Jerusalem, Israel - November 13, 2018 - BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), a Phase 3 clinical stage biopharmaceutical company focused on developing and commercializing M-001, a universal flu vaccine candidate, today announced its financial results for the quarter ended September 30, 2018.

Third Quarter 2018 Financial Summary

Results are in New Israel Shekels (NIS) and convenience translation to $US is provided using the exchange rate of 3.627 (NIS/$US) as at September 30, 2018.

  • Third quarter operating expenses were NIS 49.1m ($13.5m) compared with NIS 3.21m for the third quarter of 2017;
  • Third quarter R&D expenses amounted to NIS 45.3m ($12.5m) compared with NIS 1.17m for the third quarter of 2017;

As of September 30, 2018, BiondVax had cash and cash equivalents of NIS 53.0 million ($14.6 million) as compared to NIS 37.1 million as of June 30, 2018. Expenses are related to execution of planned ongoing operations including the launch of a pivotal, clinical efficacy, Phase 3 trial of the Company's M-001 Universal Flu Vaccine candidate, and construction of a mid-size commercial manufacturing facility.

Of note, during this third quarter a €6 million tranche was received by the Company as part of the previously announced €20 million co-financing agreement with the European Investment Bank (EIB). On October 21, 2018, after this third quarter reporting period, an additional €8 million representing the third and final tranche of the EIB agreement was received by BiondVax, and will be included in the Company's fourth quarter financial results.

** 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-season protection against current and future, seasonal and pandemic influenza virus strains. BiondVax's proprietary technology utilizes a unique combination of conserved and common influenza virus peptides, activating both arms of the immune system for a cross-protecting and long-lasting effect. In a total of 6 completed Phase 1/2 and Phase 2 human clinical trials, covering 698 participants, the vaccine has been shown to be safe, well-tolerated, and immunogenic. 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 involve certain risks and uncertainties 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, the prosecution and outcome of the ongoing Phase 2 and Phase 3 trials and any subsequent trials; timing of receipt of regulatory approval of the new manufacturing facility its products; 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 United States Food and Drug Administration or equivalent foreign regulatory agencies; the adequacy of available cash resources and the ability to raise 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, 2017 filed with the U.S. Securities and Exchange Commission, or SEC, which is available on the SEC's website, www.sec.gov, and in the Company's periodic filings with the SEC. 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,

September 30,

September 30,

2017

2017

2018

2018

Audited

Unaudited

Unaudited

N I S

U.S. dollars

CURRENT ASSETS:

Cash and cash equivalents

71,382

76,892

52,985

14,608

Short-term deposits

-

1,200

*) -

*) -

Other receivables

3,923

3,779

2,716

749

75,305

81,871

55,701

15,357

LONG‑TERM ASSETS:

Property, plant and equipment

5,510

1,308

24,175

6,665

Other long term assets

880

515

888

245

6,390

1,823

25,063

6,910

81,695

83,694

80,764

22,267

CURRENT LIABILITIES:

Trade payables

6,223

792

1,732

477

Other payables

660

2,344

981

270

6,883

3,136

2,713

747

LONG‑TERM LIABILITIES:

Liability in respect of government grants

10,300

-

12,930

3,565

Loan from others

-

-

42,770

11,792

Warrants

8,177

11,829

7,759

2,139

Severance pay liability, net

83

81

81

22

18,560

11,910

63,540

17,518

SHAREHOLDERS' EQUITY:

Ordinary shares

Authorized: 600,000,000 shares as of September
30, 2018, 2017 (unaudited) and December 31,
2017; Issued and Outstanding: 261,419,599,
179,595,199 and 261,419,599 shares
respectively

*) -

*) -

*) -

*) -

Share premium

179,669

179,182

179,871

49,592

Options

-

533

-

-

Other comprehensive income

-

-

-

Accumulated deficit

(123,417)

(111,067)

(165,360)

(45,590)

56,252

68,648

14,511

4,002

81,695

83,694

80,764

22,267

*) Represents an amount lower than NIS 1.

STATEMENTS OF COMPREHENSIVE INCOME

In thousands, except share and per share data

Convenience
translation

Year ended

December 31,

Three months ended

September 30,

Nine months ended

September 30,

Nine months

ended

September 30,

2017

2017

2018

2017

2018

2018

Unaudited

Unaudited

N I S

U.S. dollars

(In thousands, except per share data)

Operating expenses:

Research and development, net of
participations

18,777

1,174

4,347

5,070

45,297

12,488

Marketing, general and administrative

4,879

2,036

1,475

3,699

3,804

1,049

Total operating expenses

23,656

3,210

5,822

8,769

49,101

13,537

Operating loss

(23,656)

(3,210)

(5,822)

(8,769)

(49,101)

(13,537)

Financial income

18

4,558

3,729

17

9,817

2,707

Financial expense

(10,913)

(45)

(157)

(13,449)

(2,659)

(733)

Total financial income (expense), net

(10,895)

4,513

3,572

(13,432)

7,158

1,974

Net income (loss)

(34,551)

1,303

(2,250)

(22,201)

(41,943)

(11,564)

Other comprehensive loss:

Loss from available-for-sale financial
assets

(6)

(2)

-

(6)

-

-

Total comprehensive income (loss)

(34,557)

1,301

(2,250)

(22,207)

(41,943)

(11,564)

Earnings (loss) per share

Basic (NIS)

(0.17)

0.01

(0.01)

(0.12)

(0.16)

(0.04)

Diluted (NIS)

(0.17)

(0.01)

(0.01)

(0.12)

(0.16)

(0.04)

Weighted average number of shares used in
compute earnings (loss) per share

Basic

201,030,768

191,521,484

261,419,599

180,680,089

261,419,599

261,419,599

Diluted

201,030,768

201,302,584

261,419,599

180,680,089

261,419,599

261,419,599

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Disclaimer

BiondVax Pharmaceuticals Ltd. published this content on 13 November 2018 and is solely responsible for the information contained herein. Distributed by Public, unedited and unaltered, on 13 November 2018 20:28:04 UTC