Pembrolizumab

Bristol Myers Squibb has won FDA approval for an injectable version of its blockbuster cancer immunotherapy Opdivo, a regulatory decision that gives patients a more convenient dosing option and provides the pharmaceutical giant a new way to fend off coming competition. The pivotal test for injectable Opdivo evaluated the drug in renal cell carcinoma, but the approval announced late Friday spans all of the approved solid tumor indications covered by approvals for intravenously infused Opdivo as a monotherapy. BMS will market the new injectable drug as Opdivo Qvantig. Opdivo belongs to the class of therapies called checkpoint inhibitors. The drug itself is an antibody designed to block PD-1, a checkpoint protein on immune cells that stops them from recognizing cancer cells. First approved in 2014 as a treatment for melanoma, the drug has gone on to win numerous approvals in additional cancers. In the first nine months of 2024, Opdivo, in all of its approved indications, accounted for $6.8 billion in sales. The immunotherapy is BMS’s top-selling cancer product. Health IT Reducing Clinical and Staff Burnout with AI Automation As technology advances, AI-powered tools will increasingly reduce the administrative burdens on healthcare providers. By Dr. Michael Blackman, Chief Medical Officer at Greenway Health Antibody drugs are typically administered as intravenous infusions; dosing of Opdivo takes about 30 minutes. BMS said an injection of Opdivo Qvantig takes three to five minutes. In a Phase 3 test that compared monthly injections of Opdivo Qvantig to every-two-week infusions of Opdivo as a treatment for advanced or metastatic clear cell renal cell carcinoma, results showed the injectable version met the main goal of achieving comparable exposure throughout the body and similar efficacy. Results also showed the new injectable version’s safety profile was comparable to that of Opdivo. Beyond Opdivo Qvantig’s approval in all of the solid tumor indications for Opdivo, the new injectable product is approved as a monotherapy maintenance treatment after a patient has completed treatment with Opdivo plus Yervoy, a different BMS immunotherapy. The injectable version of Opdivo may also be used in combination with chemotherapy or the cancer drug cabozantinib. Opdivo Qvantig is not approved for use in combination with intravenously infused Yervoy. “Over the last decade, Opdivo has evolved as an immunotherapy option used in many indications across tumor types,” Adam Lenkowski, BMS’s executive vice president and chief commercialization officer, said in a prepared statement. “With this new option, we look forward to further helping cancer patients with an administration method that gives them faster delivery.” The faster delivery of Opdivo Qvantig is made possible by Enhanze, a drug delivery technology developed by biotech company Halozyme. Enhanze consists of an engineered enzyme that enables biologic drugs to be administered as subcutaneous injections. The key patent for Opdivo will expire in 2028, opening the door to competition from biosimilar versions of the IV infused drug. Opdivo Qvantig could help BMS retain some of its immunotherapy market share with a patent-protected alternative dosing option. presented by Health IT Transforming Patient Care: The Role of AI-Powered Assistants The progress in artificial intelligence (AI) is reshaping patient care, across various dimensions, from facilitating faster discharge to curating treatment plans and suggesting lifestyle changes. By IT Medical Other pharma giants are also pursuing subcutaneous dosing for their respective checkpoint inhibitors. In September, Roche won FDA approval for Tecentriq Hybreza, the injectable version of its PD-L1 inhibitor Tecentriq. Like Opdivo Qvantig, the Roche immunotherapy is made with Halozyme’s technology. Meanwhile, Merck last month posted positive Phase 3 data for an injectable version of its blockbuster PD-1 inhibitor, Keytruda. Injectable Keytruda employs enzyme technology from Alteogen.

Clinical and regulatory success in 2024 expected to drive value in 2025 CRANFORD, N.J., Dec. 27, 2024 /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 full year ended September 30, 2024. Fiscal Full Year 2024 Business Highlights and Subsequent Developments Achieved U.S. Food and Drug Administration (FDA) approval of LYMPHIR™ (denileukin diftitox-cxdl), an immunotherapy for the treatment of adults with relapsed or refractory cutaneous T-cell lymphoma (CTCL); Advanced manufacturing, marketing and sales activities in preparation for commercial launch of LYMPHIR in the first half of 2025; Completed the merger of Citius Pharma's oncology subsidiary with TenX Keane to form Citius Oncology, Inc., a standalone publicly traded company which began trading on the Nasdaq exchange under the ticker symbol CTOR on August 13, 2024; 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; and, Met primary and secondary endpoints in the Phase 3 Pivotal Trial of Mino-Lok®, demonstrating a statistically significant improvement in time to catheter failure of infected catheters compared to other physician-selected anti-infective lock solutions. Financial Highlights Cash and cash equivalents of $3.3 million as of September 30, 2024; R&D expenses were $11.9 million for the full year ended September 30, 2024, compared to $14.8 million for the full year ended September 30, 2023; G&A expenses were $18.2 million for the full year ended September 30, 2024, compared to $15.3 million for the full year ended September 30, 2023; Stock-based compensation expense was $11.8 million for the full year ended September 30, 2024, compared to $6.6 million for the full year ended September 30, 2023; and, Net loss was $39.4 million, or ($5.97) per share for the full year ended September 30, 2024 compared to a net loss of $32.5 million, or ($5.57) per share for the full year ended September 30, 2023. "In fiscal year 2024 we drove tremendous progress in our pipeline. It was a transformative year, marked by our first FDA approval and significant clinical milestones. The approval of LYMPHIR™ and the positive Phase 3 results for Mino-Lok® underscore our commitment to developing innovative therapies. Our team successfully responded to FDA comments related to the biologics license application for LYMPHIR and ultimately gained FDA approval. Productive engagement with the FDA regarding the positive results of our Phase 3 Mino-Lok® trial and Phase 2 Halo-Lido trial clarified our next steps for both programs. We anticipate continued engagement with the agency in the coming year and look forward to their guidance. Additionally, we are exploring strategic partnerships and licensing opportunities to maximize the potential of our portfolio and bring these important therapies to market efficiently," stated Leonard Mazur, Chairman and CEO of Citius Pharma. "Looking ahead, our priorities for fiscal year 2025 include launching LYMPHIR™ through our majority-owned subsidiary, Citius Oncology, driving the clinical and regulatory strategies for Mino-Lok® and Halo-Lido, fortifying our financial position, and applying a disciplined approach to resource allocation. We expect to launch LYMPHIR in the first half of 2025 and distribute CTOR shares to Citius Pharma shareholders by the end of the year, pending favorable market conditions. Our goal remains to deliver value for patients, healthcare providers, and shareholders. With a clear vision and a strong team, we are well-positioned to execute on our mission of bringing innovative therapies to market," added Mazur. FULL YEAR 2024 FINANCIAL RESULTS: Liquidity As of September 30, 2024, the Company had $3.3 million in cash and cash equivalents. As of September 30, 2024, the Company had 7,247,243 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 year ended September 30, 2024, the Company received net proceeds of $13.8 million from the issuance of equity. The Company expects to raise additional capital to support operations. Research and Development (R&D) Expenses R&D expenses were $11.9 million for the full year ended September 30, 2024, compared to $14.8 million for the full year ended September 30, 2023. The decrease in R&D expenses primarily reflects the completion of the Halo-Lido trial and completion of activities related to the regulatory resubmission for LYMPHIR, offset by shutdown costs associated with the end of the Phase 3 trial for Mino-Lok. We expect research and development expenses to decrease in fiscal year 2025 as we continue to focus on the commercialization of LYMPHIR through our majority-owned subsidiary, Citius Oncology and because we have completed the Phase 3 trial for Mino-Lok. General and Administrative (G&A) Expenses G&A expenses were $18.2 million for the full year ended September 30, 2024, compared to $15.3 million for the full year ended September 30, 2023. The increase was primarily due to costs associated with pre-launch and market research 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 full year ended September 30, 2024, stock-based compensation expense was $11.8 million as compared to $6.6 million for the prior year. The increase of $5.2 million is largely due to the grant of options under the Citius Oncology stock plan. Stock-based compensation expense under the Citius Oncology stock plan was $7.5 million during the year ended September 30, 2024, compared to $2.0 million for the year ended September 30, 2023, as the plan was initiated in July 2023. For the years ended September 30, 2024 and 2023, stock-based compensation expense also includes $47,547 and $130,382, respectively, for the NoveCite stock option plan. In fiscal years 2023 and 2024, we granted options to our new employees and additional options to other employees, our directors, and consultants. Net loss Net loss was $39.4 million, or ($5.97) per share for the year ended September 30, 2024, compared to a net loss of $32.5 million, or ($5.57) per share for the year ended September 30, 2023, as adjusted for the reverse stock split. The increase in net loss reflects an increase in operating expense of $5.3 million offset by a decrease of $1.6 million in other income. Operating expense increased due to increases in stock-based compensation and general and administrative expenses, which were offset by decreased 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 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 subisity and any of our other product candidates that may be approved by the FDA; 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; 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 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 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 Pharmaceuticals, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED