Galapagos Reports H1 2024 Financials and Q2 Business Update

Galapagos NV, a major biotechnology firm listed on Euronext and NASDAQ under the ticker GLPG, has released its financial results for the first half of 2024 and outlined its progress and expectations for the year. The company is actively advancing its Forward, Faster strategy, which focuses on achieving regulatory and clinical milestones, enhancing cell therapy manufacturing, and advancing early-stage programs. 

A key highlight is the submission of an IND application to the U.S. FDA for the Phase 1/2 ATALANTA-1 study of its CD19 CAR-T candidate, GLPG5101, targeting relapsed/refractory non-Hodgkin lymphoma (R/R NHL). Simultaneously, a Clinical Trial Application (CTA) was submitted to the European Medicines Agency (EMA) for a Phase 2 study of GLPG5201 aimed at treating relapsed/refractory chronic lymphocytic leukemia (R/R CLL) with or without Richter transformation (RT). An additional IND filing for the EUPLAGIA-1 Phase 1/2 study of GLPG5201 in the U.S. is scheduled for the fourth quarter of 2024.

Preliminary data from these studies indicate that both GLPG5101 and GLPG5201 show promising safety and efficacy profiles. These fresh CD19 CAR-T therapies demonstrate the feasibility of delivering treatment within a seven-day vein-to-vein timeframe, which is crucial for patients with rapidly progressing cancers.

To support its ambitious pipeline, Galapagos has significantly broadened its U.S. territorial reach through a strategic partnership with Blood Centers of America. This collaboration aims to extend the company's existing cell therapy manufacturing capabilities, which already include partnerships with Landmark Bio and Thermo Fisher Scientific. The collaboration will facilitate upcoming pivotal studies and potential commercial manufacturing near cancer treatment centers in the U.S.

Additionally, Galapagos is advancing its innovation strategy in solid tumors, marked by a new clinical collaboration with Adaptimmune. This agreement includes an option to exclusively license Adaptimmune's uza-cel, a next-generation TCR T-cell therapy targeting MAGE-A4 for head and neck cancer, among other potential solid tumor indications. Galapagos has also expanded its alliance with BridGene Biosciences to include the development of a highly selective oral SMARCA2 small molecule proteolysis-targeting chimera (PROTAC) for precision oncology.

Financially, Galapagos remains robust, with cash and current financial investments totaling €3.4 billion as of June 30, 2024. The company has reaffirmed its financial outlook for 2024, maintaining its cash burn forecast of €280 million to €320 million, excluding business development activities. Including business development, the cash burn is expected to be between €370 million and €410 million.

Regarding its half-year financial performance, the company reported net revenues of €140.3 million, up 18% from €118.6 million in the same period last year. This growth was driven by increased supply and collaboration revenues. However, the operating loss widened to €71.3 million from €27.7 million, primarily due to higher R&D expenses, which rose 34% to €145.2 million. This increase is attributed to elevated costs associated with cell therapy and oncology programs.

Notably, Galapagos experienced a significant boost in net financial income, which soared to €98.4 million from €33.1 million. The improvement was mainly due to favorable currency exchange rates and higher interest income resulting from increased interest rates.

For the second half of 2024, Galapagos plans to make further strides in its ongoing clinical trials and expand its cell therapy manufacturing network. The company aims to progress with patient recruitment in its ongoing Phase 1/2 studies for CD19 CAR-T candidates and present additional encouraging data. Furthermore, Galapagos expects to resume the Phase 1/2 PAPILIO-1 study of GLPG5301 in relapsed/refractory multiple myeloma (R/R MM) after a temporary enrollment pause.

In summary, Galapagos is making significant advances in its cell and gene therapy programs while maintaining a strong financial position. The company is well-positioned to achieve its strategic goals and deliver innovative treatments for patients with high unmet medical needs.

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