- Ultimovacs remains committed to continuing the clinical development strategy and exploring multiple pathways for UV1.
- The negative INITIUM results have had important consequences for the Company. Implemented cash preservation initiatives extends the anticipated financial runway to the fourth quarter of 2025, beyond the anticipated topline readout of the FOCUS and DOVACC trials.
- The UV1 vaccine was granted Fast Track designation from the U.S. Food and Drug Administration (FDA) and Orphan Drug designation from the European Medicines Agency (EMA) based on the data from the Phase II trial NIPU in malignant mesothelioma.
Conference call and webcast scheduled for May 7, 2024, at 14:00 (CET).
Oslo, May 7, 2024: Ultimovacs ASA (“Ultimovacs”) (OSE ULTI), a clinical-stage biotechnology company developing immunotherapeutic cancer vaccines, announces its first quarter 2024 results today.
“The period following the disappointing results of the INITIUM trial has been challenging for Ultimovacs. However, due to the promising outcomes from other UV1 trials and the broad diversity of our clinical program, we remain confident in UV1’s potential and committed to its ongoing development. The operational adjustments we have made ensure financial stability and support our progress through the next Phase II readouts and potential growth catalysts in 2024 and 2025”, said Carlos de Sousa, CEO of Ultimovacs. “We are also encouraged by the regulatory designations UV1 received based on the NIPU trial results, which demonstrated a clinically meaningful improvement in survival for patients with hard-to-treat cancers. We are looking forward to the forthcoming results from the next Phase II trial, FOCUS in head and neck cancer, expected in the third quarter.”
Fourth Quarter 2023 Business Update
Topline results reported from Phase II trial INITIUM in advanced melanoma
- In March 2024, Ultimovacs reported that the INITIUM trial did not meet the primary endpoint of improved progression-free survival (PFS).
- The data did not show differences in overall survival and objective response rate between the arms. The safety profile was consistent between the two arms, confirming the good safety profile for UV1.
- The key findings and analyses will be presented at the 2024 ASCO Annual Meeting in Chicago on June 1, 2024.
Cash preservation initiatives and operational adjustment plan implemented
- The negative INITIUM results have important consequences for the Company.
- Activity level prioritization and operational adjustments are implemented to sustain the financial runway, including a workforce reduction of approximately 40%.
- The cash preservation initiatives extend the anticipated cash runway to the fourth quarter of 2025, beyond the anticipated topline readout of the FOCUS and DOVACC trials.
- Based on current plans and forecast, the cash burn rate is estimated to be approximately 15 MNOK per quarter towards the end of 2025.
Regulatory designations for UV1 cancer vaccine for the treatment of 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.
- On February 19, 2024, Ultimovacs announced that the European Medicines Agency (EMA) granted Orphan Drug designation to the Company’s therapeutic cancer vaccine UV1 for the treatment of mesothelioma. The designation was granted based on results from the Phase II clinical trial, NIPU, evaluating UV1 added to ipilimumab and nivolumab treatment in patients with malignant pleural mesothelioma.
Clinical development update
UV1 randomized controlled Phase II trials
- NIPU (mesothelioma): Evaluating ipilimumab and nivolumab +/- UV1 vaccination as second-line treatment of patients with inoperable malignant pleural mesothelioma. Enrolled 118 patients from Australia, Spain and Scandinavia between June 2020 and January 2023. The study results were presented at the ESMO Congress in October 2023. An outline of the full trial results including subgroup analyses was published in European Journal of Cancer in March 2024. The data indicate that the epithelioid subgroup may be particularly relevant for UV1 vaccination, warranting further assessment in future studies. Mature overall survival data from the NIPU trial is expected to be reported later in 2024.
- INITIUM (melanoma): Evaluating ipilimumab and nivolumab +/- UV1 vaccination as first-line treatment of unresectable or metastatic malignant melanoma. Enrollment of 156 patients from 39 hospitals in the US, UK, Belgium and Norway, were completed between June 2020 and July 2022. Topline results were reported in March 2024. The study results will be presented at the ASCO Annual Meeting in June 2024.
- INITIUM Supplementary Study: Evaluating ipilimumab and nivolumab + UV1. Enrollment of the single arm supplementary study, which are not included in the INITIUM topline results, was completed in October 2023, with a total of 21 patients. The study will provide in-depth data on biologic activity and mode of action of the T cells induced by the UV1 vaccination on top of ipilimumab and nivolumab.
- FOCUS (head and neck cancer): Evaluating pembrolizumab +/- UV1 vaccination as first-line treatment of metastatic or recurrent head and neck squamous cell carcinoma. The enrollment of 75 patients from ten hospitals in Germany was completed between August 2021 and August 2023. The readout is expected in the third quarter of 2024.
- DOVACC (ovarian cancer): Evaluating olaparib and durvalumab +/- UV1 vs. olaparib alone as second-line maintenance treatment of high-grade BRCA negative ovarian cancer. Per date, 99 out of 184 patients from 35 hospitals in ten European countries have been enrolled, up from 75 as of the previous quarterly report. The readout is expected first half of 2025.
- LUNGVAC (non-small cell lung cancer): Evaluating cemiplimab +/- UV1 as first-line treatment of advanced or metastatic non-small cell lung cancer. Per date, 27 out of 138 patients from nine hospitals in Norway have been enrolled, up from 23 as of the previous quarterly report. In addition, 3 patients have received treatment with pembrolizumab +/- UV1. The readout is expected in the first half of 2026.
Financial update
- Following the cash preservation initiatives, Ultimovacs expects that the current cash resources will support operations to the fourth quarter of 2025 based on current programs and plans.
- Total operating expenses amounted to MNOK 28.6 in Q1 2024, and total loss was MNOK 22.8 for the period. These numbers are significantly influenced by a reversal of an accrual related to the share option program. Due to the significant drop in the company share price in Q1 2024, the social security tax accrual related to share options, which fluctuates with the Company share price, was fully reversed, resulting in an operating expense reduction of MNOK 21.0.
- Net negative cash flow from operations was MNOK 46.2 in Q1 2024, and net decrease in cash and cash equivalents, not including currency effects, was MNOK 43.7 during Q1 2024. Cash and cash equivalents amounted to MNOK 220.0 as of March 31, 2024.
The quarterly report and presentation will be published at 07:00 CET on May 7, 2024, and will be publicly available on the Ultimovacs website. The Company will conduct a conference call and webcast at 14:00 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: https://channel.royalcast.com/hegnarmedia/#!/hegnarmedia/20240507_5
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 company developing immunotherapeutic cancer vaccines with broad applicability. The lead candidate, UV1, is an off-the-shelf therapeutic cancer vaccine directed against human telomerase (hTERT), an antigen found in 85-90% of cancers in all stages of tumor development. A broad clinical program, with Phase II trials in five cancer indications enrolling more than 670 patients, is designed to investigate UV1’s impact in combination with various 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 retains all rights of the proprietary TET technology for any possible future use of formulations in various solid tumor indications. The Company is publicly 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 May 7, 2024 at 07:00 CET.
Attachments
