Agenus Inc. Price & Performance (AGEN)

Thank you, Regina. Good morning, everyone, and welcome to Agenas' fourth quarter and year end twenty twenty four 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.agenaspio.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 differ materially from expectations. Please refer to our SEC filings for further detail. Joining me today are Garo Harman, Chairman and CEO Iben O'Jay, Chief Financial Officer Robin Taylor, Chief Commercial Officer Christine Klotzkin, VP Finance and Principal Financial and Accounting Officer. Now, I will turn the call over to Garrow. 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 Agenus operational run. By the end of twenty twenty four, 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 $50,000,000 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 while groundbreaking potential of BaaS is realized. And patients have access to it as soon as possible. But Val continues to demonstrate unprecedented clinical activity. Recently, we presented at major oncology forums such as AACR, immuno oncology. For the first year that AACR organized the immuno oncology division of its annual conference. ASCO GI in January SITC in the fall, ESMO and ESMO GI, And we detail the most influential peer reviewed journals including Nature Medicine, J. Cielo, Journal of Clinical Oncology and Cancer Discovery All of these were accomplished in the last twelve months or less. We are witnessing transformative clinical outcomes in colorectal cancer and other tumors. That had 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, BadVal has demonstrated durable and I want to underline durable responses and prolonged survival in refractory microsatellite table colorectal cancer.

Now this particular kind of colorectal cancer, meaning MSS, is accounting for these days over ninety percent of CRCs We've seen encouraging activity with the additional butt valve. To FoFox which is the standard of care including [indiscernible] In first line, MSS CRC. 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 retinal cancer, surgery along with the other standards of care and be debilitating. For patients particularly the fact that CRC 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 center 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 cost. This independent validation by some of the most risk oncologists and oncology centers who are pivotal in securing approval in our breakthrough therapies significantly amplify our confidence in blood valve. And its potential for patients. Several of these trials particularly in the neo adjuvant setting, are expected to rapidly enroll in potentially organ sparing trials. [indiscernible] 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, with strategically continued monitoring and monetizing, the potential of our non core assets our high value biologics manufacturing facility in Emeryville 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 The secure funding for BAPAL on neoadjuvant treatment, of early stage well, I shouldn't say early stage, but it's immediate stage colon and rectal cancers. Where these are clear opportunities for Vuzhou to provide significant benefit to patients. With that, I'll turn it over to Christine for a quick review of our financials. Christine?

Thank you, Garo.

We ended the year 2024 with a consolidated cash balance of $40,400,000 This compares to a balance of $76,100,000 at 12/31/2023. Cash used in operations for the year ended 12/31/2024 was $168,000,000 This is reduced from $224,000,000 for the prior year. For the year ended 12/31/2024, we recognized revenue of $103,500,000 and incurred a net loss of $232,300,000 or $10.59 per share.

For the fourth quarter ended 12/31/2024, we recognized revenue of $26,800,000 and incurred a net loss of $46,800,000 or $2.04 per share.

Our revenue primarily consists of non cash royalty revenue. I'll now turn the call back to Garo.

Thank you, Christine. In summary, while we recognize that our financial position is not reflective of the high potential on the promise of our product. And it's a bit tighter than ideal. We are taking decisive actions to continue to and we will continue to take very decisive actions to bolster our cash position as well as to contain costs. Now we're very heartened by the fact that we've had significant external validation through numerous selected high quality centers that are doing trials. Such as ISTs for us, and robust clinical activity that we have seen in both These of course position us to advance our leap programs in 2025 and beyond. We remain committed and strategically aligned to deliver groundbreaking treatments for patients. This is very important because having treated now, well over 1,000 patients across nine different cancers with a heavy concentration of colon cancer and seen the benefit of patients. It's very heartening that we had kept our eye on developing but vial as a high priority for us. With that, I will end my call and I think we welcome questions that you may have.

Our first question will come from the line of Emily Bodnar with H. C. Wainwright. Please go ahead.

Hi, good morning. Thanks for taking the question. Maybe for the first one, if you can kind of help frame the cost reductions for us, particularly which programs are being impacted the most particularly on the R and D side, and especially into mid 2025 as you're guiding to additional cost cuts which programs might be impacted there? And then secondly, if you can kind of walk us through expected catalysts for 2025 and any new data updates or regulatory updates that we should be looking out for?

Okay. So the cost reduction is really center around headcount reductions. That are non essential meaning that even our priority being path valve development and registration, we have defined exactly which experts we need internal and externally And we have significantly cut down on external advisors. We have limited external advisors to those that will benefit us the most in terms of advancing [indiscernible] [indiscernible] a [indiscernible] line of registration and most of the registration work that we were undertaking under accelerated approval is already completed. So should there be a window for us and we believe there will be we will utilize a lot of the work that has been completed to seek potentially registration globally. So in terms of our pipeline products, we have not killed them We have simply shelved them for the time being. And we've done it in a way that we can reignite them because as you know, we got a significant number of products back from our partners. After they had spent excess of $800,000,000 collectively under the products not because of any product performance issues. But strictly because of the fact that IO for the time being is out of fashion. Not because we believe our products are implicated in it being not a factor, But the pharmaceutical industry, things go hot and cold.

And right now, IO is cold. And that doesn't mean that it will remain cold three to six months from now.

So we have put them on hold with an intent to reignite them quickly. In terms of catalysts for 2025 on the regulatory updates, stay tuned.

Okay, great. Thank you.

Our next question comes from the line of Mayank Mamtani with B. Riley Securities. Please go ahead.

Good morning team. Thanks for taking our questions and appreciate the detailed update here. Maybe just a similar question as asked before on the the process of monetization of non core assets. Garo, if you could comment how further along you are and what sort of economics you could derive from that? And then I have a follow-up.

Sure, Mayank. Thank you for that. And if you recall, and I'm sure that you recall, but in general, the first stage of monetization of our West Coast assets. Namely Vacaville our Berkeley facility came in the form of a mortgage that we obtained back in November And if you remember, prior to that, prior to the elections, it was almost impossible for us to obtain any mortgage. [indiscernible] But we got a $20,000,000 mortgage and a record time. Of approximately two weeks And so that was the first stage of monetization. Now in addition to that, for those of you who have been to our Emergeville facility, know that Emeryville is a highly desired state of the art manufacturing facility that is super nuts. It starts with cell lines and it finishes with packaging, filling, finishing and packaging of product. Now given the fact that there has been significant shifts in U. S. Manufacturing interest. We have seen a similar level of interest and we are in discussions including contract discussions with parties for the potential consummation or monetization of our West Coast. Manufacturing and real estate asset.

Okay. No, that's helpful. And then are you able to share your latest and greatest thoughts on what registrational program could look like? Obviously, as could GI, data recently showed a number of different directions you could in, late line, frontline, obviously, NewAdjuvant, any thoughts in each of those buckets that could be helpful for folks to understand the path to market here?

Sure. So first off, we have a mass an enormous amount of data in the late stage setting. There's no ambiguity about our ability to rescue patients with MSS CRC who had exhausted all other options. And these patients are now living longer even though we haven't done a randomized trial in late stage yet, there is no ambiguity about the fact that these patients are living much longer orders of magnitude longer than patients who have had standard of care. So we have more than doubled the response rates in these Agenus. And we have a an extension of their larger bank. That is based on our current data essentially double what you would see with San Antonio. Care. And that magnitude, of course, is of great interest to the exploration of field and patients. In fact, we have patients who are going gun disease free now. Pushing to three years. Which is almost unprecedented. [indiscernible] that's one area where with more mature data, we will make an effort to get the interest of regulators around the world. Secondly, the data from the neoadjuvant setting is unambiguous. Because when I say unambiguous, it's really black and white. These patients how to treat it only with So no chemo, no radiation, and what we're seeing is complete pathological responses in more than half patients.

And this has been by the way, there was some concern that the data was from a single center Cornell. But now the data corroborates the Cornell data in 11 centers from Europe and in four times the pace. So that's very encouraging. Because of the black and white nature of the outcomes, in MSS CRC and MSI High, We believe that there is a clear path for potential approval particularly in a setting that will be organ sparing. For example, if a patient has MSS, rectal cancer, their options are chemo, radiation, and surgery. And for these patients, retinal surgery is debilitating. And we believe that if we can show that our products [indiscernible] that will be a significant benefit to patients. Doctor. Ozay, do you have to add to that? Yes. Mark, thank you for the question. I would just elaborate on what Daryl said. In the refractory setting that between our Phase one and our Phase two trial, we have approximately three fifty patients whose data is maturing. Those trials have closed at the data is mature and we look forward to really watching this durability of response and treatment free interval mature and then obviously interact further with regulatory.

Bodies around this data. And then I think what Garo said in the the neoadjuvant setting is really remarkable in terms of its ability to change paradigms in both the MS stable obviously the MS high colorectal setting and rectal cancer is within our sites as a primary first neologramant sort of regulatory approach.

It's very helpful. Thank you, team. Looking at some of these updates in the coming months.

And by the way, we have Robert Taylor here as well. Who is one of the foremost commercial and beyond commercial experts in [indiscernible] Would you like to add your Certainly. Quite happy to. Myak, it's good to hear from you again. I think the context has been explained certainly in terms of rectal cancer, but I would also point out that both rectal and colon cancer have a significant opportunity because we're looking at not only in rectal cancer potential for hemosphering, sphering radiation, and also sphering and debilitating surgery. Because if we improve the clinical complete response rate, those patients basically will not go on to surgery. They'll still wait and [indiscernible] the evidence that we've seen so far with fairly use of immunotherapy particularly C2L-four translates into a prolonged reverse free survival. And that's a clear benefit. So across all those measures, we expect we're going to be able to [indiscernible] Similarly, in colon cancer, there is that opportunity to be able to improve [indiscernible] survival overall survival in the long run And real question about being able to reduce the amount of chemotherapy Agenus patients are receiving particularly on XALYPLAZMAIL, which has the potential for permanent [indiscernible] In the long run in these patients who [indiscernible] chemotherapy may end up with a permanent neuropathy that could be avoided And that coupled with ability to improve on event free survival and overall survival really makes bone cancer a really significant opportunity as well.

And finally, just to note that we have just there's an IST that's just initiated Memorial Sloan Kettering. Entering. With Andrea Sercak Phase two in rectal cancer that [indiscernible] they're very excited about and patients very excited about, which should be kicking off very shortly.

Thank you.

And that will conclude our question and answer session. I'll hand the call back over to Garell Orman for any closing remarks.

Once again, thank you very much for joining us. It's always a pleasure to have you and your questions. We're very excited about the prospects of our lead programs There is more reason to be excited now with the longevity of beta than even six months ago. And so we're grateful to our investigators and patients for participating in these trials to demonstrate the kind of results that we've come up with so far. And we look forward to data maturing and our trials expanded. So thank you very much.

That will conclude today's conference call. Thank you all for joining. May now disconnect.