IMV Inc. (the “Company” or “IMV”) (NASDAQ: IMV; TSX: IMV), a clinical-stage biopharmaceutical Company developing a portfolio of immune-educating therapies based on its novel DPX® platform to treat solid and hematologic cancers, announced today that the Nova Scotia Supreme Court (the “Court”) has issued an initial order (the “Initial Order”) granting the Company and its subsidiaries protection under the Companies’ Creditors Arrangement Act (R.S.C., 1985, c. C-36) (the “CCAA”). The Company will seek the recognition of the Initial Order in the United States by filing a petition commencing proceedings under the Chapter 15 of the United States Bankruptcy Code.
After a careful review of available options under our current search for strategic alternatives, and following thorough consultation with its legal and financial advisors, the Company’s Board of Directors determined that it was in the best interest of IMV and its stakeholders to file an application for creditor protection under the CCAA. As previously disclosed by the Company, despite the growing industry enthusiasm surrounding cancer vaccines and its encouraging clinical trial results, there are limited opportunities to raise additional capital in the current market conditions and IMV was unable to identify a suitable solution available in the near term.
“The decision to initiate CCAA proceedings was made keeping in mind the interest of all of our stakeholders and, in our view, was the best available option amidst a difficult market,” stated Andrew Hall, CEO of IMV Inc. “I sincerely regret the impact the restructuring of our business will have on our valued stakeholders. This has been an incredibly difficult decision, but a necessary one to ensure the best outcome for our promising technology and stakeholders.”
The Initial Order provides a stay of creditor claims and the exercise of contractual rights with a view to provide the Company some breathing room to continue its ongoing strategic review process under the oversight of the Board of Directors and with the advice of the Company’s professional advisors. In this regard, the Company anticipates that it will seek shortly the approval of the Court to initiate a formal sale and investment solicitation process intended to generate interest in either the business or the assets of the Company, or in a recapitalization of the Company, with the goal of implementing a transaction. A transaction may be in addition to, or as an alternative, to a CCAA plan of compromise or arrangement, to maximize return in respect of the Company’s business and assets. The Company hopes for an outcome that will allow its DPX delivery technology and associated lead asset, maveropepimut-S, to realize their full potential.
The Initial Order provides that the Company’s management remains responsible for the day-to-day operations of the Company and that the Board of Directors remains intact. The Company is committed to completing the restructuring process quickly and efficiently.
The Court has appointed FTI Consulting Canada Inc. to serve as the Monitor in the CCAA proceedings and to assist the Company with its restructuring efforts and report to the Court during the restructuring.
At this time, the Company expects that it will have sufficient funds to complete its CCAA proceedings and potential restructuring. The Company’s Dartmouth, Nova Scotia headquarters and laboratories remain open in a limited capacity and its clinical trials, including its phase 2b AVALON and VITALIZE trials will pause enrollment, pending the outcome of the review of strategic alternatives. IMV has sufficient drug supply to ensure that patients already in screening or enrolled in ongoing trials prior to May 1, 2023, will be able to receive their treatment.
Trading in the common shares of the Company on the Toronto Stock Exchange (the “TSX”) and the Nasdaq Capital Market (the “NASDAQ”) has been halted and it is anticipated that the trading thereof will continue to be halted until a review is undertaken by the TSX and NASDAQ regarding the suitability of the Company for listing on the TSX and NASDAQ.
Further news releases will be provided on an ongoing basis throughout the CCAA proceedings as required by law or otherwise as may be determined necessary by the Company or the Court. Documents relating to the restructuring process such as the Initial Order, the Monitor’s reports to the Court as well as other Court orders and documents shall also be published and made accessible on the Monitor’s website : http://cfcanada.fticonsulting.com/.
IMV Inc. is a clinical-stage biopharmaceutical company developing a novel class of cancer vaccines based on DPX®, our immune-educating technology platform. DPX is designed to inform a specific, coordinated and persistent anti-tumor immune response, improving the lives of patients with solid or hematological cancers. DPX can package a wide range of bioactive molecules in a single formulation to incite the tumor-killing function of multiple, distinct immune cell subtypes. IMV’s lead therapeutic candidate, maveropepimut-S (MVP-S), is a DPX-based cancer vaccine that delivers antigenic peptides from survivin, a well-recognized cancer antigen commonly overexpressed in advanced cancers. MVP-S also delivers an innate immune activator and a universal CD4 T cell helper peptide. Together, these elements are designed to foster maturation of antigen presenting cells as well as robust activation of CD8 T cell effector and memory function that drive a targeted, sustained immune response. In our clinical trials, MVP-S treatment has been well tolerated and has demonstrated favorable clinical outcomes in multiple cancer indications as well as the activation of a targeted and sustained, survivin-specific anti-tumor immune response. MVP-S is administered in very low doses approximately once every two months, which drives a persistent immune attack on tumor cells. MVP-S is currently being evaluated in Phase 2B clinical trials for advanced r/r Diffuse Large B Cell Lymphoma (DLBCL) and platinum resistant ovarian cancer. IMV is also developing a dual-targeted cancer vaccine candidate leveraging the DPX delivery platform, DPX-SurMAGE. This cancer vaccine combines antigenic peptides for both the survivin and MAGE-A9 cancer proteins to elicit immune responses to these two distinct cancer antigens simultaneously. For more information, visit https://www.imv-inc.com and connect with us on Twitter and LinkedIn.
IMV Forward-Looking Statements
This press release contains forward-looking information under applicable securities law. All information that addresses activities or developments that we expect to occur in the future is forward-looking information. Forward-looking statements use such word as “will”, “may”, “potential”, “believe”, “expect”, “continue”, “anticipate” and other similar terminology. Forward-looking statements are based on the estimates and opinions of management on the date the statements are made. In the press release, such forward-looking statements include, but are not limited to, statements relating to: (i) the outcome of the CCAA proceedings, (ii) the obtaining of the approval of the Court to initiate a formal sale and investment solicitation process to secure additional financing, sell assets, or a combination thereof, (iii) the ability of the Company to secure additional financing or otherwise enter into a transaction, and (iv) halt trading of the common shares and review of the TSX and NASDAQ regarding the suitability of the Company for listing on the TSX and NASDAQ and any outcome of such review. However, they should not be regarded as a representation that any of the plans will be achieved. Actual results may differ materially from those set forth in this press release due to risks affecting the Company, including the outcome of the CCAA proceedings and the capacity of the Company to enter into a transaction that would allow the Company to pursue its activities as a going concern, the continued listing of its common shares on a stock exchange as well as access to additional capital, the successful completion of ongoing clinical trials and the timely receipt of all regulatory approvals to commence, and then continue, clinical studies and trials and the receipt of all regulatory approvals to commercialize its products. IMV assumes no responsibility to update forward-looking statements in this press release except as required by law. These forward-looking statements involve known and unknown risks and uncertainties, and those risks and uncertainties include, but are not limited to, the ability to access capital, the successful and, generally, the timely completion of clinical trials and studies and the receipt of all regulatory approvals as well as other risks detailed from time to time in our ongoing quarterly filings and annual information form. Investors are cautioned not to rely on these forward-looking statements and are encouraged to read IMV’s continuous disclosure documents, including its current annual information form, as well as its audited annual consolidated financial statements which are available on SEDAR at http://www.sedar.com and on EDGAR at http://www.sec.gov/edgar.
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