SEELAS Life Sciences (US:SLS)2024-05-14 20:01Financial Performance - The company reported a net loss of $9.6 million for the three months ended March 31, 2024, compared to a net loss of $11.1 million for the same period in 2023, representing a 13.8% improvement[16]. - The net loss for the three months ended March 31, 2024, was $9.566 million, compared to a net loss of $11.097 million in the same period of 2023, reflecting an improvement of $1.531 million or 13.8%[114]. - Total operating expenses decreased to $9.6 million in Q1 2024 from $11.3 million in Q1 2023, reflecting a reduction of 14.5%[16]. - For the three months ended March 31, 2024, total operating expenses decreased to $9.645 million from $11.281 million in the same period of 2023, representing a reduction of approximately 14.5%[114]. - Research and development expenses were $5.111 million for the three months ended March 31, 2024, down from $7.174 million in 2023, a decrease of $2.063 million or 28.8%[115]. - General and administrative expenses increased to $4.534 million in Q1 2024 from $4.107 million in Q1 2023, an increase of $0.427 million or 10.4%[116]. - The company did not generate any revenue from product sales during the three months ended March 31, 2024, and has primarily funded operations through equity securities and convertible notes[118]. Assets and Liquidity - As of March 31, 2024, the total assets of SELLAS Life Sciences Group, Inc. were $24.4 million, a significant decrease from $6.2 million at December 31, 2023[14]. - The company had cash and cash equivalents of $18.4 million as of March 31, 2024, compared to $2.5 million at December 31, 2023, indicating a substantial increase in liquidity[14]. - As of March 31, 2024, the Company had cash and cash equivalents of approximately $18.4 million, which is expected to be insufficient to fund its operations for at least the next twelve months[31]. - The accumulated deficit as of March 31, 2024, was $226.8 million, up from $217.2 million at December 31, 2023[14]. - As of March 31, 2024, the company had an accumulated deficit of $226.8 million and cash and cash equivalents of $18.4 million, indicating potential liquidity challenges[122]. Financing Activities - The company raised approximately $18.5 million from a registered direct offering on March 19, 2024, selling 11 million shares at $1.535 each[27]. - The Company requires substantial additional financing to develop current or future product candidates, with no current commitments for additional funds[32]. - The company is currently evaluating strategies for obtaining required funding, including public and private placements of equity and debt securities[32]. - The company is actively pursuing additional financing strategies to support future operations, including public and private placements of equity and debt securities[124]. Shareholder Information - The company’s weighted-average common shares outstanding increased to 44,812,996 in Q1 2024 from 23,547,562 in Q1 2023, reflecting a significant increase in share issuance[16]. - The total common stock reserved for future issuance includes 41,802 thousand warrants, 2,155 thousand stock options, and 738 thousand restricted stock units, totaling 47,827 thousand shares[59]. - As of March 31, 2024, the company had 41,802 warrants outstanding, with 28,928 granted during the quarter and 2,950 exercised[61]. - The company granted 671,000 stock options during the three months ended March 31, 2024, with an average exercise price of $0.53[75]. - The weighted average grant date fair value of options granted during the three months ended March 31, 2024, was $0.48, compared to $2.95 in 2023[78]. - During the three months ended March 31, 2024, 54,372 shares were purchased by employees under the 2021 Employee Stock Purchase Plan for proceeds of approximately $0.1 million[83]. - The company had approximately 3,003,000 shares reserved for future grants under the 2023 Amended and Restated Equity Incentive Plan as of March 31, 2024[74]. Clinical Development - SELLAS Life Sciences Group, Inc. is focused on developing novel therapeutics for cancer, with its lead product candidate, galinpepimut-S, targeting the WT1 protein[25]. - The company completed enrollment in the REGAL study for GPS monotherapy in AML, with approximately 125 to 140 patients across 95 clinical sites, and expects interim analysis after 60 events in Q2 2024[90]. - The company is collaborating with GenFleet for the development of SLS009 in Greater China, with initial patient dosing in ongoing trials[102]. - The company is evaluating SLS009 in pediatric solid tumors and leukemia models, with relevant data expected in the second half of 2024[103]. - In the Phase 2a clinical trial of SLS009 in combination with aza/ven for r/r AML, response rates were 10% in the 45 mg cohort, 20% in the 60 mg cohort, and 50% in the 30 mg cohort[100]. - The company reported a 100% response rate in r/r AML patients with ASXL1 truncating mutations at the optimal dose level of SLS009 (30 mg twice a week)[101]. - The FDA granted Orphan Drug Product designations for SLS009 in AML and PTCL, and Fast Track designations for r/r AML and r/r PTCL[104]. - The company expects research and development expenses to increase as it conducts ongoing clinical trials and initiates additional trials[107]. - The company reported positive safety and efficacy data from the Phase 1 trial of SLS009 in mid-2023, establishing recommended Phase 2 doses of 60 mg for AML and 100 mg for lymphomas[97]. Agreements and Contracts - 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[47]. - The company recognized an initial transaction price of $9.5 million under the exclusive license agreement with 3D Medicines, which includes a $7.5 million upfront payment and $2.0 million in development milestones[66]. - There are $191.5 million in potential future development, regulatory, and sales milestones remaining under the 3D Medicines Agreement as of March 31, 2024[68]. - The company has received $10.5 million in upfront and milestone payments under the 3D Medicines Agreement, with a total of $191.5 million in potential future milestones remaining[91]. Other Information - The Company has prepaid expenses and other current assets of $2.986 million as of March 31, 2024, compared to $0.542 million as of December 31, 2023[48]. - Accrued expenses and other current liabilities decreased to $6.542 million as of March 31, 2024, from $7.650 million as of December 31, 2023[48]. - The Company has a non-cancelable operating lease with a remaining term of 1.5 years, with future minimum lease payments totaling $878 thousand[53]. - The weighted average discount rate for the Company's operating leases is approximately 13%[52]. - The Company recorded a net loss per share, with diluted loss per share calculations being anti-dilutive due to the existing net loss[39]. - Net cash used in operating activities was $10.761 million for the three months ended March 31, 2024, compared to $12.127 million in the same period of 2023, showing a decrease of 11.3%[126]. - The company did not recognize any licensing revenue during the three months ended March 31, 2024, and 2023[69]. - No unregistered sales of equity securities reported[143]. - No defaults upon senior securities reported[144]. - No mine safety disclosures applicable[145]. - No changes in trading plans by directors or officers during Q1 2024[146]. - Various exhibits related to securities purchase agreements and warrants filed[147].