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CLRB · Cellectar Biosciences, Inc.

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$2.59 +0.03 (+1.17%) At close · Aug 18
Market Cap
$24.58M
Shares
9.45M
All earnings calls

Earnings call · FY2026 Q1

Cellectar Biosciences, Inc. Q1 FY2026 Earnings Call

Cellectar Biosciences, Inc. Q1 FY2026 Earnings Call

Concluded May 14, 2026 Audio replay
May 14, 2026 24:58 23 turns
Period
FY2026 Q1
Runtime
24:58
Sources
4 artifacts

Executive readout · one minute

What matters this quarter

Cellectar reported positive 12-month Phase 2b CLOVER WaM data for iopofosine I-131 in Waldenström Macroglobulinemia and completed an oversubscribed financing of up to $140 million to fund a Phase 3 confirmatory study and potential NDA filing for accelerated approval.

Waldenstrom Macroglobulinemia unmet need 24 Phase III confirmatory trial design 23 Iopofosine I-131 CLOVER WaM Phase IIb data 21 Regulatory path and accelerated approval 18 Financing and balance sheet 11 Manufacturing and platform 3

Management tone

Confident

Net tone +85 · low hedging

Grounding quotes
  • “We entered the year with momentum. And over the past quarter, that momentum has meaningfully accelerated.”
  • “These results take on even greater significance when viewed in the broader disease context.”
  • “Taken together, the strength of our iopofosine data and the successful financing represent a clear inflection point for Cellectar.”
  • “if the patients behave as they did in the CLOVER WaM study, we would expect something closer to 15 months in the iopofosine arm, thereby essentially overpowering the study by a number of patients in order to ensure success.”

Research coverage

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Diluted EPS -$1.33
Net income -$5.65M

Research materials

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Key takeaways

What improved, and what deserves a closer read.

Constructive signals

  • Reported positive 12-month CLOVER WaM Phase 2b follow-on data, with primary and secondary endpoints met: MRR of 61.8%, ORR of 83.6%, median DoR of 17.8 months, median PFS of 13.5 months, VGPR/CR of 14.5%, and DCR of 98.2%.
  • Greater than 30% of responders maintained their responses beyond 36 months.
  • Completed an oversubscribed financing of up to $140 million ($35 million upfront plus up to $105 million in milestone-based warrants) to support the confirmatory Phase 3 study and potential commercialization.
  • Cited cash runway sufficient to fund operations, including Phase 3 initiation, into the second quarter of 2027.
  • Plans to initiate the confirmatory Phase 3 study at the very back end of 2026, with NDA submission targeted 2–3 months after initiation and potential FDA action in the second half of 2027 under breakthrough designation (six-month review).
  • Dosed first patients in the Phase 1b CLR 125 triple-negative breast cancer study, with early dosimetry, safety and efficacy data expected mid-year 2026; CLOVER WaM BTKi-post-data selected for ASCO 2026 presentation.

Risks & pressure points

  • Cash and cash equivalents declined to approximately $8.3 million at March 31, 2026 from $13.2 million at year-end 2025.
  • Net loss for Q1 2026 was $5.7 million ($1.33 per share), versus $6.6 million ($4.30 per share) in Q1 2025, with continued operating losses.
  • Milestone-based warrant tranches ($35 million each) are exercisable only if common stock trades above $3.45 with daily volume exceeding $500,000 for 20 consecutive days, and the warrants require stockholder approval at the Annual Stockholders' Meeting, introducing execution and dilution risk.
  • Management described the previously heavily pretreated CLOVER WaM population as having median four prior lines of therapy and dual-class (BTKi/rituximab) refractory rates of 58%, underscoring the difficulty of the patient population studied and uncertainty in replicating results in Phase 3.

Key moments

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“We believe iopofosine is well positioned to meet regulatory expectations and to become a foundational therapy in the WM treatment landscape.” James Caruso, CEO
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