Company Overview - SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) is a clinical-stage biopharmaceutical company focused on developing cancer therapies, particularly for hematologic malignancies [1] - The company's pipeline includes two candidates: Galinpepimut-S (GPS) and SLS009 (tambiciclib) [1] Product Pipeline - Galinpepimut-S (GPS) is an immunotherapy currently in Phase 3 clinical trials for acute myeloid leukemia (AML) [1] - SLS009 (tambiciclib) is another candidate in the company's pipeline, although specific details about its development stage are not provided [1]

[Corporate Highlights & Pipeline Update](index=1&type=section&id=Corporate%20Highlights%20%26%20Pipeline%20Update) SELLAS advanced its AML pipeline with positive SLS009 Phase 2 results and a positive IDMC recommendation for REGAL [Phase 3 REGAL Trial of GPS](index=1&type=section&id=Phase%203%20REGAL%20Trial%20of%20GPS) The IDMC recommended continuing the Phase 3 REGAL trial for GPS in AML, with final data expected by year-end 2025 - The IDMC issued a positive recommendation to continue the Phase 3 REGAL trial of GPS in AML without modification, identifying no safety concerns[5](index=5&type=chunk) - The final analysis of the REGAL trial is expected by year-end 2025, contingent on reaching 80 patient deaths[5](index=5&type=chunk) [Phase 2 Trial of SLS009 in r/r AML](index=1&type=section&id=Phase%202%20Trial%20of%20SLS009%20in%20r%2Fr%20AML) The Phase 2 SLS009 trial in r/r AML met all primary endpoints, showing a **44% response rate** and **8.9-month mOS** in AML-MRC patients - The trial met all primary endpoints, with a **44% response rate** in patients with Acute Myeloid Leukemia-Myelodysplasia-Related Changes (AML-MRC), exceeding the 20% target[7](index=7&type=chunk) - Median overall survival (mOS) was **8.9 months** in AML-MRC patients and **8.8 months** in patients refractory to venetoclax-based regimens, far exceeding the historical benchmark of **2.4 months**[7](index=7&type=chunk) [SLS009 Future Development](index=2&type=section&id=SLS009%20Future%20Development) The FDA recommended advancing SLS009 into a first-line AML trial, with an **80-patient study** planned for Q1 2026 enrollment - The FDA recommended advancing SLS009 into a trial for newly diagnosed, first-line AML patients eligible for venetoclax/azacitidine therapy[8](index=8&type=chunk) - An **80-patient randomized trial** is being prepared, with enrollment expected to start by **Q1 2026**, potentially supporting an NDA and accelerated approval[8](index=8&type=chunk) [Other Corporate Developments](index=2&type=section&id=Other%20Corporate%20Developments) SELLAS presented positive preclinical data for SLS009, expanded its Scientific Advisory Board, and was included in Russell Indexes - Presented preclinical data at ASCO 2025 showing SLS009's efficacy in ASXL1 mutated colorectal cancer[9](index=9&type=chunk) - Expanded the Scientific Advisory Board with three new members: Philip C. Amrein, MD, Alex Kentsis, MD, PhD, and Linghua Wang, MD, PhD[10](index=10&type=chunk) - Announced inclusion in the Russell 3000® and Russell 2000® Indexes[11](index=11&type=chunk) - A poster on the preclinical efficacy of SLS009 in T-Cell Prolymphocytic Leukemia (T-PLL) will be presented at ESMO 2025[12](index=12&type=chunk) [Financial Results for the Second Quarter 2025](index=3&type=section&id=Financial%20Results%20for%20the%20Second%20Quarter%202025) SELLAS reported a reduced net loss of **$6.6 million** in Q2 2025, driven by lower R&D expenses, ending with **$25.3 million** in cash [R&D Expenses](index=3&type=section&id=R%26D%20Expenses) Research and development expenses decreased to **$3.9 million** in Q2 2025, primarily due to reduced clinical trial costs R&D Expenses Comparison (in millions) | Period | 2025 | 2024 | | :--- | :--- | :--- | | **Q2** | $3.9 | $5.2 | | **H1** | $7.1 | $10.3 | [G&A Expenses](index=3&type=section&id=G%26A%20Expenses) General and administrative expenses increased to **$3.0 million** in Q2 2025, driven by higher professional fees and personnel costs G&A Expenses Comparison (in millions) | Period | 2025 | 2024 | | :--- | :--- | :--- | | **Q2** | $3.0 | $2.4 | | **H1** | $5.9 | $7.0 | [Net Loss](index=3&type=section&id=Net%20Loss) Net loss decreased to **$6.6 million** (or **$0.07 per share**) in Q2 2025, an improvement from **$7.5 million** in Q2 2024 Net Loss and Loss Per Share Comparison | Metric | Q2 2025 | Q2 2024 | H1 2025 | H1 2024 | | :--- | :--- | :--- | :--- | :--- | | **Net Loss (in millions)** | $6.6 | $7.5 | $12.4 | $17.0 | | **Loss Per Share** | $0.07 | $0.13 | $0.13 | $0.33 | [Cash Position](index=3&type=section&id=Cash%20Position) Cash and cash equivalents totaled **$25.3 million** as of June 30, 2025, with an additional **$4.0 million** from warrant exercises - Cash and cash equivalents totaled **$25.3 million** as of June 30, 2025[16](index=16&type=chunk) - The company received an additional **$4.0 million** in proceeds from warrant exercises in July 2025[16](index=16&type=chunk) [Financial Statements](index=5&type=section&id=Financial%20Statements) This section presents SELLAS Life Sciences' unaudited consolidated Statements of Operations and Balance Sheets for Q2 2025 [Consolidated Statements of Operations](index=5&type=section&id=Consolidated%20Statements%20of%20Operations) Total operating expenses were **$6.9 million** and net loss was **$6.6 million** for Q2 2025, an improvement from Q2 2024 Consolidated Statements of Operations (Unaudited, in thousands) | | Three Months Ended June 30, | Six Months Ended June 30, | | :--- | :--- | :--- | | | **2025** | **2024** | **2025** | **2024** | | **Research and development (in thousands)** | $3,871 | $5,186 | $7,076 | $10,297 | | **General and administrative (in thousands)** | $3,002 | $2,435 | $5,860 | $6,969 | | **Total operating expenses (in thousands)** | $6,873 | $7,621 | $12,936 | $17,266 | | **Loss from operations (in thousands)** | $(6,873) | $(7,621) | $(12,936) | $(17,266) | | **Interest income (in thousands)** | $272 | $151 | $522 | $230 | | **Net loss (in thousands)** | **$(6,601)** | **$(7,470)** | **$(12,414)** | **$(17,036)** | | **Net loss per share, basic and diluted (in dollars)** | $(0.07) | $(0.13) | $(0.13) | $(0.33) | [Consolidated Balance Sheets](index=6&type=section&id=Consolidated%20Balance%20Sheets) Total assets were **$32.3 million** and total stockholders' equity was **$26.1 million** as of June 30, 2025, a significant increase Consolidated Balance Sheet Highlights (Unaudited, in thousands) | | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Cash and cash equivalents (in thousands)** | $25,297 | $13,886 | | **Total current assets (in thousands)** | $29,447 | $16,327 | | **Total assets (in thousands)** | **$32,305** | **$19,432** | | **Total current liabilities (in thousands)** | $5,999 | $9,510 | | **Total liabilities (in thousands)** | $6,156 | $9,967 | | **Total stockholders' equity (in thousands)** | **$26,149** | **$9,465** | | **Total liabilities and stockholders' equity (in thousands)** | **$32,305** | **$19,432** | [About SELLAS and Forward-Looking Statements](index=4&type=section&id=About%20SELLAS%20and%20Forward-Looking%20Statements) SELLAS is a late-stage biopharmaceutical company developing cancer therapies, with forward-looking statements subject to risks - SELLAS is a late-stage biopharmaceutical company developing cancer therapies, with lead candidates GPS (targeting WT1 protein) and SLS009 (a CDK9 inhibitor)[17](index=17&type=chunk) - The report includes forward-looking statements concerning clinical development, timing of milestones, and potential regulatory approvals, which are subject to inherent risks and uncertainties[18](index=18&type=chunk)

Core Insights - SELLAS Life Sciences Group, Inc. is advancing its pipeline for Acute Myeloid Leukemia (AML) with positive results from Phase 2 trials and a recommendation to continue Phase 3 trials without modification [1][3][4] Clinical Developments - The Phase 2 trial of SLS009 achieved a 44% response rate in patients with Acute Myeloid Leukemia-Myelodysplasia-Related Changes (AML-MRC), significantly exceeding the targeted 20% overall response rate [2][4] - The FDA has recommended advancing SLS009 into a first-line AML trial, with enrollment expected to begin by Q1 2026 [1][5] - The final analysis of the Phase 3 REGAL trial for GPS is anticipated by year-end 2025, with no safety concerns identified [1][3] Financial Performance - As of June 30, 2025, the company reported cash and cash equivalents of approximately $25.3 million, with an additional $4.0 million received from warrant exercises in July 2025 [1][13] - Research and development expenses for Q2 2025 were $3.9 million, a decrease from $5.2 million in Q2 2024, primarily due to reduced clinical trial expenses [10] - The net loss for Q2 2025 was $6.6 million, compared to a net loss of $7.5 million in Q2 2024, indicating improved financial performance [12] Corporate Updates - The company has expanded its Scientific Advisory Board with three new members, enhancing its strategic guidance in oncology [7] - SELLAS has been included in the Russell 3000 and Russell 2000 indexes, which track the performance of the largest publicly traded U.S. companies [8]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 ________________________________ FORM 10-Q ________________________________ ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 OR (State of incorporation) (I.R.S. Employer Identification No.) 7 Times Square, Suite 2503, New York, NY 10036 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number: 00 ...

Core Viewpoint - SELLAS Life Sciences Group, Inc. has received a positive recommendation from the Independent Data Monitoring Committee (IDMC) to continue the Phase 3 REGAL trial of galinpepimut-S (GPS) in acute myeloid leukemia (AML) without modification, indicating a favorable risk-benefit profile and no safety concerns identified [1][2]. Group 1: Trial Details - The Phase 3 REGAL trial is a survival-driven study aimed at evaluating GPS in AML patients who have achieved complete remission following second-line salvage therapy, with the primary endpoint being overall survival [4]. - The trial completed enrollment in April 2024, with a total of 126 patients randomized, and approximately 75% of patients enrolled from study sites in the U.S. and Europe, with the U.S. being the highest enrolling country [2][4]. - The next and final analysis of the trial will occur once 80 events (deaths) have been recorded, which has not yet been reached at the time of the IDMC review [3]. Group 2: Company Overview - 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 [5]. - 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, including ASXL1 mutation [5].

Core Viewpoint - SELLAS Life Sciences Group, Inc. (SLS) has been upgraded to a Zacks Rank 2 (Buy), indicating a positive outlook on its earnings estimates, which is a significant factor influencing stock prices [1][4]. Earnings Estimates and Revisions - The Zacks rating system is based on the changing earnings picture of a company, specifically tracking the Zacks Consensus Estimate for EPS from sell-side analysts [2]. - Over the past three months, the Zacks Consensus Estimate for SELLAS Life Sciences Group has increased by 33.3% [9]. - The company is expected to earn -$0.28 per share for the fiscal year ending December 2025, showing no year-over-year change [9]. Impact of Institutional Investors - Changes in a company's future earnings potential, reflected in earnings estimate revisions, are strongly correlated with near-term stock price movements, largely due to institutional investors adjusting their valuations based on these estimates [5]. - Institutional investors typically buy or sell stocks based on changes in earnings estimates, leading to significant price movements [5]. Zacks Rating System - The Zacks Rank stock-rating system classifies stocks into five groups based on earnings estimates, with Zacks Rank 1 (Strong Buy) stocks generating an average annual return of +25% since 1988 [8]. - The upgrade of SELLAS Life Sciences Group to Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, indicating a strong potential for market-beating returns in the near term [11].

Core Insights - SELLAS Life Sciences Group has successfully met all primary endpoints in its Phase 2 trial of SLS009 (tambiciclib) for relapsed/refractory acute myeloid leukemia (r/r AML) [1][3][4] Trial Design and Objectives - The Phase 2 trial was an open-label, single-arm, multi-center study assessing the safety, tolerability, and efficacy of SLS009 in combination with venetoclax and azacitidine at two dose levels: 45 mg and 60 mg [2] - The trial aimed for a target overall response rate (ORR) of at least 20% and a median survival of at least 3 months [2] Efficacy Results - The trial exceeded the target ORR of 20%, achieving an ORR of 44% among AML MR patients at the optimal 30 mg twice a week (BIW) dose and 50% in ASXL1-mutated AML MR patients [6][12] - Median overall survival (mOS) was reported at 8.9 months for AML MR patients and 8.8 months for those refractory to venetoclax-based regimens, significantly surpassing historical benchmarks of 2.4 months [6][12] Safety Profile - SLS009 was well tolerated, with no dose-limiting toxicities observed across all treatment arms, validating its safety profile [9][12] Future Development Plans - Based on the positive Phase 2 results, the company plans to advance SLS009 into a randomized trial targeting newly diagnosed AML populations, with enrollment expected to begin by Q1 2026 [3][10][13] - The upcoming trial will include two cohorts: one for patients unlikely to benefit from standard therapy based on molecular profiling and another for patients showing early resistance to treatment [13][14] Industry Context - The results from the trial highlight a significant advancement in treatment options for patients with r/r AML, addressing a critical unmet medical need in this patient population [11][12]

Core Insights - SELLAS Life Sciences Group, Inc. has appointed Dr. Linghua Wang to its Scientific Advisory Board, enhancing its expertise in cancer research and translational science [1][2] - The company aims to leverage Dr. Wang's experience in cancer immunogenomics and computational biology to advance its scientific and clinical strategy during a critical growth phase [2][3] 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 found in multiple tumor types and has potential as both a monotherapy and in combination with other therapies [4] - The company is also developing SLS009 (tambiciclib), a differentiated small molecule CDK9 inhibitor, which has shown a high response rate in AML patients with unfavorable prognostic factors [4]

Company Overview - SELLAS Life Sciences Group, Inc. is a late-stage clinical biopharmaceutical company focused on developing novel therapies for various cancer indications [5] - The lead product candidate, GPS, targets the WT1 protein and has potential applications in both hematologic malignancies and solid tumors [5] - The company is also developing SLS009 (tambiciclib), a differentiated small molecule CDK9 inhibitor with reduced toxicity and increased potency compared to existing CDK9 inhibitors [5] Index Inclusion - SELLAS will be added to the Russell 3000 and Russell 2000 Indexes, effective after the U.S. market close on June 27, 2025, as part of the 2025 Russell indexes annual reconstitution [1] - Membership in these indexes lasts for one year and results in automatic inclusion in appropriate growth and value style indexes, enhancing visibility with institutional investors [3] Strategic Importance - The inclusion in the Russell indexes is seen as a significant corporate milestone, reflecting the company's progress in advancing its pipeline and building long-term shareholder value [4] - The company is approaching the readout of full topline Phase 2 data of SLS009 in acute myeloid leukemia (AML) and the final analysis of the Phase 3 pivotal REGAL trial of GPS in AML [4]

Core Viewpoint - Galena Biopharma, Inc. has been upgraded to a Zacks Rank 2 (Buy), indicating a positive outlook on its earnings estimates, which is a significant factor influencing stock prices [1][4][6]. Earnings Estimates and Ratings - The Zacks rating system is based solely on a company's changing earnings picture, tracking the Zacks Consensus Estimate for EPS from sell-side analysts [2]. - The recent upgrade reflects an increase in earnings estimates, which is correlated with stock price movements, particularly influenced by institutional investors [5][6]. Investment Implications - Rising earnings estimates and the Zacks rating upgrade suggest an improvement in Galena Biopharma's underlying business, likely leading to increased stock prices as investors respond positively [6][11]. - The Zacks Rank system effectively utilizes earnings estimate revisions to classify stocks, with a strong historical performance of Zacks Rank 1 stocks generating an average annual return of +25% since 1988 [8]. Earnings Estimate Revisions - For the fiscal year ending December 2025, Galena Biopharma is expected to earn -$0.28 per share, with no year-over-year change; however, the Zacks Consensus Estimate has increased by 33.3% over the past three months [9]. Market Positioning - The upgrade to Zacks Rank 2 places Galena Biopharma in the top 20% of Zacks-covered stocks based on estimate revisions, indicating potential for market-beating returns in the near term [10][11].