SLS Stock July Rout Deepens: ‘Pharma Bro’ Martin Shkreli Questions Timing Of AML Trial, Says Data May Wait Until Christmas

Shkreli reiterated his long-standing bearish stance on SLS, although he previously acknowledged making “a bad call” on Capricor after its positive HOPE-3 trial results.

• Shkreli said he was “not sure” the long-awaited Regal data would arrive this summer and said the readout could be delayed until Christmas.
• Sellas has reached 78 of the 80 events needed to trigger Regal’s final analysis, bringing the company closer to the most important catalyst in its history.
• CEO Angelos Stergiou said the company is nearing the 80-event threshold, has entered a quiet period, and is focused on database lock.

Shares of Sellas Life Sciences (SLS) came under renewed pressure early Thursday as former hedge fund manager Martin Shkreli challenged the bull case for its Phase 3 Regal trial and warned that the key acute myeloid leukemia (AML) readout could slip beyond the summer.

SLS stock extended its losses in overnight trading, falling 1% heading into Thursday after sliding 6% in the previous session. The shares are also on track for their worst monthly performance in a year.

Shkreli Doubts Summer SLS Data

Responding on X to a detailed bearish analysis of Sellas, Shkreli said: “I’m not sure we get data this summer lol, maybe Christmas.” The post Shkreli responded to said that Regal has a “high probability of failure” since its statistical design leaves GPS, or Galinpepimut-S, with little room for error. The Phase 3 trial is evaluating GPS as maintenance therapy for AML patients in second complete remission. Sellas said the study would be successful if GPS extends the median overall survival to 12.6 months, compared with 8 months with standard treatment.

The bearish thesis argues that Regal’s control patients may live longer than expected as they had already responded to salvage therapy and recovered enough to enroll. Stronger control-arm survival would raise the benefit GPS must show to achieve statistical significance. “Every extra month of control survival pushes the bar out of reach,” the user said.

Sellas has recorded 78 of the 80 events required to trigger Regal’s final analysis, placing the company close to the most important clinical readout in its history. CEO Angelos Stergiou has called the slower event accumulation encouraging. 

SLS CEO Teases GPS Ahead Of Fox Interview

Stergiou is scheduled to appear on “FOX & Friends” on Friday to discuss AI in healthcare and the next frontier of cancer immunotherapy. In announcing the segment, he highlighted the use of computational tools in developing GPS, saying early algorithms helped screen thousands of potential binders and identify peptide modifications designed to strengthen immune binding. “We tested it in the lab, and the computer was exactly right,” Stergiou said. He also said this week that Sellas is “approaching the pre-specified 80th event threshold” and has entered a quiet period on trial-specific updates. “Our executive team now remains entirely focused on operational execution, preparing for database lock, advancing our BLA/CTD regulatory work, and driving the SLS009 program forward,” he added. 

Shkreli Maintains Bearish SLS View 

Shkreli has remained a vocal skeptic of Sellas. When asked in March whether he was still bearish, he said: “Very bearish, it will fail.” He has previously questioned GPS’ mechanism of action, the strength of its clinical evidence and whether REGAL can show a meaningful survival benefit in a relatively small, difficult-to-treat AML population. His record is not flawless. After Capricor Therapeutics reported positive HOPE-3 results, Shkreli called his bearish prediction “a bad call” and apologized to followers who acted on it.

How Do Retail Traders Feel About SLS?

On Stocktwits, retail sentiment for SLS has been ‘bearish’ over the past week amid a 27% rise in 24-hour message volume.

One user speculated, “$SLS I could Totally  see the PR Drop Tomorrow.... and Go on Fox and Friends with a huge smile and  I don't know......maybe stuff to talk about.  I think the 80th happened”

View this Stocktwits post

Another user said, “$SLS I'm starting to think that they will release the 80th event along with FA. Either required by potential buyer or their new strategy. Tomorrow will be 73 days since May 11th. That's 29 days pass the statistical deadline! It can't be that much based on previous data.”

View this Stocktwits post

SLS stock has surged 557% over the past year. 

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