David Dai

David Dai sought clarification on the HARMONi-3 phase III trial update, specifically if the regulatory de-risking means Summit Therapeutics can file each histology separately, even if one cohort fails. He also asked for Summit Therapeutics' thoughts on combination strategies for non-small cell lung cancer, particularly with ADCs and chemo combos.

Answer

Dave Gancarz, Chief Business and Strategy Officer, confirmed that the separate histology analyses in HARMONi-3 are independent Intent-to-Treat (ICTs), allowing for separate filings. He expressed excitement about collaborations, including with Rev Med for RAS inhibitors and plans for additional combinations, likely with ADCs. He highlighted Summit Therapeutics' strategic advantage of not having internal ADCs, enabling them to pursue the best data-driven combinations.

David Dai of UBS Group AG inquired about the company's launch readiness for ZERKAIX and the expected performance in the initial quarters following its potential approval.

Answer

Group CEO Christian Behrenbruch affirmed that the commercial team is fully prepared for the ZERKAIX launch, as it targets the same urology and nuclear medicine customer base as Elucix, creating a straightforward path to market. Kevin Richardson, CEO of Telix Precision Medicine, noted that the successful expanded access program has already demonstrated the product's value, indicating strong market readiness.

David Dai of UBS sought confirmation that the patient ramp for Amtagvi was on track to meet the midpoint of guidance, and asked for an update on the number of newly activated ATCs versus those still in the activation process.

Answer

Chief Commercial Officer Dan Kirby clarified that the full-year guidance of $250M-$300M includes both Amtagvi and Proleukin revenue, making the required quarterly patient growth lower than the analyst's calculation. He expressed confidence in meeting the guidance, citing strong Amtagvi demand and normalizing Proleukin orders. He noted new ATCs have been activated but emphasized the focus is on the quality of centers, not just the quantity.

David Dai asked if there was any spillover impact from the holiday season on patient start forms or tumor resections.

Answer

Interim CEO Frederick Vogt stated they did not observe a general slowdown, as cancer centers typically operate through the holidays. Chief Commercial Officer Dan Kirby added that as this was the first full year of launch, they are still establishing commercial patterns and will monitor for seasonality, but none is apparent in the current data.

David Dai from UBS inquired about the specific activities Iovance undertook to improve the patient dropout rate this quarter compared to the last.

Answer

Interim CEO Frederick Vogt clarified that the improvement was not due to a single new initiative but rather the result of ongoing launch optimization. This includes educating ATCs on better patient selection and surgical resection quality. He expects this trend to continue as centers gain experience.

David Dai of UBS Group asked what is driving the long 13-month real-world duration of therapy for Chemtrac, specifically about treatment beyond progression, and inquired about the expected patient breakdown in the PRISMEL trial's control arm.

Answer

Ralph Torbay, EVP of Commercial, attributed the long duration to patients feeling good due to the favorable safety profile, and confirmed that treatment beyond progression is common in the real world. David Berman, EVP of R&D, stated that a minority of patients in the PRISMEL control arm will receive Opdualag, with the majority receiving nivolumab, but expressed confidence in beating both based on prior data.

David Dai asked for details on Revuforge's Q2 revenue, specifically the contribution from inventory versus new and refill patients. He also questioned if the stem cell transplant rate is expected to rise from the current one-third.

Answer

CFO Keith Goldan clarified that revenue growth was driven by patient demand, as inventory levels remained stable at two to three weeks. CEO Michael Metzger confirmed that they expect the transplant rate to 'materially change over time and get better' than the current one-third, driven by the trend of treating patients in earlier lines of therapy, which improves their eligibility for transplant.

David Dai from UBS sought clarification on the data cut for the upcoming ASCO presentation and asked about the baseline characteristics of patients in the pivotal trial. He also inquired about Kyowa Kirin's potential contribution to expediting the KOMET-017 trial.

Answer

CEO Troy Wilson clarified it is effectively the same data cut being submitted to the FDA, not a later one. CMO Dr. Mollie Leoni added that patient characteristics are similar to Phase I, with most having prior venetoclax treatment. She also confirmed the hope is that Kyowa Kirin's regional presence and expertise will help accelerate trial start-up and execution.