Alexa Deemer

Alexa Deemer asked if Prothena plans to share data from the PRX-019 phase I study, expected to complete in 2026, and what criteria would be necessary for the program to advance to the next stage of development.

Answer

Gene Kinney, President and CEO, explained that PRX-019 is a partnered program with Bristol Myers Squibb, and for strategic reasons, the target remains undisclosed. The phase I study will conclude in 2026, with data shared internally with BMS. The decision to publicly disseminate data and advance the program, which would trigger a milestone payment, rests with BMS as they hold global rights. Tran Nguyen, Chief Strategy Officer and CFO, reiterated that Prothena would announce if the milestone is earned.

Alexa Diemer from Cantor Fitzgerald inquired about Invivyd's plans for PEMGARDA once the next-generation product, VYD2311, receives approval, specifically asking if the company intends to wind down PEMGARDA and over what timeframe. She also asked for clarification on the required coordination between CBER and CDER for the LIBERTY study.

Answer

Marc Elia, Chairman of Invivyd's Board of Directors, stated that Invivyd has no plans to actively sunset PEMGARDA, acknowledging its differentiated molecular properties despite potential scalability challenges. Regarding the LIBERTY study, Mr. Elia explained that the coordination between CBER and CDER is a logistical step due to differing legal responsibilities for therapeutic monoclonal antibodies (CDER) and prophylactic medicines (CBER), especially when combining them in a single study. He noted that this is an unusual but interesting study, and the company anticipates alignment on the study's nature and boundaries.

Alexa Diemer asked about Invivyd's strategy for Pemgarda once the next-generation product, VYD2311, receives approval, specifically inquiring if there are plans to wind down Pemgarda and over what timeframe. She also inquired about the necessary coordination between the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER) within the FDA for the Liberty study, given the study's unique design.

Answer

Marc Elia, Chairman of Invivyd's Board of Directors, stated that there are no current plans to actively sunset Pemgarda. He acknowledged that while Pemgarda has some limitations in scalability and accessibility, it remains a differentiated medicine at the molecular level. Regarding the FDA coordination, Mr. Elia explained that the need for dialogue between CBER and CDER arises from differing legal responsibilities for prophylactic medicines (CBER) and therapeutic monoclonal antibodies (CDER) when commingling them in a single study. He noted that this is primarily a logistical step for the FDA to support labeling language, not an indication of extraordinary risk.

Alexa Deemer from Cantor Fitzgerald asked which dose or doses from the CORAL trial the company plans to advance into the Phase 3 study for IPF cough.

Answer

James Cassella, Chief Development Officer, identified the 54mg BID dose as a "sweet spot" due to its strong performance across both primary and secondary endpoints. He confirmed that the 54mg BID dose will be a key dose taken forward into the Phase 3 program, subject to FDA alignment.

Alexa Deemer from Cantor Fitzgerald asked about the breakdown of the epinephrine market between direct-to-patient retail sales and sales to institutional entities like airlines and schools.

Answer

Richard Lowenthal, Co-Founder, President and CEO, and Eric Karas, Chief Commercial Officer, clarified that nearly all current neffy sales are through the retail channel. They noted that the institutional market, such as airlines and restaurants, represents a future growth opportunity not yet included in forecasts, with some entities waiting for the 1mg dose to become available before adoption.