SEELAS Life Sciences (US:SLS)2025-11-12 21:01Financial 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]