Ultimovacs ASA

Ultimovacs ASA announced on 17 Dec 2024 its agreement to combine with Zelluna Immunotherapy AS and a fully committed private placement. Share allocations to primary insiders' closely related parties are conditional on approval by an extraordinary general meeting and completion of the transactions, as per EU Market Abuse Regulation and Norwegian Securities Trading Act.

Ultimovacs ASA (FRA:7UM) enrolled 28 patients in DVO trial, extended cash runway to Q1 2026, and works on novel drug conjugation platform. However, head and neck cancer trial results were disappointing, and lung v trial recruitment stopped. Operating loss was $29M in Q3 2024, with $103M YTD. Cash flow remains negative at $42M in Q3. Updates on DVO and LV trials expected in H1 2025.

Ultimovacs announces Q3 2024 results, extending cash runway to Q1 2026. The Phase II FOCUS trial in head and neck cancer did not meet primary endpoints. Pre-clinical research on a novel drug conjugation platform continues, with an update expected by end of 2024. DOVACC and LUNGVAC trials progress, with readouts anticipated in H1 2025. Financials show MNOK 28.8 in Q3 operating expenses and MNOK 131.0 in cash equivalents as of September 30, 2024.

Ultimovacs ASA's Phase II FOCUS trial results, published on medRxiv, showed no clinical benefits in PFS or OS when adding UV1 to pembrolizumab in late-stage HNSCC patients, missing primary and secondary endpoints. UV1 maintained a positive safety profile. The trial, led by Prof. Mascha Binder and sponsored by the University of Halle-Wittenberg, aimed to assess UV1's efficacy and tolerability as an add-on to pembrolizumab. Patients were randomized 2:1 to receive UV1+pembrolizumab or pembrolizumab alone, with primary endpoint PFS at 6 months. UV1, a universal cancer vaccine targeting telomerase, is administered via intradermal injections with GM-CSF over three months.

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Ultimovacs ASA halts LUNGVAC trial recruitment due to slow enrollment, driven by new NSCLC treatments. 31 enrolled patients will continue treatment, with topline data expected in H1 2025. Ultimovacs also conducts Phase II DOVACC trial for ovarian cancer and pre-clinical research on a novel drug conjugation platform, with updates planned by end of 2024.

Ultimovacs ASA halts recruitment for LUNGVAC trial due to slow enrollment, driven by new NSCLC treatments. All 31 enrolled patients will continue treatment, with topline data expected in H1 2025. Ultimovacs also advances UV1 in ovarian cancer and explores a novel drug conjugation platform.

Ultimovacs ASA presented updated data from the UV1 Phase II NIPU trial at the 2024 ESMO Congress, showing increased clinical benefit for the epithelioid subgroup with a median PFS improvement of 5.5 months for UV1 combined with ipilimumab and nivolumab versus 2.9 months for immunotherapy alone. The trial did not meet the primary endpoint of improved PFS but demonstrated a doubling of ORR and a 27% reduction in risk of death. The full results will be presented in a poster at the congress.