drkazmd65
1 월 전
OK - so now that 60 'events' have been reached - there's a potential breakthrough coming for SLS,....
https://www.investing.com/news/company-news/sellas-triggers-interim-analysis-in-aml-trial-93CH-3763850
NEW YORK - SELLAS Life Sciences Group, Inc. (NASDAQ: NASDAQ:SLS), a biopharmaceutical company specializing in cancer therapies, has reached a significant milestone in its Phase 3 REGAL clinical trial for acute myeloid leukemia (AML). The trial has met the pre-specified threshold of 60 events (deaths), which will prompt an interim analysis by the Independent (LON:IOG) Data Monitoring Committee (IDMC) scheduled for January 2025. The company, currently valued at $80.24 million, maintains a strong liquidity position with more cash than debt on its balance sheet, according to InvestingPro data.
The IDMC's review will assess the efficacy, futility, and safety of the company's lead product candidate, galinpepimut-S (GPS), which targets the WT1 protein found in various tumor types. This analysis is a crucial step in evaluating GPS's potential as a new treatment option for AML patients.
SELLAS's President and CEO, Angelos Stergiou, MD, ScD hc, expressed optimism about the development, attributing the progress to the support of shareholders, the dedication of clinical investigators, and the resilience of patients and their families. While the stock has experienced recent volatility, with a 7.6% decline over the past week, analysts maintain a bullish outlook with price targets ranging from $4 to $7.50. InvestingPro subscribers can access 8 additional key insights about SELLAS's financial health and market position.
The company announced that it would host a webcast call today at 9:00 am ET to discuss the process leading up to the IDMC meeting and the potential outcomes of the interim analysis. The REGAL study is an open-label registrational trial for AML patients in complete remission following second-line salvage therapy. The primary endpoint of the study is overall survival. With a healthy current ratio of 2.26, SELLAS demonstrates strong ability to meet its short-term obligations while pursuing its clinical development programs.
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In addition to GPS, SELLAS is developing SLS009, a small molecule CDK9 inhibitor that has shown promise in AML patients with unfavorable prognostic factors.
This interim analysis is part of the IDMC's ongoing responsibilities, which include periodic reviews of safety, efficacy, and futility, in addition to the interim and final analyses. While the company holds a positive outlook, it is important to note that forward-looking statements involve risks and uncertainties, and actual results may differ materially from those anticipated.
The information for this article is based on a press release statement from SELLAS Life Sciences Group, Inc.
In other recent news, SELLAS Life Sciences Group has reported promising results from their Phase 2 clinical trial for the drug SLS009, designed for patients with acute myeloid leukemia. The median overall survival for patients now exceeds 7.7 months, a significant improvement over the historically expected 2.5 months. The overall response rate in two expansion cohorts also surpassed the target response rate of 33%, reaching 56%. These encouraging results have led to upward revisions in earnings expectations by analysts from InvestingPro.
SELLAS has also secured Rare Pediatric Disease Designation from the U.S. Food and Drug Administration for SLS009 and its immunotherapeutic agent, Galinpepimut-S (GPS). This designation highlights the potential of these drugs in treating pediatric acute myeloid leukemia and pediatric acute lymphoblastic leukemia.
In other developments, the company has extended its lease agreement for its Times Square Tower headquarters through September 2026. On the financial front, SELLAS is set to raise approximately $21 million through a registered direct offering, with Maxim Group LLC acting as the placement agent. These funds are anticipated to support the company's ongoing research and development efforts. These are among the recent developments for SELLAS Life Sciences Group.
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This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.
Boxsterfan
4 월 전
Correct. To pass muster at Final Analysis, they need to be 0.636. So at the last meeting, it is very tight. My estimates show it to be at 0.619.
So in June, at 0.619, you would not get a "halt for futility" or any "futility concerns". You would only get that if the HR number was above 0.636 and you still may not get a "futility halt" if the number was just slightly above 0.636 (say 0.643) at the time they looked at the data. You need to understand that the CEO (and company) is grifting investors.
Let's put it another way, when the trial fails, what "evidence" are you going to use to sue Stergiou and/or the company for lying about the trial? You won't have any because they have covered their bases.
Boxsterfan
4 월 전
Well, I used to think Sellas was going to be a stock to play. I used to think that it was going to have some decent volatility heading into September that would have nice to swing trade. But now, I will recognize that this stock is a sham. If you just go read the posts on other boards (like Stocktwits), it is like a desperation pump show. Ignore the posters over there like @GPS_vs_SOC and a few others that post all the time. Instead, watch the posters that do post with some regularity continually saying "they bought more shares" or "this is going to rocket soon" or etc, etc, etc...
In all likelihood, GPS REGAL trial has failed. Oncology is a tough business and it is even tough when the CEO is retarded.
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