Citius Posts Wider Loss in Fiscal Q3

Citius Pharmaceuticals (CTXR -1.54%), a late-stage biopharmaceutical company focused on developing and commercializing critical care therapies, reported its earnings for the fiscal third quarter of 2025 on August 12, 2025. The quarter featured no revenue, and a net loss per share of ($0.80) (GAAP), falling short of the consensus analyst estimate of ($0.51) (GAAP). Operating expenses (GAAP) declined from last year, but liquidity remains tight even after capital raises. The quarter highlighted both notable progress towards bringing its first approved drug to market and persistent financial risks as it transitions into a commercial-stage company.

Source: Analyst estimates for the quarter provided by FactSet.

Business Overview and Recent Focus

The company specializes in developing and commercializing critical care therapies. Its lead asset, LYMPHIR, is a targeted immunotherapy for cutaneous T-cell lymphoma, a type of cancer that affects the skin’s T cells. The company’s primary focus in recent quarters has been advancing LYMPHIR from development to full commercialization within the United States, as well as progressing other pipeline candidates including its antibiotic lock solution, Mino-Lok, and the treatment CITI-002 (Halo-Lido).

Preparing for commercial launch is now the defining priority. Key success factors include building commercial infrastructure, executing product distribution partnerships, raising additional capital, and navigating regulatory pathways for other drugs in its pipeline.

Quarterly Highlights and Financial Developments

The period demonstrated concrete steps towards commercial launch of LYMPHIR. In August 2024, the U.S. Food and Drug Administration approved LYMPHIR for the treatment of cutaneous T-cell lymphoma. The company spent the quarter building inventory and finalizing agreements with third parties for manufacturing, packaging, and distribution, aiming for a planned U.S. launch in the fourth quarter of 2025. Inventory increased from $8.3 million at September 30, 2024, to $17.2 million at June 30, 2025.

Research and development expenses (GAAP) dropped 42.9% to $1.6 million, compared to the same period last year. General and administrative costs (GAAP) declined 8.3% year over year to $4.4 million, while Stock-based compensation (GAAP) fell 12.1%. These reductions helped the company to contain losses, with a total net loss (GAAP) of $9.2 million, lower than the $10.6 million GAAP net loss in Q3 FY2024. However, the company’s net loss per share of ($0.80) (GAAP) missed analyst expectations, as Wall Street had projected a somewhat narrower GAAP loss (EPS estimate: -0.51) and at least modest revenue (revenue estimate: $1.92 million).

Quarter-end cash including equivalents stood at $6.1 million, up from $3.3 million at September 30, 2024, the result of equity financing transactions finished during the quarter. The company raised $12.5 million in gross proceeds from various financings, with an additional $9 million in gross proceeds raised by its Citius Oncology arm in July 2025. Despite these infusions, the cash position may not be sufficient to support operations through the expected commercial launch, especially given the company’s quarterly net loss profile and pending commercialization spend.

Operational progress in the pipeline outside LYMPHIR included successful Phase 3 clinical results for Mino-Lok, aimed at catheter-related bloodstream infections, though regulatory and commercial timelines are not yet clear. Halo-Lido, intended to treat a different condition, completed Phase 2b trials but the earnings release flagged ongoing discussions with the FDA on both assets, but did not disclose anticipated timing or probability of approval.

Product Pipeline Context

LYMPHIR, a targeted immunotherapy, is positioned as the company’s commercial entry point and addresses an underserved market in cutaneous T-cell lymphoma. The company’s antibiotic lock solution, Mino-Lok, is designed to salvage central venous catheters from infection rather than remove and replace them, targeting infection management in critical care. CITI-002 (Halo-Lido) is being developed for relief of hemorrhoidal disease symptoms, and the company is actively engaged with the FDA to outline next steps.

Positive trial outcomes and regulatory clearance are required milestones for further value creation. The company’s success will depend heavily on the degree of market uptake following LYMPHIR’s launch, securing effective commercial partnerships for distribution, and maintaining enough financial flexibility to bridge operating costs until revenue materializes. Risks remain around execution, as well as market competition, reimbursement, and timing of additional regulatory approvals.

Outlook and Forward-Looking Information

Management did not offer forward-looking financial guidance for revenue or earnings for the remaining fiscal year or beyond. The company’s leadership emphasized preparations for the U.S. launch of LYMPHIR in the fourth quarter of 2025 but cautioned that its financial future depends on successful commercial execution and ongoing access to capital. Projected sales or gross margin guidance for the new product line was not provided.

For investors monitoring Citius Pharmaceuticals, watchpoints include the pace and scope of LYMPHIR’s commercial ramp-up, future cash infusions through warrant exercises or additional financings, and the achievement of regulatory milestones for Mino-Lok and CITI-002. The company’s continued Nasdaq listing may be at risk if financial viability and share price do not improve in the near term.

CTXR does not currently pay a dividend.

Revenue and net income presented using U.S. generally accepted accounting principles (GAAP) unless otherwise noted.