SELLAS Life Sciences Reports Full Year 2025 Financial Results and Provides Corporate Update

Resumen Rhea-AI

SELLAS Life Sciences (NASDAQ: SLS) informó los resultados del año completo 2025 y una actualización corporativa el 19 de marzo de 2026. Entre los aspectos más destacados se incluyen 71,8M de dólares en efectivo al cierre del ejercicio y 42,6M adicionales recibidos en el Q1 de 2026 por el ejercicio de warrants, el avance del ensayo fundamental de Fase 3 REGAL GPS hacia su análisis final de 80 eventos, tal como estaba previsto, y la dosificación del primer paciente en una expansión de Fase 2 de SLS009 en AML de diagnóstico reciente tras datos positivos de Fase 2 en AML r/r.

La Fase 2 de SLS009 mostró una tasa de respuesta global del 46% (29% CR/CRi) en 35 pacientes con AML r/r evaluables, con respuestas destacadas en los subgrupos ASXL1 y TP53.

Positivo

• Posición de efectivo de 71,8M de dólares al 31 de diciembre de 2025
• 42,6M adicionales recibidos por el ejercicio de warrants en el Q1 de 2026
• Fase 2 de SLS009 ORR 46% (CR/CRi 29%) en 35 pacientes con AML r/r evaluables
• REGAL Fase 3 en 72 de 80 eventos hacia el análisis final (26 de diciembre de 2025)

Negativo

• Pérdida neta de 26,9M de dólares para el año finalizado el 31 de diciembre de 2025
• El calendario del análisis final de REGAL sigue siendo incierto porque el estudio depende de eventos
• Los gastos de I+D disminuyeron a 16,0M de dólares en 2025 desde 19,1M de dólares en 2024, lo que refleja la finalización de la captación

Key Figures

Cash & equivalents: $71.8M Additional cash: $42.6M R&D expenses: $16.0M +5 more

8 metrics

Cash & equivalents $71.8M As of December 31, 2025

Additional cash $42.6M Proceeds from warrant exercises in Q1 2026 to date

R&D expenses $16.0M Full year 2025, down from $19.1M in 2024

G&A expenses $12.3M Full year 2025 vs $12.4M in 2024

Net loss $26.9M Full year 2025 vs $30.9M in 2024

EPS (basic & diluted) −$0.25 Full year 2025 vs −$0.50 in 2024

Warrant proceeds $67.2M Gross proceeds from warrant exercises in 2025

Phase 2 ORR 46% Overall response rate in 35 evaluable r/r AML-MR patients

Market Reality Check

Price: $4.95 Vol: Volume 5.34M is below the...

normal vol

$4.95 Last Close

Volume Volume 5.34M is below the 20-day average of 7.38M, suggesting muted pre-news activity. normal

Technical Trading well above the 200-day MA of $2.51, with shares at $4.95 pre-release.

Peers on Argus

SLS was down 1.79% pre-news, while peers ELTX, TLSA, CGTX, TNYA, and TRDA also s...

SLS was down 1.79% pre-news, while peers ELTX, TLSA, CGTX, TNYA, and TRDA also showed negative moves, indicating broader biotech pressure rather than an isolated move.

Previous Earnings Reports

5 past events · Latest: Nov 12 (Positive)

Same Type Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Nov 12	Q3 2025 earnings	Positive	-2.0%	Q3 2025 update with REGAL on track and ASH 2025 acceptance.
Aug 12	Q2 2025 earnings	Positive	-3.7%	Q2 2025 results and strong SLS009 Phase 2 efficacy and survival data.
May 13	Q1 2025 earnings	Positive	+7.1%	Q1 2025 update with notable SLS009 survival benefit and reduced net loss.
Mar 20	FY 2024 earnings	Positive	-0.8%	Full year 2024 results with positive REGAL interim and lower R&D and G&A.
Nov 13	Q3 2024 earnings	Neutral	+0.0%	Q3 2024 update showing REGAL progress, early SLS009 data, lower expenses.

Pattern Detected

Earnings and corporate update releases often skew positive in content but have produced mixed-to-negative next-day moves, with more divergences than alignments.

Recent Company History

Over the past five earnings-related updates from Nov 2024 through Nov 2025, SELLAS consistently highlighted progress in its AML programs, particularly the Phase 3 REGAL trial and Phase 2 SLS009 data. Financially, cash balances rose from $21M in Q3 2024 to $44.3M by Q3 2025, while net losses narrowed quarter over quarter. Despite generally constructive clinical and financial narratives, stock reactions were often modest or negative, underscoring a cautious market stance ahead of pivotal readouts.

Historical Comparison

+0.1% avg move · Across the last five earnings or annual result updates, average next‑day stock reaction was about 0....

earnings

+0.1%

Average Historical Move earnings

Across the last five earnings or annual result updates, average next‑day stock reaction was about 0.1%, with several mildly negative moves despite upbeat clinical and cash trends.

Earnings updates show a steady progression: REGAL advanced toward final analysis, SLS009 moved from early Phase 2 signals into broader AML settings, while cash balances increased and losses narrowed versus prior periods.

Regulatory & Risk Context

Active S-3 Shelf

Shelf Active

Active S-3 Shelf Registration 2025-10-10

The company has an effective Form S-3 shelf registration filed on October 10, 2025, registering multiple blocks of common stock for resale and allowing various transaction methods, as noted in the filing.

Market Pulse Summary

This announcement combines full year 2025 results with progress across GPS and SLS009 in AML. Financ...

Analysis

This announcement combines full year 2025 results with progress across GPS and SLS009 in AML. Financially, SELLAS reported a narrower net loss of $26.9M and cash of $71.8M, later strengthened by $42.6M in warrant proceeds. Clinically, the REGAL Phase 3 trial nears its 80-event trigger while SLS009 expands into first-line AML. Investors may track upcoming REGAL topline timing, SLS009 expansion data, and utilization of the existing S-3 resale registration.

Key Terms

phase 3, overall survival, median overall survival, dose-limiting toxicities, +3 more

7 terms

phase 3 medical

"Continued Advancement of Pivotal Phase 3 REGAL Trial of Galinpepimut-S (GPS)"

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

overall survival medical

"Because the final analysis is event-driven, the timing of studies with overall survival as an endpoint can vary"

Overall survival is the average or median length of time patients remain alive after starting a treatment or entering a clinical study, measured regardless of cause of death. Investors care because it is a clear, hard measure of a therapy’s real-world benefit — like timing how long a new battery actually runs — and strong improvements in overall survival can drive regulatory approval, market adoption and revenue potential.

median overall survival medical

"The median overall survival (mOS) was exceedingly higher than the expected 2.6 months"

Median overall survival is the middle point of how long patients live after starting treatment, meaning half live longer and half live shorter. It helps doctors understand how effective a treatment is and gives patients an idea of what to expect about their future.

dose-limiting toxicities medical

"No dose-limiting toxicities (DLTs) or treatment-related deaths were observed"

Dose-limiting toxicities are the harmful side effects seen in early clinical trials that are severe enough to stop researchers from raising a drug’s dose. Like a car’s speed limiter marking the safe top speed, DLTs define the maximum tolerable dose, and they matter to investors because they determine whether a medicine can reach effective levels, influence development timelines, costs, and regulatory chances, and thus affect a drug’s commercial prospects.

restricted stock units financial

"These RSUs were granted at a price of $0.00 per unit, reflecting a typical non-cash equity compensation grant"

Restricted stock units are a type of company reward where employees are promised shares of stock, but they only fully own these shares after meeting certain conditions, like staying with the company for a set time. They matter because they can become valuable assets and are often used to motivate employees to help the company succeed.

cdk9 inhibitor medical

"Tambiciclib (SLS009), a CDK9 inhibitor, promotes apoptosis and suppresses MCL-1 levels"

A CDK9 inhibitor is a drug that blocks the action of the cellular enzyme CDK9, which acts like a control switch for making certain short‑lived proteins that cells need to survive and multiply. For investors, it matters because these drugs are being developed to shut down critical survival pathways in cancers and some viral infections—think of cutting power to a factory assembly line to halt production—which can drive trial results, regulatory decisions, and company value.

apoptosis medical

"The data shows that SLS009 induces apoptosis in AML cell lines"

Apoptosis is a controlled, built‑in process where cells deliberately shut down and are safely removed, like a person retiring and clearing out their belongings so the house stays orderly. Investors care because many drugs and diagnostics target or measure this process: how well a therapy triggers or avoids apoptosis can determine clinical trial success, safety profiles, regulatory approval, and ultimately a company’s valuation.

AI-generated analysis. Not financial advice.

– Continued Advancement of Pivotal Phase 3 REGAL Trial of Galinpepimut-S (GPS) in Acute Myeloid Leukemia (AML) - Final Analysis upon Reaching 80 Events –

– First Patient Dosed in Phase 2 Trial of SLS009 in Newly Diagnosed First Line AML –

– Reported Positive Phase 2 Data of SLS009 in Relapsed/Refractory (r/r) AML at ASH 2025 –

– $71.8 Million in Cash and Cash Equivalents as of December 31, 2025; Additional $42.6 Million in Proceeds Received in Q1 2026 to Date Through Warrant Exercises –

NEW YORK, March 19, 2026 (GLOBE NEWSWIRE) -- SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) (“SELLAS’’ or the “Company”), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, today reported financial results for the full year ended December 31, 2025, and provided a corporate update.

“Based upon continued progress in our GPS and SLS009 clinical programs in AML, we believe 2026 is shaping up to be a pivotal year for SELLAS,” said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. “We are advancing toward the final analysis of our Phase 3 REGAL trial evaluating GPS in AML patients who have achieved complete remission following second-line salvage therapy. Once we reach the required pre-specified 80^th event, which will be announced, we will proceed with the necessary procedures towards database lock completion, statistical analysis, unblinding, and disclosure of topline results. If positive, REGAL could position GPS as a first- and best-in-class immunotherapeutic option in this AML population and serve as a significant value-inflection point for SELLAS.”

Dr. Stergiou continued, “We also continue to make significant progress in our SLS009 clinical program for AML. Following the positive Phase 2 results of SLS009 in r/r AML presented at ASH, particularly in high-risk molecular subtypes, we have now dosed the first patient in the expansion cohort, which is evaluating SLS009 in newly diagnosed, first-line AML patients. Additionally, our preclinical data presented at ESMO in T-PLL demonstrated a statistically significant survival benefit of SLS009 both as monotherapy and in combination with venetoclax in a patient-derived xenograft model, further supporting the breadth of the CKD9 inhibition strategy. With a catalyst rich outlook, continued clinical execution, our strongest financial position in history, and expansion into earlier treatment settings, we look forward to an important year ahead.”

Recent Corporate Highlights:

European Collaboration to Advance SLS009 Clinical Program: In January 2026, SELLAS entered into a strategic collaboration with IMPACT-AML to expand SLS009 clinical program in Europe. Under the agreement, IMPACT-AML’s STREAM clinical network will conduct a study of SLS009 in combination with AZA/VEN in newly diagnosed AML patients. The enrollment of approximately 40 patients in Europe is anticipated in Q2 2026.

Phase 3 REGAL Trial of GPS: On December 29, 2025, the Company provided an update on the pivotal Phase 3 REGAL trial, announcing that a total of 72 events had been recorded as of December 26, 2025, with the study remaining fully blinded. After reaching the required pre-specified 80^th event, customary database lock and blinded data review procedures must be completed before statistical analysis, unblinding, and disclosure of topline results. Because the final analysis is event-driven, the timing of studies with overall survival as an endpoint can vary; SELLAS will announce the 80^th event when it occurs.

Phase 2 SLS009 in r/r AML: On December 7, 2025, the Company announced that clinical data from its ongoing Phase 2 study of SLS009, in combination with azacitidine (AZA) and venetoclax (VEN) for the treatment of patients with r/r AML with myelodysplastic syndrome-related changes (AML-MR) after prior VEN-based treatment were presented at the 67th American Society of Hematology (ASH) Annual Meeting and Exposition in December 2025. SLS009 in combination with AZA/VEN demonstrated clinically meaningful activity in patients with R/R AML-MR, and among the 35 evaluable patients, the overall response rate (CR/Cri/MLFS) was 46%, including 29% achieving CR/CRi. Patients harboring ASXL1 or TP53 mutations achieved response rates of 48% and 57%, respectively. The median overall survival (mOS) was exceedingly higher than the expected 2.6 months in this R/R AML patient population, and in the least pretreated cohort, mOS reached 8.9 months. Across all cohorts, patients with one prior line of therapy experienced the greatest benefit, with a 58% response rate and mOS not yet reached. No dose-limiting toxicities (DLTs) or treatment-related deaths were observed, and the combination was well tolerated.

Expansion of SLS009 into Earlier-Line AML Treatment: Following the encouraging Phase 2 results of SLS009 in r/r AML particularly in patients with high-risk molecular subtypes, the Company has expanded the development program into earlier lines of therapy. After receiving constructive feedback from the FDA, SELLAS dosed the first patient in an 80-patient trial in newly diagnosed AML patients, as well as those who become refractory early to AZA/VEN treatment which we established through our extensive transcriptomics, genomics, and proteomics models.

Preclinical Data on SLS009 in AML at the 2026 American Association for Cancer Research (AACR): The data shows that SLS009 induces apoptosis in AML cell lines, including those harboring high-risk ASXL1 and TP53 mutations. Pharmacodynamic changes were observed as early as 8 hours after treatment and became more pronounced over time, with reductions in MCL-1 and survivin, correlating with increased apoptosis. The poster, entitled, “Tambiciclib (SLS009), a CDK9 inhibitor, promotes apoptosis and suppresses MCL-1 levels in AML cell lines” will be presented on April 21, 2026.

Preclinical Data on SLS009 in T-PLL Presented at ESMO 2025: In October 2025, preclinical data demonstrating statistically significant survival benefit of SLS009 were presented at the European Society for Medical Oncology (ESMO) Congress in Berlin, Germany. The results showed that SLS009, as a monotherapy and in combination with VEN, significantly prolonged survival compared to VEN alone in an in vivo patient-derived xenograft model of T-cell prolymphocytic leukemia (T-PLL). These findings further support the therapeutic potential of SLS009 to improve outcomes across multiple hematologic malignancies.

Virtual R&D Day on Advancing Novel Therapies in AML: On October 29, 2025, SELLAS hosted a virtual R&D Day on “Advancing Novel Therapies in Acute Myeloid Leukemia (AML)” featuring key opinion leaders and Company management. The event provided a detailed review of the Company’s ongoing Phase 3 REGAL trial of GPS and the SLS009 program, underscoring each therapy’s potential to address multiple stages of disease progression along the AML treatment continuum. To access a replay of the R&D Day, please click here.

Received $67.2 Million in Gross Proceeds from Warrant Exercises in 2025: In September and October 2025, SELLAS received a total of approximately $54.6 million in gross proceeds from the immediate exercise of existing warrants, including $23.6 million from warrants issued in January 2025 and $31.0 million from warrants issued in March and August 2024. An additional $12.6 million in proceeds was received during 2025 from the exercise of other previously outstanding warrants.

Received Additional $42.6 Million in Proceeds from Warrant Exercises in Q1 2026: Subsequent to December 31, 2025, the Company received an additional $42.6 million in proceeds from the exercise of previously outstanding warrants. These additional proceeds bolster the reported $71.8 million cash and cash equivalents as of December 31, 2025, and provide the Company with the strongest financial position in its history.

Financial Results for the Full Year 2025:

Research and Development Expenses: Research and development expenses for the year ended December 31, 2025, were $16.0 million, compared to $19.1 million for the year ended December 31, 2024. The decrease was primarily due to decreases in clinical trial expenses and clinical and regulatory consulting costs, which were primarily driven by the completion of enrollment in the REGAL study in the first quarter of 2024.

General and Administrative Expenses: General and administrative expenses for the year ended December 31, 2025, were $12.3 million, as compared to $12.4 million for the year ended December 31, 2024. The decrease was primarily attributable to a decrease in personnel related expenses.

Net Loss: The net loss was $26.9 million for the year ended December 31, 2025, or a basic and diluted loss per share of $0.25, as compared to a net loss of $30.9 million for the year ended December 31, 2024, or a basic and diluted loss per share of $0.50.

Cash Position: As of December 31, 2025, cash and cash equivalents totaled approximately $71.8 million. Subsequent to December 31, 2025, the Company received an additional $42.6 million in proceeds from the exercise of previously outstanding warrants.

About SELLAS Life Sciences Group, Inc.

SELLAS is a late-stage clinical biopharmaceutical company focused on the development of novel therapeutics for a broad range of cancer indications. SELLAS’ lead product candidate, GPS, is licensed from Memorial Sloan Kettering Cancer Center and targets the WT1 protein, which is present in an array of tumor types. GPS has the potential as a monotherapy and combination with other therapies to address a broad spectrum of hematologic malignancies and solid tumor indications. The Company is also developing SLS009 (tambiciclib) - potentially the first and best-in-class differentiated small molecule CDK9 inhibitor with reduced toxicity and increased potency compared to other CDK9 inhibitors. Data suggests that SLS009 demonstrated a high response rate in AML patients with unfavorable prognostic factors including ASXL1 mutation, commonly associated with poor prognosis in various myeloid diseases. For more information on SELLAS, please visit www.sellaslifesciences.com.

Forward-Looking Statements

This press release contains forward-looking statements. All statements other than statements of historical facts are “forward-looking statements,” including those relating to future events. In some cases, forward-looking statements can be identified by terminology such as “plan,” “expect,” “anticipate,” “may,” “might,” “will,” “should,” “project,” “believe,” “estimate,” “predict,” “potential,” “intend,” or “continue” and other words or terms of similar meaning. These statements include, without limitation, statements related to the GPS clinical development program, including the REGAL study and the timing of future milestones related thereto. These forward-looking statements are based on current plans, objectives, estimates, expectations, and intentions, and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties with oncology product development and clinical success thereof, the uncertainty of regulatory approval, and other risks and uncertainties affecting SELLAS and its development programs as set forth under the caption “Risk Factors” in SELLAS’ Annual Report on Form 10-K filed on March 19, 2026 and in its other SEC filings. Other risks and uncertainties of which SELLAS is not currently aware may also affect SELLAS’ forward-looking statements and may cause actual results and the timing of events to differ materially from those anticipated. The forward-looking statements herein are made only as of the date hereof. SELLAS undertakes no obligation to update or supplement any forward-looking statements to reflect actual results, new information, future events, changes in its expectations, or other circumstances that exist after the date as of which the forward-looking statements were made.

Investor Contact

John Fraunces
Managing Director
LifeSci Advisors, LLC
jfraunces@lifesciadvisors.com

SELLAS LIFE SCIENCES GROUP, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(Amounts in thousands, except share and per share data)

	Year Ended December 31,
	2025				2024
Operating expenses:
Research and development	$	16,022			$	19,096
General and administrative		12,252				12,417
Total operating expenses		28,274				31,513
Loss from operations		(28,274	)			(31,513	)
Non-operating income:
Interest income		1,411				632
Total non-operating income		1,411				632
Net loss	$	(26,863	)		$	(30,881	)
Per share information:
Net loss per common share, basic and diluted	$	(0.25	)		$	(0.50	)
Weighted-average common shares outstanding, basic and diluted		109,051,215				61,202,412

SELLAS LIFE SCIENCES GROUP, INC.
CONSOLIDATED BALANCE SHEETS
(Amounts in thousands, except share and per share data)

	December 31,
	2025				2024
ASSETS
Current assets:
Cash and cash equivalents	$	71,793			$	13,886
Restricted cash and cash equivalents		100				100
Prepaid expenses and other current assets		3,318				2,341
Total current assets		75,211				16,327
Operating lease right-of-use assets		963				925
Goodwill		1,914				1,914
Deposits and other assets		257				266
Total assets	$	78,345			$	19,432
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable	$	2,948			$	3,500
Accrued expenses and other current liabilities		3,525				5,466
Operating lease liabilities		544				544
Total current liabilities		7,017				9,510
Operating lease liabilities, non-current		457				457
Total liabilities		7,474				9,967
Commitments and contingencies
Stockholders’ equity:
Common stock, $0.0001 par value; 350,000,000 shares authorized, 153,103,459 and 73,977,459 shares issued and outstanding at December 31, 2025 and 2024, respectively		15				7
Additional paid-in capital		345,844				257,583
Accumulated deficit		(274,988	)			(248,125	)
Total stockholders’ equity		70,871				9,465
Total liabilities and stockholders’ equity	$	78,345			$	19,432

FAQ

What is the cash position of SELLAS (SLS) after the March 19, 2026 update?

SELLAS reported $71.8 million cash and cash equivalents as of Dec 31, 2025. According to the company, an additional $42.6 million was received in Q1 2026 from warrant exercises, strengthening liquidity for ongoing trials.

How close is SELLAS (SLS) to completing the Phase 3 REGAL final analysis for GPS?

The REGAL trial had recorded 72 of 80 required events as of Dec 26, 2025. According to the company, the final analysis will occur after the pre-specified 80th event, database lock, and blinded review are completed.

What were the Phase 2 SLS009 results reported by SELLAS (SLS) at ASH 2025?

SLS009 plus AZA/VEN showed a 46% overall response rate with 29% CR/CRi among 35 evaluable r/r AML patients. According to the company, ASXL1 and TP53 subgroups achieved 48% and 57% response rates, respectively.

Has SELLAS (SLS) expanded SLS009 into earlier-line AML treatment and when did dosing begin?

Yes. The company dosed the first patient in an 80-patient trial evaluating SLS009 in newly diagnosed, first-line AML and early AZA/VEN-refractory patients. According to the company, expansion followed constructive FDA feedback.

How did SELLAS (SLS) perform financially in 2025 on net loss and R&D spending?

SELLAS reported a $26.9 million net loss for 2025 and R&D expenses of $16.0 million. According to the company, R&D decreased versus 2024 due to completion of REGAL enrollment and lower trial costs.