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Share Name | Share Symbol | Market | Type |
---|---|---|---|
VBI Vaccines Inc | NASDAQ:VBIV | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
-0.0097 | -1.48% | 0.6473 | 0.6301 | 0.65 | 0.6473 | 0.6473 | 0.6473 | 8,803 | 14:31:38 |
VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced financial results for the fourth quarter and twelve months ended December 31, 2020. The Company also provided a corporate update and its outlook for 2021.
Annual Note from Jeff Baxter, President and CEO:
“2020 was, unfortunately, a historic year, marked by unprecedented disruption, with severe public health, societal, and economic consequence. Every single person, worldwide, felt the devastating effects of the ongoing COVID-19 pandemic. Industries and companies went through extraordinary change and, amidst the temporary adjustments, new normals were established. The impact of this pandemic is likely to be felt for years, if not decades, to come.
The events of 2020 led to impressive collaboration, progress, and transformation across the biotechnology industry, governments, and foundations. We added two new vaccine candidates to our pipeline in 2020 – a multivalent pan-coronavirus vaccine candidate, VBI-2901, and a monovalent COVID-19 vaccine candidate, VBI-2902. To support the advancement of these candidates, we received an award from the Strategic Innovation Fund of the Government of Canada and partnered with both the National Research Council of Canada (NRC), Canada’s largest federal R&D organization, and Resilience Biotechnologies, a Contract Development and Manufacturing Organization. The preclinical results of these two candidates continue to excite us and we are working hard to get these candidates into the clinic in forms that are optimized both for clinical outcome and long-term commercial viability. We recognize the possibility that COVID-19, in some form, may be here to stay, especially with the recent emergence of additional variants, and we are committed to the long-term control of known and emerging coronaviruses.
Our 2020 achievements and progress, however, extend well beyond our coronavirus programs. We successfully completed the pivotal Phase 3 program for our 3-antigen prophylactic hepatitis B (HBV) vaccine candidate and submitted applications for approval in the U.S. and Europe. We believe this vaccine candidate has the potential to be a meaningful intervention for adults in the fight against HBV and we look forward to working with both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) throughout 2021 as they conduct their review.
In addition to the advancement of these prophylactic vaccine candidates, we continue to see meaningful data generated by the clinical studies of our therapeutic vaccine candidates targeting both chronic HBV infection, VBI-2601, and recurrent glioblastoma (GBM), VBI-1901. With both of these candidates, we are seeking to address diseases that are challenging and aggressive, with few, if any, effective treatment options available to patients. Based on the positive data seen to-date, we and our partners expect to initiate subsequent clinical studies in both indications in 2021.
These achievements are a result of the continued hard work, dedication, and flexibility of every member of the VBI team. Our team remains united across the US, Canada, and Israel in our mission to protect and enhance human life, and we thank our shareholders and partners for their support. With $119.1 million in cash, cash-equivalents, and short-term investments on-hand at the end of 2020, we entered 2021 well-positioned to achieve meaningful milestones across all of our lead pipeline programs over the next 12 months, and beyond.”
Second Half 2020 Key Program Achievements and Projected Upcoming Milestones
3-Antigen Hepatitis B Vaccine Candidate
VBI-2900: Coronavirus Vaccine Program
VBI-2601 (BRII-179): HBV Immunotherapeutic Candidate
VBI-1901: Cancer Vaccine Immunotherapeutic Candidate
Financing
Financial Results for the Three and Twelve Months Ended December 2020
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, 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 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 impact of general economic, industry or political conditions in the United States or internationally; the impact of the ongoing COVID-19 pandemic on our clinical studies, manufacturing, business plan, and the global economy; 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 therapeutic candidates; the ability to obtain appropriate or necessary governmental 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 March 2, 2021, and filed with the Canadian security authorities at sedar.com on March 2, 2021, as may be supplemented or amended by the Company’s Quarterly Reports on Form 10-Q. 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)
December 31, 2020
December 31, 2019
Assets
Cash and cash equivalents
$
93,825
$
44,213
Short-term investments
25,276
-
Accounts receivable, net
77
201
Inventory, net
2,152
1,075
Prepaid expenses and other current assets
10,711
1,474
Total current assets
132,041
46,963
Property and equipment, net
10,721
10,195
Intangible assets, net
62,156
60,756
Goodwill
2,261
2,208
Other non-current assets
2,193
2,079
Total Assets
$
209,372
$
122,201
Liabilities and stockholder’s equity
Accounts payable
$
3,734
$
1,127
Other current liabilities
12,415
12,261
Deferred revenues
255
882
Current portion of lease liability
944
642
Current portion of long-term debt
-
14,845
Total current liabilities
17,348
29,757
Total non-current liabilities
20,319
4,189
Total liabilities
37,667
33,946
Total stockholders' equity
171,705
88,255
Total liabilities and stockholders' equity
$
209,372
$
122,201
VBI Vaccines Inc. and Subsidiaries
Condensed Consolidated Statement of Operations and Comprehensive Loss
(Unaudited, in Thousands Except Share and Per Share Amounts)
For the Years Ended December 31
2020
2019
Revenues
$
1,061
$
2,221
Operating expenses
Cost of revenue
9,168
7,904
Research and development
14,859
26,332
General and administrative
20,651
14,092
Impairment charges
-
6,292
Total operating expenses
44,678
54,620
Loss from operations
(43,617
)
(52,399
)
Interest (expense), net
(2,708
)
(2,196
)
Foreign exchange gain (loss)
95
(218
)
Loss before income taxes
(46,230
)
(54,813
)
Income tax benefit
-
-
Net Loss
$
(46,230
)
$
(54,813
)
Basic and diluted net loss per share
$
(0.21
)
$
(0.46
)
Weighted-average number of shares used to compute basic and diluted net loss per share
218,268,979
119,446,377
Other comprehensive income (loss) - currency translation adjustments
2,017
3,406
Comprehensive Loss
$
(44,213
)
$
(51,407
)
View source version on businesswire.com: https://www.businesswire.com/news/home/20210302005285/en/
VBI Contact Nicole Anderson Director, Corporate Communications & IR Phone: (617) 830-3031 x124 Email: IR@vbivaccines.com
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