Oslo, 22 August 2023: Ultimovacs ASA (“Ultimovacs”) (OSE ULTI), a clinical-stage biotechnology leader in novel immunotherapeutic cancer vaccines, announces its second quarter 2023 results today.
“In the first half of this year, Ultimovacs has further advanced the broad evaluation of our therapeutic cancer vaccine UV1 across key indications. Our UV1-103 study in the U.S. continues to demonstrate encouraging and lasting patient survival, a direct measure of clinical benefit in cancer trials. In addition, we recently reached an important milestone with three randomized Phase II studies fully enrolled in different cancer indications. We are eagerly awaiting the forthcoming data these trials will provide, helping us better comprehend UV1’s potential and the benefits it can provide in the clinical outcomes for the patients,” said Carlos de Sousa, CEO of Ultimovacs. “The data from these randomized Phase II studies, expected within the Company’s current financial runway, will guide us on the path towards bringing UV1 to the market and making a positive impact on the lives of cancer patients.”
Second Quarter 2023 Highlights:
- In April, Ultimovacs revised the readout timeline for INITIUM due to slower patient disease progression than anticipated. All patients have been monitored for over 12 months. Patient follow-up continues until 70 confirmed cases of cancer progression have been reached, which is still outstanding. The updated readout is now expected in the first half of 2024, with the extended period bearing minor cost implications for the Company. Assuming continued slow progression in the number of events, Ultimovacs will explore alternative approaches for data readout acceptable to regulatory authorities.
- In June, Ultimovacs reported topline results from the UV1 Phase II NIPU study. While the primary Progression Free Survival (PFS) endpoint was not met in the independent central review, a significant positive PFS outcome was measured in the on-site analyses at all five study centers in Australia, Spain, Denmark, Sweden, and Norway. Furthermore, an encouraging trend in Overall Survival (OS) benefit was observed in the UV1 arm compared to the control arm. Detailed data and updated results will be presented at an international medical conference during this fall.
- In August, the Company announced enrollment completion of 75 patients with head and neck cancer for the UV1 Phase II FOCUS study. The topline readout, including PFS and OS, will be disclosed after 12 months minimum follow up, expected in second half 2024.
- In total, more than 300 cancer patients have now received treatment with UV1 in Phase I and Phase II trials. To date, no safety concerns have been reported with the use of UV1.
- Ultimovacs has further solidified its patent estate receiving an Intention to Grant from the European patent office in April, and a Decision to Grant from the Japanese patent office in July, for the protection of UV1 cancer vaccine-checkpoint inhibitor combinations until at least 2037. These patents will be the European and Japanese counterpart of the US patent which was granted in August 2022.
- In June, the clinical and biomarker analyses of the UV1-103 Phase I trial was published in Clinical Cancer Research, a renowned peer-reviewed journal by the American Association for Cancer Research.
- In June, Ultimovacs’ Chief Scientific Officer Gustav Gaudernack was awarded the Norwegian Tech Awards’ Honorary Prize as an outstanding pioneer in the fight against cancer.
- Ultimovacs continues to expect that the current cash resources will support operations until mid-2024, based on current programs. The extension of the timeline for the INITIUM topline readout has limited financial impact for the Company.
Clinical trial enrollment updates
UV1 Phase II Program:
- INITIUM (malignant melanoma): Enrollment of 156 patients completed in JulyJune 2022. Topline readout expected in H1 2024.
- NIPU (metastatic pleural mesothelioma): Enrollment of 118 patients was completed in January 2023. Topline readout was announced in Q2 2023. Detailed and updated data expected Q4 2023.
- FOCUS (head and neck cancer): Enrollment of 75 patients completed in August 2023. Topline readout expected H2 2024.
- DOVACC (ovarian cancer): 37 out of 184 patients have been enrolled to date, up from 24 as of the previous quarterly report. Topline readout expected in H2 2024.
- LUNGVAC (non-small cell lung cancer): 11 out of 138 patients have been enrolled to date, up from 7 as of the previous quarterly report. Topline readout expected H2 2025.
TENDU Phase I trial (prostate cancer) based on the TET technology platform:
Enrollment of 12 patients was completed in mid-December 2022. Readout expected H2 2023.
- Ultimovacs expects that the current cash resources will support operations to H2 2024, based on current programs and plans, i.e., through the reporting of overall survival data in NIPU and the topline readouts in INITIUM and FOCUS. The revised time for INITIUM topline readout has minor cost implications for Ultimovacs.
- Total operating expenses amounted to MNOK 50.6 in Q2 2023, and MNOK 101.4 YTD. Total loss was MNOK 43.4 for the period and MNOK 77.5 YTD.
- Net negative cash flow from operations was MNOK 71.0 in Q2 2023, and net decrease in cash and cash equivalents, not including currency effects, was MNOK 68.1 during Q2 2023. Cash and cash equivalents amounted to MNOK 344.1 as per 30 June 2023.
The quarterly report and presentation will be published at 08:00 CEST on 22 August 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 CEST today, 22 August 2023. Questions can be submitted throughout the event. The webcast is scheduled to conclude at 14:55 CEST.
For further information, please see www.ultimovacs.com or contact:
Carlos de Sousa, CEO
Phone: +47 908 92507
Hans Vassgård Eid, CFO
Phone: +47 482 48632
Anne Worsøe, Head of Investor Relations
Phone: +47 906 86815
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 antigens and adjuvant in the same molecule and is in Phase I clinical development.
This information is subject of 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 August 22 2023 at 08:00 CET.