BRCA-mutated Ovarian Cancer

Oslo, September 11, 2024: Ultimovacs ASA (“Ultimovacs”) (OSE ULTI), a clinical-stage biotechnology company developing immunotherapeutic cancer vaccines, today announced that the company has agreed with the investigators conducting the LUNGVAC trial ( NCT05344209 ) to discontinue patient recruitment. LUNGVAC is an investigator-initiated, randomized Phase II trial designed to assess the impact of UV1 in combination with the checkpoint inhibitor cemiplimab or pembrolizumab as first-line treatment in patients with inoperable advanced or metastatic non-small cell lung cancer (NSCLC). The decision is driven by very slow recruitment in the study, which is primarily due to new treatment options available to NSCLC patients. All 31 patients that have been enrolled in the LUNGVAC study since 2022 will be treated and followed up as per the trial protocol. Topline data from these patients is expected in the first half of 2025. “We have consulted closely with the LUNGVAC investigators regarding the challenges in trial recruitment which relate to the evolution of standard of care for NSCLC patients and the resulting impact on the number of NSCLC patients eligible for the trial. Based on the investigators’ recommendations, recruitment will stop and the investigators will analyze the data on UV1 in this indication from the patients that have been enrolled so far,” said Carlos de Sousa, Chief Executive Officer at Ultimovacs. “We are grateful to the study investigators, their clinical teams and all patients who enrolled in the trial and we look forward to analyzing the topline data next year.” Currently, Ultimovacs is investigating UV1 in ovarian cancer in the ongoing Phase II DOVACC trial which evaluates a combination of olaparib and durvalumab +/- UV1 vs. olaparib alone as second-line maintenance treatment of high-grade BRCA negative ovarian cancer. Patients continue to be screened and enrolled in this trial, and topline results are expected to be available in the first half of 2025. Additionally, Ultimovacs is conducting pre-clinical research on a novel drug conjugation platform to investigate its 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. ==ENDS== About LUNGVAC The LUNGVAC trial is an investigator-initiated, randomized, comparative Phase II clinical trial in which the cancer vaccine UV1 is evaluated in combination with the checkpoint inhibitor cemiplimab or pembrolizumab as first-line treatment of NSCLC patients with advanced or metastatic disease. The trial has enrolled previously untreated patients with adenocarcinoma or squamous NSCLC, where tumor biopsies show a PD-L1-expression score equal to or above 50%. These subgroups represent approximately 30% of all advanced and metastatic NSCLC patients. Professor Odd Terje Brustugun is the principal investigator for the trial, which is sponsored by Drammen Hospital in Vestre Viken Hospital Trust, Norway. 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 that are 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. 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). For further information, please see 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 This information is considered to be 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 Hans Vassgård Eid, CFO at Ultimovacs ASA, on September 11, 2024, at 17:00 CEST.

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, CFOEmail: hans.eid@ultimovacs.comPhone: +47 482 48632 About UltimovacsUltimovacs 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. Attachments Ultimovacs-ASA-Q224-Report Ultimovacs-ASA-Q224-Presentation

Adding Ultimovacs’ cancer vaccine UV1 to checkpoint inhibitor pembrolizumab did not meet primary or secondary endpoints in patients with metastatic or recurrent head and neck squamous cell carcinoma UV1 continues to show a positive safety profile in line with other UV1 studies with similar events observed in the control arm and good tolerability As previously communicated, financial runway secured until Q4 2025 beyond expected topline results from DOVACC Phase II study in 1H2025 Within the available resources, the company is also actively developing a novel technology platform identified during the TET development and will provide an update before the end of 2024 Oslo, August 5, 2024: Ultimovacs ASA (“Ultimovacs”) (OSE ULTI), a clinical-stage biotechnology leader in novel immunotherapeutic cancer vaccines, today announced the topline results from the Phase II FOCUS trial (NCT05075122). The topline data readout demonstrated that adding UV1 to the standard of care pembrolizumab did not lead to clinical benefits in progression free survival or overall survival in those late-stage HNSCC patients, therefore, the study did not meet its primary and secondary endpoints. FOCUS is an investigator-initiated randomized Phase II clinical trial sponsored by Martin-Luther-University Halle-Wittenberg with support from Ultimovacs. It investigates Ultimovacs’ therapeutic cancer vaccine, UV1, in combination with pembrolizumab versus pembrolizumab alone, as a first-line treatment in metastatic patients or a second-line treatment in patients with recurrent PD-L1 positive head and neck squamous cell carcinoma (HNSCC). In this indication, pembrolizumab is currently considered the standard of care treatment for patients. The primary endpoint of the study is progression free survival at 6 months. All patients have been followed up for close to 12 months or longer for PFS, overall survival (OS) and safety. “We have implemented a broad Phase II clinical development program testing our cancer vaccine in a range of different indications. Unfortunately, the FOCUS study did not provide us with the results we had hoped for, and we are disappointed that UV1 was not able to provide added clinical benefit for these HNSCC patients,” said Carlos de Sousa, Chief Executive Officer at Ultimovacs. “Earlier this year we implemented a cash preservation program, enabling us to extend our runway to the fourth quarter of 2025 beyond the anticipated DOVACC Phase II topline readout in the first half of next year. Further, the Ultimovacs team is actively developing a novel technology platform identified during the TET development and we look forward to providing more details before year-end.” The FOCUS trial is being conducted at ten sites across Germany and is led by Principal Investigator Mascha Binder, M.D., Professor of Medical Oncology at the Faculty of Medicine, University Hospital of Basel. Professor Binder is a renowned oncology clinician and researcher specialized in the analysis of immune-oncology treatments and their interaction with tumor tissues. Head and neck cancer is the seventh most common type of cancer worldwide, and squamous cell carcinoma (HNSCC) represents about 90 percent of these patients. HNSCC occurs in the head and neck region, including the throat, mouth, sinuses and nose. Despite advances in treatment strategies, the prognosis for these patients is poor. Jens Bjørheim, Chief Medical Officer at Ultimovacs added, “We are disappointed that the FOCUS trial did not achieve the desired outcome for patients, which underscores the complexities of treating metastatic and recurrent head and neck cancer. This cancer type is particularly aggressive with limited treatment options and high rates of recurrence. Our broad clinical development program was designed to identify the best patient populations for UV1 and we are now focusing our efforts on the upcoming DOVACC data readout in the first half of next year.” Ultimovacs is also investigating UV1 in ovarian cancer in the ongoing Phase II DOVACC trial which evaluates a combination of olaparib and durvalumab +/- UV1 vs. olaparib alone as second-line maintenance treatment for patients with high-grade BRCA negative ovarian cancer. Topline results are expected in the first half of 2025 well within the current financial runway which reaches to the fourth quarter of 2025. The FOCUS trial (First-line metastatic Or recurrent HNSCC/Checkpoint inhibitor UV1 Study) is an investigator-sponsored, randomized, open label Phase II clinical trial. The primary objective of this study is to determine the clinical performance of UV1 vaccination as add on to standard pembrolizumab treatment as a first-line treatment in metastatic patients or a second-line treatment in patients with recurrent PD-L1 positive head and neck squamous cell carcinoma. Professor Mascha Binder is the principal investigator for the trial, which is sponsored by the Medical Faculty, University of Halle-Wittenberg in Germany. The first patient in the FOCUS trial was enrolled in August 2021, and patients have been treated at 10 sites across Germany. The trial is investigating the tolerability and efficacy addition of UV1 to standard of care treatment with programmed death receptor-1 (PD 1)-blocking antibody pembrolizumab versus pembrolizumab monotherapy. The 75 patients indicated for treatment with pembrolizumab have been randomized 2-to-1 so that 50 patients will receive UV1 and pembrolizumab and 25 patients will receive pembrolizumab alone. The primary endpoint is PFS rate at 6 months after first administration of study medication. Secondary endpoints include PFS and OS (overall survival, by Kaplan-Meier estimate), objective response rate (ORR), duration of response (DOR) and safety, with minimum 12 months follow-up. As OS is recognized as the determining efficacy measure in guiding further development in this cancer indication, the topline results will be disclosed 12 months after enrollment of the last patient, allowing simultaneous disclosure of both PFS and OS. The FOCUS Phase II trial is partially supported through an innovation grant of up to NOK 16 million from the Norwegian Research Council. Head and neck cancer is the term used to describe different malignant tumors that develop in or around the throat, larynx, nose, sinuses, and mouth. Squamous cell carcinoma represents about 90 percent of head and neck cancer patients. Overall survival of patients with metastatic or recurrent HNSCC has improved over the past decade but remains poor overall. Median overall survival is limited to less than 15 months, with the current standard of care (immune checkpoint blockade with or without chemotherapy). Many patients with HNSCC are frail and therefore cannot tolerate chemotherapy, reducing their treatment options to checkpoint inhibitor. Therefore, the development of effective and tolerable combination regimens is urgently needed, especially in first-line therapy. Ultimovacs is a clinical-stage biotechnology leader in novel immunotherapeutic cancer vaccines with broad applicability. Ultimovacs’ lead cancer vaccine candidate, UV1 is 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 universal, off-the-shelf and easy to use, and 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. UV1 is a therapeutic 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 that are 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. The content above comes from the network. if any infringement, please contact us to modify.