Ultimovacs ASA Reports Second Quarter 2022 Financial Results and Provides General Business Update

Oslo, August 19, 2022: Ultimovacs ASA ("Ultimovacs") (OSE ULTI), a clinical stage leader in immune stimulatory vaccines for cancer, announces its second quarter 2022 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 of Second Quarter 2022 and Recent Business, Clinical and Research Progress

• On 30 June 2022, Ultimovacs completed the planned recruitment of 154 patients in the INITIUM trial. Two additional patients were enrolled in July 2022, bringing the final number of patients enrolled to 156. Consistent with INITIUM’s event-driven design, topline progression-free survival results will be disclosed after progression of cancer or death has been observed in a total of 70 patients.
• On 20 June 2022, Ultimovacs announced positive 2-year overall survival data in UV1-103, the ongoing phase I clinical study of the cancer vaccine UV1 in combination with pembrolizumab for the treatment of malignant melanoma. Across all 30 patients in the study, the 24-month overall survival rate was 73%. Patients will continue to be followed for long-term survival.
• On 22 April 2022, Ultimovacs received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) concerning its US patent application on the use of vaccine-checkpoint inhibitor combinations to treat cancer (also reported in the Q1-2022 report).
  
  

Clinical Trials Enrollment Update

• INITIUM trial: Recruitment has been completed. In total 156 patients have been enrolled – 154 patients as originally planned, plus two additional patients.
• NIPU trial: 92 out of 118 patients have been enrolled to date, up from 78 as of the previous quarterly report.
• FOCUS trial: 27 out of 75 patients have been enrolled to date, up from 18 as of the previous quarterly report.
• DOVACC trial: 6 out of 184 patients have been enrolled to date, up from 4 as of the previous quarterly report. The administrative and regulatory processes of initiating the trial in more than 40 hospitals in approximately 10 countries have taken longer than expected. Until recently, only one site was actively recruiting; more hospitals are now ready to initiate patient enrollment.
• LUNGVAC trial: All preparations for recruitment of 138 patients have been completed. The first patient is expected to be enrolled in Q3 2022.
• TENDU trial: 9 patients have been enrolled to date, up from 8 as of the previous quarterly report. The three main dosing cohorts are fully enrolled, and no safety concerns or dose-limiting toxicities have been observed. Up to three additional patients will be added at the highest dose level of 960 mcg.

Scientific Publications and Presentations

• On 25 May 2022, Ultimovacs announced the publication of long-term follow-up data on UV1 in the Journal for ImmunoTherapy of Cancer (JITC).
• On 10 May 2022, Ultimovacs gave a poster presentation at the Cancer Immunotherapy (CIMT) annual meeting in Mainz, Germany. The poster presentation covered results from long-term follow-up data from the use of the UV1 vaccine in three phase I/IIa clinical trials.

Second Quarter 2022 Financial Results

• Total operating expenses amounted to MNOK 35.4 in Q2-22, and MNOK 67.3 YTD. Total loss was MNOK 22.4 for the period and MNOK 59.0 YTD.
• Net negative cash flow from operations was MNOK 33.0 in Q2-22, and net decrease in cash and cash equivalents, not including currency effects, was MNOK 31.8 during Q2-22. Cash and cash equivalents amounted to MNOK 486.3 as per 30 June 2022.
• On 21 April 2022, a total of 480,000 options to buy shares in the Company were distributed amongst the employees. The number of options granted corresponds to 1.40% of the outstanding number of shares in the Company. Following the award of the new share options, a total of 2,313,585 share options have been granted, corresponding to 6.76% of the outstanding number of shares in the Company. (also reported in the Q1-2022 report)
  
  

Carlos de Sousa, CEO of Ultimovacs, says:

“Ultimovacs is approaching a potential major clinical transition with the continuing progress during the first half of 2022 of the Company’s extensive Phase II program centered on its universal cancer vaccine, UV1.

During the past quarter, we completed recruitment of patients to the INITIUM trial of UV1 in malignant melanoma and exceeded 75% of our recruitment target for the NIPU clinical trial of UV1 in mesothelioma. We anticipate topline progression-free survival data from both of these event-driven, comparative trials in the first half of 2023. Our second technology base, the TET platform combining adjuvant and vaccine in one molecule, has also performed well, progressing smoothly through Phase I studies in patients with relapsed, resected prostate cancer. The three main dosing cohorts are fully enrolled, and no safety concerns or dose-limiting toxicities have been observed. Up to three additional patients will be added at the highest dose level of 960 mcg.

Ultimovacs continues to share clinical updates with the international research and clinical community validating our scientific approach. During the past quarter the Company has presented the results of a 7.5-year follow-up study with UV1 in three different cancers; malignant melanoma, non-small cell lung cancer and prostate cancer, showing long-lasting, UV1-specific immune responses that are associated with longer survival, and synergistic effects in combination with a range of checkpoint inhibitors.