Ultimovacs Implements Operational Adjustments to Support Continuous Advancement of the UV1 Vaccine Phase II Program

• Due to the broad diversity in the UV1 Phase II program and the encouraging results from previous UV1 trials, Ultimovacs remain confident in UV1’s potential and are strongly committed to bringing the company across the next important data points: The readout from FOCUS in Q3 2024 and DOVACC results in H1 2025
• Activity level adjustments and operational prioritization are implemented to sustain the financial runway, including a workforce reduction of approximately 40%
• The operational adjustment plan extends the anticipated cash runway to the fourth quarter of 2025, through the readout from the Phase II DOVACC trial

Oslo, April 16, 2024: Ultimovacs ASA ("Ultimovacs”) (OSE ULTI), a clinical-stage biotechnology company developing immunotherapeutic cancer vaccines, today announces a plan to optimize its business operations to support the continuous advancement of UV1 and long-term business growth.

"We remain dedicated to our investigation of the potential impact of UV1 vaccine across several cancer indications and immunotherapy combinations, and we are prepared for both challenges and accomplishments along the way. We anticipate potential growth catalysts both in 2024 and 2025,” said Carlos de Sousa, CEO at Ultimovacs. "Our objective is to create value for both patients and our shareholders while safeguarding the financial stability of the company. Aligning with this goal requires us to reduce the level of activity and make prioritization adjustments, including reducing our workforce. I wish to thank the departing employees for their incredible dedication to helping cancer patients and for their contribution to our mission.”

The operational adjustments enable an extension of the financial runway to the fourth quarter of 2025, beyond the anticipated topline readout from the Phase II DOVACC trial. Based on current plans and forecasts, the cash burn rate is estimated to be approximately NOK 15 million per quarter towards the end of 2025, prior to the initiation of potential new activities towards new clinical trials or other projects.

The company will host a webcast presentation and provide a business update on Wednesday, April 17, 2024, at 11:00 (CET). The presentation is attached. 

Link to webcast: https://channel.royalcast.com/landingpage/hegnarmedia/20240417_1/

==ENDS==

About Ultimovacs

Ultimovacs is a clinical-stage biotechnology company developing immunotherapeutic cancer vaccines. The lead cancer vaccine candidate UV1 is an off-the-shelf vaccine directed against human telomerase (hTERT), an antigen 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 investigate UV1’s impact in combination with other immunotherapies in multiple cancer types. UV1 is a patented technology owned by Ultimovacs. In addition, Ultimovacs’ adjuvant platform, based on the proprietary Tetanus-Epitope-Targeting (TET) technology, combines tumor-specific antigens and adjuvant in the same molecule and is in Phase I clinical development.

The Company is listed on the Euronext Oslo Stock Exchange (ULTI).

About the UV1 Phase II program

The immunotherapeutic cancer vaccine UV1 is investigated in combination with checkpoint inhibitors in patients with various cancer indications with diverse tumor biology. The clinical strategy behind the UV1 Phase II program’s diversity is to evaluate the potential broad applicability of the cancer vaccine when combined with other immunotherapies:

• INITIUM: Evaluating UV1 in combination with ipilimumab and nivolumab as first-line treatment for patients with malignant melanoma. Enrollment of 156 patients completed in July 2022. Sponsored by Ultimovacs. With the 18-month minimum follow-up of the patients in the INITIUM trial, the trial did not meet the primary or secondary endpoints. Median PFS was not reached in either arm. UV1 maintained its beneficial safety profile.

• NIPU: Evaluating UV1 in combination with ipilimumab and nivolumab as second-line treatment for patients with malignant pleural mesothelioma. Enrollment of 118 patients completed in January 2023. Data presented at the ESMO Congress in October 2023 showed that UV1, as an add-on to ipilimumab and nivolumab, demonstrated a statistically significant and clinically meaningful improvement in overall survival versus ipilimumab and nivolumab alone. 31% of the patients receiving the UV1 vaccine experienced an objective response, compared to 16% in the control arm. The investigator-initiated study is led by Oslo University Hospital and supported by Bristol-Myers Squibb and Ultimovacs.
  

• FOCUS: Evaluating UV1 in combination with pembrolizumab as first-line treatment for patients with head and neck cancer. Enrollment of 75 patients completed in August 2023, expected readout Q3 2024. The investigator-initiated study is led by Halle University in Germany, supported by Ultimovacs.
  
  

• DOVACC: Evaluating UV1 in combination with olaparib and durvalumab as maintenance therapy in non-BRCA mutated patients with advanced ovarian cancer. 75 of 184 patients enrolled as of Q4 2023 reporting, expected readout H1 2025. The investigator-initiated study is led by NSGO-CTU and supported by ENGOT, AstraZeneca, and Ultimovacs.
• LUNGVAC: Evaluating UV1 combined with cemiplimab as first-line treatment of non-small cell lung cancer patients. 23 of 138 patients enrolled as of Q4 2023 reporting, expected readout H1 2026. The investigator-initiated study is led by Vestre Viken (Drammen Hospital) and supported by Ultimovacs.

About UV1
UV1 is a universal cancer vaccine designed to induce a specific T-cell response against telomerase. UV1 consists of long, synthetic peptides representing a sequence in the reverse transcriptase subunit of telomerase (hTERT), shown to induce CD4+ T-cells. These CD4+ T-cells have the potential to provide inflammatory signals, and T-cell support is believed to be critical for triggering a strong anti-tumor immune response. Following intradermal injection, antigen-presenting cells (APCs) in the skin are exposed to the vaccine peptides. These APCs will process the peptides and present vaccine epitopes on Human Leukocyte Antigen (HLA) molecules to naïve T-cells in the lymph nodes. Activated vaccine-specific T-cells will then enter the circulation and search for cells displaying their cognate antigen in the context of HLA molecules.

The UV1 peptides contain several epitopes, shown to be non-restrictive in terms of (HLA) alleles for presentation. It is, therefore, not required to perform HLA pre-screening of patients, which potentially enables broad population utilization of the vaccine. UV1 is administered over three months as eight intradermal injections together with the immune-modulator GM-CSF.

For further information, please contact:

Carlos de Sousa, CEO
Email: carlos.desousa@ultimovacs.com
Phone: +47 908 92507

Anne Worsøe, Head of Investor Relations
Email: anne.worsoe@ultimovacs.com
Phone: +47 90686815

This information is considered 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 Anne Worsøe, Head of Investor Relations at Ultimovacs ASA, on April 16, 2024, at 22:10 CET.

Attachment

• 20240417 Ultimovacs Business Update webcast