Ultimovacs ASA Reports First Quarter 2024 Financial Results and Provides General Business Update - Seite 2

Cash preservation initiatives and operational adjustment plan implemented

• The negative INITIUM results have important consequences for the Company.
• Activity level prioritization and operational adjustments are implemented to sustain the financial runway, including a workforce reduction of approximately 40%.
• The cash preservation initiatives extend the anticipated cash runway to the fourth quarter of 2025, beyond the anticipated topline readout of the FOCUS and DOVACC trials.
• Based on current plans and forecast, the cash burn rate is estimated to be approximately 15 MNOK per quarter towards the end of 2025.

Regulatory designations for UV1 cancer vaccine for the treatment of mesothelioma

• On February 5, 2024, Ultimovacs announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the Company’s therapeutic cancer vaccine UV1 in combination with ipilimumab and nivolumab for the treatment of patients with unresectable malignant pleural mesothelioma to improve overall survival.
• On February 19, 2024, Ultimovacs announced that the European Medicines Agency (EMA) granted Orphan Drug designation to the Company’s therapeutic cancer vaccine UV1 for the treatment of mesothelioma. The designation was granted based on results from the Phase II clinical trial, NIPU, evaluating UV1 added to ipilimumab and nivolumab treatment in patients with malignant pleural mesothelioma.

Clinical development update

UV1 randomized controlled Phase II trials

• NIPU (mesothelioma): Evaluating ipilimumab and nivolumab +/- UV1 vaccination as second-line treatment of patients with inoperable malignant pleural mesothelioma. Enrolled 118 patients from Australia, Spain and Scandinavia between June 2020 and January 2023. The study results were presented at the ESMO Congress in October 2023. An outline of the full trial results including subgroup analyses was published in European Journal of Cancer in March 2024. The data indicate that the epithelioid subgroup may be particularly relevant for UV1 vaccination, warranting further assessment in future studies. Mature overall survival data from the NIPU trial is expected to be reported later in 2024.