FDA assigns Prescription Drug User Fee Act (PDUFA) target action date of August 13, 2024 CRANFORD, N.J., March 18, 2024 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products today announced that the U.S. Food and Drug Administration (FDA) has accepted the resubmission of the Company's Biologics License Application (BLA) for LYMPHIR™ (denileukin ...

Net operating losses converted into non-dilutive capital CRANFORD, N.J., March 7, 2024 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products today announced that the Company has received $2.4 million in non-dilutive capital through New Jersey's Technology Business Tax Certificate Transfer Program, more commonly known as the Net Operating Loss ...

CRANFORD, N.J., Feb. 26, 2024 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products, today announced that the Company filed a Form S-3 shelf registration on February 23, 2024 with the Securities and Exchange Commission to replace its currently effective shelf registration statement that expires in April 2024 pursuant to SEC rules. About Citius ...

CRANFORD, N.J., Feb. 23, 2024 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products, today announced its participation in two upcoming investor conferences. Citius Chairman and CEO Leonard Mazur will present at the BIO CEO and Investor Conference on February 26-27, 2024, and the Sidoti Small-Cap Virtual Conference on March 13-14, 2024. BIO CEO ...

Resubmitted LYMPHIR™ Biologics License Application; awaiting PDUFA date Completed enrollment in the Mino-Lok® Pivotal Phase 3 trial CRANFORD, N.J., Feb. 14, 2024 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products today reported business and financial results for the fiscal first quarter 2024 ended December 31, 2023. First Quarter 2024 Busine ...

FDA acceptance of the completed resubmission package and issuance of a Prescription Drug User Fee Act (PDUFA) date is expected within 30 days of resubmission CRANFORD, N.J., Feb. 13, 2024 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products today announced the resubmission of the Company's Biologics License Application (BLA) to the U.S. Food a ...

[PART I. FINANCIAL INFORMATION](index=4&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Financial Statements (Unaudited)](index=4&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) The company reported no revenue, a higher net loss of $9.2 million, and declining cash reserves to $20.3 million [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased to $97.4 million due to lower cash, while stockholders' equity fell to $85.3 million Condensed Consolidated Balance Sheet Highlights (Unaudited) | Account | Dec 31, 2023 | Sep 30, 2023 | Change | | :--- | :--- | :--- | :--- | | **Assets** | | | | | Cash and cash equivalents | $20,345,618 | $26,480,928 | ($6,135,310) | | Total Current Assets | $28,210,114 | $34,370,434 | ($6,160,320) | | Total Assets | $97,399,822 | $103,611,150 | ($6,211,328) | | **Liabilities & Equity** | | | | | Total Current Liabilities | $5,578,819 | $5,778,997 | ($200,178) | | Total Liabilities | $12,065,188 | $12,179,662 | ($114,474) | | Total Equity | $85,334,634 | $91,431,488 | ($6,096,854) | [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The company reported no revenue and a net loss of $9.2 million, widened by higher operating expenses Statement of Operations Summary (Unaudited) | Metric | Three Months Ended Dec 31, 2023 | Three Months Ended Dec 31, 2022 | Change | | :--- | :--- | :--- | :--- | | Revenues | $0 | $0 | - | | Research and development | $2,621,910 | $3,445,515 | ($823,605) | | General and administrative | $3,660,728 | $2,603,287 | $1,057,441 | | Stock-based compensation | $3,058,185 | $1,201,081 | $1,857,104 | | **Operating Loss** | **($9,340,823)** | **($7,249,883)** | **($2,090,940)** | | Gain on sale of NJ NOLs | $0 | $3,585,689 | ($3,585,689) | | **Net Loss** | **($9,231,185)** | **($3,593,645)** | **($5,637,540)** | | Net Loss Per Share | ($0.06) | ($0.02) | ($0.04) | [Condensed Consolidated Statements of Cash Flows](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operations was $6.1 million, reducing the quarter-end cash balance to $20.3 million Cash Flow Summary (Unaudited) | Metric | Three Months Ended Dec 31, 2023 | Three Months Ended Dec 31, 2022 | | :--- | :--- | :--- | | Net Cash Used In Operating Activities | ($6,135,310) | ($4,824,439) | | Cash and Cash Equivalents - Beginning of Period | $26,480,928 | $41,711,690 | | **Cash and Cash Equivalents - End of Period** | **$20,345,618** | **$36,887,251** | [Notes to Condensed Consolidated Financial Statements](index=8&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes highlight a going concern uncertainty, a planned merger for Citius Oncology, and the BLA resubmission for LYMPHIR - The company's available cash resources are estimated to be sufficient to fund operations only through **August 2024**, which raises **substantial doubt about its ability to continue as a going concern**[36](index=36&type=chunk) - On October 23, 2023, Citius Oncology entered into a **merger agreement with TenX Keane Acquisition**, expected to be completed in the **first half of 2024**[86](index=86&type=chunk)[87](index=87&type=chunk) - The company **terminated its patent and technology license agreement for Mino-Wrap** on December 11, 2023[42](index=42&type=chunk) - On February 13, 2024, the company filed the **Biologics License Application (BLA) resubmission package for LYMPHIR** with the FDA[89](index=89&type=chunk)[59](index=59&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=18&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) The increased net loss is attributed to higher G&A and stock compensation, with liquidity concerns necessitating future capital raises - The company expects to need to **raise additional capital** to support operations beyond August 2024[127](index=127&type=chunk) - The increase in net loss was primarily due to a **$1.1 million increase in G&A expenses**, a **$1.9 million increase in stock-based compensation**, and a **$3.5 million decrease in other income** compared to the prior year period[123](index=123&type=chunk) - **R&D expenses decreased by $0.8 million**, mainly due to lower costs for the Mino-Lok Phase 3 trial and the Halo-Lido Phase 2b trial[113](index=113&type=chunk)[114](index=114&type=chunk)[115](index=115&type=chunk) [Results of Operations](index=21&type=section&id=MD%26A_Results%20of%20Operations) R&D expenses decreased to $2.6 million while G&A and stock compensation expenses increased significantly Change in Operating Expenses (Q4 2023 vs Q4 2022) | Expense Category | Q4 2023 | Q4 2022 | Change | Reason | | :--- | :--- | :--- | :--- | :--- | | Research & Development | $2.6M | $3.4M | ($0.8M) | Decreased Mino-Lok and Halo-Lido trial costs | | General & Administrative | $3.7M | $2.6M | $1.1M | Increased pre-launch activities for LYMPHIR | | Stock-based Compensation | $3.1M | $1.2M | $1.9M | Expense from Citius Oncology stock plan | - The company announced the **completion of enrollment in its pivotal Phase 3 clinical trial for Mino-Lok** on January 2, 2024[114](index=114&type=chunk) [Liquidity and Capital Resources](index=22&type=section&id=MD%26A_Liquidity%20and%20Capital%20Resources) With $20.3 million in cash, the company faces a going concern uncertainty as funds are only sufficient through August 2024 Liquidity Position as of Dec 31, 2023 | Metric | Amount | | :--- | :--- | | Cash and cash equivalents | $20,345,618 | | Working Capital | ~$22,600,000 | | Accumulated Deficit | $171,462,564 | - Based on cash at December 31, 2023, the company expects it has **sufficient funds to continue operations only through August 2024**[127](index=127&type=chunk) [Quantitative and Qualitative Disclosures about Market Risk](index=23&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) This section is not applicable for the reporting period - Not applicable[132](index=132&type=chunk) [Controls and Procedures](index=23&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective with no material changes during the quarter - As of December 31, 2023, the Chief Executive Officer and Chief Financial Officer concluded that the company's **disclosure controls and procedures were effective**[134](index=134&type=chunk) - **No changes in internal control over financial reporting** occurred during the quarter that have materially affected, or are reasonably likely to materially affect, internal controls[135](index=135&type=chunk) [PART II. OTHER INFORMATION](index=24&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Legal Proceedings](index=24&type=section&id=Item%201.%20Legal%20Proceedings) The company reported no legal proceedings during the period - None[137](index=137&type=chunk) [Risk Factors](index=24&type=section&id=Item%201A.%20Risk%20Factors) No material changes were reported to the risk factors disclosed in the previous Annual Report - There have been **no material changes** to the Company's risk factors as disclosed in the Company's Annual Report on Form 10-K for the fiscal year ended September 30, 2023[138](index=138&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=24&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company issued 108,778 unregistered shares of common stock for investor relations services - On October 10, 2023, the company issued **108,778 shares of common stock** for investor relations services, exempt from registration under Section 4(a)(2) of the Securities Act[139](index=139&type=chunk) [Other Information](index=24&type=section&id=Item%205.%20Other%20Information) The company reported no other information for the period - None[143](index=143&type=chunk) [Exhibits](index=25&type=section&id=Item%206.%20Exhibits) Filed exhibits include the Citius Oncology merger agreement and standard officer certifications - Filed exhibits include the **Agreement and Plan of Merger and Reorganization** dated October 23, 2023, concerning Citius Oncology, Inc. and TenX Keane Acquisition[145](index=145&type=chunk)

Independent Director nominee expected to be elected at Annual Shareholders' Meeting in March 2024 CRANFORD, N.J., Jan. 23, 2024 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products today announced the nomination of seasoned pharmaceutical executive Robert J. Smith to its Board of Directors. The nomination of Mr. Smith is subject to shareholder ...

● A distribution in connection with or following the spinoff could result in substantial tax liability to us and our stockholders. We are subject to a number of risks common to companies in the pharmaceutical industry including, but not limited to, risks related to the development by us or our competitors of research and development stage products, market acceptance of its products that receive regulatory approval, competition from larger companies, dependence on key personnel, dependence on key suppliers a ...

[PART I. FINANCIAL INFORMATION](index=4&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) The company reported no revenue, a slight decrease in total assets, a net loss of $22.6 million, and consistent cash usage from operations [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) | | June 30, 2023 ($) | September 30, 2022 ($) | | :--- | :--- | :--- | | **Current Assets** | | | | Cash and cash equivalents | $33,281,830 | $41,711,690 | | Total Current Assets | $41,114,150 | $44,564,270 | | **Total Assets** | **$110,404,835** | **$113,999,302** | | **Current Liabilities** | | | | Total Current Liabilities | $5,790,857 | $4,530,012 | | **Total Liabilities** | **$12,104,668** | **$10,573,057** | | **Total Equity** | **$98,300,167** | **$103,426,245** | - Cash and cash equivalents decreased from **$41.7 million** at September 30, 2022, to **$33.3 million** at June 30, 2023[15](index=15&type=chunk) - In-process research and development (IPR&D) and Goodwill remained unchanged at **$59.4 million** and **$9.3 million**, respectively[15](index=15&type=chunk) [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) | | Three Months Ended June 30, ($) | Nine Months Ended June 30, ($) | | :--- | :--- | :--- | | | **2023** | **2022** | **2023** | **2022** | | **Revenues** | $0 | $0 | $0 | $0 | | **Research and development** | $3,764,675 | $4,888,192 | $11,937,045 | $13,798,251 | | **General and administrative** | $3,733,326 | $3,024,783 | $11,129,463 | $9,038,949 | | **Total Operating Expenses** | $8,672,112 | $8,916,652 | $26,607,295 | $25,766,479 | | **Operating Loss** | $(8,672,112) | $(8,916,652) | $(26,607,295) | $(25,766,479) | | **Gain on sale of NJ NOLs** | $0 | $0 | $3,585,689 | $0 | | **Net Loss** | **$(8,479,332)** | **$(8,863,632)** | **$(22,599,002)** | **$(25,649,906)** | | **Net Loss Per Share** | $(0.06) | $(0.06) | $(0.15) | $(0.18) | - The company generated no revenue in the reported periods[17](index=17&type=chunk) - Net loss for the nine months ended June 30, 2023, decreased to **$22.6 million** from **$25.6 million** in the prior year, primarily due to a **$3.6 million** gain on the sale of New Jersey net operating losses[17](index=17&type=chunk) [Condensed Consolidated Statements of Changes in Stockholders' Equity](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Stockholders'%20Equity) - Total stockholders' equity decreased from **$103.4 million** on October 1, 2022, to **$98.3 million** on June 30, 2023[19](index=19&type=chunk) - Key changes in equity during the nine months ended June 30, 2023, include a net loss of **$22.6 million**, stock-based compensation of **$3.5 million**, and net proceeds of **$13.8 million** from a registered direct offering[19](index=19&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) | | Nine Months Ended June 30, ($) | | :--- | :--- | | | **2023** | **2022** | | **Net Cash Used In Operating Activities** | $(22,259,997) | $(22,028,752) | | **Net Cash Provided By Financing Activities** | $13,830,137 | $0 | | **Net Change in Cash and Cash Equivalents** | $(8,429,860) | $(22,028,752) | | **Cash and Cash Equivalents - End of Period** | **$33,281,830** | **$48,044,194** | - Financing activities provided **$13.8 million** in cash during the nine months ended June 30, 2023, from a registered direct offering and stock option exercises, compared to zero in the prior-year period[23](index=23&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) - The company is a late-stage pharmaceutical company focused on critical care products in oncology, anti-infectives, and stem cell therapies, with key product candidates including Mino-Lok®, Lymphir, Mino-Wrap, and Halo-Lido[26](index=26&type=chunk)[29](index=29&type=chunk)[43](index=43&type=chunk) - The company estimates its available cash of **$33.3 million** will be sufficient to fund operations through August 2024, with continued operations beyond this date dependent on regulatory approval and additional capital[38](index=38&type=chunk)[39](index=39&type=chunk) - In May 2023, the company closed a registered direct offering of **12.5 million** shares and accompanying warrants, raising gross proceeds of **$15.0 million** and net proceeds of **$13.8 million**[60](index=60&type=chunk)[61](index=61&type=chunk) - On July 29, 2023, the company received a Complete Response Letter (CRL) from the FDA for its Lymphir BLA, requiring enhanced product testing and controls, though remediation efforts are not expected to impact its 12-month cash runway[84](index=84&type=chunk)[85](index=85&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=19&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the $22.6 million net loss, driven by lower R&D and a gain on NOLs, with cash sufficient through August 2024 [Results of Operations](index=21&type=section&id=Results%20of%20Operations) Comparison of Three Months Ended June 30, 2023 and 2022 | | 2023 ($) | 2022 ($) | Change ($) | | :--- | :--- | :--- | :--- | | **R&D Expenses** | $3.8M | $4.9M | $(1.1)M | | **G&A Expenses** | $3.7M | $3.0M | $0.7M | | **Net Loss** | $(8.5)M | $(8.9)M | $0.4M | Comparison of Nine Months Ended June 30, 2023 and 2022 | | 2023 ($) | 2022 ($) | Change ($) | | :--- | :--- | :--- | :--- | | **R&D Expenses** | $11.9M | $13.8M | $(1.9)M | | **G&A Expenses** | $11.1M | $9.0M | $2.1M | | **Net Loss** | $(22.6)M | $(25.6)M | $3.0M | - For the nine-month period, R&D expenses decreased by **$1.9 million**, primarily due to a **$2.0 million** reduction in costs for Lymphir following its Phase 3 trial completion and BLA preparation, partially offset by a **$1.5 million** increase for the Halo-Lido Phase 2b trial[116](index=116&type=chunk)[118](index=118&type=chunk)[119](index=119&type=chunk) - G&A expenses increased by **$2.1 million** for the nine-month period, mainly due to costs associated with pre-launch and market research activities for Lymphir[121](index=121&type=chunk) [Liquidity and Capital Resources](index=25&type=section&id=Liquidity%20and%20Capital%20Resources) - As of June 30, 2023, the company had cash and cash equivalents of **$33.3 million** and working capital of approximately **$35.3 million**[130](index=130&type=chunk) - Net cash used in operations for the nine months ended June 30, 2023, was **$22.3 million**[129](index=129&type=chunk) - Management expects that current cash and cash equivalents will be sufficient to fund operations through August 2024, but additional capital will be needed beyond that date[131](index=131&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=26&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) This section is not applicable to the company's operations - Not applicable[136](index=136&type=chunk) [Item 4. Controls and Procedures](index=26&type=section&id=Item%204.%20Controls%20and%20Procedures) Disclosure controls and procedures were effective as of June 30, 2023, with no material changes to internal financial reporting controls - The Chief Executive Officer and Chief Financial Officer concluded that the company's disclosure controls and procedures were effective as of June 30, 2023[138](index=138&type=chunk) - There were no changes in internal control over financial reporting during the quarter ended June 30, 2023, that have materially affected, or are reasonably likely to materially affect, internal controls[139](index=139&type=chunk) [PART II. OTHER INFORMATION](index=27&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=27&type=section&id=Item%201.%20Legal%20Proceedings) The company reports no legal proceedings - None[142](index=142&type=chunk) [Item 1A. Risk Factors](index=27&type=section&id=Item%201A.%20Risk%20Factors) No material changes to the company's risk factors have occurred since the last Form 10-K filing - There has been no change in the Company's risk factors since the Form 10-K filed with the SEC on December 22, 2022[143](index=143&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=27&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reports no unregistered sales of equity securities - None[144](index=144&type=chunk) [Item 3. Defaults Upon Senior Securities](index=27&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reports no defaults upon senior securities - None[145](index=145&type=chunk) [Item 4. Mine Safety Disclosures](index=27&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This section is not applicable to the company's operations - Not applicable[146](index=146&type=chunk) [Item 5. Other Information](index=27&type=section&id=Item%205.%20Other%20Information) In August 2023, the company extended the expiration of 4.1 million warrants, held by executives and a placement agent, by one year - In August 2023, the company extended the term by one year to August 2024 for warrants issued in 2018, including **3,921,569** warrants at an exercise price of **$1.15** per share held by CEO Leonard Mazur and EVP Myron Holubiak, and **189,412** placement agent warrants at an exercise price of **$1.5938** per share[147](index=147&type=chunk) [Item 6. Exhibits](index=28&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed, including officer certifications and Inline XBRL data files - The exhibits filed with the report include certifications from the Principal Executive Officer and Principal Financial Officer, as well as Inline XBRL documents[149](index=149&type=chunk)