Citius Pharmaceuticals, Inc. Reports Fiscal Second Quarter 2025 Financial Results and Provides Business Update
- Successful completion of Mino-Lok Phase 3 trial meeting primary endpoints
- Raised $6 million through equity issuance and additional $1.735 million in April 2025
- R&D expenses expected to decrease in fiscal 2025
- Retained Jefferies LLC to evaluate strategic alternatives for maximizing stockholder value
- Critical cash position with only $26,410 in cash reserves as of March 31, 2025
- Net loss increased to $11.5 million from $8.5 million year-over-year
- Additional capital needed beyond May 2025 for continued operations
- G&A expenses increased to $4.8 million from $4.3 million year-over-year
Insights
Citius faces critical cash constraints with only $26,410 in cash and needs funding beyond May 2025 amid LYMPHIR commercialization efforts.
The financial results reveal severe liquidity concerns for Citius Pharmaceuticals. With only
The company reported a quarterly net loss of
Two strategic initiatives stand out: First, Citius is actively pursuing financing for LYMPHIR's commercial launch while exploring strategic partners for Citius Oncology, having retained Jefferies LLC to evaluate strategic alternatives. Second, they've amended their license agreement with Eisai to align payment obligations with their commercialization timeline – a move that suggests cash conservation.
LYMPHIR remains the primary focus, with R&D expenses for this product increasing by
"As 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.
"We are also 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.
"During 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.
FISCAL SECOND QUARTER 2025 FINANCIAL RESULTS:
Liquidity
During the six months ended March 31, 2025, the Company received net proceeds of
As of March 31, 2025, the Company had
Until 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.
Research and Development (R&D) Expenses
R&D expenses were
Research and development costs for LYMPHIR were
R&D 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
We 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.
General and Administrative (G&A) Expenses
G&A expenses were
Stock-based Compensation Expense
For the quarter ended March 31, 2025, stock-based compensation expense was
Net loss
Net loss was
For the six months ended March 31, 2025, we incurred a net loss of
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. Citius Pharma owns
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 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.
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 PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) | |||||||
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 - and outstanding | - | - | |||||
Common stock - 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 | |||
Reflects a 1-for-25 reverse stock split effective November 25, 2024. |
CITIUS PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS FOR THE THREE AND SIX MONTHS ENDED MARCH 31, 2025 AND 2024 (Unaudited) | |||||||||||||||
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 | — | 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 | |||||||||||
Reflects a 1-for-25 reverse stock split effective November 25, 2024. |
CITIUS PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS FOR THE SIX MONTHS ENDED MARCH 31, 2025 AND 2024 (Unaudited) | |||||||
2025 | 2024 | ||||||
Cash Flows From Operating Activities: | |||||||
Net loss | $ | (21,792,751) | $ | (17,775,339) | |||
Adjustments to reconcile net loss to net cash used in operating activities: | |||||||
Stock-based compensation expense | 5,226,855 | 6,136,577 | |||||
Issuance of common stock for services | - | 174,225 | |||||
Amortization of operating lease right-of-use assets | 110,845 | 101,921 | |||||
Depreciation | - | 1,157 | |||||
Deferred income tax expense | 528,480 | 288,000 | |||||
Changes in operating assets and liabilities: | |||||||
Inventory | (7,070,487) | - | |||||
Prepaid expenses | (308,791) | (1,124,618) | |||||
Accounts payable | 4,441,023 | (257,827) | |||||
Accrued expenses | 8,762,217 | (325,096) | |||||
Accrued compensation | 955,048 | (1,033,907) | |||||
Operating lease liability | (117,767) | (106,414) | |||||
Net Cash Used In Operating Activities | (9,265,328) | (13,921,321) | |||||
Cash Flows From Financing Activities: | |||||||
Net proceeds from common stock offerings | 6,039,858 | - | |||||
Net Cash Provided By Financing Activities | 6,039,858 | - | |||||
Net Change in Cash and Cash Equivalents | (3,225,470) | (13,921,321) | |||||
Cash and Cash Equivalents - Beginning of Period | 3,251,880 | 26,480,928 | |||||
Cash and Cash Equivalents - End of Period | $ | 26,410 | $ | 12,559,607 | |||
Supplemental Disclosures of Cash Flow Information and Non-cash Transactions: | |||||||
Operating lease right-of-use asset and liability recorded | $ | 786,697 | $ | — |
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SOURCE Citius Pharmaceuticals, Inc.