Citius Pharmaceuticals, Inc.

Citius Pharmaceuticals, Inc.'s subsidiary, Citius Oncology, Inc., announced positive health-related quality of life (HRQoL) results from its pivotal Study 302 of LYMPHIR® (denileukin diftitox-cxdl) in adults with relapsed or refractory cutaneous T-cell lymphoma. The data, presented at the EORTC-CLTG 2026 Annual Meeting, indicated that patients who responded to LYMPHIR experienced sustained improvements in skin-related quality of life measures, including significant reductions in itch for a notable portion of heavily pretreated patients. These findings underscore the importance of quality of life considerations in treatment decisions for CTCL.

Citius Pharmaceuticals, Inc. announced that its subsidiary, Citius Oncology, Inc., presented Phase 1 clinical data at the American Society of Clinical Oncology (ASCO) Annual Meeting for LYMPHIR (denileukin diftitox-cxdl) in combination with pembrolizumab. The data evaluated patients with recurrent or refractory gynecologic malignancies, showing durable responses and manageable tolerability. Key findings included a 24% Overall Response Rate (ORR) and a median progression-free survival of 20.5 months among patients achieving clinical benefit. A Phase 2 expansion study is planned.

Citius Pharmaceuticals reported its fiscal second quarter 2026 financial results, with net product revenues of $1.7 million from the ongoing launch of LYMPHIR. The company recorded a net loss of $21.2 million, or $(0.95) per share, primarily due to a $19.7 million one-time CMO contract cancellation charge. Citius Oncology, its majority-owned subsidiary, demonstrated strong commercial progress for LYMPHIR, securing near 100% payer coverage for commercial lives. Subsequent to quarter-end, Citius Pharma raised $5 million, and Citius Oncology secured up to $36.5 million in financing, extending the operational runway through November 2026.

Citius Pharmaceuticals reported a net loss of $37.5 million for the six months ended March 31, 2026, an increase from $21.8 million in the prior year, despite generating $5.6 million in revenue from LYMPHIR sales. The company's operating expenses significantly rose to $45.7 million, and it experienced increased cash burn from operations. Management expressed substantial doubt about the company's ability to continue as a going concern beyond November 2026, though recent capital raises by Citius Pharma and its subsidiary Citius Oncology are expected to extend its cash runway.

Citius Pharmaceuticals, Inc. amended a $3.8 million promissory note with its majority-owned subsidiary, Citius Oncology, Inc., in connection with Citius Oncology's new equity financing and debt facility. The amendment aligns the note's maturity with Citius Oncology's senior debt, making the principal payable 91 days after the senior debt is fully settled. It also introduces a voluntary conversion feature, allowing Citius Pharmaceuticals to convert the outstanding principal into Citius Oncology common stock at $0.90 per share, subject to approval. Additionally, the amendment eliminates prior maturity triggers and prohibits cash prepayments before the new maturity date.

Citius Pharmaceuticals, Inc.'s majority-owned subsidiary, Citius Oncology, Inc. (CTOR), announced the initial shipment of LYMPHIR (denileukin diftitox-cxdl) to Europe. This strategic move expands international patient access through regional distribution partners and Named Patient Programs, complementing the ongoing U.S. commercial launch. LYMPHIR was approved by the U.S. FDA in August 2024 and launched in the U.S. in December 2025 for relapsed or refractory CTCL, with an estimated initial U.S. market exceeding $400 million.

Citius Pharmaceuticals, Inc. entered into a securities purchase agreement for a registered direct offering and a concurrent private placement. The registered direct offering includes 4,730,457 shares of common stock at $0.985 per share and 345,686 pre-funded warrants at $0.9849. Concurrently, the company will sell warrants to purchase up to 5,076,143 common shares in a private placement, with an exercise price of $0.86 per share. This capital raise aims to strengthen the company's financial position.