Benjamin Burnett

Benjamin Burnett asked for physician feedback on the evolving competitive landscape in advanced melanoma, particularly regarding a potential new entrant expected later in the year.

Answer

Interim CEO and President Frederick Vogt stated that Iovance views the potential new entrant as very similar to the currently marketed T-VEC, with clinical data from a much earlier-line patient population that is not comparable to Amtagvi's. He concluded that they do not anticipate a significant impact on the Amtagvi launch.

Benjamin Burnett of Stifel asked about Iovance's path to achieving its 70% gross margin goal and the specific operational levers that will be utilized to reach that target.

Answer

Interim CEO Frederick Vogt and CFO Jean-Marc Bellemin responded. They explained that increased capacity utilization at the company's ICTC facility is a primary driver. They also cited ongoing operational excellence initiatives, process improvements, automation, and better raw material cost management as key levers to improve margins over time.

Benjamin Burnett of Stifel requested more details on the planned Q2 data update for zoldonrasib and asked about overlapping toxicities and the perceived debate around combining daraxonrasib with chemotherapy.

Answer

CEO Dr. Mark Goldsmith declined to provide more color on the upcoming zoldonrasib data. He clarified there is no 'debate' on combinability, but rather a fundamental challenge that standard-of-care chemotherapy alone is often poorly tolerated by PDAC patients. The focus is on managing the chemo backbone's toxicity to ensure continuous, effective dosing of daraxonrasib.

On behalf of Benjamin Burnett, Carolina Ibanez-Ventoso asked about the key factors for the PRGN-2012 rolling BLA submission and the likelihood of an AdCom meeting, given a competitor's recent filing delay.

Answer

President and CEO Dr. Helen Sabzevari confirmed that Precigen remains on track for a BLA submission by the end of 2024. She emphasized the drug's differentiation, including its subcutaneous delivery and strong safety profile. Regarding a potential AdCom meeting, Dr. Sabzevari noted that while it is at the FDA's discretion, the remarkable consistency in complete response rates between the Phase I (50%) and Phase II (52%) trials suggests the data is robust and may not require such a review.

Carolina Ibanez-Ventoso, on behalf of Benjamin Burnett, asked about the key factors for initiating the rolling BLA submission for PRGN-2012 and the potential for an AdCom meeting with the FDA.

Answer

President and CEO Dr. Helen Sabzevari confirmed that the company is on track for a BLA submission by the end of 2024. She emphasized the drug's differentiators, such as subcutaneous delivery and strong efficacy. Regarding a potential AdCom, Dr. Sabzevari noted that while it is at the FDA's discretion, the remarkable consistency between the Phase I (50% complete response) and Phase II (52% complete response) pivotal trials may obviate the need for one.

On behalf of Ben Burnett, Carolina Ibanez-Ventoso asked about the key factors for commencing the PRGN-2012 rolling BLA submission and the potential for an AdCom meeting with the FDA.

Answer

President and CEO Dr. Helen Sabzevari confirmed that the company is on track for a year-end 2024 BLA submission. She stated that while an AdCom is at the FDA's discretion, she believes the strong consistency between the Phase I (50% complete response) and Phase II (52% complete response) pivotal trial data may obviate the need for one.