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NEW YORK - SELLAS Life Sciences Group, Inc. (NASDAQ: NASDAQ:SLS), a biopharmaceutical company with a market capitalization of $88 million dedicated to cancer treatment development, has announced encouraging results from a Phase 2a trial of SLS009 in combination with Brukinsa® (zanubrutinib) for relapsed/refractory Diffuse Large B-Cell Lymphoma (r/r DLBCL). The company’s stock has shown remarkable strength, delivering a 57% return over the past year. According to InvestingPro analysis, the stock currently appears fairly valued based on its proprietary Fair Value model. The study, conducted by GenFleet Therapeutics in China, revealed a 67% overall response rate, significantly higher than the rate for zanubrutinib alone.
The trial involved nine patients with r/r DLBCL, six of whom were classified with the more challenging non-GCB DLBCL subtype. The data showed a disease control rate of 83% for these patients. While the clinical results are promising, InvestingPro data reveals the company maintains a healthy financial position with a current ratio of 2.26, indicating strong ability to meet short-term obligations. Get access to 10+ additional exclusive ProTips and comprehensive financial metrics with InvestingPro. Notably, one patient achieved complete response, while three others experienced partial responses with significant shrinkage of target lesions. After a median follow-up of 4.6 months, the median overall survival has not been reached, with six of the nine patients still alive.
Adverse events reported were consistent with the expected safety profile of zanubrutinib, with 55.6% of patients experiencing grade ≥ 3 adverse events. Interestingly, genetic analysis indicated that the patient who achieved complete response had MYC amplification and TP53 mutations, suggesting that CDK9 inhibition with SLS009 may overcome drug resistance in TP53 mutated cancers.
SELLAS’s Chief Development Officer, Dragan Cicic, MD, highlighted the potential of SLS009 to expand treatment options for various cancers, including its advanced clinical development in acute myeloid leukemia (AML). The company remains focused on AML and chromatin mutations, including ASXL1 mutations. Analysts share this optimistic outlook, with target prices ranging from $4 to $7.50 per share, suggesting significant potential upside. The company’s next earnings report is expected on March 20, 2025, which could be a crucial catalyst for the stock’s volatile beta of 2.43.
SELLAS’s lead product candidate, GPS, targets the WT1 protein, which is prevalent in many tumor types, offering a broad application in hematologic malignancies and solid tumors. The company’s portfolio includes the CDK9 inhibitor SLS009, which has shown promise in AML patients with poor prognostic factors.
The information presented is based on a press release statement, providing a factual account of the trial’s findings without promotional language. As SELLAS and GenFleet consider the next steps for the trial, the results represent a significant development in the treatment of r/r DLBCL, particularly for patients with the more aggressive non-GCB DLBCL subtype.
In other recent news, SELLAS Life Sciences Group, Inc. announced a registered direct offering expected to raise approximately $25 million before expenses. This offering involves selling about 19.7 million shares and accompanying warrants to a healthcare-focused institutional investor. The proceeds are intended for working capital and general corporate purposes, potentially including future acquisitions. Additionally, SELLAS recently faced a market reaction following the interim analysis of its Phase 3 REGAL trial for Galinpepimut-S (GPS) in Acute Myeloid Leukemia (AML). The Independent (LON:IOG) Data Monitoring Committee recommended the trial continue without modifications, although investors reacted negatively despite favorable survival data.
Furthermore, SELLAS has amended executive severance agreements for two top executives, providing severance equivalent to 15 months of their base salary if terminated due to a change in control. The company is also advancing its cancer drug trials, with significant milestones anticipated in 2025. The Phase 3 REGAL trial is a key focus, and SELLAS is preparing for a Biologics License Application. Additionally, the company’s SLS009, a CDK9 inhibitor, is expected to deliver full topline data from its Phase 2 trial in the first half of 2025. These developments highlight SELLAS’s ongoing efforts to advance its clinical-stage portfolio in cancer therapies.
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