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     213  0 Kommentare Ultimovacs ASA Reports Fourth Quarter 2023 Financial Results and Provides General Business Update

    • Readout of topline result expected in March 2024 from UV1 randomized Phase II trial INITIUM in Ultimovacs’ lead indication, advanced malignant melanoma
    • Topline result will report primary endpoint of progression-free survival (PFS) of UV1 vaccination combined with standard of care immunotherapy over immunotherapy alone
    • Positive results from the INITIUM trial will be further presented at an international medical conference and published in a reputable medical journal
    • UV1 granted Fast Track designation from FDA based on clinically meaningful survival results in Phase II trial NIPU in mesothelioma, presented at ESMO Congress 2023
    • Sustained long-term survival data reported in UV1-103 trial in advanced malignant melanoma
    • Exploratory study TENDU based on TET technology met primary endpoint

    Conference call and webcast scheduled for February 14, 2024, at 13:00 (CET)

    Oslo, February 14, 2024: Ultimovacs ASA ("Ultimovacs") (OSE ULTI), a clinical-stage biotechnology leader in novel immunotherapeutic cancer vaccines, announces its fourth quarter 2023 results today.

    “The upcoming significant milestone is the announcement of the topline result from the INITIUM trial next month. If the trial meets the primary endpoint and demonstrates a clinical benefit over the current gold standard of immunotherapy for this indication, ipilimumab and nivolumab, it represents a significant accomplishment. From an industry perspective, it will be the first time an off-the-shelf cancer vaccine shows such an additional clinical benefit in a randomized trial in the most serious form of skin cancer”, said Carlos de Sousa, CEO of Ultimovacs.

    “Our mission is to demonstrate UV1’s value for patients. Because of the ground-breaking potential of a positive topline result, we will seek to present the full analysis at a major oncology conference and publish the results in a top-tiered medical journal. Sharing clinical trial results in peer-reviewed forums represents a validation from experts in the field, as well as an effective outreach to leaders in the global medical, investment and pharmaceutical sectors. We look forward to communicating the topline result in March and to share the full study results at the best peer-reviewed opportunity thereafter.”

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    Ultimovacs ASA Reports Fourth Quarter 2023 Financial Results and Provides General Business Update Readout of topline result expected in March 2024 from UV1 randomized Phase II trial INITIUM in Ultimovacs’ lead indication, advanced malignant melanomaTopline result will report primary endpoint of progression-free survival (PFS) of UV1 vaccination …