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SELLAS Life Sciences Group, Inc. develops novel cancer therapeutics as a late-stage clinical biopharmaceutical company. News about SLS centers on its acute myeloid leukemia programs, including galinpepimut-S (GPS), a WT1-directed peptide immunotherapy evaluated in the REGAL Phase 3 trial, and SLS009 (tambiciclib), a selective CDK9 inhibitor studied in AML settings.
Recurring updates include clinical and preclinical data presentations, trial progress, regulatory and corporate updates, financial results, cash-position disclosures, warrant exercises, and other capital-structure developments tied to funding its oncology pipeline.
SELLAS Life Sciences Group (NASDAQ: SLS), a late-stage clinical biopharmaceutical company, announced its participation in the 2024 Maxim Healthcare Virtual Summit. Dr. Angelos Stergiou, President and CEO of SELLAS, will engage in a fireside chat on Tuesday, October 15, 2024, at 9:00 am EDT.
The virtual summit will be hosted on the M-Vest platform, where investors can register to watch the fireside chat and schedule one-on-one meetings. SELLAS focuses on developing novel therapies for a broad range of cancer indications, positioning itself as a key player in the oncology therapeutics sector.
SELLAS Life Sciences Group (NASDAQ: SLS) reported Q2 2024 financial results and provided a corporate update. Key highlights include:
1. The IDMC recommended continuing the Phase 3 REGAL study in AML without modifications, with interim analysis expected by Q4 2024.
2. Positive preliminary data from the Phase 2a trial of SLS009 in r/r AML, showing ORRs of 33%, 50%, and 100% in different cohorts.
3. SLS009 received EMA Orphan Drug Designations and FDA Rare Pediatric Disease Designations.
4. $21 million raised in August 2024 at a premium to market.
5. Q2 2024 financial results: R&D expenses $5.2M, G&A expenses $2.4M, net loss $7.5M ($0.13 per share).
6. Cash position: $9.1M as of June 30, 2024, bolstered by the subsequent $21M offering.
SELLAS Life Sciences Group (NASDAQ: SLS) has received Orphan Drug Designation (ODD) from the European Medicines Agency (EMA) for SLS009, a novel CDK9 inhibitor, for treating relapsed/refractory peripheral T-cell lymphomas (PTCL). This follows recent FDA Orphan Drug and Fast Track Designations for SLS009 in PTCL. In the Phase 1 trial, SLS009 showed promising results with a 36.4% response rate in PTCL patients, surpassing the current standard of care. The drug demonstrated favorable safety and efficacy in various hematological malignancies. This designation highlights the potential of SLS009 in addressing the urgent need for new therapies in aggressive lymphomas with treatment options.
SELLAS Life Sciences Group (NASDAQ: SLS) has announced a $21.0 million registered direct offering priced at a premium to market. The offering includes 15,849,056 shares of common stock (or equivalents) and warrants to purchase an equal number of shares. The combined effective price is $1.325 per share and accompanying warrant. Warrants have an exercise price of $1.20, are immediately exercisable, and expire in five years. The offering, expected to close around August 1, 2024, is made pursuant to an effective shelf registration statement. Maxim Group is acting as the sole placement agent. The proceeds will support SELLAS's focus on developing novel therapies for various cancer indications.
SELLAS Life Sciences Group (NASDAQ: SLS) has received Rare Pediatric Disease Designation (RPDD) from the FDA for SLS009, its CDK9 inhibitor, to treat pediatric acute myeloid leukemia (AML). This marks SELLAS' second RPDD, following a designation for ALL last month. The company has opened enrollment for pediatric AML patients in an ongoing Phase 2 clinical trial.
AML is the second most common hematological malignancy in children, often with poorer prognosis compared to other pediatric cancers. The RPDD makes SLS009 eligible for a Priority Review Voucher (PRV) upon marketing approval, which can be transferred or sold. SLS009 already has Orphan Drug and Fast Track Designations for AML treatment.
SELLAS Life Sciences Group announced that the European Medicines Agency (EMA) has granted Orphan Drug Designation (ODD) for SLS009, a selective CDK9 inhibitor, for treating acute myeloid leukemia (AML).
This designation follows positive preliminary Phase 2 data and aligns with the previous FDA ODD. The designation provides financial and regulatory incentives, including a 10-year marketing exclusivity in the EU post-approval.
SLS009 is currently in a Phase 2a clinical trial evaluating its safety and efficacy. The trial targets a 20% response rate and a median survival over three months, focusing on patients with specific myelodysplasia-related mutations.
SELLAS Life Sciences has received Rare Pediatric Disease Designation (RPDD) from the FDA for its drug SLS009, targeting pediatric acute lymphoblastic leukemia (ALL), the most prevalent cancer among children.
This designation makes SLS009 eligible for a Priority Review Voucher (PRV) upon marketing approval, which can be sold, historically fetching around $100 million.
SLS009 is a selective CDK9 inhibitor that has shown a favorable safety profile in clinical trials, with no high-grade non-hematologic toxicities.
The RPDD recognizes the critical need for new treatments in pediatric ALL, where relapse rates remain high, particularly in high-risk groups.
SELLAS aims to expedite the clinical development of SLS009, offering potential new treatment options for children with ALL and improving their long-term event-free survival (EFS).
SELLAS Life Sciences (NASDAQ: SLS) announced a positive recommendation from the Independent Data Monitoring Committee (IDMC) for its Phase 3 REGAL trial in acute myeloid leukemia (AML). The IDMC advised the trial to continue without modifications, citing no safety or futility concerns. The IDMC's review of unblinded data indicated a high level of confidence that an interim analysis will occur by Q4 2024. This recommendation strengthens SELLAS' confidence in GPS (galinpepimut-S) as a potential AML treatment. The REGAL trial targets AML patients in complete remission post-second-line salvage therapy, with the primary endpoint being overall survival.
SELLAS has completed enrollment for its Phase 2a trial of SLS009 in relapsed/refractory acute myeloid leukemia (r/r AML) ahead of schedule. The trial includes 30 patients who have not responded to venetoclax-based regimens.
Initial results show promising efficacy with an overall response rate (ORR) of 33% and 50% in the 60 mg QW and 30 mg BIW dosing cohorts, respectively. Median overall survival (OS) was 5.4 months at the 45 mg QW dose, significantly higher than the 2.5 months standard of care. Notably, patients with ASXL1 mutations in the 30 mg BIW cohort achieved a 100% ORR. The trial will now proceed with two additional cohorts focusing on patients with specific genetic mutations, with further updates expected in Q3 2024.
SELLAS Life Sciences (SLS) announced its Q1 2024 financial results, highlighting significant clinical and financial milestones. The Independent Data Monitoring Committee (IDMC) recommended the continuation of the Phase 3 REGAL study without modifications and confirmed the completion of patient enrollment. Positive Phase 2 data for SLS009 in AML patients showed a 100% response rate in those with the ASXL1 mutation at a 30 mg BIW dose. Financially, R&D expenses decreased to $5.1 million, while G&A expenses rose slightly to $4.5 million. The net loss narrowed to $9.6 million, with cash reserves at $18.4 million.