SELLAS Life Sciences Group Inc (SLS) News

...now waiting for mid of January...😇🤩

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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Up next for Sellas:
1. You have been witnessing the stock price pump with the ASH 2024 Conference and data on SLS009. The reason this is a pump is because new data is not being released from the other cohorts and the P2B information. It's simply a rehash of June's data. Classic pump.

2. After the ASH 2024 Conference, you will get dilution. The company will be below $10M in cash position by 12/31/2024. In the past, this is when dilutions have occurred. No reason to expect anything different.

3. REGAL failed. They will drag this out as long as they reasonably can before shareholders start engaging lawsuits to get the data. I suspect lawsuits may be filed near the end of Q1 2025.

Stergiou is a piece of garbage. Always has been.

How can you be investing in biotech companies and not know what an "open label phase 2" trial is?

Do you understand that the data from the SLS009 P2 trial is NOT blinded? They can peek at it every morning while eating their coffee and bagel. Even if it were goods news, it is immoral for the CEO to hold back the data from investors. It's not good news or Stergiou would be sharing it.

Cheap FUD.  No company gives exact timlines when dealing with patients, the heterogeneity of cancer doesn't allow it.  The company stated 'expected' by 3rd qtr.

SLS009 updated data from Phase 2 is now 4 weeks overdue. The company specifically stated more data on SLS009 by end of Q3 2024.

More than likely, SLS009 has failed Phase 2.

Today's "fireside chat" happened for Sellas. What we re-learned:
1. Data for P3 REGAL trial is still imminent.
2. Data from SLS009 open label study is imminent.
3. RPDD with value of $0 for GPS. Pumping useless RPDD's is of no concern.
4. Everything is imminent and all is good.
5. Did I mention imminent? Because that has been the M.O. for the past year.

Huge news!! Sellas to have "fireside chat" at 2024 Maxim Healthcare Virtual Summit on Tuesday, October 15, 2024 at 9:00 am EDT. This is incredible news!! These "fireside chats" are always filled with new information and probably has tons of info on their drug candidates never heard anywhere else before. LOLOLOLOLOLOLOLOLOLOLOLOLOL

https://ir.sellaslifesciences.com/news/News-Details/2024/SELLAS-Life-Sciences-to-Participate-in-Fireside-Chat-at-the-2024-Maxim-Healthcare-Virtual-Summit/default.aspx

I'm not giving you the valuable research that I did. One thing for sure is you know little about clinical trials.

Can the BAT change during a trial? Or must these CR2 patients in that arm just live (or rather die) with the old treatments from 2019? Would that be ethical? Would that be a test of BAT if it did?

The Regal trial protocol was written in 2019… the five choices for BAT haven’t changed, yes ven/aza combo is in BAT… but lip services from leading clinicians in 2023 re: the same treatment options since ven/aza available since 2017-18… puhlease. Why don’t you give me some FACTS like I’m doing for you? Explain your BAT 13 mOS with data!

Correct, my estimate. Those VIALE-A trials on CR1 patients were 3+ years ago. Other trials on CR2 patients were also years ago. The field has moved on since then and knows how to treat patients on ven/aza with additional inhibitors depending on the karyotypes presented. MRD negative status is also a huge helper in addition to patient age.

The doctors on the conference call last January were just giving lip service. Again, are you going to be able to sue them for saying "CR2 patients have a low 5-7 months expected survival"? If BAT MOS was 6 months, you would already have your 60 events. My last estimate has BAT 13 MOS vs GPS 21 MOS (0.619). It's very tight and the fact that Abbvie and Roche are seeing no degradation in stock price (and SLS seeing absolute nothing in stock price) indicates that it is not going to be a white Christmas.

Your estimate!! So you see BAT living 13-14 mos?? Double of what the Drs conducting the trial, and the majority of CR2 trials produced? IA needs an HR on .52, and i bet they are close to that. P2 was 21 vs 5.5 mos and that was with a 12 injection schedule, not the 15 in Regal.

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.

Is that what you took from the IDMC’s last Regal update of “NO CONCERNS REGARDING SAFETY OR FUTILITY”?

REGAL has failed means that the upcoming readout will be receiving a failing grade. They can't report until the 60th event, but at this point, it is obvious that this trial is DOA. Oncology is hard.

If Regal “has failed” it would be a material event and the company must inform the public with 3 trading days! You talk about “pumpers” and yet you state the trial has failed w/o a shred of evidence! That called FUD, but you already knew that, right?

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.

SLS under $2

Is it going to be a sh_t show for Sellas? Or a REG SHO extravagammasqueeze?

SLS under $2

SLS under $2

https://duediligencegenie.com/wp-content/uploads/2024/05/Sellas-Life-Sciences.pdf This should be sticky posted.

The longer this goes, it is gonna POP… BP gotta know what SLS has, 2,assets that are extending OS 3 to 5X.

https://www.barchart.com/stocks/quotes/SLS/opinion

dilution turd

Moneymaker here folks$$$$$

VERY OBSERVANT, THANK YOU FOR THE ANALOGY! TOMORROW MIGHT MAKE A DIFFERENCE****WE SHALL SEE

Lol, oh there are still a stash of those, in the 20’s! $$$$$!!

You should have taken CVNA which go to da moon
Now back to getting richer

Huge move up could happen anytime, lottery play could go to da moon! $$$$$

With positive REGAL results this will eventually explode

According to the charters, which I am not, 9 million volume traded so far today - largest volume day in 3 years - 6 of the 9 million sold short

SLS under $2

SURPRISED SLS IS NOT MOVING**** WAS AN EXCELLENT NEWS***** HOW ARE U *******

YOU ARE NOT AS FREQUENT AS BEFORE , YOU MUST BE SOMEWHERE ELSE***SHARE THE KNOWLEDGE

Let er rip

1.27 https://twitter.com/health_stocks/status/1785649885359780011

Somebody shorted the sh.. out of this today, pretty risky at this point, but whatever….

Yahoo finance add sls and review of the conversations tab.

you have a link ?

On yahoo they are talking 4 min.

Agree, might see 1.70’s again, worth the risk with a stop limit on shares purchased at 1$ or more

ok thanks

I believe it’s gonna before EOM… pr stated idmc scheduled ‘by’ EOM…

yup think next month data phase3 end april ... should see 1.50s before data

Maybe another pop to 1.60

SLS 10Q due 3/22

SLS under $2

Hit an run with this one

No way, lotto play here. This is nothing but risk