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

• Ultimovacs remains committed to continuing the clinical development strategy and exploring multiple pathways for UV1.
  
• The negative INITIUM results have had important consequences for the Company. Implemented cash preservation initiatives extends the anticipated financial runway to the fourth quarter of 2025, beyond the anticipated topline readout of the FOCUS and DOVACC trials.
• The UV1 vaccine was granted Fast Track designation from the U.S. Food and Drug Administration (FDA) and Orphan Drug designation from the European Medicines Agency (EMA) based on the data from the Phase II trial NIPU in malignant mesothelioma.
  
  

Conference call and webcast scheduled for May 7, 2024, at 14:00 (CET).

Oslo, May 7, 2024: Ultimovacs ASA ("Ultimovacs") (OSE ULTI), a clinical-stage biotechnology company developing immunotherapeutic cancer vaccines, announces its first quarter 2024 results today.

“The period following the disappointing results of the INITIUM trial has been challenging for Ultimovacs. However, due to the promising outcomes from other UV1 trials and the broad diversity of our clinical program, we remain confident in UV1’s potential and committed to its ongoing development. The operational adjustments we have made ensure financial stability and support our progress through the next Phase II readouts and potential growth catalysts in 2024 and 2025”, said Carlos de Sousa, CEO of Ultimovacs. “We are also encouraged by the regulatory designations UV1 received based on the NIPU trial results, which demonstrated a clinically meaningful improvement in survival for patients with hard-to-treat cancers. We are looking forward to the forthcoming results from the next Phase II trial, FOCUS in head and neck cancer, expected in the third quarter.”

Fourth Quarter 2023 Business Update

Topline results reported from Phase II trial INITIUM in advanced melanoma

• In March 2024, Ultimovacs reported that the INITIUM trial did not meet the primary endpoint of improved progression-free survival (PFS).
• The data did not show differences in overall survival and objective response rate between the arms. The safety profile was consistent between the two arms, confirming the good safety profile for UV1.
• The key findings and analyses will be presented at the 2024 ASCO Annual Meeting in Chicago on June 1, 2024.