Jacob Mekhael

Jacob Mekhael from KBC Securities asked about argenx's strategy for external innovation, given its $4.3 billion cash balance. He inquired if more early-stage deals should be expected and if there are specific technologies that would align well with internal efforts.

Answer

Tim Van Hauwermeiren, Chief Executive Officer, explained that all argenx innovation starts with external collaboration. He noted that the increasing cash balance expands their search for novel biology beyond academic labs to include young biotech companies, confirming that more such biology will be integrated into their innovation mission.

Jacob Mekhael asked about argenx's strategy for external innovation, given its $4.3 billion cash balance. He inquired if the company expects more early-stage deals, similar to one earlier in the year, and if there are specific technologies that would align well with their internal efforts.

Answer

Tim Van Hauwermeiren, Chief Executive Officer, emphasized that all argenx innovation begins with external collaboration. He noted that the increasing cash balance expands their search for novel biology beyond academic labs to include constructive discussions with young biotech companies, thereby increasing their 'hunting ground' for exciting biology.

Jacob Mekhael asked how recent leadership changes at the FDA might impact the agency's perspective on point-of-care CAR-T manufacturing and its openness to innovative cell therapy delivery methods.

Answer

CEO Paulus Stoffels expressed confidence that regulators will continue to prioritize and support therapies for high unmet medical needs. He mentioned recent positive interactions with the FDA and noted that European and U.K. regulators are also showing a strong desire to drive innovation in the cell and gene therapy space, suggesting global support for their approach.

Inquired about the company's business development strategy, specifically whether they prefer licensing deals over M&A and the factors that guide this choice.

Answer

Both licensing and M&A are being considered. The focus is on high unmet need assets in immunology and oncology, from late preclinical to early clinical stages. The goal is to complement their growing internal pipeline, and they have the team and financial resources to pursue various types of deals.

Jacob Mekhael of KBC Securities asked for clarity on the company's business development approach, specifically whether there is a preference for licensing agreements versus M&A.

Answer

CFO & COO Thad Huston responded that both licensing and M&A are on the table. He emphasized that the company is looking for assets in immunology and oncology from late preclinical to early clinical stages where it can add value. He also pointed to the company's strong internal discovery pipeline and significant cash position to execute on opportunities.

Asked about plans to expand CD19 CAR-T into other autoimmune diseases and whether a basket trial would be considered. Also inquired about the progress and expected number of new U.S. manufacturing sites by the end of 2024.

Answer

The company is considering other autoimmune indications beyond lupus but does not favor a basket trial, preferring indication-specific studies for clearer data. Regarding U.S. site expansion, they are actively working with multiple centers beyond Landmark Bio but have not disclosed a specific number or timeline for 2024.

Jacob Mekhael of KBC Securities inquired about the vein-to-vein time achieved in the commercial setting, asking if the 16-day target was met. He also asked about key learnings from the initial launch and the expected timeline for EU approval and launch preparations.

Answer

Executive Christian Itin reported that the commercial turnaround time shows a 'high degree of consistency' with prior experience and is tracking within expectations. He noted key learnings involve streamlining processes to reduce workload on centers. For the EU, he confirmed the regulatory process is in its second half but declined to pinpoint a date, stating that preparations in the U.K. and Germany are underway, leveraging learnings from the U.S. launch.

Jacob Mekhael inquired about obe-cel's potential differentiation in pediatric ALL, the potential to reduce the 16-day vein-to-release time, and the company's expectations for SG&A and R&D expenses in 2025.

Answer

CEO Christian Itin noted the pediatric trial is a regulatory obligation but also an opportunity given obe-cel's consistent and safe profile. He stated that shortening the sterility test could reduce vein-to-release time by 2-5 days. CFO Robert Dolski added that while formal 2025 guidance is not yet provided, the U.S. commercial team is largely established, with only modest growth expected for the next wave of center activations.