Patient recruitment in the Phase 2B VITALIZE DLBCL trial of MVP-S plus Keytruda continues to track well, with first results expected in Q3 2022. Matthew J. Matasar, MD from Memorial Sloan Kettering Cancer Center, has joined VITALIZE as lead principal investigator of the study.
First patient dosed in the Phase 2B AVALON platinum-resistant ovarian cancer trial of MVP-S plus intermittent low-dose cyclophosphamide, with early data expected in 1H 2023.
DARTMOUTH, Nova Scotia, & CAMBRIDGE, Mass., August 11, 2022--(BUSINESS WIRE)--IMV Inc. (Nasdaq: IMV; TSX: IMV) ("IMV" or the "Company"), a clinical-stage biopharmaceutical company developing a portfolio of immune-educating therapies based on its novel DPX® platform to treat solid and hematologic cancers, today announced its financial and operational results and provided an update for the second quarter ended June 30, 2022.
"We are excited to see that our lead immunotherapy, MVP-S, is progressing well in multi-center, company-sponsored, Phase 2B trials in both diffuse large B cell lymphoma (DLBCL) and ovarian cancer," said Andrew Hall, Chief Executive Officer of IMV. "Starting with an early look at our VITALIZE data in the third quarter of 2022 and continuing through mid-2023, we expect to communicate results and translational data from all our active clinical trials that, we believe, will further validate the efficacy and safety of MVP-S. These data should bolster the enthusiasm around the unique capabilities of our delivery platform to make cancer vaccines clinically viable."
Clinical Programs with Maveropepimut-S (MVP-S)
VITALIZE Phase 2B Study in Relapsed/Refractory DLBCL ("r/r DLBCL")
IMV continues to enroll patients in the VITALIZE Phase 2B clinical trial, advancing its lead compound, maveropepimut-S (MVP-S) in a global, multi-center confirmatory trial. The VITALIZE trial is designed to further evaluate the previously observed clinical benefit of MVP-S in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in patients with r/r DLBCL. Activation of clinical sites in the EU, Australia and New Zealand is expected to accelerate recruitment that was initiated in North America earlier this year. IMV is on track to complete enrollment of the first stage of the study in H1 2023.
Matthew J. Matasar, MD has joined VITALIZE as principal investigator of the study. Dr. Matasar is the Section Head for Aggressive B-cell Lymphoma at Memorial Sloan Kettering Cancer Center in New York City. His expertise is well recognized in Hodgkin and non-Hodgkin lymphomas (including DLBCL), autologous stem cell transplantation, and cancer survivorship.
Details on the VITALIZE Phase 2B study will be presented in a poster session at the European Society for Medical Oncology (ESMO) Congress 2022 to take place September 9-13 in Paris (Poster #646TiP).
AVALON Phase 2B Trial in Platinum-Resistant Ovarian Cancer
The first patient has been dosed in the AVALON Phase 2B trial in ovarian cancer (NCT05243524). This is a single arm trial evaluating MVP-S and intermittent low-dose cyclophosphamide (CPA) in patients with recurrent, platinum-resistant ovarian cancer. The goal of the AVALON study is to further validate the encouraging data generated in the Phase 2 DeCidE trial, completed in 2021, wherein response rates doubled that of traditional chemotherapy and nearly half of patients survived 2 years.
Oliver Dorigo, M.D., Ph.D., Director and Associate Professor, Division Gynecologic Oncology, Department of Obstetrics and Gynecology at the Stanford University, CA, is the principal investigator of both the DeCidE and the AVALON studies.
Company is Exploring the Optimal Development Pathway for MVP-S in Bladder Cancer
Safety and preliminary efficacy data from the Phase 2 basket study of patients with advanced, metastatic bladder cancer utilizing a combination of MVP-S with pembrolizumab were presented by Jeremy R. Graff, Ph.D., IMV’s Chief Scientific Officer, at the American Association of Cancer Research (AACR) annual meeting on April 12, 2022. The combination was well-tolerated and showed encouraging clinical activity, particularly in patients who had received prior immune checkpoint inhibitor therapy. IMV has convened a group of KOL advisors to identify the optimal design for the next trial to evaluate MVP-S in bladder cancer.
$US10 Million Drawdown from Existing Long-Term Debt Facility
The company drew down the remaining US$10 million available under its existing US$25 million debt facility led by Horizon Technology Finance Corporation (Nasdaq: HRZN) ("Horizon"). This drawdown was made available as the Company achieved a predetermined milestone following site activation in its Phase 2B AVALON trial in platinum-resistant ovarian cancer.
Selected Upcoming Milestones
Q3 2022: First results on early patients in VITALIZE study in r/r DLBCL
H2 2022: First results from the investigator-initiated neoadjuvant breast cancer trial
H2 2022: Preliminary data from the MVP-S arm of non-muscle invasive bladder cancer (NMIBC) neoadjuvant Phase 1 study
H1 2023: Complete enrollment of stage 1 in VITALIZE study and first scan data
Summer 2023: Complete enrollment of stage 1 in AVALON study and early data
Q3 2022: Dose first patient with DPX-SurMAGE in second arm of NMIBC Phase 1 study
H1 2023: Initial data on DPX-SurMAGE arm in NMIBC trial
Overview of Second Quarter 2022 Financial Results
All dollar amounts noted herein are denominated in United States dollars (unless otherwise noted herein).
On June 30, 2022, the Company had cash and cash equivalents of $31.1 million and working capital of $27.7 million, compared with $38.6 million and $37.1 million, respectively at December 31, 2021. Based on its current plan, IMV expects its current cash position will be sufficient to fund operations into Q2 2023. Sources of cash from financing activities during the quarter primarily included the remaining $10 million under the Company’s venture debt facility with Horizon.
Research and development expenses were $6.0 million for the three months ended June 30, 2022, compared with $5.2 million for the three months ended June 30, 2021. This increase of $0.8 million was mainly due to an increase in costs for the DLBCL VITALIZE phase 2B trial and personnel costs as a result of increased headcount. This increase was partly offset by a decrease in basket trial costs, following the completion of enrollment in 2021.
General and administrative expenses were $4.6 million for the three months ended June 30, 2022, compared with $3.4 million for the three months ended June 30, 2021. This increase of $1.2 million was mainly attributable to loan interest associated with the Horizon venture debt facility, an increase in salaries and non-cash stock-based compensation, related to planned hiring and executive leadership changes.
The net loss and comprehensive loss of $9.9 million ($0.12 per share) for the three months ended June 30, 2022, was $2.5 million higher than the net loss and comprehensive loss of $7.4 million ($0.11 per share) for the three months ended June 30, 2021.
For the six-month period ended June 30, 2022, the net loss and comprehensive loss of $20.4 million ($0.25 per share) was $6.1 million higher than the net loss and comprehensive loss of $14.3 million ($0.21 per share) for the six-month period ended June 30, 2021.
As of August 10, 2022, the number of issued and outstanding common shares was 82,452,187 and a total of 16,101,369 stock options, warrants and deferred share units were outstanding.
The Corporation's unaudited interim condensed consolidated results of operations, financial condition and cash flows for the quarter ended June 30, 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/edgar as well as the Company’s website at www.imv-inc.com.
Conference Call and Webcast Information
Financial analysts are invited to join the conference call by registering at this link prior the call to receive their individual dial-in information.
Other interested parties will be able to access the live audio webcast by registering on IMV website: 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.
IMV Inc. is a clinical-stage immuno-oncology company advancing a portfolio of therapies based on the Company’s immune-educating platform, DPX®. Through a differentiated mechanism of action, the DPX platform delivers instruction to the immune system to generate a specific, robust, and persistent immune response. IMV’s lead candidate, maveropepimut-S (MVP-S), delivers antigenic peptides from survivin, a well-recognized cancer antigen commonly overexpressed in advanced cancers. MVP-S also delivers an innate immune activator and a universal CD4 T cell helper peptide. These elements foster maturation of antigen presenting cells as well as robust activation of CD8 T cell effector and memory function. MVP-S treatment has been well tolerated and has demonstrated defined clinical benefit in multiple cancer indications as well as the activation of a targeted and sustained, survivin-specific anti-tumor immune response. MVP-S is currently being evaluated in clinical trials for hematologic and solid cancers, including Diffuse Large B Cell Lymphoma (DLBCL) as well as ovarian, bladder and breast cancers. IMV is also developing a second immunotherapy leveraging the DPX immune delivery platform, DPX-SurMAGE. This dual-targeted immunotherapy combines antigenic peptides for both the survivin and MAGE-A9 cancer proteins to elicit immune responses to these two distinct cancer antigens simultaneously. A Phase 1 clinical trial in bladder cancer, using MVP-S or DPX-SurMAGE, was initiated in early 2022. For more information, visit www.imv-inc.com and connect with us on Twitter and LinkedIn.
IMV Forward-Looking Statements
This press release contains forward-looking information under applicable securities law. All information that addresses activities or developments that we expect to occur in the future is forward-looking information. Forward-looking statements use such word as "will", "may", "potential", "believe", "expect", "continue", "anticipate" and other similar terminology. Forward-looking statements are based on the estimates and opinions of management on the date the statements are made. In this press release, such forward-looking statements include, but are not limited to, statements regarding the potential impact of the VITALIZE and AVALON studies and the anticipated date data from such studies will be available; the anticipated rate of enrollment in IMV’s studies and clinical trial programs, the anticipated upcoming milestones and clinical trial outcomes with respect to IMV’s product candidates, in particular MVP-S and DPX-SurMAGE, the date to which IMV’s current cash position is expected to sufficiently fund operations; the Company’s ability to advance its development strategy, the prospects, for its lead immunotherapy and its other pipeline of immunotherapy candidates, as well as, IMV’s ability to maintain its Nasdaq listing beyond the Compliance Period. IMV Inc. assumes no responsibility to update forward-looking statements in this press release except as required by law. These forward-looking statements involve known and unknown risks and uncertainties, and those risks and uncertainties include, but are not limited to, those related to the Company’s expected timeline associated with its cash runway; the Company’s priorities with MVP-S and its DPX delivery platform, the potential for its delivery platform and the anticipated timing of enrollment and results for its clinical trial programs and studies as 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.
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Irina Koffler, Managing Director, LifeSci Advisors
O: (646) 970-4681
M: (917) 734-7387
Delphine Davan, Senior Director, Communications and Investor Relations, IMV Inc.
O: (902) 492.1819 ext: 1049
Madeline Joanis, Senior Account Executive, LifeSci Communications
M: (603) 479 5267