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

Oslo, August 21, 2024: Ultimovacs ASA ("Ultimovacs") (OSE ULTI), a clinical-stage biotechnology company developing novel immunotherapies against cancer, announces its second quarter 2024 results today.

Conference call and webcast scheduled for August 21, 2024, at 14:00 (CET). Link to webcast here.

Second Quarter 2024 Business Update

• Following the negative INITIUM result in March 2024, Ultimovacs implemented cash preservation initiatives during the second quarter of 2024 extending the anticipated cash runway to the fourth quarter of 2025, beyond the topline readout of the FOCUS trial and the anticipated topline readout of the DOVACC trial.
• In August 2024, Ultimovacs reported topline results from the Phase II FOCUS trial in head and neck cancer. The trial did not meet the primary endpoint of improved progression-free survival (PFS). Moreover, the data did not show improvement in overall survival. The safety profile was consistent between the two arms, confirming UV1’s good safety profile. The key findings and analyses from the FOCUS trial will be submitted for publication in a peer-reviewed medical journal.
• Ultimovacs is currently conducting pre-clinical research on a novel drug conjugation platform. This flexible conjugation technology, initially formed to support the expansion of our vaccine pipeline, has broader potential applicability, including additional therapeutic modalities for multiple disease areas, such as innovative drug conjugates with favorable pharmacological properties. Ultimovacs will provide an update on this technology platform to the market before the end of 2024.
  
  

Clinical development update

UV1 randomized controlled Phase II trials

• FOCUS (head and neck cancer): Evaluating pembrolizumab +/- UV1 vaccination as first-line treatment in metastatic or recurrent head and neck squamous cell carcinoma. The enrollment of 75 patients from ten hospitals in Germany was completed between August 2021 and July 2023. The topline readout was reported in August 2024. The trial did not meet the primary endpoint of improved progression-free survival (PFS). Moreover, the data did not show improvement in overall survival. The safety profile was consistent between the two arms, confirming the good safety and tolerability profile of UV1.
• 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 the European Journal of Cancer in March 2024. The data indicate a benefit for the epithelioid subgroup, warranting further assessment of UV1 in future studies. Data from the NIPU trial with longer follow up time will be presented at ESMO 2024.
• INITIUM (melanoma): Evaluating ipilimumab and nivolumab +/- UV1 vaccination as first-line treatment in unresectable or metastatic malignant melanoma. Enrollment of 156 patients from 39 hospitals in the US, UK, Belgium and Norway, was completed between June 2020 and July 2022. Topline results were reported in March 2024. As previously reported, the trial did not meet the primary endpoint of improved progression-free survival (PFS). Moreover, the data did not show improvement in overall survival. The study results were presented at the ASCO Annual Meeting in June 2024.