On May 14, 2025 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 reported business and financial results for the fiscal quarter ended March 31, 2025 (Press release, Citius Pharmaceuticals, MAY 14, 2025, View Source [SID1234653057]).

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"As we continue to focus on the planned launch of our first FDA-approved product, LYMPHIR, through Citius Oncology, we are actively engaged in securing the necessary financing to advance our launch strategy in the coming months, as well as exploring strategic partners for Citius Oncology," said Leonard Mazur, Chairman and CEO of Citius Pharmaceuticals and Citius Oncology.

"We are also in the process of preparing a submission to the FDA that reflects the valuable feedback we received from the agency concerning clinical efficacy, safety data, and in-vitro data. This submission is a key step toward supporting a future New Drug Application (NDA) for our Mino-Lok program. As a reminder, our Phase 3 Trial, which was completed last year, met its primary endpoints," added Mazur.

"During the quarter, we took deliberate steps to strengthen our financial position, including completing a registered direct offering and leveraging our existing at-the-market sales agreement to ensure capital flexibility. We also amended our license agreement with Eisai to align our payment obligations with our commercialization timeline. With these efforts underway, we believe we are positioned to deliver long-term value to patients and shareholders alike," concluded Mazur.

FISCAL SECOND QUARTER 2025 Financial Results:

Liquidity

During the six months ended March 31, 2025, the Company received net proceeds of $6 million from the issuance of equity. On April 2, 2025, the Company closed on a registered direct offering to an institutional investor of our common stock and pre-funded warrants to purchase common stock. The net proceeds to the Company from the offering were approximately $1.735 million, after deducting placement agent fees and other offering expenses payable by the Company.

As of March 31, 2025, the Company had $26,410 in cash and cash equivalents and 8,760,649 common shares outstanding excluding the April 2, 2025 financing. Citius Pharma will need to secure additional capital to support operations beyond May 2025.

Until Citius Oncology raises adequate capital through equity financings from outside investors and/or generates revenue from the future sales of LYMPHIR, Citius Pharma plans to continue to fund Citius Oncology. Citius Oncology has also retained Jefferies LLC as its exclusive financial advisor to evaluate strategic alternatives aimed at maximizing stockholder value.

Research and Development (R&D) Expenses

R&D expenses were $3.8 million for the quarter ended March 31, 2025, as compared to $3.6 million for the quarter ended March 31, 2024. For the six months ended March 31, 2025, R&D expenses were $5.9 million, as compared to $6.3 million during the six months ended March 31, 2024. R&D expenses primarily reflect LYMPHIR-related costs.

Research and development costs for LYMPHIR were $5.3 during the six months ended March 31, 2025, as compared to $3.2 million for the six months ended March 31, 2024. The $2.1 million increase in expenses was primarily due to costs associated with the expense of a drug substance batch needed for the pre license inspection of the manufacturer.

R&D expenses related to Mino-Lok decreased due to completion of the Phase 3 trial. There were no Halo Lido R&D expenses during the quarter, and $11 thousand was recorded for the six months ended March 31, 2025.

We expect that research and development expenses will continue to decrease in fiscal 2025 as we continue to focus on the commercialization of LYMPHIR and because we have completed the Phase 3 trial for Mino-Lok.

General and Administrative (G&A) Expenses

G&A expenses were $4.8 million for the quarter ended March 31, 2025, as compared to $4.3 million for the quarter ended March 31, 2024. For the six months ended March 31, 2025, G&A expenses were $10.2 million, as compared to $7.9 million for the six months ended March 31, 2024. The increase was primarily due to higher costs for pre-launch commercial 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 quarter ended March 31, 2025, stock-based compensation expense was $2.7 million, as compared to $3.1 million for the quarter ended March 31, 2024. For the six months ended March 31, 2025, stock-based compensation expense was $5.2 million, as compared to $6.1 million for the six months ended March 31, 2024. Stock-based compensation expense is primarily related to the Citius Oncology stock plans. The decrease compared to the prior year is due to lower costs associated with the Citius Pharma stock plans.

Net loss

Net loss was $11.5 million, or ($1.27) per share, for the quarter ended March 31, 2025, as compared to a net loss of $8.5 million, or ($1.34) per share, for the quarter ended March 31, 2024, as adjusted for the reverse stock split. The increase in net loss was due to a $2.6 million decrease in other income, offset by the increase in general and administrative expenses and research and development expenses.

For the six months ended March 31, 2025, we incurred a net loss of $21.8 million, as compared to a net loss of $17.8 million for the six months ended March 31, 2024. The $4.0 million increase in the net loss was primarily due to the increase of $2.2 million in general and administrative expenses and the decrease in other income of $2.9 million, partially offset by lower research and development expense and lower stock-based compensation expense.