Ultimovacs ASA: Third quarter 2021 result presentation

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 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 µg dose, enabling the trial to advance with enrollment of patients in the second cohort at the 400 µg 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

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 11 November, 2021 at 08:00 CET.

Attachments

• Ultimovacs-ASA-Q321-Report
• Ultimovacs-ASA-Q321-Presentation