Exhibit 99.1
BIONDVAX PHARMACEUTICALS LTD.
FINANCIAL STATEMENTS
AS OF JUNE 30, 2023
U.S. DOLLARS IN THOUSANDS
Unaudited
INDEX
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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.
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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.
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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.
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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.
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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.
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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 | $ | $ | $ | ( | ) | $ | ( | ) | $ |
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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.
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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.
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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 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 $
The Company’s current operating budget includes various assumptions concerning the level and timing of cash receipts and cash outlays for operating expenses and capital expenditures, including a cost saving plan. The Company is planning to finance its operations from its existing working capital resources and additional sources of capital and financing that are in the advanced planning phase. However, there is no assurance that additional capital and/or financing will be available to the Company, and even if available, whether it will be on terms acceptable to the Company or in amounts required. Accordingly, the Company’s board of directors approved a cost saving plan, to be implemented if and as required, in whole or in part, at its discretion, to allow the Company to continue its operations and meet its cash obligations. The cost saving plan consists of cutting expenditures by means of further efficiencies and synergies, which include mainly the following steps: reduction in headcount and postponing or cancelling capital expenditures that would not be required for the implementation of the revised business plan. |
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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)
The Company and the board of directors believe, however, that its existing financial resources, potential successful capital raising exercises and its operating plans, including the possible disposition of assets outside the ordinary course of business, restructuring of debt, along with the effects of the cost-saving plan, may be adequate to satisfy its expected liquidity requirements for a period of at least twelve months from the end of the filing date, although there is no guarantee.
The accompanying financial statements have been prepared assuming the Company will continue as a going concern, which contemplates the realization of assets and liabilities and commitments in the normal course of business. The financial statements for the six-months ended June 30, 2023 do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classification of liabilities that may result from uncertainty related to the Company’s ability to continue as a going concern.
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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