Citius Pharmaceuticals (CTXR) gave an update on its LYMPHIR launch at the Moody Capital Disruptive Growth & Life Science Conference on Wednesday, describing early commercial momentum for its cutaneous T-cell lymphoma treatment and outlining plans to deploy its full sales force in the coming weeks.
The Houston-based company, which began shipping LYMPHIR to wholesalers in December 2023, reported $7.1 million in revenue during the first three quarters of fiscal 2024 — the nine-month period ending June 30. Gross margin on the drug ran at 77%, according to the presentation. The company has stocked 44 institutions so far, and all three major U.S. wholesalers carry commercial supply.
Citius said 135 health plans now cover LYMPHIR, representing 100% of lives, and that Medicare reimbursement infrastructure and J-code billing are fully established. The drug carries a five-year shelf life.
LYMPHIR targets relapsed or refractory stages 1 through 3 cutaneous T-cell lymphoma after one prior systemic therapy. In a trial of 302 patients, it produced an overall response rate of 36%, with 84.4% of patients seeing a reduction in skin burden and 60% achieving durable responses. Activity onset occurred within six weeks, with lasting skin relief in approximately 6.5 months. The program benefits from 12 years of biologics exclusivity and seven years of orphan-drug protection, and two additional patents are pending for combination use with Merck's KEYTRUDA.
Competing therapies include Kyowa Kirin's Poteligeo, which posted a 21% overall response rate in trials, and Pfizer's ADCETRIS, which requires a CD30 biomarker test and carries a risk of peripheral neuropathy. Celgene and Bristol-Myers Squibb's Istodax is not actively promoted, Citius said.
The company identified a target market size of $400 million to $500 million for LYMPHIR. About 60% of CTCL patients are concentrated in 10 U.S. states, and Citius noted that 141 physicians each diagnose more than 20 patients — a group the company views as key prescribers.
Investigator-initiated studies are underway, including a CAR-T combination study at the University of Minnesota and a KEYTRUDA combination study at the University of Pittsburgh, where endometrial cancer patients showed a 33% response rate and an overall response rate of 24% across solid tumors.
At the conference, LYMPHIR's full 29-person sales force was set to be deployed within two to three weeks. Leonard Mazur, Citius's co-founder and chief executive, told attendees the company is "right about ready to explode in terms of revenue growth down the road."
Citius holds a 71% stake in Citius Oncology (CTOR), a separate publicly traded entity with a market value of roughly $100 million and 92.9 million shares outstanding. Citius Oncology raised $5 million in April.
On the balance sheet, Citius reported $17 million in cash as of June 30, 2024. Mazur said he personally invested $22.5 million directly into the company, while co-founder Myron Holubiak contributed $4 million. Recent financing included an $11.5 million warrant exercise and a $10 million debt tranche drawn against a $25 million facility. The company raised approximately $120 million in 2021, and the upfront payment for the LYMPHIR asset from Dr. Reddy's was $40 million.
Citius's pipeline also includes Mino-Lok, an antibiotic lock solution for infected central venous catheters, for which Phase III data showed a p-value of 0.0006 versus hospital-made comparator solutions. Data have been submitted to the FDA, with a decision expected in the coming months. A prescription hemorrhoid treatment called Halo-Lido remains on hold as the company conserves cash for the LYMPHIR launch.
CTXR shares closed at $0.581 on September 9, down 73% from a 52-week high of $2.19 and 52% off their one-year peak. The stock carries a market capitalization of approximately $16.5 million. Analysts maintain a price target of $4.
