Oslo, November 10, 2022: Ultimovacs ASA ("Ultimovacs") (OSE ULTI), a clinical stage leader in immune stimulatory vaccines for cancer, announces its third quarter 2022 results today.
Third Quarter 2022 Highlights:
Ultimovacs is getting close to key value inflection points: Readouts from the first two UV1 phase II studies in combination with checkpoint inhibitors, INITIUM and NIPU, are expected during the first half of 2023
Good patient enrollment continues across Ultimovacs’ phase II program, including the recruitment of the first patients in LUNGVAC, the fifth randomized phase II clinical trial with UV1 in combination with checkpoint inhibitors
New data from our phase I study UV1-103 in malignant melanoma, with the combination of UV1 and pembrolizumab, showed an encouraging 71% overall survival rate after three years in cohort 1, on top of the good safety and 33% complete response rate data previously announced for all 30 patients in the study
‘Hard-to-treat patients’ appear to have much to gain as multiple biomarker analyses of the biological samples from the UV1-103 study support the promising efficacy signals
Financially, Ultimovacs’ shareholder base and funding remain strong, with an expected financial runway until first half of 2024 based on current programs.
Carlos de Sousa, CEO of Ultimovacs, says:
“Ultimovacs made strong progress in the third quarter of 2022, building towards the topline readouts from the first two phase II trials of UV1 in combination with checkpoint inhibitors, INITIUM and NIPU. The company announced very positive three-year overall survival rate of 71% from its ongoing U.S.-based phase I trial of UV1 in metastatic malignant melanoma, backed by biomarker data from the same trial indicating that UV1 may level the odds for patients with hard-to-treat tumors. We also announced that the first patient had been randomized in LUNGVAC, the’ fifth comparative phase II clinical trial, in lung cancer.
The new data and clinical progress data reinforce our confidence that the broad applicability of UV1 in combination with anti-PD1 checkpoint inhibitors in real-world settings can provide a transformative role in treating solid tumors. Our progress is built on strong financial foundations, with an expected cash runway into H1 2024, beyond key value inflection points for the company.”
Third 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 UV1-103 trial in metastatic malignant melanoma. (post period event)
On 18 October 2022, Ultimovacs ASA announced multiple biomarker analyses data from the phase I UV1-103 malignant melanoma trial. The analyses of biological samples from the UV1-103 study support the promising efficacy signals, including enhanced efficacy in ‘hard-to-treat patients’ (post period event)
On 25 October 2022, Ultimovacs announced that the first patient had been randomized in the phase II LUNGVAC Trial. (post period event)
On 22 August 2022, Ultimovacs received a Notice of Allowance from the United States Patent and Trademarks Office (USPTO) concerning its US patent application covering methods for eliciting a T cell immune response with the UV1 universal cancer vaccine.
Clinical Trials Enrollment Update
INITIUM trial (malignant melanoma): Recruitment was completed in June 2022 with a total of 156 patients. Enrollment has started in the single arm supplementary study.
NIPU trial (mesothelioma): 108 out of 118 patients have been enrolled to date, up from 92 as of the previous quarterly report.
FOCUS trial (head and neck cancer): 41 out of 75 patients have been enrolled to date, up from 27 as of the previous quarterly report.
DOVACC trial (ovarian cancer): 7 out of 184 patients have been enrolled to date, up from 6 as of the previous quarterly report.
LUNGVAC trial (non-small cell lung cancer): The first out of 138 patients was enrolled in October 2022, and a total of 3 patients have been enrolled to date.
TENDU trial (prostate cancer): 10 out of 12 patients have been enrolled to date, up from 9 as of the previous quarterly report.
Scientific Publications and Presentations
On 18 October 2022, trial investigator Yousef Zakharia presented clinical endpoint and biomarker data from patients in the UV1-103 Phase I trial, in an oral presentation entitled “Clinical Activity of Combined Telomerase Vaccination and Pembrolizumab in Unresectable Melanoma” given at the 19th International Conference of the Society for Melanoma Research (SMR). (post period event)
On 12 September 2022, Ultimovacs announced the publication of data from its Phase I melanoma trial in Journal of Translational Medicine.
Third Quarter 2022 Financial Results
Total operating expenses amounted to MNOK 44.1 in Q3-22, and MNOK 111.4 YTD. Total loss was MNOK 38.3 for the period and MNOK 97.3 YTD.
Net negative cash flow from operations was MNOK 32.3 in Q3-22, and net decrease in cash and cash equivalents, not including currency effects, was MNOK 29.7 during Q3-22. Cash and cash equivalents amounted to MNOK 469.1 as per 30 September 2022
The quarterly report and presentation will be published at 08:00 CET 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. 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 90686815
Mary-Ann Chang, LifeSci Advisors
Phone: +44 7483 284 853
Ultimovacs is an immunotherapy company developing immune-stimulatory vaccines to treat a broad range of cancers. 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, 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, based on the proprietary Tetanus-Epitope-Targeting (TET) platform, combines tumor-specific peptides and adjuvant in the same molecule and entered Phase I studies in 2021.
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 November 10, 2022 at 08:00CET.