Denileukin Diftitox

CRANFORD, N.J., Feb. 14, 2025 /PRNewswire/ -- Citius Oncology, Inc. ("Citius Oncology" or the "Company") (Nasdaq: CTOR), a specialty biopharmaceutical company focused on the development and commercialization of novel targeted oncology therapies, today reported business and financial results for the fiscal first quarter ended December 31, 2024. Fiscal First Quarter 2025 Business Highlights and Subsequent Developments Engaged Jefferies as exclusive financial advisor to assist in evaluating strategic alternatives aimed at maximizing shareholder value, with multiple active discussions underway; Progressed commercial readiness for the planned launch of LYMPHIR™ in the first half of 2025, with key initiatives including: Manufactured sufficient inventory for launch and initial sales estimates, with additional production in process, 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; Supported two investigator-initiated trials to explore LYMPHIR's potential as an immuno-oncology combination therapy being conducted at the University of Pittsburgh Medical Center and the University of Minnesota: Shared interim trial results with the clinical community at the Society for Immunotherapy of Cancer Conference (SITC) of University of Pittsburgh Medical Center's Phase I trial of LYMPHIR with checkpoint inhibitor pembrolizumab. 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. Financial Highlights R&D expenses were $1.3 million for the first quarter ended December 31, 2024, compared to $1.2 million for the first quarter ended December 31, 2023; G&A expenses were $3.3 million for the first quarter ended December 31, 2024, compared to $1.5 million for the first quarter ended December 31, 2023; Stock-based compensation expense was $1.8 million for the first quarter ended December 31, 2024, compared to $1.9 million for the first quarter ended December 31, 2023; and, Net loss was $6.7 million, or ($0.09) per share for the first quarter ended December 31, 2024, compared to a net loss of $4.7 million, or ($0.07) per share for the first quarter ended December 31, 2023. "During the first fiscal quarter of 2025, Citius Oncology advanced key initiatives to bring LYMPHIR to market and focused on exploring strategic options to maximize shareholder value. With FDA approval of LYMPHIR for the treatment of cutaneous T-cell lymphoma (CTCL), we are determined to deliver this much-needed therapy to patients. LYMPHIR remains the only targeted systemic therapy approved for CTCL since 2018 and the only treatment with a mechanism of action that targets the IL-2 receptor. More than 84% of CTCL patients in the Phase III trial experienced skin relief from this debilitating disease," stated Leonard Mazur, Chairman and CEO of Citius Oncology. "To support the long-term growth potential of LYMPHIR, we engaged Jefferies as our exclusive financial advisor to evaluate strategic alternatives. Active discussions are currently underway; our goal remains to bring LYMPHIR to market expeditiously. We are making strong progress toward our planned commercial launch in the first half of 2025. The inventory for launch is ready and our market access efforts continue with the successful assignment of a new permanent J-code (J9161) by the Centers for Medicare & Medicaid Services set to take effect on April 1, 2025, and the inclusion of LYMPHIR in the NCCN guidelines. These are critical milestones that will help drive clinical adoption and reimbursement," added Mazur. "Beyond commercial readiness, we are actively supporting two investigator-initiated trials evaluating LYMPHIR's potential as an immuno-oncology combination therapy. Positive interim results from the University of Pittsburgh Medical Center's Phase I trial combining LYMPHIR with pembrolizumab were shared at the Society for Immunotherapy of Cancer (SITC) Conference in November, highlighting its potential to enhance treatment efficacy in recurrent solid tumors. Furthermore, the University of Minnesota has expanded its Phase I trial exploring denileukin diftitox administration prior to Chimeric Antigen Receptor (CAR-T) therapies for B-cell lymphomas, with the first patient dosed at City of Hope cancer center." "These initiatives reflect our commitment to bringing innovative cancer therapies to patients with high unmet medical needs. With the expected launch of LYMPHIR on the horizon, we remain focused on executing our commercial strategy while exploring strategic opportunities to drive long-term value," concluded Mazur. FISCAL FIRST QUARTER 2025 FINANCIAL RESULTS: Research and Development (R&D) Expenses R&D expenses were $1.3 million for the first quarter ended December 31, 2024, compared to $1.2 million for the first quarter ended December 31, 2023. The increase primarily reflects costs associated with the two investigator immuno-oncology trials which are in process. General and Administrative (G&A) Expenses G&A expenses were $3.3 million for the first quarter ended December 31, 2024, compared to $1.5 million for the first quarter ended December 31, 2023. The increase was primarily due to costs associated with pre-commercial and commercial launch activities of LYMPHIR including market research, marketing, distribution and drug product reimbursement from health plans and payers. Stock-based Compensation Expense For the first quarter ended December 31, 2024, stock-based compensation expense was $1.8 million as compared to $1.9 million for the prior year. The primary reason for the decrease in stock-based compensation expense was the decrease in the weighted average grant date fair value of the options granted during the three months ended December 31, 2024 to $0.80 per share as compared to the weighted average grant date fair value of the options granted of $1.66 per share during the year ended September 30, 2024. Net loss Net loss was $6.7 million, or ($0.09) per share for the first quarter ended December 31, 2024, compared to a net loss of $4.7 million, or ($0.07) per share for the first quarter ended December 31, 2023. The increase in net loss was primarily due to the increase in our operating expenses. About Citius Oncology, Inc. Citius Oncology specialty is a biopharmaceutical company focused on developing and commercializing 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. Citius Oncology is a publicly traded subsidiary of Citius Pharmaceuticals. 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 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 Oncology 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 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; our dependence on third-party suppliers; our ability to procure cGMP commercial-scale supply; risks related to research using our assets but conducted by third parties; our ability to maintain compliance with Nasdaq's continued listing standards; uncertainties relating to preclinical and clinical testing; 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 Oncology'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 – SOURCE Citius Oncology, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

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. 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, 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 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) 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 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.