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 ...

U.S. SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended: June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ______________ to ______________ Commission File Number 001-38174 Citius Pharmaceuticals, Inc. (Exact name of registrant as specified in its charter) | Nevada | 27-3425913 | ...

Commission File Number 001-38174 Citius Pharmaceuticals, Inc. (Exact name of registrant as specified in its charter) 11 Commerce Drive, First Floor, Cranford, NJ 07016 (Address of principal executive of ices) (Zip code) (908) 967-6677 (Registrant's telephone number, including area code) Securities registered pursuant to Section 12(b) of the Act: Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during th ...

U.S. SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended: December 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ______________ to ______________ Commission File Number 001-38174 Citius Pharmaceuticals, Inc. (Exact name of registrant as specified in its charter) | Nevada | 27-34259 ...