SELLAS Life Sciences Reports Full Year 2024 Financial Results and Provides Corporate Update

-- Announced Positive Outcome of Interim Analysis for its Pivotal Phase 3 REGAL Trial of Galinpepimut-S $(GPS.AU)$ in Acute Myeloid Leukemia $(AML.UK)$ with Next and Final Analysis Planned Upon Reaching 80 Events, Anticipated in 2025 --

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

-- Raised $25 Million in Gross Proceeds in a Registered Direct Offering in January 2025 --

NEW YORK, March 20, 2025 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. $(SLS)$ ("SELLAS" or the "Company"), 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.

"We are pleased with the progress of our pipeline as we continue to advance our two key assets through clinical development," said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. "The most anticipated milestones in 2025 will be the final analysis of our Phase 3 pivotal REGAL trial of GPS in acute myeloid leukemia $(AML.AU)$ 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 $(ORR.AU)$ 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."

Dr. Stergiou continued, "We 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."

Recent Highlights:

Announced Positive Outcome of Interim Analysis for Phase 3 REGAL Trial of GPS in AML: The interim futility, efficacy, and safety analysis was designed to assess whether the therapy is safe, demonstrates potential efficacy, and merits continuation. The IDMC's 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.

Promising Data from Phase 2a Trial of SLS009 in Combination with Zanubrutinib in DLBCL: The trial, conducted and funded by GenFleet Therapeutics (Shanghai), Inc. ("Genfleet"), was an open-label single-arm multicenter Phase 2a study in China evaluating SLS009 in combination with BTK inhibitor, Brukinsa$(R)$ (zanubrutinib) in r/r DLBCL. The results showed an overall response rate $(ORR.UK)$ 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' focus remains on AML and spliceosome--chromatin mutations, including ASXL1 mutations.

Raised $25.0 Million of Gross Proceeds from a Registered Direct Offering Priced At-the-Market under Nasdaq Rules: 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's fees and related offering expenses. The net proceeds from the offering strengthens the Company's financial position and will be used for working capital purposes and general corporate procedures, including the purchase of any pending or future acquisitions.

2024 Key Achievements:

SLS009 (tambiciclib): highly selective CDK9 inhibitor

   -- The World Health Organization (WHO) approved "tambiciclib" as the 
      recommended International Nonproprietary Name $(INN)$ for SLS009. 
 
   -- Reported positive data from the ongoing Phase 2 trial of SLS009 in r/r 
      AML in Q4 2024. 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  2.5 months. In expansion cohorts in patients with 
      AML-myelodysplasia-related changes (AML-MRC) with ASXL1 mutation and 
      mutations and cytogenic changes other than ASXL1, the ORR was 56% in 9 
      patients evaluable for efficacy, exceeding pre-specified target response 
      rate of 33%. 
 
   -- Presented data from Phase 2a trial of SLS009 in r/r AML at the 66th 
      American Society of Hematology $(ASH)$ Annual Meeting & Exposition 2024. 
 
   -- Completed enrollment in Phase 2a Trial of SLS009 in r/r AML: 30 patients 
      relapsed after or refractory to venetoclax-based regiments were enrolled 
      ahead of schedule in 5 centers across the US. 
 
   -- Opened enrollment in additional Phase 2 cohorts in venetoclax 
      combinations in r/r AML. 
 
   -- Development of SLS009 continues with the opening of two new cohorts - AML 
      MRC with ASXL1 mutations and AML with myelodysplasia-related changes 
      other than ASXL1 mutations. These new cohorts are also open for 
      enrollment of certain pediatric patients. 
 
   -- Announced positive preclinical data indicating ASXL1 mutations as 
      predictors of response to SLS009 in solid cancers. 
 
   -- Published in Oncotarget, revealing the underlying mechanisms of action 
      behind the anti-proliferative effects of SLS009 in various hematologic 
      malignancies. 
 
   -- Continued National Cancer Institute $(NCI)$ Pediatric Preclinical in Vivo 
      Testing (PIVOT) Program in pediatric tumors. 

Regulatory:

Received multiple regulatory designations: for GPS, FDA Rare Pediatric Disease Designation (RPDD) for pediatric AML; and for SLS009, RPDD for pediatric AML, pediatric acute lymphoblastic leukemia $(ALL)$, FDA Fast Track Designation for AML, and EMA orphan drug designation $(ODD)$ for AML and peripheral T-cell lymphoma (PTCL).

Financial Results for the Full Year 2024:

R&D Expenses: Research and development expenses for the year ended December 31, 2024, were $19.1 million, compared to $24.0 million for the year ended December 31, 2023. The decrease was primarily due to decreases in clinical trial expenses, manufacturing costs and clinical drug supply purchases, and clinical and regulatory consulting costs primarily driven by the completion of enrollment in the REGAL study in the first quarter of 2024 and a decrease in employee-related expenses due to a decrease in headcount.

G&A Expenses: General and administrative expenses for the year ended December 31, 2024, were $12.4 million, as compared to $13.9 million for the year ended December 31, 2023. The decrease was primarily due to a decrease in employee-related expenses due to a decrease in headcount, outside services and public company costs, and insurance premiums, partially offset by a one-time severance charge in 2024 and an increase in legal fees.

Net Loss: The net loss was $30.9 million for the year ended December 31, 2024, or a basic and diluted loss per share of $0.50, as compared to a net loss of $37.3 million for the year ended December 31, 2023, or a basic and diluted loss per share of $1.34.

Cash Position: As of December 31, 2024, cash and cash equivalents totaled approximately $13.9 million. Subsequent to December 31, 2024, on January 28, 2025, the Company received gross proceeds of $25.0 million from a registered direct offering priced at-the-market under Nasdaq rules.

About SELLAS Life Sciences Group, Inc.

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