On February 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 first quarter ended December 31, 2024 (Press release, Citius Pharmaceuticals, FEB 14, 2025, View Source [SID1234650293]).
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Fiscal First Quarter 2025 Business Highlights and Subsequent Developments
- Substantially advanced operational readiness for commercial launch of LYMPHIR in the first half of 2025;
- Secured a new permanent J-code, J9161, (Injection, denileukin diftitox-cxdl, for intravenous use, 1 microgram) for LYMPHIR, assigned by the Centers for Medicare & Medicaid Services (CMS), with an expected effective date of April 1, 2025;
- Announced promising preliminary results from an ongoing investigator-initiated Phase I clinical trial of a combined regimen of checkpoint inhibitor pembrolizumab and LYMPHIR (denileukin diftitox-cxdl) in patients with recurrent solid tumors. Presented data at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2024 Annual Meeting;
- Supported expansion of the University of Minnesota’s investigator-initiated Phase I clinical trial to evaluate the safety and efficacy of denileukin diftitox administration prior to Chimeric Antigen Receptor (CAR-T) therapies for the treatment of B-cell lymphomas with the dosing of the first patient at City of Hope cancer center;
- Engaged with the U.S. Food and Drug Administration (FDA) to clarify development paths for pipeline assets Mino-Lok and Halo-Lido;
- Advanced strategic and financing initiatives to help secure the capital needed to drive the full potential of our clinical and commercial programs.
o Citius Oncology (Nasdaq: CTOR), our majority-owned subsidiary, engaged Jefferies as exclusive financial advisor to assist in evaluating strategic alternatives aimed at maximizing shareholder value;
o Completed registered direct offerings of common stock and warrants in November 2024 and January 2025, and sold shares of common stock through the Company’s "at-the-market" facility in January 2025 for combined gross proceeds of $6.5 million;
o Effective November 25, 2024, the Company executed a reverse stock split of its common stock, at a ratio of 1-for-25; and,
- On December 18, 2024, the Company received notification that it had regained compliance with the $1.00 per share requirement for continued inclusion on the Nasdaq Stock Market.
Financial Highlights
- Cash and cash equivalents of $1.1 million as of December 31, 2024;
- R&D expenses were $2.1 million for the first quarter ended December 31, 2024, compared to $2.6 million for the first quarter ended December 31, 2023;
- G&A expenses were $5.4 million for the first quarter ended December 31, 2024, compared to $3.7 million for the first quarter ended December 31, 2023;
- Stock-based compensation expense was $2.5 million for the first quarter ended December 31, 2024, compared to $3.1 million for the first quarter ended December 31, 2023; and,
- Net loss was $10.3 million, or ($1.30) per share for the first quarter ended December 31, 2024, compared to a net loss of $9.2 million, or ($1.45) per share for the first quarter ended December 31, 2023.
"As we continue to advance our strategic priorities, we remain engaged in active discussions with potential partners who recognize the value of our pipeline and our commitment to developing innovative therapies for patients with high unmet medical needs. Securing the necessary financing to support our key programs remains a top priority, and we are evaluating multiple options to strengthen our financial position," stated Leonard Mazur, Chairman and CEO of Citius Pharmaceuticals.
"In parallel, we are making significant progress in our preparations for the anticipated launch of LYMPHIR in the first half of 2025, positioning us to bring this important therapy to patients while creating long-term value for our shareholders. We look forward to providing further updates as we execute on these critical initiatives," added Mazur.
FISCAL FIRST QUARTER 2025 Financial Results:
Liquidity
As of December 31, 2024, the Company had $1.1 million in cash and cash equivalents.
As of December 31, 2024, the Company had 7,727,243 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 quarter ended December 31, 2024, the Company received gross proceeds of $3 million from the issuance of equity. An additional $3.5 million in gross proceeds was received in January 2025 from the issuance of equity through the Company’s "at-the-market" facility and a registered direct offering of common stock and warrants. The Company expects to raise additional capital to support operations.
Research and Development (R&D) Expenses
R&D expenses were $2.1 million for the first quarter ended December 31, 2024, compared to $2.6 million for the first quarter ended December 31, 2023. The decrease in R&D expenses primarily reflects the completion of the Halo-Lido Phase 2 and Mino-Lok Phase 3 trials, offset by an increase in LYMPHIR-related expenses due to additional headcount and ongoing investigator-initiated trials.
We expect that research and development expenses will continue to decrease in fiscal 2025 because we have completed the Phase 3 trial for Mino-Lok and we remain focused on the commercialization of LYMPHIR through our majority-owned subsidiary, Citius Oncology, Inc.
General and Administrative (G&A) Expenses
G&A expenses were $5.4 million for the first quarter ended December 31, 2024, compared to $3.7 million for the first quarter ended December 31, 2023. The increase was primarily due to higher costs for pre-launch sales and marketing 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 first quarter ended December 31, 2024, stock-based compensation expense was $2.5 million as compared to $3.1 million for the prior year. Stock-based compensation expense during the quarter ended December 31, 2024 is primarily related to the Citius Oncology Plan. The decrease compared to the prior year is due to lower costs associated with the Citius Pharma stock plans.
Net loss
Net loss was $10.3 million, or ($1.30) per share for the quarter ended December 31, 2024, compared to a net loss of $9.2 million, or ($1.45) per share for the quarter ended December 31, 2023, as adjusted for the reverse stock split. The increase in net loss was due to the increase in general and administrative expenses partially offset by lower research and development expense.