SEELAS Life Sciences (SLS) - 2025 Q2 - Quarterly Results

Corporate Highlights & Pipeline Update SELLAS advanced its AML pipeline with positive SLS009 Phase 2 results and a positive IDMC recommendation for REGAL Phase 3 REGAL Trial of GPS 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] - The final analysis of the REGAL trial is expected by year-end 2025, contingent on reaching 80 patient deaths[5] Phase 2 Trial of SLS009 in r/r AML 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] - 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] SLS009 Future Development 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] - An 80-patient randomized trial is being prepared, with enrollment expected to start by Q1 2026, potentially supporting an NDA and accelerated approval[8] Other Corporate Developments 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] - Expanded the Scientific Advisory Board with three new members: Philip C. Amrein, MD, Alex Kentsis, MD, PhD, and Linghua Wang, MD, PhD[10] - Announced inclusion in the Russell 3000® and Russell 2000® Indexes[11] - A poster on the preclinical efficacy of SLS009 in T-Cell Prolymphocytic Leukemia (T-PLL) will be presented at ESMO 2025[12] Financial Results for the Second Quarter 2025 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 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 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 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 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] - The company received an additional $4.0 million in proceeds from warrant exercises in July 2025[16] Financial Statements This section presents SELLAS Life Sciences' unaudited consolidated Statements of Operations and Balance Sheets for Q2 2025 Consolidated Statements of Operations 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 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 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] - 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]