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SELLAS Life Sciences Group, Inc. (SLS)·Q2 2025 Earnings Summary

Executive Summary

  • Q2 2025 net loss improved year over year to $6.60M with EPS of $(0.07) versus $(0.13) in Q2 2024; sequentially, net loss widened from $5.81M in Q1 2025 as G&A increased with higher professional fees and stock-based comp .
  • Positive clinical momentum: IDMC recommended continuing the pivotal Phase 3 REGAL trial of GPS in AML without modification; final analysis is anticipated by year-end 2025, a clear near-term stock catalyst .
  • SLS009 Phase 2 met all primary endpoints in r/r AML; 44% ORR in AML-MRC at 30 mg BIW, with mOS of 8.9 months in AML-MRC and 8.8 months in venetoclax-refractory patients—well above historical benchmarks; FDA aligned on advancing to a first-line AML trial with enrollment anticipated by Q1 2026 .
  • Liquidity remained solid: $25.3M cash at quarter-end; an additional $4.0M was received in July from warrant exercises, supporting execution through key readouts .

What Went Well and What Went Wrong

What Went Well

  • Clinical progress and regulatory alignment: “We continue to make significant progress in advancing our AML-focused pipeline,” and FDA recommended advancing SLS009 into first-line AML with a randomized 80-patient trial targeting response rate as the primary endpoint .
  • Strong Phase 2 efficacy in r/r AML: 44% ORR in AML-MRC at 30 mg BIW; 50% ORR in AML-MRC M4/M5 subtype; mOS of 8.9 months (AML-MRC) and 8.8 months (venetoclax-refractory), far surpassing historical 2.4–2.5 months benchmarks .
  • REGAL Phase 3 de-risked: IDMC recommended continuation without modification; final survival-driven analysis expected by year-end upon reaching 80 events—an upcoming binary catalyst .

What Went Wrong

  • Sequential net loss increased: Q2 2025 net loss of $6.60M vs. $5.81M in Q1 2025; G&A was up $0.57M YoY due to professional fees, personnel, and public company costs .
  • No revenue contribution and margins not applicable: Company remains pre-commercial; financials presented solely as operating expenses and net loss, limiting near-term P&L levers .
  • Timing risk persists: REGAL’s final analysis is contingent on event accrual; as of the August 7 IDMC review, the 80-event threshold had not yet been reached, pushing resolution to later in 2025 .

Financial Results

MetricQ2 2024Q1 2025Q2 2025
R&D Expenses ($USD Millions)$5.19 $3.21 $3.87
G&A Expenses ($USD Millions)$2.44 $2.86 $3.00
Total Operating Expenses ($USD Millions)$7.62 $6.06 $6.87
Net Loss ($USD Millions)$7.47 $5.81 $6.60
EPS (Basic & Diluted, $USD)$(0.13) $(0.07) $(0.07)
Cash and Equivalents ($USD Millions)$9.15 $28.40 $25.30

KPIs (Clinical)

KPIQ2 2024Q1 2025Q2 2025
SLS009 ORR in AML-MRC (30 mg BIW)50% 67% (AML-MRC overall) 44%
SLS009 ORR in ASXL1-mutated AML-MRC (30 mg BIW)100% to date N/A disclosed50%
mOS AML-MRC (months)Not reached / not disclosed 8.9 8.9
mOS venetoclax-refractory at 30 mg BIW (months)Not reached / not disclosed 8.8 8.8

Note: Subsequent cash proceeds of $4.0M from warrant exercises in July 2025 .

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
REGAL (GPS) Final Analysis TimingFY 2025Final analysis planned upon 80 events; anticipated in 2025 Final analysis anticipated by year-end 2025; IDMC continuation without modification Maintained/clarified
SLS009 First-Line AML Trial EnrollmentQ1 2026Full Phase 2 topline data and FDA path feedback expected 1H 2025; plan to advance to randomized trial FDA alignment; randomized 80-patient trial; enrollment anticipated by Q1 2026; response rate primary endpoint Updated timeline/detail
Financial Guidance (Revenue/Margins/OpEx/Tax)2025Not provided Not provided Maintained

Earnings Call Themes & Trends

Note: No Q2 2025 earnings call transcript available in our document set; analysis reflects filings and press releases [List: earnings-call-transcript absent for 2025].

TopicPrevious Mentions (Q4 2024)Previous Mentions (Q1 2025)Current Period (Q2 2025)Trend
GPS REGAL timelineInterim analysis positive; <50% deaths; final upon 80 events in 2025 Interim analysis supports continuation; final expected in 2025 IDMC continuation; final analysis anticipated by year-end 2025 Increasingly de-risked; timeline clarified
SLS009 efficacy in AMLMedian OS >7.7 months in late 2024 data; strong ORR in AML-MRC Cohort 3: AML-MRC mOS 8.9; venetoclax-refractory mOS 8.8; ORR > target Phase 2 met endpoints; AML-MRC ORR 44%; M4/M5 ORR 50%; mOS maintained Efficacy consistent; expanded to first-line planning
Regulatory designationsMultiple FDA/EMA designations obtained in 2024 Fast Track/Orphan/RPDD reiterated Continued regulatory alignment; first-line strategy with FDA Supportive regulatory posture
Cash/index inclusionYE 2024 cash $13.9M; $25M raise in Jan 2025 Cash $28.4M; $4M warrants in April Cash $25.3M; $4M warrants in July; added to Russell 3000/2000 Sufficient liquidity; broadened investor base
Preclinical expansionsOncotarget/mechanism; PIVOT pediatric work TP53 efficacy data; ASCO colorectal ASXL1 plans ASCO ASXL1 colorectal data; ESMO T-PLL poster planned Ongoing platform derisking

Management Commentary

  • “We continue to make significant progress in advancing our AML-focused pipeline…The Phase 2 trial met all primary endpoints…Based on the strength of these data, we…advance SLS009 into the front-line setting for AML…enrollment anticipated to begin by Q1 2026.” — CEO Angelos Stergiou, MD, ScD h.c. .
  • “These SLS009 results represent an important advancement for patients with r/r AML…response rates and survival outcomes are particularly compelling…favorable safety profile…opportunity to now explore this therapy in the first-line setting.” — Dr. Yair Levy, Texas Oncology/Baylor .
  • “Following constructive FDA guidance, we are preparing the trial focused on newly diagnosed AML patients…predictive biomarker cohort and early resistance cohort…precision approach allows SELLAS to target subpopulations with high unmet need.” — Dragan Cicic, MD, CDO .

Q&A Highlights

  • No Q2 2025 earnings call transcript was available in our document set; as such, no Q&A themes or clarifications can be provided beyond the detailed guidance and commentary included in the press releases and 8-Ks [List: earnings-call-transcript absent for 2025].

Estimates Context

  • S&P Global consensus estimates for quarterly EPS and revenue were unavailable for SLS; results cannot be benchmarked to Street consensus at this time. Values retrieved from S&P Global.*

Key Takeaways for Investors

  • The binary REGAL Phase 3 readout by year-end 2025 is the principal near-term stock catalyst; IDMC’s positive continuation reduces trial risk ahead of the event-driven final analysis .
  • SLS009’s Phase 2 efficacy in high-risk AML populations (AML-MRC, ASXL1, M4/M5) with materially improved mOS and robust ORR supports the FDA-endorsed pivot into first-line AML in 2026, expanding commercial optionality if pivotal data are positive .
  • Liquidity appears adequate for near-term milestones (REGAL final analysis, trial preparations) given $25.3M quarter-end cash and $4.0M in July warrant proceeds, though incremental capital may be prudent ahead of first-line trial initiation .
  • Sequential operating expense control continues, with YoY R&D down $1.31M and total opex down $0.75M; however, G&A sequential pressures and pre-commercial status keep EPS at $(0.07) absent revenue inflows .
  • Scientific platform breadth (ASCO and upcoming ESMO) and index inclusion (Russell 3000/2000) broaden visibility and could attract incremental healthcare-focused capital into binary readouts .
  • With no available Street consensus, buyside models should emphasize scenario analysis around REGAL survival benefit and SLS009 first-line trial design, including biomarker-driven cohorts and response-rate endpoints .
  • Trading lens: Expect event-driven volatility into REGAL’s final analysis; a positive survival delta versus control would reset the risk/reward and financing outlook, while negative results would refocus the thesis on SLS009’s accelerated pathway and broader hematology indications .