Agenus Inc. (NASDAQ:AGEN) Q4 2023 Earnings Call Transcript

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Matthew Phipps: And I guess just curious, Garo, why not disclose at least some indication of the top line results, I guess, in May, given the six months follow-up by that point? Why wait till after you meet with the FDA to at least, I guess, say whether or not or endpoint has been met or something like that?

Garo Armen: It’s strictly regulatory courtesy. I think it would be not appropriate if we’re ready to present that data to the FDA to make that public right before our FDA meeting.

Matthew Phipps: Okay. And I assume then you’ll make disclosures publicly after receiving the minutes from that FDA meeting. So adding a little bit of time for that.

Operator: And next, we’ll move to Kelly Shi at Jefferies.

Unidentified Analyst: This is Sara on for Kelly. So one quick question on non-small cell lung cancer. So for the next update, given you’ve shown 56% overall response data in patients…

Garo Armen: Sara, your voice is coming very faint and there’s some crackling in the line, if you can speak closer to the microphone.

Unidentified Analyst: How about now?

Garo Armen: Yes, better.

Unidentified Analyst: Okay. Got it. So just one question on the lung cancer update. Given you’ve shown 50% overall response data in nine patients. Wondering what would be the efficacy you need to see on the next update to advance the program into the next stage of development? And if so, what would be the going forward plan for lung cancer? And also just wondering, can you remind us what other data disclosure we should expect in 2024? I believe the BMS partner TIGIT data is also expected this year as well? Just wanted to confirm.

Garo Armen: Sure. So a couple of things here. On the lung cancer, as you know, we slowed down overall enrollment in the trial. So what we’re doing right now, having dissected the data and looked at subsets of patients that have had significant responses. When I say significant response, I’m talking about complete responses, rapid complete responses at our low dose level. That, to us, is a significant outcome. So we’re in the process of now defining how we would proceed, as I said earlier, with those subsets of biomarker identifiable patients. And so that’s our next step in lung cancer, but that’s going to happen very quickly. With regard to data for the balance of this year, we have data coming — mature data coming from larger cohorts of pancreatic cancer patients in a randomized trial, that would be some time, maybe preliminary data will be by mid-year, but more mature data by the year-end.

We’ll have more mature data in melanoma. We will provide the sustainability of responses in sarcoma. And of course, you will see substantially more data in colon cancer shortly after our regulatory meetings.

Unidentified Analyst: Super helpful.

Operator: And there are no further questions at this time. I would like to turn the conference over to Garo Armen for closing remarks.

Garo Armen: Thank you very much, Audra, and thank you very much for your attentiveness and sort of fantastic questions, actually. And I think we’ve covered a great deal here, and I just want to make sure that our stakeholders are insured of our commitment to make sure that we stay focused, first of all, because we’re in a very unique environment, where resources are not as abundant as they were in the past. And so maybe that’s a good thing because it forces companies, not just us, but the industry to do things more rationally. So we intend on delivering outcomes with efficiency. We are poised to be able to potentially launch product, both from a CMC perspective, as well as from a commercial perspective. We have a terrific team in each category to do this.

In addition to that, we have assembled a very, very competent medical affairs team so that we can drive our processes through education, education of the system, patients, regulators as well as physicians that will eventually prescribe our medicines. So we are attending to all of these very important components. We are a small, large company in that sense and an old young company in many ways. Thank you very much for your attentiveness and we will communicate with you appropriately at the next time.

Operator: And this concludes today’s conference call. Thank you for your participation. You may now disconnect.

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