On February 17, 2021 Ultimovacs ASA ("Ultimovacs", ticker ULTI), a pharmaceutical company developing novel immunotherapies against cancer, reported its fourth quarter 2021 results today (Press release, Ultimovacs, FEB 17, 2021, View Source [SID1234575208]). A presentation by the company’s management team will take place today on a webcast at 09:00 CET.
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The presentation can be followed as a live webcast, which will also be available on our corporate website.
Highlights for the fourth quarter of 2020:
Ultimovacs provided details about the DOVACC trial in January 2021. Ultimovacs will participate in this randomized Phase II collaboration study, together with the Nordic Society of Gynaecological Oncology – Clinical Trial Unit (NSGO-CTU), the European Network of Gynaecological Oncological Trial Groups (ENGOT) and AstraZeneca, to evaluate Ultimovacs’ proprietary universal cancer vaccine, UV1, in combination with AstraZeneca’s durvalumab and olaparib in patients with relapsed ovarian cancer. The trial will include 184 patients in approximately 10 European countries at more than 40 sites. (Announced post balance sheet date)
In December 2020, Ultimovacs announced the FOCUS study, a Phase II randomized clinical trial that will evaluate Ultimovacs’ proprietary universal cancer vaccine, UV1, in 75 patients with recurrent or metastatic head and neck cancer who will be treated with standard of care therapy pembrolizumab. The trial will be conducted at 10 sites across Germany and led by principal investigator Prof. Mascha Binder, M.D., Medical Director and Head of the Immunological Tumor Group at University Medicine Halle, Germany.
In the INITIUM trial, 24 patients have been enrolled as per the reporting date as compared to twelve patients reported in the previous quarterly report. INITIUM is a randomized, multi-center Phase II trial evaluating UV1 in combination with ipilimumab and nivolumab as first-line treatment for patients with metastatic malignant melanoma.
In the NIPU trial, 18 patients have been enrolled as per the reporting date compared to six patients reported in the previous quarterly report. NIPU is a randomized, multi-center Phase II trial in which UV1 is being investigated in combination with ipilimumab and nivolumab as a second-line treatment in mesothelioma.
The Company is actively monitoring the COVID-19 pandemic regarding patient enrollment in its Phase II clinical trials and continues to implement activities to minimize the impact. The longer-term effect of the pandemic on the biotech industry and the general ability to conduct clinical trials is still uncertain.
Ultimovacs reported five-year overall survival data from the Phase I trial evaluating UV1 in combination with the checkpoint inhibitor, ipilimumab, in patients with metastatic malignant melanoma in December 2020. The results confirmed achievement of the primary endpoints of safety and tolerability and indicated encouraging initial signals of long-term survival benefit. At five years, the Overall Survival (OS) rate was 50% and median Progression-Free Survival (mPFS) was 6.7 months.
The Company also announced five-year overall survival data from the Phase I trial evaluating UV1 as maintenance therapy in patients with non-small cell lung cancer in October 2020. The results confirmed achievement of the primary endpoints of safety and tolerability and indicated encouraging initial signals of long-term survival benefit. At five years of follow-up, the OS rate was 33% and mPFS was 10.7 months. (Also reported in the Q3 2020 report)
Ton Berkien joined Ultimovacs’ management team as Chief Business Officer in December 2020. At Ultimovacs he will lead all business and corporate development efforts and maintain and foster connections with leading biotechnology and pharmaceutical companies.
In November 2020, a paper was published in "Frontiers in Immunology" outlining the positive long-term follow-up data from the Company’s Phase I trial evaluating UV1 in non-small cell lung cancer.
Ultimovacs has secured public grants totaling MNOK 26 to support the execution of the DOVACC and FOCUS trials. Innovation Norway has granted Ultimovacs MNOK 10 to support the Phase II DOVACC study, and the FOCUS Phase II trial is supported through an innovation grant of up to MNOK 16 from the Norwegian Research Council.
Total operating expenses amounted to MNOK 25.6 in Q4-20 and MNOK 124.1 in FY20.
Cash flow from operations was MNOK -13.1 in Q4-20. Total cash and cash equivalents were reduced by MNOK 12.5 during Q4-20, amounting to MNOK 440.9 as per 31 December 2020.
The report and presentation are also available on the company website: www.ultimovacs.com/investors/reports-and-presentations