株探米国株
日本語 英語
エドガーで原本を確認する
false 0001506251 0001506251 2025-05-14 2025-05-14 iso4217:USD xbrli:shares iso4217:USD xbrli:shares

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of

the Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported) May 14, 2025

 

Citius Pharmaceuticals, Inc.

(Exact name of registrant as specified in its charter)

 

Nevada

(State or other jurisdiction of incorporation)

 

001-38174   27-3425913
(Commission File Number)   (IRS Employer
Identification No.)

 

11 Commerce Drive, 1st Floor, Cranford, NJ   07016
(Address of principal executive offices)   (Zip Code)

 

Registrant’s telephone number, including area code (908) 967-6677

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class   Trading Symbol(s)   Name of each exchange on which registered
Common stock, $0.001 par value   CTXR   The Nasdaq Capital Market

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company ☐

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

 

 


 

Item 2.02. Results of Operations and Financial Condition.

 

On May 14, 2025, we issued a press release announcing our results of operations for the second quarter of fiscal 2025. A copy of the press release is furnished as Exhibit 99.1 to this report and is incorporated herein by reference.

 

The information in this Item 2.02 (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such a filing.

 

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit No.   Description
99.1   Press release, dated May 14, 2025.
     
104   Cover Page Interactive Date File (embedded within the Inline XBRL document).

 

1


 

SIGNATURE

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

  CITIUS PHARMACEUTICALS, INC.
   
Date: May 14, 2025 /s/ Leonard Mazur
  Leonard Mazur
  Chairman and Chief Executive Officer

 

2

EX-99.1 2 ea024197401ex99-1_citius.htm PRESS RELEASE, DATED MAY 14, 2025

Exhibit 99.1

 

 

Citius Pharmaceuticals, Inc. Reports Fiscal Second Quarter 2025 Financial Results and Provides Business Update

 

CRANFORD, 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.

 

“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 $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.

 

As 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.

 

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 $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.

 


 

Research 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.

 

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 $11 thousand was recorded for the six months ended March 31, 2025.

 

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 $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.

  

Stock-based Compensation Expense

 

For 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.

 

Net loss

 

Net 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.

 

For 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.

 

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 92% of Citius Oncology. For more information, please visit www.citiuspharma.com.

 

2


 

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 –

 

3


 

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 - $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  

 

Reflects a 1-for-25 reverse stock split effective November 25, 2024.

 

4


 

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 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  

 

Reflects a 1-for-25 reverse stock split effective November 25, 2024.

 

5


 

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     $  

 

6