On November 11, 2021 IMV Inc. ("IMV" or "the Company") (NASDAQ: IMV; TSX: IMV), a clinical-stage company developing immune-educating cancer therapies, based on its novel DPX platform, that target solid and blood cancers while preserving patients’ quality of life, reported its financial and operational results and provided an update for the third quarter ended September 30, 2021 (Press release, IMV, NOV 11, 2021, View Source [SID1234595281]).
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"IMV is undergoing a pivotal transformation. We are realigning IMV’s strategy to focus on its core competencies in immuno-oncology. We intend to move maveropepimut-S (MVP-S) forward on the path to registrational trials and to leverage our versatile DPX platform to further develop a comprehensive portfolio of cancer immunotherapies, both in-house and with partners. As we explore the potential of our DPX delivery platform and the development of new DPX-based candidates, we are actively evaluating potential licensing opportunities for our programs outside of immuno-oncology," said Andrew Hall, interim Chief Executive Officer of IMV.
"Our recent clinical results and translational data are promising and demonstrate the potential of our lead compound in both solid and blood tumors. MVP-S continues to be well-tolerated across indications. We have seen sustained response in patients who had already gone through many lines of previous treatments." Mr. Hall continued. "Additionally, our second immunotherapy candidate, DPX-SurMAGE, has shown encouraging results in preclinical studies and demonstrates the platform’s potential to deliver across multiple therapeutic targets. Together, we believe that these results clearly support the expansion of our clinical oncology pipeline across a wider range of tumor antigens and indications both through in-house efforts and an acceleration of business development initiatives."
CLINICAL UPDATE
Maveropepimut-S (MVP-S)
Phase 2 DeCidE1 Study in Advanced, Recurrent Ovarian Cancer
Oliver Dorigo, M.D., Ph.D., Director and Associate Professor, Division Gynecologic Oncology, Department of Obstetrics and Gynecology at the Stanford University, CA, is presenting a poster describing translational data from the clinical study in patients with advanced, recurrent ovarian cancer at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting.
Translational analyses showed that:
MVP-S treatment increased survivin-specific T and B cell tumor infiltration, further validating the MVP-S mechanism of action.
Immunogenic/inflamed tumors are more susceptible to treatment with MVP-S.
Potential mechanisms of primary resistance to treatment were identified.
IMV recently completed the DeCidE1 clinical trial evaluating MVP-S in association with low dose intermittent cyclophosphamide (CPA) in patients with advanced recurrent ovarian cancer. As announced in early August, the overall survival rate was 44.9% with a median overall survival of 19.9 months in a heavily pre-treated population at the two-year cut-off.
These results support further clinical evaluation. IMV expects to initiate a Phase 2B clinical trial in 2022.
Phase 2B VITALIZE Study in Relapsed/Refractory DLBCL ("r/r DLBCL").
MVP-S is currently being evaluated in a randomized Phase 2B clinical trial in combination with KEYTRUDA (pembrolizumab) and +/- intermittent low dose CPA in patients with r/r DLBCL. Recruitment has started now that multiple sites have been activated in North America.
IMV has designed the protocol to further validate the strong objective response rate observed in PD-L1 positive patients in the SPiReL Phase 2 trial.
DPX-SurMAGE in Bladder Cancer
Yves Fradet, M.D., Professor, Department of Surgery at the Faculty of Medicine, Université Laval in Quebec City presented preclinical data at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper), showing that the DPX delivery platform can be leveraged to develop novel multi-targeted T-cell activating immunotherapies.
More specifically, these studies showed that it was possible to simultaneously elicit immune responses against two cancer antigens (survivin and MAGE-A9 proteins) in bladder cancer model.
The addition of intermittent low dose cyclophosphamide (CPA) did not significantly change the immune response. DPX-SurMAGE was well-tolerated in the preclinical models.
Based on these results, IMV is currently optimizing the design of a Phase 1 trial in non-muscle invasive bladder cancer patients which is expected to begin by year-end.
Foundational Research
A second poster presentation at the AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) described that antigenic peptides, when packaged within the DPX platform, elicit specific T cell-based immune responses in a more robust and persistent manner than conventional water-based formulations.
CORPORATE UPDATE
Appointment of Joy Bessenger as SVP, Investor Relations and Corporate Strategy
Joy Bessenger was recently appointed as Senior Vice President of Investor Relations and Corporate Strategy of IMV. She brings over 17 years of experience in finance, corporate strategy and financial communications in the biotechnology and life sciences industries, with a particular focus on oncology, cell therapy and genomics. She has been actively involved in capital markets transactions and strategic planning for companies across a range of development stages. The first part of Joy’s career was spent on Wall Street in research and banking. Joy is based in New York.
Appointment of Heather Hirsch Ph.D. Vice President, Translational Research
Heather Hirsch was recently appointed as Vice President Translational Research of IMV. She brings more than 10 years of expertise in translational sciences having worked at Merck (MRK: NYSE), Jounce Therapeutics (JNCE: Nasdaq) and most recently at CRISPR Therapeutics (CRSP: Nasdaq). She has a strong background in immune-oncology, tumor microenvironment, and integrative translational analyses design to inform indication selection, mechanism of action and responder identification. Heather holds a PhD in cell and molecular biology from Michigan State University and completed post-doctoral fellowship at Harvard Medical School. Heather is based at IMV’s recently opened offices in Cambridge, Massachusetts.
Medicago Collaboration
IMV entered into a collaboration with Medicago, a biopharmaceutical company that develops virus-like particle (VLPs) against infectious diseases. The collaboration will evaluate Medicago’s VLPs encapsulated in IMV’s DPX technology. This agreement reflects IMV’s strategic shift in focus to seek licensing opportunities for its DPX platform in indications outside of immuno-oncology.
Overview of Third Quarter 2021 Financial Results
All dollar amounts noted herein are denominated in United States dollars (unless otherwise noted herein).
On September 30, 2021, the Company had cash and cash equivalents of $36.5 million and working capital of $37.3 million, compared with $36.3 million and $35.6 million, respectively at December 31, 2020. This increase primarily reflects net proceeds from the $25 million public offering completed on July 20, 2021, offset by cash used in operations year to date. Based on its current plan, IMV expects its current cash position will be sufficient to fund operations until Q3 2022.
Research and development expenses were $5.6 million for the three months ended September 30, 2021, compared with $4.9 million for the three months ended September 30, 2020. This increase of $0.7 million was mainly due to start-up costs for the Phase 2B VITALIZE study, an increase in manufacturing and development costs for MVP-S and an increase in headcount. These increases were partly offset by a decrease in development costs for DPX-COVID-19 following a shift in strategic focus.
General and administrative expenses were $5.3 million for the three months ended September 30, 2021, compared with $2.8 million for the three months ended September 30, 2020. This increase of $2.5 million was mainly attributable to an increase in salaries and non-cash stock-based compensation associated with planned hiring and executive leadership changes, foreign currency loss and, to a lesser extent, an increase in legal, professional, and recruitment fees.
Government assistance totaled $0.5 million for the three months ended September 30, 2021, compared with $1.3 million in Q3 2020. This decrease is mainly driven by a decrease in funding related to DPX-COVID-19 development costs.
The net loss and comprehensive loss of $10.4 million ($0.13 per share) for the three months ended September 30, 2021, was $5 million higher than the net loss and comprehensive loss of $5.4 million ($0.08 per share) for the three months ended September 30, 2020.
For the nine-month period ended September 30, 2021, the net loss and comprehensive loss of $24.9 million ($0.35 per share) was $7.5 million higher than the net loss and comprehensive loss of $17.4 million ($0.30 per share) for the nine-month period ended September 30, 2020.
As of November 10, 2021, the number of issued and outstanding common shares was 82,142,629 and a total of 16,289,495 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 www.imv-inc.com
SELECTED UPCOMING MILESTONES
Maveropepimut-S (MVP-S):
H2 2021: Submission of Phase 2 clinical study protocol in ovarian cancer for FDA review
H2 2021: Clinical update for the basket trial (Bladder & MSI-high tumor cancers)
H1 2022: Clinical update for the investigator-initiated breast cancer trial
Mid-2022: Clinical update for the open-label Phase 2 DLBCL trial
DPX-SurMAGE:
H2 2021: Initiation of a Phase 1 clinical study in bladder cancer at year-end
Conference Call and Webcast Information
Management will host a conference call and webcast today November 11, 2021, 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# 7079735
Other interested parties will be able to access the live audio webcast at this link: View Source The webcast will be recorded and will then be available on the IMV website for 30 days following the call.