On May 15, 2026 Citius Pharmaceuticals, Inc. ("Citius Pharma" or the "Company") (Nasdaq: CTXR), a biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products, reported business and financial results for the fiscal second quarter ended March 31, 2026, and provided a business update, including progress at its majority-owned subsidiary, Citius Oncology, Inc. (Nasdaq: CTOR).
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"The first half of fiscal 2026 demonstrated meaningful commercial progress at our majority-owned subsidiary Citius Oncology. In the four months of commercial sales since the December 2025 launch of LYMPHIR, Citius Oncology generated $5.6 million in net revenue at approximately 80% gross margins, advanced 83% of target accounts to formulary inclusion or active review, and secured payer coverage representing near 100% of covered commercial lives with no reimbursement denials reported to date. Importantly, major academic centers have begun to transition patients to local community infusion centers for treatment, a critical next phase of commercial scaling. These results reflect our efforts to build a durable patient access foundation upon which to drive growth," said Leonard Mazur, Chairman and Chief Executive Officer of Citius Pharma and Citius Oncology.
"Subsequent to quarter end, Citius Oncology secured up to $36.5 million in combined debt and equity financing through its senior secured credit facility with Avenue Capital and the exercise of outstanding warrants, complemented by Citius Pharma’s $5 million registered direct offering. Together, these proceeds are expected to fund Citius Pharma’s activities as well as the completion of the LYMPHIR commercial field force buildout by mid-summer. This will support expanded physician engagement and broader market penetration, positioning Citius Oncology to accelerate growth as the launch matures. We believe Citius Oncology maintains sufficient inventory to support anticipated commercial demand, as well as additional demand outside the U.S., as we begin to see orders for product through our global distribution partners."
"Moreover, we are encouraged by positive preliminary topline Phase 1 data from two investigator-initiated combination studies, with pembrolizumab and prior to CAR-T therapy, which reinforce LYMPHIR’s potential as a platform asset in combination regimens. At the Citius Pharma level, we also remain focused on advancing Mino-Lok and Halo-Lido with the FDA and on disciplined execution of our mission to bring first-in-class therapies to patients," concluded Mazur.
Fiscal Second Quarter 2026 Business Highlights and Subsequent Developments
● Reported key commercial metrics of LYMPHIR launch:
○ 83% of target accounts had added or were actively progressing LYMPHIR through formulary review;
○ Secured near 100% of covered commercial lives; no reimbursement denials or prior authorization barriers reported;
○ Initial accounts placing repeat orders;
○ Patients beginning to transition from larger academic cancer centers to community infusion centers;
● Announced initial shipment of LYMPHIR to Europe on April 29, 2026 through Uniphar, a leading international healthcare services company, with LYMPHIR being made available to eligible patients through Named Patient Programs (NPPs) in accordance with local regulations across 19 markets in Southern Europe, the Middle East, and additional European territories;
● Announced positive topline results from two investigator-initiated Phase 1 studies, including:
○ LYMPHIR in combination with pembrolizumab in patients with recurrent or refractory gynecologic cancers, including ovarian and endometrial malignancies;
○ LYMPHIR administered prior to commercial CD19-directed CAR-T therapy in patients with high-risk relapsed or refractory diffuse large B-cell lymphoma (DLBCL), with positive topline safety and efficacy results; and,
● Continued FDA engagement on Mino-Lok, an antibiotic lock solution to salvage catheters in patients with catheter-related bloodstream infections, and on Halo-Lido (CITI-002), a topical formulation for hemorrhoids.
Fiscal Second Quarter 2026 Financial Highlights and Subsequent Events
● Cash and cash equivalents of $4.6 million as of March 31, 2026;
● Citius Pharma closed a $5 million registered direct offering in April 2026;
● Citius Oncology secured up to $36.5 million in financing subsequent to quarter end, consisting of:
○ $11.5 million in gross proceeds received May 5, 2026 from the exercise of certain outstanding warrants;
○ a loan agreement of up to $25 million from Avenue Capital Group, with $10 million in gross proceeds funded at close on May 6, 2026, and up to $15 million available in subsequent tranches pending certain revenue and liquidity milestones; and,
● Citius Pharma and Citius Oncology collectively expect to have sufficient funds to continue operations through November 2026;
● Net product revenues of $1.7 million for the three months ended March 31, 2026, compared to no revenue in the three months ended March 31, 2025, and $5.6 million for the six months ended March 31, 2026, compared to no revenue in the six months ended March 31, 2025; quarter over quarter decline reflects larger initial orders from specialty distributors at launch in the first quarter;
● Gross profit of $1.3 million for the three months ended March 31, 2026, and $4.5 million for the six months ended March 31, 2026; approximately 80% in both periods, reflecting continued commercial progress since the December 2025 launch of LYMPHIR;
● R&D expenses of $1.6 million for the three months ended March 31, 2026, compared to $3.8 million for the three months ended March 31, 2025; and $3.2 million for the six months ended March 31, 2026, compared to $5.9 million for the six months ended March 31, 2025. The decrease in both periods primarily reflects reduced clinical development activity, as the prior-year periods included costs for a pre-license inspection batch of LYMPHIR previously manufactured;
● G&A expenses of $26.4 million for the three months ended March 31, 2026, compared to $4.8 million for the three months ended March 31, 2025, primarily driven by a $19.7 million one-time CMO contract cancellation charge. G&A expenses were $32.1 million for the six months ended March 31, 2026, compared to $10.2 million for the six months ended March 31, 2025;
● Stock-based compensation expense was $3.8 million for the three months ended March 31, 2026, compared to $2.7 million for the three months ended March 31, 2025. For the six months ended March 31, 2026, stock-based compensation was $8.1 million, compared to $5.2 million for the six months ended March 31, 2025;
● Recognized a gain of $3.8 million from the sale of New Jersey state net operating losses under the New Jersey Technology Business Tax Certificate Transfer Program; and,
● Net loss applicable to common stockholders of $21.2 million, or $(0.95) per share, for the three months ended March 31, 2026, compared to $10.9 million, or $(1.27) per share, for the three months ended March 31, 2025; and $29.5 million, or $(1.34) per share, for the six months ended March 31, 2026, compared to $20.7 million, or $(2.58) per share, for the six months ended March 31, 2025.
(Press release, Citius Pharmaceuticals, MAY 15, 2026, View Source [SID1234665768])