Oslo, 11 November 2021: Ultimovacs ASA ("Ultimovacs") (OSE ULTI), a clinical
stage leader in immune stimulatory vaccines for cancer, announces its third
quarter 2021 results today. The presentation by the company's management team
will take place at Oslo Cancer Cluster Innovation Park (Ullernchausséen 64) in
Jónas Einarsson Auditorium (2nd floor, entrance 2B) at 09:00 CET.
The presentation can also be followed as a live webcast
(https://channel.royalcast.com/hegnarmedia/#!/hegnarmedia/20211111_6) and will
be made available on the website. It will be possible to post questions during
the presentation through the webcast.
Highlights for the third quarter of 2021:
* On 26 October 2021, Ultimovacs announced that UV1, will be investigated in a
Phase II clinical trial in combination with pembrolizumab in non-small cell
lung cancer (NSCLC). The LUNGVAC trial will be a multi-center, randomized,
open-label trial which will be sponsored by Drammen Hospital, a leading
oncology research center in Norway. The trial will enroll approximately 138
patients and will be conducted at 8-10 clinical centers in Norway. (post
quarter event)
* On 13 October, 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. As previously
announced, median progression free survival for these patients was 18.9
months. (post quarter event)
* Results from the 10 patients in cohort 2 of the same trial released on 12
August also showed strong safety and efficacy data after one year (60%
objective response, 30% complete response, 90% overall survival and median
progression-free survival not reached), reinforcing the cohort 1 data
presented at ASCO. (also presented in the Q2-report)
* On 20 October 2021, Ultimovacs ASA announced that UV1, in combination with
checkpoint inhibitors has received Fast Track designation from the U.S. FDA
in the treatment of unresectable or metastatic melanoma - either as add-on
therapy to pembrolizumab or as add-on therapy to ipilimumab. (post quarter
event)
* INITIUM trial: 91 patients enrolled to date compared to 68 patients in the
previous quarterly report.
* NIPU trial: 45 patients enrolled to date compared to 38 patients in the
previous quarterly report.
* FOCUS trial: The first patient was enrolled on 4 August 2021, and 5 patients
have been enrolled to date.
* DOVACC trial: Regulatory approval is in place and the first patient is
expected to be enrolled during Q4 2021.
* TENDU trial: The Drug Safety Monitoring Board found no safety concerns
related to the first cohort of three patients at the 40 ?g dose, enabling
the trial to advance with enrollment of patients in the second cohort at the
400 ?g dose. In total, 4 patients have been enrolled to date.
* COVID-19: The effect of the pandemic on the biotech industry and the general
ability to conduct clinical trials is still uncertain and dependent on the
speed of return to a more normal situation. Ultimovacs continues to monitor
the impact from COVID-19 on its clinical trials and will update the guidance
for INITIUM and our investigator-initiated Phase II trials in our Q4 2021
report. Enrollment updates will continue to be provided in each quarterly
report.
* A private placement was successfully completed on 26 October 2021, raising
gross proceeds of MNOK 270. (post quarter event)
* Total operating expenses amounted to MNOK 42.5 in Q3-21, and MNOK 112.9 YTD.
* Cash flow from operations was MNOK -32.7 in Q3-21, and MNOK -92.0 YTD. Total
cash and cash equivalents were reduced by MNOK 32.9 during Q3-21 and
amounted to MNOK 347.8 as per 30 September 2021.
The report and presentation are also available on the Company website:
www.ultimovacs.com/investors/reports-and-presentations
(http://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 (mailto:carlos.desousa@ultimovacs.com)
Phone: +47 908 92507
Hans Vassgård Eid, CFO
Email: hans.eid@ultimovacs.com (mailto:hans.eid@ultimovacs.com)
Phone: +47 482 48632
Mary-Ann Chang, LifeSci Advisors
Email: mchang@lifesciadvisors.com (mailto: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 11 November, 2021 at 08:00 CET.