Oslo, February 16, 2023: Ultimovacs ASA (“Ultimovacs”) (OSE ULTI), a clinical-stage biotechnology leader in novel immunotherapeutic cancer vaccines, announces its fourth quarter 2022 results today.
Fourth Quarter 2022 Highlights
- Ultimovacs is on track to Phase II clinical trial readouts; topline results continue to be expected during the first half of 2023 from the first two randomized Phase II clinical trials, INITIUM in malignant melanoma and NIPU in metastatic pleural mesothelioma.
- The INITIUM and NIPU trials are evaluating the potential universal cancer vaccine and lead product candidate, UV1, in combination with checkpoint inhibitors.
- INITIUM and NIPU have an event-driven design. Both trials have completed patient enrollment. The primary endpoint is progression-free survival (PFS).
- Enrollment of patients in the Phase I TENDU study for prostate cancer patients is complete. The study is evaluating the first product candidate from Ultimovacs’ adjuvant technology platform, TET. Readout is expected during H2 2023.
- Ultimovacs expects the time the current cash resources will support operations to be extended until mid-2024, based on current programs.
Carlos de Sousa, CEO of Ultimovacs, says:
“Based on successful preparations during the last months, the Ultimovacs team is now well prepared for the important topline readouts from the first two UV1 Phase II trials in mesothelioma and malignant melanoma. We expect to receive data during the first half of 2023 from both these trials. The topline results from the Phase II clinical trials represent a potentially transformational milestone for Ultimovacs and cancer patients with unmet medical need.
We appreciate the progress during the quarter in our ambitious UV1 Phase II clinical program across five cancer indications. The NIPU study in mesothelioma, sponsored by Oslo University Hospital and supported by Ultimovacs and Bristol Myers Squibb, completed the enrollment of 118 patients in Europe and Australia. For the LUNGVAC trial in non-small cell lung cancer, the protocol was written taking into consideration the possibility of a change in reimbursement of the PD-L1 checkpoint inhibitor. Following the decision from the authorities to change the reimbursement regime, the study adapted immediately and continued enrolling and treating lung cancer patients.
Furthermore, Ultimovacs also completed the enrollment of 12 patients with prostate cancer in the first Phase I study based on the TET vaccine adjuvant technology platform. The results, expected later this year, will direct the future TET clinical development activities.
We continue to experience an increased interest in cancer vaccines in general, and we believe that a universal cancer vaccine like UV1 has the potential to make a meaningful difference in the treatment of patients with cancer. The topline readouts from the five Phase II studies will determine the times ahead for UV1. As we are approaching exciting times before we receive the first Phase II data, I am grateful to the Ultimovacs team who are relentlessly patient driven, to all our collaborators sharing our ambitions, and to our shareholders for making our progress possible.”
Fourth Quarter 2022 Summary and Recent Business, Clinical and Research Progress
- On 5 October 2022, Ultimovacs announced positive three-year results of 71% overall survival rate in Cohort 1 of the Phase I UV1-103 trial in metastatic malignant melanoma (also reported in the Q3 2022 report)
- On 18 October 2022, Ultimovacs ASA announced multiple biomarker analyses data from the Phase I UV1-103 malignant melanoma trial. These analyses support the promising efficacy signals, including enhanced efficacy in ‘hard-to-treat patients’ (also reported in the Q3 2022 report)
- On 25 October, Ultimovacs announced that the first patient had been randomized in the Phase II LUNGVAC Trial to evaluate UV1 in combination with pembrolizumab. (also reported in the Q3 2022 report)
- On 14 December 2022, Ultimovacs announced that the last patient was enrolled in the Phase I TENDU trial in prostate cancer patients, the first in-human study based on the Company’s novel TET platform. Readout is expected during H2 2023 after a minimum follow up of six months of all patients.
- On 20 December, Ultimovacs announced that as of January 1st, 2023, UV1 would be combined with the PD-1 checkpoint inhibitor cemiplimab, instead of pembrolizumab, in the LUNGVAC trial, following the decision of change of reimbursement of PD-1 checkpoint inhibitors from the Norwegian health authorities.
- On 23 January 2023, Ultimovacs announced that patient enrollment was completed in the NIPU Phase II clinical trial in metastatic pleural mesothelioma (post period event)
Update on Enrollment and Expected Timeline for Topline Readouts of the UV1 Phase II Clinical Program:
- INITIUM (malignant melanoma): Enrollment was completed in June 2022 with a total of 156 patients. Readout expected H1 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): 50 out of 75 patients have been enrolled to date, up from 41 as of the previous quarterly report. Readout expected H1 2024.
- DOVACC (ovarian cancer): 17 out of 184 patients have been enrolled to date, up from 7 as of the previous quarterly report. Readout expected H2 2024.
- LUNGVAC (non-small cell lung cancer): 2 out of 138 patients have been enrolled since January 1st, 2023, when the study started treatment with cemiplimab. 3 patients have been treated with pembrolizumab, prior to the change in reimbursement. Readout expected H2 2025.
Scientific Publications and Presentations
- On 18 October 2022, clinical endpoint and biomarker data from patients in the Phase I UV1-103 trial were presented at the 19th International Conference of the Society for Melanoma Research (SMR). The biomarker data support strong clinical responses from UV1 in combination with pembrolizumab, also in patients considered less likely to respond to monotherapy checkpoint inhibition. (Also reported in the Q3 2022 report)
- On 27-30 October 2022, the lead investigator of the Phase II DOVACC trial, Mansoor Mirza from Copenhagen University Hospital, presented a trial-in-progress poster giving an overview of the DOVACC trial at the European Society of Gynaecological Oncology (ESGO) 2022 Congress in Berlin, Germany. (Also reported in the Q3 2022 report)
- On 26 January 2023, Current Opinion in Oncology published the article ‘Therapeutic cancer vaccination against telomerase: clinical developments in melanoma’ by Espen Ellingsen, Jens Bjørheim and Gustav Gaudernack. (Post period event)
Fourth Quarter 2022 Financial Results
- Reflecting a high activity level in the broad R&D program, total operating expenses amounted to MNOK 72.3 in Q4 2022, and MNOK 183.6 in FY 2022. Total loss was MNOK 70.5 for the period and MNOK 167.8 in FY 2022.
- Net negative cash flow from operations was MNOK 50.0 in Q4 2022, and net decrease in cash and cash equivalents, not including currency effects, was MNOK 42.1 during Q4 2022. Cash and cash equivalents amounted to MNOK 425.3 as per 31 December 2022.
The quarterly report and presentation will be published at 08:00 CET on 16 February 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, 16 February 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
Phone: +47 908 92507
Anne Worsøe, Head of IR & Communication
Phone: +47 906 86815
Mary-Ann Chang, LifeSci Advisors
Phone: +44 7483 284 853
Ultimovacs is a clinical-stage biotechnology leader developing novel immunotherapeutic cancer vaccines to treat a broad range of cancer types. Ultimovacs’ lead universal cancer vaccine candidate, UV1, targets human telomerase (hTERT), present in 85-90% of cancers in all stages of tumor growth. By directing the immune system to hTERT antigens, UV1 drives CD4 helper T cells to the tumor to activate an immune system cascade and increase anti-tumor responses. With a broad Phase II program in five cancer indications enrolling more than 650 patients in Europe, the US and Australia, Ultimovacs aims to clinically demonstrate UV1’s impact in multiple cancer types, in combination with other immunotherapies, for patients with unmet needs. Ultimovacs’ second technology approach, the proprietary Tetanus-Epitope-Targeting (TET) platform, combines tumor-specific peptides and a tetanus-based adjuvant in the same molecule.
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 February 16, 2023 at 08:00CET.