Citius Pharmaceuticals, Inc. Reports Fiscal Year 2025 Financial Results and Provides Business Update
Rhea-AI Summary
Citius Oncology (NASDAQ: CTOR) launched LYMPHIR (denileukin diftitox-cxdl) in the U.S. in December 2025 after FDA approval for adult patients with relapsed or refractory Stage I-III CTCL following at least one prior systemic therapy. The company secured distribution agreements with three major U.S. wholesalers, access in 19 international markets via named patient programs, an NCCN Category 2A recommendation, and a permanent HCPCS J-code (J9161). Production is sufficient for up to 18 months estimated demand. Fiscal 2025 cash was $4.3M; net loss was $39.7M. The company raised approximately $61M in gross proceeds from financings.
Positive
- FDA approval and U.S. launch of LYMPHIR in December 2025
- Secured distribution with 3 leading U.S. wholesalers
- Access in 19 international markets via named patient programs
- ~$61M raised in gross proceeds from strategic financings
- Included in NCCN with Category 2A and assigned permanent J-code
Negative
- Cash and cash equivalents of only $4.3M at Sept 30, 2025
- No reported revenues for fiscal year 2025
- Net loss of $39.7M (loss per share $3.38) for FY2025
News Market Reaction 53 Alerts
On the day this news was published, CTXR declined 0.95%, reflecting a mild negative market reaction. Argus tracked a peak move of +24.5% during that session. Argus tracked a trough of -42.7% from its starting point during tracking. Our momentum scanner triggered 53 alerts that day, indicating high trading interest and price volatility. This price movement removed approximately $184K from the company's valuation, bringing the market cap to $19M at that time. Trading volume was exceptionally heavy at 16.3x the daily average, suggesting significant selling pressure.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
CTOR fell 10.07% while key peers showed modest moves: BIOA -2.8%, IRWD -1.23%, ANIK -0.32%, DERM +0.13%, SXTC 0%, pointing to a stock-specific reaction rather than a broad sector shift.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Dec 10 | Financing completion | Negative | -2.6% | Closed concurrent registered direct and private placement raising about $18M. |
| Dec 09 | Financing announcement | Negative | +6.4% | Announced $18M registered direct and private placement at $1.09 per share. |
| Dec 04 | Distribution deal | Positive | -8.2% | Expanded LYMPHIR distribution to Turkey and Middle East via Er-Kim deal. |
| Dec 01 | Product launch | Positive | +19.7% | Announced U.S. commercial launch of LYMPHIR for CTCL patients. |
| Nov 25 | Conference presence | Positive | +8.0% | Planned ASH exhibit to showcase FDA‑approved LYMPHIR ahead of launch. |
Recent news shows mixed reactions: offerings often drew selling, while LYMPHIR-related commercial milestones and broader corporate updates more frequently aligned with positive price moves.
Over the last month, CTOR has centered activity around the LYMPHIR franchise and related financings. The U.S. commercial launch on Dec 1, 2025 and subsequent distribution and conference updates were generally met with positive moves, though international expansion on Dec 4, 2025 saw a selloff. Two December financings around $18 million highlighted the need for launch capital, with one announcement drawing buying and the closing press release modest weakness.
Market Pulse Summary
This announcement highlights the transition from preparation to commercial execution, with LYMPHIR launched in the U.S. and access extended to 19 international markets. Financially, the company reported fiscal year R&D expenses of $9.2 million, G&A of $18.5 million, and a net loss of $39.7 million, with cash of $4.3 million. Investors may watch subsequent earnings for revenue traction from LYMPHIR, changes in operating expenses, and additional financing activity across Citius entities.
Key Terms
immunotherapy medical
cutaneous T-cell lymphoma medical
il-2 receptor-directed immunotherapy medical
named patient programs regulatory
national comprehensive cancer network medical
healthcare common procedure coding system regulatory
j-code regulatory
pharmacovigilance medical
AI-generated analysis. Not financial advice.
Subsidiary, Citius Oncology, launches cancer immunotherapy, LYMPHIR™, in the
"2025 was a pivotal year for Citius as we successfully launched LYMPHIR following its FDA approval, marking the first new systemic therapy for cutaneous T-cell lymphoma (CTCL) patients since 2018. This milestone reflects our ability to execute and our commitment to delivering impactful treatments for patients with limited options," said Leonard Mazur, Chairman and CEO of Citius Pharma. "With LYMPHIR commercially available as of December 2025, we are focused on its successful launch and adoption in 2026, with even greater opportunities ahead to drive value for patients and shareholders. We are actively engaging with the FDA to advance Mino-Lok, exploring additional indications and markets for LYMPHIR, and working diligently to strengthen our financial and operational foundation to support sustained growth. We look forward to reporting on our continued progress in the coming months."
Fiscal Year 2025 Business Highlights and Subsequent Developments
- Citius Pharma subsidiary, Citius Oncology (Nasdaq: CTOR), launched LYMPHIR™ (denileukin diftitox-cxdl), a novel IL-2 receptor-directed immunotherapy, in the
U.S. in December 2025 for the treatment of adult patients with relapsed or refractory Stage I-III CTCL after at least one prior systemic therapy; - Citius Pharma drove commercial preparations for LYMPHIR's launch through its shared management services agreement with Citius Oncology:
- Executed service agreements with the three leading
U.S. pharmaceutical wholesalers to distribute LYMPHIR throughout theU.S. ; - Secured access to LYMPHIR in 19 international markets through regional distribution partners via named patient programs (NPPs), which allows access to LYMPHIR where permitted by local law without constituting commercial approval outside the
U.S. ; - Ensured production and sufficient supply of LYMPHIR for up to 18 months of estimated commercial demand;
- Secured inclusion of LYMPHIR in the National Comprehensive Cancer Network (NCCN) guidelines and compendia with a Category 2A recommendation, and a unique, permanent Healthcare Common Procedure Coding System (HCPCS) J-code (J9161) to aid in obtaining coverage and reimbursement;
- Partnered to deploy an AI-powered sales and marketing platform to enhance commercial targeting, real-time field execution, and provider engagement; and,
- Contracted with a leading provider of global commercialization services to supply medical information, pharmacovigilance, revenue cycle management, program management, data and analytics, and channel management services;
- Executed service agreements with the three leading
- Raised approximately
$61 million - Citius Pharma closed
$25 million - Citius Oncology closed
$36 million
- Citius Pharma closed
- Continued to engage with the FDA on the paths forward for Mino-Lok and Halo-Lido.
Fiscal Year 2025 Financial Highlights
- Cash and cash equivalents of
$4.3 million - Citius Pharma did not report revenues for the year;
- R&D expenses were
$9.2 million $11.9 million - G&A expenses were
$18.5 million $18.2 million - Stock-based compensation expense was
$10.8 million $11.8 million - Net loss was
$39.7 million $3.38 $40.2 million $5.97
About Citius Oncology, Inc.
Citius Oncology, Inc. (Nasdaq: CTOR) is a platform to develop and commercialize novel targeted oncology therapies. In December 2025, Citius Oncology launched LYMPHIR, approved by the FDA for the treatment of adults with relapsed or refractory Stage I–III CTCL who had had at least one prior systemic therapy. Management estimates the initial market for LYMPHIR currently exceeds
About Citius Pharmaceuticals, Inc.
Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) is a biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products. Citius Pharma owns approximately
Forward-Looking Statements
This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements are made based on our expectations and beliefs concerning future events impacting Citius Pharma and Citius Oncology. You can identify these statements by the fact that they use words such as "will," "anticipate," "estimate," "expect," "plan," "should," and "may" and other words and terms of similar meaning or use of future dates. Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated, and, unless noted otherwise, that apply to Citius Pharma and Citius Oncology, are: our need for substantial additional funds and our ability to raise additional money to fund our operations for at least the next 12 months as a going concern; our ability to successfully commercialize LYMPHIR and establish a sustainable revenue stream; the estimated markets for LYMPHIR and our product candidates and the acceptance thereof by any market; our ability to secure strategic partnerships and expand international access to LYMPHIR; our ability to use the latest technology to support our commercialization efforts for LYMPHIR; physician and patient acceptance of LYMPHIR in a competitive treatment landscape; our reliance on third-party logistics providers, distributors, and specialty pharmacies to support commercial operations; our ability to educate providers and payers, secure adequate reimbursement, and maintain uninterrupted product supply; post-marketing requirements and ongoing regulatory compliance related to LYMPHIR; the ability of LYMPHIR and our product candidates to impact the quality of life of our target patient populations; risks relating to the results of research and development activities, including those from our existing and any new pipeline assets; our ability to procure cGMP commercial-scale supply; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; our ability to maintain Nasdaq's continued listing standards; market and other conditions; risks related to our growth strategy; patent and intellectual property matters; our ability to identify, acquire, close and integrate product candidates and companies successfully and on a timely basis; government regulation; as well as other risks described in our Securities and Exchange Commission ("SEC") filings. These risks have been and may be further impacted by any future public health risks. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Risks regarding our business are described in detail in our SEC filings which are available on the SEC's website at www.sec.gov, including in Citius Oncology's Annual Report on Form 10-K for the year ended September 30, 2025, filed with the SEC on December 23, 2025. These forward-looking statements speak only as of the date hereof, and we expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.
Investor Contact:
Ilanit Allen
ir@citiuspharma.com
908-967-6677 x113
Media Contact:
STiR-communications
Greg Salsburg
Greg@STiR-communications.com
-- Financial Tables Follow –
CITIUS PHARMACEUTICALS, INC. CONSOLIDATED BALANCE SHEETS SEPTEMBER 30, 2025 AND 2024 | ||||||||
2025 | 2024 | |||||||
ASSETS | ||||||||
Current Assets: | ||||||||
Cash and cash equivalents | $ | 4,252,290 | $ | 3,251,880 | ||||
Inventory | 22,286,693 | 8,268,766 | ||||||
Prepaid expenses | 1,395,490 | 2,700,000 | ||||||
Total Current Assets | 27,934,473 | 14,220,646 | ||||||
Operating lease right-of-use asset, net | 818,694 | 246,247 | ||||||
Other Assets: | ||||||||
Deposits | 38,062 | 38,062 | ||||||
In-process research and development | 92,800,000 | 92,800,000 | ||||||
Goodwill | 9,346,796 | 9,346,796 | ||||||
Total Other Assets | 102,184,858 | 102,184,858 | ||||||
Total Assets | $ | 130,938,025 | $ | 116,651,751 | ||||
LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
Current Liabilities: | ||||||||
Accounts payable | $ | 13,693,692 | $ | 4,927,211 | ||||
License payable | 22,650,000 | 28,400,000 | ||||||
Accrued expenses | 4,190,253 | 17,027 | ||||||
Accrued compensation | 3,292,447 | 2,229,018 | ||||||
Note payable | 1,000,000 | — | ||||||
Operating lease liability | 88,348 | 241,547 | ||||||
Total Current Liabilities | 44,914,740 | 35,814,803 | ||||||
Deferred tax liability | 7,770,760 | 6,713,800 | ||||||
Operating lease liability – non current | 724,925 | 21,318 | ||||||
Total Liabilities | 53,410,425 | 42,549,921 | ||||||
Commitments and Contingencies | ||||||||
Stockholders' Equity: | ||||||||
Preferred stock - | — | — | ||||||
Common stock - | 18,068 | 7,247 | ||||||
Additional paid-in capital | 306,336,239 | 271,440,421 | ||||||
Accumulated deficit | (238,804,129) | (201,370,218) | ||||||
Total Citius Pharmaceuticals, Inc. Stockholders' Equity | 67,550,178 | 70,077,450 | ||||||
Non-controlling interest | 9,977,422 | 4,024,380 | ||||||
Total Equity | 77,527,600 | 74,101,830 | ||||||
Total Liabilities and Equity | $ | 130,938,025 | $ | 116,651,751 | ||||
CITIUS PHARMACEUTICALS, INC. CONSOLIDATED STATEMENTS OF OPERATIONS FOR THE YEARS ENDED SEPTEMBER 30, 2025 AND 2024 | ||||||||
2025 | 2024 | |||||||
Revenues | $ | — | $ | — | ||||
Operating Expenses: | ||||||||
Research and development | 9,156,474 | 11,906,601 | ||||||
General and administrative | 18,532,843 | 18,249,402 | ||||||
Stock-based compensation – general and administrative | 10,836,291 | 11,839,678 | ||||||
Total Operating Expenses | 38,525,608 | 41,995,681 | ||||||
Operating Loss | (38,525,608) | (41,995,681) | ||||||
Other Income (Expense): | ||||||||
Interest income | 110,081 | 758,000 | ||||||
Interest expense | (267,782) | — | ||||||
Gain on sale of | — | 2,387,842 | ||||||
Total Other Income (Expense), Net | (157,701) | 3,145,842 | ||||||
Loss before Income Taxes | (38,683,309) | (38,849,839) | ||||||
Income tax expense | 1,056,960 | 576,000 | ||||||
Net Loss | (39,740,269) | (39,425,839) | ||||||
Net loss attributable to non-controlling interest | 2,306,358 | 287,000 | ||||||
Deemed dividend on warrant extension | — | (1,047,312) | ||||||
Net Loss Applicable to Common Stockholders | $ | (37,433,911) | (40,186,151) | |||||
Net Loss Per Share Applicable to Common Stockholders - Basic and Diluted | $ | (3.38) | (5.97) | |||||
Weighted Average Common Shares Outstanding | ||||||||
Basic and diluted | 11,065,225 | 6,726,999 | ||||||
CITIUS PHARMACEUTICALS, INC. CONSOLIDATED STATEMENTS OF CASH FLOWS FOR THE YEARS ENDED SEPTEMBER 30, 2025 AND 2024 | ||||||||
2025 | 2024 | |||||||
Cash Flows From Operating Activities: | ||||||||
Net loss | $ | (39,740,269) | $ | (39,425,839) | ||||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
Stock-based compensation | 10,836,291 | 11,839,678 | ||||||
Issuance of common stock for services | 26,600 | 284,176 | ||||||
Amortization of operating lease right-of-use asset | 214,250 | 208,179 | ||||||
Depreciation | — | 1,432 | ||||||
Deferred income tax expense | 1,056,960 | 576,000 | ||||||
Changes in operating assets and liabilities: | ||||||||
Inventory | (12,649,207) | (2,133,871) | ||||||
Prepaid expenses | (64,210) | (945,389) | ||||||
Accounts payable | 8,766,481 | 1,999,877 | ||||||
Accrued expenses | 4,173,226 | (459,273) | ||||||
Accrued compensation | 1,063,429 | 72,035 | ||||||
Operating lease liability | (236,289) | (218,380) | ||||||
Net Cash Used In Operating Activities | (26,552,738) | (28,201,375) | ||||||
Cash Flows From Investing Activities: | ||||||||
License payment | (5,750,000) | (5,000,000) | ||||||
Net Cash Used In Investing Activities | (5,750,000) | (5,000,000) | ||||||
Cash Flows From Financing Activities: | ||||||||
Proceeds from note payable and advance from employee | 1,300,000 | — | ||||||
Repayment of advance from employee | (300,000) | — | ||||||
Merger, net | — | (3,831,357) | ||||||
Net proceeds from common stock offerings | 32,303,148 | 13,803,684 | ||||||
Net Cash Provided By Financing Activities | 33,303,148 | 9,972,327 | ||||||
Net Change in Cash and Cash Equivalents | 1,000,410 | (23,229,048) | ||||||
Cash and Cash Equivalents – Beginning of Year | 3,251,880 | 26,480,928 | ||||||
Cash and Cash Equivalents – End of Year | $ | 4,252,290 | $ | 3,251,880 | ||||
Supplemental Disclosures of Cash Flow Information and Non-cash Activities: | ||||||||
IPR&D Milestones included in License Payable | $ | — | $ | 28,400,000 | ||||
Net Prepaid Manufacturing transferred to Inventory | $ | 1,368,720 | $ | 6,134,895 | ||||
Operating lease right-of-use asset and liability recorded | $ | 786,697 | $ | — | ||||
Interest paid | $ | 187,389 | $ | — | ||||
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SOURCE Citius Pharmaceuticals, Inc.
FAQ
What is LYMPHIR and when did CTOR launch it in the U.S.?
Which patients is LYMPHIR approved for under CTOR's FDA approval?
How much cash did CTOR report at September 30, 2025 and what is the funding raised?
Does LYMPHIR have reimbursement support to aid coverage?
Are there commercial supply and distribution arrangements for LYMPHIR?
What were CTOR's reported R&D and net loss for FY2025?
