Chen Yang

Chen Yang from Bank of America asked for confirmation on whether the last patient had been enrolled for the KOASTAL-1 study and, if so, the specific date of enrollment.

Answer

Robert Lenz, Head of Research and Development, did not comment on specific enrollment details or timelines. He reiterated the company's confidence in delivering the top-line results for KOASTAL-1 around the end of the year and stated that enrollment details would be shared with the results.

Chen Yang inquired about CureVac's interest in business development opportunities outside its core mRNA expertise and requested an update on the company's ongoing patent litigation.

Answer

CEO Alexander Zehnder stated that CureVac remains focused on oncology and infectious diseases but is open to opportunities that strengthen its portfolio within these areas. Regarding litigation, he highlighted the upcoming U.S. court case scheduled for March 2025 as the next key event.

Chen Yang from Bank of America inquired about the regulatory pathway and potential timeline for the glioblastoma program if successful. He also asked how the company prioritizes its various early-stage cancer programs given its cash position and what kind of strategic deals might be pursued by the incoming Chief Business Officer.

Answer

CDO Myriam Mendila clarified that the glioblastoma trial is a proof-of-principle study and not currently planned for further development unless highly compelling efficacy data emerges. CEO Alexander Zehnder stated that the new CBO will focus on partnerships in oncology, unpartnered infectious disease assets, and molecular therapies.

Chen Yang of Bank of America inquired about the potential regulatory pathway and timeline for the glioblastoma program if it proves successful. He also asked how CureVac prioritizes its early-stage cancer programs given its cash runway and what kind of strategic deals might be pursued by the incoming Chief Business Officer.

Answer

CDO Myriam Mendila reiterated that the glioblastoma trial is a proof-of-principle study and not planned for further development unless highly compelling efficacy data emerges. She noted program prioritization will occur after more data is available. CEO Alexander Zehnder stated that the new CBO will focus on partnerships for oncology assets, unpartnered infectious disease programs, and molecular therapies.

Asked about the appeal timeline for the patent case and its impact on damages, the path to a pivotal study for the cancer vaccine, and the timeline for new oncology programs.

Answer

The company explained that in Germany, damages assessment would run parallel to an appeal. They clarified that the current oncology programs are proof-of-concept, and the focus for future pivotal trials will be on next-generation candidates from their advanced antigen discovery platform, with a new Phase I trial planned within 18 months.

Chen Yang of Bank of America inquired about the Phase III trial design for avexitide in PBH, asking what factors beyond the previous Eiger agreement are being considered and if there's potential for a readout earlier than 2026.

Answer

Dr. Camille Bedrosian, Chief Medical Officer, confirmed the trial design is being refined based on prior FDA discussions. She reiterated key elements: a 90mg dose, a primary composite endpoint of Level 2 and 3 hypoglycemia events, and a proposed 90-participant, 12-week study. She affirmed the timeline, expecting trial initiation in Q1 2025 with top-line data anticipated in 2026.