Sign in

You're signed outSign in or to get full access.

SL

SELLAS Life Sciences Group, Inc. (SLS)·Q1 2025 Earnings Summary

Executive Summary

  • Q1 2025 showed continued operating discipline: total operating expenses fell to $6.06M, net loss narrowed to $5.81M (EPS -$0.07), and interest income increased to $0.25M; cash rose to $28.4M with an additional $4.0M received from warrant exercises post-quarter .
  • Clinical catalysts advanced: SLS009 delivered mOS of 8.9 months in AML-MRC and 8.8 months across all r/r to venetoclax regimens, with ORR of 67% in AML-MRC and 46% overall; a separate DLBCL Phase 2a combo reported 67% ORR .
  • GPS (REGAL Phase 3) interim analysis passed efficacy/futility/safety with IDMC recommending continuation; blinded data suggested pooled median survival exceeding 13.5 months, with final analysis planned upon 80 events in 2025 .
  • No Wall Street consensus from S&P Global was available for Q1 2025, so no beat/miss assessment vs estimates is possible*.

What Went Well and What Went Wrong

What Went Well

  • Operating leverage: R&D fell to $3.2M (from $5.1M YoY) and G&A to $2.9M (from $4.5M YoY), driving a narrower net loss and lower total operating expenses; management highlighted “strong momentum across our pipeline” .
  • Clinical efficacy in AML: Cohort 3 of SLS009 achieved mOS 8.9 months (AML‑MRC) and 8.8 months (all r/r to venetoclax regimens) and ORR of 67% in AML‑MRC; “unprecedented survival benefits… high response rate underscores the therapy’s efficacy profile” .
  • Regulatory and pivotal progress in GPS: REGAL Phase 3 interim analysis recommended continuation; “brings us one step closer towards potential approval” and the team is “diligently preparing for the BLA” .

What Went Wrong

  • Pre-commercial profile persists: no product revenue reported; the company remains dependent on external financing and cash burn despite improved quarterly loss and higher interest income .
  • Visibility on financial guidance limited: the Q1 release emphasized clinical timelines and milestones and did not include quantitative revenue/margin guidance or OpEx outlook .
  • Execution risk remains around regulatory approvals and clinical success, as underscored by forward-looking statement risk disclosures .

Financial Results

Income Statement Snapshot (oldest → newest)

MetricQ1 2024Q3 2024Q1 2025
Research & Development ($USD Millions)$5.111 $4.362 $3.205
General & Administrative ($USD Millions)$4.534 $2.967 $2.858
Total Operating Expenses ($USD Millions)$9.645 $7.329 $6.063
Interest Income ($USD Millions)$0.079 $0.221 $0.250
Net Loss ($USD Millions)$(9.566) $(7.108) $(5.813)
EPS (Basic & Diluted) ($USD)$(0.21) $(0.10) $(0.07)
Weighted Avg Shares (Basic & Diluted)44,812,996 68,254,021 87,760,320

Balance Sheet Snapshot (oldest → newest)

MetricSep 30, 2024Dec 31, 2024Mar 31, 2025
Cash & Cash Equivalents ($USD Millions)$21.031 $13.886 $28.397
Total Assets ($USD Millions)$26.505 $19.432 $34.956
Total Liabilities ($USD Millions)$10.613 $9.967 $7.197
Accounts Payable ($USD Millions)$4.547 $3.500 $3.756
Accrued Exp. & Other Current Liabilities ($USD Millions)$5.490 $5.466 $2.571
Stockholders’ Equity ($USD Millions)$15.892 $9.465 $27.759

KPIs (Clinical)

KPIPrior MentionsCurrent (Q1 2025)
SLS009 mOS (AML‑MRC)Median OS not reached; exceeded 7.7 months at latest follow-up (late 2024 context) 8.9 months (Cohort 3)
SLS009 mOS (All r/r to venetoclax regimens)Median OS not reached (late 2024 context) 8.8 months (Cohort 3)
SLS009 ORR (AML‑MRC)56% (selected cohorts late 2024) 67% (Cohort 3)
SLS009 ORR (All evaluable)50% at 30 mg BIW in Phase 2a selected optimal dose level (late 2024) 46% (Cohort 3)
DLBCL ORR (SLS009 + zanubrutinib)N/A67% in r/r DLBCL (Phase 2a; China)
GPS REGAL (blinded survival indication)Interim analysis projected for Q4 2024 IDMC continuation; pooled median survival suggested >13.5 months; final analysis at 80 events in 2025

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
GPS REGAL final analysis timing2025Final analysis upon reaching 80 events (anticipated 2025) Final analysis upon reaching 80 events (anticipated 2025) Maintained
SLS009 Phase 2 topline & FDA feedback1H 2025Full topline data and FDA regulatory feedback expected in 1H 2025 Full topline data and FDA regulatory feedback expected in 1H 2025 Maintained
Financial metrics (revenue, margins, OpEx, tax rate, dividends)2025Not provided in prior releases focused on clinical updates Not provided in Q1 release; focus on clinical milestones N/A

Earnings Call Themes & Trends

TopicPrevious Mentions (Q3 2024)Previous Mentions (Q4 2024/FY)Current Period (Q1 2025)Trend
GPS REGAL Phase 3Interim analysis tracked; IDMC projected Q4 2024 Interim passed; continuation; blinded survival >13.5 months; BLA preparation Interim passed; continuation; final at 80 events in 2025 Advancing to key inflection
SLS009 in AMLPhase 2a dosing cohorts; 50% response at 30 mg BIW; safety profile favorable mOS >7.7 months; ORR 56% in AML‑MRC expansion cohorts Cohort 3 mOS 8.8–8.9 months; ORR 67% (AML‑MRC), 46% overall Strengthening efficacy signals
Pediatric programsNIH PIVOT ongoing; RPDDs granted RPDDs and pediatric program updates ALL PDX models show survival roughly tripled; delayed progression in 93% models Expanding pediatric data set
Financing/liquidityCash $21.0M as of 9/30/24 Cash $13.9M at 12/31/24; $25M offering in Jan 2025 Cash $28.4M at 3/31/25; +$4.0M from warrant exercises Strengthened liquidity
Solid tumor exploration (ASXL1)Announced preclinical interest ASXL1 predictors reported ASXL1-mutated colorectal cancer data to be presented at ASCO Broadening modality scope

Management Commentary

  • “We are very encouraged by the strong momentum across our pipeline… With the full topline Phase 2 data of SLS009 anticipated soon, and the final analysis of our Phase 3 pivotal REGAL trial of GPS in AML expected later this year, we are well-positioned for an exciting and meaningful 2025.” — CEO Angelos Stergiou .
  • “The remarkable results from Cohort 3… Not only have we observed unprecedented survival benefits, but the high response rate underscores the therapy’s efficacy profile.” — CEO Angelos Stergiou (SLS009 Cohort 3) .
  • “The IDMC’s recommendation to support the continued advancement of GPS in our REGAL trial brings us one step closer towards potential approval… diligently preparing for the BLA.” — CEO Angelos Stergiou .

Q&A Highlights

  • No Q1 2025 earnings call transcript was found in the document catalog; Q&A highlights are therefore unavailable for this period.

Estimates Context

  • Wall Street consensus EPS, revenue, and EBITDA estimates via S&P Global were unavailable for Q3 2024, Q4 2024, and Q1 2025, preventing a beat/miss comparison*.
  • Given the pre-commercial stage and limited coverage, any future consensus may adjust following Phase 2 topline SLS009 data and REGAL final analysis .

Key Takeaways for Investors

  • Operating discipline is evident: total OpEx fell to $6.06M and net loss narrowed to $5.81M; interest income rose, indicating incremental cash yield support .
  • Liquidity strengthened: cash rose to $28.4M at quarter-end, augmented by $25.0M financing and $4.0M in warrant exercises, supporting clinical execution through 2025 milestones .
  • SLS009’s efficacy signal is robust in venetoclax-refractory AML, with mOS of 8.8–8.9 months and high ORR in AML‑MRC—a potential differentiator in a high-need population .
  • REGAL Phase 3 continuation with favorable blinded survival indication (>13.5 months) sets up a potentially transformative 2025 final analysis; regulatory path clarity and BLA preparation are underway .
  • Near-term catalysts: SLS009 full topline Phase 2 data and FDA regulatory feedback (1H 2025), REGAL final analysis (upon 80 events in 2025), and ASCO ASXL1-mutated colorectal data readout .
  • Risk framing: outcomes remain contingent on clinical success and regulatory approvals; forward-looking risk factors underscore execution and uncertainty inherent to oncology development .
  • Actionable setup: position sizing should reflect binary/regulatory risk; opportunistic trading around data events may be warranted given the magnitude of potential clinical and regulatory catalysts .

Footnote: *Estimates unavailable via S&P Global; no consensus data returned for the requested periods.