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Agenus Inc.
3/11/2025
Good morning and welcome to Agenis, Inc.' 's fourth quarter and year-end 2024 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 turn the call over to Zach Orman, Head of Investor Relations.
Thank you, Regina. Good morning, everyone, and welcome to Agenis' fourth quarter and year-end 2024 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 www.investors.agenisfio.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 FCC filings for further details. Joining me today are Garo Harmon, Chairman and CEO, Stephen OJ, Chief Financial Officer, Robin Taylor, Chief Commercial Officer, Christine Klotskin, VP Finance and Principal Financial and Accounting Officer. Now I'll turn the call over to Garo.
A very good morning once again from a delightful day in Lexington, Massachusetts. Thank you very much for joining us. First, let me start by saying we are, as a company, pleased to report that we delivered on our commitment to significantly reduce the genesis operational burn. By the end of 2024, we had reduced our annualized burn rate to the level that we had guided everyone. And now, we are executing on our next phase of strategic cost reductions with an annualized burn to approximate 50 million by the middle of this year. And we're very much on track for that number. Our objective is to direct every available resource towards what truly matters to our stakeholders and patients, particularly. to make sure that our groundbreaking potential of But-Val is realized and patients have access to it as soon as possible. But-Val continues to demonstrate unprecedented clinical activity. Recently, it was presented at major oncology forums, such as AACR Immune Oncology, was the first year that AACR organized the Immune Oncology Division of its annual conference. ASCO-GI in January, CITSE in the fall, ESMO and ESMO-GI. And we detailed the most influential peer-reviewed journals, including Nature Medicine, JCO, general clinical oncology, and cancer discovery. All of these were accomplished in the last 12 months or less. We are witnessing transformative clinical outcomes in colorectal cancer and other tumors that have been historically unresponsive to immunotherapy. This is based on the opinion of some of the most prestigious experts in the field. In a matter of example, but Val has demonstrated durable and I want to underline durable responses and prolonged survival in refractory microsatellite stable colorectal cancer. Now, this particular kind of colorectal cancer, meaning MSS, is accounting for, these days, over 90% of CRCs. We've seen encouraging activity with the addition of Val to ProFox, which is the standard of care, including Bev, in first-line MSS CRCs. These are early indications of activity, but in terms of both efficacy and tolerability, these early signals are very encouraging. We have also either seen complete or near complete pathological responses. Very importantly, in neoadjuvant MSS, as well as MSI-ICRC, even though the trade likes to break these into two categories. We believe, based on the results that we have seen, our agents are active in both categories of colorectal cancer. This has transformative potential to enable chemo, radiation, and possibly surgery-free options for patients. Because in some cases, like rectal cancer surgery, along with the other standards of care, can be debilitating for patients, particularly the fact that TRC and rectal cancer are now being seen more and more frequently in younger patients. I'd say these results, based on the opinion of our experts, are beyond promising. they are potentially revolutionary. Also importantly, these outcomes aren't just our internal assessment. Leading global oncology centers and experts are independently conducting investigator-sponsored trials, and in some cases, all we need to do is just provide product for them, and we incur no costs. This independent validation by some of the most respected oncologists and oncology centers who are pivotal in securing approval in our breakthrough therapies significantly amplify our confidence in blood vials and its potential for patients. Several of these trials, particularly in the neoadjuvant setting, are expected to rapidly enroll in potentially organ-sparing trials with blood trials. These trials have gotten underway. In fact, we have a new trial that's gotten underway this week with inquiries that have come in from patients ahead of the official opening of the trial. Additionally, we've strategically continued monitoring and monetizing, the potential of our non-core assets, our high-value biologics manufacturing facility in Emeraldville and Berkeley, our land in Vacaville to fortify our balance sheet currently, our high-priority projects. We're engaged in also late-stage partnership discussions to secure funding for BotVal and but bowel development and registration. With an emphasis on neoadjuvant treatment of early stage, well, I shouldn't say early stage, but intermediate stage colon and rectal cancers. Where these are clear opportunities for but bowel to provide significant benefit to patients. With that, I'll turn it over to Christine for a quick review of our financials. Christine?
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