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 Financial Highlights "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 LYMPHIRTM 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 LYMPHIRTM 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 LYMPHIRTM, 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 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 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 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. CONSOLIDATED BALANCE SHEETS SEPTEMBER 30, 2024 AND 2023 2024 2023 ASSETS Current Assets: Cash and cash equivalents $ 3,251,880 $ 26,480,928 Inventory 8,268,766 — Prepaid expenses 2,700,000 7,889,506 Total Current Assets 14,220,646 34,370,434 Property and equipment, net — 1,432 Operating lease right-of-use asset, net 246,247 454,426 Other Assets: Deposits 38,062 38,062 In-process research and development 92,800,000 59,400,000 Goodwill 9,346,796 9,346,796 Total Other Assets 102,184,858 68,784,858 Total Assets $ 116,651,751 $ 103,611,150 LIABILITIES AND STOCKHOLDERS' EQUITY Current Liabilities: Accounts payable $ 4,927,211 $ 2,927,334 License payable 28,400,000 — Accrued expenses 17,027 476,300 Accrued compensation 2,229,018 2,156,983 Operating lease liability 241,547 218,380 Total Current Liabilities 35,814,803 5,778,997 Deferred tax liability 6,713,800 6,137,800 Operating lease liability – non current 21,318 262,865 Total Liabilities 42,549,921 12,179,662 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; 7,247,243 and 6,354,371 shares issued and outstanding at September 30, 2024 and 2023, respectively 7,247 6,354 Additional paid-in capital 271,440,421 253,056,133 Accumulated deficit (201,370,218) (162,231,379) Total Citius Pharmaceuticals, Inc. Stockholders' Equity 70,077,450 90,831,108 Non-controlling interest 4,024,380 600,380 Total Equity 74,101,830 91,431,488 Total Liabilities and Equity $ 116,651,751 $ 103,611,150 Reflects a 1-for-25 reverse stock split effective November 25, 2024. CITIUS PHARMACEUTICALS, INC. CONSOLIDATED STATEMENTS OF OPERATIONS FOR THE YEARS ENDED SEPTEMBER 30, 2024 AND 2023 2024 2023 Revenues $ — $ — Operating Expenses: Research and development 11,906,601 14,819,729 General and administrative 18,249,402 15,295,584 Stock-based compensation – general and administrative 11,839,678 6,616,705 Total Operating Expenses 41,995,681 36,732,018 Operating Loss (41,995,681) (36,732,018) Other Income: Interest income, net 758,000 1,179,417 Gain on sale of New Jersey net operating losses 2,387,842 3,585,689 Total Other Income Net 3,145,842 4,765,106 Loss before Income Taxes (38,849,839) (31,966,912) Income tax expense 576,000 576,000 Net Loss (39,425,839) (32,542,912) Net loss attributable to non-controlling interest 287,000 - Deemed dividend on warrant extension (1,047,312) (1,151,208) Net Loss Applicable to Common Stockholders $ (40,186,151) (33,694,120) Net Loss Per Share Applicable to Common Stockholders - Basic and Diluted $ (5.97) (5.57) Weighted Average Common Shares OutstandingBOSTON — State Senate Democrats moved Thursday to crack down on motorists who fail to stop for school buses as part of an end-of-term sprint to tie up loose legislative ends. The Senate Ways and Means Committee began polling its members just after 11 a.m. on a trio of bills, including one allowing cities and towns to install monitoring technology on school buses that would record vehicles that fail to stop when required. The Senate gaveled in a few minutes later, and the bill could receive a vote before senators adjourn. Javascript is required for you to be able to read premium content. Please enable it in your browser settings.
Back in 2004, the world was a very different place. Smartphones were in their infancy, with the first iPhone not yet released. Social media was still in its early stages, and the idea of streaming services like Netflix and Spotify was just a distant dream. The internet was slower, and connectivity was nowhere near as widespread as it is today. We were on the brink of a digital revolution, but we had yet to witness the full extent of its impact.Taiwan Semiconductor Manufacturing Company (TSMC) continues to impress with its strong performance, as evidenced by its impressive sales figures for the month of November. In November, TSMC reported a total revenue of 2760.6 billion New Taiwan Dollars, marking a significant year-on-year growth of 34%.
No. 23 Texas A&M aims to hand Oregon first loss at Players EraWe must think historically to cool down our post-election emotions. Historical perspectives clarify our recent presidential election and lower its post-election temperature. Let’s start with feudalism, of kings and lords, which we inherited from our Anglo-European past which had ruled the known world for over a millennium. Then, the American Revolution came and overthrew feudalism and ushered in a new democratic system, governed by ourselves and leaders chosen by us according to our own precepts of freedom. This post-feudal new world lasted for over two centuries — until this past Nov. 5. Contrary to its conventional images of the Dark Ages and oppression, a few scholars have considered feudalism as an ideal system of social order and as a pre-modern community of peace and harmony. As historical fact, this idyllic feudalism, where lords and peasants lived in good order and harmony, came to its end: Earth-shaking events were coming in waves, most notably in scientific discoveries, religious revolts, radical perspectives in Renaissance and Enlightenment, and the emboldening New World — which told feudal rulers that their time was up. Two types of responses, quite fateful for their historic consequences, emerged from feudal societies to face the inevitable “modern” world: One from the Old World and the other from the New World. The Old World, mostly European, decided to welcome the new developments by prudently combining their existing tradition, religion and habits with the new ways of thinking — half-feudal and half-democratic — that would accommodate the changes without destroying their old system. With this new combination, where society is modern but people think traditional, the Old World kept its community and social order in a form generally known as “social democracy” which continues today in most European nations. The New World produced a rather different response. With the backdrop of open land and physical distance from the Old World, the American colonies chose a completely radical break from feudalism. Following the Revolution, the New World realized humanity’s fondest dream of “liberal democracy” (emphasizing individual liberty, unlike Europe’s social democracy), as the new model for idealized self-governance and America’s own self-image as “the Shining City on a Hill.” Liberal democracy satisfied the restless American soul for nearly two centuries, first with wide open frontier society of freedom and equality and later with consumer capitalism to its heart’s content. No nation on Earth or in history had enjoyed the range of physical comfort and convenience like post-World War II American consumers. The age of affluence was upon America, which created an entirely new kind of human generations and personality: The typically solitary American consumer lived in a post-human society, always restless in search of something better for himself. He wanted everything he consumed to be better than before, faster and louder, more thrilling and pleasing. Article continues after... Cross|Word Flipart Typeshift SpellTower Really Bad Chess Hollywood responded with the entertainment revolution, expanding three television channels to 3,000 with cable TV, then to three million with the internet to meet the new demands. America even conquered the time-and-space limitations of nature: entertainment was now always available across time and space — night or day, here or yonder, at will. Upon the consumer’s instant command, movie stars sang, danced, and told jokes and athletes ran and jumped — all to please the new lord. In this society where everything seemed possible and available, the line of sanity between reality and fantasy blurred, and the largely frivolous “choices” covered up the harsh conditions of powerlessness for the masses under the liberal-democratic version of the American Dream. Liberal democracy is both a blessing and a curse. As a blessing, it allows maximum individual indulgences. As the curse, the very nature of individual choice makes it difficult for us to control the consequences of our own choice. Such a system requires a high degree of citizen intelligence and social consciousness. It’s like giving a child a loaded gun and expecting a happy ending. With the gun, the child already possesses the power not to be responsible, like those who struggle with credit cards, even with pre-set limits. No such systems ever survived their own indulgences, and America’s libertine (woke?) anything-goes culture — expertly orchestrated by America’s best and brightest — could not moderate its own civic degeneration. These master psychologists, working for politicians and corporations, kept us deep in our own cesspool, flailing with minor daily irritations that morphed into major political wraths. Under Democrats, life was a sweet dream only in illusion or hypocrisy as our economic cruelty did not (and does not) allow such fantasies to become reality. With the world’s largest wealth-poverty gap, individual lives can improve indefinitely only in Hollywood dreams and Disney fantasies. Soon Democrats, already characterized as an “elitist” party, were seen as largely unrelated to the actual daily lives of working Americans. Still dreaming of the pre-capitalist era, liberal America had become ungovernable and its lives unlivable. The stage was now set for Donald Trump who promised to clear the liberal swamp with his imperial magic wand. Back in power, he is remaking everything in America except money and entertainment. This way, Trump is having the best of both worlds — populist and capitalist: He gets votes from dumb masses and dollars from smart billionaires. Democrats are just in shock and awe of his genius. As democracy replaced feudalism, Trump’s imperial democracy is replacing liberal democracy. In this new era that began on Nov. 5, we have taken our first baby steps, like Adam and Eve after the fall, toward an entirely unknown future — both foreboding and expectant. There, waiting for us is the judgment on the liberal fruit of indulgence that we had picked and consumed, a gift from the capitalist-serpent who whispered to us that we could live “as gods.” Historians would write the rest. Jon Huer, columnist for the Recorder and retired professor, lives in Greenfield and writes for posterity.CT town’s first selectmen announces he will resign Jan. 1
UAB secures 98-86 win against Louisiana
LOUISVILLE — Junior high students at North Clay School District are helping students in Africa by building a solar suitcase that will light the way for learning. North Clay is one of 13 schools in the state participating in the We Share Solar program. Launched for the first time in Illinois this year, the program offers a unique science, technology, engineering and math (STEM) educational experience that combines solar STEM education with real-world impact to engage and inspire students to become the next generation of “Solar Solutionaries.” North Clay science teacher Adam Frederick learned the program was seeking applicants and applied last year. The school was then chosen to build one of many portable 12-volt DC solar suitcases that will bring electricity to people at Bidi Bidi Refugee Settlement in northwestern Uganda — the second largest refugee settlement in the world. The settlement has 270,000 South Sudanese refugees and no electricity in its 40 schools. Once assembled, the suitcases are powerful enough to illuminate two to three classrooms and charge devices such as mobile phones or tablets. It is the first time the school has participated in such a project, according to Frederick, who is trying to build out science and STEM projects at the school. Frederick said he jumped at the opportunity because it has a global impact on a lot of people. “It shows our students real-life skills and things they can apply, and what they’re doing in the classroom can affect people outside the classroom,” he said. After Thanksgiving, the school received six training cases and one to be sent to Uganda. Frederick said it took about a week to build the solar cases; three days were spent assembling them. Students spent the rest of the time on projects that included taking voltage and amperage readings. The students completed the solar suitcases just before winter break. Frederick said the students had some knowledge going into the project, having already studied circuitry and wiring, but with the project, they learned about solar power and how solar cells generate electricity. They also learned about teamwork, as the project required each student to perform a task within each group. Eighth grader Jailyn Gaddy’s job was builder. “They would hand me tools, and I would have to put all the little pieces together for it,” she said. She found getting all the different wires in the right places challenging. “If you didn’t put it in the right little place, then it (light) wouldn’t turn on,” she said. Eighth grader Charlee Wendling loves wiring. She served as project manager. Her task was reading the manual and instructing the other members of her group on how to build it. Aside from learning how to build a solar suitcase, the two learned something else. Gaddy figured some places in the world didn’t have as much electricity as she is accustomed to, but to learn they had none surprised her. “I was excited because I was learning that we were going to get to share light with kids that don’t have any light at their school. We’re very fortunate here to have so much light in most of our buildings,” she said. As part of the project, the students wrote letters and created personalized artwork to send with the solar suitcase. “The art really kind of showcases some beautiful things about what they learned about the students in Uganda and how that blends with our community as well,” said English teacher Jessica Bell. The artwork included agriculture that represented Illinois such as corn and pumpkins. “We learned in Uganda they have different types of ag over there too and that we’re, in a lot of cases, very similar,” said Bell. The students also learned about refugee camps. “My favorite part was probably learning about the refugee camps because I didn’t really realize a lot of that stuff ’til I actually got taught about it,” said Gaddy. Gaddy also realized through the project the disparity that exists in different parts of the world. “How some places can have more than others even though we’re in the same world,” she said. The We Share Solar Suitcase will arrive in Uganda sometime next year with others. The class will receive updates on where it goes and possibly responses from the students benefiting from it. The school will continue with the program for the next three years. The program is funded through Cultivate Power, which manages solar farms in the state. While Frederick considers the school’s science program “pretty hands-on,” he said the We Share Solar program is unique because students can take what they’ve learned and apply it immediately instead of in the future. “They’re taking what we’ve learned in class and seeing it being applied directly to affect somebody else’s life, and I find that very important to them to see that they don’t have to wait until they’ve graduated and had a bunch of training to start applying these things outside the classroom,” he said. Bell likes that the project not only gets kids more involved but also combines learning in both science and language writing. “Students just learn so much more when we can engage them across the subject line,” she said. She added the students also really enjoyed doing it. “I saw a lot of kids – not to be cheesy – but light up at getting to create something like this and knowing that they’re really putting something out there that’s going to help someone else besides them. You see them really grow and learn from that,” she said.In addition to the strength of the consumer sector, other factors are contributing to the bullish sentiment in the A-share market. Government policies aimed at boosting domestic consumption and supporting key industries have sparked optimism among investors. The ongoing economic recovery and efforts to stimulate growth are creating a conducive environment for companies to thrive and expand. As a result, A-share companies are enjoying tailwinds that are propelling them to record highs and attracting both domestic and international investors.With his clever and playful use of hidden messages in his poem, Yang Shize effectively addressed the swirling rumors and gossip about his romantic life. By openly acknowledging his single status in a creative and indirect way, he managed to deftly navigate the tricky terrain of celebrity relationships and maintain a sense of mystery and intrigue around his personal life.