Summit Therapeutics Inc.

Good morning and welcome to Summit Therapeutics second quarter 2024 earnings and update call. All participants will be in listen-only mode until the question and answer portion of this 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. And please note that today's call is being recorded. If you would like to ask a question during the Q&A session, simply press star followed by the number one on your telephone keypad. And if you would like to withdraw your question at any time, you can press star one again. And at this time, I would like to turn the call over to Dave Genkars, 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.smmtx.com. Joining me on the call today is Bob Duggan, our Chairman of the Board and Chief Executive Officer, Dr. Maki Zangane, 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 statements made by our management team and some responses to questions that we may 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, Dave. Good morning, everyone, and thank you for joining us today. We're very proud of the recent accomplishments of Team Summit and the expanding positive information that continues to be brought to light surrounding Ivanisumab, our lead investigational asset. The past few months have been pivotal to the positive development and awareness of Ivanisumab, as well as in expanding physician, caretaker, hospital, payer, and patient awareness of Summit Therapeutics' mission and vision, namely, to build a viable organization that makes a significant positive difference for the betterment of patients encountering serious unmet oncology medical needs. Specifically, Ibenizumab created positive Phase III data updates from Harmony A and Harmony II, both of which were randomized single-region clinical trials in non-small-cell lung cancer conducted by our partners at Acaso. Harmony A results supported Ibenizumab receiving its first regulatory approval in China for patients with advanced non-small-cell lung cancer who have progressed following an EGFR TKI. In Harmony 2, ibenizumab monotherapy beat pembrolizumab monotherapy head-to-head in the study's primary endpoint of PFS, making ibenizumab the first drug to achieve a clinically meaningful efficacy benefit over pembrolizumab in a randomized phase 3 clinical trial in non-small cell lung cancer. Additional data from this pre-specified interim analysis will be presented at an upcoming major medical conference this quarter. In addition, we raised an unsolicited $200 million at a premium over the then-current market price, extending our cash runway and increasing our resources to execute our expansive goals. Manmeet will provide more details about our financial position in a few minutes. Summits to multi-regional registration of Phase III non-small cell lung cancer trials, Harmony and Harmony III, continue to enroll. Harmony remains on track to complete its planned enrollment later this year. Alongside our partners at ACESSO, Avenisimab data was featured at ASCO, as well as Harmony A data being published in JAMA, Journal of American Medical Association. This, in addition to smaller conferences and best of ASCO follow-up meetings, have been excellent in fostering KOL discussions regarding the future of cancer therapy, including the potential for Avenisimab. These efforts were further bolstered as we continue to ramp our investigator-sponsored trial, or IST, program. Last month, we announced a five-year strategic collaboration with MD Anderson to accelerate development of ibenizumab through the opportunity to conduct multiple clinical trials with one of the world's most respected medical healthcare institutions. These efforts are in addition to our continued collaboration with our partners at Acaso who continue to generate patient positive data in phase two settings in both lung cancer and solid tumors outside of lung cancer, data which can help support additional late stage clinical trials. These accomplishments have been foundational to our 2024 goals of successfully executing on our registrational phase three trials while expanding our clinical development program. Mackey will further expound upon these accomplishments, including additional strides we have made to drive our firm, continued belief and conviction in Team Summit and the potential of Avanisimab in non-small cell lung cancer and beyond. We are an experienced, mission-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 in ibanesimab 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.