{"id":828249,"date":"2025-03-20T16:10:13","date_gmt":"2025-03-20T20:10:13","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/sellas-life-sciences-reports-full-year-2024-financial-results-and-provides-corporate-update\/"},"modified":"2025-03-20T16:10:13","modified_gmt":"2025-03-20T20:10:13","slug":"sellas-life-sciences-reports-full-year-2024-financial-results-and-provides-corporate-update","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/sellas-life-sciences-reports-full-year-2024-financial-results-and-provides-corporate-update\/","title":{"rendered":"SELLAS Life Sciences Reports Full Year 2024 Financial Results and Provides Corporate Update"},"content":{"rendered":"
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\n \u2013 Announced Positive Outcome of Interim Analysis for its Pivotal Phase 3 REGAL Trial of Galinpepimut-S (GPS) in Acute Myeloid Leukemia (AML) with Next and Final Analysis Planned Upon Reaching 80 Events, Anticipated in 2025 \u2013<\/em>\n <\/p>\n

\n \u2013 Reported Positive Overall Survival and Overall Response Rate Data from the Ongoing Phase 2 Trial of SLS009 (Tambiciclib) in r\/r AML \u2013 Full Data and FDA Regulatory Path Feedback Expected in 1H 2025 \u2013<\/em>\n <\/p>\n

\n \u2013 Raised $25 Million in Gross Proceeds in a Registered Direct Offering in January 2025 \u2013<\/em>
\n \n <\/p>\n

NEW YORK, March 20, 2025 (GLOBE NEWSWIRE) — SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (\u201cSELLAS\u2019\u2019 or the \u201cCompany\u201d), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, today reported financial results for the full year ended December 31, 2024, and provided a corporate update.<\/p>\n

\u201cWe are pleased with the progress of our pipeline as we continue to advance our two key assets through clinical development,\u201d said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. \u201cThe most anticipated milestones in 2025 will be the final analysis of our Phase 3 pivotal REGAL trial of GPS in acute myeloid leukemia (AML) and the full topline Phase 2 data of SLS009 in AML, both of which represent significant opportunities and offer hope to AML patients in need. If successful, the REGAL trial provides a pathway for regulatory approval in AML, and GPS could become a transformative treatment for patients in their second complete remission. Furthermore, the promising data from the ongoing Phase 2 trial of SLS009 has shown a 56% overall response rate (ORR) in AML patients with myelodysplasia-related changes (AML MRC) prospectively enrolled in two expansion cohorts, exceeding the prespecified target ORR of 33%. In the optimal dosing regimen of 30 mg BIW, the median overall survival (mOS) has not been reached but exceeds 7.7 months at the latest follow-up, where the expected mOS is historically approximately 2.5 months.\u201d<\/p>\n

Dr. Stergiou continued,\u00a0\u201cWe are especially encouraged by the multiple regulatory designations granted to our programs in 2024, including three FDA Rare Pediatric Disease Designations, one FDA Fast Track Designation, and two EMA Orphan Drug Designations, which reflect the significant potential impact of our therapies and provide valuable regulatory benefits that may accelerate development and potential approval. With strong regulatory recognition and two potentially pivotal inflection points ahead, we remain committed to driving innovation and delivering value to patients and shareholders.\u201d<\/p>\n

\n Recent Highlights: <\/strong>\n <\/p>\n

\n Announced Positive Outcome of Interim Analysis for Phase 3 REGAL Trial of GPS in AML: <\/strong>The interim futility, efficacy, and safety analysis was designed to assess whether the therapy is safe, demonstrates potential efficacy, and merits continuation. The IDMC\u2019s review supports the continuation of the study according to its original protocol. Based on this positive evaluation, GPS has shown preliminary signals of effectiveness, allowing the trial to advance toward completion. Fewer than 50% of enrolled patients were confirmed deceased after the median follow-up of 13.5 months, indicating a median survival of over 13.5 months in the trial vs. historical median survival of 6 months for conventional therapy, as reported in a similar Phase 2 study. The next and final analysis will be conducted once 80 events (deaths) are reached, further determining the potential of GPS in addressing the needs of AML patients. SELLAS anticipates that 80 events will be reached this year.<\/p>\n

\n Promising Data from Phase 2a Trial of SLS009 in Combination with Zanubrutinib in DLBCL: <\/strong>The trial, conducted and funded by GenFleet Therapeutics (Shanghai), Inc. (\u201cGenfleet\u201d), was an open-label single-arm multicenter Phase 2a study in China evaluating SLS009 in combination with BTK inhibitor, Brukinsa\u00ae<\/sup> (zanubrutinib) in r\/r DLBCL. The results showed an overall response rate (ORR) of 67%, more than double the expected ORR of zanubrutinib alone. Among responders, one achieved complete response (CR), while three had partial response (PR) with target lesion shrinkages of 89%, 78%, and 56%, respectively. As of the last follow-up, after the median of 4.6 (range: 1.4 – 7.4) months follow-up, median overall survival (OS) was not reached, and 6 out of 9 patients were alive. GenFleet will determine the next steps in development around lymphoma as SELLAS\u2019 focus remains on AML and spliceosome\u2013chromatin mutations, including ASXL1 mutations.<\/p>\n

\n Raised $25.0 Million of Gross Proceeds from a Registered Direct Offering Priced At-the-Market under Nasdaq Rules<\/strong>: On January 28, 2025, SELLAS announced the closing of a $25 million registered direct offering with a single healthcare-focused institutional investor before deducting placement agent\u2019s fees and related offering expenses. The net proceeds from the offering strengthens the Company\u2019s financial position and will be used for working capital purposes and general corporate procedures, including the purchase of any pending or future acquisitions.<\/p>\n

\n 2024 Key Achievements:<\/strong>\n <\/p>\n

\n SLS009 (tambiciclib): highly selective CDK9 inhibitor<\/strong>\n <\/p>\n