NEW YORK, Sept. 30, 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 will host a virtual R&D Day on Wednesday, October 29, 2025 at 10:00 AM ET featuring key opinion leaders (KOLs), alongside company management, to discuss the unmet medical need and evolving treatment landscape for acute myeloid leuke ...

Core Points - SELLAS Life Sciences Group, Inc. announced the immediate exercise of warrants to purchase up to 19,685,040 shares of common stock for gross cash proceeds of approximately $23.6 million [1][2] - The investor will receive new unregistered warrants at an exercise price of $1.88, which will be exercisable immediately and will expire in five years and six months [2] - The transaction is expected to close on or about September 12, 2025, subject to customary closing conditions [2] Company Overview - SELLAS is a late-stage clinical biopharmaceutical company focused on developing novel therapies for various cancer indications [6] - The lead product candidate, GPS, targets the WT1 protein present in multiple tumor types and has potential as both a monotherapy and in combination with other therapies [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 [6]

Core Insights - Solaris Resources Inc. has signed a landmark agreement with the Pueblo Shuar Arutam organization, enhancing its social engagement efforts and supporting the Warintza Project in Ecuador [2][3] - The agreement establishes formal relationships with all Indigenous organizations surrounding the Warintza Project, reinforcing the company's commitment to community-led development [3][4] Social Engagement and Partnerships - The agreement with PSHA, representing nearly 10,000 people organized into 47 Shuar centers, follows a Letter of Intent signed in February 2025 and builds on previous partnerships with local Shuar centers [3][4] - Solaris has also established a trilateral cooperation agreement with the Interprovincial Federation of Shuar Centers and a partnership with the Alliance for Entrepreneurship and Innovation of Ecuador, creating a strong social foundation for the Warintza Project [4] Project Development and De-Risking Initiatives - Solaris is advancing critical de-risking initiatives essential for the Warintza Project's development timeline, including the submission of the Technical Environmental Impact Assessment [5][6] - The final Technical EIA report has been submitted and is currently under government review, following positive engagement with Ecuador's Ministry of Environment and Energy [6][8] - A site visit by government officials in July 2025 marked progress towards the Free, Prior and Informed Consultation process, which is expected to commence in the coming months [7][8] Pre-Feasibility Study and Resource Estimates - The Warintza Pre-Feasibility Study is progressing with positive momentum, incorporating an updated Mineral Resource Estimate that includes resources from Warintza West, expected to be completed in the second half of 2025 [9][10] - Solaris is focused on long-term value creation and aims for a Final Investment Decision, supported by strengthened community partnerships and a reinforced financial position following a recent transaction with Royal Gold [10][11] Exploration Opportunities - Beyond the defined Mineral Resource Estimate, Solaris is pursuing high-impact exploration opportunities within the broader Warintza district, which is considered highly prospective and underexplored [11][12]

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]