BiondVax Announces Second Quarter 2018 Financial Results

Jerusalem, Israel - August 22, 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 June 30, 2018.Second Quarter 2018 Financial SummaryResults are in New Israel Shekels (NIS) and convenience translation to $US is provided using the exchange rate of 3.65 (NIS/$US) as at June 30, 2018.

  • Second quarter operating expenses were NIS 30.6m ($8.4m) compared with NIS 2.59m for the second quarter of 2017;
  • Second quarter R&D expenses amounted to NIS 29.2m ($8m) compared with NIS 2m for the second quarter of 2017;

As of June 30, 2018, BiondVax had cash and cash equivalents of NIS 37.1 million ($10.1 million) as compared to NIS 36.6m as of March 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.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.comForward Looking StatementsThis 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 and the Tel-Aviv Stock Exchange. We undertake no obligation to revise or update any forward-looking statement for any reason.

 ** Tables to Follow **

BALANCE SHEETS

In thousands, except per share data

Conveniencetranslation

December 31,

June 30,

June 30,

2017

2017

2018

2018

Audited

Unaudited

Unaudited

N I S

U.S. dollars

CURRENT ASSETS:

Cash and cash equivalents

71,382

31,334

37,128

10,172

Marketable securities

-

4,067

-

Short-term deposits

-

1,200

-

-

Other receivables

3,923

2,812

4,067

1,114

75,305

39,413

41,195

11,286

LONG‑TERM ASSETS:

Property, plant and equipment

5,510

1,233

18,793

5,149

Other long term assets

880

505

880

241

6,390

1,738

19,673

5,390

81,695

41,151

60,868

16,676

CURRENT LIABILITIES:

Trade payables

6,223

1,188

1,323

363

Other payables

660

664

780

214

6,883

1,852

2,103

577

LONG‑TERM LIABILITIES:

Liability in respect of government grants

10,300

-

12,790

3,504

Loan from others

-

-

20,710

5,674

Warrants

8,177

18,231

8,475

2,322

Severance pay liability, net

83

79

79

22

18,560

18,310

42,054

11,522

SHAREHOLDERS' EQUITY:

Ordinary shares of NIS 0.0000001 par value:

 Authorized: 391,000,000 shares as of June 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

132,824

179,821

49,265

Options

-

533

-

-

 Other comprehensive income

-

2

-

-

Accumulated deficit

(123,417)

(112,370)

(163,110)

(44,688)

56,252

20,989

16,711

4,577

81,695

41,151

60,868

16,676

*)            Represents an amount lower than NIS 1.

 

STATEMENTS OF COMPREHENSIVE INCOME

In thousands, except per share data

Convenience translation

Year ended

December 31,

Three months ended

June 30,

Six months ended

June 30,

Six months

ended

June 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

2,022

29,205

3,896

40,950

11,219

Marketing, general and administrative

4879

569

1,445

1,663

2,329

638

Total operating expenses

23,656

2,591

30,650

5,559

43,279

11,857

Operating loss

(23,656)

(2,591)

(30,650)

(5,559)

(43,279)

(11,857)

Financial income

18

5

6,386

13

6,386

1,255

Financial expense

(10,913)

(9,086)

(1,227)

(17,958)

(2,800)

(273)

0

Total finance (expense) income, net

(10,895)

(9,081)

5,159

(17,945)

3,586

982

Net loss 

(34,551)

(11,672)

(25,491)

(23,504)

(39,693)

(10,875)

Other comprehensive loss:

Items to be reclassified to profit or loss in subsequent periods:

Loss from available-for-sale financial assets

(6)

(4)

-

(4)

-

-

Total comprehensive loss

(34,557)

(11,676)

(25,491)

(23,508)

(39,693)

(10,875)

Basic and diluted net loss per share (NIS)

(0.17)

(0.07)

(0.10)

(0.14)

(0.15)

(0.04)

Weighted average number of shares outstanding used to compute basic anddiluted loss per share

201,030,768

175,809,413

261,419,599

169,182,101

261,419,599

261,419,599

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