Summit Therapeutics Inc.

Good morning and welcome to Summit Therapeutics third quarter 2024 earnings and update call. All participants will be in a listen only mode until the question and answer portion of the call. We do not expect any technical difficulties today. However, in the event that we lose the webcast connection and are unable to provide any updates, please wait up to 10 minutes for resolution. Please refer to the company's website for updates. Please note that today's call is being recorded. After the speaker's remarks, there will be a question and answer session. If you would like to ask a question during this time, simply press star followed by the number one on your telephone keypad. If you would like to withdraw your question, again, press star one. Thank you. At this time, I would like to turn the call over to Dave Gankars, Summit Therapeutics Chief Business and Strategy Officer. You may proceed.

Good morning, and thank you for joining us. Our press release was issued earlier this morning and is available on the homepage of our website. Our Form 10-Q was also filed earlier this morning 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 Chief Executive Officer. Dr. Marquis Zongede, our Chief Executive Officer and President, Manmeet Soni, our Chief Operating Officer and Chief Financial Officer, and Dr. Alan 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, Mechie, and Monmouth, we will take questions. And with that, I'd like to turn the call over to Bob.

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 Ivanissimab, our lead investigational asset. There have been several meaningful achievements around the progress of Ivanissimab 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 three trial Harmony 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 three clinical trial portfolio. We will provide additional context in a few moments around Harmony 3's expanded patient population. We have completed enrollment of our global Phase III Harmony 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 Harmony top-line data in mid-2025. In addition, we received fast-track designation from the FDA for this setting in the United States. Following the positive results of HARMONY-2, we announced our intentions for launching a third global phase three trial, HARMONY-7, studying Ivernissimab monotherapy in patients with first-line metastatic non-small cell lung cancer whose tumors have high PD-L1 expression. Additionally, encouraging phase two data featuring Ivernissimab from China was featured at World Lung and the 2024 European Society for Medical Oncology, or ESMO. annual meeting in prairie operative non-small cell lung cancer, as well as indications outside of non-small cell lung cancer, including advanced triple negative breast cancer, recurrent metastatic head and neck cancer, and microsatellite stable metastatic colorectal cancer. Each of these phase two studies were sponsored by Oceso, with data generated and analyzed by Oceso. These encouraging data reflect why we are continuing to explore the expansion of our clinical development of ibanizumab outside of metastatic non-small cell lung cancer. In addition, we raised $235 million from leading biotech investors and individuals, including insiders, extending our cash runway and increasing our resources to execute upon expansive goals. Manmeet will provide more details about our financial position in a few minutes. These accomplishments have been foundational to our 2024 goals of successfully executing on our registrational phase three trials while expanding our clinical development plan. McKee will further discuss these accomplishments, including additional strides taken to drive our continued belief and conviction in Team Summit and the potential of venesumab in non-small cell lung cancer and indications beyond lung. We are a mission-driven organization with the 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 in Ibenizumab to help us realize this goal. With that, I will turn the call over to my key for additional context and recent highlights for consideration.