Release Date: October 31, 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 EUR3.3 billion, supporting its pipeline development.
- The company received IND clearance from the FDA for GLPG-5101, marking significant regulatory progress.
- Galapagos NV (GLPG) is advancing its R&D pipeline with four clinical candidates for 11 indications and over 15 preclinical programs.
- The company is expanding its decentralized CAR-T manufacturing network in the US and Europe, enhancing operational capabilities.
- Galapagos NV (GLPG) reported a net profit of EUR49 million for the first nine months of 2024, driven by fair value adjustments and interest income.
Negative Points
- Increased R&D costs are impacting financials, driven by investments in oncology and collaborations.
- The company faces challenges in the competitive CAR-T therapy market, particularly with BCMA-targeted therapies.
- There is uncertainty regarding the timeline for potential market entry of CAR-T programs, dependent on regulatory processes.
- Galapagos NV (GLPG) is experiencing a cash burn, with a net decrease of EUR346 million in cash position over the first nine months of 2024.
- The company is still in the early stages of its pipeline development, with many programs yet to reach clinical trials.
Q & A Highlights
Q: Can you provide insights on the BCMA CAR-T 301 trial and any changes in future enrollment criteria?
A: Paulus Stoffels, CEO, explained that BCMA-targeted CAR-T therapies can lead to Parkinson's due to BCMA expression in the brain. The company has conducted thorough due diligence and incorporated findings into the protocol, ensuring expansive discussions between medical monitors and investigators to address patient safety.
Q: What details can you share about the data to be presented at ASH for EUPLAGIA and ATALANTA?
A: Paulus Stoffels, CEO, stated that due to the ASH embargo, details cannot be disclosed until November 5. The company looks forward to sharing the data once the embargo is lifted.
Q: What is your approach to business development next year, and what types of deals are you open to?
A: Paulus Stoffels, CEO, mentioned that Galapagos is focused on oncology and immunology, particularly precision oncology and CAR-T opportunities. The company aims to leverage its strong cash position to broaden its portfolio.
Q: Is there potential for your CAR-T programs, particularly F101, to enter the market earlier, and how confident are you in obtaining breakthrough therapy designation?
A: Paulus Stoffels, CEO, noted that the company plans to include the first patient in the study by year-end and expand to other centers next year. They are confident in the data's strength and will follow the scientific and regulatory process to determine timelines.
Q: Have you run any test runs for GLPG-5101 since the IND clearance, and are there any barriers specific to the US clinical infrastructure?
A: Thad Huston, CFO and COO, confirmed no concerns regarding the median seven-day vein-to-vein time. The approach is consistent across the US and Europe, with productive interactions with the FDA providing important insights.
Q: Can you provide more information on the new bispecific CAR-T advancing into IND-enabling studies?
A: Paulus Stoffels, CEO, explained that the bispecific CAR-T addresses CD19 escape, a resistance issue. The preclinical data is promising, and more details will be shared during an R&D day next year.
Q: Are you still prioritizing CAR-T for autoimmune diseases, and what is your approach to program prioritization?
A: Paulus Stoffels, CEO, stated that while the field is crowded, they are interested in B-cell depletion mechanisms and will carefully choose when to step in with best-in-class products.
Q: Can you provide more color on the TYK2 program and its timelines?
A: Wulf Böcher, Head of Immunology, confirmed that the Phase 2 studies in dermatomyositis and lupus are progressing well, with data expected in 2025 and 2026. The TYK2 inhibitor is differentiated by preserving the IL-10 pathway, which is crucial for regulatory T cell differentiation.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
