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IMV Inc.

Q12021

5/12/2021

speaker
Taka
Conference Operator

Good morning and thank you for standing by. Welcome to the IMV Inc. first quarter 2021 conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1 on your telephone. If you require any further assistance, please press star 0. I would now like to hand the conference over to Pierre Labbé, Chief Financial Officer. Thank you. Please go ahead.

speaker
Pierre Labbé
Chief Financial Officer

Thank you, Taka. Good morning, everyone. My name is Pierre Labbé, CFO at IMB, and I'm pleased to welcome you to our clinical and operational update and first quarter financial results conference call. I'm joined today by Fred Orr, our Chief Executive Officer, and Andrew Aul, our Chief Business Officer, who will be available for the question and answer period at the end of the call. Fred will begin with an overview of the company's operational highlights, and Andrew will follow with comments about the clinical program. I will conclude with the financial summary of the course. During this call, we will discuss our business outlook and make forward-looking statements. Any forward-looking statements made today are pursuant to and within the meaning of the safe harbor provisions of applicable securities laws. These comments are based on current expectations of management regarding future events and operating performance. There are no guarantees of future performance or results. All forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These risks are discussed in our continuous disclosure documents filed in compliance with applicable securities law. The press release, the MD&A, and the financial statements are all posted on our website at imv-inc.com. If you wish to receive a copy of these documents, please do not hesitate to contact us. Finally, take note that we will take questions only from cell-side panelists. I will now turn the call over to Fred. Fred?

speaker
Fred Orr
Chief Executive Officer

Thank you, Pierre. Good morning, everyone, and welcome. I am very pleased today to have the opportunity to review our progress in the first quarter, including important milestones in our cancer T cell therapy program. Our clinical programs continue to progress according to plan, including the initiation of our phase-through relapse refractory DL-BCL study in combination with MERS-Kitruda. With respect to this important study, we completed regulatory filings, and we have started enrolling clinical sites in the U.S. and Canada and are expanding into other countries. At the same time, we continue to expand the footprint of mavropepimutase beyond the current ongoing trials in solid and hematological malignancies. Earlier this week, we announced a new investigator-initiated study in breast cancer, which we plan to initiate in the third quarter of this year. Andrew will provide further details about this study later in the call, but I want to share the enthusiasm that we have about this study. First of all, surviving has been identified by investigators at Providence Cancer Institute in Portland, Oregon, has a biomarker of resistance to treatment in this patient population. This discovery is giving us the opportunity for the first time to test our surviving targeted T cell therapy in an earlier line of treatment. It is also a neoadjuvant study. providing a unique opportunity to access complete tumor resection after surgery and thus demonstrate the in vivo response to our therapy. We believe that both the level of information and demonstration that can come out of this study has the potential to create significant value for our platform and our shareholders. We are also on track to initiate in the second half of the year a phase one study in non-muscle invasive bladder cancer through a collaboration with the research center of University Laval in Quebec City. This study is sponsored by IMV and will be partly funded by government grants. In this study, which is also in an earlier line of treatment, we will be targeting mage protein family member A9 and surviving. Both have been associated with the biology of bladder cancer and a poorer prognosis. This is an exciting milestone for the company as this is the first in human trial for our second immunotherapy, DPX-RMH. This trial has the potential to further demonstrate the versatility of our platform and its ability to generate targeted T cell therapies for various indications. Andrew will also give more detail about this dual targeted immunotherapy later in the presentation. Before I turn the conference to Andrew, I wish to welcome to IMV2 exceptional new board members, Mr. Kai Kovalenko and Dr. Michael Callas, following the recent departure of Wayne Pisano and the announced retirement of James Hall following this year's annual meeting. I would like to take this opportunity to thank both of them, Wayne and James, for their dedication and guidance throughout the years and wish them the very best going forward. Mr. Kyle Tuvalanka currently serves as Chief Financial Officer and Chief Operating Officer at Goldfinch Bio, a precision medicine company. Kyle brings over 20 years of experience as a senior leader in the biopharmaceutical industry with a successful track record in forming and negotiating strategy collaborations, leading financings, including the idea of blueprint medicine, as well as building and directing business and finance functions. I also want to welcome Dr. Michael Kalos, a pioneer and internationally recognized expert in T-cell therapy and immunotherapy, who brings over 25 years of experience across cell therapy and immuno-oncology in global organizations such as Jensen and Eli Lilly. The laboratory is founded and directed at the University of Pennsylvania, played a key role in the success of the cell therapy program at Penn, including the clinical development that led to the approval of Kim Rhea, the first-ever FDA-approved CAR T-cell therapy. Finally, a management update today. Dr. Joanne Schindler gave her resignation for personal reasons effective June 11, 2021. Over the next week, Joanne will transition responsibilities while remaining in her role as chief medical officer and we are actively working with our recruitment firm to hire a new chief medical officer who will drive MAVOPEPIMIT-S towards registration. In the meantime, our clinical and regulatory teams will continue to execute and keep on track of our development program. We thank Joanne for her contribution during her tenure and wish her the very best. This concludes my opening remarks, and I will now turn the conference over to Andrew for a more detailed review of our clinical program.

Disclaimer

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