Latest news with #CitiusPharmaceuticals
Malaysian Reserve
08-07-2025
- Business
- Malaysian Reserve
Citius Pharmaceuticals Regains Compliance with Nasdaq Minimum Bid Price Requirement
CRANFORD, N.J. , July 8, 2025 /PRNewswire/ — Citius Pharmaceuticals, Inc. ('Citius Pharma' or the 'Company') (Nasdaq: CTXR) today announced that it has received formal notification from The Nasdaq Stock Market LLC ('Nasdaq') indicating that for 10 consecutive trading days, from June 20, 2025 to July 3, 2025, the closing bid price of the Company's common stock was at $1.00 per share or greater, and accordingly, the Company regained compliance with Nasdaq Listing Rule 5550(a)(2). The previously scheduled Nasdaq Hearing Panel has been cancelled. Nasdaq informed the Company that Citius Pharma's securities will continue to be listed and traded on the Nasdaq Stock Market. 'We are pleased to have regained compliance with Nasdaq's minimum bid price requirement,' said Leonard Mazur, Chairman and CEO of Citius Pharmaceuticals. 'This reflects our continued focus on bringing critical care products to patients and creating long-term value for our shareholders.' About Citius Pharmaceuticals, Inc. Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) 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 is actively engaged with the FDA to outline next steps for both programs. Citius Pharmaceuticals owns 92% of Citius Oncology. For more information, please visit 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 or Citius Oncology. 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 and Citius Oncology, are: our ability to maintain compliance with Nasdaq's continued listing standards; our ability to commercialize LYMPHIR and any of our other product candidates that may be approved by the FDA; our ability to use the latest technology to support our commercialization efforts; our need for substantial additional funds; our ability to successfully implement and maintain distribution agreements with current or other future distribution partners; potential disruptions or performance issues involving third-party logistics providers; 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 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; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; 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 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 Securities and Exchange Commission ('SEC') filings which are available on the SEC's website at Investor Contact:Ilanit AllenVP, Corporate Communications & Investor RelationsCitius Pharmaceuticals, ext. 113 Media Contact:Greg SalsburgSTiR-communicationsGreg@ ext. 113
Yahoo
07-07-2025
- Business
- Yahoo
Citius Pharmaceuticals Prepares for Q2 2025 Commercial Launch of FDA-Approved Cancer Drug LYMPHIR
Citius Pharmaceuticals Inc. (NASDAQ:CTXR) is one of the best hot stocks to buy according to Wall Street analysts. In the middle of June, Citius Oncology, which is an oncology-focused subsidiary of Citius Pharmaceuticals, announced that it is nearing completion of preparations for the commercial launch of LYMPHIR. LYMPHIR is an FDA-approved immunotherapy for the treatment of adults with relapsed or refractory cutaneous T-cell lymphoma/CTCL, indicated for Stage I-III disease after at least one prior systemic therapy. The company anticipates a US launch of LYMPHIR in H2 2025. Citius Oncology has completed commercial-scale manufacturing of LYMPHIR, with sufficient packaged and labeled inventory to meet projected demand for 12 to 18 months post-launch. The product supports a shelf life of 60 months. To facilitate broad access and timely delivery across the US, Citius Oncology has executed one and is finalizing other distribution services agreements with multiple top-tier global pharmaceutical logistics partners. An experienced physician performing a procedure using specialty pharmaceutical products. The commercial team has developed a targeted launch strategy using a proprietary GenAI model to identify and engage key accounts. A suite of marketing and educational materials, such as clinical guides, dosing protocols, and disease awareness content, has been developed for providers, patients, and caregivers. LYMPHIR's inclusion in the National Comprehensive Cancer Network/NCCN Clinical Practice Guidelines, along with the assignment of a permanent J-code under HCPCS and ongoing engagement with payors, positions the product for efficient reimbursement and coverage upon launch. Citius Pharmaceuticals Inc. (NASDAQ:CTXR) is a biopharmaceutical company that develops and commercializes critical care products. While we acknowledge the potential of CTXR as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the . READ NEXT: and . Disclosure: None. This article is originally published at Insider Monkey. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
05-05-2025
- Business
- Yahoo
Citius Pharmaceuticals to Present at the Jefferies Global Healthcare Conference
CEO Leonard Mazur to present on Thursday, June 5, 2025, at 3:10 pm ET CRANFORD, N.J., May 5, 2025 /PRNewswire/ -- Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) and its oncology subsidiary, Citius Oncology, Inc. (Nasdaq: CTOR), today announced that Leonard Mazur, Chairman and Chief Executive Officer of both companies, will present at the Jefferies Global Healthcare Conference, taking place June 3 – June 5, 2025 in New York City. Conference Details: Presentation: 3:10 pm ET on Thursday, June 5, 2025* Location: New York City Webcast: A live and archived webcast of the presentation will be available here. A replay will be available for a limited time following the presentation on the Events & Presentations portion of the Citius website In addition to the formal presentation, Mr. Mazur will participate in one-on-one meetings with institutional investors throughout the conference. Investors interested in scheduling a meeting should contact their Jefferies representative. *Please note that the presentation date and time are subject to change. Participants should refer to the final program agenda for up-to-date information. About Citius Oncology, Inc. Citius Oncology, Inc. (Nasdaq: CTOR) is a platform to develop and commercialize novel targeted oncology therapies. In August 2024, its primary asset, LYMPHIR, was approved by the FDA for the treatment of adults with relapsed or refractory CTCL who had had at least one prior systemic therapy. Management estimates the initial market for LYMPHIR currently exceeds $400 million, is growing, and is underserved by existing therapies. Robust intellectual property protections that span orphan drug designation, complex technology, trade secrets and pending patents for immuno-oncology use as a combination therapy with checkpoint inhibitors would further support Citius Oncology's competitive positioning. For more information, please visit About Citius Pharmaceuticals, Inc. Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) 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 is actively engaged with the FDA to outline next steps for both programs. Citius Pharmaceuticals owns 92% of Citius Oncology. For more information, please visit Investor Contact: Ilanit Allenir@ x113 Media Contact: STiR-communicationsGreg SalsburgGreg@ View original content to download multimedia: SOURCE Citius Pharmaceuticals, Inc. Sign in to access your portfolio
Yahoo
14-02-2025
- Business
- Yahoo
Citius Pharmaceuticals, Inc. Reports Fiscal First Quarter 2025 Financial Results and Provides Business Update
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 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 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 Allenir@ 908-967-6677 x113 Media Contact: STiR-communicationsGreg SalsburgGreg@ -- Financial Tables Follow – CITIUS PHARMACEUTICALS, INC. CONDENSED CONSOLIDATED BALANCE SHEETS(Unaudited)December 31, September 30, 2024 2024 ASSETSCurrent Assets:Cash and cash equivalents$ 1,100,079 $ 3,251,880 Inventory 14,381,3698,268,766 Prepaid expenses 2,845,7392,700,000 Total Current Assets 18,327,18714,220,646 Operating lease right-of-use asset, net 191,412246,247 Deposits 38,06238,062 In-process research and development 92,800,00092,800,000 Goodwill 9,346,7969,346,796 Total Other Assets 102,184,858102,184,858 Total Assets$ 120,703,457 $ 116,651,751 LIABILITIES AND STOCKHOLDERS' EQUITYCurrent Liabilities:Accounts payable$ 7,364,120 $ 4,927,211 License payable 28,400,00028,400,000 Accrued expenses 6,242,17817,027 Accrued compensation 2,595,0912,229,018 Operating lease liability 204,569241,547 Total Current Liabilities 44,805,95835,814,803 Deferred tax liability 6,978,0406,713,800 Operating lease liability - noncurrent -21,318 Total Liabilities 51,783,99842,549,921 Commitments and ContingenciesStockholders' Equity:Preferred stock - $0.001 par value; 10,000,000 shares authorized; no shares issued and outstanding -- Common stock - $0.001 par value; 16,000,000 shares authorized; 7,727,243 and 7,247,243 shares issued and outstanding at December 31, 2024 and September 30, 2024, respectively 7,7277,247 Additional paid-in capital 276,538,816271,440,421 Accumulated deficit (211,138,464)(201,370,218) Total Citius Pharmaceuticals, Inc. Stockholders' Equity 65,408,07970,077,450 Non-controlling interest 3,511,3804,024,380 Total Equity 68,919,45974,101,830 Total Liabilities and Equity$ 120,703,457 $ 116,651,751Reflects 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 ExpensesResearch and development 2,127,0382,621,910 General and administrative 5,387,7523,660,728 Stock-based compensation - general and administrative 2,524,8243,058,185 Total Operating Expenses 10,039,6149,340,823 Operating Loss (10,039,614)(9,340,823) Other IncomeInterest income 22,608253,638 Total Other Income 22,608253,638 Loss before Income Taxes (10,017,006)(9,087,185) Income tax expense 264,240144,000 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 OutstandingBasic and diluted 7,492,4606,358,237Reflects 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 2,524,8243,058,185 Issuance of common stock for services -76,146 Amortization of operating lease right-of-use asset 54,83550,430 Depreciation -578 Deferred income tax expense 264,240144,000 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 366,073273,688 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 3,251,88026,480,928 Cash and Cash Equivalents - End of Period$ 1,100,079 $ 20,345,618 View original content to download multimedia: SOURCE Citius Pharmaceuticals, Inc. 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