SELLAS Life Sciences shares drop 14% amid REGAL delay, challenging $2.2 billion valuation

SLS closed Friday, July 24, at $11.32, down 8.27%. Volume was 6.73 million shares, below the 9.28 million 65-day average. The stock lost 9.26% across the week’s five sessions. SELLAS issued no company press release explaining Friday’s decline. Pre-readout positioning is plausible, but the exact cause remains unverified. The Wall Street Journal

The latest verified count remains 78 deaths, as of May 11. SELLAS said it would announce when the 80th event was confirmed. No such announcement appeared through July 26. That absence does not prove the event has not occurred. Site reporting and event reconciliation can create delays. SEC

REGAL’s primary endpoint is overall survival after a second AML remission. The final analysis uses 80 deaths across both randomized treatment groups. SELLAS said a hazard ratio near 0.636 would achieve significance. It illustrated that as 12.6 months versus eight months median survival. That comparison is a statistical design assumption, not a forecast. ClinicalTrials.gov

No. The monitoring committee said GPS cleared the preset futility threshold. It also reported no safety concern and recommended continuing without changes. Pooled, blinded median survival exceeded 13.5 months at the January 2025 review. Separately, 80% of sampled GPS recipients developed a specific T-cell response. Neither disclosure replaces the final treatment-arm survival comparison. Sellas Life Sciences

At $11.32, SELLAS had an implied equity value near $2.23 billion. That calculation uses 196.63 million shares reported on June 2. SELLAS has no approved product generating commercial revenue. The company recorded an $8.4 million first-quarter net loss. Its valuation therefore depends mainly on GPS and SLS009 development outcomes. The Wall Street Journal

Cash and equivalents totaled $107.1 million on March 31. Warrant exercises added approximately $28.7 million during April and May. That implies $135.8 million before subsequent operating spending. First-quarter operating cash use was $8.8 million. Management said available funding covered at least twelve months from May 12. Current cash remains undisclosed, while post-readout spending could increase. SEC

Shares outstanding increased from 186.03 million to 196.63 million by June 2. That represents 5.7% growth in roughly three weeks. At March 31, approximately 30.3 million warrants remained outstanding. Many were subsequently exercised, but the latest remaining total was not disclosed. SELLAS also maintains a $150 million at-the-market equity facility. No ATM shares had been sold as of the May 12 filing. SEC

The latest relapsed AML dataset included 35 evaluable patients. SLS009 with azacitidine and venetoclax produced a 46% overall response rate. Complete remission or CRi occurred in 29% of patients. Those receiving only one previous therapy line showed a 58% response rate. However, the study was small and lacked a randomized control group. An 80-patient first-line trial targets topline results during 2026’s fourth quarter. Sellas Life Sciences

Reported short interest totaled 55.28 million shares on July 15. That was 12.7% below the June 30 reported position. Data providers place short interest around 28% to 30% of float. Estimated covering time ranges from roughly five to six trading days. That remains large enough to intensify trial-driven moves in either direction. The next official settlement date is July 31, publishing August 11. MarketBeat

The clearest trigger remains confirmation of REGAL’s 80th death event. A decision in SELLAS’ arbitration with 3D Medicines could also arrive. The disputed development milestones total $13 million, alongside other claimed damages. January’s arbitration hearing is complete, but no decision date was disclosed. SELLAS had posted no scheduled investor event for July 27–31. Both catalysts are genuine. Their timing remains unknown. SEC