Full Press Release Details
Citius Pharmaceuticals, Inc. Reports Fiscal
First Quarter 2025 Financial Results and Provides Business Update
CRANFORD, N.J., February 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
first quarter ended December 31, 2024.
Fiscal First Quarter 2025 Business Highlights
and Subsequent Developments
Financial Highlights
"As we continue to advance our strategic
priorities, we remain engaged in active discussions with potential partners who recognize the value of our pipeline and our commitment
to developing innovative therapies for patients with high unmet medical needs. Securing the necessary financing to support our key programs
remains a top priority, and we are evaluating multiple options to strengthen our financial position," stated Leonard Mazur, Chairman
and CEO of Citius Pharmaceuticals.
"In parallel, we are making significant
progress in our preparations for the anticipated launch of LYMPHIR in the first half of 2025, positioning us to bring this important
therapy to patients while creating long-term value for our shareholders. We look forward to providing further updates as we execute on
these critical initiatives," added Mazur.
FIRST QUARTER 2025 Financial Results:
As of December 31, 2024, the Company had $1.1
million in cash and cash equivalents.
As of December 31, 2024, the Company had 7,727,243
common shares outstanding, as adjusted for the 1-for-25 reverse stock split of the Company's common stock, effected on November
During the quarter ended December 31, 2024, the
Company received gross proceeds of $3 million from the issuance of equity. An additional $3.5 million in gross proceeds was received in
January 2025 from the issuance of equity through the Company's "at-the-market" facility and a registered direct offering
of common stock and warrants. The Company expects to raise additional capital to support operations.
Research and Development (R&D) Expenses
R&D expenses were $2.1 million for the first
quarter ended December 31, 2024, compared to $2.6 million for the first quarter ended December 31, 2023. The decrease in R&D expenses
primarily reflects the completion of the Halo-Lido Phase 2 and Mino-Lok Phase 3 trials, offset by an increase in LYMPHIR-related expenses
due to additional headcount and ongoing investigator-initiated trials.
We expect that research and development expenses
will continue to decrease in fiscal 2025 because we have completed the Phase 3 trial for Mino-Lok and we remain focused on the commercialization
of LYMPHIR through our majority-owned subsidiary, Citius Oncology, Inc.
General and Administrative (G&A) Expenses
G&A expenses were $5.4 million for the first
quarter ended December 31, 2024, compared to $3.7 million for the first quarter ended December 31, 2023. The increase was primarily due
to higher costs for pre-launch sales and marketing 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
Stock-based Compensation Expense
For the first quarter ended December 31, 2024,
stock-based compensation expense was $2.5 million as compared to $3.1 million for the prior year. Stock-based compensation expense during
the quarter ended December 31, 2024 is primarily related to the Citius Oncology Plan. The decrease compared to the prior year is due to
lower costs associated with the Citius Pharma stock plans.
Net loss was $10.3 million, or ($1.30) per share
for the quarter ended December 31, 2024, compared to a net loss of $9.2 million, or ($1.45) per share for the quarter ended December 31,
2023, as adjusted for the reverse stock split. The increase in net loss was due to the increase in general and administrative expenses
partially offset by lower research and development expense.
About Citius Pharmaceuticals, Inc.
Citius 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. For more information, please visit www.citiuspharma.com.
Forward-Looking Statements
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 for at least the next 12 months as a going concern; our ability
to commercialize LYMPHIR through our majority-owned subsidiary 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; 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 ability to maintain compliance
with Nasdaq's continued listing standards; 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 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 -
CITIUS PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
| December 31, | September 30, | |||||||
| 2024 | 2024 | |||||||
| ASSETS | ||||||||
| Current Assets: | ||||||||
| Cash and cash equivalents | $ | 1,100,079 | $ | 3,251,880 | ||||
| Inventory | 14,381,369 | 8,268,766 | ||||||
| Prepaid expenses | 2,845,739 | 2,700,000 | ||||||
| Total Current Assets | 18,327,187 | 14,220,646 | ||||||
| Operating lease right-of-use asset, net | 191,412 | 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 | $ | 120,703,457 | $ | 116,651,751 | ||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current Liabilities: | ||||||||
| Accounts payable | $ | 7,364,120 | $ | 4,927,211 | ||||
| License payable | 28,400,000 | 28,400,000 | ||||||
| Accrued expenses | 6,242,178 | 17,027 | ||||||
| Accrued compensation | 2,595,091 | 2,229,018 | ||||||
| Operating lease liability | 204,569 | 241,547 | ||||||
| Total Current Liabilities | 44,805,958 | 35,814,803 | ||||||
| Deferred tax liability | 6,978,040 | 6,713,800 | ||||||
| Operating lease liability - noncurrent | - | 21,318 | ||||||
| Total Liabilities | 51,783,998 | 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; 7,727,243 and 7,247,243 shares issued and outstanding at December 31, 2024 and September 30, 2024, respectively | 7,727 | 7,247 | ||||||
| Additional paid-in capital | 276,538,816 | 271,440,421 | ||||||
| Accumulated deficit | (211,138,464 | ) | (201,370,218 | ) | ||||
| Total Citius Pharmaceuticals, Inc. Stockholders' Equity | 65,408,079 | 70,077,450 | ||||||
| Non-controlling interest | 3,511,380 | 4,024,380 | ||||||
| Total Equity | 68,919,459 | 74,101,830 | ||||||
| Total Liabilities and Equity | $ | 120,703,457 | $ | 116,651,751 |
Reflects a 1-for-25 reverse stock split effective
CITIUS PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
FOR THE THREE MONTHS ENDED DECEMBER 31, 2024
| Three Months Ended | ||||||||
| December 31, | December 31, | |||||||
| 2024 | 2023 | |||||||
| Revenues | $ | - | $ | - | ||||
| Operating Expenses | ||||||||
| Research and development | 2,127,038 | 2,621,910 | ||||||
| General and administrative | 5,387,752 | 3,660,728 | ||||||
| Stock-based compensation - general and administrative | 2,524,824 | 3,058,185 | ||||||
| Total Operating Expenses | 10,039,614 | 9,340,823 | ||||||
| Operating Loss | (10,039,614 | ) | (9,340,823 | ) | ||||
| Other Income | ||||||||
| Interest income | 22,608 | 253,638 | ||||||
| Total Other Income | 22,608 | 253,638 | ||||||
| Loss before Income Taxes | (10,017,006 | ) | (9,087,185 | ) | ||||
| Income tax expense | 264,240 | 144,000 | ||||||
| Net Loss | (10,281,246 | ) | (9,231,185 | ) | ||||
| Net loss attributable to non-controlling interest | 513,000 | - | ||||||
| Net Loss Applicable to Common Stockholders | $ | (9,768,246 | ) | $ | (9,231,185 | ) | ||
| Net Loss Per Share - Basic and Diluted | $ | (1.30 | ) | $ | (1.45 | ) | ||
| Weighted Average Common Shares Outstanding | ||||||||
| Basic and diluted | 7,492,460 | 6,358,237 |
Reflects a 1-for-25 reverse stock split effective
CITIUS PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
FOR THE THREE MONTHS ENDED DECEMBER 31, 2024
| 2024 | 2023 | |||||||
| Cash Flows From Operating Activities: | ||||||||
| Net loss | $ | (10,281,246 | ) | $ | (9,231,185 | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Stock-based compensation expense | 2,524,824 | 3,058,185 | ||||||
| Issuance of common stock for services | - | 76,146 | ||||||
| Amortization of operating lease right-of-use asset | 54,835 | 50,430 | ||||||
| Depreciation | - | 578 | ||||||
| Deferred income tax expense | 264,240 | 144,000 | ||||||
| Changes in operating assets and liabilities: | ||||||||
| Inventory | (6,112,603 | ) | - | |||||
| Prepaid expenses | (145,739 | ) | 25,010 | |||||
| Accounts payable | 2,436,909 | (280,083 | ) | |||||
| Accrued expenses | 6,225,151 | (199,403 | ) | |||||
| Accrued compensation | 366,073 | 273,688 | ||||||
| Operating lease liability | (58,296 | ) | (52,676 | ) | ||||
| Net Cash Used In Operating Activities | (4,725,852 | ) | (6,135,310 | ) | ||||
| Cash Flows From Financing Activities: | ||||||||
| Net proceeds from registered direct offering | 2,574,051 | - | ||||||
| Net Cash Provided By Financing Activities | 2,574,051 | - | ||||||
| Net Change in Cash and Cash Equivalents | (2,151,801 | ) | (6,135,310 | ) | ||||
| Cash and Cash Equivalents - Beginning of Period | 3,251,880 | 26,480,928 | ||||||
| Cash and Cash Equivalents - End of Period | $ | 1,100,079 | $ | 20,345,618 |