A Randomized, Open-Label Study of the Efficacy and Safety of Galinpepimut-S (GPS) Maintenance Monotherapy Compared to Investigators Choice of Best Available Therapy in Subjects with Acute Myeloid Leukemia Who Have Achieved Complete Remission After Second-Line Salvage Therapy

Start Date20 Oct 2022

Sponsor / Collaborator

Sellas Life Sciences Group Ltd.

[+1]

CTR20221740

/ Active, not recruitingPhase 1

评价3D189在血液肿瘤患者中的安全性和免疫原性的I期临床研究

[Translation] Phase I clinical study evaluating the safety and immunogenicity of 3D189 in patients with hematological malignancies

主要目的：评价3D189在血液肿瘤患者中的安全性和免疫原性。次要目的：初步评价3D189在血液肿瘤患者中的抗肿瘤活性。

[Translation]

Primary objective: To evaluate the safety and immunogenicity of 3D189 in patients with hematological malignancies. Secondary objective: To preliminarily evaluate the anti-tumor activity of 3D189 in patients with hematological malignancies.

Start Date20 Sep 2022

Sponsor / Collaborator

Lyophilization Services of New England, Inc.

[+2]

NCT05320809

/ Active, not recruitingPhase 1

A Phase I Study to Evaluate the Safety and Immunogenicity of 3D189 in Patients With Hematologic Malignancies

To assess the safety, immunogenicity and preliminary efficacy of 3D189 in patients with hematological malignancies.

Start Date01 Aug 2022

Sponsor / Collaborator

Aitisi Biotechnology (Shanghai) Co. Ltd.

100 Clinical Results associated with Galinpepimut-S

100 Translational Medicine associated with Galinpepimut-S

100 Patents (Medical) associated with Galinpepimut-S

304

Literatures (Medical) associated with Galinpepimut-S

01 Mar 2025·International Journal of Biological Macromolecules

Synergistic enhancement of hydrophobicity and mechanical properties of cellulose paper by (3-glycidoxypropyl) trimethoxy and rosin

Article

Author: Xu, Yang ; Zhang, Jun ; Yang, Yongbin ; Yang, Jia ; Liu, Jianrong

Cellulose-based paper is inherently poor in hydrophobicity and mechanical strength, limiting its practical applications in daily life such as packaging materials, water-resistant labels, and disposable tableware. This study aimed to develop an effective and eco-friendly strategy to address these limitations by enhancing the hydrophobicity and mechanical properties of cellulose paper. To achieve this, an internal sizing agent was prepared by combining (3-glycidoxypropyl) trimethoxy (GPS) with natural rosin. This sizing agent was applied to cellulose paper, and its effectiveness was evaluated. Fourier transform infrared spectroscopy (FTIR) and X-ray photoelectron spectroscopy (XPS) confirmed the successful introduction of rosin and GPS into the cellulose fiber network, forming covalent bonds. The variation in the microstructure and surface elemental distribution of the sizing cellulose paper was further analyzed by scanning electron microscopy (SEM) and energy-dispersive X-ray spectroscopy (EDS). Thermogravimetric analysis (TGA) was conducted to evaluate the improved thermostability of the sizing cellulose paper. These structural improvements, including covalent bond formation and gap filling, contributed to the enhanced hydrophobicity and mechanical properties of the paper. This study provides a convenient and cost-effective approach to enhancing the functional properties of cellulose paper, offering new possibilities for its practical applications in eco-friendly packaging materials, disposable paper products, and high-performance paper-based packaging.

01 Feb 2025·Journal of Pharmaceutical Sciences

In-situ formation and evaluation of N-nitrosamine drug substance related impurities in glycopeptides implying orbitrap mass spectrometry

Article

Author: Shah, Ravi P ; Sharma, Nitish ; Paritala, Sree Teja

Nitrosamines, a class of N-nitroso compounds, have raised significant health concerns due to their established carcinogenicity. ICH M7 enlisted N-nitroso compounds in the so called cohorts of concern due to their carcinogenic effects. Glycopeptides (GPs) are complex molecules composed of peptide and glycan moieties. GPs serve as the last resort for the mitigation of bacterial infections, particularly against gram-positive bacteria. GPs are susceptible to nitrosamine drug substance related impurities (NDSRIs) contamination due to the presence of secondary amine in their core structure. The incidence of formation of NDSRI impurities in GPs could be either during their semi-synthetic route or storage. However, till date, no studies have been reported on the occurrence of NDSRI in GPs which is a pre-requisite. Hence, the current study investigates the plausible mechanisms and detection methods for the NDSRI in GPs. In-situ studies were performed to evaluate the possible formation of NDSRI in GPs. In the current study, GPs of different generations were screened for their potential of forming NDSRI impurities implying nitrosating agent. LC and LCHRMS/MS studies were performed to identify the in-situ generated impurities. Interestingly, the formation of NDSRIs is evident in all the selected GPs. The molecular mechanisms and pathways for individual GPs and respective NDSRIs were elucidated. Interestingly, isomeric NDSRIs were also identified during in-situ generated samples. Using CPCA the potency scores and acceptable intakes for the NDSRIs were evaluated. Thus, this work aims to enhance the safety and efficacy of GPs ensuring compliance with the regulatory standards by advancing the understanding of NDSRIs in GPs.

01 Feb 2025·International Immunopharmacology

Gentiopicroside ameliorates synovial inflammation and fibrosis in KOA rats by modulating the HMGB1-mediated PI3K/AKT signaling axis

Article

Author: Mao, Jun ; Li, Zhenhui ; Liu, Deren ; Wei, Yibao ; Liao, Taiyang ; Kang, Junfeng ; Wang, Peimin ; Jie, Lishi ; Shi, Lei ; Ma, Zhenyuan ; Wu, Peng

BACKGROUNDKnee osteoarthritis (KOA) is a degenerative joint disease characterized by synovial inflammation and fibrosis. Gentiopicroside (GPS), one of the main active ingredients of Gentiana macrophylla, is widely used in anti-inflammatory and anti-fibrotic therapies. However, the exact mechanism by which GPS treats synovial inflammation and fibrosis in KOA remains unclear.METHODSFibroblast-like synoviocytes (FLSs) were stimulated with lipopolysaccharide (LPS) to induce inflammation and fibrosis, and CCK-8 was performed to determine the viability of GPS-treated FLSs, using immunofluorescence to examine the expression of P-PI3K and P-AKT, confocal microscopy was used to identify intracellular HMGB1 translocation. The KOA rat model was established by anterior cruciate ligament transection (ACLT) and subsequently subjected to GPS intervention. Inflammatory cytokines (TNF-α, IL-1β, and IL-6), fibrosis-related indicators (TGF-β, collagen I, TIMP1, and α-SMA), and HMGB1/PI3K/AKT signaling axis-related proteins and gene expression of fibroblast-like synoviocytes and synovial tissues were detected by Western blotting and real-time PCR. The histopathology of the synovium of the rats was assessed using Hematoxylin-eosin (HE), Sirius Red, and Masson staining. Immunohistochemistry was performed to detect the expression of HMGB1, P-PI3K, and P-AKT.RESULTSThe present study revealed that GPS intervention significantly ameliorated inflammation and fibrosis in LPS-stimulated FLSs and KOA rat synovium. Immunofluorescence demonstrated that GPS inhibited the release of HMGB1 from the nucleus. Furthermore, GPS intervention down-regulates the levels of proteins and gene associated with the HMGB1/PI3K/AKT signaling pathway.CONCLUSIONGPS ameliorated synovial inflammation and fibrosis in KOA rats, which may involve HMGB1-mediated activation of the PI3K/AKT signaling axis.

News (Medical) associated with Galinpepimut-S

23 Jan 2025

·ir.sellaslifesciences.com

SELLAS Life Sciences Announces Positive Outcome of Interim Analysis for its Pivotal Phase 3 REGAL Trial of GPS in Acute Myeloid Leukemia

- 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 - NEW YORK, Jan. 23, 2025 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS’’ or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, today announced that Independent Data Monitoring Committee (IDMC) has completed pre-specified interim analysis of the Phase 3 REGAL trial of galinpepimut-S (GPS) in acute myeloid leukemia (AML). Following this interim analysis triggered by 60 events (deaths) in the study population, the IDMC has recommended that the trial continue without modifications. The interim futility, efficacy, and safety analysis is designed to assess whether the therapy is safe, demonstrates potential efficacy, and merits continuation. The IDMC’s review of the interim data supports the continuation of the study according to its original protocol. Based on this positive evaluation, GPS has shown preliminary signals of effectiveness, allowing the trial to advance toward completion. 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. “I am thrilled by the positive outcome of the interim analysis of our Phase 3 REGAL trial, marking the successful achievement of the most significant milestone for our GPS program to date. The IDMC’s recommendation to support the continued advancement of GPS in our REGAL trial brings us one step closer towards potential approval for the treatment of AML,” said Angelos Stergiou, MD, ScD hc, President and Chief Executive Officer of SELLAS. “Based on all available data, we believe that GPS could become a transformative treatment option for AML, offering hope to patients with limited choices, especially those with relapsed or refractory disease. We are optimistic about the IDMC’s recommendation to continue the study without modifications, and diligently preparing for the Biologics License Application (BLA). Importantly, the REGAL trial provides a clear and straightforward path toward seeking regulatory approval for patients with AML in their second complete remission. We look forward to completing the trial with the final analysis to be conducted once 80 events are reached.” The Company is blinded to the trial outcomes, following regulations that safeguard study integrity. However, select blinded data has been presented, revealing that fewer than half of the enrolled patients have been confirmed deceased approximately 10 months after completion of enrollment, and an approximate median follow-up of 13.5 months (range 1 month to more than 3 years). This suggested a pooled median survival exceeding 12 months, compared to the expected survival of approximately 6 months in a similar patient population (patients in second complete remission who did not receive a transplant after the second remission). Separately, a blinded analysis of early immune response in a randomly selected sample of patients receiving GPS showed GPS-specific immune response in 80% of patients. These data are consistent with previous GPS trials. In the Phase 2 study in AML patients in second complete remission, the median overall survival of GPS-treated patients was 21 months versus 5.4 months for patients on standard of care therapy and a GPS-specific immune response of 64%. These promising data have encouraged the Company to continue preparations for the preclinical, clinical, manufacturing, and quality assurance components of the BLA regulatory submission in anticipation of final clinical data. No drug has yet been approved specifically for maintenance of remission in AML patients in CR2, further emphasizing the significance of this development. “The interim results represent a major step forward in the treatment of AML, offering hope for patients in remission,” said Dr. Yair Levy, Director of Hematologic Malignancies Research at Texas Oncology Baylor University Medical Center. “I am very hopeful that we will see a new standard of care in treating AML patients based on the outcomes we have observed in previous GPS trials.” In his comments during a recent webinar on January 8, Dr. Levy also stated, that he believes “that if approved, GPS would be highly accepted by the medical community and patients, and would become a standard-of-care in this high unmet need population. In addition to efficacy, this is also an extremely well-tolerated therapy. GPS efficacy does not come at the cost of quality of life. GPS has been shown to be very safe, with minimal side effects … This is particularly important, given that up to 60% of patients who receive standard therapies experience severe side effects, usually in the form of decreased white blood cell count, platelet count, and red blood cell count. These low counts, or cytopenias, often necessitate frequent hospitalizations or other interventions.” REGAL is a Phase 3 open-label registrational clinical trial for GPS in AML patients who have achieved complete remission following second-line salvage therapy (CR2 patients). The primary endpoint is overall survival. The IDMC is an independent group of medical, scientific, and biostatistics experts who are responsible for reviewing and evaluating patient safety and efficacy data for REGAL, and for monitoring quality and overall conduct to ensure the validity, scientific and clinical merits of the study. The IDMC charter provides for periodic reviews of safety, efficacy, and futility in addition to the interim and final analyses. About SELLAS Life Sciences Group, Inc. SELLAS is a late-stage clinical biopharmaceutical company focused on the development of novel therapeutics for a broad range of cancer indications. SELLAS’ lead product candidate, GPS, is licensed from Memorial Sloan Kettering Cancer Center and targets the WT1 protein, which is present in an array of tumor types. GPS has the potential as a monotherapy and combination with other therapies to address a broad spectrum of hematologic malignancies and solid tumor indications. The Company is also developing SLS009 (formerly GFH009) - potentially the first and best-in-class differentiated small molecule CDK9 inhibitor with reduced toxicity and increased potency compared to other CDK9 inhibitors. Data suggests that SLS009 demonstrated a high response rate in AML patients with unfavorable prognostic factors including ASXL1 mutation, commonly associated with poor prognosis in various myeloid diseases. For more information on SELLAS, please visit www.sellaslifesciences.com. Forward-Looking Statements This press release contains forward-looking statements. All statements other than statements of historical facts are “forward-looking statements,” including those relating to future events. In some cases, forward-looking statements can be identified by terminology such as “plan,” “expect,” “anticipate,” “may,” “might,” “will,” “should,” “project,” “believe,” “estimate,” “predict,” “potential,” “intend,” or “continue” and other words or terms of similar meaning. These statements include, without limitation, statements related to the GPS clinical development program, including the REGAL study and the timing of future milestones related thereto. These forward-looking statements are based on current plans, objectives, estimates, expectations, and intentions, and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties with oncology product development and clinical success thereof, the uncertainty of regulatory approval, and other risks and uncertainties affecting SELLAS and its development programs as set forth under the caption “Risk Factors” in SELLAS’ Annual Report on Form 10-K filed on March 28, 2024 and in its other SEC filings. Other risks and uncertainties of which SELLAS is not currently aware may also affect SELLAS’ forward-looking statements and may cause actual results and the timing of events to differ materially from those anticipated. The forward-looking statements herein are made only as of the date hereof. SELLAS undertakes no obligation to update or supplement any forward-looking statements to reflect actual results, new information, future events, changes in its expectations, or other circumstances that exist after the date as of which the forward-looking statements were made. Investor Contact Bruce Mackle Managing Director LifeSci Advisors, LLC SELLAS@lifesciadvisors.com Media Contact Michael Fitzhugh LifeSci Communications mfitzhugh@lifescicomms.com

Phase 3Phase 2Clinical Result

10 Dec 2024

·www.globenewswire.com

SELLAS Life Sciences Triggers Interim Analysis in Phase 3 REGAL Trial of GPS in Acute Myeloid Leukemia

- Study Reaches Pre-Specified Threshold of 60 Events (Deaths) Initiating the Interim Analysis – - REGAL Independent Data Monitoring Committee to Perform Interim Analysis in January 2025 - - Company to Host Webcast Call Today at 9:00 am ET NEW YORK, Dec. 10, 2024 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS’’ or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, today 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 conduct a thorough review of the current REGAL data, and the interim analysis will provide an assessment of efficacy, futility as well as safety of GPS. “This is an exciting and very important milestone in our efforts to bring forward a new potential treatment option for AML patients,” said Angelos Stergiou, MD, ScD hc, President and Chief Executive Officer of SELLAS. “Our mission at SELLAS is to develop novel therapies that prolong patients’ lives, and the outcome of the interim analysis will hopefully bring us closer to the potential of adding GPS as a powerful ally in the battle against AML. Today, we are here thanks to the unwavering support of our shareholders, dedication of our clinical investigators and the resilience of our patients and their families. The IDMC will now carefully review and analyze all the data and have scheduled a meeting in January to review results to date. We are extremely grateful to everybody who have contributed to the REGAL study, and we look forward to sharing the IDMC’s feedback and recommendations as soon as they become available.” 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. To access the webinar, please use the following information: Date:Tuesday, December 10, 2024Time:9:00 a.m. Eastern TimeWebcast:SELLAS GPS REGAL About SELLAS Life Sciences Group, Inc. SELLAS is a late-stage clinical biopharmaceutical company focused on the development of novel therapeutics for a broad range of cancer indications. SELLAS’ lead product candidate, GPS, is licensed from Memorial Sloan Kettering Cancer Center and targets the WT1 protein, which is present in an array of tumor types. GPS has the potential as a monotherapy and combination with other therapies to address a broad spectrum of hematologic malignancies and solid tumor indications. The Company is also developing SLS009 (formerly GFH009) - potentially the first and best-in-class differentiated small molecule CDK9 inhibitor with reduced toxicity and increased potency compared to other CDK9 inhibitors. Data suggests that SLS009 demonstrated a high response rate in AML patients with unfavorable prognostic factors including ASXL1 mutation, commonly associated with poor prognosis in various myeloid diseases. For more information on SELLAS, please visit www.sellaslifesciences.com. About the GPS Phase 3 REGAL Study REGAL is a Phase 3 open-label registrational clinical trial for GPS in AML patients who have achieved complete remission following second-line salvage therapy (CR2 patients). The primary endpoint is overall survival. The IDMC is an independent group of medical, scientific, and biostatistics experts who are responsible for reviewing and evaluating patient safety and efficacy data for REGAL, and for monitoring quality and overall conduct to ensure the validity, scientific and clinical merits of the study. The IDMC charter provides for periodic reviews of safety, efficacy, and futility in addition to the interim and final analyses. Forward-Looking Statements This press release contains forward-looking statements. All statements other than statements of historical facts are “forward-looking statements,” including those relating to future events. In some cases, forward-looking statements can be identified by terminology such as “plan,” “expect,” “anticipate,” “may,” “might,” “will,” “should,” “project,” “believe,” “estimate,” “predict,” “potential,” “intend,” or “continue” and other words or terms of similar meaning. These statements include, without limitation, statements related to the GPS clinical development program, including the REGAL study and the timing of future milestones related thereto. These forward-looking statements are based on current plans, objectives, estimates, expectations, and intentions, and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties with oncology product development and clinical success thereof, the uncertainty of regulatory approval, and other risks and uncertainties affecting SELLAS and its development programs as set forth under the caption “Risk Factors” in SELLAS’ Annual Report on Form 10-K filed on March 28, 2024 and in its other SEC filings. Other risks and uncertainties of which SELLAS is not currently aware may also affect SELLAS’ forward-looking statements and may cause actual results and the timing of events to differ materially from those anticipated. The forward-looking statements herein are made only as of the date hereof. SELLAS undertakes no obligation to update or supplement any forward-looking statements to reflect actual results, new information, future events, changes in its expectations, or other circumstances that exist after the date as of which the forward-looking statements were made. Investor Contact Bruce MackleManaging DirectorLifeSci Advisors, LLCSELLAS@lifesciadvisors.com Media Contact Michael FitzhughLifeSci Communicationsmfitzhugh@lifescicomms.com

Phase 3

13 Nov 2024

·www.globenewswire.com

SELLAS Life Sciences Reports Third Quarter 2024 Financial Results and Provides Corporate Update

– Pre-specified Events to Trigger Interim Analysis of Phase 3 REGAL Study in Patients with Acute Myeloid Leukemia (AML) Remains on Track for Q4 2024 – – Data from the Phase 2a Trial of SLS009 in Relapsed/Refractory AML After Venetoclax Failure to be Presented at the Upcoming American Society of Hematology (ASH) Annual Meeting in December – – GPS Granted FDA Rare Pediatric Disease Designation (RPDD) for the Treatment of Pediatric AML – NEW YORK, Nov. 13, 2024 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS’’ or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, today reported financial results for the third quarter ended September 30, 2024, and provided a corporate update. “We continue to make considerable progress across our pipeline, and we are particularly excited to announce the updated SLS009 Phase 2a data at ASH in December and to provide topline data from cohorts four and five in patients with relapsed/refractory (R/R) acute myeloid leukemia (AML) this quarter,” said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. “We are extremely grateful to the patients and their families, principal investigators and study teams, SELLAS employees, and all of those who have contributed to our Phase 3 REGAL study of galinpepimut-S (GPS). We are excited to be on the cusp of potentially adding a novel immunotherapy to physicians’ arsenals in their mission to prolong patients’ lives. We are looking forward to the significant milestones on the horizon, with interim analysis from our Phase 3 REGAL study of GPS in AML anticipated in the coming weeks.” Pipeline HighlightsGalinpepimut-S (GPS): Wilms Tumor-1 (WT1) targeting immunotherapeutic Phase 3 REGAL study in AML: In June, the IDMC conducted a prespecified risk-benefit assessment of unblinded data from the study and recommended that the trial continue without modifications. 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. Granted FDA Rare Pediatric Disease Designation (RPDD): The FDA granted Rare Pediatric Disease Designation (RPDD) to GPS for the treatment of pediatric AML. GPS has already demonstrated promise in clinical settings for AML, which could extend to pediatric patients. SLS009: highly selective and specific CDK9 inhibitor ASH Poster Presentation Upcoming December 8, 2024: Phase 2a Study of SLS009, a Highly Selective CDK9 Inhibitor, In Combination with Azacitidine and Venetoclax for Relapsed/Refractory Acute Myeloid Leukemia After Prior Venetoclax Treatment. The study enrolled 30 patients across three dosing levels (DLs) of SLS009:45 mg IV QW, DL2: 60 mg IV QW, and DL3: 30 mg IV BIW. SLS009 was well-tolerated across the DLs tested with no dose-limiting toxicities (DLTs) observed. Among 29 evaluable pts, 16 (55%) had ≥50% reduction in bone marrow (BM) blasts compared to baseline (DL1: 60%; DL2: 33%; DL3: 80%). Nine (31%) patients achieved an overall response (i.e., CR+CRi+MLFS), including 5 (17%) who achieved CR/CRi. The response rates per dose level were 10% in DL1, 33% in DL2, and 50% in DL3. All 9 responders had AML- Myelodysplasia Related (AML-MR) (9/23 of AMLMR pts responded) and 8/15 pts (53%) with somatic MR mutations responded. Among those with ASXL1 mutations, 5/9 (56%) achieved an overall response. 2/9 (22%) with TP53 mutations achieved a response including one patient with concomitant TP53 and ASXL1 mutation who had an ongoing response at data cut-off. Fifteen patients were still alive at the time of the data cutoff and the median OS for the trial has not been reached. Additional Phase 2 Cohorts in Venetoclax Combinations in r/r AML Continue Enrollment: Development of SLS009 continued with the ongoing enrollment of two additional cohorts: AML with myelodysplasia-related changes (AML MRC) with ASXL1 mutations and AML with myelodysplasia-related changes other than ASXL1 mutations. These cohorts are also open for enrollment of certain pediatric patients. Additional topline data updates are expected in the fourth quarter of 2024. National Institute of Health PIVOT program in Pediatric Tumors: The program in multiple pediatric cancer indications continues in collaboration with the National Cancer Institute (NCI). Initial safety and efficacy data are expected to be reported in the fourth quarter of 2024. Recently Granted Regulatory Designations for SLS009: The FDA granted Rare Pediatric Disease Designation (RPDD) to SLS009 for the treatment of pediatric ALL in June 2024 and the FDA granted RPDD to SLS009 for the treatment of pediatric AML in July 2024. Also, the EMA granted Orphan Drug Designation for SLS009 in AML and in PTCL in June 2024 and July 2024, respectively. The FDA previously granted SLS009 Orphan Drug Designations in AML and PTCL and Fast Track designations for r/r AML and r/r PTCL. Financial Results for the Third Quarter 2024: R&D Expenses: Research and development expenses for the quarter ended September 30, 2024, were $4.4 million, compared to $5.8 million for the same period in 2023. The decrease was primarily due to decreases in global clinical supply purchases, consultants, personnel-related expenses due to changes in headcount, and clinical trial expenses. G&A Expenses: General and administrative expenses for the third quarter of 2024 were $3.0 million, compared to $3.5 million for the same period in 2023. The decrease was primarily attributed to personnel-related expenses due to changes in headcount and insurance premiums. Net Loss: The net loss was $7.1 million for the third quarter of 2024, or a basic and diluted loss per share of $0.10, as compared to a net loss of $9.3 million for the third quarter of 2023, or a basic and diluted loss per share of $0.33. The net loss was $24.1 million for the nine months ended September 30, 2024, or a basic and diluted loss per share of $0.42, as compared to a net loss of $29.2 million for the same period in 2023, or a basic and diluted loss per share of $1.09. Cash Position: As of September 30, 2024, cash and cash equivalents totaled approximately $21 million. About SELLAS Life Sciences Group, Inc. SELLAS is a late-stage clinical biopharmaceutical company focused on the development of novel therapeutics for a broad range of cancer indications. SELLAS’ lead product candidate, GPS, is licensed from Memorial Sloan Kettering Cancer Center and targets the WT1 protein, which is present in an array of tumor types. GPS has the potential as a monotherapy and combination with other therapies to address a broad spectrum of hematologic malignancies and solid tumor indications. The Company is also developing SLS009 (formerly GFH009) - potentially the first and best-in-class differentiated small molecule CDK9 inhibitor with reduced toxicity and increased potency compared to other CDK9 inhibitors. Data suggests that SLS009 demonstrated a high response rate in AML patients with unfavorable prognostic factors including ASXL1 mutation, commonly associated with poor prognosis in various myeloid diseases. For more information on SELLAS, please visit www.sellaslifesciences.com. Forward-Looking Statements This press release contains forward-looking statements. All statements other than statements of historical facts are “forward-looking statements,” including those relating to future events. In some cases, forward-looking statements can be identified by terminology such as “plan,” “expect,” “anticipate,” “may,” “might,” “will,” “should,” “project,” “believe,” “estimate,” “predict,” “potential,” “intend,” or “continue” and other words or terms of similar meaning. These statements include, without limitation, statements related to the GPS clinical development program, including the REGAL study and the timing of future milestones related thereto. These forward-looking statements are based on current plans, objectives, estimates, expectations, and intentions, and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties with oncology product development and clinical success thereof, the uncertainty of regulatory approval, and other risks and uncertainties affecting SELLAS and its development programs as set forth under the caption “Risk Factors” in SELLAS’ Annual Report on Form 10-K filed on March 28, 2024 and in its other SEC filings. Other risks and uncertainties of which SELLAS is not currently aware may also affect SELLAS’ forward-looking statements and may cause actual results and the timing of events to differ materially from those anticipated. The forward-looking statements herein are made only as of the date hereof. SELLAS undertakes no obligation to update or supplement any forward-looking statements to reflect actual results, new information, future events, changes in its expectations, or other circumstances that exist after the date as of which the forward-looking statements were made. Investor Contact Bruce Mackle Managing Director LifeSci Advisors, LLC SELLAS@lifesciadvisors.com SELLAS LIFE SCIENCES GROUP, INC.CONSOLIDATED STATEMENTS OF OPERATIONS(Amounts in thousands, except share and per share data)(Unaudited) Three Months Ended September 30, Nine Months Ended September 30, 2024 2023 2024 2023 Operating expenses: Research and development$4,362 $5,813 $14,659 $18,910 General and administrative 2,967 3,548 9,936 10,782 Total operating expenses 7,329 9,361 24,595 29,692 Loss from operations (7,329) (9,361) (24,595) (29,692)Non-operating income: Change in fair value of warrant liability — — — 4 Interest income 221 94 451 484 Total non-operating income 221 94 451 488 Net loss$(7,108) $(9,267) $(24,144) $(29,204) Per share information: Net loss per common share, basic and diluted$(0.10) $(0.33) $(0.42) $(1.09)Weighted-average common shares outstanding, basic and diluted 68,254,021 28,355,427 56,940,617 26,767,914 SELLAS LIFE SCIENCES GROUP, INC.CONSOLIDATED BALANCE SHEETS(Amounts in thousands, except share and per share data)(Unaudited) September 30, 2024 December 31, 2023 ASSETS Current assets: Cash and cash equivalents$21,031 $2,530 Restricted cash and cash equivalents 100 100 Prepaid expenses and other current assets 2,904 542 Total current assets 24,035 3,172 Operating lease right-of-use assets 513 858 Goodwill 1,914 1,914 Deposits and other assets 43 275 Total assets$26,505 $6,219 LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT) Current liabilities: Accounts payable$4,547 $5,639 Accrued expenses and other current liabilities 5,490 7,650 Operating lease liabilities 576 446 Total current liabilities 10,613 13,735 Operating lease liabilities, non-current — 460 Total liabilities 10,613 14,195 Commitments and contingencies Stockholders’ equity (deficit): Common stock, $0.0001 par value; 350,000,000 shares authorized, 64,381,979 and 32,132,890 shares issued and outstanding at September 30, 2024 and December 31, 2023, respectively 6 3 Additional paid-in capital 257,274 209,265 Accumulated deficit (241,388) (217,244)Total stockholders’ equity (deficit) 15,892 (7,976)Total liabilities and stockholders’ equity (deficit)$26,505 $6,219

Phase 2Clinical ResultFast TrackOrphan DrugFinancial Statement

100 Deals associated with Galinpepimut-S

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Acute Myeloid Leukemia	Phase 3	India	SELLAS Life Sciences Group, Inc.	08 Feb 2021
Acute Myeloid Leukemia	Phase 3	Taiwan Province	SELLAS Life Sciences Group, Inc.	08 Feb 2021
Acute Myeloid Leukemia	Phase 3	Serbia	SELLAS Life Sciences Group, Inc.	08 Feb 2021
Acute Myeloid Leukemia	Phase 3	United States	SELLAS Life Sciences Group, Inc.	08 Feb 2021
Acute Myeloid Leukemia	Phase 3	Greece	SELLAS Life Sciences Group, Inc.	08 Feb 2021
Acute Myeloid Leukemia	Phase 3	Poland	SELLAS Life Sciences Group, Inc.	08 Feb 2021
Acute Myeloid Leukemia	Phase 3	France	SELLAS Life Sciences Group, Inc.	08 Feb 2021
Acute Myeloid Leukemia	Phase 3	Spain	SELLAS Life Sciences Group, Inc.	08 Feb 2021
Acute Myeloid Leukemia	Phase 3	Hungary	SELLAS Life Sciences Group, Inc.	08 Feb 2021
Acute Myeloid Leukemia	Phase 3	Germany	SELLAS Life Sciences Group, Inc.	08 Feb 2021

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04229979 (REGAL, GlobeNewswire) Manual	Phase 3	Acute Myeloid Leukemia	-	galinpepimut-S	(hrncvesftv) = syuxybffoh vbvhfxwjtu (gqfxphvrft )	Positive	23 Jan 2025
NCT04229979 (REGAL, GlobeNewswire) Manual	Phase 3	Acute Myeloid Leukemia	-	Conventional Therapy	(hrncvesftv) = jmmgcpqmjq vbvhfxwjtu (gqfxphvrft )	Positive	23 Jan 2025
NCT01266083 (CTgov)	Phase 2	Acute Myeloid Leukemia \| Acute Lymphoblastic Leukemia	22	GM-CSF+Galinpepimut-S	(xmrsazknuz) = txzmuqszgt ywuigwwwqh (flxbnljqws, jywdbbwqdt - nxlpjdbwkz) View more	-	19 Nov 2024
NCT01827137 (CTgov)	Phase 1/2	Multiple Myeloma	20	GM-CSF+Lenalidomide+Galinpepimut-S+bortezomib	vfrdmvdhzi(cemnypwsbh) = ohhpxrzzmr nqzvveguly (nmtifbxygz, osyefqtxbw - farwszxxkk) View more	-	19 Sep 2024
NCT04229979 (REGAL, Biospace) Manual	Phase 3	Acute Myeloid Leukemia Maintenance	-	galinpepimut-S	(wgeyhqmomn) = None ktcymurgxs (nkziuulufk )	Positive	17 Jun 2024
NCT04040231 (GlobeNewswire) Manual	Phase 1	Malignant Pleural Mesothelioma	10	Galinpepimut-S+Opdivo	(iddvxdzznm) = rdnchfudkf jmqzcwjwgh (qkfiplukaj )	Positive	27 Dec 2023
NCT03761914 (Biospace) Manual	Phase 1/2	Ovarian Cancer	17	Pembrolizumab+Galinpepimut-S	(tiqfhcirro) = omjoudoilv tljecdfgmu (zrpsyzwvvu ) View more	Positive	10 Nov 2022
NCT03761914 (Biospace) Manual	Phase 1/2	Ovarian Cancer	17	Pembrolizumab	(tiqfhcirro) = ioetnmodqd tljecdfgmu (zrpsyzwvvu ) View more	Positive	10 Nov 2022
NCT04040231 (Corporate Publications) Manual	Phase 1	Mesothelioma Second line	8	Opdivo+Galinpepimut-S	(ybeootzbsr) = gvcwpilqfw dmplltwism (ckjqrvdtef ) View more	Positive	08 Jun 2022
NCT03761914 (Corporate Publications) Manual	Phase 1/2	Ovarian Cancer WT1 Positive	17	Galinpepimut-S+Pembrolizumab	(kgsjwubmas) = The safety profile of GPS in combination with pembrolizumab was similar to pembrolizumab alone, with the only addition of low-grade rapidly resolving local reactions at the GPS injection site, consistent with observations from other GPS clinical studies. godxpfeelw (mggcquclzx ) View more	Positive	26 May 2022
NCT03761914 (Corporate Publications) Manual	Phase 1/2	Ovarian Cancer WT1 Positive	17	Pembrolizumab		Positive	26 May 2022
NCT01827137 (EBMT2018)	Phase 2	Multiple Myeloma Maintenance WT1	18	Galinpepimut-S	(hsgofpymru) = gvxwyxnmxh cuhisndrxe (tmgpabfeyr ) View more	-	24 Sep 2018

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