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Thank you for standing by, and welcome to Agenus First Quarter 2024 Results Conference Call. All lines have been placed on mute to prevent any background noise. After the speakers’ remarks, there will be a question-and-answer session. [Operator Instructions] Thank you. I would now like to turn the call over to

Thank you, Michelle [ph], 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 subjects to risks and uncertainties, and we refer you to our SEC filings available on our website for more details on these risks. Joining me today are Dr. Garo Armen, Chairman and Chief Executive Officer; Dr. Steven O’Day, Chief Medical Officer; and Christine Klaskin, Vice President of Finance. Dr. Robin Taylor, Chief Commercial Officer; and Dr. Todd Yancy, Chief Strategic Advisor, will be participating in the Q&A session. Now, I'd like to turn the call over to Garo to highlight our progress in the first quarter. Garo?

Thank you, Steven. In parallel with our scientific BLA submission, all of us at Agenus are focused on preparing for the launch of BOT and BAL. Our Emeryville based CMC Team is well prepared to supply BOT and BAL, both to our third-party CMO partners and subsequently at our wholly-owned and operated GMP-grade commercial facility. With respect to commercial preparations, I have hired a highly experienced and passionate leadership team across sales and marketing, marketing access and commercial operations. Together, the members of the commercial leadership team have successfully led or participated in over 20 launches of novel therapeutics or label expansions in colorectal cancer and other solid tumors. We are partnering closely with our Global Medical Affairs and clinical teams to gather insights from the world’s experts on GI oncology and we’ve conducted market research with over 150 US based GI oncologists across academic and community settings. From both, to market research and our direct discussions with GI oncologists, it is clear that there is significant anticipation for BOT and BAL which underscores the urgency we feel to deliver this important treatment option to patients. Now, I'll turn the call over to Christine to discuss financials.

Thank you, Robin. As Garo mentioned, we ended our first quarter of 2024 with a cash and cash equivalent balance of $52.9 million; this compares to $76.1 million at year-end. Also as Garo mentioned, this morning we announced a $100 million agreement with Ligand Pharmaceuticals consisting of an initial investment of $75 million, with an option to invest an additional $25 million; thus strengthening our cash position. Our cash used in operations for this first quarter was $38 million compared to $40 million during the fourth quarter ended December 31, 2023. For the first quarter ended March 31, 2024 we recognized revenue of $28 million and incurred a net loss of $63.5 million which includes non-cash expenses of $38 million. This compares to a net loss of $70.9 million which includes non-cash expenses of $25 million for the same period in 2023. Our net loss per share for this first quarter is $3.04 which compares to $4.31 per share for the first quarter of 2023. I'll now turn the call back to Garo.

Thank you very much, Steven, Robin and Christine. As we conclude today’s earnings call, I want to recap the pivotal developments we anticipate in the coming months at Agenus. We are on-track to secure a significant cash infusion of upto $200 million by mid-year. We will strengthened our cash position and support our clinical research and development activities, our registration efforts and our commercialization efforts. Another key milestone will be our meeting with the FDA, an important [indiscernible] before we have their concordance in initiating our biologics license application. Additionally, we will present our Phase 2 for colorectal cancer along with additional data in this indication from investigator sponsored trials, which we believe will further strengthen the strong rational of our therapies. And these data presentations are expected to be happening at major conferences. Furthermore, we expect to release as Steven said, promising Phase 1 and 2 data in melanoma, lung cancer, sarcoma and pancreatic cancer in the second half of this year. We are very encouraged with the outcomes of these trials. These all represent cancers where there is a clinical need for effective therapies. These developments underscore our dedication through innovation and oncology and also highlight our potential to make a meaningful impact on patients’ lives by offering potentially chemo-free durable benefit [ph] to patients who had limited treatment options left. Thank you very much once again to our shareholders for your continued support and trust in Agenus. We look forward to sharing more about our progress in these exciting endavours as the year unfolds. Now, I believe we're ready for any questions you may have.

[Operator Instructions] Your first question comes from the line of Emily Bodnar of HC Wainright.

Congrats on the progress. First question, could you confirm how many patients you've treated with BOT/BAL at the recommended Phase 2 dose across the Phase 1b and Phase 2 studies specifically for MS CRC patients without? And your confidence, I guess, that you have enough efficacy data to support an accelerated approval? And then second question, if you can kind of discuss how you're thinking about strategy for BOT/BAL in melanoma and pancreatic cancer? And if you feel like these are indications that you may also seek regulatory approval for if the Phase 2 data are positive? Or if you're kind of near-term commercial focus is just on CRC?

Your next question comes from the line of Mayank Mamtani of B. Riley Securities.

Congrats on the updates noted earlier. So in prior press release team, you've mentioned that your emerging data in Phase 2 is encouraging. And today, I think you said it's comparable to what you noted in Phase 1 at a similar stage. Are you able to give a little bit more detail on what parameters we are talking about and it's comparable to your expectation at the outset and especially given you're enrolling slightly earlier stage patients there? And then secondly, on the -- if you are able to clarify the FDA meeting has been scheduled. And if there's a minimum follow-up from the Phase 2 cohort that you're trying to accomplish before you're able to submit a package that would go alongside that everything. And I have a couple of follow-ups.

Okay. On the first question, Mayank, we have said repeatedly, that we will not discuss the details of this study and please understand everybody that we're not trying to be cute here, it is just a courtesy call that we will not discuss the data and ensure we have an opportunity to present it to the FDA. And subsequent to that, our preference is, of course, to present the data which we consider a very important set of data that will address the selection of the dose, contribution of the elements and the efficacy to support the data that we have seen in earlier trials and a major. That would be our preference to do it. So you will get no further details on this until these steps are underway. In terms of FDA meeting, the FDA meeting request is going in as we speak. And we expect that based on the time lines, we will be granted a meeting sometime in the second half of July. And this is data that we have not releasing for that we're now making it public. And as soon as the meeting is scheduled, of course, depending on the circumstances, we may make certain statements about it. But I believe that the outcome of this meeting will be 1 of the most important milestones for the company as we potentially gear up accelerated approval filing in the next months following the meeting. But be rest assured that we are going on all full cylinders as they say, on all modules or are getting ready in a state of readiness for all modules that could potentially be submitted post the FDA meeting.

I appreciate that color. On the follow-up from the Phase 2, like you are at, I think, 14 months follow-up in the -- from the Phase 1. Is there a particular requirement or best practices in terms of how much follow-up you need to have from Phase 2? Or is that sort of subject to discussion?

Okay. So on this, of course, the FDA has guidance that is based on historical precedents on the minimum follow. But we have had significant input from our regulatory advisers on what that minimum should be. Of course, ideally, we can wait 5 years but we're not going to do that. But the minimum enrollment in the Phase 2 ended in October 2023. And based on that, you can sort of extrapolate what the follow-up period will be between now and the potential FDA meeting. And then beyond the FDA meeting, from that point to the filing of a BLA with the clinical module.

Makes sense. And then on the number of ISTs that have come up on clinicaltrials.gov. Are you able to comment on what sort of BOT dose level you're using in most of these ISTs? And also about CRC specifically, I believe with one IST data that you expect in the relative near term in the earlier line setting, even if you're able to comment on the implications of that data set in informing what the Phase 3 trial could look like? And then I have 1 last financial question after that.

So thank you, Mayank, for that question. We have been confronted with an unprecedented number of ISTs. Now what is that number? It's well over 50 IST requests. Clearly, given our resources and I don't mean just financial resources, because a number of the ICTs do not require my financial resource from the company but people, human resources, we cannot satisfy all of these IST requests. So we have zeroing on a handful of them. And these handful of ISTs are selected based on potential data generation for approval of our agents in subsequent trials. And also, of course, the rationale of generating significant clinical data that will be supporting the rationale of pursuing BOT/BAL in several different indicators that are important to us. So these will be reviewed or are in the process of being reviewed on an ongoing basis and we'll make prudent decisions in collaboration with some of our advisers and key but also be rest assured that during the time of our regulatory discussions, we are particularly sensitive to not expending our IST programs, so that we do not get caught in generating data that cannot be tabulated, cleaned up in time to be provided to the FDA for the potential BLA consideration. So all these considerations are a critical part of our total process. Now in addition to that, I think you had another question on ISTs that whether or not it's specific to CRC. That, of course, brings a number of the are not specific to CRC. They are in pancreatic, melanoma, lung, sarcomas. There's a great deal of interest in sarcoma because of the efficacy that we've seen or, I should say, significant clinical activity that we see -- the reason I'm saying I shouldn't say efficacy is because that's a term that the FDA has the best tool that happens we have to be careful how we use the terms of activities. But because of the significant activity that we have seen in the sarcoma patients that failed everything else and they're not responding to any other treatments. There is, of course, a lot of interest in pursuing not just ISTs but also approval strategies. But as I said earlier, we are very, very cognizant to the focus that we need to have on CRC right now.

Got it. And then lastly, in the nondilutive financing, the total of $200 million, if you include some of the expected syndicated offering. Just if you're able to comment on how much contribution BOT/BAL versus the other partner programs in this broader deal concept, that would be helpful, just a rough range, Garo.

So I mean, there is -- the relative contribution is articulated in our press release or the Ligand press release that was put out this morning at 7:30. So -- but other than that, we cannot discuss any additional details. Suffice it to say that this financing completely provides us with the freedom to pursue BOT/BAL on our own and pursue BOT/BAL in connection with partners worldwide. So this particular transaction has absolutely no bearing or puts any restrictions on our ability to advance BOT/BAL to -- in collaboration with partners and by ourselves. In other words, the economics of this transaction are defined and that was in the press release. And beyond that, I believe that we are in a superb position to exploit our commercial opportunity with BOT/BAL. And that will be, of course, for the benefit of both the company, our future potential partners and for the benefit of Ligand.

Your next question comes from the line of Kelly Shi of Jefferies.

This is Dave [ph] on for Kelly Shi. My question is about the catalyst in the second half. You said there will be a number of data in melanoma, lung, pancreatic in the second half. Can you provide like expectation, what kind of data we should expect and number of patients and those details?

Okay. So clearly, if the data was expected to be not hazardous, we wouldn't be talking that. But can I provide you with specifics on the data that will compromise our ability to present it in a conferences, the answer is no. So we'll have to see as the data matures, we're very encouraged with what we're seeing across a number of indications. As we said before, that includes melanoma, lung cancer, sarcoma, pancreatic cancer and even others. So please be patient and allow us to make the appropriate disclosures and have an opportunity to present the data to review conferences and also in publications.

Your next question comes from the line of Matthew Phipps of William Blair.

Congrats on the Ligand financing. Just wondering, the additional $25 million that can come from Ligand. Is that purely based on Ligand's decision? Or is there anything that can trigger that decision?

Yes, it is based on Ligand's decision.

Great. And then maybe for Dr. O'Day. The melanoma on the slide that's on the front line trial and front line registrational trial versus standard of care. Wondering if you consider that to be PD-1 monotherapy, PD-1 -- a different PD-1 CTLA4 or PD-1 LAG-3 at this point?

[Operator Instructions] Your next question comes from the line -- I think we lost -- all right. So, we have the next question from Gabriel Kims [ph].

Congratulations on the Ligand financing. Could you just say when is the anticipated closing date? And then, I had a follow-up.

Yes, we can hear you.

I think we mentioned that we expect to close the transaction this month.

Okay. Wonderful. And then in terms of share count, are you able to provide an end of quarter or current share count?

I don't have the share count with me but I believe going into all of this, it was 20 million, something like that. Christine, do you have the exact share count?

Yes, it's just over 20 million. And we did file our 10-Q this morning, so you can see that on our filing.

Okay. And is that also -- okay, wonderful. So that's the current share count as well.

Yes.

There are no further questions at this time. I will now turn the conference back over to Garo Armen for the closing remarks.

Thank you very much. Thank you very much for your attention and your patience. As you know, a number of our shareholders were concerned about how we would be able to get our financial conditions strengthened, our balance sheet strengthened. And what I expect is that today's announcement is the very first step in this process. And so throughout the next weeks, months, we will see additional activities that I expect will strengthen our balance sheet and allow us to be able to pursue our very important mission of getting BOT/BAL to the finish line. Thank you very much.