AI Earnings Predictions for SELLAS Life Sciences Group Inc. (SLS)

EX-99.1

2 sls-202608118xkexhibit991.htm

EX-99.1

Document

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 comp

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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): July 24, 2026

SELLAS

Life Sciences Group, Inc.

(Exact name of registrant as specified in its charter)

Delaware

001-33958

20-8099512

(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 class Trading

symbol(s) Name of each exchange on which

registered

Common Stock, $0.0001 par value per share SLS The 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 2.02Results of Operations and Financial Condition.

As of June 30, 2026, SELLAS Life Sciences Group, Inc. (the “Company”) estimates that its unaudited cash and cash equivalents position was $138.3 million. This amount is unaudited and preliminary and is subject to the completion of financial closing procedures, including management’s reviews. As a result, this amount may differ materially from the amount that will be reflected in the Company’s financial statements as of and for the six months ended June 30, 2026.

Item 8.01Other Events

As previously disclosed, the Company commenced a binding arbitration against 3D Medicines, Inc. (“3D Medicines”), administered by the Hong Kong International Arbitration Centre (“HKIAC”). On July 24, 2026, the sole arbitrator in the arbitration proceeding rendered a decision dismissing the Company’s claims. As permitted by HKIAC rules, the arbitrator administratively allocated a portion of 3D Medicines’ legal fees and costs in the amount of approximately $1.0 million to be paid by the Company.

3D Medicines announced that it will continue to progress the development and commercialization of galinpepimut-S (“GPS”) in the Greater China territory in accordance with the terms of the exclusive license agreement, pursuant to which $191.5 million in potential future milestone payments remain as of March 31, 2026, including the $13.0 million milestone payments that were in dispute in the arbitration.

2

Item 9.01.Financial Statements and Exhibits.

(d)          Exhibits

Exhibit Number

Description

104

Cover Page Interactive Data File (embedded within the Inline XBRL document)

3

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: July 27, 2026 By: /s/ John T. Burns

Name: John T. Burns

Title: Senior Vice President, Chief Financial Officer

4

EX-99.1

2 sls-202605128xkexhibit991.htm

EX-99.1

Document

Exhibit 99.1

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

– Contract Research Organization for the Pivotal Phase 3 REGAL Trial of Galinpepimut-S (GPS) in Acute Myeloid Leukemia (AML) Informed the Company that 78 Events have Occurred in the Trial as of May 11, 2026; SELLAS Remains Blinded to Trial Outcomes –

– Final Analysis of REGAL Trial of GPS in AML to be Conducted Following the 80th Event –

– Ongoing Dosing of Patients in Phase 2 Trial of SLS009 in Newly Diagnosed First Line AML –

–$107.1 Million in Cash and Cash Equivalents as of March 31, 2026; Additional $7.5 Million in Proceeds Received in Q2 2026 to Date through Warrant Exercises –

NEW YORK, NY May 12, 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 first quarter ended March 31, 2026, and provided a corporate update.

“The first quarter of 2026 marked an important period for SELLAS as we continued to execute across our clinical programs while preparing for the anticipated pivotal Phase 3 REGAL trial data readout,” said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. “We are grateful for the ongoing commitment of the patients, caregivers, and investigators participating in the pivotal Phase 3 REGAL trial and we believe that the upcoming results, triggered by reaching the pre-specified 80th event, will be an important milestone for the Company.”

“In parallel, we are generating increasingly compelling data with SLS009, including recent preclinical findings presented at AACR demonstrating potent, mechanistically driven activity in AML through suppression of key survival pathways such as MCL-1 and induction of apoptosis, including in high-risk genetic subtypes like TP53 and ASXL1 mutations. Importantly, we have begun dosing patients in our Phase 2 study of SLS009 in newly diagnosed, first-line AML, targeting high-risk populations unlikely to benefit from standard therapies, including venetoclax. With REGAL approaching its critical readout and SLS009 advancing across clinical and translational fronts, we believe that SELLAS is entering an exciting time with multiple, high-value potential catalysts that could transform the AML treatment landscape.”

Recent Corporate Highlights:

Phase 3 REGAL Trial of GPS: Ongoing Phase 3 REGAL trial evaluating GPS in AML patients who have achieved complete remission following second-line salvage therapy. Reaching the required pre-specified 80th event (death) will trigger the customary database lock, blinded data review procedures prior to statistical analysis, unblinding, and disclosure of topline results. As of May 11, 2026, 78 events have occurred and SELLAS will provide an update and announce when the 80th event has been reached.

Ongoing dosing of SLS009 in earlier-line AML: SELLAS has initiated an 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. The

topline data are expected in Q4 2026. Additional information about the trial can be found at clinicaltrials.gov (NCT04588922).

Preclinical Data on SLS009 in AML Presented at the 2026 American Association for Cancer Research (AACR): The data show 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 levels that correlated with increased apoptosis. The poster, entitled “Tambiciclib (SLS009), a CDK9 inhibitor, promotes apoptosis and suppresses MCL-1 levels in AML cell lines,” can be viewed here.

At-the-Market (ATM) Offering: SELLAS established an ATM equity offering under its S-3ASR shelf registration, providing the Company with the ability to raise up to $150 million in capital over time. The facility, to be utilized through TD Cowen, enables flexible and opportunistic access to the equity markets. The Company has not sold any shares of common stock through its ATM to date.

Financial Results for the First Quarter 2026:

Research and Development Expenses: Research and development expenses for the quarter ended March 31, 2026, were $5.1 million, compared to $3.2 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 for GPS following the final analysis of the REGAL study.

General and Administrative Expenses: General and administrative expenses for the first quarter of 2026 were $4.1 mil