Citius Oncology — Fiscal Q4 2026 Earnings Summary

Financial Performance:

• Preliminary, unaudited 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.
• 950 LYMPHIR vials were ordered by prescribing centers from wholesalers during the fiscal fourth quarter, compared to 926 vials in the fiscal third quarter.
• Revenue recognition is based on LYMPHIR units sold to wholesalers net of estimated gross-to-net adjustments; complete fiscal fourth quarter and fiscal year 2026 financial results, including revenue and earnings, are expected to be reported in December 2026 via Form 10-K.
• The preliminary unit data is subject to completion of year-end closing procedures and the audit of fiscal 2026 financial statements; actual results may differ.

Guidance and Future Outlook:

• Management expects the momentum from the fourth quarter to carry 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 calendar year 2026.
• Management anticipates continued sales growth as LYMPHIR becomes further established in the CTCL market.
• The company notes a need for substantial additional funds and is assessing its ability to raise money to fund operations for at least the next 12 months as a going concern.

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.
• An expanded commercial team achieved nationwide coverage in August 2026, contributing to the doubling of unit sales.
• LYMPHIR was FDA approved and launched in the U.S. in December 2025.

Market and Competitive Landscape:

• Management estimates the initial CTCL market for LYMPHIR currently exceeds $400 million, is growing, and is underserved by existing therapies.
• The company holds robust intellectual property protections including orphan drug designation, complex technology, trade secrets, and pending patents for immuno-oncology use as a combination therapy with checkpoint inhibitors.
• The competitive landscape includes physician and patient acceptance challenges in a competitive treatment environment.

Risks and Challenges:

• Preliminary, unaudited unit information may differ from final results upon audit completion.
• 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.
• Risks include the need for substantial additional funding, the ability to regain compliance with Nasdaq's continued listing standards, and the ability to successfully commercialize the product to establish a sustainable revenue stream.
• Operational risks include reliance on third-party logistics, distributors, and specialty pharmacies, as well as the need to obtain a new bulk drug substance supplier.
• Challenges include the ability to educate providers and payers, secure adequate reimbursement, and maintain uninterrupted product supply.

Management Commentary and Tone:

• Leonard Mazur, Chairman and CEO, stated that the fiscal fourth quarter showed continued institutional demand and that unit sales more than doubled as the expanded commercial team reached nationwide coverage.
• Management expressed confidence that momentum built in the fourth quarter will continue into fiscal 2027 with deeper market penetration.
• The tone reflects optimism regarding the product's establishment in the CTCL market despite acknowledging significant execution and funding risks.

Other Key Points:

• Citius Oncology is a majority-owned subsidiary of Citius Pharmaceuticals, Inc. (Nasdaq: CTXR).
• Citius Pharmaceuticals' late-stage pipeline includes Mino-Lok® (catheter lock solution) and CITI-002 (Halo-Lido, topical hemorrhoid treatment); Mino-Lok met endpoints in its Phase 3 trial, and both programs are engaging with the FDA.
• Complete fiscal 2026 financial results will be filed in the Annual Report on Form 10-K in December 2026.
• The company is actively seeking to expand international access to LYMPHIR and secure strategic partnerships.