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    Earnings call· Jun 2026(Q2 FY26)

    Cellectar Biosciences Q2 FY26 earnings call CLRB

    Aug 13, 2026 Source

    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

    4
    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

    Operational metrics

    21
    Cash and cash equivalents
    $34.0 millioncompared to $13.2 million as of December 31, 2025
    Q2 FY26

    Reflects cash generated from the initial portion of the May financing.

    Research and Development expenses
    $4.6 millioncompared to approximately $2.4 million for the three months ended June 30, 2025
    Q2 FY26

    Increase largely reflected increased clinical study activity for CLR125 in TNBC and initiation of the confirmatory study of Iopopacin I-131 in WM.

    General and Administrative expenses
    $2.6 millioncompared to 3.6 million for the same period in 2025
    Q2 FY26

    Decrease driven primarily by reduced professional fees, pre-commercialization efforts, and personnel costs.

    Net loss
    $6.9 millioncompared with $5.4 million
    Q2 FY26
    Net loss per share
    $0.57compared with $3.39 per share
    Q2 FY26
    Potential capital from financing
    $140 million
    FY26-FY31

    Oversubscribed financing completed in May 2026.

    Warrant Tranche A expiry
    July 7, 2027
    FY27

    Warrants are callable for cash if milestone and VWAP/liquidity criteria are met.

    Warrant Tranche B expiry
    July 7, 2028
    FY28

    Warrants are callable for cash if milestone and VWAP/liquidity criteria are met.

    Warrant Tranche C expiry
    July 7, 2031
    FY31

    Warrants are callable for cash if milestone and VWAP/liquidity criteria are met.

    Warrant strike price
    $2.65
    Q2 FY26

    For all three tranches of warrants.

    Warrant call VWAP threshold
    $3.45
    Q2 FY26

    One of two criteria for warrants to be callable for cash.

    Warrant call trading liquidity threshold
    $500,000
    Q2 FY26

    One of two criteria for warrants to be callable for cash.

    Iopopacin I-131 WM Major Response Rate
    79.2%
    Q2 FY26

    Presented at ASCO 2026.

    Iopopacin I-131 WM Overall Response Rate
    87.5%
    Q2 FY26

    Presented at ASCO 2026.

    Iopopacin I-131 WM Clinical Benefit Rate
    100%
    Q2 FY26

    Presented at ASCO 2026.

    Iopopacin I-131 WM Median Duration of Response
    16 months
    Q2 FY26

    Presented at ASCO 2026.

    Iopopacin I-131 WM Median Duration of Response
    17.8 months
    Q2 FY26

    Full 12-month follow-up data.

    Iopopacin I-131 WM Major Response Rate
    approximately 62%
    Q2 FY26

    Full 12-month follow-up data.

    Iopopacin I-131 WM Very Good Partial Response (VGPR) and Complete Response (CR) Rate
    14.5%
    Q2 FY26

    Rate increased over time in late-line, highly refractory patients.

    Targeting ligand stability
    more than five years
    Q2 FY26

    Produced at commercial scale.

    Finished product production capacity
    about 100 patients per week
    Q2 FY26

    Easily achievable with existing infrastructure.

    Industry KPIs

    10
    MetricValueDetails
    Launch access metrics—
    Pipeline read out calendarClover-WAM study (Iopopacin I-131 in WM) 12-month follow-up data reported; CLR125 Phase 1B initial data expected late 2026/early 2027
    Product franchise net sales—
    Regulatory approvals filingsIopopacin I-131 for WM NDA submission
    Peak long term sales guidance—
    Therapeutic drug market share—
    Prescription volume new starts—
    Clinical trial efficacy safety dataIopopacin I-131 in WM (BTKI-treated patients): 79.2% major response rate, 87.5% overall response rate, 100% clinical benefit rate, median DoR 16 months.%
    Collaboration milestone royalty revenue—
    Cumulative patients uptake since launch—

    Deals & partnerships

    1
    Multiple investorsOversubscribed financing providing upfront capital and future milestone-tied capital through warrants.Up to $140 millionTranche 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

    4

    Iopopacin I-131 Phase 3 First Patient In

    Late 2026 or early 2027
    CurrentSite activation activities initiated
    TargetFirst 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.

    Q&A highlights

    4

    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 read6 chapters

    Detailed Narrative

    01

    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.

    02

    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.

    03

    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).

    04

    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.

    05

    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.

    06

    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.

    AI-generated summary of the company’s earnings call. Not investment advice.