10-Q

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 10-Q

(Mark One)

☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended March 31, 2023

☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from ___________ to ___________

Commission File Number: 001-37353

BIONDVAX PHARMACEUTICALS LTD.

(Exact name of registrant as specified in its charter)

Israel	Not Applicable
(State or other jurisdiction of incorporation or organization)	(I.R.S. Employer Identification No.)

Jerusalem BioPark, 2^nd Floor
Hadassah Ein Kerem Campus
Jerusalm, Israel

(Address of principal executive offices)

Registrant’s telephone number, including area code: (+972) 8-930-2529

Securities registered pursuant to Section 12(b) of the Act: None

Title of each class	Trading Symbol(s)	Name of each exchange on which registered
American Depositary Shares, each representing 400 Ordinary Shares, no par value	BVXV	The Nasdaq Capital Market
Ordinary Shares, no par value		The Nasdaq Capital Market*

* Not for trading; only in connection with the registration of American Depositary Shares.

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.

Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).

Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company filer. See definition of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large Accelerated Filer	☐	Accelerated Filer	☐
Non-Accelerated Filer	☒	Smaller Reporting Company	☒
		Emerging Growth Company	☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).

Yes ☐ No ☒

As of May 10, 2023, there were 1,313,623,184 ordinary shares issued and outstanding.

General and Where You Can Find Other Information

Unless otherwise indicated, all references to the “Company,” “we,” “our,” “BiondVax” and “BiondVax Pharmaceuticals” refer to BiondVax Pharmaceuticals Ltd., a company limited by shares organized under the laws of Israel. References to “revenues” refer to net revenues. References to “U.S. dollars,” “dollars,” “U.S. $” and “$” are to the lawful currency of the United States of America, and references to “NIS” are to new Israeli shekels.

BIONDVAX PHARMACEUTICALS LTD.

BIONDVAX PHARMACEUTICALS LTD.

FORM 10-Q

INDEX

		Page
PART I- FINANCIAL INFORMATION
Item 1	Financial Statements	1
	Balance Sheets as of March 31, 2023 (unaudited) and December 31, 2022	1
	Statements of Operations for the three months ended March 31, 2023 and 2022 (unaudited)	3
	Statements of Stockholders’ Equity for three months ended March 31, 2023 and 2022 (unaudited)	5
	Condensed Consolidated Statements of Cash Flows for the three months ended March 31, 2023 and 2022 (unaudited)	6
	Notes to Condensed Consolidated Financial Statements	8
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	16
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	24
Item 4.	Control and Procedures	24
PART II- OTHER INFORMATION
Item 1.	Legal Proceedings	25
Item 1A.	Risk Factors	25
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	25
Item 3.	Defaults Upon Senior Securities	25
Item 4.	Mine Safety Disclosures	25
Item 5.	Other Information	25
Item 6.	Exhibits	25

i

PART I – FINANCIAL INFORMATION

Item 1. Financial Statements

BIONDVAX PHARMACEUTICALS LTD.

CONDENSED BALANCE SHEETS (Unaudited)

U.S. dollars in thousands (except share and per share data)

	March 31,		December 31,
	2023		2022
	Unaudited		Audited
ASSETS
CURRENT ASSETS:
Cash and cash equivalents	$	10,799	$	14,075
Restricted cash		127		140
Prepaid expenses and other receivables		119		155
Total current assets		11,045		14,370
NON-CURRENT ASSETS:
Property, plant and equipment, net		10,817		11,245
Operating lease right-of-use assets		1,430		1,452
Total non-current assets		12,247		12,697
Total assets	$	23,292	$	27,067

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

1

BIONDVAX PHARMACEUTICALS LTD.

CONDENSED BALANCE SHEETS (Unaudited)

U.S. dollars in thousands (except share and per share data)

	March 31,			December 31,
	2023			2022
	Unaudited			Audited
LIABILITIES AND SHAREHOLDERS’ EQUITY
CURRENT LIABILITIES:
Trade payables	$	1,313		$	716
Operating lease liabilities		420			382
Other payables		846			1,240
Total current liabilities		2,579			2,338
NON-CURRENT LIABILITIES:
Warrants liability		2,664			5,329
Loan from others		21,851			20,082
Non-current operating lease liabilities		1,008			1,078
Total non-current liabilities		25,523			26,489
CONTINGENT LIABILITIES AND COMMITMENTS
SHAREHOLDERS’ EQUITY (DEFICIT):
Ordinary shares of no par value: Authorized: 20,000,000,000 shares at March 31, 2023 and at December 31, 2022; Issued and outstanding 1,313,623,184 shares at March 31, 2023 and 989,290,784  shares at December 31, 2022		-			-
Additional paid-in capital		116,431			116,082
Accumulated deficit		(119,350	)		(115,835	)
Accumulated other comprehensive loss		(1,891	)		(2,007	)
Total shareholders’ deficit		(4,810	)		(1,760	)
Total liabilities and shareholders’ deficit	$	23,292		$	27,067

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

2

BIONDVAX PHARMACEUTICALS LTD.

CONDENSED STATEMENTS OF OPERATIONS (Unaudited)

U.S. dollars in thousands (except share and per share data)

	Three months ended March 31,
	2023			2022
	Unaudited			Unaudited
Research and development	$	1,995		$	1,163
Marketing, general and administrative		1,191			1,452
Total operating loss		3,186			2,615
Financial loss (income), net		329			(140	)
Net loss	$	3,515		$	2,475
Basic and diluted net loss per share		(0.003	)		(0.003	)
Weighted average number of shares used for computing basic and diluted net loss per share		1,295,256,604			744,711,465

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

3

BIONDVAX PHARMACEUTICALS LTD.

CONDENSED STATEMENTS OF COMPREHENSIVE LOSS (Unaudited)

U.S. dollars in thousands (except share and per share data)

	Three months ended March 31,
	2023			2022
	Unaudited			Unaudited
Net loss	$	3,515		$	2,475
Other comprehensive (income) loss:
Foreign currency translation adjustments		(116	)		34
Total comprehensive loss	$	3,399		$	2,509

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

4

BIONDVAX PHARMACEUTICALS LTD.

CONDENSED STATEMENTS OF CHANGES I N SHAREHOLDERS’ EQUITY (Unaudited)

U.S. dollars in thousands (except share and per share data)

	Ordinary shares				Additional paid-in		Accumulated comprehensive			Accumulated			Total shareholders’
	Number		Amount		capital		loss			deficit			equity
Balance as of January 1, 2023		989,290,784	$	-	$	116,082	$	(2,007	)	$	(115,835	)	$	(1,760	)
Exercise of warrants		324,000,000		-		97		-			-			97
Vested RSU’s		332,400		-		-		-			--			-
Share-based compensation		-		-		252		-			-			252
Other comprehensive income		-		-		-		116			-			116
Net loss		-		-		-		-			(3,515	)		(3,515	)
Balance as of March 31, 2023		1,313,623,184	$	-	$	116,431	$	(1,891	)	$	(119,350	)		(4,810	)

	Ordinary shares				Additional paid-in		Accumulated comprehensive			Accumulated			Total shareholders’
	Number		Amount		capital		loss			deficit			equity
Balance as of January 1, 2022		739,048,544		-		113,076		(2,055	)		(110,039	)		982
Issuance of shares, net of issuance costs of $6		6,000,000		-		216		-			-			216
Share-based compensation		-				485		-			-			485
Other comprehensive loss		-		-		-		(34	)		-			(34	)
Net loss		-		-		-		-			(2,475	)		(2,475	)
Balance as of March 31, 2022		745,048,544	$	-	$	113,777	$	(2,089	)	$	(112,514	)	$	(862	)

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

5

BIONDVAX PHARMACEUTICALS LTD.

CONDENSED STATEMENTS OF CASH FLOWS (Unaudited)

U.S. dollars in thousands (except share and per share data)

	Three months ended March 31,
	2023			2022
	Unaudited			Unaudited
Cash flows from operating activities:
Net loss	$	(3,515	)	$	(2,475	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation of property, plant and equipment		138			134
Expense of in-process research and development		-			209
Financial expenses related to loan from others		2,354			28
Share-based compensation		252			485
Decrease in other receivables		31			123
Warrants revaluation		(2,568	)		-
Changes in operating lease right-of-use assets		(18	)		63
Increase in trade payables		629			311
Changes in operating lease liabilities		7			(62	)
(Decrease) increase in other payables		(369	)		79
Net cash used in operating activities		(3,059	)		(1,105	)
Cash flows from investing activities:
Purchase of property, plant and equipment		(6	)		(521	)
Net cash used in investing activities	$	(6	)	$	(521	)

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

6

BIONDVAX PHARMACEUTICALS LTD.

CONDENSED STATEMENTS OF CASH FLOWS

U.S. dollars in thousands (except share and per share data)

	Three months ended March 31,
	2023			2022
	Unaudited			Unaudited
Cash flows from financing activities:
	$	-		$	-
Net cash provided by financing activities		-			-
Effect of exchange rate changes on cash, cash equivalents and restricted cash		(224	)		(359	)
Decrease in cash, cash equivalents and restricted cash		(3,289	)		(1,985	)
Cash, cash equivalents and restricted cash at the beginning of the period		14,215			17,517
Cash, cash equivalents and restricted cash at the end of the period	$	10,926		$	15,532
Supplementary disclosure of cash flows activities:
(1) Cash paid during the year for:
Interest	$	725		$	-
(2) Non-cash transactions:
Exercise of warrants liability to equity	$	97		$	-
Reconciliation of cash, cash equivalents and restricted cash:
Cash and cash equivalents	$	10,799		$	15,392
Restricted cash		127			140
Cash, cash equivalents and restricted cash	$	10,926		$	15,532

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

7

BIONDVAX PHARMACEUTICALS LTD.

NOTES TO CONDENSED FINANCIAL STATEMENTS (Unaudited)

U.S. dollars in thousands (except share and per share data and unless otherwise indicated)

NOTE 1:- GENERAL

a. Biondvax Pharmaceuticals Ltd. (the “Company”), is a biotechnology company focused on developing, manufacturing, and commercializing innovative immunotherapeutic products primarily for the treatment of infectious and autoimmune diseases. The Company was incorporated on July 21, 2003 in Israel, and started its activity on March 31, 2005. The Company’s principal executive offices, manufacturing site and R&D laboratories are located at Jerusalem, Israel.

b. On December 22, 2021, the Company signed an exclusive, worldwide, license agreement with the Max Planck Society (“MPG”), the parent organization of the Max Planck Institute for Multidisciplinary Sciences, and the University Medical Center Göttingen (“UMG”), both in Germany, for the development and commercialization of an innovative Covid-19 NanoAb therapy and an accompanying research collaboration agreement with MPG and UPG in support of the abovementioned development of a COVID-19 NanoAb. The agreements became effective January 1, 2022 and provide for an upfront payment, development and sales milestones and royalties based on sales and sharing of sublicense revenues.

c. On March 23, 2022, the Company executed an additional research collaboration agreement (RCA) with MPG and UMG covering discovery, selection and characterization of NanoAbs for several other disease indications with large and growing markets that leverage their unique and strong binding affinity, stability at high temperatures, and potential for more effective and convenient routes of administration. These targets are the basis for validated and currently marketed monoclonal antibodies, including for conditions such as psoriasis, asthma, macular degeneration, and psoriatic arthritis. According to the contract, BiondVax will have an exclusive option for exclusive license agreement for the development and commercialization of each of the NanoAbs covered by the agreement with MPG and UMG. On February 7, 2022 the Company issued 15,000 ADSs (6,000,000 shares) to Max-Planck-Gesellschaft zur Förderung der Wissenschaften e.V. under our exclusive, worldwide, License Agreement with MPG and UMG pursuant to Regulation S under the Securities Act;

d. As of March 31, 2023, the Company’s cash and cash equivalents totaled $10,799. In the three months ended March 31, 2023, the Company had an operating loss of $3,186 and negative cash flows from operating activities of $3,059. The Company’s current operating budget includes various assumptions concerning the level and timing of cash receipts and cash outlays for operating expenses and capital expenditures, including a cost saving plan. The Company is planning to finance its operations from its existing working capital resources and additional sources of capital and financing. However, there is no assurance that additional capital and/or financing will be available to the Company, and even if available, whether it will be on terms acceptable to the Company or in amounts required. Accordingly, the Company’s board of directors approved a cost saving plan, to be implemented if and as required, in whole or in part, at its discretion, to allow the Company to continue its operations and meet its cash obligations. The cost saving plan consists of cutting expenditures by means of further efficiencies and synergies, which include mainly the following steps: reduction in headcount and postponing or cancelling capital expenditures that would not be required for the implementation of the revised business plan. Nevertheless, the Company and the board of directors believe that its existing financial resources and its operating plans, including the effects of the costs saving plan, will be adequate to satisfy its expected liquidity requirements for a period of at least twelve months from the end of the filing date.

8

BIONDVAX PHARMACEUTICALS LTD.

NOTES TO CONDENSED FINANCIAL STATEMENTS (Unaudited)

U.S. dollars in thousands (except share and per share data and unless otherwise indicated)

NOTE 1:- GENERAL (Cont.)

e. Basis of presentation of the financial statements:

The accompanying unaudited condensed financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and in accordance with the instructions to Form 10-Q and Article 10 of Regulation S-X promulgated by the U.S Securities and Exchange Commission (the “SEC”). Certain information or footnote disclosures normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted, pursuant to the rules and regulations of the SEC for interim financial reporting. Accordingly, they do not include all the information and footnotes necessary for a complete presentation of financial position, results of operations, or cash flows. In the opinion of management, the accompanying unaudited condensed financial statements include all adjustments, consisting of a normal recurring nature, which are necessary for a fair presentation of the financial position, operating results and cash flows for the periods presented.

The accompanying unaudited condensed financial statements should be read in conjunction with the Company’s Annual Report on Form 10-K as of December 31, 2022 filed with the SEC on April 17, 2023. The interim period results do not necessarily indicate the results that may be expected for any other interim period or for the full fiscal year.

f. Use of estimates:

The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates, judgments and assumptions that affect the amounts reported in the financial statements and accompanying notes. The Company’s management believes that the estimates, judgment and assumptions used are reasonable based upon information available at the time they are made. These estimates, judgments and assumptions can affect the reported amounts of assets and liabilities at the dates of the financial statements, and the reported amount of expenses during the reporting periods. Actual results could differ from those estimates.

g. Cash equivalents:

Cash equivalents are short-term highly liquid deposits that are readily convertible to cash with original maturities of three months or less, at the date acquired.

h. Restricted cash:

Restricted cash are deposits with original maturities of three months or less and are used as security for the Company’s credit cards and rent. Restricted cash amounted to $127 and $140 as of March 31, 2023 and December 31, 2022 respectively.

i. Warrants:

The Company accounts for warrants as either equity-classified or liability-classified instruments based on an assessment of the warrant’s specific terms and applicable authoritative guidance. The assessment considers whether the warrants are freestanding financial instruments, meet the definition of a liability under ASC 480, and meet all of the requirements for equity classification, including whether the warrants are indexed to the Company’s own common stock. Warrants that determined to be classified as equity, are recorded as a component of additional paid-in capital. Warrants that determined to be classified as liabilities are recorded at their initial fair value on the date of issuance and remeasured to fair value at each balance sheet date thereafter. Changes in the estimated fair value of the warrants are recognized in financial expenses, net in the statements of operations.

j. Recently adopted accounting pronouncements:

In June 2016, the FASB issued ASU 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”). ASU 2016-13 requires the measurement of all expected credit losses for financial assets held at the reporting date based on historical experience, current conditions, and reasonable and supportable forecasts. ASU 2016-13 requires enhanced qualitative and quantitative disclosures to help investors and other financial statement users better understand significant estimates and judgments used in estimating credit losses, as well as the credit quality and underwriting standards of an organization’s portfolio. ASU 2016-13 is effective for fiscal years beginning after December 15, 2022, and interim periods within those fiscal years. The adoption of this ASU did not have a significant impact on the Company’s financial statements and disclosures.

9

BIONDVAX PHARMACEUTICALS LTD.

NOTES TO CONDENSED FINANCIAL STATEMENTS (Unaudited)

U.S. dollars in thousands (except share and per share data and unless otherwise indicated)

NOTE 2:- FAIR VALUE MEASUREMENTS

In accordance with ASC No. 820, the Company measures warrants liability at fair value classified within Level 2 as the valuation inputs are based on quoted prices and market observable data of similar instruments.

The following table presents assets measured at fair value on a recurring basis as of March 31, 2023:

	March 31,		December 31,
	2023		2022
	Unaudited		Audited
	Fair value measurement using input Level 2
Non-current liabilities:
Warrants liability	$	2,664	$	5,329
Total liabilities	$	2,664	$	5,329

The carrying amounts of cash and cash equivalents, restricted cash, prepaid expenses and other receivables, trade payables and other current payables approximate their fair value due to the short-term maturity of such instruments.

NOTE 3:- LOAN FROM OTHERS

a. On June 19, 2017, the Company entered into a Finance Contract with the European Investment bank (EIB) for a total amount of approximately $22,422 (€ 20,000) and up to 50% of the Company’s expected cost of developing and marketing the Company’s product candidate, M-001. In addition, as a repayment features, EIB was entitled to receive the higher between 3% of any M-001 sales revenues for a period of ten years, or realizing a cash-on-cash multiple of 2.8 times

During 2018, the Company received approximately $23,599 (€ 20,000) in two tranches of approximately $7,080 (€ 6,000) and the third tranche of approximately $9,439 (€ 8,000).
On October 7, 2019, the Company received the remaining approximately $4,390 (€ 4,000).

In the event the Company elects to prepay the EIB financing, or in the event the EIB shall demand prepayment following certain events, including a change of control, senior management changes or merger events, the Company shall be required to pay EIB the principal amount of the tranches already paid, or the Prepayment Amount, plus the greater of:

(i) the amount, as determined by EIB required in order for the EIB to realize an internal rate of return on the relevant amount prepaid of 20%; and

(ii) the Prepayment Amount.

The Finance Contract also stipulates that in the event the EIB demands prepayment of the loan due to any prepayment event to non-EIB lenders, the Company shall be obligated to pay the Prepayment Amount plus an additional reduced amount. In addition, and as consideration for the EIB financing, the EIB shall be entitled to 3% of any annual M-001 sales revenues.

b. On April 22, 2019, the Committee of EIB Bank agreed to expand the 2017 financing agreement to the Company by an additional approximately $4,502 (€ 4,000) to a total of approximately $27,013 (€ 4,000). An amendment to that effect was signed in June 2019 (the “Amendment”). Those funds were received in October 2019 and 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, as repayment features, EIB is entitled to receive the higher between 3% of any M-001 sales revenues for a period of twelve years or realizing a cash-on-cash multiple of 2.8 times

10

BIONDVAX PHARMACEUTICALS LTD.

NOTES TO CONDENSED FINANCIAL STATEMENTS (Unaudited)

U.S. dollars in thousands (except share and per share data and unless otherwise indicated)

NOTE 3:- LOAN FROM OTHERS (Cont.)

c. On October 23, 2020, the Company announced Phase 3 clinical trial results of the M-001 universal vaccine product. The results did not demonstrate a statistically significant difference between the vaccinated group and the placebo group in reduction of flu illness and severity. Therefore, the study failed to meet both the primary and secondary efficacy endpoints. However, the study’s primary safety endpoint was met.

As a result of the Phase 3 clinical trial failure, Company’s management estimates that there will be no future revenues from the M-001 product. Therefore, most likely, there will be no future royalty payments to EIB.

Under the Finance Contract, the EIB may accelerate all loans extended thereunder if an event of default has occurred, which includes, amongst other things, an event of default arising from the occurrence of a material adverse change, defined as any event or change of condition, which in the opinion of the EIB, has a material adverse effect on: our ability to perform our obligations under the Finance Documents; our business, operations, property, condition (financial or otherwise) or prospects; or the rights or remedies of the EIB under the Finance Contract, amongst other things. If the EIB determines that an event of default has occurred, it could accelerate the amounts outstanding under the Finance Contract, making those amounts immediately due and payable.

In accordance with the EIB loan agreement, and due to the above, the Company was required to pay EIB the principal amount of the tranches already loaned by the EIB to the Company, within five years of the date of each tranche of the loan. On December 31, 2020, the Company re-evaluated the loan in the sum of $ 29,443. As a result, the Company recorded an amount of $ 6,162 as revaluation income of the EIB loan.

On January 26, 2021, the EIB notified the Company that they welcome the Company’s efforts to secure future equity financing in an amount not less than $ 2,000 in order to enable the Company to pursue new business opportunities, strengthen the Company balance sheet and invest in growth. Thus, within that context, the EIB wrote in their letter that they will not consider the failure of the Company’s pivotal phase 3 trial for M-001 to meet the primary and secondary efficacy endpoints as a trigger for prepayment of a loan extended under the Finance Contract. However, EIB cautioned the Company that their letter is not a consent, agreement, amendment or waiver in respect of the terms of the Finance Contract, reserving any other right or remedy the EIB may have now or subsequently.

d. On August 9, 2022, the Company signed a loan restructuring agreement with the European Investment Bank (EIB) for the new terms of its outstanding approximately $24,554 (€ 24,000) loan to the Company. The new terms include:

1. An extension of the maturity dates from 2023 (approximately $20,462) and 2024 (approximately $4,092) until December 31, 2027.

2. Interest on the Loan will begin to accrue starting January 1, 2022, at an annual rate of 7%. The interest payments will be deferred until the new maturity date and will be added to the principal balance at the end of each year during the loan period.

11

BIONDVAX PHARMACEUTICALS LTD.

NOTES TO CONDENSED FINANCIAL STATEMENTS (Unaudited)

U.S. dollars in thousands (except share and per share data and unless otherwise indicated)

NOTE 3:- LOAN FROM OTHERS (Cont.)

3. An amount of $ 900 (approximately € 880) were paid by BiondVax on August 15, 2022, shortly after the execution of the relevant amendment letter with the EIB and was applied to reduce the outstanding loan. Going forward 10% of any capital raises until maturity will be used to further repay the Loan principal including any outstanding accrued interest.

4. If the Company sales exceed approximately $5,332 (€ 5,000), 3% of the revenues will be paid to the EIB as royalties until the EIB receives (from the Loan repayment, inter alia the interest and the royalties) the higher of (i) a total of 2.8 times the original approximately $25,596 (€ 24,000) principal (as provided in the original Loan agreement) and (ii) 20% IRR on the principal.

5. In case the Company decides to discharge all liabilities under the finance contract, inter alia payments of the variable remuneration, the Company would need to repay to the EIB an indemnity amount in addition to the Loan principal and the accrued interest. The indemnity amount will be calculated such that the EIB receives an additional payment equal to the greater of (i) the prepayment amount (i.e. twice the prepayment amount in the aggregate) and (ii) the amount required to realize 20% IRR on the prepayment amount at the time of prepayment.

The Company recorded the cash received in each tranche and a corresponding liability to repay the cash. The Company evaluates the estimated cash flows from the EIB loan at each reporting period. When the estimated cash flows change from the estimates used as of the date on which the EIB loan was issued, the EIB loan’s carrying amount is adjusted to an amount equal to the present value of the estimated remaining future payments, discounted by using the original effective interest rate. The adjustment to the carrying amount is recognized in earnings as an adjustment to interest expenses, in the period in which the change in estimate occurred.

On December 31, 2022 as a result of the loan restructure, the Company recorded an amount of $ 7,168 under finance income. Interest expense related to the EIB loan were to $87

On February 16, 2023, $725 was paid to the EIB as part of the loan restructure agreement.

For the three month ended at March 31, 2023 the company recorded $1,769 under finance expenses due to the loan revaluation.

As of March 31, 2022, the outstanding principal amount related to the EIB loan in nominal terms is $ 26,105.

NOTE 4:- CONTINGENT LIABILITIES AND COMMITMENTS

Since 2006, the Company received approximately $5,830 in grants from the Israeli Innovation Authority (IIA), formerly known as the Office of the Chief Scientist. The grants were for research and development of M-001.

In return to those grants, the Company undertook to pay royalties amounting to 3%-5% on the revenues derived from sales of products or services developed in whole or in part using these grants. The maximum aggregate royalties paid generally cannot exceed 100% of the grants received by the Company, plus annual interest generally equal to the 12-month LIBOR applicable to dollar deposits, as published on the first business day of each calendar year. The maximum royalty amounts payable by the Company as of March 31, 2023 is approximately $ 5,830 which represents the total gross amount of grants actually received by the Company from the IIA including accrued interest. As of March 31, 2023, the Company had not paid any royalties to the IIA.

In light of the Phase 3 clinical trial results (see also Note 3.c above), the Company does not currently expect any future revenues from M-001 and therefore do not currently expect to make any royalty payments to the IIA and the Company does not record a liability for amounts received from IIA until the related revenues are recognized. In the event of failure of a project that was partly financed by the IIA, the Company will not be obligated to pay any royalties or repay the amounts received.

The Company also subject to various other restrictions pursuant to the grant, including limitations on transferring IP developed with grant funds. In light of the Company’s new strategy, it does not expect these restrictions to be material to its ongoing operations.

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BIONDVAX PHARMACEUTICALS LTD.

NOTES TO CONDENSED FINANCIAL STATEMENTS (Unaudited)

U.S. dollars in thousands (except share and per share data and unless otherwise indicated)

NOTE 5:- SHAREHOLDERS’ EQUITY

a. Rights attached to shares:

An Ordinary share confers upon its holder(s) a right to vote at the general meeting, a right to participate in distribution of dividends, and a right to participate in the distribution of surplus assets upon liquidation of the Company.

b. On December 22, 2021, the Company signed definitive agreements with the Max Planck Society (“MPG”), the parent organization of the Max Planck Institute for Biophysical Chemistry, and the University Medical Center Göttingen (“UMG”), both in Germany, to enter into a strategic collaboration for the development and commercialization of innovative Covid-19 NanoAbs, effective from January 1, 2022. The agreements provide for an upfront payment, development and sales milestones and royalties based on sales and sharing of sublicense revenues.

In accordance with the agreement the company issued 150,000 restricted ADS share at no cost to Max planck as an upfront payment for the license, the shares are blocked for a period of three years. The company evaluate the fair value of the license at $153. The fair value was calculated by an independent valuation, at a discount rate of 31% under the following principles:

Stock price	1.48
Variance	150	%
Risk free interest	1	%

c. On November 10, 2022, the Company announced that it plans to affect a ratio change of the Company’s American Depositary Shares (ADSs) to its non-traded ordinary shares from the current ratio of one (1) ADS representing forty (40) ordinary shares to a new ratio of one (1) ADS representing four hundred (400) ordinary shares. The ratio change will have the same effect as a reverse split of the existing ADSs of one (1) new ADS for every ten (10) old ADSs. The effective date for the ratio change was November 25, 2022.

d. On December 13 2022, an amendment to the Company’s Articles of Association increasing the registered share capital of the Company by an additional 18,200,000,000 Ordinary Shares (the equivalent of 45,500,000 ADSs) such that the total registered share capital of the Company would consist of 20,000,000,000 Ordinary Shares, no par value (the equivalent of 50,000,000 ADSs).

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BIONDVAX PHARMACEUTICALS LTD.

NOTES TO CONDENSED FINANCIAL STATEMENTS (Unaudited)

U.S. dollars in thousands (except share and per share data and unless otherwise indicated)

NOTE 5:- SHAREHOLDERS’ EQUITY (Cont.)

e. On December 20, 2022, the Company closed an underwritten public offering with gross proceeds to the Company of $8,000,000, before deducting underwriting discounts and other expenses payable by the Company. The offering consisted of 1,600,000 units and pre-funded units. Each unit consisted of one American Depositary Share (“ADS”) and two warrants, each to purchase one ADS, and each pre-funded unit consists of one pre-funded warrant to purchase one ADS and two warrants each to purchase one ADS. One of the warrants will expire three years from the date of issuance, and the other warrant will expire one year from the date of issuance and may be exercised for half an ADS on or prior to six (6) months following the original issuance for no additional consideration. Each ADS (or pre-funded warrant) was sold together with two warrants at a combined purchase price of $5.00 per unit (or $4.99 per pre-funded unit after reducing $0.01 attributable to the exercise price of the pre-funded warrants). Each ADS represents 400 of our ordinary shares, no par value per share. The Company received a net sum of $7,231 after deduction of underwriter discount and issuance expenses of $769. The warrants were classified as liabilities, initially and subsequently measured at fair value through earnings pursuant to ASC 480 as the warrants are not considered indexed to the Company’s own shares.

f. On January 5, 2023, the Company issued 810,000 ADSs (324,000,000 shares) as a result of exercise of warrants in consideration of

NOTE 6:- SHARE-BASED COMPENSATION

a. Option plans:

Options granted under the Company’s 2005 Israeli Share Option Plan (“Plan”) were exercisable in accordance with the terms of the Plan, within 10 years from the date of grant, against payment of an exercise price. The options generally vest over a period of three or four years.

In March 2018, the Company’s Board of Directors approved the adoption of the Company’s 2018 Israeli Share Option Plan (“2018 Plan”) for the grant of options and restricted shares (“RSU”) to employees, directors and service providers. The options are exercisable within 10 years from the date of grant, against payment of the exercise price, in accordance with the terms of the 2018 Plan. The options generally vest over a period of three or four years.

There were no grants during the three-month ended March 31, 2023.

b. The total share-based compensation expense related to all of the Company’s equity-based awards, recognized for the years ended March 31, 2023 and 2022 is comprised as follows:

	Three months ended March 31,
	2023		2022
	Unaudited		Unaudited
Research and development expenses	$	31	$	19
Marketing, general and administrative expenses		221		466
Total share-based compensation	$	252	$	485

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BIONDVAX PHARMACEUTICALS LTD.

NOTES TO CONDENSED FINANCIAL STATEMENTS (Unaudited)

U.S. dollars in thousands (except share and per share data and unless otherwise indicated)

NOTE 6:- SHARE-BASED COMPENSATION (Cont.)

c. A summary of restricted shares and restricted share activity as of March 31, 2023 is as follows:

	Number of restricted share units			Weighted average grant date fair value
Unvested as of December 31, 2022		107,768		$	6.49
Granted		125,607			2.22
Vested		(1,083	)		9.76
Forfeited		-			-
Unvested as of March 31, 2023 (Unaudited)		232,292		$	4.17

During the three-month ended March 31, 2023, the company granted 125,607 RSU’s ADS to employees and officers, the RSU’s shall be vested in three years and the fair value of the said grant was $278.

As of March 31, 2023, there are $514 of total unrecognized costs related to share-based compensation that is expected to be recognized over a period of up to four years.

The fair value of the granted RSUs was determent according to the market stock price at the day of grant.

NOTE 7:- BASIC AND DILUTED NET LOSS PER SHARE 

The following table sets forth the computation of basic and diluted net loss per share:

	Three months ended March 31,
	2023			2022
	Unaudited			Unaudited
Numerator for basic and diluted net loss per share:
Net loss	$	(3,515	)	$	(2,475	)
Denominator for basic and diluted net loss per share:
Weighted average shares outstanding		1,295,256,604			744,711,465

All outstanding employees options, employees restricted shares and warrants for the three months ended March 31, 2023 and 2022 have been excluded from the calculation of the diluted net loss per share, because all such securities are anti-dilutive for all periods presented. The total number of potential shares excluded from the calculation of diluted net loss per share are as follows:

	Three months ended March 31,
	2023		2022
	Unaudited		Unaudited
Employees RSUs and options		121,285,269		64,507,360
Warrants		1,040,940,000		-
Total		1,162,225,269		64,507,360

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ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATION

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited consolidated financial statements and notes thereto included in Part I, Item 1 of this Quarterly Report on Form 10-Q and with our audited financial statements and notes thereto for the year ended December 31, 2022, included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2022 filed on April 17, 2023 (the “Annual Report”) with the U.S. Securities and Exchange Commission (the “SEC”). This Quarterly Report on Form 10-Q contains forward looking statements, including without limitation, statements related to our plans, strategies, objectives, expectations, intentions and adequacy of resources. Investors are cautioned that such forward-looking statements involve risks and uncertainties including without limitation the following: (i) our plans, strategies, objectives, expectations and intentions are subject to change at any time at our discretion; (ii) our plans and results of operations will be affected by our ability to manage growth; and (iii) other risks and uncertainties indicated from time to time in our filings with the Securities and Exchange Commission.

In some cases, you can identify forward-looking statements by terminology such as ‘may,’ ‘will,’ ’should,’ ‘could,’ ‘expects,’ ‘plans,’ ‘intends,’ ‘anticipates,’ ‘believes,’ ‘estimates,’ ‘predicts,’ ‘potential,’ or ‘continue’ or the negative of such terms or other comparable terminology. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance, or achievements. Moreover, neither we nor any other person assumes responsibility for the accuracy and completeness of such statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. We are under no duty to update any of the forward-looking statements after the date of this report.

Our Company

BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV) is a biopharmaceutical company focused on developing, manufacturing and commercializing innovative immunotherapeutic products primarily for the treatment of infectious and autoimmune diseases. Since its inception, the Company has executed eight clinical trials including a seven country, 12,400 participant phase 3 trial of its prior lead drug candidate, a universal influenza vaccine candidate (“M-001”), and has built a GMP biologics manufacturing facility for biopharmaceutical products. While M-001 did not meet its clinical endpoints and is no longer under development, the Company has developed a highly experienced pharmaceutical industry leadership team and built its own fully equipped biotechnology drug manufacturing site. After receiving the phase 3 trial results in Q3 2020, the Company performed a turnaround process, raised capital, hired new talent (including a new CEO) and in-licensed new intellectual property, and is in the process of developing a pipeline of diversified and commercially viable products built around an innovative nanosized antibody (NanoAb) platform collaboration. NanoAbs are nanosized antibodies derived from camelid animals and are also known as VHH-antibodies or Nanobodies. “Nanobody” is a trademark registered by ABLYNX N.V., a wholly owned subsidiary of Sanofi. BiondVax has no affiliation with and is not endorsed by Sanofi.

As part of the abovementioned turnaround, on December 22, 2021, the Company signed a definitive exclusive, worldwide, License Agreement (“LA”) with the Max Planck Society (“MPG”), the parent organization of the Max Planck Institute for Multidisciplinary Sciences, and the University Medical Center Göttingen (“UMG”), both in Gottingen, Germany, for the development and commercialization of innovative NanoAbs for the treatment of COVID-19. The agreement provides for an upfront payment, development and sales milestones and royalties based on sales and sharing of sublicense revenues. In addition, the Company signed an accompanying Research Collaboration Agreement (“aRCA”) with MPG and UMG in support of the abovementioned development of a COVID-19 NanoAb. The aRCA provides for monthly payments to MPG and UMG and has a term until the earlier of two years or the date the Company enters into first in-human clinical trials with the COVID-19 NanoAb.

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On March 23, 2022, we signed a five-year Research Collaboration Agreement (“RCA”; collectively, with the LA and aRCA, the “MPG/UMG Agreements”) with MPG and UMG covering the discovery, selection and characterization of NanoAbs for up to nine molecular targets that have the potential to be further developed into drug candidates for the treatment of disease indications such as psoriasis, psoriatic arthritis, asthma and wet macular degeneration. These are all large and growing markets with underserved medical needs. In each case, the molecular target has been validated as an appropriate target for therapeutic intervention through inhibition by an antibody, thereby significantly reducing the discovery work that typically entails many years of research, high cost and high risk of failure. We believe that we can leverage our NanoAbs’ unique and strong binding affinity, stability at high temperatures, and potential for more effective and convenient routes of administration towards competitive commercial viability. We believe that since these are clinical validated targets, we can develop NanoAb treatments with reduced risk and cost, and accelerate the time from NanoAb selection to initiation of clinical development. Each NanoAb candidate is therefore positioned as a “biobetter” piggybacking on prior discoveries of others to mitigate risk but with significant potential advantages over existing therapeutics. In addition, each NanoAb constitutes a novel molecule for which we file patent applications thereby creating a proprietary position. BiondVax has the exclusive option for an exclusive, pre-negotiated worldwide license agreement for the development and commercialization of each of the NanoAbs covered by the RCA with MPG and UMG.

Our Strategy

Beginning with the MPG/UMG Agreements, the Company intends to implement a strategy that will build a diversified pipeline of assets along several axes, as follows:

● a pipeline of products for prevention and/or treatment of illnesses with large market opportunities for more effective treatments:

o Each product candidate originated through the MPG/UMG Agreements would be designed to interact with a target previously validated as an appropriate target for therapeutic intervention by an antibody already on the market.

o Each therapeutic indication nevertheless is underserved by existing antibody treatments and a large market opportunity exists for a proprietary NanoAb with improved attributes.

● a pipeline that would take advantage of the unique physicochemical attributes of our NanoAbs, including:

o Nano size and physical stability – our NanoAbs are approximately 1/10^th the size of regular antibodies and have a durable molecular structure. This allows them to be delivered through routes of administration (e.g., intra-dermal, nasal, inhalation, etc.) not particularly amenable to regular antibodies, which are too large and/or easily break down under pressure, opening new or enlarged market opportunities for our NanoAbs.

o Ultra-high thermo-stability – our NanoAbs retain biological activity even at high temperatures. This provides extended shelf life and reduces the need for cold chain shipping and storage.

o Extremely high binding affinity to the target with effective neutralization. Binding affinity is the likelihood that a drug molecule (e.g., a single NanoAb) will find, and attach to its designated target (e.g., a single COVID-19 virus) thereby contributing to therapeutically relevant neutralization of the target. Our COVID-19 NanoAb, for example, has demonstrated binding affinity and neutralization at doses anywhere from 100 to 1000 times lower than the publicly reported doses of other antibodies. This could translate to faster onset of medical efficacy or in some cases it may translate to lower required human dosage compared to other antibodies. That said, this should be demonstrated in clinical trials.

o High specificity - Our NanoAbs have high specificity to their intended target, and therefore fewer of them are expected to bind to targets other than the designated target, resulting in fewer side effects, . Furthermore, and because of their relatively short half-life, any NanoAbs, that do not bind to a target are expected to be quickly degraded or excreted from the body, thus also limiting future adverse effects.

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● a pipeline of products that can progress through the discovery stage and enter the clinic relatively quickly compared to traditional monoclonal antibody drug discovery.

o Traditional monoclonal antibody drug discovery entails years of research identifying and validating a target, identifying the appropriate type of molecule to interact with that target, validating that the mechanism of action can produce a therapeutically relevant benefit with a satisfactory safety profile and that the drug can be produced at an acceptable cost of goods.

o Together with an international management consulting firm, we have triaged through more than 800 potential molecular targets for our NanoAbs and selected those that had already been validated as targets for commercially available monoclonal antibodies. Furthermore, we filtered for targets for disease treatments that still leave a large unmet need or a large, underserved patient population. We then selected those targets that we believe have the highest commercial value but lowest clinical development costs (small sized clinical trials with fastest timeline to in human proof of concept).

o Our collaborators at MPG/UMG have been able to generate large libraries of NanoAbs against most of our pre-validated targets within the first 12 months of the collaboration and in many cases have selected from those libraries a small portfolio of candidates that meet or are close to meetinga set of pre-agreed Compound Acceptance Criteria, which we have agreed make them potentially appropriate for further development.

o As a consequence, over the next 12 to 24 months, subject to having sufficient capital, we believe we will be in a position to execute our exclusive option for exclusive license for development and commercialization of several of the abovementioned nanoAbs and advance them, in addition to our COVID-19 NanoAb, through remaining pre-clinical development and , subject to available capital resources, an updated analysis of market opportunities, partner interest and other relevant factors determined at the time, potentially initiate first in human clinical trials, all in a time frame we believe to be much quicker, at a cost much lower, and with fewer unknowns/less risk than traditional monoclonal antibodies drug discovery at the same stage of development.

● A pipeline of products that can be developed through the various Chemistry, Manufacturing and Controls steps (CMC) and then be produced for clinical development and potentially initial commercial volumes required for product launch at a low cost of goods at our existing manufacturing facility in Jerusalem, built to GMP specifications.

o Our NanoAbs are produced in yeast, a relatively low cost and rapid production system compared to the manufacture of regular antibodies. Regular antibodies are produced in mammalian cell lines that take considerable time to establish, require a much more sophisticated production facility, have lower yields and involve more expensive processing to harvest and purify the ultimate drug substance.

o processing to harvest and purify the ultimate drug substance.

o Our facility in Jerusalem is equipped to take the candidates generated by MPG/UMG and immediately begin development of NanoAbs for pre-clinical testing and ultimately produce clinical grade NanoAbs.

o By conducting these activities in-house, we will be in a position to avoid the delays and high costs typically associated with third party contract manufacturers and have more direct control over the process.

If successfully implemented, this strategy would provide BiondVax with a diverse multi-dimensional pipeline that we believe has been substantially de-risked without necessarily limiting the upside potential. We would also expect to have considerable flexibility regarding partnering with other companies in the pharmaceutical industry, out-licensing, joint ventures and the like. The Company is currently actively engaged in identifying and evaluating many of these opportunities. Notwithstanding the Company’s efforts to mitigate the risk associated with the development of our NanoAbs, there remains significant risk of failure, as described below under “Risks Related to Our Business”, associated with product development, manufacturing, regulatory matters, capital availability, commercialization, and other factors relevant to small companies, such as the Company, engaged in early stage pharmaceutical development activities. 

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Our Competitive Strengths

We believe that our people, process and technology give us distinct advantages over our competitors, as follows:

● People: Our leadership team has deep biotech and pharmaceutical industry experience, including our Chairman of the Board Mark Germain ( former Co-Chairman of Pluri (previously Pluristem Therapeutics), and a co-founder and former director of a number of other biotechnology companies including, without limitation, Alexion, Neurocrine, ChromaDex Inc., Stem Cell Innovations Inc., Omnimmune Corp. and Collexis Holdings Inc.), Board director Samuel Moed (former Senior VP Corporate Strategy at Bristol Myers Squibb), Board director Jay Green (former Senior VP Finance and CFO of GSK’s global vaccines business) and COO Elad Mark (formerly employed by Novartis). Our CEO, Amir Reichman, has extensive vaccines R&D, supply chain, manufacturing, and engineering experience from Novartis in the U.S. and GSK in Europe. Furthermore, our Chief Science Officer, Dr. Tamar Ben-Yedidia, oversaw M-001 development from early research at the Weizmann Institute through the pivotal Phase 3 clinical trial. Dr. Ben-Yedidia conducted her preliminary research in the 1990’s under the guidance of Professor Ruth Arnon. Professor Arnon continues to serve as head of BiondVax’s Scientific Advisory Board.

● Process: After years of experience, BiondVax has developed a mature set of business processes including pre-clinical and clinical development, regulatory, quality and GMP manufacturing processes. These processes can help us accelerate time to market for future in-licensed assets and hence provide us with a competitive value proposition versus other companies our size. In the past, we conducted a pivotal Phase 3 trial in over 100 clinical trial sites in seven Eastern European countries, subject to, among others, the regulation of the European Medicines Agency (EMA). The trial was completed on time and on budget. Our Phase 3 clinical trial was initiated after we completed two Phase 1/2 clinical trials and three Phase 2 clinical trials in Israel pursuant to clinical trial protocols approved by the Israeli Ministry of Health, a Phase 2b clinical trial in Europe, and a Phase 2 clinical trial sponsored and conducted by the NIH/NIAID in the USA.

● Technology: Our existing and advanced GMP manufacturing facility in Jerusalem uses an agile and modular ’Single Use’ infrastructure that can be used for a wide variety of applications and technologies, such as the production of recombinant proteins, nanobodies and other vaccines and treatments. In addition, we have advanced automation, data management and IT systems necessary for regulatory compliant clinical development, clinical supplies and commercial supplies.

Marketing and Sales

We do not currently have any pharmaceutical product marketing or sales capabilities. We intend to license to, or enter into strategic alliances, with third parties in the pharmaceutical business, which are equipped to market and/or sell any products that we acquire or develop in the future. We may seek to establish such capabilities internally in the future, if and when appropriate, in addition to any such licensing arrangements or strategic alliances.

Competition

Generally, our competitors include large, fully integrated pharmaceutical companies as well as companies and academic research institutes in various developmental stages attempting to develop (i) COVID-19 antibody therapeutics (such as Invivyd (formerly Adagio Therapeutics), Vir Biotechnology, and ExeVir) as well as (ii) other products for the prevention and treatment of disease targets that are the subject of our broader agreement with MPG and UMG, including MoonLake Immunotherapeutics AG for the development of antibodies against psoriasis

Manufacturing

We built, own, and operate a biologics manufacturing facility in Jerusalem, which is capable of manufacturing GMP-compliant product candidates for use in either clinical trials or for small to medium scale commercial supply. We have manufactured the COVID-19 NanoAbs for our preclinical in vivo study in our facility, and although we currently anticipate using our facility for future manufacturing of product candidates, we may also rely on a third party CMO.

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Finance Contract with European Investment Bank

We borrowed 24 million Euro under a finance contract (the “Finance Contract”) with the European Investment Bank (the “EIB”), to finance a portion of the cost of developing our previous leading drug candidate M-001 and our GMP biologics manufacturing facility. As part of the Finance Contract, we also entered into a security agreement (the “Security Agreement”), whereby we created a first ranking floating charge in favor of EIB over substantially all of our assets (other than certain licensed intellectual property related to our former M-001 program).

On August 10, 2022, we announced the successful conclusion of negotiations and formal approval by the EIB of new terms of its outstanding €24 million loan (the “Loan”) to BiondVax, including:

● Loan extension: An extension of the maturity dates from 2023 (€20 million) and 2024 (€4 million) until December 2027.

● Interest accrual: Although the Loan has been outstanding since 2018, interest on the Loan will only begin to accrue starting January 1, 2022, at an annual rate of 7%. The interest payments will be deferred until the new maturity date and will be added to the principal balance at the end of each year during the Loan period.

● Principal repayment: $900,000 was paid by BiondVax shortly after the execution of the relevant amendment letter with the EIB and was applied to reduce the outstanding Loan. An additional approximately $725,000 was paid during February 2023 in connection with the financing completed in December 2022 and going forward 10% of any capital raises until maturity will be used to further repay the Loan principal including any outstanding accrued interest.

● Variable remuneration to the EIB: Once BiondVax’s commercial sales exceed €5 million, 3% of BiondVax’s topline revenues will be paid to the EIB as royalties until the EIB receives (from the Loan repayment, inter alia the interest and the royalties) the higher of (i) a total of 2.8 times the original €24 million principal (as provided in the original Loan agreement) and (ii) 20% IRR on the principal calculated from January 1, 2022.

● Prepayment indemnity: In case BiondVax decides to discharge all liabilities under the Finance Contract, inter alia, payments of the variable remuneration, BiondVax would need to repay to the EIB an indemnity amount in addition to the Loan principal and the accrued interest. The indemnity will be calculated such that the EIB receives an additional payment equal to the greater of (i) the prepayment amount (i.e. twice the prepayment amount in the aggregate) and (ii) the amount required to realize 20% IRR on the prepayment amount at the time of prepayment.

RESULTS OF OPERATIONS

Three months ended March 31, 2023, as compared to March 31, 2022

To date, we have funded our operations primarily through (i) the sale of equity securities in both public and private offerings, (ii) a rights offering, (iii) exercises of warrants issued in connection with our initial public offering in the U.S., (iv) funding received from the IIA, and (iv) proceeds from the Finance Contract with the EIB. In February 2021, December 2021, and December 2022 we raised gross proceeds of approximately $13.8 million, $9.8 million, and $8 million respectively, in underwritten offerings of the ADSs (and, in December 2022, two warrants to purchase ADSs for each ADS offered). As of March 31, 2023, we had $10.9 million of cash and cash equivalents and short-term deposits.

We expect that we will incur additional losses soon as a result of our research and development activities. Such research and development activities will require us to obtain and expend further resources if we are to be successful. As a result, we expect to continue to incur operating losses, and we may be required to obtain additional funds to further develop our research and development programs. As a result of our research and development activities and our failure to generate revenues since our inception, among other things, our net loss for the three months ended March 31, 2023, was $3.5 million.

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Operating Expenses

Research and development expenses. Our research and development expenses for the three months ended March 31, 2023, amounted to $2 million, compared to $1.2 million for the three months ended March 31, 2022. The increase of $0.8 million was primarily due to the launch of our NanoAb development. Our research and development expenses consist primarily of salaries and related personnel expenses, fees paid to consultants, patent-related legal fees, costs of preclinical studies, drug and laboratory supplies, and costs for facilities and equipment. We charge all research and development expenses to operations as they are incurred. We expect our research and development expenses to remain our primary expense in the near future. Increases or decreases in research and development expenditures are attributable to the number and/or duration of the clinical studies that we conduct.

We expect that a large percentage of our research and development expenses in the future will be incurred in support of our future clinical development projects. Due to the inherently unpredictable nature of clinical development processes, we are unable to estimate with any certainty the costs we will incur. Clinical development timelines, the probability of success and development costs can differ materially from expectations.

Our future research and development expenses will depend on any Company product candidate’s commercial potential. As we obtain results from clinical studies, we may elect to discontinue or delay clinical studies for any Company product candidate in certain indications in order to focus our resources on more promising product candidates. Completion of clinical studies may take several years or more, but the length of time generally varies according to the type, complexity, novelty and intended use of a product candidate.

The lengthy process of completing clinical studies and seeking regulatory approval for any Company product candidate requires the expenditure of substantial resources. Any failure or delay in completing clinical studies, or in obtaining regulatory approvals, could cause a delay in generating product revenue and cause our research and development expenses to increase and, in turn, have a material adverse effect on our operations. Because of the risk factors set forth below in Item 1A, we are not able to estimate with any certainty when we would recognize any net cash inflows from our projects.

Developing bio-pharmaceutical vaccines and medicines, conducting clinical trials, obtaining commercial manufacturing capabilities and commercializing products is expensive and we will need to raise substantial additional funds to achieve our strategic objectives. Although we believe that our existing cash resources (inclusive of gross proceeds of approximately $8 million received by the Company from a public follow-on offering completed in December 2022) will be sufficient to fund our projected cash requirements at current monthly rates for at least the next 12 months, we will require significant additional financing in the future to fund our operations, including if and when we conduct clinical trials, obtain regulatory approval and obtain commercial manufacturing capabilities for any Company product candidate and commercialize such product candidates. Our future capital requirements will depend on many factors, including:

● the progress and costs of our clinical trials and other research and development activities;

● the scope, prioritization and number of our clinical trials and other research and development programs;

● the amount of revenues and contributions we receive under future licensing, collaboration, development and commercialization arrangements with respect to our Company product candidates;

● the costs of the development and expansion of our operational infrastructure;

● the costs and timing of obtaining regulatory approvals for our Company product candidates;

● the ability of us, or our collaborators, to achieve development milestones, marketing approvals and other events or developments under our potential future licensing agreements;

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● the costs of filing, prosecuting, enforcing and defending patent claims and other intellectual property rights;

● the costs and timing of building and securing manufacturing arrangements for clinical or commercial production;

● the costs of contracting with third parties to provide sales and marketing capabilities for us or establishing such capabilities ourselves;

● the costs of acquiring or undertaking development and commercialization efforts for any Company product candidate or platforms;

● the magnitude of our general and administrative expenses; and

● any cost that we may incur under future in- and out-licensing arrangements relating to one or more of our Company product candidates.

Until we can generate significant recurring revenues, we expect to satisfy our future cash needs through the net proceeds received from future private or public equity raising, grants from governmental agencies such as the IIA, debt or equity or other non-dilutive financings such as the loan from EIB, among other financing mechanisms. We cannot be certain that additional funding will be available to us on acceptable terms, if at all. If funds are not available, we may be required to delay, reduce the scope of or eliminate research or development plans for, or commercialization efforts with respect to any Company product candidate.

Since 2006, we received $5.8 million in IIA grants and Euro 24 million ($25.6 million) in EIB loans.

Marketing, General and Administrative Expenses:

Our general and administrative expenses for the three months ended March 31, 2023 amounted to $1.2 million, compared to $1.4 million for the three months ended March 31, 2022. The decrease was mostly due to share based payment expenses of $0.24 million, professional services expenses of $0.1 million offset with an increase in salary expenses of $0.17 million and marketing expenses of $0.19 million. Our general and administrative expenses consist primarily of salaries and expenses related to employee benefits, including share-based compensation, for our general and administrative employees, which includes employees in executive and operational roles, including finance and human resources, as well as consulting, legal and professional services related to our general and administrative operations.

Net Loss

As a result of the foregoing research and development, marketing general and administrative expenses, and as we have not yet generated revenues since our inception, our net loss for the three months ended March 31, 2023 was $3.5 million, compared to our net loss for the three months ended March 31, 2022 of $2.47 million.

LIQUIDITY AND CAPITAL RESOURCES

Since our inception, we have funded our operations primarily through public and private offerings of our equity securities in Israel and the U.S., grants from the OCS (today known as the IIA), grants received by the Israeli Ministry of Economy and European grants under the UNISEC consortium and the loan from the EIB. Information regarding the outstanding loan from the EIB is set forth above in “Finance Contract with European Investment Bank.”

As of March 31, 2023, we had cash and cash equivalents and short-term deposits of $10.9 million as compared to 15.5 million as of March 31, 2022. Our cash and cash equivalents are denominated in US dollars.

Net cash used in operating activities was $3.1 million for the quarter ended March 31, 2023, compared with net cash used in operating activities of $1.1 million for the quarter ended March 31, 2022.

Net cash used by investing activities for the quarter ended March 31, 2023 was $0.006 million compared with net cash used by investing activities of $0.5 million for the quarter ended March 31, 2022, and primarily reflects the purchase of fixed assets.

We had no cash provided by financing activities for the quarters ended March 31, 2023 and 2022.

22

At March 31, 2023, our accumulated deficit amounted to $119.3 million. We had working capital of $ 8.4 million as of March 31, 2023. In the future, we may raise additional capital from external sources in order to continue the longer-term efforts contemplated under our business plan. We expect to continue incurring losses for the foreseeable future and may need to raise additional capital to pursue our product development initiatives, to penetrate markets for the sale of our Company product candidates and continue operations as presently maintained. We cannot provide any assurance that we will raise additional capital. Our management believes that we have access to capital resources through possible public or private equity offerings, debt financings, corporate collaborations or other means; however, we have not secured any commitment for new financing at this time nor can we provide any assurance that new financing will be available on commercially acceptable terms, if at all. If the economic climate in the U.S. deteriorates, our ability to raise additional capital could be negatively impacted. If we are unable to secure additional capital, we may be required to curtail our research and development initiatives and take additional measures to reduce costs in order to conserve cash in amounts sufficient to sustain operations and meet our obligations. These measures could cause significant delays in our efforts to commercialize our products, which is critical to the realization of our business plan and our future operations.

On February 2, 2021, the Company closed an underwritten offering in which it sold 2,434,783 ADSs at a public offering price of $4.95 per ADS. On February 10, 2021, Aegis Capital Corp., the sole bookrunning manager for the underwritten offering, fully exercised its over-allotment option to purchase an additional 365,217 ADSs, bringing total gross proceeds to the Company from the offering including exercise of the over-allotment option of approximately $13.8 million. The Company received a net sum of $12.836 million and a net sum of $12.465 million after deduction of issuance expenses.

On December 29, 2021, the Company closed an underwritten offering in which it sold 4,144,068 ADSs at a public offering price of $2.36 per ADS for total proceeds of approximately $9.780 million, including ADSs acquired upon the full exercise by Aegis Capital Corp., the sole bookrunning manager for the underwritten offering, of its over-allotment option to purchase additional ADSs. The Company received a net sum of $9.020 million and a net sum of $8.817 million after deduction of issuance expenses.

On December 20, 2022, the Company closed an underwritten offering in which it sold 1,600,000 units and pre-funded units. Each unit consisted of one ADS and two warrants, each to purchase one ADS, and each pre-funded unit consisted of one pre-funded warrant to purchase one ADS and two warrants each to purchase one ADS. Each ADS (or pre-funded warrant) was sold together with two warrants at a combined purchase price of $5.00 per unit (or $4.999 per pre-funded unit after reducing $0.001 attributable to the exercise price of the pre-funded warrants). One of the warrants will expire three years from the date of issuance, and the other warrant will expire one year from the date of issuance and may be exercised for half an ADS on or prior to six (6) months following the original issuance for no additional consideration. The Company received a net sum of $7.3 million and a net sum of $7.2 million after deduction of issuance expenses.

Critical Accounting Policies

The preparation of financial statements and the related notes thereto included elsewhere in this annual report in conformity with U.S. GAAP requires management to make estimates, judgments and assumptions that affect the amounts reported in the financial statements and accompanying notes. The Company’s management believes that the estimates, judgment and assumptions used are reasonable based upon information available at the time they are made. These estimates, judgments and assumptions can affect the reported amounts of assets and liabilities at the dates of the financial statements, and the reported amount of expenses during the reporting periods. Actual results could differ from those estimates.

We believe that the following accounting policies involve a substantial degree of judgment and complexity, and accordingly, these are the policies we believe are the most critical to aid in fully understanding and evaluating our financial condition and results of operations. See also note 2 to our financial statements included elsewhere in this annual report.

23

Impairment of long-lived assets

The Company’s long-lived assets are reviewed for impairment in accordance with ASC No. 360 “Property, Plant and Equipment,” whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. If indicators of impairment exist and the undiscounted future cash flows that the assets are expected to generate are less than the carrying value of the assets, the Company reduces the carrying amount of the assets through an impairment charge, to their estimated fair values. During the three months ended March 31, 2023 and 2022, no impairment indicators have been identified.

Fair value of financial instruments

The accounting guidance for fair value provides a framework for measuring fair value, clarifies the definition of fair value, and expands disclosures regarding fair value measurements. Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability (an exit price) in an orderly transaction between market participants at the reporting date. The accounting guidance establishes a three-tiered hierarchy, which prioritizes the inputs used in the valuation methodologies in measuring fair value as follows:

● Level 1: Quoted prices (unadjusted) in active markets that are accessible at the measurement date for assets or liabilities. The fair value hierarchy gives the highest priority to Level 1 inputs.

● Level 2: Observable inputs that are based on inputs not quoted on active markets but corroborated by market data.

● Level 3: Unobservable inputs are used when little or no market data are available.

Item 3. Quantitative and Qualitative Disclosures About Market Risk.

As a smaller reporting company this item is not required.

Item 4. Controls and Procedures.

Evaluation of Disclosure Controls and Procedures.

We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in our Securities Exchange Act of 1934 filings are recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including our Chief Executive Officer (Principal Executive Officer) and Chief Financial Officer (Principal Financial Officer), as appropriate, to allow timely decisions regarding required disclosure. In designing and evaluating the disclosure controls and procedures, management recognized that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, as ours are designed to do, and management was necessarily required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures.

Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, has evaluated the effectiveness of our disclosure controls and procedures (as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) as of March 31, 2023 (the “Evaluation Date”). Based on such evaluation, those officers have concluded that, as of the Evaluation Date, our disclosure controls and procedures were effective.

Changes in Internal Control Over Financial Reporting.

There have been no changes in our internal control over financial reporting that occurred during the quarter ended March 31, 2023 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

24

PART II - OTHER INFORMATION

Item 1. Legal Proceedings.

From time to time, the Company may become involved in legal proceedings or be subject to claims arising in the ordinary course of its business. The Company is not presently a party to any legal proceedings that, if determined adversely to it, would individually or taken together have a material adverse effect on its business, operating results, financial condition, or cash flows. Regardless of the outcome, litigation can have an adverse impact on the Company because of defense and settlement costs, diversion of management resources and other factors.

Item 1A. Risk Factors.

Our business, financial condition, results of operations, and cash flows may be impacted by a number of factors, many of which are beyond our control, including those set forth in our most recent Annual Report on Form 10-K for the year ended December 31, 2022, the occurrence of any one of which could have a material adverse effect on our actual results.

There have been no material changes to the Risk Factors previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2022.   

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.

There were no unregistered sales of the Company’s equity securities during the period ended March 31, 2023 that were not previously reported in a Current Report on Form 8-K.

Item 3. Defaults Upon Senior Securities.

There were no defaults upon senior securities during the period ended March 31, 2023.

Item 4. Mine Safety Disclosures

Not Applicable.

Item 5. Other Information.

There is no other information required to be disclosed under this item that was not previously disclosed.

Item 6. Exhibits.

Exhibit No.	Description
31.1*	Certification by the Principal Executive Officer of Registrant pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 (Rule 13a-14(a) or Rule 15d-14(a)).
31.2*	Certification by the Principal Financial Officer of Registrant pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 (Rule 13a-14(a) or Rule 15d-14(a)).
32.1**	Certification by the Principal Executive Officer pursuant to 18 U.S.C. 1350 as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
32.2**	Certification by the Principal Financial Officer pursuant to 18 U.S.C. 1350 as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
101.INS	Inline XBRL Instant Document
101.SCH	Inline XBRL Taxonomy Extension Schema Document
101.CAL	Inline XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF*	Inline XBRL Taxonomy Extension Definition Linkbase Document
101.LAB*	Inline XBRL Taxonomy Extension Label Linkbase Document
101.PRE*	Inline XBRL Taxonomy Extension Presentation Linkbase Document
104	Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101).

* Filed herewith.

25

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: May 15, 2023	By:	/s/ Amir Reichman
		Amir Reichman
		Chief Executive Officer
		(Principal Executive Officer)

Date: May 15, 2023	By:	/s/ Uri Ben-Or
		Uri Ben-Or
		Chief Financial Officer
		(Principal Financial Officer)

26

EX-31.1

Exhibit 31.1

CERTIFICATION

PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

I, Amir Reichman, certify that:

1. I have reviewed this report on Form 10-Q of BiondVax Pharmaceuticals Ltd.;

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rule 13a-15(f) and 15d-15(f)) for the registrant and have:

a)	Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiary, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b)	Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c)	Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d)	Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

a)	All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial data; and
b)	Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Date: May 15, 2023

By:	/s/ Amir Reichman
Name:	Amir Reichman
Title:	Chief Executive Officer
	(Principal Executive Officer)

EX-31.2

Exhibit 31.2

CERTIFICATION

PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

I, Uri Ben-Or, certify that:

1. I have reviewed this report on Form 10-Q of BiondVax Pharmaceuticals Ltd.;

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rule 13a-15(f) and 15d-15(f)) for the registrant and have:

a)	Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiary, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b)	Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c)	Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d)	Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

a)	All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial data; and
b)	Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Date: May 15, 2023

By:	/s/ Uri Ben-Or
	Uri Ben-Or
	Chief Financial Officer
	(Principal Financial Officer)

EX-32.1

Exhibit 32.1

Certification Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

(Subsections (a) and (b) of Section 1350, Chapter 63 of Title 18, United States Code)

In connection with the Quarterly Report on Form 10-Q of BiondVax Pharmaceuticals Ltd. (the “Company”) for the period ended March 31, 2023 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), Amir Reichman, Chief Executive Officer, of BiondVax Pharmaceuticals Ltd., an Israel corporation, do hereby certify, pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (subsections (a) and (b) of Section 1350, Chapter 63 of Title 18, United States Code) that:

(1) The Report of the Company fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

Dated: May 15, 2023	/s/ Amir Reichman
	Amir Reichman
	Chief Executive Officer (Principal Executive Officer)

A signed original of this written statement required by Section 906 has been provided to BiondVax Pharmaceuticals Ltd. and will be retained by BiondVax Pharmaceuticals Ltd. and furnished to the Securities and Exchange Commission or its staff upon request.

EX-32.2

Exhibit 32.2

Certification Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

(Subsections (a) and (b) of Section 1350, Chapter 63 of Title 18, United States Code)

In connection with the Quarterly Report on Form 10-Q of BiondVax Pharmaceuticals Ltd. (the “Company”) for the period ended March 31, 2023 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), Uri Ben-Or, Chief Financial Officer, of BiondVax Pharmaceuticals Ltd., an Israel corporation, do hereby certify, pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (subsections (a) and (b) of Section 1350, Chapter 63 of Title 18, United States Code) that:

(1) The Report of the Company fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

Dated: May 15, 2023	/s/ Uri Ben-Or
	Uri Ben-Or
	Chief Financial Officer (Principal Financial Officer)

A signed original of this written statement required by Section 906 has been provided to BiondVax Pharmaceuticals Ltd. and will be retained by BiondVax Pharmaceuticals Ltd. and furnished to the Securities and Exchange Commission or its staff upon request.

XML

Document And Entity Information - shares	3 Months Ended
	Mar. 31, 2023	May 10, 2023
Document Information Line Items
Entity Registrant Name	BiondVax Pharmaceuticals Ltd.
Document Type	10-Q
Current Fiscal Year End Date	--12-31
Entity Common Stock, Shares Outstanding		1,313,623,184
Amendment Flag	false
Entity Central Index Key	0001611747
Entity Current Reporting Status	Yes
Entity Filer Category	Non-accelerated Filer
Document Period End Date	Mar. 31, 2023
Document Fiscal Year Focus	2023
Document Fiscal Period Focus	Q1
Entity Small Business	true
Entity Emerging Growth Company	false
Entity Shell Company	false
Document Quarterly Report	true
Document Transition Report	false
Entity File Number	001-37353
Entity Incorporation, State or Country Code	L3
Entity Tax Identification Number	00-0000000
Entity Address, Address Line One	Jerusalem BioPark
Entity Address, Address Line Two	2nd Floor Hadassah Ein Kerem Campus
Entity Address, City or Town	Jerusalm
Entity Address, Country	IL
City Area Code	(+972)
Local Phone Number	8-930-2529
Entity Interactive Data Current	Yes
Entity Address, Postal Zip Code	00000
American Depositary Shares, each representing 400 Ordinary Shares, no par value
Document Information Line Items
Trading Symbol	BVXV
Title of 12(b) Security	American Depositary Shares, each representing 400 Ordinary Shares, no par value
Security Exchange Name	NASDAQ
Ordinary Shares, no par value
Document Information Line Items
Title of 12(b) Security	Ordinary Shares, no par value
Security Exchange Name	NASDAQ

XML

Condensed Balance Sheets (Unaudited) - USD ($) $ in Thousands	Mar. 31, 2023	Dec. 31, 2022
CURRENT ASSETS:
Cash and cash equivalents	$ 10,799	$ 14,075
Restricted cash	127	140
Prepaid expenses and other receivables	119	155
Total current assets	11,045	14,370
NON-CURRENT ASSETS:
Property, plant and equipment, net	10,817	11,245
Operating lease right-of-use assets	1,430	1,452
Total non-current assets	12,247	12,697
Total assets	23,292	27,067
CURRENT LIABILITIES:
Trade payables	1,313	716
Operating lease liabilities	420	382
Other payables	846	1,240
Total current liabilities	2,579	2,338
NON-CURRENT LIABILITIES:
Warrants liability	2,664	5,329
Loan from others	21,851	20,082
Non-current operating lease liabilities	1,008	1,078
Total non-current liabilities	25,523	26,489
SHAREHOLDERS’ EQUITY (DEFICIT):
Ordinary shares of no par value: Authorized: 20,000,000,000 shares at March 31, 2023 and at December 31, 2022; Issued and outstanding 1,313,623,184 shares at March 31, 2023 and 989,290,784 shares at December 31, 2022
Additional paid-in capital	116,431	116,082
Accumulated deficit	(119,350)	(115,835)
Accumulated other comprehensive loss	(1,891)	(2,007)
Total shareholders’ deficit	(4,810)	(1,760)
Total liabilities and shareholders’ deficit	$ 23,292	$ 27,067

XML

Condensed Balance Sheets (Unaudited) (Parentheticals) - $ / shares	Mar. 31, 2023	Dec. 31, 2022
Statement of Financial Position [Abstract]
Ordinary shares, par value (in Dollars per share)
Ordinary shares, shares authorized	20,000,000,000	20,000,000,000
Ordinary shares,shares issued	1,313,623,184	989,290,784
Ordinary shares, shares outstanding	1,313,623,184	989,290,784

XML

Condensed Statements of Operations (Unaudited) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2023	Mar. 31, 2022
Income Statement [Abstract]
Research and development	$ 1,995	$ 1,163
Marketing, general and administrative	1,191	1,452
Total operating loss	3,186	2,615
Financial loss (income), net	329	(140)
Net loss	$ 3,515	$ 2,475
Basic and diluted net loss per share (in Dollars per share)	$ (0.003)	$ (0.003)
Weighted average number of shares used for computing basic and diluted net loss per share (in Shares)	1,295,256,604	744,711,465

XML

Condensed Statements of Operations (Unaudited) (Parentheticals) - $ / shares	3 Months Ended
	Mar. 31, 2023	Mar. 31, 2022
Income Statement [Abstract]
Diluted net loss per share	$ (0.003)	$ (0.003)
Weighted average number of shares used for computing Diluted	1,295,256,604	744,711,465

XML

Condensed Statements of Comprehensive Loss (Unaudited) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2023	Mar. 31, 2022
Statement of Comprehensive Income [Abstract]
Net loss	$ 3,515	$ 2,475
Foreign currency translation adjustments	(116)	34
Total comprehensive loss	$ 3,399	$ 2,509

XML

Condensed Statements of Changes in Shareholders' Equity (Unaudited) - USD ($) $ in Thousands	Ordinary shares	Additional paid-in capital	Accumulated comprehensive loss	Accumulated deficit	Total
Balance at Dec. 31, 2021		$ 113,076	$ (2,055)	$ (110,039)	$ 982
Balance (in Shares) at Dec. 31, 2021	739,048,544
Issuance of shares, net of issuance costs of $6		216			216
Issuance of shares, net of issuance costs of $6 (in Shares)	6,000,000
Share-based compensation		485			485
Other comprehensive income (loss)			(34)		(34)
Net loss				(2,475)	(2,475)
Balance at Mar. 31, 2022		113,777	(2,089)	(112,514)	(862)
Balance (in Shares) at Mar. 31, 2022	745,048,544
Balance at Dec. 31, 2022		116,082	(2,007)	(115,835)	(1,760)
Balance (in Shares) at Dec. 31, 2022	989,290,784
Exercise of warrants		97			97
Exercise of warrants (in Shares)	324,000,000
Vested RSU’s
Vested RSU’s (in Shares)	332,400
Share-based compensation		252			252
Other comprehensive income (loss)			116		116
Net loss				(3,515)	(3,515)
Balance at Mar. 31, 2023		$ 116,431	$ (1,891)	$ (119,350)	$ (4,810)
Balance (in Shares) at Mar. 31, 2023	1,313,623,184

XML

Condensed Statements of Changes in Shareholders' Equity (Unaudited) (Parentheticals) $ in Thousands	3 Months Ended
	Mar. 31, 2022 USD ($)
Condensed Statements of Changes in Shareholders Equity Unaudited [Abstract]
Net of issuance costs	$ 6

XML

Condensed Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2023	Mar. 31, 2022
Cash flows from operating activities:
Net loss	$ (3,515)	$ (2,475)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation of property, plant and equipment	138	134
Expense of in-process research and development		209
Financial expenses related to loan from others	2,354	28
Share-based compensation	252	485
Decrease in other receivables	31	123
Warrants revaluation	(2,568)
Changes in operating lease right-of-use assets	(18)	63
Increase in trade payables	629	311
Changes in operating lease liabilities	7	(62)
(Decrease) increase in other payables	(369)	79
Net cash used in operating activities	(3,059)	(1,105)
Cash flows from investing activities:
Purchase of property, plant and equipment	(6)	(521)
Net cash used in investing activities	(6)	(521)
Cash flows from financing activities:
Proceed from issuance of warrants
Net cash provided by financing activities
Effect of exchange rate changes on cash, cash equivalents and restricted cash	(224)	(359)
Decrease in cash, cash equivalents and restricted cash	(3,289)	(1,985)
Cash, cash equivalents and restricted cash at the beginning of the period	14,215	17,517
Cash, cash equivalents and restricted cash at the end of the period	10,926	15,532
Interest	725
Exercise of warrants liability to equity	97
Cash and cash equivalents	10,799	15,392
Restricted cash	127	140
Cash, cash equivalents and restricted cash	$ 10,926	$ 15,532

XML

General

3 Months Ended

Mar. 31, 2023

General [Abstract]

GENERAL

NOTE 1:- GENERAL

a. Biondvax Pharmaceuticals Ltd. (the “Company”), is a biotechnology company focused on developing, manufacturing, and commercializing innovative immunotherapeutic products primarily for the treatment of infectious and autoimmune diseases. The Company was incorporated on July 21, 2003 in Israel, and started its activity on March 31, 2005. The Company’s principal executive offices, manufacturing site and R&D laboratories are located at Jerusalem, Israel.

b. On December 22, 2021, the Company signed an exclusive, worldwide, license agreement with the Max Planck Society (“MPG”), the parent organization of the Max Planck Institute for Multidisciplinary Sciences, and the University Medical Center Göttingen (“UMG”), both in Germany, for the development and commercialization of an innovative Covid-19 NanoAb therapy and an accompanying research collaboration agreement with MPG and UPG in support of the abovementioned development of a COVID-19 NanoAb. The agreements became effective January 1, 2022 and provide for an upfront payment, development and sales milestones and royalties based on sales and sharing of sublicense revenues.

c. On March 23, 2022, the Company executed an additional research collaboration agreement (RCA) with MPG and UMG covering discovery, selection and characterization of NanoAbs for several other disease indications with large and growing markets that leverage their unique and strong binding affinity, stability at high temperatures, and potential for more effective and convenient routes of administration. These targets are the basis for validated and currently marketed monoclonal antibodies, including for conditions such as psoriasis, asthma, macular degeneration, and psoriatic arthritis. According to the contract, BiondVax will have an exclusive option for exclusive license agreement for the development and commercialization of each of the NanoAbs covered by the agreement with MPG and UMG. On February 7, 2022 the Company issued 15,000 ADSs (6,000,000 shares) to Max-Planck-Gesellschaft zur Förderung der Wissenschaften e.V. under our exclusive, worldwide, License Agreement with MPG and UMG pursuant to Regulation S under the Securities Act;

d. As of March 31, 2023, the Company’s cash and cash equivalents totaled $10,799. In the three months ended March 31, 2023, the Company had an operating loss of $3,186 and negative cash flows from operating activities of $3,059. The Company’s current operating budget includes various assumptions concerning the level and timing of cash receipts and cash outlays for operating expenses and capital expenditures, including a cost saving plan. The Company is planning to finance its operations from its existing working capital resources and additional sources of capital and financing. However, there is no assurance that additional capital and/or financing will be available to the Company, and even if available, whether it will be on terms acceptable to the Company or in amounts required. Accordingly, the Company’s board of directors approved a cost saving plan, to be implemented if and as required, in whole or in part, at its discretion, to allow the Company to continue its operations and meet its cash obligations. The cost saving plan consists of cutting expenditures by means of further efficiencies and synergies, which include mainly the following steps: reduction in headcount and postponing or cancelling capital expenditures that would not be required for the implementation of the revised business plan. Nevertheless, the Company and the board of directors believe that its existing financial resources and its operating plans, including the effects of the costs saving plan, will be adequate to satisfy its expected liquidity requirements for a period of at least twelve months from the end of the filing date.

e. Basis of presentation of the financial statements:

The accompanying unaudited condensed financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and in accordance with the instructions to Form 10-Q and Article 10 of Regulation S-X promulgated by the U.S Securities and Exchange Commission (the “SEC”). Certain information or footnote disclosures normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted, pursuant to the rules and regulations of the SEC for interim financial reporting. Accordingly, they do not include all the information and footnotes necessary for a complete presentation of financial position, results of operations, or cash flows. In the opinion of management, the accompanying unaudited condensed financial statements include all adjustments, consisting of a normal recurring nature, which are necessary for a fair presentation of the financial position, operating results and cash flows for the periods presented.

The accompanying unaudited condensed financial statements should be read in conjunction with the Company’s Annual Report on Form 10-K as of December 31, 2022 filed with the SEC on April 17, 2023. The interim period results do not necessarily indicate the results that may be expected for any other interim period or for the full fiscal year.

f. Use of estimates:

The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates, judgments and assumptions that affect the amounts reported in the financial statements and accompanying notes. The Company’s management believes that the estimates, judgment and assumptions used are reasonable based upon information available at the time they are made. These estimates, judgments and assumptions can affect the reported amounts of assets and liabilities at the dates of the financial statements, and the reported amount of expenses during the reporting periods. Actual results could differ from those estimates.

g. Cash equivalents:

Cash equivalents are short-term highly liquid deposits that are readily convertible to cash with original maturities of three months or less, at the date acquired.

h. Restricted cash:

Restricted cash are deposits with original maturities of three months or less and are used as security for the Company’s credit cards and rent. Restricted cash amounted to $127 and $140 as of March 31, 2023 and December 31, 2022 respectively.

i. Warrants:

The Company accounts for warrants as either equity-classified or liability-classified instruments based on an assessment of the warrant’s specific terms and applicable authoritative guidance. The assessment considers whether the warrants are freestanding financial instruments, meet the definition of a liability under ASC 480, and meet all of the requirements for equity classification, including whether the warrants are indexed to the Company’s own common stock. Warrants that determined to be classified as equity, are recorded as a component of additional paid-in capital. Warrants that determined to be classified as liabilities are recorded at their initial fair value on the date of issuance and remeasured to fair value at each balance sheet date thereafter. Changes in the estimated fair value of the warrants are recognized in financial expenses, net in the statements of operations.

j. Recently adopted accounting pronouncements:

In June 2016, the FASB issued ASU 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”). ASU 2016-13 requires the measurement of all expected credit losses for financial assets held at the reporting date based on historical experience, current conditions, and reasonable and supportable forecasts. ASU 2016-13 requires enhanced qualitative and quantitative disclosures to help investors and other financial statement users better understand significant estimates and judgments used in estimating credit losses, as well as the credit quality and underwriting standards of an organization’s portfolio. ASU 2016-13 is effective for fiscal years beginning after December 15, 2022, and interim periods within those fiscal years. The adoption of this ASU did not have a significant impact on the Company’s financial statements and disclosures.

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Fair Value Measurements

3 Months Ended

Mar. 31, 2023

Fair Value Disclosures [Abstract]

FAIR VALUE MEASUREMENTS

NOTE 2:- FAIR VALUE MEASUREMENTS

In accordance with ASC No. 820, the Company measures warrants liability at fair value classified within Level 2 as the valuation inputs are based on quoted prices and market observable data of similar instruments.

The following table presents assets measured at fair value on a recurring basis as of March 31, 2023:

	March 31,		December 31,
	2023		2022
	Unaudited		Audited
	Fair value measurement using input Level 2
Non-current liabilities:
Warrants liability	$	2,664	$	5,329
Total liabilities	$	2,664	$	5,329

The carrying amounts of cash and cash equivalents, restricted cash, prepaid expenses and other receivables, trade payables and other current payables approximate their fair value due to the short-term maturity of such instruments.

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Loan from Others

3 Months Ended

Mar. 31, 2023

Loan from Others [Abstract]

LOAN FROM OTHERS

NOTE 3:- LOAN FROM OTHERS

a. On June 19, 2017, the Company entered into a Finance Contract with the European Investment bank (EIB) for a total amount of approximately $22,422 (€ 20,000) and up to 50% of the Company’s expected cost of developing and marketing the Company’s product candidate, M-001. In addition, as a repayment features, EIB was entitled to receive the higher between 3% of any M-001 sales revenues for a period of ten years, or realizing a cash-on-cash multiple of 2.8 times

During 2018, the Company received approximately $23,599 (€ 20,000) in two tranches of approximately $7,080 (€ 6,000) and the third tranche of approximately $9,439 (€ 8,000).
On October 7, 2019, the Company received the remaining approximately $4,390 (€ 4,000).

In the event the Company elects to prepay the EIB financing, or in the event the EIB shall demand prepayment following certain events, including a change of control, senior management changes or merger events, the Company shall be required to pay EIB the principal amount of the tranches already paid, or the Prepayment Amount, plus the greater of:

(i) the amount, as determined by EIB required in order for the EIB to realize an internal rate of return on the relevant amount prepaid of 20%; and

(ii) the Prepayment Amount.

The Finance Contract also stipulates that in the event the EIB demands prepayment of the loan due to any prepayment event to non-EIB lenders, the Company shall be obligated to pay the Prepayment Amount plus an additional reduced amount. In addition, and as consideration for the EIB financing, the EIB shall be entitled to 3% of any annual M-001 sales revenues.

b. On April 22, 2019, the Committee of EIB Bank agreed to expand the 2017 financing agreement to the Company by an additional approximately $4,502 (€ 4,000) to a total of approximately $27,013 (€ 4,000). An amendment to that effect was signed in June 2019 (the “Amendment”). Those funds were received in October 2019 and 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, as repayment features, EIB is entitled to receive the higher between 3% of any M-001 sales revenues for a period of twelve years or realizing a cash-on-cash multiple of 2.8 times

c. On October 23, 2020, the Company announced Phase 3 clinical trial results of the M-001 universal vaccine product. The results did not demonstrate a statistically significant difference between the vaccinated group and the placebo group in reduction of flu illness and severity. Therefore, the study failed to meet both the primary and secondary efficacy endpoints. However, the study’s primary safety endpoint was met.

As a result of the Phase 3 clinical trial failure, Company’s management estimates that there will be no future revenues from the M-001 product. Therefore, most likely, there will be no future royalty payments to EIB.

Under the Finance Contract, the EIB may accelerate all loans extended thereunder if an event of default has occurred, which includes, amongst other things, an event of default arising from the occurrence of a material adverse change, defined as any event or change of condition, which in the opinion of the EIB, has a material adverse effect on: our ability to perform our obligations under the Finance Documents; our business, operations, property, condition (financial or otherwise) or prospects; or the rights or remedies of the EIB under the Finance Contract, amongst other things. If the EIB determines that an event of default has occurred, it could accelerate the amounts outstanding under the Finance Contract, making those amounts immediately due and payable.

In accordance with the EIB loan agreement, and due to the above, the Company was required to pay EIB the principal amount of the tranches already loaned by the EIB to the Company, within five years of the date of each tranche of the loan. On December 31, 2020, the Company re-evaluated the loan in the sum of $ 29,443. As a result, the Company recorded an amount of $ 6,162 as revaluation income of the EIB loan.

On January 26, 2021, the EIB notified the Company that they welcome the Company’s efforts to secure future equity financing in an amount not less than $ 2,000 in order to enable the Company to pursue new business opportunities, strengthen the Company balance sheet and invest in growth. Thus, within that context, the EIB wrote in their letter that they will not consider the failure of the Company’s pivotal phase 3 trial for M-001 to meet the primary and secondary efficacy endpoints as a trigger for prepayment of a loan extended under the Finance Contract. However, EIB cautioned the Company that their letter is not a consent, agreement, amendment or waiver in respect of the terms of the Finance Contract, reserving any other right or remedy the EIB may have now or subsequently.

d. On August 9, 2022, the Company signed a loan restructuring agreement with the European Investment Bank (EIB) for the new terms of its outstanding approximately $24,554 (€ 24,000) loan to the Company. The new terms include:

1. An extension of the maturity dates from 2023 (approximately $20,462) and 2024 (approximately $4,092) until December 31, 2027.

2. Interest on the Loan will begin to accrue starting January 1, 2022, at an annual rate of 7%. The interest payments will be deferred until the new maturity date and will be added to the principal balance at the end of each year during the loan period.

3. An amount of $ 900 (approximately € 880) were paid by BiondVax on August 15, 2022, shortly after the execution of the relevant amendment letter with the EIB and was applied to reduce the outstanding loan. Going forward 10% of any capital raises until maturity will be used to further repay the Loan principal including any outstanding accrued interest.

4. If the Company sales exceed approximately $5,332 (€ 5,000), 3% of the revenues will be paid to the EIB as royalties until the EIB receives (from the Loan repayment, inter alia the interest and the royalties) the higher of (i) a total of 2.8 times the original approximately $25,596 (€ 24,000) principal (as provided in the original Loan agreement) and (ii) 20% IRR on the principal.

5. In case the Company decides to discharge all liabilities under the finance contract, inter alia payments of the variable remuneration, the Company would need to repay to the EIB an indemnity amount in addition to the Loan principal and the accrued interest. The indemnity amount will be calculated such that the EIB receives an additional payment equal to the greater of (i) the prepayment amount (i.e. twice the prepayment amount in the aggregate) and (ii) the amount required to realize 20% IRR on the prepayment amount at the time of prepayment.

The Company recorded the cash received in each tranche and a corresponding liability to repay the cash. The Company evaluates the estimated cash flows from the EIB loan at each reporting period. When the estimated cash flows change from the estimates used as of the date on which the EIB loan was issued, the EIB loan’s carrying amount is adjusted to an amount equal to the present value of the estimated remaining future payments, discounted by using the original effective interest rate. The adjustment to the carrying amount is recognized in earnings as an adjustment to interest expenses, in the period in which the change in estimate occurred.

On December 31, 2022 as a result of the loan restructure, the Company recorded an amount of $ 7,168 under finance income. Interest expense related to the EIB loan were to $87

On February 16, 2023, $725 was paid to the EIB as part of the loan restructure agreement.

For the three month ended at March 31, 2023 the company recorded $1,769 under finance expenses due to the loan revaluation.

As of March 31, 2022, the outstanding principal amount related to the EIB loan in nominal terms is $ 26,105.

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Contingent Liabilities and Commitments

3 Months Ended

Mar. 31, 2023

Contingent Liabilities and Commitments [Abstract]

CONTINGENT LIABILITIES AND COMMITMENTS

NOTE 4:- CONTINGENT LIABILITIES AND COMMITMENTS

Since 2006, the Company received approximately $5,830 in grants from the Israeli Innovation Authority (IIA), formerly known as the Office of the Chief Scientist. The grants were for research and development of M-001.

In return to those grants, the Company undertook to pay royalties amounting to 3%-5% on the revenues derived from sales of products or services developed in whole or in part using these grants. The maximum aggregate royalties paid generally cannot exceed 100% of the grants received by the Company, plus annual interest generally equal to the 12-month LIBOR applicable to dollar deposits, as published on the first business day of each calendar year. The maximum royalty amounts payable by the Company as of March 31, 2023 is approximately $ 5,830 which represents the total gross amount of grants actually received by the Company from the IIA including accrued interest. As of March 31, 2023, the Company had not paid any royalties to the IIA.

In light of the Phase 3 clinical trial results (see also Note 3.c above), the Company does not currently expect any future revenues from M-001 and therefore do not currently expect to make any royalty payments to the IIA and the Company does not record a liability for amounts received from IIA until the related revenues are recognized. In the event of failure of a project that was partly financed by the IIA, the Company will not be obligated to pay any royalties or repay the amounts received.

The Company also subject to various other restrictions pursuant to the grant, including limitations on transferring IP developed with grant funds. In light of the Company’s new strategy, it does not expect these restrictions to be material to its ongoing operations.

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Shareholders' Equity

3 Months Ended

Mar. 31, 2023

Shareholders' Equity [Abstract]

SHAREHOLDERS’ EQUITY

NOTE 5:- SHAREHOLDERS’ EQUITY

a. Rights attached to shares:

An Ordinary share confers upon its holder(s) a right to vote at the general meeting, a right to participate in distribution of dividends, and a right to participate in the distribution of surplus assets upon liquidation of the Company.

b. On December 22, 2021, the Company signed definitive agreements with the Max Planck Society (“MPG”), the parent organization of the Max Planck Institute for Biophysical Chemistry, and the University Medical Center Göttingen (“UMG”), both in Germany, to enter into a strategic collaboration for the development and commercialization of innovative Covid-19 NanoAbs, effective from January 1, 2022. The agreements provide for an upfront payment, development and sales milestones and royalties based on sales and sharing of sublicense revenues.

In accordance with the agreement the company issued 150,000 restricted ADS share at no cost to Max planck as an upfront payment for the license, the shares are blocked for a period of three years. The company evaluate the fair value of the license at $153. The fair value was calculated by an independent valuation, at a discount rate of 31% under the following principles:

Stock price	1.48
Variance	150	%
Risk free interest	1	%

c. On November 10, 2022, the Company announced that it plans to affect a ratio change of the Company’s American Depositary Shares (ADSs) to its non-traded ordinary shares from the current ratio of one (1) ADS representing forty (40) ordinary shares to a new ratio of one (1) ADS representing four hundred (400) ordinary shares. The ratio change will have the same effect as a reverse split of the existing ADSs of one (1) new ADS for every ten (10) old ADSs. The effective date for the ratio change was November 25, 2022.

d. On December 13 2022, an amendment to the Company’s Articles of Association increasing the registered share capital of the Company by an additional 18,200,000,000 Ordinary Shares (the equivalent of 45,500,000 ADSs) such that the total registered share capital of the Company would consist of 20,000,000,000 Ordinary Shares, no par value (the equivalent of 50,000,000 ADSs).

e. On December 20, 2022, the Company closed an underwritten public offering with gross proceeds to the Company of $8,000,000, before deducting underwriting discounts and other expenses payable by the Company. The offering consisted of 1,600,000 units and pre-funded units. Each unit consisted of one American Depositary Share (“ADS”) and two warrants, each to purchase one ADS, and each pre-funded unit consists of one pre-funded warrant to purchase one ADS and two warrants each to purchase one ADS. One of the warrants will expire three years from the date of issuance, and the other warrant will expire one year from the date of issuance and may be exercised for half an ADS on or prior to six (6) months following the original issuance for no additional consideration. Each ADS (or pre-funded warrant) was sold together with two warrants at a combined purchase price of $5.00 per unit (or $4.99 per pre-funded unit after reducing $0.01 attributable to the exercise price of the pre-funded warrants). Each ADS represents 400 of our ordinary shares, no par value per share. The Company received a net sum of $7,231 after deduction of underwriter discount and issuance expenses of $769. The warrants were classified as liabilities, initially and subsequently measured at fair value through earnings pursuant to ASC 480 as the warrants are not considered indexed to the Company’s own shares.

f. On January 5, 2023, the Company issued 810,000 ADSs (324,000,000 shares) as a result of exercise of warrants in consideration of

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Share-Based Compensation

3 Months Ended

Mar. 31, 2023

Share-Based Compensation [Abstract]

SHARE-BASED COMPENSATION

NOTE 6:- SHARE-BASED COMPENSATION

a. Option plans:

Options granted under the Company’s 2005 Israeli Share Option Plan (“Plan”) were exercisable in accordance with the terms of the Plan, within 10 years from the date of grant, against payment of an exercise price. The options generally vest over a period of three or four years.

In March 2018, the Company’s Board of Directors approved the adoption of the Company’s 2018 Israeli Share Option Plan (“2018 Plan”) for the grant of options and restricted shares (“RSU”) to employees, directors and service providers. The options are exercisable within 10 years from the date of grant, against payment of the exercise price, in accordance with the terms of the 2018 Plan. The options generally vest over a period of three or four years.

There were no grants during the three-month ended March 31, 2023.

b. The total share-based compensation expense related to all of the Company’s equity-based awards, recognized for the years ended March 31, 2023 and 2022 is comprised as follows:

	Three months ended March 31,
	2023		2022
	Unaudited		Unaudited
Research and development expenses	$	31	$	19
Marketing, general and administrative expenses		221		466
Total share-based compensation	$	252	$	485

c. A summary of restricted shares and restricted share activity as of March 31, 2023 is as follows:

	Number of restricted share units			Weighted average grant date fair value
Unvested as of December 31, 2022		107,768		$	6.49
Granted		125,607			2.22
Vested		(1,083	)		9.76
Forfeited		-			-
Unvested as of March 31, 2023 (Unaudited)		232,292		$	4.17

During the three-month ended March 31, 2023, the company granted 125,607 RSU’s ADS to employees and officers, the RSU’s shall be vested in three years and the fair value of the said grant was $278.

As of March 31, 2023, there are $514 of total unrecognized costs related to share-based compensation that is expected to be recognized over a period of up to four years.

The fair value of the granted RSUs was determent according to the market stock price at the day of grant.

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Basic and Diluted Net Loss Per Share

3 Months Ended

Mar. 31, 2023

Earnings Per Share [Abstract]

BASIC AND DILUTED NET LOSS PER SHARE

NOTE 7:- BASIC AND DILUTED NET LOSS PER SHARE 

The following table sets forth the computation of basic and diluted net loss per share:

	Three months ended March 31,
	2023			2022
	Unaudited			Unaudited
Numerator for basic and diluted net loss per share:
Net loss	$	(3,515	)	$	(2,475	)
Denominator for basic and diluted net loss per share:
Weighted average shares outstanding		1,295,256,604			744,711,465

All outstanding employees options, employees restricted shares and warrants for the three months ended March 31, 2023 and 2022 have been excluded from the calculation of the diluted net loss per share, because all such securities are anti-dilutive for all periods presented. The total number of potential shares excluded from the calculation of diluted net loss per share are as follows:

	Three months ended March 31,
	2023		2022
	Unaudited		Unaudited
Employees RSUs and options		121,285,269		64,507,360
Warrants		1,040,940,000		-
Total		1,162,225,269		64,507,360

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Accounting Policies, by Policy (Policies)

3 Months Ended

Mar. 31, 2023

Accounting Policies [Abstract]

Basis of presentation of the financial statements

Basis of presentation of the financial statements:

The accompanying unaudited condensed financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and in accordance with the instructions to Form 10-Q and Article 10 of Regulation S-X promulgated by the U.S Securities and Exchange Commission (the “SEC”). Certain information or footnote disclosures normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted, pursuant to the rules and regulations of the SEC for interim financial reporting. Accordingly, they do not include all the information and footnotes necessary for a complete presentation of financial position, results of operations, or cash flows. In the opinion of management, the accompanying unaudited condensed financial statements include all adjustments, consisting of a normal recurring nature, which are necessary for a fair presentation of the financial position, operating results and cash flows for the periods presented.

The accompanying unaudited condensed financial statements should be read in conjunction with the Company’s Annual Report on Form 10-K as of December 31, 2022 filed with the SEC on April 17, 2023. The interim period results do not necessarily indicate the results that may be expected for any other interim period or for the full fiscal year.

Use of estimates

Use of estimates:

The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates, judgments and assumptions that affect the amounts reported in the financial statements and accompanying notes. The Company’s management believes that the estimates, judgment and assumptions used are reasonable based upon information available at the time they are made. These estimates, judgments and assumptions can affect the reported amounts of assets and liabilities at the dates of the financial statements, and the reported amount of expenses during the reporting periods. Actual results could differ from those estimates.

Cash and cash equivalents

Cash equivalents:

Cash equivalents are short-term highly liquid deposits that are readily convertible to cash with original maturities of three months or less, at the date acquired.

Restricted cash

Restricted cash:

Restricted cash are deposits with original maturities of three months or less and are used as security for the Company’s credit cards and rent. Restricted cash amounted to $127 and $140 as of March 31, 2023 and December 31, 2022 respectively.

Warrants

Warrants:

The Company accounts for warrants as either equity-classified or liability-classified instruments based on an assessment of the warrant’s specific terms and applicable authoritative guidance. The assessment considers whether the warrants are freestanding financial instruments, meet the definition of a liability under ASC 480, and meet all of the requirements for equity classification, including whether the warrants are indexed to the Company’s own common stock. Warrants that determined to be classified as equity, are recorded as a component of additional paid-in capital. Warrants that determined to be classified as liabilities are recorded at their initial fair value on the date of issuance and remeasured to fair value at each balance sheet date thereafter. Changes in the estimated fair value of the warrants are recognized in financial expenses, net in the statements of operations.

Recently adopted accounting pronouncements

Recently adopted accounting pronouncements:

In June 2016, the FASB issued ASU 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”). ASU 2016-13 requires the measurement of all expected credit losses for financial assets held at the reporting date based on historical experience, current conditions, and reasonable and supportable forecasts. ASU 2016-13 requires enhanced qualitative and quantitative disclosures to help investors and other financial statement users better understand significant estimates and judgments used in estimating credit losses, as well as the credit quality and underwriting standards of an organization’s portfolio. ASU 2016-13 is effective for fiscal years beginning after December 15, 2022, and interim periods within those fiscal years. The adoption of this ASU did not have a significant impact on the Company’s financial statements and disclosures.

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Fair Value Measurements (Tables)

3 Months Ended

Mar. 31, 2023

Fair Value Disclosures [Abstract]

Schedule of presents assets measured at fair value on a recurring basis

	March 31,		December 31,
	2023		2022
	Unaudited		Audited
	Fair value measurement using input Level 2
Non-current liabilities:
Warrants liability	$	2,664	$	5,329
Total liabilities	$	2,664	$	5,329

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Shareholders' Equity (Tables)

3 Months Ended

Mar. 31, 2023

Shareholders' Equity [Abstract]

Schedule of valuation assumption

Stock price	1.48
Variance	150	%
Risk free interest	1	%

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Share-Based Compensation (Tables)

3 Months Ended

Mar. 31, 2023

Share-Based Compensation [Abstract]

Schedule of total share-based compensation expense

	Three months ended March 31,
	2023		2022
	Unaudited		Unaudited
Research and development expenses	$	31	$	19
Marketing, general and administrative expenses		221		466
Total share-based compensation	$	252	$	485

Schedule of restricted shares and restricted share units activity

	Number of restricted share units			Weighted average grant date fair value
Unvested as of December 31, 2022		107,768		$	6.49
Granted		125,607			2.22
Vested		(1,083	)		9.76
Forfeited		-			-
Unvested as of March 31, 2023 (Unaudited)		232,292		$	4.17

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Basic and Diluted Net Loss Per Share (Tables)

3 Months Ended

Mar. 31, 2023

Schedule Of Computation Of Net Loss Per Share [Abstract]

Schedule of number of shares and loss used in the computation of loss per share

	Three months ended March 31,
	2023			2022
	Unaudited			Unaudited
Numerator for basic and diluted net loss per share:
Net loss	$	(3,515	)	$	(2,475	)
Denominator for basic and diluted net loss per share:
Weighted average shares outstanding		1,295,256,604			744,711,465

Schedule of diluted weighted average number of shares outstanding

	Three months ended March 31,
	2023		2022
	Unaudited		Unaudited
Employees RSUs and options		121,285,269		64,507,360
Warrants		1,040,940,000		-
Total		1,162,225,269		64,507,360

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General (Details) - USD ($)	1 Months Ended	3 Months Ended
	Mar. 23, 2022	Mar. 31, 2023	Dec. 31, 2022
General [Abstract]
Shares issued (in Shares)	15,000
Shares amount (in Shares)	6,000,000
Cash		$ 10,799,000
Operating loss		3,186,000,000
Cash flows from operating activities		3,059,000,000
Restricted cash amounted		$ 127	$ 140

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Fair Value Measurements (Details) - Schedule of presents assets measured at fair value on a recurring basis - Fair value measurement using input Level 2 [Member] - USD ($) $ in Thousands	Mar. 31, 2023	Mar. 31, 2022
Non-current liabilities:
Warrants liability	$ 2,664	$ 5,329
Total liabilities	$ 2,664	$ 5,329

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Loan from Others (Details) $ in Thousands			1 Months Ended			3 Months Ended		12 Months Ended
	Feb. 16, 2023 USD ($)	Aug. 09, 2022 USD ($)	Jan. 26, 2021 USD ($)	Oct. 23, 2020 USD ($)	Jun. 19, 2017	Mar. 31, 2023 USD ($)	Mar. 31, 2022 USD ($)	Dec. 31, 2022 USD ($)	Dec. 31, 2018 USD ($)	Dec. 31, 2018 EUR (€)	Aug. 09, 2022 EUR (€)	Dec. 31, 2020 USD ($)	Oct. 07, 2019 USD ($)	Oct. 07, 2019 EUR (€)	Apr. 22, 2019
Loan from Others (Details) [Line Items]
Finance contract description					the Company entered into a Finance Contract with the European Investment bank (EIB) for a total amount of approximately $22,422 (€ 20,000) and up to 50% of the Company’s expected cost of developing and marketing the Company’s product candidate, M-001. In addition, as a repayment features, EIB was entitled to receive the higher between 3% of any M-001 sales revenues for a period of ten years, or realizing a cash-on-cash multiple of 2.8 times
Received amount									$ 23,599	€ 20,000
Received remaining amount													$ 4,390	€ 4,000
Relevant amount prepaid percentage						20.00%
Sales revenues percentage						3.00%
Financing agreement description															the Committee of EIB Bank agreed to expand the 2017 financing agreement to the Company by an additional approximately $4,502 (€ 4,000) to a total of approximately $27,013 (€ 4,000). An amendment to that effect was signed in June 2019 (the “Amendment”). Those funds were received in October 2019 and 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, as repayment features, EIB is entitled to receive the higher between 3% of any M-001 sales revenues for a period of twelve years or realizing a cash-on-cash multiple of 2.8 times
Re-evaluated the loan												$ 29,443
Revaluation income				$ 6,162
Future equity financing			$ 2,000
Outstanding loan amount		$ 24,554									€ 24,000
Loan restructuring agreement, description		1.An extension of the maturity dates from 2023 (approximately $20,462) and 2024 (approximately $4,092) until December 31, 2027. 2.Interest on the Loan will begin to accrue starting January 1, 2022, at an annual rate of 7%. The interest payments will be deferred until the new maturity date and will be added to the principal balance at the end of each year during the loan period.  3.An amount of $ 900 (approximately € 880) were paid by BiondVax on August 15, 2022, shortly after the execution of the relevant amendment letter with the EIB and was applied to reduce the outstanding loan. Going forward 10% of any capital raises until maturity will be used to further repay the Loan principal including any outstanding accrued interest.  4.If the Company sales exceed approximately $5,332 (€ 5,000), 3% of the revenues will be paid to the EIB as royalties until the EIB receives (from the Loan repayment, inter alia the interest and the royalties) the higher of (i) a total of 2.8 times the original approximately $25,596 (€ 24,000) principal (as provided in the original Loan agreement) and (ii) 20% IRR on the principal.  5.In case the Company decides to discharge all liabilities under the finance contract, inter alia payments of the variable remuneration, the Company would need to repay to the EIB an indemnity amount in addition to the Loan principal and the accrued interest. The indemnity amount will be calculated such that the EIB receives an additional payment equal to the greater of (i) the prepayment amount (i.e. twice the prepayment amount in the aggregate) and (ii) the amount required to realize 20% IRR on the prepayment amount at the time of prepayment.
Finance income								$ 7,168
Interest expense related								$ 87
Loan restructure agreement	$ 725
Finance expenses due to the loan revaluation						$ 1,769
Outstanding principal amount							$ 26,105
Two Tranches [Member]
Loan from Others (Details) [Line Items]
Received amount									7,080	6,000
Third Tranche [Member]
Loan from Others (Details) [Line Items]
Received amount									$ 9,439	€ 8,000

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Contingent Liabilities and Commitments (Details)	3 Months Ended
	Mar. 31, 2023 USD ($)
Contingent Liabilities and Commitments (Details) [Line Items]
Grants received (in Dollars)	$ 5,830
Grants received	100.00%
Total gross amount (in Dollars)	$ 5,830
Minimum [Member]
Contingent Liabilities and Commitments (Details) [Line Items]
Pay royalty amount percentage	3.00%
Maximum [Member]
Contingent Liabilities and Commitments (Details) [Line Items]
Pay royalty amount percentage	(5.00%)

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Shareholders' Equity (Details) - USD ($)	1 Months Ended
	Dec. 20, 2022	Jan. 05, 2023	Dec. 13, 2022	Dec. 22, 2021
Shareholders' Equity (Details) [Line Items]
Ordinary shares, issued	400		20,000,000,000
Gross proceeds (in Dollars)	$ 8,000,000,000
Offering units	1,600,000
Expire term	3 years
Purchase price per unit (in Dollars per share)	$ 5
Pre-funded unit (in Dollars per share)	4.99
Exercise price (in Dollars per share)	$ 0.01
Received net amount (in Dollars)	$ 7,231,000
Deduction of underwriter discount and issuance expenses (in Dollars)	$ 769,000
Warrant [Member]
Shareholders' Equity (Details) [Line Items]
Ordinary shares, issued		324,000,000
Expire term	1 year
Articles of Association [Member]
Shareholders' Equity (Details) [Line Items]
Ordinary shares, issued			18,200,000,000
ADR [Member]
Shareholders' Equity (Details) [Line Items]
Ordinary shares, issued				150,000
Fair value of license (in Dollars)				$ 153
Discount rate				31.00%
Ordinary shares, issued			50,000,000
ADR [Member] | Warrant [Member]
Shareholders' Equity (Details) [Line Items]
Ordinary shares, issued		810,000
ADR [Member] | Articles of Association [Member]
Shareholders' Equity (Details) [Line Items]
Ordinary shares, issued			45,500,000

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Shareholders' Equity (Details) - Schedule of valuation assumption	3 Months Ended
	Mar. 31, 2023 $ / shares
Schedule Of Valuation Assumption Abstract
Stock price (in Dollars per share)	$ 1.48
Variance	150.00%
Risk free interest	1.00%

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Share-Based Compensation (Details) - USD ($)	1 Months Ended	3 Months Ended
	Mar. 31, 2018	Mar. 31, 2023
Share-Based Compensation (Details) [Line Items]
Option vested period description		The options generally vest over a period of three or four years.
Total unrecognized cost (in Dollars)		$ 514
Expected recognized period		4 years
Option Plan [Member]
Share-Based Compensation (Details) [Line Items]
Exercisable terms		10 years
2018 Plan [Member]
Share-Based Compensation (Details) [Line Items]
Exercisable terms	10 years
Option vested period description	The options generally vest over a period of three or four years.
RSU’s [Member]
Share-Based Compensation (Details) [Line Items]
Fair value said grant (in Dollars)		$ 278,000
RSU’s [Member] | ADS [Member]
Share-Based Compensation (Details) [Line Items]
Employees and officers (in Shares)		125,607

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Share-Based Compensation (Details) - Schedule of total share-based compensation expense - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2023	Mar. 31, 2022
Schedule of Total Share Based Compensation Expense [Abstract]
Research and development expenses	$ 31	$ 19
Marketing, general and administrative expenses	221	466
Total share-based compensation	$ 252	$ 485

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Share-Based Compensation (Details) - Schedule of restricted shares and restricted share units activity	3 Months Ended
	Mar. 31, 2023 $ / shares shares
Schedule of Restricted Shares And Restricted Share Units Activity [Abstract]
Number of restricted shares, Beginning balance | shares	107,768
Weighted average grant date fair value, Beginning balance | $ / shares	$ 6.49
Number of restricted shares, Granted | shares	125,607
Weighted average grant date fair value, Granted | $ / shares	$ 2.22
Number of restricted shares, Vested | shares	(1,083)
Weighted average grant date fair value, Vested | $ / shares	$ 9.76
Number of restricted shares, Forfeited | shares
Weighted average grant date fair value, Forfeited | $ / shares
Number of restricted shares, Ending balance | shares	232,292
Weighted average grant date fair value, Ending balance | $ / shares	$ 4.17

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Basic and Diluted Net Loss Per Share (Details) - Schedule of number of shares and loss used in the computation of loss per share - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2023	Mar. 31, 2022
Numerator for basic and diluted net loss per share:
Net loss	$ (3,515)	$ (2,475)
Denominator for basic and diluted net loss per share:
Weighted average shares outstanding	1,295,256,604	744,711,465

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Basic and Diluted Net Loss Per Share (Details) - Schedule of diluted weighted average number of shares outstanding - shares	3 Months Ended
	Mar. 31, 2023	Mar. 31, 2022
Schedule of Diluted Weighted Average Number of Shares Outstanding [Abstract]
Employees RSUs and options	121,285,269	64,507,360
Warrants	1,040,940,000
Total	1,162,225,269	64,507,360