SEELAS Life Sciences (US:SLS)2025-05-13 20:01Financial Performance - The company incurred a net loss of $5.81 million for the three months ended March 31, 2025, an improvement compared to a net loss of $9.57 million for the same period in 2024, reflecting a reduction of about 39%[17]. - Total operating expenses decreased to $6.06 million in Q1 2025 from $9.65 million in Q1 2024, marking a decline of approximately 37%[17]. - The net loss for Q1 2025 was $5.8 million, compared to a net loss of $9.6 million in Q1 2024, reflecting an improvement of approximately 39.2%[121]. - Non-operating income increased to $0.3 million in Q1 2025 from $0.1 million in Q1 2024, marking a growth of 200%[127]. - The net cash used in operating activities was $9.1 million in Q1 2025, compared to $10.8 million in Q1 2024, indicating a reduction of approximately 15.8%[137][138]. Assets and Financing - As of March 31, 2025, the company reported total assets of $34.96 million, a significant increase from $19.43 million as of December 31, 2024, representing a growth of approximately 80%[15]. - Cash and cash equivalents at the end of Q1 2025 were approximately $28.4 million, up from $13.9 million at the end of 2024, indicating a growth of about 104%[31]. - The company has an accumulated deficit of $253.94 million as of March 31, 2025, compared to $248.13 million at the end of 2024[15]. - The company expects its cash and cash equivalents will not be sufficient to fund operations for at least the next twelve months, raising substantial doubt about its ability to continue as a going concern[132]. - The company requires substantial additional financing to develop current or future product candidates, with no current commitments for additional funds[34]. Research and Development - The company’s lead product candidate, galinpepimut-S (GPS), targets the Wilms Tumor 1 (WT1) protein, with potential applications in various cancer types[26]. - The company anticipates an increase in research and development expenses as it conducts ongoing clinical trials and initiates new ones[114]. - Research and development expenses decreased to $3.2 million in Q1 2025 from $5.1 million in Q1 2024, a reduction of approximately 37.2%[122]. - The company has received $10.5 million in upfront payments under the 3D Medicines Agreement, with potential future milestones totaling $191.5 million[30]. - The REGAL study for GPS monotherapy in AML has enrolled 126 patients across 95 clinical sites, with an interim analysis planned after 60 events (deaths) and a final analysis after 80 events[96]. Stock and Equity - The company reported a weighted-average common shares outstanding of 87,760,320 for Q1 2025, compared to 44,812,996 for Q1 2024[17]. - As of March 31, 2025, the Company reported a net loss per share, with potentially dilutive securities outstanding totaling 82,823,000 shares, compared to 44,695,000 shares in the same period of 2024[51]. - The Company has total common stock reserved for future issuance amounting to 84,209,000 shares as of March 31, 2025[67]. - The company granted 817 stock options during the three months ended March 31, 2025, with an average exercise price of $0.95[84]. - As of March 31, 2025, approximately 1,356,000 shares were reserved for future grants under the 2023 Amended and Restated Equity Incentive Plan[80]. Clinical Trials and Product Development - SLS009, a CDK9 inhibitor, completed a Phase 1 trial with positive safety and efficacy data, establishing a recommended Phase 2 dose of 60 mg once weekly for AML[102]. - In the Phase 2a trial of SLS009, the overall response rate (ORR) in Cohort 3 was 46%, exceeding the targeted ORR of 20%[106]. - The median overall survival (mOS) for patients in Cohort 3 was 8.8 months, with mOS for AML MR patients reaching 8.9 months[106]. - SLS009 demonstrated a high response rate of 67% in patients with ASXL1 mutations, indicating its potential as a targeted therapy[106]. - The FDA granted Orphan Drug Designations for SLS009 in AML and PTCL, and Fast Track designations for r/r AML and r/r PTCL[111]. Expenses and Liabilities - General and administrative expenses are expected to rise as the company prepares for potential commercialization of product candidates[118]. - General and administrative expenses fell to $2.9 million in Q1 2025 from $4.5 million in Q1 2024, representing a decrease of about 35.6%[126]. - The Company’s operating lease liabilities as of March 31, 2025, amount to $870,000, with future minimum lease payments totaling $952,000[60]. - The Company’s weighted average discount rate for operating leases is approximately 13%[58]. - Accrued expenses and other current liabilities decreased to $2,571,000 as of March 31, 2025, from $5,466,000 as of December 31, 2024[54]. Licensing and Agreements - The Company has an exclusive license agreement with GenFleet Therapeutics, involving an upfront fee of $10 million and potential milestone payments totaling up to $140 million[62]. - The company recognized an initial transaction price of $9.5 million from the exclusive license agreement with 3D Medicines Inc., including a $7.5 million upfront payment and $2.0 million in development milestones[75]. - There is a potential future revenue of $191.5 million in development, regulatory, and sales milestones remaining under the 3D Medicines Agreement as of March 31, 2025[76]. - The company has not recognized any royalty revenue from licensing arrangements during the three months ended March 31, 2025[77]. Other Information - The company is currently evaluating the impact of new accounting standards on its financial disclosures, with no material impact expected upon adoption[52][53]. - No unregistered sales of equity securities reported[154]. - No defaults upon senior securities reported[155]. - No mine safety disclosures applicable[156]. - No changes in trading plans by directors or officers during the quarter ended March 31, 2025[157].