New Jersey biotech Citius Pharmaceuticals is transitioning from a development-stage company to revenue generation as it prepares to commercially launch LYMPHIR™, the only FDA-approved IL-2R-targeted systemic therapy for cutaneous T-cell lymphoma, in Q4 2025. In this interview, the CEO Leonard Mazur shares how they’ve advanced three distinct programs across oncology, infectious disease, and gastrointestinal disorders—navigating pandemic disruptions and late-stage clinical execution while maintaining financial flexibility through strategic capital raises exceeding $150 million.

Building a Multi-Asset Pipeline from Critical Care Origins

Founded in 2013 by biotech entrepreneur Leonard Mazur and former Roche Labs U.S. President Myron Holubiak, Citius secured an exclusive license from MD Anderson Cancer Center to develop Mino-Lok as its initial focus. The antibiotic lock solution for catheter salvage in bloodstream infections established the company’s foundation in critical care before expanding into immuno-oncology with LYMPHIR and gastrointestinal disorders with CITI-002 (Halo-Lido).

The founding team brought complementary expertise to the venture. Mazur’s five decades of biotech experience included previous ventures at Akrimax Pharmaceuticals, Genesis Pharmaceuticals, and executive positions at ICN Pharma, BASF, and Cooper Labs. Holubiak, now Vice Chairman, contributed deep commercialization knowledge from pioneering work in pharma commercialization.

Targeting Three Distinct Underserved Patient Populations

Each asset in Citius’s pipeline addresses a specific unmet medical need. LYMPHIR targets relapsed or refractory cutaneous T-cell lymphoma, a rare, chronic and disfiguring non-Hodgkin lymphoma that lacks durable systemic treatment options. The therapy works by targeting the IL-2 receptor on malignant T-cells and regulatory T-cells, enabling tumor cell death and transient immune modulation.

Mino-Lok provides a non-invasive alternative to catheter removal for patients with catheter-related bloodstream infections. The formulation combines minocycline, EDTA, and ethanol to disrupt biofilms and kill embedded pathogens without systemic toxicity, offering a solution to costly and disruptive catheter replacement.

Halo-Lido addresses symptomatic hemorrhoids with a dual-action topical formulation of lidocaine and halobetasol. Designed for rapid symptom relief and local anti-inflammatory effects, it represents the first prescription-strength combination therapy for severe Grade II–III cases in a highly prevalent condition with limited treatment options.

Navigating Clinical Execution Through Pandemic Disruptions

The company demonstrated operational resilience during its Mino-Lok Phase 3 trial, which faced considerable challenges during the COVID-19 pandemic. Hospital site restrictions, enrollment delays, and patient hesitancy due to infection risk threatened trial progress. Citius responded by implementing remote monitoring, expanding trial sites internationally, and maintaining close investigator engagement. These efforts enabled successful enrollment completion and achievement of statistically significant primary and secondary endpoints, with catheter salvage rates showing strong statistical significance (p=0.0006) alongside strong tolerability.

LYMPHIR’s pivotal Phase 3 trial demonstrated a 36% overall response rate with rapid symptom relief and no cumulative toxicity, leading to FDA approval in 2024. The therapy has since been added to the NCCN Guidelines as Category 2A, supported by strong engagement with key opinion leaders in hematology and dermatology as well as patient advocacy groups.

Halo-Lido completed a Phase 2b trial, with planning underway for next-stage regulatory discussions to support a potential New Drug Application. The company has shown ability to efficiently execute across varying clinical designs—from oncology and infectious disease to localized gastrointestinal disorders—while meeting FDA standards.

Outsourced Manufacturing Strategy Enables Multi-Program Scalability

Citius has adopted a fully outsourced manufacturing model, partnering with best-in-class contract development and manufacturing organizations across all three programs. This approach ensures flexibility, quality, and scalability without the capital burden of building in-house infrastructure.

For LYMPHIR, commercial-scale production is already underway with inventory secured for the Q4 2025 launch. The company has 12–18 months of post-launch inventory in place, with the product maintaining a 60-month shelf life. Mino-Lok and Halo-Lido clinical supplies are supported by third-party manufacturers with specialized expertise in sterile injectables and topical formulations, respectively.

The company prioritized early engagement with established CDMOs to manage formulation, packaging, and regulatory compliance across all programs. This proactive approach to vendor selection has been critical to maintaining quality standards while advancing multiple assets in parallel without manufacturing delays.

Capital Strategy: Building Financial Flexibility for Multiple Shots on Goal

Citius has secured significant capital through a combination of founder investment and public offerings. The founders invested $26.5 million directly, and the company’s multiple fundraising efforts have raised in excess of $150 million in gross proceeds. These funds proved critical in expanding the pipeline to include LYMPHIR and completing Phase 3 trials for both LYMPHIR and Mino-Lok, as well as the Phase 2b trial for Halo-Lido.

The company benefits from an ecosystem of clinical and institutional partnerships. Beyond the original MD Anderson collaboration, LYMPHIR development has been informed by strong relationships with U.S. hematology and dermatology key opinion leaders. Halo-Lido’s development incorporates clinical input from colorectal specialists and primary care stakeholders, ensuring clinical designs align with real-world needs and reimbursement landscapes.

From Development to Revenue: Near-Term Commercial Catalysts

Over the next 12–18 months, Citius is executing against multiple catalysts centered on its transition to a revenue-generating biopharmaceutical company. The U.S. commercial launch of LYMPHIR represents the company’s entry into commercial operations, with potential strategic partnerships to expand the therapy’s global footprint and maximize commercial potential for Mino-Lok and Halo-Lido.

Mr. Mazur emphasised, “One of the most important lessons from Citius’s journey is the value of hiring exceptional talent at every stage. Building a strong cross-functional team has been critical to advancing multiple programs in parallel. Success in clinical development demands more than strong data; it requires foresight, operational alignment, and stakeholder engagement. And, importantly, you’re likely to need more capital than you think, so take advantage of moments when the capital markets are friendly to build as much financial flexibility into your strategy as possible.”