SELLAS Life Sciences Group, Inc. · NASDAQ:SLS
SELLAS Life Sciences — Investor Presentation (August 2025)
34 slides from SELLAS Life Sciences's investor presentation, August 2025
Slide 1: SELLAS Life Sciences Group Corporate Presentation
SELLAS Life Sciences Group Corporate Presentation August 2025 NASDAQ: SLS
Slide 2: Forward Looking Statements
Forward Looking Statements This presentation contains forward-looking statements. Such forward-looking statements can be identified by the use of the words “expect,” “believe,” “will,” “anticipate,” “estimate,” “plan,” “project” and other words of similar import. The forward-looking statements in th
Slide 3: SELLAS Mission: Extending Patient Lives with Novel Therapies
SELLAS Mission: Extending Patient Lives with Novel Therapies Two Clinical Stage Assets Each Potentially First & Best in Class AML Lead Indication for Both Galinpepimut-S (GPS) Innovative Immunotherapy Engineered to Target Wilms Tumor 1 (WT1) Antigen • Phase 3 REGAL clinical trial for acute myeloid l
Slide 4: AML Treatment Overview and Addressable Market
AML Treatment Overview and Addressable Market Annual AML Incidence (Adults)1 GPS and SLS009 Have Potential for Broad AML Applicability US EU5 Japan ~21K ~16K ~4.5K 1st Line Therapy 80% patients2 Chemotherapy, Targeted Therapy 1st Relapse; 2nd Line Therapy SLS009 in AML 30-35% patients2 Chemotherapy,
Slide 5: GPS: Innovative WT1 Targeting Immunotherapy
GPS Innovative WT1 Targeting Immunotherapy
Slide 6: GPS: Innovative Technology with Broad Immuno-Oncology Applicability
GPS: Innovative Technology with Broad Immuno-Oncology Applicability GPS Drug Candidate • Highly engineered immunotherapy designed to increase immunogenicity and break tolerance • Heteroclitic multivalent mixture of engineered and artificially mutated peptides targeting 25 select WT1 epitopes • CD4 a
Slide 7: GPS Designed to Promote Immune Response and Sustain Remission
GPS Designed to Promote Immune Response and Sustain Remission GPS Treatment Antigen Presentation S.C. Antigen-in-oil Microemulsion injection (WT1 peptide) in subcutaneous microparticles interstitial space or Mixture of 2 native and 2 synthetic WT1 peptides Dendritic Cells Macrophages IL-12 IL-1, IL-
Slide 8: GPS-Treated Lymphocytes Reactive to WT1 Protein
GPS-Treated Lymphocytes Reactive to WT1 Protein Epitope Spreading: Evidence of epitope spreading in GPS treated patients1: A Key Element for Cancer Immunotherapy Lymphocyte reactivity to WT1 protein epitopes for which patient was not specifically immunized2 GPS-specific T-cells recognize • CD8+ T ce
Slide 9: GPS: Clinical Development in AML
GPS Clinical Development in AML
Slide 10: Overall Survival in GPS Treated AML CR1 Patients Far Exceeded Historical Comparators
Overall Survival in GPS Treated AML CR1 Patients Far Exceeded Historical Comparators Phase 2 Open-label Clinical Trial in AML CR1 Patients All Age Patients Overall Survival (OS) GPS vs Standard of Care (SOC) 67.6 months vs 17.5 - 25 months including allogeneic stem cell transplant >60 Years Patients
Slide 11: Survival Benefit Seen in AML Patients in CR2
Survival Benefit Seen in AML Patients in CR2 Phase 2 Open-label Clinical Trial in Contemporaneously Treated AML CR2 Patients at Moffitt Cancer Center (MCC)1,2 Median Overall Survival (All Age Patients):GPS vs SOC Relapse Free Survival (All Age Patients):GPS vs SOC 21.0 months vs 5.4 months (p<0.02)
Slide 12: REGAL Phase 3 Registration Enabling Clinical Trial in CR2 AML
REGAL Phase 3 Registration Enabling Clinical Trial in CR2 AML Target Population and Treatment: Open Label, Randomized Endpoints; Inclusion Criteria Multi-Center Phase 3 Trial Interim/Final Analysis AML in CR2/ CRp2¹ or GPS Primary Endpoint: Overall Survival later CR patients ≥18 yrs N=125 - 140 Mont
Slide 13: GPS: Combination with Checkpoint Inhibitors
GPS Combination with Checkpoint Inhibitors
Slide 14: GPS Activity Demonstrated in Combo with Checkpoint Inhibitors in WT1 Expressing Solid Tumors
GPS Activity Demonstrated in Combo with Checkpoint Inhibitors in WT1 Expressing Solid Tumors WT1-specific IgG titers over time Open-label Phase 1 Clinical Trial of GPS + Nivolumab in MRD Negative, WT1+ Ovarian Cancer Patients After 1st or 2nd Salvage Chemotherapy Key Points: • Primary Endpoint met:
Slide 15: GPS Combination With Checkpoint Inhibitor: R/R Ovarian Cancer
GPS Combination With Checkpoint Inhibitor: R/R Ovarian Cancer Open-label Phase 1/2 Clinical Trial GPS + Pembrolizumab Confirmatory Topline data reported November 2023: • Disease Control Rate (DCR) (overall response rate + rate of stable disease) of 50.1% for combination at a median follow-up of 14.4
Slide 16: GPS in Combination With Checkpoint Inhibitor: MPM
GPS in Combination With Checkpoint Inhibitor: MPM Open-label Phase 1 IST of GPS + nivolumab in relapsed/refractory MPM post 1L SOC Therapy (Pemetrexed) at MSKCC: Primary endpoints of safety and efficacy met STUDY POPULATION (n=10) Weeks 0 and 2: Weeks 4,6,8,10,12,14: Weeks 18: Metastatic or recurren
Slide 17: 3D Medicines License and REGAL Study Participation
3D Medicines License and REGAL Study Participation Exclusive License Granted Financial Terms Participation in REGAL: to 3D Medicines for Greater Upfront cash payment and milestones potential for accelerated China in December 2020 of $10.5 million received to date entry into Greater China market Roya
Slide 18: SLS009: Highly Innovative Next Generation CDK9 Inhibitor
SLS009 Highly Innovative Next Generation CDK9 Inhibitor
Slide 19: SLS009: Highly Specific and Selective Next Generation CDK9 Inhibitor
SLS009: Highly Specific and Selective Next Generation CDK9 Inhibitor CDK9 (with Cyclin T1) forms Positive Transcription Elongation Factor b (P-TEFb) which enables transcription elongation of mRNA strands P-TEFb is crucial for the survival of cancer cells, including the regulation of short-lived, ant
Slide 20: SLS009: Novel CDK9 Inhibitor for Transcriptional Driven Tumors
SLS009: Novel CDK9 Inhibitor for Transcriptional Driven Tumors Broad applicability across cancer types with potential for both hematologic and solid cancers Phase 2 Programs • Phase 2 open-label, single-arm, multi-center study in AML to evaluate safety, tolerability, and efficacy at two dose levels,
Slide 21: SLS009 Mechanism of Action in ASXL1 Mutated AML
SLS009 Mechanism of Action in ASXL1 Mutated AML BRD4 Full length ASXL1 Does not bind to BRD4 Mutated ASXL1 Binds to BRD4 • Transcription speed is regulated by the BRD4 – PTEF b – RNAPolII axis BRD4 • ASXL1 frameshift mutations are a gain of function mutations RNAPolII • C terminal truncated ASXL1 bi
Slide 22: Clinical Stage Selective CDK9 inhibitors: Preclinical Comparison
Clinical Stage Selective CDK9 inhibitors: Preclinical Comparison Preclinical data demonstrate potential for superior safety and efficacy compared to a key IV CDK9 inhibitor in development Cell lines SLS009 IC50 (72h) VIP152 (formerly BAY-125112) IC50 (72h) AML 4.8 ~33 nM 15.9 ~136 nM Significantly l
Slide 23: AML: SLS009 and Aza/Ven Combination Preclinical Synergies
AML: SLS009 and Aza/Ven Combination Preclinical Synergies Main anti-apoptotic proteins in AML are BCL-2, MCL-1, and BCL-xL MCL-1 upregulation is considered to be the main mechanism of resistance to venetoclax (BCL-2 inhibitor) SLS009 suppresses production of MCL-1 Most leukemic cells are sensitive t
Slide 24: Lymphoma: SLS009 and BTKi Combination Preclinical Synergies
Lymphoma: SLS009 and BTKi Combination Preclinical Synergies DMSO Ibrutinib Zanubrutinib LOXO305 SLS009 (100nM, 6h) - 1 nM 10 nM 1 nM 10 nM 20nM 60nM 01 BTK inhibition primes diffuse large B cell lymphoma (DLBCL) - + - + - + - + - + - + - + cells for apoptosis by inducing BIM accumulation 01 BIM SLS0
Slide 25: SLS009 Clinical Development
SLS009 Clinical Development Phase 1 Trial r/r hematologic cancers Target Population Administration and Dose Escalation Algorithm Endpoints and Assessments and Study Design N = Up to 80 patients Administration Schedule: BIW or QW 21 days cycles, continued Primary Endpoints: until intolerable toxiciti
Slide 26: SLS009 Biological and Clinical Activity in Phase 1
SLS009 Biological and Clinical Activity in Phase 1 • 9 mg BIW: -50.0% BMB reduction at week 4, pretreatment blast burden 40.0% AML • 15 mg BIW: -53.8% BMB reduction at week 4, pretreatment blast burden 45.5% Patients • 30 mg QW: -57.1% BMB reduction, pretreatment blast burden 7.0% • CR achieved at w
Slide 27: SLS009 + aza/ven combination P2a Trial in r/r AML – Trial Design
SLS009 + aza/ven combination P2a Trial in r/r AML – Trial Design Target Population and Study Administration and Treatment Algorithm Endpoints and Assessments Design N = Up to 60 patients Initiated end of June 2023 I/E criteria: Primary Endpoints: SLS009 Day 1 • Patients ≥ 18 yrs of age • Composite c
Slide 28: SLS009 – All Primary Endpoints Met in Phase 2 Study
SLS009 – All Primary Endpoints Met in Phase 2 Study • Higher response rates and median overall survival observed in r/r AML patients receiving SLS009 + ven/aza therapy versus historical results in venetoclax-based regimens alone • Excellent safety profile: no dose-limiting toxicities (DLT) at any of
Slide 29: SLS009 – Front Line Trial Planned Following FDA Guidance
SLS009 – Front Line Trial Planned Following FDA Guidance Following a productive end of Phase 2 meeting, the FDA recommended that SELLAS proceed into a trial to also include newly diagnosed, first-line AML patients unlikely to benefit from venetoclax/ azacitidine (aza/ven) therapy, where the Agency b
Slide 30: About ASXL1 Mutations
About ASXL1 Mutations ASXL1 mutations are associated with poor prognosis in myeloid diseases • Lower response to the current treatment options • Lower median survival • Increased AML transformation for MDS ASXL1 mutations in Hematologic Malignancies with ASXL1m Frequency ≥5% US Condition Condition A
Slide 31: Two Clinical Stage Cancer Therapies with Minimal Competition
Two Clinical Stage Cancer Therapies with Minimal Competition Compound Indication Combo agent Preclinical Phase 1 Phase 2 Phase 3 Anticipated Milestones Interim Analysis: 1Q2025 Maintenance in AML Next and Final Analysis: expected CR2/CRp2 (REGAL) by year-end 2025 GPS 2nd/3rd Line Ovarian pembrolizum
Slide 32: Experienced Management Team
Experienced Management Team ANGELOS STERGIOU,M.D., ScD h.c. President, CEO & Board Director DRAGAN CICIC, M.D. SVP, Chief Development Officer JOHN T. BURNS, CPA SVP, Chief Financial Officer ANDREW ELNATAN SVP, Regulatory Affairs, CMC & Quality STACY E. YEUNG VP, Legal Affairs, Head of Compliance, &
Slide 33: Scientific Advisory Board and Board of Directors
Scientific Advisory Board and Board of Directors Board of Directors Scientific Advisory Board Philip C. Amrein, M.D. John Varian Massachusetts General Hospital Board Chair Alex Kentsis, M.D., Ph.D. Jane Wasman Memorial Sloan Kettering Cancer Center Nom & Corp Gov Chair Guenther Koehne, M.D., Ph.D. M
Slide 34: Thank you!
Thank you! NASDAQ: SLS
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