On November 12, 2020 Ultimovacs ASA ("Ultimovacs", ticker ULTIMO), a pharmaceutical company developing novel immunotherapies against cancer, reported its third quarter 2020 results today (Press release, Ultimovacs, NOV 12, 2020, View Source [SID1234570679]). A presentation by the Company’s management team will take place today on a webcast at 09:00 CEST.
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The presentation can be followed as a live webcast, accessible directly through this link or through the link displayed under Reports and Presentations in the investor section of Ultimovacs’ corporate website www.ultimovacs.com.
Highlights for the third quarter of 2020:
In the INITIUM trial, a total of twelve patients have been enrolled as per reporting date (compared to three patients reported in the previous quarterly report). INITIUM is a randomized, multi-center Phase II trial evaluating UV1 as a treatment for first-line patients with metastatic malignant melanoma.
In the NIPU trial, a total of six patients have been enrolled as per reporting date (compared to four patients reported in the previous quarterly report). NIPU is a randomized, multi-center Phase II trial in which UV1 is investigated as a second-line treatment in mesothelioma.
The Covid-19 situation has so far had fairly limited impact regarding site openings and patient inclusion in the Phase II clinical trials. The longer-term effect of the pandemic on the biotech industry and the general ability to conduct clinical trials is still uncertain.
In the fully enrolled US-based Phase I trial in malignant melanoma, positive topline results from the first cohort of 20 patients were announced in September 2020. The results confirm achievement of the primary endpoints of safety and tolerability and indicate initial signs of clinical response; the 12-month Overall Survival (OS) rate was 85% and median Progression Free Survival (mPFS) was not reached after 12 months.
Five-year overall survival data from the Phase I trial evaluating UV1 as maintenance therapy in patients with non-small cell lung cancer was reported in October 2020. The results confirm achievement of the primary endpoints of safety and tolerability and indicate encouraging initial signals of long-term survival benefit. At the five-year landmark, the OS rate was 33% and mPFS was 10.7 months. (Post-period event)
In May 2020, Ultimovacs announced a collaboration with a non-specified big pharma company and a leading European oncology clinical trial group to evaluate UV1 in a third Phase II clinical trial. As communicated in September 2020, finalization of the agreement and announcement of the collaboration is expected during the fourth quarter of 2020.
The regulatory approval is now in place to start the Phase I TENDU trial. This trial will investigate a prostate cancer specific vaccine based on the TET technology. The first patient is expected to be enrolled in the first quarter of 2021.
Total operating expenses amounted to MNOK 31.1 in Q3-20 and MNOK 98.6 YTD. Cash flow from operations was MNOK -29.6 in Q3-20. Total cash and cash equivalents were reduced by MNOK 29.2 during Q3-20, amounting to MNOK 453.5 as per 30 September 2020.
The full report and presentation are also available under Reports and Presentations in the investor section of Ultimovacs’ corporate website www.ultimovacs.com.