Citius Pharmaceuticals Reports Strong Financial Performance and Strategic Developments for Fiscal Year 2024

Citius Pharmaceuticals: A Year of Transformation

Citius Pharmaceuticals, Inc. has made remarkable progress throughout the fiscal year ending September 30, 2024, setting a clear trajectory for future developments in the biopharmaceutical landscape. This year is particularly notable as it marks the company’s first FDA approval, which promises positive implications for its market presence moving forward.

One of the major highlights of the year was the successful FDA approval of LYMPHIR™ (denileukin diftitox-cxdl), an innovative immunotherapy designed for adults with relapsed or refractory cutaneous T-cell lymphoma (CTCL). This milestone not only showcases Citius Pharma's dedication to developing critical care products but also enhances its reputation in the competitive biopharmaceutical market.

In preparation for the commercial launch of LYMPHIR, expected in the first half of 2025, Citius has ramped up its manufacturing, marketing, and sales efforts. The company's proactive approach is indicative of its commitment to ensuring that this groundbreaking therapy reaches its intended patients as swiftly as possible.

Additionally, Citius Pharmaceuticals expanded its portfolio through the merger of its oncology subsidiary with TenX Keane, creating Citius Oncology, Inc. This newly formed company has begun trading on the Nasdaq under the ticker CTOR, further establishing Citius Pharma's position in the oncology sector. The completion of this merger not only signifies growth but also signals a strategic move to enhance operational focus on oncology-related therapies.

Citius Pharma has also supported two investigator-initiated trials to evaluate the potential of LYMPHIR in immuno-oncology combination therapies. Both trials, conducted at reputable institutions such as the University of Pittsburgh Medical Center and the University of Minnesota, speak volumes about the ongoing clinical exploration surrounding LYMPHIR.

The knowledge shared at significant conferences, including the Society for Immunotherapy of Cancer (SITC), on the interim results from LYMPHIR's clinical trials underscores Citius's commitment to transparency and engagement with the clinical community.

Citius Pharmaceuticals also reported notable financial results this year. The company ended the fiscal year with cash and cash equivalents amounting to $3.3 million. Research and Development expenses saw a decline to $11.9 million, demonstrating a strategic shift in resource allocation following the completion of certain trials. In contrast, General and Administrative expenses increased to $18.2 million, attributed to pre-launch activities for LYMPHIR, which are essential for ensuring a successful market entry.

Despite these expenditures, Citius reported a net loss of $39.4 million for the fiscal year, slightly higher than last year’s net loss of $32.5 million. Such losses are typical for biopharmaceutical companies in the development phase of new therapies, especially those preparing for growth and market entry like Citius Pharma. The company remains optimistic about the potential of its existing products and pipeline projects.

Looking ahead into fiscal year 2025, Citius Pharmaceuticals has laid out clear priorities, including the anticipated launch of LYMPHIR through its majority-owned subsidiary, Citius Oncology. The company is also focusing on clinical and regulatory strategies for its other significant projects, Mino-Lok® and Halo-Lido, as well as strengthening its financial position.

Chairman and CEO, Leonard Mazur, stated, "Our mission is clear: to create value for patients and healthcare providers. With a robust team and strategic plans, we are excited about our direction as we enter 2025."

In conclusion, Citius Pharmaceuticals, Inc. is poised for significant advancements in the coming year. With the recent FDA approval, strategic partnerships, and an unwavering commitment to innovation, the company is well-prepared to deliver its transformative therapies to the market and drive patient care outcomes. Keep an eye on Citius as it embarks on what promises to be a pivotal journey in the biopharmaceutical realm.