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Cellectar Biosciences, Inc. (CLRB)·Q1 2025 Earnings Summary

Executive Summary

  • Q1 2025 reduced operating expenses drove a narrower net loss of $6.6M and basic/diluted EPS of ($0.14), compared to ($26.6M) and ($0.91) in Q1 2024, reflecting lower R&D and G&A spending .
  • EPS beat Wall Street consensus: split-adjusted actual EPS was ($4.20) versus consensus ($4.90), a $0.70 beat; revenue remained pre-commercial at $0.00, consistent with consensus $0.00* [GetEstimates Q1 2025].
  • Near-term catalysts: management will present CLOVER-WaM Phase 2 data to EMA in Q2 and expects feedback on a conditional approval pathway before end of Q3 2025; company engaged Oppenheimer to explore strategic alternatives .
  • Regulatory path clarified: Phase 3 WM confirmatory study set as randomized, controlled, 100 patients per arm with accelerated approval on MRR and full approval on PFS; study initiation depends on funding or strategic collaboration .

What Went Well and What Went Wrong

What Went Well

  • Clear regulatory momentum: “We plan to present these data to the EMA during the second quarter of 2025… We anticipate a response… before the end of the third quarter of this year” .
  • Strong efficacy profile supports EMA strategy: Major Response Rate (MRR) 58.2% overall; 59.0% in BTKi-treated WM patients, underpinning conditional approval pursuit .
  • Cost discipline: R&D fell to ~$3.4M (from ~$7.1M YoY) and G&A to ~$3.0M (from ~$4.9M YoY), narrowing net loss and extending runway into Q4 2025 .

What Went Wrong

  • NDA delay: Additional clinical data needed for iopofosine I-131 in WM defers the U.S. filing timeline, pushing reliance onto a funded confirmatory Phase 3 .
  • Funding dependency: WM Phase 3 initiation and early-stage radioconjugate trials (CLR 121125 TNBC; CLR 121225 PDAC) are contingent on securing capital/partners .
  • Cash decline: Cash fell to $13.9M from $23.3M QoQ, still projected to fund operations into Q4 2025; nevertheless, runway and trial cost needs heighten financing risk .

Financial Results

Metric ($USD)Q1 2024Q3 2024Q1 2025
Research & Development Expense$7.088M $5.493M $3.427M
General & Administrative Expense$4.913M $7.834M $2.974M
Total Operating Expenses$12.001M $13.328M $6.401M
Net Loss($26.642M) ($14.665M) ($6.604M)
EPS (Basic & Diluted)($0.91) ($0.37) ($0.14)

Notes:

  • CLRB reported no revenue line in quarterly statements; the company remains pre-commercial .

KPI Snapshot (Clinical efficacy supporting WM strategy)

KPIValueSource
Overall Response Rate (ORR) – CLOVER-WaM Phase 283.6% ASH oral presentation summary
Major Response Rate (MRR) – Overall58.2% ASH oral presentation summary
Major Response Rate (MRR) – BTKi-treated59.0% Q1 press release
Comparator PFS (Rituximab monotherapy)~6 months Q1 call
Iopofosine PFS (last reported)>11 months Q1 call

Guidance Changes

MetricPeriodPrevious GuidanceCurrent GuidanceChange
EMA conditional approval pathway feedback timingQ3 2025Not specifiedExpect EMA feedback before end of Q3 2025 Raised specificity (new timing)
WM Phase 3 designConfirmatory studyRandomized, 100 pts/arm; MRR for accelerated approval; PFS for full approval Same; investigator choice comparator with likely rituximab options Maintained/clarified
WM Phase 3 costProgram$40–$45M total; ~$30M to full enrollment Same cost guidance reiterated Maintained
Cash runwayCompanyInto Q4 2025 Into Q4 2025 Maintained
Phase 1 trials (CLR 121125 TNBC; CLR 121225 PDAC)InitiationPrepared to initiate in 1H25 Prepared; initiation dependent on funding Maintained with funding caveat
Strategic alternativesCorporateNot previously announcedExploring full range; Oppenheimer engaged New (Q1 development)

Earnings Call Themes & Trends

TopicQ3 2024 (Previous Mentions)Q4 2024 (Previous Mentions)Q1 2025 (Current Period)Trend
Regulatory pathway (FDA/EMA)Planned NDA filing; oral presentation at ASH Achieved FDA alignment on accelerated path; Phase 3 design EMA conditional approval pursuit; Q3 feedback expected Improving clarity; EU path maturing
Funding/strategic alternativesRaised $19.4M via warrants; potential $73.3M further Restructuring; NASDAQ compliance options (incl. reverse split authorization) Engaged Oppenheimer; exploring mergers/licensing/JVs Funding urgency elevated; non-dilutive options prioritized
Product performance (WM efficacy)Positive CLOVER-WaM results highlighted MRR 58.2% and strong benefit reiterated BTKi-treated MRR 59.0% emphasized Consistent strength
Supply chain/manufacturingMulti-sourced supply agreements (SpectronRx; Northstar) CMC/multi-sourcing to support commercialization Not expanded this quarterDe-risking sustained
R&D execution (solid tumors)Preparing alpha/Auger PRCs for solid tumor trials Prepared for Phase 1; INDs advancing Trials prepared; dependent on funding Ready; gating on capital

Management Commentary

  • “We plan to present these data to the EMA during the second quarter of 2025… We anticipate a response… before the end of the third quarter of this year.” — James Caruso, President & CEO .
  • “We ended the quarter with cash and cash equivalents of $13.9 million… adequate to fund budgeted operations into the fourth quarter of 2025.” — Chad Kolean, CFO .
  • “The path to achieve conditional approval of iopofosine I 131 is based on MRR and… full approval based on PFS… randomized controlled Phase III… ~100 patients per arm.” — Jarrod Longcor, COO .

Q&A Highlights

  • Comparator strategy: Investigator’s choice of two NCCN-listed options with rituximab central; company expects clear superiority versus ~10–30% major response rates and sub-6 month PFS in late-line settings .
  • Early-line considerations: Running against rituximab in earlier lines would require much larger trials due to higher response rates (60–80%), making them cost prohibitive vs current late-line focus .
  • EMA conditional approval probability/commercial outlook: Management cited a 60% historical conditional approval rate and PRIME designation; Europe’s high rituximab utilization could aid positioning in a superiority study, potentially offsetting lower pricing via volume .

Estimates Context

MetricQ1 2025 ConsensusQ1 2025 ActualSurprise
Primary EPS Consensus Mean (split-adjusted)($4.90)*($4.20)*+$0.70 (beat)
Revenue Consensus Mean$0.00*n/a (no revenue line reported) —

Notes:

  • Press release EPS was ($0.14) pre-split, equivalent to ($4.20) after the 1-for-30 reverse split announced subsequently (0.14 × 30 = 4.20)* .
  • Values retrieved from S&P Global.*

Key Takeaways for Investors

  • Regulatory clarity is strengthening: EMA feedback on conditional approval pathway expected by Q3 2025, while FDA-confirmed Phase 3 design de-risks U.S. approval path .
  • Trial economics are defined: WM confirmatory study cost $40–$45M (≈$30M to full enrollment) with accelerated approval on MRR possible soon after enrollment completion; funding/partnering is pivotal .
  • Efficacy differentiates: MRR 58.2% overall and 59.0% post-BTKi supports superiority vs rituximab comparators, a key narrative driver for conditional approval and eventual market adoption .
  • Capital strategy in focus: Oppenheimer engagement signals active pursuit of non-dilutive options (licensing/regional/global) to initiate Phase 3 and advance solid tumor assets; watch for deal announcements .
  • Cost discipline improved P&L: Q1 OpEx halved YoY; runway intact into Q4 2025, but timing of a strategic transaction remains the major gating factor for clinical progress .
  • Stock catalysts: EMA conditional approval pathway clarity, initiation/funding of the WM Phase 3, and any licensing/strategic alternatives outcomes are likely to drive near-term sentiment .
  • Solid tumor platform optionality: Prepared Phase 1 designs in PDAC (actinium-225) and TNBC (Auger I-125) broaden upside, contingent on capital access .

Appendix Citations

  • Q1 2025 8-K press release and financials:
  • Q1 2025 call transcript:
  • Q4 2024 call and FY press release:
  • Q3 2024 8-K:

*Values retrieved from S&P Global.