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First LYMPHIR revenue as Citius Oncology (NASDAQ: CTOR) narrows quarterly loss

Filing Impact
(Moderate)
Filing Sentiment
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

Citius Oncology reported its first fiscal 2026 quarter, highlighted by the initial U.S. launch of LYMPHIR and the Company’s first commercial revenue. Revenue reached $3,944,111, all from initial LYMPHIR sales in December 2025, generating gross profit of $3,154,903.

Total operating expenses were $8,407,179, driven by general and administrative costs and $3,956,050 of stock-based compensation. Citius Oncology posted a net loss of $5,534,069, or $0.06 per share, improving from a $6,659,205 loss, or $0.09 per share, a year earlier. Cash and cash equivalents were $7,295,451, and stockholders’ equity was $58,413,701 as of December 31, 2025. Management emphasized the strategic shift to a commercial oncology business centered on LYMPHIR in a market they estimate currently exceeds $400,000,000.

Positive

  • Transition to revenue-generating stage: Citius Oncology reported its first commercial revenue of $3,944,111 from LYMPHIR’s U.S. launch in the quarter ended December 31, 2025, marking a shift from pure development to an operating commercial oncology company.

Negative

  • None.

Insights

First LYMPHIR sales mark Citius Oncology’s shift to a revenue-generating commercial model.

Citius Oncology reported its first commercial revenue of $3.94M from LYMPHIR in the quarter ended December 31, 2025, confirming that U.S. launch has progressed to initial distributor sales and early physician use. Gross profit of $3.15M indicates attractive contribution margins at this early stage.

Operating expenses of $8.41M, including $3.96M of stock-based compensation, kept the company in a net loss of $5.53M, though this narrowed from $6.66M a year earlier. Cash of $7.30M and equity of $58.41M frame the current balance-sheet capacity to fund commercialization efforts.

Management highlights an estimated initial LYMPHIR market exceeding $400M and underscores a focus on physician adoption, formulary access, and AI-enabled commercial execution. Future quarters’ disclosures of LYMPHIR sales trends and expense levels will be key to understanding how quickly revenue can scale relative to ongoing investment.

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of

the Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported) February 13, 2026

 

Citius Oncology, Inc.

(Exact name of registrant as specified in its charter)

 

Delaware

(State or other jurisdiction of incorporation)

 

001-41534   99-4362660
(Commission File Number)   (IRS Employer
Identification No.)

 

11 Commerce Drive, 1st Floor, Cranford, NJ   07016
(Address of principal executive offices)   (Zip Code)

 

Registrant’s telephone number, including area code (908) 967-6677

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class   Trading Symbol(s)   Name of each exchange on which registered
Common Stock   CTOR   The Nasdaq Capital Market

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

 

 

 

 

 

 

Item 2.02. Results of Operations and Financial Condition.

 

On February 13, 2026, Citius Oncology, Inc. (the “Company,” “we,” or “our”) issued a press release announcing our results of operations for the first quarter of fiscal 2026. A copy of the press release is furnished as Exhibit 99.1 to this report and is incorporated herein by reference.

 

The information in this Item 2.02 (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such a filing.

 

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit No.   Description
99.1   Press release, dated February 13, 2026.
104   Cover Page Interactive Data File, formatted in Inline Extensible Business Reporting Language (iXBRL).

 

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SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

  CITIUS ONCOLOGY, INC.
   
Date: February 13, 2026 /s/ Leonard Mazur
  Leonard Mazur
  Chairman and Chief Executive Officer

 

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Exhibit 99.1

 

 

Citius Oncology, Inc. Announces First Reported Revenue Following Successful Launch of LYMPHIR™

 

Company reports $3.9 million in revenue generated from initial sales in December 2025 and provides first fiscal quarter 2026 financial results

 

CRANFORD, N.J., February 13, 2026– Citius Oncology, Inc. (“Citius Oncology”) (Nasdaq: CTOR), the oncology-focused subsidiary of Citius Pharmaceuticals, Inc. (“Citius Pharma”) (Nasdaq: CTXR), today reported financial results for the fiscal first quarter ended December 31, 2025, and provided a business update.

 

“The first quarter of fiscal 2026 marked a pivotal inflection point for Citius Oncology with the successful U.S. commercial launch of LYMPHIR and the Company’s first reported revenue,” said Leonard Mazur, Chairman and Chief Executive Officer of Citius Oncology and Citius Pharma. “This transition from a development-stage organization to a commercial oncology company reflects years of deliberate preparation and coordination across our clinical, manufacturing, distribution, and commercial infrastructure.”

 

“With initial distributor sales complete nationwide, we are now focused on accelerating physician adoption and expanding patient access. Since the start of calendar 2026, physicians have begun to initiate patients on LYMPHIR, and our formulary review efforts are progressing as planned. We are preparing to expand our field presence to support a highly concentrated prescriber base in this rare cancer setting, supported by an advanced AI-enabled commercial platform designed to drive efficient market penetration,” added Mazur.

 

“As LYMPHIR is now broadly available, we remain focused on execution, capital management, and evaluating strategic opportunities that we believe can meaningfully enhance long-term shareholder value,” concluded Mazur.

 

Business Highlights and Subsequent Developments

 

Initiated U.S. commercial launch of LYMPHIR™ (denileukin diftitox-cxdl) in December 2025, establishing Citius Oncology as a commercial-stage oncology company with an FDA-approved IL-2 receptor-directed immunotherapy for adult patients with relapsed or refractory Stage I–III cutaneous T-cell lymphoma (CTCL) following at least one prior systemic therapy;

 

Established nationwide specialty distribution infrastructure, completing initial distributor sales to ensure immediate product availability across U.S. treatment centers and support rapid physician adoption;

 

 

 

 

Initiated treatment of CTCL patients at leading U.S. cancer centers;

 

Deployed an AI-enabled commercial platform to drive targeted physician engagement, optimize field execution, and efficiently penetrate a highly concentrated prescriber base; and,

 

Advanced international access strategy outside the U.S. through regional distribution partners and Named Patient Programs (NPPs) in key European and Middle Eastern markets, enabling patient access where permitted by local law without constituting commercial approval;

 

Continued to expand long-term value optionality through investigator-initiated Phase I combination studies evaluating LYMPHIR:

 

in combination with pembrolizumab in patients with recurrent solid tumors; and,

 

as part of lymphodepletion regimens prior to CAR-T therapy, supporting potential future label expansion opportunities.

 

First Quarter 2026 Financial Highlights

 

Cash and cash equivalents totaled $7.3 million as of December 31, 2025;

 

Completed a registered offering in December 2025, generating net proceeds of approximately $15.1 million;

 

Revenue of $3.9 million during the quarter ended December 31, 2025 reflects sales related to the launch of LYMPHIR;

 

Research and development expenses were $1.0 million, compared to $1.3 million in the prior-year period, reflecting reduced clinical development activity;

 

General and administrative expenses were $2.9 million, compared to $3.3 million in the prior-year period;

 

Stock-based compensation expense totaled $4.0 million, primarily related to equity grants issued in September 2025, compared to $1.8 million in the prior-year period; and,

 

Net loss for the quarter was $5.5 million, or $(0.06) per share, compared to a net loss of $6.7 million, or $(0.09) per share, for the prior-year period.

 

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.

 

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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 75% 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 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 are: our ability to maintain Nasdaq’s continued listing standards; 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; 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; risks relating to the results of research and development activities, including those from 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; market and other conditions; risks related to our growth strategy; patent and intellectual property matters; 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 –

 

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CITIUS ONCOLOGY, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(Unaudited)

 

   December 31,
2025
   September 30,
2025
 
Current Assets:        
Cash and cash equivalents  $7,295,451   $3,924,908 
Accounts receivable, net of allowances   4,049,111     
Inventory   22,639,342    22,286,693 
Prepaid expenses   3,162,940    1,331,280 
Total Current Assets   37,146,844    27,542,881 
           
Other Assets:          
In-process research and development, net of accumulated amortization   72,826,562    73,400,000 
Total Other Assets   72,826,562    73,400,000 
           
Total Assets  $109,973,406   $100,942,881 
LIABILITIES AND STOCKHOLDERS’ EQUITY          
Current Liabilities:          
Accounts payable  $10,446,900   $13,234,684 
License payable   18,250,000    22,650,000 
Accrued expenses   4,518,916    4,093,124 
Due to related party   11,494,578    9,513,771 
Total Current Liabilities   44,710,394    49,491,579 
           
Deferred tax liability   3,049,200    2,784,960 
Note payable to related party   3,800,111    3,800,111 
Total Liabilities   51,559,705    56,076,650 
Stockholders’ Equity:          
Preferred stock - $0.0001 par value; 10,000,000 shares authorized: no shares issued and outstanding        
Common stock - $0.0001 par value; 400,000,000 shares authorized at December 31, 2025 and September 30, 2025; 84,797,846 and 83,513,442 shares issued and outstanding at December 31, 2025 and September 30, 2025, respectively   8,480    8,351 
Additional paid-in capital   127,979,246    108,897,836 
Accumulated deficit   (69,574,025)   (64,039,956)
Total Stockholders’ Equity   58,413,701    44,866,231 
Total Liabilities and Stockholders’ Equity  $109,973,406   $100,942,881 

 

4

 

 

CITIUS ONCOLOGY, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

FOR THE THREE MONTHS ENDED DECEMBER 31, 2025 AND 2024

(Unaudited)

 

   Three Months Ended 
   December 31,   December 31, 
   2025   2024 
Revenue  $3,944,111   $ 
Cost of revenues   (789,208)    
Gross Profit   3,154,903     
           
Operating Expenses          
Research and development   1,018,352    1,264,508 
Amortization of in-process research and development   573,438     
General and administrative   2,859,339    3,321,979 
Stock-based compensation – general and administrative   3,956,050    1,808,478 
Total Operating Expenses   8,407,179    6,394,965 
           
Operating Loss   (5,252,276)   (6,394,965)
           
Other Income (Expense)          
Interest income   28,288     
Interest expense   (45,841)    
Total Other Income (Expense), Net   (17,553)    
Loss before Income Taxes   (5,269,829)   (6,394,965)
Income tax expense   264,240    264,240 
           
Net Loss  $(5,534,069)  $(6,659,205)
           
Net Loss Per Share - Basic and Diluted  $(0.06)  $(0.09)
           
Weighted Average Common Shares Outstanding          
Basic and diluted (includes pre-funded warrants from the December 2025 offering)   87,462,385    71,552,402 

 

5

 

 

CITIUS ONCOLOGY, INC.

Condensed Consolidated STATEMENTS OF CASH FLOWS

FOR THE THREE MONTHS ENDED DECEMBER 31, 2025 AND 2024

(Unaudited)

 

   2025   2024 
Cash Flows From Operating Activities:        
Net loss  $(5,534,069)  $(6,659,205)
Adjustments to reconcile net loss to net cash provided by operating activities:          
Stock-based compensation expense   3,956,050    1,808,478 
Amortization of in-process research and development   573,438    - 
Deferred income tax expense   264,240    264,240 
Changes in operating assets and liabilities:          
Accounts receivable, net of allowances   (4,049,111)   - 
Inventory   (352,649)   (6,112,603)
Prepaid expenses   (1,831,660)   - 
Accounts payable   (2,787,784)   2,162,955 
Accrued expenses   425,792    6,228,612 
Due to related party   1,980,807    2,307,523 
Net Cash (Used In) Provided By Operating Activities   (7,354,946)   - 
Cash Flows From Investing Activities          
License payments   (4,400,000)   - 
Net Cash Used In Investing Activities   (4,400,000)   - 
Cash Flows From Financing Activities          
Net proceeds from issuance of common stock   15,125,489    - 
Net Cash Provided by Financing Activities   15,125,489    - 
Net Change in Cash and Cash Equivalents   3,370,543    - 
Cash and Cash Equivalents – Beginning of Period   3,924,908    112 
Cash and Cash Equivalents – End of Period  $7,295,451   $112 
Supplemental Disclosures of Cash Flow Information and Non-cash Transactions:          
Interest Paid  $14,460   $- 

 

6

 

FAQ

What revenue did Citius Oncology (CTOR) report for Q1 fiscal 2026?

Citius Oncology reported $3,944,111 in revenue for the fiscal first quarter ended December 31, 2025. All revenue came from initial U.S. distributor sales of LYMPHIR following its commercial launch in December 2025, representing the company’s first reported product revenue.

What was Citius Oncologys net loss and EPS for the quarter ended December 31, 2025?

Citius Oncology recorded a net loss of $5,534,069, or $0.06 per share, for the three months ended December 31, 2025. This compares with a net loss of $6,659,205, or $0.09 per share, for the same period in 2024, reflecting a narrower quarterly loss.

How profitable were LYMPHIR sales for Citius Oncology in the first quarter of fiscal 2026?

Initial LYMPHIR sales generated $3,154,903 in gross profit on revenue of $3,944,111 and cost of revenues of $789,208. This early gross profit contribution demonstrates positive unit economics at launch, even as overall operations remain loss-making due to research, commercial, and administrative spending.

What is the estimated market opportunity for LYMPHIR mentioned by Citius Oncology?

Management estimates the initial market for LYMPHIR exceeds $400 million and is growing, targeting adults with relapsed or refractory Stage I–III CTCL after at least one prior systemic therapy. They also describe this market as underserved by existing treatments, supporting LYMPHIR’s competitive positioning.

What were Citius Oncologys cash and total assets at December 31, 2025?

As of December 31, 2025, Citius Oncology reported cash and cash equivalents of $7,295,451 and total assets of $109,973,406. Stockholders’ equity totaled $58,413,701, while total liabilities were $51,559,705, framing the company’s financial position entering LYMPHIR’s commercial rollout.

How did Citius Oncology fund its operations during the first quarter of fiscal 2026?

During the quarter, Citius Oncology used $7,354,946 in operating cash and $4,400,000 for license payments, while receiving $15,125,489 in net proceeds from issuing common stock. These financing inflows more than offset operating and investing outflows, increasing cash to $7,295,451.

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