Agenus Inc.

Good morning and welcome to Adjennis Inc's first quarter 2025 earnings conference call. Currently all participants are in a listen-only mode. A question and answer session will follow the formal remarks. As a reminder, this conference is being recorded. I will now hand the call over to Zach Armin, head of investor relations. Please go ahead.

Thank you, operator. Welcome to Adjennis' first quarter 2025 financial results and corporate update call. Earlier today, we issued a press release detailing our financial results and key corporate developments. A copy of the press release is available on our website at .adjennisbio.com. Before we begin, I'd like to remind everyone that today's discussion will include forward-looking statements. These statements are subject to risks and uncertainties which may cause actual results to differ materially from expectations. Please refer to our SEC filings for further detail. Joining me today are Garo Armin, PhD, chairman and CEO, Dr. Stephen O'Day, MD, chief medical officer, Robin Taylor, PhD, chief commercial officer, Richard Goldberg, MD, chief development officer, and Christine Claskin, VP, finance and principal financial and accounting officer. Now I'll turn the call over to Dr. Garo Armin.

Thank you, everybody. Thank you for joining us today. Before we start, on today's call, I will cover six priorities. I should say we will collectively cover six priorities. First, we are going to present to you the newest but ball data, validating durable responses in historically untreatable cold tumors. And I might stress that we're talking about new data and more mature data. We're going to talk about the strategic hire of Dr. Richard Goldberg and his mandate to steer our regulatory path. Next, we'll talk about operational efficiencies that are on track to cut our operational cash burn to below 50 million annualized in the second half of this year. And fourth, four formal near-term transaction proposals that we have received including an Emeryville facility sale, a significant equity investment at a big premium, and two but-bell licensing deals, each individually or in combination, are designed to materially strengthen our balance sheet. And lastly, the changes in the new FDA policies that could favor rapid approval of transformative therapies and our recent request for a type B meeting. And we'll provide you with some details as to the rationale of this. So before I get into the business update, I'd like to acknowledge a critical and growing public health crisis. This underpins everything we do at Agenis. Colorectal cancer is under rise, particularly among younger people under the age of 50. Colorectal cancer incidences have doubled in the U.S. adults under 55 from 1995 to 2019, less than 25 years. By 2030, colorectal cancer is projected to become the leading cause of cancer related death in men under 50 in the United States. These younger patients especially need treatments other than chemotherapy, radiation, and life-altering surgeries, particularly in the young. This is important for the young and the old, but particularly in the young, these life-altering treatments can have a lasting devastating effect. And hence, they deserve an alternative without life-changing side effects. And that's what we offer to patients. These younger patients, the new leadership is particularly aware of this. The new leadership at HHS and the FDA recognize this grim reality of today's treatment. One of the president's first actions with Senator Kennedy, I'm sorry, the Make America Healthy Again Commission, which is set to ensure and issue its report any day now. Secretary Kennedy has pledged to root out conflicts of interest. And FDA Commissioner Dr. Marty McCary has repeatedly stressed the need to accelerate approval of meaningful treatments. I underline meaningful treatments. This shift in regulatory environment is deeply encouraging to us. And for the entire research community, discovering and developing novel and effective therapies. So it's an exciting time for us and some of our peers. We have new data, new leadership, new efficiencies, and a new environment at the FDA and the government. So we'll talk about these one by one. For Botanicalimab and Botanicalimab, which we call Bot-Bow as you know, we are generating consistent and compelling data across different lines of treatment, both in the new adjuvant setting and in later line. And across multiple cold tumors that have historically defined standard immunoncology therapies. These include MSS colorectal cancer, a huge problem. Certain breast cancers, sarcomas, hepatocelular carcinoma, and many more. At AACR 2025, two weeks ago, there was a groundbreaking presentation by Dr. Miriam Chalabi of the Netherlands Cancer Institute. She presented results from the investigator-sponsored study of neoases. And cancer study, remember, this is many different types of cancers in the new adjuvant. And if you remember, so far, prior to this, we had generated data in the new adjuvant setting of colon cancer. So this takes that concept and broadens it to many other cancers.