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

    2/14/25 4:30:00 PM ET
    $CTOR
    $CTXR
    Biotechnology: Pharmaceutical Preparations
    Health Care
    Biotechnology: Pharmaceutical Preparations
    Health Care
    Get the next $CTOR alert in real time by email

    CRANFORD, N.J., Feb. 14, 2025 /PRNewswire/ -- 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

    • Substantially advanced operational readiness for commercial launch of LYMPHIR in the first half of 2025;
    • Secured a new permanent J-code, J9161, (Injection, denileukin diftitox-cxdl, for intravenous use, 1 microgram) for LYMPHIR™, assigned by the Centers for Medicare & Medicaid Services (CMS), with an expected effective date of April 1, 2025;
    • Announced promising preliminary results from an ongoing investigator-initiated Phase I clinical trial of a combined regimen of checkpoint inhibitor pembrolizumab and LYMPHIR (denileukin diftitox-cxdl) in patients with recurrent solid tumors. Presented data at the Society for Immunotherapy of Cancer (SITC) 2024 Annual Meeting;
    • Supported expansion of the University of Minnesota's investigator-initiated Phase I clinical trial to evaluate the safety and efficacy of denileukin diftitox administration prior to Chimeric Antigen Receptor (CAR-T) therapies for the treatment of B-cell lymphomas with the dosing of the first patient at City of Hope cancer center;
    • Engaged with the U.S. Food and Drug Administration (FDA) to clarify development paths for pipeline assets Mino-Lok® and Halo-Lido;
    • Advanced strategic and financing initiatives to help secure the capital needed to drive the full potential of our clinical and commercial programs.
      • Citius Oncology (NASDAQ:CTOR), our majority-owned subsidiary, engaged Jefferies as exclusive financial advisor to assist in evaluating strategic alternatives aimed at maximizing shareholder value;
      • Completed registered direct offerings of common stock and warrants in November 2024 and January 2025, and sold shares of common stock through the Company's "at-the-market" facility in January 2025 for combined gross proceeds of $6.5 million;
      • Effective November 25, 2024, the Company executed a reverse stock split of its common stock, at a ratio of 1-for-25; and,
    • On December 18, 2024, the Company received notification that it had regained compliance with the $1.00 per share requirement for continued inclusion on the Nasdaq Stock Market.

    Financial Highlights

    • Cash and cash equivalents of $1.1 million as of December 31, 2024;
    • 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;
    • 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;
    • Stock-based compensation expense was $2.5 million for the first quarter ended December 31, 2024, compared to $3.1 million for the first quarter ended December 31, 2023; and,
    • Net loss was $10.3 million, or ($1.30) per share for the first quarter ended December 31, 2024, compared to a net loss of $9.2 million, or ($1.45) per share for the first quarter ended December 31, 2023.

    "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.

    FISCAL FIRST QUARTER 2025 FINANCIAL RESULTS:

    Liquidity

    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 25, 2024.

    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 expenses.

    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

    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

    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 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.

    Investor Contact:

    Ilanit Allen

    [email protected] 

    908-967-6677 x113

    Media Contact:

    STiR-communications

    Greg Salsburg

    [email protected] 

    -- Financial Tables Follow –

     

    CITIUS PHARMACEUTICALS, INC.

    CONDENSED CONSOLIDATED BALANCE SHEETS

    (Unaudited)







    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 November 25, 2024.

     

    CITIUS PHARMACEUTICALS, INC.

    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

    FOR THE THREE MONTHS ENDED DECEMBER 31, 2024 AND 2023

    (Unaudited)







    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 November 25, 2024.

     

    CITIUS PHARMACEUTICALS, INC.

    CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

    FOR THE THREE MONTHS ENDED DECEMBER 31, 2024 AND 2023

    (Unaudited)







    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

     

    Citius Pharmaceuticals, a late-stage biopharmaceutical company (PRNewsfoto/Citius Pharmaceuticals, Inc.)

     

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/citius-pharmaceuticals-inc-reports-fiscal-first-quarter-2025-financial-results-and-provides-business-update-302377211.html

    SOURCE Citius Pharmaceuticals, Inc.

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      8/12/24 8:00:00 AM ET
      $CTXR
      Biotechnology: Pharmaceutical Preparations
      Health Care
    • Citius Pharmaceuticals to Host Investor Call to Discuss Topline Results of Phase 3 Trial of Mino-Lok Antibiotic Lock Solution

      Management call scheduled for Monday, June 3, 2024 at 8:30 AM ET CRANFORD, N.J., May 29, 2024 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (NASDAQ:CTXR), a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products, today announced that it will host an investor call on Monday, June 3, 2024 at 8:30 am ET to discuss the topline results of its Phase 3 Trial of Mino-Lok antibiotic lock solution. Citius Chairman and CEO, Leonard Mazur, will be joined by members of the management team to discuss the results of the Phase 3 Trial and the clinical need for Mino-Lok in patients with catheter-related blood

      5/29/24 8:30:00 AM ET
      $CTXR
      Biotechnology: Pharmaceutical Preparations
      Health Care