Ness Ziona, Israel, Nov. 28, 2016 — BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV, TASE: BVXV), a clinical stage biopharmaceutical company focused on developing and commercializing a vaccine against current and future seasonal and pandemic influenza strains, today announced its third quarter 2016 financial results for the quarter ended September 30, 2016 and provided a business update.

Third Quarter 2016 Financial Summary

Results are in New Israel Shekels (NIS) and convenience translation to US$ is provided using the exchange rate of 3.758 (NIS/US$) as at September 30, 2016.

  • Third quarter operating expenses were NIS 3.47m ($923,000) compared with NIS 2.21m for the third quarter of 2015;
  • Third quarter R&D expenses amounted to NIS 2.42 ($644,000) compared with NIS 1.24m for the third quarter of 2015;
  • Cash, cash equivalents and short and long-term marketable securities at the end of the quarter were NIS 29.67m ($7.97m) compared with NIS 37.53m as of December 31, 2015;

 Recent Corporate Update

  • The European UNISEC consortium sponsored Phase 2b processed the final participant in September. Study samples are currently being analyzed by the consortium and are expected to be finalized and released in the coming months.
  • Preparations for the United States NIH Phase 2 clinical trial is ongoing and progressing according to plan.
  • Professor Shai Ashkenazi, an experienced clinician-researcher who has guided multiple vaccines through clinical and regulatory approval phases to market was appointed to BiondVax’s Scientific Advisory Board.

Dr. Ron Babecoff, CEO of BiondVax commented: “I am pleased that we are working according to plans both in the US and Europe.”

About BiondVax

BiondVax is a biopharmaceutical company developing a universal flu vaccine. The vaccine is designed to provide multi-season protection against most seasonal and pandemic human influenza virus strains. BiondVax’s proprietary technology utilizes a unique combination of conserved and common peptides from influenza virus proteins, activating both arms of the immune system for a cross-protecting and long-lasting effect. BiondVax is traded on NASDAQ: BVXV and TASE: BVXV. For more information, please visit www.biondvax.com.

Contact Details

Joshua Phillipson
Business Development Manager
+972 8 930 2529
j.phillipson@biondvax.com
Kenny Green
Investor Relations
+1 646 201 9246
kenny@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 risk that drug development involves a lengthy and expensive process with uncertain outcome, the results of the contemplated  Phase 2 & 3 trials, the impact of the global economic environment on the Company customer target base, the adequacy of available cash resource and the ability to raise capital when needed. The risks, uncertainties and assumptions referred to above are discussed in detail in our reports filed with the Securities and Exchange Commission, including our Prospectus which was declared effective on May 11, 2015. BiondVax Pharmaceuticals Ltd. undertakes no obligation to update or revise any forward-looking statements.

 

** Tables to Follow **

 

 BALANCE SHEETS

Convenience
translation
(Note 2)

December 31,

September 30,

September 30,

2015

2015

2016

2016

Audited

Unaudited

Unaudited

N I S

U.S. dollars

(In thousands except share and per share data)

CURRENT ASSETS:

Cash and cash equivalents

33,470

36,294

15,091

4,016

Short term bank deposit

578

10,510

2,797

Marketable securities

2,016

2,016

2,017

537

Other receivables

1,442

1,594

727

193

36,928

40,482

28,345

7,543

LONG‑TERM ASSETS:

    Marketable securities

2,048

2,047

2,050

545

Property, plant and equipment

2,044

2,191

1,592

424

Other long term assets

287

24

370

98

4,379

4,262

4,012

1,067

41,307

44,744

32,357

8,610

CURRENT LIABILITIES:

Trade payables

931

571

477

127

Other payables

768

758

466

124

1,699

1,329

943

251

LONG‑TERM LIABILITIES:

Options

5,994

6,863

3,528

938

Severance pay liability, net

69

67

74

20

6,063

6,930

3,602

958

SHAREHOLDERS’ EQUITY (DEFICIT):

Ordinary shares of NIS 0.0000001 par value:

 Authorized: 391,000,000 shares as of September
30, 2016, 2015 (unaudited) and December 31,
2015; Issued and Outstanding: 135,097,367,
shares as of September 30, 2016, 2015
(unaudited) and December 31, 2015.

*) –

*) –

*) –

*) –

Share premium

110,679

110,352

111,697

29,722

Options

2,536

2,536

2,536

675

 Other comprehensive income

12

12

8

2

Accumulated deficit

(79,682)

(76,415)

(86,429)

(22,998)

33,545

36,485

27,812

7,401

41,307

44,744

32,357

8,610

*)            Represents an amount lower than NIS 1.

 

STATEMENTS OF COMPREHENSIVE INCOME

Convenience
translation

(Note 2)

Year ended

December 31,

Three months ended

September 30,

Nine months ended

September 30,

Nine months

ended

September
30,

2015

2015

2016

2015

2016

2016

Audited

Unaudited

Unaudited

N I S

U.S. dollars

(In thousands, except per share data)

Operating expenses:

Research and development, net of participations

7,906

1,247

2,421

5,032

5,962

1,586

Marketing, general and administrative

3,397

966

1,049

2,216

2,819

750

Total operating expenses

11,303

2,213

3,470

7,248

8,781

2,336

Operating loss

11,303

2,213

3,470

7,248

8,781

2,336

Financial income

1,118

1,540

10

651

59

16

Financial expense

(24)

(5)

(291)

(20)

(491)

(131)

Financial  income (expenses) due to revaluations of options

10

812

1,395

(315)

2,466

656

Total finance income , net

1,104

2,347

1,114

316

2,034

541

Net loss (income)                                          

10,199

(134)

2,356

6,932

6,747

1,795

Other comprehensive loss (income):

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

Gain (loss) from available-for-sale financial
assets

(5)

(2)

1

(5)

(4)

(1)

Total comprehensive loss (income)

10,204

(132)

2,355

6,937

6,751

1,796

Basic and diluted net loss per share (NIS)

0.10

(0.00)

0.02

0.07

0.05

0.01

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

105,522,642

135,097,367

135,097,367

95,519,426

135,097,367

135,097,367