SELLAS Life Sciences Group, Inc. - SLS STOCK NEWS

SELLAS Life Sciences Group announced positive data from Phase 2 trial of SLS009, a CDK9 inhibitor, in relapsed/refractory acute myeloid leukemia (r/r AML). Key findings include:

- Median Overall Survival exceeding 7.7 months in the 30 mg BIW cohort for venetoclax-refractory patients (vs. historical 2.5 months)
- 56% Overall Response Rate in AML-MRC patients, surpassing the 33% target
- Well-tolerated safety profile with no new safety signals

The trial included 14 patients in Cohort 3 and 14 in Cohorts 4-5, with 9 evaluable patients at analysis. The study evaluates SLS009 in combination with venetoclax and azacitidine at different dose levels, focusing on ASXL1 mutated AML patients and those with myelodysplasia-related molecular abnormalities.

SELLAS Life Sciences Group announced promising preclinical study results showing ASXL1 mutations as a key predictor of SLS009 response in solid cancers. The study revealed high efficacy in 67% of ASXL1 mutated solid cancers compared to 0% in non-ASXL1 mutated cancers. In colorectal cancer (CRC MSI-H), ASXL1 mutations were found in 58% of cases, with high efficacy in 57% of mutated cell lines. In non-small cell lung cancer (NSCLC), 100% efficacy was observed in ASXL1 mutated cell lines. SLS009 outperformed the positive control in 5 out of 9 cell lines, positioning it as a promising therapeutic candidate.

SELLAS Life Sciences Group (NASDAQ: SLS) reported Q3 2024 financial results and pipeline updates. The company's Phase 3 REGAL study interim analysis for AML treatment remains on track for Q4 2024. Their drug candidate SLS009 showed promising results in Phase 2a trials, with a 31% overall response rate in relapsed/refractory AML patients. Financial highlights include Q3 R&D expenses of $4.4M (down from $5.8M in 2023), G&A expenses of $3.0M (down from $3.5M), and a net loss of $7.1M ($0.10 per share). Cash position stands at $21M as of September 30, 2024.

SELLAS Life Sciences (NASDAQ: SLS) announced promising results from its Phase 2a trial of SLS009, a CDK9 inhibitor, in treating relapsed/refractory acute myeloid leukemia (r/r AML). The findings will be presented at the 66th ASH Annual Meeting in December 2024.

The trial, involving 30 patients, demonstrated a 50% response rate at the optimal dose level of 30 mg twice weekly. Notable outcomes include a median overall survival of 5.5 months at 45 mg once weekly, compared to less than 2.5 months with standard care. The treatment showed particular effectiveness in patients with AML-myelodysplasia-related changes, especially those with ASXL1 mutations, achieving a 56% response rate in this group.

SELLAS Life Sciences Group (NASDAQ: SLS) has received Rare Pediatric Disease Designation (RPDD) from the FDA for Galinpepimut-S (GPS) in treating pediatric acute myeloid leukemia (AML). GPS, an immunotherapeutic targeting Wilms Tumor-1, is currently in a Phase 3 REGAL trial for adult AML patients, with an interim analysis expected in Q4 2024.

The RPDD makes GPS eligible for a Priority Review Voucher (PRV) upon marketing approval, which can be transferred or sold, with recent valuations around $100 million. GPS has shown promise in clinical settings, particularly in younger patients. In a Phase 2 trial with adult AML patients, GPS demonstrated a median overall survival of 67.6 months across all ages, with even better outcomes in younger patients.

AML prognosis in refractory/relapsed pediatric patients remains poor, with a 5-year overall survival rate of 33% for all patients, and only 15.7% for those whose remission lasted less than 12 months. About 50% of children with pediatric AML relapse, highlighting the need for new treatment options.

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.