Medivir (MVIR) Q3 2025 earnings summary

Executive summary

• Announced a fully guaranteed rights issue, supported by main shareholders, to fund a randomized phase II study of fostrox + Lenvima in second-line advanced liver cancer, targeting rapid data generation and robust comparative efficacy and safety data.

• Fostrox, an oral, liver-targeted treatment, is positioned as a first-in-class option for advanced HCC, with positive phase 1b/2a data showing median TTP of 10.9 months and OS of 13.7 months, and a new Japanese patent for the fostrox + lenvatinib combination.

• Signed an exclusive global licensing agreement for Remetinostat with Biossil, with potential milestone payments up to $60 million, additional royalties, and sublicensing revenue share.

• Remetinostat, a topical HDAC inhibitor, has shown positive phase 2 data in BCC and CTCL, with over 50% of lesions achieving complete pathological resolution in BCC and a favorable safety profile.

• Market opportunity for second-line HCC is projected to exceed $2.5 billion by 2030, with fostrox + Lenvima targeting first-to-market status.

Financial highlights

• Q3 revenue was SEK 0.9 million, consistent year-over-year; for January–September, SEK 3.0 million, up from SEK 2.5 million.

• Operating loss for Q3 was SEK -13.6 million, improved from last year; EBITDA loss for Q3 was SEK -12.9 million.

• Cash flow from operating activities for Q3 was SEK -14.1 million, substantially lower than the same period last year.

• Cash and cash equivalents at end of Q3 were SEK 23.5 million; projected cash runway until end of 2027 with the planned rights issue.

• Basic and diluted EPS for Q3 was SEK -0.13 (vs. -0.30); for January–September, SEK -0.45 (vs. -0.85).

Outlook and guidance

• Planned phase II study of fostrox + Lenvima to enroll 80 patients in collaboration with the Korean Cancer Study Group, with study initiation targeted for early 2026 and data expected in 2027.

• The rights issue and current cash are expected to fund operations through 2027, supporting future oncology clinical projects.

• Ongoing discussions with potential partners and investors for fostrox; future development path depends on phase II data and investor interest.

• Board assesses that conditions for continued operation exist.

• Market opportunity for 2nd line HCC is projected to exceed $2.5 billion by 2030.