Oslo, 17 February 2022: Ultimovacs ASA (“Ultimovacs”) (OSE ULTI), a clinical stage leader in immune stimulatory vaccines for cancer, announces its fourth quarter 2021 results today.
The presentation by the company’s management team can be followed as a live webcast at 09:00 CET and will be made available on the website. It will be possible to post questions during the presentation through the webcast.
Highlights for the fourth quarter of 2021:
- On December 2, 2021, Ultimovacs announced that UV1 received Orphan Drug designation from the U.S. FDA in the treatment of malignant melanoma.
- On October 26, 2021, Ultimovacs announced a new Phase II clinical trial (LUNGVAC) investigating UV1 in combination with pembrolizumab in non-small cell lung cancer (NSCLC). (also presented in the Q3 report)
- On October 20, 2021, Ultimovacs announced that UV1 received Fast Track designation from the U.S. FDA in the treatment of unresectable or metastatic melanoma. (also presented in the Q3 report)
- On October 13, 2021, Ultimovacs announced that the overall survival rate after two years of follow-up in the Phase I clinical trial of UV1 combined with pembrolizumab was 80% in this first cohort of 20 patients. (also presented in the Q3 report)
Clinical trial enrollment update
- INITIUM trial: 120 patients have been enrolled to date, up from 91 as of the previous quarterly report.
- NIPU trial: 66 patients have been enrolled to date, up from 45 as of the previous quarterly report.
- FOCUS trial: 10 patients have been enrolled to date, up from 5 as of the previous quarterly report.
- DOVACC trial: The first patient was enrolled on 15 December 2021, and 2 patients have been enrolled to date.
- TENDU trial: 6 patients have been enrolled to date in this dose escalation study compared to 4 patients in the previous quarterly report, completing treatment of the second cohort. No safety concerns emerged in the first two dose level cohorts, allowing the enrollment of patients in the third, final dose cohort.
- COVID-19: Although Ultimovacs remain optimistic regarding progress in the Company’s broad clinical program, the effect of the pandemic on the biotech industry and the conduct of clinical trials is still uncertain. Ultimovacs will continue to provide enrollment updates in each quarterly report.
- Despite earlier and current pandemic-related challenges, the levels of patient enrollment have been increasing recently in both the INITIUM and NIPU studies. Ultimovacs’ updated guidance is that both studies are estimated to have readouts during the first half of 2023, rather than during the second half of 2022 as indicated in the early guidance given in 2019 before either study started.
- The DOVACC and FOCUS trials are still in their early stages of hospitals/clinical site activation, and the start-up phase of both has taken somewhat longer than originally planned. Ultimovacs has guided that the readouts of topline results are expected to take place in 2023 and have done so since the trials began. In the LUNGVAC trial, Ultimovacs expects the first patient to be enrolled during the first half of 2022 with topline results expected by the end of 2024. Once each of these trials has progressed sufficiently to provide a reliable trajectory beyond initiation, Ultimovacs will review guidance and expect to give an update with the Q4 2022 report.
Financial
- Total operating expenses amounted to MNOK 50.9 in Q4-21, and MNOK 163.8 in FY21.
- Net negative cash flow from operations was MNOK 33.9 in Q4-21, and MNOK 125.8 in FY21. Total cash and cash equivalents increased by MNOK 227.9 during Q4-21 and amounted to MNOK 574.2 as per 31 December 2021.
- A private placement was successfully completed on October 26, 2021, raising gross proceeds of MNOK 270 (net MNOK 259.0). (also presented in the Q3-report)
The report and presentation are also available on the Company website:
www.ultimovacs.com/investors/reports-and-presentations
For further information, please visit www.ultimovacs.com or contact:
Carlos de Sousa, CEO
Email: carlos.desousa@ultimovacs.com
Phone: +47 908 92507
Hans Vassgård Eid, CFO
Email: hans.eid@ultimovacs.com
Phone: +47 482 48632
Mary-Ann Chang, LifeSci Advisors
Email: mchang@lifesciadvisors.com
Phone: +44 7483 284 853
This information is considered to be inside information pursuant to the EU Market Abuse Regulation and is subject to the disclosure requirements pursuant to Section 5-12 in the Norwegian Securities Trading Act.
This stock exchange announcement was published by Joachim Midttun, Finance Manager at Ultimovacs ASA, on 17 February, 2021 at 08:00 CET.
