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CITIUS ONCOLOGY, INC.

CIK: 1851484 Filed: December 23, 2025 10-K

Key Highlights

  • Citius Oncology, Inc. became a publicly-traded company via a reverse merger in August 2024, remaining majority-owned by Citius Pharmaceuticals, Inc.
  • The company's primary objective is to commercialize its product, LYMPHIR™ (denileukin diftitox).
  • As of March 31, 2025, the market value of shares held by non-affiliates was $5.1 million.

Financial Analysis

CITIUS ONCOLOGY, INC. Annual Report - How They Did This Year

This past year, Citius Oncology, Inc. (trading as CTOR on The NASDAQ Capital Market) saw some big changes and is looking to make its mark in the oncology space.

A New Beginning: The Reverse Merger A major event for the company was the reverse merger in August 2024. Citius Oncology became its own publicly-traded company, though it's still majority-owned by Citius Pharmaceuticals, Inc. This move was intended to help them focus on their specific goals.

Their Main Focus: LYMPHIR™ Citius Oncology's primary goal is to successfully bring their product, LYMPHIR™ (denileukin diftitox), to market. This is their registered trademark, and they're working hard to get it to patients.

Important Financial Considerations & Risks The company's independent auditors have raised a significant concern: there's "substantial doubt about our ability to continue as a going concern." This means there are serious questions about whether the company can stay in business without significant changes or new funding. They've also stated they need a lot more money to keep operations going.

As of March 31, 2025, the market value of their shares held by everyday investors (non-affiliates) was around $5.1 million. As of December 23, 2025, there were about 84.8 million shares of their common stock outstanding.

Beyond the immediate need for funds, the company faces several other challenges:

  • Commercializing LYMPHIR: Getting their product to market successfully involves covering licensing fees, manufacturing costs, and other expenses. There's no guarantee it will be accepted by the market.
  • Manufacturing: They need to secure reliable, commercial-scale manufacturing for their product.
  • Staying on NASDAQ: They need to meet the ongoing requirements to keep their stock listed on the NASDAQ exchange.
  • Finding Partners: Their ability to secure financing and strategic partnerships is key to their future.
  • Building the Team: They need to attract and retain qualified management and technical staff to grow the business.

These are all important factors to keep in mind as they move forward.

Key Takeaways for Investors:

  • Citius Oncology, Inc. became a publicly-traded company via a reverse merger in August 2024, remaining majority-owned by Citius Pharmaceuticals, Inc.
  • The company's main objective is to commercialize its product, LYMPHIR™ (denileukin diftitox).
  • Auditors have expressed "substantial doubt" about the company's ability to continue as a going concern, citing a significant need for additional funding.
  • As of March 31, 2025, the market value of shares held by non-affiliates was $5.1 million, with approximately 84.8 million shares outstanding as of December 23, 2025.
  • Key challenges include successful commercialization and manufacturing of LYMPHIR, maintaining NASDAQ listing, securing partnerships, and building its team.

Risk Factors

  • Auditors have expressed "substantial doubt" about the company's ability to continue as a going concern.
  • There is a significant need for additional funding to keep operations going.
  • Challenges exist in commercializing LYMPHIR, including market acceptance, licensing fees, and manufacturing costs.
  • The company needs to secure reliable, commercial-scale manufacturing for LYMPHIR.
  • There is a risk of not meeting ongoing requirements to keep its stock listed on the NASDAQ exchange.
  • The company's future depends on its ability to secure financing, strategic partnerships, and attract qualified management and technical staff.

Why This Matters

The auditor's explicit statement of "substantial doubt about our ability to continue as a going concern" is a critical red flag for any investor. This indicates severe financial instability and an urgent, significant need for additional capital. For current shareholders, this could mean substantial dilution through new equity offerings, or in a worst-case scenario, the company's inability to continue operations. This warning immediately places Citius Oncology in a high-risk, highly speculative investment category.

Despite these financial pressures, the company's entire value proposition hinges on the successful commercialization of its single product, LYMPHIR™. Investors are essentially betting on the company's ability to navigate complex and costly challenges, including securing reliable manufacturing, achieving market acceptance, and covering licensing fees, all while operating under immense financial strain. The path to bringing a pharmaceutical product to market is fraught with uncertainty, making this a high-stakes gamble.

The recent reverse merger in August 2024 made Citius Oncology a publicly traded entity, yet its small market value for non-affiliates ($5.1 million) and majority ownership by Citius Pharmaceuticals suggest it's a nascent, thinly traded stock. This can lead to significant price volatility and liquidity issues, further complicating investment decisions. The company's ability to secure financing and strategic partnerships, alongside building a competent team, will be paramount to its survival.

What Usually Happens Next

Given the dire financial warning, the immediate focus for Citius Oncology will be to secure the necessary funding to continue operations. Investors should closely monitor any announcements regarding equity offerings, debt financing, or strategic partnerships that include significant capital injections. The terms of any such financing will be crucial, as they could lead to substantial dilution for existing shareholders or impose restrictive covenants.

Concurrently, the company must demonstrate tangible progress on its primary asset, LYMPHIR™. This includes providing updates on securing commercial-scale manufacturing agreements, any remaining regulatory milestones, and the development of a robust commercialization strategy. Any delays in these areas, or signs of difficulty in market acceptance, would further exacerbate the company's financial challenges and negatively impact investor confidence.

Beyond funding and product development, investors should watch for the company's ability to maintain its NASDAQ listing, which often involves meeting minimum share price or market capitalization requirements. Additionally, securing strategic partnerships for commercialization, distribution, or even a potential acquisition would be significant positive developments. The stability and growth of its management and technical teams will also be key indicators of its long-term viability.

Financial Metrics

Market Value ( Non- Affiliate Shares) $5.1 million (as of March 31, 2025)
Shares Outstanding 84.8 million (as of December 23, 2025)

Document Information

Analysis Processed

December 24, 2025 at 09:02 AM

Important Disclaimer

This AI-generated analysis is for informational purposes only and does not constitute financial or investment advice. Always consult with qualified professionals and conduct your own research before making investment decisions.