Citius Pharmaceuticals Inc. Common - CTXR STOCK NEWS

Citius Oncology (Nasdaq: CTOR), a majority-owned subsidiary of Citius Pharmaceuticals (Nasdaq: CTXR), has engaged Jefferies as its exclusive financial advisor to explore strategic alternatives for maximizing shareholder value. The company is considering various options including partnerships, joint ventures, mergers, acquisitions, and licensing transactions.

The announcement comes as Citius Oncology prepares to launch LYMPHIR™, their recently FDA-approved therapy for treating patients with relapsed or refractory Stage I-III cutaneous T-cell lymphoma (CTCL) who have undergone at least one prior systemic therapy.

The company has not established a specific timeline for this strategic review process and will only disclose developments if the Board of Directors approves a specific transaction or deems disclosure necessary. There is no guarantee that this process will result in any strategic transaction.

Citius Pharmaceuticals (CTXR) reported fiscal year 2024 results, highlighting key achievements including FDA approval of LYMPHIR™ for CTCL treatment and positive Phase 3 trial results for Mino-Lok®. The company reported cash and equivalents of $3.3 million as of September 30, 2024. Financial results show R&D expenses decreased to $11.9 million from $14.8 million, while G&A expenses increased to $18.2 million from $15.3 million. Net loss widened to $39.4 million ($5.97 per share) compared to $32.5 million ($5.57 per share) in 2023. The company completed merger of its oncology subsidiary to form Citius Oncology (CTOR) and plans LYMPHIR commercial launch in first half of 2025.

Citius Pharmaceuticals announced a productive Type C meeting with the FDA following the successful completion of their Phase 3 clinical trial for Mino-Lok®. The meeting focused on discussing clinical trial data and establishing a pathway for future New Drug Application (NDA) submission. The FDA provided clear and actionable guidance regarding the novel catheter lock solution designed to salvage central venous catheters in patients with bloodstream infections. The company reports that Mino-Lok® demonstrated compelling clinical outcomes in Phase 3, potentially offering an alternative to catheter removal that could reduce healthcare costs and improve patient outcomes.

Citius Pharmaceuticals announced a 1-for-25 reverse stock split effective November 25, 2024, with split-adjusted trading beginning November 26 under the symbol CTXR. The split aims to regain Nasdaq compliance by increasing the share price above the $1.00 minimum bid requirement. The action will reduce authorized shares from 400 million to 16 million, and outstanding shares from approximately 193 million to 7.7 million. No fractional shares will be issued, with rounding up to the nearest whole share. The split will also affect outstanding warrants and stock options, with proportionate adjustments to exercise prices.

Citius Pharmaceuticals (Nasdaq: CTXR) has closed a $3 million registered direct offering, selling 12,000,000 shares of common stock with accompanying warrants at $0.25 per share and warrant. The warrants are immediately exercisable at $0.25 per share and expire in five years. H.C. Wainwright & Co. served as the exclusive placement agent. The company plans to use the net proceeds for general corporate purposes, including pre-clinical and clinical development of product candidates, working capital, and capital expenditures.

Citius Pharmaceuticals (Nasdaq: CTXR) has announced a $3 million registered direct offering of 12,000,000 shares of common stock and accompanying warrants. The offering price is set at $0.25 per share and warrant, with warrants exercisable immediately at $0.25 per share and expiring in five years. H.C. Wainwright & Co is serving as the exclusive placement agent. The company plans to use the proceeds for general corporate purposes, including pre-clinical and clinical development of product candidates, working capital, and capital expenditures. The offering is expected to close around November 18, 2024.

Citius Pharmaceuticals and Citius Oncology announced preliminary results from a Phase I trial evaluating the combination of pembrolizumab (KEYTRUDA®) and LYMPHIR™ in patients with recurrent solid tumors, focusing on gynecological cancers like ovarian, endometrial, and cervical. The trial showed a 27% Objective Response Rate (ORR) and a 33% Clinical Benefit Rate (CBR) with a median Progression-Free Survival (PFS) of 57 weeks. The regimen was well-tolerated, with no serious immune-related adverse events. The study, nearing completion, will enroll three more patients. The results suggest LYMPHIR may enhance the efficacy of immune checkpoint inhibitors like pembrolizumab. The trial's promising outcomes support expanding research into a Phase II study to evaluate the combination's benefits across a broader range of solid tumors.

Citius Pharmaceuticals (CTXR) announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference from September 9-11, 2024, in New York City. CEO Leonard Mazur will present on September 10, 2024, at 9:00 am ET at the Lotte New York Palace Hotel and host one-on-one investor meetings.

Key business developments to be discussed include:

• FDA approval of LYMPHIR™ for cutaneous T-cell lymphoma treatment
• Merger of a subsidiary with TenX Keane, forming Citius Oncology (CTOR)
• Successful Phase 3 Pivotal Trial of Mino-Lok®, an antibiotic lock solution for catheter-related bloodstream infections

Investors can register on the conference website and join the live webcast presentation.

Citius Pharmaceuticals and Citius Oncology announced that LYMPHIR™ has been added to the NCCN Clinical Practice Guidelines in Oncology with a Category 2A recommendation. This inclusion supports LYMPHIR as an appropriate treatment option for patients with Cutaneous T-cell Lymphoma (CTCL) who have undergone at least one prior systemic therapy.

LYMPHIR, a novel immunotherapy targeting the interleukin-2 receptor on malignant T-cells and Tregs, was recently approved by the FDA based on results from the Phase 3 Pivotal Study 302. The addition to NCCN Guidelines is expected to facilitate adoption and ease reimbursement, particularly for patients eligible for CMS coverage.