SpringWorks Therapeutics (SWTX) Corporate Presentation summary

Corporate overview and financial position

• OGSIVEO is the first and only FDA-approved therapy for desmoid tumors, rapidly established as the systemic standard of care with over $115M in net revenue since launch and strong physician adoption.

• Mirdametinib NDA for NF1-PN granted Priority Review, with potential for a second FDA approval in early 2025; European regulatory reviews for both lead assets are ongoing.

• Diversified pipeline includes late- and early-stage targeted oncology programs, with expansion into solid tumors and hematological cancers.

• Strong financial position with $498.1M in cash, no debt, and operations funded through profitability in 1H 2026.

• Durable IP protection for lead assets, with patent expiries extending to 2043 and Orphan Drug exclusivity.

OGSIVEO (nirogacestat) in desmoid tumors

• Demonstrated significant efficacy: 41% objective response rate, 71% reduction in risk of progression vs. placebo, and rapid, sustained improvements in pain and quality of life.

• Over 800 unique patients filled OGSIVEO scripts in September 2024; ~10,000 patients identified via ICD-10 claims in the first year.

• Broad payer coverage with ~98% reimbursement and strong uptake as first-line therapy; 90% of sarcoma centers of excellence have prescribed OGSIVEO.

• Long-term data show increased response rates and tumor reduction with extended treatment; ovarian toxicity is generally transient and resolves in most cases.

• International expansion underway, with anticipated EU approval and first launch in Germany in 1H 2025; Japan study initiating in 2025.

Mirdametinib in NF1-PN

• Addresses substantial unmet need for both adult and pediatric NF1-PN patients, with no approved options for adults and limited options for children.

• Phase 2b ReNeu trial showed robust antitumor activity: 41% confirmed response in adults, 52% in children, with deep and durable responses and significant improvements in pain and quality of life.

• Manageable safety profile with low rates of severe adverse events and high rates of treatment continuation in both cohorts.

• NDA accepted with Priority Review (PDUFA: Feb 28, 2025); MAA validated by EMA with potential EU approval in 2025.

• High physician enthusiasm: 96% found mirdametinib's profile more compelling than selumetinib for pediatric NF1-PN; 100% believe it will address key unmet needs in adults.