Full Press Release Details
Subsidiary, Citius Oncology, launches cancer immunotherapy, LYMPHIR™, in the U.S. in December 2025
CRANFORD, N.J.,Dec. 23, 2025/PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius Pharma" or the "Company") (Nasdaq: CTXR), a biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products today reported business and financial results for the fiscal year ended September 30, 2025.
"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
Fiscal Year 2025 Financial Highlights
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 $400 million, is growing, and is underserved by existing therapies. Robust intellectual property protections that span orphan drug designation, complex technology, trade secrets and pending patents for immuno-oncology use as a combination therapy with checkpoint inhibitors would further support Citius Oncology's competitive positioning. For more information, please visitwww.citiusonc.com.
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 78% of Citius Oncology. In December 2025, Citius Oncology launched LYMPHIR, a targeted immunotherapy for the treatment of adults with relapsed or refractory Stage I–III CTCL who had had at least one prior systemic therapy. Citius Pharma's late-stage pipeline also includes Mino-Lok®, a catheter lock solution to salvage catheters in patients with catheter-related bloodstream infections, and CITI-002 (Halo-Lido), a topical formulation for the relief of hemorrhoids. A pivotal Phase 3 trial for Mino-Lok and a Phase 2b trial for Halo-Lido were completed in 2023. Mino-Lok met primary and secondary endpoints of its Phase 3 trial. Citius Pharma is actively engaged with the FDA to outline next steps for both programs. For more information, please visitwww.citiuspharma.com.
Forward-Looking StatementsThis 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 atwww.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 Allenir@citiuspharma.com908-967-6677 x113
Media Contact:STiR-communicationsGreg SalsburgGreg@STiR-communications.com
-- Financial Tables Follow –
| CITIUS PHARMACEUTICALS, INC.CONSOLIDATED BALANCE SHEETSSEPTEMBER 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 - $0.001 par value; 10,000,000 shares authorized; no shares issuedand outstanding | — | — | ||||||
| Common stock - $0.001 par value; 250,000,000 and 16,000,000 shares authorized atSeptember 30, 2025 and 2024, respectively; 18,067,744 and 7,247,243 sharesissued and outstanding at September 30, 2025 and 2024, respectively | 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 OPERATIONSFOR 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 New Jersey net operating losses | — | 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 FLOWSFOR 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 | $ | — |