CITIUS ONCOLOGY, INC. (CTOR)·Q3 2024 Earnings Summary

Executive Summary

• CTOR’s fiscal Q3 2024 fell within a transformational period: the FDA approved LYMPHIR (denileukin diftitox-cxdl) in August 2024, and management prepared for a commercial launch in H1 2025, building inventory and finalizing supply chain and sales infrastructure .
• The company furnished full-year FY2024 results via an 8-K (Item 2.02) rather than discrete Q3 figures; FY2024 revenue was $0, operating expenses rose materially, and net loss expanded to $21.1M (-$0.31 per share) versus $12.7M (-$0.19) in FY2023 .
• Key catalysts into 2025 include LYMPHIR launch timing (H1 2025), NCCN guideline inclusion, and a unique HCPCS J‑code application, all supportive of reimbursement and clinical adoption .
• Consensus estimates for Q3 2024 (EPS, revenue) were not retrievable in this session; estimates would be sourced from S&P Global when available.

What Went Well and What Went Wrong

What Went Well

• FDA approval of LYMPHIR for relapsed/refractory CTCL, described by management as “the only targeted systemic therapy approved since 2018” and with a unique IL‑2 receptor mechanism; a major strategic milestone for commercial entry .
• Commercial launch readiness advanced: initial inventory manufactured, supply chain agreements finalized, field force recruitment commenced, and prescriber engagement initiated .
• Payer and clinical pathway positioning: NCCN inclusion and application for a unique HCPCS J‑code to enable accurate reimbursement at launch .

What Went Wrong

• Operating costs rose ahead of launch: G&A increased to $8.1M (FY2024) from $5.9M (FY2023) and stock‑based compensation rose to $7.5M from $2.0M, driving a larger net loss of $21.1M vs. $12.7M .
• Balance sheet constraints: cash and cash equivalents were $112 at year‑end, while license payable was $28.4M, highlighting capital needs to support commercialization .
• No quarterly (Q3) P&L disclosure; investors lack period‑specific visibility, as the company furnished full‑year results via Item 2.02 rather than a standalone Q3 press release/call .

Financial Results

Note: CTOR did not disclose standalone Q3 2024 revenue/EPS/margins; the company furnished FY2024 results encompassing Q3 via Item 2.02.

Income Statement (FY 2023 → FY 2024)

Balance Sheet (Sep 30, 2023 → Sep 30, 2024)

Disclosure Note

• The company furnished full‑year results (Item 2.02) and did not publish discrete Q3 2024 revenue/EPS/margin figures in a standalone Q3 earnings release or call transcript .

Guidance Changes

Earnings Call Themes & Trends

No Q3 2024 earnings call transcript is available in company documents for CTOR; themes below reflect management commentary in FY2024 press materials.

Management Commentary

• “The FDA’s approval of LYMPHIR for the treatment of cutaneous T‑cell lymphoma marks a significant advancement… It is the only targeted systemic therapy approved for CTCL patients since 2018 and the only therapy with a mechanism of action that targets the IL‑2 receptor.” — Leonard Mazur, Chairman & CEO .
• “We expect [the merger and Nasdaq listing] to facilitate greater access to capital to fund LYMPHIR’s launch and the Company’s future growth.” — Leonard Mazur .
• “Promising preliminary results” from investigator‑initiated combination trials suggest potential for enhanced efficacy in recurrent solid tumors; further preliminary results expected in 2025 (including CAR‑T combinations) .

Q&A Highlights

• No Q3 2024 earnings call transcript or Q&A published; the company furnished full‑year results via Item 2.02 .

Estimates Context

• Wall Street consensus for Q3 2024 EPS and revenue could not be retrieved in this session; estimates would be sourced from S&P Global when available.
• Given the lack of quarterly disclosure and pre‑commercial status (FY2024 revenue $0), investors should treat near‑term estimates as contingent on launch timing, reimbursement dynamics, and initial adoption ramp .

Key Takeaways for Investors

• FDA approval de‑risks regulatory execution; focus shifts to commercial launch in H1 2025 and initial adoption in CTCL centers .
• Reimbursement infrastructure is progressing (HCPCS J‑code application) and NCCN inclusion strengthens clinical and payer pathways at launch .
• Operating expenses rose significantly ahead of launch (G&A to $8.1M; SBC to $7.5M), resulting in a larger FY2024 net loss of $21.1M; tight cost control will be important post‑launch .
• Balance sheet shows minimal cash ($112) and a $28.4M license payable; capital access remains a core execution risk flagged in forward‑looking statements .
• The initial LYMPHIR market opportunity is estimated at >$400M, providing medium‑term upside if reimbursement and clinical adoption track expectations .
• Absence of discrete Q3 metrics suggests focusing on FY disclosures and operational milestones (inventory, supply chain, field force), with attention to 2025 commercialization KPIs .
• Near‑term trading catalysts: launch timing confirmations, J‑code status, early demand indicators, and any financing updates to support commercialization .

Appendix: Source Notes

• The company furnished full‑year FY2024 results via 8‑K Item 2.02; no standalone Q3 press release or call transcript was found in company documents for the Q3 window .
• Full‑year financial tables (revenue, operating expenses, net loss, balance sheet, cash flows) are from the press release and 8‑K exhibit .
• Launch timing, NCCN inclusion, J‑code application, and commercialization preparation activities are from management’s updates in the press release and 8‑K exhibit .
• Forward‑looking risk disclosures (including capital needs and commercialization risks) are included in the press release and 8‑K .