Citius Oncology, Inc. Reports Fiscal First Quarter 2025 Financial Results and Provides Business Update
Rhea-AI Summary
Citius Oncology (NASDAQ: CTOR) reported its fiscal Q1 2025 financial results and business updates. The company has engaged Jefferies to explore strategic alternatives for maximizing shareholder value. Key developments include preparation for LYMPHIR™ launch in H1 2025, with inventory ready and a new permanent J-code (J9161) effective April 1, 2025.
Financial results show R&D expenses of $1.3M (vs $1.2M in Q1 2024), G&A expenses of $3.3M (vs $1.5M), and stock-based compensation of $1.8M (vs $1.9M). The company reported a net loss of $6.7M ($0.09 per share) compared to $4.7M ($0.07 per share) in Q1 2024.
Two investigator-initiated trials are exploring LYMPHIR's potential in combination therapies, with interim results presented at SITC Conference showing promise in combination with pembrolizumab for recurrent solid tumors.
Positive
- Secured permanent J-code (J9161) for LYMPHIR, effective April 1, 2025
- Completed manufacturing inventory for launch and initial sales
- 84% of CTCL patients in Phase III trial experienced skin relief
- Positive interim results from combination therapy trials
Negative
- Net loss increased to $6.7M from $4.7M year-over-year
- G&A expenses more than doubled to $3.3M from $1.5M
- R&D expenses increased to $1.3M from $1.2M
Insights
The Q1 FY2025 results highlight both opportunities and challenges for Citius Oncology as it approaches a critical commercialization phase. The 120% increase in G&A expenses to
The secured permanent J-code (J9161) represents a important milestone that will streamline reimbursement processes and potentially accelerate market adoption. Medicare and private insurers typically align their systems with these codes, which can significantly reduce billing complications and payment delays - a critical factor for new specialty drugs in the oncology space.
The engagement of Jefferies as financial advisor signals a potential inflection point. Given LYMPHIR's unique position as the only IL-2 receptor-targeted therapy for CTCL approved since 2018, and its impressive
The expansion of investigator-initiated trials, particularly the combination studies with pembrolizumab and CAR-T therapies, suggests potential market expansion beyond the initial CTCL indication. These studies could significantly enhance LYMPHIR's commercial value proposition by demonstrating efficacy in broader patient populations.
From a financial perspective, the decrease in stock-based compensation's weighted average grant date fair value from
Fiscal First Quarter 2025 Business Highlights and Subsequent Developments
- Engaged Jefferies as exclusive financial advisor to assist in evaluating strategic alternatives aimed at maximizing shareholder value, with multiple active discussions underway;
- Progressed commercial readiness for the planned launch of LYMPHIR™ in the first half of 2025, with key initiatives including:
- Manufactured sufficient inventory for launch and initial sales estimates, with additional production in process,
- Secured a new permanent J-code, J9161, (Injection, denileukin diftitox-cxdl, for intravenous use, 1 microgram) for LYMPHIR, assigned by the Centers for Medicare & Medicaid Services (CMS), with an expected effective date of April 1, 2025;
- Supported two investigator-initiated trials to explore LYMPHIR's potential as an immuno-oncology combination therapy being conducted at the University of Pittsburgh Medical Center and the University of
Minnesota :- Shared interim trial results with the clinical community at the Society for Immunotherapy of Cancer Conference (SITC) of University of Pittsburgh Medical Center's Phase I trial of LYMPHIR with checkpoint inhibitor pembrolizumab.
- Supported expansion of the University of
Minnesota's investigator-initiated Phase I clinical trial to evaluate the safety and efficacy of denileukin diftitox administration prior to Chimeric Antigen Receptor (CAR-T) therapies for the treatment of B-cell lymphomas with the dosing of the first patient at City of Hope cancer center.
Financial Highlights
- R&D expenses were
$1.3 million $1.2 million - G&A expenses were
$3.3 million $1.5 million - Stock-based compensation expense was
$1.8 million $1.9 million - Net loss was
$6.7 million $0.09 $4.7 million $0.07
"During the first fiscal quarter of 2025, Citius Oncology advanced key initiatives to bring LYMPHIR to market and focused on exploring strategic options to maximize shareholder value. With FDA approval of LYMPHIR for the treatment of cutaneous T-cell lymphoma (CTCL), we are determined to deliver this much-needed therapy to patients. LYMPHIR remains the only targeted systemic therapy approved for CTCL since 2018 and the only treatment with a mechanism of action that targets the IL-2 receptor. More than
"To support the long-term growth potential of LYMPHIR, we engaged Jefferies as our exclusive financial advisor to evaluate strategic alternatives. Active discussions are currently underway; our goal remains to bring LYMPHIR to market expeditiously. We are making strong progress toward our planned commercial launch in the first half of 2025. The inventory for launch is ready and our market access efforts continue with the successful assignment of a new permanent J-code (J9161) by the Centers for Medicare & Medicaid Services set to take effect on April 1, 2025, and the inclusion of LYMPHIR in the NCCN guidelines. These are critical milestones that will help drive clinical adoption and reimbursement," added Mazur.
"Beyond commercial readiness, we are actively supporting two investigator-initiated trials evaluating LYMPHIR's potential as an immuno-oncology combination therapy. Positive interim results from the University of Pittsburgh Medical Center's Phase I trial combining LYMPHIR with pembrolizumab were shared at the Society for Immunotherapy of Cancer (SITC) Conference in November, highlighting its potential to enhance treatment efficacy in recurrent solid tumors. Furthermore, the University of
"These initiatives reflect our commitment to bringing innovative cancer therapies to patients with high unmet medical needs. With the expected launch of LYMPHIR on the horizon, we remain focused on executing our commercial strategy while exploring strategic opportunities to drive long-term value," concluded Mazur.
FISCAL FIRST QUARTER 2025 FINANCIAL RESULTS:
Research and Development (R&D) Expenses
R&D expenses were
General and Administrative (G&A) Expenses
G&A expenses were
Stock-based Compensation Expense
For the first quarter ended December 31, 2024, stock-based compensation expense was
Net loss
Net loss was
About Citius Oncology, Inc.
Citius Oncology specialty is a biopharmaceutical company focused on developing and commercializing novel targeted oncology therapies. In August 2024, its primary asset, LYMPHIR, was approved by the FDA for the treatment of adults with relapsed or refractory CTCL who had had at least one prior systemic therapy. Management estimates the initial market for LYMPHIR currently exceeds
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, and, unless noted otherwise, that apply to 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 commercialize LYMPHIR and any of our other product candidates that may be approved by the FDA; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; the estimated markets for our product candidates and the acceptance thereof by any market; the ability of our product candidates to impact the quality of life of our target patient populations; our dependence on third-party suppliers; our ability to procure cGMP commercial-scale supply; risks related to research using our assets but conducted by third parties; our ability to maintain compliance with Nasdaq's continued listing standards; uncertainties relating to preclinical and clinical testing; 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; competition; 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, 2024, filed with the SEC on December 27, 2024, as amended on January 27, 2025 and as updated by our subsequent filings with the SEC. 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, 2024 | September 30, 2024 | |||||||
Current Assets: | ||||||||
Cash and cash equivalents | $ | 112 | $ | 112 | ||||
Inventory | 14,381,369 | 8,268,766 | ||||||
Prepaid expenses | 2,700,000 | 2,700,000 | ||||||
Total Current Assets | 17,081,481 | 10,968,878 | ||||||
Other Assets: | ||||||||
In-process research and development | 73,400,000 | 73,400,000 | ||||||
Total Other Assets | 73,400,000 | 73,400,000 | ||||||
Total Assets | $ | 90,481,481 | $ | 84,368,878 | ||||
LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
Current Liabilities: | ||||||||
Accounts payable | $ | 5,874,577 | $ | 3,711,622 | ||||
License payable | 28,400,000 | 28,400,000 | ||||||
Accrued expenses | 6,228,612 | — | ||||||
Due to related party | 2,896,329 | 588,806 | ||||||
Total Current Liabilities | 43,399,518 | 32,700,428 | ||||||
Deferred tax liability | 1,992,240 | 1,728,000 | ||||||
Note payable to related party | 3,800,111 | 3,800,111 | ||||||
Total Liabilities | 49,191,869 | 38,228,539 | ||||||
Stockholders' Equity: | ||||||||
Preferred stock - | — | — | ||||||
Common stock - | 7,155 | 7,155 | ||||||
Additional paid-in capital | 87,220,249 | 85,411,771 | ||||||
Accumulated deficit | (45,937,792) | (39,278,587) | ||||||
Total Stockholders' Equity | 41,289,612 | 46,140,339 | ||||||
Total Liabilities and Stockholders' Equity | $ | 90,481,481 | $ | 84,368,878 | ||||
CITIUS ONCOLOGY, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS FOR THE THREE MONTHS ENDED DECEMBER 31, 2024 AND 2023 (Unaudited) | ||||||||
2024 | 2023 | |||||||
Revenues | $ | — | $ | — | ||||
Operating Expenses: | ||||||||
Research and development | 1,264,508 | 1,148,495 | ||||||
General and administrative | 3,321,979 | 1,517,908 | ||||||
Stock-based compensation – general and administrative | 1,808,478 | 1,917,000 | ||||||
Total Operating Expenses | 6,394,965 | 4,583,403 | ||||||
Loss before Income Taxes | (6,394,965) | (4,583,403) | ||||||
Income tax expense | 264,240 | 144,000 | ||||||
Net Loss | $ | (6,659,205) | $ | (4,727,403) | ||||
Net Loss Per Share – Basic and Diluted | $ | (0.09) | $ | (0.07) | ||||
Weighted Average Common Shares Outstanding – Basic and Diluted | 71,552,402 | 67,500,000 | ||||||
CITIUS ONCOLOGY, INC. CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS FOR THE THREE MONTHS ENDED DECEMBER 31, 2024 AND 2023 (Unaudited) | ||||||||
2024 | 2023 | |||||||
Cash Flows From Operating Activities: | ||||||||
Net loss | $ | (6,659,205) | $ | (4,727,403) | ||||
Adjustments to reconcile net loss to net cash provided by operating activities: | ||||||||
Stock-based compensation expense | 1,808,478 | 1,917,000 | ||||||
Deferred income tax expense | 264,240 | 144,000 | ||||||
Changes in operating assets and liabilities: | ||||||||
Inventory | (6,112,603) | - | ||||||
Prepaid expenses | - | - | ||||||
Accounts payable | 2,162,955 | (1,084,027) | ||||||
Accrued expenses | 6,228,612 | (199,155) | ||||||
Due to related party | 2,307,523 | 3,949,585 | ||||||
Net Cash Provided By Operating Activities | - | - | ||||||
Net Change in Cash and Cash Equivalents | - | - | ||||||
Cash and Cash Equivalents – Beginning of Period | 112 | - | ||||||
Cash and Cash Equivalents – End of Period | $ | 112 | $ | - | ||||
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SOURCE Citius Oncology, Inc.
FAQ
What were Citius Oncology's (CTOR) Q1 2025 financial results?
When will LYMPHIR be launched by Citius Oncology (CTOR)?
What is the new J-code for CTOR's LYMPHIR and when is it effective?
What was the efficacy rate of LYMPHIR in CTCL patients during Phase III trials?
How did CTOR's G&A expenses change in Q1 2025 compared to Q1 2024?
