Citius Oncology, Inc. Announces First Reported Revenue Following Successful Launch of LYMPHIR™
Rhea-AI Summary
Citius Oncology (Nasdaq: CTOR) reported first reported revenue of $3.9 million from the December 2025 commercial launch of LYMPHIR (denileukin diftitox-cxdl) and provided fiscal Q1 2026 results for the quarter ended December 31, 2025. The company is now a commercial-stage oncology firm with an FDA-approved IL-2 receptor-directed therapy for relapsed or refractory Stage I–III CTCL.
Other Q1 highlights include $7.3 million cash on hand, a December registered offering that raised net proceeds of $15.1 million, R&D of $1.0 million, G&A of $2.9 million, and a net loss of $5.5 million ($(0.06) per share).
Positive
- First revenue of $3.9M from LYMPHIR launch in December 2025
- FDA-approved commercial product for relapsed/refractory Stage I–III CTCL
- Registered offering generated $15.1M net proceeds in December 2025
- Nationwide distribution established to enable immediate product availability
Negative
- Net loss of $5.5M in fiscal Q1 2026
- Stock-based compensation of $4.0M in the quarter, materially above prior-year
- Cash balance of $7.3M as of December 31, 2025 may limit runway without further funding
Key Figures
Market Reality Check
Peers on Argus
CTOR was up 4.42% while close peers showed mixed moves: IRWD up 3.83%, SXTC up 3.54%, BIOA and DERM down 3–4%. Momentum scanner saw one peer up and one down, supporting a stock-specific reaction rather than a sector-wide move.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Feb 11 | EU access agreement | Positive | +0.0% | Expanded LYMPHIR access in Europe via Uniphar managed access programs. |
| Dec 23 | FY25 results | Neutral | +1.6% | Reported FY25 figures and financing activity following LYMPHIR launch preparations. |
| Dec 23 | Parent FY25 update | Neutral | +1.6% | Parent company business update highlighting LYMPHIR launch and access milestones. |
| Dec 10 | Offering closing | Negative | -2.6% | Closed $18M registered direct and private placement supporting LYMPHIR launch. |
| Dec 09 | Offering announcement | Negative | +6.4% | Announced $18M concurrent offering; stock initially reacted positively despite dilution. |
Recent financings and commercialization milestones have generally seen modestly positive or aligned price reactions, with one notable divergence on an offering announcement.
Over the last few months, CTOR has moved from financing its launch to executing on commercialization. December 2025 offerings (news IDs 945743, 946572) funded LYMPHIR’s rollout, with mixed immediate reactions. Fiscal 2025 results and a broader Citius Pharma update (news IDs 951225, 951226) coincided with small gains. The February 11, 2026 European distribution deal (news ID 1011461) saw no price change, framing today’s first revenue report as the next step in the same commercialization arc.
Market Pulse Summary
This announcement marks CTOR’s transition to a commercial oncology company, with first-quarter LYMPHIR revenue of $3.9 million and cash of $7.3 million as of December 31, 2025. Operating metrics show lower R&D and G&A and an improved net loss of $5.5 million, offset by higher stock-based compensation of $4.0 million. Investors may watch future quarters for revenue trajectory, cash management, and progress in combination studies and international access programs.
Key Terms
registered offering financial
ai-enabled commercial platform technical
immunotherapy medical
phase i medical
car-t therapy medical
named patient programs regulatory
stock-based compensation financial
AI-generated analysis. Not financial advice.
Company reports
"The first quarter of fiscal 2026 marked a pivotal inflection point for Citius Oncology with the successful
"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
as of December 31, 2025;$7.3 million - Completed a registered offering in December 2025, generating net proceeds of approximately
;$15.1 million - Revenue of
during the quarter ended December 31, 2025 reflects sales related to the launch of LYMPHIR;$3.9 million - Research and development expenses were
, compared to$1.0 million in the prior-year period, reflecting reduced clinical development activity;$1.3 million - General and administrative expenses were
, compared to$2.9 million in the prior-year period;$3.3 million - Stock-based compensation expense totaled
, primarily related to equity grants issued in September 2025, compared to$4.0 million in the prior-year period; and,$1.8 million - Net loss for the quarter was
, or$5.5 million per share, compared to a net loss of$(0.06) , or$6.7 million per share, for the prior-year period.$(0.09)
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 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 –
CITIUS ONCOLOGY, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) | |||||||
December 31, | September 30, | ||||||
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 - | — | — | |||||
Common stock - | 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 | |||
CITIUS ONCOLOGY, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS FOR THE THREE MONTHS ENDED DECEMBER 31, 2025 AND 2024 (Unaudited) | |||||||
Three Months Ended | |||||||
December | December | ||||||
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 | |||||
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 | $ | - | |||
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SOURCE Citius Oncology, Inc.