Zeltherva (galinpepimut-S) / Memorial Sloan-Kettering Cancer Center, SELLAS Life Sciences, 3DMed, Ayala Pharma - LARVOL DELTA

REGAL: Galinpepimut-S Versus Investigator's Choice of Best Available Therapy for Maintenance in AML CR2/CRp2 (clinicaltrials.gov) - P3 | N=127 | Active, not recruiting | Sponsor: Sellas Life Sciences Group | Trial primary completion date: Sep 2025 ➔ Dec 2025

Monotherapy • Trial primary completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

SELLAS Life Sciences Group to Host Virtual R&D Day on October 29, 2025: Advancing Novel Therapies in Acute Myeloid Leukemia (AML): An Overview of the Ongoing Phase 3 REGAL Trial of Galinpepimut-S (GPS) and SLS009 Program Update (GlobeNewswire) - "SELLAS will also present an update of SLS009....plans for a newly diagnosed and frontline AML study anticipated to begin in the first quarter of 2026."

New trial • Trial status • Acute Myelogenous Leukemia

Phase 3 REGAL Trial of GPS (GlobeNewswire) - "The final analysis will be conducted once 80 events (deaths) are reached and is anticipated by year-end."

P3 data • Acute Myelogenous Leukemia

SELLAS Life Sciences Announces Independent Data Monitoring Committee Periodic Review and Positive Recommendation to Continue Pivotal Phase 3 REGAL Trial of GPS in AML Without Modification (GlobeNewswire) - "SELLAS Life Sciences...announced that the Independent Data Monitoring Committee (IDMC) has completed a pre-specified analysis of the Phase 3 REGAL trial of galinpepimut-S (GPS) in acute myeloid leukemia (AML), and has issued a positive recommendation to continue the trial without modification...The IDMC concluded that the risk-benefit profile of GPS supports continued evaluation under the current study protocol. No safety concerns were identified, and available efficacy data were consistent with expectations for continued trial conduct....As of the time of this IDMC review, that threshold has not yet been reached."

DSMB • Acute Myelogenous Leukemia

Study of 3D189 in Patients With Hematologic Malignancies (clinicaltrials.gov) - P1 | N=15 | Active, not recruiting | Sponsor: 3D Medicines | Trial completion date: Dec 2024 ➔ Dec 2026 | Trial primary completion date: Dec 2024 ➔ Jun 2026

Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Multiple Myeloma • Myelodysplastic Syndrome • Non-Hodgkin’s Lymphoma • Oncology • WT1

REGAL: Galinpepimut-S Versus Investigator's Choice of Best Available Therapy for Maintenance in AML CR2/CRp2 (clinicaltrials.gov) - P3 | N=128 | Active, not recruiting | Sponsor: Sellas Life Sciences Group | Trial completion date: Mar 2025 ➔ Dec 2026 | Trial primary completion date: Dec 2024 ➔ Sep 2025

Monotherapy • Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

SELLAS Life Sciences Reports First Quarter 2025 Financial Results and Provides Corporate Update (GlobeNewswire) - "Research and development expenses for the quarter ended March 31, 2025, were $3.2 million, compared to $5.1 million for the same period in 2024. The $1.9 million decrease was primarily due to decreases in clinical trial expenses, manufacturing costs, and clinical drug supply purchases, and clinical and regulatory consulting costs primarily driven by the completion of enrollment in the REGAL study in the first quarter of 2024."

Commercial • Acute Myelogenous Leukemia

SELLAS Life Sciences Reports Full Year 2024 Financial Results and Provides Corporate Update (GlobeNewswire) - Sellas Life Sciences Group | "The most anticipated milestones in 2025 will be the final analysis of our Phase 3 pivotal REGAL trial of GPS in acute myeloid leukemia...The next and final analysis will be conducted once 80 events (deaths) are reached, further determining the potential of GPS in addressing the needs of AML patients. SELLAS anticipates that 80 events will be reached this year."

P3 data • Acute Myelogenous Leukemia

SELLAS Life Sciences Announces Positive Outcome of Interim Analysis for its Pivotal Phase 3 REGAL Trial of GPS in Acute Myeloid Leukemia (GlobeNewswire) - P3 | N=128 | REGAL (NCT04229979) | Sponsor: Sellas Life Sciences Group | "REGAL Successfully Passes Event-Driven (60 Deaths) Interim Analysis for Efficacy, Futility, and Safety: The Independent Data Monitoring Committee (IDMC) Recommended Continuation of the Clinical Trial Without Modification; Based on a Review of Unblinded Data, the IDMC Confirmed that GPS Exceeded the Predetermined Futility Criteria, Noted no Safety Concerns and Commended SELLAS for its Operational Excellence and Study Data Integrity; Fewer than 50% of Enrolled Patients Confirmed Deceased After the Median Follow-Up of 13.5 Months, Indicating a Median Survival of Over 13.5 Months in the Trial vs. Historical Median Survival of 6 Months for Conventional Therapy, as Reported in Similar Phase 2 Study; 80% of Randomly Selected REGAL GPS Patients Showed a Specific T-Cell Immune Response, Surpassing the Results From the Previous Phase 2 Study; Next and Final Analysis Planned Upon Reaching 80 Events."

DSMB • P3 data • Acute Myelogenous Leukemia

Combining a WT1 Vaccine (Galinpepimut-S) With Checkpoint Inhibition (Nivolumab) in Patients With WT1-Expressing Diffuse Pleural Mesothelioma: A Phase 1 Study. (PubMed, JTO Clin Res Rep) - "We enrolled patients with progressive or recurrent DPM treated with at least one course of pemetrexed-based chemotherapy. Median progression-free survival was 3.9 months and the median overall survival was 7.4 months. Coadministration of GPS and nivolumab reported a tolerable toxicity profile and induced immune responses in a subset of patients, but initial response and survival benefit were limited possibly owing to the small sample size."

Checkpoint inhibition • Journal • P1 data • Malignant Pleural Mesothelioma • Mesothelioma • Oncology • Pleural Mesothelioma • Solid Tumor • PD-L1 • WT1

Expected Milestones in 2025: Galinpepimut-S (GPS): Wilms Tumor-1 (WT1) targeting immunotherapeutic (GlobeNewswire) - "The interim analysis from the ongoing REGAL global Phase 3 registrational clinical trial of GPS in patients with AML who have achieved complete remission following second-line salvage therapy (CR2 patients) is expected in January 2025. Based on the results of this analysis, the IDMC will provide recommendations to either stop the trial early for efficacy, stop for futility, or continue the study without modification."

P3 data • Acute Myelogenous Leukemia

SELLAS Life Sciences Triggers Interim Analysis in Phase 3 REGAL Trial of GPS in Acute Myeloid Leukemia (GlobeNewswire) - "SELLAS Life Sciences Group, Inc...announced that the pre-specified threshold of 60 events (deaths) has been reached in its ongoing Phase 3 REGAL clinical trial of galinpepimut-S (GPS) in acute myeloid leukemia (AML), triggering the interim analysis to be conducted by the Independent Data Monitoring Committee (IDMC)...'The IDMC will now carefully review and analyze all the data and have scheduled a meeting in January to review results to date.'....The Company will host a call today to review the process leading up to the IDMC meeting and the potential outcomes of the REGAL interim analysis."

Trial status • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

Galinpepimut-S in Combination With Pembrolizumab in Patients With Selected Advanced Cancers (clinicaltrials.gov) - P1/2 | N=26 | Completed | Sponsor: Sellas Life Sciences Group | Active, not recruiting ➔ Completed | N=90 ➔ 26

Combination therapy • Enrollment change • Metastases • Trial completion • Acute Myelogenous Leukemia • Breast Cancer • Colon Adenocarcinoma • Colon Cancer • Colorectal Cancer • Hematological Malignancies • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Negative Breast Cancer • Leukemia • Lung Cancer • Oncology • Ovarian Cancer • Small Cell Lung Cancer • Solid Tumor • Triple Negative Breast Cancer • BRCA • HER-2 • KRAS • MUC16 • PGR • WT1

Using a Targeted Cancer Vaccine (Galinpepimut-S) with Immunotherapy (Nivolumab) in Mesothelioma (clinicaltrials.gov) - P1 | N=10 | Completed | Sponsor: Memorial Sloan Kettering Cancer Center | Active, not recruiting ➔ Completed | Trial completion date: Jul 2025 ➔ Nov 2024 | Trial primary completion date: Jul 2025 ➔ Nov 2024

Checkpoint inhibition • Trial completion • Trial completion date • Trial primary completion date • Malignant Pleural Mesothelioma • Mesothelioma • Nephrology • Oncology • Solid Tumor • Wilms Tumor • WT1

REGAL: galinpepimut-S vs. best available therapy as maintenance therapy for acute myeloid leukemia in second remission. (PubMed, Future Oncol) - P3 | "Clinical trial registration: https://clinicaltrials.gov/study/NCT04229979. The clinical trial identifier is NCT04229979."

Clinical • Journal • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Leukemia • Nephrology • Oncology • Solid Tumor • Transplantation • Wilms Tumor • WT1

SELLAS Life Sciences Reports Third Quarter 2024 Financial Results and Provides Corporate Update (GlobeNewswire) - "Pipeline Highlights:...(i) Phase 3 REGAL study in AML:...Based on a detailed analysis of all unblinded data, the IDMC projected that the interim analysis (60 events) will occur in the fourth quarter of 2024; (ii) SLS009:...Additional Phase 2 Cohorts in Venetoclax Combinations in r/r AML Continue Enrollment:...These cohorts are also open for enrollment of certain pediatric patients. Additional topline data updates are expected in the fourth quarter of 2024."

Enrollment status • P2 data • P3 data • Acute Myelogenous Leukemia

SELLAS Announces U.S. FDA Rare Pediatric Disease Designation (RPDD) Granted to Galinpepimut-S (GPS) for the Treatment of Pediatric Acute Myeloid Leukemia (GlobeNewswire) - "SELLAS Life Sciences...announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation (RPDD) to topic-S (GPS), an immunotherapeutic targeting Wilms Tumor-1 (WT1), for the treatment of pediatric acute myeloid leukemia (AML)....'In our Phase 2 trial in adult patients which included patients as young as 25, clinical benefits were significantly higher in younger patients, which was expected based on the mechanism of action of GPS that is mediated via the immune system that is generally better preserved in younger patients, and even more so in children.'"

FDA event • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

Galinpepimut-S (WT-1 Analog Peptide) Vaccine in Malignant Pleural Mesothelioma After Combined Modality Therapy (clinicaltrials.gov) - P2 | N=41 | Completed | Sponsor: Sellas Life Sciences Group | N=31 ➔ 41

Enrollment change • Malignant Pleural Mesothelioma • Mesothelioma • Oncology • Solid Tumor • WT1

WT1 Vaccine Treatment of Patients With Multiple Myeloma After Autologous Stem Cell Transplantation (clinicaltrials.gov) - P1/2 | N=20 | Completed | Sponsor: Sellas Life Sciences Group | Unknown status ➔ Completed | Phase classification: PN/A ➔ P1/2

Phase classification • Trial completion • Bone Marrow Transplantation • Hematological Malignancies • Multiple Myeloma • Oncology • Transplantation • CD4 • WT1

Study of 3D189 in Patients With Hematologic Malignancies (clinicaltrials.gov) - P1 | N=15 | Active, not recruiting | Sponsor: 3D Medicines | Trial primary completion date: May 2024 ➔ Dec 2024

Trial primary completion date • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Leukemia • Lymphoma • Multiple Myeloma • Myelodysplastic Syndrome • Non-Hodgkin’s Lymphoma • Oncology • WT1

Using a Targeted Cancer Vaccine (Galinpepimut-S) With Immunotherapy (Nivolumab) in Mesothelioma (clinicaltrials.gov) - P1 | N=10 | Active, not recruiting | Sponsor: Memorial Sloan Kettering Cancer Center | Trial completion date: Jul 2024 ➔ Jul 2025 | Trial primary completion date: Jul 2024 ➔ Jul 2025

Checkpoint inhibition • Trial completion date • Trial primary completion date • Malignant Pleural Mesothelioma • Mesothelioma • Nephrology • Oncology • Solid Tumor • Wilms Tumor • WT1

SELLAS Life Sciences Reports Second Quarter 2024 Financial Results and Provides Corporate Update (GlobeNewswire) - "Phase 3 REGAL study in AML:...Based on a detailed analysis of all unblinded data, the IDMC projects that the interim analysis (60 events) will occur by the fourth quarter of 2024....SLS009: highly selective and specific CDK9 inhibitor:...Additional Phase 2 Cohorts in Venetoclax Combinations in r/r AML Opened for Enrollment: Development of SLS009 continued with the opening of two new cohorts - AML with myelodysplasia-related changes (AML MRC) with ASXL1 mutations and AML with myelodysplasia related changes other than ASXL1 mutations. These new cohorts are also open for enrollment of certain pediatric patients."

Enrollment status • P3 data • Acute Myelogenous Leukemia

SELLAS Life Sciences Announces Positive Recommendation from the Independent Data Monitoring Committee of the Phase 3 REGAL Trial in Acute Myeloid Leukemia (SELLAS Life Sciences Press Release) - "SELLAS Life Sciences Group, Inc...announced a positive review of the ongoing Phase 3 REGAL clinical trial of galinpepimut-S (GPS) in acute myeloid leukemia (AML) by the Independent Data Monitoring Committee (IDMC). The IDMC conducted a prespecified risk-benefit assessment of unblinded data from the study and has recommended that the trial continue without modifications. Based on a detailed analysis of all unblinded data, the IDMC projects with a high level of confidence that the interim analysis (60 events) will occur by the fourth quarter of 2024...'The committee’s review did not raise any safety or futility concerns, further strengthening our confidence in the potential of GPS as a safe and effective treatment option for AML patients.'..."

DSMB • Acute Myelogenous Leukemia

Combining a WT1 cancer vaccine (galinpepimut-S) with checkpoint inhibition (nivolumab) in patients with WT1-expressing diffuse pleural mesothelioma (DPM): A phase I study. (ASCO 2024) - P1 | " We enrolled patients with WT1-positive metastatic or recurrent and measurable DPM treated with at least one course of pemetrexed-based chemotherapy. Coadministration of galinpepimut-S and nivolumab demonstrated a tolerable toxicity profile and induced immune responses in a subset of patients as indicated by immunophenotyping and disease control rate of 30% at 8 weeks but initial response and survival benefit were limited which may be due to the small sample size."

Checkpoint inhibition • Clinical • P1 data • Malignant Pleural Mesothelioma • Mesothelioma • Oncology • Solid Tumor • Wilms Tumor • CD4 • CD8 • IL15 • IL2 • PD-L1 • WT1

Phase 1 Study Evaluates Combination of WT1 Cancer Vaccine Plus Nivolumab in WT1-Expressing DPM (DocWire) - P1 | N=10 | NCT04040231 | "Combining the WT1 cancer vaccine galinpepimut-S with nivolumab 'demonstrated a tolerable toxicity profile” and induced immune responses in a subset of in patients with WT1-expressing diffuse pleural mesothelioma (DPM), according to results of a recent phase 1 study....Among the 10 patients who received the treatment, 70% had treatment-related adverse events (AEs) that “were mostly mild,” according to the study investigators. However, 2 patients experienced a grade ≥3 AE. The study showed that 4 (50%) of 8 patients had T-cell responses to WT1 peptides. No partial responses occurred, but 3 patients had “prolonged stable disease,' with up to 17% decrease in their tumor volume. The median OS was 13.5 months from the most recent prior line of therapy."

P1 data • Malignant Pleural Mesothelioma • Mesothelioma