Immunocore Holdings plc (NASDAQ:IMCR) Q2 2023 Earnings Call Transcript

Unidentified Analyst: Hi, good morning. This is [Jay] on for Peter. Thanks for taking our question. I just want to get a little more color around the organic growth for the second quarter for KIMMTRAK? And if you could give any – talk to the volume of – volume growth versus price growth? And any one-timers we should be thinking about here stocking orders and pricing benefits for U.S. versus ex- U.S.? Thank you.

Brian Di Donato: Thank you for that question. So most of the growth was driven from the U.S. with the 14% quarter-over-quarter growth. That was pure demand growth. We did not see any difference in patterns of stocking per se. And you have to consider that we took a price increase at the beginning of the year in January of 2.5%.

Operator: Thank you. Our next question comes from the line of Nick [indiscernible] with Goldman Sachs. Please proceed with your question.

Unidentified Analyst: Hi, there. It’s Nick on for Rajan. And thanks for taking my questions. If we could just come back to the PRISM trial and the design there. I was just wondering what the rationale was for the selection of the two doses, they seem to – or at least optically, they look quite far apart. Is – why was there not a dose in between? Is that something that you’ve agreed with the FDA? And then looking further ahead, could you just give us an idea of what you see as the bar for efficacy and what good data would delight you. Thank you.

Bahija Jallal: David?

David Berman: Yes. So with the selection of the two doses, we had multiple doses that were active and well tolerated in Phase 1. In fact, we had a sevenfold dose range. We have 20 micrograms all the way up to 160 micrograms. And we chose the 160 originally based on modeling and simulation, although we had fewer patients at the lower doses. And I think that was the reason for the need to explore a lower dose. When it came to the selection of the lower dose, we had two choices, 20 or 40. 20 was the threshold dose and we felt just in general, a good drug development never to choose the lowest dose because of variability in PK, you’ll end up with some patients having too low of exposure. And so, that really set us on choice of 40.

With regard to the bar for efficacy, the nivolumab median PFS has really ranged, I think, between 4.7 months to, I think, 8 months. The most recent RELATIVITY-047 was 4.7 months from a median perspective, we’re going to have a blended median PFS because we’ll have some patients who are on Opdualag or some patients who are on nivo, but I think that the median PFS blended is probably still going to be less than 8 months. It just will depend on how many patients are randomized to the Opdualag.

Operator: Thank you. Our next question comes from the line of Jeff Hung with Morgan Stanley. Please proceed with your question.

Jeff Hung: Thanks for taking my question. How is enrollment going for the PRAME, A02 trial? And what should we expect to see in the first half ’24 data? Thanks.

Clayton Robertson: Great. Mohamed, do you want to take that?

Mohammed Dar: Sure. As we had said earlier, we have moved from a Phase 1 footing to a Phase 2 footing. So we continue to open up additional sites and continue to accrue to our multiple priority expansion cohorts as well as the standard of care combination. So all of that continues to go according to plan. And as we’ve said, we plan to share the data as it matures in the first half of next year?

Operator: Thank you. Our next question comes from the line of Gil Blum with Needham & Co. Please proceed with your question.