Agenus Inc. (NASDAQ:AGEN) Q1 2024 Earnings Call Transcript

Garo Armen: 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.

Mayank Mamtani: 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.

Garo Armen: 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.

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

Unidentified Analyst: 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?

Garo Armen: 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.

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

Matthew Phipps: 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?

Garo Armen: Yes, it is based on Ligand’s decision.

Matthew Phipps: 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?

Garo Armen: Perfect question for one of the world’s foremost experts on melanoma that is our Dr. Steven O’Day.

Steven O’Day: So Matt, can you clarify the question? Again, I didn’t quite get the first line piece of it.

Matthew Phipps: Yes. So there’s a slide you guys in your new deck that says first-line melanoma registrational study versus first-line standard of care. Just kind of curious what you consider to be that standard of care right now because there’s maybe 3 different I-O regimens out there.

Steven O’Day: Yes. Well, as you know, the front line treatment is split sort of between PD-1 monotherapy, PD-1 LAG-3 or PD-1 CTLA 4. I think what we’re discussing going forward and presenting later this year is a refractory setting. And obviously, we need to see what that data as it fully matures in the coming weeks and months. This is a refractory PD-1 and PD-1 CTLA-4 and BRAF refractory setting. So depending on the strength of this data and sort of the further discussions, obviously, if there is an accelerated path, it would likely lead to a first-line confirmatory trial. Again, the FDA would have to advise on the best comparator arm in that setting.

Operator: [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].

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

Operator: Yes, we can hear you.

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

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