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Cellectar Biosciences (CLRB) Q2 FY26 earnings call: guidance and Q&A

Earnings call· Jun 2026 (Q2 FY26)· Health Care· Aug 13, 2026

Source: earnings call transcript

Executive summary

Cellectar Biosciences Q2 FY26 — Iopopacin WM Confirmatory Study Initiated, Mid-2027 NDA Target

Cellectar Biosciences is entering a transformational period, driven by significant clinical and regulatory progress for Iopopacin I-131 in Waldenstrom's macroglobulinemia, targeting a mid-2027 NDA submission. The company also strengthened its financial position with an oversubscribed financing and is advancing its broader PDC platform with programs like CLR125 in TNBC. Management is focused on executing key milestones, including the initiation of the confirmatory Phase 3 study for Iopopacin and reporting initial data for CLR125.

Highlights

5

  • Successfully completed an oversubscribed financing with potential for up to $140 million in capital, including $35 million upfront.

  • Full 12-month follow-up results from the Clover-WAM study for Iopopacin in WM reinforced depth and durability of response, meeting primary and secondary endpoints.

  • Initiated site activation activities for the planned confirmatory Phase 3 study for Iopopacin in WM, a critical regulatory milestone.

  • New data presented at ASCO 2026 for Iopopacin in WM patients treated immediately after BTKI therapy showed a 79.2% major response rate, 87.5% overall response rate, and 100% clinical benefit rate with a median duration of response of 16 months.

  • Enrolled and dosed the first patients in the Phase 1B trial of CLR125 in triple-negative breast cancer.

Concerns

2

  • Research and Development expenses increased to $4.6 million in Q2 FY26 from $2.4 million in Q2 FY25 due to increased clinical study activity.

  • Net loss for Q2 FY26 was $6.9 million, compared to $5.4 million in Q2 FY25.

Guidance & targets

CategoryTargetConfidence
Iopopacin I-131 New Drug Application (NDA) Submission
Mid-2027
high materiality
High
Iopopacin I-131 FDA Review Period
Approximately 6 months
high materiality
High
Iopopacin I-131 Confirmatory Phase 3 Study First Patient In
Late this year or early next year
high materiality
High
CLR125 Phase 1B Initial Dosimetry, Safety, and Efficacy Data
Later this year or early next year
medium materiality
Medium

Deals & partnerships

Multiple investors Oversubscribed financing providing upfront capital and future milestone-tied capital through warrants. Up to $140 million Tranche A expires July 7, 2027; Tranche B expires July 7, 2028; Tranche C expires July 7, 2031

Issued common shares, pre-funded warrants, and three tranches of warrants (approx. 13.2 million each) with a strike price of $2.65. Warrants are callable if milestones are met and VWAP is at least $3.45 for 20 consecutive trading days with average liquidity of $500,000.

What to watch in Q3 FY26

Iopopacin I-131 Phase 3 First Patient In

Late 2026 or early 2027
Current Site activation activities initiated
Target First patient enrolled

Why it matters

This is a critical catalyst and an important step towards the planned accelerated approval submission for Iopopacin in WM.

We view the initiation of patient dosing in this trial as a significant upcoming catalyst and believe that could occur late this year or early this year. next year and is an important step toward bringing hypopasine to patients who urgently need new treatment options.

Find out whether CLRB delivers this. Inve re-checks your case every morning.

Q&A highlights

Detailed steps and gating factors for first patient enrollment in the confirmatory Phase 3 WM study, and specific criteria that trigger the potential FDA submission for accelerated approval.

Management detailed the extensive process for initiating a Phase 3 study, including CRO contracting, site identification, feasibility, site qualification (for radiopharmaceuticals), IRB review, site contracting, training, and site initiation. They expect first sites to open in a handful of months and first patient in late 2026/early 2027. For FDA submission, the study needs to be 'initiated and ongoing,' which they interpret as having 10-20 sites open and a couple of patients enrolled at submission, with 5% or more patients enrolled by regulatory action (6-8 months post-submission).

“Our interpretation of that is that we want to have a number of sites open somewhere, perhaps 10 to 20 sites open at the time of submission. And we want to be in a position that we've gotten a couple patients enrolled, preferably at the time of submission, and then having somewhere between 5% or more patients enrolled by the time there's regulatory action.”

asked by Kevin DeGeeter · answered by James Caruso

2 min read 6 chapters

Detailed narrative

Iopopacin I-131 in WM

The company's near-term priority is advancing Iopopacin I-131 for relapsed or refractory Waldenstrom's macroglobulinemia (WM), particularly for patients whose disease progressed after BTK inhibitor therapy. This represents a significant unmet medical need and an attractive opportunity for a differentiated treatment. The full 12-month follow-up results from the Clover-WAM study reinforced the depth and durability of response, meeting both primary and secondary endpoints.

Clinical Data for Iopopacin

New data presented at ASCO 2026 from the Clover-WAM study highlighted outcomes in WM patients treated immediately following BTKI therapy, showing a 79.2% major response rate, an 87.5% overall response rate, and 100% clinical benefit rate, with a median duration of response of 16 months.

The full 12-month follow-up data for all patients showed a median durability of 17.8 months and approximately 62% achieving a major response, with very good partial response and complete response rates increasing to 14.5% in these late-line, highly refractory patients.

PDC Platform Validation and Expansion

The phospholipid drug conjugate (PDC) platform is a highly differentiated targeting technology designed to selectively deliver therapeutic payloads to cancer cells, including primary tumors, metastatic lesions, and cancer stem cells. Its versatility allows combination with various payloads and isotopes (beta-emitting, OGIE-emitting, alpha-emitting radiotherapeutics).

The success with Iopopacin is validating the platform and creating a strong foundation for future pipeline expansion, including CLR125 (OGIE-emitting program in solid tumors) and CLR225 (alpha-emitting program).

Financing and Financial Strength

An oversubscribed financing completed in May has the potential to provide up to $140 million in capital, with $35 million upfront and up to $105 million tied to future milestones. This significantly strengthens the balance sheet and provides resources to execute the WM strategy, advance regulatory initiatives, and invest in the broader radiopharmaceutical pipeline.

The company ended Q2 FY26 with $34.0 million in cash and cash equivalents, up from $13.2 million at year-end 2025.

Manufacturing and Commercial Strategy

The company has been producing the targeting ligand for its radiopharmaceuticals at commercial scale for several years, with over five years of stability data. While the isotope and finished product are near-term, just-in-time productions, the commercial infrastructure is built out and ready, capable of producing for about 100 patients per week.

The company is evaluating commercialization options for Iopopacin, including self-commercialization due to the targeted market (80% of WM patients in 15 states) or partnering with third parties.

Actinium-225 Supply Chain

The supply chain for Actinium-225, a key component for alpha-emitting programs like CLR225, has improved over the past year with new suppliers coming online (SpectronRx, Northstar, Ionetics, Nucleus). While future constriction is possible as programs advance, Cellectar has a multi-sourcing strategy for all components, including ready supply agreements with four parties for Actinium-225, to ensure access for its programs.

Summary of the company's earnings call; see how call summaries are prepared. Not investment advice.