VBI Vaccines Inc/BC (Form: 8-K, Received: 03/10/2021 07:38:49)

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

Date of report (Date of earliest event reported): March 9, 2021

VBI VACCINES INC.

(Exact name of registrant as specified in its charter)

British Columbia, Canada

001-37769

N/A

(State or other jurisdiction

of incorporation)

(Commission

File Number)

(IRS Employer

Identification No.)

222 Third Street, Suite 2241

Cambridge, Massachusetts

02142

(Address of principal executive offices)

(Zip Code)

(617) 830-3031

(Registrant’s telephone number, including area code)

N/A

(Former Name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol(s)		Name of exchange on which registered
Common Shares, no par value per share		VBIV		The NASDAQ Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒

Item 1.01 Entry into a Material Definitive Agreement.

On March 9, 2021, Variation Biotechnologies Inc., a Canadian federal corporation and a wholly-owned subsidiary of VBI Vaccines Inc. (together with Variation Biotechnologies Inc., the “Company”) and the Coalition for Epidemic Preparedness Innovations (the “CEPI”) entered into a funding agreement (the “Agreement”), pursuant to which CEPI will provide up to $33 million to support the advancement of the Company’s enveloped virus like particle (“eVLP”) vaccine candidates against SARS-CoV-2 variants, including the B.1.351 variant first identified in South Africa. The Company is to use commercially reasonable efforts to undertake the development of such vaccine candidates.

CEPI will make payments to the Company in tranches covering the agreed-upon budget for six-month periods subject to certain conditions as set forth in the Agreement. The Company is entitled to submit its first payment request to CEPI upon execution of the Agreement. Payments to the Company under the Agreement will be made in U.S. dollars.

Pursuant the Agreement, during the COVID-19 pandemic and until the end of the pandemic period (as determined by the World Health Organization (“WHO”) and/or CEPI pursuant to the Agreement) (the “Pandemic Period”), subject to certain of the Company’s pre-existing agreements, the Company has agreed to offer for purchase by CEPI, the Gavi Vaccine Alliance (“Gavi”), or their respective designees a percentage of the Company’s capacity to produce the vaccines under the Agreement. The relevant percentage varies depending on the stage of vaccine development for which CEPI provides funding, ranging from preclinical to full approval and registration.

For a period lasting until the later of five years from the end of the Pandemic Period and ten years from the effective date of the Agreement, if CEPI determines (using reasonable discretion, in consultation with the Company) that a regional but not global outbreak exists, subject to certain of the Company’s pre-existing agreements, the Company will offer for purchase by CEPI, Gavi, or their respective designees a percentage of the quantity of vaccines equal to the percentage previously produced for CEPI, Gavi, or their respective designees as described above multiplied by the percentage of the world population residing in the region of the outbreak. In addition, during this same period, the Company has agreed to also continue to produce and supply vaccines under the Agreement for purchase by CEPI, Gavi, or their respective designees as they require to meet the needs of certain low and lower-middle income countries, in quantities to be agreed upon in an advance purchase agreement with the Company. The Company has agreed to negotiate such advance purchase agreement with CEPI, Gavi, or their respective designees, but is not bound by volume commitments other than with respect to any regional outbreak as described above.

The Company is required to supply vaccines under the Agreement to economies represented by the COVID-19 Global Vaccine Access Facility in a similar timeframe to other third-party customers. The Company is also required to provide information about production, supply, pricing, and sales of the vaccines under the Agreement sufficient for CEPI to evaluate the Company’s compliance with the Agreement.

Pursuant to the Agreement, the Company has agreed that its pricing will be as reasonably required to achieve equitable access for populations in need and an appropriate return on investment and to ensure that ongoing vaccine supply is commercially sustainable. In furtherance of this, the Company has agreed to limit the sale price of the vaccines covered by the Agreement during the Pandemic Period, and after the Pandemic Period for certain low and middle income countries, according to a formula and the economic circumstances of the country of allocation.

The Company and CEPI expect that Gavi or a respective designee will provide funding to purchase the vaccines covered by the Agreement. The Company will promptly respond to any request for proposal for a COVID-19 vaccine identified by Gavi, UNICEF, or CEPI, and the Company will negotiate in good faith with Gavi or a respective designee to sign a purchase commitment or order to supply such vaccines under the Agreement. Such negotiations will be guided by and reflect the principle that the Company will not suffer financial losses when supplying vaccines under the Agreement to any market and will also take into account the amount of funding provided by CEPI.

The Company and CEPI agreed on the importance of global equitable access to any vaccines produced pursuant to the Agreement. In consideration for the Company’s agreement to comply with the provisions of the Agreement concerning equitable access, including as described above, CEPI has agreed to forego any share of any commercial benefits derived from the vaccines under the Agreement during the Pandemic Period (e.g., sales of vaccines at market prices, commercial licensing of intellectual property). After the Pandemic Period (excluding any period of regional outbreak), the Company will notify CEPI of any commercial benefits from sales (other than in certain low or lower-middle income countries) of a vaccine under the Agreement for which CEPI has provided funding through Phase 2 clinical studies, and the Company and CEPI will discuss the sharing of such commercial benefits in good faith through an appropriate mechanism agreed in 90 days.

Pursuant to the Agreement, the Company has agreed that, due to the potentially limited nature of clinical trial subject pools in areas of outbreak, if WHO, CEPI, or a relevant regulatory authority determine that another product should be prioritized for clinic trials in a certain area over a vaccine covered by the Agreement, the Company will not unreasonably proceed with a clinical trial unless required to do so by a relevant regulatory authority or pre-existing agreement. The Company has also agreed not to unreasonably decline to participate in a Phase IIb or III clinical trials as requested and funded by WHO and/or CEPI to compare vaccines covered by the Agreement with other COVID-19 candidates, and, following any such participation, the Company will provide to CEPI a copy of the final study report.

The Company is to pursue the regulatory activities with Health Canada and/or FDA and/or EMA regarding the vaccine candidates subject to the Agreement in consultation with CEPI.

During the Term (as defined below), CEPI will have the first right (but not the obligation) to provide funding to the Company for any additional COVID-19 vaccine candidate that only contains SARS-CoV-2 antigens. If the Company identifies any such additional COVID-19 vaccine candidate, the Company will provide CEPI with notice and such relevant information as CEPI may request. If CEPI elects to provide funding support, the Company and CEPI will discuss in good faith and agree to the process for developing and deploying such additional COVID-19 vaccine candidate. Additionally, during the Term and for five years afterwards, CEPI may propose to discuss with the Company funding for an additional COVID-19 vaccine candidate or a project that could be used in respect of any unknown disease that could pose an increased health risk, as identified by CEPI or WHO.

Pursuant to the Agreement, the Company will retain ownership of its intellectual property owned or controlled throughout the term of the Agreement, subject to the rights of CEPI under the Agreement. The Company will also own any intellectual property invented by either the Company or CEPI in connection with the activities contemplated by the Agreement, as well as all tangible materials and results made or developed by or on behalf of the Company in connection with the Agreement.

Pursuant to the Agreement, the Company has granted to CEPI a worldwide, non-exclusive, irrevocable, fully paid up, royalty free public health license to all relevant intellectual property necessary to use the vaccines covered by the Agreement as part of the public health response to the COVID-19 outbreak and other coronavirus outbreaks, on the condition that CEPI may only exercise the rights granted under this public health license in the event that CEPI is not in material breach of the Agreement and one or more of the following events occurs: (i) the Company declines to participate in additional work or project expansion that CEPI has offered to fund, (ii) CEPI and the Company agree, in good faith, that the Company shall not be able to perform the activities under an agreed work package, (iii) the Company is in material breach of the Agreement or the equitable access plan and has not cured such breach within thirty (30) business days of notification of such breach by CEPI, unless otherwise mutually agreed in writing, or (iv) the Agreement is terminated by CEPI pursuant to clauses related to default, insolvency, unavailability to perform project activities, failure to satisfy payment criteria, or fraud.

Under the Agreement, if the Company (a) reasonably requires any additional future funding for the development, manufacture, and/or deployment of one of the vaccines covered by the Agreement, in addition to the funding to be provided by CEPI, or (b) receives any offer or indication of interest from a third party to provide funding support for the development, manufacture, and/or deployment of a vaccine covered by the Agreement, the Company must notify CEPI, and CEPI will have the first right (but not the obligation) to provide such further funding, in its sole discretion.

Under the Agreement, CEPI’s maximum aggregate liability to the Company arising out of the Agreement will not exceed the aggregate of the Company’s total work budget or CEPI’s insurance cover if it acquires the right to administer the vaccine under the Agreement for public health purposes, provided, however, that the liability of CEPI or the Company will not be limited with respect to (i) personal injury or death arising out of such party’s negligence or (ii) fraud, fraudulent misrepresentation, or intentional misconduct.

The Agreement will commence on March 9, 2021 (“Effective Date”) and will continue until the earlier of (i) five years after the Effective Date, (ii) the time that all activities in all work packages under the Agreement have been completed, and (iii) the termination of the Agreement (“Term”). The Company or CEPI can terminate the Agreement following an insolvency event or settlement or other material breach by the other party that is not cured within 30 business days. Pursuant to the Agreement, CEPI has certain discretionary termination rights, including if CEPI determines that the Company is involved in material safety, regulatory, scientific misconduct, or ethical issues or is no longer able to fulfill its obligations under the Agreement. Following termination by CEPI, the Company will use all reasonable endeavors, at CEPI’s cost, to provide CEPI with all relevant project materials, information, technology and data for CEPI’s use.

Neither CEPI nor the Company may assign its rights or obligations under the Agreement without the other party’s consent, provided that CEPI may do so to an organization of equivalent charitable mission and the Company may do so to an affiliate as part of a sale of the Company’s entire business.

The Agreement also contains provisions related to the parties’ agreement on access to various records, clinical trial protocols and management, publication of project data, and other compliance matters.

Item 8.01 Other Events.

On March 9, 2021, the Company issued a press release announcing the initiation of enrollment of its Phase 1/2 clinical study of VBI-2902, the Company’s monovalent eVLP COVID-19 vaccine candidate expressing the SARS-CoV-2 spike protein. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is hereby incorporated by reference herein.

On March 10, 2021, the Company issued a press release announcing the entry into the Agreement with CEPI. A copy of the press release is attached as Exhibit 99.2 to this Current Report on Form 8-K and is hereby incorporated by reference herein.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.		Description

99.1		Press Release dated March 9, 2021
99.2		Press Release dated March 10, 2021
104		Cover Page Interactive Data File (formatted as Inline XBRL)

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

	VBI Vaccines Inc.

Date: March 10, 2021	By:	/s/ Jeff Baxter
		Jeff Baxter
		President and Chief Executive Officer

Exhibit 99.1

VBI Vaccines Announces Initiation of Enrollment in Adaptive Phase 1/2 Study of
Prophylactic COVID-19 Vaccine Candidate, VBI-2902

-	Initial data from Phase 1 of the study expected by the end of Q2 2021, subject to rate of enrollment
-	Adaptive Phase 1/2 study supported by previously announced contribution from Strategic Innovation Fund of Canadian Government of up to CAD$56 million
-	Initiation of Phase 1/2 study of pan-coronavirus vaccine candidate, VBI-2901, anticipated later in 2021

OTTAWA, Ontario (March 9, 2021) – VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today announced the initiation of enrollment of its Phase 1/2 clinical study of VBI-2902, the Company’s monovalent enveloped virus-like particle (eVLP) COVID-19 vaccine candidate.

“We are excited to begin the clinical assessment of our eVLP approach to vaccination against coronaviruses with this first clinical study of VBI-2902,” said Jeff Baxter, President and CEO of VBI. “We are committed to bringing forward candidates that add meaningful clinical and medical benefit to those already approved – be it as a one-dose administration, more durable immune responses, and/or providing broader protection against known and emerging variants of COVID-19. We are grateful for the support of our Canadian partners at the Department of Innovation, Science and Economic Development, the National Research Council of Canada, and Resilience Biotechnologies. We look forward to sharing initial data from this study in the coming months.”

“Our Government is investing in a range of Made-in-Canada solutions to support our fight against COVID-19,” said François-Philippe Champagne, Canada’s Minister of Innovation, Science and Industry. “Today’s news is a welcome development, bringing VBI one step closer to delivering a safe and effective COVID-19 vaccine for Canadians. Through this investment, we continue to expand our toolbox to help fight this pandemic as well as future pandemics.”

Mitch Davis, President, National Research Council Canada, further commented, “The National Research Council of Canada and VBI Vaccines have a long-standing collaboration in research. Since March 2020, we have been working jointly with their research operations in Ottawa on activities for pre-clinical evaluation, optimization, and manufacturing process development of this COVID-19 vaccine candidate. We are very pleased to see this candidate reach the important milestone of human clinical trials.”

The adaptive Phase 1/2 clinical study is randomized, observer-blind, placebo-controlled, and will evaluate the safety, tolerability, and immunogenicity of VBI-2902, adjuvanted with aluminum phosphate. The Phase 1 portion of the study will evaluate a one- and two-dose regimen of a 5µg dose of VBI-2902, and is planned to enroll up to 60 healthy adults age 18-54. Contingent upon rate of enrollment, the initial data from Phase 1 of this study are expected by the end of Q2 2021. The Phase 2 portion of the study is expected to be a dose-escalation extension study, assessing one- and two-dose regimens, that will enroll an expanded adult population across three age cohorts: 18-54, 55-65, and 65+. The study will be conducted at nine clinical sites in Canada.

The execution of this adaptive Phase 1/2 study is supported by funding from the Strategic Innovation Fund of the Government of Canada. VBI’s coronavirus vaccine program is being developed at the Company’s research facilities in Ottawa, Canada, and with the National Research Council of Canada (NRC), a collaboration that was recently expanded to include additional joint research and development activities for pre-clinical evaluation, optimization of clinical candidates, and manufacturing scale-up.

About VBI’s Coronavirus Vaccine Program: VBI-2900

VBI-2900 consists of two enveloped virus-like particle (eVLP) vaccine candidates: (1) VBI-2901, a trivalent pan-coronavirus vaccine expressing the SARS-CoV-2, SARS-CoV, and MERS-CoV spike proteins, and (2) VBI-2902, a monovalent COVID-19-specific vaccine expressing the SARS-CoV-2 spike protein. The vaccine program was developed in collaboration with the National Research Council (NRC) beginning in early 2020, with promising preclinical data announced August 2020 enabling the selection of the two clinical candidates. Through their Strategic Innovation Fund, the Government of Canada has awarded VBI up to CAD$56 million to support clinical development through Phase 2 studies, to be paid as retrospective reimbursement for eligible expenses incurred.

The initial Phase 1/2 study of VBI-2902 initiated in March 2021. Work remains ongoing to further optimize and manufacture VBI-2901, with a Phase 1/2 study initiation anticipated later in 2021.

About Coronaviruses

Coronaviruses are a large family of enveloped viruses that usually cause respiratory illnesses of varying severity, including the common cold and pneumonia. Only seven coronaviruses are known to cause disease in humans, four of which most frequently cause symptoms of the common cold. Three of the seven coronaviruses, however, have more serious outcomes in people: (1) SARS-CoV-2, a novel coronavirus identified as the cause of coronavirus disease 2019 (COVID-19); (2) MERS-CoV, identified in 2012 as the cause of Middle East respiratory syndrome (MERS); and (3) SARS-CoV, identified in 2002 as the cause of an outbreak of severe acute respiratory syndrome (SARS).^1,2

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.

1.	“Coronavirus.” World Health Organization, https://www.who.int/health-topics/coronavirus.
2.	“Coronaviruses.” National Institute of Allergy and Infectious Diseases, https://www.niaid.nih.gov/diseases-conditions/coronaviruses

VBI Contact

Nicole Anderson

Director, Corporate Communications & IR

Phone: (617) 830-3031 x124

Email: IR@vbivaccines.com

Exhibit 99.2

CEPI and VBI Vaccines collaborate to advance vaccine candidates against COVID-19 variants

	●	Up to $33m of funding will support development of VBI’s enveloped virus-like particle (eVLP) vaccine candidates against COVID-19 variants of concern.

	●	Phase 1 clinical study of VBI’s eVLP vaccine candidate, VBI-2905, targeting the B.1.351 variant, anticipated to initiate mid-year 2021.

OSLO/CAMBRIDGE, Mass., 10 March 2021—CEPI, the Coalition for Epidemic Preparedness Innovations, and VBI Vaccines Inc. (Nasdaq: VBIV), today announced a partnership to develop VBI’s enveloped virus like particle (eVLP) vaccine candidates against SARS-CoV-2 variants, including the B.1.351 variant, also known as 501Y.V2, first identified in South Africa.

CEPI will provide up to $33m to support the advancement of VBI-2905, a monovalent eVLP candidate expressing the pre-fusion form of the spike protein from the B.1.351 strain, through Phase 1 clinical development. As part of the agreement, this funding will also support preclinical expansion of additional multivalent vaccine candidates designed to evaluate the potential breadth of VBI’s eVLP technology. This preclinical expansion is intended to develop clinic-ready vaccine candidates capable of addressing emerging variants.

Dr Richard Hatchett, CEO of CEPI, said:

“Remarkable progress has been made to develop safe and effective vaccines against COVID-19, but in parallel to the global roll out of vaccines we must now redouble our R&D efforts so we have the tools we need to tackle emerging variants of the virus. I am delighted that CEPI will support the development of VBI’s promising vaccine candidates against variants of concern, which crucially can be made globally accessible through COVAX if proven to be safe and effective.

“Today, CEPI also launches its 5-year plan to substantially reduce, and in the long-term even eliminate, the risk of epidemic and pandemic diseases, including coronaviruses. If we are to achieve this future, we must act now by investing in crucial R&D to optimise our vaccination strategies and technologies.”

Jeff Baxter, President and CEO of VBI, said:

“We are grateful for CEPI’s partnership, support, and confidence in our eVLP approach to vaccine development. We look forward to working with CEPI, who has played a crucial role in the development of COVID-19 vaccines over the last 12 months, and we remain steadfast in our mission to contribute to the end of the ongoing pandemic and the long-term protection against coronaviruses.”

VBI’s eVLP technology has been supported by investment from the Government of Canada, which is a long-standing and vital CEPI supporter and investor.

Karina Gould, Canadian Minister of International Development, said:

“Canada is deeply committed to its vaccine partnerships. The innovative collaboration announced today will help to ensure that millions will have access to safe vaccines against COVID-19 and future infectious disease threats.”

Race against viral mutation

CEPI is investing in the development of vaccines against COVID-19 variants to help the world to stay one step ahead of the virus.

The virus that causes COVID-19 is constantly mutating. Variant B.1.1.7 (first identified in the UK) is up to 70% more transmissible than the virus that emerged in Wuhan and has since been confirmed to be associated with an increased risk of hospitalisation and death. Variants B.1.351 and P.1 (identified in South Africa and Brazil, respectively) are even more concerning. They spread rapidly, can reinfect people who have been infected before, and they are rendering our countermeasures—including our vaccines and monoclonal-antibody treatments—less effective. The increased transmissibility of these variants could result in a reversal in the global downward trends in transmission seen in recent weeks resulting in a renewed burden on health systems, and more deaths.

Equitable access key to ending acute phase of pandemic

The rate of viral mutation is a function of the global spread of the virus, so it is imperative to control transmission everywhere. CEPI is therefore committed to enabling global equitable access to COVID-19 vaccines and, through this agreement, CEPI and VBI have agreed that the vaccine candidates supported by CEPI will be made available to the COVAX Facility for procurement and allocation, if proven to be safe and effective. The COVAX Facility aims to ensure equitable access to COVID-19 vaccines for all countries, at all levels of development, that wish to participate. To date, COVAX has delivered vaccines to over 30 countries, with the aim of distributing 2 billion doses globally in 2021.

VBI’s eVLP Coronavirus Vaccine Candidates

VBI Vaccines is advancing a suite of coronavirus vaccine candidates, under the VBI-2900 program, developed using the Company’s proprietary eVLP platform technology in collaboration with the National Research Council of Canada. Coronaviruses are enveloped by nature which make them a prime target for VBI’s eVLP platform technology. VBI’s eVLP technology is flexible and highly customizable, allowing for expression of multiple protein antigens of interest on the surface of the particles. eVLPs create a close mimic of the natural presentation of viruses and they carry multiple copies of the target protein, designed to trigger a potent immune response.

Through this partnership with CEPI, VBI will develop VBI-2905 through Phase 1, and additional multivalent candidates through preclinical studies. VBI and CEPI expect to initiate Phase 1 studies of VBI-2905 – the first eVLP-based vaccine candidate in the CEPI portfolio - mid-year 2021.

An adaptive Phase 1/2 study of VBI-2902 is already ongoing at nine clinical sites in Canada, having initiated earlier in March 2021, and is supported by a contribution from the Canadian Government’s Strategic Innovation Fund.

—END—

Notes to Editors

Preclinical Data from VBI’s eVLP Coronavirus Vaccine Candidates

Previous preclinical studies suggest the highly potent and immunogenic potential of the eVLP platform. In a series of preclinical studies of VBI-2902, a monovalent eVLP expressing the stabilized pre-fusion form of the SARS-CoV-2 spike protein, neutralizing antibody (nAb) geometric mean titers (GMT) elicited by the vaccine candidate registered 4x higher than the GMT of high-titer convalescent sera after one dose, increasing to 64x higher after two doses. Additionally, preclinical evaluation of VBI-2901, a trivalent eVLP candidate expressing the SARS-CoV-2, SARS-CoV (SARS), and MERS-CoV (MERS) spike proteins, showed the vaccine induced antibody titers to all three coronaviruses expressed in the vaccine, in addition to a seasonal human coronavirus, HCoV-OC43. Broadened reactivity to HCoV-OC43, a coronavirus not expressed in the vaccine candidate, suggests that VBI’s multivalent eVLPs may allow for the production of broadly reactive antibodies, which offer potential for protection from known and emerging variants of COVID-19.

CEPI’s $3.5 billion investment case – The Urgency of Now. Turning the tide against epidemic and pandemic infectious diseases

The full investment case, published today, may be accessed at www.endpandemics.cepi.net.

About CEPI

CEPI is an innovative partnership between public, private, philanthropic, and civil organisations, launched at Davos in 2017, to develop vaccines to stop future epidemics. CEPI has moved with great urgency and in coordination with WHO in response to the emergence of COVID-19. CEPI has initiated 12 partnerships to develop vaccines against the novel coronavirus. The programmes will leverage rapid response platforms already supported by CEPI as well as new partnerships. The aim is to advance COVID-19 vaccine candidates into clinical testing as quickly as possible.

Before the emergence of COVID-19 CEPI’s priority diseases included Ebola virus, Lassa virus, Middle East Respiratory Syndrome coronavirus, Nipah virus, Rift Valley Fever virus and Chikungunya virus. CEPI also invested in platform technologies that can be used for rapid vaccine and immunoprophylactic development against unknown pathogens (Disease X).

Follow our news page for the latest updates. Follow us on Twitter and LinkedIn.

About VBI Vaccines Inc

Website Home: http://www.vbivaccines.com/

News and Resources: http://www.vbivaccines.com/news-and-resources/

Investors: http://www.vbivaccines.com/investors/

About COVAX

COVAX is the vaccines pillar of the ACT-Accelerator. It is co-led by CEPI, Gavi, the Vaccine Alliance, and the World Health Organization (WHO) with lead delivery partner UNICEF, working in partnership with developed and developing country vaccine manufacturers, the World Bank, Civil Society Organisations and others. COVAX is the only global initiative that is working with governments and manufacturers to ensure COVID-19 vaccines are available worldwide to economies of all financial means.

Cautionary Statement on Forward-looking Information

Media Contacts

CEPI

Email: press@cepi.net

Phone: +44 7387 055214

VBI Vaccines Inc

Nicole Anderson

Director, Corporate Communications & IR

Email: IR@vbivaccines.com

Phone: (617) 830-3031 x124