2022-06-01 | NDAQ:BVXV | Press release

JERUSALEM, June 1, 2022 /PRNewswire/ — BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV), a biopharmaceutical company focused on the development, manufacture and commercialization of innovative products for the prevention and treatment of infectious diseases and other illnesses, today released its first quarter financial results for the quarter ended March 31, 2022 and provided a company update.

Company update

  • The development of the NanoAb program is proceeding as planned:

    oh Successful technology transfer demonstrated from the Max Planck Institute for Multidisciplinary Sciences (MPG) to the BiondVax manufacturing facility in Jerusalem. The tests showed that BiondVax was able to successfully manufacture its first NanoAb under exclusive license for the treatment of COVID-19 and demonstrated strong neutralization of live COVID–19 virus in–vitro at levels similar to those demonstrated by the NanoAbs originally produced at MPG.

    o NanoAbs produced at BiondVax facilities have similarly demonstrated strong capacity for in vitro neutralization of COVID-19 after being sprayed through a medical deviceinhaler which should be used in the first-in-man clinical trials planned for 2023.

    o A novel NanoAb targeting Omicron that was generated at MPG was recently shown to successfully neutralize the Omicron variant of COVID-19 in vitro. This NanoAb is expected to be manufactured and used in BiondVax’s first-in-man clinical trials.
  • Our team of 26 full-time employees includes 12 new employees who joined BiondVax in 2022 to support all aspects of BiondVax’s NanoAb program, including quality assurance, quality control, R&D, manufacturing, testing preclinical and clinical.
  • In April and May, BiondVax hosted two webinars for investors and presented in person at the Biomed Israel and HC Wainwright Global Investment conferences.

First Quarter 2022 Financial Summary

Results are in new Israeli shekels (NIS) and the convenient US dollar translation is provided using the exchange rate of 3.176 (NIS/US$), the rate at the close of business on March 31, 2022.

  • Total operating expenses for the three months ended March, 31st2022 were 8.3 million shekels ($2.6 million) compared to 6.8 million shekels for the three months ended March, 31st2021.
  • R&D costs for the three months ended March, 31st2022 were NIS 3.65 million ($1.1 million) compared to 2.8 million shekels for the three months ended March 31, 2021. This increase is mainly due to the activity related to the new NanoAb program.
  • Marketing, general and administrative expenses for the three months ended March, 31st2022 were 4.6 million shekels ($1.5 million) compared to NIS 4.0 million for the three months ended March, 31st2021.

From March 31, 2022BiondVax had cash and cash equivalents 48.9 million shekels ($15.4 million) compared to NIS 54.0 million of the December 31, 2021.

Unaudited first quarter financial results will be submitted to the Securities and Exchange Commission. A summary is included in the tables below.

About BiondVax

BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV) is a biopharmaceutical company focused on developing, manufacturing and marketing innovative products for the prevention and treatment of infectious and other diseases. Since its inception, the company has completed eight clinical trials, including a phase 3 trial in seven countries and 12,400 participants of its candidate vaccine and has built a state-of-the-art manufacturing facility for biopharmaceuticals. With highly experienced leadership in the pharmaceutical industry, BiondVax aims to develop a pipeline of diverse and commercially viable products and platforms, starting with an innovative nanoscale antibody (NanoAb) pipeline. For more information, please visit www.biondvax.com.

Contact details

Company: Joshua E. Phillipson | +972 8 930 2529 | j.phillipson@biondvax.com

Investor Relations: kenny green | +1 212 378 8040 | kgreen@edisongroup.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. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, future financial condition, future revenues, projected expenditures, outlook, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements regardingng the timing of future clinical trials, the therapeutic and commercial potential of NanoAbs and execonclusion of a definitive amendment agreement with the EIB. These forward-looking statements reflect management’s current beliefs regarding certain current and future events and are subject to various risks, uncertainties and assumptions that could cause actual 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 the therapeutic and commercial potential of NanoAbs will not be realized; the risk of delay of preclinical and clinical data of the NanoAbs, if any; the risk that BiondVax and the EIB fail to reach an agreement on the restructuring of the European Investment Bank loan; the risk that BiondVax may not be able to obtain additional capital on attractive terms, if at all; the risk that the European Investment Bank may accelerate lending under its financing agreement with BiondVax; risks related to the COVID-19 (coronavirus) pandemic; BiondVax’s ability to acquire rights to additional product opportunities; BiondVax’s ability to enter into collaborations on terms acceptable to BiondVax or not at all; time of receipt of regulatory approval of BiondVax’s manufacturing facility in Jerusalem, as appropriate or required; the risk that the manufacturing facility cannot be used for a wide variety of applications and other vaccine and treatment technologies, and the risk that drug development will involve a long and expensive process with uncertain outcomes. More detailed information about the risks and uncertainties affecting the Company can be found under the heading “Risk Factors” in the Company’s Annual Report on Form 20-F filed with the Securities and Exchange Commission on March 25, 2022. BiondVax undertakes no obligation to revise or update any forward-looking statement for any reason.

BALANCE SHEET

In thousands, except per share and per share data

Convenience

Translation

The 31st of December,

March, 31st,

March, 31st,

2021

2021

2022

2022

Checked

Unaudited

Unaudited

NIS

U.S. dollars

CURRENT ASSETS:

Cash and cash equivalents

54,036

48,577

48,886

15,391

Other receivables

1,012

481

619

196

55,048

49,058

49,505

15,587

LONG-TERM ASSETS:

Fixed assets

38,519

39,252

39,745

12,514

Right-of-use assets

5,588

5,978

5,359

1,687

Other long-term assets

444

436

929

293

44,551

45,666

46,033

14,494

99,599

94,724

95,538

30,081

CURRENT LIABILITIES:

Payables

3,107

2,085

4,102

1,292

Operating lease debts

773

641

802

253

Loan from others

62,346

Other debts

3,327

1,640

3,598

1,133

7,207

66,712

8,502

2,677

LONG-TERM LIABILITIES:

Operating lease debts

5,712

5,978

5,585

1,759

Loan from others

63,252

65,187

20,524

Other debts

1,135

Severance benefits liability, net

95

95

95

30

69,059

7,208

70,867

22,313

EQUITY:

Common shares without par value: Permitted:

1,800,000,000 and 700,000,000 shares at

March 31, 2022 December 31, 2021 and

March 31, 2021, respectively; Issued and

in circulation: 745 048 544, 739 048 544 and

573,285,824 shares March 31, 2022,

December 31, 2021 and March 31, 2021,

respectively

*) –

*) –

*) –

*) –

Premium

388 104

353,783

390 356

122,908

Accumulated deficit

(364,771)

(332,979)

(374,187)

(117,817)

23,333

20,804

16,169

5,091

99,599

94,724

95,538

30,081

*) Represents less than NISUSD 1.

STATES OF GLOBAL LOSS

In thousands, except per share and per share data

Convenience

Translation

Year ended

The 31st of December,

Three months completed

March, 31st,

Three months

ended

March, 31st,

2021

2021

2022

2022

Checked

Unaudited

Unaudited

NIS

U.S. dollars

Operating costs :

Research and development, net of

holdings

10,341

2,750

3,653

1,150

Marketing, general and administrative

24,528

4,005

4,633

1,459

Other income

(40)

Total operating expenses (revenue)

34,829

6,755

8,286

2,609

Operating profit (loss)

(34,829)

(6,755)

(8,286)

(2,609)

Financial products

5,716

1,182

1,212

382

Financial charge

(10,865)

(2,613)

(2,342)

(737)

Net loss and total comprehensive loss

(39,978)

(8,186)

(9,416)

(2,965)

Basic and diluted net loss per share

(0.07)

(0.02)

(0.02)

(0.005)

Weighted average number of shares

exceptional used to calculate base

and diluted loss per share

564 575 967

530 840 391

570 114 429

570 114 429

The notes to the Company’s quarterly report form an integral part of the financial statements. Complete financial results are available on Form 6-K for filing with the Securities and Exchange Commission.

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SOURCE BiondVax Pharmaceuticals Ltd.

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