PR Newswire
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
- 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 the U.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;
- Raised approximately $61 million in gross proceeds from capital raises:
- Citius Pharma closed $25 million in gross proceeds from strategic financings during and after the fiscal year end; and,
- Citius Oncology closed $36 million in gross proceeds from strategic financings during and after the fiscal year end; and,
- 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 as of September 30, 2025;
- Citius Pharma did not report revenues for the year;
- R&D expenses were $9.2 million for the full year ended September 30, 2025, compared to $11.9 million for the full year ended September 30, 2024;
- G&A expenses were $18.5 million for the full year ended September 30, 2025, compared to $18.2 million for the full year ended September 30, 2024;
- Stock-based compensation expense was $10.8 million for the full year ended September 30, 2025, compared to $11.8 million for the full year ended September 30, 2024; and,
- Net loss was $39.7 million, or ($3.38) per share for the fiscal year ended September 30, 2025 compared to a net loss of $40.2 million, or ($5.97) per share for the full year ended September 30, 2024.
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 visit www.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 visit www.citiuspharma.com.
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
[email protected]
908-967-6677 x113
Media Contact:
STiR-communications
Greg Salsburg
[email protected]
— Financial Tables Follow –
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|
||||||||
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|
||||||||
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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 |
||||||
|
|
27,934,473 |
14,220,646 |
||||||
|
|
818,694 |
246,247 |
||||||
|
|
||||||||
|
Deposits |
38,062 |
38,062 |
||||||
|
In-process research and development |
92,800,000 |
92,800,000 |
||||||
|
Goodwill |
9,346,796 |
9,346,796 |
||||||
|
|
102,184,858 |
102,184,858 |
||||||
|
|
$ |
130,938,025 |
$ |
116,651,751 |
||||
|
|
||||||||
|
|
||||||||
|
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 |
||||||
|
|
44,914,740 |
35,814,803 |
||||||
|
Deferred tax liability |
7,770,760 |
6,713,800 |
||||||
|
Operating lease liability – non current |
724,925 |
21,318 |
||||||
|
|
53,410,425 |
42,549,921 |
||||||
|
|
||||||||
|
|
||||||||
|
Preferred stock – $0.001 par value; 10,000,000 shares authorized; no shares issued |
|
|
||||||
|
Common stock – $0.001 par value; 250,000,000 and 16,000,000 shares authorized at |
18,068 |
7,247 |
||||||
|
Additional paid-in capital |
306,336,239 |
271,440,421 |
||||||
|
Accumulated deficit |
(238,804,129) |
(201,370,218) |
||||||
|
|
67,550,178 |
70,077,450 |
||||||
|
Non-controlling interest |
9,977,422 |
4,024,380 |
||||||
|
|
77,527,600 |
74,101,830 |
||||||
|
|
$ |
130,938,025 |
$ |
116,651,751 |
||||
|
|
||||||||
|
|
|
|||||||
|
|
$ |
— |
|
|
||||
|
|
||||||||
|
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 |
||||||
|
|
38,525,608 |
41,995,681 |
||||||
|
|
(38,525,608) |
(41,995,681) |
||||||
|
|
||||||||
|
Interest income |
110,081 |
758,000 |
||||||
|
Interest expense |
(267,782) |
— |
||||||
|
Gain on sale of New Jersey net operating losses |
— |
2,387,842 |
||||||
|
|
(157,701) |
3,145,842 |
||||||
|
|
(38,683,309) |
(38,849,839) |
||||||
|
Income tax expense |
1,056,960 |
576,000 |
||||||
|
|
(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) |
||||||
|
|
$ |
(37,433,911) |
(40,186,151) |
|||||
|
|
$ |
(3.38) |
(5.97) |
|||||
|
|
||||||||
|
Basic and diluted |
11,065,225 |
6,726,999 |
||||||
|
|
||||||||
|
|
|
|||||||
|
|
||||||||
|
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) |
||||||
|
|
(26,552,738) |
(28,201,375) |
||||||
|
|
||||||||
|
License payment |
(5,750,000) |
(5,000,000) |
||||||
|
|
(5,750,000) |
(5,000,000) |
||||||
|
|
||||||||
|
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 |
||||||
|
|
33,303,148 |
9,972,327 |
||||||
|
|
1,000,410 |
(23,229,048) |
||||||
|
|
3,251,880 |
26,480,928 |
||||||
|
|
$ |
4,252,290 |
$ |
3,251,880 |
||||
|
|
||||||||
|
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.
