Scinai Immunotherapeutics Ltd 6-K/A, filed Aug 14, 2023
Scinai Immunotherapeutics Ltd. (SCNI)
About this 6-K/A
Scinai Immunotherapeutics Ltd filed this 6-K/A on August 14, 2023.
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 2023
Commission File Number:
(Translation of registrant’s name into English)
Jerusalem BioPark, 2nd Floor
Hadassah Ein Kerem Campus
Jerusalem, Israel
(Address of principal executive offices)
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 ☐
Explanatory Note
This Amendment No. 1 to the Report on Form 6-K, originally filed with the Securities and Exchange Commission on August 11, 2023, is being filed solely for the purposes of furnishing unaudited interim condensed consolidated financial statements as of June 30, 2023, and incorporating certain exhibits into registration statements of the registrant.
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. 333-271293 and File No. 333-239344), Form F-1 (File No. 333-267648) 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Form F-3 (File No. 333-240189), to be a part thereof from the date on which this report is submitted, to the extent not superseded by documents or reports subsequently filed or furnished.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 No. | Description | |
| 99.1 | Press Release, dated August 11, 2023. | |
| 99.2 | Unaudited Interim Condensed Consolidated Financial Statements as of June 30, 2023. |
1
SIGNATURE
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. | ||
| By: | /s/ Amir Reichman | |
| Amir Reichman | ||
| Chief Executive Officer | ||
August 14, 2023
2
Exhibit 99.1
BiondVax Reports Second Quarter Financial Results and Provides Business Update
Jerusalem, Israel – Aug. 11, 2023 – via IBN - BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), a biotechnology company focused on developing, manufacturing, and commercializing innovative immunotherapeutic products primarily for the treatment of infectious and autoimmune diseases, announces the publication today of its financial results for the second quarter ended June 30, 2023, and provided a business update.
Second Quarter 2023 Financial Summary
| ● | R&D expenses for the three months ended June 30, 2023, amounted to $1.45 million compared with $1.97 million for the three months ended June 30, 2022. |
| ● | Marketing, general and administrative expenses for the three months ended June 30, 2023, amounted to $1.14 million compared with $1.29 million for the three months ended June 30, 2022. |
| ● | Total operating expenses for the three months ended June 30, 2023, amounted to $2.56 million compared with $3.26 million for the three months ended June 30, 2022. |
| ● | Financial (loss) income for the three months ended June 30, 2023, amounted to $1.16 million loss compared with $0.28 million income for the three months ended June 30, 2022. |
| ● | Net loss for the three months ended June 30, 2023, amounted to $3.76 million compared with $2.98 million for the three months ended June 30, 2022. |
As of June 30, 2023, BiondVax had cash and cash equivalents of $7.6 million as compared to $14.2 million as of December 31, 2022. In the six months ended June 30, 2023, BiondVax had an operating loss of $7.3 million and negative cash flows from operating activities of $5.9 million. BiondVax’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-savings plan. BiondVax is planning to finance its operations from its existing working capital resources and additional sources of capital and financing with respect to which the Company has initiated actions. However, there is no assurance that additional capital and/or financing will be available to BiondVax, and even if available, whether it will be on terms acceptable to BiondVax or in amounts required. Accordingly, BiondVax’s board of directors approved the cost-savings plan mentioned above, to be implemented if and as required, in whole or in part, at its discretion, to allow BiondVax to continue its operations and meet its cash obligations. The cost-savings plan consists of cutting expenditures by means of further efficiencies and synergies, which include mainly the reduction in headcount and postponing or cancelling capital expenditures that would not be required for the implementation of the revised business plan. BiondVax’s Board of Directors believes that BiondVax’s existing financial resources, potential successful capital raisings and its current operating plans (including the possible disposition of assets outside the ordinary course of business) and restructuring of debt, along with the effects of the cost-savings plan, may be adequate to satisfy its expected liquidity requirements for a period of at least twelve months from the date hereof, although there is no guarantee.
BiondVax’s unaudited financial results will be submitted to the Securities and Exchange Commission on Form 6-K. A summary of such results is included in the tables below.
Business Update
| ● | CDMO: |
| o | As announced previously, BiondVax has decided to leverage its aseptic manufacturing site and laboratories by creating a CDMO business unit in parallel to its innovative R&D business unit. The CDMO business unit offers biological drug development services with a focus on preclinical and small clinical stage biopharmaceutical companies. These companies tend to have limited capital and require cost effective drug development services that can be executed in very short timelines. These companies also typically lack the resources required to build their own laboratories and production lines for biological drug development. They also often encounter challenges working with large CDMOs due to the relatively high costs, long timelines and lack of agility in their processes. To overcome these challenges, preclinical and small clinical stage companies may outsource product development to a boutique CDMO such as the one owned by BiondVax. In particular, BiondVax’s CDMO business unit allows clients to leverage BiondVax’s expertise in process development, optimization, scale-up, GMP manufacturing for clinical trials, and navigating complex regulatory frameworks. Additional information is available at www.biondvax.com/cdmo. |
| ● | Pipeline Development: |
| o | In June 2023, BiondVax signed an exclusive license agreement with Max Planck Innovation for development and commercialization of a novel anti-IL-17 NanoAb (VHH antibody) for treatment of autoimmune and inflammatory diseases including psoriasis. We are aggressively advancing the NanoAb preclinical development and expect the IL-17 NanoAb to enter clinical testing in 2024. |
| o | BiondVax is pursuing a strategic partnership for its COVID-19 self-administered inhaled NanoAb therapeutic/prophylactic which demonstrated highly promising in vivo results in animals. |
| o | NanoAbs for treatment of additional autoimmune diseases such as asthma and wet AMD are being developed at Max Planck and University Medical Center Göttingen as part of their research collaboration agreement with BiondVax. BiondVax holds exclusive options for exclusive licenses at pre agreed financial terms for each of the resulting nanoAbs. |
About BiondVax
BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV) is a biotechnology 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 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.
Company Contact Details
Joshua E. Phillipson | +972 8 930 2529 | j.phillipson@biondvax.com
2
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 cash liquidity, strategy, future operations, future financial position, future revenue, projected expenses, prospects, plans and objectives of management are forward-looking statements. 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, and the risk that BiondVax may not be able to execute its operating plan; the risk that the therapeutic and commercial potential of NanoAbs will not be met; the risk of a delay in the preclinical and clinical trials data for NanoAbs, if any; the risk that our business strategy may not be successful; the risk that the European Investment Bank (EIB) may accelerate the loans under its finance contract with BiondVax; risks relating to the SARS-CoV-2 (COVID-19) virus; 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 10-K filed with the Securities and Exchange Commission on April 17, 2023. BiondVax undertakes no obligation to revise or update any forward-looking statement for any reason.
Wire Service Contact:
IBN
Los Angeles, California
www.InvestorBrandNetwork.com
310.299.1717 Office
Editor@InvestorBrandNetwork.com
3
CONDENSED BALANCE SHEETS (Unaudited)
U.S. dollars in thousands (except share and per share data)
| June 30, | December 31, | |||||||
| 2023 | 2022 | |||||||
| Unaudited | Audited | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | $ | 7,506 | $ | 14,075 | ||||
| Restricted cash | 126 | 140 | ||||||
| Prepaid expenses and other receivables | 138 | 155 | ||||||
| Total current assets | 7,770 | 14,370 | ||||||
| NON-CURRENT ASSETS: | ||||||||
| Property, plant and equipment, net | 10,802 | 11,245 | ||||||
| Operating lease right-of-use assets | 1,325 | 1,452 | ||||||
| Total non-current assets | 12,127 | 12,697 | ||||||
| Total assets | $ | 19,897 | $ | 27,067 | ||||
| LIABILITIES AND SHAREHOLDERS’ EQUITY | ||||||||
| CURRENT LIABILITIES: | ||||||||
| Trade payables | $ | 651 | $ | 716 | ||||
| Operating lease liabilities | 394 | 382 | ||||||
| Other payables | 843 | 1,240 | ||||||
| Total current liabilities | 1,888 | 2,338 | ||||||
| NON-CURRENT LIABILITIES: | ||||||||
| Warrants liability | 902 | 5,329 | ||||||
| Loan from others | 23,292 | 20,082 | ||||||
| Non-current operating lease liabilities | 927 | 1,078 | ||||||
| Total non-current liabilities | 25,121 | 26,489 | ||||||
| CONTINGENT LIABILITIES AND COMMITMENTS | ||||||||
| SHAREHOLDERS’ EQUITY (DEFICIT): | ||||||||
| Ordinary shares of no par value: Authorized: 20,000,000,000 shares at June 30, 2023 and at December 31, 2022; Issued and outstanding 1,453,970,784 shares at June 30, 2023 and 989,290,784 shares at December 31, 2022 | - | - | ||||||
| Additional paid-in capital | 117,740 | 116,082 | ||||||
| Accumulated deficit | (123,112 | ) | (115,835 | ) | ||||
| Accumulated other comprehensive loss | (1,740 | ) | (2,007 | ) | ||||
| Total shareholders’ deficit | (7,112 | ) | (1,760 | ) | ||||
| Total liabilities and shareholders’ deficit | $ | 19,897 | $ | 27,067 | ||||
4
CONDENSED STATEMENTS OF OPERATIONS (Unaudited)
U.S. dollars in thousands (except share and per share data)
| Three months ended June 30, | Six months ended June 30, | |||||||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||||||
| Unaudited | ||||||||||||||||
| Research and development expenses, net | $ | 1,454 | $ | 1,974 | $ | 3,449 | $ | 3,137 | ||||||||
| Marketing, general and administrative | 1,141 | 1,289 | 2,332 | 2,741 | ||||||||||||
| Total operating loss | 2,595 | 3,263 | 5,781 | 5,878 | ||||||||||||
| Financial loss (income), net | 1,167 | (280 | ) | 1,496 | (420 | ) | ||||||||||
| Net loss | $ | 3,762 | $ | 2,983 | $ | 7,277 | $ | 5,458 | ||||||||
| Net loss per share attributable to ordinary shareholders, basic and diluted | (0.003 | ) | (0.004 | ) | (0.006 | ) | (0.01 | ) | ||||||||
| Basic and diluted net loss per share | ||||||||||||||||
| Weighted average number of shares used for computing basic and diluted net loss per share | 1,351,850,046 | 746,898,671 | 1,322,019,241 | 745,817,220 | ||||||||||||
5
CONDENSED STATEMENTS OF COMPREHENSIVE LOSS (Unaudited)
U.S. dollars in thousands (except share and per share data)
Three
months ended | Six months ended June 30, | |||||||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||||||
| Unaudited | ||||||||||||||||
| Net loss | (3,762 | ) | (2,983 | ) | (7,277 | ) | (5,458 | ) | ||||||||
| Other comprehensive (income) loss: | ||||||||||||||||
| Foreign currency translation adjustments | 151 | (13 | ) | 267 | (47 | ) | ||||||||||
| Total comprehensive loss | $ | 3,611 | $ | (2,996 | ) | $ | 7,010 | $ | (5,505 | ) | ||||||
The notes in BiondVax’s quarterly report are an integral part of the financial statements. The notes to the financial results will be available in the Form 6-K to be filed by BiondVax with the Securities and Exchange Commission.
6
Exhibit 99.2
BIONDVAX PHARMACEUTICALS LTD.
FINANCIAL STATEMENTS
AS OF JUNE 30, 2023
U.S. DOLLARS IN THOUSANDS
Unaudited
INDEX
- - - - - - - - - - - - - -
- 1 -
BIONDVAX PHARMACEUTICALS LTD.
CONDENSED BALANCE SHEETS (Unaudited)
U.S. dollars in thousands (except share and per share data)
| June 30, | December 31, | |||||||
| 2023 | 2022 | |||||||
| Unaudited | Audited | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | $ | $ | ||||||
| Restricted cash | ||||||||
| Prepaid expenses and other receivables | ||||||||
| Total current assets | ||||||||
| NON-CURRENT ASSETS: | ||||||||
| Property, plant and equipment, net | ||||||||
| Operating lease right-of-use assets | ||||||||
| Total non-current assets | ||||||||
| Total assets | $ | $ | ||||||
The accompanying notes are an integral part of the unaudited condensed financial statements.
- 2 -
BIONDVAX PHARMACEUTICALS LTD.
CONDENSED BALANCE SHEETS (Unaudited)
U.S. dollars in thousands (except share and per share data)
| June 30, | December 31, | |||||||
| 2023 | 2022 | |||||||
| Unaudited | Audited | |||||||
| LIABILITIES AND SHAREHOLDERS’ EQUITY | ||||||||
| CURRENT LIABILITIES: | ||||||||
| Trade payables | $ | $ | ||||||
| Operating lease liabilities | ||||||||
| Other payables | ||||||||
| Total current liabilities | ||||||||
| NON-CURRENT LIABILITIES: | ||||||||
| Warrants liability | ||||||||
| Loan from others | ||||||||
| Non-current operating lease liabilities | ||||||||
| Total non-current liabilities | ||||||||
| CONTINGENT LIABILITIES AND COMMITMENTS | ||||||||
| SHAREHOLDERS’ EQUITY (DEFICIT): | ||||||||
| Ordinary shares of | ||||||||
| Additional paid-in capital | ||||||||
| Accumulated deficit | ( | ) | ( | ) | ||||
| Accumulated other comprehensive loss | ( | ) | ( | ) | ||||
| Total shareholders’ deficit | ( | ) | ( | ) | ||||
| Total liabilities and shareholders’ deficit | $ | $ | ||||||
The accompanying notes are an integral part of the unaudited condensed financial statements.
- 3 -
BIONDVAX PHARMACEUTICALS LTD.
CONDENSED STATEMENTS OF OPERATIONS (Unaudited)
U.S. dollars in thousands (except share and per share data)
| Three
months ended June 30, | Six
months ended June 30, | |||||||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||||||
| Unaudited | ||||||||||||||||
| Research and development expenses, net | $ | $ | $ | $ | ||||||||||||
| Marketing, general and administrative | ||||||||||||||||
| Total operating loss | ||||||||||||||||
| Financial loss (income), net | ( | ) | ( | ) | ||||||||||||
| Net loss | $ | $ | $ | $ | ||||||||||||
| ( | ) | ( | ) | ( | ) | ( | ) | |||||||||
| Basic and diluted net loss per share | ||||||||||||||||
The accompanying notes are an integral part of the unaudited condensed financial statements.
- 4 -
BIONDVAX PHARMACEUTICALS LTD.
CONDENSED STATEMENTS OF COMPREHENSIVE LOSS (Unaudited)
U.S. dollars in thousands (except share and per share data)
Three
months ended | Six
months ended June 30, | |||||||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||||||
| Unaudited | ||||||||||||||||
| Net loss | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Other comprehensive (income) loss: | ||||||||||||||||
| Foreign currency translation adjustments | ( | ) | ( | ) | ||||||||||||
| Total comprehensive loss | $ | $ | ( | ) | $ | $ | ( | ) | ||||||||
The accompanying notes are an integral part of the unaudited condensed financial statements.
- 5 -
BIONDVAX PHARMACEUTICALS LTD.
CONDENSED STATEMENTS OF CHANGES IN SHAREHOLDERS’ EQUITY (Unaudited)
U.S. dollars in thousands (except share and per share data)
| Three months ended June 30, 2023 | ||||||||||||||||||||||||
| Ordinary shares | Additional paid-in | Accumulated comprehensive | Accumulated | Total shareholders’ | ||||||||||||||||||||
| Number | Amount | capital | loss | deficit | equity | |||||||||||||||||||
| Balance as of March 31, 2023 | $ | $ | $ | ( | ) | $ | ( | ) | $ | ( | ) | |||||||||||||
| Exercise of warrants | ||||||||||||||||||||||||
| Vested RSU’s | ||||||||||||||||||||||||
| Issuance of warrants | ||||||||||||||||||||||||
| Share-based compensation | ||||||||||||||||||||||||
| Other comprehensive income | - | |||||||||||||||||||||||
| Net loss | - | ( | ) | ( | ) | |||||||||||||||||||
| Balance as of June 30, 2023 | $ | $ | $ | ( | ) | $ | ( | ) | ( | ) | ||||||||||||||
| Six months ended June 30, 2023 | ||||||||||||||||||||||||
| Ordinary shares | Additional paid-in | Accumulated comprehensive | Accumulated | Total shareholders’ | ||||||||||||||||||||
| Number | Amount | capital | loss | deficit | equity | |||||||||||||||||||
| Balance as of January 1, 2023 | $ | $ | $ | ( | ) | $ | ( | ) | $ | ( | ) | |||||||||||||
| Exercise of warrants | ||||||||||||||||||||||||
| Vested RSU’s | ||||||||||||||||||||||||
| Issuance of warrants | ||||||||||||||||||||||||
| Share-based compensation | ||||||||||||||||||||||||
| Other comprehensive income | - | |||||||||||||||||||||||
| Net loss | - | ( | ) | ( | ) | |||||||||||||||||||
| Balance as of June 30, 2023 | $ | $ | $ | ( | ) | $ | ( | ) | ( | ) | ||||||||||||||
The accompanying notes are an integral part of the unaudited condensed financial statements.
- 6 -
BIONDVAX PHARMACEUTICALS LTD.
CONDENSED STATEMENTS OF CHANGES IN SHAREHOLDERS’ EQUITY (Unaudited)
U.S. dollars in thousands (except share and per share data)
| Three months ended June 30, 2022 | ||||||||||||||||||||||||
| Ordinary shares | Additional paid-in | Accumulated comprehensive | Accumulated | Total shareholders’ | ||||||||||||||||||||
| Number | Amount | capital | loss | deficit | equity | |||||||||||||||||||
| Balance as of March 31, 2022 | ( | ) | ( | ) | ( | ) | ||||||||||||||||||
| Expiration of employees options | ||||||||||||||||||||||||
| Share-based compensation | ||||||||||||||||||||||||
| Vested RSU’s | ||||||||||||||||||||||||
| Other comprehensive loss | - | ( | ) | ( | ) | |||||||||||||||||||
| Net loss | - | ( | ) | ( | ) | |||||||||||||||||||
| Balance as of June 30, 2022 | $ | $ | $ | ( | ) | $ | ( | ) | $ | |||||||||||||||
| Six months ended June 30, 2022 | ||||||||||||||||||||||||
| Ordinary shares | Additional paid-in | Accumulated comprehensive | Accumulated | Total shareholders’ | ||||||||||||||||||||
| Number | Amount | capital | loss | deficit | equity | |||||||||||||||||||
| Balance as of January 1, 2022 | ( | ) | ( | ) | ||||||||||||||||||||
| Issuance of shares, net of issuance costs of $ | ||||||||||||||||||||||||
| Vested RSU’s | ||||||||||||||||||||||||
| Expiration of employees options | ||||||||||||||||||||||||
| Share-based compensation | ||||||||||||||||||||||||
| Other comprehensive loss | - | ( | ) | ( | ) | |||||||||||||||||||
| Net loss | - | ( | ) | ( | ) | |||||||||||||||||||
| Balance as of June 30, 2022 | $ | $ | $ | ( | ) | $ | ( | ) | $ | |||||||||||||||
- 7 -
BIONDVAX PHARMACEUTICALS LTD.
CONDENSED STATEMENTS OF CASH FLOWS (Unaudited)
U.S. dollars in thousands (except share and per share data)
| Six months ended June 30, | ||||||||
| 2023 | 2022 | |||||||
| Unaudited | Unaudited | |||||||
| Cash flows from operating activities: | ||||||||
| Net loss | $ | ( | ) | $ | ( | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Depreciation of property, plant and equipment | ||||||||
| Expense of in-process research and development | ||||||||
| Financial expenses related to loan from others | ||||||||
| Share-based compensation | ||||||||
| Decrease in other receivables | ||||||||
| Warrants revaluation | ( | ) | ||||||
| Changes in operating lease right-of-use assets | ( | ) | ( | ) | ||||
| Increase in trade payables | ( | ) | ( | ) | ||||
| Changes in operating lease liabilities | ||||||||
| (Decrease) increase in other payables | ( | ) | ( | ) | ||||
| Net cash used in operating activities | ( | ) | ( | ) | ||||
| Cash flows from investing activities: | ||||||||
| Purchase of property, plant and equipment | ( | ) | ( | ) | ||||
| Net cash used in investing activities | $ | ( | ) | $ | ( | ) | ||
The accompanying notes are an integral part of the unaudited condensed financial statements.
- 8 -
BIONDVAX PHARMACEUTICALS LTD.
CONDENSED STATEMENTS OF CASH FLOWS
U.S. dollars in thousands (except share and per share data)
| Six months ended June 30, | ||||||||
| 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 | ( | ) | ( | ) | ||||
| Decrease in cash, cash equivalents and restricted cash | ( | ) | ( | ) | ||||
| Cash, cash equivalents and restricted cash at the beginning of the period | ||||||||
| Cash, cash equivalents and restricted cash at the end of the period | $ | $ | ||||||
| Supplementary disclosure of cash flows activities: | ||||||||
| (1) Cash paid during the year for: | ||||||||
| Interest | $ | $ | ||||||
| (2) Non-cash transactions: | ||||||||
| Issuance of warrants | ||||||||
| Exercise of warrants liability to equity | $ | $ | ||||||
| Reconciliation of cash, cash equivalents and restricted cash: | ||||||||
| Cash and cash equivalents | $ | $ | ||||||
| Restricted cash | ||||||||
| Cash, cash equivalents and restricted cash | $ | $ | ||||||
The accompanying notes are an integral part of the unaudited condensed financial statements.
- 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 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 UMG 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 February 7, 2022 the Company issued |
| d. | 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. |
| e. | As of June 30, 2023, the Company’s cash and cash equivalents
totaled $ |
- 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 2:- 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 $ |
During 2018, the Company received
approximately $
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 the EIB the principal amount of the tranches already paid, or the Prepayment Amount, plus the greater of:
| (i) | the amount, as determined by the EIB required in order for the EIB to realize an internal rate of return
on the relevant amount prepaid of |
| (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
| b. | On April 22, 2019, the Committee of the EIB Bank agreed to expand the 2017 financing agreement to the
Company by an additional approximately $ |
According to the Amendment, as repayment
features, the EIB is entitled to receive the higher between
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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 2:- 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 believes that there will be no revenues from the M-001 product. Therefore, most likely, there will be no 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 the EIB the principal amount of the tranches already loaned by the EIB to the Company
within
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 $
| d. | On August 9, 2022, the Company signed a loan restructuring agreement with the EIB for the new terms of
its outstanding approximately $ |
| 1. | An extension of the maturity dates from 2023 (approximately $ |
| 2. | Interest on the Loan will begin to accrue starting January 1, 2022, at an annual rate of |
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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 2:- LOAN FROM OTHERS (Cont.)
| 3. | An amount of $ |
| 4. | If the Company sales exceed approximately $ |
| 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 |
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 $
On February 16, 2023, $
For the six-months ended at June 30,
2023 the company recorded $
As of June 30, 2023, the outstanding
principal amount related to the EIB loan in nominal terms is $
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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 3:- CONTINGENT LIABILITIES AND COMMITMENTS
Since 2006, the Company received approximately
$
In return for those grants, the Company
undertook to pay royalties amounting to
In light of the Phase 3 clinical trial results (see also Note 3.c above), the Company does not currently expect any revenues from M-001 and therefore does not currently expect to make any royalty payments to the IIA. Therefore, the Company does not record a liability for amounts received from IIA. As previously discussed, in the event of failure of a project that was partly financed by the IIA, the Company is not obligated to pay any royalties or repay the amounts received.
The Company is 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.
NOTE 4:- SHAREHOLDERS’ EQUITY
| a. | On December 20, 2022, the Company closed an underwritten public offering with gross proceeds to the Company
of $ |
| b. | On January 5, 2023, the Company issued |
| c. | During June, 2023, the Company issued |
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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:- 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
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
There were no option grants during the six months ended June 30, 2023.
| b. |
Six
months ended | ||||||||
| 2023 | 2022 | |||||||
| Unaudited | Unaudited | |||||||
| Research and development expenses | $ | $ | ||||||
| Marketing, general and administrative expenses | ||||||||
| Total share-based compensation | $ | $ | ||||||
During the six months ended June 30,
2023, the company granted
As of June 30, 2023, there are $
The fair value of the granted RSUs was determined based on the stock marketprice of the Company’s ADS on the day of grant.
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