Tuesday - January 7, 2025
CAMBRIDGE, Mass. / May 15, 2024 / Business Wire / VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today provided a business update and announced financial results for the quarter ended March 31, 2024.
“To date in 2024, our focus has centered around pipeline execution, expanding access and increased uptake of PreHevbrio in targeted market segments, and execution of strategic partnerships to drive opportunity for our portfolio assets, create shareholder value, and strengthen our balance sheet,” said Jeff Baxter, VBI’s President and CEO. “We remain committed to creating opportunities for our vaccines, candidates, and technologies to meaningfully impact public health and the lives of patients, providers, and families.”
Recent Key Program Achievements and Projected Upcoming Milestones
PreHevbrio® [Hepatitis B Vaccine (Recombinant)]
VBI-1901: Cancer Vaccine Immunotherapeutic Candidate – Glioblastoma (GBM)
Novel mRNA-Launched eVLP (MLE) Technology Platform
Other Achievements and Upcoming Milestones
Recent Peer-Reviewed Publications
Financial Results for the Three Months Ended March 2024
Use of Non-GAAP Financial Measures
Net Loss, Excluding Foreign Exchange Loss, and Net Loss Per Share, Excluding Foreign Exchange Loss, are non-GAAP financial measures and are defined as Net Loss and Net Loss Per Share excluding the foreign exchange loss in both calculations. Net Loss, Excluding Foreign Exchange Loss, and Net Loss Per Share, Excluding Foreign Exchange Loss, are not intended to replace Net Loss or Net Loss Per Share or other measures of financial performance reported in accordance with generally accepted accounting principles (GAAP). VBI’s management believes that the presentation of Net Loss, Excluding Foreign Exchange Loss, and Net Loss Per Share, Excluding Foreign Exchange Loss, are useful to investors because management does not consider foreign exchange loss, which is primarily driven by changes in exchange rates related to certain intercompany loans, and is a non-recurring item, when evaluating VBI’s operating performance. Non-GAAP financial measures are meant to supplement, and to be viewed in conjunction with, GAAP financial results. The presentation of these non-GAAP financial measures should not be considered in isolation or as a substitute for comparable GAAP financial measures and should be read only in conjunction with the Company’s financial statements prepared in accordance with GAAP. Reconciliations of the Company’s non-GAAP measures are included below.
The following represents a reconciliation of Net Loss to Net Loss, Excluding Foreign Exchange Loss, and Net Loss Per Share to Net Loss Per Share, Excluding Foreign Exchange Loss. See “Non-GAAP Financial Information” below for additional information regarding this non-GAAP financial measure, and “GAAP to Non-GAAP Reconciliation” for a reconciliation of this non-GAAP financial measure to net loss and net loss per share.
GAAP to Non-GAAP Reconciliations
The following represents a reconciliation of Net Loss to Net Loss Excluding Impairment Charges and Foreign Exchange Loss and Net Loss per Share Excluding Foreign Exchange Loss.
| Three Months Ended March 31 | |||||||
| 2024 |
| 2023 | |||||
| (Unaudited) (In 000’s except share and per share amounts) | |||||||
Net Loss | $ | (17,900 | ) | $ | (27,751 | ) | ||
Foreign exchange loss |
| 4,330 |
|
| 6,813 |
| ||
Net loss, excluding impairment charges and foreign exchange loss | $ | (13,570 | ) | $ | (20,938 | ) | ||
Weighted-average number of shares |
| 24,584,798 |
|
| 8,608,539 |
| ||
Net loss per share, excluding impairment charges and foreign exchange loss | $ | (0.55 | ) | $ | (2.43 | ) | ||
|
|
|
About PreHevbrio [Hepatitis B Vaccine (Recombinant)]
PreHevbrio is the only 3-antigen hepatitis B vaccine, comprised of the three surface antigens of the hepatitis B virus – Pre-S1, Pre-S2, and S. It is approved for use in the U.S., European Union/European Economic Area, United Kingdom, Canada, and Israel. The brand names for this vaccine are: PreHevbrio® (US/Canada), PreHevbri® (EU/EEA/UK), and Sci-B-Vac® (Israel).
Please visit www.PreHevbrio.com for U.S. Important Safety Information for PreHevbrio [Hepatitis B Vaccine (Recombinant)], or please see U.S. Full Prescribing Information.
U.S. Indication
PreHevbrio is indicated for prevention of infection caused by all known subtypes of hepatitis B virus. PreHevbrio is approved for use in adults 18 years of age and older.
U.S. Important Safety Information (ISI)
Do not administer PreHevbrio to individuals with a history of severe allergic reaction (e.g. anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component of PreHevbrio.
Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of PreHevbrio.
Immunocompromised persons, including those on immunosuppressant therapy, may have a diminished immune response to PreHevbrio.
PreHevbrio may not prevent hepatitis B infection, which has a long incubation period, in individuals who have an unrecognized hepatitis B infection at the time of vaccine administration.
The most common side effects (> 10%) in adults age 18-44, adults age 45-64, and adults age 65+ were pain and tenderness at the injection site, myalgia, fatigue, and headache.
There is a pregnancy exposure registry that monitors pregnancy outcomes in women who received PreHevbrio during pregnancy. Women who receive PreHevbrio during pregnancy are encouraged to contact 1-888-421-8808 (toll-free).
To report SUSPECTED ADVERSE REACTIONS, contact VBI Vaccines at 1-888-421-8808 (toll-free) or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.
Please see Full Prescribing Information.
About VBI Vaccines Inc.
VBI Vaccines Inc. (“VBI”) is a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease. Through its innovative approach to virus-like particles (“VLPs”), including a proprietary enveloped VLP (“eVLP”) platform technology and a proprietary mRNA-launched eVLP (“MLE”) platform technology, VBI develops vaccine candidates that mimic the natural presentation of viruses, designed to elicit the innate power of the human immune system. VBI is committed to targeting and overcoming significant infectious diseases, including hepatitis B, coronaviruses, and cytomegalovirus (CMV), as well as aggressive cancers including glioblastoma (GBM). VBI is headquartered in Cambridge, Massachusetts, with research operations in Ottawa, Canada, and a research and manufacturing site in Rehovot, Israel.
Website Home: http://www.vbivaccines.com/
News and Resources: http://www.vbivaccines.com/news-and-resources/
Investors: http://www.vbivaccines.com/investors/
Cautionary Statement on Forward-looking Information
Certain statements in this press release that are forward-looking and not statements of historical fact are forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and are forward-looking information within the meaning of Canadian securities laws (collectively, “forward-looking statements”). The Company cautions that such forward-looking statements involve risks and uncertainties that may materially affect the Company’s results of operations. Such forward-looking statements are based on the beliefs of management as well as assumptions made by and information currently available to management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including but not limited to, the Company’s ability to regain and maintain compliance with the listing standards of the Nasdaq Capital Market, the Company’s ability to satisfy all of the conditions to the consummation of the transactions with Brii Biosciences, the Company’s ability to comply with its obligations under its loan agreement with K2 HealthVentures, the impact of general economic, industry or political conditions in the United States or internationally; the impact of the COVID-19 endemic on our clinical studies, manufacturing, business plan, and the global economy; the ability to successfully manufacture and commercialize PreHevbrio/PreHevbri; the ability to establish that potential products are efficacious or safe in preclinical or clinical trials; the ability to establish or maintain collaborations on the development of pipeline candidates and the commercialization of PreHevbrio/PreHevbri; the ability to obtain appropriate or necessary regulatory approvals to market potential products; the ability to obtain future funding for developmental products and working capital and to obtain such funding on commercially reasonable terms; the Company’s ability to manufacture product candidates on a commercial scale or in collaborations with third parties; changes in the size and nature of competitors; the ability to retain key executives and scientists; and the ability to secure and enforce legal rights related to the Company’s products. A discussion of these and other factors, including risks and uncertainties with respect to the Company, is set forth in the Company’s filings with the SEC and the Canadian securities authorities, including its Annual Report on Form 10-K filed with the SEC on April 16, 2024, and filed with the Canadian security authorities at sedarplus.ca on April 16, 2024, as may be supplemented or amended by the Company’s Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Given these risks, uncertainties and factors, you are cautioned not to place undue reliance on such forward-looking statements, which are qualified in their entirety by this cautionary statement. All such forward-looking statements made herein are based on our current expectations and we undertake no duty or obligation to update or revise any forward-looking statements for any reason, except as required by law.
VBI Vaccines Inc. and Subsidiaries | |||||||
Selected Condensed Consolidated Balance Sheet | |||||||
(Unaudited, In Thousands) | |||||||
| Three Months Ended March 31 | ||||||
| 2024 |
| 2023 | ||||
| (Unaudited) (In 000’s except share and per share amounts) | ||||||
Assets |
|
| |||||
Cash | $ | 12,595 |
| $ | 23,685 | ||
Accounts receivable, net |
| 227 |
|
| - | ||
Inventory, net |
| 9,944 |
|
| 8,499 | ||
Prepaid expenses and other current assets |
| 3,595 |
|
| 4,047 | ||
Total current assets |
| 26,361 |
|
| 36,231 | ||
Property and equipment, net |
| 9,088 |
|
| 9,665 | ||
Intangible assets, net |
| 35,734 |
|
| 36,499 | ||
Goodwill |
| 1,107 |
|
| 1,130 | ||
Other non-current assets |
| 3,153 |
|
| 3,426 | ||
Total Assets | $ | 75,443 |
| $ | 86,951 | ||
|
|
| |||||
Liabilities and stockholders’ equity |
|
| |||||
Accounts payable | $ | 8,871 |
| $ | 6,431 | ||
Other current liabilities |
| 68,723 |
|
| 69,305 | ||
Total current liabilities |
| 77,594 |
|
| 75,736 | ||
Total non-current liabilities |
| 3,316 |
|
| 3,688 | ||
Total liabilities |
| 80,910 |
|
| 79,424 | ||
Total stockholders' equity |
| (5,467 | ) |
| 7,527 | ||
Total liabilities and stockholders' equity | $ | 75,443 |
| $ | 86,951 |
VBI Vaccines Inc. and Subsidiaries | ||||||||
Condensed Consolidated Statement of Operations and Comprehensive Loss | ||||||||
(Unaudited, In Thousands Except Share and Per Share Amounts) | ||||||||
| Three Months Ended March 31 | |||||||
| 2024 |
| 2023 | |||||
| (Unaudited) | |||||||
Revenues, net | $ | 1,214 |
| $ | 485 |
| ||
Operating expenses | ||||||||
Cost of revenues |
| 2,724 |
|
| 3,559 |
| ||
Research and development |
| 2,571 |
|
| 3,151 |
| ||
Sales, general, and administrative |
| 7,671 |
|
| 13,284 |
| ||
Total operating expenses |
| 12,966 |
|
| 19,994 |
| ||
Loss from operations |
| (11,752 | ) |
| (19,509 | ) | ||
Interest expense, net of interest income |
| (1,818 | ) |
| (1,429 | ) | ||
Foreign exchange loss |
| (4,330 | ) |
| (6,813 | ) | ||
Loss before income taxes |
| (17,900 | ) |
| (27,751 | ) | ||
Income tax benefit |
| - |
|
| - |
| ||
Net Loss | $ | (17,900 | ) | $ | (27,751 | ) | ||
Basic and diluted net loss per share | $ | (0.73 | ) | $ | (3.22 | ) | ||
Weighted-average number of shares used to compute basic and diluted net loss per share |
| 24,584,798 |
|
| 8,608,539 |
| ||
Other comprehensive income |
| 3,484 |
|
| 6,599 |
| ||
Comprehensive Loss | $ | (14,416 | ) | $ | (21,152 | ) |
Last Trade: | US$0.07 |
Daily Volume: | 0 |
Market Cap: | US$1.870M |
April 16, 2024 April 11, 2024 April 09, 2024 |
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