Citius Pharmaceuticals Inc (CTXR)

Citius Oncology Highlights Phase 1 Data in an Investigator-Initiated Study of LYMPHIR® (denileukin diftitox-cxdl) in Combination with Pembrolizumab in Recurrent or Refractory Gynecologic MalignanciesJune 1, 2026 7:00 AM
PR Newswire (US) Investigator-initiated study data presented May 30, 2026, at the American Society of Clinical Oncology (ASCO) Annual Meeting demonstrated durable responses and manageable tolerability in heavily pre-treated patients20.5 months of median progression-free survival observed among 48% of efficacy-evaluable patients achieving clinical benefit (10 of 21) Responses were observed in patients previously treated with immune checkpoint inhibitors, including a 33% objective response rate in patients with relapsed or refractory endometrial cancerCRANFORD, N.J., June 1, 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 highlighted Phase 1 clinical data presented May 30, 2026, at the American Society of Clinical Oncology (ASCO) Annual Meeting evaluating LYMPHIR (denileukin diftitox-cxdl) in combination with pembrolizumab in patients with recurrent or refractory gynecologic malignancies. The poster presentation (Abstract #2564) was presented by investigators from the University of Pittsburgh Medical Center (UPMC) Magee-Womens Hospital. "LYMPHIR's ability to transiently deplete immunosuppressive regulatory T-cells may help address immune resistance in the tumor microenvironment and enhance the effect of checkpoint inhibitors. The encouraging clinical signals and tolerability profile observed in this study support continued clinical evaluation of this "chemo-free" immunomodulatory approach, especially in tumors where resistance to checkpoint inhibitors remains a significant challenge," said Dr. Myron S. Czuczman, Chief Medical Officer of Citius Oncology.The open-label Phase 1 study evaluated LYMPHIR in combination with pembrolizumab in 25 heavily pre-treated patients (21 evaluable for efficacy) with recurrent or metastatic solid tumors, primarily gynecologic malignancies. Enrolled patients had received a median of five prior therapies, and more than half had previously received anti-PD-1 or PD-L1 therapy.Key Efficacy and Safety findings presented at ASCO included:24% Overall Response Rate (ORR) among the 21 efficacy-evaluable patients (5 partial responses).Median duration of response (mDOR) had not yet been reached because only 1 of the 5 partial responders had progressed at the time of analysis (80% of PRs were continuing to experience clinical benefit). The current duration of response times (time since PR was achieved) were 4.2-35 months with a median of 21.1 months.33% ORR in endometrial cancer patients previously treated with checkpoint inhibitors, including one patient with an ongoing response greater than three years.48% of efficacy-evaluable patients (10 of 21) achieved clinical benefit, defined as complete response (CR), partial response (PR), or durable stable disease lasting at least six months:Median progression-free survival (mPFS) of 20.5 months (95% CI: 6.5 – NA) among the 10 patients who achieved clinical benefit; overall mPFS across all 21 efficacy-evaluable patients was 5.8 months (95% CI: 2.2 – NA);5 patients had a PFS of > 20 months including 1 patient with > 30 months PFS;Of the 24/25 pts evaluable for dose limiting toxicities (DLTs), only 1 case of reversible Gr 3 capillary leak syndrome (CLS) was observed at the highest dose level. A maximum tolerated dose was not achieved.16 serious adverse events were observed in seven patients treated at the highest dose level. No new safety signals or grade 3 or greater immune-related adverse events were observed.Dr. Alexander Olawaiye, a professor and one of the gynecologic cancer researchers at UPMC Magee-Womens Hospital and lead investigator of the study, added, "Patients with recurrent gynecologic malignancies who progress following immunotherapy often have limited treatment options. The clinical activity observed with denileukin diftitox-cxdl plus pembrolizumab, including durable responses and prolonged disease control in heavily pre-treated patients, is notable. Given the lack of effective salvage treatments for these patients, especially those that have failed prior immune-checkpoint inhibition, the novel combination of LYMPHIR plus pembrolizumab provides a potential viable therapeutic option. Importantly, the safety profile observed was manageable in this heavily pre-treated population, supporting continued evaluation in larger studies."Ongoing translational studies are evaluating the impact of the combination on regulatory T-cells, immune effector cells, and the tumor microenvironment to help identify potential biomarkers in order to optimize future development strategies. A Phase 2 expansion study is being planned to further evaluate the combination in gynecologic cancers, including less heavily pre-treated and prior immunotherapy-exposed patient populations.About the StudyThis open-label, dose-escalation, investigator-initiated Phase?1 study (NCT05200559), led by Dr. Alexander B Olawaiye at UPMC Magee-Womens Hospital, enrolled 25 patients with recurrent or metastatic solid tumors who had received at least one prior line of therapy. LYMPHIR was administered intravenously on Days?1–3 of each 21-day cycle at escalating doses (3, 6, 9, and 12 mcg/kg), along with pembrolizumab (200?mg IV) on Day?1. Patients who completed eight cycles of combination therapy were continued on pembrolizumab monotherapy until disease progression. Citius Oncology provided study drug and financial support to the investigator-initiated study; the study was designed, conducted, and analyzed by the UPMC investigators.Important note on investigational use: The use of LYMPHIR in this study was investigational and outside of its FDA-approved indication of relapsed or refractory Stage I–III cutaneous T-cell lymphoma. LYMPHIR is not approved by the FDA for the treatment of gynecologic malignancies or any solid tumor, and the safety and efficacy of LYMPHIR in this setting have not been established. This Phase 1 study was not designed or powered to evaluate clinical efficacy, and no conclusions can be drawn regarding comparative effectiveness or long-term outcomes. Early-stage clinical data may not be predictive of results from larger or later-stage studies.About Gynecologic CancersRecurrent or metastatic ovarian and endometrial cancers are two of the most common gynecologic malignancies in the United States. Endometrial cancer is the most frequently diagnosed gynecologic cancer, with an estimated 70,000 new endometrial cancer cases expected in the United States in 20261, while ovarian cancer remains the deadliest with approximately 12,700 deaths per year (51.6%) and approximately 20,000 new diagnoses each year in the United States2. These cancers are often detected at advanced stages, and although many patients initially respond to platinum-based chemotherapy, most experience relapse and develop resistance. Survival rates in the recurrent setting remain poor, and responses to current immunotherapies such as PD-1 inhibitors are limited, highlighting a significant unmet need for novel treatment approaches. LYMPHIR's transient depletion of regulatory T-cells in combination with anti-PD-1 checkpoint inhibition may potentially enhance host anti-tumor immune responses and help overcome immunotherapy resistance in these difficult-to-treat tumors.About LYMPHIR (denileukin diftitox-cxdl)LYMPHIR is a targeted immune therapy for relapsed or refractory cutaneous T-cell lymphoma (CTCL) indicated for use in Stage I-III disease after at least one prior systemic therapy. It is a recombinant fusion protein that combines the IL-2 receptor binding domain with diphtheria toxin (DT) fragments. The agent specifically binds to IL-2 receptors on the cell surface, causing diphtheria toxin fragments that have entered cells to inhibit protein synthesis. After uptake into the cell, the DT fragment is cleaved and the free DT fragments inhibit protein synthesis, resulting in cell death. Denileukin diftitox-cxdl-associated anti-tumor activity is achieved via a direct cytocidal action on IL-2R-expressing tumors and depletion of host immunosuppressive regulatory T lymphocytes (Tregs).In 2021, reformulated denileukin diftitox received regulatory approval in Japan for the treatment of relapsed or refractory CTCL and peripheral T-cell lymphoma (PTCL). Subsequently, in 2021, Citius acquired an exclusive license with rights to develop and commercialize reformulated denileukin diftitox in all markets except for India, Japan and certain parts of Asia. LYMPHIR (denileukin diftitox-cxdl) was approved by the FDA and subsequently launched in the U.S. in December 2025.About Citius Oncology, Inc.Citius Oncology, Inc. (Nasdaq: CTOR) is a platform to develop and commercialize novel targeted oncology therapies. In December 2025, Citius Oncology launched LYMPHIR, approved by the FDA for the treatment of adults with relapsed or refractory Stage I–III CTCL who had had at least one prior systemic therapy. Management estimates the initial CTCL market for LYMPHIR currently exceeds $400 million, is growing, and is underserved by existing therapies. Robust intellectual property protections that span orphan drug designation, complex technology, trade secrets and pending patents for immuno-oncology use as a combination therapy with checkpoint inhibitors would further support Citius Oncology's competitive positioning. For more information, please visit www.citiusonc.com.Forward-Looking Statements This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements are made based on our expectations and beliefs concerning future events impacting Citius Oncology. You can identify these statements by the fact that they use words such as "will," "anticipate," "estimate," "expect," "plan," "should," and "may" and other words and terms of similar meaning or use of future dates. Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price.  Factors that could cause actual results to differ materially from those currently anticipated are: our need for substantial additional funds and our ability to raise additional money to fund our operations for at least the next 12 months as a going concern; our ability to successfully commercialize LYMPHIR and establish a sustainable revenue stream; our ability to regain compliance with Nasdaq's continued listing standards; our ability to obtain, perform under and maintain third party agreements and relationships, including obtaining a new bulk drug substance supplier; risks relating to the results of research and development activities, including those from our existing and any new pipeline assets; early-stage clinical data may not be predictive of results from larger or later-stage studies; our ability to secure and maintain strategic partnerships and expand international access to LYMPHIR; the estimated markets for LYMPHIR and our product candidates and the acceptance thereof by any market; our ability to use the latest technology to support our commercialization efforts for LYMPHIR; physician and patient acceptance of LYMPHIR in a competitive treatment landscape; our reliance on third-party logistics providers, distributors, and specialty pharmacies to support commercial operations; our ability to educate providers and payers, secure adequate reimbursement, and maintain uninterrupted product supply; post-marketing requirements and ongoing regulatory compliance related to LYMPHIR; the ability of LYMPHIR and our product candidates to impact the quality of life of our target patient populations; our ability to procure cGMP commercial-scale supply; risks related to our growth strategy; patent and intellectual property matters; government regulation; as well as other risks described in our Securities and Exchange Commission ("SEC") filings. These risks have been and may be further impacted by any future public health risks. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Risks regarding our business are described in detail in our SEC filings which are available on the SEC's website at www.sec.gov, including in Citius Oncology's Annual Report on Form 10-K for the year ended September 30, 2025, filed with the SEC on December 23, 2025. These forward-looking statements speak only as of the date hereof, and we expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.REFERENCES:American Cancer Society. Cancer Facts & Figures 2026 (projected). Atlanta: American Cancer Society; 2026. https://www.cancer.org/cancer/types/endometrial-cancer/about/key-statistics.htmlNational Cancer Institute. Surveillance, Epidemiology, and End Results Program (SEER). Cancer Stat Facts: Uterine and Ovarian Cancer. https://seer.cancer.gov/statfacts/html/ovary.htmlLYMPHIR (denileukin diftitox-cxdl)INDICATIONLYMPHIR is an IL2-receptor-directed cytotoxin indicated for the treatment of adult patients with r/r Stage I-III cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy.IMPORTANT SAFETY INFORMATION BOXED WARNING: CAPILLARY LEAK SYNDROMECapillary leak syndrome (CLS), including life-threatening or fatal reactions, can occur in patients receiving LYMPHIR. Monitor patients for signs and symptoms of CLS during treatment. Withhold LYMPHIR until CLS resolves, or permanently discontinue based on severity.WARNINGS AND PRECAUTIONS Capillary Leak SyndromeLYMPHIR can cause capillary leak syndrome (CLS), including life-threatening or fatal reactions. CLS was defined in the clinical trials as the occurrence of at least 2 of the following symptoms at any time during LYMPHIR therapy: hypotension, edema, and serum albumin

Citius Pharmaceuticals, Inc. Reports Fiscal Second Quarter 2026 Financial Results and Provides Business UpdateMay 15, 2026 4:30 PM
PR Newswire (US) $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 financingAdvanced 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 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 DevelopmentsReported 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 EventsCash 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.About Citius Oncology, Inc.Citius Oncology, Inc. (Nasdaq: CTOR) is a platform to develop and commercialize novel targeted oncology therapies. In December 2025, Citius Oncology launched LYMPHIR, approved by the FDA for the treatment of adults with relapsed or refractory Stage I–III CTCL who had had at least one prior systemic therapy. Management estimates the initial market for LYMPHIR currently exceeds $400 million, is growing, and is underserved by existing therapies. Robust intellectual property protections that span orphan drug designation, complex technology, trade secrets and pending patents for immuno-oncology use as a combination therapy with checkpoint inhibitors would further support Citius Oncology's competitive positioning. For more information, please visit www.citiusonc.com.About Citius Pharmaceuticals, Inc. Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) is a biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products. Citius Pharma owns approximately 71% of Citius Oncology. In December 2025, Citius Oncology launched LYMPHIR, a targeted immunotherapy for the treatment of adults with relapsed or refractory Stage I–III CTCL who had had at least one prior systemic therapy. Citius Pharma's late-stage pipeline also includes Mino-Lok®, a catheter lock solution to salvage catheters in patients with catheter-related bloodstream infections, and CITI-002 (Halo-Lido), a topical formulation for the relief of hemorrhoids. A pivotal Phase 3 trial for Mino-Lok and a Phase 2b trial for Halo-Lido were completed in 2023. Mino-Lok met primary and secondary endpoints of its Phase 3 trial. Citius Pharma is actively engaged with the FDA to outline next steps for both programs. For more information, please visit www.citiuspharma.com.Forward-Looking StatementsThis press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements are made based on our expectations and beliefs concerning future events impacting Citius Pharmaceuticals. You can identify these statements by the fact that they use words such as "will," "anticipate," "estimate," "expect," "plan," "should," and "may" and other words and terms of similar meaning or use of future dates. Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price.  Factors that could cause actual results to differ materially from those currently anticipated are: our need for substantial additional funds and our ability to raise additional money to fund our operations for at least the next 12 months as a going concern; our ability to obtain, perform under and maintain financing, strategic and third party agreements and relationships, including obtaining a new bulk drug substance supplier; our ability to regain compliance with Nasdaq's continued listing standards; our ability to successfully commercialize LYMPHIR and establish a sustainable revenue stream; the estimated markets for LYMPHIR and our product candidates and the acceptance thereof by any market; our ability to secure strategic partnerships and expand international access to LYMPHIR; our ability to use the latest technology to support our commercialization efforts for LYMPHIR; physician and patient acceptance of LYMPHIR in a competitive treatment landscape; our reliance on third-party logistics providers, distributors, and specialty pharmacies to support commercial operations; our ability to educate providers and payers, secure adequate reimbursement, and maintain uninterrupted product supply; post-marketing requirements and ongoing regulatory compliance related to LYMPHIR; the ability of LYMPHIR and our product candidates to impact the quality of life of our target patient populations; risks relating to the results of research and development activities, including those from any new pipeline assets; our ability to procure cGMP commercial-scale supply; market and other conditions; risks related to our growth strategy; patent and intellectual property matters; government regulation; as well as other risks described in our Securities and Exchange Commission ("SEC") filings. These risks have been and may be further impacted by any future public health risks. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Risks regarding our business are described in detail in our SEC filings which are available on the SEC's website at www.sec.gov, including in Citius Oncology's Annual Report on Form 10-K for the year ended September 30, 2025, filed with the SEC on December 23, 2025 and as amended on January 28, 2026. These forward-looking statements speak only as of the date hereof, and we expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.Investor Contact:
Ilanit Allen
ir @crsrs-6677 x113Media Contact:
STiR-communications
Greg Salsburg
Greg@STiR-communications.com – Financial Tables Follow – CITIUS PHARMACEUTICALS, INC.CONDENSED CONSOLIDATED BALANCE SHEETS(Unaudited)


March 31,

September 30,


2026

2025
ASSETS





Current Assets:





Cash and cash equivalents
$4,590,174

$4,252,290
Accounts receivable, net of allowances

1,079,055


-
Inventory

22,659,590


22,286,693
Prepaid expenses

3,356,882


1,395,490
Total Current Assets

31,685,701


27,934,473









Operating lease right-of-use asset, net

794,518


818,694









Deposits

38,062


38,062
In-process research and development, net of accumulated amortization

90,506,250


92,800,000
Deferred financing costs

169,252


-
Goodwill

9,346,796


9,346,796
Total Other Assets

100,060,360


102,184,858









Total Assets
$132,540,579

$130,938,025









LIABILITIES AND STOCKHOLDERS' EQUITY







Current Liabilities:







Accounts payable
$9,453,803

$13,693,692
License payable

17,650,000


22,650,000
Accrued expenses

24,138,264


4,190,253
Accrued compensation

3,602,007


3,292,447
Note payable

-


1,000,000
Operating lease liability

171,495


88,348
Total Current Liabilities

55,015,569


44,914,740









Deferred tax liability

7,803,790


7,770,760
Operating lease liability – noncurrent

636,667


724,925
Total Liabilities

63,456,026


53,410,425









Commitments and Contingencies
















Stockholders' Equity:







Preferred stock - $0.001 par value; 10,000,000 shares authorized; no shares issued
and outstanding

-


-
Common stock - $0.001 par value; 250,000,000 shares authorized; 22,376,427 and
18,067,744 shares issued and outstanding at March 31, 2026 and September 30,
2025, respectively

22,376


18,068
Additional paid-in capital

329,775,214


306,336,239
Accumulated deficit

(268,256,054)


(238,804,129)
Total Citius Pharmaceuticals, Inc. Stockholders' Equity

61,541,536


67,550,178
Non-controlling interest

7,543,017


9,977,422
Total Equity

69,084,553


77,527,600









Total Liabilities and Equity
$132,540,579

$130,938,025
 CITIUS PHARMACEUTICALS, INC.CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONSFOR THE THREE AND SIX MONTHS ENDED MARCH 31, 2026 AND 2025(Unaudited)


Three Months Ended

Six Months Ended


March 31,

March 31,

March 31,

March 31,


2026

2025

2026

2025
Revenues
$1,667,298

$—

$5,611,409

$—
Cost of revenues

(328,878)


—


(1,118,086)


—
Gross Profit

1,338,420


—


4,493,323


—

















Operating Expenses















Research and development

1,633,518


3,766,525


3,233,237


5,893,563
Amortization of in-process research and development

1,720,312


—


2,293,750


—
General and administrative

26,391,101


4,792,122


32,111,828


10,179,874
Stock-based compensation – general and administrative

3,788,275


2,702,031


8,068,502


5,226,855
Total Operating Expenses

33,533,206


11,260.678


45,707,317


21,300,292

















Operating Loss

(32,194,786)


(11,260,678)


(41,213,994)


(21,300,292)

















Other Income (Expense)















Interest income

53,584


13,413


98,681


36,021
Gain on sale of New Jersey net operating losses

3,833,277


—


3,833,277


—
Interest expense

(33,031)


—


(188,569)


—
Total Other Income, Net

3,853,830


13,413


3,743,389


36,021

















Loss before Income Taxes

(28,340,956)


(11,247,265)


(37,470,605)


(21,264,271)
Income tax expense (benefit)

(231,210)


264,240


33,030


528,480

















Net Loss

(28,109,746)


(11,511,505)


(37,503,635)


(21,792,751)
Net loss attributable to non-controlling interest

6,878,606


595,000


8,051,710


1,108,000

















Net loss applicable to common stockholders
$(21,231,140)

$(10,916,505)

$(29,451,925)

$(20,684,751)

















Net Loss Per Share - Basic and Diluted
$(0.95)

$(1.27)

$(1.34)

$(2.58)

















Weighted Average Common Shares Outstanding















Basic and diluted (includes pre-funded warrants from the
October 2025 offering)

22,376,427


8,581,207


21,931,009


8,029,834
 CITIUS PHARMACEUTICALS, INC.CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWSFOR THE SIX MONTHS ENDED MARCH 31, 2026 AND 2025(Unaudited)


2026

2025
Cash Flows From Operating Activities:





Net loss
$(37,503,635)

$(21,792,751)
Adjustments to reconcile net loss to net cash used in operating activities:







Stock-based compensation expense

8,068,502


5,226,855
Issuance of common stock for services

107,510


-
Issuance of common stock warrant

68,597


-
Amortization of in-process research and development

2,293,750


-
Amortization (accretion) of operating lease right-of-use asset

24,176


110,845
Deferred income tax expense

33,030


528,480
Changes in operating assets and liabilities:







Accounts receivable, net of allowances

(1,079,055)


-
Inventory

(372,897)


(7,070,487)
Prepaid expenses

(1,961,392)


(308,791)
Accounts payable

(4,239,889)


4,441,023
Accrued expenses

19,948,011


8,762,217
Accrued compensation

309,560


955,048
Operating lease liability

(5,111)


(117,767)
Net Cash Used In Operating Activities

(14,308,843)


(9,265,328)









Cash Flows From Investing Activities:







License fee payments

(5,000,000)


—
Net Cash Used in Investing Activities

(5,000,000)


—









Cash Flows From Financing Activities:







Repayment of note payable

(1,000,000)


—
Deferred financing costs

(169,252)


—
Proceeds from exercise of Citius Oncology pre-funded warrants

818


—
Net proceeds from common stock offerings

20,815,161


6,039,858
Net Cash Provided By Financing Activities

19,646,727


6,039,858









Net Change in Cash and Cash Equivalents

337,884


(3,225,470)
Cash and Cash Equivalents - Beginning of Period

4,252,290


3,251,880
Cash and Cash Equivalents - End of Period
$4,590,174

$26,410
Supplemental Disclosures of Cash Flow Information and Non-cash Transactions:







Interest paid
$105,310

$—
Operating lease right-of-use asset and liability recorded
$—

$786,697
  View original content to download multimedia:https://www.prnewswire.com/news-releases/citius-pharmaceuticals-inc-reports-fiscal-second-quarter-2026-financial-results-and-provides-business-update-302773890.htmlSOURCE Citius Pharmaceuticals, Inc. Original: Citius Pharmaceuticals, Inc. Reports Fiscal Second Quarter 2026 Financial Results and Provides Business Update

Citius Oncology, Inc. Reports Fiscal Second Quarter 2026 Financial Results and Provides Business UpdateMay 15, 2026 4:30 PM
PR Newswire (US) $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 reviewCRANFORD, 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 launch, which include strong formulary and payer access, a funded commercial buildout, and healthy margins, are all moving in the right direction," added Mazur."Building on the commercial foundation we are establishing in the U.S., we have initiated our first European shipment as part of the international distribution agreements we have in place across 19 markets in Southern Europe, the Middle East, and additional Western and Eastern European territories. At the same time, we continue to strengthen LYMPHIR's long-term value proposition through our support of clinical evidence generation. Recent preliminary topline Phase 1 investigator-initiated trial data reinforce the immuno-oncology rationale for LYMPHIR in combination settings, including its T-regulatory cell (Treg) depletion mechanism, and we look forward to additional data readouts in the future. Together, these execution milestones and data-driven catalysts reinforce our view that LYMPHIR can be developed beyond U.S. CTCL as a platform asset in combination regimens. We look forward to sharing continued positive momentum as LYMPHIR establishes itself as a meaningful new option in the treatment of relapsed or refractory CTCL, and we remain confident in its broader long-term commercial potential," concluded Mazur.Fiscal Second Quarter 2026 Business Highlights and Subsequent DevelopmentsAdvanced formularly inclusion with 83% of target accounts having added or actively progressing LYMPHIR through formulary review;Secured near 100% of covered commercial lives; no reimbursement denials or prior authorization barriers reported;Initiated community infusion center penetration, with patients beginning to transition from larger academic cancer centers, a critical next phase of commercial scaling;Initiated shipment of LYMPHIR to Europe, with LYMPHIR being made available through Named Patient Programs (NPPs) per local regulations;Continued deployment of a proprietary AI-powered machine learning platform to support targeted physician engagement and efficient penetration of the highly concentrated CTCL prescriber base;Recruited and trained initial field sales team, with expanded field force recruitment underway;Announced positive topline results from two investigator-initiated Phase 1 studies evaluating LYMPHIR in combination settings, including:Phase 1 trial of LYMPHIR in combination with pembrolizumab (KEYTRUDA®) in patients with recurrent or refractory gynecologic cancers, including ovarian and endometrial malignancies;Phase 1 trial of LYMPHIR administered prior to 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,Initiated evaluation of new bulk drug substance (BDS) suppliers with letter of intent with a new contract manufacturing organization (CMO) expected by the end of June 2026; $22.7 million of finished goods and work-in-process inventory as of March 31, 2026 to support anticipated commercial demand during the transition;Fiscal Second Quarter 2026 Financial Highlights and Subsequent DevelopmentsCash and cash equivalents of $2.6 million as of March 31, 2026, prior to the up to $36.5 million concurrent debt and equity financings that closed in early May 2026;Secured up to $36.5 million in combined financing subsequent to quarter end, consisting of:a senior secured term loan facility of up to $25 million from Avenue Venture Opportunities Fund II, L.P. (Avenue Capital Group), with $10 million funded at close on May 6, 2026, up to $7 million available beginning October 1, 2026 subject to revenue and liquidity milestones, and up to $8 million available beginning January 1, 2027 subject to additional revenue milestones; and,approximately $11.5 million in gross proceeds received May 5, 2026 from the exercise of certain outstanding warrants; and,Net product revenues of $1.7 million for the three months ended March 31, 2026, compared to no revenue for the three months ended March 31, 2025; and $5.6 million for the six months ended March 31, 2026, compared to no revenue for the six months ended March 31, 2025;Gross profit of $1.3 million (80% margin) for the three months ended March 31, 2026, and $4.5 million (80% margin) for the six months ended March 31, 2026;R&D expenses of $1.1 million for the three months ended March 31, 2026, compared to $3.1 million for the three months ended March 31, 2025; and $2.1 million for the six months ended March 31, 2026, compared to $4.4 million for the six months ended March 31, 2025;G&A expenses of $23.6 million for the three months ended March 31, 2026, compared to $2.2 million for the three months ended March 31, 2025, primarily driven by the $19.7 million one-time CMO contract cancellation charge. G&A expenses were $26.5 million for the six months ended March 31, 2026, compared to $5.6 million for the six months ended March 31, 2025;Stock-based compensation expense of $3.5 million for the three months ended March 31, 2026, compared to $2.1 million for the three months ended March 31, 2025; and $7.5 million for the six months ended March 31, 2026, compared to $3.9 million for the six months ended March 31, 2025;Recognized a gain of $1.76 million from the sale of New Jersey state net operating losses under the New Jersey Technology Business Tax Certificate Transfer Program; and,Net loss of $26.6 million for the three months ended March 31, 2026, compared to a net loss of $7.7 million for the three months ended March 31, 2025; and a net loss of $32.1 million for the six months ended March 31, 2026, compared to a net loss of $14.4 million for the six months ended March 31, 2025.Fiscal Second Quarter 2026 Financial Results:LiquidityAs of March 31, 2026, the Company had $2.6 million in cash and cash equivalents.Subsequent to quarter end, on May 5, 2026, the Company received approximately $11.5 million in gross proceeds from the exercise of certain outstanding warrants, and on May 6, 2026, the Company funded $10 million in gross proceeds under the first tranche of a senior secured term loan facility with Avenue Capital Group providing access to up to $25 million in total gross proceeds.We plan to continue to partially rely on funding from Citius Pharma, to raise capital through equity and debt financings, and to generate revenue from sales of LYMPHIR. We also have retained Jefferies LLC as our exclusive financial advisor in evaluating strategic alternatives aimed at maximizing shareholder value.After giving effect to the May 2026 equity and debt financings, we expect that Citius Oncology and Citius Pharma collectively will have sufficient funds to continue operations through November 2026.   Net RevenueNet product revenues were $1.7 million for the three months ended March 31, 2026, compared to no revenue for the three months ended March 31, 2025. For the six months ended March 31, 2026, net product revenues were $5.6 million, compared to no revenue for the six months ended March 31, 2025.The Company launched LYMPHIR in December 2025. The quarterly decrease in product revenues is primarily attributable to larger initial orders in the quarter ended December 31, 2025, as US distributors established their initial inventories. We believe that revenues will increase in the future as LYMPHIR gains market acceptance and initial accounts continue placing repeat orders. At the end of April 2026, we announced an initial shipment of LYMPHIR to Europe.Research and Development (R&D) ExpensesR&D expenses were $1.1 million for the three months ended March 31, 2026, compared to $3.1 million for the three months ended March 31, 2025, a decrease of $2.0 million. For the six months ended March 31, 2026, R&D expenses were $2.1 million, compared to $4.4 million for the six months ended March 31, 2025, a decrease of $2.3 million. 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.General and Administrative (G&A) ExpensesG&A expenses were $23.6 million for the three months ended March 31, 2026, compared to $2.2 million for the three months ended March 31, 2025, an increase of $21.4 million. For the six months ended March 31, 2026, G&A expenses were $26.5 million, compared to $5.5 million for the six months ended March 31, 2025, an increase of $21.9 million. The increase in both periods was primarily driven by a $19.7 million one-time contract cancellation charge related to the CMO termination recognized in March 2026.Stock-based Compensation ExpenseStock-based compensation expense was $3.5 million for the three months ended March 31, 2026, compared to $2.1 million for the three months ended March 31, 2025. For the six months ended March 31, 2026, stock-based compensation was $7.5 million, compared to $3.9 million for the six months ended March 31, 2025.Net LossNet loss was $26.6 million for the three months ended March 31, 2026, compared to $7.7 million for the three months ended March 31, 2025, an increase of $18.9 million. For the six months ended March 31, 2026, net loss was $32.1 million, compared to $14.4 million for the six months ended March 31, 2025, an increase of $17.7 million. The increase in net loss for the three-month period was primarily attributable to the $19.7 million CMO contract cancellation charge, partially offset by $1.7 million in LYMPHIR revenues and the $1.76 million gain on the sale of New Jersey net operating losses.About Citius Oncology, Inc.Citius Oncology, Inc. (Nasdaq: CTOR) is a platform to develop and commercialize novel targeted oncology therapies. In December 2025, Citius Oncology launched LYMPHIR, approved by the FDA for the treatment of adults with relapsed or refractory Stage I–III CTCL who had had at least one prior systemic therapy. Management estimates the initial market for LYMPHIR currently exceeds $400 million, is growing, and is underserved by existing therapies. Robust intellectual property protections that span orphan drug designation, complex technology, trade secrets and pending patents for immuno-oncology use as a combination therapy with checkpoint inhibitors would further support Citius Oncology's competitive positioning. For more information, please visit www.citiusonc.com.About Citius Pharmaceuticals, Inc.Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) is a biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products. Citius Pharma owns approximately 71% of Citius Oncology. In December 2025, Citius Oncology launched LYMPHIR, a targeted immunotherapy for the treatment of adults with relapsed or refractory Stage I–III CTCL who had had at least one prior systemic therapy. Citius Pharma's late-stage pipeline also includes Mino-Lok®, a catheter lock solution to salvage catheters in patients with catheter-related bloodstream infections, and CITI-002 (Halo-Lido), a topical formulation for the relief of hemorrhoids. A pivotal Phase 3 trial for Mino-Lok and a Phase 2b trial for Halo-Lido were completed in 2023. Mino-Lok met primary and secondary endpoints of its Phase 3 trial. Citius Pharma is actively engaged with the FDA to outline next steps for both programs. For more information, please visit www.citiuspharma.com.Forward-Looking StatementsThis press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements are made based on our expectations and beliefs concerning future events impacting Citius Oncology. You can identify these statements by the fact that they use words such as "will," "anticipate," "estimate," "expect," "plan," "should," and "may" and other words and terms of similar meaning or use of future dates. Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price.  Factors that could cause actual results to differ materially from those currently anticipated are: our need for substantial additional funds and our ability to raise additional money to fund our operations for at least the next 12 months as a going concern; our ability to obtain, perform under and maintain financing, strategic and third party agreements and relationships, including obtaining a new bulk drug substance supplier; our ability to regain compliance with Nasdaq's continued listing standards; our ability to successfully commercialize LYMPHIR and establish a sustainable revenue stream; the estimated markets for LYMPHIR and our product candidates and the acceptance thereof by any market; our ability to secure strategic partnerships and expand international access to LYMPHIR; our ability to use the latest technology to support our commercialization efforts for LYMPHIR; physician and patient acceptance of LYMPHIR in a competitive treatment landscape; our reliance on third-party logistics providers, distributors, and specialty pharmacies to support commercial operations; our ability to educate providers and payers, secure adequate reimbursement, and maintain uninterrupted product supply; post-marketing requirements and ongoing regulatory compliance related to LYMPHIR; the ability of LYMPHIR and our product candidates to impact the quality of life of our target patient populations; risks relating to the results of research and development activities, including those from any new pipeline assets; our ability to procure cGMP commercial-scale supply; market and other conditions; risks related to our growth strategy; patent and intellectual property matters; government regulation; as well as other risks described in our Securities and Exchange Commission ("SEC") filings. These risks have been and may be further impacted by any future public health risks. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Risks regarding our business are described in detail in our SEC filings which are available on the SEC's website at www.sec.gov, including in Citius Oncology's Annual Report on Form 10-K for the year ended September 30, 2025, filed with the SEC on December 23, 2025. These forward-looking statements speak only as of the date hereof, and we expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.Investor Contact:
Ilanit Allen
ir @crsrs-6677 x113Media Contact:
STiR-communications
Greg Salsburg
Greg@STiR-communications.com – Financial Tables Follow –CITIUS ONCOLOGY, INC.CONDENSED CONSOLIDATED BALANCE SHEETS(Unaudited)


March 31,
2026

September 30,
2025
Current Assets:





Cash and cash equivalents
$2,632,634

$3,924,908
Accounts receivable, net of allowances

1,079,055


—
Inventory

22,659,590


22,286,693
Prepaid expenses

3,052,387


1,331,280
Total Current Assets

29,423,666


27,542,881









Other Assets:







In-process research and development, net of accumulated amortization

71,106,250


73,400,000
Deferred financing costs

169,252


—
Total Other Assets

71,275,502


73,400,000









Total Assets
$100,699,168

$100,942,881
LIABILITIES AND STOCKHOLDERS' EQUITY







Current Liabilities:







Accounts payable
$8,883,239

$13,234,684
License payable

17,650,000


22,650,000
Accrued expenses

24,057,573


4,093,124
Due to related party

8,221,486


9,513,771
Total Current Liabilities

58,812,298


49,491,579









Deferred tax liability

2,817,990


2,784,960
Note payable to related party

3,800,111


3,800,111
Total Liabilities

65,430,399


56,076,650
Stockholders' Equity:







Preferred stock - $0.0001 par value; 10,000,000 shares authorized: no shares issued
     and outstanding

—


—
Common stock - $0.0001 par value; 400,000,000 shares authorized at March 31,
     2026 and September 30, 2025; 92,981,204 and 83,513,442 shares issued and
     outstanding at March 31, 2026 and September 30, 2025, respectively

9,298


8,351
Additional paid-in capital

131,443,191


108,897,836
Accumulated deficit

(96,183,720)


(64,039,956)
Total Stockholders' Equity

35,268,769


44,866,231
Total Liabilities and Stockholders' Equity
$100,699,168

$100,942,881
 CITIUS ONCOLOGY, INC.CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONSFOR THE THREE AND SIX MONTHS ENDED MARCH 31, 2026 AND 2025 (Unaudited)


Three Months Ended

Six Months Ended


March 31,

March 31,

March 31,

March 31,


2026

2025

2026

2025
Revenues
$1,667,298

$—

$5,611,409

$—
Cost of revenues

(328,878)


—


(1,118,086)


—
Gross Profit

1,338,420


—


4,493,323


—

















Operating Expenses















Research and development

1,079,354


3,139,413


2,097,706


4,403,921
Amortization of in-process research and development

1,720,312


—


2,293,750


—
General and administrative

23,625,639


2,243,327


26,484,978


5,565,306
Stock-based compensation – general and administrative

3,526,710


2,088,572


7,482,760


3,897,050
Total Operating Expenses

29,952,015


7,471,312


38,359,194


13,866,277

















Operating Loss

(28,613,595)


(7,471,312)


(33,865,871)


(13,866,277)

















Other Income (Expense)















Interest income

43,721


—


72,009


—
Gain on sale of New Jersey net operating losses

1,762,000


—


1,762,000


—
Interest expense

(33,031)


—


(78,872)


—
Total Other Income

1,772,690


—


1,755,137


—

















Loss before Income Taxes

(26,840,905)


(7,471,312)


(32,110,734)


(13,866,277)
Income tax expense (benefit)

(231,210)


264,240


33,030


528,480

















Net Loss
$(26,609,695)

$(7,735,552)

$(32,143,764)

$(14,394,757)

















Net Loss Per Share - Basic and Diluted
$(0.27)

$(0.11)

$(0.34)

$(0.20)

















Weighted Average Common Shares Outstanding















Basic and diluted (includes pre-funded warrants from the
     December 2025 offering)

100,027,204


71,552,402


93,657,757


71,552,402
 CITIUS ONCOLOGY, INC.CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWSFOR THE SIX MONTHS ENDED MARCH 31, 2026 AND 2025(Unaudited)


2026

2025
Cash Flows From Operating Activities:





Net loss
$(32,143,764)

$(14,394,757)
Adjustments to reconcile net loss to net cash provided by operating activities:







Stock-based compensation expense

7,482,760


3,897,050
Amortization of in-process research and development

2,293,750


-
Deferred income tax expense

33,030


528,480
Changes in operating assets and liabilities:







Accounts receivable, net of allowances

(1,079,055)


-
Inventory

(372,897)


(7,070,487)
Prepaid expenses

(1,721,107)


-
Accounts payable

(4,351,445)


3,964,688
Accrued expenses

19,964,449


8,722,168
Due to related party

(1,292,285)


4,352,858
Net Cash (Used In) Provided By Operating Activities

(11,186,564)


-
Cash Flows From Investing Activities







    License payments

(5,000,000)


-
Net Cash Used In Investing Activities

(5,000,000)


-
Cash Flows From Financing Activities







    Deferred financing costs

(169,252)


-
    Net proceeds from issuance of common stock

15,063,542


-
Net Cash Provided by Financing Activities

14,894,290


-
Net Change in Cash and Cash Equivalents

(1,292,274)


-
Cash and Cash Equivalents – Beginning of Period

3,924,908


112
Cash and Cash Equivalents – End of Period
$2,632,634

$112
Supplemental Disclosures of Cash Flow Information and Non-cash
     Transactions:







Interest Paid
$14,460

$-
  View original content to download multimedia:https://www.prnewswire.com/news-releases/citius-oncology-inc-reports-fiscal-second-quarter-2026-financial-results-and-provides-business-update-302773892.htmlSOURCE Citius Oncology, Inc. Original: Citius Oncology, Inc. Reports Fiscal Second Quarter 2026 Financial Results and Provides Business Update

Citius Oncology Ships First International Order of LYMPHIR™ to EuropeApril 29, 2026 8:00 AM
PR Newswire (US)

Order fulfilment expands international patient access to LYMPHIR following initial U.S. launchDistribution by regional partners through Named Patient Programs in specific international marketsCRANFORD, N.J., April 29, 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 the initial shipment of LYMPHIR™ (denileukin diftitox-cxdl) to Europe through one of its regional distribution partners, marking an important milestone in expanding access to the therapy for patients outside the United States. LYMPHIR will be made available to eligible patients through Named Patient Programs (NPPs) in accordance with local regulations in each country.







The initiation of European distribution represents a strategic step in the Company's broader effort to extend access to LYMPHIR for patients with limited treatment options, while continuing to prioritize disciplined and targeted market entry."Reaching this milestone underscores our commitment to ensuring that patients in need can access LYMPHIR beyond the United States," said Leonard Mazur, Chairman and Chief Executive Officer of Citius Oncology. "Through our distribution partners, we are enabling physicians to request LYMPHIR for appropriate patients via established Named Patient Programs, providing a pathway to treatment where approved alternatives may be limited. Importantly, this progress complements the strong early foundation we are building in the U.S., where we continue to see encouraging adoption across key treatment centers."In the United States, Citius Oncology continues to execute its commercial launch strategy, with ongoing progress in formulary access, expanding payer coverage, and increasing engagement across both academic and community oncology settings. The Company remains focused on supporting physician education and facilitating patient access as LYMPHIR becomes integrated into clinical practice.LYMPHIR was approved by the U.S. Food and Drug Administration in August 2024 for the treatment of adult patients with Stage I–III relapsed or refractory cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy, and was commercially launched in the United States in December 2025.LYMPHIR does not have marketing authorization from the European Medicines Agency in Europe or other countries outside the United States. Access is being provided solely through Named Patient Programs in accordance with applicable local laws and regulations.About LYMPHIR™ (denileukin diftitox-cxdl)LYMPHIR is a targeted immune therapy for relapsed or refractory cutaneous T-cell lymphoma (CTCL) indicated for use in Stage I-III disease after at least one prior systemic therapy. It is a recombinant fusion protein that combines the IL-2 receptor binding domain with diphtheria toxin (DT) fragments. The agent specifically binds to IL-2 receptors on the cell surface, causing diphtheria toxin fragments that have entered cells to inhibit protein synthesis. After uptake into the cell, the DT fragment is cleaved and the free DT fragments inhibit protein synthesis, resulting in cell death. Denileukin diftitox-cxdl demonstrated the ability to deplete immunosuppressive regulatory T lymphocytes (Tregs) and antitumor activity through a direct cytocidal action on IL-2R-expressing tumors.In 2021, denileukin diftitox received regulatory approval in Japan for the treatment of relapsed or refractory CTCL and peripheral T-cell lymphoma (PTCL). Subsequently, in 2021, Citius acquired an exclusive license with rights to develop and commercialize denileukin diftitox in all markets except for India, Japan and certain parts of Asia. LYMPHIR (denileukin diftitox-cxdl) was approved by the FDA and subsequently launched in the U.S. in December 2025.About Citius Oncology, Inc.Citius Oncology, Inc. (Nasdaq: CTOR) is a platform to develop and commercialize novel targeted oncology therapies. In December 2025, Citius Oncology launched LYMPHIR, approved by the FDA for the treatment of adults with relapsed or refractory Stage I–III CTCL who had had at least one prior systemic therapy. Management estimates the initial market for LYMPHIR currently exceeds $400 million, is growing, and is underserved by existing therapies. Robust intellectual property protections that span orphan drug designation, complex technology, trade secrets and pending patents for immuno-oncology use as a combination therapy with checkpoint inhibitors would further support Citius Oncology's competitive positioning. For more information, please visit www.citiusonc.com.Forward-Looking Statements This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements are made based on our expectations and beliefs concerning future events impacting Citius Oncology. You can identify these statements by the fact that they use words such as "will," "anticipate," "estimate," "expect," "plan," "should," and "may" and other words and terms of similar meaning or use of future dates. Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price.  Factors that could cause actual results to differ materially from those currently anticipated are: our ability to successfully commercialize LYMPHIR and establish a sustainable revenue stream; our ability to secure and maintain strategic partnerships and expand international access to LYMPHIR; the estimated markets for LYMPHIR and our product candidates and the acceptance thereof by any market; risks relating to the results of research and development activities, including those from our existing and any new pipeline assets; our need for substantial additional funds and our ability to raise additional money to fund our operations for at least the next 12 months as a going concern; early-stage clinical data may not be predictive of results from larger or later-stage studies; our ability to maintain Nasdaq's continued listing standards; our ability to use the latest technology to support our commercialization efforts for LYMPHIR; physician and patient acceptance of LYMPHIR in a competitive treatment landscape; our reliance on third-party logistics providers, distributors, and specialty pharmacies to support commercial operations; our ability to educate providers and payers, secure adequate reimbursement, and maintain uninterrupted product supply; post-marketing requirements and ongoing regulatory compliance related to LYMPHIR; the ability of LYMPHIR and our product candidates to impact the quality of life of our target patient populations; our ability to procure cGMP commercial-scale supply; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; market and other conditions; risks related to our growth strategy; patent and intellectual property matters; government regulation; as well as other risks described in our Securities and Exchange Commission ("SEC") filings. These risks have been and may be further impacted by any future public health risks. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Risks regarding our business are described in detail in our SEC filings which are available on the SEC's website at www.sec.gov, including in Citius Oncology's Annual Report on Form 10-K for the year ended September 30, 2025, filed with the SEC on December 23, 2025. These forward-looking statements speak only as of the date hereof, and we expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.LYMPHIR™ (denileukin diftitox-cxdl)INDICATIONLYMPHIR is an IL2-receptor-directed cytotoxin indicated for the treatment of adult patients with r/r Stage I-III cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy.IMPORTANT SAFETY INFORMATION BOXED WARNING: CAPILLARY LEAK SYNDROMECapillary leak syndrome (CLS), including life-threatening or fatal reactions, can occur in patients receiving LYMPHIR. Monitor patients for signs and symptoms of CLS during treatment. Withhold LYMPHIR until CLS resolves, or permanently discontinue based on severity.WARNINGS AND PRECAUTIONS Capillary Leak SyndromeLYMPHIR can cause capillary leak syndrome (CLS), including life-threatening or fatal reactions. CLS was defined in the clinical trials as the occurrence of at least 2 of the following symptoms at any time during LYMPHIR therapy: hypotension, edema, and serum albumin

Citius Pharmaceuticals Announces Closing of Registered Direct Offering of $5 Million Priced At-The-Market Under Nasdaq RulesApril 24, 2026 4:30 PM
PR Newswire (US)

CRANFORD, N.J., April 24, 2026 /PRNewswire/ -- Citius Pharmaceuticals Inc. (Nasdaq: CTXR) ("Citius Pharma" or the "Company"), a biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products, today announced the closing of its previously announced registered direct offering priced at-the-market under Nasdaq rules for the purchase of an aggregate of 5,076,143 shares of its common stock (or pre-funded warrants in lieu thereof) at a purchase price of $0.985 per share (or pre-funded warrant in lieu thereof). In a concurrent private placement, the Company issued unregistered warrants to purchase up to 5,076,143 shares of common stock at an exercise price of $0.86 per share that are exercisable immediately upon issuance and will expire five years following the effective date of a registration statement registering the shares issuable upon exercise of the warrants.H.C. Wainwright & Co. acted as the exclusive placement agent for the offering.The aggregate gross proceeds to the Company from the offering were approximately $5 million, before deducting the placement agent fees and other offering expenses payable by the Company. The Company currently intends to use the net proceeds from the offering to support the commercial launch of LYMPHIR™, including milestone, regulatory and other payments, development initiatives for all of our product candidates, as well as for general corporate purposes.The common stock (or pre-funded warrants) (but not the unregistered warrants and the shares of common stock underlying the unregistered warrants) described above were offered pursuant to a "shelf" registration statement (File No. 333-277319) filed with the Securities and Exchange Commission ("SEC") on February 23, 2024 and declared effective on March 1, 2024. The registered direct offering was made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. The prospectus supplement and the accompanying prospectus relating to the registered direct offering was filed with the SEC and is available at the SEC's website at www.sec.gov. Electronic copies of the prospectus supplement and the accompanying prospectus relating to the registered direct offering may also be obtained by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by telephone at (212) 856-5711 or e-mail at placements@hcwco.com.The unregistered warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act"), and/or Regulation D promulgated thereunder and, along with the shares of common stock underlying such unregistered warrants, have not been registered under the Securities Act, or applicable state securities laws. Accordingly, the unregistered warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.About Citius Pharmaceuticals, Inc. Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) is a biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products. Citius Pharma owns approximately 71% of Citius Oncology. In December 2025, Citius Oncology launched LYMPHIR, a targeted immunotherapy for the treatment of adults with relapsed or refractory Stage I–III CTCL who had had at least one prior systemic therapy. Citius Pharma's late-stage pipeline also includes Mino-Lok®, a catheter lock solution to salvage catheters in patients with catheter-related bloodstream infections, and CITI-002 (Halo-Lido), a topical formulation for the relief of hemorrhoids. A pivotal Phase 3 trial for Mino-Lok and a Phase 2b trial for Halo-Lido were completed in 2023. Mino-Lok met primary and secondary endpoints of its Phase 3 trial. Citius Pharma is actively engaged with the FDA to outline next steps for both programs. For more information, please visit www.citiuspharma.com.Forward Looking Statements This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements are made based on our expectations and beliefs concerning future events impacting Citius Pharma. You can identify these statements by the fact that they use words such as "will," "anticipate," "estimate," "expect," "plan," "should," and "may" and other words and terms of similar meaning or use of future dates. Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price, and includes all statements related to the intended use of net proceeds from the offering. Factors that could cause actual results to differ materially from those currently anticipated are: our need for substantial additional funds and our ability to raise additional money to fund our operations for at least the next 12 months as a going concern; our ability to successfully commercialize LYMPHIR and establish a sustainable revenue stream; the estimated markets for LYMPHIR and our product candidates and the acceptance thereof by any market; our ability to secure strategic partnerships and expand international access to LYMPHIR; our ability to use the latest technology to support our commercialization efforts for LYMPHIR; physician and patient acceptance of LYMPHIR in a competitive treatment landscape; the ability of LYMPHIR and our product candidates to impact the quality of life of our target patient populations; our ability to maintain Nasdaq's continued listing standards; our reliance on third-party logistics providers, distributors, and specialty pharmacies to support commercial operations; our ability to educate providers and payers, secure adequate reimbursement, and maintain uninterrupted product supply; post-marketing requirements and ongoing regulatory compliance related to LYMPHIR; risks relating to the results of research and development activities, including those from any new pipeline assets; our ability to procure cGMP commercial-scale supply; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; market and other conditions; risks related to our growth strategy; patent and intellectual property matters; government regulation; as well as other risks described in our SEC filings. These risks have been and may be further impacted by any future public health risks. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Risks regarding our business are described in detail in our SEC filings which are available on the SEC's website at www.sec.gov, including in Citius Pharma's Annual Report on Form 10-K for the year ended September 30, 2025, filed with the SEC on December 23, 2025, as amended January 28, 2026, as updated by our subsequent filings with the SEC. These forward-looking statements speak only as of the date hereof, and we expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.Investor Contact 
Ilanit Allen
ir @crsrs-6677 x113Media Contact 
STiR-communications
Greg Salsburg
Greg@STiR-communications.com





View original content to download multimedia:https://www.prnewswire.com/news-releases/citius-pharmaceuticals-announces-closing-of-registered-direct-offering-of-5-million-priced-at-the-market-under-nasdaq-rules-302753106.htmlSOURCE Citius Pharmaceuticals, Inc.

Original: Citius Pharmaceuticals Announces Closing of Registered Direct Offering of $5 Million Priced At-The-Market Under Nasdaq Rules

Citius Pharmaceuticals Secures $5M Through Equity OfferingApril 24, 2026 10:48 AM
IH Market News
Citius Pharmaceuticals Inc. (NASDAQ:CTXR) announced it has entered into a definitive agreement to raise approximately $5 million via a registered direct offering alongside a concurrent private placement.



Offering Structure



The company will issue 5,076,143 shares of common stock at $0.985 per share in an at-the-market priced transaction under Nasdaq rules.In parallel, Citius will grant warrants to purchase up to 5,076,143 additional shares at an exercise price of $0.86 per share. These warrants will be exercisable immediately and remain valid for five years following the effective date of a related registration statement.The deal is expected to generate gross proceeds of about $5 million before fees and expenses, with closing anticipated shortly, subject to customary conditions.



Market Context



The capital raise comes as Citius shares trade around $0.93, reflecting a decline of nearly 49% over the past six months, although the stock has recovered roughly 20% since the start of the year.H.C. Wainwright & Co. is acting as the exclusive placement agent for the transaction.



Use of Proceeds



Citius said it intends to deploy the net proceeds to:




Support the commercial rollout of LYMPHIR



Fund milestone, regulatory and related payments



Advance development of its product pipeline



Cover general corporate expenses




The financing comes at a pivotal time, with analysts expecting the company to reach profitability in fiscal 2026, projecting earnings per share of $1.62.



Product Portfolio and Pipeline



Citius develops critical care therapies and holds a majority stake in Citius Oncology, where it owns approximately 71%.In December 2025, its oncology unit launched LYMPHIR, a targeted immunotherapy for adults with relapsed or refractory Stage I–III cutaneous T-cell lymphoma (CTCL) who have received prior systemic treatment.The broader pipeline includes:




Mino-Lok, a catheter lock solution



CITI-002, a topical treatment for haemorrhoids




Both candidates completed clinical trials in 2023.



Governance Update



Separately, the company recently held its 2026 annual shareholder meeting, where seven directors—including Leonard Mazur, Myron Holubiak, Suren Dutia, Dr. Eugene Holuka, Dennis M. McGrath, Robert Smith and Carol Webb—were elected to serve one-year terms on the board.



Regulatory Details



The common stock is being issued under a shelf registration statement filed with the U.S. Securities and Exchange Commission in February 2024 and declared effective in March 2024.The warrants are being offered in a private placement under exemptions provided by Section 4(a)(2) of the Securities Act of 1933.Citius Pharmaceuticals stock price

Original: Citius Pharmaceuticals Secures $5M Through Equity Offering

Citius Pharmaceuticals Announces a Registered Direct Offering of $5 Million Priced At-The-Market Under Nasdaq RulesApril 24, 2026 8:00 AM
PR Newswire (US)

CRANFORD, N.J., April 24, 2026 /PRNewswire/ -- Citius Pharmaceuticals Inc. (Nasdaq: CTXR) ("Citius Pharma" or the "Company"), a biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products, today announced that it has entered into a definitive agreement for the purchase of an aggregate of 5,076,143 shares of its common stock  (or pre-funded warrants in lieu thereof) at a purchase price of $0.985 per share (or pre-funded warrant in lieu thereof) in a registered direct offering priced at-the-market under Nasdaq rules. In a concurrent private placement, the Company will issue unregistered warrants to purchase up to 5,076,143 shares of common stock at an exercise price of $0.86 per share that will be exercisable immediately upon issuance and will expire five years following the effective date of a registration statement registering the shares issuable upon exercise of the warrants.  The closing of the offering is expected to occur on or about April 24, 2026, subject to the satisfaction of customary closing conditions.H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.The aggregate gross proceeds to the Company from the offering are expected to be approximately $5 million, before deducting the placement agent fees and other offering expenses payable by the Company.  The Company currently intends to use the net proceeds from the offering to support the commercial launch of LYMPHIR™, including milestone, regulatory and other payments, development initiatives for all of our product candidates, as well as for general corporate purposes.The common stock (or pre-funded warrants) (but not the unregistered warrants and the shares of common stock underlying the unregistered warrants) described above are being offered pursuant to a "shelf" registration statement (File No. 333-277319) filed with the Securities and Exchange Commission ("SEC") on February 23, 2024 and declared effective on March 1, 2024. The registered direct offering is being made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. The prospectus supplement and the accompanying prospectus relating to the registered direct offering will be filed with the SEC and be available at the SEC's website at www.sec.gov. Electronic copies of the prospectus supplement and the accompanying prospectus relating to the registered direct offering may also be obtained, when available, by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by telephone at (212) 856-5711 or e-mail at placements@hcwco.com.The unregistered warrants described above are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act"), and/or Regulation D promulgated thereunder and, along with the shares of common stock underlying such unregistered warrants, have not been registered under the Securities Act, or applicable state securities laws. Accordingly, the unregistered warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.About Citius Pharmaceuticals, Inc. Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) is a biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products. Citius Pharma owns approximately 71% of Citius Oncology. In December 2025, Citius Oncology launched LYMPHIR, a targeted immunotherapy for the treatment of adults with relapsed or refractory Stage I–III CTCL who had had at least one prior systemic therapy. Citius Pharma's late-stage pipeline also includes Mino-Lok®, a catheter lock solution to salvage catheters in patients with catheter-related bloodstream infections, and CITI-002 (Halo-Lido), a topical formulation for the relief of hemorrhoids. A pivotal Phase 3 trial for Mino-Lok and a Phase 2b trial for Halo-Lido were completed in 2023. Mino-Lok met primary and secondary endpoints of its Phase 3 trial. Citius Pharma is actively engaged with the FDA to outline next steps for both programs. For more information, please visit www.citiuspharma.com.Forward Looking Statements This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements are made based on our expectations and beliefs concerning future events impacting Citius Pharma. You can identify these statements by the fact that they use words such as "will," "anticipate," "estimate," "expect," "plan," "should," and "may" and other words and terms of similar meaning or use of future dates. Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price, and includes all statements related to the completion of the offering, the satisfaction of customary closing conditions related to the offering, and the intended use of net proceeds from the offering.  Factors that could cause actual results to differ materially from those currently anticipated are: related to the closing of the offering, our need for substantial additional funds and our ability to raise additional money to fund our operations for at least the next 12 months as a going concern; our ability to successfully commercialize LYMPHIR and establish a sustainable revenue stream; the estimated markets for LYMPHIR and our product candidates and the acceptance thereof by any market; our ability to secure strategic partnerships and expand international access to LYMPHIR; our ability to use the latest technology to support our commercialization efforts for LYMPHIR; physician and patient acceptance of LYMPHIR in a competitive treatment landscape; the ability of LYMPHIR and our product candidates to impact the quality of life of our target patient populations; our ability to maintain Nasdaq's continued listing standards; our reliance on third-party logistics providers, distributors, and specialty pharmacies to support commercial operations; our ability to educate providers and payers, secure adequate reimbursement, and maintain uninterrupted product supply; post-marketing requirements and ongoing regulatory compliance related to LYMPHIR; risks relating to the results of research and development activities, including those from any new pipeline assets; our ability to procure cGMP commercial-scale supply; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; market and other conditions; risks related to our growth strategy; patent and intellectual property matters; government regulation; as well as other risks described in our SEC filings. These risks have been and may be further impacted by any future public health risks. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Risks regarding our business are described in detail in our SEC filings which are available on the SEC's website at www.sec.gov, including in Citius Pharma's Annual Report on Form 10-K for the year ended September 30, 2025, filed with the SEC on December 23, 2025, as amended January 28, 2026, as updated by our subsequent filings with the SEC. These forward-looking statements speak only as of the date hereof, and we expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.Investor Contact 
Ilanit Allen
ir @crsrs-6677 x113Media Contact 
STiR-communications
Greg Salsburg
Greg@STiR-communications.com





View original content to download multimedia:https://www.prnewswire.com/news-releases/citius-pharmaceuticals-announces-a-registered-direct-offering-of-5-million-priced-at-the-market-under-nasdaq-rules-302752444.htmlSOURCE Citius Pharmaceuticals, Inc.

Original: Citius Pharmaceuticals Announces a Registered Direct Offering of $5 Million Priced At-The-Market Under Nasdaq Rules

CTXR.........................................https://stockcharts.com/sc3/ui/?s=CTXR&p=W&b=5&g=0&id=p86431144783

Citius Oncology Provides Commercial Update on LYMPHIR™ Launch Highlighting Early Adoption and Expanding Clinical DevelopmentMarch 31, 2026 9:11 AM
PR Newswire (US)

Broad institutional uptake among leading cancer centers and payer coverage supports early prescribing momentum and clinical integrationCRANFORD, N.J., March 31, 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 provided a commercial update on the U.S. launch of LYMPHIR™ (denileukin diftitox-cxdl) for the treatment of cutaneous T-cell lymphoma (CTCL), highlighting continued adoption across leading oncology centers, broad payer coverage progress, and advancing investigator-led clinical studies.







"We are encouraged by the early commercial indicators for LYMPHIR, including the pace of formulary adoption, breadth of payer coverage, and increasing repeat orders from leading oncology centers," said Leonard Mazur, Chairman and CEO of Citius Oncology and Citius Pharma. "As our commercial organization continues to scale and institutions complete formulary inclusion, we expect continued expansion in prescribing activity, including into community settings. Together with further clinical validation through ongoing investigator-led studies, these trends support LYMPHIR's potential not only for continued integration in the CTCL treatment landscape, but also its potential as a part of a combination immunotherapy regimen in other cancers."Key Early Launch Metrics:Sequential growth in orders from target institutions since launch, with initial accounts already placing repeat orders, indicating early prescribing continuity;Strong institutional uptake, with 83% of target accounts having added or actively progressing LYMPHIR through formulary review;Broad and expanding market access with ~135 health plans, representing ~80% of covered lives, secured and reimbursement systems established;No reported reimbursement denials or prior authorization barriers;Increasing demand for in-services and clinical education;Initial penetration into community infusion centers underway with patients beginning to transition from larger cancer centers; and,Commercial buildout proceeding, with field team onboarding in the coming month and broader field expansion in progress with our contracted sales organization.Commercial Execution Advancing with Expanding Market Access and Field DeploymentCommercial execution continues to advance with the onboarding of field teams, targeted deployment of medical education and digital campaigns, attendance at major medical meetings and increasing interaction with physicians, pharmacy stakeholders, and community centers to support the finalization of order sets and initiate patient treatment, which typically precedes broader patient start acceleration following formulary inclusion.Commercial supply remains well positioned to support anticipated U.S. demand, and international expansion is underway through executed distribution agreements across Europe and the Middle East.Clinical Development Expands Through Leading Academic CollaborationsIn parallel, Citius Oncology is advancing LYMPHIR's clinical development through collaborations with leading academic centers to further evaluate its potential across broader oncology settings. At the University of Minnesota, an investigator-sponsored study is evaluating LYMPHIR prior to CAR-T therapy in relapsed/refractory diffuse large B-cell lymphoma, with positive topline data presented at the ASTCT 2026 Annual Meeting and additional analyses underway. At UPMC, a Phase I study evaluating LYMPHIR in combination with pembrolizumab in solid tumors has been completed, with positive topline results submitted for presentation at an upcoming oncology conference. Discussions are ongoing regarding next-stage development. These efforts support a broader strategy to evaluate LYMPHIR as a potential combination therapy across immuno-oncology settings.Together, these commercial and clinical developments support a disciplined launch trajectory and provide a solid foundation for continued adoption of LYMPHIR.About LYMPHIR™ (denileukin diftitox-cxdl)LYMPHIR is a targeted immune therapy for relapsed or refractory cutaneous T-cell lymphoma (CTCL) indicated for use in Stage I-III disease after at least one prior systemic therapy. It is a recombinant fusion protein that combines the IL-2 receptor binding domain with diphtheria toxin (DT) fragments. The agent specifically binds to IL-2 receptors on the cell surface, causing diphtheria toxin fragments that have entered cells to inhibit protein synthesis. After uptake into the cell, the DT fragment is cleaved and the free DT fragments inhibit protein synthesis, resulting in cell death. Denileukin diftitox-cxdl demonstrated the ability to deplete immunosuppressive regulatory T lymphocytes (Tregs) and antitumor activity through a direct cytocidal action on IL-2R-expressing tumors.In 2021, denileukin diftitox received regulatory approval in Japan for the treatment of relapsed or refractory CTCL and peripheral T-cell lymphoma (PTCL). Subsequently, in 2021, Citius acquired an exclusive license with rights to develop and commercialize denileukin diftitox in all markets except for India, Japan and certain parts of Asia. LYMPHIR (denileukin diftitox-cxdl) was approved by the FDA and subsequently launched in the U.S. in December 2025.About Citius Oncology, Inc.Citius Oncology, Inc. (Nasdaq: CTOR) is a platform to develop and commercialize novel targeted oncology therapies. In December 2025, Citius Oncology launched LYMPHIR, approved by the FDA for the treatment of adults with relapsed or refractory Stage I–III CTCL who had had at least one prior systemic therapy. Management estimates the initial market for LYMPHIR currently exceeds $400 million, is growing, and is underserved by existing therapies. Robust intellectual property protections that span orphan drug designation, complex technology, trade secrets and pending patents for immuno-oncology use as a combination therapy with checkpoint inhibitors would further support Citius Oncology's competitive positioning. For more information, please visit www.citiusonc.com.Forward-Looking Statements This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements are made based on our expectations and beliefs concerning future events impacting Citius Oncology. You can identify these statements by the fact that they use words such as "will," "anticipate," "estimate," "expect," "plan," "should," and "may" and other words and terms of similar meaning or use of future dates. Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price.  Factors that could cause actual results to differ materially from those currently anticipated are: our ability to successfully commercialize LYMPHIR and establish a sustainable revenue stream; risks relating to the results of research and development activities, including those from our existing and any new pipeline assets; our need for substantial additional funds and our ability to raise additional money to fund our operations for at least the next 12 months as a going concern; the estimated markets for LYMPHIR and our product candidates and the acceptance thereof by any market; early-stage clinical data may not be predictive of results from larger or later-stage studies; our ability to maintain Nasdaq's continued listing standards; our ability to secure strategic partnerships and expand international access to LYMPHIR; our ability to use the latest technology to support our commercialization efforts for LYMPHIR; physician and patient acceptance of LYMPHIR in a competitive treatment landscape; our reliance on third-party logistics providers, distributors, and specialty pharmacies to support commercial operations; our ability to educate providers and payers, secure adequate reimbursement, and maintain uninterrupted product supply; post-marketing requirements and ongoing regulatory compliance related to LYMPHIR; the ability of LYMPHIR and our product candidates to impact the quality of life of our target patient populations; our ability to procure cGMP commercial-scale supply; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; market and other conditions; risks related to our growth strategy; patent and intellectual property matters; government regulation; as well as other risks described in our Securities and Exchange Commission ("SEC") filings. These risks have been and may be further impacted by any future public health risks. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Risks regarding our business are described in detail in our SEC filings which are available on the SEC's website at www.sec.gov, including in Citius Oncology's Annual Report on Form 10-K for the year ended September 30, 2025, filed with the SEC on December 23, 2025. These forward-looking statements speak only as of the date hereof, and we expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.LYMPHIR™ (denileukin diftitox-cxdl)INDICATIONLYMPHIR is an IL2-receptor-directed cytotoxin indicated for the treatment of adult patients with r/r Stage I-III cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy.IMPORTANT SAFETY INFORMATION BOXED WARNING: CAPILLARY LEAK SYNDROMECapillary leak syndrome (CLS), including life-threatening or fatal reactions, can occur in patients receiving LYMPHIR. Monitor patients for signs and symptoms of CLS during treatment. Withhold LYMPHIR until CLS resolves, or permanently discontinue based on severity.WARNINGS AND PRECAUTIONS Capillary Leak SyndromeLYMPHIR can cause capillary leak syndrome (CLS), including life-threatening or fatal reactions. CLS was defined in the clinical trials as the occurrence of at least 2 of the following symptoms at any time during LYMPHIR therapy: hypotension, edema, and serum albumin

CTXR............................................https://stockcharts.com/sc3/ui/?s=CTXR&p=W&b=5&g=0&id=p86431144783

Citius Oncology Announces Positive Topline Results from Investigator-Initiated Phase 1 Study of LYMPHIR™ in Combination with Pembrolizumab in Relapsed or Refractory Gynecologic CancersMarch 10, 2026 8:47 AM
PR Newswire (US)

Study data from patients with relapsed or refractory gynecologic cancers signals the potential of LYMPHIR to augment immune checkpoint inhibitor efficacyTopline data of University of Pittsburgh-led trial to be presented at an upcoming international cancer conference later this yearCRANFORD, 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, we may have a transformational therapy on our hands," said Dr. Alexander Olawaiye, principal investigator of the study.About the StudyThis open-label, dose-escalation, investigator-initiated Phase?1 study (NCT05200559), led by Dr. Alexander B Olawaiye at UPMC Magee-Women's Hospital, enrolled patients with recurrent or metastatic solid tumors who had received at least one prior line of therapy. LYMPHIR was administered intravenously on Days?1–3 of each 21-day cycle at escalating doses (3, 6, 9, and 12 mcg/kg), along with pembrolizumab (200?mg IV) on Day?1. Patients who completed eight cycles of combination therapy were continued on pembrolizumab monotherapy until disease progression.The use of LYMPHIR in this study was investigational and outside of its FDA-approved indication. The Phase 1 study was not designed or powered to evaluate clinical efficacy, and no conclusions can be drawn regarding comparative effectiveness or long-term outcomes.About Gynecologic CancersRecurrent or metastatic ovarian and endometrial cancers are two of the most common gynecologic malignancies in the United States. Endometrial cancer is the most frequently diagnosed gynecologic cancer, with an estimated 70,000 new cases expected in 20261, while ovarian cancer remains the deadliest with approximately 12,700 deaths per year (51.6% 5 year survival) and approximately 20,000 new diagnoses each year2. These cancers are often detected at advanced stages, and although many patients initially respond to platinum-based chemotherapy, most experience relapse and develop resistance. Survival rates in the recurrent setting remain poor, and responses to current immunotherapies such as PD-1 inhibitors are limited, highlighting a significant unmet need for novel treatment approaches. LYMPHIR's transient depletion of regulatory T-cells may enhance anti-tumor immune responses and help overcome immunotherapy resistance in these difficult-to-treat tumors.About LYMPHIR™ (denileukin diftitox-cxdl)LYMPHIR is a targeted immune therapy for relapsed or refractory cutaneous T-cell lymphoma (CTCL) indicated for use in Stage I-III disease after at least one prior systemic therapy. It is a recombinant fusion protein that combines the IL-2 receptor binding domain with diphtheria toxin (DT) fragments. The agent specifically binds to IL-2 receptors on the cell surface, causing diphtheria toxin fragments that have entered cells to inhibit protein synthesis. After uptake into the cell, the DT fragment is cleaved and the free DT fragments inhibit protein synthesis, resulting in cell death. Denileukin diftitox-cxdl demonstrated the ability to deplete immunosuppressive regulatory T lymphocytes (Tregs) and antitumor activity through a direct cytocidal action on IL-2R-expressing tumors.In 2021, denileukin diftitox received regulatory approval in Japan for the treatment of relapsed or refractory CTCL and peripheral T-cell lymphoma (PTCL). Subsequently, in 2021, Citius acquired an exclusive license with rights to develop and commercialize denileukin diftitox in all markets except for India, Japan and certain parts of Asia. LYMPHIR (denileukin diftitox-cxdl) was approved by the FDA and subsequently launched in the U.S. in December 2025.About Citius Oncology, Inc.Citius Oncology, Inc. (Nasdaq: CTOR) is a platform to develop and commercialize novel targeted oncology therapies. In December 2025, Citius Oncology launched LYMPHIR, approved by the FDA for the treatment of adults with relapsed or refractory Stage I–III CTCL who had had at least one prior systemic therapy. Management estimates the initial market for LYMPHIR currently exceeds $400 million, is growing, and is underserved by existing therapies. Robust intellectual property protections that span orphan drug designation, complex technology, trade secrets and pending patents for immuno-oncology use as a combination therapy with checkpoint inhibitors would further support Citius Oncology's competitive positioning. For more information, please visit www.citiusonc.com.Forward-Looking Statements This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements are made based on our expectations and beliefs concerning future events impacting Citius Oncology. You can identify these statements by the fact that they use words such as "will," "anticipate," "estimate," "expect," "plan," "should," and "may" and other words and terms of similar meaning or use of future dates. Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price.  Factors that could cause actual results to differ materially from those currently anticipated are: risks relating to the results of research and development activities, including those from our existing and any new pipeline assets; early-stage clinical data may not be predictive of results from larger or later-stage studies; our need for substantial additional funds and our ability to raise additional money to fund our operations for at least the next 12 months as a going concern; our ability to successfully commercialize LYMPHIR and establish a sustainable revenue stream; the estimated markets for LYMPHIR and our product candidates and the acceptance thereof by any market; our ability to secure strategic partnerships and expand international access to LYMPHIR; our ability to maintain Nasdaq's continued listing standards; our ability to use the latest technology to support our commercialization efforts for LYMPHIR; physician and patient acceptance of LYMPHIR in a competitive treatment landscape; our reliance on third-party logistics providers, distributors, and specialty pharmacies to support commercial operations; our ability to educate providers and payers, secure adequate reimbursement, and maintain uninterrupted product supply; post-marketing requirements and ongoing regulatory compliance related to LYMPHIR; the ability of LYMPHIR and our product candidates to impact the quality of life of our target patient populations; our ability to procure cGMP commercial-scale supply; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; market and other conditions; risks related to our growth strategy; patent and intellectual property matters; government regulation; as well as other risks described in our Securities and Exchange Commission ("SEC") filings. These risks have been and may be further impacted by any future public health risks. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Risks regarding our business are described in detail in our SEC filings which are available on the SEC's website at www.sec.gov, including in Citius Oncology's Annual Report on Form 10-K for the year ended September 30, 2025, filed with the SEC on December 23, 2025. These forward-looking statements speak only as of the date hereof, and we expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.REFERENCES:American Cancer Society. Cancer Facts & Figures 2026 (projected). Atlanta: American Cancer Society; 2026. https://www.cancer.org/cancer/types/endometrial-cancer/about/key-statistics.htmlNational Cancer Institute. Surveillance, Epidemiology, and End Results Program (SEER). Cancer Stat Facts: Uterine and Ovarian Cancer. https://seer.cancer.gov/statfacts/html/ovary.htmlKEYTRUDA® is a registered trademark of Merck & Co., Inc.LYMPHIR™ (denileukin diftitox-cxdl)INDICATIONLYMPHIR is an IL2-receptor-directed cytotoxin indicated for the treatment of adult patients with r/r Stage I-III cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy.IMPORTANT SAFETY INFORMATION BOXED WARNING: CAPILLARY LEAK SYNDROMECapillary leak syndrome (CLS), including life-threatening or fatal reactions, can occur in patients receiving LYMPHIR. Monitor patients for signs and symptoms of CLS during treatment. Withhold LYMPHIR until CLS resolves, or permanently discontinue based on severity.WARNINGS AND PRECAUTIONS Capillary Leak SyndromeLYMPHIR can cause capillary leak syndrome (CLS), including life-threatening or fatal reactions. CLS was defined in the clinical trials as the occurrence of at least 2 of the following symptoms at any time during LYMPHIR therapy: hypotension, edema, and serum albumin

CTXR...........................https://stockcharts.com/sc3/ui/?s=CTXR&p=W&b=5&g=0&id=p86431144783

Citius Pharmaceuticals, Inc. Announces First Reported Revenue Following Successful Launch of LYMPHIR™February 13, 2026 8:00 AM
PR Newswire (US)

Company reports $3.9 million in revenue generated from initial sales in December 2025 and provides first fiscal quarter 2026 financial resultsCRANFORD, N.J., Feb. 13, 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 first quarter ended December 31, 2025, and provided a business update, including progress at its majority-owned subsidiary, Citius Oncology, Inc. (Nasdaq: CTOR)."I am thrilled to report that we have successfully transitioned to a revenue generating company following Citius Oncology's December 2025 launch of LYMPHIR. We recorded $3.9 million in revenue during the quarter, reflecting the initial sales at Citius Oncology's nationwide network of distributors. This milestone is the result of years of focused execution designed to translate innovation into tangible value for the cutaneous T-cell community and Citius stakeholders alike. I congratulate the entire Citius team on an outstanding effort to bring LYMPHIR to market," said Leonard Mazur, Chairman and Chief Executive Officer of Citius Oncology and Citius Pharma."While we are still in the early stages of the launch, we expect momentum to build as we continue to stand up the full commercial organization and more fully deploy our technology-driven platform to expand patient access and drive market penetration. Looking ahead, we see multiple avenues for growth, including encouraging early signals from investigator-initiated studies, opportunities to expand access in international markets, and the potential to build a durable oncology franchise. Most importantly, LYMPHIR now offers patients living with cutaneous T-cell lymphoma a meaningful new treatment option and a more hopeful future," added Mazur."We remain committed to financial stewardship to sustain this momentum, and focused execution to advance our late-stage pipeline, which includes Mino-Lok and Halo-Lido. Our goal remains to serve our community with first-in-class critical care products, and in so doing maximize long-term shareholder value," concluded Mazur.Business Highlights and Subsequent DevelopmentsCommercial inflection achieved through majority-owned subsidiary: Citius Oncology successfully launched LYMPHIR™ (denileukin diftitox-cxdl) in the U.S. in December 2025 for adult patients with relapsed or refractory Stage I–III cutaneous T-cell lymphoma (CTCL) following at least one prior systemic therapy;Early physician adoption underway: Initial specialty distributor sales were completed nationwide, enabling product availability across U.S. treatment centers. Patients have begun receiving LYMPHIR at leading cancer centers;Commercial execution supported by technology: Citius Oncology deployed an AI-enabled commercial platform to support targeted physician engagement and efficient penetration of a highly concentrated prescriber base in this rare oncology market;International patient access advancing: Agreements have been negotiated with regional partners to enable patient access to LYMPHIR utilizing Named Patient Programs (NPPs) where permitted in territories throughout European and the Middle East;Continued support of promising upside opportunities for LYMPHIR: Preliminary topline data from two investigator-initiated Phase I combination studies evaluating the potential to expand clinical utility and future label expansion opportunities. include:use in combination with pembrolizumab in patients with recurrent solid tumors;incorporation as part of lymphodepletion regimens prior to CAR-T therapy;Late-stage pipeline progress maintained: Citius Pharma continues to advance Mino-Lok®, an antibiotic lock solution to salvage catheters when treating catheter-related bloodstream infections, and Halo-Lido (CITI-002), a topical prescription formulation for hemorrhoids. The Company remains engaged with the FDA regarding both programs.First Quarter 2026 Financial HighlightsCash and cash equivalents totaled $7.7 million as of December 31, 2025;Generated net proceeds of approximately $20.9 million from equity financings during the quarter, including capital raised at both Citius Pharma and Citius Oncology;Consolidated revenue was $3.9 million, reflecting initial U.S. sales of LYMPHIR at Citius Oncology;Research and development expenses were $1.6 million, compared to $2.1 million in the prior-year period, reflecting reduced clinical development activity;General and administrative expenses totaled $5.7 million, compared to $5.4 million in the prior-year period;Stock-based compensation expense totaled $4.3 million, compared to $2.5 million in the prior-year period; and,Net loss applicable to common stockholders was $8.2 million, or $(0.41) per share, compared to a net loss of $9.8 million, or $(1.30) per share, in the prior-year period.About Citius Pharmaceuticals, Inc. 
Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) is a biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products. Citius Pharma owns approximately 74.8% of Citius Oncology. In December 2025, Citius Oncology launched LYMPHIR, a targeted immunotherapy for the treatment of adults with relapsed or refractory Stage I–III CTCL who had had at least one prior systemic therapy. Citius Pharma's late-stage pipeline also includes Mino-Lok®, a catheter lock solution to salvage catheters in patients with catheter-related bloodstream infections, and CITI-002 (Halo-Lido), a topical formulation for the relief of hemorrhoids. A pivotal Phase 3 trial for Mino-Lok and a Phase 2b trial for Halo-Lido were completed in 2023. Mino-Lok met primary and secondary endpoints of its Phase 3 trial. Citius Pharma is actively engaged with the FDA to outline next steps for both programs. For more information, please visit www.citiuspharma.com.About Citius Oncology, Inc.
Citius Oncology, Inc. (Nasdaq: CTOR) is a platform to develop and commercialize novel targeted oncology therapies. In December 2025, Citius Oncology launched LYMPHIR, approved by the FDA for the treatment of adults with relapsed or refractory Stage I–III CTCL who had had at least one prior systemic therapy. Management estimates the initial market for LYMPHIR currently exceeds $400 million, is growing, and is underserved by existing therapies. Robust intellectual property protections that span orphan drug designation, complex technology, trade secrets and pending patents for immuno-oncology use as a combination therapy with checkpoint inhibitors would further support Citius Oncology's competitive positioning. For more information, please visit www.citiusonc.com.Forward-Looking Statements
This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements are made based on our expectations and beliefs concerning future events impacting Citius Oncology. You can identify these statements by the fact that they use words such as "will," "anticipate," "estimate," "expect," "plan," "should," and "may" and other words and terms of similar meaning or use of future dates. Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated are: our ability to successfully commercialize LYMPHIR and establish a sustainable revenue stream; the estimated markets for LYMPHIR and our product candidates and the acceptance thereof by any market; our ability to secure strategic partnerships and expand international access to LYMPHIR; our ability to use the latest technology to support our commercialization efforts for LYMPHIR; physician and patient acceptance of LYMPHIR in a competitive treatment landscape; the ability of LYMPHIR and our product candidates to impact the quality of life of our target patient populations; our need for substantial additional funds and our ability to raise additional money to fund our operations for at least the next 12 months as a going concern; our ability to maintain Nasdaq's continued listing standards; our reliance on third-party logistics providers, distributors, and specialty pharmacies to support commercial operations; our ability to educate providers and payers, secure adequate reimbursement, and maintain uninterrupted product supply; post-marketing requirements and ongoing regulatory compliance related to LYMPHIR; risks relating to the results of research and development activities, including those from any new pipeline assets; our ability to procure cGMP commercial-scale supply; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; market and other conditions; risks related to our growth strategy; patent and intellectual property matters; government regulation; as well as other risks described in our Securities and Exchange Commission ("SEC") filings. These risks have been and may be further impacted by any future public health risks. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Risks regarding our business are described in detail in our SEC filings which are available on the SEC's website at www.sec.gov, including in Citius Oncology's Annual Report on Form 10-K for the year ended September 30, 2025, filed with the SEC on December 23, 2025. These forward-looking statements speak only as of the date hereof, and we expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.Investor Contact:
Ilanit Allen
ir @crsrs-6677 x113Media Contact:
STiR-communications
Greg Salsburg
Greg@STiR-communications.com -- Financial Tables Follow – CITIUS PHARMACEUTICALS, INC.CONDENSED CONSOLIDATED BALANCE SHEETS(Unaudited)


December 31,

September 30,

2025

2025ASSETS




Current Assets:




Cash and cash equivalents
$7,721,393

$4,252,290Accounts receivable, net of allowances

4,049,111


-Inventory

22,639,342


22,286,693Prepaid expenses

3,535,287


1,395,490Total Current Assets

37,945,133


27,934,473







Operating lease right-of-use asset, net

835,177


818,694







Deposits

38,062


38,062In-process research and development, net of accumulated amortization

92,226,562


92,800,000Goodwill

9,346,796


9,346,796Total Other Assets

101,611,420


102,184,858







Total Assets
$140,391,730

$130,938,025







LIABILITIES AND STOCKHOLDERS' EQUITY






Current Liabilities:






Accounts payable
$11,021,412

$13,693,692License payable

18,250,000


22,650,000Accrued expenses

4,693,307


4,190,253Accrued compensation

3,094,395


3,292,447Note payable

1,000,000


1,000,000Operating lease liability

148,006


88,348Total Current Liabilities

38,207,120


44,914,740







Deferred tax liability

8,035,000


7,770,760Operating lease liability – noncurrent

681,640


724,925Total Liabilities

46,923,760


53,410,425







Commitments and Contingencies














Stockholders' Equity:






Preferred stock - $0.001 par value; 10,000,000 shares authorized; no shares issued
     and outstanding

-


-Common stock - $0.001 par value; 250,000,000 shares authorized; 22,376,427 and
     18,067,744 shares issued and outstanding at December 31, 2025 and September
     30, 2025, respectively

22,376


18,068Additional paid-in capital

326,960,700


306,336,239Accumulated deficit

(247,024,914)


(238,804,129)Total Citius Pharmaceuticals, Inc. Stockholders' Equity

79,958,162


67,550,178Non-controlling interest

13,509,808


9,977,422Total Equity

93,467,970


77,527,600







Total Liabilities and Equity
$140,391,730

$130,938,025 CITIUS PHARMACEUTICALS, INC.CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONSFOR THE THREE MONTHS ENDED DECEMBER 31, 2025 AND 2024(Unaudited)


Three Months Ended

December 31,

December 31,

2025

2024Revenue
$3,944,111


—Cost of revenues

(789,208)


—Gross Profit

3,154,903


—







Operating Expenses






Research and development

1,599,719


2,127,038Amortization of in-process research and development

573,438


—General and administrative

5,720,727


5,387,752Stock-based compensation – general and administrative

4,280,227


2,524,824Total Operating Expenses

12,174,111


10,039,614Operating Loss

(9,019,208)


(10,039,614)Other Income (Expense)






Interest income

45,097


22,608Interest expense

(155,538)


—Total Other Income (Expense)

(110,441)


22,608Loss before Income Taxes

(9,129,649)


(10,017,006)Income tax expense

264,240


264,240Net Loss

(9,393,889)


(10,281,246)Net loss attributable to non-controlling interest

1,173,104


513,000Net loss applicable to common stockholders
$(8,220,785)

$(9,768,246)







Net Loss Per Share - Basic and Diluted
$(0.38)

$(1.30)







Weighted Average Common Shares Outstanding






Basic and diluted (include pre-funded warrants from the October
2025 offering)

21,495,274


7,492,460 CITIUS PHARMACEUTICALS, INC.CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWSFOR THE THREE MONTHS ENDED DECEMBER 31, 2025 AND 2024(Unaudited)


2025

2024Cash Flows From Operating Activities:




Net loss
$(9,393,889)

$(10,281,246)Adjustments to reconcile net loss to net cash used in operating activities:






Stock-based compensation expense

4,280,227


2,524,824Issuance of common stock for services

107,510


—Issuance of common stock warrant

68,597


—Amortization of in-process research and development

573,438


—Amortization (accretion) of operating lease right-of-use asset

(16,483)


54,835Deferred income tax expense

264,240


264,240Changes in operating assets and liabilities:






Accounts receivable, net of allowances

(4,049,111)


—Inventory

(352,649)


(6,112,603)Prepaid expenses

(2,139,797)


(145,739)Accounts payable

(2,672,280)


2,436,909Accrued expenses

503,054


6,225,151Accrued compensation

(198,052)


366,073Operating lease liability

16,373


(58,296)Net Cash Used In Operating Activities

(13,008,822)


(4,725,852)







Cash Flows From Investing Activities:






License fee payments

(4,400,000)


—Net Cash Used in Investing Activities

(4,400,000)


—







Cash Flows From Financing Activities:






Net proceeds from common stock offerings

20,877,925


2,574,051Net Cash Provided By Financing Activities

20,877,925


2,574,051







Net Change in Cash and Cash Equivalents

3,469,103


(2,151,801)Cash and Cash Equivalents - Beginning of Period

4,252,290


3,251,880Cash and Cash Equivalents - End of Period
$7,721,393

$1,100,079Supplemental Disclosures of Cash Flow Information and Non-cash Transactions:






Interest paid
$14,460

$—





View original content to download multimedia:https://www.prnewswire.com/news-releases/citius-pharmaceuticals-inc-announces-first-reported-revenue-following-successful-launch-of-lymphir-302687092.htmlSOURCE Citius Pharmaceuticals, Inc.

Original: Citius Pharmaceuticals, Inc. Announces First Reported Revenue Following Successful Launch of LYMPHIR™

Citius Oncology, Inc. Announces First Reported Revenue Following Successful Launch of LYMPHIR™February 13, 2026 8:00 AM
PR Newswire (US)

Company reports $3.9 million in revenue generated from initial sales in December 2025 and provides first fiscal quarter 2026 financial resultsCRANFORD, N.J., Feb. 13, 2026 /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 first quarter ended December 31, 2025, and provided a business update.







"The first quarter of fiscal 2026 marked a pivotal inflection point for Citius Oncology with the successful U.S. commercial launch of LYMPHIR and the Company's first reported revenue," said Leonard Mazur, Chairman and Chief Executive Officer of Citius Oncology and Citius Pharma. "This transition from a development-stage organization to a commercial oncology company reflects years of deliberate preparation and coordination across our clinical, manufacturing, distribution, and commercial infrastructure.""With initial distributor sales complete nationwide, we are now focused on accelerating physician adoption and expanding patient access. Since the start of calendar 2026, physicians have begun to initiate patients on LYMPHIR, and our formulary review efforts are progressing as planned. We are preparing to expand our field presence to support a highly concentrated prescriber base in this rare cancer setting, supported by an advanced AI-enabled commercial platform designed to drive efficient market penetration," added Mazur."As LYMPHIR is now broadly available, we remain focused on execution, capital management, and evaluating strategic opportunities that we believe can meaningfully enhance long-term shareholder value," concluded Mazur.Business Highlights and Subsequent DevelopmentsInitiated U.S. commercial launch of LYMPHIR™ (denileukin diftitox-cxdl) in December 2025, establishing Citius Oncology as a commercial-stage oncology company with an FDA-approved IL-2 receptor-directed immunotherapy for adult patients with relapsed or refractory Stage I–III cutaneous T-cell lymphoma (CTCL) following at least one prior systemic therapy;Established nationwide specialty distribution infrastructure, completing initial distributor sales to ensure immediate product availability across U.S. treatment centers and support rapid physician adoption;Initiated treatment of CTCL patients at leading U.S. cancer centers;Deployed an AI-enabled commercial platform to drive targeted physician engagement, optimize field execution, and efficiently penetrate a highly concentrated prescriber base; and,Advanced international access strategy outside the U.S. through regional distribution partners and Named Patient Programs (NPPs) in key European and Middle Eastern markets, enabling patient access where permitted by local law without constituting commercial approval;Continued to expand long-term value optionality through investigator-initiated Phase I combination studies evaluating LYMPHIR:in combination with pembrolizumab in patients with recurrent solid tumors; and,as part of lymphodepletion regimens prior to CAR-T therapy, supporting potential future label expansion opportunities.First Quarter 2026 Financial HighlightsCash and cash equivalents totaled $7.3 million as of December 31, 2025;Completed a registered offering in December 2025, generating net proceeds of approximately $15.1 million;Revenue of $3.9 million during the quarter ended December 31, 2025 reflects sales related to the launch of LYMPHIR;Research and development expenses were $1.0 million, compared to $1.3 million in the prior-year period, reflecting reduced clinical development activity;General and administrative expenses were $2.9 million, compared to $3.3 million in the prior-year period;Stock-based compensation expense totaled $4.0 million, primarily related to equity grants issued in September 2025, compared to $1.8 million in the prior-year period; and,Net loss for the quarter was $5.5 million, or $(0.06) per share, compared to a net loss of $6.7 million, or $(0.09) per share, for the prior-year period.About Citius Oncology, Inc.Citius Oncology, Inc. (Nasdaq: CTOR) is a platform to develop and commercialize novel targeted oncology therapies. In December 2025, Citius Oncology launched LYMPHIR, approved by the FDA for the treatment of adults with relapsed or refractory Stage I–III CTCL who had had at least one prior systemic therapy. Management estimates the initial market for LYMPHIR currently exceeds $400 million, is growing, and is underserved by existing therapies. Robust intellectual property protections that span orphan drug designation, complex technology, trade secrets and pending patents for immuno-oncology use as a combination therapy with checkpoint inhibitors would further support Citius Oncology's competitive positioning. For more information, please visit www.citiusonc.com.About Citius Pharmaceuticals, Inc. Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) is a biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products. Citius Pharma owns approximately 75% of Citius Oncology. In December 2025, Citius Oncology launched LYMPHIR, a targeted immunotherapy for the treatment of adults with relapsed or refractory Stage I–III CTCL who had had at least one prior systemic therapy. Citius Pharma's late-stage pipeline also includes Mino-Lok®, a catheter lock solution to salvage catheters in patients with catheter-related bloodstream infections, and CITI-002 (Halo-Lido), a topical formulation for the relief of hemorrhoids. A pivotal Phase 3 trial for Mino-Lok and a Phase 2b trial for Halo-Lido were completed in 2023. Mino-Lok met primary and secondary endpoints of its Phase 3 trial. Citius Pharma is actively engaged with the FDA to outline next steps for both programs. For more information, please visit www.citiuspharma.com.Forward-Looking StatementsThis press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements are made based on our expectations and beliefs concerning future events impacting Citius Oncology. You can identify these statements by the fact that they use words such as "will," "anticipate," "estimate," "expect," "plan," "should," and "may" and other words and terms of similar meaning or use of future dates. Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price.  Factors that could cause actual results to differ materially from those currently anticipated are: our ability to maintain Nasdaq's continued listing standards; our ability to successfully commercialize LYMPHIR and establish a sustainable revenue stream; the estimated markets for LYMPHIR and our product candidates and the acceptance thereof by any market; our ability to secure strategic partnerships and expand international access to LYMPHIR; our ability to use the latest technology to support our commercialization efforts for LYMPHIR; physician and patient acceptance of LYMPHIR in a competitive treatment landscape; our reliance on third-party logistics providers, distributors, and specialty pharmacies to support commercial operations; our ability to educate providers and payers, secure adequate reimbursement, and maintain uninterrupted product supply; post-marketing requirements and ongoing regulatory compliance related to LYMPHIR; the ability of LYMPHIR and our product candidates to impact the quality of life of our target patient populations; our need for substantial additional funds and our ability to raise additional money to fund our operations for at least the next 12 months as a going concern; risks relating to the results of research and development activities, including those from any new pipeline assets; our ability to procure cGMP commercial-scale supply; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; market and other conditions; risks related to our growth strategy; patent and intellectual property matters; government regulation; as well as other risks described in our Securities and Exchange Commission ("SEC") filings. These risks have been and may be further impacted by any future public health risks. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Risks regarding our business are described in detail in our SEC filings which are available on the SEC's website at www.sec.gov, including in Citius Oncology's Annual Report on Form 10-K for the year ended September 30, 2025, filed with the SEC on December 23, 2025. These forward-looking statements speak only as of the date hereof, and we expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.Investor Contact:
Ilanit Allen
ir @crsrs-6677 x113Media Contact:
STiR-communications
Greg Salsburg
Greg@STiR-communications.com -- Financial Tables Follow – CITIUS ONCOLOGY, INC.CONDENSED CONSOLIDATED BALANCE SHEETS(Unaudited)


December 31,
2025

September 30,
2025Current Assets:




Cash and cash equivalents
$7,295,451

$3,924,908Accounts receivable, net of allowances

4,049,111


—Inventory

22,639,342


22,286,693Prepaid expenses

3,162,940


1,331,280Total Current Assets

37,146,844


27,542,881







Other Assets:






In-process research and development, net of accumulated amortization

72,826,562


73,400,000Total Other Assets

72,826,562


73,400,000







Total Assets
$109,973,406

$100,942,881LIABILITIES AND STOCKHOLDERS' EQUITY






Current Liabilities:






Accounts payable
$10,446,900

$13,234,684License payable

18,250,000


22,650,000Accrued expenses

4,518,916


4,093,124Due to related party

11,494,578


9,513,771Total Current Liabilities

44,710,394


49,491,579







Deferred tax liability

3,049,200


2,784,960Note payable to related party

3,800,111


3,800,111Total Liabilities

51,559,705


56,076,650Stockholders' Equity:






Preferred stock - $0.0001 par value; 10,000,000 shares authorized: no shares issued
     and outstanding

—


—Common stock - $0.0001 par value; 400,000,000 shares authorized at December 31,
     2025 and September 30, 2025; 84,797,846 and 83,513,442 shares issued and
     outstanding at December 31, 2025 and September 30, 2025, respectively

8,480


8,351Additional paid-in capital

127,979,246


108,897,836Accumulated deficit

(69,574,025)


(64,039,956)Total Stockholders' Equity

58,413,701


44,866,231Total Liabilities and Stockholders' Equity
$109,973,406

$100,942,881 CITIUS ONCOLOGY, INC.CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONSFOR THE THREE MONTHS ENDED DECEMBER 31, 2025 AND 2024(Unaudited)


Three Months Ended

December
31,

December
31,

2025

2024   Revenue
$3,944,111

$—   Cost of revenues

(789,208)


—   Gross Profit

3,154,903


—







Operating Expenses






Research and development

1,018,352


1,264,508Amortization of in-process research and development

573,438


—General and administrative

2,859,339


3,321,979Stock-based compensation – general and administrative

3,956,050


1,808,478Total Operating Expenses

8,407,179


6,394,965







Operating Loss

(5,252,276)


(6,394,965)







Other Income (Expense)






Interest income

28,288


—Interest expense

(45,841)


—Total Other Income (Expense), Net

(17,553)


—Loss before Income Taxes

(5,269,829)


(6,394,965)Income tax expense

264,240


264,240







Net Loss
$(5,534,069)

$(6,659,205)







Net Loss Per Share - Basic and Diluted
$(0.06)

$(0.09)







Weighted Average Common Shares Outstanding






   Basic and diluted (includes pre-funded warrants from the December 2025 offering)           

87,462,385


71,552,402 CITIUS ONCOLOGY, INC.CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWSFOR THE THREE MONTHS ENDED DECEMBER 31, 2025 AND 2024(Unaudited)


2025

2024   Cash Flows From Operating Activities:




Net loss
$(5,534,069)

$(6,659,205)Adjustments to reconcile net loss to net cash provided by operating activities:






      Stock-based compensation expense

3,956,050


1,808,478      Amortization of in-process research and development

573,438


-      Deferred income tax expense

264,240


264,240   Changes in operating assets and liabilities:






      Accounts receivable, net of allowances

(4,049,111)


-      Inventory

(352,649)


(6,112,603)      Prepaid expenses

(1,831,660)


-      Accounts payable

(2,787,784)


2,162,955      Accrued expenses

425,792


6,228,612      Due to related party

1,980,807


2,307,523Net Cash (Used In) Provided By Operating Activities

(7,354,946)


-Cash Flows From Investing Activities






    License payments

(4,400,000)


-Net Cash Used In Investing Activities

(4,400,000)


-Cash Flows From Financing Activities






    Net proceeds from issuance of common stock

15,125,489


-Net Cash Provided by Financing Activities

15,125,489


-Net Change in Cash and Cash Equivalents

3,370,543


-Cash and Cash Equivalents – Beginning of Period

3,924,908


112Cash and Cash Equivalents – End of Period
$7,295,451

$112Supplemental Disclosures of Cash Flow Information and Non-cash Transactions:   






Interest Paid
$14,460

$- 



View original content to download multimedia:https://www.prnewswire.com/news-releases/citius-oncology-inc-announces-first-reported-revenue-following-successful-launch-of-lymphir-302687114.htmlSOURCE Citius Oncology, Inc.

Original: Citius Oncology, Inc. Announces First Reported Revenue Following Successful Launch of LYMPHIR™

Citius Oncology Expands International Distribution of LYMPHIR™ to European Union Through Exclusive Agreement with UnipharFebruary 11, 2026 8:00 AM
PR Newswire (US)

Third international distribution agreement further advances global access strategy with major markets in EuropeCRANFORD, N.J., Feb. 11, 2026 /PRNewswire/ -- Citius Oncology, Inc. ("Citius Oncology") (Nasdaq: CTOR), the oncology-focused subsidiary of Citius Pharmaceuticals, Inc. ("Citius Pharma") (Nasdaq: CTXR), today announced that it has entered into an exclusive distribution agreement with  Uniphar ("Uniphar"), a leading international healthcare services company, to support access to LYMPHIR™ (denileukin diftitox-cxdl) outside the United States. This agreement represents Citius Oncology's third international distribution partnership and further advances the Company's strategy to expand global access to LYMPHIR through established regional partners.







Under the terms of the agreement, Uniphar will serve as the exclusive distribution partner for LYMPHIR in designated international territories in Western and Eastern Europe through country-specific managed access programs, where permitted by local law. Uniphar will oversee market access and distribution activities in selected territories. Citius Oncology will supply finished product and provide ongoing support in accordance with the agreement. LYMPHIR is not approved for commercial use outside the United States and, where permitted by local law, will be provided in the territories covered by this agreement solely through country-specific managed access programs, which do not constitute marketing authorization or a commercial launch."This agreement with Uniphar builds on the momentum of our international expansion efforts and reflects our commitment to partnering with experienced organizations that have deep regional expertise and proven execution capabilities," said Leonard Mazur, Chairman and Chief Executive Officer of Citius Oncology and Citius Pharmaceuticals. "As our third international distribution agreement, this partnership further strengthens our ability to responsibly expand access to LYMPHIR for patients with limited treatment options, while continuing to lay the groundwork for long-term global growth.""We are thrilled to partner with Citius Oncology to expand access to LYMPHIR across Europe. Uniphar is committed to connecting patients with innovative therapies, and this agreement strengthens our ability to support clinicians and improve outcomes for those living with or relapsed or refractory cutaneous T-cell lymphoma (CTCL)," stated Brian O'Shaughnessy, Chief Commercial Officer of Uniphar.This agreement follows Citius Oncology's previously announced international distribution partnerships, including exclusive arrangements in Southern Europe, the Balkans, Turkey, and the Middle East. Together, these collaborations underscore the Company's disciplined approach to international expansion through trusted partners with local expertise and established infrastructure. About LYMPHIR™ (denileukin diftitox-cxdl)LYMPHIR is a targeted immune therapy for relapsed or refractory cutaneous T-cell lymphoma (CTCL) indicated for use in Stage I-III disease after at least one prior systemic therapy. It is a recombinant fusion protein that combines the IL-2 receptor binding domain with diphtheria toxin (DT) fragments. The agent specifically binds to IL-2 receptors on the cell surface, causing diphtheria toxin fragments that have entered cells to inhibit protein synthesis. After uptake into the cell, the DT fragment is cleaved and the free DT fragments inhibit protein synthesis, resulting in cell death. Denileukin diftitox-cxdl demonstrated the ability to deplete immunosuppressive regulatory T lymphocytes (Tregs) and antitumor activity through a direct cytocidal action on IL-2R-expressing tumors.In 2021, denileukin diftitox received regulatory approval in Japan for the treatment of relapsed or refractory CTCL and peripheral T-cell lymphoma (PTCL). Subsequently, in 2021, Citius acquired an exclusive license with rights to develop and commercialize denileukin diftitox in all markets except for India, Japan and certain parts of Asia. LYMPHIR (denileukin diftitox-cxdl) was approved by the FDA and subsequently launched in the U.S. in December 2025.About Cutaneous T-cell LymphomaCutaneous T-cell lymphoma is a type of cutaneous non-Hodgkin lymphoma (NHL) that comes in a variety of forms and is the most common type of cutaneous lymphoma. In CTCL, T-cells, a type of lymphocyte that plays a role in the immune system, become cancerous and develop into skin lesions, leading to a decrease in the quality of life of patients with this disease due to severe pain and pruritus. Mycosis Fungoides (MF) and Sézary Syndrome (SS) comprise the majority of CTCL cases.  Depending on the type of CTCL, the disease may progress slowly and can take anywhere from several years to upwards of ten to potentially reach tumor stage. However, once the disease reaches this stage, the cancer is highly malignant and can spread to the lymph nodes and internal organs, resulting in a poor prognosis. Given the duration of the disease, patients typically cycle through multiple agents to control disease progression. CTCL affects men twice as often as women and is typically first diagnosed in patients between the ages of 50 and 60 years of age. Other than allogeneic stem cell transplantation, for which only a small fraction of patients qualify, there is currently no curative therapy for advanced CTCL.About Uniphar Plc.Headquartered in Dublin, Ireland, Uniphar is an international diversified healthcare services business servicing the requirements of more than 200 multinational pharmaceutical and medical technology manufacturers across three divisions - Uniphar Pharma, Uniphar Medtech and Uniphar Supply Chain & Retail. The Group is active in Europe, North America, APAC and MENA.Uniphar Pharma integrates Development, Clinical, Access, Medical, Commercial, Distribution and Global Sourcing to support the full product lifecycle – from early-stage research through to commercialization and beyond. Uniphar's unified platform spans regulatory strategy, clinical trial support, medical affairs, market access, patient engagement, commercial services, distribution and supply chain.Operating across 180 countries with a global team of 3,500+, Uniphar bridges manufacturers, healthcare providers, and patients — accelerating access to innovative therapies, improving patient outcomes, and delivering value across the healthcare ecosystem.For more information, please visit www.uniphar.com About Citius Oncology, Inc.Citius Oncology, Inc. (Nasdaq: CTOR) is a platform to develop and commercialize novel targeted oncology therapies. In December 2025, Citius Oncology launched LYMPHIR, approved by the FDA for the treatment of adults with relapsed or refractory Stage I–III CTCL who had had at least one prior systemic therapy. Management estimates the initial market for LYMPHIR currently exceeds $400 million, is growing, and is underserved by existing therapies. Robust intellectual property protections that span orphan drug designation, complex technology, trade secrets and pending patents for immuno-oncology use as a combination therapy with checkpoint inhibitors would further support Citius Oncology's competitive positioning. For more information, please visit www.citiusonc.com.About Citius Pharmaceuticals, Inc. Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) is a biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products. Citius Pharma owns 75% of Citius Oncology. In December 2025, Citius Oncology launched LYMPHIR, a targeted immunotherapy for the treatment of adults with relapsed or refractory Stage I–III CTCL who had had at least one prior systemic therapy. Citius Pharma's late-stage pipeline also includes Mino-Lok®, a catheter lock solution to salvage catheters in patients with catheter-related bloodstream infections, and CITI-002 (Halo-Lido), a topical formulation for the relief of hemorrhoids. A pivotal Phase 3 trial for Mino-Lok and a Phase 2b trial for Halo-Lido were completed in 2023. Mino-Lok met primary and secondary endpoints of its Phase 3 trial. Citius Pharma is actively engaged with the FDA to outline next steps for both programs. For more information, please visit www.citiuspharma.com.Forward-Looking StatementsThis press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements are made based on our expectations and beliefs concerning future events impacting Citius Oncology. You can identify these statements by the fact that they use words such as "will," "anticipate," "estimate," "expect," "plan," "should," and "may" and other words and terms of similar meaning or use of future dates. Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price.  Factors that could cause actual results to differ materially from those currently anticipated, and, unless noted otherwise, that apply to Citius Oncology, are: our need for substantial additional funds and our ability to raise additional money to fund our operations for at least the next 12 months as a going concern; our ability to successfully commercialize LYMPHIR and establish a sustainable revenue stream; the estimated markets for LYMPHIR and our product candidates and the acceptance thereof by any market; our ability to secure strategic partnerships and expand international access to LYMPHIR; our ability to maintain Nasdaq's continued listing standards; our ability to use the latest technology to support our commercialization efforts; physician and patient acceptance of LYMPHIR in a competitive treatment landscape; our reliance on third-party logistics providers, distributors, and specialty pharmacies to support commercial operations; our ability to educate providers and payers, secure adequate reimbursement, and maintain uninterrupted product supply; post-marketing requirements and ongoing regulatory compliance related to LYMPHIR; the ability of LYMPHIR and our product candidates to impact the quality of life of our target patient populations; risks relating to the results of research and development activities, including those from our existing and any new pipeline assets; our ability to procure cGMP commercial-scale supply; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; market and other conditions; risks related to our growth strategy; patent and intellectual property matters; our ability to identify, acquire, close and integrate product candidates and companies successfully and on a timely basis; government regulation; as well as other risks described in our Securities and Exchange Commission ("SEC") filings. These risks have been and may be further impacted by any future public health risks. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Risks regarding our business are described in detail in our SEC filings which are available on the SEC's website at www.sec.gov, including in Citius Oncology's Annual Report on Form 10-K for the year ended September 30, 2025, filed with the SEC on December 23, 2025, as updated by our subsequent filings with the SEC. These forward-looking statements speak only as of the date hereof, and we expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.Investor Contact:
Ilanit Allen
ir @crsrs-6677 x113Media Contact:
STiR-communications
Greg Salsburg
Greg@STiR-communications.com 



View original content to download multimedia:https://www.prnewswire.com/news-releases/citius-oncology-expands-international-distribution-of-lymphir-to-european-union-through-exclusive-agreement-with-uniphar-302684833.htmlSOURCE Citius Oncology, Inc.

Original: Citius Oncology Expands International Distribution of LYMPHIR™ to European Union Through Exclusive Agreement with Uniphar

CTXR.............................................https://stockcharts.com/sc3/ui/?s=CTXR&p=W&b=5&g=0&id=p86431144783

CTXR..............................https://stockcharts.com/h-sc/ui?s=CTXR&p=W&b=5&g=0&id=p86431144783

ctxr.............................................https://stockcharts.com/h-sc/ui?s=ctxr&p=W&b=5&g=0&id=p86431144783

CTXR 1.33 news .. Citius Oncology Deploys AI Platform to Amplify the Performance of its Commercial Team Ahead of LYMPHIR Launch https://finance.yahoo.com/news/citius-oncology-deploys-ai-platform-124700527.html

NASD short interest as of 06/30: 970,000, which is about 9% of the float but lower than 6/15

Possible short squeeze on news. Until then.....

https://nasdaqtrader.com/Trader.aspx?id=ShortInterest

Does anyone have live short interest data? Live short data would be more valuable than screen prints of a CTXR chart. The only trustworthy data available (without paying) is NASDAQ, and it's stale by the time we see it.

https://nasdaqtrader.com/Trader.aspx?id=ShortInterest

The NASDAQ short interest numbers today at market close will be as of June 30, which is stale data, but still interesting. CTXR has been heavily shorted for a long time, but in the past year it was pretty steady at only about 5%.... until June 13th when it jumped to over 10%. Bad timing for the shorties, but it's a pretty safe guess that after they got singed and covered, they jumped back on around July 1st.

I'm guessing that our Angry Prince Edward is one of those shorts.

CTXR could be a good candidate for a short squeeze. I sold my CTXR to take my profits and am waiting on the sidelines to see how far the shorts drive it back down, but while I owned it, Fidelity wanted to borrow my CTXR shares. I found that odd because I didn't think Fidelity allowed penny stock shorting.

Best of luck to those holding!

LMAO. Classic.

Typical for a penny stock investor.

So emotional and childish.

Always the case of someone who deals in penny stocks and has no idea what they are talking about.

Never answers a question, continually reverts to the childest comments when confronted and proven completely wrong.

Doesn't understand the problems of CTXR.

.

haha, you think you're not showing any anger or agression? Not trying to bully everyone you encounter here?

You call me an "amateur." An amateur would have read your 6/10 FUDster bashing and walked away. Instead, I bought, and turned a quick double.

You insult me at every turn, but I don't mind because I'm making money while you apparently are steaming because your short didn't work out in the past three weeks. I'm still not going to call you an amateur. You're just another gambler like the rest of us OTC players. The difference is: you have anger issues and bullying issues.

That's your problem, not mine or anyone else's. Buh bye.

That's bullshit. And, your anger and abusive tone are bullshit.

You have that backwards. I am not showing any anger. Again, you have a reading comprehension problem. Read your posts, then you see anger and an abusive tone..

Secondly, CTXR's price is after a 1 for 25 reverse split, so the $1 price is .04 from the pre-split shares. Why wouldn't anyone think that was good?

Where was I bashing CTXR?

I said this back in 8/24, that's bashing:

BLA approval is expected (NOT GUARANTEED) in 5 business days or less.

The buying continues for CTXR. Pre-market this morning currently has the stock price up another 4% @ $1.06.

July 3rd 2024 it closed @ .485.

You bashed CTXR under a buck and it quickly went over two bucks. You were bullying a poster who tried to post a positive sentiment about the dilution.

That's bullshit. And, your anger and abusive tone are bullshit.

Fine, if you're not going to keep your word and stop responding to me, I'LL take the reins.

So funny.


My BS about what?

I'll wait right here.

Still waiting for an answer on this:

Again, where did I say anything about prior facts about the trading history results for you to say I left out prior facts?

I liked it better when you thought I wasn't worthy of your bullshit.

Can we go back to that?

Thanks in advance.

LMAO.

Again, where did I say anything about prior facts about the trading results for you to say I left out prior facts?

You have a reading comprehension problem.

But I expect that from an amateur.

Yes, that's what you said, partially at least. Shall we repeat it? "Stop the childist nonsense. No, you haven't been following it for years. Yes I have been following CTXR for years. And what I wrote wasn't childish nonsense. Last response from me, I have much more important things to do than to talk childish nonsense." Guess you finished all those important things.

Regarding your other post: You're cherry-picking that post here by leaving out the most important paragraph -- the paragraph to which I was responding. Here is your FULL post -- bolding emphasis mine -- does my response make sense now? Not bad???

CTXR is down(.38) 27.74% Pre-market- bad reaction.

Dilution with no sales.

How much do you know about this company? You saw on the most up list yesterday. I have been following this company for years and know it inside and out. This recently underwent a 1:25 reverse split and is still trading below $1. The CEO is known to be incompetent.
Suggest do your research for the last 4 years of this company. And now you're saying this: Classic penny stock investor, emotional over a penny stock. You are the one getting emotional here, wouldn't you agree?

I bought that selloff that followed your FUD on June 10th, and I doubled my money. Calmly. Without emotion. I guess I should thank you?

LMAO!

One thing you forgot to mention was the history of CTXR being heavily shorted. You also forgot to mention CTXR's 2017 reverse split, and the $15 million "dilution with no sales" they did in April 2024. Apparently, when you say you know a company "inside and out," you actually don't.

But you have a FUD job to do here. Don't let me distract you. Shine on, crazy diamond.

What in the world does this have to do with what I posted? I said nothing about any past facts about the company. So funny.

This is what I posted.

"Stop the childist nonsense. No, you haven't been following it for years.

Last response from me, I have much more important things to do than to talk childish nonsense."

My other post:
Not bad???

CTXR is down(.38) 27.74% Pre-market- bad reaction.

Dilution with no sales.




Classic penny stock investor, emotional over a penny stock.

CTXR is possibly a short squeeze opportunity. It would be nice to know the real-time short numbers.

If anyone has live shorting data, that would be helpful. NASDAQ data is always old -- the next report coming out July 10 will be "as of" June 30.

Shorts got burned a little on this current run up. Maybe not BURNED, but certainly SINGED.

CTXR................................https://stockcharts.com/h-sc/ui?s=CTXR&p=W&b=5&g=0&id=p86431144783

CTXR......................................................https://stockcharts.com/h-sc/ui?s=CTXR&p=W&b=5&g=0&id=p86431144783

CTXR...............................https://stockcharts.com/h-sc/ui?s=CTXR&p=W&b=5&g=0&id=p86431144783

LOL GetCitiusOK? I like that.

Shenzhen CICD used to show a picture of the assembled electronic device. They don't show the picture any more but the actual device arrives in the USA as a sealed device with battery and wire loop.

Kelly doesn't solder or seal or assembled anything. Somebody in the USA drops the fully assembled device in a box with some literature. KT Tape too -- nobody at KT Tape assembles anything plastic or electronic. The Chinese manufacturer puts the KT logo, or the RecoveryRx logo, on the device, and anyone else wanting to do that can have their own logo put on the device and sell it, since the patents are gone.

Kelly doesn't "clearly write" anything. Read her quote again. She is vague and obtuse as usual. She says that "enough of the COGS" is done in the USA to say "MADE in the USA" but what does that mean? They probably pay the Chinese manufacturer $10 per unit or close to that, so the spend another
$11 dropping that assembled device into a box? BS, I say, and the FTC apparently agrees with me because someone complained to the FTC and now "MADE in the USA" is gone from the website.

CTXR is tricky. The recent dilution was done at $1.00 so I think this selling under $1.00 is overdone. I've been buying because I already have enough CTOR and that price isn't coming back to earth, even though the company just said, in typical Safe Harbor Positive Spin wording, that product launch is not going to happen in the first half of 2025 as previously forecast.

According to Vegas Pro’s Facebook pic the device components are made overseas but KW clearly writes that all the pieces are put together in Maryland and then boxed. Is that a lie that is clearly stated on the Pain Page? Are you Citius about it simply being dropped into the box ?

You're accusing me of lying and "threatening" to not reply to anything else I say.... and I'M the one guilty of "childish nonsense?"

"Last response from you?" That's great because I wasn't writing for you anyway. I was writing for the other guy you were bullying with your childish nonsense.

I've been following dozens if not hundreds of developmental biotechs since 1999. CTXR is a familiar story.

One thing you forgot to mention was the history of CTXR being heavily shorted. You also forgot to mention CTXR's 2017 reverse split, and the $15 million "dilution with no sales" they did in April 2024. Apparently, when you say you know a company "inside and out," you actually don't.

But you have a FUD job to do here. Don't let me distract you. Shine on, crazy diamond.

Stop the childist nonsense. No, you haven't been following it for years.

Last response from me, I have much more important things to do than to talk childish nonsense.

You can respond, but nothing will be returned.

I, too, have been following CTXR for years, and I bought some today at a buck.

CTXR is a pennystock developmental biotech. "Dilution with no sales" is how the game is played. This is gambling. I don't plan to hold it for long. There could be some pop here upon product launch. Or maybe it'll close red that day. Whatever, it's gambling.

Citius did a shitty thing to existing CTXR shareholders when they split off CTOR but I wasn't an existing shareholder then. I bought a pile of CTOR during the fire sales but now that's doubled so I won't be buying any more CTOR. CTXR at a buck, though, is a good gamble, IMO.

Best of luck to my fellow gamblers!

Not bad???

CTXR is down(.38) 27.74% Pre-market- bad reaction.

Dilution with no sales.

How much do you know about this company? You saw on the most up list yesterday. I have been following this company for years and know it inside and out. This recently underwent a 1:25 reverse split and is still trading below $1. The CEO is known to be incompetent.
Suggest do your research for the last 4 years of this company.

This news isn't bad following the increased AS last night. Money raised at the market instead of significantly discounted to help with the launch !

https://lifesciencereport.com/news/nasdaq/ctxr/citius-pharmaceuticals-announces-a-registered-direct-offering-of-up-to-15-8-million-priced-at-the-market-under-nasdaq-rules

LMAO.

Why is that a laugh for me? OMG!

A classic response.

Here’s another laugh for you https://stockinsights.ai/us/CTXR/8-K/capital-structure-changes-20250609-0c3?utm_source=twitter&utm_medium=social&utm_id=secfilingsdigest

Oh. So the phone allows someone to respond after 3 months. So funny.

Can only reply to posts off my phone unlike on the desktop.

CTXR.................................https://stockcharts.com/h-sc/ui?s=CTXR&p=W&b=5&g=0&id=p86431144783

LMAO.

Reacting to a post over 3 months old. Too funny.

And a 1st time poster here.LMAO.

Big news today. In at 1.71 on a pullback from the $2.38 high.

Yeah so. No kidding. Why would i care , i don't own it. Just posted.

That post was 3 weeeks ago.

What is your point. Is this supposed to mean anything.

,