Release Date: August 02, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Galapagos NV (GLPG, Financial) has a strong cash position of EUR3.4 billion, supporting future growth and R&D investments.
- The company has made significant regulatory progress, including the submission of an IND for the ATALANTA Phase 1/2 study of 5101 in refractory, relapsed non-Hodgkin lymphoma.
- Galapagos NV (GLPG) is expanding its cell therapy manufacturing network, including a new agreement with Blood Centers of America for the US territory.
- The company has presented encouraging safety, efficacy, and durability data for its CAR-T programs, particularly 5101 and 5201, in various scientific conferences.
- Galapagos NV (GLPG) has entered into a promising collaboration with Adaptimmune, adding TCR T-cell therapy to its pipeline and expanding into the solid tumor space.
Negative Points
- The company reported an increase in R&D costs compared to the previous year, driven by investments in oncology and small molecules.
- There were two deaths reported during the ATALANTA study, raising concerns about the safety profile of the treatments.
- The PAPILIO Phase 1/2 BCMA-directed multiple myeloma program observed a case of Parkinsonism, leading to a temporary pause in enrollment.
- Galapagos NV (GLPG) anticipates a higher cash burn for 2024, updated to EUR370 million to EUR410 million, primarily due to the Adaptimmune collaboration.
- The competitive landscape in the multiple myeloma space poses challenges for the prioritization and future of the 5301 program.
Q & A Highlights
Q: Can you discuss the key aspects of manufacturing site readiness and QC that facilitated the IND submission for 5101? What remains to be done for 5202?
A: We completed the tech transfer to Landmark Bio, which was crucial for the IND filing. We had multiple interactions with the FDA to optimize our proposal. The IND for 5101 has been submitted and is under evaluation. For 5201, we anticipate filing later this year after completing the tech transfer process.
Q: Regarding the Parkinsonism observed in the 5301 study, is it similar to other BCMA CAR-Ts? What protocol amendments were made?
A: The Parkinsonism observed is consistent with what has been seen in other BCMA-targeted CAR-T therapies. We paused the study to review the patient history and implemented additional safety measures. The protocol amendments focus on enhanced monitoring.
Q: How did the first-gen afami-cel asset influence your decision to partner with Adaptimmune on the next-gen asset? What can you share about future business development efforts?
A: We were impressed with Adaptimmune's clinical results with afami-cel, which led to our collaboration on uza-cel. Business development will be key to broadening our portfolio, and we will continue to look for licensing deals and acquisitions to complement our pipeline.
Q: Can you confirm if the protocol amendment for the 5301 study is more about monitoring rather than mitigation? How many patients were dosed before observing the adverse event?
A: The protocol amendments are indeed focused on monitoring. We will share detailed safety and efficacy data in 2025.
Q: Can you speak to the BridGene SMARCA2 project and its approach compared to other assets in the space? What drove the selection of SMARCA2 as the first target molecule?
A: SMARCA2 is a dependency in SMARCA4 deficient non-small cell lung cancer. We aim to develop a best-in-class oral selective PROTAC by leveraging BridGene's expertise and our internal capabilities. This approach combines the best of both worlds to accelerate time to patients.
Q: Regarding the adverse event in the multiple myeloma trial, what happened to the patient, and how does this affect the priority of 5301 compared to other programs?
A: We cannot share individual patient data. The 5301 study is in the dose-finding phase, and we will evaluate its future based on safety and efficacy data. Our key priorities remain 5101 and 5201, with a focus on starting critical studies in 2025.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
