Full Press Release Details
Pharmaceuticals, Inc. Reports Fiscal Second Quarter 2025 Financial Results and Provides Business Update
N.J., May 14, 2025 -- Citius Pharmaceuticals, Inc. ("Citius Pharma" or the "Company") (Nasdaq: CTXR), a biopharmaceutical
company dedicated to the development and commercialization of first-in-class critical care products today reported business and financial
results for the fiscal quarter ended March 31, 2025.
we continue to focus on the planned launch of our first FDA-approved product, LYMPHIR, through Citius Oncology, we are actively engaged
in securing the necessary financing to advance our launch strategy in the coming months, as well as exploring strategic partners for
Citius Oncology," said Leonard Mazur, Chairman and CEO of Citius Pharmaceuticals and Citius Oncology.
in the process of preparing a submission to the FDA that reflects the valuable feedback we received from the agency concerning clinical
efficacy, safety data, and in-vitro data. This submission is a key step toward supporting a future New Drug Application (NDA) for our
Mino-Lok program. As a reminder, our Phase 3 Trial, which was completed last year, met its primary endpoints," added Mazur.
the quarter, we took deliberate steps to strengthen our financial position, including completing a registered direct offering and leveraging
our existing at-the-market sales agreement to ensure capital flexibility. We also amended our license agreement with Eisai to align our
payment obligations with our commercialization timeline. With these efforts underway, we believe we are positioned to deliver long-term
value to patients and shareholders alike," concluded Mazur.
SECOND QUARTER 2025 Financial Results:
the six months ended March 31, 2025, the Company received net proceeds of $6 million from the issuance of equity. On April 2, 2025, the
Company closed on a registered direct offering to an institutional investor of our common stock and pre-funded warrants to purchase common
stock. The net proceeds to the Company from the offering were approximately $1.735 million, after deducting placement agent fees and
other offering expenses payable by the Company.
of March 31, 2025, the Company had $26,410 in cash and cash equivalents and 8,760,649 common shares outstanding excluding the April 2,
2025 financing. Citius Pharma will need to secure additional capital to support operations beyond May 2025.
Citius Oncology raises adequate capital through equity financings from outside investors and/or generates revenue from the future sales
of LYMPHIR, Citius Pharma plans to continue to fund Citius Oncology. Citius Oncology has also retained Jefferies LLC as its exclusive
financial advisor to evaluate strategic alternatives aimed at maximizing stockholder value.
and Development (R&D) Expenses
expenses were $3.8 million for the quarter ended March 31, 2025, as compared to $3.6 million for the quarter ended March 31, 2024. For
the six months ended March 31, 2025, R&D expenses were $5.9 million, as compared to $6.3 million during the six months ended March
31, 2024. R&D expenses primarily reflect LYMPHIR-related costs.
and development costs for LYMPHIR were $5.3 during the six months ended March 31, 2025, as compared to $3.2 million for the six months
ended March 31, 2024. The $2.1 million increase in expenses was primarily due to costs associated with the expense of a drug substance
batch needed for the pre license inspection of the manufacturer.
expenses related to Mino-Lok decreased due to completion of the Phase 3 trial. There were no Halo Lido R&D expenses during the quarter,
and $11 thousand was recorded for the six months ended March 31, 2025.
expect that research and development expenses will continue to decrease in fiscal 2025 as we continue to focus on the commercialization
of LYMPHIR and because we have completed the Phase 3 trial for Mino-Lok.
and Administrative (G&A) Expenses
expenses were $4.8 million for the quarter ended March 31, 2025, as compared to $4.3 million for the quarter ended March 31, 2024. For
the six months ended March 31, 2025, G&A expenses were $10.2 million, as compared to $7.9 million for the six months ended March
31, 2024. The increase was primarily due to higher costs for pre-launch commercial activities associated with LYMPHIR. General and administrative
expenses consist primarily of compensation costs, professional fees for legal, regulatory, accounting, and corporate development services,
and investor relations expenses.
Compensation Expense
the quarter ended March 31, 2025, stock-based compensation expense was $2.7 million, as compared to $3.1 million for the quarter ended
March 31, 2024. For the six months ended March 31, 2025, stock-based compensation expense was $5.2 million, as compared to $6.1 million
for the six months ended March 31, 2024. Stock-based compensation expense is primarily related to the Citius Oncology stock plans. The
decrease compared to the prior year is due to lower costs associated with the Citius Pharma stock plans.
loss was $11.5 million, or ($1.27) per share, for the quarter ended March 31, 2025, as compared to a net loss of $8.5 million, or ($1.34)
per share, for the quarter ended March 31, 2024, as adjusted for the reverse stock split. The increase in net loss was due to a $2.6
million decrease in other income, offset by the increase in general and administrative expenses and research and development expenses.
the six months ended March 31, 2025, we incurred a net loss of $21.8 million, as compared to a net loss of $17.8 million for the six
months ended March 31, 2024. The $4.0 million increase in the net loss was primarily due to the increase of $2.2 million in general and
administrative expenses and the decrease in other income of $2.9 million, partially offset by lower research and development expense
and lower stock-based compensation expense.
Citius Pharmaceuticals, Inc.
Pharma is a biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products. In
August 2024, the FDA approved LYMPHIR , a targeted immunotherapy for an initial indication in the treatment of cutaneous T-cell
lymphoma. Citius Pharma's late-stage pipeline also includes Mino-Lok , an antibiotic 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. Citius Pharma owns 92% of
Citius Oncology. For more information, please visit www.citiuspharma.com.
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 Pharma. 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 Pharma are: our
need for substantial additional funds and our ability to raise additional money to fund our operations beyond May 2025 and for at least
the next 12 months as a going concern; our ability to commercialize LYMPHIR, including covering the costs of licensing payments, product
manufacturing and other third-party goods and services, through our majority-owned subsidiary and any of our other product candidates
that may be approved by the FDA; our ability to maintain compliance with Nasdaq's continued listing standards; 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;
risks related to research using our assets but conducted by third parties; risks relating to the results of research and development
activities, including those from our existing and any new pipeline assets; our dependence on third-party suppliers; our ability to procure
cGMP commercial-scale supply; uncertainties relating to preclinical and clinical testing; the early stage of products under development;
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 Pharma'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, Citius Pharma's Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, filed with the SEC on May 14, 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.
Financial Tables Follow -
PHARMACEUTICALS, INC.
CONSOLIDATED BALANCE SHEETS
| March 31, | September 30, | |||||||
| 2025 | 2024 | |||||||
| ASSETS | ||||||||
| Current Assets: | ||||||||
| Cash and cash equivalents | $ | 26,410 | $ | 3,251,880 | ||||
| Inventory | 15,339,253 | 8,268,766 | ||||||
| Prepaid expenses | 3,008,791 | 2,700,000 | ||||||
| Total Current Assets | 18,374,454 | 14,220,646 | ||||||
| Operating lease right-of-use asset, net | 922,099 | 246,247 | ||||||
| Deposits | 38,062 | 38,062 | ||||||
| In-process research and development | 92,800,000 | 92,800,000 | ||||||
| Goodwill | 9,346,796 | 9,346,796 | ||||||
| Total Other Assets | 102,184,858 | 102,184,858 | ||||||
| Total Assets | $ | 121,481,411 | $ | 116,651,751 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current Liabilities: | ||||||||
| Accounts payable | $ | 9,368,234 | $ | 4,927,211 | ||||
| License payable | 28,400,000 | 28,400,000 | ||||||
| Accrued expenses | 8,779,244 | 17,027 | ||||||
| Accrued compensation | 3,184,066 | 2,229,018 | ||||||
| Operating lease liability | 145,098 | 241,547 | ||||||
| Total Current Liabilities | 49,876,642 | 35,814,803 | ||||||
| Deferred tax liability | 7,242,280 | 6,713,800 | ||||||
| Operating lease liability - noncurrent | 786,697 | 21,318 | ||||||
| Total Liabilities | 57,905,619 | 42,549,921 | ||||||
| Commitments and Contingencies | ||||||||
| Stockholders' Equity: | ||||||||
| Preferred stock - $0.001 par value; 10,000,000 shares authorized; no shares issued and outstanding | - | - | ||||||
| Common stock - $0.001 par value; 16,000,000 shares authorized; 8,760,649 and 7,247,243 shares issued and outstanding at March 31, 2025 and September 30, 2024, respectively | 8,761 | 7,247 | ||||||
| Additional paid-in capital | 282,705,620 | 271,440,421 | ||||||
| Accumulated deficit | (222,054,969 | ) | (201,370,218 | ) | ||||
| Total Citius Pharmaceuticals, Inc. Stockholders' Equity | 60,659,412 | 70,077,450 | ||||||
| Non-controlling interest | 2,916,380 | 4,024,380 | ||||||
| Total Equity | 63,575,792 | 74,101,830 | ||||||
| Total Liabilities and Equity | $ | 121,481,411 | $ | 116,651,751 |
a 1-for-25 reverse stock split effective November 25, 2024.
PHARMACEUTICALS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
THE THREE AND SIX MONTHS ENDED MARCH 31, 2025 AND 2024
| Three Months Ended | Six Months Ended | |||||||||||||||
| March 31, | March 31, | March 31, | March 31, | |||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Revenues | $ | - | $ | - | $ | - | $ | - | ||||||||
| Operating Expenses | ||||||||||||||||
| Research and development | 3,766,525 | 3,605,898 | 5,893,563 | 6,227,808 | ||||||||||||
| General and administrative | 4,792,122 | 4,285,911 | 10,179,874 | 7,946,639 | ||||||||||||
| Stock-based compensation - general and administrative | 2,702,031 | 3,078,392 | 5,226,855 | 6,136,577 | ||||||||||||
| Total Operating Expenses | 11,260,678 | 10,970,201 | 21,300,292 | 20,311,024 | ||||||||||||
| Operating Loss | (11,260,678 | ) | (10,970,201 | ) | (21,300,292 | ) | (20,311,024 | ) | ||||||||
| Other Income | ||||||||||||||||
| Interest income | 13,413 | 182,205 | 36,021 | 435,843 | ||||||||||||
| Gain on sale of New Jersey net operating losses | - | 2,387,842 | - | 2,387,842 | ||||||||||||
| Total Other Income | 13,413 | 2,570,047 | 36,021 | 2,823,685 | ||||||||||||
| Loss before Income Taxes | (11,247,265 | ) | (8,400,154 | ) | (21,264,271 | ) | (17,487,339 | ) | ||||||||
| Income tax expense | 264,240 | 144,000 | 528,480 | 288,000 | ||||||||||||
| Net Loss | $ | (11,511,505 | ) | $ | (8,544,154 | ) | $ | (21,792,751 | ) | $ | (17,775,339 | ) | ||||
| Net loss attributable to non-controlling interest | 595,000 | - | 1,108,000 | - | ||||||||||||
| Net loss applicable to common stockholders | (10,916,505 | ) | (8,544,154 | ) | (20,684,751 | ) | (17,775,339 | ) | ||||||||
| Net Loss Per Share - Basic and Diluted | $ | (1.27 | ) | $ | (1.34 | ) | $ | (2.58 | ) | $ | (2.79 | ) | ||||
| Weighted Average Common Shares Outstanding | ||||||||||||||||
| Basic and diluted | 8,581,207 | 6,362,890 | 8,029,834 | 6,360,551 |
a 1-for-25 reverse stock split effective November 25, 2024.