BiondVax Announces Second Quarter 2020 Financial Results

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 .

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 Details
Joshua 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

Year ended

December 31,

Three months ended

June 30,

Six months ended

June 30,

Six months

ended

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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SOURCE BiondVax Pharmaceuticals Ltd.


Company Codes: NASDAQ-SMALL:BVXV
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