6-K
Scinai Immunotherapeutics Ltd. (SCNI)
UNITEDSTATES
SECURITIESAND EXCHANGE COMMISSION
Washington,D.C. 20549
FORM6-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 June 2022
Commission File Number: 001-37353
BIONDVAXPHARMACEUTICALS LTD.
(Translation of registrant’s name into English)
JerusalemBioPark, 2nd Floor
HadassahEin 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 June 1, 2022, BiondVax Pharmaceuticals Ltd. issued a press release announcing first quarter 2022 financial results and providing a business update.
Exhibit Index
| Exhibit No. | Description |
|---|---|
| 99.1 | Press Release dated June 1, 2022 |
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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: June 3, 2022 | By: | /s/ Amir Reichman |
| Amir Reichman | ||
| Chief Executive Officer |
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Exhibit99.1
BiondVaxAnnounces First Quarter 2022 Financial Results and Provides Business Update
Jerusalem,Israel – June 1, 2022 – BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), a biopharmaceuticals company focused on developing, manufacturing and commercializing innovative products for the prevention and treatment of infectious diseases and other illnesses, today published its first quarter financial results for the quarter ended March 31, 2022 and provided a business update.
BusinessUpdate
| ● | Development<br> of the NanoAb program is proceeding according to plan: |
|---|---|
| ○ | Demonstrated successful technology transfer from the Max Planck Institute for Multidisciplinary Sciences<br> (MPG) to BiondVax’s manufacturing facility in Jerusalem. Testing showed that BiondVax<br> was able to successfully manufacture its first exclusively licensed NanoAb for the treatment<br> of COVID-19 and demonstrated strong neutralization of live COVID-19 virus in-vitro<br> at levels similar to those demonstrated by NanoAbs originally produced at MPG. |
| --- | --- |
| ○ | The<br> NanoAbs produced at BiondVax's facility demonstrated similarly strong COVID-19 in-vitro neutralization capacity after being sprayed through a medical device inhaler that is<br> expected to be used in the first in-human clinical trials planned for 2023. |
| --- | --- |
| ○ | A<br> new NanoAb targeting Omicron that was generated at MPG was recently shown to successfully<br> neutralize the Omicron variant of COVID-19 in-vitro. This NanoAb is expected to be manufactured<br> and used in BiondVax’s first in-human clinical trials. |
| --- | --- |
| ● | Our<br> team of 26 full-time employees includes 12 new employees who joined BiondVax in 2022 to support<br> all aspects of BiondVax’s NanoAb program, including quality assurance, quality control,<br> R&D, manufacturing, preclinical and clinical trials. |
| --- | --- |
| ● | In<br> April and May, BiondVax hosted two investor webinars and presented in person at the Biomed<br> Israel and HC Wainwright Global Investment conferences. |
| --- | --- |
FirstQuarter 2022 Financial Summary
Resultsare in New Israel Shekels (NIS) and convenience translation to $US is provided using the exchange rate of 3.176 (NIS/$US), the rate asof the close of business on March 31, 2022.
| ● | Total operating expenses for the three months ended March 31, 2022 were NIS 8.3 million ($2.6<br> million) compared to NIS 6.8 million for the three months ended March 31, 2021. |
|---|---|
| ● | R&D expenses for the three months ended March 31, 2022 were NIS 3.65 million ($1.1 million)<br> compared to NIS 2.8 million for the three months ended March 31, 2021. This increase was<br> primarily due to activity related to the new NanoAb program. |
| --- | --- |
| ● | Marketing, general and administrative expenses for the three months ended March 31, 2022 were NIS<br> 4.6 million ($1.5 million) compared to NIS 4.0 million for the three months ended March 31,<br> 2021. |
| --- | --- |
As of March 31, 2022, BiondVax had cash and cash equivalents of NIS 48.9 million ($15.4 million) as compared to NIS 54.0 million as of December 31, 2021.
Unaudited first quarter financial results will be submitted to the Securities and Exchange Commission. A summary is included in the tables below.
Jerusalem BioPark, 2^nd^ floor ● Hadassah Ein Kerem Campus ● Jerusalem, Israel
Telephone: +972-8-9302529 ● Fax: +972-8-9302531 ● www.BiondVax.com
AboutBiondVax
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. For more information, please visit www.biondvax.com.
ContactDetails
Company: Joshua E. Phillipson | +972 8 930 2529 | j.phillipson@biondvax.com
Investor Relations: Kenny Green | +1 212 378 8040 | kgreen@edisongroup.com
ForwardLooking Statements
Thispress 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 limitedto, statements regarding the timing of future clinical trials, the therapeutic and commercial potential of NanoAbs and execution of adefinitive amendment agreement with EIB. These forward-looking statements reflect management’s current views with respect to certaincurrent and future events and are subject to various risks, uncertainties and assumptions that could cause the results to differ materiallyfrom those expected by the management of BiondVax Pharmaceuticals Ltd. Risks and uncertainties include, but are not limited to, the riskthat the therapeutic and commercial potential of NanoAbs will not be met; the risk of a delay in the preclinical and clinical data forNanoAbs, if any; the risk that BiondVax and EIB will not reach agreement with respect to the restructuring of the loan from EuropeanInvestment Bank; the risk that BiondVax may not be able to secure additional capital on attractive terms, if at all; the risk that theEuropean 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 collaborationson 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 andother vaccine and treatment technologies, and the risk that drug development involves a lengthy and expensive process with uncertainoutcomes. More detailed information about the risks and uncertainties affecting the Company is contained under the heading “RiskFactors” in the Company's Annual Report on Form 20-F filed with the Securities and Exchange Commission on March 25, 2022. BiondVaxundertakes no obligation to revise or update any forward-looking statement for any reason.
Jerusalem BioPark, 2^nd^ floor ● Hadassah Ein Kerem Campus ● Jerusalem, Israel
Telephone: +972-8-9302529 ● Fax: +972-8-9302531 ● www.BiondVax.com
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BALANCESHEETS
In thousands, except share and per share data
| Convenience | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Translation | ||||||||||||
| December 31, | March 31, | March 31, | ||||||||||
| 2021 | 2021 | 2022 | 2022 | |||||||||
| Audited | Unaudited | Unaudited | ||||||||||
| N I S | U.S. dollars | |||||||||||
| CURRENT ASSETS: | ||||||||||||
| Cash and cash equivalents | 54,036 | 48,577 | 48,886 | 15,391 | ||||||||
| Other receivables | 1,012 | 481 | 619 | 196 | ||||||||
| 55,048 | 49,058 | 49,505 | 15,587 | |||||||||
| LONG-TERM ASSETS: | ||||||||||||
| Property, plant and equipment | 38,519 | 39,252 | 39,745 | 12,514 | ||||||||
| Right-of-use assets | 5,588 | 5,978 | 5,359 | 1,687 | ||||||||
| Other long-term assets | 444 | 436 | 929 | 293 | ||||||||
| 44,551 | 45,666 | 46,033 | 14,494 | |||||||||
| 99,599 | 94,724 | 95,538 | 30,081 | |||||||||
| CURRENT LIABILITIES: | ||||||||||||
| Trade payables | 3,107 | 2,085 | 4,102 | 1,292 | ||||||||
| Operating lease liabilities | 773 | 641 | 802 | 253 | ||||||||
| Loan from others | - | 62,346 | - | |||||||||
| Other payables | 3,327 | 1,640 | 3,598 | 1,133 | ||||||||
| 7,207 | 66,712 | 8,502 | 2,677 | |||||||||
| LONG-TERM LIABILITIES: | ||||||||||||
| Operating lease liabilities | 5,712 | 5,978 | 5,585 | 1,759 | ||||||||
| Loan from others | 63,252 | - | 65,187 | 20,524 | ||||||||
| Other payables | - | 1,135 | - | - | ||||||||
| Severance pay liability, net | 95 | 95 | 95 | 30 | ||||||||
| 69,059 | 7,208 | 70,867 | 22,313 | |||||||||
| SHAREHOLDERS' EQUITY: | ||||||||||||
| Ordinary shares of no par value: Authorized: 1,800,000,000 and 700,000,000 shares at March 31, 2022 December 31, 2021 and March 31, 2021, respectively; Issued and outstanding: 745,048,544 , 739,048,544 and 573,285,824 shares March 31, 2022, December 31, 2021 and March 312021, respectively | -* | ) | -* | ) | -* | ) | -* | ) | ||||
| Share premium | 388,104 | 353,783 | 390,356 | 122,908 | ||||||||
| Accumulated deficit | (364,771 | ) | (332,979 | ) | (374,187 | ) | (117,817 | ) | ||||
| 23,333 | 20,804 | 16,169 | 5,091 | |||||||||
| 99,599 | 94,724 | 95,538 | 30,081 | |||||||||
| *) | Represents less<br> than NIS\USD 1. | |||||||||||
| --- | --- |
Jerusalem BioPark, 2^nd^ floor ● Hadassah Ein Kerem Campus ● Jerusalem, Israel
Telephone: +972-8-9302529 ● Fax: +972-8-9302531 ● www.BiondVax.com
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STATEMENTSOF COMPREHENSIVE LOSS
In thousands, except share and per share data
| Convenience <br> translation | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Year ended December 31, | Three months ended<br><br> March 31, | Three months<br> ended <br> March 31, | ||||||||||
| 2021 | 2021 | 2022 | 2022 | |||||||||
| Audited | Unaudited | Unaudited | ||||||||||
| NIS | U.S. dollars | |||||||||||
| Operating expenses: | ||||||||||||
| Research and development, net of participations | 10,341 | 2,750 | 3,653 | 1,150 | ||||||||
| Marketing, general and administrative | 24,528 | 4,005 | 4,633 | 1,459 | ||||||||
| Other income | (40 | ) | - | - | - | |||||||
| Total operating expenses (income) | 34,829 | 6,755 | 8,286 | 2,609 | ||||||||
| - | ||||||||||||
| Operating income (loss) | (34,829 | ) | (6,755 | ) | (8,286 | ) | (2,609 | ) | ||||
| Financial income | 5,716 | 1,182 | 1,212 | 382 | ||||||||
| Financial expense | (10,865 | ) | (2,613 | ) | (2,342 | ) | (737 | ) | ||||
| Net loss and total comprehensive loss | (39,978 | ) | (8,186 | ) | (9,416 | ) | (2,965 | ) | ||||
| Basic and Diluted net loss per share | (0.07 | ) | (0.02 | ) | (0.02 | ) | (0.005 | ) | ||||
| Weighted average number of shares outstanding used to compute basic and diluted loss per share | 564,575,967 | 530,840,391 | 570,114,429 | 570,114,429 |
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, 2^nd^ floor ● Hadassah Ein Kerem Campus ● Jerusalem, Israel
Telephone: +972-8-9302529 ● Fax: +972-8-9302531 ● www.BiondVax.com
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