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So I should say we will collectively cover six priorities. First, we are going to present to you the newest buckball data validating durable responses in historically untreat cold tumors. And I might stress that we're talking about new data and more mature data. We're gonna talk about the strategic hire of doctor Richard Goldberg. And his mandate to steer our regulatory path. Next, we'll talk about operational efficiency. That are on track to cut our operational cash burn to below $50,000,000 annualized in the second half of this year. And fourth, for formal, near term transaction proposals that we have received including an Emeryville facility sale a significant equity investment at a big premium and two Butt 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 Agenus.
15m 2s
Colorectal cancer is on the rise. Particularly among younger people 50. Colorectal cancer incidences have doubled in The US adults 55 from 1995 to 02/2019. Less than twenty five years. By 2030, colorectal cancer is projected to become the leading cause of cancer. Related death in men 50. In The United States These younger patients especially need treatments other than chemotherapy, radiation, and life altering surgeries. Particularly in the young, 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 think 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 treatments. One of the president's first actions with senator Kenneth I'm sorry, secretary Kennedy was to set up 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 doctor Marty Makary has repeatedly stressed the need accelerate approval of meaningful treatments.
17m 11s
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 botanilimab and balstilimab, which we call back balance. You know? We are generating consistent and compelling data across different lines of treatment. Both in the neoadjuvant setting and in later line. And across multiple cold tumors, that have historically defined standard immuno oncology therapies. These include MSS colorectal cancer, a huge problem. Certain breast cancers, sarcomas, hepatocellular carcinoma, and many more. At AACR twenty twenty five, two weeks ago, there was a groundbreaking presentation by doctor Miriam Cholabi of the Netherlands Cancer Institute. She presented results from the investigator sponsored study of NEOASIS and cancer study Remember, this is many different types of cancers. In the neoadjuvant setting. 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.
19m 20s
The study showed pathological complete responses across multiple cancers. No dose limiting toxicities. And all patients proceeded to surgery on schedule. Very important. As doctor Cholabi stated, these findings substantiate the importance of this immunotherapy in early treatment settings or I should say, earlier treatment settings because these patients are not really early cancer patients. They're stage three. And highlight the broad potential utility of this combination She was she was aching of butt In liver cancer, doctor Anthony Alcuhuri chief of section of developmental therapeutics at the USC Norris Comprehensive Cancer Center presented Phase I data in HCC cohort data of BatBal. In patients heavily pre treated with available therapies including PD L1 blockade, plus Avastin which are the standard of care in last line, and still demonstrated deep and durable disease control. Very important for patients. Let me talk about our new leadership. And, of course, we have fantastic leadership, but this is new leadership. To be added on.
20m 58s
To support this next phase of development, we welcome Doctor. Richard Goldberg, a world renowned GI oncology expert as our chief development Officer.
21m 12s
His leadership will be pivotal as we advance towards regulatory filings in metastatic CRC and other tumor types. Doctor Goldberg recently authored a guest editorial in the cancer letter. Arguing that IO approvals should be customized to spare patients unnecessary life changing toxicities. The same thing that we talked about. Rather than speak on his behalf, I'd like to invite him to share his perspectives directly with us today. Doctor Goldberg, Thank you, Garo, for that kind introduction.
22m 3s
Five years ago, I stepped away from formal leadership roles in academic oncology and from active clinical practice. That time has allowed me to support companies working on new treatments for GI cancer. And to deepen my involvement in patient advocacy.
22m 20s
But throughout that time, I keep hearing the same message. From patients from their families, and from colleagues We need better treatments, especially for colorectal cancer. People want more time, better time, and ultimately, they want hope for a cure. This need is especially acute for patients with MSS colorectal existing immunotherapies have offered little benefit. As an adviser, I've had the opportunity to evaluate many programs. What stood out about Agenus and what ultimately brought me back into a full time leadership role was a potential for bot and bow. This combination represents one of the most advances I've seen in my career. It has the potential to shift outcomes. Not just in colorectal cancer, but across a range of difficult to treat solid tumors, which represent the biggest challenges in achieving cancer cure.
23m 19s
The opportunity to help move these agents forward to gain FDA approval, and make them accessible to oncologists and patients across the world is what's compelled me to reenter the field. I'm excited to be here. And I look forward to working with the exceptional team at Agenus to bring forward new hope and meaningful treatments for our patients. These patients especially need treatments other than chemotherapy and radiation and life altering surgeries. They deserve an alternative without life changing side effects. The new leadership at HHS and FDA recognize this Thank you, Gareth.
24m 7s
Thank you very much, Richard. It's a real privilege to have you on board. Given your career and given the fact that you know this disease inside out, and you've been gracious enough to invest the time to really understand our data inside out. And so with that kind of endorsement, we're very grateful for your leadership. In our next chapter. As we indicated in our March call, we are on track to cut our annualized operational cash burn below 50,000,000 in the second half of twenty twenty five. This is going to free resources to unlock BatBow and its full potential not just in colorectal cancer, but beyond. Because as we mentioned, [indiscernible] is a very powerful IO agent that shows activity and this is corroborated by some of the leading experts across different cancers that are familiar with IO. So before we move on to the review by Christine, let me address capital strategy head on. Over the past several weeks, Agenus has received four formal written proposals. That would inject or should have the potential to inject substantial new capital. The proposals would allow us to monetize on our state of the art Emeryville biologics facility. Each of these proposals also have the potential to expand into broader strategic collaborations.
26m 5s
A third proposal offers a significant equity investment at a meaningful premium to our current share price. And a fourth contemplates a bought by licensing agreement with upfront cash milestones, and double digit royalties. Our Board and our advisors are evaluating these proposals. With a high sense of urgency, I might add, And we anticipate announcing at least one of these transactions in the coming days or maybe a few weeks. Any of them would materially strengthen our balance sheet while preserving long term upside for shareholders and most importantly, accelerating our mission to bring lifesaving therapies to patients. [indiscernible] strong scientific momentum, we remain equally focused on operational discipline.
27m 12s
With that, I will turn it over to Christine to briefly review the financials. Christine?
27m 20s
Thank you, Garo. We ended the first quarter twenty twenty five with a consolidated cash balance of $18,500,000 compared to $40,400,000 at year end 2024. Cash used in operations for the first quarter ended 03/31/2025 was $25,600,000 which is reduced from $38,200,000 for the same period in 2024. For the first quarter ended 03/31/2025, we recognized revenue of $24,100,000 and incurred a net loss of $26,400,000 or $1.03 per share. For the first quarter of twenty twenty four, we recognized revenue of $28,000,000 and incurred a net loss of $63,500,000 or $3.04 per share. Our revenue primarily includes noncash royalty revenue. I'll turn the call back now to Garo to close out the call.
28m 27s
Thank you very much, Christine. So in closing, for all the reasons we've discussed today, which include new data, new leadership, new efficiencies, and a new regulatory environment in addition to anticipated near term corporate transactions We believe Agenus offers a great deal for patients, and all stakeholders. It is for these reasons that on May 5, Agenus formally requested a type b meeting with the FDA for 1,200 patients and now that is with a two year follow-up. Showing deep and durable responses And these deep and durable responses, by the way, are the hallmarks of effective IO treatments as our Chief Medical Officer has always said, And so we believe [indiscernible] every statutory criterion for potential accelerated approval. We're hopeful that the agency will engage promptly and judge our submission on its merits Our conviction in Batbao's curative potential has never been stronger. And our team is absolutely resolved in delivering this breakthrough to patients who have waited far too long far too long Thank you very much for your continued support and attention. And operator, we are ready for questions now.
30m 27s
Thank you. We will now begin the question and answer session. Your first question comes from the line of Emily Bodnar from H. C. Wainwright. Your line is open.
30m 44s
Hi, good morning. Thanks for taking the questions. I guess, to start with your commentary about regulatory interaction. How much like, longer term follow-up do you have from the phase two study? And have you hit on the overall survival endpoint yet? And then assuming that you speak to them, if they come back and say that you still need the phase three study, can you comment on your ability to run a phase three study and what that might look like? Thank you.
31m 19s
Sure. So I will ask doctor Steven O'Dea comment on the longer term efficacy data. And perhaps I can ask doctor Buell, who has graced us with her presence today, in addition to her responsibilities at Mink As you know, she is the chairman of the executive board of Agenus. And overseeing all of our regulatory efforts. On the Phase two question Phase three question. Doctor. O'Day, Thank you, Emily. So last year when we presented to the FDA our dataset, both our Phase one and our Phase two [indiscernible] July based on a March data cut. So we'll have approximately one more year of data both in our phase one and our phase two. The median follow-up for the Phase I, which now includes one hundred and twenty three patients, is eighteen months. A substantial increase in duration from last year. The Phase II trial has approximately just over twelve months of median follow-up, also significantly more than it did last year. So the combination of both our Phase I and Phase II data with the longer follow-up will obviously be significant factor in the in the next, review with the FDA.
32m 42s
You, Steven. And, also, remember what's remarkable about these three seemingly separate studies that is phase one, cohort one, phase one cohort two, and phase two. Is the consistency of data across the board which obviously makes the results much more credible. And in terms of our next steps, as you know, last year when we had the meeting with the FDA, they made in our opinion, an erroneous judgment based on a paper that was published which excluded some critical references and some critical data. And, of course, this is not their fault.
33m 32s
But because they have a lot on their plate, But this erroneous decision resulted in them telling us that perhaps this study even with longer term follow-up, may not be adequate for approval. And but what is very clear and starkingly clear to us is that the longer term follow-up is very indicative of survival benefits. I mean, these patients, you can follow-up for two years, five years. At some point, you need to give in and say, this is indicative of survival. And so this is what we're basically making a point at. And doctor Goldberg, of course, looked at all of this data and concurred with this conclusion. That's one of the reasons he's here Otherwise, this, very, very accomplishment would have been very difficult to bring in from his so called retirement at a young age. So so I'm going to pass it on to doctor Buell now. To make comments about phase three because, of course, we're making plans for phase three. But the question becomes [indiscernible] indication and what types of phase three trials we're pursuing. That's the view.
35m
Thanks very much, Gara. I'm just gonna reiterate a couple of points here, Emily. You're quite aware of the work that we've done, and I think it's an important time. We're grateful for the agency partnership as we concluded our July meeting last year. And now we're we're as they've requested, we're coming back with additional data. And Steven just mentioned, we have more than forty percent additional patients, more patients on the Phase one with very mature follow-up. And then, of course, an additional year of follow-up on the randomized phase two, which did include a standard of care arm. We expect to present data on these data sets at a major upcoming conference that will be near term. So you'll have sense of the depth and durability of the responses. But but as Carol mentioned, previously the FDA had mentioned to us again, this was a year ago, that they advised submission of the results, and this is specifically an outcome of the meeting, due to the the modest overall response rates and the fact that the ability of the response rates to reasonably predict a meaningful benefit for patients.
36m 9s
Now, the reason that this response is really quite surprising to us was that given the clinical outcomes, that we submitted at the time, we demonstrated more than fourfold four to fivefold improvement in tumor shrinkage or response rates and a more than doubling of overall survival in this very hard to treat cancer. And since then, now nearly a year later, our data have further matured reinforcing and extending the clinical impact in which in fact, we've got some patients out beyond four years with no progression. So we're really quite excited to bring the data back to the agency and I think with this new, evolving administration, we share the urgency to bring new medicines to patients, particularly in this growing prevalent disease right now that's impacting the young as well. As far as next steps, we'll also talk with the agency about our randomized design. We're presenting two different approaches to the agency because we have quite frankly, as Carol mentioned, parties who are really interested in helping us accelerate the development of these for patients with the highest unmet need for which there are currently no available therapies and for patients building on what you observe from the ASCO GI data.
37m 26s
And Miriam Cholabi's data in patients in the earliest disease disease.
37m 32s
Thank you, Jen. So as we all know, besides the important box checking regulation rules and regulations, Drugs have to be [indiscernible] To be efficacious, In other words, they're active. And they're safe. I mean, safety is, of course, relative to the patient population that we're going after. And one of the most striking features of butt valve is that in the neoadjuvant setting, the efficacy, is black and white. [indiscernible] we're not aware of very many agents out there. Let alone IO agents. That within a span of four to eight weeks, result in complete resolution of the tumor. And this is what we've seen visually and in terms of pathologic complete responses in the new adjuvant setting. As to as Jen talked about, in the late line setting, I think she was being modest by calling the response rate modest. Of course, she also mentioned that it is three, four times better than anything out there Because as you know, in late line setting, response rates of approved products out there range from 1% to a maximum of 7%. And depending on the patient population, we're at least twice that in most cases, three times that. [indiscernible] a longevity of the durable responses which should translate to survival benefit.
39m 25s
So that's the specific nuance here. Thank you.
39m 33s
Thank you.
39m 36s
Your next question comes from the line of Mayank Mamtani from B. Riley Securities. Your line is open.
39m 44s
Yes. Good morning, team. Thanks for taking our questions and please to see Doctor. Goldberg joined the team here. Are you able to discuss any development plan changes or update in light of the recent AACR update? [indiscernible] OASIS trial did have some non CRC patients like TNBC and also obviously you have the late line SCC cohort update. So I just curious how as you go into a Type B meeting, some of these non CRC phenotypes kind of play a role in your longer term development strategy? Or or are you just very focused on CRC to get this meeting very, very focused on on CRC if you could clarify that. And then I have a follow-up.
40m 32s
So we believe that the shortest distance presentation and approval is in the colorectal cancer setting.
40m 42s
And there are two settings where we believe that this is important.
40m 46s
One is in refractory disease, either third or fourth line therapy, And one of the interesting observations from the emerging data is that the response rate looks the same in third line, and in fourth line. I've so that, I I think, makes it clear that the mechanism of of these drugs is divergent from the other drugs that patients have been exposed to. And the other area that we're excited about is in the neoadjuvant setting. As you may be aware, there was a recent presentation from the team at Memorial Sloan Kettering. On their MSI high patients are showing activity in both MSI high colon cancer and MSI high non colorectal And we believe that our approach is going to expand that indication to the much larger subset of patients who are microsatellite stable, who are not MS high.
41m 57s
But the path that they have blazed in the MSI high group is a a path that we hope to follow in the neoadjuvant setting.
42m 6s
Both in rectal cancer and potentially in colon cancer, where the potential to avoid all of the toxicities of surgery, radiation, and chemotherapy would be welcome. By patients.
42m 24s
Does that address your question, my Yes. I guess the type b meeting focus, I I I heard that it's gonna be primarily CRC focused. Is that fair? And having those two indications, Lakeline and and the adjuvant. Yeah. That that's clear. I guess, are you able to comment on when do you expect the type b meeting to occur and, gather the the strategic discussions that you alluded to I believe, would need to have those minutes in hand before you're able to you know, move forward in a in a meaningful way. Is that fair?
43m 3s
Okay. I'll let Jen answer this very important question.
43m 7s
Hi, ma'am. We actually have quite a bit of, of data and information from the FDA, which has satisfied the discussions that you're referring to, the strategic discussion. The path forward from our perspective is really quite clear. The opportunity is what we wanna speak with the agency, which is a that fastest path to get these products available to patients. That's independent of the strategic discussions.
43m 29s
Yeah. [indiscernible] And lastly, if you're able to comment on the European counterparts also as that obviously has been a separate engagement. So any update there?
43m 46s
Sure. Jen will tell you what our history has been with Europe because right after the unsatisfactory meeting with the FDA last June, we engaged with CHMP and the European authorities And the outcome of those meetings, I'll let Jen comment on.
44m 6s
Thanks thanks, Geralt. Mayank, we we have not previously discussed this, so this is really the first that we're disclosing. The interactions with CHMP and the scientific advisory group last year was incredibly productive. The team was very prepared, impressively so. They agreed with us on our selected dose. They've agreed that we had a achieved contribution of components, and they agreed with a two arm randomized trial for for registration. Now the conditional approval pathway is a possibility for us that we're going to go ahead and pursue. We're talking with the U. S. FDA and we plan to talk with European the EMA, and essentially in parallel the initial interactions with the FDA will incur first, though.
44m 51s
Thank you.
44m 52s
Understood. Thank you for taking our questions.
44m 57s
Your next question comes from the line of Matthew Phipps from William Blair. Your line is open.
45m 3s
Good morning. Thanks for all the detail here on the updates. Garrett, I I think before you've provided some valuation framework the Enroville facility, and I'm wondering if that value has increased given the focus on kind of onshoring pharmaceutical manufacturing over the past few months?
45m 24s
I think this is a very, very good And when I say good, I'm not dodging the question. Matt. I believe that the totality of the value we will derive out of the Emeryville facility. Will reflect that premium.
45m 45s
Of course, if we had the luxury to wait another six to twelve months, I think that we could get a lot more for it. But right now, it is a relatively inexpensive access to capital and hence we are pursuing that route even though we believe the value will continue to go up.
46m 10s
Yep. That's fair. And then I I'm sure you can't give us too much more details on on some of these agreements beyond what you already gave. But the the licensing agreement, can you just say if that is geographic geographic specific or if it is broader worldwide?
46m 28s
So the the two agreements which have been submitted to us in writing, proposals, are global.
46m 40s
Two additional agreements that we are potentially looking at as an important option for us. Are geo geography specific. So depending on our cost of capital considerations and immediate needs, of course, the global licensing agreements would contemplate third parties underwriting the entire cost of additional trials and registration for butt So it has that appeal because it will further drive our operating burn rate down. And but, let us sort through these because the sequence with which we consummate some of these agreements and bring in cash and create value. Will be critical in determining our next steps.
47m 37s
Okay. Great. Thanks. Thanks, Carol.
47m 41s
Your next question comes from the line of Colleen Cusi from Baird. Your line is open.
47m 49s
Great. Good morning. Thanks for for taking our questions.
47m 53s
Have you had any interactions yet with the new FDA at this point ahead of the Part B meeting? And can you provide a little more color on the publication that you mentioned that led the FDA to its conclusion last summer and why you think that might a different situation this summer.
48m 8s
Okay.
48m 8s
So I will I will answer the second question first. The publication we're talking about, I believe that you'll correct me if I'm wrong, was a New England Journal of Medicine article by doctors Richard Pazder and Julia Bieber. And this article made a point that IO in combination with other agents where the response rates are at a certain threshold do not necessarily result in long term survival. However, it's a big however, Number one, these protocols discussed by and large were not IO only protocols. There was IO mainly PD one plus something else. And so that doesn't really reflect the power of the lasting durable responses generated by CTLA for agents. That is a very important point.
49m 15s
Very, very important point. And secondly, this article excluded a number of cases. We can think about four, five cases. Where low response rates and when I say low response rate, I'm not I'm talking about single digits, I'm talking about 15, 20% response rate. Did indeed translate to longer term survival. So it was somewhat partial in detecting the the facts. And, of course, that's one issue. Now the second question that you asked, have we engaged with the new FDA? The answer is no. We have not. Because the new FDA is comprised of leadership, like doctor Marty Makary, and a lot of the senior people at the FDA, and I'm not talking about cancer division, a lot of the senior people, and even in the cancer division, a lot of the senior senior people have left. And so we're looking at our type b meeting as an opportunity to reengage the agency. However, the first step for us is to present the totality of the data. And when I talk about totality of the data, remember doctor Goldberg made the point that our sharpshooting strategy will be colorectal cancer. However, the totality of data comprising our trials across nine different cancers.
50m 54s
And of those nine different cancers, about five of them both in numbers and in terms of durability of responses have matured to a point where we can proudly demonstrate the consistency of data one cancer to another to another to another. So that's what we will be presenting as well.
51m 19s
Great. That's helpful. Thank you. And Doctor. Goldberg congrats on the new role. Wanted to ask much of your time do you anticipate being focused on metastatic CRC versus neoadjuvant CRC versus all the other tumor types? That [indiscernible] Well, so I think BotBell has demonstrated a activity really in in virtually every setting it's been. It's [indiscernible] The main reason to focus on colorectal cancer is that there's such a strong need, expressed by patients and physicians to have an IO intervention that realizes some of the benefits that have been enjoyed by MSI high patients in the much larger subset of colorectal cancer patients that are MSS. And and the data for activity of the preapproved drugs in late line metastatic colorectal cancer. Is quite modest. And while the oncology community has embraced those drugs, the patient community is disappointed by what they bring. And is looking for something better.
52m 32s
So we believe that the comparators in the setting of advanced disease, third and fourth line disease, are favorable compared to our arms to the activity that Agenus has observed in the early trials. Now from my perspective, the most potential is probably in the neoadjuvant setting. I you know, the the groundbreaking study by Andrea Sirczak and her colleagues at Sloan Kettering in MSI high tumors where patients avoided chemotherapy, radiation, and surgery. I is really startling. And I benefits patients in ways that we couldn't have imagined. Even five years ago.
53m 28s
We believe that that's translatable to rectal cancer patients with MSS tumors.
53m 34s
Using this intervention.
53m 36s
And to colon cancer patients, and tumors above the rectum where potentially we could come up with a surgery free world for managing stage three colon cancer.
53m 51s
Thank you, Richard.
53m 54s
Great. Thank you. And one last one, I may. Could you talk about your strategy of sharing the Phase two data with The Street? Whether that would be, you know, in conjunction with the FDA meeting or or after?
54m 5s
Sure. I think that's doable and I would I just wanna draw your attention. To the, neoadjuvant protocol that was presented at AACR. Whereby Miriam Cholabi presented data on patients with a fantastically acceptable safety profile. In fact, there were no real showstoppers in the safety of the the drug. And of course, this is in the earlier disease setting. With lower doses twenty five and fifty. But nonetheless, there were no real safety signals of any sort, including colitis to to really worry about. So we believe that depending on the disease setting, as Richard said, neoadjuvant offers the largest potential and earlier the better intervention philosophy, of course. Particularly with immunotherapy. And in that setting, we think we're going to be, based on all of the studies that had taken place, we're gonna be dealing with a safety profile that will be very, very acceptable to patients.
55m 19s
Thanks for taking our questions.
55m 23s
And there are no further questions at this time. I will now turn the call back over to Garo Armen for closing remarks.
55m 30s
Thank you very much, everyone. We are very grateful for your attention and for your persistence with what we're doing for the benefit of patients and our stakeholders, as I mentioned. We're also very grateful to our extended team doctor Richard Goldberg, deeper level of expertise in a disease that is the focus of our attention right now. And this particular disease is becoming a major problem in the young, and the kinds of morbidities generated by existing treatments. Chemotherapy, radiation, and surgery could be eliminated, potentially And this is a very important, issue because as I said before, both with the young and the old, of course, these are important. But with somebody having to live with these morbidities for the rest of their lives, You know, we're getting patients as young as eight years old with metastatic colon cancer.
56m 37s
Which is something remarkable. And so for a young person, to live with these difficulties for the rest of their lives is a big bigger So we're very grateful for all of your attention. And we've been on a path to do what is in the best interest of these patients. And as I said, with our stakeholders, and we very much appreciate your support.
56m 59s
Thank you.
57m
This concludes today's conference call. Thank you for your participation. May now disconnect.
Key Insights
Agenus presented new and more mature data for its BatBal (botanilimab and balstilimab) combination, showing durable responses across multiple historically untreatable "cold" tumors, including MSS colorectal cancer, certain breast cancers, sarcomas, and hepatocellular carcinoma, with no dose-limiting toxicities and all patients proceeding to surgery on schedule.
The company announced the strategic hire of Dr. Richard Goldberg as Chief Development Officer to steer regulatory strategy, particularly for metastatic colorectal cancer (CRC) and other tumor types, emphasizing the urgent need for better treatments in MSS CRC.
Agenus is on track to reduce its annualized operational cash burn to below $50 million in the second half of 2025, down from $25.6 million used in Q1 2025, and is actively pursuing four formal transaction proposals (including a facility sale, significant equity investment at a premium, and two global or geographic-specific BatBal licensing deals) to materially strengthen its balance sheet.
For Q1 2025, Agenus reported $18.5 million in cash (down from $40.4 million at year-end 2024), $24.1 million in revenue (primarily noncash royalty), and a net loss of $26.4 million ($1.03 per share), showing improvement from a $63.5 million net loss in Q1 2024.
The company has formally requested a Type B meeting with the FDA for BatBal in CRC, presenting data with two-year follow-up and deep, durable responses; they are also pursuing conditional approval pathways in Europe and expect to present updated data at a major upcoming conference, with the goal of accelerated approval and expanded indications.
