Oslo, May 10, 2023: Ultimovacs ASA ("Ultimovacs") (OSE ULTI), a clinical-stage biotechnology leader in novel immunotherapeutic cancer vaccines, announces its first quarter 2023 results today.
First Quarter 2023 Highlights
- Ultimovacs is well prepared for the data readout from the first two randomized UV1 Phase II studies in malignant melanoma (INITIUM) and metastatic pleural mesothelioma (NIPU).
- Data from the INITIUM study were previously expected during the first half of 2023, based on historical timelines for the disease progression and standard of care treatment. In April, Ultimovacs announced that it is taking longer than anticipated for the 156 patients in the INITIUM trial to experience disease progression. This is positive for the patients and guidance for readout was extended to the second half of 2023 from first half.
- Enrollment of 118 patients in the NIPU trial was completed in January 2023. Topline data continues to be expected during the first half of 2023.
- Enrollment in the randomized Phase II study in head and neck cancer (FOCUS) is on track and has reached 80%, with 61 out of 75 the patients recruited.
- Ultimovacs received from the European Patent Office a Notice of Intention to Grant a patent on UV1 in combination with checkpoint inhibitors, a counterpart to the U.S. patent granted last year.
- Ultimovacs continues to expect that the current cash resources will support operations until mid-2024, based on current programs. The extension of timeline for INITIUM topline readout has limited financial impact for Ultimovacs.
Carlos de Sousa, CEO of Ultimovacs, says:
“In the first quarter of 2023, Ultimovacs made overall good progress with our ambitious Phase II clinical program to assess the universal cancer vaccine UV1 in a broad range of indications. Patients participating in the INITIUM study in malignant melanoma are taking longer than anticipated to experience disease progression when comparing with historical data. Although we have not yet received the trial data, we are optimistic and encouraged by this positive development for the patients. We now expect to announce the topline results from INITIUM in the second half of 2023. The NIPU trial in metastatic pleural mesothelioma completed enrollment in January this year, and we continue to expect results in this first half of 2023. Enrollment in the FOCUS study in head and neck cancer is on track, and we expect results in first half of next year. With three sets of data from randomized, comparative Phase II trials expected within a year, we are looking forward to an exciting time ahead as these data will provide important direction on the best path forward towards regulatory approval.”
Update on UV1 Phase II Clinical Development Program
- INITIUM (malignant melanoma): Enrollment was completed in July 2022 with a total of 156 patients. Readout expected H2 2023.
- NIPU (metastatic pleural mesothelioma): Enrollment was completed in January 2023 with a total of 118 patients. Readout expected H1 2023.
- FOCUS (head and neck cancer): 61 out of 75 patients have been enrolled to date, up from 50 as of the previous quarterly report. Readout expected H1 2024.
- DOVACC (ovarian cancer): 24 out of 184 patients have been enrolled to date, up from 17 as of the previous quarterly report. Readout expected H2 2024.
- LUNGVAC (non-small cell lung cancer): 7 out of 138 patients have been enrolled to date, up from 2 as of the previous quarterly report. 3 patients treated with pembrolizumab prior to the change in reimbursement, will be maintained as a separate sub-group in the trial. Readout expected H2 2025.
First Quarter 2023 Financial Results
- Total operating expenses amounted to MNOK 50.8 in Q1 2023, and total loss was MNOK 34.1 for the period.
- Net negative cash flow from operations was MNOK 36.6 in Q1 2023, and net decrease in cash and cash equivalents, not including currency effects, was MNOK 34.0. Cash and cash equivalents amounted to MNOK 405.5 as per 31 March 2023.
The quarterly report and presentation will be published at 08:00 CET on 10 May 2023 and will be publicly available at the Ultimovacs webpage. The presentation by the company's management team can be followed as a live webcast at 14:00 CET today, 10 May 2023. The presentation will be held in English and questions can be submitted throughout the event. The presentation is scheduled to conclude at 14:55 CET.
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 Investor Relations
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 which 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 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 May 10, 2023 at 08:00 CET.
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