Full Press Release Details
Citius Oncology, Inc. Reports Fiscal First Quarter
2025 Financial Results and Provides Business Update
CRANFORD, N.J., February 14, 2025 -- Citius
Oncology, Inc. ("Citius Oncology" or the "Company") (Nasdaq: CTOR), a specialty biopharmaceutical company focused
on the development and commercialization of novel targeted oncology therapies, today reported business and financial results for the fiscal
first quarter ended December 31, 2024.
Fiscal First Quarter 2025 Business Highlights
and Subsequent Developments
Financial Highlights
"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 84% of CTCL patients in the Phase III trial experienced skin relief from this debilitating
disease," stated Leonard Mazur, Chairman and CEO of Citius Oncology.
"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
"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 Minnesota has expanded its Phase I trial exploring denileukin diftitox administration
prior to Chimeric Antigen Receptor (CAR-T) therapies for B-cell lymphomas, with the first patient dosed at City of Hope cancer center."
"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
first quarter 2025 Financial Results:
Research and Development (R&D) Expenses
R&D expenses were $1.3 million for the first
quarter ended December 31, 2024, compared to $1.2 million for the first quarter ended December 31, 2023. The increase primarily reflects
costs associated with the two investigator immuno-oncology trials which are in process.
General and Administrative (G&A) Expenses
G&A expenses were $3.3 million for the first
quarter ended December 31, 2024, compared to $1.5 million for the first quarter ended December 31, 2023. The increase was primarily due
to costs associated with pre-commercial and commercial launch activities of LYMPHIR including market research, marketing, distribution
and drug product reimbursement from health plans and payers.
Stock-based Compensation Expense
For the first quarter ended December 31, 2024,
stock-based compensation expense was $1.8 million as compared to $1.9 million for the prior year. The primary reason for the decrease
in stock-based compensation expense was the decrease in the weighted average grant date fair value of the options granted during the three
months ended December 31, 2024 to $0.80 per share as compared to the weighted average grant date fair value of the options granted of
$1.66 per share during the year ended September 30, 2024.
Net loss was $6.7 million, or ($0.09) per share
for the first quarter ended December 31, 2024, compared to a net loss of $4.7 million, or ($0.07) per share for the first quarter ended
December 31, 2023. The increase in net loss was primarily due to the increase in our operating expenses.
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 $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. Citius Oncology
is a publicly traded subsidiary of Citius Pharmaceuticals. For more information, please visit www.citiusonc.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, 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
-- Financial Tables Follow -
CITIUS ONCOLOGY, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
| 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 - $0.0001 par value; 10,000,000 shares authorized: no shares issued and outstanding | - | - | ||||||
| Common stock - $0.0001 par value; 100,000,000; 71,552,402 shares issued and outstanding at December 31, 2024 and September 30, 2024 | 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
| 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.
Consolidated STATEMENTS OF CASH FLOWS
FOR THE THREE MONTHS ENDED DECEMBER 31, 2024
| 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 | $ | - |