Agenus Inc.

Good morning. My name is Jeannie and I will be your conference operator today. At this time, I would like to welcome everyone to the AGENAS Q3 2023 Earnings Conference Call. All lines have been placed on mute to prevent any background noise. 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 the star 1. Thank you. Zach Arman, you may begin your conference.

Thank you, operator, and thank you all for joining us today. Today's call is being webcast and will be available on our website for replay. I'd like to remind you that this call will include forward-looking statements, including statements regarding our clinical development, regulatory, and commercial plans and timelines. as well as timelines for data release and partnership opportunities, among other updates. These statements are subject to risks and uncertainties, and we refer you to our ITC filings available on our website for more details on these risks. Joining me today are Dr. Garrow Harmon, Chairman and Chief Executive Officer, Dr. Stephen O'Day, Chief Medical Officer, Chief Commercial Officer, we will be participating in the Q&A session. Now, I'd like to turn the call over to Gero to highlight our progress and speak to our outlets for the remainder of the year. Gero.

Thank you, Zach. Ladies and gentlemen, as we gather today for the earnings call, let's reflect on the remarkable patient outcomes from our Botanacillinab trial. As underscored by our leading experts and researchers, we're witnessing sustained benefits in treating some of the most challenging cancers. Based on these observations and for the sake of cancer patients, our urgent mission is to set a new benchmark in cancer care, providing patients with longer-term, potentially curative benefit with some patients experiencing treatable toxicities. Our bot therapy is showing promise across various cancer stages and types, with benefits seen in some of the most treatment-resistant so-called cold tumors. In addition, recent data presented at our corporate event in Madrid during ESMO reveal but potential in earlier stages of cancer where remarkable rapid responses were observed with the possibility to prevent significant treatment-related morbidities, including the potential need for colostomy. Moving forward, we're concentrating on three key priorities. Submitting our first biologics license application for colorectal cancer, prioritizing other clinical programs with the potential for rapid approval, and importantly, smartly allocating resources to achieve our goals. Accordingly, we're gearing up our first bulk BLA submission in mid-2024 with a focus on late-stage colorectal cancer. Dr. Yancy will delve deeper into this topic shortly. The cancer community's enthusiasm and rapid involvement in our Phase II clinical trials in MSF-CRC highlights an urgent unmet need. To address this, we have started a compassionate youth program with the aim of broadening it into an extended access program next year. With very limited options to treat patients with advanced colorectal cancer, the positive trend and lasting responses in our studies strengthen our conviction in butt valves potential. Our top priority is obtaining butt valve approval in MSS TRC in order to allow patients access to this important IO treatment, offering them new hope, which does not exist today. Our second area of focus is advancing our prioritized clinical programs, which include refractory pancreatic cancer and neoadjuvant setting in CRC. Dr. Odey will detail the exciting data that showcases BUS potential in these cold, solid tumors. In addressing our financial capabilities to drive our objectives, we're already taking and continue to take steps to contain costs. These steps are important, particularly given the current challenging environment in the biotech sector. Our immediate prospects for additional cash infusion that does not involve stock issuance includes milestone payments from one of our partner programs expected by the end of December 2023. That's this year. In addition to this expected milestone, we are in the process of the sale of two non-strategic assets and pursuing the partial sale of milestones and royalties due to agendas from our partner programs. These three sales are expected to close by the end of the first quarter half of 2024. The potential proceeds from these four transactions are estimated at approximately $200 million in total. With our cash balance at the end of Q3, Along with these four planned transactions, we believe we are sufficiently funded through the end of 2024. In addition to these planned transactions, we're also in advanced discussions for a potential structure financing for BuckValve, as well as a potential corporate collaboration with a large pharma or biotech company. That ends my formal remarks, introductory remarks, and now I'll be handing it over to Dr. O'Dea to shed light on our latest findings and data updates. Stephen?