Breakeven Date Change • May 20
No longer forecast to breakeven The 3 analysts covering Mendus no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of kr95.0m in 2028. New consensus forecast suggests the company will make a loss of kr68.2m in 2028. Announcement • May 02
Mendus AB (publ) to Report Q1, 2026 Results on May 08, 2026 Mendus AB (publ) announced that they will report Q1, 2026 results at 8:00 AM, Central European Standard Time on May 08, 2026 Announcement • Apr 22
Mendus AB Announces First Patient Enrolled in the Vital-Cml Trial Mendus AB announced that the first patient has been enrolled in the VITAL-CML trial, which evaluates Mendus’ lead product vididencel in chronic myeloid leukemia (CML). Following recent regulatory approval, the first patient has now been enrolled into the company-sponsored phase 1b trial. The VITAL-CML trial is led by Prof Dr Bjørn Tore Gjertsen (University of Bergen and Haukeland University Hospital, Norway) and evaluates vididencel in chronic phase CML patients with a sub-optimal response to currently approved tyrosine kinase inhibitors (TKIs). The VITAL-CML trial will recruit up to 24 patients, with initial topline safety and early molecular response data based on the first 8 patients treated expected in the second half of 2026. If positive, this will trigger the onset of the VITAL-TFR2 Phase 2a trial to assess the role of vididencel to improve TFR rates in patients who failed an earlier TFR attempt. Chronic myeloid leukemia (CML) is a clonal myeloproliferative neoplasm originating in hematopoietic stem cells. It is commonly associated with the Philadelphia chromosome translocation, resulting in activation of the BCR::ABL1 oncoprotein, with or without additional mutations in myeloid associated genes that fuel cancer growth in the blood and bone marrow, disrupting the production of healthy blood cells. CML is commonly treated with tyrosine kinase inhibitors (TKIs) that inhibit the BCR::ABL1 kinase activity. Because these treatments are effective, overall survival of CML patients is similar to that of the general population and attention in the treatment of CML has shifted to quality of life and, ultimately, treatment-free remission (TFR). An estimated number of > 300,000 people live with CML in Europe and the US only, with a global estimate of around 5 million and a prevalence plateau that may reach as many as 10 million people affected by the disease. Vididencel is an off-the-shelf, active immunotherapy designed to stimulate immune control of residual disease and improve disease-fee and overall survival following first-line treatment of tumors with a high recurrence rate including myeloid blood cancers. Vididencel comprises irradiated leukemic-derived dendritic cells that are administered via intradermal injection. Vididencel has demonstrated an excellent safety profile in multiple clinical trials, with temporary local injection site reactions as the main side effect and no serious product-related side effects reported to date. The product is manufactured using a proprietary cell line and a scalable manufacturing process that does not require patient material or genetic engineering. Vididencel has a strong regulatory dossier including an EMA ATMP Manufacturing Certificate, Orphan Drug and Fast Track Designations. Announcement • Nov 07
Mendus AB (publ), Annual General Meeting, May 08, 2026 Mendus AB (publ), Annual General Meeting, May 08, 2026. Location: stockholm Sweden Announcement • Jun 03
Mendus AB's Alison Trial Data Presented At ASCO 2025 Demonstrates Successful Induction of Tumor-Directed Immune Responses in High-Risk Ovarian Cancer Mendus AB announced a summary of the data presented at the 61 Annual American Society of st. Clinical Oncology conference (ASCO 2025) held from May 30 to June 3, 2025, in Chicago, Illinois, from the ongoing ALISON trial with Mendus' lead product vididencel in ovarian cancer. The data demonstrate that stable disease is associated with the successful induction of tumor-directed immune responses following vididencel treatment in this indication. The Phase 1 ALISON trial evaluates safety, efficacy and immunogenicity of vididencel in patients with high-grade mutation agnostic serous ovarian cancer (HGSOC). Mendus and academic collaborators from the University Medical Center Groningen (UMCG) presented data at ASCO 2025 demonstrating that in the majority of patients vididencel treatment resulted in immune responses against one or more tumor antigens frequently upregulated in HGSOC and that these responses were associated with higher stable disease rates. Vididencel was found to be safe and effective, with the intradermal injection-site cutaneous reaction being the principal side effect and no adverse events above grade 2. At week 22 from start of vididencel treatment, 10 patients participating in the ALISON trial had stable disease and 7 had progressive disease, with all patients still alive. Stable disease rates were highest (67%) in patients with vididencel-induced immune responses (VIR) as compared to patients without VIR (40%). Updated survival data until March 2025 showed that 7 patients continued to have stable disease and 10 patients had developed progressive disease at a median follow-up of 19 months, with 10 patients still alive. Stable Disease was associated with vididencel- induced immune responses, with VIR observed in 6 out of 7 of the patients with stable disease. Furthermore, two patients with VIR were reported to have stable disease for more than 3 years. Mendus and UMCG have engaged in a research and clinical development collaboration since 2019. The collaboration comprises the single-center Phase 1 ALISON trial with vididencel in HGSOC and a preclinical research program to develop novel immunotherapies for gynecological cancers, including therapies based on tumor-infiltrating lymphocytes. Enrolment and week 22 analysis has been completed for all 17 participants of the ALISON trial. Long-term follow-up to assess potential survival benefit of vididencel treatment is ongoing. A next read-out of the trial based on 2-year follow-up is anticipated in the fourth quarter of 2025. Announcement • May 05
Mendus AB (Publ) Announces Chief Medical Officer Changes Mendus AB announced the appointment of Tariq Mughal, MD FRCP FRCPath, as Chief Medical Officer, May 5, 2025. Tariq Mughal completed his medical training in London, UK, and in Denver, Colorado, USA. In his clinical career, Dr. Mughal specialized in acute myeloid leukemia, chronic myeloid leukemia, malignant melanoma, and breast cancer, ushering precision medicine into the NHS and beyond. Since 2011, he has been a Clinical Professor of Medicine at Tufts University Cancer Centre, Boston, MA. Prior to joining Mendus, Dr. Mughal was Senior Vice President and Head of Clinical Drug Development at Stemline Therapeutics/Menarini, New York, NY, and previously served as Vice President Clinical/Medical Affairs at Foundation Medicine/Roche, Cambridge, MA. Dr. Mughal will oversee Mendus’ global clinical development strategy and transition to a late-stage clinical oncology company, including the preparations for the registration trial with vididencel in acute myeloid leukemia (AML), broadening of the addressable patient population in AML and other blood-borne tumors, and earlier-stage pipeline programs. Dr. Jeroen Rovers, who has served as Mendus CMO since 2018, has decided to step back after a short transition period. Announcement • Dec 09
Mendus AB Presents Positive Survival Data from the Ongoing Advance II Phase 2 Trial at the ASH 2024 Conference Mendus AB announced that it has presented positive survival data from the ongoing ADVANCE II Phase 2 trial at the ASH 2024 conference. The data showed that the majority of AML patients treated with vididencel remain alive and disease-free in long-term follow-up, with a median follow-up of 41.8 months. The ADVANCE II Phase 2 trial is an international multi-center Phase 2 trial evaluating vididencel as maintenance treatment for AML patients in first complete remission (CR1) following chemotherapy. Patients participating in the trial were ineligible for HSCT and had measurable residual disease (MRD), which is associated with increased relapse rates. The ADVANCE II trial has completed the active study phase of 70-week follow-up from the start of vididencel treatment and patients are now in long-term follow up. The updated ADVANCE II data presented at ASH show that 13 out of 20 patients treated with vididencel were alive and 11 patients were still in CR1 as of the November 4, 2024 cut-off-date, with a median follow-up of 41.8 months. Median relapse-free (RFS) and overall survival (OS) was not reached, as the majority of patients remained alive and disease-free. All patients had passed 3-year follow-up and 2 patients completed 5-year follow-up. The 1-year survival stood at 88%, 3-year survival at 71% and the estimated 5-year survival was 58%. The only drug approved for post-chemo AML maintenance therapy is oral azacitidine, which in MRD-positive patients led to a median RFS of 7.1 months and a median OS of 14.6 months in the registration trial1. The estimated 3-year OS for the whole treated patient population which included MRD-positive and -negative patients was 37.4% and 5-year OS was 26.5%. Immunomonitoring data from the ADVANCE II trial presented at ASH demonstrated that patients with multiple T cell responses following vididencel treatment (sustained vaccine-induced responses, or sVIR) had a significantly better OS than patients without a sVIR (p=0.036) and a higher number of MRD responses, with 6 our of 9 patients showing MRD clearance or > 10-fold reduction in MRD level. There were also clear differences between patient groups at baseline. Particularly patients with high levels of B cells and low levels of inhibitory T cells showed significantly improved OS (p=0.0109) and the majority of these patients (6 out of 8) demonstrated sVIR following vididencel treatment. The data confirm that vididencel stimulates a broad, active immune response against residual disease, which is associated with improved clinical outcome. In addition to the ADVANCE II Phase 2 trial data in the post-chemotherapy maintenance setting, Mendus presented two abstracts based on preclinical data exploring the use of vididencel in additional patient populations. AML patients ineligible for high-intensity chemotherapy can be treated today with a combination of azacitidine (AZA) and venetoclax (VEN). In vitro data demonstrated that AZA and VEN do not interfere with vididencel’s mode of action and that VEN stimulates the processing of vididencel by antigen-presenting cells. In vivo data confirmed that vididencel and AZA+VEN act synergistically in a humanized mouse model for AML, supporting the clinical exploration of vididencel in AML patients treated with AZA+VEN. The second preclinical abstract addressed the potential use of vididencel in chronic myeloid leukemia (CML). Data showed that vididencel can stimulate cellular immunity against a CML cell line and investigated the combination potential of vididencel with different tyrosine kinase inhibitor drugs currently used for the treatment of CML. The possibility to improve immunity against residual cancer cells with vididencel addresses the need to improve treatment-free remission rates, allowing CML patients to control their disease without the need for life-long medication. New Risk • Nov 16
New major risk - Revenue size The company makes less than US$1m in revenue. Total revenue: kr6.9m (US$632k) This is considered a major risk. Companies with a small amount of revenue are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Earnings are forecast to decline by an average of 0.3% per year for the foreseeable future. Revenue is less than US$1m (kr6.9m revenue, or US$632k). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (kr156m net loss in 3 years). Share price has been volatile over the past 3 months (9.0% average weekly change). Shareholders have been diluted in the past year (17% increase in shares outstanding). Market cap is less than US$100m (€40.2m market cap, or US$42.3m). Announcement • Nov 11
Mendus AB (publ), Annual General Meeting, May 09, 2025 Mendus AB (publ), Annual General Meeting, May 09, 2025. Announcement • Nov 08
Mendus AB (publ) to Report Fiscal Year 2024 Final Results on Apr 18, 2025 Mendus AB (publ) announced that they will report fiscal year 2024 final results at 5:30 PM, Central European Standard Time on Apr 18, 2025 New Risk • Oct 25
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 2.8% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risk Earnings are forecast to decline by an average of 2.8% per year for the foreseeable future. Minor Risks Less than 1 year of cash runway based on current free cash flow (-kr178m). Currently unprofitable and not forecast to become profitable over next 3 years (kr153m net loss in 3 years). Share price has been volatile over the past 3 months (7.7% average weekly change). Shareholders have been diluted in the past year (17% increase in shares outstanding). Revenue is less than US$5m (kr32m revenue, or US$3.0m). Market cap is less than US$100m (€44.6m market cap, or US$48.3m). Breakeven Date Change • Oct 01
No longer forecast to breakeven The 3 analysts covering Mendus no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of kr390.0m in 2025. New consensus forecast suggests the company will make a loss of kr62.0m in 2026. Buy Or Sell Opportunity • Sep 05
Now 24% overvalued Over the last 90 days, the stock has fallen 15% to €0.72. The fair value is estimated to be €0.58, however this is not to be taken as a sell recommendation but rather should be used as a guide only. Revenue has grown by 126% over the last 3 years. Earnings per share has grown by 47%. Revenue is forecast to grow by 220% in a year. Earnings are forecast to grow by 77% in the next year. Breakeven Date Change • May 20
Forecast to breakeven in 2025 The 2 analysts covering Mendus expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of kr132.2m in 2025. Average annual earnings growth of 69% is required to achieve expected profit on schedule. Announcement • May 18
Mendus AB (Publ) Announces Board Changes Mendus AB (publ) at its annual general meeting held on May 17, 2024, Christine Lind and Andrea van Elsas have declined re-election as directors. Sven Andreasson was elected as chairman of the board of directors. Announcement • Apr 16
Mendus AB (Publ) Announces Board Changes Mendus AB (publ) announced that at its Annual General Meeting to be held on 17 May 2024, Christine Lind and Andrea van Elsas have declined re-election. Announcement • Mar 27
Mendus AB (publ) Announces Ethics Committee Approval for the AMLM22-CADENCE Trial with Lead Product Vididencel in AML Mendus AB (publ) announced Human Research Ethics Committee (HREC) approval to initiate the AMLM22-CADENCE trial, which studies Mendus' lead product vididencel as a novel maintenance therapy in acute myeloid leukemia (AML). Following positive Phase 2 monotherapy data from the ongoing ADVANCE II trial with vididencel in AML patients with measurable residual disease (MRD), Mendus announced a collaboration with the Australasian Leukaemia and Lymphoma Group (ALLG) to expand the clinical development of vididencel in December 2023. Mendus and ALLG will study vididencel as a novel AML maintenance treatment in combination with oral azacitidine (AZA), currently the only approved AML maintenance drug, in a multi-center, randomized controlled Phase 2 trial (AMLM22-CADENCE). In the AMLM22-C ADENCE trial, patients in first complete remission following high-intensity chemotherapy will receive standard treatment with AZA or the combination of AZA + vididencel. Vididencel will be administered as 4 biweekly intradermal injections, followed by 3 booster injections up to 6 months after start of treatment. The first stage of the trial will randomize 40 patients and in the second stage, efficacy of the combination will be assessed in an additional 100 patients. This approach will enable safety evaluations and assessment of the therapy. By the end of 2023, Mendus and ALLG had completed the preparations for the start of the trial, with the CADENCE protocol domain submitted to the Human Research Ethics Committee (H REC) within the ALLG AMLM22 platform. On March 27, 2024, Mendus and ALLG announce that HREC approval was granted, allowing for clinical site initiation and start of enrolment of the trial in April 2024. Based on positive FDA feedback, safety data from the AML22-CADENCE trial can be used for the global registration dossier for vididencel in AML in the second half of 2025, based on trial protocol development and large-scale GMP manufacturing of vididencel. New Risk • Feb 18
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -kr91m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-kr91m free cash flow). Share price has been highly volatile over the past 3 months (63% average weekly change). Shareholders have been substantially diluted in the past year (332% increase in shares outstanding). Revenue is less than US$1m (kr1.0m revenue, or US$101k). Minor Risk Market cap is less than US$100m (€35.7m market cap, or US$38.5m). Announcement • Dec 22
Mendus AB (Publ) Announces Clinical Pipeline Update Mendus AB 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. 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). 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. Announcement • Dec 14
Mendus AB (Publ) Appoints Ted Fjällman as Board Member Mendus AB (publ) announces that Ted Fjällman was elected as new board member for the period until the end of the next annual general meeting. It was further resolved that the current board members, Christine Lind, Sven Andreasson, Dharminder Chahal, Andrea van Elsas, Hans Preusting and Helén Tuvesson shall remain as board members for the period until the end of the next annual general meeting and Christine Lind shall remain as chairman of the board. Announcement • Dec 12
Mendus AB Announces Positive Survival Data from Phase 2 Advance II Trial Evaluating Vididencel as Maintenance Therapy for AML at ASH 2023 Mendus AB announced positive updated survival data from the Phase 2 ADVANCE II trial evaluating vididencel (DCP-001) in acute myeloid leukemia (AML) at the American Society of Hematology's 65th Annual Meeting (ASH 2023). The longer-term follow up data showed durable treatment responses with survival benefit exceeding historical results expected from the current standard of care in AML maintenance therapy. ADVANCE II is a Phase 2 monotherapy trial evaluating vididencel as a maintenance therapy in acute myeloid leukemia (AML) for patients brought into first complete remission (CR1) through chemotherapy, but with measurable residual disease (MRD). Professor Dr. Arjan van de Loosdrecht, Principal Investigator, presented updated median relapse-free survival (RFS) and median overall survival (OS) data during an oral presentation on December 11 at the ASH 2023 meeting held in San Diego, California December 9-12. Additionally, Mendus and academic collaborators presented two posters at the meeting, featuring immunomonitoring data that supports vididencel's mechanism of action as an immunotherapy which stimulates anti-tumor activity and improves immune control over residual cancer cells. Phase 2 ADVANCE II trial updated survival data: The ADVANCE II monotherapy trial (N=20) previously completed a 70-week follow-up period from the start of vididencel treatment and patients are now in long-term follow up. As of November 24, 2023, the median follow-up for the entire study population was 31.6 months (range: 6.6-60 months). Median RFS stood at 30.4 months and median OS was not reached, with 14/20 patients still alive and 11 still in CR1 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. The only drug approved for AML maintenance therapy is oral azacitidine, which in MRD positive patients led to a median RFS of 7.1 months versus 2.7 months in the placebo arm and an OS of 14.6 months versus 10.4 months in the placebo arm of the registration trial. Immune responses were measured on blood samples before, during and after treatment with vididencel. Seventeen patients (85%) showed at least one vaccine-induced T-cell response (VIR) against tumor-associated antigens present in vididencel. Patients remaining in CR during treatment had a significantly higher number of VIRs then patients who relapsed and a clear correlation is seen between the number of VIRs and survival. Patients with 3 or more VIRs were all still alive (100% OS) at the cut-off date. Blood samples were additionally analyzed to evaluate changes in immune cells induced by vididencel. Increased frequencies of circulating B-cells and dendritic cells were observed, with the level of dendritic cells at the end of treatment correlating with longer RFS and OS. In depth analysis of skin biopsies of the area where vididencel was injected showed a strong influx of immune cells, indicative of an immune response being triggered. Close interaction was observed between host T-cells and host dendritic cells in the skin as part of the immune priming process following vididencel administration. Patients with an MRD response demonstrated better RFS and OS, with all patients with an MRD response still alive. Announcement • Nov 04
Mendus Announces Phase 1 vididencel Clinical Trial Results in AML and High-Risk MDS Patients Published in Peer-Reviewed Medical Journal Mendus AB announced the publication of additional Phase 1 clinical trial data on its lead development program vididencel in the peer-reviewed medical journal HemaSphere. The data supports the potential of vididencel as a novel acute myeloid leukemia (AML) maintenance therapy and provides valuable insights for the current and future clinical trials with vididencel in AML and high-risk MDS. The publication, titled “Durable Responses and Survival in High-Risk Myelodysplastic Syndrome and Acute Myeloid Leukemia Patients Receiving the Allogeneic Leukemia-derived Dendritic Cell Vaccine DCP-001”, and written by researchers from the Amsterdam UMC, Cancer Center Amsterdam and Erasmus University Medical Center, describes the long-term follow up data and additional patient characteristics from the Phase 1 clinical trial evaluating vididencel (DCP-001) in acute myeloid leukemia (AML) and high-risk myelodysplastic syndromes (MDS). In the Phase 1 clinical trial 12 patients were treated with vididencel (product ID: DCP-001), six patients with AML, three patients with AML with prior MDS and three patients with MDS with excess of blasts. Seven out of twelve patients showed a response to treatment; five patients showed progression of disease. The main discriminating variables in favor of response were patients who entered the study either in complete remission or who had stable disease status and a low percentage of blasts in the bone marrow at study entry. Importantly, there was no association found between response and disease risk classification with the majority of responding patients having an adverse cytogenetic risk profile, which is highly encouraging given the difficulty in effecting positive outcomes for these patients with a poor prognosis. In the seven responders, a median relapse free survival (RFS) of 420 days (˜ 14 months) and a median overall survival (OS) of 1090 days (˜ 36 months) was observed as compared to a median OS of 144 days in the five non-responders. The longest surviving patient experienced an RFS of 1,849 days (˜ 5 years) and OS of 2,160 days (˜ 5.9 years) after treatment with vididencel. In a subset of three patients, who initially responded to vididencel but later relapsed, post-vaccination treatment with azacitidine was evaluated and resulted in one complete remission and two partial responses. The data suggest that azacitidine and vididencel may act synergistically. Announcement • Nov 03
Mendus AB (Publ) Announces Multiple Abstracts to Be Presented At Ash 2023 Including Oral Presentation on Advance Ii Survival Data Mendus AB (publ) announced the presentation of three abstracts related to the development of Mendus' lead product candidate vididencel in acute myeloid leukemia (AML) at the American Society of Hematology's upcoming 65th Annual Meeting, held in San Diego, California December 9-12, 2023 (ASH 2023). Relapse-free and overall survival data from the ongoing ADVANCE II monotherapy trial will be presented as an oral presentation. Two additional abstracts will be presented by Mendus and academic collaborators based on immunomonitoring data, supporting vididencel's mechanism of action. Of note, the oral presentation will present results from the ADVANCE II trial based on survival data which extend past the cut-off date as published in the ASH abstract submitted.ASH 2023 will take place on December 9- 12, 2023 at the San Diego Convention Center in San Diego, California, and virtually. Details of the Mendus abstracts to be presented are below: 1. Title: Induction of Cellular and Humoral Immune Responses Is Associated with Durable Remissions in MRD+ AML-Patients after Maintenance Treatment with an Allogeneic Leukemia-Derived Dendritic Cell Vaccine. Abstract Number: 769. Presenter: Prof Dr A.A. van de Loosdrecht (Am Amsterdam UMC, The Netherlands) Session Name: 704. Cellular Immunotherapies: Early Phase and Investigational Therapies: Novel Approaches to Enhance Cellular Therapies and Immune Responses in Leukemias and Lymphomas Session Date:, December 11, 2023. Presentation Time: 6:00 PM - 8:00 PM. Location: San Diego Convention Center, Halls G-H. 3. Intradermal Vaccination with Vididencel in MRD + AML-Patients Leads to Increase in Antigen Presenting Cells and T-Cells to the Injection Site, Visualized Using Imaging Mass Cytometry, Showing Local Immune Cell Interactions Leading to Systemic Immune Responses.Abstract Number: 2942. Presenter: Dr O. Sefland (Haukeland University Hospital, Bergen University, Norway) Session Name: 617. Acute Myeloid Leukemias: Biomarkers, Molecular Markers and Minimal Residual Disease in Diagnosis and Prognosis: Poster II. Session Date: Sunday, December 10, 2023. Presentation time: 6:00 PM -8:00 PM. Location:San Diego Convention Center, Halls G. 3. Title: Intradermal Vaccination With Vididencel in MRD+ AML -Patients Leads to Increase Injection Site, Visualized using Imaging Mass Cytometry, showing Local Immune Cell Interaction Leading to Systemic Immune responsible to Systemic Immune Responsedes. Abstract Number: 2942.Presenter: Dr. O. Sefland (Haukeland University Hospital,Bergen University, Norway) Session name: 617. AcuteMyeloid Leukemias; Biomarkers, MolecularMarkers and Minimal Residal Disease in Diagnosis and ProGNosis: Poster II. Session date: Sunday, December 10, 2020. Presentation Time: 6.00 PM - 8:00PM. Location: San Diego Convention center, Halls G-H. Announcement • Sep 21
Mendus AB to Present Novel Data Supporting the Broad Potential of its Proprietary Cancer Vaccine Platform at CICON23 Mendus AB will present novel clinical and preclinical data on the mode of action of its lead clinical program vididencel at CICON23 – the International Cancer Immunotherapy Conference in Milan, Italy. The data further validate vididencel’s proposed mechanism of action and demonstrate that immune responses triggered by the cell-based cancer vaccine in patients with Acute Myeloid Leukemia (AML) and ovarian cancer are largely comparable. This underlines the potential for a broad applicability of vididencel across different cancer types. The corresponding posters will be presented at CICON23 on September 22, and afterward made available on the Company’s website. The first data set presented at CICON compared the immune responses observed in the currently active clinical trials evaluating vididencel, the ADVANCE II Phase 2 study in AML patients in complete remission with measurable residual disease (MRD) and the ALISON Phase 1 study in ovarian cancer patients at a high risk of relapse after debulking surgery and chemotherapy. Vaccine-induced responses (VIR) were observed in 17 out of 20 AML patients and, at this stage, in 6 out of 7 evaluable ovarian cancer patients. These responses were primarily targeting tumor-associated antigens (TAAs) that are expressed by the vididencel product, such as WT-1 and PRAME. Additionally, in ovarian cancer patients the immune response expanded to include a TAA that is overexpressed in cancer cells but not included in vididencel’s antigen repertoir. In the ADVANCE II study, the number of observed VIRs correlated with clinical responses and survival benefits, which cannot yet be determined for the ALISON study. The second data set presented at CICON further examined the mechanism of action of vididencel building on previously disclosed data sets. The data were generated in collaboration with the Department of Tumor Immunology, Radboud Institute for Molecular Life Sciences, at the Radboud University Medical Centre, in Nijmegen, the Netherlands. It was previously shown that upon intradermal administration vididencel is absorbed by skin-resident antigen-presenting cells (APCs), which concomitantly become activated to prime the immune system. In a new in vitro study, Mendus and its collaboration partner further investigated how such an indirect priming mechanisms via APCs can result in the activation of antigen-specific T cells. Vididencel is currently being evaluated in AML and ovarian cancer as a potential maintenance therapy to reduce or prevent tumor recurrence. Vididencel is an off-the-shelf, intradermal vaccine derived from the Company’s proprietary DCOne leukemic cell line. In December 2022, the Company presented positive results from the ADVANCE II study in AML at the American Society of Hematology (ASH) Annual Meeting. The analysis demonstrated the potential of vididencel to control MRD and induce durable relapse-free survival in the majority of patients. Mendus expects to present a next survival update in the fourth quarter of 2023. Additionally, Mendus anticipates starting a new Phase 2 clinical trial evaluating the combination of vididencel with oral azacitidine, currently the only approved drug in AML maintenance, in H2 2023, as a step-up to pivotal-stage development. Announcement • Sep 08
Mendus AB Receives U.S. FDA Fast Track Designation forididencel in Acute Myeloid Leukemia Mendus AB announced that it has received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for the Company's lead program, vididencel, for the treatment of Acute Myeloid Leukemia (AML) in complete remission with residual disease. Advantages of the Fast Track Designation include close and early interactions with the FDA to support accelerated approval, as well as the possibility of a "rolling review" for a subsequent market application. The FDA's decision was based on the previously communicated results from the ADVANCE II clinical trial, which delivered promising survival read-outs and underpinned the safety of vididencel as a monotherapy in AML. Vididencel had already been assigned Orphan Drug Designation for treatment of AML in the US and Europe. Additionally, Mendus had recently been granted an Advanced Therapy Medicinal Product (ATMP) certificate by the European Medicines Agency (EMA) following a review of manufacturing quality and non-clinical data for its lead pipeline program vididencel.ididencel is currently being evaluated in AML and ovarian cancer as a potential maintenance therapy to reduce or prevent tumor recurrence. Vididencel is an off-the-shelf, intradermal vaccine derived from the Company's proprietary DCOne leukemic cell line. In December 2022, the Company presented positive results from the ADVANCE II study in AML at the American Society of Hematology (ASH) Annual Meeting. The analysis demonstrated the potential of vididencel to control measurable residual disease (MRD) and induce durable relapse-free survival in the majority of patients. Mendus expects to present a next survival update in the fourth quarter of 2023. Additionally, Mendus anticipates to start a new Phase 2 clinical trial evaluating a combination of vididencel with oral azacitidine (Onureg®, the current standard of care in AML maintenance) in H2 2023, as a step-up to pivotal-stage development. New Risk • Aug 29
New minor risk - Profitability The company is currently unprofitable and not forecast to become profitable over the next 2 years. Trailing 12-month net loss: kr141m Forecast net loss in 2 years: kr8.5m This is considered a minor risk. Companies that are not profitable are more likely to be burning through cash and less likely to be well established. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. Without profits, the company is under pressure to grow significantly while potentially having to reduce costs and possibly needing to take on debt or raise capital to remain afloat. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (97% average weekly change). Shareholders have been substantially diluted in the past year (333% increase in shares outstanding). Revenue is less than US$1m (kr1.4m revenue, or US$125k). Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (kr8.5m net loss in 2 years). Market cap is less than US$100m (€22.7m market cap, or US$24.6m). Breakeven Date Change • Aug 29
Forecast breakeven date pushed back to 2025 The 2 analysts covering Mendus previously expected the company to break even in 2024. New consensus forecast suggests losses will reduce by 0.5% per year to 2024. The company is expected to make a profit of kr385.0m in 2025. Average annual earnings growth of 70% is required to achieve expected profit on schedule. New Risk • Aug 07
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 239% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (41% average weekly change). Shareholders have been substantially diluted in the past year (239% increase in shares outstanding). Revenue is less than US$1m (kr1.4m revenue, or US$129k). Minor Risk Market cap is less than US$100m (€25.4m market cap, or US$28.0m). New Risk • Jun 22
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: €8.47m (US$9.28m) This is considered a major risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (33% average weekly change). Revenue is less than US$1m (kr1.4m revenue, or US$128k). Market cap is less than US$10m (€8.47m market cap, or US$9.28m). Announcement • Jun 20
Mendus AB Appoints Lewis Lanier to Scientific Advisory Board Mendus AB (publ) announced the appointment of Lewis Lanier, PhD, Professor Emeritus in Microbiology and Immunology at University of California, San Francisco (UCSF), to the Mendus’ Scientific Advisory Board (SAB). Dr. Lanier is a world-leading expert on natural killer (NK) cells, and is renowned for his contributions to the characterization of how NK cells distinguish between healthy cells and infected or cancerous cells. He has published seminal work on key receptors that activate and inhibit NK cells, and has shown how they can be applied to fight cancer cells. Dr. Lanier complements the Mendus SAB, which comprises Inge Marie Svane, MD PhD, Sjoerd van der Burg, PhD, Tanja de Gruijl, PhD, and is being chaired by Ada Kruisbeek, PhD. Pawel Kalinski, MD PhD, will retire as SAB member. Dr. Lewis Lanier has served as the chair of the Department of Microbiology and Immunology, the co-leader of the Cancer Immunology and Immunotherapy Program at the UCSF’s Comprehensive Cancer Center, and Director of the Parker Institute for Cancer Immunotherapy (PICI). He has published more than 400 scientific articles and is a Senior Editor of the Journal of Experimental Medicine, and has served as an Editorial Board Member of the Journal of Immunology, Annual Review of Immunology, Immunological Reviews, Tissue Antigens, Human Immunology, Immunogenetics, and Immunity. In recognition of his scientific contributions, he was awarded the William B. Coley Award for Distinguished Research in Basic Tumor Immunology from the Cancer Research Institute in New York in 2002, was given the Rose Payne Award for contributions to the field of Immunogenetics by the American Society for Histocompatibility and Immunogenetics in 2005, was elected to the US National Academy of Sciences, in 2010, and was named a Fellow of the American Academy of Microbiology by the American Society for Microbiology and elected to the American Academy of Arts and Sciences in 2011. Announcement • Jun 12
Mendus AB Presents Comprehensive Advance II Immunomonitoring Data at the EHA Annual Meeting 2023 Mendus AB presented new clinical data from the Phase 2 ADVANCE II clinical trial in acute myeloid leukemia (AML) maintenance at the European Hematology Association (EHA) 2023 Hybrid Congress. The data demonstrate that vididencel treatment led to increased levels of activated, cancer-killing T cells and reduced levels of inhibitory, immune-suppressive T cells in the majority of patients. Patients with an MRD response, the primary endpoint of the study, had the highest levels of these functional tumor antigen-specific T cells and showed a trend towards higher levels of circulating antigen-presenting cells (APCs) and B cells following vididencel treatment. Altogether, the data provides a clear proof of the mechanism of action of Mendus' lead development program. At the time of the data cut for EHA 2023, analysis of circulating immune cells had been performed in 20 evaluable AML patients to investigate the immune system activation induced upon treatment with vididencel. Functional T-cell analysis showed vaccine induced responses (VIRs) to antigens present in vididencel in 17 out of 20 patients, with highest number of VIRs in MRD responders, providing a positive correlation of VIRs with clinical outcomes. Analysis of individual immune cell populations showed changes in both the innate and adaptive immune cell compartments, with higher levels of tumor-reactive T cells and reduced numbers of inhibiting LAG3-expressing T-cells measured in circulation. Announcement • Jun 09
Mendus AB (publ) announced that it expects to receive funding from Flerie Invest AB Mendus AB (publ) announced a round of funding on June 8, 2023. The transaction is subject to approval by an Extraordinary General Meeting, expected to be held on July 10, 2023.
On the same date, the company issue common shares for gross proceeds of SEK 90 million in its first tranche closing. The transaction included participation from new investor, Flerie Invest AB for a majority stake. As part of the transaction, Ted Fjällman of Flerie Invest AB will join the board of directors of the company. subject to shareholder approval. Breakeven Date Change • May 15
No longer forecast to breakeven The 2 analysts covering Mendus no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of kr166.8m in 2024. New consensus forecast suggests the company will make a loss of kr76.9m in 2024. Breakeven Date Change • Feb 18
Forecast breakeven date pushed back to 2024 The analyst covering Mendus previously expected the company to break even in 2023. New forecast suggests losses will reduce by 6.7% to 2023. The company is expected to make a profit of kr411.0m in 2024. Average annual earnings growth of 51% is required to achieve expected profit on schedule. Announcement • Feb 08
Mendus AB (publ) to Report Fiscal Year 2022 Final Results on Apr 17, 2023 Mendus AB (publ) announced that they will report fiscal year 2022 final results on Apr 17, 2023 Announcement • Dec 13
Mendus AB (publ) Presents Positive Survival Data from the Advance II Trial Evaluating DCP-001 as A Maintenance Therapy in AML At the American Society of Hematology Meeting Mendus AB presented survival data based on the completed active study period and long-term follow-up to date from the Company’s ADVANCE II clinical trial at the 64th American Society of Hematology Annual Meeting (ASH). ADVANCE II is a Phase 2 monotherapy trial evaluating DCP-001 as a maintenance therapy in acute myeloid leukemia (AML) for patients brought into complete remission through chemotherapy, but with measurable residual disease (MRD). The ADVANCE II trial has completed the 70-week follow-up period after start of DCP-001 treatment, and patients are now in long-term follow up. Median follow-up for the entire study population at the data cut-off for ASH on 22nd of November was 19.4 months. Median relapse-free survival (RFS) was not yet reached, with 12 out of 20 patients still in complete remission, ranging from 16 to 47 months after start of treatment. Median overall survival (OS) currently stands at 30.9 months. The only drug approved for AML maintenance therapy is oral azacitidine, which in MRD positive patients led to a median relapse free survival (RFS) of 7.1 months versus 2.7 months in the placebo arm and an overall survival (OS) of 14.6 months versus 10.4 months in the placebo arm of the registration trial. Increased immune responses against tumor-associated antigens were seen in 17 out of 20 patients following DCP-001 administration, with a significantly higher number of immune responses observed in patients with an MRD response. As reported earlier, treatment with DCP-001 resulted in an MRD response in 7 out of 20 evaluable patients, with 5 patients converting to MRD negativity and 2 patients with a decline in MRD of at least 10-fold. Patients converting to MRD negativity following DCP-001 treatment continue to have a significantly better overall survival, with all still being alive to date. Longer-term follow up confirms the excellent safety profile of DCP-001, with no drug-related serious adverse events reported and injection-site reactions as the most common drug-related adverse events. Breakeven Date Change • Nov 16
Forecast to breakeven in 2023 The 2 analysts covering Mendus expect the company to break even for the first time. New consensus forecast suggests losses will reduce by 3.0% to 2022. The company is expected to make a profit of kr93.7m in 2023. Average annual earnings growth of 84% is required to achieve expected profit on schedule. Board Change • Nov 16
High number of new and inexperienced directors There are 9 new directors who have joined the board in the last 3 years. The company's board is composed of: 9 new directors. 2 experienced directors. No highly experienced directors. Member of Scientific Advisory Board Pawel Kalinski is the most experienced director on the board, commencing their role in 2018. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Announcement • Oct 17
Mendus to Report Positive Clinical and Preclinical Data in Ovarian Cancer At the European Society of Gynaecological Oncology 2022 Congress Mendus AB (publ) announced the upcoming presentation of first clinical data from the ongoing ALISON Phase I trial evaluating safety and feasibility of its maintenance immunotherapy product candidate DCP-001 in ovarian cancer. The initial data demonstrates that DCP-001 was safe and well-tolerated, confirming the benign safety profile of DCP-001 observed in multiple completed and ongoing clinical trials. This supports its suitability as a maintenance therapy and justifies continued development of this novel immunotherapy concept in ovarian cancer, the deadliest gynaecological cancer due to its high recurrence rate. The presentation at the ESGO Congress will also include new preclinical data demonstrating the synergistic effects of combining DCP-001 vaccination with intratumoral immune priming. This novel therapeutic strategy of combining local and systemic intervention benefits from Mendus’ unique expertise in both areas and resulted in a very potent suppression of tumor growth, including complete tumor regressions in a humanized mouse model for ovarian cancer. Announcement • Jul 14
Mendus AB (Publ) Publishes Preclinical Data Demonstrating Significant Anti-Tumor Synergies of Intratumoral Immune Priming with CTLA-4 Inhibition Mendus AB announced the publication of in vivo data demonstrating significant anti-tumor synergies between the Company’s allogeneic dendritic cell-based immune primer program ilixadencel and immune checkpoint inhibition via CTLA-4 blockade in the peer-reviewed journal OncoImmunology. Cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) is an inhibitory checkpoint receptor and blocking has the potential to release the "brakes" on patients' endogenous immune systems. The US Food and Drug Administration (FDA) approved the first anti CTLA-4 antibody, ipilimumab (Yervoy®), for the treatment of late-stage melanoma in 2011 and several CTLA-4 targeting programs are in clinical development today. Despite achieving durable responses and improved overall survival using CTLA-4 blockade in many patients, it is estimated that up to 80% still do not respond possibly attributed to a lack of pre-existing immunity. Mendus’ current generation immune primer, ilixadencel, has been evaluated in a broad range of tumors and has demonstrated an excellent safety profile across all studies with encouraging signs of efficacy when combined with other treatment modalities including checkpoint inhibitor pembrolizumab and kinase inhibitors. In the preclinical study published today, mice were transplanted subcutaneously with CT-26 colorectal cancer cells and were subsequently treated with an intratumoral injection of ilixadencel, an intravenously given antagonistic anti-CTLA-4 antibody, a combination of both or placebo. Neither ilixadencel, nor anti-CTLA-4 treatment alone affected tumor progression or prolonged survival significantly. However, combined treatment with ilixadencel and anti-CTLA-4 significantly delayed tumor progression and led to tumor remission with 7 out of 10 mice surviving longer than 70 days with no detectable tumor. All surviving mice were subsequently re-challenged with CT-26 cells and all mice rejected the newly inoculated tumors compared to the control mice, where none rejected the reintroduced CT-26 cells, indicating the establishment of an immunological memory response. Several findings of the study demonstrated a profound remodeling of the initially immunosuppressive tumor microenvironment following the combined use of ilixadencel and the anti-CTLA-4 inhibitor. Changes to the TME were visible in gene set analyses of significant pathway signatures including upregulated pathways that affect the myeloid compartment, antigen presentation, the lymphoid compartment, and cytokines/chemokine regulation. On a cellular level, changes in the combination arm included intratumoral infiltration of immune cells with anti-cancer features, including host dendritic cells with high antigen-presenting capacity and activation phenotypes, macrophages with M1-like phenotype, activated neutrophils and inflammatory monocytes. Combined, these changes led to a suitable TME for the expansion of CD8+ tissue-resident memory T cells which was positively correlated with elevated potential tumor-reactive CD8+ T cells in the tumor and “tumor-matching” CD8+ T cells in peripheral blood. Moreover, splenocytes from mice in the combination treatment group secreted significantly higher IFN-? upon stimulation with a CT-26-derived model neoantigen, confirming the induction of a tumor-specific CD8+ T-cell response. Depletion of CD8+ T cells totally abolished the therapeutic benefit. Announcement • May 16
Immunicum AB (publ) Announces Positive Interim Results from ADVANCE II Study in AML Maintenance Treatment Immunicum AB (publ) announced updated interim results from the ongoing ADVANCE II clinical trial evaluating the company’s lead development program DCP-001, a novel therapeutic option for acute myeloid leukemia (AML) maintenance therapy in patients with measurable residual disease (MRD). The analysis demonstrates the therapeutic potential of DCP-001 to control MRD based on the complete read-out of all 20 evaluable patients. In addition, the interim survival data provides for a first strong indication on how the effects of DCP-001 vaccination observed on MRD translate into relapse-free and overall survival benefits for this patient population. The previously reported clean safety and tolerability profile of DCP-001 was confirmed. The international, multi center, open-label Phase II study ADVANCE II enrolled AML patients in complete remission (CR) following chemotherapy induction, but who remained MRD positive and were therefore deemed to be at elevated risk of relapse. Patients in the ADVANCE II trial were divided into two cohorts of 10 patients each, administered with two different dose levels of DCP-001, 25 and 50 million cells/vaccination. Patients in each cohort received four biweekly doses of DCP-001, followed by additional booster administrations at weeks 14 and 18. MRD responses were recorded at 14, 20, and 32 weeks and patients were followed for up to 70 weeks after first administration. Median follow up of patients at the cut-off date for the interim analysis was 14.3 months. The primary endpoint of the study is MRD response, and the secondary endpoints of relapse free survival (RFS) and overall survival (OS). Board Change • Apr 27
High number of new and inexperienced directors There are 9 new directors who have joined the board in the last 3 years. The company's board is composed of: 9 new directors. 2 experienced directors. No highly experienced directors. Member of Scientific Advisory Board Pawel Kalinski is the most experienced director on the board, commencing their role in 2018. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Announcement • Feb 18
Immunicum AB (publ) to Report Fiscal Year 2021 Final Results on Apr 15, 2022 Immunicum AB (publ) announced that they will report fiscal year 2021 final results on Apr 15, 2022 Announcement • Dec 12
Immunicum Presents Phase II Data Demonstrating Reduced MRD and Improved Survival with DCP-001 Treatment in AML Patients at ASH 2021 Immunicum AB (publ) will present positive data from its ADVANCE II Phase II study at the 63rdAmerican Society of Hematology (ASH) Annual Meeting being held in Atlanta, Georgia from December 11-14, 2021. The Phase II data demonstrate the ability of DCP-001 to convert or significantly reduce detectable minimal residual disease (MRD) in acute myeloid leukemia (AML) patients, with fully converted patients demonstrating greater overall survival. The results of the trial also reinforced data from a preceding Phase I trial demonstrating intradermal injection of DCP-001 to be generally well-tolerated. The Phase II study enrolled twenty-six AML patients in complete remission (CR) following chemotherapy induction, but who remained MRD positive and were therefore deemed to be at elevated risk of relapse. Of twenty patients with evaluable MRD levels post-vaccination, six demonstrated a measurable improvement in MRD status with four of those patients converting from MRD positive to MRD negative, and two patients achieving a substantial reduction in MRD throughout the course of the trial. Patients who converted from MRD positive to MRD negative over the course of the trial were observed to have improved survival over those not having fully converted. An additional seven patients remained in CR with stable MRD levels and only six patients encountered relapse. Intradermal injections of DCP-001 were well tolerated, with only limited drug related side effects. No serious adverse events were reported in conjunction with DCP-001. Patients in the ADVANCE II trial were divided into two cohorts, with each administered a different dose level of DCP-001 biweekly for four times, followed by additional booster administrations at weeks 14 and 18. MRD responses were recorded at 14, 20, and 32 weeks and patients were followed for up to 70 weeks after first administration. Median follow up of patients was 389 and 224 days for the two dose cohorts respectively. The primary endpoint of the study is MRD response, and the projected secondary endpoints of relapse free survival (RFS) and overall survival (OS) are still to be evaluated. The trial is continuing follow-up on patients to assess MRD responses over time and to assess relapse free (RFS) and overall (OS) survival. Breakeven Date Change • Dec 07
Forecast to breakeven in 2023 The 2 analysts covering Immunicum expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of kr203.0m in 2023. Average annual earnings growth of 74% is required to achieve expected profit on schedule. Announcement • Dec 03
Immunicum Announces Completion of Phase Ib Portion and Early Closure of ILIAD Study Immunicum AB announced the completion of the Phase Ib portion of the ILIAD study evaluating the Company’s off-the-shelf, cell-based immune primer ilixadencel in combination with anti-PD1 checkpoint inhibitor (CPI) pembrolizumab (Keytruda®) in different cancer indications. All subjects in the Phase Ib portion have completed the initial follow-up period for safety and response evaluation, with a positive safety review by the Data Safety Monitoring Board reported last July. Responses to treatment were observed in patients previously treated with CPIs and not in CPI-naive patients. As the latter was the intended patient population for the Phase II part of the study, the company has made the determination to close the study at this stage and not proceed with the Phase II portion. The Phase Ib ILIAD combination trial included cancer patients eligible for pembrolizumab therapy based on its approved label by the FDA. A total of twenty-one subjects were enrolled: ten of those with types head- and neck squamous cell carcinoma (HNSCC), six with melanoma, two with gastroesophageal junction adenocarcinoma (GEJAC), one with non-small cell lung cancer (NSCLC), one with uterine carcinoma and one with cervical cancer. All patients treated within this study suffered from advanced stage disease and were heavily pre-treated with several lines of treatment. A total of sixteen patients were enrolled that had prior exposure to pembrolizumab and progressed on this checkpoint inhibitor, and five patients were enrolled without any prior exposure to pembrolizumab. Among the ten HNSCC patients enrolled, a partial response was observed in two, with those two having been among a subgroup of six patients that tested negative for human papilloma virus (HPV) and had prior pembrolizumab exposure. Additionally, stable disease was observed in four subjects with prior pembrolizumab exposure. Of those stable disease subjects, one had HNSCC, one had melanoma, one had NSCLC and one had GEJAC. Observed responses in the CPI pre-treated patients will be further evaluated on a case-by-case basis. Of the five patients that were enrolled in the Phase Ib portion of the ILIAD study without any prior exposure to pembrolizumab, none had any observable response. As previously reported, no dose-limiting toxicities were observed in the ILIAD study, up to the highest dose of 20 million cells per injection, and no adverse events were reported which were life-threatening or led to death. Only two severe adverse events (grade 3) related to ilixadencel were reported, which were injection-related reactions. All other reported adverse events related to ilixadencel were mild to moderate. Announcement • Nov 22
Immunicum AB Publishes DCP-001 Mechanism of Action in the Journal Cells Immunicum AB announced that the publication of a scientific journal article describing the mechanism of action for its cell-based cancer relapse vaccine DCP-001. The publication in the peer-reviewed journal Cells details the interaction between DCP-001 and antigen-presenting cells and the cellular pathways involved. The study supports a mechanism of action whereby transfer of antigenic material, including tumor-associated antigens, and activation of the patient’s own antigen-presenting cells upon injection of DCP-001 in the skin leads to the induction of immune responses against tumor cells. The proposed mechanism of action supports the development of DCP-001 as an allogeneic, off-the-shelf product which activates the patient’s own immune system, with an excellent safety profile and with relative ease of administration via intradermal injection, not requiring lymphodepletion or other preconditioning. Immunicum conducted the study in collaboration with leading immunology researchers at the Amsterdam University Medical Center and Northeastern University in Boston. The data published in Cells show that DCP-001 exchanges its cellular content with antigen-presenting cells via a phagocytosis process, in which phosphatidylserine plays an important role and which is further enhanced by the blocking of CD47. The study included an ex vivo model for intradermal injection using human skin tissue samples. Following intradermal injection, DCP-001 initiates the activation of skin-resident alloreactive T-cells, causing local inflammation and attraction of host dendritic cells. DCP-001 is digested by the attracted DCs, resulting in a transfer of tumor-associated antigens, which in turn leads to the migration of the patient's own DCs toward draining lymph nodes to initiate the tumor-specific T-cell priming process. The described mechanism of action supports the promising characteristics of DCP-001 as a cancer relapse vaccine providing active immunization and durable anti-tumor immune response aiming to reduce tumor recurrence. Announcement • Jun 24
Immunicum Announces Enrollment of First Patient in Phase I ALISON Study Evaluating Cancer Relapse Vaccine Candidate DCP-001 in Ovarian Cancer Immunicum AB (publ) announced that the first patient has been enrolled in the Phase I ALISON clinical study evaluating DCP-001, the Company’s lead cancer relapse vaccine candidate, in High-Grade Serous Ovarian Cancer (HGSOC) patients following primary standard of care treatment. The ALISON study is carried out by Professor Hans Nijman and his research group in Groningen, the Netherlands, and investigates the ability of DCP-001 to trigger the immune system to control cancer cells that may have remained in the body after surgery and treatment with chemotherapy in order to prevent or reduce tumor reccurence. This is the first study using Immunicum’s cancer relapse vaccine approach to target a solid tumor indication and will evaluate the safety, feasibility and immunogenicity of DCP-001. The Phase I ALISON study is a single-center, open-label study evaluating safety and efficacy of DCP-001 in High-Grade Serous Ovarian Cancer (HGSOC) patients. HGSOC is a unique type of epithelial cancer that is characterized by the loss of function of the tumor suppressor protein, p53, which can lead to chemotherapy resistance and disease relapse. The vaccination regimen with DCP-001 will be scheduled after standard of care treatment, which includes chemotherapy either before or after debulking surgery, and will start 6 weeks following the last cycle of chemotherapy. Patients will receive 4 bi-weekly vaccinations with 25 million cells per DCP-001 vaccination and 2 additional booster vaccinations with 10 million cells per vaccination. Patient follow-ups will be conducted for 24 months. The primary endpoint of the study is change from baseline of DCP-001 vaccine antigen-specific T cells in peripheral blood after treatment. Key secondary endpoints include safety and tolerability after repeated DCP-001 dosing as well as recurrence free survival (RFS) and overall survival (OS) during the follow-up period. Recent Insider Transactions • Jun 22
Chief Executive Officer recently bought €241k worth of stock On the 17th of June, Erik Manting bought around 534k shares on-market at roughly €0.45 per share. This was the largest purchase by an insider in the last 3 months. This was Erik's only on-market trade for the last 12 months. Executive Departure • May 06
Independent Director has left the company On the 5th of May, Steven Glazer's tenure as Independent Director ended after 4.5 years in the role. We don't have any record of a personal shareholding under Steven's name. A total of 5 executives have left over the last 12 months. Announcement • May 04
Immunicum AB Presents Preclinical Data for Ilixadencel and DCP-001 At the 18Th Cancer Immunotherapy Annual Meeting Immunicum AB announced the publication of two abstracts for oral presentations covering preclinical data on its lead programs, ilixadencel and DCP-001, at the 18th Cancer Immunotherapy (CIMT) Annual Meeting, held virtually from May 10 to May 12, 2021. The presentations cover updated preclinical data on the combination of ilixadencel with a checkpoint inhibitor targeting CTLA4 and new preclinical data on the mechanism of action of DCP-001 and its combination with the emerging immunotherapy target CD47. The data covered in the ilixadencel abstract published by the conference extends data from previous preclinical experiments of ilixadencel in combination with an anti-CTLA4 checkpoint inhibitor in a CT26 colon carcinoma animal model, which demonstrated that the combination of ilixadencel and anti-CTLA4 led to complete eradication of tumors in 50-80% of the treated animals. These effects were mainly driven by CD8+ T cells and, in the new data to be presented at CIMT, characterization of CD8+ T cells from blood samples confirmed that the combination of ilixadencel and anti-CTLA4 therapy increased the frequency of CD8+ T cells with the specific markers NKG2D, CX3CR1 and CD39. These markers indicate a crucial population related to tumor-infiltrating cells with a ‘tumor-matched’ phenotype that is able to attack cancer cells. For the abstract covering DCP-001, new preclinical data elucidate the mechanism of action through which DCP-001 can induce specific anti-tumor immunity in patients’ immune cells. The preclinical evaluation of DCP-001 mixed with the host immune cells, called peripheral blood mononuclear cells (PBMCs), shows the induction of the production of various pro-inflammatory cytokines and chemokines by these PBMCs. In addition, DCP-001 was efficiently taken up by immature monocyte-derived dendritic cells, and the blockade of the “don’t eat me” signal and emerging immunotherapy target CD47 enhanced the uptake of DCP-001. These results suggest a vital role for the patient’s immune cells in triggering the immune response upon DCP-001 vaccination and support the clinical rationale for further combination therapies including CD47 inhibitors. Executive Departure • Mar 05
Chief Medical Officer has left the company On the 1st of March, Peter Suenaert's tenure as Chief Medical Officer ended after less than a year in the role. We don't have any record of a personal shareholding under Peter's name. A total of 4 executives have left over the last 12 months. Announcement • Mar 03
Immunicum AB Appoints Jeroen Rovers, M.D., Ph.D., to the Position of Chief Medical Officer Immunicum AB announced that Jeroen Rovers, M.D., Ph.D., has been appointed to the position of Chief Medical Officer. The appointment is effective today. Dr. Rovers transitions from his role as Managing Director of DCprime and continues to serve on Immunicum’s management team. Peter Suenaert, M.D., Ph.D., current CMO of Immunicum, will remain with the Company as clinical advisor, continuing to support the clinical development team and ensuring a smooth transition process. Dr. Rovers joined DCprime as Chief Medical Officer at the end of 2018 and has been serving as Managing Director for DCprime following the business combination with Immunicum in December of last year. Prior to DCprime, he was Chief Medical Officer at Kiadis, a company focused on developing cell-based immunotherapies. As part of the management team at Kiadis, he brought the company public through an IPO. Before Kiadis, Dr. Rovers held Chief Medical Officer and senior clinical development positions at Ceronco Biosciences and Dutch biotechnology company Organon, prior to its acquisition by MSD. Earlier in his career, he held senior positions at Wyeth Pharmaceuticals and Biolitec Pharma Ltd.Dr. Rovers trained as a pharmaceutical physician at the European Center of Pharmaceutical Medicine in Basel, Switzerland; he obtained his M.D. and Ph.D. in Medicine from Leiden University, the Netherlands. Announcement • Feb 22
Immunicum Announces Survival Benefit in Phase II MERECA Trial of Ilixadencel in Kidney Cancer Immunicum AB (publ) announced updated survival data from the Company’s randomized Phase II MERECA trial evaluating its off-the-shelf immune primer, ilixadencel, in combination with sunitinib in the first-line treatment of newly diagnosed patients with metastatic renal cell carcinoma (mRCC). In the MERECA study, 88 patients were randomly assigned to the ilixadencel combination group, or sunitinib control group, and subsequently followed for survival. As previously reported in August 2020, the co-primary endpoint of median OS was reached at 25.3 months in the sunitinib control group, while the median OS in the ilixadencel treatment group has now been reached at 35.6 months. Is New 90 Day High Low • Feb 20
New 90-day low: €0.67 The company is down 14% from its price of €0.78 on 20 November 2020. The German market is up 10.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is up 10.0% over the same period. Announcement • Feb 19
Immunicum AB Receives Orphan Drug Designation from EMA for Ilixadencel as Treatment for Gastrointestinal Stromal Tumors Immunicum AB announced that the European Medicines Agency Committee for Orphan Medicinal Products (COMP) has issued a positive opinion on the Company’s application for orphan designation status for its Phase II clinical candidate, ilixadencel, a cell-based, off-the-shelf immune primer, for the treatment of Gastrointestinal Stromal Tumors (GIST). The COMP opinion was based on results from the Phase I/II clinical trial in GIST, a rare and difficult-to treat cancer indication belonging to the group of cancers referred to as soft tissue sarcomas (STS). To qualify for Orphan Designation in the EU, an investigational medicine must be intended to treat a seriously debilitating or life-threatening condition that affects fewer than five in 10,000 people in the EU and there must be sufficient data to suggest the investigational medicine may produce clinically relevant outcomes. Applications for orphan designation are examined by the EMA’s COMP, which adopts an opinion that is forwarded to the European Commission. The European Commission’s decision follows a few weeks after the COMP opinion is issued. Orphan drug designation provides companies with certain benefits and incentives, including ten years of market exclusivity upon marketing authorization, clinical protocol assistance, access to a centralized marketing authorization procedure and reduced regulatory fees. Executive Departure • Feb 03
Independent Chairman Michael S. Oredsson has left the company On the 22nd of January, Michael S. Oredsson's tenure as Independent Chairman ended after 2.7 years in the role. As of September 2020, Michael S. personally held only 17.56k shares (€17k worth at the time). A total of 2 executives have left over the last 12 months. Announcement • Feb 02
Immunicum AB (Publ) Announces Executive Changes Immunicum AB (publ) announced that effective immediately, Lotta Ferm joined the leadership team as interim Chief Financial Officer succeeding Peter Hein, who will leave at the end of February. The overlap will allow for a smooth transition process during the month of February. Lotta Ferm has nearly 30 years of finance and controlling experience from a range of corporations including most recently Doktor24 Healthcare AB and Medivir AB in the healthcare and life science sectors. She has held CFO, Head of Finance and Head of Controlling positions consistently over the last decade and led the corporate finance and accounting functions for multiple transitions for dynamic and innovative companies. Announcement • Jan 24
Immunicum AB (publ) Approves Election of New Board Members Immunicum AB (publ) announced that at its EGM held on 22 January 2021, the EGM resolved to elect Dharminder Chahal and Andrea van Elsas as new board members. Announcement • Jan 22
Immunicum AB (publ) Announces Transitions in Board of Directors Immunicum AB (publ) announced that Michael Oredsson has decided to resign his position as chairman and member of Immunicum’s Board of Directors, effective as of the Extraordinary General Meeting (EGM) that will be held on January 22, 2021. The Board has agreed to appoint Christine Lind, currently serving as board member, as interim chairman until the next Annual General Meeting (AGM), to be held on May 4, 2021. Is New 90 Day High Low • Jan 19
New 90-day low: €0.70 The company is down 15% from its price of €0.82 on 21 October 2020. The German market is up 10.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is up 4.0% over the same period. Announcement • Jan 02
Immunicum AB (publ) Receives FDA Orphan Drug Designation for Ilixadencel as a Treatment for Hepatocellular Carcinoma (HCC) Immunicum AB (publ) announced that it has received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for the Company’s lead candidate, ilixadencel, a cell-based, off-the-shelf immune primer, for the treatment of Hepatocellular Carcinoma (HCC). The designation was based on data from a Phase I/II clinical trial of ilixadencel in patients with unresectable and/or metastatic HCC. The Orphan Drug Act was enacted in the United States to support the development of new drugs and biologics for rare diseases through financial incentives, such as partial tax credit for clinical trial costs, and up to seven years of market exclusivity upon regulatory product approval. Announcement • Dec 30
Immunicum AB (publ) Announces Changes to the Nomination Committee Immunicum AB (publ) announced changes to the Nomination Committee as a result of the recently completed issue in kind in connection with the business combination with DCprime, whereby the ownership structure of Immunicum has changed. In light of the statements above, the Nomination Committee is now composed of the following individuals: Erik Esveld, appointed by Van Herk Investments BV; Jannis Kitsakis, appointed by The Fourth Swedish National Pension Fund; Martin Lindström, appointed by Loggen Invest AB; Jamal El-Mosleh, appointed by Holger Blomstrand byggnads AB. Announcement • Dec 23
Immunicum AB (publ) (OM:IMMU) completed the acquisition of DCPrime B.V. from Van Herk Investments B.V. and others. Immunicum AB (publ) (OM:IMMU) entered into a share purchase agreement to acquire DCPrime B.V. from Van Herk Investments B.V. and others for €58.8 million on November 18, 2020. Under the terms, Immunicum will issue 73 million shares as representing 44% stake of Immunicum on a fully diluted basis, out of that Van Herk will hold 43% stake. Consideration shares has a customary lock-up provisions for 12 months. Van Herk would be obligated to make a public offer for all shares in Immunicum within four weeks thereafter. The newly combined company will maintain its corporate headquarters in Stockholm, Sweden and consolidate research, process development and future manufacturing efforts at the location in Leiden, the Netherlands. Erik Manting, Ph.D., currently CEO of DCprime, will join Immunicum’s leadership team as Chief Business Officer and deputy CEO. Jeroen Rovers, MD, Ph.D., currently Chief Medical Officer at DCprime, will have the role of the Managing Director of DCprime in the combination. As part of transaction, Dharminder Chahal chairman of DCprime and Erik Manting, Ph.D. Chief Executive Officer of DCprime minority shareholders in DCprime will become shareholders in Immunicum following the transaction. Closing of the Transaction is conditional upon approval of issuance of the shares by the shareholders of Immunicum approval and publication of the prospectus, and Van Herk’s acquisition of the minority shareholders’ shares in DCprime. As of December 18, 2020 the transaction was approved by Immunicum shareholders. The closing of the Transaction is expected to take place on December 21, 2020. Erik Penser Bank AB acted as financial advisor and Mats Dahlberg of Advokatfirman Delphi KB acted as legal advisor for Immunicum. Kempen & Co N.V. acted as financial advisor, Jonas Forsén, Fredrik Lundén and Wilhelm Lüning of Advokatfirman Cederquist KB and Christiaan de Brauw of Allen & Overy Amsterdam acted as legal advisors for DCprime.
Immunicum AB (publ) (OM:IMMU) completed the acquisition of DCPrime B.V. from Van Herk Investments B.V. and others on December 21, 2020. As part of transaction, Van Herk Investments B.V. acquired shares of minority shareholders and paid them in cash and partly in newly issued shares that Van Herk is receiving in Immunicum. Announcement • Dec 18
Immunicum AB (Publ) Announces Completion of Patient Recruitment for Phase Ib Portion of ILIAD Combination Clinical Trial Immunicum AB announced the completion of patient recruitment for the Phase Ib portion of the ongoing ILIAD (ILIxadencel in combination with checkpoint inhibitors in Advanced cancer patients) trial. The primary objective of the Phase Ib study is to evaluate the safety and tolerability as well as define the dose regimen for the company’s lead cell-based candidate, ilixadencel, in combination with the checkpoint inhibitor, Keytruda (pembrolizumab), in a total of 21 patients. The follow-up period for the Phase Ib portion of the trial will include imaging of up to 6 months for evaluation of safety, dosing and signs of efficacy. Topline results of the Phase Ib trial are expected during the third quarter of 2021. The Phase Ib/II ILIAD combination trial includes patients who are candidates for pembrolizumab therapy in its approved label by the FDA, which includes, among others, the tumor types head and neck squamous cell carcinoma, non-small cell lung cancer and gastric and gastroesophageal junction adenocarcinoma. In terms of dosing, three patients were planned to receive two intratumoral doses of 3 million cells, six patients two doses of 10 million cells, six patients three doses of 10 million cells and the last six patients will receive one dose of 20 million cells followed by two doses of 10 million cells. Throughout the duration of the trial, the Dose Escalation Committee (DEC) has assessed ilixadencel’s safety profile. The last update from the DEC in October confirmed there had been no dose-limiting toxicities. The Phase II portion of the ILIAD trial can subsequently continue with the selected dose regimen from the Phase Ib. Announcement • Nov 20
Immunicum AB (publ) (OM:IMMU) entered into a share purchase agreement to acquire DCPrime B.V. from Van Herk Investments B.V. and others for €58.8 million. Immunicum AB (publ) (OM:IMMU) entered into a share purchase agreement to acquire DCPrime B.V. from Van Herk Investments B.V. and others for €58.8 million on November 18, 2020. Under the terms, Immunicum will issue 73 million shares as representing 44% stake of Immunicum on a fully diluted basis, out of that Van Herk will hold 43% stake. Consideration shares has a customary lock-up provisions for 12 months. Van Herk would be obligated to make a public offer for all shares in Immunicum within four weeks thereafter. The newly combined company will maintain its corporate headquarters in Stockholm, Sweden and consolidate research, process development and future manufacturing efforts at the location in Leiden, the Netherlands. Erik Manting, Ph.D., currently CEO of DCprime, will join Immunicum’s leadership team as Chief Business Officer and deputy CEO. Jeroen Rovers, MD, Ph.D., currently Chief Medical Officer at DCprime, will have the role of the Managing Director of DCprime in the combination. Closing of the Transaction is conditional upon approval of issuance of the shares by the shareholders of Immunicum approval and publication of the prospectus, and Van Herk’s acquisition of the minority shareholders’ shares in DCprime. The closing of the Transaction is expected to take place on December 21, 2020. Erik Penser Bank AB acted as financial advisor and Advokatfirman Delphi KB acted as legal advisor for Immunicum. Kempen & Co N.V. acted as financial advisor, Jonas Forsén, Fredrik Lundén and Wilhelm Lüning of Advokatfirman Cederquist KB and Allen & Overy Amsterdam acted as legal advisors for DCprime.