SELLAS Life Sciences Reports Second Quarter 2026 Financial Results and Provides Corporate Update

Rhea-AI Summary

SELLAS Life Sciences (NASDAQ:SLS) reported second quarter 2026 results and clinical updates for its lead oncology programs GPS and SLS009. The Phase 3 REGAL trial of GPS in acute myeloid leukemia is approaching the pre-specified 80th event that will trigger final efficacy analysis and potential preparation for a Biologics License Application.

For SLS009, 28 patients have been enrolled in an 80-patient Phase 2 first-line AML trial, with topline data expected in Q4 2026, and preclinical data in pancreatic ductal adenocarcinoma showed activity in RAS inhibitor–resistant cells. Research and development expenses rose to $6.3 million, general and administrative expenses to $4.4 million, and net loss to $9.6 million in Q2 2026. Cash and cash equivalents totaled $138.3 million as of June 30, 2026.

Positive

• Cash and equivalents $138.3M at June 30, 2026
• Phase 3 REGAL trial nearing 80th event for final GPS analysis
• Phase 2 SLS009 AML trial 28 of 80 patients enrolled
• SLS009 preclinical data activity in RAS inhibitor–resistant PDAC cells

Negative

• Q2 2026 R&D expenses increased to $6.3M from $3.9M YoY
• Q2 2026 G&A expenses increased to $4.4M from $3.0M YoY
• Q2 2026 net loss widened to $9.6M from $6.6M YoY
• First-half 2026 net loss $18.0M versus $12.4M in 2025

News Explained

SELLAS’s August 11, 2026 quarterly report records 201,918,874 common shares issued and outstanding at June 30, 2026, versus 153,103,459 at December 31, 2025. The reported common-share base is therefore larger, which can change existing holders’ ownership percentages if the additional shares were issued to other holders.

Market Context

The tag-specific earnings record includes a 25.1% 24-hour gain for news_id 1056157. That history con...

Analysis

The tag-specific earnings record includes a 25.1% 24-hour gain for news_id 1056157. That history contextualizes this quarter’s clinical milestones and higher expenses; the active S-3ASR and high short positioning remain risks to monitor.

Key Figures

Cash and equivalents: $138.3 million SLS009 enrollment: 28 patients Trial size: 80 patients +5 more

8 metrics

Cash and equivalents $138.3 million As of June 30, 2026

SLS009 enrollment 28 patients Phase 2 trial in newly diagnosed AML

Trial size 80 patients SLS009 Phase 2 trial

Topline data timing Q4 2026 Expected SLS009 Phase 2 topline data

R&D expenses $6.3 million Q2 2026 vs. $3.9 million in Q2 2025

G&A expenses $4.4 million Q2 2026 vs. $3.0 million in Q2 2025

Net loss $9.6 million Q2 2026 vs. $6.6 million in Q2 2025

Loss per share $0.05 Basic and diluted Q2 2026 vs. $0.07 in Q2 2025

Previous Earnings Reports

5 past events · Latest: May 12 (Positive)

Same Type Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
May 12	Q1 earnings	Positive	+25.1%	Q1 results advanced REGAL and initiated SLS009 first-line AML dosing
Mar 19	FY2025 earnings	Positive	-8.5%	Year-end results reported cash, warrant proceeds, and positive SLS009 response data
Nov 12	Q3 earnings	Positive	-2.0%	Q3 update reiterated REGAL timing and reported positive SLS009 preclinical data
Aug 12	Q2 earnings	Positive	-3.7%	Q2 update cited positive SLS009 responses and FDA-recommended first-line advancement
May 13	Q1 earnings	Positive	+7.1%	Q1 update reported SLS009 survival and response results plus REGAL interim data

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Tag-specific earnings events produced two aligned reactions and three divergences, including both positive and negative post-news moves.

Key Terms

phase 3, database lock, transcriptomics, proteomics

4 terms

phase 3 medical

"Final Analysis of Phase 3 REGAL Trial of Galinpepimut-S"

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.

database lock technical

"which will trigger the customary database lock"

A database lock is the point in a clinical trial when the collected study data are finalized and no further changes or corrections are allowed, so analysts can run the official statistical tests. For investors this matters because it usually precedes public results or regulatory filings—think of it like sealing and signing off an exam before grading: once locked, the timing and content of the readout become clearer and uncertainty about last-minute data edits is reduced.

transcriptomics technical

"identified through extensive transcriptomics, genomics, and proteomics models"

Analysis of all the RNA molecules a cell produces, showing which genes are actively being used at a given time—like reading which recipes are being pulled from a cookbook to see what’s actually being cooked. For investors, transcriptomics helps reveal how diseases work, whether a drug is hitting its target, and which patient groups are most likely to benefit, making it a tool for valuing therapies, guiding clinical trials, and spotting diagnostic or therapeutic opportunities.

proteomics technical

"identified through extensive transcriptomics, genomics, and proteomics models"

Proteomics is the large-scale study of all the proteins produced by a cell, tissue or organism, like taking a full inventory and watching how the workforce and machines inside a factory behave. For investors, proteomics matters because it helps identify drug targets, disease indicators and responses to treatments—information that can speed development, reduce risk, guide partnerships and reveal new commercial opportunities in biotech and diagnostics.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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 - Final Analysis of Phase 3 REGAL Trial of Galinpepimut-S (GPS) in Acute Myeloid Leukemia to be Conducted Following the 80^th Event -

- 28 Patients Enrolled in Phase 2 Trial of SLS009 in Newly Diagnosed First-Line AML; Topline Data Expected in Q4 2026 -

 - Strong Preclinical Indications of Efficacy of SLS009 in Advanced Pancreatic Cancer Resistant to RAS inhibitors, Clinical Development Preparations Ongoing -

- $138.3 Million in Cash and Cash Equivalents as of June 30, 2026 -

NEW YORK, Aug. 11, 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 second quarter ended June 30, 2026, and provided a corporate update.

“The second quarter was an important period of execution for SELLAS as we continued to advance both of our lead clinical programs, GPS and SLS009,” said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. “For GPS, we are approaching the pre-specified 80^th event in the Phase 3 REGAL trial marking a critical step toward the final efficacy analysis and, if successful, a potential BLA submission to the FDA. At the same time, we are making meaningful progress with SLS009 in our ongoing Phase 2 frontline AML study, where dosing continues and enrollment is tracking ahead of industry standards, with topline data expected in the fourth quarter of 2026. In addition, we have obtained promising results from preclinical studies in pancreatic ductal adenocarcinoma (PDAC) and intend to support clinical development at a top-tier academic institution. Together, these programs reflect our commitment to developing differentiated therapies that may address significant unmet needs for patients with AML and support meaningful long-term value creation for SELLAS.”

Recent Corporate Highlights:

Phase 3 REGAL Trial of GPS: Ongoing Phase 3 trial in AML patients who have achieved complete remission following second-line salvage therapy. The Company will announce when the required pre-specified 80^th event occurs, which will trigger the customary database lock, blinded data review procedures before statistical analysis, unblinding, and disclosure of topline results.

Ongoing dosing of SLS009 in earlier-line AML: 28 patients have been enrolled, and enrollment and dosing continue in the ongoing 80-patient Phase 2 trial in newly diagnosed AML patients, including those who become refractory early to AZA/VEN treatment identified through extensive transcriptomics, genomics, and proteomics models. Topline data expected in Q4 2026. Additional information about the trial can be found at clinicaltrials.gov (NCT04588922).

Potential expansion of SLS009 into solid cancers: SLS009 has demonstrated the ability to act as a single agent in PDAC cells largely resistant to leading RAS inhibitors and synergize with the RAS inhibition mechanism of action. The data from these preclinical experiments are expected to be presented at an upcoming medical conference.

Financial Results for the Second Quarter 2026:

Research and Development Expenses: Research and development expenses for the quarter ended June 30, 2026, were $6.3 million, compared to $3.9 million for the same period in 2025. Research and development expenses in the first half of 2026 were $11.4 million compared to $7.1 million for the same period in 2025. The increase was primarily due to increases in manufacturing costs, clinical and regulatory consulting, and clinical trial expenses in preparation for a potential Biologics License Application (BLA) for GPS following the final analysis of the REGAL study.

General and Administrative Expenses: General and administrative expenses for the second quarter of 2026 were $4.4 million, as compared to $3.0 million for the same period in 2025. General and administrative expenses in the first half of 2026 were $8.5 million compared to $5.9 million for the same period in 2025.  The increase was primarily due to increases in professional fees and non-cash stock-based compensation.

Net Loss: The net loss was $9.6 million for the second quarter of 2026, or a basic and diluted loss per share of $0.05, as compared to a net loss of $6.6 million for the second quarter of 2025, or a basic and diluted loss per share of $0.07. The net loss was $18.0 million for the first half of 2026, or a basic and diluted loss per share of $0.10, as compared to a net loss of $12.4 million for the second quarter of 2025, or a basic and diluted loss per share of $0.13.

Cash Position: As of June 30, 2026, cash and cash equivalents totaled approximately $138.3 million.

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)
(Unaudited)
	Three Months Ended June 30,								Six Months Ended June 30,
	2026				2025				2026				2025
Operating expenses:
Research and development	$	6,272			$	3,871			$	11,401			$	7,076
General and administrative		4,357				3,002				8,480				5,860
Total operating expenses		10,629				6,873				19,881				12,936
Loss from operations		(10,629	)			(6,873	)			(19,881	)			(12,936	)
Non-operating income:
Interest income		1,024				272				1,869				522
Total non-operating income		1,024				272				1,869				522
Net loss	$	(9,605	)		$	(6,601	)		$	(18,012	)		$	(12,414	)
Per share information:
Net loss per common share, basic and diluted	$	(0.05	)		$	(0.07	)		$	(0.10	)		$	(0.13	)
Weighted-average common shares outstanding, basic and diluted		189,183,620				98,558,567				180,878,720				93,189,273

SELLAS LIFE SCIENCES GROUP, INC.
CONSOLIDATED BALANCE SHEETS
(Amounts in thousands, except share and per share data)
(Unaudited)
	June 30, 2026				December 31, 2025
ASSETS
Current assets:
Cash and cash equivalents	$	138,343			$	71,793
Restricted cash and cash equivalents		100				100
Prepaid expenses and other current assets		4,062				3,318
Total current assets		142,505				75,211
Operating lease right-of-use assets		710				963
Goodwill		1,914				1,914
Deposits and other assets		253				257
Total assets	$	145,382			$	78,345
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable	$	3,086			$	2,948
Accrued expenses and other current liabilities		3,903				3,525
Operating lease liabilities		580				544
Total current liabilities		7,569				7,017
Operating lease liabilities, non-current		157				457
Total liabilities		7,726				7,474
Commitments and contingencies
Stockholders’ equity:
Common stock, $0.0001 par value; 350,000,000 shares authorized, 201,918,874 and 153,103,459 shares issued and outstanding at June 30, 2026 and December 31, 2025, respectively		20				15
Additional paid-in capital		430,636				345,844
Accumulated deficit		(293,000	)			(274,988	)
Total stockholders’ equity		137,656				70,871
Total liabilities and stockholders’ equity	$	145,382			$	78,345

FAQ

How did SELLAS Life Sciences (SLS) perform financially in Q2 2026?

SELLAS reported a Q2 2026 net loss of $9.6 million, or $0.05 per share. According to SELLAS, research and development expenses were $6.3 million and general and administrative expenses were $4.4 million for the quarter ended June 30, 2026.

What is the status of the Phase 3 REGAL trial of GPS at SELLAS (SLS)?

The Phase 3 REGAL trial of GPS in AML is ongoing and approaching the pre-specified 80th event. According to SELLAS, this event will trigger database lock, blinded review, statistical analysis, unblinding, and disclosure of topline results for the study.

How many patients are enrolled in the SLS009 Phase 2 AML trial as of Q2 2026?

SELLAS has enrolled 28 patients in its 80-patient Phase 2 trial of SLS009 in newly diagnosed AML. According to SELLAS, enrollment and dosing continue, and topline data from this first-line AML study are expected in the fourth quarter of 2026.

What preclinical results has SELLAS (SLS) reported for SLS009 in pancreatic cancer?

SLS009 showed activity as a single agent in pancreatic ductal adenocarcinoma cells largely resistant to leading RAS inhibitors. According to SELLAS, SLS009 also synergized with RAS inhibition, and these preclinical data are expected to be presented at an upcoming medical conference.

What is SELLAS Life Sciences' cash position as of June 30, 2026 (SLS)?

SELLAS reported $138.3 million in cash and cash equivalents as of June 30, 2026. According to SELLAS, total assets were $145.4 million and stockholders’ equity was $137.7 million, indicating a balance sheet dominated by cash resources and limited liabilities.

How did SELLAS Life Sciences’ operating expenses change in the first half of 2026?

Total operating expenses for the first half of 2026 were $19.9 million, up from $12.9 million in 2025. According to SELLAS, research and development reached $11.4 million and general and administrative expenses were $8.5 million, driven by manufacturing, clinical, regulatory, and professional costs.

What are SELLAS Life Sciences’ lead product candidates GPS and SLS009?

GPS is a WT1-targeting cancer immunotherapy, and SLS009 (tambiciclib) is a CDK9 inhibitor. According to SELLAS, GPS is in a Phase 3 AML trial, while SLS009 is being evaluated in a Phase 2 AML study and preclinical pancreatic cancer models.