Mendus (IMMU) Q2 2025 earnings summary

Executive summary

• ADVANCE II Phase II trial in AML showed improved T cell repertoire, broad immune stimulation, and 58% estimated 5-year survival, supporting use across AML subtypes, including NPM1 mutation.

• ALISON Phase I ovarian cancer trial demonstrated tumor-directed immune responses linked to progression-free survival, with 67% of stable disease patients showing vididencel-induced responses.

• Strengthened late-stage development team with the appointment of Dr. Tariq Mughal as Chief Medical Officer.

• US patent granted for vididencel in ovarian cancer, supporting future commercialization.

• Manufacturing alliance with NorthX Biologics progressing for large-scale clinical material delivery and first GMP batches expected before year-end.

Financial highlights

• Q2 2025 net loss was SEK 22.7 million, improved from SEK 38.2 million in Q2 2024; H1 2025 net loss was SEK 53.2 million.

• Cash position at end of Q2 2025 was SEK 58.9 million, providing runway until Q1 2026.

• Cash burn for Q2 was SEK 26.9 million; H1 cash burn was SEK 42.9 million.

• Equity ratio remained strong at 93% at the end of Q2 2025.

• R&D expenses for Q2 2025 were SEK 15.5 million, representing 61% of operating expenses.

Outlook and guidance

• Pivotal-stage readiness for vididencel in AML expected in H2 2025, with ongoing regulatory interactions and preparations for a global registration trial.

• Next read-out of the ALISON ovarian cancer trial anticipated in Q4 2025, including two-year survival data.

• Multiple new trial opportunities planned to broaden addressable patient populations in AML and CML.

• Ongoing efforts to secure additional financing to fund operations beyond early 2026.

• Strategy update planned for early fall (late September/early October).