IMV Inc. (IMV) News

IMV Strengthens Its Financial Position With the $US10 Million Drawdown From Its Existing Long-Term Debt Facility

Wed, 22 Jun 2022 07:05:00 -0400

IMV achieves predetermined milestone to access the remaining $US10 Million under its Debt Facility with Horizon

Phase 2b AVALON trial in platinum-resistant ovarian cancer open for enrollment

DARTMOUTH, Nova Scotia & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- IMV Inc. (NASDAQ: IMV; TSX: IMV), a clinical-stage company developing a portfolio of immune-educating therapies based on its novel DPX^® platform to treat solid and hematologic cancers, today announced the drawdown of the remaining US$10 million available under its existing US$25 million debt facility led by Horizon Technology Finance Corporation (Nasdaq: HRZN) ("Horizon"). This drawdown has been made available as the Company achieved a predetermined milestone following site activation in its Phase 2b AVALON trial in platinum-resistant ovarian cancer.

“The execution of our clinical team to launch the AVALON trial has permitted us to access this capital in a timely manner,” said Andrew Hall, Chief Executive Officer of IMV. “Our balance sheet has been strengthened by this debt facility. It provides operating cash into the second quarter of 2023, as per our current business plan, to continue to advance the development of our lead compound in Diffuse Large B-Cell Lymphoma (DLBCL) and ovarian cancer, while building incremental value through our DPX technology platform.”

“Horizon is pleased to continue supporting IMV as the company makes important progress with the AVALON trial,” said Gerald A. Michaud, President of Horizon. “We believe in IMV’s mission of building a new class of effective cancer immunotherapies that preserve patients’ quality of life.”

US$15 million of the US$25 million facility was already drawn down in December 2021, of which CAD$4.5 million was used to pay off IMV’s existing term loan with the government of Nova Scotia. The remaining proceeds from this facility are being used to support the ongoing clinical development of key investigational product candidates within IMV’s pipeline and for general working capital purposes.

In connection with this financing, IMV has agreed to issue warrants (the “Loan Warrants”) to purchase up to 568,180 common shares of the Company (the “Shares”) at an exercise price of US$1.32 per Share until December 17, 2031. 454,544 Loan Warrants were issued on December 17, 2021, and the balance of 113,636 Loan Warrants have been issued in connection with the drawdown of the additional US$10 million available under this facility. The Loan Warrants and the Shares issuable upon exercise thereof will be subject to a statutory hold period of four months following the issuance of the Loan Warrants in accordance with applicable securities laws. For the purpose of Toronto Stock Exchange (“TSX”) approval, the Company is relying on the exemption set forth in Section 602.1 of the TSX Company Manual, which provides that the TSX will not apply its standards to certain transactions involving eligible interlisted issuers on a recognized exchange, such as NASDAQ, provided that the transaction is being completed in compliance with the requirements of such other recognized exchange.

The securities offered have not been and will not be registered under the U.S. Securities Act of 1933, as amended (the “U.S. Securities Act”), or any state securities laws, and may not be offered or sold to, or for the account or benefit of, persons in the United States or U.S. persons (as such term is defined in Regulation S under the U.S. Securities Act) absent registration under the U.S. Securities Act and all applicable state securities laws, or compliance with an exemption from such registration requirements. This press release shall not constitute an offer to sell, or the solicitation of an offer to buy, nor shall there be any sale of the securities in any jurisdiction in which such offer, solicitation or sale would be unlawful.

About IMV

IMV Inc. is a clinical-stage immuno-oncology company advancing a portfolio of therapies based on the Company’s immune-educating platform: the DPX® technology. Through a differentiated mechanism of action, the DPX platform delivers instruction to the immune system to generate a specific, robust, and persistent immune response. IMV’s lead candidate, maveropepimut-S (MVP-S), delivers antigenic peptides from survivin, a well-recognized cancer antigen commonly overexpressed in advanced cancers. MVP-S also delivers an innate immunity activator and a universal CD4 T cell helper peptide. These elements foster maturation of antigen presenting cells as well as robust activation of CD8 T cell effector and memory function. MVP-S treatment has been well tolerated and has demonstrated defined clinical benefit in multiple cancer indications as well as the activation of a targeted and sustained, survivin-specific anti-tumor immune response. MVP-S is currently being evaluated in clinical trials for hematologic and solid cancers, including Diffuse Large B Cell Lymphoma (DLBCL) as well as ovarian, bladder and breast cancers. IMV is also developing a second immunotherapy leveraging the DPX immune delivery platform, DPX-SurMAGE. This dual-targeted immunotherapy combines antigenic peptides for both the survivin and MAGE-A9 cancer proteins to elicit immune responses to these two distinct cancer antigens simultaneously. A Phase 1 clinical trial in bladder cancer was initiated in early 2022. For more information, visit www.imv-inc.com and connect with us on Twitter and LinkedIn.

About Horizon Technology Finance

Horizon Technology Finance Corporation (NASDAQ: HRZN) is a leading specialty finance company that provides capital in the form of secured loans to venture capital backed companies in the technology, life science, healthcare information and services, and sustainability industries. The investment objective of Horizon is to maximize its investment portfolio’s return by generating current income from the debt investments it makes and capital appreciation from the warrants it receives when making such debt investments. Headquartered in Farmington, Connecticut, Horizon also has regional offices in Pleasanton, California and Reston, Virginia. To learn more, please visit horizontechfinance.com.

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 regarding the potential impact of the Company’s current cash operating position and the Company’s ability to advance its development strategy, as well as the prospects, for its lead immunotherapy and its other pipeline of immunotherapy candidates. 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 access to capital, the successful design and completion of 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 Inc. 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, those related to the Company’s business plan and expected timeline associated with its cash runway; the Company’s priorities with MVP-S and its DPX delivery platform, the potential for its delivery platform and the anticipated timing of enrollment and results for its clinical trial programs and studies as others 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 www.sedar.com and on EDGAR at www.sec.gov/edgar.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220622005356/en/

Investor Relations
Irina Koffler, Managing Director, LifeSci Advisors
O: (646) 970-4681
M: (917) 734-7387
[email protected]

Media
Delphine Davan, Senior Director, Communications and Investor Relations, IMV Inc.
O: (902) 492.1819 ext: 1049
[email protected]

Madeline Joanis, Senior Account Executive, LifeSci Communications
(603) 479 5267
[email protected]

Source: IMV Inc.

IMV Inc. to Present at the H.C. Wainwright Global Investment Conference

Tue, 17 May 2022 08:05:00 -0400

H.C. Wainwright Global Investment Conference
Format: Presentation and one-on-one investor meetings
Date: Wednesday May 25, 2022
Time: 9:30 a.m. ET

A link to this presentation is available under the ‘Events, Webcasts & Presentations' section of IMV’s website and a replay of the presentation will be available in for 90 days.

About IMV

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 regarding the potential impact of the VITALIZE study and the anticipated date data from such study is available, the Company’s ability to advance its development strategy, as well as the prospects, for its lead immunotherapy and its other pipeline of immunotherapy candidates. 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 access to capital, the successful design and completion of 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 Inc. 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, those related to the Company’s expected timeline associated with its cash runway; the Company’s priorities with MVP-S and its DPX delivery platform, the potential for its delivery platform and the anticipated timing of enrollment and results for its clinical trial programs and studies as others 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 www.sedar.com and on EDGAR at www.sec.gov/edgar.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220517005793/en/

Investor Relations

Joy Bessenger, Senior Vice President, Investor Relations and Corporate Strategy
O: (902) 492.1819 ext: 2009
E: [email protected]

Irina Koffler, Managing Director, LifeSci Advisors
O: (646) 970-4681
M: (917) 734-7387
E: [email protected]

Media

Delphine Davan, Senior Director, Communications and Investor Relations, IMV Inc.
M: (514) 968 1046
E: [email protected]

Madeline Joanis, Senior Account Executive, LifeSci Communications
M: (603) 479 5267
E: [email protected]

Source: IMV Inc.

IMV Inc. Announces First Quarter 2022 Financial and Operational Results

Fri, 13 May 2022 07:05:00 -0400

Positive clinical results in bladder cancer were presented at the AACR annual meeting, including

2 confirmed complete responses (CRs) and 3 partial responses (PRs) per RECIST v1.1;
CRs and PRs were observed in patients previously treated with checkpoint inhibitors;
Treatment with MVP-S/CPA and pembrolizumab was well-tolerated with mostly grade 1-2 injection site reactions, and no severe adverse events attributed to MVP-S;

New data were presented about DPX-based therapies’ mechanism of action.

Results from preclinical and clinical studies demonstrate that Natural Killer (NK) cells are also involved in the anti-cancer efficacy of DPX-based therapy.

Michael P. Bailey was appointed Chairman of the Board.

“A top priority for 2022 is to accelerate MVP-S towards registration trials. The positive clinical data we presented on MVP-S in combination with pembrolizumab in bladder cancer patients at the recent AACR annual meeting support IMV’s prior results in solid and hematologic cancer,” said Andrew Hall, Chief Executive Officer of IMV. “These results further underscore our conviction in the value of our DPX platform. In parallel, we are actively looking for opportunities to leverage our DPX delivery platform and expand our pipeline through business development. We continue to enrich our understanding of the DPX mechanism through foundational science and translational research.”

Clinical Programs with Maveropepimut-S (MVP-S)

VITALIZE Phase 2B Study in Relapsed/Refractory DLBCL ("r/r DLBCL")

In January 2022, the Company announced that the first patient was dosed in VITALIZE Phase 2B clinical trial, advancing IMV’s lead compound, MVP-S on the path to a registration trial. This trial is designed to further evaluate the clinical benefit of MVP-S in combination with Merck’s anti-PD-1 therapy, KEYTRUDA^® (pembrolizumab), in patients with r/r DLBCL. Fifteen clinical sites are now activated in the U.S., Canada, Australia and New Zealand. The Company is activating more sites in North America, Europe, Asia and Australia to accelerate enrollment. Early data from the initial patient group is expected in the third quarter of 2022.

AVALON Phase 2B Study in Platinum-Resistant Ovarian Cancer

The Company is preparing to initiate AVALON, a Phase 2B, single arm trial evaluating MVP-S and intermittent low-dose CPA in subjects with platinum-resistant ovarian cancer. The goal of this trial is to further validate the encouraging data observed in our Phase 2 DeCidE trial, which was completed in 2021. The design of the study has been approved by the FDA and Health Canada earlier this year. Site selection and activation are ongoing, and the first patient is expected to be dosed in H2 2022.

Positive Clinical Results in Bladder Cancer Presented at AACR Annual Meeting

Safety and preliminary efficacy data on a combination of MVP-S with pembrolizumab from the Phase 2 basket study of patients with advanced, metastatic bladder cancer were presented at the American Association of Cancer Research (AACR) annual meeting. Seventeen subjects with advanced, metastatic bladder cancer, who on average had received two prior lines of therapy, were enrolled in this arm of the Phase 2 basket study. The combination showed encouraging clinical activity, particularly in patients who had received prior immune checkpoint inhibitor therapy.

Key findings in this cohort included:

Treatment with MVP-S/CPA and pembrolizumab was well-tolerated with mostly grade 1-2 injection site reactions, and no severe adverse events attributed to MVP-S;
Of the 17 treated patients, 5 showed response: 2 confirmed CRs and 3 PRs per RECIST v1.1;
Complete and partial responses were observed in patients previously treated with checkpoint inhibitors;
Clinical response was most evident in patients with survivin-specific T cells; and
One patient is still on treatment after 18 months and remains a complete responder

KOL discussions are ongoing to map out the clinical opportunities for MVP-S in bladder cancer.

Clinical Program with IMV’s Second DPX-based Product Candidate, DPX-SurMAGE

IMV initiated a Phase 1 clinical trial evaluating both MVP-S and DPX-SurMAGE, in patients with non-muscle invasive bladder cancer (NMIBC) in early 2022. The first patient was dosed early April 2022. Preliminary data are expected by the end of 2022.

Foundational Science

AACR 2022 Annual Meeting Presentation: NK Cells are involved in Promoting Anti-tumor Responses to DPX-based Immunotherapy

It has been previously shown in clinical trials that MVP-S consistently incites a robust and persistent, survivin-specific immune response and promotes T and B cell infiltration into tumor tissues. At AACR, new data were presented providing the first evidence from preclinical and clinical studies that Natural Killer (NK) cells are also involved in the anti-cancer efficacy of DPX-based therapy.

Corporate Update

Michael P. Bailey appointed as Chairman of the Board, effective May 1, 2022.

Mr. Bailey has more than 30 years of pharmaceutical industry experience, having been instrumental in the commercial planning and launch of several new medicines across multiple oncology indications. He is currently President and Chief Executive Officer of AVEO Oncology, where he played a critical role in the approval of AVEO’s lead compound, FOTIVDA® (tivozanib), a treatment targeting renal cell carcinoma. Mr. Bailey has served on IMV’s Board of Directors since mid 2020.

Selected Upcoming Milestones

Maveropepimut-S (MVP-S):

Q3 2022: Early data look for the open label VITALIZE Phase 2 DLBCL trial
Q3 2022: Initiate enrollment in AVALON Phase 2b trial in platinum-resistant ovarian cancer
Q4 2022: Early data look for the investigator-initiated breast cancer trial
H1 2023: Early data look from the AVALON trial in platinum resistant ovarian cancer

DPX-SurMAGE:

Q4 2022: Early data look from Phase 1 Non-muscle invasive bladder cancer study in Canada

OVERVIEW OF FIRST QUARTER 2022 FINANCIAL RESULTS

All dollar amounts noted herein are denominated in United States dollars (unless otherwise noted herein).

As of March 31, 2022, the Company had cash and cash equivalents of $28.7 million and working capital of $27.1 million, compared with $38.6 million and $37.1 million, respectively at December 31, 2021. Based on its current operating plan, which includes the additional $10 million available under the Horizon Venture Debt Facility and excludes the $47.5 million remaining under our current At-The-Market facility, IMV expects its current cash position will be sufficient to fund operations into Q2 2023.

Research and development expenses were $6.6 million for the three months ended March 31, 2022, compared with $4.7 million for the three months ended March 31, 2021. This increase was mainly due to a rise in expenses related to the manufacturing and development costs for MVP-S, start-up costs for the VITALIZE DLBCL phase 2B trial, and personnel costs due to an increase in headcount. This increase was partly offset by a decrease in basket trial costs following completion of enrollment in 2021.

General and administrative expenses were $4.0 million for the three months ended March 31, 2022, compared with $3.2 million for the three months ended March 31, 2021. This increase of $0.8 million was largely attributable to salaries and non-cash stock-based compensation related to planned hiring and executive leadership changes as well as loan interest associated with the Horizon Venture Debt Facility.

The net loss and comprehensive loss of $10.5 million ($0.13 per share) for the three months ended March 31, 2022, was $3.5 million higher than the net loss and comprehensive loss of $7 million ($0.10 per share) for the three months ended March 31, 2021.

As of May 12, 2022, the number of issued and outstanding common shares was 82,269,462 and a total of 16,799,130 shares are reserved for the issuance of outstanding stock options, warrants and deferred share units.

The Company’s unaudited interim condensed consolidated results of operations, financial condition and cash flows for the quarter ended March 31, 2022, and the related management's discussion and analysis (MD&A) are available on SEDAR at www.sedar.com and on EDGAR at www.sec.gov as well as the Company’s website at www.imv-inc.com.

Conference Call and Webcast Information

Management will host a conference call and webcast today May 13, 2022, at 8:00 a.m. ET. Financial analysts are invited to join the conference call by dialing 1-844-461-9932 (U.S. and Canada) or 1-636-812-6632 (international) and using the conference ID: 5396906.

Other interested parties will be able to access the live audio webcast at this link: https://ir.imv-inc.com/events-and-presentations. The webcast will be recorded and will then be available on the Company’s website for 30 days following the call.

About IMV

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 regarding the potential impact of the VITALIZE study and the anticipated date data from such study and from other ongoing studies of the Company are available, the Company’s ability to advance its development strategy, the potential to expand the Company’s pipeline through business development, the expected dosing timeline for the AVALON Phase 2B trial, the expected timing for data to be available from the Phase I clinical trial evaluating MVP-S and DPX-SurMAGE, the sufficiency of the Company’s cash position, the upcoming milestones discussed in this release, and the prospects for its lead immunotherapy and its other pipeline of immunotherapy candidates. 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 access to capital, the successful design and completion of 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 Inc. 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, those related to the Company’s expected timeline associated with its cash runway; the Company’s priorities with MVP-S and its DPX delivery platform, the potential for its delivery platform and the anticipated timing of enrollment and results for its clinical trial programs and studies as others risks detailed from time to the Company’s ongoing quarterly and annual filings with Canadian securities regulators and the U.S. Securities and Exchange Commission. Investors. 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 www.sedar.com and on EDGAR at www.sec.gov.

IMV INC.
Consolidated Statements of Loss and Comprehensive Loss
(In thousands of United States dollars, except for share and per share amounts)

	Three Months ended, March 31,
	2022 $	2021 $
Revenue
Interest Income	24	69
Total revenue	24	69
Expenses
Research and development	6,631	4,744
General and administrative	3,990	3,161
Government assistance	(378)	(1,234)
Accreted interest and valuation adjustments	304	355
Total operating expenses	10,547	7,026
Net loss and comprehensive loss	(10,523)	(6,957)
Basic and diluted loss per share	(0.13)	(0.10)
Weighted-average shares outstanding	82,208,052	67,475,149

IMV INC.
Consolidated Statements of Financial Position
(In thousands of United States dollars, except for share and per share amounts)

	March 31, 2022		December 31, 2021
Assets
Current assets
Cash and cash equivalents	$	28,689	$	38,616
Accounts receivable		921		602
Prepaid expenses		5,524		6,037
Investment tax credits receivable		1,527		1,135
Total current assets		36,661		46,390
Property and equipment		4,172		3,731
Total assets	$	40,833	$	50,121
Liabilities and Equity
Current liabilities
Accounts payable, accrued and other liabilities	$	8,815	$	8,607
Current portion of long-term debt		75		73
Current portion of lease obligations		277		265
Warrant liabilities		363		318
Total current liabilities		9,530		9,263
Lease obligation		1,335		1,387
Long-term debt		18,269		17,929
Total liabilities		29,314		28,579
Equity		11,699		21,542
Total liabilities and equity	$	40,833	$	50,121

View source version on businesswire.com: https://www.businesswire.com/news/home/20220513005106/en/

Investor Relations

Joy Bessenger, Senior Vice President, Investor Relations and Corporate Strategy, IMV Inc.
O: (902) 492.1819 ext: 2009
E: [email protected]

Irina Koffler, Managing Director, LifeSci Advisors
O: (646) 970-4681
M: (917) 734-7387
E: [email protected]

Media

Delphine Davan, Senior Director, Communications and Investor Relations, IMV Inc.
O: (902) 492.1819 ext: 1049
E: [email protected]

Madeline Joanis, Senior Account Executive, LifeSci Communications
M: (603) 479 5267
E: [email protected]

Source: IMV Inc.

IMV Inc. to Announce First Quarter 2022 Results and Host a Conference Call and Webcast on May 13, 2022

Fri, 06 May 2022 07:05:00 -0400

DARTMOUTH, Nova Scotia & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- IMV Inc. (Nasdaq: IMV; TSX: IMV) (“IMV” or “the Company”), a clinical-stage company developing a portfolio of immune-educating therapies based on its novel DPX platform to treat solid and hematologic cancers, today announced that it will hold a conference call and webcast on Friday, May 13, 2022, at 8:00 a.m. ET to discuss the company’s 2022 first quarter financial and operational results.

Financial analysts are invited to join the conference call by dialing 1-844-461-9932 (U.S. and Canada) or 1-636-812-6632 (international) and using the conference ID: 5396906

About IMV

IMV Inc. is a clinical-stage immuno-oncology company advancing a portfolio of therapies based on the Company’s immune-educating platform: the DPX® technology. Through a differentiated mechanism of action, the DPX platform delivers instruction to the immune system to generate a specific, robust, and persistent immune response. IMV’s lead candidate, maveropepimut-S (MVP-S), delivers antigenic peptides from survivin, a well-recognized cancer antigen commonly overexpressed in advanced cancers. MVP-S also delivers an innate immunity activator and a universal CD4 T cell helper peptide. These elements foster maturation of antigen presenting cells as well as robust activation of CD8 T cell effector and memory function. MVP-S treatment has been well tolerated and has demonstrated defined clinical benefit in multiple cancer indications as well as the activation of a targeted and sustained, survivin-specific anti-tumor immune response. MVP-S is currently being evaluated in clinical trials for hematologic and solid cancers, including Diffuse Large B Cell Lymphoma (DLBCL) as well as ovarian, bladder and breast cancers. IMV is also developing a second immunotherapy leveraging the DPX immune delivery platform, DPX-SurMAGE. This dual-targeted immunotherapy combines antigenic peptides for both the survivin and MAGE-A9 cancer proteins to elicit immune responses to these two distinct cancer antigens simultaneously. A Phase 1 clinical trial in bladder cancer will open early 2022. For more information, visit 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 regarding the Company’s ability to advance its development strategy, as well as the prospects, for its lead immunotherapy and its other pipeline of immunotherapy candidates. 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 access to capital, the successful design and completion of 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 Inc. 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 www.sedar.com and on EDGAR at www.sec.gov/edgar.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220506005045/en/

Investor Relations
Joy Bessenger, Senior Vice President, Investor Relations and Corporate Strategy
O: (902) 492-1819 ext: 2009
E: [email protected]

Irina Koffler, Managing Director, LifeSci Advisors
O: (646) 970-4681
M: (917) 734-7387
E: [email protected]

Media
Delphine Davan, Senior Director, Communications and Investor Relations, IMV Inc.
M: (514) 968-1046
E: [email protected]

Madeline Joanis, Senior Account Executive, LifeSci Communications
M: (603) 479-5267
E: [email protected]

Source: IMV Inc.

IMV’s Lead Compound to Be Showcased in Two Presentations at the 2022 ASCO Annual Meeting

Thu, 28 Apr 2022 07:05:00 -0400

DARTMOUTH, Nova Scotia & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical-stage company developing a portfolio of immune-educating therapies based on its novel DPX® platform to treat solid and hematologic cancers, today announced the Company’s lead compound, maveropepimut-S (MVP-S), will be showcased in two presentations in breast and ovarian cancer at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting. The meeting will be held in-person and virtually June 3-7, 2022, in Chicago, Illinois.

Presentation Details

Neoadjuvant Survivin-targeted Immunotherapy Maveropepimut-S (MVP-S) to increase Th1 Immune Response in Ki67-high Hormone Receptor Positive (HR+) Early-stage Breast Cancer (ESBC)

Presenter: Sasha E. Stanton, M.D., Ph.D., Medical Oncologist and Assistant member, Cancer Immunoprevention Laboratory Earle A. Chiles Research Institute at the Providence Cancer Institute, Portland, OR
Poster Number: TPS1119
Date/Time: Monday, June 6, 2022, 8:00 AM-11:00 AM CDT

Pembrolizumab, Maveropepimut-S and Low Dose Cyclophosphamide in Advanced Epithelial Ovarian Cancer –Results from Phase 1 and Expansion Cohort of PESCO Trial

Presenter: Ana Veneziani, M.D., Ph.D., Clinical Research Fellow at the Princess Margaret Cancer Centre, Toronto, ON
Poster Number: 5505
Date/Time: Monday, June 6, 2022, 8:00 AM-11:00 AM CDT

The presentations will be available on the IMV website under the Scientific Publications & Posters section following the meeting.

About IMV

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 regarding the potential impact of the VITALIZE study and the anticipated date data from such study is available, the Company’s ability to advance its development strategy, as well as the prospects, for its lead immunotherapy and its other pipeline of immunotherapy candidates. 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 access to capital, the successful design and completion of 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 Inc. 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, those related to the Company’s expected timeline associated with its cash runway; the Company’s priorities with MVP-S and its DPX delivery platform, the potential for its delivery platform and the anticipated timing of enrollment and results for its clinical trial programs and studies as others 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 www.sedar.com and on EDGAR at www.sec.gov/edgar

View source version on businesswire.com: https://www.businesswire.com/news/home/20220428005463/en/

Investor Relations

Joy Bessenger, Senior Vice President, Investor Relations and Corporate Strategy, IMV Inc.
O: (902) 492.1819 ext: 2009
E: [email protected]

Irina Koffler, Managing Director, LifeSci Advisors
O: (646) 970-4681
M: (917) 734-7387
E: [email protected]

Media

Delphine Davan, Senior Director, Communications and Investor Relations, IMV Inc.
O: (902) 492.1819 ext: 1049
E: [email protected]

Madeline Joanis, Senior Account Executive, LifeSci Communications
M: (603) 479 5267
E: [email protected]

Source: IMV Inc.

IMV Inc. Names Michael P. Bailey Chairman of The Board

Fri, 22 Apr 2022 07:05:00 -0400

DARTMOUTH, Nova Scotia & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- IMV Inc. (Nasdaq: IMV; TSX: IMV) (“IMV” or “the Company”), a clinical-stage company developing a portfolio of immune-educating therapies based on its novel DPX platform to treat solid and hematologic cancers, today announced that its Board of Directors has elected Michael P. Bailey, President and Chief Executive Officer of AVEO Oncology, to Chairman of the Board, effective May 1, 2022. Mr. Bailey has served on the IMV Board of Directors since 2020 and chairs the governance committee, as well as serving as a member of the audit and clinical governance committees.

“Michael has brought a connectivity in biotech and a depth of expertise in clinical strategy, business development and commercialization to the IMV Board. We are excited to leverage his knowledge and experience as we transition into late-stage clinical development and renew our focus on Business Development opportunities for our DPX platform,” said Andrew Hall, Chief Executive Officer of IMV. “The Board and I would like to express our thanks to Andy who has served as Board Chairman since 2016 and has made important contributions in IMV’s development. He will work closely with Michael in an orderly transition of the Board Chairman’s responsibilities.”

Mr. Bailey has more than 30 years of pharmaceutical industry experience, having been instrumental in the commercial planning and launch of several new medicines across multiple oncology indications. Most recently, he played a critical role in the approval of AVEO’s lead compound, FOTIVDA^® (tivozanib), a treatment targeting relapsed and refractory advanced renal cell carcinoma for patients who have failed at least two prior therapies. He joined AVEO as Chief Commercial Officer in 2010; then served as Chief Business Officer from 2013 until his appointment as CEO and member of their Board in 2015. Prior to joining AVEO, Mr. Bailey served as Chief Commercial Officer and Senior Vice President of Business Development at Synta Pharmaceuticals. Previously, he led ImClone Systems’ (now Eli Lilly) worldwide commercial organization. During his tenure at ImClone, he was responsible for all commercial aspects of the planning and launch of ERBITUX^® (cetuximab) across multiple oncology indications, as well as new product planning for the ImClone development portfolio, which included CYRAMZA^®(ramucirumab) and necitumumab. In addition, Mr. Bailey was a key member of the strategic leadership committees for ImClone and its North American and worldwide partnerships. Prior to joining ImClone, Mr. Bailey managed the cardiovascular development portfolio at Genentech, Inc., and was a key member of their global commercial partnership teams.

About IMV

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 regarding the potential impact of the VITALIZE study and the anticipated date data from such study is available, the Company’s ability to advance its development strategy, as well as the prospects, for its lead immunotherapy and its other pipeline of immunotherapy candidates. 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 access to capital, the successful design and completion of 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 Inc. 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, those related to the Company’s expected timeline associated with its cash runway; the Company’s priorities with MVP-S and its DPX delivery platform, the potential for its delivery platform and the anticipated timing of enrollment and results for its clinical trial programs and studies as others 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 www.sedar.com and on EDGAR at www.sec.gov/edgar

View source version on businesswire.com: https://www.businesswire.com/news/home/20220422005144/en/

Investor Relations
Joy Bessenger, Senior Vice President, Investor Relations and Corporate Strategy, IMV Inc.
O: (902) 492.1819 ext: 2009
E: [email protected]

Irina Koffler, Managing Director, LifeSci Advisors
O: (646) 970-4681
M: (917) 734-7387
E: [email protected]

Media
Delphine Davan, Senior Director, Communications and Investor Relations, IMV Inc.
O: (902) 492.1819 ext: 1049
E: [email protected]

Madeline Joanis, Senior Account Executive, LifeSci Communications
M: (603) 479 5267
E: [email protected]

Source: IMV Inc.

IMV Inc. Presents Clinical Benefit of MVP-S in Combination with Pembrolizumab in Bladder Cancer at the AACR Annual Meeting

Fri, 08 Apr 2022 17:00:00 -0400

Combination of MVP-S/CPA and pembrolizumab showed encouraging clinical activity in advanced, metastatic bladder cancer patients, particularly in patients who had received prior immune checkpoint inhibitor therapy

The combination treatment was well-tolerated with adverse events mostly grade 1 or 2

KOL discussions are ongoing to map out clinical opportunities in bladder cancer

DARTMOUTH, Nova Scotia & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- IMV Inc. (NASDAQ: IMV; TSX: IMV), a clinical-stage company developing a portfolio of immune-educating therapies based on its novel DPX® platform to treat solid and hematologic cancers, today announced safety and preliminary efficacy data of the combination of the Company’s lead immunotherapy candidate, maveropepimut-S (MVP-S), with pembrolizumab from a Phase 2 basket study of patients with advanced, metastatic bladder cancer. Data will be presented at a mini-symposium on Immunotherapy Combination Strategies in Clinical Trials at the American Association for Cancer Research (AACR) Annual Meeting, taking place April 8-13, 2022, in New Orleans, Louisiana.

Seventeen subjects with advanced, metastatic bladder cancer, who on average had received two prior lines of therapy, were enrolled in this arm of the Phase 2 basket study (NCT03836352) and treated with the combination of MVP-S/CPA and pembrolizumab. The preliminary results, described below, suggest that IMV’s therapy may provide a well-tolerated therapeutic alternative for advanced, metastatic bladder cancer patients in need of new treatment options.

“The basket trial was designed to identify signals of clinical benefit for the combination of MVP-S/ CPA and pembrolizumab,” said Jeremy Graff, Ph.D., Chief Scientific Officer at IMV Inc. “We are very encouraged to see such positive clinical results, particularly in advanced, metastatic bladder cancer patients that had already been treated with immune checkpoint inhibitors. We are now meeting with top key opinion leaders in the field to design follow-on trials to deepen our understanding of this clinical benefit.”

Key Findings

Five out of 17 subjects showed response (2 confirmed complete responses (CRs) and 3 additional partial responses);
Three of these, including both confirmed CRs, had progressed on prior anti-PD-1/L1 therapy;
Long-term clinical benefit was observed in several subjects as was an increase in detectable survivin-specific T cells in peripheral blood; one patient remains on treatment after 18 months;
The combination treatment was well-tolerated, with the majority of adverse events being grade 1 or grade 2.

This presentation will be available on the conference platform and on the IMV website under the Scientific Publications & Posters section following the meeting.

Presentation details:

Safety, preliminary efficacy and pharmacodynamic (PD) analysis of maveropepimut-S, intermittent low-dose cyclophosphamide and pembrolizumab in patients with advanced, metastatic bladder cancer

Presenter: Jeremy R. Graff, Ph.D., Chief Scientific Officer at IMV
Session Title: Immunotherapy Combination Strategies in Clinical Trials
Presentation Number: CT035
Session Date and Time: Tuesday, Apr. 12, 2022, 2:30 p.m. - 4:30 p.m. CST

About IMV

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 regarding the potential impact of the VITALIZE study and the anticipated date data from such study is available, the Company’s ability to advance its development strategy, as well as the prospects, for its lead immunotherapy and its other pipeline of immunotherapy candidates. 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 access to capital, the successful design and completion of 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 Inc. 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, those related to the Company’s expected timeline associated with its cash runway; the Company’s priorities with MVP-S and its DPX delivery platform, the potential for its delivery platform and the anticipated timing of enrollment and results for its clinical trial programs and studies as others 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 www.sedar.com and on EDGAR at www.sec.gov/edgar.

View source version on businesswire.com: https://www.businesswire.com/news/home/20211202005351/en/

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Investor Relations
Joy Bessenger, Senior Vice President, Investor Relations and Corporate Strategy, IMV Inc.
O: (902) 492.1819 ext: 2009
E: [email protected]

Irina Koffler, Managing Director, LifeSci Advisors
O: (646) 970-4681
M: (917) 734-7387
E: [email protected]

Media
Delphine Davan, Senior Director, Communications and Investor Relations, IMV Inc.
O: (902) 492.1819 ext: 1049
E: [email protected]

Madeline Joanis, Senior Account Executive, LifeSci Communications
M: (603) 479 5267
E: [email protected]

Source: IMV Inc.

IMV to Present at IMMUNOLOGY™ 2022, the AAI Annual Meeting

Wed, 06 Apr 2022 07:05:00 -0400

DARTMOUTH, Nova Scotia & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical-stage company developing a portfolio of immune-educating therapies based on its novel DPX® platform to treat solid and hematologic cancers, today announced the Company will present a poster at IMMUNOLOGY™ 2022, the annual meeting of the American Association of Immunologists (AAI). The meeting will be held May 6-10, 2022, in Portland, Oregon.

Presentation Details

Proteomic analysis of plasma exosomes as biomarkers of response to MVP-S based immunotherapy

Presenter: Brennan Dirk, Ph.D., Research Scientist, IMV Inc.
Poster Number: 837 (abstract number)
Date/Time: Saturday, May 7 @ 2:30 – 3:45 PM

The presentation will be available on the conference platform and on the IMV website under the Scientific Publications & Posters section following the meeting.

About IMV

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 regarding the potential impact of the VITALIZE study and the anticipated date data from such study is available, the Company’s ability to advance its development strategy, as well as the prospects, for its lead immunotherapy and its other pipeline of immunotherapy candidates. 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 access to capital, the successful design and completion of 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 Inc. 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, those related to the Company’s expected timeline associated with its cash runway; the Company’s priorities with MVP-S and its DPX delivery platform, the potential for its delivery platform and the anticipated timing of enrollment and results for its clinical trial programs and studies as others 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 www.sedar.com and on EDGAR at www.sec.gov/edgar

View source version on businesswire.com: https://www.businesswire.com/news/home/20220406005309/en/

Investor Relations

Joy Bessenger, Senior Vice President, Investor Relations and Corporate Strategy, IMV Inc.
O: (902) 492.1819 ext: 2009
E: [email protected]

Irina Koffler, Managing Director, LifeSci Advisors
O: (646) 970-4681
M: (917) 734-7387
E: [email protected]

Media

Delphine Davan, Senior Director, Communications and Investor Relations, IMV Inc.
O: (902) 492.1819 ext: 1049
E: [email protected]

Madeline Joanis, Senior Account Executive, LifeSci Communications
M: (603) 479 5267
E: [email protected]

Source: IMV Inc.

IMV Inc. to Present at Two Upcoming Investor Conferences

Mon, 04 Apr 2022 07:05:00 -0400

21^st Annual Needham Virtual Healthcare Conference
Format: Presentation and one-on-one investor meetings
Date: Thursday April 14, 2022
Time: 12:45 p.m. ET
Webcast: Click Here

Wells Fargo Biotech Forum
Format: One-on-one investor meetings
Date: April 12-13

A replay for the 21^st Annual Needham Virtual Annual Healthcare Conference presentation will be available in the ‘Events, Webcasts & Presentations' section of IMV’s website for 90 days.

About IMV

IMV Inc. is a clinical-stage immuno-oncology company advancing a portfolio of therapies based on the Company’s immune-educating platform: the DPX™ technology. Through a differentiated mechanism of action, the DPX platform delivers instructions to the immune system and generates a specific, robust, and persistent immune response. IMV’s lead candidate, maveropepimut-S (MVP-S) delivers antigenic peptides of survivin, a well-recognized cancer antigen. Treatments with MVP-S have demonstrated the activation of a targeted and sustained anti-tumor immune response, correlated with clinical benefit and have been well tolerated across all clinical trials. MVP-S is currently being evaluated in clinical trials for blood and solid cancers, including in Diffuse Large B Cell Lymphoma (DLBCL) as well as ovarian, bladder and breast cancers. IMV is also developing a second immunotherapy leveraging the DPX immune delivery platform, DPX-SurMAGE. This dual-targeted immunotherapy combines antigenic peptides for both the survivin and MAGE-A9 cancer proteins to elicit immune responses to these two distinct cancer antigens simultaneously. A Phase 1 clinical trial in bladder cancer was initiated in early 2022. For more information, visit 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 regarding the potential impact of the VITALIZE study and the anticipated date data from such study is available, the Company’s ability to advance its development strategy, as well as the prospects, for its lead immunotherapy and its other pipeline of immunotherapy candidates. 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 access to capital, the successful design and completion of 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 Inc. 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, those related to the Company’s expected timeline associated with its cash runway; the Company’s priorities with MVP-S and its DPX delivery platform, the potential for its delivery platform and the anticipated timing of enrollment and results for its clinical trial programs and studies as others 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 www.sedar.com and on EDGAR at www.sec.gov/edgar.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220404005304/en/

Investor Relations

Joy Bessenger, Senior Vice President, Investor Relations and Corporate Strategy, IMV Inc.
O: (902) 492.1819 ext: 2009
E: [email protected]

Irina Koffler, Managing Director, LifeSci Advisors
O: (646) 970-4681
M: (917) 734-7387
E: [email protected]

Media

Delphine Davan, Senior Director, Communications and Investor Relations, IMV Inc.
O: (902) 492.1819 ext: 1049
E: [email protected]

Madeline Joanis, Senior Account Executive, LifeSci Communications
M: (603) 479 5267
E: [email protected]

Source: IMV Inc.

IMV Inc. Announces Fourth Quarter and Full Year 2021 Financial and Operational Results

Thu, 17 Mar 2022 07:05:00 -0400

First patient dosed in VITALIZE Phase 2B trial in relapsed/refractory DLBCL

Metastatic bladder cancer cohort data from Phase 2 basket trial to be presented at late-breaking symposium at AACR

Phase 2B Avalon trial in advanced ovarian cancer to start in second half 2022

Cash runway extended into second quarter 2023

“2022 is off to a promising start, following the accomplishments across our pipeline in 2021,” said Andrew Hall, Chief Executive Officer of IMV. “Our lead compound, MVP-S, has now shown defined clinical benefit across multiple cancers, in both hematological and solid tumors. We also extended our cash runway into the second quarter of 2023 through equity and non-dilutive debt.”

“A top priority for the year ahead is to move MVP-S forward on the path toward registration based on the strength of the data observed across several indications to date. In parallel, we continue to look for opportunities to leverage our DPX^® delivery platform through business development activities,” continued Mr. Hall. “Our technology is a highly versatile platform that uniquely mimics the natural flow of antigens to instruct a specific and persistent immune response. The DPX delivery platform has broad potential to generate value in immuno-oncology and eventually other therapeutic areas.”

Clinical Programs with Maveropepimut-S (MVP-S)

VITALIZE Phase 2B Study in Relapsed/Refractory DLBCL ("r/r DLBCL")

IMV aims to further validate the strong therapeutic potential previously seen in PD-L1 positive patients who were administered a combination regimen of pembrolizumab, MVP-S and cyclophosphamide (CPA) in its SPiReL Phase 2 study. Eleven clinical sites are now activated in the US and Canada. The Company is currently activating more sites in North America, Europe, Asia and Australia to accelerate enrollment. Early data review from the initial patient group is expected in summer 2022.

Phase 2 Basket Trial in Multiple Advanced Metastatic Solid Tumors

In December 2021, IMV announced the completion of enrollment in its Phase 2 basket trial in collaboration with Merck. This trial’s objectives were to identify and select the best solid tumor opportunities for the combination of MVP-S with Merck’s anti PD-1 checkpoint inhibitor Keytruda® and CPA. Topline data from the metastatic bladder cohort were particularly promising. Clinical benefit (measured as complete responses, partial responses, and stable disease by standard RECIST criteria) was observed in advanced, metastatic bladder cancer patients, including in patients who had received prior immune checkpoint inhibitor therapy.

Data observed in this cohort of the trial will be presented at a late-breaking oral symposium at the American Association of Cancer Research (AACR) annual meeting in April 2022.

Presentation Number: CT035

Session Date and Time: Tuesday Apr. 12, 2022, 2:30 p.m. - 4:30 p.m. CST

AVALON Phase 2B Trial in Platinum-Resistant Ovarian Cancer.

The Company is preparing to initiate AVALON, Phase 2B, single arm trial evaluating MVP-S and intermittent low-dose CPA in subjects with platinum-resistant ovarian cancer. The goal of this trial is to further evaluate the data observed in our Phase 2 DeCidE trial. The AVALON design was informed by results from the DeCidE study, completed in 2021. Among patients with advanced and recurrent ovarian cancer receiving MVP-S and intermittent, low-dose CPA, nearly half survived to 2 years. Treatment-related adverse events (AEs) were mostly Grade 1 and Grade 2 and tolerable. Translational analyses from DeCidE (presented at the SITC annual meeting and ESMO-IO congress in 2021) implicated roles for both T and B cells in the sustained, anti-tumor immune response induced by MVP-S. Site selection and activation are ongoing, and the first patient is expected to be dosed in H2 2022.

Phase 1B Trial in HR+/HER2- Breast Cancer

In November 2021, enrollment was initiated in the Phase 1B trial of MVP-S in hormone receptor positive/HER2-negative (HR+/HER2-) breast cancer. For the first time, MVP-S is being evaluated in a neoadjuvant setting with an aromatase inhibitor. Across the three arms of this study, MVP-S will be evaluated in 18 subjects with resectable, non-metastatic HR+/HER2- breast cancer. This investigator-initiated phase 1B clinical study is being conducted at the Providence Cancer Institute in Oregon. Early data are expected to be presented in late 2022.

Clinical Programs with IMV’s Second DPX-based Product Candidate, DPX-SurMAGE

IMV initiated a Phase 1 clinical trial evaluating both MVP-S and DPX-SurMAGE, in patients with non-muscle invasive bladder cancer (NMIBC) in early 2022. Preliminary data are expected by the end of 2022.

Research and Development Day Held on February 24

IMV hosted a “Research and Development Day” for the investment community via webcast on February 24, 2022. The event featured a presentation by Michael Kalos, Ph.D., member of IMV’s Board of Directors and internationally recognized pioneer in T cell therapy and immunotherapy. During the presentation, Dr. Kalos gave an overview of the differentiated capabilities of IMV’s DPX delivery technology. IMV’s Chief Scientific Officer, Dr. Jeremy Graff, further detailed the unique mechanism of action of the DPX platform, its differentiation from first generation cancer vaccine efforts and data from the lead DPX product, MVP-S, which provide the clinical and pre-clinical proof of concept for DPX-based immune instruction. A replay of the event can be found here.

Selected Upcoming Milestones

Maveropepimut-S (MVP-S):

April 2022: Present detailed top line data on the bladder cancer cohort from the basket trial at a late-breaking oral presentation at the annual AACR meeting.
Summer 2022: Provide clinical update on the open-label Phase 2B VITALIZE r/r DLBCL trial.
H2 2022: Initiate enrollment in AVALON open-label Phase 2B Avalon platinum-resistant ovarian cancer trial.
December 2022: Present first clinical and translational results update for the investigator-initiated breast cancer trial.
Q4 2022: Present preliminary Phase 1 data from the MVP-S and DPX-SurMAGE in non-muscle invasive bladder cancer (NMIBC).

Corporate Updates

Andrew Hall Appointed as Chief Executive Officer (CEO)

The company’s Board of Directors appointed Andrew Hall to the role of Chief Executive Officer and Director of the Board, effective January 1, 2022.

Kabir Mody, M.D. Appointed as Medical Director

Dr. Kabir Mody joined IMV earlier this year as Medical Director. Dr. Mody brings experience in clinical oncology from the Mayo Clinic where he most recently served as vice chair to the Division of Hematology/Oncology and as Associate Professor of Medicine.

Anthony Atala, M.D. Joined as Clinical Advisor

Anthony Atala, M.D., is an American bioengineer, urologist, and pediatric surgeon. Dr. Atala is the G. Link Professor and Director of the Wake Forest Institute for Regenerative Medicine, and the W. Boyce Professor and Chair of the Department of Urology at Wake Forest University. His work focuses on growing human cells, tissues and organs. Fifteen applications of technologies developed in Dr. Atala's laboratory have been used clinically in patients. Dr. Atala has led or served on several national professional and government committees, including the National Institutes of Health working group on Cells and Developmental Biology, and the National Cancer Institute’s Advisory Board.

Overview of Full Year 2021 Financial Results

As of December 31, 2021, the Company had cash and cash equivalents of $38.6 million, compared to $36.3 million as of December 31, 2020. The increase in cash primarily reflects proceeds from the $25 million public offering completed on July 20th, $15 million in proceeds from the first tranche of the Horizon Venture Debt Facility and $2.3 million in proceeds raised from the October 2020 At-The-Market (ATM) offering, offset by cash used for operations and the repayment of a debt facility. Based on its current operating plan, IMV expects its current cash position will be sufficient to fund operations into the second quarter of 2023.

Research and development expenses were $23 million for the year ended December 31, 2021, compared with $19.9 million for the year ended December 31, 2020. This increase of $3.2 million was mainly due to a rise in expenses related to the manufacturing and development costs for MVP-S, start-up costs for the DLBCL phase 2B trial, and personnel costs due to an increase in headcount. The increase was offset in part by a decline in DPX-COVID-19 development costs due to program deprioritization as part of a strategic realignment and the completion of the ovarian trial.

General and administrative expenses were $16 million for the year ended December 31, 2021, compared with $11.3 million for the year ended December 31, 2020. This increase was largely attributable to salaries and non-cash stock-based compensation related to planned hiring and executive leadership changes, an increase for the Company’s insurance premium, an increase in professional fees, as well as an increase in board directors’ compensation.

The net loss and comprehensive loss of $36.7 million ($0.49 per share) for the year ended December 31, 2021, was $10.5 million higher than the net loss and comprehensive loss for the year ended December 31, 2020.

On March 16, 2022, the number of issued and outstanding Common Shares was 82,221,363 and a total of 19,642,549 shares are reserved for the issuance of outstanding stock options, warrants and deferred share units.

The Company’s audited annual consolidated results of operations, financial condition and cash flows for the year ended December 31, 2021 and the related management's discussion and analysis (MD&A) are available on SEDAR at www.sedar.com and on EDGAR at www.sec.gov/edgar as well as on the Company’s website at www.imv-inc.com

Conference Call and Webcast Information

Management will hold a conference call and webcast on Thursday, March 17, 2022, at 8:00 a.m. EST to discuss the company’s 2021 fourth quarter and fiscal year-end financial and operational results.

Financial analysts are invited to join the conference call by dialing 1-844-461-9932 (U.S. and Canada) or 1-636-812-6632 (international) and using the conference ID: 5049587

About IMV

IMV Inc. is a clinical-stage immuno-oncology company advancing a portfolio of therapies based on the Company’s immune-educating platform: the DPX™ technology. Through a differentiated mechanism of action, the DPX platform delivers instruction to the immune system to generate a specific, robust, and persistent immune response. IMV’s lead candidate, maveropepimut-S (MVP-S), delivers antigenic peptides of survivin, a well-recognized cancer antigen commonly overexpressed in advanced cancers. MVP-S treatment has been well tolerated and has demonstrated defined clinical benefit in multiple cancer indications as well as the activation of a targeted and sustained, survivin-specific anti-tumor immune response. MVP-S is currently being evaluated in clinical trials for hematologic and solid cancers, including Diffuse Large B Cell Lymphoma (DLBCL) as well as ovarian, bladder and breast cancers. IMV is also developing a second immunotherapy leveraging the DPX immune delivery platform, DPX-SurMAGE. This dual-targeted immunotherapy combines antigenic peptides for both the survivin and MAGE-A9 cancer proteins to elicit immune responses to these two distinct cancer antigens simultaneously. A Phase 1 clinical trial in bladder cancer, evaluating both MVP-S and DPX-SurMAGE, was initiated in early 2022. For more information, visit 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 regarding the potential impact of the VITALIZE study and the anticipated date data from such study is available, the Company’s ability to advance its development strategy, as well as the prospects, for its lead immunotherapy and its other pipeline of immunotherapy candidates. 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 access to capital, the successful design and completion of 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 Inc. 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, those related to the Company’s expected timeline associated with its cash runway; the Company’s priorities with MVP-S and its DPX delivery platform, the potential for its delivery platform and the anticipated timing of enrollment and results for its clinical trial programs and studies as others 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 www.sedar.com and on EDGAR at www.sec.gov/edgar



IMV INC.
Consolidated Statements of Loss and Comprehensive Loss
(In thousands of United States dollars, except for share and per share amounts)

	Years ended December 31,
	2021 $		2020 $
Revenue
Subcontract revenue	-		3
Interest Income	188		222
Total revenue	188		225
Expenses
Research and development	23,080		19,904
General and administrative	16,020		11,344
Government assistance	(3,230	)	(4,991	)
Accreted interest and valuation adjustments	907		27
Total operating expenses	36,777		26,284
Net loss	(36,589	)	(26,059	)
Currency translation adjustment	-		2,660
Total comprehensive loss	(36,589	)	23,399
Basic and diluted loss per share	(0.49	)	(0.39	)
Weighted-average shares outstanding	74,198,439		60,305,264



IMV INC.
Consolidated Statements of Financial Position
(In thousands of United States dollars, except for share and per share amounts)

	December 31, 2021		December 31, 2020
Assets
Current assets
Cash and cash equivalents	$	38,616	$	36,268
Accounts receivable		602		1,574
Prepaid expenses		6,037		4,416
Investment tax credits receivable		1,135		1,519
Total current assets		46,390		43,777
Property and equipment		3,731		2,221
Total assets	$	50,121	$	45,998
Liabilities and Equity
Current liabilities
Accounts payable and accrued liabilities	$	8,607	$	7,228
Current portion of long-term debt		73		856
Current portion of lease obligations		265		109
Warrant liabilities		318		-
Total current liabilities		9,263		8,193
Lease obligation		1,387		953
Long-term debt		17,929		6,050
Total liabilities		28,579		15,196
Equity		21,542		30,802
Total liabilities and equity	$	50,121	$	45,998

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Investor Relations

Joy Bessenger, Senior Vice President, Investor Relations and Corporate Strategy
O: (902)492.1819
E: [email protected]

Marc Jasmin, Senior Director, Investor Relations, IMV Inc.
O: (902) 492-1819 ext: 1042
M: (514) 617-9481 E: [email protected]

Irina Koffler, Managing Director, LifeSci Advisors
O: (646) 970-4681
M: (917) 734-7387
E: [email protected]

Media

Delphine Davan, Senior Director, Communications and Investor Relations, IMV Inc.
M: (514) 968 1046
E: [email protected]

Madeline Joanis, Senior Account Executive, LifeSci Communications
M: (603) 479 5267
E: [email protected]

Source: IMV Inc.