Ultimovacs ASA Q2 2024 Financial Results and Business Update

Ultimovacs ASA, a clinical-stage biotechnology firm specializing in novel cancer immunotherapies, has released its second quarter 2024 financial results. The company, headquartered in Oslo, has scheduled a conference call and webcast to discuss these results on August 21, 2024, at 14:00 CET.

Business and Clinical Development Updates

In the wake of the disappointing results from the INITIUM trial in March 2024, Ultimovacs initiated several cash preservation measures in the second quarter of 2024. These measures are intended to extend the company's cash runway until the fourth quarter of 2025. This is expected to cover the period beyond the anticipated topline readouts of the FOCUS and DOVACC trials. 

In August 2024, Ultimovacs reported topline results from its Phase II FOCUS trial, which evaluated the use of UV1 in combination with pembrolizumab for head and neck cancer. Unfortunately, the trial did not meet its primary endpoint of improving progression-free survival (PFS) and showed no improvement in overall survival. Nevertheless, the safety profile of UV1 was consistent, reinforcing its known safety. Key findings from this trial will be submitted for publication in a medical journal.

Ultimovacs is also progressing with pre-clinical research on a new drug conjugation platform. Originally designed to expand their vaccine pipeline, this technology has broader applications, including the development of innovative drug conjugates for various diseases. An update on this platform will be provided to the market before the end of 2024.

Progress in Phase II Trials

The company has several ongoing Phase II trials involving UV1:

- FOCUS Trial (Head and Neck Cancer): The trial involved 75 patients from ten hospitals in Germany, with enrollment completed between August 2021 and July 2023. The primary endpoint was not met, and no improvement in overall survival was observed.

- NIPU Trial (Mesothelioma): This trial enrolled 118 patients from Australia, Spain, and Scandinavia between June 2020 and January 2023. Data indicated a benefit for the epithelioid subgroup, prompting further studies. Additional data will be presented at the ESMO 2024.

- INITIUM Trial (Melanoma): Enrolling 156 patients across 39 hospitals in the US, UK, Belgium, and Norway, this trial's topline results were also negative. The data were presented at ASCO in June 2024. A supplementary study involving 21 patients will provide more in-depth biological data.

- DOVACC Trial (Ovarian Cancer): This trial is evaluating UV1 in combination with olaparib and durvalumab. As of now, 120 out of 184 patients have been enrolled in 35 hospitals across ten European countries. Readout is expected in the first half of 2025.

- LUNGVAC Trial (Non-Small Cell Lung Cancer): This study is assessing UV1 in combination with a PD-1 checkpoint inhibitor. Currently, 31 out of 138 patients have been enrolled in nine hospitals in Norway, with a readout expected in the first half of 2026.

Phase I Trials

The UV1-103 Phase I trial in melanoma reported that all patients who were alive at 3 years remained alive at 4 years, marking a significant milestone. This trial is now concluded.

Financial Highlights

Following the negative outcomes from the INITIUM trial, Ultimovacs has implemented cost-saving measures, including a 40% workforce reduction. These steps are expected to sustain financial stability until the fourth quarter of 2025. The company's cash burn rate is estimated to be around 15 MNOK per quarter. Operating expenses for Q2 2024 totaled MNOK 45.3, with a total loss of MNOK 44.8 for the period. Net negative cash flow from operations was MNOK 50.5, with cash and cash equivalents amounting to MNOK 170.4 as of June 30, 2024.

The quarterly report and presentation will be available on the Ultimovacs website. A conference call and webcast will be conducted at 14:00 CET on August 21, 2024, with the webcast archived for later viewing.

Ultimovacs continues to focus on developing its UV1 cancer vaccine and innovating within the biotechnology space, committed to enhancing the efficacy of cancer treatments through novel immunotherapy solutions.

How to obtain the latest research advancements in the field of biopharmaceuticals?

In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!