Oslo, November 8, 2023: Ultimovacs ASA ("Ultimovacs") (OSE ULTI), a clinical-stage biotechnology leader in novel immunotherapeutic cancer vaccines, announces its third quarter 2023 results today.

“The recent months have allowed us to further advance the clinical development of our universal therapeutic cancer vaccine, UV1. The first data from a randomized Phase II study reported that UV1 showed a clinically meaningful survival benefit in cancer patients suffering from malignant mesothelioma, a very hard-to-treat form of cancer,” said Carlos de Sousa, Chief Executive Officer of Ultimovacs. “The oral data presentation at the renowned ESMO congress coupled with the enduring long-term survival rates from the 4-year follow-up of the UV1-103 trial are a testament to UV1’s potential. Our goal is to make a positive impact on the lives of cancer patients, and the data we have accrued to date confirm our belief that UV1 can make a difference for cancer patients.”

Third Quarter 2023 Highlights

Ultimovacs’ universal cancer vaccine UV1 demonstrated clinically meaningful prolonged survival over standard of care immunotherapy in NIPU, the first randomized Phase II clinical trial - a remarkable milestone for the Company.

Phase II study NIPU in malignant mesothelioma

• NIPU trial principal investigator, Professor Åslaug Helland, MD, PhD, reported the results from the study in second-line treatment of patients with malignant mesothelioma as an oral presentation at the ESMO Congress 2023 in Madrid in October. The data presented showed that UV1, as an add-on to the checkpoint inhibitors ipilimumab and nivolumab, demonstrated a clinically meaningful overall survival benefit after a relevant observation period, with no added toxicities compared to ipilimumab and nivolumab alone. The study also reported that 31% of the patients treated experienced an objective response, as compared to 16% in the control arm. An analysis of the Hazard Ratio in Overall Survival showed that UV1 cancer vaccination combined with ipilimumab and nivolumab reduced the risk of death by 27% and met the protocol’s predefined threshold for statistical significance.
• On October 9, 2023, Ultimovacs announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to the Company’s therapeutic cancer vaccine UV1 for the treatment of patients with mesothelioma.

Phase II study INITIUM in unresectable or metastatic malignant melanoma

• On October 31, 2023, Ultimovacs announced that the protocol for the UV1 Phase II INITIUM study in malignant melanoma has been amended based on acceptance by the relevant regulatory authorities. This confirms the topline readout from the study in the first half of 2024, as previously communicated. By mid-January 2024, the last enrolled patient will have completed follow-up for 18 months, and all patients will have achieved a mean follow-up time of approximately 24 months. The topline readout is expected to be announced two to three months later. The original trial protocol set a final data analysis after cancer progression had been verified in 70 patients. The amendment was implemented based on the observation that it takes longer than anticipated for patients in the study to experience progression of the disease. The protocol amendment will maintain the integrity of the study statistics without materially affecting the scientific value of the clinical trial.
• On November 2, 2023, the Company announced the completed enrollment of 21 patients in the INITIUM supplementary single-arm study in malignant melanoma. The objective of the study is to elucidate and describe that an immune response specific to the UV1 vaccine transfers into anti-tumor activity and clinical benefit for the patients.

Phase II study FOCUS in head and neck cancer

• On August 3, 2023, the Company announced that the Phase II FOCUS study had completed enrollment of 75 patients with head and neck cancer (also reported in the Q2-2023 report). The study will provide randomized data on the benefit of UV1 vaccination as an add-on to standard pembrolizumab treatment. The topline readout, including Progression Free Survival (PFS) and Overall Survival (OS), will be disclosed after 12 months minimum follow-up, expected during H2 2024.

Phase I study UV1-103 in malignant melanoma

• On October 12, 2023, Ultimovacs reported sustained long-term overall survival in patients treated with UV1 cancer vaccine in the UV1-103 Phase I study in malignant melanoma. No confirmed patient deaths occurred in cohort 1 between the 3-year and 4-year follow-up period.

Intellectual Property

• Ultimovacs received a Decision to Grant from the Japanese patent office (PN822210JP) in July 2023. The patent is the Japanese counterpart of the European and US patents previously granted. These patents protect UV1 cancer vaccine-checkpoint inhibitor combinations until at least 2037, and cover UV1 combined with CTLA-4, PD-1 or PD-L1 checkpoint inhibitors. 

Clinical trial enrollment updates

UV1 Phase II program

• INITIUM (malignant melanoma): The enrollment of 156 patients was completed in July 2022. Readout is expected in the first half of 2024.
• NIPU (metastatic pleural mesothelioma): The enrollment of 118 patients was completed in January 2023. The positive overall results from the study were reported in October 2023.
• FOCUS (head and neck cancer): The enrollment of 75 patients was completed in August 2023. The readout is expected in the second half of 2024.
• DOVACC (ovarian cancer): 46 out of 184 patients have been enrolled to date, up from 37 as of the previous quarterly report. 
• LUNGVAC (non-small cell lung cancer): 13 out of 138 patients have been enrolled to date, up from 11 as of the previous quarterly report.
• An update on the expected timeline for readout from the Phase II studies DOVACC and LUNGVAC will be provided with the Q4 2023 report.

• INITIUM Supplementary Study: Enrollment in the single-arm supplementary study, which will not be included in the INITIUM topline readout, was completed in October 2023 with a total of 21 patients. 

TENDU Phase I trial (prostate cancer) based on the TET technology platform:

• The enrollment of 12 patients was completed in mid-December 2022. The results from the study will be reported in Q4 2023.

Financial update

• Ultimovacs expects that the current cash resources will support operations to H2 2024, based on current programs and plans, through the topline readouts in INITIUM and FOCUS.
• Total operating expenses amounted to MNOK 54.7 in Q3 2023 and MNOK 156.1 YTD. Total loss was MNOK 55.8 for the period and MNOK 133.3 YTD.
• Net negative cash flow from operations was MNOK 40.7 in Q3 2023, and net decrease in cash and cash equivalents, not including currency effects, was MNOK 37.6 during Q3 2023. Cash and cash equivalents amounted to MNOK 300.3 as of September 30, 2023.

The quarterly report and presentation will be published at 07:00 CET on November 8, 2023, and will be publicly available on the Ultimovacs website. The presentation by the Company's management can be followed as a live webcast at 14:00 CET today, November 8, 2023. Questions can be submitted throughout the event. The webcast is scheduled to conclude at 14:55 CET.
Link to webcast here.

For further information, please see 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

Anne Worsøe, Head of IR
Email: anne.worsoe@ultimovacs.com
Phone: +47 906 86815

About Ultimovacs
Ultimovacs is a clinical-stage biotechnology leader in novel immunotherapeutic cancer vaccines with broad applicability. Ultimovacs’ lead cancer vaccine candidate UV1 is directed against human telomerase (hTERT) an antigen that is present in 85-90% of cancers in all stages of tumor growth. A broad clinical program, with Phase II trials in five cancer indications enrolling more than 670 patients, aims to demonstrate UV1’s impact in combination with other immunotherapies in multiple cancer types expressing telomerase and where patients have unmet medical needs. UV1 is universal, off-the-shelf, and easy to use, and is a patented technology owned by Ultimovacs.

In addition, Ultimovacs’ adjuvant platform, based on the proprietary Tetanus-Epitope-Targeting (TET) technology, combines tumor-specific peptides and adjuvant in the same molecule and is in Phase I clinical development.

This information is subject to the disclosure requirements pursuant to Section 5-12 in the Norwegian Securities Trading Act.

This stock exchange announcement was published by Anne Worsøe, Head of Investor Relations at Ultimovacs ASA, on November 8, 2023, at 07:00 CET.