Oslo, February 16, 2023: Ultimovacs ASA (“Ultimovacs”) (OSE ULTI), a leading biotechnology company developing novel clinical-stage cancer immunotherapeutic vaccines, today reports its results for the fourth quarter of 2022.
Highlights of the fourth quarter of 2022
Ultimovacs On Track For Phase II Clinical Trial Results; Top-line results from the first two randomized phase II clinical trials, INITIUM in malignant melanoma and NIPU in metastatic pleural mesothelioma, are still expected in the first half of 2023. UV1, in combination with checkpoint inhibitors. INITIUM and NIPU have an event-driven design. Both studies have completed patient recruitment. The primary endpoint is progression-free survival (PFS). Patient enrollment in the Phase I TENDU trial for patients with prostate cancer has been completed. The study evaluates the first product candidate of Ultimovacs’ TET adjuvant technology platform. The reading is expected in the second half of 2023. Ultimovacs anticipates that the time that current cash will support operations will be extended to mid-2024 based on current programs.
Carlos de Sousa, CEO of Ultimovacs says:
“Based on the successful preparations over the last few months, the Ultimovacs team is now well prepared for the important results of the first two UV1 Phase II studies in mesothelioma and malignant melanoma. We expect to receive data from these two studies in the first half of 2023. The top-line results from the Phase II clinical trials represent a potentially transformative milestone for ultimovacs and cancer patients with unmet medical needs.
We appreciate progress during the quarter in our ambitious UV1 Phase II clinical program in five cancer indications. The NIPU study of mesothelioma, sponsored by Oslo University Hospital and supported by Ultimovacs and Bristol Myers Squibb, completed enrollment of 118 patients in Europe and Australia. For the LUNGVAC study in non-small cell lung cancer, the protocol was written with consideration for the possibility of a change in reimbursement of the PD-L1 checkpoint inhibitor. After the authorities’ decision to change the reimbursement system, the study was immediately adjusted and the enrollment and treatment of lung cancer patients continued.
In addition, Ultimovacs has also completed the enrollment of 12 prostate cancer patients in the first phase I study based on the TET vaccine-adjuvant technology platform. The results, which are expected later this year, will guide future clinical development activities of TET.
We continue to see growing interest in cancer vaccines in general and believe that a universal cancer vaccine like UV1 has the potential to make a meaningful difference in the treatment of cancer patients. The topline readings from the five Phase II studies will determine the times ahead for UV1. With exciting times ahead before we receive the first Phase II data, I am grateful to the Ultimovacs team who are endlessly patient, all of our employees who share our ambitions, and our shareholders who have made our progress possible. “
Summary of the fourth quarter of 2022 and current business, clinical and research progress
On October 5, 2022, Ultimovacs announced positive three-year results of 71% overall survival in cohort 1 of the phase I study UV1-103 in metastatic malignant melanoma (also reported in Q3 2022 report). On October 18, 2022, Ultimovacs ASA announced multiple biomarkers analyzing data from the phase I study UV1-103 in melanoma. These analyzes support the promising efficacy signals, including improved efficacy in “difficult-to-treat patients” (also reported in the Q3 2022 report). UV1 in combination with pembrolizumab. (also reported in Q3 2022 report) On December 14, 2022, Ultimovacs announced that it has enrolled the last patient in the Phase I TENDU study in prostate cancer patients, the first in-human study to be performed on the novel TET platform of the company based. The evaluation is expected in the second half of 2023 after a follow-up period of at least six months for all patients. On December 20, Ultimovacs announced that effective January 1, 2023, UV1 will be combined with the PD-1 checkpoint inhibitor cemiplimab instead of pembrolizumab in the LUNGVAC study following the decision to change the reimbursement of PD-1 Checkpoint Inhibitors was taken by the Norwegian health authorities. On January 23, 2023, Ultimovacs announced that it had completed patient enrollment in the NIPU’s Phase II clinical trial in metastatic pleural mesothelioma (post-period event).
Update on enrollment and expected schedule for topline readouts of UV1 clinical phase II 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 of 75 patients enrolled to date, up from 41 in the previous quarterly report. Readout expected H1 2024. DOVACC (ovarian cancer): 17 of 184 patients enrolled to date, up from 7 in the previous quarterly report. Readout expected H2 2024. LUNGVAC (non-small cell lung cancer): 2 of 138 patients were enrolled since January 1, 2023, when cemiplimab treatment was enrolled in the study. 3 patients were treated with pembrolizumab prior to the reimbursement change. Reading expected in H2 2025.
Scientific publications and presentations
On October 18, 2022, clinical endpoint and biomarker data from patients in the phase I study UV1-103 were presented at the 19th International Conference of the Society for Melanoma Research (SMR). The biomarker data support a strong clinical response of UV1 in combination with pembrolizumab, even in patients who are less likely to respond to monotherapy checkpoint inhibition. (Also reported in Q3 2022 report) On October 27-30, 2022, the lead investigator of the phase II DOVACC study, Mansoor Mirza from Copenhagen University Hospital, presented a trial-in-progress poster with an overview of DOVACC -Study at the Congress of the European Society for Gynecological Oncology (ESGO) 2022 in Berlin, Germany. (Also reported in Q3 2022 Report) On January 26, 2023, Current Opinion in Oncology published the article “Telomerase Therapeutic Cancer Vaccination: Clinical Developments in Melanoma” by Espen Ellingsen, Jens Bjørheim and Gustav Gaudernack. (event after period)
Fourth quarter 2022 financial results
Due to the high activity of the broad R&D program, the total operating costs amounted to MNOK 72.3 in Q4 2022 and MNOK 183.6 in FY 2022. The total loss was MNOK 70.5 for the period and MNOK 167.8 in FY2022. Negative net cash flow from operations was MNOK 50.0 in Q4 2022 and the net decrease in cash and cash equivalents, excluding currency effects, was MNOK 42.1 in Q4 2022. Cash and cash equivalents amounted to MNOK 425.3 as of December 31, 2022.
The quarterly report and presentation will be released on February 16, 2023 at 08:00 CET and will be publicly available on Ultimovacs’ website. The company’s management team’s presentation can be followed as a live webcast today, February 16, 2023 at 2:00 p.m. CET. The presentation will be in English and questions can be submitted throughout the event. The presentation is expected to end at 14:55 CET.
For more information, visit www.ultimovacs.com or contact:
Carlos de Sousa, CEO
Email: [email protected]
Telephone: +47 908 92507
Anne Worsøe, Head of IR & Communications
Email: [email protected]
Telephone: +47 906 86815
Mary-Ann Chang, LifeSci consultant
Email: [email protected]
Telephone: +44 7483 284 853
About Ultimovacs
Ultimovacs is a leading clinical-stage biotechnology company developing novel cancer immunotherapeutic vaccines to treat a broad spectrum of cancers. Ultimovacs’ lead universal cancer vaccine candidate, UV1, targets human telomerase (hTERT), which is present in 85-90% of cancers at all stages of tumor growth. By targeting the immune system to hTERT antigens, UV1 drives CD4 helper T cells to the tumor to activate an immune system cascade and enhance anti-tumor responses. With a broad phase II program in five cancer indications, involving more than 650 patients in Europe, US and Australia, Ultimovacs aims to clinically demonstrate the effects of UV1 in multiple cancer types in combination with other immunotherapies for patients with unmet needs to demonstrate. Ultimovacs’ second approach to technology, the proprietary tetanus epitope targeting (TET) platform, combines tumor-specific peptides and a tetanus-based adjuvant in the same molecule.
This information is considered inside information under the EU Market Abuse Regulation and is subject to disclosure requirements under Section 5-12 of the Norwegian Securities Trading Act.
This exchange announcement was published by Joachim Midttun, Finance Manager at Ultimovacs ASA, on February 16, 2023 at 08:00 CET.
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