Imagine a smaller, clinical-stage version of Gilead Sciences, but focused on highly specialized critical care solutions rather than broad antiviral franchises.

Think of it as a small, independent R&D engine, akin to a tiny division of Johnson & Johnson, solely dedicated to advancing a few specialized critical care drug candidates through clinical trials.

It's like a biotech startup aiming to develop the next breakthrough in critical care, similar in ambition to how Moderna or Biogen tackle significant diseases, but with its primary drug candidates currently in late-stage clinical trials.

• LYMPHIR™ (denileukin diftitox): A re-formulated biologic drug candidate for the treatment of persistent or recurrent cutaneous T-cell lymphoma (CTCL).
• Mino-Lok™: An investigational antibiotic lock solution designed to salvage infected indwelling catheters in patients with catheter-related bloodstream infections (CRBSIs).
• Halo-Lido: A topical drug candidate combining halobetasol and lidocaine for the symptomatic treatment of hemorrhoids.

Citius Pharmaceuticals (CTXR) is a late-stage biopharmaceutical company that currently has no commercial revenue-generating products on the market. Therefore, it does not have major customers in the traditional sense at this time.

However, upon potential approval and commercialization of its pipeline products, Citius Pharmaceuticals' sales model would primarily involve selling to other companies in the healthcare supply chain.

Specifically, if its products like LYMPHIR™ (for CTCL) and Mino-Lok™ (for CRBSIs) are approved, they would be distributed through major pharmaceutical wholesalers to reach healthcare institutions such as hospitals and specialized cancer treatment centers. For a product like Halo-Lido, Citius Pharmaceuticals has indicated an intention to out-license it, meaning another pharmaceutical company would be its direct customer for that product.

Therefore, Citius Pharmaceuticals would primarily sell to other companies, specifically:

• Pharmaceutical Wholesalers/Distributors: These companies act as intermediaries, purchasing drugs from manufacturers and distributing them to hospitals, clinics, and pharmacies. Major players in this space are:
  • AmerisourceBergen (ABC)
  • Cardinal Health (CAH)
  • McKesson Corporation (MCK)
• Other Pharmaceutical Companies: If Citius Pharmaceuticals out-licenses any of its products (e.g., Halo-Lido), the licensing partner would be a direct customer for that particular product. The specific company would depend on future licensing agreements.

• Lonza Group AG (LONN.SW)

Leonard Mazur, Co-Founder, CEO & Chairman of the Board of Directors

Mr. Mazur is an accomplished entrepreneur and pharmaceutical industry executive with notable success in founding and building multiple healthcare companies and creating value for investors over five decades. He co-founded and served as Chairman of Leonard-Meron Biosciences, Inc. before its merger with Citius in March 2016. Mr. Mazur was also the co-founder and Vice Chairman of Akrimax Pharmaceuticals, LLC, and co-founded and served as Chief Operating Officer of Triax Pharmaceuticals LLC from 2005 to 2012. As founder and Chief Executive Officer of Genesis Pharmaceuticals, Inc., he successfully negotiated its sale to Pierre Fabre, a leading global pharmaceutical company, in 2003. He also has extensive sales, marketing, and business development experience from previous tenures at Medicis Pharmaceutical Corporation, ICN Pharmaceuticals, Inc., Knoll Pharma, and Cooper Laboratories, Inc.

Jaime Bartushak, Chief Financial Officer & Chief Business Officer

Mr. Bartushak is an experienced finance and operations professional for early-stage pharmaceutical companies, with over 20 years of expertise in corporate finance, business development, M&A, restructuring, capital formation, and strategic planning. He is a founder of Leonard-Meron Biosciences, where he was instrumental in obtaining initial investment capital for its start-up in 2014. Mr. Bartushak also helped lead the sale of PreCision Dermatology, Inc. to Valeant Pharmaceuticals International, Inc., and previously led the financial efforts for the successful sale of Triax Pharmaceuticals to PreCision Dermatology.

Myron Holubiak, Co-Founder, Executive Vice Chairman

Mr. Holubiak possesses extensive experience in managing and leading both large and emerging pharmaceutical and life sciences companies. He was a co-founder, director, and CEO of Leonard-Meron Biosciences, Inc. prior to its merger with Citius in March 2016. From 1998 to 2001, he served as President of Roche Laboratories, Inc., transforming it into a leading antibiotic and biotechnology company. Mr. Holubiak also founded Emron, Inc., a health economics and managed care consulting company, and was Chairman of the Board of Bioscrip, Inc. from 2012 through 2016.

Dr. Myron Czuczman, M.D., Chief Medical Officer & Executive Vice President

Dr. Czuczman completed his Internal Medicine residency training at Weill Cornell North Shore University/MSKCC Program, followed by Medical Oncology/Hematology fellowship training at Memorial Sloan-Kettering Cancer Center in New York City.

Gary F. Talarico, EVP, Operations

Mr. Talarico has successfully built and led all commercial activities for a number of start-up companies. He was a founder, partner, and Executive Vice President of Leonard-Meron Biosciences, Inc., where he was instrumental in acquiring its lead product. Previously, Mr. Talarico served as Senior Vice President of Triax Pharmaceuticals from its founding to the sale of its assets. He was also a founder and Executive Vice President of Sales and Marketing for Reliant Pharmaceuticals, LLC, which was later sold to GlaxoSmithKline plc.

The key risks to Citius Pharmaceuticals (CTXR) include its precarious financial health and ongoing need for additional capital, significant reliance on the commercial success of its lead product LYMPHIR, and the persistent threat of stock price volatility and potential delisting.

1. Financial Health and Need for Additional Capital

Citius Pharmaceuticals faces substantial financial challenges, characterized by critically low cash reserves and a high quarterly burn rate. As of December 31, 2024, the company reported only $1.1 million in cash and cash equivalents, alongside a net loss of $10.3 million for the quarter. Despite recent capital raises, the current cash position appears insufficient to support the upcoming commercial launch of LYMPHIR and ongoing operations, indicating an urgent need for additional financing. The company has historically relied on issuing debt and equity to fund operations, which can lead to significant dilution for existing shareholders.

2. Reliance on LYMPHIR's Commercial Success

The company's future prospects are heavily dependent on the successful commercialization of LYMPHIR (denileukin diftitox-cdxl), an FDA-approved immunotherapy for cutaneous T-cell lymphoma. While LYMPHIR's commercial launch is targeted for the first half of 2025, it faces hurdles such as competition from existing therapies and the necessity for robust sales execution. Citius Pharmaceuticals has incurred consistent losses and anticipates continued losses, making LYMPHIR's revenue generation critical for the company to achieve profitability. The financial success of LYMPHIR is a high-stakes gamble for the company's sustainability.

3. Stock Price Volatility and Delisting Risk

Citius Pharmaceuticals has experienced significant stock price volatility and has faced challenges maintaining compliance with Nasdaq's minimum bid price requirement. The company narrowly avoided delisting in December 2024 after its stock price rebounded. The market price of CTXR's common stock is highly volatile, which could result in investors losing a substantial portion of their investment. Further declines in share price or delisting from Nasdaq could adversely affect investor confidence, reduce the value of equity compensation plans, and negatively impact the company's ability to retain employees.

The most clear emerging threat to Citius Pharmaceuticals (CTXR) is the advancement and potential approval of CorMedix's DefenCath. DefenCath (taurolidine and heparin) is an investigational antimicrobial catheter lock solution designed to prevent catheter-related bloodstream infections (CRBSIs) in patients with central venous catheters. It directly competes with Citius's lead product candidate, Mino-Lok, which is also an antimicrobial catheter lock solution for the treatment of CRBSIs.

CorMedix has completed its Phase 3 clinical trials for DefenCath and has been engaged with the U.S. FDA regarding its New Drug Application (NDA) resubmission, targeting approval and potential launch. If approved, DefenCath could enter the market ahead of or concurrently with Mino-Lok, directly competing for market share and potentially establishing itself as a standard of care for CRBSI prevention and treatment before Mino-Lok achieves widespread adoption, thus significantly impacting Mino-Lok's commercial potential.

Citius Pharmaceuticals (CTXR) has several main products in its pipeline, each addressing distinct markets:

• LYMPHIR (formerly I/ONTAK/E7777) for Cutaneous T-cell Lymphoma (CTCL)
  • U.S. Market: The addressable U.S. market for patients with advanced stage relapsed or refractory CTCL is estimated to be approximately $300 million to $400 million.
  • Global Market: The global Cutaneous T-cell Lymphoma market size is projected to grow from USD 3.416 billion in 2024 to USD 5.65 billion by 2035.
• Mino-Lok for Catheter-Related Bloodstream Infections (CRBSIs)
  • U.S. Market: The market potential for an effective antibiotic lock therapy in the U.S. is estimated at over $750 million per year.
  • Global Market: The worldwide market is expected to grow to $1.84 billion by 2028.
• Halo-Lido (CITI-002) for Hemorrhoids
  • U.S. Market: The addressable market for Halo-Lido is more than $2 billion, based on annual over-the-counter hemorrhoid product sales in the U.S.
• Mino-Wrap for reducing tissue expander infections following breast reconstructive surgeries
  • Market Size: null
• Novecite for Acute Respiratory Distress Syndrome (ARDS)
  • Market Size: null

Citius Pharmaceuticals (CTXR) is poised for significant revenue growth over the next 2-3 years, driven primarily by the commercialization of its late-stage pipeline assets and strategic corporate maneuvers. Key drivers include:

1. Commercialization of LYMPHIR™ (formerly I/ONTAK): LYMPHIR, an immunotherapy for relapsed or refractory cutaneous T-cell lymphoma (CTCL), received FDA approval in August 2024. Citius Pharmaceuticals plans its commercial launch for the fourth quarter of 2025. Analysts estimate the addressable U.S. market for LYMPHIR to be between $300 million and $400 million, with potential for further market expansion. The company also intends to spin off its oncology assets, including LYMPHIR, into a new standalone publicly traded company, Citius Oncology, Inc., which is expected to unlock value and provide focused resources for commercialization.

2. Potential FDA Approval and Launch of Mino-Lok®: Mino-Lok is an antibiotic lock solution designed to salvage infected central venous catheters (CVCs) in patients with catheter-related bloodstream infections (CRBSIs). The Phase 3 pivotal trial for Mino-Lok concluded in December 2023, with positive results. If approved, Mino-Lok could be the first and only FDA-approved product of its kind, addressing a worldwide market estimated to be greater than $1.8 billion for CRBSI and central line-associated bloodstream infection (CLABSI).

3. Advancement and Potential Commercialization of Halo-Lido: Halo-Lido is a proprietary topical cream for the prescription treatment of hemorrhoids. The company reported positive results from its Phase 2b clinical study in June 2023. Citius plans to hold an End-of-Phase 2 meeting with the FDA in the first half of 2024 to plan for its Phase 3 trial. If approved, Halo-Lido has the potential to be the first and only FDA-approved prescription therapy for hemorrhoids in a U.S. market with an addressable value exceeding $2 billion.

4. Strategic Spin-off of Citius Oncology: The planned spin-off of Citius Oncology, Inc., which will hold the LYMPHIR asset, is a significant strategic move. This transaction is anticipated to unlock shareholder value by creating two focused public companies. It is also expected to facilitate greater access to capital markets for the oncology business, thereby supporting its growth and commercialization efforts, and indirectly benefiting the remaining Citius Pharmaceuticals pipeline through a more streamlined corporate structure and investment focus.

Share Issuance

• Citius Pharmaceuticals closed a registered direct offering on October 21, 2025, raising approximately $6.0 million in gross proceeds through the issuance of 3,973,510 shares (or pre-funded warrants) and accompanying common warrants. The net proceeds are intended to support the commercial launch of LYMPHIR™, product development initiatives, and general corporate purposes.
• Citius Oncology, a subsidiary of Citius Pharmaceuticals, closed a registered direct offering and concurrent private placement on September 10, 2025, generating approximately $9.0 million in gross proceeds by selling 5,142,858 shares of common stock and unregistered warrants.
• In January 2021, Citius Pharmaceuticals announced a private placement to institutional and accredited investors, raising approximately $20.0 million through the issuance of 15,455,960 shares of common stock and warrants. The company planned to use the net proceeds for general corporate purposes, including pre-clinical and clinical development of product candidates and capital expenditures.

Outbound Investments

• In August 2024, Citius Pharmaceuticals completed the merger of its oncology subsidiary with TenX Keane Acquisition, forming Citius Oncology, Inc., with Citius Pharma retaining approximately 90% ownership.
• Citius Pharmaceuticals acquired an exclusive license with rights to develop and commercialize LYMPHIR™ (formerly E7777) in all markets except Japan and certain parts of Asia in 2021. This was a corporate asset purchase deal with Dr. Reddy's Laboratories.

Capital Expenditures

• Net proceeds from the August 2020 public offering of approximately $8.4 million were intended for general corporate purposes, including working capital and capital expenditures, alongside funding for the Phase 3 Mino-Lok® trial, Mino-Wrap development, and the Phase 2b Halo-Lido cream trial.
• The $20.0 million private placement in January 2021 also stated that net proceeds would be used for general corporate purposes, including capital expenditures, in addition to pre-clinical and clinical development.