Ilixadencel

Press Release Stockholm, Sweden, February 14, 2024 Positive ADVANCE II data at ASH caps strong 2023 The fourth quarter of 2023 closes a crucial year for Mendus and delivered additional milestones to further strengthen the development of our lead product vididencel as a novel maintenance treatment for acute myeloid leukemia (AML). Mendus is at an exciting point in its journey, supported by continued positive clinical data confirming the potential of vididencel to significantly improve disease-free and overall survival in AML. In addition to the financing round and NorthX manufacturing collaboration reported in Q3, Mendus announced in Q4 a collaboration with the Australasian Leukaemia and Lymphoma Group (ALLG) to significantly expand the clinical evaluation of vididencel in combination with current standard of care. The alliances with NorthX and ALLG allow Mendus to take major steps in the advancement of vididencel’s clinical development in AML. Mendus presented three clinical abstracts at the 65th American Society of Hematology Annual Meeting (ASH 2023) in December, including an oral presentation of the ADVANCE II trial survival data. ADVANCE II is a Phase 2 monotherapy trial focused on AML patients in first complete remission after chemotherapy, but with measurable residual disease (MRD), which is associated with a high probability of disease relapse. The presented data showed 14 of 20 patients to be alive in long-term follow-up, with median relapse-free survival currently at 30.4 months (2.5 years). Immunomonitoring data demonstrate broad activation of the immune system following vididencel treatment, associated with the observed durable clinical remissions. The positive survival data presented at ASH strengthen the case that vididencel represents one of the most promising AML maintenance therapies currently in development. The positive ADVANCE II trial results encourage us to push forward the clinical development of vididencel in AML. As a first next step to expand clinical testing, we announced during the fourth quarter a collaboration with the ALLG, a world-leading clinical trial research group focused on blood-borne tumors. Mendus and ALLG will study vididencel in combination with oral azacitidine (AZA), currently the only approved AML maintenance treatment, in the randomized multi-center AMLM22 CADENCE trial, an adaptive Phase 2 trial consisting of two stages. In December, Mendus and ALLG had completed the preparation for the start of the CADENCE trial in the ALLG AMLM22 adaptive platform, with the CADENCE protocol submitted to the central ethical committee of participating hospitals. Upon committee approval, the trial will be open for enrolment. The first stage of the study will assess the safety of vididencel in combination with oral AZA in 40 patients randomized to either receive vididencel + AZA or AZA alone. In the second stage, the efficacy of the combination will be assessed in an additional 100 patients. In November we were pleased to announce the publication of data from the completed Phase 1 trial with vididencel in high-risk MDS and AML patients, in the peer-reviewed medical journal HemaSphere. The publication showed that survival following vididencel treatment was largely determined by low disease burden at the start of treatment, confirming the therapeutic setting of the ADVANCE II Phase 2 trial. There was no correlation with commonly used risk-scoring criteria for AML, indicating that also patients with adverse cytogenetic risk profiles can respond to vididencel therapy. Finally, the Phase 1 trial data support the combination potential of vididencel with AZA, the combination to be studied in the CADENCE trial. Based on the ADVANCE II data and data from the first stage of the CADENCE trial, Mendus expects to be in a position to engage in a global registration path for vididencel in 2025. Additional trials may also allow Mendus to broaden the positioning of vididencel in AML maintenance and adjacent indications, such as myelodysplastic syndromes (MDS). Mendus has announced in June an alliance with the Sweden-based cell and gene therapy manufacturer NorthX Biologics to set up large-scale manufacturing for registrational studies and future commercial launch of vididencel. Mendus provided a clinical pipeline update in December, confirming full recruitment of the ALISON Phase 1 trial with vididencel in ovarian cancer and continued commitment to prepare a trial in soft tissue sarcomas with its intratumoral immune primer ilixadencel. A primary read-out of the ALISON trial is expected in the second half of 2024. The successful read-out of the ADVANCE II trial and the progress realized in 2023 puts Mendus in a strong position to expand the clinical development of vididencel in AML and to prepare for a global registration strategy. Combined with additional clinical pipeline progress and ongoing exciting research programs addressing novel therapeutic concepts, we look forward to an eventful 2024. Many thanks to our shareholders, partners and other stakeholders for supporting the team at Mendus. Erik Manting CEO SIGNIFICANT EVENTS OF Q4 2023 Net sales for the period amounted to KSEK – (–).Result for the period amounted to KSEK -41,165 (-43,280).Earnings and diluted earnings per share totalled SEK -0.05 (-0.22).Mendus Phase 1 vididencel clinical trial results in AML and high-risk MDS patients published in peer-reviewed medical journal.Mendus presents updated ALISON clinical trial data for vididencel in ovarian cancer at SITC 2023.Mendus to Host KOL Event to Review Phase 2 Data with Vididencel in Acute Myeloid Leukemia Presented at ASH 2023 on December 14, 2023.Mendus and Australasian Leukaemia & Lymphoma Group to expand clinical testing of vididencel as maintenance treatment for AML.Mendus announces positive survival data from Phase 2 ADVANCE II trial evaluating vididencel as maintenance therapy for AML at ASH 2023.At the extraordinary general meeting (the “EGM”) of Mendus AB on 13 December 2023, the EGM resolved, in accordance with the major shareholders’ proposal, on the election of a new board member and the determination of remuneration. The EGM further resolved, in accordance with the board of directors’ proposal, on amendment of the articles of association and the resolution on an issue of warrants of series 2023/2027 and to implement a performance-based incentive program 2023/2027Mendus reports completion of the long-term follow up of the MERECA trial studying the intratumoral immune primer ilixadencel in metastatic renal cell carcinoma (mRCC). Mendus also confirms that the Phase 1 ALISON trial with its cancer maintenance therapy vididencel in ovarian cancer is now fully recruited. SIGNIFICANT EVENTS AFTER END OF REPORTING PERIOD No significant events after the end of the reporting period. FINANCIAL SUMMARY 2023202220232022Amount in KSEKOct - DecOct - DecJan - DecJan - DecRevenue0000Operating profit/loss-42 720-41 557-100 650-133 957Net profit/loss-41 165-43 280-101 619-138 786Earnings/loss per share, before and after dilution (SEK)-0,05-0,22-0,22-0,70Cash120 78241 851120 78241 851Shareholders equity704 727514 439704 727514 439Number of employees27333031 WEBCAST INVESTOR CALL, FEBRUARY 14, 10:00 The company will hold a conference call and an online presentation on the same day at 10:00 CET. The call will be hosted by CEO Erik Manting. The presentation will be in English and followed by a question-and-answer session. Listen to the presentation webcast: https://ir.financialhearings.com/mendus-q4-2023 The full report is attached as PDF and is available on the company’s website: https://mendus.com/investors/financial-reports/ FOR MORE INFORMATION, PLEASE CONTACT:Erik Manting, CEOE-mail: ir@mendus.com ABOUT MENDUS AB (publ)Mendus is dedicated to changing the course of cancer treatment by addressing tumor recurrence and improving survival outcomes for cancer patients, while preserving quality of life. We are leveraging our unparalleled expertise in allogeneic dendritic cell biology to develop an advanced clinical pipeline of novel, off-the-shelf, cell-based immunotherapies which combine clinical efficacy with a benign safety profile. Based in Sweden and The Netherlands, Mendus is publicly traded on the Nasdaq Stockholm under the ticker IMMU.ST. https://www.mendus.com/ Attachments 240214_Mendus_Q4 PR ENG 240214 Mendus.Q4_2023_ENG_02.14

Mendus AB (“Mendus” publ; IMMU.ST), a biopharmaceutical company focused on immunotherapies addressing tumor recurrence, announced an update on the status and outlook of its clinical pipeline programs. Mendus reports completion of the long-term follow up of the MERECA trial studying the intratumoral immune primer ilixadencel in metastatic renal cell carcinoma (mRCC). The long-term follow up data confirmed the observations previously reported, with no significant survival difference between the ilixadencel plus sunitinib treatment arm versus the sunitinib-only control arm of the trial. The final results of the MERECA trial confirm the decision not to pursue mRCC as a possible indication for ilixadencel. Mendus continues to explore the clinical development of ilixadencel in soft tissue sarcomas (STS) in the first half of 2024, versus earlier guidance of starting a trial before 2023YE. “The data from the MERECA trial do not support continued development in renal cell carcinoma. However, ilixadencel remains a promising product candidate for difficult-to-treat solid tumors, such as soft tissue sarcomas”, said Erik Manting, CEO of Mendus. Mendus also confirms that the Phase 1 ALISON trial with its cancer maintenance therapy vididencel in ovarian cancer is now fully recruited (17 patients). Mendus had earlier reported initial positive interim data from the ALISON trial, based on the induction of immune responses against tumor antigens previously shown to be relevant for ovarian cancer and confirming a strong safety profile for vididencel in this indication. Mendus expects further read outs of the trial in 2024, including a survival analysis in 2024H2. Mendus recently announced positive data from the Phase 2 ADVANCE II trial with its lead product vididencel in acute myeloid leukemia (AML). The data presented on December 11, 2023 at the American Society of Hematology Annual Meeting (ASH 2023), demonstrated durable clinical remissions in AML patients diagnosed with measurable residual disease (MRD). “The data with our lead product vididencel recently reported at ASH demonstrated durable clinical benefit in AML, an indication with very high unmet medical need. Mendus therefore remains focused on the regulatory path and increasing the development efforts for vididencel in AML”, Erik Manting added. As a next step in the development of vididencel in AML, Mendus has announced a collaboration with the Australasian Leukaemia and Lymphoma Group (ALLG) to study vididencel in combination with the current standard of care in AML maintenance treatment, oral azacitidine, in a 2-stage, control-arm trial including up to 140 patients. Mendus is dedicated to changing the course of cancer treatment by addressing tumor recurrence and improving survival outcomes for cancer patients, while preserving quality of life. We are leveraging our unparalleled expertise in allogeneic dendritic cell biology to develop an advanced clinical pipeline of novel, off-the-shelf, cell-based immunotherapies which combine clinical efficacy with a benign safety profile. Based in Sweden and The Netherlands, Mendus is publicly traded on the Nasdaq Stockholm under the ticker IMMU.ST. http://www.mendus.com/ The completed Phase 2 MERECA trial (NCT02432846) was an international, multicenter, open-label, randomized, controlled study evaluating the safety and efficacy of ilixadencel in metastatic renal cell carcinoma (mRCC). A total of 86 metastatic mRCC patients were treated, of which 56 were given ilixadencel as an intratumor administration, followed by surgery to remove the kidney tumor and standard treatment with sunitinib, and 30 patients were treated with sunitinib only. Results from the MERECA trial published earlier demonstrated that the primary endpoint of 18 months survival showed no significant differences between the ilixadencel arm and control group. Median OS was 35.6 months for the ilixadencel arm, as compared to 25.3 months in the control group1. At completion of the long-term follow-up period of 5 years post-treatment of last patient enrolled, there was no significant survival difference between the two treatment arms, with 32.1% of patients alive in the ilixadencel arm, as compared to 26.7% in the control arm. The MERECA trial data do not support the development of ilixadencel in mRCC. The Phase 1 ALISON trial (NCT04739527) is a single-center, open-label study evaluating safety and efficacy of vididencel (DCP-001) in high-grade serous ovarian cancer (HGSOC) patients. The ALISON trial evaluates the use of vididencel as a maintenance immunotherapy, aimed to prolong disease-free survival following primary treatment comprising debulking surgery and chemotherapy. The primary endpoint of the trial is the number of patients with vididencel-induced antigen-specific T cells responses in peripheral blood after treatment. Key secondary endpoints include safety and tolerability after repeated vididencel dosing, as well as recurrence free survival (RFS) and overall survival (OS) during a 2-year follow-up period. Patient enrolment (17) has been completed and further analysis of vididencel-induced immune responses, safety and potential survival benefit will continue in 2024. The Phase 2 ADVANCE II trial (NCT03697707) is an international, multicenter, open-label study evaluating safety and efficacy of vididencel (DCP-001) in acute myeloid leukaemia (AML). Patients were in remission following chemotherapy, but diagnosed with persistent measurable residual disease (MRD). Patients received four biweekly doses of vididencel, followed by additional booster administrations at weeks 14 and 18. Blood and tissue samples were collected for assessments of MRD and immune response monitoring. The active study phase comprising a 70-week follow-up period from the start of vididencel treatment was completed and patients are now in long-term follow up. As per the most recent read-out November 24, 2023, the median follow-up for the entire study population was 31.6 months. Median RFS stood at 30.4 months and median OS was not reached, with 14/20 patients still alive and 11 still in remission at the cut-off date. The RFS at 2 years was 56%, and the estimated 2-year and 3-year OS stood at 74.9% and 64.7%, respectively. Reduction in MRD and induction of immune responses was associated with RFS and OS benefit, confirming the vididencel mechanism of action as an immunotherapy which improves immunity against residual cancer cells. Vididencel treatment was generally well-tolerated and safe, with drug-related adverse events limited to injection-site reactions and no reported drug-related serious adverse events. The positive ADVANCE II data support the continued development of vididencel in AML. The content above comes from the network. if any infringement, please contact us to modify.