IRLAB Therapeutics (IRLAB) Q3 2025 earnings summary

Executive summary

• Submitted clinical trial application for IRL757 in Parkinson's disease and apathy to EMA; patient recruitment expected by end of 2025; received additional $4 million for IRL757 study from MSRD.

• Rights issue completed, raising SEK 115.7 million, providing capital for IRL1117 and pirepemat development.

• New patent for mesdopetam granted in China, securing market exclusivity in major markets until mid-2040s.

• Gustaf Albert appointed as new CFO, effective November 17.

Financial highlights

• Cash and cash equivalents at period end: SEK 110.1 million (Q3 2025), up from SEK 90.4 million year-over-year.

• Net sales for Jan–Sep 2025: SEK 42.7 million, down from SEK 51.8 million year-over-year.

• Operating loss for Jan–Sep 2025: SEK -71.5 million, nearly flat year-over-year.

• Earnings per share before and after dilution: SEK -1.42 (vs. SEK -1.50 prior year).

• R&D costs: SEK 99.8 million, representing 83% of total operating expenses.

Outlook and guidance

• Focus on advancing IRL757 study, maintaining cost control, and retaining organizational competence.

• Phase Ib study for IRL757 expected to begin patient recruitment by end of 2025, pending EMA approval.

• Key milestones in next 12-18 months: Mesdopetam Phase III initiation, Pirepemat dose optimization, IRL757 Phase Ib start, and Phase I readiness for IRL942 and IRL1117.

• Ongoing efforts to secure out-licensing or partnership for mesdopetam.