On December 27, 2024 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 full year ended September 30, 2024 (Press release, Citius Pharmaceuticals, DEC 27, 2024, View Source [SID1234649328]).

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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 (SITC) (Free SITC Whitepaper) Conference (SITC) (Free SITC Whitepaper) 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.