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Scinai Immunotherapeutics Ltd 6-K, filed Aug 24, 2020

Scinai Immunotherapeutics Ltd. (SCNI)

6-K 2020-08-24 For: 2020-08-23
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Added on April 09, 2026

About this 6-K

Scinai Immunotherapeutics Ltd filed this 6-K on August 24, 2020.

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 6-K

Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16

Under the Securities Exchange Act of 1934

For the Month of August 2020

Commission File Number: 001-37353

BIONDVAX PHARMACEUTICALS LTD.

(Translation of registrant’s name into English)

Jerusalem BioPark, 2nd Floor

Hadassah Ein Kerem Campus

Jeusalem, Israel

(Address of principal executive office)

Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.

Form 20-F ☒     Form 40-F ☐

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ____

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ____

On August 20, 2020, BiondVax Pharmaceuticals Ltd. issued a press release announcing second quarter 2020 financial results.

Exhibit Index

Exhibit No. Description
99.1 Press Release dated August 20, 2020

This Report on Form 6-K is hereby incorporated by reference into the Company’s Registration Statement on Form F-3 (Registration No. 333-240189) and its Registration Statement on Form S-8 (Registration No. 333-239344).

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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: August 23, 2020 By: /s/ Ron Babecoff
Ron Babecoff
Chief Executive Officer

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Exhibit 99.1



BiondVaxAnnounces Second Quarter 2020 Financial Results

Jerusalem, Israel – August 20, 2020 – BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), a clinical stage biopharmaceutical company focused on developing and commercializing M-001, a universal influenza vaccine candidate, today announced its second quarter financial results for the quarter ended June 30, 2020.


SecondQuarter 2020 Financial Summary

Resultsare in New Israel Shekels (NIS) and convenience translation to $US is provided using the exchange rate of3.466   (NIS/$US)as at June 30, 2020.

Total operating expenses for the second quarter were NIS 16.0 million (approximately $4.61 million) compared with NIS 19.7 million for the second quarter of 2019.

● R&D<br> expenses for the second quarter amounted to NIS 11.9 million (approximately $3.4 million)<br> compared with NIS 15.2 million for the second quarter of 2019.
● Net<br> loss for the second quarter was NIS 42 million (approximately $12.1 million) compared<br> to net loss of NIS 47.4 million for the second quarter of 2019.
--- ---

The decrease in total operating expenses compared to the second quarter of 2019 was primarily due to fewer costs associated with the nearly complete pivotal Phase 3 trial and completion of construction of the manufacturing facility.

As of June 30, 2020, BiondVax had cash and cash equivalents of NIS 38.7 million (approximately $11.2 million) compared to NIS 72.4 million as of December 31, 2019.

*Tables to follow*

AboutBiondVax

BiondVax (NASDAQ: BVXV) is a Phase 3 clinical stage biopharmaceutical company developing a universal flu vaccine. The vaccine candidate, called M-001, is designed to provide multi-strain and multi-season protection against current and future, seasonal and pandemic influenza. BiondVax’s proprietary technology utilizes a unique combination of conserved and common influenza virus peptides intended to stimulate both arms of the immune system for a cross-protecting and long-lasting effect. In a total of seven completed Phase 1/2 and Phase 2 clinical trials enrolling 818 participants, the vaccine has been shown to be safe, well-tolerated, and immunogenic. The ongoing pivotal Phase 3 clinical trial aims to assess safety and effectiveness of M-001 in reducing flu illness and severity. For more information, please visit www.biondvax.com.


ContactDetails

Joshua E. Phillipson | +972 8 930 2529 | j.phillipson@biondvax.com


ForwardLooking Statements

Thispress release contains forward-looking statements within the meaning of the Private Litigation Reform Act of 1995. Words suchas “expect,” “believe,” “intend,” “plan,” “continue,” “may,”“will,” “anticipate,” and similar expressions are intended to identify forward-looking statements. Theseforward-looking statements reflect the management’s current views with respect to certain current and future events andare subject to various risks, uncertainties and assumptions that could cause the results to differ materially from those expectedby the management of BiondVax Pharmaceuticals Ltd. Risks and uncertainties include, but are not limited to, risks relating tothe COVID-19 (coronavirus) pandemic, the prosecution, timing and results of the ongoing Phase 2 and Phase 3 trials and any subsequenttrials; timing of receipt of regulatory approval of our manufacturing facility in Jerusalem; ability to demonstrate the efficacyand safety of the vaccine; the timing of clinical trials and marketing approvals; the risk that drug development involves a lengthyand expensive process with uncertain outcome; the ability of the Company to maintain, preserve and defend its intellectual propertyand patents granted; whether our vaccine candidate will successfully advance through the clinical trial process on a timely basis,or at all, and receive approval from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies; the adequacyof available cash resources and the ability to raise additional capital when needed. More detailed information about the risksand uncertainties affecting the Company is contained under the heading “Risk Factors” in our Annual Report on Form20-F for the year ended December 31, 2019 filed with the U.S. Securities and Exchange Commission, or SEC, which is available onthe SEC’s website, www.sec.gov. We undertake no obligation to revise or update any forward-looking statement for any reason.

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BALANCESHEETS

In thousands, except share and per share data

Convenience
Translation
December 31 June 30, June 30,
2019 2019 2020 2020
Audited Unaudited Unaudited
N I S U.S. dollars
CURRENT ASSETS:
Cash and cash equivalents 72,467 33,916 38,752 11,181
Other receivables 656 1,258 2,467 712
73,123 35,174 41,219 11,893
LONG-TERM ASSETS:
Property, plant and equipment 34,981 32,475 36,937 10,658
Right-of-use assets 7,136 7,610 6,662 1,922
Other long-term assets 510 510 891 257
42,627 40,595 44,490 12,837
-
115,750 75,769 85,709 24,730
CURRENT LIABILITIES:
Trade payables 17,062 7,977 4,070 1,174
Operating lease liabilities 694 686 676 195
Other payables 1,203 1,348 1,609 464
18,959 10,011 6,355 1,835
LONG-TERM LIABILITIES:
Liability in respect of government grants 14,812 14,621 12,686 3,660
Operating lease liabilities 6,809 7,076 6,457 1,863
Loan from others 123,780 110,971 122,041 35,211
Warrants 16,354 5,517 - -
Severance pay liability, net 89 86 92 26
161,844 138,271 141,276 40,760
SHAREHOLDERS’ EQUITY:
Ordinary shares of no par value: Authorized: 600,000,000, 391,000,000 and 600,000,000 shares at June 30, 2020 and 2019 (unaudited) and December 31, 2019, respectively; Issued and outstanding: 460,822,640, 261,419,599 and 402,351,657 shares at June 30, 2020 and 2019 (unaudited) and December 31, 2019, respectively *)- *)- *)- *)-
Share premium 255,285 185,454 304,089 87,735
Accumulated deficit (320,338 ) (257,967 ) (366,011 ) (105,600 )
(65,053 ) (72,513 ) (61,922 ) (17,865 )
115,750 75,769 85,709 24,730
*) Represents<br> less than NIS\USD 1.
--- ---
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STATEMENTSOF COMPREHENSIVE INCOME (LOSS)

Inthousands, except share and per share data

Convenience translation
Year ended December 31, Three months ended <br><br>June 30, Six months ended <br><br>June 30, Six months<br> <br>ended<br> <br>June 30,
2019 2019 2020 2019 2020 2020
Audited Unaudited Unaudited
N I S U.S. dollars
(In thousands, except per share data)
Operating expenses:
Research and development, net of participations 68,645 15,172 11,948 20,904 31,016 8,949
Marketing, general and administrative 9,706 4,518 4,139 5,951 5,120 1,477
Total operating expenses 78,351 19,690 16,087 26,855 36,136 10,426
-
Operating loss (78,351 ) (19,690 ) (16,087 ) (26,855 ) (36,136 ) (10,426 )
Financial income 4 - (11,291 ) 24 5,211 1,503
Financial expense (30,847 ) (27,699 ) (14,600 ) (19,992 ) (14,748 ) (4,255 )
Net loss (109,194 ) (47,389 ) (41,978 ) (46,823 ) (46,673 ) (13,177 )
Basic and diluted net loss per share (NIS) (0.33 ) (0.18 ) (0.10 ) (0.18 ) (0.11 ) (0.03 )
Weighted average number of shares outstanding used to compute basic and diluted loss per share 326,651,721 261,482,786 433,498,227 261,435,179 431,485,801 431,485,801

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