AI assistant
Zelluna ASA — Earnings Release 2021
Feb 17, 2022
3779_rns_2022-02-17_ea23d7c1-d143-4499-9e8a-1c956464b401.html
Earnings Release
Open in viewerOpens in your device viewer
Ultimovacs ASA: Fourth quarter 2021 result presentation
Ultimovacs ASA: Fourth quarter 2021 result presentation
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 (https://channel.royalcast.com/hegnarmedia/#!/hegnarmedia/20220217_12)
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: [email protected]
Phone: +47 908 92507
Hans Vassgård Eid, CFO
Email: [email protected]
Phone: +47 482 48632
Mary-Ann Chang, LifeSci Advisors
Email: [email protected]
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.