Citius Pharmaceuticals Advances Toward Market with Groundbreaking Treatments

Citius Pharmaceuticals Inc. (NASDAQ: CTXR) is making significant strides in addressing critical healthcare challenges with two of its leading products nearing market readiness. The company’s innovative treatments, Mino-Lok and LYMPHIR, are poised to offer substantial benefits to both patients and healthcare providers.

Mino-Lok, a novel antibiotic lock solution combining minocycline, ethanol, and edetate disodium, aims to treat catheter-related bloodstream infections. This solution could provide an alternative to the current standard of care, which involves removing and replacing central venous catheters (CVCs). By potentially reducing serious adverse events like air embolism and bleeding, Mino-Lok could also result in significant cost savings for hospitals. CEO and co-founder Leonard Mazur highlighted the company’s “extremely positive” topline data from a Phase 3 Trial and mentioned ongoing discussions with the U.S. Food and Drug Administration (FDA) to advance Mino-Lok toward approval.

Once approved, Mino-Lok will be the only FDA-backed product for infected catheters on the market, presenting a substantial market opportunity estimated at $2 billion. This development could change the landscape of infection management in healthcare settings, offering a safer and more cost-effective option for hospitals and patients.

In parallel, Citius is advancing LYMPHIR, a recombinant fusion protein designed to treat T-cell lymphomas, including peripheral T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL). The FDA has granted orphan drug designation to LYMPHIR, and the Biologics License Application (BLA) has been accepted, with a decision expected by August 13. If approved, Citius plans to commercialize LYMPHIR later this year, with an estimated market opportunity of $300 to $400 million. The introduction of LYMPHIR could provide a new therapeutic option for patients with these rare cancers, potentially improving treatment outcomes.

In addition to these product advancements, Citius is enhancing shareholder value by spinning out its wholly-owned oncology unit to form Citius Oncology, a standalone publicly traded entity. This strategic move, executed via a SPAC deal with TenX Keane (NASDAQ: TENK), is expected to unlock significant value for shareholders. Citius Pharma will hold a majority ownership of approximately 90% in Citius Oncology, valued at $675 million.

The creation of Citius Oncology is aimed at developing and commercializing novel targeted oncology therapies, with LYMPHIR as the first product to hit the market. This transaction is expected to provide improved access to public equity markets, facilitating the commercialization of LYMPHIR and enabling the exploration of additional value-creating opportunities. Mazur, who has invested $22.5 million of his own money in the business, emphasized the potential for profitability during the first year on the market, benefiting Citius shareholders.

These developments highlight Citius Pharmaceuticals’ commitment to addressing unmet medical needs while simultaneously creating value for its shareholders. The successful commercialization of Mino-Lok and LYMPHIR could significantly impact the healthcare industry, offering new treatment options and improving patient outcomes.