Citius Pharmaceuticals, Inc. — Fiscal Third Quarter 2026 Earnings Summary

Financial Performance

• Generated $1.5 million in revenue for the three months ended June 30, 2026, compared to $0 in the same period in 2025; revenue totaled $7.1 million for the nine months ended June 30, 2026, compared to $0 in 2025.
• Reported gross profit of $1.0 million (67% gross margin) for the three months ended June 30, 2026, and $5.5 million (77% gross margin) for the nine months ended June 30, 2026.
• Research and development expenses were $1.1 million for the three months ended June 30, 2026 (down from $1.6 million in 2025) and $4.3 million for the nine months ended June 30, 2026 (down from $7.5 million in 2025).
• General and administrative expenses were $6.1 million for the three months ended June 30, 2026 (up from $4.4 million in 2025) and $38.3 million for the nine months ended June 30, 2026 (up from $14.6 million in 2025), primarily due to a non-recurring $19.7 million contract cancellation charge in March 2026 and increased commercial launch expenses.
• Stock-based compensation expense was $3.8 million for the three months ended June 30, 2026 (up from $2.7 million in 2025) and $11.9 million for the nine months ended June 30, 2026 (up from $7.9 million in 2025).
• Net loss applicable to common stockholders was $8.9 million ($0.34 per share) for the three months ended June 30, 2026, compared to $8.8 million ($0.80 per share) in 2025; for the nine months ended June 30, 2026, net loss was $38.3 million ($1.64 per share), compared to $29.5 million ($3.27 per share) in 2025.
• Cash and cash equivalents stood at $17.0 million as of June 30, 2026, up from $4.3 million as of September 30, 2025.
• Total assets were $142.3 million as of June 30, 2026, compared to $130.9 million as of September 30, 2025.
• Total liabilities were $66.3 million as of June 30, 2026, compared to $53.4 million as of September 30, 2025.
• Net cash used in operating activities was $23.0 million for the nine months ended June 30, 2026, compared to $14.7 million in 2025.
• Net cash provided by financing activities was $42.7 million for the nine months ended June 30, 2026, compared to $17.5 million in 2025.

Guidance and Future Outlook

• Management indicated that the LYMPHIR launch continues to build momentum and remains the primary driver of the business.
• The company aims to facilitate increased engagement with priority treatment centers, support formulary adoption, and broaden access for eligible patients as the launch matures.
• Management remains focused on disciplined execution and building the long-term sustainable value of LYMPHIR.
• The company is actively engaged with the FDA to outline next steps for Mino-Lok and Halo-Lido programs following completed pivotal Phase 3 and Phase 2b trials.
• Management estimates the initial market for LYMPHIR exceeds $400 million, is growing, and is underserved by existing therapies.

Business Segments and Product Lines

• LYMPHIR, a targeted immunotherapy for relapsed or refractory Stage I–III CTCL, is the sole commercial product driving revenue.
• LYMPHIR is available at 44 leading academic oncology centers, NCCN institutions, and community infusion centers.
• Institutional vial orders increased, with new institutions placing orders; new institution orders grew by 80% and institutional vial orders from wholesalers grew by 31% during the quarter.
• July 2026 saw 383 vials ordered by institutions from wholesalers, the largest vial order month to date.
• The company secured near universal payer coverage with no reported reimbursement denials or preauthorization barriers.
• Citius Oncology's commercial and medical affairs teams were expanded by 21 commercial field-based professionals and eight medical science liaisons, totaling 29 professionals, with nationwide deployment completed in August 2026.
• Phase 1 data presented at ASCO 2026 showed LYMPHIR in combination with pembrolizumab in gynecologic malignancies achieved a 24% overall response rate, 48% clinical benefit rate, and a median progression-free survival of 20.5 months among patients achieving clinical benefit.
• Phase 1 data presented at the 2026 ASTCT & CIBMTR Tandem Meetings showed LYMPHIR administered prior to CAR-T therapy in high-risk relapsed or refractory DLBCL achieved an 86% objective response rate (57% complete response, 29% partial response) with no dose-limiting toxicities.
• The late-stage pipeline includes Mino-Lok (catheter lock solution) and CITI-002 (Halo-Lido, topical hemorrhoid relief), both of which met primary and secondary endpoints in completed trials.

Market and Competitive Landscape

• LYMPHIR targets an estimated initial market exceeding $400 million.
• The company cites robust intellectual property protections including orphan drug designation, complex technology, trade secrets, and pending patents for immuno-oncology use as combination therapy with checkpoint inhibitors.
• The company relies on EVERSANA as its exclusive commercialization partner for nationwide deployment.
• The company faces competition in a competitive treatment landscape and relies on physician and patient acceptance of LYMPHIR.

Risks and Challenges

• The company requires substantial additional funds and must raise additional money to fund operations for at least the next 12 months as a going concern.
• The company must regain compliance with Nasdaq's continued listing standards.
• Risks include the ability to successfully commercialize LYMPHIR, establish a sustainable revenue stream, and obtain regulatory approval for Mino-Lok and Halo-Lido.
• The company faces risks related to obtaining a new bulk drug substance supplier, securing strategic partnerships, and maintaining uninterrupted product supply.
• Potential risks include post-marketing requirements, ongoing regulatory compliance, and the ability to procure cGMP commercial-scale supply.
• The company relies on third-party logistics providers, distributors, and specialty pharmacies to support commercial operations.

Management Commentary and Tone

• Leonard Mazur, Chairman and CEO, stated that the LYMPHIR launch demonstrated meaningful progress in formulary access and treatment-driven demand as physicians gain familiarity with the product's differentiated clinical profile.
• Management expressed confidence that the expanded organization will facilitate increased engagement with priority treatment centers and support formulary adoption.
• Mazur highlighted that positive clinical signals from Phase 1 trials point to LYMPHIR's potential beyond cutaneous T-cell lymphoma.
• The tone of management commentary was focused on disciplined execution and building long-term sustainable value despite significant operating losses.

Other Key Points

• Closed a registered direct offering in April 2026 for net proceeds of approximately $4.5 million.
• Received approximately $9.7 million in net proceeds from the exercise of certain warrants.
• Funded $10.0 million under the first tranche of a Citius Oncology senior secured term loan facility of up to $25.0 million.
• Citius Oncology appointed Jonathan Peri, Ph.D., J.D., as an independent director effective August 10, 2026, expanding the board to nine members.
• Citius Pharmaceuticals owns approximately 62% of Citius Oncology.
• A gain on the sale of New Jersey net operating losses of $3.8 million was recognized in the nine months ended June 30, 2026.
• A non-recurring $19.7 million contract cancellation charge was recognized in March 2026.
• Citius Pharma's common stock outstanding increased to 27,452,570 shares as of June 30, 2026, from 18,067,744 shares as of September 30, 2025.