Financial Performance - The company incurred a net loss of $5.81 million for the three months ended March 31, 2025, an improvement compared to a net loss of $9.57 million for the same period in 2024, reflecting a reduction of about 39%[17]. - Total operating expenses decreased to $6.06 million in Q1 2025 from $9.65 million in Q1 2024, marking a decline of approximately 37%[17]. - The net loss for Q1 2025 was $5.8 million, compared to a net loss of $9.6 million in Q1 2024, reflecting an improvement of approximately 39.2%[121]. - Non-operating income increased to $0.3 million in Q1 2025 from $0.1 million in Q1 2024, marking a growth of 200%[127]. - The net cash used in operating activities was $9.1 million in Q1 2025, compared to $10.8 million in Q1 2024, indicating a reduction of approximately 15.8%[137][138]. Assets and Financing - As of March 31, 2025, the company reported total assets of $34.96 million, a significant increase from $19.43 million as of December 31, 2024, representing a growth of approximately 80%[15]. - Cash and cash equivalents at the end of Q1 2025 were approximately $28.4 million, up from $13.9 million at the end of 2024, indicating a growth of about 104%[31]. - The company has an accumulated deficit of $253.94 million as of March 31, 2025, compared to $248.13 million at the end of 2024[15]. - The company expects its cash and cash equivalents will not be sufficient to fund operations for at least the next twelve months, raising substantial doubt about its ability to continue as a going concern[132]. - The company requires substantial additional financing to develop current or future product candidates, with no current commitments for additional funds[34]. Research and Development - The company’s lead product candidate, galinpepimut-S (GPS), targets the Wilms Tumor 1 (WT1) protein, with potential applications in various cancer types[26]. - The company anticipates an increase in research and development expenses as it conducts ongoing clinical trials and initiates new ones[114]. - Research and development expenses decreased to $3.2 million in Q1 2025 from $5.1 million in Q1 2024, a reduction of approximately 37.2%[122]. - The company has received $10.5 million in upfront payments under the 3D Medicines Agreement, with potential future milestones totaling $191.5 million[30]. - The REGAL study for GPS monotherapy in AML has enrolled 126 patients across 95 clinical sites, with an interim analysis planned after 60 events (deaths) and a final analysis after 80 events[96]. Stock and Equity - The company reported a weighted-average common shares outstanding of 87,760,320 for Q1 2025, compared to 44,812,996 for Q1 2024[17]. - As of March 31, 2025, the Company reported a net loss per share, with potentially dilutive securities outstanding totaling 82,823,000 shares, compared to 44,695,000 shares in the same period of 2024[51]. - The Company has total common stock reserved for future issuance amounting to 84,209,000 shares as of March 31, 2025[67]. - The company granted 817 stock options during the three months ended March 31, 2025, with an average exercise price of $0.95[84]. - As of March 31, 2025, approximately 1,356,000 shares were reserved for future grants under the 2023 Amended and Restated Equity Incentive Plan[80]. Clinical Trials and Product Development - SLS009, a CDK9 inhibitor, completed a Phase 1 trial with positive safety and efficacy data, establishing a recommended Phase 2 dose of 60 mg once weekly for AML[102]. - In the Phase 2a trial of SLS009, the overall response rate (ORR) in Cohort 3 was 46%, exceeding the targeted ORR of 20%[106]. - The median overall survival (mOS) for patients in Cohort 3 was 8.8 months, with mOS for AML MR patients reaching 8.9 months[106]. - SLS009 demonstrated a high response rate of 67% in patients with ASXL1 mutations, indicating its potential as a targeted therapy[106]. - The FDA granted Orphan Drug Designations for SLS009 in AML and PTCL, and Fast Track designations for r/r AML and r/r PTCL[111]. Expenses and Liabilities - General and administrative expenses are expected to rise as the company prepares for potential commercialization of product candidates[118]. - General and administrative expenses fell to $2.9 million in Q1 2025 from $4.5 million in Q1 2024, representing a decrease of about 35.6%[126]. - The Company’s operating lease liabilities as of March 31, 2025, amount to $870,000, with future minimum lease payments totaling $952,000[60]. - The Company’s weighted average discount rate for operating leases is approximately 13%[58]. - Accrued expenses and other current liabilities decreased to $2,571,000 as of March 31, 2025, from $5,466,000 as of December 31, 2024[54]. Licensing and Agreements - The Company has an exclusive license agreement with GenFleet Therapeutics, involving an upfront fee of $10 million and potential milestone payments totaling up to $140 million[62]. - The company recognized an initial transaction price of $9.5 million from the exclusive license agreement with 3D Medicines Inc., including a $7.5 million upfront payment and $2.0 million in development milestones[75]. - There is a potential future revenue of $191.5 million in development, regulatory, and sales milestones remaining under the 3D Medicines Agreement as of March 31, 2025[76]. - The company has not recognized any royalty revenue from licensing arrangements during the three months ended March 31, 2025[77]. Other Information - The company is currently evaluating the impact of new accounting standards on its financial disclosures, with no material impact expected upon adoption[52][53]. - No unregistered sales of equity securities reported[154]. - No defaults upon senior securities reported[155]. - No mine safety disclosures applicable[156]. - No changes in trading plans by directors or officers during the quarter ended March 31, 2025[157].

Core Insights - SLS009 (tambiciclib) shows potential in overcoming resistance to the azacitidine-venetoclax regimen in TP53 mutated Acute Myeloid Leukemia (AML) cells, with promising preclinical efficacy data presented at the AACR conference [1][2][3] Company Overview - SELLAS Life Sciences Group, Inc. is a late-stage clinical biopharmaceutical company focused on developing novel therapies for various cancer indications, with SLS009 being a key candidate [7] Preclinical Findings - SLS009, a selective CDK9 inhibitor, can induce apoptosis in TP53 mutated AML cells by targeting proteins like MCL-1 and survivin, achieving up to 97% reduction in leukemia cell populations when combined with azacitidine-venetoclax, and up to 80% as a monotherapy [2][3] - Immunoblot analysis indicates near-complete removal of targeted proteins within 8 hours of SLS009 exposure [2] Clinical Trial Progress - SLS009 is currently in Phase 2 clinical trials for relapsed or refractory AML, showing a median overall survival (mOS) of 8.8 months for all patients and 8.9 months for AML myelodysplasia-related changes (MRC) patients, significantly exceeding the historical benchmark of 2.5 months [3][6] - Response rates among patients with specific mutations include 67% for ASXL1, 60% for RUNX1, and 33% for TP53 [3] Expert Commentary - Experts highlight the significance of SLS009 in addressing the unmet needs of TP53 mutated AML, which has poor outcomes even with existing therapies [4]

Core Viewpoint - SELLAS Life Sciences Group, Inc. is set to present preclinical efficacy data of SLS009 (tambiciclib) in ASXL1 mutated colorectal cancer at the 2025 ASCO Annual Meeting, highlighting its potential in cancer treatment [1][2]. Group 1: Product Development - SLS009 is currently undergoing a Phase 2 open-label, single-arm, multi-center study to evaluate its safety, tolerability, and efficacy in combination with venetoclax and azacitidine for AML patients with ASXL1 mutations [3]. - The study aims to identify biomarkers for the target patient population and enrich further trials [3]. - Initial clinical safety and efficacy data for SLS009 have been made available [3]. Group 2: Company Overview - SELLAS is a late-stage clinical biopharmaceutical company focused on developing novel therapeutics for various cancer indications [4]. - The lead product candidate, GPS, targets the WT1 protein and has potential applications in both monotherapy and combination therapy for hematologic malignancies and solid tumors [4]. - SLS009 is positioned as a potentially first and best-in-class small molecule CDK9 inhibitor, showing a high response rate in AML patients with unfavorable prognostic factors, including ASXL1 mutations [4].

Core Insights - SELLAS Life Sciences Group, Inc. announced promising results from Cohort 3 of the Phase 2 trial for SLS009, a CDK9 inhibitor, showing a median overall survival (mOS) of 8.9 months in patients with AML-MRC and 8.8 months in all relapsed or refractory patients, significantly surpassing the historical benchmark of 2.5 months [1][2] - The overall response rate (ORR) achieved was 67% in AML-MRC patients and 46% in all evaluable patients, exceeding the targeted ORR of 20% [1][2] Company Overview - SELLAS is a late-stage clinical biopharmaceutical company focused on developing novel therapies for various cancer indications, with SLS009 being a key candidate [7] - The company aims to address critical unmet medical needs in heavily pretreated AML patients, particularly those with adverse genetic mutations [2][7] Trial Details - The ongoing Phase 2 trial is an open-label, single-arm, multi-center study evaluating the safety, tolerability, and efficacy of SLS009 in combination with venetoclax and azacitidine [6] - The trial has expanded to include additional cohorts targeting specific mutations, including ASXL1, to further validate the therapy's potential [6] Patient Characteristics - In Cohort 3, 14 patients were treated, with 71% having AML-MRC and a median age of 71 years [5] - The cohort included patients with various mutations, with a median of 1 prior failed therapy [5] Efficacy Results - The mOS for all patients in Cohort 3 was 8.8 months, with a 67% ORR in AML-MRC patients and 46% in all evaluable patients [5] - Specific mutation responses included 75% in myelomonocytic AML, 67% in ASXL1, 60% in RUNX1, and 33% in TP53 [5] Safety Profile - SLS009 was well-tolerated with no new safety signals observed, indicating a favorable safety profile in the patient population [5]

Financial Performance - SELLAS reported a net loss of $30.9 million for the year ended December 31, 2024, compared to a net loss of $37.3 million for 2023, representing a 17.5% improvement [13]. - The total operating expenses for 2024 were $31.5 million, down from $37.9 million in 2023, reflecting a decrease of 16.8% [19]. - As of December 31, 2024, cash and cash equivalents totaled approximately $13.9 million, up from $2.5 million in 2023 [14]. - SELLAS raised $25 million in gross proceeds from a registered direct offering in January 2025, strengthening its financial position [8]. Research and Development - Research and development expenses decreased to $19.1 million in 2024 from $24.0 million in 2023, a reduction of 20.4% primarily due to lower clinical trial and manufacturing costs [11]. - SELLAS received multiple regulatory designations in 2024, including three FDA Rare Pediatric Disease Designations and one FDA Fast Track Designation for its therapies [10]. - The company completed enrollment in the Phase 2a trial of SLS009 in r/r AML ahead of schedule, enrolling 30 patients across five centers in the US [9]. Clinical Outcomes - The overall response rate (ORR) for SLS009 in AML patients with myelodysplasia-related changes was 56%, exceeding the pre-specified target ORR of 33% [4]. - The median overall survival (mOS) for SLS009 in AML patients has not been reached but exceeds 7.7 months, compared to a historical mOS of approximately 2.5 months [9]. - The interim analysis of the Phase 3 REGAL trial of GPS in AML indicated a median survival of over 13.5 months, significantly higher than the historical median survival of 6 months for conventional therapy [5].

Core Insights - SELLAS Life Sciences Group, Inc. announced positive interim analysis results for its Phase 3 REGAL trial of Galinpepimut-S (GPS) in Acute Myeloid Leukemia (AML), with the final analysis expected in 2025 [1][3] - The company reported promising data from the ongoing Phase 2 trial of SLS009 (Tambiciclib) in relapsed/refractory AML, with an overall response rate of 56% and a median overall survival exceeding 7.7 months [2][12] - SELLAS raised $25 million in gross proceeds from a registered direct offering in January 2025, enhancing its financial position [5][6] Clinical Development - The REGAL trial of GPS has shown preliminary signals of effectiveness, with fewer than 50% of enrolled patients confirmed deceased after a median follow-up of 13.5 months, indicating a median survival of over 13.5 months compared to the historical median of 6 months for conventional therapies [3] - The Phase 2 trial of SLS009 in AML has exceeded its prespecified target overall response rate of 33%, demonstrating a 56% response rate in patients with myelodysplasia-related changes [2][12] - Multiple regulatory designations were granted to SELLAS' programs in 2024, including FDA Rare Pediatric Disease Designations and Fast Track Designation, which may accelerate development and approval processes [2][8] Financial Performance - Research and development expenses for the year ended December 31, 2024, were $19.1 million, a decrease from $24.0 million in 2023, primarily due to reduced clinical trial expenses and a decrease in headcount [9] - General and administrative expenses decreased to $12.4 million in 2024 from $13.9 million in 2023, attributed to lower employee-related expenses and outside services [10] - The net loss for the year ended December 31, 2024, was $30.9 million, or a loss per share of $0.50, compared to a net loss of $37.3 million and a loss per share of $1.34 in 2023 [11][18] Cash Position - As of December 31, 2024, cash and cash equivalents totaled approximately $13.9 million, bolstered by the $25 million raised in January 2025 [13][5] Regulatory Achievements - The company received several regulatory designations for its therapies, including FDA Rare Pediatric Disease Designation for pediatric AML and EMA orphan drug designation for AML and peripheral T-cell lymphoma [8]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 ________________________________ FORM 10-K ________________________________ (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________ to _________ Commission File Number: 001-33958 SELLAS Life Sciences G ...

HIGHLIGHTS: Solaris has formed an Inter-Institutional working group with the Arutam Shuar People (“PSHA”), ratified through the signing of a Letter of Intent (“LOI”) The Company has formed an Inter-Institutional working group with the PSHA, together with our host communities of Warints and Yawi and the Ecuadorian StateThe PSHA and its Governing Council ratified this process through the signing of a LOI aimed at advancing dialogue in order to reach a future cooperation agreement Expanded Infill resource dri ...

- Combination Achieved a 67% of Overall Response Rate, More than Double that of Zanubrutinib Alone; 83% Disease Control Rate in Difficult-to-Treat Non-GCB DLBCL (ABC DLBCL) Patients - - Median Overall Survival Not Reached Yet – 67% of Patients Still Alive - NEW YORK, Feb. 20, 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 ...

NEW YORK, Jan. 28, 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 it has entered into a securities purchase agreement with a single healthcare-focused institutional investor for the purchase and sale of 19,685,040 shares of its common stock (or common stock equivalents in lieu thereof) and warrants to ...