Scinai Immunotherapeutics Ltd 6-K/A, filed Aug 29, 2022
Scinai Immunotherapeutics Ltd. (SCNI)
About this 6-K/A
Scinai Immunotherapeutics Ltd filed this 6-K/A on August 29, 2022.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
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
Commission File Number: 001-37353
(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): ____
EXPLANATORY NOTE
This Report on Form 6-K (including the text under “Second Quarter 2022 Financial Summary” in Exhibit 99.1 and Exhibit 99.2) is hereby incorporated by reference into the registrant’s Registration Statements on Form S-8 (File No. 333-239344) and Form F-3 (File No. 333-240189), to be a part thereof from the date on which this report is submitted, to the extent not superseded by documents or reports subsequently filed or furnished.
Exhibit Index
| Exhibit No. | Description | |
| 99.1 | Press Release dated August 25, 2022 | |
| 99.2 | Unaudited Interim Condensed Consolidated Financial Statements as of June 30, 2022 |
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 29, 2022 | By: | /s/ Amir Reichman |
| Amir Reichman | ||
| Chief Executive Officer | ||
2
Exhibit 99.1
BiondVax announces Second Quarter 2022 Financial Results and Provides Business Update
JERUSALEM, Aug. 25, 2022 /PRNewswire/ -- BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), which focuses on developing, manufacturing and commercializing innovative products for the prevention and treatment of infectious diseases and other illnesses, today published its financial results for the quarter ended June 30, 2022 and provided a business update.
Business Update
| ● | Development of the NanoAb program is proceeding according to plan. A pilot quantity of the lead NanoAb, a COVID-19 therapy, was manufactured in-house then sent for preclinical inhalation device evaluation and selection of an inhaler for human use. |
| ● | In September 2022, BiondVax plans to initiate an inhalation proof of concept study with its anti-SARS-COV-2 NanoAbs in COVID-19 infected animals with readout expected in November 2022. |
| ● | BiondVax currently holds several anti-SARS-COV-2 NanoAb candidates, generated and initially characterized by Max Planck Institute for Multidisciplinary Sciences in Göttingen together with University Medical Center Göttingen and exclusively licensed from Max-Planck-Innovation GmbH, which demonstrated high affinity to and strong neutralization of COVID-19 VoCs including Omicron BA1&2 and will be testing them in the coming months for neutralization of BA2.75 and BA5. |
| ● | BiondVax received supportive Scientific Advice from the Paul Ehrlich Institute (PEI) for its COVID-19 NanoAb development plans. PEI supported BiondVax’s plan for first-in-human clinical trial to be conducted directly in sick patients as a combined Phase 1/2a, testing both safety and efficacy, thereby shortening BiondVax’s clinical development timelines. |
| ● | As part of their broader research collaboration with BiondVax, the researchers at Max Planck Institute for Multidisciplinary Sciences in Göttingen and University Medical Center Gottingen have been able to successfully isolate new NanoAbs targeting IL-17A/F and other cytokines, which can be used for treatment of other diseases such as psoriasis, psoriatic arthritis, asthma, and macular degeneration. BiondVax has an exclusive option for an exclusive license to further develop and commercialize these drug candidates. |
Second Quarter 2022 Financial Summary
Results are in New Israel Shekels (NIS) and convenience translation to $US is provided using the exchange rate of 3.5 (NIS/$US), the rate as of the close of business on June 30, 2022.
| ● | R&D expenses for the three months ended June 30, 2022 were NIS 6.5 million ($1.85 million) compared to NIS 1.9 million for the three months ended June 30, 2021. Total R&D expenses for the six months ended June 30, 2022 were NIS 10.1 million ($2.9 million) compared to NIS 4.6 million for the six months ended June 30, 2021. These increases were primarily due to drug development activities related to the new COVID-19 NanoAb program licensed from Max-Planck-Innovation GmbH in December 2021. |
| ● | Marketing, general and administrative expenses for the three months ended June 30, 2022 were NIS 4.3 million ($1.2 million) compared to NIS 7.0 million for the three months ended June 30, 2021. Total marketing, general and administrative expenses for the six months ended June 30, 2022 were NIS 8.9 million ($2.5 million) compared to NIS 11 million for the six months ended June 30, 2021. These decreases were primarily due to salaries and related expenses of NIS 1.2 million and share based payment of NIS 1 million. |
| ● | Financial expenses for the three months ended June 30, 2022 were NIS 2.1 million ($0.6 million) compared to NIS 3.0 million for the three months ended June 30, 2021. Financial expenses for the six months ended June 30, 2022 were NIS 3.2 million ($1 million) compared to NIS 4.5 million for the six months ended June 30, 2021. These decreases were primarily due to currency exchange differences and EIB loan financial expenses. |
| ● | Total operating expenses for the three months ended June 30, 2022 were NIS 10.8 million ($3.1 million) compared to NIS 8.9 million for the three months ended June 30, 2021. Total operating expenses for the six months ended June 30, 2022 were NIS 19 million ($5.5 million) compared to NIS 15.6 million for the six months ended June 30, 2021. |
| ● | Net loss for the for the three months ended June 30, 2022 was NIS 12.9 million ($3.7 million) compared to NIS 12.0 million for the three months ended June 30, 2021. Net loss for the six months ended June 30, 2022 was NIS 22.3 million ($6.4 million) compared to NIS 20.2 million for the six months ended June 30, 2021. These increases were primarily due to an increase in R&D expenses, offset by a decrease in marketing, general and administrative expenses as described above. |
As of June 30, 2022, BiondVax had cash and cash equivalents of NIS 39.5 million ($11.3 million) compared to NIS 54.0 million as of December 31, 2021.
Unaudited second quarter financial results will be submitted to the Securities and Exchange Commission. A summary is included in the tables below.
About BiondVax
BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV) is a biopharmaceutical company focused on developing, manufacturing and commercializing innovative products for the prevention and treatment of infectious diseases and other illnesses. Since its inception, the company has executed eight clinical trials including a seven country, 12,400 participant Phase 3 trial of its vaccine candidate and has built a state-of-the-art manufacturing facility for biopharmaceutical products. With highly experienced pharmaceutical industry leadership, BiondVax is aiming to develop a pipeline of diversified and commercially viable products and platforms beginning with an innovative nanosized antibody (NanoAb) pipeline. www.biondvax.com.
Contact Details
Company: Joshua E. Phillipson | +972 8 930 2529 | j.phillipson@biondvax.com
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Litigation Reform Act of 1995. Words such as “expect,” “believe,” “intend,” “plan,” “continue,” “may,” “will,” “anticipate,” and similar expressions are intended to identify forward-looking statements. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, future financial position, future revenue, projected expenses, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements regarding the timing of future clinical trials, and the therapeutic and commercial potential of NanoAbs. 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 the therapeutic and commercial potential of NanoAbs will not be met; the risk of a delay in the preclinical and clinical data for NanoAbs, if any; the risk that BiondVax and EIB will not reach agreement with respect to the restructuring of the loan from European Investment Bank; 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; 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 March 25, 2022. BiondVax undertakes no obligation to revise or update any forward-looking statement for any reason.
2
BALANCE SHEETS
In thousands, except share and per share data
| Convenience | ||||||||||||||||
| Translation | ||||||||||||||||
| December 31, | June 30, | June 30, | ||||||||||||||
| 2021 | 2021 | 2022 | 2022 | |||||||||||||
| Audited | Unaudited | Unaudited | ||||||||||||||
| NIS | N I S | U.S. dollars | ||||||||||||||
| CURRENT ASSETS: | ||||||||||||||||
| Cash and cash equivalents | 54,036 | 39,883 | 39,499 | 11,285 | ||||||||||||
| Other receivables | 1,012 | 2,641 | 626 | 179 | ||||||||||||
| Total current assets | 55,048 | 42,524 | 40,125 | 11,464 | ||||||||||||
| LONG TERM ASSETS: | ||||||||||||||||
| Property, plant and equipment | 38,519 | 38,979 | 39,250 | 11,214 | ||||||||||||
| Right-of-use assets | 5,588 | 6,109 | 5,227 | 1,494 | ||||||||||||
| Restricted cash | 444 | 437 | 484 | 138 | ||||||||||||
| Other long-term assets | - | - | 485 | 139 | ||||||||||||
| Total non-current assets | 44,551 | 45,525 | 45,446 | 12,985 | ||||||||||||
| Total assets | 99,599 | 88,049 | 85,571 | 24,449 | ||||||||||||
| LIABILITIES AND SHAREHOLDERS’ EQUITY | ||||||||||||||||
| CURRENT LIABILITIES: | ||||||||||||||||
| Trade payables | 3,107 | 2,635 | 2,057 | 588 | ||||||||||||
| Operating lease liabilities | 773 | 764 | 857 | 245 | ||||||||||||
| Loan from others | - | 64,248 | 18,706 | 5,345 | ||||||||||||
| Other payables | 3,327 | 1,739 | 1,898 | 542 | ||||||||||||
| Total current liabilities | 7,207 | 69,386 | 23,518 | 6,720 | ||||||||||||
| LONG TERM LIABILITIES: | ||||||||||||||||
| Operating lease liabilities | 5,712 | 6,047 | 5,536 | 1,582 | ||||||||||||
| Loan from others | 63,252 | - | 51,954 | 14,843 | ||||||||||||
| Other payables | - | 1,135 | - | - | ||||||||||||
| Severance pay liability, net | 95 | 95 | 95 | 27 | ||||||||||||
| Total long-term liabilities | 69,059 | 7,277 | 57,585 | 16,452 | ||||||||||||
| SHAREHOLDERS’ EQUITY: | ||||||||||||||||
| Ordinary shares of no par value: Authorized: 1,800,000,000 shares at June 30, 2022, (unaudited) June 30, 2021 (unaudited) and at December 31, 2021; Issued and outstanding: 747,153,064 shares at June 30, 2022 (unaudited), 573,285,824 shares at June 30, 2021 (unaudited) and 739,048,544 shares at December 31, 2021 | (* | ) | (* | ) | (* | ) | (* | ) | ||||||||
| Share premium | 388,104 | 356,358 | 391,507 | 111,859 | ||||||||||||
| Accumulated deficit | (364,771 | ) | (344,972 | ) | (387,039 | ) | (110,582 | ) | ||||||||
| Total Equity | 23,333 | 11,386 | 4,468 | 1,277 | ||||||||||||
| Total liabilities and shareholders’ equity | 99,599 | 88,049 | 85,571 | 24,449 | ||||||||||||
| (*) | Represents less than NIS\USD 1. |
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, | |||||||||||||||||||||||
| 2021 | 2021 | 2022 | 2021 | 2022 | 2022 | |||||||||||||||||||||
| Audited | Unaudited | Unaudited | ||||||||||||||||||||||||
| N I S | U.S. dollars | |||||||||||||||||||||||||
| (In thousands, except per share data) | ||||||||||||||||||||||||||
| Operating expenses: | ||||||||||||||||||||||||||
| Research and development, net of participations | 10,341 | 1,900 | 6,495 | 4,653 | 10,148 | 2,900 | ||||||||||||||||||||
| Marketing, general and administrative | 24,528 | 7,002 | 4,286 | 11,007 | 8,919 | 2,548 | ||||||||||||||||||||
| Other income | (40 | ) | - | - | - | - | - | |||||||||||||||||||
| Total operating expenses | 34,829 | 8,902 | 10,781 | 15,660 | 19,067 | 5,448 | ||||||||||||||||||||
| Operating loss | (34,829 | ) | (8,902 | ) | (10,781 | ) | (15,660 | ) | (19,067 | ) | (5,448 | ) | ||||||||||||||
| Financial income | 5,716 | - | 1,571 | 822 | 2,783 | 796 | ||||||||||||||||||||
| Financial expense | (10,865 | ) | (3,091 | ) | (3,642 | ) | (5,341 | ) | (5,984 | ) | (1,710 | ) | ||||||||||||||
| Net loss and total comprehensive loss | (39,978 | ) | (11,993 | ) | (12,852 | ) | (20,179 | ) | (22,268 | ) | (6,362 | ) | ||||||||||||||
| Basic and diluted net loss per share | (0.07 | ) | (0.03 | ) | (0.02 | ) | (0.04 | ) | (0.03 | ) | (0.01 | ) | ||||||||||||||
| Weighted average number of shares outstanding used to compute basic and diluted loss per share | 564,575,9 67 | 573,205 ,607 | 746,898,6 71 | 552,140,0 30 | 745,817, 220 | 745,817,2 20 | ||||||||||||||||||||
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.
4
Exhibit 99.2
BIONDVAX PHARMACEUTICALS LTD.
INTERIM FINANCIAL STATEMENTS
AS OF JUNE 30, 2022
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-12 |
- - - - - - - - - - -
F-1
BIONDVAX PHARMACEUTICALS LTD.
BALANCE SHEETS
In thousands, except share and per share data
| Convenience | ||||||||||||||||
| Translation | ||||||||||||||||
| (Note 2) | ||||||||||||||||
| December 31, | June 30, | June 30, | ||||||||||||||
| 2021 | 2021 | 2022 | 2022 | |||||||||||||
| Audited | Unaudited | Unaudited | ||||||||||||||
| NIS | N I S | U.S. dollars | ||||||||||||||
| CURRENT ASSETS: | ||||||||||||||||
| Cash and cash equivalents | ||||||||||||||||
| Other receivables | ||||||||||||||||
| Total current assets | ||||||||||||||||
| LONG TERM ASSETS: | ||||||||||||||||
| Property, plant and equipment | ||||||||||||||||
| Right-of-use assets | ||||||||||||||||
| Restricted cash | ||||||||||||||||
| Other long-term assets | - | - | ||||||||||||||
| Total non-current assets | ||||||||||||||||
| Total assets | ||||||||||||||||
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
| Convenience | ||||||||||||||||
| Translation | ||||||||||||||||
| (Note 2) | ||||||||||||||||
| December 31 | June 30, | June 30, | ||||||||||||||
| 2021 | 2021 | 2022 | 2022 | |||||||||||||
| Audited | Unaudited | Unaudited | ||||||||||||||
| N I S | U.S. dollars | |||||||||||||||
| LIABILITIES AND SHAREHOLDERS’ EQUITY | ||||||||||||||||
| CURRENT LIABILITIES: | ||||||||||||||||
| Trade payables | ||||||||||||||||
| Operating lease liabilities | ||||||||||||||||
| Loan from others | - | |||||||||||||||
| Other payables | ||||||||||||||||
| Total current liabilities | ||||||||||||||||
| LONG TERM LIABILITIES: | ||||||||||||||||
| Operating lease liabilities | ||||||||||||||||
| Loan from others | - | |||||||||||||||
| Other payables | - | - | - | |||||||||||||
| Severance pay liability, net | ||||||||||||||||
| Total long-term liabilities | ||||||||||||||||
| SHAREHOLDERS’ EQUITY: | ||||||||||||||||
| Ordinary shares of par value: Authorized: | ) | ) | ) | ) | ||||||||||||
| Share premium | ||||||||||||||||
| Accumulated deficit | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Total Equity | ||||||||||||||||
| Total liabilities and shareholders’ equity | ||||||||||||||||
| (*) |
The accompanying notes are an integral part of the interim financial statements.
| August 25, 2022 | ||||||
| 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
BIONDVAX PHARMACEUTICALS LTD.
STATEMENTS OF COMPREHENSIVE LOSS
In thousands, except share and per share data
Convenience (Note 2) | ||||||||||||||||||||||||
Year ended December 31, | Three months ended June 30, | Six months ended June 30, | Six months ended June 30, | |||||||||||||||||||||
| 2021 | 2021 | 2022 | 2021 | 2022 | 2022 | |||||||||||||||||||
| Audited | Unaudited | Unaudited | ||||||||||||||||||||||
| N I S | U.S. dollars | |||||||||||||||||||||||
| (In thousands, except per share data) | ||||||||||||||||||||||||
| Operating expenses: | ||||||||||||||||||||||||
| Research and development, net of participations | ||||||||||||||||||||||||
| Marketing, general and administrative | ||||||||||||||||||||||||
| Other income | ( | ) | ||||||||||||||||||||||
| Total operating expenses | ||||||||||||||||||||||||
| Operating loss | ( | ) | ( | ) | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||||||
| - | ||||||||||||||||||||||||
| Financial income | ||||||||||||||||||||||||
| Financial expense | ( | ) | ( | ) | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||||||
| Net loss and total comprehensive loss | ( | ) | ( | ) | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||||||
| ( | ) | ( | ) | ( | ) | ( | ) | ( | ) | ( | ) | |||||||||||||
The accompanying notes are an integral part of the interim financial statements.
F-4
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 equity | |||||||||||||
| Unaudited | ||||||||||||||||
| NIS in thousands | ||||||||||||||||
| Balance as of January 1, 2022 | ( | ) | ||||||||||||||
| Total comprehensive loss | ( | ) | ( | ) | ||||||||||||
| Issuance of shares, net | ||||||||||||||||
| Deferred issuance expenses | ( | ) | ||||||||||||||
| Share-based compensation | ||||||||||||||||
| Balance as of June 30, 2022 | ( | ) | ||||||||||||||
| Balance as of June 30, 2022 (convenience translation into U.S. dollars (see Note 2)) | ( | ) | ||||||||||||||
| Share capital | Share premium | Accumulated deficit | Total deficiency | |||||||||||||
| Unaudited | ||||||||||||||||
| NIS in thousands | ||||||||||||||||
| Balance as of March 31, 2022 | ( | ) | ||||||||||||||
| Total comprehensive loss | ( | ) | ( | ) | ||||||||||||
| Deferred issuance expenses | ( | ) | - | ( | ) | |||||||||||
| Share-based compensation | - | - | ||||||||||||||
| Balance as of June 30, 2022 | ( | ) | ||||||||||||||
| Balance as of June 30, 2022 (convenience translation into U.S. dollars (see Note 2)) | ( | ) | ||||||||||||||
| (*) | 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 equity | |||||||||||||
| Unaudited | ||||||||||||||||
| NIS in thousands | ||||||||||||||||
| Balance as of January 1, 2021 | ( | ) | ( | ) | ||||||||||||
| Total comprehensive loss | - | - | ( | ) | ( | ) | ||||||||||
| Issuance of shares, net | - | |||||||||||||||
| Share-based compensation | - | - | ||||||||||||||
| Balance as of June 30, 2021 | (*) | ( | ) | |||||||||||||
| Balance as of June 30, 2021 (convenience translation into U.S. dollars (see Note 2)) | ( | ) | ||||||||||||||
| Share capital | Share premium | Accumulated deficit | Total deficiency | |||||||||||||
| Unaudited | ||||||||||||||||
| NIS in thousands | ||||||||||||||||
| Balance as of March 31, 2021 | ( | ) | ||||||||||||||
| Total comprehensive loss | - | - | ( | ) | ( | ) | ||||||||||
| Share-based compensation | - | - | ||||||||||||||
| Balance as of June 30, 2021 | ( | ) | ||||||||||||||
| Balance as of June 30, 2021 (convenience translation into U.S. dollars (see Note 2)) | ( | ) | ||||||||||||||
| (*) | 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, 2021 | ( | ) | ( | ) | ||||||||||||
| Total comprehensive loss | - | - | ( | ) | ( | ) | ||||||||||
| Issuance of Ordinary shares, net of issuance costs | - | - | ||||||||||||||
| Share-based compensation | - | - | ||||||||||||||
| Balance as of December 31, 2021 | ( | ) | ||||||||||||||
| Balance as of December 31, 2021 (convenience translation into U.S. dollars (see Note 2)) | ( | ) | ||||||||||||||
The accompanying notes are an integral part of the interim financial statements.
F-7
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, | |||||||||||||||||||||
| 2021 | 2021 | 2022 | 2021 | 2022 | 2022 | |||||||||||||||||||
| Audited | Unaudited | Unaudited | ||||||||||||||||||||||
| N I S | U.S. dollars | |||||||||||||||||||||||
| Cash flows from operating activities: | ||||||||||||||||||||||||
| Net loss | ( | ) | ( | ) | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||||||
| 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 | ||||||||||||||||||||||||
| Net financial expenses (income) | ( | ) | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||||||||
| Capital gain | ( | ) | ||||||||||||||||||||||
| Increase in liability with respect to loans from others | ||||||||||||||||||||||||
| Share-based compensation | ||||||||||||||||||||||||
| Changes in asset and liability items: | ||||||||||||||||||||||||
| Increase (decrease) in other receivables | ( | ) | ( | ) | ( | ) | ||||||||||||||||||
| Increase (decrease) in trade payables | ( | ) | ( | ) | ( | ) | ||||||||||||||||||
| Increase (decrease) in short- and long-term other payables | ( | ) | ( | ) | ( | ) | ||||||||||||||||||
| ( | ) | ( | ) | ( | ) | ( | ) | ( | ) | |||||||||||||||
| Cash paid and received during the year for: | ||||||||||||||||||||||||
| Interest paid | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||||||||||
| ( | ) | ( | ) | ( | ) | ( | ) | |||||||||||||||||
| Net cash flows used in operating activities | ( | ) | ( | ) | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||||||
| (*) | 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 | | Three months ended June 30, | Six months ended June 30, | Six months ended June 30, | ||||||||||||||||||||
| 2021 | 2021 | 2022 | 2021 | 2022 | 2022 | |||||||||||||||||||
| Audited | Unaudited | Unaudited | ||||||||||||||||||||||
| N I S | U.S. dollars | |||||||||||||||||||||||
| Cash Flows from Investing Activities: | ||||||||||||||||||||||||
| Purchase of property and equipment | ( | ) | ( | ) | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||||||
| Proceeds from sale of property and equipment | ||||||||||||||||||||||||
| Increase (decrease) in other long term assets | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||||||||||
| Net cash used in investing activities | ( | ) | ( | ) | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||||||
| Cash Flows from Financing Activities: | ||||||||||||||||||||||||
| Repayment of operating lease liabilities | ( | ) | ( | ) | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||||||
| Deferred issuance expenses | ( | ) | ( | ) | ( | ) | ||||||||||||||||||
| Proceeds from exercise of warrants to public | ||||||||||||||||||||||||
| Proceeds from issuance of shares, net of issuance costs | ||||||||||||||||||||||||
| Net cash provided by (used in) financing activities | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||||||||||
| Exchange differences on balances of cash and cash equivalents | ( | ) | ||||||||||||||||||||||
| Increase (decrease) in cash and cash equivalents | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||||||||||
| Balance of cash and cash equivalents at the beginning of the period | ||||||||||||||||||||||||
| Balance of cash and cash equivalents at the end of the period | ||||||||||||||||||||||||
| Non cash financing activities | ||||||||||||||||||||||||
| Right-of-use asset recognized with corresponding lease liability | ||||||||||||||||||||||||
| Intangible asset | ||||||||||||||||||||||||
The accompanying notes are an integral part of the interim financial statements.
F-9
BIONDVAX PHARMACEUTICALS LTD.
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 |
Following the failure of M-001 in Phase 3 clinical trials, BiondVax reapplied for disbursement of the Grant in light of its new agreements with Max Planck Institute for Multidisciplinary Sciences in Göttingen together with University Medical Center Göttingen. In July 2022, the Investment Center of the Ministry of Economy and Industry informed the Company that (i) the disbursement was not approved, due to the early stage of the Company’s NanoAb program and (ii) the Company may reapply for disbursement in March 2023, conditioned on the Company demonstrating meeting certain milestones related to the development of its NanoAb program. The Company intends to appeal the decision.
| d. | 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. |
| e. | 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 agreements, the Company issued 150,000 ADSs at no cost to MPG as an upfront payment for the license.
| Stock price | ||||
| Variance | % | |||
| Risk free interest | % |
F-10
BIONDVAX PHARMACEUTICALS LTD.
NOTES TO INTERIM FINANCIAL STATEMENTS
In thousands, except share and per share data
NOTE 1: GENERAL (Cont.)
On March 23, 2022, the Company executed an additional research collaboration agreement with MPG and UMG covering development and commercialization of NanoAbs for several other disease indications with large market sizes that leverage their unique 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.
| f. |
| g. |
| h. |
In the future, the Company may raise additional capital from external sources in order to continue the longer-term efforts contemplated under its business plan. The Company expects to continue incurring losses for the foreseeable future and may need to raise additional capital to pursue its product development initiatives, to penetrate markets for the sale of our Company product candidates and continue operations as presently maintained. The Company cannot provide any assurance that it will raise additional capital. Management believes that the Company has access to capital resources through possible public or private equity offerings, debt financings, corporate collaborations or other means; however, the Company has not secured any commitment for new financing at this time, nor can the Company provide any assurance that new financing will be available on commercially acceptable terms, if at all. If the Company is unable to secure additional capital, it may be required to curtail its research and development initiatives and take additional measures to reduce costs in order to conserve cash in amounts sufficient to sustain operations and meet its obligations. These measures could cause significant delays in the Company’s efforts to commercialize its products, which is critical to the realization of the Company’s business plan and its future operations.
The Company’s management and Board of Directors are of the opinion that its current financial resources will be sufficient to continue the development of the Company’s products for at least the next twelve months.
NOTE 2: CONVENIENCE TRANSLATION INTO U.S. DOLLARS
The financial statements as of June
30, 2022 and for the six months then ended have been translated into dollars using the representative exchange rate as of that date ($ 1 = NIS
F-11
BIONDVAX PHARMACEUTICALS LTD.
NOTES TO INTERIM FINANCIAL STATEMENTS
In thousands, except share and per share data
NOTE 3: SIGNIFICANT ACCOUNTING POLICIES
These financial statements have been prepared in a condensed format as of June 30, 2022, 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, 2021, 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: SUBSEQUENT EVENTS
On August 10, 2022, the company received approval
by the European Investment Bank for the new terms of its outstanding €
The new terms include:
| ● | An extension of the maturity dates from 2023 (€ |
| ● | Interest on the Loan will begin to accrue starting January
1, 2022, at an annual rate of |
| ● | $ |
| ● | 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 principle 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. |
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F-12