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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): July 30, 2024

 

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.)

 

160 Second Street, Floor 3

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 1.03Bankruptcy or Receivership

 

On August 2, 2024, the United States Bankruptcy Court for the District of Delaware granted provisional relief under Chapter 15 of the U.S. Bankruptcy Code, and scheduled a further hearing to consider the recognition of the July 30, 2024, Ontario Superior Court of Justice (Commercial List) order, which granted VBI Vaccines Inc. (the “Company”) protection under the Companies’ Creditors Arrangement Act, R.S.C. 1985, c. C-36, as amended.

 

Item 3.01Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard; Transfer of Listing

 

On July 30, 2024, the Company received a letter (the “Delisting Notice”) from the listing qualifications department staff (the “Staff”) of the Nasdaq Stock Market LLC (“Nasdaq”) notifying the Company that in accordance with Nasdaq Listing Rules 5101, 5110(b), and IM-5101-1, the Staff has determined that the Company’s common shares, no par value per share (the “Common Shares”), will be delisted from Nasdaq. The Company does not intend to appeal the Staff’s delisting determination. As a result of the Delisting Notice, trading of the Common Shares will be suspended at the opening of business on August 8, 2024, and Nasdaq will file a Form 25-NSE with the Securities and Exchange Commission (“SEC”), which will remove the Common Shares from listing and registration on Nasdaq. Nasdaq has not specified a date on which the Form 25-NSE will be filed.

 

In the Delisting Notice, the Staff stated that its determination is based on several factors, including (i) the Company’s intention to commence a case under Chapter 15 of the United States Bankruptcy Code (the “Bankruptcy Code”) to seek recognition of the initial order granting the company protection under the Companies’ Creditors Arrangement Act, R.S.C. 1985, c. C-36, as amended (the “CCAA”) and the public concerns raised by such filing, (ii) concerns regarding the residual equity interest of the existing listed securities holders, and (iii) concerns about the Company’s ability to sustain compliance with all requirements for continued listing on Nasdaq, including the Company’s ongoing noncompliance with the minimum stockholders’ equity requirement pursuant to Nasdaq Listing Rule 5550(b)(1) and the minimum bid price requirement pursuant to Nasdaq Listing Rule 5550(a)(2). As previously disclosed, on May 24, 2024, the Company received a notification from the Staff indicating that the Company no longer satisfies Nasdaq Listing Rule 5550(b)(1), and on November 1, 2023, the Company received a notification from the Staff indicating that the Company no longer satisfies Nasdaq Listing Rule 5550(a)(2).

 

As previously disclosed, on July 30, 2024, after considering all strategic alternatives following consultation with its legal and financial advisors, the Company and its subsidiaries commenced voluntary restructuring under the jurisdiction of the Ontario Superior Court of Justice (Commercial List) pursuant to the CCAA. In connection with these proceedings, the Company and certain of its subsidiaries commenced a case under Chapter 15 of the Bankruptcy Code under the jurisdiction of the U.S. Bankruptcy Court for the District of Delaware and intend to do so as well under the relevant provisions of the Israeli Insolvency and Economic Rehabilitation Law, 2018 (“Israeli Insolvency Law”).

 

The Company expects to cease reporting as a public reporting company. The Company has not arranged for listing or registration, and does not currently intend to arrange for listing or registration, of its Common Shares on another national securities exchange or for quotation in a quotation medium.

 

Item 8.01Other Events

 

On August 2, 2024, the Company issued a press release announcing the U.S. Order and the receipt of the Delisting Notice. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein.

 

 
 

 

Cautionary Information Regarding Trading in the Company’s Securities

 

The Company cautions that trading in the Company’s securities during the pendency of the restructuring proceedings is highly speculative and poses substantial risks. Trading prices for the Company’s securities may bear little or no relationship to the actual value realized, if any, by holders of the Company’s securities in the restructuring proceedings. Accordingly, the Company urges extreme caution with respect to existing and future investments in its securities.

 

Forward-Looking Statements

 

This Current Report on Form 8-K contains “forward-looking statements” within the meaning of the safe harbor provisions of Section 27A of the Securities Act and Section 21E of the Exchange Act and “forward-looking information” within the meaning of applicable Canadian securities legislation (collectively, “forward-looking statements”). Forward-looking statements are not statements of historical facts and often contain words such as “may,” “will,” “expect,” “believe,” “anticipate,” “plan,” “estimate,” “seek,” “could,” “should,” “intend,” “potential,” or words of similar meaning. Forward-looking statements are based on management’s current expectations, beliefs, assumptions and estimates regarding the company, industry, economic conditions, government regulations and other factors. Forward-looking statements may include, for example, statements regarding the timing, manner, outcome and impact of the restructuring proceedings, and other statements regarding the Company’s plans, strategies, prospects and expectations concerning the Company’s business, operating results, financial condition, liquidity and other matters that do not relate strictly to historical facts. These statements are subject to significant risks, uncertainties, and assumptions that are difficult to predict and could cause actual results to differ materially and adversely from those expressed or implied in the forward-looking statements, including risks and uncertainties regarding the Company’s ability to successfully complete a sale process under Chapter 15 and/or the CCAA and/or Israeli Insolvency Law; potential adverse effects of the restructuring proceedings on the Company’s liquidity and results of operations; the Company’s ability to obtain timely approval by the applicable courts with respect to the motions filed in the restructuring proceedings; objections to the Company’s sale process, the Debtor-In-Possession facility (“DIP Facility”) Facility, or other pleadings filed that could protract the restructuring proceedings; employee attrition and the Company’s ability to retain senior management and other key personnel due to the distractions and uncertainties, including the Company’s ability to provide adequate compensation and benefits during restructuring proceedings; the Company’s ability to comply with the restrictions imposed by the DIP Facility and other financing arrangements; the Company’s ability to maintain relationships with suppliers, customers, employees and other third parties and regulatory authorities as a result of the Chapter 15, CCAA filings, and proceedings under the Israeli Insolvency Law; the applicable rulings in the restructuring proceedings, including the approval of the DIP Facility, and the outcome of the restructuring proceedings generally; the length of time that the Company will operate under Chapter 15, CCAA protection, and protection under Israeli Insolvency Law and the continued availability of operating capital during the pendency of the proceedings; risks associated with third party motions in the restructuring proceedings, which may interfere with the Company’s ability to consummate a sale; and increased administrative and legal costs related to the Chapter 15, the CCAA proceedings, proceedings under Israeli Insolvency Law, and other litigation and inherent risks involved in a bankruptcy process. Forward-looking statements are also subject to the risk factors and cautionary language described from time to time in the reports the Company files with the SEC, including those in “Item 1A - Risk Factors” in the Company’s most recent Annual Report on Form 10-K and any updates thereto in the Company’s Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Additional factors, events, or uncertainties that may emerge from time to time, or those that the Company currently deems to be immaterial, could cause the Company’s actual results to differ, and it is not possible for the Company to predict all of them. The Company makes forward-looking statements based on currently available information, and the Company assumes no obligation to, and expressly disclaim any obligation to, update or revise publicly any forward-looking statements made in this Current Report on Form 8-K, whether as a result of new information, future events or otherwise, except as required by law.

 

Item 9.01Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit No.   Description
     
99.1   Press Release, dated August 2, 2024
104   Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

 
 

 

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: August 2, 2024 By: /s/ Jeffrey R. Baxter
    Jeffrey R. Baxter
    President and Chief Executive Officer

 

 

 

Exhibit 99.1

 

 

VBI Vaccines Provides an Update on its Restructuring Proceedings

 

CAMBRIDGE, Mass. (August 2, 2024) – VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, today provided an update on the restructuring proceedings announced on July 30, 2024.

 

U.S. Chapter 15 Filing

 

On August 2, 2024, the United States Bankruptcy Court for the District of Delaware granted provisional relief under Chapter 15 of the U.S. Bankruptcy Code, and scheduled a further hearing to consider the recognition of the July 30, 2024, Ontario Superior Court of Justice (Commercial List) order (“Initial Order”), which granted the company protection under the Companies’ Creditors Arrangement Act, R.S.C. 1985, c. C-36, as amended (“CCAA”).

 

NASDAQ Listing

 

On July 30, 2024, the Company received a letter from the listing qualifications department staff of the Nasdaq Stock Market LLC (“Nasdaq”) notifying the Company that its common shares will be delisted from Nasdaq effective as of opening of business on August 8, 2024. The Company does not intend to appeal the delisting determination.

 

Stikeman Elliott LLP, Haynes and Boone, LLP, Morris, Nicols, Arsht & Tunnell LLP, and Pearl Cohen Zedek Latzer Baratz are acting as legal advisors to VBI. As previously announced, Ernst & Young Inc. (“EY”) has been appointed as Monitor in the CCAA proceedings and the proposed sale and investment solicitation process (“SISP”).

 

Additional information regarding the CCAA proceeding can be found on the Monitor’s website here, or by contacting the Monitor at vbi.monitor@ca.ey.com or 1-888-338-1764. Additional information regarding the Chapter 15 Case can be found here.

 

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, risks and uncertainties regarding the Company’s ability to successfully complete a sale process under Chapter 15 and/or the CCAA and/or Israeli Insolvency Law; potential adverse effects of the Restructuring Proceedings on the Company’s liquidity and results of operations; the Company’s ability to obtain timely approval by the applicable courts in Canada, US, and Israel, with respect to the motions filed in or in connection with the Restructuring Proceedings; objections to the Company’s sale process, the DIP Loan, or other pleadings filed that could protract the restructuring proceedings; employee attrition and the Company’s ability to retain senior management and other key personnel due to the distractions and uncertainties, including the Company’s ability to provide adequate compensation and benefits during the Restructuring Proceedings; the Company’s ability to comply with the restrictions imposed by the DIP Loan and other financing arrangements; the Company’s ability to maintain relationships with suppliers, customers, employees and other third parties and regulatory authorities as a result of the Chapter 15, CCAA filings, and proceedings under the Israeli Insolvency Law; the applicable rulings in the Restructuring Proceedings, including the approval of the DIP Loan, and the outcome of the Restructuring Proceedings generally; the length of time that the Company will operate under Chapter 15, CCAA protection, and protection under the Israeli Insolvency Law, and the continued availability of operating capital during the pendency of the proceedings; risks associated with third party motions in the Restructuring Proceedings and/or under Israeli Insolvency Law, which may interfere with the Company’s ability to consummate a sale; and increased administrative and legal costs related to the Chapter 15, the CCAA proceedings, and proceedings under Israeli Insolvency Law, and other litigation and inherent risks involved in a bankruptcy process, 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 and continuing effects of the COVID-19 epidemic 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 sedarplus.ca 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.

 

VBI Contact

Email: IR@vbivaccines.com

 

   

 

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