Oslo, August 21, 2024: Ultimovacs ASA (“Ultimovacs”) (OSE ULTI), a clinical-stage biotechnology company developing novel immunotherapies against cancer, announces its second quarter 2024 results today.
Conference call and webcast scheduled for August 21, 2024, at 14:00 (CET). Link to webcast here.
Second Quarter 2024 Business Update
- Following the negative INITIUM result in March 2024, Ultimovacs implemented cash preservation initiatives during the second quarter of 2024 extending the anticipated cash runway to the fourth quarter of 2025, beyond the topline readout of the FOCUS trial and the anticipated topline readout of the DOVACC trial.
- In August 2024, Ultimovacs reported topline results from the Phase II FOCUS trial in head and neck cancer. The trial did not meet the primary endpoint of improved progression-free survival (PFS). Moreover, the data did not show improvement in overall survival. The safety profile was consistent between the two arms, confirming UV1’s good safety profile. The key findings and analyses from the FOCUS trial will be submitted for publication in a peer-reviewed medical journal.
- Ultimovacs is currently conducting pre-clinical research on a novel drug conjugation platform. This flexible conjugation technology, initially formed to support the expansion of our vaccine pipeline, has broader potential applicability, including additional therapeutic modalities for multiple disease areas, such as innovative drug conjugates with favorable pharmacological properties. Ultimovacs will provide an update on this technology platform to the market before the end of 2024.
Clinical development update
UV1 randomized controlled Phase II trials
- FOCUS (head and neck cancer): Evaluating pembrolizumab +/- UV1 vaccination as first-line treatment in 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 July 2023. The topline readout was reported in August 2024. The trial did not meet the primary endpoint of improved progression-free survival (PFS). Moreover, the data did not show improvement in overall survival. The safety profile was consistent between the two arms, confirming the good safety and tolerability profile of UV1.
- 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 the European Journal of Cancer in March 2024. The data indicate a benefit for the epithelioid subgroup, warranting further assessment of UV1 in future studies. Data from the NIPU trial with longer follow up time will be presented at ESMO 2024.
- INITIUM (melanoma): Evaluating ipilimumab and nivolumab +/- UV1 vaccination as first-line treatment in unresectable or metastatic malignant melanoma. Enrollment of 156 patients from 39 hospitals in the US, UK, Belgium and Norway, was completed between June 2020 and July 2022. Topline results were reported in March 2024. As previously reported, the trial did not meet the primary endpoint of improved progression-free survival (PFS). Moreover, the data did not show improvement in overall survival. The study results were presented at the ASCO Annual Meeting in June 2024.
- INITIUM Supplementary Study: Evaluating ipilimumab and nivolumab + UV1. Enrollment in the single arm supplementary study, which is 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. The results are expected to be submitted for publication in a peer-reviewed medical journal by the end of this year.
- DOVACC (ovarian cancer): Evaluating olaparib and durvalumab +/- UV1 vs. olaparib alone as second-line maintenance treatment in high-grade BRCA negative ovarian cancer. As of date, 120 out of 184 patients have been enrolled in 35 participating hospitals in ten European countries, in comparison to 99 patients as per the previous quarterly report. The readout is expected in the first half of 2025.
- LUNGVAC (non-small cell lung cancer): Evaluating PD-1 check point inhibitor +/- UV1 as first-line treatment of advanced or metastatic non-small cell lung cancer. As of date, 31 out of 138 patients have been enrolled in nine participating hospitals in Norway, up from 30 patients as of the previous quarterly report. The readout is expected in the first half of 2026.
UV1 Phase I trials
- UV1-103 (melanoma): on June 11, 2024, Ultimovacs ASA announced overall survival (OS) data from both cohorts in the UV1-103 Phase I clinical trial in malignant melanoma. All patients in the trial who were alive at 3 years remain alive at 4 years (69.5%) with a minimum follow-up period of 4 years (median 53.0 months). Following the readout of the 4-year survival data, the trial is concluded.
Financial update
- Following the negative INITIUM result in March 2024, Ultimovacs implemented cash preservation initiatives during the second quarter of 2024 extending the anticipated cash runway to the fourth quarter of 2025, beyond the anticipated topline readout of the DOVACC trial. Activity level prioritization and operational adjustments are implemented to sustain the financial runway, including a workforce reduction of approximately 40%. Based on current plans and forecast, the cash burn rate is estimated to be approximately 15 MNOK per quarter towards the end of 2025.
- Total operating expenses amounted to MNOK 45.3 in Q2 2024, and MNOK 74.0 YTD. Total loss was MNOK 44.8 for the period and MNOK 67.5 YTD.
- Net negative cash flow from operations was MNOK 50.5 in Q2 2024, and net decrease in cash and cash equivalents, not including currency effects, was MNOK 49.2 during Q2 2024. Cash and cash equivalents amounted to MNOK 170.4 as per 30 June 2024.
The quarterly report and presentation will be published at 07:00 CET on August 21, 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 here.
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
About Ultimovacs
Ultimovacs is a clinical-stage biotechnology company developing novel immunotherapies against cancer. The product candidate UV1 is an off-the-shelf therapeutic cancer vaccine designed to enhance the benefits of immunotherapy and improve cancer treatment efficacy for patients. UV1 triggers an immune response against the shared cancer antigen telomerase, a target present in 85-90% of all cancer indications across disease stages.
Ultimovacs is investigating the safety and efficacy of UV1 in a wide-ranging clinical development program including various cancer indications and different immunotherapy combinations. The ongoing Phase II program comprises five randomized clinical trials in melanoma, mesothelioma, head and neck cancer, ovarian cancer, and non-small cell lung cancer. More than 750 patients in the U.S., Europe, and Australia are being enrolled in all Phase I and Phase II trials in the current program.
Furthermore, Ultimovacs is developing a novel conjugation technology, initially formed to support the expansion of our vaccine pipeline. With the objective of driving value and future pipeline growth, this flexible conjugation technology has the potential to be broadly applicable to a variety of therapeutic modalities, such as innovative drug conjugates with favorable pharmacological properties, and in multiple disease areas.
Ultimovacs is listed on the 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 August 21, 2024 at 07:00 CET.