SELLAS Life Sciences Reports First Quarter 2026 Financial Results and Provides Corporate Update
Rhea-AI Summary
SELLAS Life Sciences (NASDAQ:SLS) reported Q1 2026 results and key clinical milestones in AML. The pivotal Phase 3 REGAL trial of GPS has reached 78 of 80 events, which will trigger final analysis at the 80th event.
SELLAS began dosing an 80-patient Phase 2 trial of SLS009 in newly diagnosed AML and presented preclinical AML data at AACR. Q1 research and development expenses were $5.1M, general and administrative expenses were $4.1M, and net loss was $8.4M. Cash and equivalents were $107.1M plus $7.5M from warrant exercises in Q2. An ATM facility up to $150M was established but not yet used.
AI-generated analysis. Not financial advice.
Positive
- REGAL Phase 3 AML trial at 78 of 80 required events
- Phase 2 SLS009 trial in 80 newly diagnosed AML patients initiated
- Preclinical SLS009 data in high-risk AML presented at 2026 AACR
- Cash and equivalents of $107.1M plus $7.5M warrant proceeds
- New $150M ATM equity facility provides additional capital flexibility
Negative
- Q1 2026 net loss increased to $8.4M from $5.8M
- Research and development expenses rose to $5.1M from $3.2M
- General and administrative expenses increased to $4.1M from $2.9M
News Market Reaction – SLS
On the day this news was published, SLS gained 25.10%, reflecting a significant positive market reaction. Argus tracked a peak move of +25.0% during that session. Our momentum scanner triggered 35 alerts that day, indicating elevated trading interest and price volatility. This price movement added approximately $193M to the company's valuation, bringing the market cap to $963.26M at that time.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
SLS gained 4.79% on the update, while close biotech peers were mixed: ELTX +13.82%, TLSA -4.38%, CGTX -2.48%, TNYA -4.03%, TRDA +0.57%. The pattern points to a stock-specific reaction.
Previous Earnings Reports
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Mar 19 | Full-year 2025 results | Positive | -8.5% | Stronger cash and REGAL/SLS009 progress but shares fell post-earnings. |
| Nov 12 | Q3 2025 earnings | Positive | -2.0% | On-track REGAL timeline and added SLS009 data met with share weakness. |
| Aug 12 | Q2 2025 earnings | Positive | -3.7% | Strong SLS009 efficacy and cash update followed by a negative move. |
| May 13 | Q1 2025 earnings | Positive | +7.1% | Positive SLS009 and REGAL updates coincided with a price gain. |
| Mar 20 | Full-year 2024 results | Positive | -0.8% | Positive interim REGAL data and financing were followed by a slight dip. |
Earnings and corporate updates have often been followed by negative price reactions despite generally constructive clinical and cash updates.
Across prior earnings and annual results, SELLAS repeatedly highlighted progress of the Phase 3 REGAL GPS trial and the advancement of SLS009 into front‑line AML, alongside stepwise cash increases from warrants and offerings. Price reactions around those events were mostly negative despite positive clinical details. Today’s Q1 2026 results reiterate REGAL’s approach to the 80th event and show cash of $107.1M, building on earlier balance‑sheet strengthening while keeping the AML-focused strategy intact.
Historical Comparison
Past earnings and annual updates for SLS averaged a -1.59% move, often negative despite constructive news. Today’s positive reaction contrasts with that pattern for similar "earnings"-tagged events.
Earnings updates have tracked REGAL from interim analyses toward the event-driven final readout and documented SLS009’s evolution from relapsed/refractory data into randomized front-line AML trials, alongside growing cash resources.
Regulatory & Risk Context
An effective S-3ASR shelf filed on 2026-03-20 allows SELLASto issue securities, including up to $150,000,000 of common stock via an at-the-market program with TD Cowen; shelf usage is 0 to date, but it provides capacity for future equity financing.
Market Pulse Summary
The stock surged +25.1% in the session following this news. A strong positive reaction aligns with the constructive mix of cash strength, REGAL nearing its 80th event, and expansion of SLS009 into first‑line AML. Historically, earnings updates averaged a -1.59% move, so a large gain would mark a departure from past behavior. Investors would need to weigh financing flexibility under the $150M ATM and active shelf against the high development spend and lack of revenue when judging sustainability.
Key Terms
phase 3 medical
complete remission medical
biologics license application regulatory
apoptosis medical
pharmacodynamic medical
cdk9 inhibitor medical
atm equity offering financial
s-3asr shelf registration regulatory
AI-generated analysis. Not financial advice.
– 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 –
–
NEW YORK, May 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 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
Financial Results for the First Quarter 2026:
Research and Development Expenses: Research and development expenses for the quarter ended March 31, 2026, were
General and Administrative Expenses: General and administrative expenses for the first quarter of 2026 were
Net Loss: The net loss was
Cash Position: As of March 31, 2026, cash and cash equivalents totaled approximately
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 March 31, | |||||||
| 2026 | 2025 | ||||||
| Operating expenses: | |||||||
| Research and development | $ | 5,129 | $ | 3,205 | |||
| General and administrative | 4,123 | 2,858 | |||||
| Total operating expenses | 9,252 | 6,063 | |||||
| Loss from operations | (9,252 | ) | (6,063 | ) | |||
| Non-operating income: | |||||||
| Interest income | 845 | 250 | |||||
| Total non-operating income | 845 | 250 | |||||
| Net loss | $ | (8,407 | ) | $ | (5,813 | ) | |
| Per share information: | |||||||
| Net loss per common share, basic and diluted | $ | (0.05 | ) | $ | (0.07 | ) | |
| Weighted-average common shares outstanding, basic and diluted | 172,481,541 | 87,760,320 | |||||
| SELLAS LIFE SCIENCES GROUP, INC. CONSOLIDATED BALANCE SHEETS (Amounts in thousands, except share and per share data) (Unaudited) | |||||||
| March 31, 2026 | December 31, 2025 | ||||||
| ASSETS | |||||||
| Current assets: | |||||||
| Cash and cash equivalents | $ | 107,097 | $ | 71,793 | |||
| Restricted cash and cash equivalents | 100 | 100 | |||||
| Prepaid expenses and other current assets | 3,972 | 3,318 | |||||
| Total current assets | 111,169 | 75,211 | |||||
| Operating lease right-of-use assets | 839 | 963 | |||||
| Goodwill | 1,914 | 1,914 | |||||
| Deposits and other assets | 255 | 257 | |||||
| Total assets | $ | 114,177 | $ | 78,345 | |||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||||
| Current liabilities: | |||||||
| Accounts payable | $ | 3,633 | $ | 2,948 | |||
| Accrued expenses and other current liabilities | 2,261 | 3,525 | |||||
| Operating lease liabilities | 562 | 544 | |||||
| Total current liabilities | 6,456 | 7,017 | |||||
| Operating lease liabilities, non-current | 309 | 457 | |||||
| Total liabilities | 6,765 | 7,474 | |||||
| Commitments and contingencies | |||||||
| Stockholders’ equity: | |||||||
| Common stock, | 18 | 15 | |||||
| Additional paid-in capital | 390,789 | 345,844 | |||||
| Accumulated deficit | (283,395 | ) | (274,988 | ) | |||
| Total stockholders’ equity | 107,412 | 70,871 | |||||
| Total liabilities and stockholders’ equity | $ | 114,177 | $ | 78,345 | |||
