SpringWorks Therapeutics Announces Q2 2024 Financial Results and Business Highlights

SpringWorks Therapeutics, a biopharmaceutical company specializing in rare diseases and cancer, revealed their financial results for the second quarter of 2024 and shared updates on recent developments. The firm reported a net product revenue of $40.2 million from OGSIVEO® (nirogacestat) during this period. This medication, aimed at adults with desmoid tumors, is performing well in the U.S. market since its launch.

CEO Saqib Islam highlighted the company’s achievements and future plans, emphasizing the completion of a New Drug Application (NDA) submission for mirdametinib, intended for treating children and adults with NF1-PN (Neurofibromatosis Type 1 with Plexiform Neurofibromas). This positions the company to potentially offer a second treatment option by 2025. The focus for the latter half of 2024 will be on expanding OGSIVEO's use, preparing for the mirdametinib launch, progressing with European regulatory processes for both drugs, and advancing their emerging drug portfolio for unmet medical needs.

Several milestones were noted for OGSIVEO. The drug’s launch has been commercially successful, and the company has introduced new tablet forms to enhance patient convenience. A Marketing Authorization Application (MAA) for this medication is under review in Europe. Furthermore, additional analyses from the Phase 3 DeFi trial, presented at the 2024 ASCO Annual Meeting, underscored the drug's consistent safety and efficacy. The company anticipates presenting long-term follow-up data from this trial later in the year and reporting initial data from a Phase 2 trial for ovarian granulosa cell tumors.

For mirdametinib, the company completed an NDA submission to the FDA and plans to submit an MAA in Europe by the end of 2024. Results from the Phase 2b ReNeu trial exhibited high response rates and quality of life improvements for both adults and children with NF1-PN. These findings were shared at several prominent conferences and will be submitted for publication later in the year. Additionally, initial data from a Phase 1/2 trial on pediatric low-grade gliomas showed promising activity, with ongoing patient recruitment for the Phase 2 portion.

SpringWorks’ emerging pipeline includes a Phase 1b trial of brimarafenib (BGB-3245) for RAF mutant solid tumors, with more data expected in 2025. They are also conducting several combination therapy trials and initiated a Phase 1a trial for SW-682, targeting Hippo mutant solid tumors.

The company has strengthened its leadership team by appointing Martin Mackay, Ph.D., to the Board of Directors, bringing extensive R&D experience from major pharmaceutical companies.

Financially, the company reported significant increases in both selling, general, and administrative (SG&A) expenses ($57.8 million) and research and development (R&D) expenses ($44.4 million) for the second quarter of 2024, when compared to the same period in 2023. This increase reflects heightened commercial activities and preparations for future product launches. Despite a net loss of $39.9 million for the quarter, the company holds a robust financial position with cash, cash equivalents, and marketable securities totaling $521.9 million as of June 30, 2024.

In summary, SpringWorks Therapeutics continues to advance its pipeline and expand its commercial operations, with notable progress in the development and regulatory processes of key therapies. The company remains focused on delivering life-changing treatments for rare diseases and cancers, leveraging its strong financial footing and strategic leadership appointments.