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SELLAS Life Sciences Group, Inc. (SLS)·Q4 2024 Earnings Summary

Executive Summary

  • Q4 2024 centered on pivotal clinical milestones: REGAL Phase 3 interim analysis was triggered at 60 events (deaths) on December 10, with the IDMC scheduled for January and subsequently recommending the study continue without modifications, positioning GPS for a final analysis at 80 events anticipated in 2025 .
  • SLS009 (tambiciclib) delivered positive expansion-cohort signals in r/r AML: median overall survival not yet reached and exceeding 7.7 months at latest follow-up; ORR reached 56% in AML-MRC expansion cohorts versus the pre-specified 33% target, strengthening the 2025 regulatory path narrative .
  • Operating discipline persisted: full-year 2024 R&D fell to $19.1M from $24.0M YoY; G&A fell to $12.4M from $13.9M, trimming the net loss to $30.9M ($0.50 per share) versus $37.3M in 2023; year-end cash was $13.9M, augmented by $25M gross proceeds in January 2025, improving liquidity into 2025 milestones .
  • Estimate context: S&P Global Wall Street consensus for Q4 2024 EPS and revenue was unavailable for SLS, limiting beat/miss framing; trading catalysts remain clinical (IDMC outcome, 80-event final readout) and regulatory feedback on SLS009 in 1H 2025 .

What Went Well and What Went Wrong

What Went Well

  • REGAL interim analysis threshold reached; IDMC subsequently recommended continuation without modifications, sustaining the path to final analysis at 80 events in 2025 and reinforcing trial integrity .
  • SLS009 Phase 2 in r/r AML showed durable survival and response signals: mOS surpassing 7.7 months at optimal 30 mg BIW dose; 56% ORR in AML-MRC expansion cohorts, exceeding the 33% target; management emphasized “significant milestone” and transformative potential .
  • Opex rationalization: 2024 R&D and G&A down YoY, narrowing full-year net loss; balance sheet strengthened by a $25M direct offering in January 2025, providing runway for upcoming data and potential regulatory interactions .

What Went Wrong

  • No Q4 2024 earnings call transcript was available, limiting direct Q&A visibility; the quarter relied on 8‑K and clinical webcasts for qualitative context .
  • Revenue and conventional margin analytics remained inapplicable for development-stage operations, constraining standard EPS/Revenue beat/miss framing; S&P Global consensus estimates for Q4 were unavailable .
  • Continuing partner dispute risk: 3D Medicines arbitration highlighted commercialization uncertainty in Greater China, a non-core but potential long-term monetization lever .

Financial Results

Quarterly operating metrics (development-stage)

MetricQ2 2024Q3 2024
R&D Expense ($USD Millions)$5.2 $4.4
G&A Expense ($USD Millions)$2.4 $3.0
Total Operating Expenses ($USD Millions)$7.6 $7.3
Net Loss ($USD Millions)$(7.5) $(7.1)
Diluted EPS ($USD)$(0.13) $(0.10)
Cash & Equivalents ($USD Millions)$9.1 $21.0

Note: A standalone Q4 2024 quarterly P&L was not furnished; full-year results cover FY 2024 inclusive of Q4 .

Full-year comparison

MetricFY 2023FY 2024
R&D Expense ($USD Millions)$24.0 $19.1
G&A Expense ($USD Millions)$13.9 $12.4
Total Operating Expenses ($USD Millions)$37.9 $31.5
Net Loss ($USD Millions)$(37.3) $(30.9)
Diluted EPS ($USD)$(1.34) $(0.50)
YE Cash & Equivalents ($USD Millions)$2.5 $13.9

Balance sheet trajectory

MetricQ2 2024Q3 2024YE 2024
Cash & Equivalents ($USD Millions)$9.1 $21.0 $13.9
Total Assets ($USD Millions)$15.1 $26.5 $19.4
Total Liabilities ($USD Millions)$12.2 $10.6 $10.0
Stockholders’ Equity ($USD Millions)$2.9 $15.9 $9.5

KPIs (clinical efficacy signals)

KPIQ2 2024 (context)Q3 2024Q4 2024
SLS009 r/r AML mOS (optimal dose)Not reached (preliminary); strong anti-leukemic activity across cohorts Not reached (trial-level; 15 patients alive at cutoff) Not yet reached; exceeds 7.7 months in 30 mg BIW cohort
SLS009 ORR (dose cohorts)33% (60 mg QW); 50% (30 mg BIW); 100% in ASXL1 at 30 mg BIW (to date) 31% overall across evaluable; 50% in 30 mg BIW dose cohort 56% in AML-MRC expansion cohorts (ASXL1 and other)
REGAL (GPS)IDMC recommended continuation without modifications in June (risk-benefit) Interim analysis projected Q4 2024; RPDD (pediatric AML) granted Interim analysis triggered at 60 events Dec 10; IDMC set for January

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
REGAL (GPS) interim analysis timingQ4 2024Interim analysis anticipated in Q4 2024 Triggered Dec 10; IDMC meeting in January 2025 Achieved milestone
REGAL (GPS) final analysis2025N/AFinal analysis at 80 events anticipated in 2025 New timing detail
SLS009 Phase 2 AML full topline + FDA feedback1H 2025Updated prelim data at ASH Dec 2024 Full data and FDA regulatory path feedback expected in 1H 2025 Firmed timeframe
Liquidity actionsQ1 2025$21M gross capital raise in Aug 2024 $25M registered direct offering closed Jan 28, 2025 Strengthened cash runway

Earnings Call Themes & Trends

TopicPrevious Mentions (Q2 → Q3)Current Period (Q4 2024)Trend
AML REGAL trial progressionIDMC prespecified risk-benefit review; continue without modifications (June); interim analysis projected Q4 2024 60-event interim analysis triggered Dec 10; IDMC in January; later continuation recommendation without modifications (reported in 10-K) Advancing per protocol; positive oversight continuity
SLS009 efficacy (r/r AML)Preliminary ORR 33%/50% (60 mg QW/30 mg BIW); ASXL1 cohort 100% to date 31% overall evaluable; strong BM blast reductions; continued enrollment; expansion cohorts opened mOS >7.7 months; ORR 56% in AML-MRC expansions
Regulatory designationsEMA ODD (AML/PTCL), FDA RPDD (AML/ALL), Fast Track (AML/PTCL) GPS RPDD (pediatric AML) Continued multi‑designation support
Liquidity & capital$21M gross raise (premium to market) $21M cash at 9/30 YE cash $13.9M; $25M offering Jan 2025
Legal/partneringN/A in Q2; routine collaboration updatesContinuing arbitration with 3D Medicines (noted Jan outlook) Arbitration referenced in 10-K

Management Commentary

  • “We are pleased with the progress of our pipeline… the most anticipated milestones in 2025 will be the final analysis of our Phase 3 pivotal REGAL trial of GPS in AML and the full topline Phase 2 data of SLS009 in AML…” — CEO Angelos Stergiou .
  • “This is an exciting and very important milestone… the outcome of the interim analysis will hopefully bring us closer to the potential of adding GPS as a powerful ally in the battle against AML.” — CEO on REGAL 60-event trigger .
  • “In the optimal dosing regimen of 30 mg BIW, the median overall survival has not been reached but exceeds 7.7 months…” — CEO on SLS009 AML efficacy .

Q&A Highlights

  • IDMC process clarity: management outlined open/closed session structure, O’Brien-Fleming boundary use, and potential recommendations (continue, modify, discontinue), emphasizing efficacy/futility/safety assessments and FDA notification protocol if early efficacy unblinding is recommended .
  • Study scale and event design: 126 patients enrolled; interim at ~48% event rate (60 deaths), final at 80 events (~63%), reinforcing event-driven timing uncertainty and milestone expectations .
  • 2025 priorities: FDA feedback on SLS009 in r/r AML in 1H 2025 and active BD/partnership exploration to accelerate pipeline, with liquidity management and non-dilutive options noted .

Estimates Context

  • S&P Global consensus for Q4 2024 EPS and revenue was unavailable for SLS; results cannot be framed as beats/misses versus Street for the quarter [GetEstimates: Q4 2024 returned no data].
  • Investor implication: near-term price action likely tied to clinical/regulatory catalysts (IDMC outcome communications and subsequent 80-event final analysis timing; SLS009 full data and FDA feedback) rather than traditional quarterly financial beats/misses .

Key Takeaways for Investors

  • GPS (REGAL) advanced through interim with positive IDMC oversight; final analysis at 80 events is a 2025 binary, with potential for accelerated regulatory path if efficacy is robust .
  • SLS009 AML data continue to outperform historical benchmarks in the venetoclax-failure setting (mOS >7.7 months vs ~2.5 months historical), with biomarker-driven cohorts strengthening the registrational rationale; FDA feedback in 1H 2025 is a key catalyst .
  • Operating discipline reduced opex and net loss YoY; January’s $25M financing extends runway into 2025 inflection points, moderating funding risk near-term .
  • Absence of Q4 consensus estimates and revenue mix shifts focus from earnings to clinical progress; trading setup is event-driven with asymmetric outcomes around IDMC communications and final readout timing .
  • Watch Greater China dynamics (3D Medicines arbitration) for optionality but not thesis-critical in 2025; U.S./EU development remains the core value driver .
  • Near-term positioning: event-driven exposure with risk controls; medium-term thesis hinges on GPS AML approval potential and SLS009’s path to expedited development in r/r AML supported by biomarker enrichment .