Full Press Release Details
Citius Oncology, Inc. Reports Fiscal Full Year
2024 Financial Results and Provides Business Update
CRANFORD, N.J., December 27, 2024 -- 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
full year ended September 30, 2024.
Fiscal Full Year 2024 Business Highlights and
Subsequent Developments
Financial Highlights
"Reflecting on 2024, Citius Oncology has
achieved pivotal milestones that underscore our commitment to advancing cancer therapeutics," stated Leonard Mazur, Chairman and
CEO of Citius Oncology. "The FDA's approval of LYMPHIR for the treatment of cutaneous T-cell lymphoma marks a significant advancement
in providing new options for patients battling this challenging disease. It is the only targeted systemic therapy approved for CTCL patients
since 2018 and the only therapy with a mechanism of action that targets the IL-2 receptor. Additionally, the successful merger forming
Citius Oncology, now trading on Nasdaq under the ticker CTOR, strengthens our position in the oncology sector. We expect it to facilitate
greater access to capital to fund LYMPHIR's launch and the Company's future growth. With a Phase I investigator-initiated
clinical trial combining LYMPHIR with pembrolizumab demonstrating promising preliminary results, indicating potential for enhanced treatment
efficacy in recurrent solid tumors, and preliminary results expected from a second investigator trial with CAR-T therapies in 2025, we
remain excited about the potential of LYMPHIR as a combination immunotherapy."
"These accomplishments reflect the dedication
of our team and the trust of our investors. As we look ahead, we remain steadfast in our mission to develop innovative therapies that
improve the lives of cancer patients worldwide," added Mazur.
Year 2024 Financial Results:
Research and Development (R&D) Expenses
R&D expenses were $4.9 million for the full
year ended September 30, 2024, compared to $4.2 million for the full year ended September 30, 2023. The increase reflects development
activities completed for the resubmission of the Biologics License Application of LYMPHIR in January 2024, which were associated with
the complete response letter remediation.
General and Administrative (G&A) Expenses
G&A expenses were $8.1 million for the full
year ended September 30, 2024, compared to $5.9 million for the full year ended September 30, 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 full year ended September 30, 2024, stock-based
compensation expense was $7.5 million as compared to $2.0 million for the prior year. The primary reason for the $5.5 million increase
was due to the amounts being realized over 12 months in the year ended September 30, 2024, as compared to three months post-plan adoption
in the year ended September 30, 2023.
Net loss was $21.1 million, or ($0.31) per share
for the year ended September 30, 2024, compared to a net loss of $12.7 million, or ($0.19) per share for the year ended September 30,
2023. The $8.5 million 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 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; 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 obtain, perform under and maintain financing and strategic agreements and relationships; 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 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.
-- Financial Tables Follow -
CITIUS ONCOLOGY, INC.
CONSOLIDATED BALANCE SHEETS
SEPTEMBER 30, 2024 AND 2023
| 2024 | 2023 | |||||||
| Current Assets: | ||||||||
| Cash and cash equivalents | $ | 112 | $ | - | ||||
| Inventory | 8,268,766 | - | ||||||
| Prepaid expenses | 2,700,000 | 7,734,895 | ||||||
| Total Current Assets | 10,968,878 | 7,734,895 | ||||||
| Other Assets: | ||||||||
| In-process research and development | 73,400,000 | 40,000,000 | ||||||
| Total Other Assets | 73,400,000 | 40,000,000 | ||||||
| Total Assets | $ | 84,368,878 | $ | 47,734,895 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current Liabilities: | ||||||||
| Accounts payable | $ | 3,711,622 | $ | 1,289,045 | ||||
| License payable | 28,400,000 | - | ||||||
| Accrued expenses | - | 259,071 | ||||||
| Due to related party | 588,806 | 19,499,119 | ||||||
| Total Current Liabilities | 32,700,429 | 21,047,235 | ||||||
| Deferred tax liability | 1,728,000 | 1,152,000 | ||||||
| Note payable to related party | 3,800,111 | - | ||||||
| Total Liabilities | 38,228,540 | 22,199,235 | ||||||
| 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 and 67,500,000 shares issued and outstanding at September 30, 2024 and 2023, respectively | 7,155 | 6,750 | ||||||
| Additional paid-in capital | 85,411,771 | 43,658,750 | ||||||
| Accumulated deficit | (39,278,587 | ) | (18,129,840 | ) | ||||
| Total Stockholders' Equity | 46,140,339 | 25,535,660 | ||||||
| Total Liabilities and Stockholders' Equity | $ | 84,368,878 | $ | 47,734,895 |
CITIUS ONCOLOGY, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
FOR THE YEARS ENDED SEPTEMBER 30, 2024 AND 2023
| 2024 | 2023 | |||||||
| Revenues | $ | - | $ | - | ||||
| Operating Expenses: | ||||||||
| Research and development | 4,925,001 | 4,240,451 | ||||||
| General and administrative | 8,148,929 | 5,915,290 | ||||||
| Stock-based compensation - general and administrative | 7,498,817 | 1,965,500 | ||||||
| Total Operating Expenses | 20,572,747 | 12,121,241 | ||||||
| Loss before Income Taxes | (20,572,747 | ) | (12,121,241 | ) | ||||
| Income tax expense | 576,000 | 576,000 | ||||||
| Net Loss | $ | (21,148,747 | ) | $ | (12,697,241 | ) | ||
| Net Loss Per Share - Basic and Diluted | $ | (0.31 | ) | $ | (0.19 | ) | ||
| Weighted Average Common Shares Outstanding - Basic and Diluted | 68,053,607 | 67,500,000 |
CITIUS ONCOLOGY, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
FOR THE YEARS ENDED SEPTEMBER 30, 2024 AND 2023
| 2024 | 2023 | |||||||
| Cash Flows From Operating Activities: | ||||||||
| Net loss | $ | (21,148,747 | ) | $ | (12,697,241 | ) | ||
| Adjustments to reconcile net loss to net cash provided by operating activities: | ||||||||
| Stock-based compensation expense | 7,498,817 | 1,965,500 | ||||||
| Deferred income tax expense | 576,000 | 576,000 | ||||||
| Changes in operating assets and liabilities: | ||||||||
| Inventory | (2,133,871 | ) | - | |||||
| Prepaid expenses | (1,100,000 | ) | (5,044,713 | ) | ||||
| Accounts payable | 2,422,577 | 1,196,734 | ||||||
| Accrued expenses | (259,071 | ) | (801,754 | ) | ||||
| Due to related party | 14,270,648 | 14,805,474 | ||||||
| Net Cash Provided By Operating Activities | 126,353 | - | ||||||
| Cash Flows From Investing Activities: | ||||||||
| License payment | (5,000,000 | ) | - | |||||
| Net Cash Used In Investing Activities | (5,000,000 | ) | - | |||||
| Cash Flows From Financing Activities: | ||||||||
| Cash contributed by parent | 3,827,944 | - | ||||||
| Merger, net | (2,754,296 | ) | - | |||||
| Proceeds from issuance of note payable to related party | 3,800,111 | - | ||||||
| Net Cash Provided By Financing Activities | 4,873,759 | - | ||||||
| Net Change in Cash and Cash Equivalents | 112 | - | ||||||
| Cash and Cash Equivalents - Beginning of Year | - | - | ||||||
| Cash and Cash Equivalents - End of Year | $ | 112 | $ | - | ||||
| Supplemental Disclosures of Cash Flow Information and Non-cash Activities: | ||||||||
| IPR&D Milestones included in License Payable | $ | 28,400,000 | $ | - | ||||
| Capital Contribution of due to related party by parent | $ | 33,180,961 | $ | - | ||||
| Prepaid Manufacturing transferred to Inventory | $ | 6,134,895 | $ | - |