On May 13, 2022 IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical-stage company developing a portfolio of immune-educating therapies based on its novel DPX platform to treat solid and hematologic cancers, reported its financial and operational results and provided an update for the first quarter ended March 31, 2022 (Press release, IMV, MAY 13, 2022, View Source [SID1234614484]).
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"A top priority for 2022 is to accelerate MVP-S towards registration trials. The positive clinical data we presented on MVP-S in combination with pembrolizumab in bladder cancer patients at the recent AACR (Free AACR Whitepaper) annual meeting support IMV’s prior results in solid and hematologic cancer," said Andrew Hall, Chief Executive Officer of IMV. "These results further underscore our conviction in the value of our DPX platform. In parallel, we are actively looking for opportunities to leverage our DPX delivery platform and expand our pipeline through business development. We continue to enrich our understanding of the DPX mechanism through foundational science and translational research."
Clinical Programs with Maveropepimut-S (MVP-S)
VITALIZE Phase 2B Study in Relapsed/Refractory DLBCL ("r/r DLBCL")
In January 2022, the Company announced that the first patient was dosed in VITALIZE Phase 2B clinical trial, advancing IMV’s lead compound, MVP-S on the path to a registration trial. This trial is designed to further evaluate the clinical benefit of MVP-S in combination with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in patients with r/r DLBCL. Fifteen clinical sites are now activated in the U.S., Canada, Australia and New Zealand. The Company is activating more sites in North America, Europe, Asia and Australia to accelerate enrollment. Early data from the initial patient group is expected in the third quarter of 2022.
AVALON Phase 2B Study in Platinum-Resistant Ovarian Cancer
The Company is preparing to initiate AVALON, a Phase 2B, single arm trial evaluating MVP-S and intermittent low-dose CPA in subjects with platinum-resistant ovarian cancer. The goal of this trial is to further validate the encouraging data observed in our Phase 2 DeCidE trial, which was completed in 2021. The design of the study has been approved by the FDA and Health Canada earlier this year. Site selection and activation are ongoing, and the first patient is expected to be dosed in H2 2022.
Positive Clinical Results in Bladder Cancer Presented at AACR (Free AACR Whitepaper) Annual Meeting
Safety and preliminary efficacy data on a combination of MVP-S with pembrolizumab from the Phase 2 basket study of patients with advanced, metastatic bladder cancer were presented at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) annual meeting. Seventeen subjects with advanced, metastatic bladder cancer, who on average had received two prior lines of therapy, were enrolled in this arm of the Phase 2 basket study. The combination showed encouraging clinical activity, particularly in patients who had received prior immune checkpoint inhibitor therapy.
Key findings in this cohort included:
Treatment with MVP-S/CPA and pembrolizumab was well-tolerated with mostly grade 1-2 injection site reactions, and no severe adverse events attributed to MVP-S;
Of the 17 treated patients, 5 showed response: 2 confirmed CRs and 3 PRs per RECIST v1.1;
Complete and partial responses were observed in patients previously treated with checkpoint inhibitors;
Clinical response was most evident in patients with survivin-specific T cells; and
One patient is still on treatment after 18 months and remains a complete responder
KOL discussions are ongoing to map out the clinical opportunities for MVP-S in bladder cancer.
Clinical Program with IMV’s Second DPX-based Product Candidate, DPX-SurMAGE
IMV initiated a Phase 1 clinical trial evaluating both MVP-S and DPX-SurMAGE, in patients with non-muscle invasive bladder cancer (NMIBC) in early 2022. The first patient was dosed early April 2022. Preliminary data are expected by the end of 2022.
Foundational Science
AACR 2022 Annual Meeting Presentation: NK Cells are involved in Promoting Anti-tumor Responses to DPX-based Immunotherapy
It has been previously shown in clinical trials that MVP-S consistently incites a robust and persistent, survivin-specific immune response and promotes T and B cell infiltration into tumor tissues. At AACR (Free AACR Whitepaper), new data were presented providing the first evidence from preclinical and clinical studies that Natural Killer (NK) cells are also involved in the anti-cancer efficacy of DPX-based therapy.
Corporate Update
Michael P. Bailey appointed as Chairman of the Board, effective May 1, 2022.
Mr. Bailey has more than 30 years of pharmaceutical industry experience, having been instrumental in the commercial planning and launch of several new medicines across multiple oncology indications. He is currently President and Chief Executive Officer of AVEO Oncology, where he played a critical role in the approval of AVEO’s lead compound, FOTIVDA (tivozanib), a treatment targeting renal cell carcinoma. Mr. Bailey has served on IMV’s Board of Directors since mid 2020.
Selected Upcoming Milestones
Maveropepimut-S (MVP-S):
Q3 2022: Early data look for the open label VITALIZE Phase 2 DLBCL trial
Q3 2022: Initiate enrollment in AVALON Phase 2b trial in platinum-resistant ovarian cancer
Q4 2022: Early data look for the investigator-initiated breast cancer trial
H1 2023: Early data look from the AVALON trial in platinum resistant ovarian cancer
DPX-SurMAGE:
Q4 2022: Early data look from Phase 1 Non-muscle invasive bladder cancer study in Canada
OVERVIEW OF FIRST QUARTER 2022 FINANCIAL RESULTS
All dollar amounts noted herein are denominated in United States dollars (unless otherwise noted herein).
As of March 31, 2022, the Company had cash and cash equivalents of $28.7 million and working capital of $27.1 million, compared with $38.6 million and $37.1 million, respectively at December 31, 2021. Based on its current operating plan, which includes the additional $10 million available under the Horizon Venture Debt Facility and excludes the $47.5 million remaining under our current At-The-Market facility, IMV expects its current cash position will be sufficient to fund operations into Q2 2023.
Research and development expenses were $6.6 million for the three months ended March 31, 2022, compared with $4.7 million for the three months ended March 31, 2021. This increase was mainly due to a rise in expenses related to the manufacturing and development costs for MVP-S, start-up costs for the VITALIZE DLBCL phase 2B trial, and personnel costs due to an increase in headcount. This increase was partly offset by a decrease in basket trial costs following completion of enrollment in 2021.
General and administrative expenses were $4.0 million for the three months ended March 31, 2022, compared with $3.2 million for the three months ended March 31, 2021. This increase of $0.8 million was largely attributable to salaries and non-cash stock-based compensation related to planned hiring and executive leadership changes as well as loan interest associated with the Horizon Venture Debt Facility.
The net loss and comprehensive loss of $10.5 million ($0.13 per share) for the three months ended March 31, 2022, was $3.5 million higher than the net loss and comprehensive loss of $7 million ($0.10 per share) for the three months ended March 31, 2021.
As of May 12, 2022, the number of issued and outstanding common shares was 82,269,462 and a total of 16,799,130 shares are reserved for the issuance of outstanding stock options, warrants and deferred share units.
The Company’s unaudited interim condensed consolidated results of operations, financial condition and cash flows for the quarter ended March 31, 2022, and the related management’s discussion and analysis (MD&A) are available on SEDAR at www.sedar.com and on EDGAR at www.sec.gov as well as the Company’s website at www.imv-inc.com
Conference Call and Webcast Information
Management will host a conference call and webcast today May 13, 2022, at 8:00 a.m. ET. Financial analysts are invited to join the conference call by dialing 1-844-461-9932 (U.S. and Canada) or 1-636-812-6632 (international) and using the conference ID: 5396906.
Other interested parties will be able to access the live audio webcast at this link: View Source The webcast will be recorded and will then be available on the Company’s website for 30 days following the call.