UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16
Under the Securities Exchange Act of 1934
For the Month of August 2021
Commission File Number: 001-37353
BIONDVAX PHARMACEUTICALS LTD.
(Translation of registrant’s name into English)
Jerusalem BioPark, 2nd Floor
Hadassah Ein Kerem Campus
Jerusalem, Israel
(Address of principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.
Form 20-F ☒ Form 40-F ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ____
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ____
On August 26, 2021, BiondVax Pharmaceuticals Ltd. issued a press release announcing second quarter 2021 financial results.
Exhibit Index
Exhibit No. |
Description | |
99.1 | Press Release dated August 26, 2021 | |
99.2 | BiondVax Pharmaceuticals Ltd. unaudited interim financial statements for the period ending June 30, 2021 |
This Report on Form 6-K is hereby incorporated by reference into the Company’s Registration Statement on Form F-3 (Registration No. 333-240189) and its Registration Statement on Form S-8 (Registration No. 333-239344).
1
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
BiondVax Pharmaceuticals Ltd. | ||
Date: August 26, 2021 | By: | /s/ Amir Reichman |
Amir Reichman | ||
Chief Executive Officer |
2
Exhibit 99.1
BiondVax Announces Second Quarter 2021 Financial Results and Provides Business Update
Jerusalem, Israel – August 26, 2021 – BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), a biopharmaceutical company focused on developing, manufacturing and ultimately commercializing products for the prevention and treatment of infectious diseases and related illnesses, today published its second quarter financial results for the quarter ended June 30, 2021.
Financial Summary
Results are in New Israel Shekels (NIS) and convenience translation to $US is provided using the exchange rate of 3.26 (NIS/$US), the rate as of the close of business on June 30, 2021.
● | R&D expenses for the three months ended June 30, 2021 decreased to NIS 1.9 million ($0.6 million) from NIS 11.9 million for the three months ended June 30, 2020. This decrease was primarily attributable to expenses related to a Phase 3 clinical trial and related operations at our manufacturing facility. As previously reported, the trial concluded in Q4 2020. |
● | Marketing, general and administrative expenses for the three months ended June 30, 2021 increased to NIS 7 million ($2.1 million) from NIS 4.1 million for the three months ended June 30, 2020. This increase of NIS 2.9 million ($0.6 million) was primarily due to salary and salary related expenses related to the former CEO’s termination, an increase in Board of Directors expenses, the new CEO’s salary, share based compensation expenses, and an increase in professional services. |
● | Operating expenses for the three months ended June 30, 2021 were NIS 8.9 million ($2.7 million) compared with NIS 16.0 million for the three months ended June 30, 2020. |
● | Financial expenses for the three months ended June 30, 2021 were NIS 3.1 million ($0.95 million) compared with NIS 25.9 million for the three months ended June 30, 2020. This reduction was attributable primarily due to a decrease in financial expenses as a result of a $21 million warrants revaluation charge during the three months ended June 30, 2020 compared to none in the three months ended June 30, 2021. |
As of June 30, 2021, BiondVax had cash and cash equivalents of NIS 39.9 million ($12.2 million) as compared to NIS 48.6 million as of March 31, 2021.
Unaudited Q2 financial results will be submitted to the Securities and Exchange Commission. A summary is included in the tables below.
CEO Statement
Chief Executive Officer of BiondVax Mr. Amir Reichman commented, “Since joining the Company earlier this year, my team and I, with the support of the Board of Directors, have been identifying and are assessing a number of promising technologies and potential partners with the goal of building a diversified pipeline of biological products and platforms for therapeutic use through in licensing, co-developing, acquiring or partnering. Our potential partners include top tier researchers, institutes and/or companies that possess relevant Intellectual Property that may fit with BiondVax’s strategic aspirations, experience and capabilities. We are currently engaged in deep-dive evaluations of some particularly intriguing opportunities. In collaboration with these potential partners and relevant experts we are assessing these potential avenues from several perspectives, including scientific merit, complementary synergies with our manufacturing infrastructure and product development expertise, as well as their potential for commercial market success.”
Jerusalem BioPark, 2nd floor ● Hadassah Ein Kerem Campus ● Jerusalem, Israel
Telephone: +972-8-9302529 ● Fax: +972-8-9302531 ● www.BiondVax.com
Reichman continued, “Last week, I relocated with my family to Israel from Belgium where I had been serving in a senior leadership role at GSK Vaccines headquarters. I am pleased to now be working face-to-face with the highly experienced, motivated and talented BiondVax team, and I am increasingly optimistic with regard to our potential to rebuild BiondVax to become a successful biopharmaceutical company excelling in identifying, developing, manufacturing and ultimately commercializing biological therapeutics and vaccines.”
About BiondVax
BiondVax Pharmaceuticals Ltd. (NASDAQ: BVXV) is a biopharmaceutical company focused on developing, manufacturing and ultimately commercializing products for the prevention and treatment of infectious diseases and related illnesses. The Company had been developing M-001, a novel influenza vaccine candidate that was designed to provide multi-strain and multi-season protection against current and future seasonal and pandemic influenza. In seven Phase 1/2 and Phase 2 clinical trials designed to test for immunogenicity, the Company was able to demonstrate M-001 was effective in stimulating an immune response to a broad range of influenza virus strains. In October 2020, the Company completed a Phase 3 clinical trial of M-001 which did not meet the trial’s primary and secondary efficacy endpoints. The Company is now pursuing the goal of developing a pipeline of diversified and commercially viable products and platforms.
Contact Details
Company: Joshua E. Phillipson | +972 8 930 2529 | j.phillipson@biondvax.com
Investor Relations: Kenny Green (Israel) | +1 646 201 9246 | kgreen@edisongroup.com
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Litigation Reform Act of 1995. Words such as “expect,” “believe,” “intend,” “plan,” “continue,” “may,” “will,” “anticipate,” and similar expressions are intended to identify forward-looking statements, including statements regarding future business strategies that BiondVax may explore. These forward-looking statements reflect management’s current views with respect to certain current and future events and are subject to various risks, uncertainties and assumptions that could cause the results to differ materially from those expected by the management of BiondVax Pharmaceuticals Ltd. Risks and uncertainties include, but are not limited to, the risk that BiondVax may not be able to secure additional capital on attractive terms, if at all; the risk that the European Investment Bank may accelerate the loans under its finance contract with BiondVax; the risk that BiondVax may not execute a strategic alternative to M-001 or implement a strategy that will diversify BiondVax’s risk, and, if executed, may not be successful; risks relating to the COVID-19 (coronavirus) pandemic; BiondVax’s ability to acquire rights to additional product opportunities; BiondVax’s ability to enter into collaborations on terms acceptable to BiondVax or at all; timing of receipt of regulatory approval of BiondVax’s manufacturing facility in Jerusalem, if at all or when required; the risk that the manufacturing facility will not be able to be used for a wide variety of applications and other vaccine and treatment technologies, and the risk that drug development involves a lengthy and expensive process with uncertain outcomes. More detailed information about the risks and uncertainties affecting the Company is contained under the heading “Risk Factors” in the Company's Annual Report on Form 20-F filed with the Securities and Exchange Commission on May 13, 2021. BiondVax undertakes no obligation to revise or update any forward-looking statement for any reason.
Jerusalem BioPark, 2nd floor ● Hadassah Ein Kerem Campus ● Jerusalem, Israel
Telephone: +972-8-9302529 ● Fax: +972-8-9302531 ● www.BiondVax.com
2
BALANCE SHEETS
In thousands, except share and per share data
Convenience Translation | ||||||||||||||||
December 31, | June 30, | June 30, | ||||||||||||||
2020 | 2020 | 2021 | 2021 | |||||||||||||
Audited | Unaudited | Unaudited | ||||||||||||||
N I S | U.S. dollars | |||||||||||||||
CURRENT ASSETS: | ||||||||||||||||
Cash and cash equivalents | 9,421 | 38,752 | 39,883 | 12,234 | ||||||||||||
Other receivables | 1,204 | 2,467 | 2,641 | 810 | ||||||||||||
10,625 | 41,219 | 42,524 | 13,044 | |||||||||||||
LONG-TERM ASSETS: | ||||||||||||||||
Property, plant and equipment | 39,607 | 36,937 | 38,979 | 11,957 | ||||||||||||
Right-of-use assets | 6,206 | 6,662 | 6,109 | 1,874 | ||||||||||||
Other long-term assets | 473 | 891 | 437 | 134 | ||||||||||||
46,286 | 44,490 | 45,525 | 13,965 | |||||||||||||
56,911 | 85,709 | 88,049 | 27,009 | |||||||||||||
CURRENT LIABILITIES: | ||||||||||||||||
Trade payables | 1,868 | 4,070 | 2,635 | 808 | ||||||||||||
Operating lease liabilities | 654 | 676 | 764 | 234 | ||||||||||||
Loan from others | 60,421 | - | 64,248 | 19,708 | ||||||||||||
Other payables | 1,246 | 1,609 | 1,739 | 534 | ||||||||||||
64,189 | 6,355 | 69,386 | 21,284 | |||||||||||||
LONG-TERM LIABILITIES: | ||||||||||||||||
Liability in respect of government grants | - | 12,686 | - | - | ||||||||||||
Operating lease liabilities | 6,088 | 6,457 | 6,047 | 1,855 | ||||||||||||
Loan from others | - | 122,041 | - | - | ||||||||||||
Other payables | 1,135 | - | 1,135 | 348 | ||||||||||||
Severance pay liability, net | 95 | 92 | 95 | 29 | ||||||||||||
7,318 | 141,276 | 7,277 | 2,232 | |||||||||||||
SHAREHOLDERS' EQUITY: | ||||||||||||||||
Ordinary shares of no par value: Authorized: 1,800,000,000 shares at June 30, 2021 (unaudited) and 600,000,000 shares at June 30, 2020 (unaudited) and 700,000 shares at December 31, 2020, respectively; Issued and outstanding: 573,285,824 shares at June 30, 2021 (unaudited), 460,822,640 shares at June 30, 2020 (unaudited) and 461,285,824 shares at December 31, 2020 | - | *) | - | *) | - | *) | - | *) | ||||||||
Share premium | 310,197 | 304,089 | 356,358 | 109,313 | ||||||||||||
Accumulated deficit | (324,793 | ) | (366,011 | ) | (344,972 | ) | (105,820 | ) | ||||||||
(14,596 | ) | (61,922 | ) | 11,386 | 3,493 | |||||||||||
56,911 | 85,709 | 88,049 | 27,009 |
*) | Represents less than 1 NIS\USD |
Jerusalem BioPark, 2nd floor ● Hadassah Ein Kerem Campus ● Jerusalem, Israel
Telephone: +972-8-9302529 ● Fax: +972-8-9302531 ● www.BiondVax.com
3
STATEMENTS OF COMPREHENSIVE LOSS
In thousands, except share and per share data
Convenience translation | ||||||||||||||||||||||||
Year ended December 31, |
Three months ended June 30, |
Six months ended June 30, |
Six months ended
June 30, |
|||||||||||||||||||||
2020 | 2020 | 2021 | 2020 | 2021 | 2020 | |||||||||||||||||||
Audited | Unaudited | Unaudited | ||||||||||||||||||||||
N I S | U.S. dollars | |||||||||||||||||||||||
(In thousands, except per share data) | ||||||||||||||||||||||||
Operating expenses: | ||||||||||||||||||||||||
Research and development, net of participations | 51,463 | 11,948 | 1,900 | 31,016 | 4,653 | 1,427 | ||||||||||||||||||
Marketing, general and administrative | 16,687 | 4,139 | 7,002 | 5,120 | 11,007 | 3,376 | ||||||||||||||||||
Other income | (75,484 | ) | - | - | - | - | - | |||||||||||||||||
Total operating expenses (income) | (7,334 | ) | 16,087 | 8,902 | 36,136 | 15,660 | 4,803 | |||||||||||||||||
Operating income (loss) | 7,334 | (16,087 | ) | (8,902 | ) | (36,136 | ) | (15,660 | ) | (4,803 | ) | |||||||||||||
Financial income | 3,843 | (11,291 | ) | (360 | ) | 5,211 | 822 | 252 | ||||||||||||||||
Financial expense | (15,632 | ) | (14,600 | ) | (2,731 | ) | (14,748 | ) | (5,341 | ) | (1,638 | ) | ||||||||||||
Net loss and total comprehensive loss | (4,455 | ) | (41,978 | ) | (11,993 | ) | (46,673 | ) | (20,179 | ) | (6,189 | ) | ||||||||||||
Basic and diluted net loss per share | (0.01 | ) | (0.10 | ) | (0.03 | ) | (0.11 | ) | (0.04 | ) | (0.01 | ) | ||||||||||||
Weighted average number of shares outstanding used to compute basic and diluted loss per share | 443,260,878 | 433,498,227 | 573,205,607 | 431,485,801 | 552,140,030 | 552,140,030 |
The notes in the Company’s quarterly report are an integral part of the financial statements. The complete financial results are available in the Form 6-K to be filed with the Securities and Exchange Commission.
Jerusalem BioPark, 2nd floor ● Hadassah Ein Kerem Campus ● Jerusalem, Israel
Telephone: +972-8-9302529 ● Fax: +972-8-9302531 ● www.BiondVax.com
4
Exhibit 99.2
BIONDVAX PHARMACEUTICALS LTD.
INTERIM FINANCIAL STATEMENTS
AS OF JUNE 30, 2021
NIS IN THOUSANDS
UNAUDITED
INDEX
Page |
|
Balance Sheets | F-2 - F-3 |
Statements of Comprehensive Loss | F-4 |
Statements of Changes in Shareholders’ Equity (Deficiency) | F-5 – F-7 |
Statements of Cash Flows | F-8- F-9 |
Notes to Interim Financial Statements | F-10 - F-13 |
- - - - - - - - - - -
F-1
BALANCE SHEETS
In thousands, except share and per share data
December 31, | June 30, |
Convenience
|
||||||||||||||
2020 | 2020 | 2021 | 2021 | |||||||||||||
Audited | Unaudited | Unaudited | ||||||||||||||
N I S | U.S. dollars | |||||||||||||||
CURRENT ASSETS: | ||||||||||||||||
Cash and cash equivalents | 9,421 | 38,752 | 39,883 | 12,234 | ||||||||||||
Other receivables | 1,204 | 2,467 | 2,641 | 810 | ||||||||||||
10,625 | 41,219 | 42,524 | 13,044 | |||||||||||||
LONG-TERM ASSETS: | ||||||||||||||||
Property, plant and equipment | 39,607 | 36,937 | 38,979 | 11,957 | ||||||||||||
Right-of-use assets | 6,206 | 6,662 | 6,109 | 1,874 | ||||||||||||
Other long-term assets | 473 | 891 | 437 | 134 | ||||||||||||
46,286 | 44,490 | 45,525 | 13,965 | |||||||||||||
56,911 | 85,709 | 88,049 | 27,009 |
The accompanying notes are an integral part of the interim financial statements.
F-2
BIONDVAX PHARMACEUTICALS LTD.
BALANCE SHEETS
In thousands, except share and per share data
December 31 | June 30, |
Convenience
Translation (Note 2c) June 30, |
||||||||||||||
2020 | 2020 | 2021 | 2021 | |||||||||||||
Audited | Unaudited | Unaudited | ||||||||||||||
N I S | U.S. dollars | |||||||||||||||
CURRENT LIABILITIES: | ||||||||||||||||
Trade payables | 1,868 | 4,070 | 2,635 | 808 | ||||||||||||
Operating lease liabilities | 654 | 676 | 764 | 234 | ||||||||||||
Loan from others | 60,421 | - | 64,248 | 19,708 | ||||||||||||
Other payables | 1,246 | 1,609 | 1,739 | 534 | ||||||||||||
64,189 | 6,355 | 69,386 | 21,284 | |||||||||||||
LONG-TERM LIABILITIES: | ||||||||||||||||
Liability in respect of government grants | - | 12,686 | - | - | ||||||||||||
Operating lease liabilities | 6,088 | 6,457 | 6,047 | 1,855 | ||||||||||||
Loan from others | - | 122,041 | - | - | ||||||||||||
Other payables | 1,135 | - | 1,135 | 348 | ||||||||||||
Severance pay liability, net | 95 | 92 | 95 | 29 | ||||||||||||
7,318 | 141,276 | 7,277 | 2,232 | |||||||||||||
SHAREHOLDERS’ EQUITY: | ||||||||||||||||
Ordinary shares of no par value: Authorized: 1,800,000,000 shares at June 30, 2021 (unaudited) and 600,000,000 shares at June 30, 2020 (unaudited) and 700,000 shares at December 31, 2020, respectively; Issued and outstanding: 573,285,824 shares at June 30, 2021 (unaudited), 460,822,640 shares at June 30, 2020 (unaudited) and 461,285,824 shares at December 31, 2020 | - | *) | - | *) | - | *) | - | *) | ||||||||
Share premium | 310,197 | 304,089 | 356,358 | 109,313 | ||||||||||||
Accumulated deficit | (324,793 | ) | (366,011 | ) | (344,972 | ) | (105,820 | ) | ||||||||
(14,596 | ) | (61,922 | ) | 11,386 | 3,493 | |||||||||||
56,911 | 85,709 | 88,049 | 27,009 |
*) | Represents less than NIS\USD 1. |
The accompanying notes are an integral part of the interim financial statements.
August 26, 2021 | ||||||
Date of approval of the | Mark Germain | Amir Reichman | Uri Ben-Or | |||
financial statements | Chairman of the Board | Chief Executive officer | Chief Financial officer |
F-3
STATEMENTS OF COMPREHENSIVE LOSS
In thousands, except share and per share data
Convenience translation (Note 2) | ||||||||||||||||||||||||
Year ended December 31, |
Three months ended
June 30, |
Six months ended
June 30, |
Six months
ended June 30, |
|||||||||||||||||||||
2020 | 2020 | 2021 | 2020 | 2021 | 2020 | |||||||||||||||||||
Audited | Unaudited | Unaudited | ||||||||||||||||||||||
N I S | U.S. dollars | |||||||||||||||||||||||
(In thousands, except per share data) | ||||||||||||||||||||||||
Operating expenses: | ||||||||||||||||||||||||
Research and development, net of participations | 51,463 | 11,948 | 1,900 | 31,016 | 4,653 | 1,427 | ||||||||||||||||||
Marketing, general and administrative | 16,687 | 4,139 | 7,002 | 5,120 | 11,007 | 3,376 | ||||||||||||||||||
Other income | (75,484 | ) | - | - | - | - | - | |||||||||||||||||
Total operating expenses (income) | (7,334 | ) | 16,087 | 8,902 | 36,136 | 15,660 | 4,803 | |||||||||||||||||
Operating income (loss) | 7,334 | (16,087 | ) | (8,902 | ) | (36,136 | ) | (15,660 | ) | (4,803 | ) | |||||||||||||
Financial income | 3,843 | (11,291 | ) | (360 | ) | 5,211 | 822 | 252 | ||||||||||||||||
Financial expense | (15,632 | ) | (14,600 | ) | (2,731 | ) | (14,748 | ) | (5,341 | ) | (1,638 | ) | ||||||||||||
Net loss and total comprehensive loss | (4,455 | ) | (41,978 | ) | (11,993 | ) | (46,673 | ) | (20,179 | ) | (6,189 | ) | ||||||||||||
Basic and diluted net loss per share | (0.01 | ) | (0.10 | ) | (0.03 | ) | (0.11 | ) | (0.04 | ) | (0.01 | ) | ||||||||||||
Weighted average number of shares outstanding used to compute basic and diluted loss per share | 443,260,878 | 433,498,227 | 573,205,607 | 431,485,801 | 552,140,030 | 552,140,030 |
The accompanying notes are an integral part of the interim financial statements.
F-4
STATEMENTS OF CHANGES IN SHAREHOLDERS’ EQUITY (DEFICIENCY)
In thousands, except share and per share data
Share capital | Share premium |
Accumulated deficit |
Total equity (deficiency) |
|||||||||||||
Unaudited | ||||||||||||||||
NIS in thousands | ||||||||||||||||
Balance as of January 1, 2021 | - | *) | 310,197 | (324,793 | ) | (14,596 | ) | |||||||||
Total comprehensive loss | - | - | (20,179 | ) | (20,179 | ) | ||||||||||
Issuance of shares, net | - | *) | 42,129 | - | 42,129 | |||||||||||
Share-based compensation | - | 4,032 | - | 4,032 | ||||||||||||
Balance as of June 30, 2021 | - | *) | 356,358 | (344,972 | ) | 11,386 | ||||||||||
Balance as of June 30, 2021 (convenience translation into U.S. dollars (see Note 2c) | - | *) | 109,312 | (105,820 | ) | 3,493 |
Share capital | Share premium |
Accumulated deficit |
Total deficiency |
|||||||||||||
Unaudited | ||||||||||||||||
NIS in thousands | ||||||||||||||||
Balance as of March 31, 2021 | - | *) | 353,783 | (332,979 | ) | 20,804 | ||||||||||
Total comprehensive loss | - | - | (11,993 | ) | (11,993 | ) | ||||||||||
Share-based compensation | - | 2,575 | - | 2,575 | ||||||||||||
Balance as of June 30, 2021 | - | *) | 356,358 | (344,972 | ) | 11,386 | ||||||||||
Balance as of June 30, 2021 (convenience translation into U.S. dollars (see Note 2c) | - | *) | 109,312 | (105,820 | ) | 3,493 |
*) | Represents less than NIS\USD 1. |
The accompanying notes are an integral part of the interim financial statements.
F-5
BIONDVAX PHARMACEUTICALS LTD.
STATEMENTS OF CHANGES IN SHAREHOLDERS’ EQUITY (DEFICIENCY)
In thousands, except share and per share data
Share capital | Share premium |
Accumulated deficit |
Total deficiency |
|||||||||||||
Unaudited | ||||||||||||||||
NIS | ||||||||||||||||
Balance as of January 1, 2020 | - | *) | 255,285 | (320,338 | ) | (65,053 | ) | |||||||||
Total comprehensive loss | - | - | (45,673 | ) | (45,673 | ) | ||||||||||
Exercise of warrants | - | 45,274 | - | 45,274 | ||||||||||||
Share-based compensation | - | 3,530 | - | 3,530 | ||||||||||||
Balance as of June 30, 2020 | - | *) | 304,089 | (366,011 | ) | (61,922 | ) | |||||||||
Balance as of June 30, 2020 (convenience translation into U.S. dollars (see Note 2c) | - | *) | 93,279 | (112,273 | ) | (18,994 | ) |
Share capital | Share premium | Accumulated deficit | Total deficiency | |||||||||||||
Unaudited | ||||||||||||||||
NIS in thousands | ||||||||||||||||
Balance as of April 1, 2020 | - | *) | 262,729 | (324,033 | ) | (61,304 | ) | |||||||||
Total comprehensive loss | - | - | (41,978 | ) | (41,978 | ) | ||||||||||
Exercise of warrants | - | 38,034 | - | 38,034 | ||||||||||||
Share-based compensation | - | 3,326 | - | 3,326 | ||||||||||||
Balance as of June 30, 2020 | - | *) | 304,089 | (366,011 | ) | (61,922 | ) | |||||||||
Balance as of June 30, 2020 (convenience translation into U.S. dollars (see Note 2c) | - | *) | 93,279 | (112,273 | ) | (18,994 | ) |
*) | Represents less than NIS\USD 1. |
The accompanying notes are an integral part of the interim financial statements.
F-6
BIONDVAX PHARMACEUTICALS LTD.
STATEMENTS OF CHANGES IN SHAREHOLDERS’ EQUITY (DEFICIENCY)
In thousands, except share and per share data
Share capital | Share premium |
Accumulated deficit |
Total deficiency |
|||||||||||||
Audited | ||||||||||||||||
NIS in thousands | ||||||||||||||||
Balance as of January 1, 2020 | - | *) | 255,285 | (320,338 | ) | (66,053 | ) | |||||||||
Total comprehensive loss | - | - | (4,455 | ) | (4,455 | ) | ||||||||||
Exercise of warrants | - | 45,274 | - | 45,274 | ||||||||||||
Exercise of options | - | 166 | - | 166 | ||||||||||||
Share-based compensation | - | 9,472 | - | 9,472 | ||||||||||||
Balance as of December 31, 2020 | - | *) | 310,197 | (324,793 | ) | (14,596 | ) | |||||||||
Balance as of December 31, 2020 (convenience translation into U.S. dollars (see Note 2c) | - | *) | 95,152 | (99,630 | ) | 4,478 |
*) | Represents less than NIS\USD 1. |
The accompanying notes are an integral part of the interim financial statements.
F-7
STATEMENTS OF CASH FLOWS
In thousands, except share and per share data
Convenience translation (Note 2) | ||||||||||||||||||||||||
Year ended
December 31, |
Three months ended
June 30, |
Six months ended
June 30, |
Six months ended June 30, |
|||||||||||||||||||||
2020 | 2020 | 2021 | 2020 | 2021 | 2021 | |||||||||||||||||||
Audited | Unaudited | Unaudited | ||||||||||||||||||||||
N I S | U.S. dollars | |||||||||||||||||||||||
Cash flows from operating activities: | ||||||||||||||||||||||||
Net loss | (4,455 | ) | (41,978 | ) | (11,993 | ) | (45,673 | ) | (20,179 | ) | (6,189 | ) | ||||||||||||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||||||||||||||||||
Adjustments to profit and loss items: | ||||||||||||||||||||||||
Depreciation of property, plant and equipment and right-of-use assets | 2,436 | 603 | 604 | 1,204 | 1,209 | 371 | ||||||||||||||||||
Net financial expenses (income) | 12,940 | 21,601 | 520 | 13,062 | (471 | ) | (144 | ) | ||||||||||||||||
Capital gain | (160 | ) | - | - | (160 | ) | - | - | ||||||||||||||||
Increase (decrease) in liability with respect to loans from others | (63,359 | ) | 4,257 | 1,902 | (1,739 | ) | 3,827 | 3,174 | ||||||||||||||||
Decrease in liability with respect to government grants | (14,812 | ) | (305 | ) | - | (2,126 | ) | - | - | |||||||||||||||
Share-based compensation | 9,472 | 3,326 | 2,575 | 3,530 | 4,032 | 1,237 | ||||||||||||||||||
Change in employee benefit liabilities, net | 6 | 2 | - | 3 | - | - | ||||||||||||||||||
(53,477 | ) | 29,484 | 5,601 | 13,774 | 8,597 | 4,638 | ||||||||||||||||||
Changes in asset and liability items: | ||||||||||||||||||||||||
Increase in other receivables | (548 | ) | (927 | ) | (2,191 | ) | (1,811 | ) | (1,467 | ) | (450 | ) | ||||||||||||
Increase (decrease) in trade payables | (15,194 | ) | 792 | 550 | (12,992 | ) | 767 | 235 | ||||||||||||||||
Increase in short- and long-term other payables | 1,178 | 801 | 99 | 405 | 493 | 151 | ||||||||||||||||||
(14,564 | ) | 666 | (1,542 | ) | (14,398 | ) | (207 | ) | (64 | ) | ||||||||||||||
Cash paid and received during the year for: | ||||||||||||||||||||||||
Interest paid | (45 | ) | (12 | ) | 24 | (24 | ) | 15 | 4 | |||||||||||||||
Interest received | 2 | 1 | - | 1 | - | - | ||||||||||||||||||
(43 | ) | (11 | ) | 24 | (23 | ) | 15 | 4 | ||||||||||||||||
Net cash flows used in operating activities | (72,539 | ) | (11,839 | ) | (7,910 | ) | (46,320 | ) | (11,774 | ) | (3,612 | ) |
*) | Represents an amount lower than NIS\USD 1. |
The accompanying notes are an integral part of the interim financial statements.
F-8
BIONDVAX PHARMACEUTICALS LTD.
STATEMENTS OF CASH FLOWS
In thousands, except share and per share data
Convenience translation (Note 2) | ||||||||||||||||||||||||
Year ended
December 31, |
Three months ended
June 30, |
Six months ended
June 30, |
Six months
ended June 30, |
|||||||||||||||||||||
2020 | 2020 | 2021 | 2020 | 2021 | 2021 | |||||||||||||||||||
Audited | Unaudited | Unaudited | ||||||||||||||||||||||
N I S | U.S. dollars | |||||||||||||||||||||||
Cash Flows from Investing Activities: | ||||||||||||||||||||||||
Purchase of property and equipment | (6,132 | ) | (1,315 | ) | (106 | ) | (2,687 | ) | (128 | ) | (39 | ) | ||||||||||||
Proceeds from sale of property and equipment | 160 | - | - | 160 | - | - | ||||||||||||||||||
Increase (decrease) in other long term assets | 37 | 8 | (1 | ) | (381 | ) | 36 | 11 | ||||||||||||||||
Net cash used in investing activities | (5,935 | ) | (1,307 | ) | (107 | ) | (2,908 | ) | (92 | ) | (28 | ) | ||||||||||||
Cash Flows from Financing Activities: | ||||||||||||||||||||||||
Repayment of operating lease liabilities | (1,240 | ) | (310 | ) | (317 | ) | (622 | ) | (623 | ) | (171 | ) | ||||||||||||
Proceeds from exercise of options to employees | 166 | |||||||||||||||||||||||
Proceeds from exercise of warrants to public | 14,790 | 10,344 | - | 14,790 | - | 12,923 | ||||||||||||||||||
Proceeds from issuance of shares, net of issuance costs | - | - | - | - | 42,129 | - | ||||||||||||||||||
Net cash provided by (used in) financing activities | 13,716 | 10,034 | (317 | ) | 14,168 | 41,506 | 12,732 | |||||||||||||||||
Exchange differences on balances of cash and cash equivalents | 1,712 | (642 | ) | (360 | ) | 1,345 | 822 | 252 | ||||||||||||||||
Increase (decrease) in cash and cash equivalents | (63,046 | ) | (3,754 | ) | (8,694 | ) | (33,715 | ) | 30,462 | 9,345 | ||||||||||||||
Balance of cash and cash equivalents at the beginning of the period | 72,467 | 42,506 | 48,577 | 72,467 | 9,421 | 2,890 | ||||||||||||||||||
Balance of cash and cash equivalents at the end of the period | 9,421 | 38,752 | 39,883 | 38,752 | 39,883 | 12,235 | ||||||||||||||||||
Non cash financing activities | ||||||||||||||||||||||||
Exercise of warrants to the public | 30,484 | 27,690 | - | 30,484 | - | - |
The accompanying notes are an integral part of the interim financial statements.
F-9
NOTES TO INTERIM FINANCIAL STATEMENTS
In thousands, except share and per share data
NOTE 1: GENERAL
a. | BiondVax Pharmaceuticals Ltd. (“the Company”) is focused on developing and ultimately commercializing products for prevention and treatment of infectious diseases and related illnesses. The Company was incorporated on July 21, 2003 in Israel, and started its activity on March 31, 2005. The Company’s principal executive offices and main laboratory are located at Jerusalem BioPark, 2nd floor, Hadassah Ein Kerem Campus, Jerusalem, Israel, next to Hadassah University Hospitals and Hebrew University’s Medical School. |
b. | On May 15, 2015, the Company completed a public offering of securities in the United States. |
c. | On March 28, 2017, the Company received an approval from the Investment Center of the Ministry of Economy and Industry of the State of Israel, for a grant (“the Grant”) representing 20% of a NIS 20,000 budget to be utilized towards the construction of a factory for the production of Phase 3 and commercial batches of the Company’s product. The receipt of the Grant was subject to certain terms and conditions, including those outlined under the Israeli Encouragement of Capital Investment Law,1959. The terms and conditions included, inter alia, the following: (a) at least 24% of the investments in the planned manufacturing facility’s fixed assets would be financed by additional share capital; (b) the Company would maintain its intellectual property and manufacturing facility in Israel for a period of at least 10 years. |
To the report date the Investment Center of the Ministry of Economy and Industry of the State of Israel has yet to approve the grant to the company.
d. | On June 19, 2017, the Company entered into a Finance Contract with the European Investment bank (EIB) for a total amount of € 20,000 (approximately $ 23,200) and up to 50% of the Company’s expected cost of developing and marketing the Company’s product candidate, M-001. In addition, as 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. |
e. | On April 22, 2019, the EIB agreed to expand the 2017 financing agreement to the Company by an additional € 4,000 to a total of € 24,000 (approximately $ 27,600). |
f. | On October 23, 2020, the Company announced Phase 3 clinical trial results of its 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. |
g. | On January 26, 2021, the EIB notified us, among other things, that they will not consider the failure of our pivotal phase 3 trial for M-001 to meet the primary and secondary efficacy endpoints as a trigger for prepayment of the loan extended under the Finance Contract. |
F-10
BIONDVAX PHARMACEUTICALS LTD.
NOTES TO INTERIM FINANCIAL STATEMENTS
In thousands, except share and per share data
NOTE 1: GENERAL (Cont.)
However, the EIB cautioned us 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. There is no guarantee that the decision by the EIB in their letter will not change at any time and without any notice or that the EIB will not determine that an event of default has occurred under the Finance Contract, which could result in all loans extended under the Finance Contract being accelerated and secured creditor remedies being exercised. If some or all of the loans under the Finance Contract are accelerated by the EIB, or secured creditor remedies are exercised, we expect such events to adversely impact our ability to continue as a going concern.
As of June 30, 2021, the EIB loan balance is $19,708 (approximately NIS 64,248).
h. | On January 21, 2021, the Company announced the appointment of Amir Reichman as its new Chief Executive Officer. Mr. Reichman and Dr. Ron Babecoff, its founder and former CEO, shared duties during a transition period while Mr. Reichman completed his former work obligations. Effective March 2, 2021, Mr. Reichman assumed the CEO position full time and Dr. Babecoff continued as Senior Advisor to the Company. |
i. | 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 $13,800. The Company received a net sum of $12,750 (approximately NIS 42,129). |
j. | In the six months ended June 30, 2021, the Company incurred a loss of NIS 20,179 ($ 6,189) and negative cash flows from operating activities of NIS 11,774 ($ 3,612) and it has an accumulated deficit of NIS 344,972 ($ 105,820) as of that date. |
To date the Company has not generated any revenues and will need additional funds to finance its operations in the future.
Furthermore, the Company intends to continue to finance its operating activities by raising capital. There are no assurances that the Company will be successful in obtaining an adequate level of financing needed for its long-term research, development and potential commercialization activities.
If the Company will not have the sufficient liquidity resources, the Company may not be able to continue the development of its prospective products or may be required to implement a cost reduction and may be required to delay part of its development program. The Company’s management and Board of Directors are of the opinion that its current financial resources will be sufficient to continue the operations of the Company for at least the next twelve months.
F-11
BIONDVAX PHARMACEUTICALS LTD.
NOTES TO FINANCIAL STATEMENTS
In thousands, except share and per share data
NOTE 2:- CONVENIENCE TRANSLATION INTO U.S. DOLLARS
The financial statements as of June 30, 2021 and for the six months then ended have been translated into dollars using the representative exchange rate as of that date ($ 1 = NIS 3.26). The translation was made solely for the convenience of the reader. The amounts presented in these financial statements should not be construed to represent amounts receivable or payable in dollars or convertible into dollars, unless otherwise indicated in these statements.
NOTE 3: SIGNIFICANT ACCOUNTING POLICIES
These financial statements have been prepared in a condensed format as of June 30, 2021, and for the three and six months then ended (“interim financial statements”). These financial statements should be read in conjunction with the Company’s annual financial statements as of December 31, 2020, and for the year then ended and accompanying notes (“annual financial statements”).
Basis of preparation of the interim financial statements
The interim consolidated financial statements have been prepared in accordance with generally accepted accounting principles for the preparation of financial statements for interim periods, as prescribed in IAS 34, “Interim Financial Reporting”, and in accordance with the disclosure requirements of Chapter D of the Securities Regulations (Periodic and Immediate Reports), 1970.
The significant accounting policies and methods of computation adopted in the preparation of the interim financial statements are consistent with those followed in the preparation of the Company’s annual financial statements.
NOTE 4: MAJOR EVENTS DURING THE PERIOD
a. | On April 6, 2021, the Company held an Extraordinary Meeting of Shareholders (the “Meeting”). At the Meeting, among other approved resolutions, the Company approved grants to the board members and CEO: |
1. | 30,000 RSUs to 6 directors, to vest in equal monthly installments during a period of three (3) years (if they continue to serve as directors) commencing one (1) month following the date of shareholder approval and would become fully vested, in accordance with the terms of the grant, on April 6, 2024. The RSUs would be subject to accelerated vesting in the event of a change of control. |
2. | Options to purchase 150,000 ADSs of the Company at an exercise price of the greater of (i) $6.95, which is the greater of (x) 130% of the average closing price on Nasdaq during the 30 trading days prior to board approval and (y) 130% of the weighted average closing price on Nasdaq during the 30 calendar days prior to board approval), and (ii) 100% of the weighted average closing price on Nasdaq in the 30 calendar days prior to shareholder approval. The options, which would include the ability to exercise on a cashless basis, would vest in equal monthly installments during a period of three (3) years commencing one (1) month following the date of shareholder approval and would become fully vested, in accordance with the terms of the grant, on April 6, 2024. The options would be subject to accelerated vesting and would become immediately exercisable in the event of a change of control. In addition, the options would have a term of ten (10) years following the date of shareholder approval and, to the extent the options are vested, such vested options would continue to be exercisable during such term in the event of termination of service to the Company without cause. |
F-12
BIONDVAX PHARMACEUTICALS LTD.
NOTES TO INTERIM FINANCIAL STATEMENTS
In thousands, except share and per share data
NOTE 4: MAJOR EVENTS DURING THE PERIOD (cont.)
3. | An amendment to the Company’s Articles of Association increasing the registered share capital of the Company by an additional 1,100,000,000 Ordinary Shares (the equivalent of 27.5 million ADSs) such that the total registered share capital of the Company would consist of 1,800,000,000 Ordinary Shares, no par value (the equivalent of 45 million ADSs). |
4. | The Company will issue to the new CEO 600,000 restricted share units (the “RSUs”) under the Company’s 2018 Israeli Share Option Plan, which will vest over a period of five years, 20% to vest each year on the anniversary date of the commencement date, and would become fully vested, in accordance with the terms of the grant, on March 2, 2026. The ADSs underlying the RSUs may not be sold by Mr. Reichman during the term of his employment. |
5. | The shareholders approved the amendment to the following options held by directors of the Company, as follows: Mr. Mark Germain (130,710 options), Prof. Avner Rotman (20,000 options), Mr. Adi Raviv (18,000 options), Prof. George H. Lowell (20,000 options), Dr. Morris Laster (18,000 options), Dr. Yael Margolin (18,000 options) and Mr. Isaac Devash (18,000 options) as follows: |
a. | accelerated vesting and the ability to immediately exercise such options in the event of a change of control; and |
b. | to the extent vested, allow the options to be exercised during the existing ten (10) year terms of the options in the event of the foregoing directors’ termination of service to the Company without cause. |
NOTE 4: SUBSEQUENT EVENTS
- - - - - - - - - - -
F-13