• Regal reached its 80th event, triggering final analysis, with topline results expected in Q4.
• SLS009 frontline data are expected in Q4, with previously treated AML results scheduled for presentation at ASH on Dec.14.
• Stocktwits sentiment slipped to “neutral” even as 24-hour message volume jumped 193%.

Shares of Sellas Life Sciences Group (SLS) rose nearly 1% overnight heading into Tuesday as retail traders anticipated Regal trial results and quarterly earnings, with analysts forecasting a smaller loss per share than a year earlier.

SLS stock climbed nearly 2% on Monday, recording its second straight session in the green. 

Sellas’ Regal Moves Toward Final Readout

Sellas disclosed last month that Regal had reached its pre-specified 80th event, triggering the final analysis. The next steps include database lock, unblinding and statistical analysis ahead of an expected Q4 readout.

The Phase 3 trial evaluates Galinpepimut-S (GPS) as maintenance treatment for acute myeloid leukemia (AML) patients in second complete remission, with overall survival as its primary endpoint. “Reaching the 80th event represents a critical milestone in the REGAL trial,” CEO Angelos Stergiou said. 

Last week, Stergiou reiterated that Sellas anticipates reporting the primary endpoint data soon. 

SLS Q3 Preview

On a quarter-over-quarter basis, analysts expect no revenue and a loss of $0.05 per share, both unchanged from the previous quarter, according to Koyfin. Operating loss is projected to narrow slightly to $10.42 million from $10.63 million.

On a year-over-year basis, revenue is expected to remain nil, while loss per share is forecast to narrow to $0.05 from $0.07, according to Fiscal AI. Operating loss, however, is expected to widen to $10.4 million from $7.41 million. Sellas last reported $138.3 million in cash and cash equivalents as of June 30, alongside a Q2 net loss of $9.6 million.

Earnings And Buyout Speculation Swirl Around SLS

On Stocktwits, retail sentiment for SLS slipped to ‘neutral’ from ‘bullish’ levels a day ago amid a 193% jump in 24-hour message volumes.

One user said a quarterly filing and corporate update could arrive Tuesday or Thursday.

Another user said, “The next 2 weeks are either going to set me back a few years of saving, or practically buy me a house.” A separate user said, “As soon as top line data comes out, the BO will be announced.” The user also suggested news could arrive around earnings. 

SLS009 Gives Sellas Another Q4 Data Catalyst

Sellas also expects Q4 topline data from its ongoing 80-patient Phase 2 study of SLS009 in newly diagnosed AML.

Separately, the company plans to present completed Phase 2 data in previously treated AML at ASH on Dec. 14. At the selected dose, response rates were 54% in monocytic AML and 57% in TP53-mutated AML, with median overall survival of 5.8 and 8.8 months, respectively. 

SLS stock has jumped 128% year-to-date.

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