IMV Inc. (IMV) News

Clinical Response and Translational Data from DeCidE1, a Phase 2 Study of DPX-Survivac Immunotherapy in Patients with Advanced Recurrent Ovarian Cancer

Fri, 29 May 2020 08:05:00 -0400

Survivin-targeted T cell therapy continues to show significant, durable anti-tumor activity and is well-tolerated in this hard-to-treat cancer patient population

5/19 patients (26%) achieved a partial regression on target lesions

Strong translational data link the observed clinical benefits with DPX-Survivac’s unique mechanism of action; 87% of subjects showing survivin-specific immune response

Poster to be presented by Oliver Dorigo, MD, Ph.D. at the ASCO20 Virtual Scientific Program

DARTMOUTH, Nova Scotia--(BUSINESS WIRE)-- IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical-stage biopharmaceutical company pioneering a novel class of targeted cancer immunotherapies and vaccines against infectious diseases, today reported updated clinical response and translational data from DeCidE1, its Phase 2 study evaluating the safety and efficacy of DPX-Survivac with intermittent low-dose cyclophosphamide (CPA) in patients with recurrent, advanced platinum-sensitive and -resistant ovarian cancer.

Results from the ongoing study showed prolonged durable clinical responses, alongside favorable tolerability, and strong translational data linking the observed clinical benefit with DPX-Survivac’ mechanism of action. Oliver Dorigo, M.D., Ph.D., Principal Investigator of the DeCidE1 study, is presenting these results in a poster presentation at the American Society of Clinical Oncology 2020 (ASCO20) Virtual Scientific Program.

“IMV’s targeted T-cell therapy continues to elicit a rapid and robust immune response with survivin-specific T cells infiltrating tumors as soon as 56 days post-treatment. These results validate DPX-Survivac’s unique mechanism of action and support the hypothesis that survivin-specific T cells can translate into clinical benefits when sustained over an extended period of time,” said Dr. Dorigo associate professor and director of gynecologic oncology at Stanford University. “These results support DPX-Survivac as a new and much-needed treatment option, with potential to improve the quality of life in women with recurrent late-stage ovarian cancer, a hard-to-treat indication where other immunotherapies have so far had limited success.”

“With these results, DPX-Survivac continues to exhibit significant and durable anti-tumor activity, paving the way for targeted T cell therapies in advanced recurrent ovarian cancer and other solid tumors. In particular, we are quite pleased to observe an additional patient with stable disease (SD) convert to partial response (PR), implying the potential for responses to deepen over time with ongoing therapy. Additionally, DPX-Survivac continues to be well tolerated, which is especially meaningful compared to single-agent chemotherapy and other approaches in development,” said Joanne Schindler, M.D., D.V.M., Chief Medical Officer at IMV. “We believe these results highlight DPX-Survivac’s potential to alter the treatment landscape in advanced ovarian cancer and support its continued development. We look forward to providing updates from other studies evaluating DPX-Survivac, in multiple solid tumors and r/r DLBCL, later this year.”

Updated Results from DeCidE1

As of data cut-off date, May 2, 2020, 19 patients were evaluable for efficacy with four patients (21%) still receiving treatment. Notably, 18/19 evaluable patients had stage 3 or 4 disease at time of diagnosis, the majority of whom had received >3 lines of prior therapy and were platinum resistant. Key findings on the safety and efficacy of DPX-Survivac/CPA are outlined below:

5/19 patients (26%) achieved a PR with tumor regression >30% on target lesions
15/19 patients (79%) achieved disease control, defined as Stable Disease (SD) or Partial Response (PR) on target lesions
- Tumor shrinkage of target lesions was observed in 10 patients (53%)
Overall, treatment was well-tolerated. The majority of treatment-related adverse events reported were Grade 1 events and related to reactions at the injection site.

Durable clinical benefits lasting ≥ 6 months were observed in seven patients (37%)

5/7 patients (71%) have now reached duration of clinical benefit > 10 months including three patients with PR and two patients with SD
The two patients with SD are about to reach the 1-year mark

Translational analyses on longitudinally collected peripheral blood mononuclear cell (PBMC) and tumor tissue samples link observed clinical benefit and survivin-specific T cells, supporting DPX-Survivac’s unique mechanism of action. Key translational findings are outlined below:

Treatment generated a survivin-specific CD8+ T cell response in PBMC samples of 14/16 (87%) evaluable patients.
Treatment induced infiltration of survivin-specific T cell clones into the tumors as early as day 56 following treatment, which was shown in an analysis of the TCRβ repertoires in five subjects who achieved stable disease.

These data are presented in a poster session (Abstract Number: 6075) at the ASCO20 Virtual Scientific Program, available on-demand to ASCO20 participants beginning at 8:00 am ET on Friday, May 29, 2020. A copy of the poster is available under “Scientific Posters” in the "Events, Webcasts & Presentations" section of IMV’s website.

About the DeCidE1 Study

“DeCidE1” is a Phase 2 multicenter, open-label study evaluating the safety and effectiveness of DPX-Survivac, with intermittent low-dose cyclophosphamide (CPA) used as an immunomodulator to increase the level of survivin-specific T cells. This Phase 2 arm enrolled 19 evaluable patients with recurrent, advanced platinum-sensitive and –resistant ovarian cancer. Except for one patient, all patients had stage 3 or 4 disease at time of diagnosis. 12 patients had received 3 or more lines of prior therapy.

Patients received 2 subcutaneous injections of DPX-Survivac three weeks apart and every eight weeks thereafter, and intermittent low dose CPA one week on and one week off for up to 1 year. Paired tumor biopsies were performed prior to treatment and on treatment.

Primary endpoints of this study are overall response rate, disease control rate and safety. Secondary endpoints include cell mediated immunity, immune cell infiltration in paired biopsy samples, duration of response, time to progression, overall survival and biomarker analyses.

About DPX-Survivac

DPX-Survivac is the lead candidate in IMV’s new class of targeted immunotherapies designed to elicit antigen-specific functional, robust and sustained de novo T cell response. IMV believes this mechanism of action is key to generating durable solid tumor regressions. DPX-Survivac consists of five unique HLA-restricted survivin peptides formulated in IMV’s proprietary DPX drug delivery platform and known to induce a cytotoxic CD8+ T cell response against survivin expressing cancer cells.

Survivin, recognized by the National Cancer Institute (NCI) as a promising tumor-associated antigen, is broadly over-expressed in most cancer types and plays an essential role in antagonizing cell death, supporting tumor-associated angiogenesis and promoting resistance to chemotherapies. IMV has identified over 20 cancer indications in which survivin can be targeted by DPX-Survivac.

DPX-Survivac has received Fast Track designation from the U.S. Food and Drug Administration (FDA) as maintenance therapy in advanced ovarian cancer, as well as orphan drug designation status from the U.S. FDA and the European Medicines Agency (EMA) in the ovarian cancer indication.

About IMV

IMV Inc. is a clinical stage biopharmaceutical company dedicated to making immunotherapy more effective, more broadly applicable, and more widely available to people facing cancer and other serious diseases. IMV is pioneering a new class of cancer-targeted immunotherapies and vaccines based on the Company’s proprietary drug delivery platform. This patented technology leverages a novel mechanism of action that enables the programming of immune cells in vivo, which are aimed at generating powerful new synthetic therapeutic capabilities. IMV’s lead candidate, DPX-Survivac, is a T cell-activating immunotherapy that combines the utility of the platform with a target: survivin. IMV is currently assessing DPX-Survivac as a monotherapy in advanced ovarian cancer, as well as a combination therapy in multiple clinical studies with Merck. IMV is also developing a DPX-based vaccine to fight against COVID-19. Visit www.imv-inc.com and connect with us on Twitter and LinkedIn.

Cautionary Language Regarding Forward-Looking Statements

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

Josh Rappaport, Director, Stern IR
O: (212) 362-1200
E: [email protected]

Media
Delphine Davan, Director of Communications, IMV
O: (514) 968-1046
E: [email protected]

Source: IMV Inc.

IMV Announces Selection of a Vaccine Candidate Against COVID-19 to Advance Into Human Clinical Studies

Thu, 21 May 2020 07:05:00 -0400

Majority of 23 peptide epitopes selected by IMV demonstrated robust antibody responses in an animal model after first and second dose in DPX formulation without any additional adjuvant

DPX-COVID-19 to utilize multi-target approach, to optimize immune response against virus’ weaknesses, enhance efficacy at preventing infection and reduce potential for immune escape

Phase 1 clinical study of DPX-COVID-19 is scheduled during summer 2020

DARTMOUTH, Nova Scotia--(BUSINESS WIRE)-- IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical-stage biopharmaceutical company pioneering a novel class of cancer immunotherapies and vaccines against infectious diseases, today announced positive preclinical results demonstrating robust immunogenic and antibody responses from the majority of peptide epitopes. Based on these data, the Company has selected multiple peptide epitopes to be formulated within its DPX platform to form a vaccine candidate against the novel coronavirus, DPX-COVID-19.

“These preclinical data are highly encouraging, showing that peptides formulated within the DPX platform have induced early and strong immunogenic response in an animal model. Notably, the antibody responses observed were equivalent or superior to levels achieved with DPX-RSV, which delivered a robust and sustained immune response in a Phase 1 study,” said Marianne Stanford, Ph.D., Vice President Research and Development at IMV. “Based on these results, our team has down selected a combination of peptides that have demonstrated immunogenicity and target several areas of the virus mechanism of entry in a non-overlapping fashion. DPX-COVID-19 is designed to focus the immune response on the weaknesses for the virus, to potentially increase its efficacy at preventing the infection and to efficiently inhibit virus entry into cells, thereby reducing the potential for immune escape, even in case of a mutation.”

“These results reflect the promise and versatility of our DPX platform technology, which has enabled our team to develop a new targeted vaccine candidate just two months after launching into development. Moreover, as we have shown across our clinical studies to date, our unique, targeted approach has elicited favorable results in sensitive populations, including older adult and immunocompromised patients who are most susceptible to this virus,” said Frederic Ors, President and CEO at IMV. “We are working closely with our collaborators to advance DPX-COVID-19 with urgency and remain on track to launch a Phase 1 clinical study in summer 2020.”

IMV and its collaborators have rapidly advanced a DPX-based vaccine for COVID-19, since announcing plans in March. The Company used sequences of the virus and immunoinformatics to predict and identify several hundred epitopes, of which 23 were selected for validation in preclinical studies based on their biological relevance to the virus and potential to generate neutralizing antibodies against SARS-CoV-2. Preclinical studies have been ongoing since the beginning of April, with the goal to validate and down select the most promising peptide candidates targeting weaknesses of the virus.

In preclinical animal models, IMV evaluated all 23 peptides formulated within the DPX platform. The majority of peptide epitopes tested generated targeted antibody responses after the first and second dose, without requiring an adjuvant. Based on these results, IMV has selected an optimal combination of peptides based on the best antibody responses for each of the key mechanisms for attachment, fusion and entry of SARS-CoV-2 into human cells. The antibody responses observed were equivalent or superior to a DPX-based peptide epitope vaccine (DPX-RSV) used as a reference to evaluate the level of immunogenicity in these preclinical studies. DPX-RSV is a vaccine candidate against respiratory syncytial virus (RSV), another RNA respiratory virus, and has demonstrated high functional antibody titers (up to 100-fold increase over placebo maintained for at least 421 days¹) in a Phase 1 clinical study in older adults (age 50-64).

Further vaccination-challenge preclinical assays in animal models are currently performed and IMV intends to publish results of preclinical studies in a peer-reviewed scientific journal in the coming weeks.

In April, IMV conducted a pre-Clinical Trial Application (CTA) meeting with Health Canada and is finalizing a design for a Phase 1 clinical study of DPX-COVID-19. The randomized, placebo-controlled study is expected to enroll approximately 84 healthy subjects in two age strata and to assess two different doses of DPX-COVID-19. The Company is on track to initiate this study in the summer of 2020.

About DPX-COVID-19

DPX-COVID-19 is IMV’s vaccine candidate against the novel strain of coronavirus that is causing the current pandemic. It is a DPX-based formulation of multiple peptides of the SARS-CoV-2 that generated early and strong immune responses during the preclinical assays in animal models. A first-in-human Phase 1 clinical study is scheduled to initiate during summer 2020. Fully synthetic, DPX-COVID-19 has the potential for fast and large-scale manufacturing to supply a significant number of doses rapidly compared to more conventional vaccines. For more information, visit www.imv-inc.com

About IMV

Cautionary Language Regarding Forward-Looking Statements

The Company 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 Company’s ability to develop a DPX-based vaccine candidate against the COVID-19 through the successful and timely completion of preclinical assays, studies and clinical trials, the receipt of all regulatory approvals by the Company to commence and then continue clinical studies and trials, and, if successful, the commercialization of its proposed vaccine candidate related to COVID-19, the Company’s ability to raise sufficient capital, including potentially through grant awards available in Canada, to fund such clinical studies and trials and the production of any COVID-19 vaccine, the ultimate applicability of any third-party research and studies in related coronavirus and SARS studies and sequencing, the Company’s ability to enter into agreements with the proposed lead investigators to assist in the clinical development on its vaccine candidate related to COVID-19, the Company’s ability to collaborate with governmental authorities with respect to such clinical development, the coverage and applicability of the Company’s intellectual property rights to any vaccine candidate related to COVID-19, the ability of the Company to manufacture any vaccine candidate related to COVID-19 rapidly and at scale, the ability for the Company to accurately assess and anticipate the impact of COVID-19 on the Company’s other clinical studies and trials and operations generally and other risks detailed from time to time in the Company’s ongoing filings and in its annual information form filed with the Canadian regulatory authorities on SEDAR as www.sedar.com and with the United States Securities and Exchange Commission on EDGAR at www.sec.gov/edgar. Investors are cautioned not to rely on these forward-looking statements and are encouraged to read the Company’s continuous disclosure documents which are available on SEDAR and on EDGAR.

¹ https://pubmed.ncbi.nlm.nih.gov/29617814/

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Investor Relations

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

Josh Rappaport, Director, Stern IR
O: (212) 362-1200
E: [email protected]

Media

Delphine Davan, Director of Communications, IMV
O: (902) 492-1819
E: [email protected]

Source: IMV Inc.

IMV Inc. Provides Clinical and Operational Update and Announces First Quarter 2020 Financial Results

Fri, 15 May 2020 07:05:00 -0400

Phase 2 SPiReL study of DPX-Survivac combination regimen with Keytruda® in r/r DLBCL successfully reached primary efficacy endpoint with 64% (7/11) of evaluable patients demonstrating a clinical response
Translational and updated clinical response data from Phase 2 DeCidE1 study of DPX-Survivac in advanced ovarian cancer to be presented by Oliver Dorigo, MD, Ph.D., at the upcoming 2020 ASCO Virtual Scientific Program
DPX-COVID-19, a vaccine candidate against COVID-19, on schedule to complete preclinical studies before the end of May and progressing towards initiation of Phase 1 study expected this summer
Completed CAD $25.1M private placement with new and existing institutional investors, extending cash runway well into 2021
Management to host a conference call and webcast today at 8:00 a.m. ET

DARTMOUTH, Nova Scotia--(BUSINESS WIRE)-- IMV Inc. (the “Company” or “IMV”) (TSX:IMV; NASDAQ:IMV), a clinical-stage biopharmaceutical company pioneering a novel class of cancer immunotherapies and vaccines against infectious diseases, today announced financial results for the first quarter ended March 31, 2020 and provided an update on its clinical and operational progress.

“Despite the current pandemic, we have continued to validate our platform and advance our clinical pipeline targeting various cancers and other serious diseases, including COVID-19,” said Frederic Ors, Chief Executive Officer at IMV. “Today, we are especially pleased to announce that SPiReL, a Phase 2 study of a DPX-Survivac combination regimen in patients with r/r DLBCL, has met its primary efficacy endpoint. This represents a significant milestone for DPX-Survivac, which has so far demonstrated the ability to shrink both solid and hematological tumors with long-lasting clinical responses and a differentiated safety profile. We believe these results in r/r DLBCL, taken together with emerging data from our DeCidE1 study in advanced ovarian cancer, support our plan to accelerate development in both of these indications.”

Mr. Ors continued, “Our recent financing fortifies our corporate position, with cash to fund operations for more than 12 months and several milestones anticipated across our portfolio in the interim. We look forward to presenting translational and updated clinical response data from DeCidE1 at the ASCO20 Virtual Scientific Program, and to further updates from each of our Phase 2 studies of DPX-Survivac later this year. Additionally, we are preparing to advance a DPX-based vaccine candidate for COVID-19, which is on track to enter into clinical trials later this summer.”

DPX-Survivac Clinical Program Updates

Phase 2 SPiReL Study in Recurrent / Refractory Diffuse Large B-Cell Lymphoma (r/r DLBCL)

SPiReL is an investigator-initiated Phase 2 study evaluating DPX-Survivac/CPA in combination with Keytruda® (pembrolizumab) in r/r DLBCL. The study is led by Dr. Neil Berinstein, MD, FFCP©, ABIM, hematologist-oncologist at the Odette Cancer Centre at Sunnybrook Health Sciences Centre in Toronto, Ontario.

The study has met its primary efficacy endpoint with 64% (7/11) of evaluable patients demonstrating a clinical response so far. The study remains ongoing and the top line data are expected to be presented at a conference later in 2020.

In December 2019, updated clinical results were reported in a poster presentation at the American Society of Hematology (ASH) annual meeting in Orlando, FL. At the time of this presentation, 17 subjects were enrolled in the study, of which nine (9/17) were evaluable. At that time, three (3/9) complete responses (CR) and two partial responses (PR) had been observed, with an overall response rate (ORR) of 59% (5/9).

As of May 7, 2020, 20 patients have been enrolled across five different clinical sites in Canada.

Phase 2 DeCidE1 Study in Advanced Recurrent Ovarian Cancer

DeCidE1 is a Phase 2 multicenter, randomized, open-label study to evaluate the safety and efficacy of DPX-Survivac with intermittent low dose cyclophosphamide (CPA). This Phase 2 arm enrolled 22 patients with recurrent, advanced platinum-sensitive and/or resistant ovarian cancer.

In February, IMV reported interim data from this study, including:

15/19 (79%) evaluable subjects demonstrated disease control, including 10 tumor regressions (53%);
7/19 subjects (37%) achieved clinical benefit with partial response or stable disease lasting > 6 months; and
Treatment was well-tolerated with majority of adverse events being grade 1-2 reactions at the injection site.

At the time of the data cutoff, six (31%) patients remained on therapy. Five (26%) of these patients were still on treatment at > 6 months. Additional data are available here.

An abstract has been selected for a poster presentation at the upcoming American Society of Clinical Oncology (ASCO) Virtual Scientific Program, which will be held May 29–31, 2020. The poster presentation by Oliver Dorigo, MD, Ph.D., Associate Professor of Obstetrics and Gynecology (Oncology), Stanford University Medical Center, Stanford, CA will provide translational data and an update on clinical responses and their duration.

Phase 2 Basket Trial in Multiple Advanced Metastatic Solid Tumors

The Basket Trial is an open label, multi-center Phase 2 study, evaluating the safety and efficacy of DPX-Survivac/CPA in combination with Keytruda® across five cohorts of patients with bladder cancer, liver cancer (hepatocellular carcinoma), ovarian cancer (with and without CPA), NSCLC and tumors shown to be positive for the microsatellite instability high (MSI-H) biomarker.

As of May 7, 2020, a total of 92 patients out of the planned 184 patients were enrolled across all five indications at 19 clinical sites in Canada and the US.

The COVID-19 pandemic has impacted data collection and validation processes and IMV now anticipates reporting updated results from this study in the second half of 2020.

DPX-COVID-19 Vaccine Program Update

In early March, IMV announced plans to develop a DPX-based vaccine candidate for COVID-19 in collaboration with experts in the field. IMV is on schedule to complete preclinical studies before the end of May and is on track to initiate a Phase 1 clinical study for DPX-COVID-19 this summer.

Since this update, IMV has met with Health Canada in preparation for its clinical trial application (CTA) and is in the process of finalizing its Phase 1 design. The randomized, placebo-controlled study will enroll approximately 84 healthy subjects in two age strata and will assess two different doses of DPX-COVID-19.

IMV has also submitted to relevant authorities’ requests for grants for its DPX-COVID-19 program.

IMV will provide regular updates on the development of DPX-COVID-19 and more information can be found on the dedicated DPX-COVID-19 page on the Company’s website.

Update on Business and Clinical Operations in the Context of COVID-19 Pandemic

IMV continues to closely monitor the COVID-19 pandemic and adapt its business operations while prioritizing the health and well-being of patients, clinical investigators, and personnel. In accordance with recommendations from health authorities, IMV has transitioned to a remote working arrangement to protect employees and the broader community while maintaining business continuity. All clinical trial sites remain open and active with a heightened focus on patient safety and data integrity. While the effects of the pandemic are expected to slow the pace of patient recruitment due to the diversion of healthcare resources to COVID-19 response activities, they have not had a material impact on the Company’s financial condition, liquidity, or longer-term strategic development plans.

To date, the COVID-19 pandemic has impacted data collection and validation processes and as outlined above, this has delayed the planned readout from the Phase 2 basket study of DPX-Survivac/CPA in combination with Keytruda®. The Company continues to monitor this situation and will provide regular updates in the future.

Upcoming Milestones

Over the course of upcoming quarters, the Company expects to deliver the following milestones:

Initiation of Phase 1 clinical trial for DPX-COVID-19 in the summer of 2020
Top line Phase 2 clinical results update in the DLBCL combination trial in 2020
Update on the Phase 2 clinical results in the ovarian monotherapy trial at ASCO 2020
Updated Phase 2 clinical results for Basket trial in 2H 2020.

Overview of Q1 2020 Financial Results

Research and development expenses increased by $2,811,000 for the quarter ended March 31, 2020, compared to Q1 2019. These increases are mainly due to a spike in enrollment prior to the onset of the pandemic related to the ongoing basket trial and non-recurring purchases of GMP grade raw materials and contract manufacturing for DPX-Survivac. The purchases of GMP grade materials in 2019 and Q1 2020 covers all the needs of the Corporation for ongoing DPX-Survivac trials until mid-2021. The increase in research and development expenses is, to a lesser extent, also attributable to preclinical development of DPX-SurMAGE for bladder cancer and personnel costs due to an increase in headcount.

General and administrative expenses increased by $1,073,000 for the quarter ended March 31, 2020 compared to Q1 2019. This increase is mainly due to non-cash DSU compensation caused by share price fluctuation, foreign exchange loss, and investor relations activities, including travel costs incurred prior to the start of the COVID-19 pandemic. The Company expects reduced comparative volatility in the DSU compensation expense from Q3 2020 onward as a result of electing to settle all future DSU redemptions in shares effective August 8, 2019.

The net loss and comprehensive loss of $9,664,000 ($0.19 per share) the quarter ended March 31, 2020 was $3,721,000 higher than the net loss and comprehensive loss for the quarter ended March 31, 2019.

At March 31, 2020, the Corporation had cash and cash equivalents of $7,372,000 and working capital of $4,553,000, compared with $14,066,000 and $13,199,000, respectively at December 31, 2019. This does not reflect the proceeds from the CDN $25,100,000 private placement completed on May 7^th, 2020 or utilization of the ATM Distribution subsequent to the period end date. Based on its current plan, IMV expects its current cash position will be sufficient to fund operations for more than 12 months.

For the quarter ended March 31, 2020, IMV's cash burn rate, defined as net loss for the period adjusted for operations not involving cash (interest on lease obligation, depreciation, accretion of long-term debt, stock-based compensation and DSU compensation), was $8,646,000. IMV expects the cash burn for the remainder of 2020 to return to $5-6,000,000 per quarter due to the impact of COVID-19 and the non-recurring expenditures incurred in Q1 2020.

As of May 14, 2020, the number of issued and outstanding common shares was 60,454,474 and a total of 5,079,375 stock options, deferred share units and warrants were outstanding.

The Company's unaudited interim condensed consolidated results of operations, financial condition and cash flows for the quarter ended March 31, 2020 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.

Conference Call and Webcast Information

Management will host conference call and webcast today, May 15, 2020 at 8:00 a.m. ET. Financial analysts are invited to join the conference call by dialing (866) 211-3204 (U.S. and Canada) or (647) 689-6600 (international) using the conference ID# 8081886 Other interested parties will be able to access the live audio webcast at this link: https://ir.imv-inc.com/events-and-presentations.

About IMV

IMV Inc. is a clinical stage biopharmaceutical company dedicated to making immunotherapy more effective, more broadly applicable, and more widely available to people facing cancer and other serious diseases. IMV is pioneering a new class of cancer immunotherapies and vaccines against infectious diseases based on the Company’s proprietary drug delivery platform, DPX. This patented technology leverages a novel mechanism of action that enables the programming of immune cells in vivo, which are aimed at generating powerful new synthetic therapeutic capabilities. IMV’s lead candidate, DPX-Survivac, is a T cell-activating immunotherapy that combines the utility of the platform with a target: survivin. IMV is currently assessing DPX-Survivac as a monotherapy in advanced ovarian cancer, as well as a combination therapy in multiple clinical studies with Merck. Visit www.imv-inc.com and connect with us on Twitter and LinkedIn.

Cautionary Language Regarding Forward-Looking Statements

IMV INC.
Unaudited Interim Condensed Consolidated Statements of Loss and Comprehensive Loss
(In thousands of Canadian dollars, except shares and per share amounts)

	Three months ended, March 31,
	2020 $	2019 $
Revenue
Subcontract revenue	–	8
Interest Income	68	74
Total revenue	68	82
Expenses
Research and development	6,824	4,013
General and administrative	3,033	1,960
Government assistance	(558)	(346)
Accreted interest	433	398
Total operating expenses	9,732	6,025
Net loss and comprehensive loss	(9,664)	(5,943)
Basic and diluted loss per share	(0.19)	(0.13)
Weighted-average shares outstanding	50,719,488	46,712,436

IMV INC.
Unaudited Interim Condensed Consolidated Statements of Financial Position
(In thousands of Canadian dollars, except shares and per share amounts)

	March 31,		December 31,
	2020		2019
Assets
Current assets
Cash and cash equivalents	$	7,372	$	14,066
Accounts receivable		653		845
Prepaid expenses		2,676		3,032
Investment tax credits receivable		1,886		1,661
Total current assets		12,587		19,604
Property and equipment		2,742		2,830
Total assets	$	15,329	$	22,434
Liabilities and Equity
Current liabilities
Accounts payable and accrued liabilities	$	7,525	$	6,157
Amounts due to directors		64		60
Current portion of long-term debt		342		88
Current portion of lease obligations		103		100
Total current liabilities		8,034		6,405
Lease obligation		1,181		1,208
Long-term debt		8,529		8,373
Total liabilities		17,744		15,986
Equity		(2,415)		6,448
Total liabilities and equity	$	15,329	$	22,434

View source version on businesswire.com: https://www.businesswire.com/news/home/20200515005219/en/

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

Josh Rappaport, Director, Stern IR
O: (212) 362-1200
[email protected]

Media
Delphine Davan, Director of Communications, IMV
M: (514) 968-1046
[email protected]

Source: IMV Inc.

IMV Inc. Announces Closing of $25.1 Million Private Placement

Thu, 07 May 2020 10:16:00 -0400

DARTMOUTH, Nova Scotia--(BUSINESS WIRE)-- IMV Inc. (“IMV” or the “Company”) (Nasdaq: IMV; TSX: IMV), a clinical-stage biopharmaceutical company pioneering a novel class of cancer immunotherapies and vaccines to fight against infectious diseases including COVID-19, today announced that it has completed its previously announced non-brokered private placement (the “Private Placement”) of 8,770,005 units of the Company (each, a “Unit”) at Cdn$2.86 per Unit for gross proceeds of approximately Cdn$25.1 million. The size of the Private Placement has increased by approximately Cdn$2.8 million following our earlier announcement on April 30, 2020.

Each Unit consists of one common share of the Company (“Common Share”) and 0.35 of one common share purchase warrant (each whole common share purchase warrant, a “Warrant”). Each Warrant entitles its holder to purchase one Common Share at an exercise price of Cdn$3.72 per share and is exercisable until May 7, 2022.

The private placement is being co-led by Fonds de Solidarité FTQ, an existing investor, and Lumira Ventures, a new investor in the Company, along with participation by Altium Capital, also a new investor in IMV, together with incumbent investors.

The Company intends to use the net proceeds from the Private Placement for the clinical development of its lead candidate, DPX-Survivac, currently being assessed in advanced ovarian cancer, as well as in multiple clinical studies in combination with Merck’s Keytruda®. The balance of the net proceeds will be used for general corporate purposes, including funding research and development, preclinical and clinical expenses, and corporate costs.

All securities issued pursuant to the Private Placement will be subject to a four month and one day hold period in Canada in accordance with applicable securities laws.

Fred Ors, President and CEO of IMV commented, “We are pleased to welcome both Lumira Ventures and Altium Capital as new investors and thank Fonds de Solidarité FTQ for their leadership in this round of financing. We greatly appreciate the confidence shown in the Company. We look forward to further advancing our existing clinical pipeline and leveraging our unique and proprietary delivery platform against other selected targets including COVID-19.”

“Since 1989, the Fonds de Solidarité FTQ has supported the life sciences sector with direct investments in companies and in specialized funds which invest in Québec. More than ever, it is important to proactively support our portfolio companies like IMV that give hope to patients in particular and society in general, whether it be for the fight against cancer or COVID-19,” said Didier Leconte, Vice-President for Investments, Life Sciences and Funds of Funds, at the Fonds de Solidarité FTQ.

“We believe that an effective immunotherapy treatment must be capable of eliciting rapid, robust, and long-lasting responses and we have been impressed with the ability of the DPX platform to produce clinical evidence of such type of immune responses. We are happy to support IMV in advancing such a differentiated immunotherapy approach to potentially provide a much needed new treatment option for women with advanced ovarian cancer.” said Daniel Hétu, Managing director at Lumira Ventures.

About IMV

IMV Inc. is a clinical stage biopharmaceutical company dedicated to making immunotherapy more effective, more broadly applicable, and more widely available to people facing cancer and other serious diseases. IMV is pioneering a new class of immunotherapies based on the Company’s proprietary drug delivery platform (DPX). This patented technology leverages a novel mechanism of action that enables the programming of immune cells in vivo, which are aimed at generating powerful new synthetic therapeutic capabilities. IMV’s lead candidate, DPX-Survivac, is a T cell-activating immunotherapy that combines the utility of the platform with a target: survivin. IMV is currently assessing DPX-Survivac in advanced ovarian cancer, as well as in a combination therapy in multiple clinical studies with Merck’s Keytruda®. IMV is also developing a DPX-based vaccine to fight against COVID-19. Connect at www.imv-inc.com.

Cautionary Language Regarding Forward-Looking Statements

The Units, Common Shares and Warrants have not been registered under the United States Securities Act of 1933, as amended, and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements.

View source version on businesswire.com: https://www.businesswire.com/news/home/20200507005653/en/

Investor Relations

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

Josh Rappaport, Director, Stern IR
O: (212) 362-1200
E: [email protected]

Media

Delphine Davan, Director of Communications, IMV
M: (514) 968-1046
E: [email protected]

Source: IMV Inc.

IMV Inc. to Announce First Quarter 2020 Results and Host a Conference Call and Webcast on May 15, 2020

Mon, 04 May 2020 07:05:00 -0400

DARTMOUTH, Nova Scotia--(BUSINESS WIRE)-- IMV Inc. (“IMV” or the “Corporation”) (Nasdaq: IMV; TSX: IMV), a clinical-stage biopharmaceutical company pioneering a novel class of cancer immunotherapies and vaccines to fight against infectious diseases including COVID-19, announced today that it will hold a conference call and webcast on Friday, May 15, 2020 at 8:00 a.m. ET to discuss the company’s first quarter 2020 financial and operational results.

Financial analysts are invited to join the conference call by dialing (866) 211-3204 (U.S. and Canada) or (647) 689-6600 (international) using the conference ID: 8081886.

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 IMV website for 30 days following the call.

About IMV

IMV Inc. is a clinical stage biopharmaceutical company dedicated to making immunotherapy more effective, more broadly applicable, and more widely available to people facing cancer and other serious diseases. IMV is pioneering a new class of cancer immunotherapies and vaccines based on the Company’s proprietary drug delivery platform (DPX). This patented technology leverages a novel mechanism of action that enables the programming of immune cells in vivo, which are aimed at generating powerful new synthetic therapeutic capabilities. IMV’s lead candidate, DPX-Survivac, is a T cell-activating immunotherapy that combines the utility of the platform with a target: survivin. IMV is currently assessing DPX-Survivac in advanced ovarian cancer, as well as in a combination therapy in multiple clinical studies with Merck’s Keytruda^®. IMV is also developing a DPX-based vaccine to fight against COVID-19. For more information, visit www.imv-inc.com and follow us on Twitter and LinkedIn.

Cautionary Language Regarding Forward-Looking Statements

Such statements 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 and uncertainties affecting the Company and its products.

The Company 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 Company’s ability to develop a DPX-based vaccine candidate against the COVID-19 through the successful and timely completion of preclinical assays, studies and clinical trials, the receipt of all regulatory approvals by the Company to commence and then continue clinical studies and trials, and, if successful, the commercialization of its proposed vaccine candidate related to COVID-19, the Company’s ability to raise sufficient capital, including potentially through grant awards available in Canada, to fund such clinical studies and trials and the production of any COVID-19 vaccine, the ultimate applicability of any third-party research and studies in related coronavirus and SARS studies and sequencing, the Company’s ability to enter into agreements with the proposed lead investigators to assist in the clinical development on its vaccine candidate related to COVID-19, the Company’s ability to collaborate with governmental authorities with respect to such clinical development, the coverage and applicability of the Company’s intellectual property rights to any vaccine candidate related to COVID-19, the ability of the Company to manufacture any vaccine candidate related to COVID-19 rapidly and at scale, the ability for the Company to accurately assess and anticipate the impact of COVID-19 on the Company’s other clinical studies and trials and operations generally and other risks detailed from time to time in the Company’s ongoing filings and in its annual information form filed with the Canadian regulatory authorities on SEDAR as www.sedar.com and with the United States Securities and Exchange Commission on EDGAR at www.sec/edgar. Investors are cautioned not to rely on these forward-looking statements and are encouraged to read the Company’s continuous disclosure documents which are available on SEDAR and on EDGAR.

View source version on businesswire.com: https://www.businesswire.com/news/home/20200504005052/en/

Media
Delphine Davan, Director, Communications, IMV
M: (514) 968-1046
E: [email protected]

Source: IMV Inc.

IMV Announces Proposed $22.3 Million Private Placement

Thu, 30 Apr 2020 07:05:00 -0400

DARTMOUTH, Nova Scotia--(BUSINESS WIRE)-- IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical-stage biopharmaceutical company, today announced its intention to complete a private placement (the “Private Placement”) of 7,797,203 units of the Company (each, a “Unit”) at the market price of Cdn$2.86 per Unit based on the volume-weighted average price calculated over the 5 days ending Friday, April 24, 2020.

With aggregate gross proceeds of approximately Cdn$22.3 million this non-brokered private placement is being co-led by Fonds de Solidarité FTQ, an existing investor, and Lumira Ventures, a new investor in the Company, along with participation by Altium Capital, also a new investor in IMV and including other institutional investors. The Company intends to use the net proceeds from the Private Placement for the clinical development of its lead candidate, DPX-Survivac, currently being assessed in advanced ovarian cancer, as well as in multiple clinical studies in combination with Merck’s Keytruda®. The balance of the net proceeds will be used for general corporate purposes, including funding research and development, preclinical and clinical expenses, and corporate costs.

Each Unit will consist of one common share of the Company (“Common Share”) and 0.35 of one common share purchase warrant (each whole common share purchase warrant, a “Warrant”). Each Warrant will have an exercise price of Cdn$3.72 and will be exercisable until 24 months after its issuance.

The Company anticipates that the Private Placement will close on or about May 7, 2020. The Private Placement is conditional upon the Company receiving the conditional approval of the Toronto Stock Exchange (the “TSX”) to list the Common Shares underlying the Units and the Warrants on the TSX. Listing will be subject to satisfying all of the requirements of the TSX. The Private Placement is also subject to the requirements of the NASDAQ Stock Market (“NASDAQ”).

All securities issued pursuant to the Private Placement will be subject to a four month and one day hold period in Canada in accordance with applicable securities laws.

About IMV

IMV Inc. is a clinical stage biopharmaceutical company dedicated to making immunotherapy more effective, more broadly applicable, and more widely available to people facing cancer and other serious diseases. IMV is pioneering a new class of immunotherapies based on the Company’s proprietary drug delivery platform (DPX). This patented technology leverages a novel mechanism of action that enables the programming of immune cells in vivo, which are aimed at generating powerful new synthetic therapeutic capabilities. IMV’s lead candidate, DPX-Survivac, is a T cell-activating immunotherapy that combines the utility of the platform with a target: survivin. IMV is currently assessing DPX-Survivac in advanced ovarian cancer, as well as in a combination therapy in multiple clinical studies with Merck’s Keytruda^®. IMV is also developing a DPX-based vaccine to fight against COVID-19. Connect at www.imv-inc.com.

Cautionary Language Regarding Forward-Looking Statements

View source version on businesswire.com: https://www.businesswire.com/news/home/20200430005268/en/

Investor Relations

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

Josh Rappaport, Director, Stern IR
O: (212) 362-1200
E: [email protected]

Media

Delphine Davan, Director of Communications, IMV
M: (514) 968-1046
E: [email protected]

Source: IMV Inc.

IMV to Participate in Adelaide Capital’s Virtual COVID & Healthcare Mini Conference

Tue, 21 Apr 2020 17:05:00 -0400

DARTMOUTH, Nova Scotia--(BUSINESS WIRE)-- IMV Inc. (Nasdaq: IMV; TSX: IMV) a clinical-stage biopharmaceutical company, today announced that Company’s management will be participating in Adelaide Capital’s Virtual COVID & Healthcare Mini Conference on April 23, 2020 from 12pm-5pm ET.

The conference will showcase the role Canadian companies are playing to help fight the coronavirus pandemic. IMV will present its plans around its DPX-COVID-19 candidate currently in development with well-respected Canadian experts.

The conference will consist of 20-minute presentations followed by a panel discussing some of the key issues involved in the crisis today and a featured keynote by Next Edge Capital’s Eden Rahim entitled “Signal from the Noise: A compass to finding COVID19 investment opportunities.” In participating in this conference, IMV will be supporting the HandSan Project.

Please RSVP for this event directly through the link provided by Adelaide Capital. IMV is scheduled to make its virtual presentation at 2:20 pm. Eastern Time and will then take part in the panel discussion scheduled later that day at 3:40 pm.

A copy of IMV’s presentation will be available in the “Events, Webcasts and Presentations” of the investors section of the IMV website. IMV will also continue to provide updates on the development of DPX-COVID-19, and is working on a dedicated DPX-COVID-19 page on its website.

About IMV

IMV Inc. is a clinical stage biopharmaceutical company dedicated to making immunotherapy more effective, more broadly applicable, and more widely available to people facing cancer and other serious diseases. IMV is pioneering a new class of immunotherapies based on the Company’s proprietary drug delivery platform (DPX). This patented technology leverages a novel mechanism of action that enables the programming of immune cells in vivo, which are aimed at generating powerful new synthetic therapeutic capabilities. IMV’s lead candidate, DPX-Survivac, is a T cell-activating immunotherapy that combines the utility of the platform with a target: survivin. IMV is currently assessing DPX-Survivac in advanced ovarian cancer, as well as in a combination therapy in multiple clinical studies with Merck’s Keytruda^®. IMV is also developing a DPX-based vaccine to fight against COVID-19. Connect at www.imv-inc.com.

About Adelaide Capital

Adelaide Capital is a full-service Investor Relations firm that brings to the table a unique and powerful perspective and a re-engineered IR business model. Our extensive capital markets experience allows us to go deeper, strategically assessing each client company and tailoring a plan that charts the best path to success. Specializing in small and mid-cap companies, our offering is enhanced by a truly formidable factor—our personal connection to a sizable and valuable network of investors throughout North America and around the world.

Cautionary Language Regarding Forward-Looking Statements

The Company 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 Company’s ability to develop a DPX-based vaccine candidate against the COVID-19 through the successful and timely completion of preclinical assays, studies and clinical trials, the receipt of all regulatory approvals by the Company to commence and then continue clinical studies and trials, and, if successful, the commercialization of its proposed vaccine candidate related to COVID-19, the Company’s ability to raise sufficient capital, including potentially through grant awards available in Canada, to fund such clinical studies and trials and the production of any COVID-19 vaccine, the ultimate applicability of any third-party research and studies in related coronavirus and SARS studies and sequencing, the Company’s ability to enter into agreements with the proposed lead investigators to assist in the clinical development on its vaccine candidate related to COVID-19, the Company’s ability to collaborate with governmental authorities with respect to such clinical development, the coverage and applicability of the Company’s intellectual property rights to any vaccine candidate related to COVID-19, the ability of the Company to manufacture any vaccine candidate related to COVID-19 rapidly and at scale, the ability for the Company to accurately assess and anticipate the impact of COVID-19 on the Company’s other clinical studies and trials and operations generally and other risks detailed from time to time in the Company’s ongoing filings and in its annual information form filed with the Canadian regulatory authorities on SEDAR as www.sedar.com and with the United States Securities and Exchange Commission on EDGAR at www.sec/edgar. Investors are cautioned not to rely on these forward-looking statements and are encouraged to read the Company’s continuous disclosure documents which are available on SEDAR and on EDGAR.

View source version on businesswire.com: https://www.businesswire.com/news/home/20200421005781/en/

Investor Relations

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

Josh Rappaport, Director, Stern IR
O: (212) 362-1200
E: [email protected]

Media

Delphine Davan, Director of Communications, IMV
M: (514) 968-1046
E: [email protected]

Source: IMV Inc.

IMV Inc. Announces Fourth Quarter and Full Year 2019 Financial and Operational Results

Mon, 30 Mar 2020 17:05:00 -0400

Launched development program for a DPX-based vaccine candidate against COVID-19

Reported updated Phase 2 data from DeCidE1 study in advanced ovarian cancer; These encouraging results support DPX-Survivac being amongst the first in vivo T cell therapy to demonstrate meaningful clinical activity in a hard-to-treat solid tumor with 37% (7/19) evaluable subjects achieving durable clinical benefit lasting ≥ 6 months

Updated Phase 2 data from SPiReL study evaluating DPX-Survivac as a combination therapy in r/r DLBCL presented at ASH 2019, where 78% (7/9) evaluable subjects exhibited clinical benefit, including three complete responses and two partial responses.

One subject, who received three prior lines of systemic therapies and failed autologous stem cell transplant, reached a complete response at the first on-study scan following treatment with the DPX-Survivac combination regimen and remained free of disease recurrence after completing the study

Demonstrated, through our trials, DPX-Survivac’s ability to elicit sustained clinical activity in both solid and hematologic tumors with a favorable tolerability and safety profile

Implemented, in the context of the COVID-19 pandemic, measures to ensure the continuity of its business and clinical activities

Management to host conference call and webcast tomorrow at 8:00 a.m. ET

DARTMOUTH, Nova Scotia--(BUSINESS WIRE)-- IMV Inc. (the “Company” or “IMV”) (TSX:IMV; NASDAQ:IMV), a clinical-stage biopharmaceutical company pioneering a novel class of immunotherapies, today announced its financial and operational results for the fourth quarter and full year ended December 31, 2019.

“We have made significant progress this past year at IMV, with multiple encouraging readouts from clinical and translational studies of our lead candidate, DPX-Survivac. Taken together, these data not only provide important validation of our platform’s novel mechanism and survivin as a target antigen, but also demonstrate its ability to elicit sustained clinical activity in both solid and hematologic tumors,” said Frederic Ors, Chief Executive Officer of IMV. “In particular, the recent results from DeCidE1, our ongoing Phase 2 study in advanced ovarian cancer, show DPX-Survivac’s potential to deliver improved outcomes over standard-of-care chemotherapy across key measures in a heavily pre-treated solid tumor population while also providing for excellent benefits and being well tolerated by patients during treatment.”

Mr. Ors continued, “More recently, the 2019 novel coronavirus (COVID-19) pandemic has significantly impacted businesses across all sectors and the healthcare industry is not spared. In this context, we implemented a continuity plan for our current business and clinical operations following the FDA guidance. Vaccines against infectious disease have been a core part of IMV’s heritage across the DPX platform technology, and we have decided to launch the development of a DPX-based vaccine against COVID-19.”

“Even in these challenging times, we expect to keep a forward momentum with planned updates from ongoing Phase 2 studies. Looking ahead, as we hope to accumulate proof-of-concept in multiple hard-to-treat indications, we plan to engage with the U.S. Food and Drug Administration (FDA) on the design of potential pivotal trials in support of an accelerated pathway for DPX-Survivac in advanced ovarian cancer and r/r DLBCL."

Development of the DPX-COVID-19 vaccine candidate

On Wednesday, March 18, 2020, IMV announced in a press release plans to develop of a DPX-based vaccine candidate for COVID-19 in collaboration with experts in the field. Earlier today, we announced an update on our progress:

The Company has used sequences of the virus and immunoinformatics to predict and identify several hundred epitopes, of which 23 were selected for their biological relevance to the virus and potential to generate neutralizing antibodies against SARS-CoV-2;
Based on this analysis, IMV has begun manufacturing peptide candidates targeting these epitopes as well as planning with IMV’s suppliers and contract manufacturers to prepare for the cGMP batch required to support a clinical study in humans;
In collaboration with Gary Kobinger, Ph.D., Director of the Research Centre on Infectious Diseases at the University Laval in Quebec City, preclinical assays in animal models are also planned in April through May of this year to validate the safety and potency of the vaccine candidate before initiating the human clinical study;
In collaboration with Joanne Langley, M.D. at the Canadian Center for Vaccinology (CCfV) and the Canadian Immunization Research Network (CIRN) the design of a Phase 1 clinical study in 48 healthy subjects has been completed and clinical sites identified in both Nova Scotia and Quebec;
IMV has initiated discussions with Health Canada in preparation for a Clinical Trial Application (CTA). A meeting is being scheduled in the week of April 20, 2020 with the goal to initiate the clinical study in the summer of 2020; and
The company has submitted several grant applications in Canada in an effort to help support its clinical program.

IMV will continue to provide updates on the development of DPX-COVID-19, and is working on a dedicated DPX-COVID-19 page on its website.

DPX-Survivac Clinical Program Updates

Phase 2 DeCidE1 Study in Advanced Recurrent Ovarian Cancer

DeCidE1 is a Phase 2 multicenter, randomized, open-label study to evaluate the safety and efficacy of DPX-Survivac with intermittent low dose cyclophosphamide (CPA). This phase 2 arm enrolled 22 patients with recurrent, advanced platinum-sensitive and/or resistant ovarian cancer.

In February 2020, IMV reported interim data from this study, demonstrating amongst others:

15/19 (79%) evaluable subjects demonstrated disease control, including 10 tumor regressions (53%);
7/19 subjects (37%) achieved clinical benefit with partial/stable responses lasting > 6 months; and
Treatment was well-tolerated with majority of adverse events being grade 1-2 reactions at the injection site.

At the time of the data cutoff, six (31%) patients remained on therapy. Five (26%) of these patients were still on treatment at > 6 months. Additional data available here.

Phase 2 SPiReL Study in r/r DLBCL

SPiReL is an investigator-initiated Phase 2 study evaluating DPX-Survivac and CPA in combination with Keytruda® (pembrolizumab) in r/r DLBCL.

In December 2019, updated clinical results were reported in a poster presentation at the American Society of Hematology (ASH) annual meeting in Orlando, FL. Highlights of the data included:

7/9 (77.8%) evaluable subjects exhibited clinical benefit, including three (33.3%) complete responses and two (22.2%) partial responses;
Reproducible survivin-specific T cell responses observed in all subjects that achieved clinical responses on treatment;
One subject, who received three prior lines of systemic therapies and failed autologous stem cell transplant, reached a complete response at the first on-study scan following treatment with the DPX-Survivac combination regimen and remained free of disease recurrence after completing the study; and
Clinical benefits and favorable toxicity profile observed in a heterogenous population of r/r DLBCL patients, including patients of advanced age and/or with comorbidities, who are more susceptible to adverse effects and more difficult to treat.

The study remains ongoing, with preliminary topline results expected in 2020.

Phase 2 Basket Trial in Multiple Advanced Metastatic Solid Tumors

The Basket Trial is an open label, multi-center Phase 2 study, evaluating the safety and efficacy of DPX-Survivac and CPA in combination with Keytruda® across five cohorts of patients with bladder cancer, liver cancer (hepatocellular carcinoma), ovarian cancer (with and without CPA), NSCLC and tumors shown to be positive for the microsatellite instability high (MSI-H) biomarker.

As of March 24, 2020, a total of 82 patients were enrolled across all five indications out of a maximum target number of 184 patients.

In the context of the COVID-19 pandemic, IMV expects to report preliminary topline clinical results on several of the solid tumor indications later in 2020.

Clinical Translational Studies

In November 2019, IMV presented translational data from the DeCidE1 clinical study at the 34^th Annual Meeting of the Society for the Immunotherapy of Cancer (SITC) in National Harbor, MD. The data validate DPX-Survivac’s underlying mechanism of action and are available here.

In February 2020, Dr. Oliver Dorigo, MD, Ph.D. presented, on behalf of IMV, translational data supporting DPX-Survivac’s mechanism of action at the ASCO-SITC Clinical Immuno-Oncology Symposium in Orlando, FL. The data included samples collected from three Phase 1 and/or Phase 2 studies evaluating DPX-Survivac alone or in a combination regimen in patients with advanced, platinum-sensitive or resistant ovarian cancer and are available here.

Operational Highlights:

Update on IMV’s clinical operation following the COVID-19 pandemic: It is anticipated that the COVID-19 pandemic crisis will impact ongoing trial activities across the industry due to the pressure placed on the healthcare system as well as governmental and institutional restrictions. IMV’s clinical team is working closely with each clinical site and our CRO on a contingency plan to ensure that patient safety and the integrity of data is maintained. IMV is following the FDA guidance issued for the COVID-19 pandemic: “FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic Guidance for Industry, Investigators, and Institutional Review Boards".

Additionally, the team continues to monitor updated institutional, regional and national guidance to fully comply with applicable guidelines as they are issued. It is noted that some clinical sites have paused or slowed enrollment in clinical trials, while other sites, less impacted, are continuing activities as planned. The overall enrollment rate may decrease, but clinical activities are continuing, and patients are encouraged to comply with directives from public health officials and, subject to such compliance, to attend visits as planned or to discuss alternatives with their physician.

The current activities performed at central labs to assess the eligibility of patients and the management of clinical samples is not impacted, and IMV is working with the vendors to ensure continuity of activities. Finally, drug supply is not expected to be impacted at this time. As added precaution, IMV is working on a contingency plan to ensure proper provisioning of drugs to all clinical sites in the event of future transportation or other constraints.

Appointment of Joanne Schindler, M.D., D.V.M. as Chief Medical Officer: Dr. Schindler joined IMV in November 2019 and has over 15 years of experience in the biopharmaceutical industry, primarily in early-stage oncology drug development. Most recently, she served as Vice President, Clinical Development at H3 Biomedicine, and will oversee IMV’s clinical development efforts.

Research collaboration with Navidea Biopharmaceuticals: In November 2019, IMV entered into a preclinical research collaboration with Navidea to explore the potential combinatory effect of DPX-based immunotherapies with Navidea’s activated macrophage-targeting therapeutics. IMV and Navidea will jointly conduct research throughout the duration of the study.

Upcoming Milestones:

Over the course of upcoming quarters, the Company expects to deliver the following milestones:

Top line Phase 2 clinical results update in the DLBCL combination trial in 2020
Updated Phase 2 clinical results for Basket trial in 2Q20
Potential initiation of Phase 1 clinical trial for DPX-COVID-19 during the summer of 2020

Overview of Year-End 2019 Financial Results

Research and development expenses increased by $6,044,000 for the year ended December 31, 2019, compared to 2018. These increases are mainly due to expenses related to the ongoing basket trial, pre-clinical development of DPX-SurMAGE for bladder cancer and personnel costs due to an increase in headcount. The increase is also attributable to manufacturing activities to support the increased clinical activity, which included purchasing raw materials and contract manufacturing organization costs.

General and administrative expenses increased by $897,000 for the year ended December 31, 2019 compared to 2018. This increase is mainly due to personnel costs as a result of increased head count, investor relations activities, a full year of increased insurance premiums and regulatory fees following the Nasdaq listing in mid-2018, and a full year of increased rent, lease interest accretion, and utilities following the move to its new Dartmouth facility in mid-2018.

The net loss and comprehensive loss of $27,365,000 ($0.55 per share) the year ended December 31, 2019 was $5,430,000 higher than the net loss and comprehensive loss for the year ended December 31, 2018.

At December 31, 2019, the Corporation had cash and cash equivalents of $14,066,000 and working capital of $13,199,000, compared with $14,895,000 and $12,247,000, respectively at December 31, 2018. For the year ended December 31, 2019, IMV's cash burn rate, defined as net loss for the period adjusted for operations not involving cash (interest on lease obligation, depreciation, accretion of long-term debt, stock-based compensation and DSU compensation), was $25.5 million. IMV expects research and development expenditures to increase over time due to the continuing development of product candidates and other clinical, preclinical, and regulatory activities.

As of March 30, 2020, the number of issued and outstanding common shares was 51,028,180 and a total of 1,959,452 stock options and deferred share units were outstanding.

The Corporation's audited annual consolidated results of operations, financial condition and cash flows for the year ended December 31, 2019 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.

Conference Call and Webcast Information

Management will host conference call and webcast tomorrow, March 31, 2020 at 8:00 a.m. ET. Financial analysts are invited to join the conference call by dialing (866) 211-3204 (U.S. and Canada) or (647) 689-6600 (international) using the conference ID# 7482187 Other interested parties will be able to access the live audio webcast at this link: https://ir.imv-inc.com/events-and-presentations.

About IMV

IMV Inc. is a clinical stage biopharmaceutical company dedicated to making immunotherapy more effective, more broadly applicable, and more widely available to people facing cancer and other serious diseases. IMV is pioneering a new class of immunotherapies and vaccines based on the Company’s proprietary drug delivery platform (DPX). This patented technology leverages a novel mechanism of action that enables the programming of immune cells in vivo, which are aimed at generating powerful new synthetic therapeutic capabilities. IMV’s lead candidate, DPX-Survivac, is a T cell-targeted immunotherapy that combines the utility of the platform with a target: survivin. IMV is currently assessing DPX-Survivac targeted therapy in advanced ovarian cancer, as well as a combination therapy in multiple clinical studies with Merck. Connect at www.imv-inc.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 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 intention to develop a DPX-based vaccine candidate against COVID-19, the Company’s belief that the DPX-based platform creates the opportunity for accelerated development and rapid, large-scale production of a COVID-19 vaccine, the Company’s belief in the potential efficacy of its DPX-based vaccine against COVID-19, the Company’s belief in the benefits of the third-party research and studies in related coronavirus and SARS studies and third-party sequencing data and their applicability to the Company’s DPX platform and a DPX platform related vaccine, the expected milestone completion dates and the Company’s anticipated results and expected timing of such results from its DPX cancer and infectious disease studies. Such statements 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 and uncertainties affecting the Company and its products. The Company 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 Company’s ability to develop a DPX-based vaccine candidate against the COVID-19 through the successful and timely completion of clinical trials and studies, the receipt of all regulatory approvals by the Company to commence and then continue clinical studies, and, if successful, the commercialization of its proposed vaccine candidate related to COVID-19, the Company’s ability to raise sufficient capital to fund such clinical trials and studies and the production of any COVID-19 vaccine, the ultimate applicability of any third-party research and studies in related coronavirus and SARS studies and sequencing, the Company’s ability to enter into agreements with the proposed lead investigators to assist in the clinical development on its vaccine candidate related to COVID-19, the Company’s ability to collaborate with governmental authorities with respect to such clinical development, the coverage and applicability of the Company’s intellectual property rights to any vaccine candidate related to COVID-19, the ability of the Company to manufacture any vaccine candidate related to COVID-19 rapidly and at scale and other risks detailed from time to time in the Company’s ongoing filings and in its annual information form filed with the Canadian regulatory authorities on SEDAR as www.sedar.com and with the United States Securities and Exchange Commission on EDGAR at www.sec.gov/edgar. Investors are cautioned not to rely on these forward-looking statements and are encouraged to read the Company’s continuous disclosure documents which are available on SEDAR and on EDGAR.

IMV INC.
Consolidated Statements of Loss and Comprehensive Loss
(In thousands of Canadian dollars, except shares and per share amounts)

	Years ended December 31,
	2019	2018
	$	$
Revenue
Subcontract revenue	59	82
Interest Income	509	401
Total revenue	568	483
Expenses
Research and development	18,986	12,852
General and administrative	10,140	9,243
Government assistance	(2,432)	(1,062)
Accreted interest	1,239	1,385
Total operating expenses	27,933	22,418
Net loss and comprehensive loss	(27,365)	(21,935)
Basic and diluted loss per share	(0.55)	(0.50)
Weighted-average shares outstanding	49,653,578	43,766,951

IMV INC.
Consolidated Statements of Financial Position
(In thousands of Canadian dollars, except shares and per share amounts)
	December 31,		December 31,
	2019		2018
Assets
Current assets
Cash and cash equivalents	$	14,066	$	14,895
Accounts receivable		845		1,337
Prepaid expenses		3,032		2,699
Investment tax credits receivable		1,661		1,111
Total current assets		19,604		20,042
Property and equipment		2,830		2,883
Total assets	$	22,434	$	22,925
Liabilities and Equity
Current liabilities
Accounts payable and accrued liabilities	$	6,157	$	7,575
Amounts due to directors		60		49
Current portion of long-term debt		88		81
Current portion of lease obligations		100		90
Total current liabilities		6,405		7,795
Lease obligation		1,208		1,308
Deferred share units		–		1,436
Long-term debt		8,373		8,069
Total liabilities		15,986		18,608
Equity		6,448		4,317
Total liabilities and equity	$	22,434	$	22,925

View source version on businesswire.com: https://www.businesswire.com/news/home/20200330005730/en/

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

Josh Rappaport, Director, Stern IR
O: (212) 362-1200
E: [email protected]

Media
Mrs. Delphine Davan, Director, Communications, IMV
M: (514) 968-1046
E: [email protected]

Source: IMV Inc.

IMV Inc. Provides Updates on the Development of DPX-COVID-19 Vaccine, Its Ongoing Business and Clinical Operations

Mon, 30 Mar 2020 07:05:00 -0400

DARTMOUTH, Nova Scotia--(BUSINESS WIRE)-- IMV Inc. (Nasdaq: IMV) (TSX: IMV), a clinical-stage biopharmaceutical company (the “Company” or “IMV”), today provided updates on the development of DPX-COVID-19, a vaccine candidate against the novel coronavirus, and on the Company’s business and clinical operations amid the COVID-19 pandemic.

“As the COVID-19 pandemic continues to spread, we have taken all necessary measures to prioritize the health and safety of our employees, patients, investigators and each of their families. In parallel, we remain committed to serving the unmet needs of patients, both through our efforts to potentially develop a prophylactic vaccine to curb this novel coronavirus and across our ongoing clinical studies with DPX-Survivac in advanced-stage cancer patients,” said Frederic Ors, Chief Executive Officer of IMV. “We are committed to progressing the development of our DPX-COVID-19 vaccine candidate working expeditiously with our partners to advance human clinical studies as fast as possible.”

Update on IMV’s Development of DPX-COVID-19

On Wednesday, March 18, 2020, IMV announced in a press release plans to develop of a DPX-based vaccine for COVID-19 in collaboration with well-respected experts. Since the genomic and proteomic sequences of the novel coronavirus (SARS-Cov2) were made available, the Company has made significant progress as follows:

The Company has used sequences of the virus and immunoinformatics to predict and identify several hundred epitopes, of which 23 were selected for their biological relevance to the virus and potential to generate neutralizing antibodies against SARS-CoV-2.

Based on this analysis, IMV has begun manufacturing peptide candidates targeting these epitopes as well as planning with IMV’s suppliers and contract manufacturers to prepare for the cGMP batch required to support a clinical study in humans.

In collaboration with Gary Kobinger, Ph.D., Director of the Research Centre on Infectious Diseases at the University Laval in Quebec City, preclinical assays in animal models are also planned in April through May of this year to validate the safety and potency of the vaccine candidate before initiating the human clinical study.

In collaboration with Joanne Langley, M.D. at the Canadian Center for Vaccinology (CCfV) and the Canadian Immunization Research Network (CIRN) the design of a Phase 1 clinical study in 48 healthy subjects has been completed and clinical sites identified in both Nova Scotia and Quebec.

IMV has initiated discussions with Health Canada in preparation for a Clinical Trial Application (CTA). A meeting is being scheduled in the week of April 20, 2020 with the goal to initiate the clinical study in the summer of 2020.

The company has submitted several grant applications in Canada in an effort to help support its clinical program.

IMV will continue to provide updates on the development of DPX-COVID-19, and is working on a dedicated DPX-COVID-19 page on its website.

Update on IMV’s Business and Clinical Operations

IMV prioritizes the health and safety of its employees and their families, and of the patients, investigators and healthcare professionals involved in clinical studies of DPX candidates.

Business Operations:

In line with public health interventions recommended to impede the spread of COVID-19, IMV has implemented policies to protect its team: Health Canada hygiene measures were enforced on premises; the Company suspended all corporate travel outside Canada and between corporate offices in Québec and Dartmouth; and the Company’s IT infrastructure has been revised to support employees working from home.

With its COVID-19 development activities and its ongoing clinical trials, IMV is considered as an essential health and community service provider and is making all efforts to comply with the classification requirements of Nova Scotia and Quebec.

The Company has taken additional action to maximize social distancing, including reviewing individual lab schedules on a weekly basis to ensure the continuity of activities in the lab and assessing activities to require the minimum number of people who can perform the activity safely and with appropriate quality.

Clinical Operations:

It is anticipated that the COVID-19 pandemic crisis will impact ongoing trial activities across the industry due to the pressure placed on the healthcare system as well as governmental and institutional restrictions.

IMV’s clinical team is working closely with each clinical site and our CRO on a contingency plan to ensure that patient safety and the integrity of data is maintained.

IMV is following the FDA guidance issued for the COVID-19 pandemic: “FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic Guidance for Industry, Investigators, and Institutional Review Boards".

Additionally, the team continues to monitor updated institutional, regional and national guidance to fully comply with applicable guidelines as they are issued. It is noted that some clinical sites have paused or slowed enrollment in clinical trials, while other sites, less impacted, are continuing activities as planned. The overall enrollment rate may decrease, but clinical activities are continuing, and patients are encouraged to attend visits as planned or to discuss alternatives with their physician.

The current activities performed at central labs to assess the eligibility of patients and the management of clinical samples is not impacted, and IMV is working with the vendors to ensure continuity of activities.

Drug supply is not expected to be impacted at this time. As added precaution, IMV is working on a contingency plan to ensure proper provisioning of drugs to all clinical sites in the event of future transportation or other constraints.

About the DPX Platform

DPX is the Company’s proprietary lipid-based delivery platform with no aqueous component in the final formulation. The DPX platform can be formulated with peptide antigens. Its unique “no release” mechanism of action allows antigen presenting cells (APCs) to be attracted to the injection site, facilitating a robust and sustained immune response within lymph nodes. Fully synthetic, easy to manufacture; each product is stored in dry form and reconstituted in lipids for injection, providing an extended shelf life and simple handling and administration in the clinic. More details about the DPX mechanism of action here: https://imv-inc.com/platform.

About IMV

IMV Inc. is a clinical stage biopharmaceutical company dedicated to making immunotherapy more effective, more broadly applicable, and more widely available to people facing cancer and other serious diseases. IMV is pioneering a new class of immunotherapies based on the Company’s proprietary drug delivery platform (DPX). This patented technology leverages a novel mechanism of action that enables the programming of immune cells in vivo, which are aimed at generating powerful new synthetic therapeutic capabilities. IMV’s lead candidate, DPX-Survivac, is a T cell-activating immunotherapy that combines the utility of the platform with a target: survivin. IMV is currently assessing DPX-Survivac in advanced ovarian cancer, as well as in a combination therapy in multiple clinical studies with Merck’s Keytruda^®. Connect at www.imv-inc.com .

Cautionary Language Regarding 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 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 progress in developing a DPX-based vaccine candidate against COVID-19, the Company’s belief that the DPX-based platform creates the opportunity for production of a COVID-19 vaccine, the Company’s belief in the potential efficacy of its DPX-based vaccine against COVID-19, the anticipated timing of the Company’s preclinical assays, studies and clinical trials related to its DPX-based vaccine against COVID-19 and the expected impact of COVID-19 on the Company’s other clinical studies and trials and its operations generally. Such statements 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 and uncertainties affecting the Company and its products. The Company 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 Company’s ability to develop a DPX-based vaccine candidate against the COVID-19 through the successful and timely completion of preclinical assays, studies and clinical trials, the receipt of all regulatory approvals by the Company to commence and then continue clinical studies and trials, and, if successful, the commercialization of its proposed vaccine candidate related to COVID-19, the Company’s ability to raise sufficient capital, including potentially through grant awards available in Canada, to fund such clinical studies and trials and the production of any COVID-19 vaccine, the ultimate applicability of any third-party research and studies in related coronavirus and SARS studies and sequencing, the Company’s ability to enter into agreements with the proposed lead investigators to assist in the clinical development on its vaccine candidate related to COVID-19, the Company’s ability to collaborate with governmental authorities with respect to such clinical development, the coverage and applicability of the Company’s intellectual property rights to any vaccine candidate related to COVID-19, the ability of the Company to manufacture any vaccine candidate related to COVID-19 rapidly and at scale, the ability for the Company to accurately assess and anticipate the impact of COVID-19 on the Company’s other clinical studies and trials and operations generally and other risks detailed from time to time in the Company’s ongoing filings and in its annual information form filed with the Canadian regulatory authorities on SEDAR as www.sedar.com and with the United States Securities and Exchange Commission on EDGAR at www.sec/edgar. Investors are cautioned not to rely on these forward-looking statements and are encouraged to read the Company’s continuous disclosure documents which are available on SEDAR and on EDGAR.

View source version on businesswire.com: https://www.businesswire.com/news/home/20200330005157/en/

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

Josh Rappaport, Director, Stern IR
O: (212) 362-1200
E: [email protected]

Media:
Delphine Davan, Director, Communications, IMV
M: (514) 968-1046
E: [email protected]

Source: IMV Inc.

IMV to Announce Fourth Quarter and Full Year 2019 Financial and Operational Results and Host Investor Conference Call and Webcast on March 31, 2020

Wed, 25 Mar 2020 07:05:00 -0400

DARTMOUTH, Nova Scotia--(BUSINESS WIRE)-- IMV Inc. (“IMV” or the “Corporation”) (Nasdaq: IMV; TSX: IMV), a clinical-stage biopharmaceutical company pioneering a novel class of immunotherapies, announced today that it will hold a conference call and webcast on Tuesday, March 31, 2020 at 8:00 a.m. Eastern Time to discuss the company’s 2019 fourth quarter and full year financial and operational results.

Financial analysts are invited to join the conference call by dialing (866) 211-3204 (U.S. and Canada) or (647) 689-6600 (international) using the conference ID: 7482187.

About IMV

IMV Inc. is a clinical stage biopharmaceutical company dedicated to making immunotherapy more effective, more broadly applicable, and more widely available to people facing cancer and other serious diseases. IMV is pioneering a new class of immunotherapies based on the Company’s proprietary drug delivery platform. This patented technology leverages a novel mechanism of action that enables the programming of immune cells in vivo, which are aimed at generating powerful new synthetic therapeutic capabilities. IMV’s lead candidate, DPX-Survivac, is a T cell-activating immunotherapy that combines the utility of the platform with a target: survivin. IMV is currently assessing DPX-Survivac in advanced ovarian cancer, as well as in a combination therapy in multiple clinical studies with Merck’s Keytruda^®. Connect at www.imv-inc.com.

IMV Forward-Looking Statements

View source version on businesswire.com: https://www.businesswire.com/news/home/20200325005056/en/

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

Josh Rappaport, Director, Stern IR
O: (212) 362-1200
E: [email protected]

Media
Mrs. Delphine Davan, Director of Communications, IMV
M: (514) 968-1046
E: [email protected]

Source: IMV Inc.