Sellas held $134.7 million in cash at September-end, while Q3 net loss widened to $10.1 million despite a narrower per-share loss.
- SLS009’s Phase 2 study in newly diagnosed AML enrolled 40 of 80 planned patients, with preliminary results expected in Q4.
- Separate SLS009 data headed to ASH showed a 34% response rate across all doses.
- The company is preparing to study SLS009 in pancreatic cancer patients after lab findings supported research into treatment resistance.
Shares of Sellas Life Sciences (SLS) surged 17% in after-hours trading on Thursday after the company said that its key leukemia trial results are expected this month, with its CEO pointing to the treatment’s potential to become a “transformative” immunotherapy if successful.
SLS stock fell nearly 5% on Thursday to $8.03, with shares on track to post their third straight weekly decline.
Sellas Narrows Wait For Regal AML Results
The update is related to the Phase 3 Regal trial of Galinpepimut-S (GPS) in acute myeloid leukemia (AML). The November timeline narrows Sellas’ earlier guidance for results in the fourth quarter.
“In our ongoing Phase 3 REGAL trial of GPS, we are focused on completing the final analysis following the announcement of 80th event, and we expect to announce topline primary endpoint results this month,” CEO Angelos Stergiou said. “If successful, we believe GPS could be a transformative new immunotherapy for AML patients in second complete remission.”
Regal is testing GPS as a maintenance treatment for AML patients who have returned to remission after treatment for a relapse. The study’s main goal is to determine whether GPS helps these patients live longer. GPS is licensed from Memorial Sloan Kettering Cancer Center and targets WT1, a protein found in a range of cancers.
Sellas disclosed late last month that the trial had reached its prespecified 80th death, the milestone required to begin its final analysis. This process involves finalizing and reviewing the trial database, revealing treatment assignments and analyzing the results.
Sellas’ Second Cancer Drug Nears Key Updates
Beyond GPS, Sellas is advancing its second leukemia drug, Tambiciclib, or SLS009, with investors looking ahead to fresh trial results and a major medical conference presentation.
The company has enrolled 40 patients in its planned 80-patient Phase 2 study in newly diagnosed AML, up from 28 disclosed in August. The study includes patients whose disease stops responding early to Azacitidine and Venetoclax, an existing drug combination. Enrollment and treatment are currently continuing, with preliminary results expected in the fourth quarter.
The development comes after a completed Phase 2 study in patients whose leukemia returned or failed to respond after prior Venetoclax-based treatment. Sellas will present the findings on Dec.14 at the American Society of Hematology (ASH) meeting in New Orleans.
The study enrolled 62 patients and combined SLS009 with azacitidine and venetoclax. Across all doses, 34% of the 59 patients evaluated responded to treatment. At the dose of 30 milligrams twice weekly, 54% of patients with monocytic AML, a leukemia subtype, responded, with median survival of 5.8 months. Among patients with a TP53 mutation, 57% responded, with median survival of 8.8 months.
Sellas Holds $134.7M As Trial Costs Climb
Sellas ended September with $134.7 million in cash and cash equivalents, down from $138.3 million in June. “With $134.7 million in cash and cash equivalents as of September 30, we are well positioned to further advance these programs,” Stergiou said.
Third-quarter (Q3) net loss widened to $10.1 million from $6.8 million a year earlier, while loss per share narrowed to $0.05 from $0.06. Meanwhile, research and development spending rose to $7 million from $4.2 million as Sellas prepared for a potential GPS approval application after Regal’s final analysis.
Sellas Eyes Pancreatic Cancer Next
Additionally, Sellas is preparing to study SLS009 in pancreatic cancer patients after laboratory findings presented in September. Working with the University of Wisconsin-Madison, researchers tested SLS009 in cancer models grown from patient tissue, including one resistant to Daraxonrasib. They also tested it alongside the experimental drug ZEN3694.
Sellas said that the findings support further research into overcoming treatment resistance. However, patient trials are yet to begin.
How Do Retail Traders Feel About SLS?
On Stocktwits, retail sentiment for SLS improved to ‘neutral’ from ‘bearish’ levels a day ago amid a 58% jump in 24-hour message volumes.
One user speculated, “$SLS SLS got the data within 48 hours of end of trial – probably by the time the 80th event was actually PR’ed. They already have preliminary analysis and know within reason whether the trial succeeded. That LinkedIn post was made by an informed CEO. IMO, we are as close to being certain of success as you can be without the coming PR.”
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Another user said, “$SLS We can expect new silent period after ASH when SLS 009 Phase 2 data pops and BO offers set in.”
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SLS stock has risen 113% year-to-date.
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