Ultimovacs ASA Reports Fourth Quarter 2023 Financial Results and Provides General Business Update
- Readout of topline result expected in March 2024 from UV1 randomized Phase II trial INITIUM in Ultimovacs’ lead indication, advanced malignant melanoma
- Topline result will report primary endpoint of progression-free survival (PFS) of UV1 vaccination combined with standard of care immunotherapy over immunotherapy alone
- Positive results from the INITIUM trial will be further presented at an international medical conference and published in a reputable medical journal
- UV1 granted Fast Track designation from FDA based on clinically meaningful survival results in Phase II trial NIPU in mesothelioma, presented at ESMO Congress 2023
- Sustained long-term survival data reported in UV1-103 trial in advanced malignant melanoma
- Exploratory study TENDU based on TET technology met primary endpoint
Conference call and webcast scheduled for February 14, 2024, at 13:00 (CET)
Oslo, February 14, 2024: Ultimovacs ASA ("Ultimovacs") (OSE ULTI), a clinical-stage biotechnology leader in novel immunotherapeutic cancer vaccines, announces its fourth quarter 2023 results today.
“The upcoming significant milestone is the announcement of the topline result from the INITIUM trial next month. If the trial meets the primary endpoint and demonstrates a clinical benefit over the current gold standard of immunotherapy for this indication, ipilimumab and nivolumab, it represents a significant accomplishment. From an industry perspective, it will be the first time an off-the-shelf cancer vaccine shows such an additional clinical benefit in a randomized trial in the most serious form of skin cancer”, said Carlos de Sousa, CEO of Ultimovacs.
“Our mission is to demonstrate UV1’s value for patients. Because of the ground-breaking potential of a positive topline result, we will seek to present the full analysis at a major oncology conference and publish the results in a top-tiered medical journal. Sharing clinical trial results in peer-reviewed forums represents a validation from experts in the field, as well as an effective outreach to leaders in the global medical, investment and pharmaceutical sectors. We look forward to communicating the topline result in March and to share the full study results at the best peer-reviewed opportunity thereafter.”
Fourth Quarter 2023 Highlights
Near-term readout of UV1 Phase II study INITIUM in unresectable or metastatic malignant melanoma
- On January 16, 2024, Ultimovacs announced that the last patient enrolled in the INITIUM trial has now been followed for 18 months, thereby enabling readout of the primary endpoint. The Company expects to announce topline results from the randomized Phase II clinical trial in March this year. With a positive topline result from the trial, the ambition is to present the study results at an upcoming international oncology conference and in a high impact medical journal.
- On October 31, 2023, Ultimovacs announced that a suggested INITIUM study protocol amendment allowing data cut-off 18 months after inclusion of last patient if 70 endpoints have not occurred was accepted by relevant regulatory authorities. The amendment followed the observation that very few endpoints occurred during 2023. By mid-January 2024, the last enrolled patient had completed follow-up time of 18 months triggering data cut-off. The protocol amendment maintains the integrity of the study statistics without materially affecting the scientific value of the clinical trial. The topline result from the study is expected in March 2024.
- On November 2, 2023, the Company announced the completed enrollment of 21 patients in the INITIUM supplementary single-arm study in malignant melanoma. Study objectives are to investigate how immune responses against telomerase transfers into anti-tumor activity and further to clinical benefit for patients.
Clinically meaningful survival data reported at the ESMO Congress in UV1 Phase II study NIPU in malignant mesothelioma
- NIPU trial principal investigator, Professor Åslaug Helland, MD, PhD, reported the results from the study in second-line treatment of patients with malignant mesothelioma as an oral presentation at the ESMO Congress 2023 in Madrid in October. The data presented showed that UV1, as add-on to the checkpoint inhibitors ipilimumab and nivolumab, demonstrated a clinically meaningful overall survival benefit after a relevant observation period, with no added toxicities compared to ipilimumab and nivolumab alone. The study also reported that 31% of the patients treated with UV1 experienced an objective response, as compared to 16% in the control arm. An analysis of the Hazard Ratio in Overall Survival showed that UV1 cancer vaccination combined with ipilimumab and nivolumab reduced the risk of death by 27%.
- On October 9, 2023, Ultimovacs announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation (ODD) to the Company’s therapeutic cancer vaccine UV1 for the treatment of patients with mesothelioma.
- On February 5, 2024, Ultimovacs announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the Company’s therapeutic cancer vaccine UV1 in combination with ipilimumab and nivolumab for the treatment of patients with unresectable malignant pleural mesothelioma to improve overall survival.
Demonstrated sustained long-term survival in Phase I study UV1-103 in malignant melanoma
- On October 12, 2023, Ultimovacs reported sustained long-term overall survival in patients treated with UV1 cancer vaccine in the UV1-103 Phase I study in malignant melanoma. No confirmed patient deaths occurred in Cohort 1 between the 3-year and 4-year follow-up period.
Exploratory Phase I TENDU study of TET technology met primary endpoint
- On December 18, 2023, Ultimovacs announced that the dose-escalation, first-in-human Phase I trial showed good safety and tolerability across all dose cohorts and met the primary endpoint of the study. Data included observations of immune activation with vaccine specific T cell responses. In addition to the trial results, advancements in preclinical research, technology development and product manufacturing provide a valuable foundation for the future development of the TET technology and TET-based vaccine candidates.
Clinical trials update
UV1 Phase II program
- INITIUM (malignant melanoma): Evaluating ipilimumab and nivolumab +/- UV1. The enrollment of 156 patients was completed in July 2022. Topline results are expected in March 2024.
- INITIUM Supplementary Study: Evaluating UV1 + ipilimumab and nivolumab. Enrollment of the single arm supplementary study, which will not be included in the INITIUM topline results, was completed in October 2023, with a total of 21 patients.
- NIPU (metastatic pleural mesothelioma): Evaluating ipilimumab and nivolumab +/- UV1. The enrollment of 118 patients was completed in January 2023. The study results were presented at the ESMO Congress in October 2023.
- FOCUS (head and neck cancer): Evaluating pembrolizumab +/- UV1. The enrollment of 75 patients was completed in August 2023. The readout is expected in the second half of 2024.
- DOVACC (ovarian cancer): Evaluating olaparib and durvalumab +/- UV1 vs. olaparib alone. 75 out of 184 patients have been enrolled to date, up from 46 as of the previous quarterly report. The multinational trial in ten European countries took longer to initiate than anticipated during the pandemic. The readout is expected in H1 2025 (previously guided to H2 2024).
- LUNGVAC (non-small cell lung cancer): Evaluating cemiplimab +/- UV1. 23 out of 138 patients have been enrolled to date, up from 13 as of the previous quarterly report. In addition, 3 patients have received treatment with pembrolizumab +/- UV1. The sponsor is currently investigating various possibilities to accelerate the trial enrollment. The readout is expected in H1 2026 (previously guided to H2 2025).
TENDU Phase I trial (prostate cancer) based on the TET technology platform:
- The enrollment of 12 patients was completed in December 2022. The results from the study were announced in December 2023.
Financial update
- Ultimovacs expects that the current cash resources will support operations through 2024 based on current programs and plans.
- Total operating expenses amounted to MNOK 59.6 in Q4 2023 and MNOK 215.7 FY 2023. Total loss was MNOK 55.9 for the period and MNOK 189.2 in FY2023.
- Net negative cash flow from operations was MNOK 42.4 in Q4 2023, and net decrease in cash and cash equivalents, not including currency effects, was MNOK 38.9 during Q4 2023. Cash and cash equivalents amounted to MNOK 266.6 as of December 31, 2023.
The quarterly report and presentation will be published at 07:00 CET on February 14, 2024 and will be publicly available on the Ultimovacs website. The Company will conduct its fourth quarter conference call and webcast at 13:00 CET the same day. Questions can be submitted throughout the event. The webcast will be archived for replay following the conference call.
Link to webcast here.
For further information, please see www.ultimovacs.com or contact:
Carlos de Sousa, CEO
Email: [email protected]
Phone: +47 908 92507
Hans Vassgård Eid, CFO
Email: [email protected]
Phone: +47 482 48632
Anne Worsøe, Head of Investor Relations
Email: [email protected]
Phone: +47 906 86815
About Ultimovacs
Ultimovacs is a clinical-stage biotechnology leader in novel immunotherapeutic cancer vaccines with broad applicability. Ultimovacs’ lead candidate, UV1, is an off-the-shelf therapeutic cancer vaccine 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 a patented technology owned by Ultimovacs.
In addition, Ultimovacs holds all rights of the proprietary TET technology platform for any possible future use of formulations in various solid tumor indications. The Company is listed on Euronext Oslo Stock Exchange (OSE:ULTI).
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, Financial Manager at Ultimovacs ASA, on February 14, 2024 at 07:00 CET.
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