IMV Inc. Announces First Quarter 2021 Financial and Operational Results and Expansion of its Clinical Pipeline
IMV Inc. reported its Q1 2021 financial and operational results, highlighting a net loss of $7 million ($0.10 per share), a slight decrease from $7.2 million in Q1 2020. As of March 31, 2021, cash reserves stood at $30.5 million, expected to fund operations until Q1 2022. Key developments include the initiation of a Phase 2B trial for maveropepimut-S in DLBCL and a Phase 1 study for DPX-SurMAGE in bladder cancer, supported by a C$1.8 million grant. New board members with expertise in immuno-oncology were appointed, while the company expects a clinical update on trials later this year.
- Initiation of Phase 2B clinical trial for maveropepimut-S in Q2 2021.
- Commencement of a Phase 1 clinical trial for DPX-SurMAGE in bladder cancer in H2 2021, backed by C$1.8 million grant.
- Appointment of experienced board members to enhance strategic direction.
- Net loss of $7 million for Q1 2021, reflecting ongoing financial challenges.
- Decrease in cash reserves from $36.3 million in Q4 2020 to $30.5 million in Q1 2021.
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 first quarter ended March 31, 2021.
“We remain focused on our commitment to provide effective and well-tolerated immunotherapies for patients with difficult-to-treat cancers. Clinical programs with our lead immunotherapy are progressing as expected, and we are pleased that maveropepimut-S will soon be evaluated in subjects with HR+/HER2- breast cancer, another unmet medical need,” announced Fred Ors, Chief Executive Officer at IMV. “We are reaching another milestone as our second immunotherapy, DPX-SurMAGE, is entering into a clinical trial in patients with bladder cancer later this year with the support of a C
Clinical Programs
Maveropepimut-S: Phase 2B Study in Relapsed/Refractory DLBCL ("r/r DLBCL")
Following the results of the SPiReL study presented at The Society for Immunotherapy of Cancer (SITC) 35th Anniversary Annual Meeting in November, the Company announced in April that it has entered into an agreement with Merck (NYSE: MRK) to initiate a Phase 2B clinical trial to evaluate its lead compound, maveropepimut-S in combination with KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy in r/r DLBCL. The study is expected to begin in Q2.
Maveropepimut-S: Phase 2 DeCidE1 Study in Advanced, Recurrent Ovarian Cancer
IMV is currently analyzing translational data with the goal of identifying markers of activity to inform future development and to finalize the design of our Phase 2B trial.
Maveropepimut-S: Phase 2 Basket Trial in Multiple Advanced Metastatic Solid Tumors
Enrollment continues for subjects with metastatic bladder cancer, liver cancer (hepatocellular carcinoma, HCC), and for the microsatellite instability high (MSI-H) tumors. IMV intends to provide a clinical update on the trial in the second half of this year.
Maveropepimut-S with Standard of Care, with/without Radiotherapy, or Cyclophosphamide in Breast Cancer
This investigator-initiated clinical study will be conducted at the Providence Cancer Institute in Portland, Oregon. It is a three-arm Phase 1b trial designed to assess the combination of maveropepimut-S plus standard-of-care aromatase inhibitor with/without radiotherapy or CPA prior to surgery. Across the three arms of this study, IMV’s lead compound will be evaluated in 18 subjects with resectable, non-metastatic HR+/HER2 high breast cancer.
The Hormone Receptive (HR+) and HER2 negative (HER2-) is the most common form of breast cancer representing more than
This investigator-initiated clinical study is expected to begin during Q3 2021.
DPX-SurMAGE, a First-in-Human Dual T Cell Therapy for Bladder Cancer
This IMV-sponsored trial will be led by Yves Fradet, M.D., professor of surgery and researcher in cancer immunotherapy at le Centre de recherche du CHU de Québec-Université Laval and his team, in collaboration with IMV’s team.
Both survivin and MAGE-9 have been associated with a poorer prognosis in bladder cancer and represent promising therapeutic targets to improve outcomes. Dr. Fradet’s team identified immunogenic peptides of the MAGE protein family member A9 (MAGE-A9), a protein which is frequently expressed in various human cancers including bladder, lung, and kidney. These peptides will then be combined with selected immunogenic peptides from the survivin protein. Researchers believe that the formulation of MAGE-A9 and survivin peptides with the DPX platform can generate a sustained, dual targeted T cell response that has the potential to destroy tumors with limited off-target events. Dr. Fradet and his team will evaluate DPX-SurMAGE in an initial clinical application in non-muscle invasive and muscle invasive bladder cancer.
IMV and the CHUQ have successfully completed preclinical evaluations which support the clinical development of DPX-SurMAGE in two distinct Phase 1 studies:
- DPX-SurMAGE with or without CPA prior to transurethral resection of recurrent low-grade or high-grade non-muscle invasive bladder cancer
- DPX-SurMAGE, CPA and anti-PD-1 for the treatment of muscle invasive bladder cancer prior and after cystectomy.
Based on the current timeline, IMV anticipates that the Phase 1 clinical study will be initiated in subjects with non-muscle invasive cancer in the second half of this year.
DPX-COVID-19: A DPX-Based Vaccine Candidate Against SARS-CoV-2
Due to the evolution of the regulatory landscape and at the request of the Canadian regulatory authorities the Company is currently conducting complementary preclinical studies, including evaluating the impact of new variants, and will provide an update once these preclinical studies are completed.
Changes in Board of Directors and Management
Appointment of Mr. Kyle Kuvalanka to the Board of Directors
IMV recently announced the appointment of Mr. Kyle Kuvalanka to the Board of Directors on April 1, 2021. Bringing over 20 years of experience as a senior leader in the biopharmaceutical industry, Mr. Kuvalanka has a successful track record in forming and negotiating strategic collaborations, leading financings, facilitating strategy development, as well as building and directing business and finance functions. Currently, Mr. Kuvalanka serves as Chief Financial Officer and Chief Operating Officer at Goldfinch Bio, a kidney precision medicines company.
Appointment of Dr. Michael Kalos to the Board of Directors
On May 11, 2021, IMV also announced the appointment of Michael Kalos, Ph.D. to its Board of Directors effective May 11, 2021. Dr. Kalos is an internationally recognized expert in T cell therapy and immunotherapy. He brings over 25 years of experience and expertise in cell therapy and immuno-oncology. In his career, Mr. Kalos served as Vice President of Immuno-oncology and Oncology Cell Therapies at Janssen and as Chief Scientific Officer of immuno-oncology at Eli Lilly.
Wayne Pisano, who has served on IMV's Board of Directors since October 2011, retired at the end of the quarter. James Hall will be retiring from the Board of Directors after the annual general meeting in June 2021. James served as a board member for more than 11 years. Andy Sheldon, Board Chairman of IMV, commented: "We are very grateful to Wayne and James for more than 10 years of dedicated service to IMV. On behalf of my fellow board members and IMV's management team, I would like to thank them for their long service and important contribution to the Company."
Departure of Dr. Joanne Schindler
Dr. Joanne Schindler gave her resignation as Chief Medical Officer (CMO) for personal reasons, effective June 11, 2021. Over the next weeks, Dr. Schindler will transition responsibilities while remaining fully empowered in her role as IMV’s Chief Medical Officer. The Company is actively working with a recruitment firm to hire a new CMO who will drive maveropepimut-S towards registration. Fred Ors, CEO, commented: "We thank Joanne for her contribution during her tenure and wish her the best in the future."
Overview of First quarter 2021 Financial Results
All dollar amounts noted herein are denominated in United States dollars (unless otherwise noted herein).
As of March 31, 2021, the Company had cash and cash equivalents of
Research and development expenses were
General and administrative expenses were
Government assistance totaled
The net loss and comprehensive loss of
As of May 11, 2021, the number of issued and outstanding common shares was 67,795,933 and a total of 5,072,928 stock options, warrants 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, 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 as well as the Company’s website at https://www.imv-inc.com/investors/financial-information/financial-results.
Selected Upcoming Milestones
Maveropepimut-S
- Q2 2021: Beginning of Phase 2B DLBCL trial
- Q2 2021: Translational and biomarker clinical update for ovarian cancer
- Q3 2021: Initiation of investigator-led study in breast cancer
- H2 2021: Meeting with FDA and final design for next clinical study in ovarian cancer
- H2 2021: Clinical update basket trial
- H1 2022: Clinical update Phase 2B DLBCL trial
DPX-SurMAGE
- H2 2021: Initiation of a Phase 1 clinical study in bladder cancer
Conference Call and Webcast Information
Management will host a conference call and webcast today May 12, 2021 at 8:00 a.m. ET. Investment professionals 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# 9284231
Other interested parties can 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 based on the Company’s proprietary delivery platform (DPX). This patented technology leverages a differentiated mechanism of action that generates a targeted and durable immune activation with limited side effects. IMV’s lead candidate, Maveropepimut-S, is a T cell-activating immunotherapy that combines the utility of the platform with a novel cancer target: survivin. IMV is currently assessing Maveropepimut-S in advanced ovarian cancer, breast cancer, as well as a combination therapy in multiple clinical studies with Merck. IMV is also evaluating DPX-SurMAGE, a dual targeted immunotherapy, in bladder cancer and developing a DPX-based vaccine to fight against COVID-19. 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 anticipated timing, enrollment of subjects and results from the Company’s clinical studies and trials for its various drugs and therapies, the anticipated timing of meetings and submissions with the FDA for the Company’s various drugs and therapies and the potential for synergistic action and results from the use of combined immunotherapies by the Company for various diseases. 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
IMV INC.
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(In thousands of United States dollars, except for share and per share amounts) |
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|
|
|
|
|
|
|
|
Three Months ended, March 31, |
||||
|
|
|
|
|
2021 $ |
|
2020 $ |
Revenue |
|
|
|
|
|
|
|
Interest Income |
|
|
|
|
69 |
|
51 |
Total revenue |
|
|
|
|
69 |
|
51 |
Expenses |
|
|
|
|
|
|
|
Research and development |
|
|
|
|
4,744 |
|
5,079 |
General and administrative |
|
|
|
|
3,161 |
|
2,257 |
Government assistance |
|
|
|
|
(1,234) |
|
(415) |
Accreted interest and valuation adjustments |
|
|
|
|
355 |
|
322 |
Total operating expenses |
|
|
|
|
7,026 |
|
7,243 |
Net loss |
|
|
|
|
(6,957) |
|
(7,192) |
Currency translation adjustment |
|
|
|
|
- |
|
(47) |
Total comprehensive loss |
|
|
|
|
(6,957) |
|
(7,239) |
Basic and diluted loss per share |
|
|
|
|
(0.10) |
|
(0.14) |
Weighted-average shares outstanding |
|
|
|
|
67,475,149 |
|
50,719,488 |
IMV INC. |
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Consolidated Statements of Financial Position |
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(In thousands of United States dollars, except for share and per share amounts) |
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|
March 31, 2021 |
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December 31, 2020 |
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Assets |
|
|
|
|
|
||||
Current assets |
|
|
|
|
|
||||
Cash and cash equivalents |
$ |
30,453 |
|
$ |
36,268 |
||||
Accounts receivable |
|
967 |
|
|
1,574 |
||||
Prepaid expenses |
|
4,493 |
|
|
4,416 |
||||
Investment tax credits receivable |
|
1,250 |
|
|
1,519 |
||||
Total current assets |
|
37,163 |
|
|
43,777 |
||||
Property and equipment |
|
2,229 |
|
|
2,221 |
||||
Total assets |
$ |
39,392 |
|
$ |
45,998 |
||||
Liabilities and Equity |
|
|
|
|
|
||||
Current liabilities |
|
|
|
|
|
||||
Accounts payable, accrued and other liabilities |
$ |
4,606 |
|
$ |
7,228 |
||||
Current portion of long-term debt |
|
868 |
|
|
856 |
||||
Current portion of lease obligations |
|
113 |
|
|
109 |
||||
Total current liabilities |
|
5,587 |
|
|
8,193 |
||||
Lease obligation |
|
936 |
|
|
953 |
||||
Long-term debt |
|
6,271 |
|
|
6,050 |
||||
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FAQ
What were the financial results for IMV in Q1 2021?
IMV reported a net loss of $7 million ($0.10 per share) for Q1 2021.
What is the status of IMV's clinical trials?
IMV plans to start a Phase 2B trial for maveropepimut-S in Q2 2021, and a Phase 1 trial for DPX-SurMAGE in H2 2021.
How much cash did IMV have as of March 31, 2021?
As of March 31, 2021, IMV had cash and cash equivalents of $30.5 million.
What new appointments were made to IMV's board recently?
IMV appointed Kyle Kuvalanka and Dr. Michael Kalos to its Board of Directors.
IMV
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