SEELAS Life Sciences (SLS) - 2023 Q4 - Annual Results

SELLAS Life Sciences 2023 Full Year Financial Results and Corporate Update CEO Statement and Strategic Outlook CEO highlights strong early 2024 pipeline progress, including Phase 3 REGAL enrollment and promising SLS009 Phase 2a data - Key achievements highlighted for early 2024 include promising Phase 2a data for SLS009 in r/r AML, completion of enrollment for the Phase 3 REGAL study, and receiving FDA Fast Track Designation for SLS009[4] - The company's priorities for 2024 are to report data from the Phase 3 REGAL trial (GPS in AML), additional data from the Phase 2a study of SLS009 in r/r AML, and topline data from the Phase 1b/2 study of SLS009 in Peripheral T-cell Lymphoma (PTCL)[4] Corporate and Clinical Development Update Recent Highlights (Q1 2024) Early 2024 highlights include completed Phase 3 REGAL enrollment, strong SLS009 Phase 2a AML data, and a $20.0 million capital raise - Completed enrollment in the Phase 3 REGAL study for GPS in AML. The Steering Committee review suggests an interim analysis may be imminent, with the next IDMC meeting scheduled for late April 2024[5][7] SLS009 Phase 2a Study in r/r AML - Response Rates (as of March 15, 2024) | Dose Cohort | Response Rate | Response Rate (with Biomarkers) | | :--- | :--- | :--- | | 45 mg (safety) | 10% | 57% (across all levels) | | 60 mg QW | 20% | 57% (across all levels) | | 60 mg (30 mg BIW - optimal) | 50% | 100% | - The U.S. FDA granted Fast Track Designation to SLS009 for the treatment of relapsed/refractory AML, aiming to facilitate its development and review[12] - Secured $20.0 million in gross proceeds from a registered direct offering on March 19, 2024, to be used for R&D, working capital, and general corporate purposes[9] 2024 Milestones Key 2024 milestones include interim and final analyses for GPS Phase 3 REGAL study and further SLS009 data from AML and PTCL trials - Galinpepimut-S (GPS): - Phase 3 REGAL study (AML): Interim analysis is anticipated in 1H 2024, with the final analysis expected by the end of 2024[13] - SLS009 (CDK9 inhibitor): - Phase 2a (r/r AML): Additional data expected in 1H 2024 - Phase 1b/2 (r/r PTCL): Interim analysis projected to occur in 1H 2024 - Phase 1b/2 (r/r DLBCL): First patient was dosed in March 2024 in a combination trial with Brukinsa® (zanubrutinib) - NCI PIVOT Program (pediatric cancers): Initial safety and efficacy data expected throughout 2H 2024[17] 2023 Highlights In 2023, SELLAS advanced GPS with positive trial data and favorable FDA CMC meeting, while SLS009 completed Phase 1, initiated new trials, and received key FDA designations - Galinpepimut-S (GPS): - Presented positive data from a Phase 1/2 trial in combination with Keytruda® in ovarian cancer - Reported positive follow-up data from a Phase 1 trial with Opdivo® in mesothelioma - Concluded a favorable Type C meeting with the FDA regarding Chemistry, Manufacturing, and Controls (CMC) for a potential BLA submission[17] - SLS009: - Completed the Phase 1 trial, establishing the recommended Phase 2 dose at 60 mg for AML and 100 mg for lymphomas - Initiated a Phase 2a study in AML and a potentially registrational Phase 1b/II trial in r/r PTCL[16][18][21] - SLS009 received multiple FDA regulatory designations in 2023: - Orphan Drug Designation (ODD) for AML - ODD for PTCL - Fast Track Designation for r/r PTCL[21] Financial Results for the Full Year 2023 Statement of Operations Analysis Full year 2023 net loss decreased to $37.3 million from $41.3 million in 2022, primarily due to the absence of a $10.0 million acquired R&D expense Full Year 2023 vs. 2022 Financial Performance | Metric | 2023 | 2022 | Change Driver | | :--- | :--- | :--- | :--- | | R&D Expenses | $24.0 million | $20.3 million | Increased clinical trial expenses for Phase 3 REGAL and SLS009 trials. | | G&A Expenses | $13.9 million | $12.6 million | Increase in personnel and intellectual property expenses. | | Acquired In-Process R&D | $0 | $10.0 million | One-time expense for in-licensing of SLS009 in 2022. | | Net Loss | ($37.3 million) | ($41.3 million) | Reduced due to absence of acquired IPR&D, offset by higher operating expenses. | | Net Loss Per Share | ($1.34) | ($2.13) | Improvement reflects lower net loss and higher weighted average shares. | Financial Position and Liquidity The company ended 2023 with $2.5 million in cash, subsequently raising $29.0 million in gross proceeds through two offerings in early 2024 - Cash and cash equivalents totaled approximately $2.5 million as of December 31, 2023[24] - Subsequent to year-end, the company significantly improved its liquidity by raising capital: - January 8, 2024: Received $9.0 million in gross proceeds from a public offering - March 19, 2024: Received $20.0 million in gross proceeds from a registered direct offering[24] Consolidated Financial Statements Consolidated Statements of Operations For 2023, total operating expenses were $37.9 million and net loss was $37.3 million, an improvement from $43.0 million and $41.3 million respectively in 2022 Consolidated Statements of Operations (Amounts in thousands) | Account | Year Ended Dec 31, 2023 (in thousands) | Year Ended Dec 31, 2022 (in thousands) | | :--- | :--- | :--- | | Licensing revenue | $0 | $1,000 | | Research and development | $24,007 | $20,268 | | General and administrative | $13,862 | $12,582 | | Acquired in-process R&D | $0 | $10,000 | | Total operating expenses | $37,869 | $42,950 | | Loss from operations | ($37,869) | ($41,950) | | Net loss | ($37,340) | ($41,301) | | Net loss per share | ($1.34) | ($2.13) | Consolidated Balance Sheets As of December 31, 2023, total assets were $6.2 million, down from $20.9 million in 2022, with a stockholders' deficit of $8.0 million Consolidated Balance Sheets (Amounts in thousands) | Account | December 31, 2023 (in thousands) | December 31, 2022 (in thousands) | | :--- | :--- | :--- | | Cash and cash equivalents | $2,530 | $17,125 | | Total current assets | $3,172 | $17,756 | | Total assets | $6,219 | $20,943 | | Total current liabilities | $13,735 | $15,515 | | Total liabilities | $14,195 | $16,092 | | Total stockholders' (deficit) equity | ($7,976) | $4,851 |