Summit Therapeutics Inc. (NASDAQ:SMMT) Q3 2024 Earnings Conference Call October 30, 2024 9:00 AM ET

Company Participants

Dave Gancarz - Chief Business and Strategy Officer
Bob Duggan - Chairman and CEO
Maky Zanganeh - CEO and President
Manmeet Soni - COO and CFO
Allen Yang - Chief Medical Officer

Conference Call Participants

Mitchell Kapoor - H. C. Wainwright
Brad Canino - Stifel
Yigal Nochomovitz - Citi

Operator

Good morning. And welcome to Summit Therapeutics' Q3 2024 Earnings and Update Call. All participants will be in a listen only mode until the question-and-answer portion of the call [Operator Instructions]. Please refer to the company's Web site for updates. Please note that today's call is being recorded. After the speakers' remarks, there will be a question-and-answer session. Thank you.

At this time, I would like to turn the call over to Dave Gancarz, Summit Therapeutics' Chief Business and Strategy Officer. You may proceed.

Dave Gancarz

Good morning, and thank you for joining us. Our press release was issued earlier this morning and is available on the homepage of our Web site. Our Form 10-Q was also filed earlier this morning and is available on our Web site. Today's call is being simultaneously webcast and an archived replay will also be made available later today on our Web site, www.smmttx.com. Joining me on the call today is Bob Duggan, our Chairman of the Board and Chief Executive Officer; Dr. Maky Zanganeh, our Chief Executive Officer and President; Manmeet Soni, our Chief Operating Officer and Chief Financial Officer; and Dr. Allen Yang, our Chief Medical Officer. Before we get started with the rest of the call, I would like to note that some of the statements made by our management team today and some responses to questions that we will make may be considered forward looking statements based on our current expectations. Summit cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward looking statements. Please refer to our SEC filings for information about these risks and uncertainties. Summit undertakes no obligation to update these forward looking statements, except as required by law. Following comments from Bob, Maky and Manmeet, we will take questions. And with that, I'd like to turn the call over to Bob.

Bob Duggan

Thank you, Dave. Good morning, everyone. Thank you for joining us today. I'm very proud of the recent accomplishment of Team Summit and the continuing positive information to be shared surrounding ivonescimab, our lead investigational asset. There have been several meaningful achievements around the progress of ivonescimab since our last earnings call, both with our partners in China as well as here in the US and Western markets. We continue to progress towards our mission of building an organization making a significant positive difference in serious unmet medical needs. Specifically, we intend to amend the protocol for our multi-regional Phase 3 trial HARMONi-3 to now evaluate patients with first line treatment for metastatic non-small cell lung cancer with both squamous and non-squamous histologies. The prior trial design previously included only tumors of squamous histology. This is a significant immediate expansion of total addressable market of our current Phase 3 clinical trial portfolio. We will provide additional context in a few moments around HARMONi-3's expanded patient population. We have completed enrollment of our global Phase 3 HARMONi trial in patients with EGFR mutated advanced non-small cell lung cancer who have progressed after treatment with the third generation EGFR tyrosine kinase inhibitor or TKI. As previously announced, we expect HARMONi top line data in mid-2025. In addition, we received fast track designation from the FDA for this setting in the United States.