Citius Pharmaceuticals Inc. (NASDAQ: CTXR) is nearing critical milestones with two lead products that could significantly impact the medical and pharmaceutical industries. Mino-Lok and LYMPHIR, both on the cusp of commercialization, address major health issues such as catheter-related bloodstream infections and T-cell lymphomas.
Mino-Lok is an innovative antibiotic lock solution that combines minocycline, ethanol, and edetate disodium to treat patients with catheter-related bloodstream infections. Unlike traditional methods that require the removal and replacement of central venous catheters (CVCs), Mino-Lok offers a less invasive alternative. This could reduce the risk of serious adverse events like air embolism and bleeding, potentially saving hospitals both time and money.
Citius Pharmaceuticals CEO and co-founder Leonard Mazur shared that the company has obtained “extremely positive” topline data from a Phase 3 trial of Mino-Lok. The company is now in discussions with the U.S. Food and Drug Administration (FDA) to advance the product further. Upon FDA approval, Mino-Lok would be the only authorized product for infected catheters on the market, presenting a significant opportunity for Citius. According to Mazur, the market potential for Mino-Lok is estimated at around $2 billion.
The second promising product, LYMPHIR, is a recombinant fusion protein designed to treat T-cell lymphomas. This drug combines the interleukin-2 (IL-2) receptor binding domain with diphtheria toxin fragments, specifically targeting IL-2 receptors on cell surfaces to inhibit protein synthesis. LYMPHIR has already received orphan drug designation from the FDA for treating peripheral T-cell lymphoma (PTCL) and Cutaneous T-cell lymphoma (CTCL).
In March, the FDA accepted Citius’s Biologics License Application (BLA) for LYMPHIR, with a decision expected by August 13, 2024. If approved, Citius plans to commercialize LYMPHIR later this year, with market opportunities estimated between $300 to $400 million. Mazur emphasized that LYMPHIR is an additive treatment and will not cannibalize existing market shares.
In addition to advancing these critical products, Citius is also taking steps to enhance shareholder value by spinning off its wholly-owned oncology unit to form Citius Oncology, a stand-alone publicly traded entity. This move will be executed through a SPAC deal with TenX Keane (NASDAQ: TENK). Citius Pharmaceuticals will receive 67.5 million shares in Citius Oncology at $10 per share, valuing its stake at $675 million and retaining approximately 90% ownership.
This strategic transaction is designed to unlock significant value for shareholders by separating the oncology business. It aims to increase access to capital markets and further develop new applications and intellectual property. Citius Oncology will focus on developing and commercializing novel targeted oncology therapies, with LYMPHIR leading the charge. The deal is expected to provide improved access to public equity markets, facilitating the commercialization of LYMPHIR and positioning the company for additional value-creating opportunities.
Mazur noted that this Nasdaq listing via the SPAC deal not only prevents shareholder dilution but also positions Citius for profitability in its first year on the market. With Mazur's substantial personal investment of $22.5 million, the company appears well-poised to benefit its shareholders significantly.
