CTXR

$5.6 Million in net revenue for the first half of fiscal 2026 from ongoing launch of LYMPHIR® Citius Pharma raised $5 million in a registered direct offering; Citius Oncology secured up to $36.5 million in debt and equity financing Advanced patient access with payer coverage near 100% of commercial lives and 83% of LYMPHIR target accounts on formulary or in review CRANFORD, N.J., May 15, 2026 /PRNewswire/ -- 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, today 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). "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...

$5.6 million in net revenue for the first half of fiscal 2026 as LYMPHIR® launch progresses Up to $36.5 million in debt and equity capital secured Broad payer coverage established with no reimbursement denials 83% of target accounts on formulary or in review CRANFORD, N.J., May 15, 2026 /PRNewswire/ -- Citius Oncology, Inc. ("Citius Oncology" or the "Company") (Nasdaq: CTOR), the oncology-focused subsidiary of Citius Pharmaceuticals, Inc. ("Citius Pharma") (Nasdaq: CTXR), today reported financial results for the fiscal second quarter ended March 31, 2026, and provided a business update. "LYMPHIR's commercial launch gives us confidence in the trajectory ahead. In the first six months of fiscal 2026, which includes only four months of commercial sales since LYMPHIR's December 2025 launch, we generated $5.6 million in net revenue at gross margins of approximately 80%. This reflects initial orders by distributors during the first quarter, and subsequent reorders during the second quarter as we begin to see increased institutional demand for the therapy. As leading medical centers continue to add LYMPHIR to formulary and we build out our sales force, we believe we are moving through the expected transition from initial channel fill to sustained treatment-driven demand. We have achieved strong institutional penetration for a newly launched specialty therapy, with 83% of our target accounts having added LYMPHIR or actively progressing it through formulary review. Payer coverage has expanded to near 100% of covered commercial lives, with no reimbursement denials reported to date," said Leonard Mazur, Chairman and Chief Executive Officer of Citius Oncology and Citius Pharma. "With market access efforts underway, our focus is on establishing LYMPHIR's position in the CTCL treatment journey. The financing we secured, subsequent to quarter end, is the catalyst that provides us with resources to complete the buildout of our commercial field force. We expect to have the full commercial team deployed by mid-summer. We have ample finished goods and work-in-process inventory on hand to support anticipated commercial demand for the foreseeable future. A fully staffed sales organization, reinforced by broad market access and sufficient inventory to support anticipated demand, is how we plan to drive continued momentum. The fundamentals of a successful specialty pharmaceutical...

Study data from patients with relapsed or refractory gynecologic cancers signals the potential of LYMPHIR to augment immune checkpoint inhibitor efficacy Topline data of University of Pittsburgh-led trial to be presented at an upcoming international cancer conference later this year CRANFORD, N.J., March 10, 2026 /PRNewswire/ -- Citius Oncology, Inc. ("Citius Oncology") (Nasdaq: CTOR), an oncology‑focused biopharmaceutical company and majority‑owned subsidiary of Citius Pharmaceuticals, Inc. ("Citius Pharma") (Nasdaq: CTXR), today announced positive topline results from a completed investigator‑initiated Phase 1 clinical trial conducted by University of Pittsburgh investigators. This study evaluated the direct T-regulatory (Treg) cell depletion activity of LYMPHIR™ (denileukin diftitox‑cxdl) in combination with the PD-1 immune checkpoint inhibitor pembrolizumab (KEYTRUDA®) in patients with recurrent or refractory gynecologic cancers, including ovarian and endometrial malignancies. Patients with relapsed or refractory gynecological cancer have poor prognoses and very limited treatment options. This dose-escalation Phase 1 non-chemotherapy based clinical study aimed to establish a recommended dose of LYMPHIR in combination with pembrolizumab for a Phase 2 study. In 25 evaluable patients, no unexpected safety signals or serious immune-related adverse events were observed at any dose level. "We are encouraged by the favorable safety profile and sustained disease control observed in this heavily pretreated patient population. Evidence from the study suggests augmented anti-tumor activity when LYMPHIR is combined with KEYTRUDA and warrants further exploration in Phase 2 settings," stated Dr. Myron Czuczman, Executive Vice President and Chief Medical Officer of Citius Oncology and Citius Pharma. The trial explored efficacy and demonstrated a 24 % objective response rate (ORR) and a 48 % clinical benefit rate (CBR, defined as complete response, partial response and/or stable disease for six months or greater) among 21 evaluable patients. Full safety and clinical efficacy results are expected to be presented at an international cancer conference later this year. "The efficacy signal shown by this combination is incredibly exciting considering the minimal impact immuno-oncology has made in ovarian cancer thus far. If these findings are confirmed in subsequent studies,...

Subsidiary, Citius Oncology, launches cancer immunotherapy, LYMPHIR™, in the U.S. in December 2025 CRANFORD, N.J., Dec. 23, 2025 /PRNewswire/ -- 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 today reported business and financial results for the fiscal year ended September 30, 2025. "2025 was a pivotal year for Citius as we successfully launched LYMPHIR following its FDA approval, marking the first new systemic therapy for cutaneous T-cell lymphoma (CTCL) patients since 2018. This milestone reflects our ability to execute and our commitment to delivering impactful treatments for patients with limited options," said Leonard Mazur, Chairman and CEO of Citius Pharma. "With LYMPHIR commercially available as of December 2025, we are focused on its successful launch and adoption in 2026, with even greater opportunities ahead to drive value for patients and shareholders. We are actively engaging with the FDA to advance Mino-Lok, exploring additional indications and markets for LYMPHIR, and working diligently to strengthen our financial and operational foundation to support sustained growth. We look forward to reporting on our continued progress in the coming months." Fiscal Year 2025 Business Highlights and Subsequent Developments Citius Pharma subsidiary, Citius Oncology (Nasdaq: CTOR), launched LYMPHIR™ (denileukin diftitox-cxdl), a novel IL-2 receptor-directed immunotherapy, in the U.S. in December 2025 for the treatment of adult patients with relapsed or refractory Stage I-III CTCL after at least one prior systemic therapy; Citius Pharma drove commercial preparations for LYMPHIR's launch through its shared management services agreement with Citius Oncology: Executed service agreements with the three leading U.S. pharmaceutical wholesalers to distribute LYMPHIR throughout the U.S.; Secured access to LYMPHIR in 19 international markets through regional distribution partners via named patient programs (NPPs), which allows access to LYMPHIR where permitted by local law without constituting commercial approval outside the U.S.; Ensured production and sufficient supply of LYMPHIR for up to 18 months of estimated commercial demand; Secured inclusion of LYMPHIR in the National Comprehensive Cancer Network (NCCN) guidel...

Cancer Immunotherapy, LYMPHIR™, launched in the U.S. in December 2025 Completed $36 million in strategic financings, of which $18 million was via private placement and concurrent registered direct offering on December 10, 2025, to strengthen cash position and support continued commercialization of LYMPHIR CRANFORD, N.J., Dec. 23, 2025 /PRNewswire/ -- Citius Oncology, Inc. ("Citius Oncology") (Nasdaq: CTOR), the oncology-focused subsidiary of Citius Pharmaceuticals, Inc. ("Citius Pharma") (Nasdaq: CTXR), today reported financial results for the fiscal year ended September 30, 2025, and provided a business update. "2025 was a landmark year for Citius Oncology. With the U.S. commercial launch of LYMPHIR now underway, we have shifted from a pre-revenue to a revenue generating company," said Leonard Mazur, Chairman and CEO of Citius Oncology and parent company Citius Pharmaceuticals. "Our focus now is on driving adoption, delivering value to patients, and realizing the full commercial potential of our first‑in‑class therapy. We intend to leverage our advanced AI-driven analytics to refine targeting, optimize field execution, and maximize commercial efficiency. In parallel, we have also begun laying the groundwork for international access with key distribution partners spanning 19 markets in Southern Europe and the Middle East via Named Patient Programs. These foundational efforts position us to scale and deliver sustained value to patients and shareholders alike." Fiscal Year 2025 Business Highlights and Subsequent Developments Launched LYMPHIR™ (denileukin diftitox-cxdl), a novel IL‑2 receptor-directed immunotherapy, in the U.S. in December 2025 for the treatment of adult patients with relapsed or refractory Stage I–III cutaneous T‑cell lymphoma (CTCL) after at least one prior systemic therapy; Executed service agreements with the three leading U.S. pharmaceutical wholesalers to distribute LYMPHIR to healthcare organizations, including major medical centers and specialized hospitals treating oncology patients, community oncology practices, and infusion centers throughout the U.S.; Secured access to LYMPHIR in 19 international markets through regional distribution partners via Named Patient Programs (NPPs), marking the first step in the Company's global access strategy; NPPs allow access to LYMPHIR where permitted by local law without constituting commercial appr...

Citius Oncology (CTOR) reported a loss of $0.34 per diluted share in the 12 months ended Sept. 30, w

LYMPHIR commercial availability planned for the fourth quarter of 2025 $12.5 million in gross financings raised during the quarter by Citius Pharmaceuticals, with an additional $9 million raised by Citius Oncology in July 2025, to facilitate LYMPHIR pre-launch initiatives and drive successful market introduction CRANFORD, N.J., Aug. 12, 2025 /PRNewswire/ -- Citius Oncology, Inc. ("Citius Oncology" or the "Company") (Nasdaq: CTOR), a specialty biopharmaceutical company focused on the development and commercialization of novel targeted oncology therapies, today reported business and financial results for the fiscal third quarter ended June 30, 2025. "Citius Oncology is in the final stages of preparation for the U.S. commercial launch of LYMPHIR™," said Leonard Mazur, Chairman and CEO of Citius Oncology and Citius Pharmaceuticals. "We successfully raised capital to support our pre-launch activities and secured distribution service agreements with leading global providers. Our launch strategy leverages cutting-edge technology and targeted marketing to reach the cutaneous T-cell lymphoma patients and providers who can benefit most from this important therapy. With launch supplies ready, distribution agreements in place, and strong engagement from key opinion leaders, we plan to make LYMPHIR available in the fourth quarter of 2025." FISCAL THIRD QUARTER 2025 FINANCIAL HIGHLIGHTS: On July 17, 2025, Citius Oncology completed a public offering generating net proceeds of approximately $7.4 million, after deducting placement agent fees and other offering expenses; R&D expenses were $938,000 for the quarter ended June 30, 2025, as compared to $1.1 million for the quarter ended June 30, 2024; G&A expenses were $1.9 million for the quarter ended June 30, 2025, as compared to $1.5 million for the quarter ended June 30, 2024; Stock-based compensation expense was $2.1 million, as compared to $2.0 million for the quarter ended June 30, 2024; Net loss was $5.4 million, or ($0.08) per share, for the quarter ended June 30, 2025, as compared to a net loss of $4.8 million, or ($0.07) per share, for the quarter ended June 30, 2024; and, As of June 30, 2025, the Company had $112 in cash and cash equivalents and 71,552,402 common shares outstanding. Citius Oncology is a subsidiary of Citius Pharma. During the three months ended June 30, 2025, Citius Pharma received net proceeds from...

$12.5 million in gross financings raised during the quarter, with an additional $9 million raised by Citius Oncology in July 2025, to facilitate LYMPHIR pre-launch initiatives and drive successful market introduction CRANFORD, N.J., Aug. 12, 2025 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius Pharma" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products, today reported financial results for its fiscal third quarter ended June 30, 2025, and provided a business update. "During the third quarter, Citius advanced its strategic priorities, and we believe we are now operationally positioned to transition from a development-stage enterprise to a fully integrated commercial organization. Final preparations are underway by our oncology subsidiary for the planned U.S. launch of LYMPHIR™ in the fourth quarter of 2025," said Leonard Mazur, Chairman and CEO of Citius Pharmaceuticals. "In June 2025, we completed a $6 million registered direct offering, with the potential for an additional $9.8 million upon full warrant exercise, to fund commercialization activities and corporate operations. In July 2025, Citius Oncology further strengthened its capital position with $9 million in gross proceeds from a public offering. These financings, any proceeds we might receive from exercise of the June 2025 warrants and other capital raising activities during the quarter, together with the completion of major launch-enabling activities including commercial-scale manufacturing, labeling, packaging, and distribution services agreements with leading specialty pharmaceutical partners indicate we are well-prepared to deliver LYMPHIR to patients with cutaneous T-cell lymphoma, an underserved population in need of new treatment options. At the same time, we remain focused on advancing Mino-Lok and continue to engage with the U.S. Food and Drug Administration as we evaluate the best path forward for this potentially transformative antibiotic lock solutions for patients with catheter-related bloodstream infections," added Mazur. FISCAL THIRD QUARTER 2025 FINANCIAL RESULTS: R&D expenses were $1.6 million for the quarter ended June 30, 2025, compared to $2.8 million for the quarter ended June 30, 2024; G&A expenses were $4.4 million for the quarter ended June 30, 2025, as compar...

CRANFORD, N.J., May 14, 2025 /PRNewswire/ -- 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 today reported business and financial results for the fiscal quarter ended March 31, 2025. "As we continue to focus on the planned launch of our first FDA-approved product, LYMPHIR, through Citius Oncology, we are actively engaged in securing the necessary financing to advance our launch strategy in the coming months, as well as exploring strategic partners for Citius Oncology," said Leonard Mazur, Chairman and CEO of Citius Pharmaceuticals and Citius Oncology. "We are also in the process of preparing a submission to the FDA that reflects the valuable feedback we received from the agency concerning clinical efficacy, safety data, and in-vitro data. This submission is a key step toward supporting a future New Drug Application (NDA) for our Mino-Lok program. As a reminder, our Phase 3 Trial, which was completed last year, met its primary endpoints," added Mazur. "During the quarter, we took deliberate steps to strengthen our financial position, including completing a registered direct offering and leveraging our existing at-the-market sales agreement to ensure capital flexibility. We also amended our license agreement with Eisai to align our payment obligations with our commercialization timeline. With these efforts underway, we believe we are positioned to deliver long-term value to patients and shareholders alike," concluded Mazur. FISCAL SECOND QUARTER 2025 FINANCIAL RESULTS: Liquidity During the six months ended March 31, 2025, the Company received net proceeds of $6 million from the issuance of equity. On April 2, 2025, the Company closed on a registered direct offering to an institutional investor of our common stock and pre-funded warrants to purchase common stock. The net proceeds to the Company from the offering were approximately $1.735 million, after deducting placement agent fees and other offering expenses payable by the Company. As of March 31, 2025, the Company had $26,410 in cash and cash equivalents and 8,760,649 common shares outstanding excluding the April 2, 2025 financing. Citius Pharma will need to secure additional capital to support operations beyond May 2025. Until Citius Oncology raises adequat...