PR Newswire | Aug 20, 2020 04:01PM EDT

08/20 15:01 CDT

BiondVax Announces Second Quarter 2020 Financial Results JERUSALEM, Aug. 20, 2020

JERUSALEM, Aug. 20, 2020 /PRNewswire/ -- 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.

Second Quarter 2020 Financial Summary

Results are in New Israel Shekels (NIS) and convenience translation to $US is provided using the exchange rate of 3.466 (NIS/$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 expenses for the second quarter amounted to NIS 11.9 million (approximately $3.4 million) compared with NIS 15.2 million for the second quarter of 2019. * Net loss for the second quarter was NIS 42 million (approximately $12.1 million) compared 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*

About BiondVax

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.

Contact DetailsJoshua 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. These forward-looking statements reflect the 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, risks relating to the COVID-19 (coronavirus) pandemic, the prosecution, timing and results of the ongoing Phase 2 and Phase 3 trials and any subsequent trials; timing of receipt of regulatory approval of our manufacturing facility in Jerusalem; ability to demonstrate the efficacy and safety of the vaccine; the timing of clinical trials and marketing approvals; the risk that drug development involves a lengthy and expensive process with uncertain outcome; the ability of the Company to maintain, preserve and defend its intellectual property and 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 adequacy of available cash resources and the ability to raise additional capital when needed. More detailed information about the risks and uncertainties affecting the Company is contained under the heading "Risk Factors" in our Annual Report on Form 20-F for the year ended December 31, 2019 filed with the U.S. Securities and Exchange Commission, or SEC, which is available on the SEC's website, www.sec.gov. We undertake no obligation to revise or update any forward-looking statement for any reason.

BALANCE SHEETS

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 less than NIS\USD 1.

STATEMENTS OF COMPREHENSIVE INCOME (LOSS)

In thousands, except share and per share data

Convenience translation

Six months Year ended Three months ended Six months ended ended December 31, June 30, June 30, 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 68,645 15,172 11,948 20,904 31,016 8,949 participations

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

(30,847) (27,699) (14,600) (19,992) (14,748) (4,255)Financial expense

Net loss (47,389) (41,978) (46,823) (46,673) (13,177) (109,194)

Basic and diluted net loss per share (0.33) (0.18) (0.10) (0.18) (0.11) (0.03) (NIS)

Weighted average number of shares outstanding used to compute basic 326,651,721 261,482,786 433,498,227 261,435,179 431,485,801 431,485,801 and diluted loss per share

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SOURCE BiondVax Pharmaceuticals Ltd.