JERUSALEM, ISRAEL / ACCESSWIRE / May 15, 2023 / (via IBN) -- BiondVax Pharmaceuticals Ltd. (Nasdaq:BVXV), a biotechnology company focused on developing, manufacturing, and commercializing innovative immunotherapeutic products primarily for the treatment of infectious and autoimmune diseases, today published its financial results for the first quarter ended March 31, 2023, and provided a business update.
First Quarter 2023 Financial Summary
- R&D expenses for the three months ended March 31, 2023, amounted to $2 million compared with $1.2 million for the three months ended March 31, 2022. The increase of $0.8 million was primarily due to the initiation of R&D activities for the innovative nanosized antibody (NanoAb) platform.
- Marketing, general and administrative expenses for the three months ended March 31, 2023, amounted to $1.2 million compared with $1.4 million for the three months ended March 31, 2022.
- Total operating expenses for the three months ended March 31, 2023, amounted to $3.2 million compared with $2.6 for the three months ended March 31, 2022.
- Financial (loss) income for the three months ended March 31, 2023, amounted to $(0.3) million compared with $0.14 million for the three months ended March 31, 2022.
- Net loss for the three months ended March 31, 2023, amounted to $3.5 million compared with $2.47 million for the three months ended March 31, 2022.
As of March 31, 2023, BiondVax had cash and cash equivalents of $10.9 million as compared to $14.2 million as of December 31, 2022. The decrease in cash from December 31, 2022, to March 31, 2023, was primarily due to net cash used in operating activities of $3.1 million.
The complete unaudited financial results are available in the Company's Quarterly Report on Form 10-Q for the period ended March 31, 2023, filed with the Securities and Exchange Commission. A summary is included in the tables below.
Business Update
- BiondVax is offering its cGMP manufacturing capabilities to interested parties, including aseptic fill and finish suite, laboratories and experienced professionals for CDMO services. This may optimize use of BiondVax's assets and generate revenues, while enabling the Company to prioritize its NanoAb pipeline development. Additional information is available at www.biondvax.com/cdmo.
- The Company shared positive preclinical in vivo data indicating that the innovative inhaled anti-SARS-CoV-2 NanoAb virtually prevented illness when administered prophylactically. The results also demonstrated that when administered therapeutically, the inhaled NanoAb virtually eliminated the virus in lungs, and led to a significantly shorter and milder illness. The Company previously announced that it will focus on further NanoAb development beginning with NanoAbs targeting immune system cytokines such as IL-17 as drug candidates for the potential treatment of psoriasis and psoriatic arthritis.
- In pursuit of scientific and business development collaborations, in Q1 2023, the Company attended the BioTech Showcase 2023 in San Francisco, the BIO CEO & Investor Conference in New York, and BIO Europe Spring in Basel, Switzerland.
About BiondVax
BiondVax Pharmaceuticals Ltd. (Nasdaq: BVXV) is a biotechnology company focused on developing, manufacturing, and commercializing innovative immunotherapeutic products primarily for the treatment of infectious and autoimmune diseases. Since its inception, the company has executed eight clinical trials including a seven-country, 12,400-participant Phase 3 trial of its vaccine candidate and has built a state-of-the-art manufacturing facility for biopharmaceutical products. With highly experienced pharmaceutical industry leadership, BiondVax is aiming to develop a pipeline of diversified and commercially viable products and platforms beginning with an innovative nanosized antibody (NanoAb) pipeline. www.biondvax.com.
Contact Details
Investor Relations | +972 8 930 2529 | [email protected]
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 position, future revenue, projected expenses, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements regarding the timing of future preclinical clinical trials, and the therapeutic and commercial potential of NanoAbs. These forward-looking statements reflect 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 BiondVax may not be able to secure additional capital on attractive terms, if at all; the risk that the therapeutic and commercial potential of NanoAbs will not be met; the risk of a delay in the preclinical and clinical trials data for NanoAbs, if any; the risk that our business strategy may not be successful; the risk that the European Investment Bank (EIB) may accelerate the loans under its finance contract with BiondVax; risks relating to the SARS-CoV-2 (COVID-19) virus; BiondVax's ability to acquire rights to additional product opportunities; BiondVax's ability to enter into collaborations on terms acceptable to BiondVax or at all; timing of receipt of regulatory approval of BiondVax's manufacturing facility in Jerusalem, if at all or when required; the risk that the manufacturing facility will not be able to be used for a wide variety of applications and other vaccine and treatment technologies; and the risk that drug development involves a lengthy and expensive process with uncertain outcomes. More detailed information about the risks and uncertainties affecting the Company is contained under the heading "Risk Factors" in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission on April 17, 2023. BiondVax undertakes no obligation to revise or update any forward-looking statement for any reason.
CONDENSED BALANCE SHEETS (Unaudited)
U.S. dollars in thousands (except share and per share data)
| March 31, | December 31, | |||||||
| 2023 | 2022 | |||||||
| Unaudited | Audited | |||||||
ASSETS | ||||||||
CURRENT ASSETS: | ||||||||
Cash and cash equivalents | $ | 10,799 | $ | 14,075 | ||||
Restricted cash | 127 | 140 | ||||||
Prepaid expenses and other receivables | 119 | 155 | ||||||
Total current assets | 11,045 | 14,370 | ||||||
NON-CURRENT ASSETS: | ||||||||
Property, plant and equipment, net | 10,817 | 11,245 | ||||||
Operating lease right-of-use assets | 1,430 | 1,452 | ||||||
Total non-current assets | 12,247 | 12,697 | ||||||
Total assets | $ | 23,292 | $ | 27,067 | ||||
LIABILITIES AND SHAREHOLDERS' EQUITY | ||||||||
CURRENT LIABILITIES: | ||||||||
Trade payables | $ | 1,313 | $ | 716 | ||||
Operating lease liabilities | 420 | 382 | ||||||
Other payables | 846 | 1,240 | ||||||
Total current liabilities | 2,579 | 2,338 | ||||||
NON-CURRENT LIABILITIES: | ||||||||
Warrants liability | 2,664 | 5,329 | ||||||
Loan from others | 21,851 | 20,082 | ||||||
Non-current operating lease liabilities | 1,008 | 1,078 | ||||||
Total non-current liabilities | 25,523 | 26,489 | ||||||
CONTINGENT LIABILITIES AND COMMITMENTS | ||||||||
SHAREHOLDERS' EQUITY (DEFICIT): | ||||||||
Ordinary shares of no par value: Authorized: 20,000,000,000 shares at March 31, 2023, and at December 31, 2022; Issued and outstanding 1,313,623,184 shares at March 31, 2023, and 989,290,784 shares at December 31, 2022 | - | - | ||||||
Additional paid-in capital | 116,431 | 116,082 | ||||||
Accumulated deficit | (119,350 | ) | (115,835 | ) | ||||
Accumulated other comprehensive loss | (1,891 | ) | (2,007 | ) | ||||
Total shareholders' deficit | (4,810 | ) | (1,760 | ) | ||||
Total liabilities and shareholders' deficit | $ | 23,292 | $ | 27,067 | ||||
CONDENSED STATEMENTS OF OPERATIONS (Unaudited)
U.S. dollars in thousands (except share and per share data)
| Three months ended March 31, | ||||||||
| 2023 | 2022 | |||||||
| Unaudited | Unaudited | |||||||
Research and development | $ | 1,995 | $ | 1,163 | ||||
Marketing, general and administrative | 1,191 | 1,452 | ||||||
Total operating loss | 3,186 | 2,615 | ||||||
Financial loss (income), net | 329 | (140 | ) | |||||
Net loss | $ | 3,515 | $ | 2,475 | ||||
Basic and diluted net loss per share | (0.003 | ) | (0.003 | ) | ||||
Weighted average number of shares used for computing basic and diluted net loss per share | 1,295,256,604 | 744,711,465 | ||||||
The accompanying notes in the Company's financial report are an integral part of the financial statements. The complete financial results are available on Form 10-Q filed with the Securities and Exchange Commission (SEC).
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SOURCE: BiondVax Pharmaceuticals Ltd.