SELLAS Life Sciences Group (SLS) Company Report

SELLAS Life Sciences Group (NASDAQ: SLS) provided an update on its Phase 3 REGAL trial evaluating GPS as a potential maintenance therapy in patients with Acute Myeloid Leukemia (AML).
The final analysis of the REGAL trial is event-driven, triggered by the occurrence of 80 events (deaths).
As of December 26, 2025, the Contract Research Organization informed SELLAS that 72 events have occurred in the trial.
SELLAS remains blinded to trial outcomes, and while the 80th event was expected before year-end, survival times appear longer than anticipated.

Dec 29, 2025, 1:35 PM

Press Release

SELLAS Life Sciences Presents Positive Phase 2 Data for SLS009 in AML-MR

SLS

SELLAS Life Sciences Group presented positive Phase 2 clinical data for its drug candidate SLS009 in combination with azacitidine and venetoclax for relapsed or refractory acute myeloid leukemia (AML-MR) at the ASH 2025 meeting.
The study demonstrated a 46% overall response rate across all cohorts, including a 58% overall response rate in patients with one prior line of therapy.
Median overall survival (mOS) reached 8.9 months in the least pretreated patient cohort, significantly exceeding the historical benchmark of approximately 2.5 months.
The combination was safe and feasible with no dose-limiting toxicities, and an expansion study for newly diagnosed AML with high-risk features is planned for Q1 2026.

Dec 7, 2025, 11:00 PM

Press Release

SELLAS Life Sciences Reports Q3 2025 Financial Results and Corporate Update

SLS

Earnings

New Projects/Investments

SELLAS Life Sciences Group, Inc. reported a net loss of $6.8 million for the third quarter of 2025, or $0.06 per basic and diluted share, compared to a net loss of $7.1 million, or $0.10 per share, for the same period in 2024.
As of September 30, 2025, the company held $44.3 million in cash and cash equivalents, with an additional $29.1 million in net proceeds received in October 2025 from warrant exercises.
The Phase 3 REGAL trial of GPS is advancing as planned, with the final analysis anticipated by year-end 2025.
Positive Phase 2 data for SLS009 in relapsed or refractory (R/R) AML was accepted for presentation at ASH 2025, and the initiation of a trial for newly diagnosed first-line AML patients is expected in Q1 2026.

Nov 12, 2025, 9:08 PM

8-K

SELLAS Life Sciences Reports Q3 2025 Financial Results and Corporate Update

SLS

Earnings

New Projects/Investments

SELLAS Life Sciences reported a net loss of $6.8 million for the third quarter of 2025, or $(0.06) per basic and diluted share.
As of September 30, 2025, the company held $44.3 million in cash and cash equivalents, with an additional $29.1 million in net proceeds received in October 2025 from warrant exercises.
The Phase 3 REGAL trial of GPS is advancing as planned, with the final analysis anticipated by year-end 2025.
Positive Phase 2 data for SLS009 in R/R AML was accepted for presentation at ASH 2025, and the initiation of a trial for newly diagnosed first-line AML patients is expected in Q1 2026.

Nov 12, 2025, 9:05 PM

Press Release

SELLAS Provides Update on GPS and SLS009 Clinical Programs and Financing

SLS

New Projects/Investments

Guidance Update

SELLAS has significantly strengthened its balance sheet with $31 million in gross proceeds from warrant exercises this week, in addition to nearly $24 million last month, to support its clinical programs.
The Phase 3 RIGEL trial for GPS (Galinpepimut-S) in AML is nearing a key milestone, with the 80th event expected by year-end 2025. The trial has observed unexpectedly long survival times, which is considered an encouraging sign for the potential efficacy of GPS as a first-in-class maintenance therapy.
SELLAS plans to advance its SLS009 (Tebonciclib) program into the frontline setting for newly diagnosed AML patients and those refractory to venetoclax and azacitidine by Q1 2026, with initial data anticipated later that year. This follows promising Phase 1/2 data showing improved median overall survival to 8-9 months in venetoclax-refractory patients.

Oct 29, 2025, 2:00 PM

Transcript

SELLAS Life Sciences Group Announces Exercise of Warrants for $31 Million Gross Proceeds

SLS

SELLAS Life Sciences Group announced the immediate exercise of existing warrants by an institutional investor, generating approximately $31.0 million in gross cash proceeds.
The exercised warrants, originally issued in March and August 2024, allowed for the purchase of up to 22,363,714 shares of common stock.
In consideration for the exercise, the investor will receive new registered warrants to purchase an equivalent number of shares (22,363,714) at an exercise price of $2.00 per share, exercisable immediately and expiring in five years.
The closing of this transaction is expected to occur on or about October 28, 2025.
The company will pay financial advisors an aggregate fee of 5.75% of the gross proceeds and reimburse legal expenses up to $60,000.

Oct 27, 2025, 12:35 PM

8-K

SELLAS Life Sciences Group Announces Warrant Exercise and Gross Proceeds

SLS

SELLAS Life Sciences Group announced the immediate exercise of existing warrants, previously issued in March and August 2024, to purchase up to 22,363,714 shares of its common stock.
This transaction is expected to generate approximately $31.0 million in gross cash proceeds for the company.
In consideration for the immediate exercise, the investor will receive new registered warrants to purchase up to 22,363,714 shares of common stock at an exercise price of $2.00, which will be exercisable immediately and expire five years from the date of issuance.
The closing of this transaction is expected to occur on or about October 28, 2025.

Oct 27, 2025, 12:30 PM

Press Release

Red Sea Global Announces Shura Island Resorts and Golf Course Opening

SLS

New Projects/Investments

Product Launch

Hiring

Red Sea Global (RSG) announced the imminent opening of the first resorts and attractions on Shura Island in September, including the SLS, EDITION, and InterContinental hotels.
The initial phase also features the debut of Shura Links, Saudi Arabia's first island golf course.
Shura Island is planned to host 11 international standard resorts in total, with the first exclusive residences available for delivery by the end of 2025.
This initiative is a core component of Saudi Arabia's Vision 2030 for economic diversification and is projected to create 120,000 new jobs.

Sep 15, 2025, 11:30 AM

Press Release

Red Sea Global Announces Shura Island Openings

SLS

New Projects/Investments

Product Launch

Red Sea Global (RSG) announced that the first resorts and attractions on Shura Island will begin opening to guests in the coming weeks, with Shura Links, Saudi Arabia’s first island golf course, also set to open in September.
Phase one of the launch includes the debut of SLS, EDITION, and InterContinental hotels.
Shura Island is planned to eventually host 11 world-class resorts, all scheduled to open over the next few months.
The first exclusive homes on Shura Island, announced earlier this year, are expected to be ready for handover at the end of 2025.