Core Viewpoint - SELLAS Life Sciences Group, Inc. is advancing its Phase 3 REGAL trial for GPS as a potential maintenance therapy in patients with acute myeloid leukemia (AML) after second complete remission, with the trial currently reporting 72 events as of December 26, 2025, and awaiting the 80 events needed for final analysis [1][3][7] Group 1: Trial Update - The Independent Data Monitoring Committee (IDMC) recommended that the Phase 3 REGAL trial continue without modification, with expectations that the required 80 events (deaths) for final analysis would occur before year-end [2] - As of December 26, 2025, the trial has recorded 72 events, and SELLAS remains blinded to all efficacy and survival data outcomes, meaning this update does not affect future statistical analyses [3][7] - The final analysis is event-driven, and the company will announce when the 80th event occurs [3][7] Group 2: Company Commitment and Expert Insights - The CEO of SELLAS expressed appreciation for the dedication of participants in the REGAL trial, noting that survival times appear longer than expected, which may increase the probability of a successful study [4] - Dr. Yair Levy, a member of the REGAL Steering Committee, highlighted the significance of the REGAL study in evaluating GPS for AML patients who cannot undergo transplant, with an expected median overall survival of around eight months for current treatments [4] - The company is committed to advancing breakthrough therapies like GPS that have the potential to significantly improve patient outcomes in AML [4] Group 3: About the REGAL Trial - The REGAL trial (NCT04229979) is a Phase 3 randomized registrational clinical trial for GPS in AML patients who have achieved complete remission following second-line salvage therapy [5] - The primary endpoint of the trial is overall survival, and the IDMC is responsible for monitoring patient safety and efficacy data [5] Group 4: About SELLAS Life Sciences - SELLAS is a late-stage clinical biopharmaceutical company focused on developing novel therapeutics for various cancer indications, with its lead product candidate GPS targeting the WT1 protein present in multiple tumor types [6] - The company is also developing SLS009, a differentiated small molecule CDK9 inhibitor, which has shown a high response rate in AML patients with unfavorable prognostic factors [8]

Core Insights - SELLAS Life Sciences Group, Inc. announced promising clinical data for SLS009, a CDK9 inhibitor, in combination with azacitidine and venetoclax for treating relapsed or refractory acute myeloid leukemia with myelodysplastic syndrome-related changes [1][3] Group 1: Clinical Study Details - The Phase 2 study involved 35 evaluable patients with a median age of 69, where 98% had ELN adverse-risk AML, with common mutations including ASXL1, RUNX1, TP53, and SRSF2 [2] - The overall response rate for SLS009 in combination with AZA/VEN was 46%, with 29% achieving complete response (CR) or CR with incomplete blood count recovery (CRi) [3] - Patients with ASXL1 and TP53 mutations had response rates of 48% and 57%, respectively, with median overall survival (mOS) significantly exceeding the expected 2.6 months [3] Group 2: Safety and Tolerability - No dose-limiting toxicities (DLTs) or treatment-related deaths were reported, indicating that the combination therapy was well tolerated [3][5] - The combination therapy demonstrated a median overall survival of 8.9 months in the least pretreated cohort, with a 58% response rate in patients with one prior line of therapy [5] Group 3: Future Plans and Implications - The company plans to expand the study to evaluate SLS009 plus AZA/VEN in newly diagnosed AML with high-risk features in Q1 2026 [5] - The results suggest that SLS009 may effectively overcome resistance to venetoclax-based regimens by targeting MCL-1, a key resistance mechanism in AML [4]

Core Insights - Several small-cap healthcare and biotech companies experienced significant price increases in after-hours trading following earnings updates or upcoming financial disclosures [1] Company Summaries - MacroGenics, Inc. (MGNX) saw a 10.2% rise to $1.62 after hours, recovering from a 3.29% decline during the regular session. The company reported a third-quarter net income of $16.8 million, or $0.27 per share, down from $56.3 million, or $0.90 per share, year-over-year. Revenue fell to $72.8 million from $110.7 million [2] - SELLAS Life Sciences Group, Inc. (SLS) advanced 9.4% to $1.63 in after-hours trading. The company narrowed its quarterly net loss to $6.8 million, or $0.06 per share, compared to $7.1 million, or $0.10 per share, in the prior-year quarter. As of September 30, 2025, SELLAS reported cash and equivalents of approximately $44.3 million [3] - Standard BioTools Inc. (LAB) increased by 4.24% to $1.23 after hours, despite no official press releases or updates on Wednesday. The stock had closed slightly lower during the regular session [4] - KORU Medical Systems, Inc. (KRMD) gained 8.47% to $4.10 after hours, following a 1.34% increase earlier in the day. The company reported a narrower net loss of $0.8 million for the third quarter, compared to $1.6 million in the prior-year period. Revenue rose 27.2% to $10.4 million. KORU also raised its full-year revenue guidance to a range of $40.5 million - $41.0 million and reaffirmed its gross margin outlook of 61%-63% [5] - Hyperfine, Inc. (HYPR) climbed 8.18% to $1.19 after hours. No new announcements were made on Wednesday, but the company is scheduled to release its third-quarter results on Thursday, with analysts anticipating a loss of $0.10 per share and revenue of $3.52 million [6] - Wave Life Sciences Ltd. (WVE) added 5.68% to reach $7.35 in after-hours trading. The company reported a third-quarter net loss of $53.9 million, an improvement from $61.8 million in the prior-year quarter. Revenue for the period was $7.6 million, compared to a negative revenue figure of ($7.7) million last year [7]

Financial Performance - SELLAS reported a net loss of $6.8 million for Q3 2025, a decrease from a net loss of $7.1 million in Q3 2024, resulting in a basic and diluted loss per share of $0.06 compared to $0.10 in the prior year[12][19]. - General and administrative expenses for Q3 2025 were $2.9 million, slightly down from $3.0 million in Q3 2024, with total G&A expenses for the nine months ended September 30, 2025, at $8.7 million compared to $9.9 million in the prior year[11][19]. - The total operating expenses for Q3 2025 were $7.1 million, a decrease from $7.3 million in Q3 2024, with total operating expenses for the nine months ended September 30, 2025, at $20.0 million compared to $24.6 million in 2024[19]. Research and Development - Research and development expenses for Q3 2025 were $4.2 million, down from $4.4 million in Q3 2024, with total R&D expenses for the nine months ended September 30, 2025, at $11.3 million compared to $14.7 million for the same period in 2024[10][19]. - Positive Phase 2 data for SLS009 in relapsed or refractory AML has been accepted for presentation at the ASH Annual Meeting in December 2025, with a new trial for first-line AML patients expected to begin in Q1 2026[5][6]. - Preclinical data on SLS009 presented at ESMO 2025 showed significant survival benefits in T-PLL, supporting its therapeutic potential across multiple hematologic malignancies[7]. Financial Position - As of September 30, 2025, cash and cash equivalents totaled approximately $44.3 million, with an additional $29.1 million received from warrant exercises in October 2025[14][9]. - SELLAS received approximately $54.6 million in gross proceeds from warrant exercises in September and October 2025, enhancing its financial position[9]. Clinical Trials - The Phase 3 REGAL trial of GPS is on track, with the final analysis expected by year-end 2025 after reaching 80 events (deaths)[4]. Company Outlook - The company is entering a transformative period of growth and value creation, bolstered by a strong financial foundation and multiple upcoming catalysts[3].

Core Insights - SELLAS Life Sciences Group, Inc. reported positive developments in its clinical programs, particularly for SLS009 and GPS, with significant upcoming milestones and a strong financial position [1][2][3] Financial Performance - As of September 30, 2025, the company had cash and cash equivalents totaling approximately $44.3 million, with an additional $29.1 million received from warrant exercises in October 2025 [1][11] - Research and development expenses for Q3 2025 were $4.2 million, a decrease from $4.4 million in Q3 2024, primarily due to reduced clinical trial expenses [8] - General and administrative expenses for Q3 2025 were $2.9 million, slightly down from $3.0 million in Q3 2024, attributed to lower professional fees [9] - The net loss for Q3 2025 was $6.8 million, or a loss per share of $0.06, compared to a net loss of $7.1 million, or $0.10 per share, in Q3 2024 [10][16] Clinical Developments - The Phase 3 REGAL trial of GPS is progressing as planned, with a final analysis expected by year-end 2025 after reaching 80 events [3] - Positive Phase 2 data for SLS009 in relapsed/refractory AML has been accepted for presentation at the ASH Annual Meeting in December 2025, with plans for an 80-patient trial in newly diagnosed AML patients expected to start in Q1 2026 [4][6] - Preclinical data presented at ESMO 2025 showed significant survival benefits of SLS009 in T-cell prolymphocytic leukemia (T-PLL), supporting its potential across various hematologic malignancies [5] Corporate Events - A virtual R&D Day was held on October 29, 2025, showcasing the company's ongoing clinical trials and receiving positive feedback from key opinion leaders [6] - The company raised approximately $54.6 million in gross proceeds from warrant exercises in September and October 2025, enhancing its financial foundation [7]

Financial Performance - Net loss for the three months ended September 30, 2025, was $6,791,000, a decrease from $7,108,000 in the same period of 2024, reflecting a 4.5% improvement[17] - The company incurred a net loss of $19.2 million during the nine months ended September 30, 2025, with cash used in operations amounting to $23.5 million[37] - The accumulated deficit as of September 30, 2025, was $267.3 million, indicating ongoing financial challenges[37] - The company anticipates continued operating losses and negative cash flows for the next few years, necessitating additional funding to support operations[37] Assets and Liabilities - Total current assets increased to $49,051,000 as of September 30, 2025, compared to $16,327,000 on December 31, 2024, representing a 200% increase[15] - Cash and cash equivalents at the end of the period increased to $44,320,000 from $13,886,000 at the end of 2024, marking a 219% increase[15] - Total stockholders' equity rose to $45,630,000 as of September 30, 2025, compared to $9,465,000 at the end of 2024, indicating a 382% increase[15] - Total liabilities decreased to $5,925,000 as of September 30, 2025, from $9,967,000 at the end of 2024, indicating a 40.9% reduction[15] Cash Flow and Financing Activities - Net cash used in operating activities for the nine months ended September 30, 2025, was $23,468,000, a decrease from $28,249,000 in the same period of 2024, showing a 16.5% improvement[24] - Proceeds from the issuance of common stock and warrants amounted to $23,051,000 for the nine months ended September 30, 2025, compared to $46,093,000 in the same period of 2024[24] - The company generated $53.9 million in net cash from financing activities during the nine months ended September 30, 2025, compared to $46.8 million for the same period in 2024[154][155] - The company expects its cash and cash equivalents, along with the net proceeds from the October 2025 Inducement, to fund operations for at least the next twelve months[35] Research and Development - Research and development expenses for the nine months ended September 30, 2025, were $11,292,000, down 23.5% from $14,659,000 in the same period of 2024[17] - The company anticipates an increase in research and development expenses as it prepares for a potential BLA filing for GPS and trials for newly diagnosed AML patients[134] - Research and development expenses for Q3 2025 were $4.2 million, a decrease from $4.4 million in Q3 2024, while nine-month expenses were $11.3 million compared to $14.7 million in the prior year[129][130][132] Stock and Equity - The weighted-average common shares outstanding increased to 108,396,260 for the three months ended September 30, 2025, from 68,254,021 in the same period of 2024, reflecting a 58.8% increase[17] - The Company has a total of 68,057 thousand potentially dilutive securities outstanding as of September 30, 2025, which are excluded from the diluted net loss per share calculation[55] - The Company has granted 1,241,000 restricted stock units (RSUs) during the nine months ended September 30, 2025, with an average grant date fair value of $0.96[96] Agreements and Milestones - The Company entered into an exclusive license agreement with GenFleet Therapeutics, involving an upfront payment of $10 million and potential milestone payments totaling up to $140 million[68] - The Company has potential future milestone payments of $191.5 million under the 3D Medicines Agreement, contingent on development and regulatory achievements[34] - The Company recognized an initial transaction price of $9.5 million under the 3D Medicines Agreement, including a $7.5 million upfront fee[80] Clinical Trials and Designations - GPS has received Orphan Drug Designations from the FDA for AML, malignant pleural mesothelioma, and multiple myeloma, as well as Fast Track designations for AML, MPM, and MM[107] - SLS009 completed a Phase 1 clinical trial in mid-2023, showing positive safety and efficacy data for relapsed and/or refractory AML and refractory lymphoma, with recommended Phase 2 doses of 60 mg weekly for AML and 100 mg weekly for lymphomas[110] - In July 2025, the Phase 2 trial of SLS009 in r/r AML met all primary endpoints, achieving an overall response rate of 33% across 54 evaluable patients, with 44% in AML MR patients[114] General and Administrative Expenses - General and administrative expenses for Q3 2025 were $2.9 million, down from $3.0 million in Q3 2024, primarily due to a decrease in legal fees[135] - General and administrative expenses decreased by $1.2 million to $8.7 million for the nine months ended September 30, 2025, compared to $9.9 million for the same period in 2024[136]

Core Insights - The article discusses the impact of fake news on publicly traded companies, highlighting a recent incident involving Papa John's International Inc. and comparing it to past cases of market manipulation through false reports [1]. Group 1: Papa John's Incident - A false report claimed a $65-per-share acquisition offer from TriArtisan Capital Advisors, leading to significant stock volatility for Papa John's [8]. - The stock rose 18% intraday but ultimately settled 7.04% higher at $43.97, with a subsequent after-hours decline of 0.38% [8]. - Year-to-date, the stock has advanced 1.59%, but it has fallen 17.63% over the year [8]. Group 2: Vinci SA Case - In November 2016, Vinci SA's stock plummeted over 18% due to a fake press release claiming the firing of its CFO and the discovery of €3.5 billion in hidden losses [2][3]. - The company denied the claims, and the stock recovered, but the incident temporarily erased billions in market value [3]. Group 3: Avon Products Hoax - In May 2015, a fraudulent filing to the SEC claimed a non-existent firm intended to buy Avon Products for $18.75 per share, causing a 20% spike in stock price [4][5]. - The surge led to multiple trading halts before Avon confirmed the offer was false, revealing vulnerabilities in the SEC's filing system [5]. Group 4: Galena Biopharma Scheme - A 2017 SEC complaint detailed a "pump-and-dump" scheme involving Galena Biopharma, now Sellas Life Sciences Group Inc., where writers were paid to publish bullish articles, driving the stock price up by over 900% [6][7]. - This operation aimed to mislead both human investors and trading algorithms by creating the illusion of independent analyses [7].

Core Insights - Solaris Resources Inc. announced the results of a Pre-Feasibility Study (PFS) for its Warintza Project, highlighting a significant increase in mineral resources and the establishment of maiden mineral reserves [2][5][28] - The Warintza Project is positioned to capitalize on a tightening copper market, with exceptional economics and a strong community support framework [4][6][20] Mineral Resource and Reserves - The updated Mineral Resource Estimate (2025 MRE) includes 3.7 billion tonnes of Measured and Indicated Resources, 2.1 billion tonnes of Inferred Resources, and 1.3 billion tonnes of Mineral Reserves [5][26] - The 2025 MRE reflects a 312% increase in Measured plus Indicated Mineral Resources compared to the 2024 MRE, with significant new mineralization identified [26][39] Economic Metrics - The project is expected to generate an average annual copper equivalent production of over 300,000 tonnes in the first five years and over 240,000 tonnes during the first 15 years [7][14] - The post-tax net present value (NPV) is estimated at US$4,617 million, with a post-tax internal rate of return (IRR) of 26% [7][29] - Initial capital costs are projected at US$3.7 billion, with a payback period of 2.6 years post-tax [7][29] Production and Operating Costs - The average All-In Sustaining Cost (AISC) is projected at US$0.85 per pound of payable copper for the first five years and US$1.07 for the first 15 years [7][29] - The project will utilize conventional open-pit mining methods, with a low strip ratio of 0.53 to 1, enhancing its economic viability [24][46] Community and Environmental Engagement - The company has established formal agreements with local Indigenous communities, ensuring shared benefits and participatory decision-making [20][21] - Solaris maintains close engagement with government authorities to facilitate permitting and environmental assessments [22][36] Infrastructure and Accessibility - The Warintza Project benefits from strong existing infrastructure, including paved highways and proximity to ports, which supports efficient transportation of materials [19][58] - The power supply for the project will be sourced from a 62.1 km overhead transmission line, ensuring adequate energy for operations [59]

Core Insights - SELLAS Life Sciences Group, Inc. is advancing its late-stage clinical biopharmaceutical development, particularly focusing on SLS009 for relapsed or refractory acute myeloid leukemia (r/r AML) [1][2] - The Phase 2 study of SLS009 will be presented at the upcoming ASH Annual Meeting, highlighting its potential in combination with azacitidine and venetoclax [1][3] - The company emphasizes the growing evidence supporting SLS009's efficacy across hematologic malignancies, with preclinical data demonstrating its cytotoxic effects on AML cell lines [2][4] Company Overview - SELLAS is a late-stage clinical biopharmaceutical company dedicated to developing novel therapies for various cancer indications, with a lead product candidate, GPS, targeting the WT1 protein [4] - SLS009, a CDK9 inhibitor, is positioned as a potentially first-in-class treatment with reduced toxicity and increased potency compared to existing CDK9 inhibitors [4] - The company aims to address significant unmet needs in treating difficult-to-manage cancers, particularly in patients with unfavorable prognostic factors like ASXL1 mutations [4]

Core Points - SELLAS Life Sciences hosted an R&D Day to discuss advancements and future directions in their research and development efforts [1][2] - The agenda included opening remarks by the CEO, followed by discussions on the AML treatment landscape and the company's product offerings [2][3] Group 1: Company Overview - The company is focused on addressing unmet needs in the treatment of Acute Myeloid Leukemia (AML) [2] - GPS and SLS009 are positioned within the current standards of care for AML [2] Group 2: Research and Development - Dr. Omer Jamy provided context on the AML treatment landscape, highlighting areas of unmet need [2] - Dr. Panagiotis Tsirigotis and Dr. Dragan Cicic discussed the mechanism of action and differentiation of GPS, along with details of the Phase III REGAL trial [3]