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SELLAS Life Sciences (SLS) widens Q2 2026 loss as trial spending rises

(Moderate)
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

SELLAS Life Sciences Group, Inc. reported second quarter 2026 results and a corporate update. The late-stage oncology company is advancing its lead programs GPS and SLS009 in acute myeloid leukemia (AML) and exploring SLS009 in solid tumors such as pancreatic ductal adenocarcinoma.

For the quarter ended June 30, 2026, SELLAS recorded a net loss of $9.6 million, or $0.05 per share, compared with a net loss of $6.6 million, or $0.07 per share, a year earlier. Operating expenses rose to $10.6 million from $6.9 million, driven mainly by higher research and development spending to support the Phase 3 REGAL trial of GPS and potential BLA preparation, as well as increased general and administrative costs.

As of June 30, 2026, cash and cash equivalents totaled $138.3 million. The Phase 3 REGAL trial in AML is approaching the pre-specified 80th event that will trigger final efficacy analysis. The Phase 2 SLS009 trial in newly diagnosed AML has enrolled 28 of a planned 80 patients, with topline data expected in the fourth quarter of 2026. Preclinical data suggest SLS009 activity in pancreatic cancer models resistant to RAS inhibitors, with clinical development preparations underway.

Positive

  • None.

Negative

  • Quarterly net loss increased to $9.6 million from $6.6 million year over year, reflecting higher operating expenses as R&D and G&A spending rose to support clinical and corporate activities.

Filing Explained

As of June 30, 2026, SELLAS reported 201,918,874 common shares issued and outstanding, up from 153,103,459 at December 31, 2025. For holders who did not receive proportionate shares, the larger share base reduces their percentage ownership; the filing does not identify the transaction behind the increase.

Item 2.02 Results of Operations and Financial Condition Financial
Disclosure of earnings results, typically an earnings press release or preliminary financials.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
Net loss Q2 2026 $9,605 thousand Net loss for the three months ended June 30, 2026
Net loss Q2 2025 $6,601 thousand Net loss for the three months ended June 30, 2025
Operating expenses Q2 2026 $10,629 thousand Total operating expenses for the three months ended June 30, 2026
R&D expenses Q2 2026 $6,272 thousand Research and development expenses for the three months ended June 30, 2026
G&A expenses Q2 2026 $4,357 thousand General and administrative expenses for the three months ended June 30, 2026
Cash and cash equivalents $138,343 thousand Cash and cash equivalents as of June 30, 2026
Total assets $145,382 thousand Total assets as of June 30, 2026
Patients enrolled SLS009 Phase 2 28 patients Patients enrolled in the ongoing 80-patient Phase 2 SLS009 trial in AML
Biologics License Application regulatory
"in preparation for a potential Biologics License Application (BLA) for GPS"
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.
Phase 3 REGAL trial medical
"For GPS, we are approaching the pre-specified 80th event in the Phase 3 REGAL trial"
pancreatic ductal adenocarcinoma medical
"promising results from preclinical studies in pancreatic ductal adenocarcinoma (PDAC)"
A fast-growing cancer that starts in the cells lining the pancreas’ small ducts; it is the most common and aggressive form of pancreatic cancer. It matters to investors because its severity and limited treatment options drive high unmet medical need, large potential markets for effective drugs or diagnostics, and strong sensitivity of company valuations to clinical trial results, regulatory approvals, or changes in treatment guidelines—similar to how fixing a main leak can prevent major damage in a building.
CDK9 inhibitor medical
"SLS009 (tambiciclib) - potentially the first and best-in-class differentiated small molecule 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.
additional paid-in capital financial
"Additional paid-in capital | | 430,636"
Amount of money shareholders have paid to a company for shares that is above the stock’s nominal or par value; think of it as the extra premium paid when a group buys a ticket that has a low listed price. It matters to investors because it represents permanent capital on the balance sheet that can cushion losses, affect book value per share and indicate how much fresh cash equity holders have contributed beyond the minimum share value.
Net loss Q2 2026 $9,605 thousand vs $6,601 thousand in Q2 2025
Net loss six months 2026 $18,012 thousand vs $12,414 thousand for six months 2025
R&D expenses Q2 2026 $6,272 thousand vs $3,871 thousand in Q2 2025
G&A expenses Q2 2026 $4,357 thousand vs $3,002 thousand in Q2 2025
Cash and cash equivalents $138,343 thousand vs $71,793 thousand at December 31, 2025

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

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FAQ

What were SELLAS Life Sciences (SLS) key financial results for Q2 2026?

SELLAS reported a Q2 2026 net loss of $9.6 million, or $0.05 per share, versus a $6.6 million net loss, or $0.07 per share, in Q2 2025, as operating expenses rose with advancing clinical programs and corporate costs.

How much cash did SELLAS Life Sciences (SLS) have as of June 30, 2026?

As of June 30, 2026, SELLAS held $138.3 million in cash and cash equivalents. This balance, up from $71.8 million at December 31, 2025, provides resources to fund ongoing clinical trials and corporate activities described in the update.

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

The Phase 3 REGAL trial of GPS in AML is ongoing and approaching the pre-specified 80th event. That event will trigger database lock, blinded review, statistical analysis, unblinding, and subsequent disclosure of topline efficacy results, supporting potential BLA planning.

How is SELLAS Life Sciences (SLS) progressing its SLS009 Phase 2 AML trial?

SELLAS has enrolled 28 patients in its ongoing 80-patient Phase 2 SLS009 trial in newly diagnosed AML. Enrollment and dosing continue, and the company expects to report topline data in the fourth quarter of 2026, according to the update.

Is SELLAS Life Sciences (SLS) developing SLS009 for solid tumors?

Yes. SLS009 has shown preclinical activity in pancreatic ductal adenocarcinoma cells largely resistant to leading RAS inhibitors and synergy with RAS inhibition. SELLAS plans to support clinical development at a top-tier academic institution and present data at an upcoming conference.

How did SELLAS Life Sciences (SLS) operating expenses change in Q2 2026?

Total operating expenses rose to $10.6 million in Q2 2026 from $6.9 million in Q2 2025. Research and development expenses increased to $6.3 million, while general and administrative expenses grew to $4.4 million, mainly from manufacturing, clinical, regulatory, and professional costs.
0001390478FALSE00013904782026-08-112026-08-11

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Date of report (Date of earliest event reported): August 11, 2026
 SELLAS Life Sciences Group, Inc.
(Exact name of registrant as specified in its charter)
Delaware001-3395820-8099512
(State or other jurisdiction of incorporation or organization)
(Commission
File Number)
(I.R.S. Employer
Identification No.)
7 Times Square, Suite 2503
New York, NY 10036
(Address of Principal Executive Offices) (Zip Code)
Registrant’s telephone number, including area code: (646) 200-5278

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligations of the registrant under any of the following provisions:
    Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
    Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
    Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
    Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
Title of each classTrading symbol(s)Name of each exchange on which registered
Common Stock, $0.0001 par value per shareSLSThe Nasdaq Stock Market LLC
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.




Item 2.02. Results of Operations and Financial Condition.

On August 11, 2026, SELLAS Life Sciences Group, Inc. (“SELLAS”) issued a press release (the “Press Release”) announcing its financial results for the quarter ended June 30, 2026 and providing a corporate update.

A copy of the Press Release is furnished hereto as Exhibit 99.1 and is incorporated by reference herein. The information contained in this Item 2.02 and in the Press Release furnished as Exhibit 99.1 to this Current Report on Form 8-K shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained in this Item 2.02 and in the Press Release furnished as Exhibit 99.1 to this Current Report on Form 8-K shall not be incorporated by reference into any filing with the SEC made by SELLAS whether made before or after the date hereof, regardless of any general incorporation language in such filing.







Item 9.01.    Financial Statements and Exhibits.

(d)    Exhibits
Exhibit NumberDescription
99.1
Press Release dated August 11, 2026
104Cover Page Interactive Data File (embedded within the Inline XBRL document)



SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
 
SELLAS Life Sciences Group, Inc.
Date:August 11, 2026By:/s/ John T. Burns
Name:John T. Burns
Title:Senior Vice President, Chief Financial Officer



Exhibit 99.1
SELLAS Life Sciences Reports Second Quarter 2026 Financial Results and Provides Corporate Update

Final Analysis of Phase 3 REGAL Trial of Galinpepimut-S (GPS) in Acute Myeloid Leukemia to be Conducted Following the 80th 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, NY, August 11, 2026 -- 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 80th 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 80th 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,
2026202520262025
Operating expenses:
Research and development$6,272 $3,871 $11,401 $7,076 
General and administrative4,357 3,002 8,480 5,860 
Total operating expenses10,629 6,873 19,881 12,936 
Loss from operations(10,629)(6,873)(19,881)(12,936)
Non-operating income:
Interest income1,024 272 1,869 522 
Total non-operating income1,024 272 1,869 522 
Net loss$(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 diluted189,183,620 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, 2026December 31, 2025
ASSETS
Current assets:
Cash and cash equivalents$138,343 $71,793 
Restricted cash and cash equivalents100 100 
Prepaid expenses and other current assets4,062 3,318 
Total current assets142,505 75,211 
Operating lease right-of-use assets710 963 
Goodwill1,914 1,914 
Deposits and other assets253 257 
Total assets$145,382 $78,345 
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable$3,086 $2,948 
Accrued expenses and other current liabilities3,903 3,525 
Operating lease liabilities580 544 
Total current liabilities7,569 7,017 
Operating lease liabilities, non-current157 457 
Total liabilities7,726 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, respectively20 15 
Additional paid-in capital430,636 345,844 
Accumulated deficit(293,000)(274,988)
Total stockholders’ equity137,656 70,871 
Total liabilities and stockholders’ equity$145,382 $78,345 

Filing Exhibits & Attachments

4 documents