IRLAB Therapeutics (IRLAB) Q4 2025 earnings summary

Executive summary

• Advanced Parkinson's disease pipeline with multiple assets in clinical and preclinical stages, including IRL757, mesdopetam, pirepemat, IRL942, and IRL1117.

• IRL757 advanced to Phase Ib for apathy in Parkinson's, with all clinical sites activated, recruitment ongoing, and study fully funded through MSRD/Otsuka collaboration.

• Mesdopetam completed key milestones, with Phase III program design aligned with FDA and EMA, strong market interest, and new patents granted in US, EU, and China.

• Pirepemat demonstrated significant reduction in fall rates in Phase IIb, with expert support for further development and regulatory strategy underway.

• Strategic partnerships and business development intensified, including collaboration with Biomia to expand CNS drug discovery using the ISP platform.

Financial highlights

• Net sales for 2025 were SEK 57.5 million, down from SEK 94.6 million in 2024; Q4 net sales SEK 14.7 million vs. SEK 42.8 million prior year.

• Operating loss widened to SEK -93.4 million from SEK -75.1 million; Q4 operating loss SEK -21.9 million vs. SEK -3.0 million.

• Cash and cash equivalents at year-end were SEK 82 million, up from SEK 66.9 million.

• Cash flow from operating activities improved to SEK -55.2 million from SEK -65.6 million.

• Loss for the year was SEK -110.0 million, compared to SEK -83.1 million in 2024.

Outlook and guidance

• Focus on securing partnerships and financing for Phase III mesdopetam and further development of pirepemat.

• IRL757 Phase Ib study execution and evaluation to guide next steps.

• IRL1117 preclinical development to advance toward Phase I readiness.

• Actively seeking collaborations and licensing deals to secure future funding.

• Continued prioritization of resource efficiency and strategic innovation.