Citius Pharmaceuticals Announces Q2 2024 Financial Results and Business Update
Citius Pharmaceuticals, Inc., a biopharmaceutical company headquartered in Cranford, New Jersey, revealed its financial and business progress for the second fiscal quarter of 2024, which concluded on March 31, 2024. The company’s endeavors include the advancement of several key pharmaceutical products and financial maneuvers aimed at sustaining and expanding its operations.
Key Developments in Business and Products
Citius Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for LYMPHIR™, an innovative oncology therapy targeting IL-2 receptors. The FDA has set August 13, 2024, as the Prescription Drug User Fee Act (PDUFA) target action date.
Additionally, data analysis is currently being conducted on the completed Mino-Lok® Pivotal Phase 3 trial. This trial is significant as it focuses on a unique treatment developed to salvage infected catheters. The company expects to release topline results later in the second quarter of 2024.
Citius has also been in continuous discussions with the FDA regarding the next developmental phase for Halo-Lido, a compound aimed at treating hemorrhoids.
In a strategic move, Citius plans to merge its wholly owned subsidiary with TenX Keane Acquisition, culminating in the formation of Citius Oncology, Inc. This new entity is pending review by the Securities and Exchange Commission (SEC) and TenX shareholder approval.
In corporate governance, Robert Smith has been elected to the Citius Board of Directors. Financially, the company strengthened its capital by completing a $15 million registered direct offering in April 2024, thereby extending its cash runway.
Financial Overview
As of March 31, 2024, Citius Pharmaceuticals reported having $12.6 million in cash and cash equivalents. The aforementioned capital raise in April 2024 generated an additional $15 million, which is expected to support the company's operations through December 2024. Future fundraising efforts are anticipated to sustain operations beyond this period.
Research and Development (R&D) Expenses
For the quarter ending March 31, 2024, R&D expenses stood at $3.6 million, a decrease from $4.7 million for the same period in 2023. Over the six-month span ending March 31, 2024, R&D costs were $6.2 million, compared to $8.2 million in the previous year. The reduction was primarily due to the completion of specific trials and activities such as the Mino-Lok Phase 3 trial and LYMPHIR BLA resubmission.
General and Administrative (G&A) Expenses
G&A expenses in the quarter ending March 31, 2024, were $4.3 million, down from $4.8 million in the same period in 2023. However, for the six months ending March 31, 2024, G&A expenses increased to $7.9 million from $7.4 million in the prior year, largely due to pre-launch and market research activities for LYMPHIR.
Stock-Based Compensation
The stock-based compensation expense saw a significant rise, reaching $3.1 million for the quarter ending March 31, 2024, compared to $1.2 million in the same period in 2023. For the six-month period, the expense was $6.1 million, up from $2.4 million in the previous year.
Net Loss
Citius reported a net loss of $8.5 million, or ($0.05) per share, for the quarter ending March 31, 2024, compared to a net loss of $10.5 million, or ($0.07) per share, in the prior year. For the six months ending March 31, 2024, the net loss was $17.8 million, or ($0.11) per share, compared to $14.1 million, or ($0.10) per share, in 2023. The increase in net loss was primarily attributed to higher stock-based compensation expenses.
Future Outlook
Citius Pharmaceuticals continues to focus on the commercialization of LYMPHIR and the progression of its clinical trials, including the planned Phase 3 trial for Halo-Lido. The company aims to capitalize on the potential approval of LYMPHIR and the formation of Citius Oncology to enhance its market presence and attract further investment.
Chairman and CEO Leonard Mazur expressed optimism about the progress made in the quarter and reiterated the company’s commitment to managing finances effectively while advancing its critical care products. The successful completion of recent financial initiatives is anticipated to bolster Citius’ strategic plans and operational capacity.
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