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Citius Oncology — Fiscal Fourth Quarter 2026 Earnings Summary

  • Financial Performance:

    • Preliminary, unaudited LYMPHIR unit sales to U.S. wholesalers reached 792 units for the quarter ended September 30, 2026, compared to 360 units in the prior quarter (ended June 30, 2026), representing a 120% increase.
    • Prescribing centers ordered 950 LYMPHIR vials from wholesalers during the fiscal fourth quarter, compared to 926 vials in the fiscal third quarter.
    • Revenue recognition occurs when wholesaler orders are fulfilled, net of estimated gross-to-net adjustments; specific revenue dollar amounts are not disclosed in this release.
    • The company expects to report complete fiscal fourth quarter and fiscal year 2026 results in December 2026 via its Form 10-K filing.
  • Guidance and Future Outlook:

    • Management expects the momentum from the fourth quarter to continue into fiscal 2027, driven by growing institutional demand and deeper penetration into academic and community treatment centers.
    • The company is more than halfway to its goal of having LYMPHIR on formulary at 100 priority institutions by the end of the calendar year.
    • Management anticipates continued sales growth as LYMPHIR becomes further established in the CTCL market.
  • Business Segments and Product Lines:

    • LYMPHIR (denileukin diftitox-cxdl) is the sole commercial product, a targeted immunotherapy for relapsed or refractory cutaneous T-cell lymphoma (CTCL) indicated for Stage I–III disease after at least one prior systemic therapy.
    • The number of institutions ordering LYMPHIR increased to 54 as of the release date, up from 44 as of August 14, 2026.
    • The expanded commercial team achieved nationwide coverage in August 2026, contributing to the doubling of unit sales to wholesalers.
    • The company estimates the initial CTCL market for LYMPHIR exceeds $400 million, is growing, and is underserved by existing therapies.
  • Market and Competitive Landscape:

    • LYMPHIR was FDA approved and launched in the U.S. in December 2025.
    • The company holds robust intellectual property protections including orphan drug designation, complex technology, trade secrets, and pending patents for immuno-oncology combination therapy with checkpoint inhibitors.
    • Citius Oncology is a majority-owned subsidiary of Citius Pharmaceuticals, Inc. (Nasdaq: CTXR).
  • Risks and Challenges:

    • Preliminary unit information is based on management estimates and is subject to change upon completion of year-end closing procedures and the audit of fiscal 2026 financial statements.
    • Quarterly shipments may fluctuate based on wholesaler purchasing patterns and inventory levels.
    • The company may not achieve its goal of having LYMPHIR on formulary at 100 priority institutions by calendar year-end.
    • There is a need for substantial additional funds and uncertainty regarding the ability to raise money to fund operations for at least the next 12 months as a going concern.
    • Risks include the ability to regain compliance with Nasdaq's continued listing standards, physician and patient acceptance in a competitive landscape, and the ability to secure a new bulk drug substance supplier.
    • The company relies on third-party logistics providers, distributors, and specialty pharmacies for commercial operations.
  • Management Commentary and Tone:

    • Leonard Mazur, Chairman and CEO, stated that the fiscal fourth quarter showed continued institutional demand and that unit sales to wholesalers more than doubled as the expanded commercial team reached nationwide coverage.
    • Management expressed confidence that momentum built in the fourth quarter will carry forward into fiscal 2027.
  • Other Key Points:

    • Citius Oncology is a platform to develop and commercialize novel targeted oncology therapies.
    • Citius Pharmaceuticals, the majority owner, has a late-stage pipeline including Mino-Lok® (catheter lock solution) and CITI-002 (Halo-Lido, topical hemorrhoid relief), with a Phase 3 trial for Mino-Lok meeting primary and secondary endpoints in 2023.
    • Citius Pharma is actively engaged with the FDA to outline next steps for its pipeline programs.
    • The press release includes a standard forward-looking statements disclaimer noting that actual results may differ materially from anticipated results due to various risks and uncertainties.
Company
CITIUS PHARMACEUTICALS INC
Sector
Healthcare
Industry
Biotechnology