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

Rhea-AI Summary

SELLAS Life Sciences (NASDAQ: SLS) reported third-quarter financial results and expects Phase 3 REGAL primary endpoint results in November 2026. The trial reached its required 80th event in October, triggering final analysis procedures for galinpepimut-S in acute myeloid leukemia (AML).

Cash and cash equivalents were $134.711 million at September 30, versus $71.793 million at year-end 2025. Quarterly net loss widened to $10.091 million from $6.791 million, while loss per share narrowed to $0.05 from $0.06.

The ongoing 80-patient Phase 2 SLS009 trial in newly diagnosed AML has enrolled 40 patients; SELLAS expects preliminary topline data in Q4 2026. In a completed relapsed/refractory AML study, 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. SELLAS is also preparing for pancreatic cancer clinical development following preclinical studies.

8 points · 0 major

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It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.

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0 major · 6 points

Hollow bars mark forward-looking points. How the balance works

Positive

• Moderate pointCash and cash equivalents rose to $134.711 million at September 30, 2026, from $71.793 million at year-end 2025.
• Moderate point. Forward-looking: it has not happened yet and may not happen.REGAL reached its required 80th event in October; SELLAS expects primary endpoint results in November 2026.
• Moderate point. Forward-looking: it has not happened yet and may not happen.SLS009 Phase 2 enrollment reached 40 patients of 80; SELLAS expects preliminary data in Q4 2026.
• Minor pointMonocytic AML response rate was 54%, with median overall survival of 5.8 months versus historical outcomes of approximately 2.5 months.
• Minor pointTP53-mutated AML response rate was 57%, with median overall survival of 8.8 months versus historical outcomes of approximately 2.5 months.

3 minor points

• Minor point. Forward-looking: it has not happened yet and may not happen.Preclinical pancreatic cancer findings support further investigation; SELLAS is preparing for clinical development in that indication.
• Minor pointInterest income increased to $1.218 million from $0.292 million in Q3; nine-month income reached $3.087 million versus $0.814 million.
• Minor pointStockholders’ equity increased to $131.805 million at September 30, 2026, from $70.871 million at year-end 2025.

Negative

• Moderate pointQ3 net loss widened to $10.091 million from $6.791 million; loss per share narrowed to $0.05 from $0.06.
• Moderate pointResearch and development expenses rose to $7.029 million from $4.216 million in Q3; nine-month expenses reached $18.430 million versus $11.292 million.
• Moderate pointGeneral and administrative expenses rose to $4.280 million from $2.867 million in Q3; nine-month expenses reached $12.760 million versus $8.727 million.
• Moderate pointOutstanding shares increased to 203,527,833 at September 30, 2026, from 153,103,459 at year-end 2025, diluting existing holders.
• Minor pointNine-month net loss widened to $28.103 million from $19.205 million; loss per share narrowed to $0.15 from $0.20.
• Minor pointTotal liabilities increased to $9.286 million at September 30, 2026, from $7.474 million at year-end 2025.

News Explained

At the third-quarter cash-use rate, September 30 cash equaled 2,086.4 days of the last reported operating cash use.

SELLAS reports 203,527,833 shares issued and outstanding at September 30, 2026, versus 153,103,459 at December 31, 2025; the higher count means each share represented a smaller fraction of the company’s common equity at quarter-end.

At September 30, 2026, $134.711 million in cash and equivalents equals 2,086.4 days of the last reported quarterly operating cash use at that quarter’s rate.

Sources and calculations

• SELLAS Life Sciences third-quarter 2026 results and corporate update (2026-11-12)
• Third-quarter 2026 fundamentals (2026Q3)

• Available liquidity against the last reported quarterly operating outflow, in days at that rate $134,711,000 / ($5,940,000 / 92) = 2086.4 days

Key Figures

Cash and cash equivalents: Approximately $134.7 million Net loss: $10.1 million SLS009 trial enrollment: 40 of 80 patients +5 more

Cash and cash equivalents

Approximately $134.7 million

As of September 30, 2026

Net loss

$10.1 million

Q3 2026; compared with $6.8 million in Q3 2025

SLS009 trial enrollment

40 of 80 patients

Phase 2 trial in newly diagnosed AML

Preliminary topline data timing

Expected in Q4 2026

Phase 2 trial in newly diagnosed AML

Overall response rate

54%

Patients with relapsed/refractory monocytic AML

Median overall survival

5.8 months

Patients with relapsed/refractory monocytic AML

Overall response rate

57%

Patients with TP53-mutated AML

Median overall survival

8.8 months

Patients with TP53-mutated AML

Previous Earnings Reports

2 past events · Latest: Aug 11

Same Type 2 events

1. Aug 11

   Q2 earnings report

   24h Move

   +6.5%

   SLS009 first-line AML enrollment reached 28 of 80, while GPS approached final analysis.

2. May 12

   Q1 earnings report

   24h Move

   +25.1%

   REGAL reached 78 of 80 events and SLS009 began dosing an 80-patient trial.

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

Key Terms

biologics license application, overall response rate, median overall survival, cdk9 inhibitor

4 terms

biologics license application regulatory

"in preparation for a potential Biologics License Application (BLA)"

A biologics license application is a formal request submitted to regulatory authorities seeking approval to market a new biological medicine, such as vaccines or treatments made from living organisms. It is a comprehensive review process that evaluates the safety, effectiveness, and manufacturing quality of the product. For investors, receiving approval signals that a biological therapy can be sold to the public, potentially leading to revenue growth and market success.

overall response rate medical

"achieved a 54% ORR with a median overall survival (mOS) of 5.8 months"

Overall response rate is the percentage of patients in a clinical study whose measurable disease shrinks or disappears after receiving a treatment. Investors watch it like a product’s “hit rate” because higher response rates can signal a drug’s effectiveness, boost chances of regulatory approval and market demand, and affect a company’s future revenue prospects, similar to how a higher batting average suggests a more reliable player.

median overall survival medical

"with a median overall survival (mOS) of 5.8 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.

cdk9 inhibitor technical

"a highly selective CDK9 inhibitor"

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.

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

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- Topline Primary Endpoint Results of the Phase 3 REGAL Trial of Galinpepimut-S (GPS) in Acute Myeloid Leukemia Following the 80th Event to Report this Month -

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

- $134.7 Million in Cash and Cash Equivalents as of September 30, 2026 -

NEW YORK, Nov. 12, 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 third quarter ended September 30, 2026, and provided a corporate update.

“We continue to execute across both of our clinical programs as we approach several important milestones,” said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS Life Sciences. “In our ongoing Phase 3 REGAL trial of GPS, we are focused on completing the final analysis following the announcement of 80th event, and we expect to announce topline primary endpoint results this month. If successful, we believe GPS could be a transformative new immunotherapy for AML patients in second complete remission. In parallel, enrollment and dosing continue in our Phase 2 trial of tambiciclib (SLS009) in newly diagnosed AML, with preliminary topline data expected in the fourth quarter. As announced earlier this month, we look forward to presenting our Phase 2 data in relapsed/refractory AML at the upcoming ASH in December. We were also encouraged by the preclinical data presented at AACR in pancreatic cancer models, including in resistance to a RAS inhibitor, and we are continuing our preparations for clinical development in that indication. With $134.7 million in cash and cash equivalents as of September 30, we are well positioned to further advance these programs.”

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. In October 2026, the Company announced the required pre-specified 80^th event occurred, triggering the customary database lock, blinded data review procedures before statistical analysis, unblinding, and disclosure of topline results, which the Company expects to report this month.

Ongoing dosing of SLS009 in earlier-line AML: 40 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. Preliminary topline data is expected in Q4 2026. Additional information about the trial can be found at clinicaltrials.gov (NCT04588922).

Phase 2 Data of Tambiciclib (SLS009) in Combination with Azacitidine and Venetoclax in Relapsed/Refractory AML to be presented at upcoming 2026 American Society of Hematology (ASH) Annual Meeting: In November, the Company announced that it will present data from its completed Phase 2 study of tambiciclib (SLS009) for the treatment of relapsed or refractory acute myeloid leukemia (r/r AML) at the 68th American Society of Hematology (ASH) Annual Meeting and Exposition, being held December 12–15, 2026, in New Orleans, Louisiana. Patients with relapsed/refractory monocytic AML achieved a 54% ORR with a median overall survival (mOS) of 5.8 months and patients with TP53-mutated AML achieved a 57% ORR and a mOS of 8.8 months, comparing favorably to historical outcomes in these adverse-risk settings of ~2.5 months.

The Phase 2 trial evaluated SLS009, a highly selective CDK9 inhibitor, in combination with azacitidine (AZA) and venetoclax (VEN) for the treatment of patients with r/r AML after prior VEN-based treatment.

Presented Preclinical Data Demonstrating SLS009 Activity in Pancreatic Cancer Models at the 2026 AACR Conference on Pancreatic Cancer: In September, the Company presented preclinical data from studies evaluating SLS009 (tambiciclib), its highly selective cyclin-dependent kinases 9 (CDK9) inhibitor, in patient-derived organoid models of pancreatic ductal adenocarcinoma (PDAC). The data were presented at the American Association for Cancer Research (AACR) Conference on Pancreatic Cancer: New Frontiers in Biology and Therapeutic Development. The studies, conducted in collaboration with researchers at the University of Wisconsin–Madison, evaluated SLS009 in MYC-amplified PDAC models, including a model resistant to the recently approved RAS inhibitor daraxonrasib (RMC-6236), as well as in combination with the BET inhibitor ZEN3694. MYC amplification is a biologically recognized mechanism of RAS targeting resistance.

The findings support further investigation of CDK9 inhibition as a strategy to enhance RAS-directed therapy and potentially address MYC-associated resistance in pancreatic cancer. The BET combination data provide additional mechanistic support for SLS009-based approaches designed to disrupt MYC-dependent transcriptional programs and suggest the potential to enhance BET inhibition at lower drug exposures.

Financial Results for the Third Quarter 2026:

Research and Development Expenses: Research and development expenses for the quarter ended September 30, 2026, were $7.0 million, compared to $4.2 million for the same period in 2025. Research and development expenses were $18.4 million for the nine months ended September 30, 2026, compared to $11.3 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 third quarter of 2026 were $4.3 million, as compared to $2.9 million for the same period in 2025. General and administrative expenses for the nine months ended September 30, 2026 were $12.8 million compared to $8.7 million for the same period in 2025. The increase was primarily due to increases in non-cash stock-based compensation and professional fees.

Net Loss: The net loss was $10.1 million for the third quarter of 2026, or a basic and diluted loss per share of $0.05, as compared to a net loss of $6.8 million for the third quarter of 2025, or a basic and diluted loss per share of $0.06. The net loss was $28.1 million for the nine months ended September 30, 2026, or a basic and diluted loss per share of $0.15, as compared to a net loss of $19.2 million for the same period in 2025, or a basic and diluted loss per share of $0.20.

Cash Position: As of September 30, 2026, cash and cash equivalents totaled approximately $134.7 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 and SLS009 clinical development programs, 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

Media Contact

Joan Bosisio
VP, Scientific & Medical Communications
Simpson Healthcare
jbosisio@simpsonhealthcare.com

SELLAS LIFE SCIENCES GROUP, INC. CONSOLIDATED STATEMENTS OF OPERATIONS (Amounts in thousands, except share and per share data) (Unaudited)
	Three Months Ended September 30,								Nine Months Ended September 30,
		2026				2025				2026				2025
Operating expenses:
Research and development	$	7,029			$	4,216			$	18,430			$	11,292
General and administrative		4,280				2,867				12,760				8,727
Total operating expenses		11,309				7,083				31,190				20,019
Loss from operations		(11,309	)			(7,083	)			(31,190	)			(20,019	)
Non-operating income:
Interest income		1,218				292				3,087				814
Total non-operating income		1,218				292				3,087				814
Net loss	$	(10,091	)		$	(6,791	)		$	(28,103	)		$	(19,205	)
Per share information:
Net loss per common share, basic and diluted	$	(0.05	)		$	(0.06	)		$	(0.15	)		$	(0.20	)
Weighted-average common shares outstanding, basic and diluted		202,437,078				108,396,260				188,143,803				98,313,970

SELLAS LIFE SCIENCES GROUP, INC. CONSOLIDATED BALANCE SHEETS (Amounts in thousands, except share and per share data) (Unaudited)
	September 30, 2026				December 31, 2025
ASSETS
Current assets:
Cash and cash equivalents	$	134,711			$	71,793
Restricted cash and cash equivalents		100				100
Prepaid expenses and other current assets		3,763				3,318
Total current assets		138,574				75,211
Operating lease right-of-use assets		578				963
Goodwill		1,914				1,914
Deposits and other assets		25				257
Total assets	$	141,091			$	78,345
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable	$	2,089			$	2,948
Accrued expenses and other current liabilities		6,598				3,525
Operating lease liabilities		599				544
Total current liabilities		9,286				7,017
Operating lease liabilities, non-current		—				457
Total liabilities		9,286				7,474
Commitments and contingencies
Stockholders’ equity:
Common stock, $0.0001 par value; 350,000,000 shares authorized, 203,527,833 and 153,103,459 shares issued and outstanding at September 30, 2026 and December 31, 2025, respectively		20				15
Additional paid-in capital		434,876				345,844
Accumulated deficit		(303,091	)			(274,988	)
Total stockholders’ equity		131,805				70,871
Total liabilities and stockholders’ equity	$	141,091			$	78,345

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

When does SELLAS expect Phase 3 REGAL results?

SELLAS expects topline primary endpoint results in November 2026. The required pre-specified 80th event occurred in October, triggering database lock and blinded data review before statistical analysis, unblinding and disclosure.

When will SELLAS report preliminary SLS009 data in newly diagnosed AML?

SELLAS expects preliminary topline data in Q4 2026 from its ongoing Phase 2 trial in newly diagnosed AML. Enrollment and dosing continue, with 40 patients enrolled in the 80-patient trial.

Why did SELLAS research and development expenses increase in 2026?

SELLAS attributes the increase primarily to manufacturing costs, clinical and regulatory consulting, and clinical trial expenses in preparation for a potential Biologics License Application for GPS following the final REGAL analysis.

What treatment combination was tested in SELLAS’ completed relapsed or refractory AML trial?

The completed Phase 2 trial evaluated SLS009 with azacitidine and venetoclax in patients with relapsed or refractory AML after prior venetoclax-based treatment. SELLAS plans to present the data at the American Society of Hematology meeting on December 12–15, 2026.