Citius Oncology to Participate in USCLC Annual Workshop 2026, Highlighting LYMPHIRâ"¢ in Discussions with Leading Cutaneous Lymphoma Experts Accessibility StatementSkip Navigation Citius Oncology to meet with cutaneous T-cell lymphoma (CTCL) specialists as part of ongoing clinical engagement; one-on-one meetings available CRANFORD, N.J., March 24, 2026 /PRNewswire/ -- Citius Oncology, Inc. ("Citius Oncology") (Nasdaq: CTOR), an oncologyfocused biopharmaceutical company and majorityowned subsidiary of Citius ...

Core Insights - Citius Oncology announced positive topline results from a Phase 1 clinical trial of LYMPHIR in combination with pembrolizumab for patients with relapsed or refractory gynecologic cancers, indicating potential for enhanced efficacy of immune checkpoint inhibitors [1][2] - The study showed a 24% objective response rate (ORR) and a 48% clinical benefit rate (CBR) among evaluable patients, suggesting promising anti-tumor activity [1] Company Overview - Citius Oncology is focused on developing and commercializing novel targeted oncology therapies, with LYMPHIR being a key product approved for treating relapsed or refractory cutaneous T-cell lymphoma [1][2] - The company has robust intellectual property protections, including orphan drug designation and pending patents for immuno-oncology applications, which strengthen its competitive position in the market [2] Clinical Study Details - The Phase 1 study was led by the University of Pittsburgh and involved 25 evaluable patients, with no unexpected safety signals reported [1] - LYMPHIR was administered intravenously in escalating doses alongside pembrolizumab, with the aim of establishing a recommended dose for future studies [1] Market Potential - The initial market for LYMPHIR is estimated to exceed $400 million and is considered underserved by existing therapies, indicating significant growth potential [2] - The combination therapy approach with LYMPHIR and pembrolizumab may address the unmet needs in treating recurrent or metastatic gynecologic cancers, which have limited treatment options [1][2]

Citius Pharmaceuticals Inc. (NASDAQ:CTXR) is one of the stocks that should double in 3 years. On February 13, Citius Pharmaceuticals officially transitioned into a revenue-generating company following the December 2025 commercial launch of LYMPHIR. For FQ1 2026, the company reported $3.9 million in consolidated revenue, reflecting initial sales through a nationwide network of specialty distributors. This was achieved via Citius Pharma’s majority-owned subsidiary, Citius Oncology, Inc., which introduced the ...

Core Viewpoint - Citius Pharmaceuticals, Inc. has secured $3.8 million in non-dilutive capital through New Jersey's Technology Business Tax Certificate Transfer Program, enhancing its financial flexibility and supporting its strategic initiatives, including the commercial launch of LYMPHIR and advancing its late-stage pipeline programs [1]. Group 1: Financial Support and Strategy - The funding received from the New Jersey Economic Development Authority (NJEDA) allows Citius Pharma to convert net operating losses into cash, which can be used for various expenditures [1]. - The company emphasizes disciplined capital allocation to drive long-term shareholder value while advancing critical therapies for patients [1]. Group 2: Product Development and Pipeline - Citius Pharma's late-stage pipeline includes Mino-Lok®, a solution for catheter-related bloodstream infections, and CITI-002 (Halo-Lido), a topical formulation for hemorrhoid relief [1]. - The pivotal Phase 3 trial for Mino-Lok was completed in 2023, meeting both primary and secondary endpoints, and the company is actively engaging with the FDA for next steps [1].

Financial Performance - Citius Pharmaceuticals reported $3.9 million in revenue for the fiscal first quarter 2026, generated from initial sales of LYMPHIR in December 2025[1][2]. - The net loss applicable to common stockholders was $8.2 million, or $(0.38) per share, compared to a net loss of $9.8 million, or $(1.30) per share, in the prior-year period[8][15]. - Net loss for 2025 was $9,393,889, an improvement from a net loss of $10,281,246 in 2024[17]. - Stock-based compensation expense increased to $4,280,227 in 2025 from $2,524,824 in 2024[17]. - Net cash used in operating activities rose to $13,008,822 in 2025 compared to $4,725,852 in 2024[17]. Cash and Financing - Cash and cash equivalents totaled $7.7 million as of December 31, 2025, with net proceeds of approximately $20.9 million from equity financings during the quarter[8]. - Net proceeds from common stock offerings significantly increased to $20,877,925 in 2025 from $2,574,051 in 2024[17]. - Cash and cash equivalents at the end of the period reached $7,721,393 in 2025, up from $1,100,079 in 2024[17]. Research and Development - Research and development expenses decreased to $1.6 million from $2.1 million in the prior-year period, reflecting reduced clinical development activity[8]. - Citius Pharma is advancing its late-stage pipeline, which includes Mino-Lok and Halo-Lido, with ongoing engagement with the FDA[4][8]. Market Strategy and Opportunities - The company aims to expand patient access and market penetration through a technology-driven platform and anticipates growth from international market opportunities[3]. - Citius Oncology's LYMPHIR is targeted for adult patients with relapsed or refractory Stage I–III cutaneous T-cell lymphoma, with an estimated initial market exceeding $400 million[5][9]. - The company has initiated agreements for international patient access to LYMPHIR through Named Patient Programs in Europe and the Middle East[8]. - Citius Oncology has deployed an AI-enabled commercial platform to enhance physician engagement and market penetration in a concentrated prescriber base[8]. Operational Changes - General and administrative expenses increased to $5.7 million compared to $5.4 million in the prior-year period[8]. - License fee payments in investing activities amounted to $4,400,000 in 2025, with no such payments in 2024[17]. - Changes in accounts receivable resulted in a decrease of $4,049,111 in 2025, with no allowances reported in 2024[17]. - Inventory decreased by $352,649 in 2025, a significant improvement compared to a decrease of $6,112,603 in 2024[17]. - Accrued expenses decreased by $5,722,097 in 2025, contrasting with an increase of $6,225,151 in 2024[17]. - Interest paid in 2025 was $14,460, with no interest paid reported in 2024[17].

Revenue and Profitability - Revenue for the three months ended December 31, 2025, was $3,944,111, compared to no revenue in the same period in 2024[151] - Gross profit for the three months ended December 31, 2025, was $3,154,903, with a cost of revenues of $789,208[151] - Net product revenues for the three months ended December 31, 2025, were $3,944,111, with a gross profit margin of approximately 80%[154] Operating Performance - Operating loss for the three months ended December 31, 2025, was $9,019,208, an improvement from a loss of $10,039,614 in the same period in 2024[151] - Total operating expenses increased to $12,174,111 for the three months ended December 31, 2025, compared to $10,039,614 in 2024[151] - The company incurred a net loss of $9,393,889 for the three months ended December 31, 2025, an improvement from a net loss of $10,281,246 in the same period of 2024, reflecting a decrease of $887,357[166] Research and Development - Research and development expenses decreased to $1,599,719 for the three months ended December 31, 2025, from $2,127,038 in 2024[151] - Research and development costs for LYMPHIR decreased to $1,509,595 for the three months ended December 31, 2025, down from $1,727,540 in the same period of 2024, a decrease of 12.7%[159] - The amortization of in-process research and development was $573,438 for the three months ended December 31, 2025[151] - Amortization of in-process research and development for the three months ended December 31, 2025, was $573,438, commencing upon revenue generation from LYMPHIR[160] Cash and Financing - As of December 31, 2025, the company had an accumulated deficit of approximately $247 million and $7.7 million in cash, with a negative working capital of approximately $262,000[168] - The company received net proceeds of approximately $5.8 million from equity offerings during the three months ended December 31, 2025[169] - The company has outstanding milestone payments and purchase commitments totaling approximately $6.8 million to Eisai and $18.25 million to Dr. Reddy's as of December 31, 2025[172] Future Outlook - The company expects revenues to increase as LYMPHIR gains market acceptance, indicating a positive future outlook[155] Interest Income - The company recorded interest income of $45,097 for the three months ended December 31, 2025, compared to $22,608 in 2024[151] - Interest income for the three months ended December 31, 2025, was $45,097, compared to $22,608 in the same period of 2024, reflecting an increase of 99.5%[163] Milestones - The first commercial sale of LYMPHIR occurred in December 2025, marking a significant milestone for the company[148] - The company has limited revenues from the sale of LYMPHIR, which commenced in December 2025[135]

Core Viewpoint - Citius Pharmaceuticals, Inc. has reported its first revenue of $3.9 million following the launch of LYMPHIR, marking a significant milestone in its transition to a revenue-generating company [1]. Business Highlights - The company successfully launched LYMPHIR in December 2025, generating initial sales through a nationwide network of distributors [1]. - Citius Pharma anticipates growth opportunities through early signals from investigator-initiated studies and potential international market expansion [1]. - The company is focused on advancing its late-stage pipeline, which includes Mino-Lok and Halo-Lido, while maintaining financial stewardship [1]. Financial Highlights - For the fiscal first quarter ended December 31, 2025, Citius reported a net loss of $8.2 million, or $(0.41) per share, an improvement from a net loss of $9.8 million, or $(1.30) per share, in the prior-year period [1]. - Stock-based compensation expenses increased to $4.3 million from $2.5 million year-over-year, while general and administrative expenses rose slightly to $5.7 million [1]. - Research and development expenses decreased to $1.6 million from $2.1 million, reflecting reduced clinical development activity [1]. Cash Flow and Financing - The company generated net proceeds of approximately $20.9 million from equity financings during the quarter [1]. - Cash and cash equivalents totaled $7.7 million as of December 31, 2025, compared to $4.3 million at the end of the previous quarter [1]. Market Potential - The initial market for LYMPHIR is estimated to exceed $400 million and is considered underserved by existing therapies [1]. - Citius Oncology's robust intellectual property protections, including orphan drug designation and pending patents, support its competitive positioning in the oncology market [1].

Core Viewpoint - Citius Oncology, Inc. has successfully launched LYMPHIR, generating $3.9 million in revenue for the first fiscal quarter of 2026, marking a significant transition from a development-stage organization to a commercial oncology company [1]. Business Highlights and Subsequent Developments - The company is focused on accelerating physician adoption and expanding patient access to LYMPHIR, with initial distributor sales completed nationwide [1]. - Citius Oncology is preparing to expand its field presence to support a concentrated prescriber base in the rare cancer setting, utilizing an AI-enabled commercial platform for market penetration [1]. - The company is exploring strategic opportunities to enhance long-term shareholder value while managing capital effectively [1]. Financial Highlights for First Quarter 2026 - The net loss for the quarter was $5.5 million, or $(0.06) per share, an improvement from a net loss of $6.7 million, or $(0.09) per share, in the prior-year period [1]. - Stock-based compensation expense increased to $4.0 million, primarily due to equity grants, compared to $1.8 million in the previous year [1]. - General and administrative expenses decreased to $2.9 million from $3.3 million, while research and development expenses were reduced to $1.0 million from $1.3 million [1]. - The company completed a registered offering in December 2025, generating net proceeds of approximately $15.1 million, and reported cash and cash equivalents of $7.3 million as of December 31, 2025 [1]. Market Opportunity - The initial market for LYMPHIR is estimated to exceed $400 million and is considered underserved by existing therapies [1]. - Citius Oncology holds robust intellectual property protections, including orphan drug designation and pending patents for immuno-oncology use, which support its competitive positioning [1].

Core Insights - Citius Oncology has entered into an exclusive distribution agreement with Uniphar to expand access to LYMPHIR in Europe, marking its third international distribution partnership [1][2] - The agreement allows Uniphar to manage access and distribution of LYMPHIR in specific territories in Western and Eastern Europe through country-specific managed access programs [1] - LYMPHIR is a targeted immune therapy for relapsed or refractory cutaneous T-cell lymphoma (CTCL) and is not yet approved for commercial use outside the United States [1][2] Company Overview - Citius Oncology, a subsidiary of Citius Pharmaceuticals, focuses on developing and commercializing novel targeted oncology therapies [2] - The initial market for LYMPHIR is estimated to exceed $400 million and is considered underserved by existing therapies [2] - Citius Oncology has robust intellectual property protections, including orphan drug designation and pending patents for immuno-oncology use [2] Product Information - LYMPHIR (denileukin diftitox-cxdl) is indicated for use in Stage I-III CTCL after at least one prior systemic therapy [1] - The drug works by binding to IL-2 receptors on cancer cells, leading to cell death through inhibition of protein synthesis [1] - In 2021, denileukin diftitox received regulatory approval in Japan for treating relapsed or refractory CTCL and peripheral T-cell lymphoma [1] Distribution Partner - Uniphar is an international healthcare services company that supports over 200 pharmaceutical and medical technology manufacturers [2] - The partnership with Citius Oncology aims to improve patient outcomes for those with relapsed or refractory CTCL [1][2] - Uniphar operates across 180 countries and integrates various services to support the full product lifecycle from research to commercialization [2]

Market Performance - U.S. stocks experienced an upward trend, with the Dow Jones index increasing by over 200 points, closing up 0.48% at 48,673.55. The NASDAQ rose 0.09% to 23,582.81, and the S&P 500 gained 0.25% to 6,927.29 [1] - Consumer staples shares rose by 0.7%, while communication services stocks fell by 0.1% [1] Economic Indicators - U.S. initial jobless claims decreased by 10,000 to 214,000 for the week ending December 20, which was better than market estimates of 223,000 [2][10] Commodity Market - In commodity trading, oil prices fell by 0.2% to $58.28, gold decreased by 0.3% to $4,493.50, and silver dropped by 0.2% to $71.00. Conversely, copper rose by 0.2% to $5.5640 [5] European Market - European shares showed mixed results, with the eurozone's STOXX 600 gaining 0.1%, while Spain's IBEX 35 Index fell by 0.06%. London's FTSE 100 decreased by 0.19%, Germany's DAX 40 rose by 0.23%, and France's CAC 40 slipped by 0.01% [6] Asian Market - Asian markets closed mixed, with Japan's Nikkei 225 down 0.14%, Hong Kong's Hang Seng up 0.17%, China's Shanghai Composite up 0.53%, and India's BSE Sensex down 0.14% [7] Company Updates - Edgewise Therapeutics Inc (NASDAQ:EWTX) shares surged 21% to $26.36 following updates from the ongoing CIRRUS-HCM Phase 2 trial of EDG-7500 [9] - Multi Ways Holdings Ltd (NYSE:MWG) shares increased by 62% to $0.41 after reporting a year-over-year increase in H1 EPS results [9] - Omeros Corp (NASDAQ:OMER) shares rose 68% to $14.72 after the FDA approved YARTEMLEA for treating hematopoietic stem cell transplant–associated thrombotic microangiopathy [9] - Hycroft Mining Holding Corporation (NASDAQ:HYMC) shares fell 10% to $24.56 after a significant rally, influenced by commodity market conditions and a major divestiture by AMC Entertainment Holdings Inc (NYSE:AMC) [9] - Citius Pharmaceuticals Inc (NASDAQ:CTXR) shares dropped 24% to $0.80 despite reporting better-than-expected earnings for the fourth quarter [9] - SMX (Security Matters) PLC (NASDAQ:SMX) shares decreased by 9% to $135.00 [9]