VBI Announces Agreement to Sell Manufacturing Capabilities, Certain Related Assets, and Enter Into New License Agreement with Brii Biosciences

Rhea-AI Summary

VBI Vaccines Inc. (VBIV) announced agreements with Brii Biosciences for up to $33 million in consideration, involving the acquisition of intellectual property, manufacturing capabilities, and exclusive licensing for immunotherapeutic candidates. The deal aims to reduce VBI's debt and enhance financial stability.

Insights

Financial Analyst

The transaction between VBI Vaccines Inc. and Brii Biosciences is poised to have a substantial impact on VBI's financial health. The infusion of up to $33 million in consideration is significant, given that it is tied to the transfer of manufacturing capabilities, intellectual property and regional licensing rights. This deal could potentially alleviate VBI’s financial strain by reducing its total debt principal to $17 million. The reduction in long-term burn and debt overhang is a strategic move that may enhance VBI's ability to invest in its pipeline and could positively influence investor confidence.

Furthermore, the licensing of VBI-1901 in the APAC region could open up new revenue streams and increase the company's market presence in a high-growth territory. However, the actual financial benefit hinges on the achievement of certain milestones, which introduces a degree of uncertainty. Investors should monitor the progress of these milestones closely as they will directly influence the financial outcomes of the deal.

Medical Research Analyst

The intellectual property transaction for VBI-2601, an immunotherapeutic candidate for hepatitis B and the licensing of VBI-1901 for glioblastoma in the Asia Pacific region are critical moves for VBI's therapeutic pipeline. The focus on immunotherapeutics is timely, as this area of medicine is rapidly expanding and there is a high unmet need for innovative treatments in diseases like HBV and GBM. The transfer of this IP and the exclusive licensing deal could accelerate the development and commercialization of these candidates in a region with a significant patient population.

However, the success of these candidates in clinical trials and subsequent regulatory approval will be a determining factor for the long-term impact of this transaction. Stakeholders should consider not only the financial implications but also the clinical progress of these candidates when evaluating the potential benefits of the deal.

Market Research Analyst

The strategic decision by VBI to divest certain assets and focus on core capabilities reflects a broader industry trend where biopharmaceutical companies streamline operations to optimize resource allocation. By transferring manufacturing facilities and technology to Brii Bio, VBI may benefit from reduced operational costs and increased efficiency. This could improve their competitiveness in the biopharmaceutical market.

Additionally, the APAC region is a burgeoning market for healthcare and pharmaceuticals, with increasing demand for innovative treatments. The exclusive license agreement for VBI-1901 in this region, excluding Japan, positions VBI to capitalize on market growth. However, it is essential to acknowledge the competitive landscape and regulatory challenges within the APAC region that could influence the success of VBI's commercialization efforts.

• VBI to receive up to $33 million in consideration, subject to achievement of certain activities, for:
  • VBI’s manufacturing capabilities and certain related assets at Rehovot manufacturing facility
  • Intellectual property for VBI-2601, VBI’s hepatitis B immunotherapeutic candidate
  • Exclusive Asia Pacific (APAC), excluding Japan, license for development and commercialization of VBI-1901, VBI’s glioblastoma immunotherapeutic candidate
• Following completion of the full transaction, VBI expects its total debt principal under its current facility with K2 HealthVentures to be significantly reduced to $17 million

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- VBI Vaccines Inc. (Nasdaq: VBIV) (“VBI” or the “Company”), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced agreements whereby Brii Biosciences (“Brii Bio”), subject to certain activities, is expected to: (i) acquire the intellectual property for VBI-2601, VBI’s HBV immunotherapeutic development program, and eliminate payment obligations from the July 2023 agreements between VBI and Brii Bio, (ii) acquire manufacturing capabilities and certain related assets at VBI’s Rehovot, Israel manufacturing facility, and (iii) enter into an exclusive license to develop and commercialize VBI-1901, VBI’s glioblastoma (GBM) immunotherapeutic candidate, in the Asia Pacific region (APAC), excluding Japan. Additionally, subject to certain approvals, VBI and Brii Bio will work together to transfer the manufacturing technologies of VBI-2601 to a site designated by Brii Bio. VBI received $2.5 million of consideration upon signing of definitive documents and is expected to receive up to an additional $30.5 million of consideration, subject to achievement of certain activities, with a target completion date of June 30, 2024.

Jeff Baxter, President and CEO of VBI, stated: “We believe that this transaction improves the financial stability of VBI and balances the potential value creation within our development and commercial portfolio with a streamlined and focused resource deployment. Upon successful completion of all transactions, we anticipate that we will have reduced the long-term burn of the company, and reduced our debt overhang by about 70%. We remain steadfast in our belief that our pipeline can have a meaningful impact on patients, providers, and public health, and we believe this deal better positions us to deliver on this mission.”

The proceeds from these agreements will be used for reduction of debt under the Company’s current facility with K2 HealthVentures.

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 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 satisfy all of the conditions to the consummation of the transactions with Brii described above, 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 pandemic and the continuing effects of the COVID-19 pandemic 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 March 13, 2023, and filed with the Canadian security authorities at sedar.com on March 13, 2023, 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240214531599/en/

VBI

Nicole Anderson

Director, Corporate Communications & IR

Phone: (617) 830-3031 x124

Email: IR@vbivaccines.com

Source: VBI Vaccines Inc.

FAQ

What is the total consideration VBI is set to receive?

VBI is expected to receive up to $33 million in consideration.

What assets are involved in the agreements between VBI and Brii Biosciences?

The agreements include VBI's manufacturing capabilities, certain related assets at the Rehovot facility, and the intellectual property for VBI-2601 and VBI-1901.

What is the purpose of the exclusive license granted to Brii Biosciences?

Brii Biosciences has been granted an exclusive license to develop and commercialize VBI-1901, VBI's glioblastoma immunotherapeutic candidate, in the Asia Pacific region (APAC), excluding Japan.

How will the transaction impact VBI's debt?

Upon completion, VBI expects its total debt principal under the current facility with K2 HealthVentures to be significantly reduced to $17 million.

What is the target completion date for the additional consideration VBI is expected to receive?

The target completion date for the additional $30.5 million of consideration is June 30, 2024.