		(19,006	)
Basic and diluted net loss per share (in NIS)		(0.34	)		(0.01	)		(0.05	)		(0.16	)		(0.23	)		(0.07	)
Weighted average number of shares outstanding used to compute basic and diluted loss per share		261,419,599			261,419,599			377,899,911			261,419,599			290,794,601			290,794,601

The accompanying notes are an integral part of the financial statements.

3 

BIONDVAX PHARMACEUTICALS LTD.

STATEMENTS OF CHANGES IN SHAREHOLDERS’ EQUITY (DEFICINECY)

In thousands

	Share capital		Share premium		Accumulated deficit			Total deficiency
	Unaudited
	N I S
Balance as of January 1, 2019 (audited)		*)-		179,929		(211,144	)		(31,215	)
Issuance of ordinary shares, net of issuance costs		*)-		70,390		-			70,390
Exercise of options		*)-		1,402		-			1,402
Total comprehensive loss		-		-		(66,178	)		(66,178	)
Share-based compensation		-		5,168		-			5,168
Balance as of September 30, 2019		*)-		256,889		(277,322	)		(20,433	)
Balance as of September 30, 2019 (convenience translation into U.S. dollars (Note 2)		*)-		73,776		(79,644	)		(5,868	)

	Share capital		Share premium		Accumulated deficit			Total equity
	Unaudited
	N I S
Balance as of January 1, 2018 (audited)		*)-		179,669		(123,417	)		56,252
Total comprehensive loss		-		-		(41,943	)		(41,943	)
Share-based compensation		-		202		-			202
Balance as of September 30, 2018		*)-		179,871		(165,360	)		14,511

*) Represents an amount lower than NIS 1.

The accompanying notes are an integral part of the financial statements.

4 

BIONDVAX PHARMACEUTICALS LTD.

STATEMENTS OF CHANGES IN SHAREHOLDERS’ EQUITY (DEFICIENCY)

In thousands

	Share capital		Share premium		Accumulated deficit			Total deficiency
	Unaudited
	N I S
Balance as of July 1, 2019		*)-		185,454		(257,967	)		(72,513	)
Issuance of ordinary shares, net of issuance costs		*)-		70,390		-			70,390
Total comprehensive loss		-		-		(19,355	)		(19,355	)
Share-based compensation		-		1,045		-			1,045
Balance as of September 30, 2019		*)-		256,889		(277,322	)		(20,433	)

	Share capital		Share premium		Accumulated deficit			Total equity
	Unaudited
	N I S
Balance as of July 1, 2018		*)-		179,821		(163,110	)		16,711
Total comprehensive loss		-		-		(2,250	)		(2,250	)
Share-based compensation		-		50		-			50
Balance as of September 30, 2018		*)-		179,871		(165,360	)		14,511

	Share capital		Share premium		Accumulated deficit			Total Equity (deficiency)
	Audited
	N I S
Balance as of January 1, 2018		*)-		179,669		(123,417	)		56,252
Total comprehensive loss		-		-		(87,727	)		(87,727	)
Share-based compensation		-		260		-			260
Balance as of December 31, 2018		*)-		179,929		(211,144	)		(31,215	)

*) Represents an amount lower than NIS 1.

The accompanying notes are an integral part of the financial statements.

5 

BIONDVAX PHARMACEUTICALS LTD.

STATEMENTS OF CASH FLOWS

In thousands

																Convenience translation (Note 2)
	Year ended December 31,			Three months ended September 30,						Nine months ended September 30,						Nine months ended September 30,
	2018			2018			2019			2018			2019			2019
	Audited			Unaudited												Unaudited
	N I S															U.S. dollars
Cash flows from operating activities:
Net loss		(87,727	)		(2,250	)		(19,355	)		(41,943	)		(66,178	)		(19,006	)
Adjustments to reconcile net (loss) to net cash used in operating activities:
Adjustments to profit and loss items:
Depreciation of property, plant and right of use asseets.		260			(179	)		554			235			1,079			310
Net financial expenses (income)		(2,053	)		(4,258	)		3,207			(9,839	)		6,586			1,891
Capital loss		597			634			-			634			-			-
Increase in liability with respect to loans from others		9,202			-			(2,618	)		-			13,993			4,019
Increase in liability with respect to government grants		4,343			140			(167	)		2,630			(189	)		(54	)
Share-based compensation		260			50			1,045			202			5,168			1,484
Change in accrued severance pay, net		(1	)		2			1			(2	)		5			1
		12,608			(3,611	)		2,022			(6,140	)		26,642			7,651
Changes in asset and liability items:
Decrease (increase) in other receivables		2,958			1,401			(629	)		1,257			(922	)		(265	)
Increase (decrease) in trade payables		14,500			409			(6,425	)		(4,441	)		(19,171	)		(5,506	)
Increase (decrease) in other payables		416			201			(528	)		321			(256	)		(74	)
		17,874			2,011			(7,582	)		(2,863	)		(20,349	)		(5,845	)
Cash paid and received during the period for:
Interest paid		(46	)		(16	)		(11	)		(28	)		(121	)		(34	)
Interest received		98			71			-			97			1			*)-
		52			55			(11	)		69			(120	)		(34	)
Net cash flows used in operating activities		(57,193	)		(3,795	)		(24,926	)		(50,877	)		(60,005	)		(17,235	)

The accompanying notes are an integral part of the financial statements.

6 

BIONDVAX PHARMACEUTICALS LTD.

STATEMENTS OF CASH FLOWS

In thousands

																Convenience translation (Note 2)
	Year ended December 31,			Three months ended September 30,						Nine months ended September 30,						Nine months ended September 30,
	2018			2018			2019			2018			2019			2019
	Audited			Unaudited												Unaudited
	N I S															U.S. dollars
Cash flows from investing activities:
Purchase of property and equipment		(23,731	)		(5,936	)		(2,164	)		(19,633	)		(6,441	)		(1,850	)
Proceeds from sale of property and equipment		137			50			-			50			-			-
Increase (decrease) in other long term assets		140			(8	)		3			(8	)		233			67
Net cash used in investing activities		(23,454	)		(5,894	)		(2,161	)		(19,591	)		(6,208	)		(1,783	)
Cash flows from financing activities:
Proceeds from loan from others		84,321			25,417			-			50,689			-			-
Lease hold payments								(314	)					(943	)		(271	)
Proceeds from issuance of shares, net		-			-			70,390			-			70,578			20,269
Net cash provided by financing activities		84,321			25,417			70,076			50,689			69,635			19,998
Exchange differences on balances of cash and cash equivalents		827			(417	)		(1,658	)		1,382			(4,058	)		(1,163	)
Increase (decrease) in cash and cash equivalents		4,501			15,857			41,331			(18,397	)		(636	)		(183	)
Balance of cash and cash equivalents at the beginning of the period		71,382			37,128			33,916			71,382			75,883			21,793
Balance of cash and cash equivalents at the end of the period		75,883			52,985			75,247			52,985			75,247			21,610
Non cash financing activities:
Exercise of options to public		-			-			-			-			1,214			349

The accompanying notes are an integral part of the financial statements.

7 

BIONDVAX PHARMACEUTICALS LTD.

NOTES TO FINANCIAL STATEMENTS

In thousands (except share and per share data)

NOTE 1: GENERAL

a. BiondVax Pharmaceuticals Ltd. (“the Company”) is focused on developing and ultimately, commercializing immunomodulation therapies for infectious diseases. The Company was incorporated on July 21, 2003 and started its activity on March 31, 2005.

b. On June 7, 2007, the Company issued ordinary shares and options on the TASE.

c. On May 15, 2015, the Company completed a public offering of securities in the United States.

d. On March 28, 2017, the Company received an approval from the Investment Center of the Ministry of Economy and Industry of the State of Israel, for a grant representing 20% of NIS 20,000 budget to be utilized towards the construction of a factory for the production of Phase 3 and commercial batches of the Company is product (“the Grant”). The receipt of the Grant is subject to certain terms and conditions, including those outlined under the Israeli Encouragement of Capital Investment Law,1959. The terms and conditions include, inter alia, the following: (a) at least 24% of the investments in the planned manufacturing facility’s fixed assets will be financed by additional share capital; (b) the Company will maintain its intellectual property and manufacturing facility in Israel for a period of at least 10 years.

e. On June 19, 2017, the Company entered into a Finance Contract with The European Investment bank (EIB) for a total amount of € 20,000 (approximately $ 23,000) and up to 50% of the Company expected cost of developing and marketing the Company’s product candidate, M-001. In addition, EIB shall be entitled to the higher between 3% of any annual M-001 sales revenues for a period of ten years, or EIB realizing cash-on-cash Multiple of 2.8.

On April 22, 2019, the Committee of the European Investment Bank (EIB) agreed to extend the 2017 financing agreement to the Company by an additional € 4,000, signed on June 2019 (the “Amendment”). The funds will be used in support of the ongoing pivotal, clinical efficacy, Phase 3 trial of BiondVax’s M-001 Universal Flu Vaccine candidate in Europe.

According to the Amendment, EIB shall be entitled to, the higher between, 3% of any annual M-001 sales revenues for a period of twelve years or EIB realizing cash-on-cash Multiple of 2.8.

As of the reporting date , the Company received a total amout of € 20,000 (approximately $ 23,000) out of the 2017 financing agreement.

8 

BIONDVAX PHARMACEUTICALS LTD.

NOTES TO FINANCIAL STATEMENTS

In thousands (except share and per share data)

NOTE 1: GENERAL (Cont.)

f. On August 30, 2017, the Company announced that its Board of Directors has decided to voluntarily delist from the Tel Aviv Stock Exchange (TASE), while remaining listed on NASDAQ. The Company announced that the delisting process of BiondVax’s shares from trading on the TASE will take place by the end of 2017. On October 30, 2017, the Company announced the delisting procedure and timeline. On June 13, 2019, the Company issued 334,520 ordinary shares (equivalent to 8,363 NASDAQ listed ADSs) in consideration of NIS 188 (approximately $ 53).

g. On July 16 2019, the Company closed a public offering and issued 3,057,466 NASDAQ listed ADSs (equivalent to 122,298,640 ordinary shares) and 18,298,898 ordinary shares (equivalent to 457,472 NASDAQ listed ADSs) in consideration of $ 20,000 (approximately NIS 71,300 million) to a number of investores.

Angels Investments in High Tech Ltd. (“AIHT”) exercised their option to purchase, under the same terms of the public offering, 2,203,640 ADSs and 141,538 ordinary shares offered in the public offering that were not purchased by other shareholders. In total, Mr. Nacht’s investment through AIHT in this offering was approximately $ 16,670, making AIHT a controlling shareholder (as defined under the Israeli Companies Law) with a holding of about 42% in BiondVax.

h. In the nine months ended September 30, 2019, the Company incurred a loss of NIS 66,178 ($ 19,006) and negative cash flows from operating activities of NIS 60,005 ($ 17,235) and it has an accumulated deficit of NIS 277,322 ($ 79,644) as of that date.

To date the Company has not generated any revenues yet and will need additional funds to finance its Phase 3 clinical trials in the future.

Furthermore, the Company intends to continue to finance its operating activities by raising capital. There are no assurances that the Company will be successful in obtaining an adequate level of financing needed for its long-term research and development activities.

If the Company will not have the sufficient liquidity resources, the Company may not be able to continue the development of all its products or may be required to implement a cost reduction and may be required to delay part of its development program. The Company’s management and Board of Directors are in the opinion that its current financial resources will be sufficient to continue the development of the Company’s products for at least the next twelve months.

NOTE 2:- CONVENIENCE TRANSLATION INTO U.S. DOLLARS

The financial statements as of September 30, 2019 and for the nine months then ended have been translated into dollars using the representative exchange rate as of that date ($ 1 = NIS 3.482). The translation was made solely for the convenience of the reader. The amounts presented in these financial statements should not be construed to represent amounts receivable or payable in dollars or convertible into dollars, unless otherwise indicated in these statements.

9 

BIONDVAX PHARMACEUTICALS LTD.

NOTES TO FINANCIAL STATEMENTS

In thousands (except share and per share data)

NOTE 3: SIGNIFICANT ACCOUNTING POLICIES

a. Basis of preparation of the interim financial statements:

The interim consolidated financial statements have been prepared in accordance with generally accepted accounting principles for the preparation of financial statements for interim periods, as prescribed in IAS 34, “Interim Financial Reporting”, and in accordance with the disclosure requirements of Chapter D of the Securities Regulations (Periodic and Immediate Reports), 1970.

The significant accounting policies and methods of computation adopted in the preparation of the interim financial statements are consistent with those followed in the preparation of the Company’s annual financial statements, except as described below:

b. Leases:

As detailed in paragraph c(1) below regarding the initial adoption of IFRS 16, “Leases” (“the Standard”), the Company chose to adopt the provisions of the Standard using the modified retrospective approach (without restatement of comparative figures).

The accounting policy on leases applied before December 31, 2018 is as follows:

The criteria for classifying leases as finance or operating leases depend on the substance of the agreements and are made at the inception of the lease in accordance with the following principles as set out in IAS 17.

Operating leases:

Leases in which substantially all the risks and rewards of ownership of the leased asset are not transferred to the Group are classified as operating leases. Lease payments are recognized as an expense in profit or loss on a straight-line basis over the lease term.

The accounting policy on leases applied effective from January 1, 2019 is as follows:

The Company accounts for a contract as a lease when the contract terms convey the right to use an underlying asset for a period of time in exchange for consideration.

1. The Company as a lessee:

For leases in which the Company is the lessee, the Company recognizes on the commencement date of the lease a right-of-use asset and a lease liability, excluding leases whose term is up to 12 months and leases for which the underlying asset is of low value. For these leases, the Company has elected to recognize the lease payments as an expense in profit or loss on a straight-line basis over the lease term. In measuring the lease liability, the Company has elected to apply the practical expedient in the Standard and does not separate the lease components from the non-lease components (such as management and maintenance services, etc.) included in a single contract.

10 

BIONDVAX PHARMACEUTICALS LTD.

NOTES TO FINANCIAL STATEMENTS

In thousands (except share and per share data)

NOTE 3:- SIGNIFICANT ACCOUNTING POLICIES (Cont.)

Leases which entitle employees to a company car as part of their employment terms are accounted for as employee benefits in accordance with the provisions of IAS 19 and not as subleases.

On the commencement date, the lease liability includes all unpaid lease payments discounted at the interest rate implicit in the lease, if that rate can be readily determined, or otherwise using the Company’s incremental borrowing rate. After the commencement date, the Company measures the lease liability using the effective interest rate method.

On the commencement date, the right-of-use asset is recognized in an amount equal to the lease liability plus lease payments already made on or before the commencement date and initial direct costs incurred. The right-of-use asset is measured applying the cost model and depreciated over the shorter of its useful life or the lease term. The Company tests for impairment of the right-of-use asset whenever there are indications of impairment pursuant to the provisions of IAS 36.

2. Variable lease payments that depend on an index:

On the commencement date, the Company uses the index rate prevailing on the commencement date to calculate the future lease payments.

For leases in which the Company is the lessee, the aggregate changes in future lease payments resulting from a change in the index are discounted (without a change in the discount rate applicable to the lease liability) and recorded as an adjustment of the lease liability and the right-of-use asset. The effect of the change in the index on current payments is recorded in profit or loss.

3. Lease extension and termination options:

A non-cancellable lease term includes both the periods covered by an option to extend the lease when it is reasonably certain that the extension option will be exercised and the periods covered by a lease termination option when it is reasonably certain that the termination option will not be exercised.

In the event of any change in the expected exercise of the lease extension option or in the expected non-exercise of the lease termination option, the Company remeasures the lease liability based on the revised lease term using a revised discount rate as of the date of the change in expectations. The total change is recognized in the carrying amount of the right-of-use asset until it is reduced to zero, and any further reductions are recognized in profit or loss.

11 

BIONDVAX PHARMACEUTICALS LTD.

NOTES TO FINANCIAL STATEMENTS

In thousands (except share and per share data)

NOTE 3:- SIGNIFICANT ACCOUNTING POLICIES (Cont.)

4. Lease modifications:

If a lease modification does not reduce the scope of the lease and does not result in a separate lease, the Company remeasures the lease liability in the modified contract at the revised discount rate on the modification date and carries the change in the lease liability to the right-of-use asset.

If a lease modification reduces the scope of the lease, the Company recognizes a profit or loss arising from the partial or full reduction in the carrying amount of the right-of-use asset and the lease liability. The Company subsequently remeasures the carrying amount of the lease liability according to the revised lease terms, at the revised discount rate on the modification date and carries the change in the lease liability to the right-of-use asset.

c. Initial adoption of new financial reporting and accounting standards and amendments to existing financial reporting and accounting standards:

Initial adoption of IFRS 16, “Leases”:

In January 2016, the IASB issued IFRS 16, “Leases” (“the Standard”), which supersedes IAS 17, “Leases” (“the old Standard”), IFRIC 4, “Determining Whether an Arrangement Contains a Lease”, and SIC-15, “Operating Leases - Incentives”. According to the Standard, a lease is a contract, or part of a contract, that conveys the right to use an asset for a period of time in exchange for consideration.

The effects of the adoption of the Standard are as follows:

● According to the Standard, lessees are required to recognize all leases in the statement of financial position (excluding certain exceptions, see below). Lessees will recognize a liability for lease payments with a corresponding right-of-use asset, similar to the accounting treatment for finance leases under the existing standard, IAS 17, “Leases”. Lessees will also recognize interest expense and depreciation expense separately.

● Variable lease payments that are not dependent on changes in the CPI or interest rates, but are based on performance or usage are recognized as an expense by the lessees as incurred or recognized as income by the lessors as earned.

● In the event of changes in variable lease payments that are CPI-linked, lessees are required to remeasure the lease liability and record the effect of the remeasurement as an adjustment to the carrying amount of the right-of-use asset.

12 

BIONDVAX PHARMACEUTICALS LTD.

NOTES TO FINANCIAL STATEMENTS

In thousands (except share and per share data)

NOTE 3:- SIGNIFICANT ACCOUNTING POLICIES (Cont.)

● The Standard includes two exceptions which allow lessees to account for leases based on the existing accounting treatment for operating leases - leases for which the underlying asset is of low financial value and short-term leases (up to one year).

● The accounting treatment by lessors remains substantially unchanged from the existing standard, namely classification of a lease as a finance lease or an operating lease.

The Standard has been applied for the first time in these financial statements. As permitted by the Standard, the Company elected to adopt the provisions of the Standard using the modified retrospective method whereby the carrying amount of the right-of-use assets is identical to the carrying amount of the lease liability.

According to this approach, no comparative figures are restated. The carrying amount of the lease liability as of the date of initial adoption of the Standard is calculated using the Company’s incremental borrowing rate on the date of initial adoption of the Standard.

See details of the accounting policy applied from the date of initial adoption of the Standard in paragraph b above.

The main effect of the initial adoption of the Standard relates to existing leases in which the Company acts as lessee. According to the Standard, as explained in paragraph b above, excluding certain practical expedients, the Company recognizes for each lease contract in which it acts as lessee the carrying amount of the lease liability against the carrying amount of the right-of-use asset, as opposed to the accounting policy adopted in the old Standard according to which the lease payments in leases in which substantially all the risks and rewards incidental to ownership of the leased asset were not effectively transferred to the lessee were recognized as an expense in profit or loss using the straight-line method over the lease term.

Following are data relating to the initial adoption of the Standard as of January 1, 2019, in respect of existing leases as of that date:

13 

BIONDVAX PHARMACEUTICALS LTD.

NOTES TO FINANCIAL STATEMENTS

In thousands (except share and per share data)

NOTE 3:- SIGNIFICANT ACCOUNTING POLICIES (Cont.)

a) Effects of the initial application of the Standard on the Company’s financial statements as of January 1, 2019:

	According to the previous accounting policy			The change		As presented according to IFRS 16
	NIS
As of January 1, 2019:
Non-current assets:
Right-of-use assets		-			8,084		8,084
Current liabilities:
Current maturity of lease liability		-			1,096		1,096
Non-current liabilities:
Lease liability		-			6,988		6,988
Accumulated deficit		(211,144	)		-		(211,144	)

b) The Company hired an external valuation expert for determining the nominal interest rate for discounting its leases based on the companies’ financing risk, the average life of the leases and other economic variables. A weighted average incremental borrowing rate of 7.9% was used to discount future lease payments in the calculation of the lease liability on the date of initial adoption of the Standard.

14 

BIONDVAX PHARMACEUTICALS LTD.

NOTES TO FINANCIAL STATEMENTS

In thousands (except share and per share data)

NOTE 3:- SIGNIFICANT ACCOUNTING POLICIES (Cont.)

c) Reconciliation of total commitment for future minimum lease payments as disclosed in Note 12e to the annual financial statements as of December 31, 2018, to the lease liability as of January 1, 2019:

	January 1, 2019
	NIS
Total future minimum lease payments for non-cancellable leases as per IAS 17 according to the financial statements as of December 31, 2018		10,932
Total undiscounted lease liabilities as per IFRS 16		10,932
Effect of discount of future lease payments at the Company’s incremental borrowing rate on initial date of adoption		(2,848	)
Total lease liabilities resulting from initial adoption of IFRS 16 as of January 1, 2019		8,084

d) Practical expedients applied in the initial adoption of the Standard:

(1) The Company elected not to reassess based on the principles in the Standard whether contracts are or contain a lease, and instead continued to classify contracts as leases that were previously identified as leases under IAS 17.

(2) The Company elected to apply a single discount rate to a portfolio of leases with reasonably similar characteristics.

(3) The Company elected to rely on its assessment of whether leases are onerous by applying IAS 37, as an alternative to performing an impairment review of the right-of-use asset on the date of initial adoption.

(4) The Company elected not to recognize a lease liability and right-of-use asset for leases whose term ends within 12 months of the date of initial adoption, and instead accounted for such leases as short-term leases.

(5) The Company elected to exclude initial direct costs from the measurement of right-of-use assets at the date of initial adoption.

(6) The Company elected to use hindsight in determining the lease term in contracts containing options to extend or terminate the lease.

15 

BIONDVAX PHARMACEUTICALS LTD.

NOTES TO FINANCIAL STATEMENTS

In thousands (except share and per share data)

NOTE 4:- FINANCIAL INSTRUMENTS

Fair value measurement:

As of September 30, 2019, warrants liability is measured at fair value and classified as Level 1 while loans from others and government grant are classified as Level 2.

During the nine months of 2019 there were no transfers in respect of fair value measurement of any financial instrument between Level 1 and Level 2, and there were no transfers into or out of Level 3 fair value measurements of any financial instrument.

NOTE 5:- SUBSEQUENT EVENT

On October 7 2019, the Company received the remaining € 4,000 EIB (see also Note 1e).

- - - - - - - - - - - - -

 16