Summit Therapeutics Inc.

Hello and welcome to the Summit Therapeutics Q1 2025 earnings conference call. I would now like to turn the call over to our Chief Business and Strategy Officer, Dave Van Kars. Please go ahead, sir.

Good afternoon and thank you for joining us. A press release was issued earlier this afternoon and is available on the homepage of our website. Our Form 10Q was also filed and is available on our website. Today's call is being simultaneously webcast and an archived replay will also be made available later today on our website, www.smmttx.com. Joining me on the call today is Bob Duggan, our chairman of the board and co-chief executive officer. Dr. Maki Zangane, our co-chief executive officer and president. Manmeet Soni, our chief operating officer and chief financial officer. Dr. Alan Yang, our chief medical officer. and Dr. Jack West, Vice President and our Thoracic Oncology TA head. 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 and some responses to questions that we make today 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, Maki, and Manmeet, we will take questions. With that, I would like to turn the call over to Bob.

Thank you, Jay. Good afternoon, everyone, and thank you for joining us today. As you can imagine, I'm very proud of, as well as encouraged by, the ongoing accomplishments of Team Summit and the continuing positive information and enthusiasm surrounding avanizumab, our lead medicinal investigational asset. We have begun 2025 with excellent progress and continue to take meaningful steps in the development of avanizumab. We continue to advance our mission of building a viable organization, making a significant positive difference in serious unmet medical needs. Specifically, last week, our partner, Akeso, made two important as well as material announcements. First, Avenisumab received approval from NMPA, the health authority in China, as frontline monotherapy treatment for patients with NSTLC whose tumors have positive PD-L1 expressions. This marks an important regulatory milestone for our partners at Acaso and adds to the growing evidence of iponizumab's differentiated profile and its potential to make a significant difference in the lives of patients dealing with hard to treat cancers. On behalf of the summit team, we want to extend our congratulations to our partners at Acaso for this achievement and our gratitude for our strong ongoing partnership. This approval was based on positive PFS results from ACESSO's Harmony II trial, which was disclosed at last year's World Conference on Lung Cancer. Additionally, to supplement this groundbreaking PFS data that represented the first drug to achieve a statistically significant benefit over pembrolizumab in a Phase III clinical trial, the NMPA requested that ACESSO perform an interim analysis of overall survival. Last week, the KESO reported on the health authority requested early interim analysis. The analysis showed a clinically meaningful and strongly positive trend favoring Ivanizumab at 39% data maturity with a hazard ratio of 0.777, implying a potential 22% reduction in the risk of death compared to Pembroke. To be clear, at Summit, we are pleased and excited about this remarkable outcome. McKee will discuss this a little further in a few moments. Additionally, a Kessels Harmony VI Phase III clinical trial met its primary endpoint of progression pre-survival at a pre-specified interim analysis conducted by an independent data monitoring committee. This trial evaluated ibanizumab in combination with chemotherapy against tizolizumab, a PD-1 inhibitor, in combination with chemotherapy in patients with advanced squamous non-small cell lung cancer, regardless of PD-L1 expression. Conducted in China by our partners at Akeso, the trial showed statistically significant and clinically meaningful improvement in progression-free survival for ibanizumab plus chemotherapy. Akeso noted that no new safety signals were identified. This marks the first known Phase III trial in NS-CLC to show significant improvement over a PD-1 or PD-L1 inhibitor combined with chemotherapy in a head-to-head setting. Following the success of Akeso's Harmony II study, this is the second instance where Ivanisumab-based regimens have demonstrated significant benefits in frontline treatment in non-small cell lung cancer. The full data set for Harmony 6 is planned to be presented at an upcoming major medical conference later this year. Turning to our own global phase three trials, we expect top line data in mid 2025 from Harmony, our global phase three trial in patients with EGFR mutated advanced non-small cell lung cancer who have progressed after treatment with a third generation EGFR tyrosine kinase inhibitor. As a reminder, HARMONY is Summit's first global registrational phase three trial and received fast track designation from the U.S. FDA. We are also excited to see progress and the expansion of our venous mesh studies through collaborations with leading organizations for which McKee will provide additional data. We will provide details in the future on additional catalysts, including top line results from our first Registrational Phase III Harmony Trial and our clinical development plans beyond non-small cell lung cancer, both of which will be provided later in 2025. McKee will further discuss these accomplishments, driving our strong, unyielding belief in what can be accomplished by Team Summit and our conviction in the potential of Ivanisimab. We are a mission and purpose-driven organization with a collective goal to improve quality of life, increase potential duration of life, and resolve serious medical needs. We believe we have the right team and the right molecule of Inisimab to realize this goal. Not only do we have the right team, we have the right partner. The courage displayed by Michelle Shaw and the Keso team to conduct a head-to-head study against Pembro was rewarded by the results and well-deserved second approval for Ivanisumab in China. However, it also served to raise the awareness of Ivanisumab globally when Ivo became the first drug to demonstrate an improvement head-to-head in a phase three trial versus Pembro. Blockbuster drug development takes courage, and Akeso has demonstrated this courage on more than a few occasions, unlike many companies that have tried to but failed. With that, I will turn the call over to Maki for additional context and recent highlights for your consideration. Maki, are you ready to jump in?