# EDGAR Filing Document

**Accession Number:** 0001506251
**File Stem:** 0001213900-25-116760
**Filing Date:** 2025-12
**Character Count:** 46962
**Document Hash:** 4364b4dcc73a00f939b88e0feb6a57ea
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001213900-25-116760.hdr.sgml**: 20251201

**ACCESSION NUMBER**: 0001213900-25-116760

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 44

**CONFORMED PERIOD OF REPORT**: 20251201

**ITEM INFORMATION**: Regulation FD Disclosure

**ITEM INFORMATION**: Other Events

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20251201

**DATE AS OF CHANGE**: 20251201

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Citius Pharmaceuticals, Inc.
- **CENTRAL INDEX KEY:** 0001506251
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 273425913
- **STATE OF INCORPORATION:** NV
- **FISCAL YEAR END:** 0930

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-38174
- **FILM NUMBER:** 251540509

**BUSINESS ADDRESS:**
- **STREET 1:** 11 COMMERCE DRIVE
- **STREET 2:** 1ST FLOOR
- **CITY:** CRANFORD
- **STATE:** NJ
- **ZIP:** 07016
- **BUSINESS PHONE:** (908) 967-6676

**MAIL ADDRESS:**
- **STREET 1:** 11 COMMERCE DRIVE
- **STREET 2:** 1ST FLOOR
- **CITY:** CRANFORD
- **STATE:** NJ
- **ZIP:** 07016

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** Trail One, Inc.
- **DATE OF NAME CHANGE:** 20110314

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** TrailOne, Inc.
- **DATE OF NAME CHANGE:** 20101119

?xml version='1.0' encoding='ASCII'?

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

**FORM 8-K**

CURRENT REPORT

Pursuant to Section 13 or 15(d) of

the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported) <u>December 1, 2025</u>

**<u>Citius Pharmaceuticals, Inc.</u>**

(Exact name of registrant as specified in its charter)

<u>Nevada</u>

(State or other jurisdiction of incorporation)

<u>001-38174</u> <u>27-3425913</u> <br> (Commission File Number) (IRS Employer Identification No.)

<u>11 Commerce Drive, 1st Floor, Cranford, NJ</u> <u>07016</u> <br> (Address of principal executive offices) (Zip Code)

Registrant's telephone number, including area code <u>(908) 967-6677</u>

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

---

| | | |
|:---|:---|:---|
| &nbsp;&nbsp;Title of each class | &nbsp;&nbsp;Trading Symbol(s) | &nbsp;&nbsp;Name of each exchange on which registered |
| Common stock, $0.001 par value | CTXR | The Nasdaq Capital Market |

---

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

**Item 7.01 Regulation FD Disclosure.**

On December 1, 2025, Citius Pharmaceuticals, Inc. posted an updated Corporate Presentation on its website. A copy of the Corporate Presentation is attached hereto as Exhibit 99.1 and incorporated herein by reference.

The information in this Item 7.01 (including Exhibit 99.1) shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934 (the "Exchange Act") or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such a filing.

**Item 8.01 Other Events.**

On December 1, 2025, Citius Oncology, Inc. (Nasdaq: CTOR), our majority-owned subsidiary, issued a press release announcing the commercial launch of LYMPHIR™ (denileukin diftitox-cxdl), a novel IL-2 receptor-directed fusion protein approved by the U.S. Food and Drug Administration for the treatment of adult patients with relapsed or refractory Stage I–III cutaneous T-cell lymphoma after at least one prior systemic therapy. A copy of the press release is attached hereto as Exhibit 99.2 and is incorporated herein by reference.

**Item 9.01. Financial Statements and Exhibits.**

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;(d) Exhibits

---

| | |
|:---|:---|
| **Exhibit No.** | **Description** |
| 99.1 | [Corporate Presentation of December 2025.](ea026756201ex99-1_citius.htm) |
| 99.2 | [Press release issued by Citius Oncology, dated December 1, 2025](ea026756201ex99-1_citius.htm) |
| 104 | Cover Page Interactive Date File (embedded within the Inline XBRL document). |

---

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

---

| | |
|:---|:---|
|  | **CITIUS PHARMACEUTICALS, INC.** |
| Date: December 1, 2025 | /s/ Leonard Mazur |
|  | Leonard Mazur |
|  | Chairman and Chief Executive Officer |

---

## Exhibit 99.1

**Exhibit 99.1**

![](ex99-1_001.jpg)

NASDAQ: CTXR Citius Pharmaceuticals, Inc. (NASDAQ: CTXR) Corporate Overview DECEMBER 2025

![](ex99-1_002.jpg)

FORWARD - LOOKING STATEMENTS NASDAQ: CTXR 2 This presentation has been prepared by Citius Pharmaceuticals, Inc . (the "Company") for informational purposes only and not for any other purpose . Nothing contained in this presentation is, or should be construed as, a recommendation, promise or representation by the Company or any director, employee, agent, or adviser of the Company . This presentation does not purport to be all - inclusive or to contain all of the information you may desire . The information contained in this presentation and the comments and remarks of the representatives of the Company made during any presentation to which this presentation relates are integrally related and, as such, are intended to be delivered and understood together . Information provided in this presentation speaks only as of the date hereof . The Company assumes no obligation to update any statement after the date of this presentation as a result of new information, subsequent events or any other circumstances . This presentation does not constitute an offer or invitation for the sale or purchase of securities or to engage in any other transaction with the Company or its affiliates . The information in this presentation is not targeted at the residents of any particular country or jurisdiction and is not intended for distribution to, or use by, any person in any jurisdiction or country where such distribution or use would be contrary to local law or regulation . This presentation contains forward - looking statements that involve substantial risks and uncertainties . In some cases, you can identify forward - looking statements by the words "may", "might", "will", "could", "would", "should", "expect", "intend", "plan", "goal", "objective", "anticipate", "believe", "estimate", "predict", "potential", "continue" and "ongoing", or the negative of these terms, or other comparable terminology intended to identify statements about the future . These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward - looking statements . The forward - looking statements and opinions contained in this presentation are based upon estimates and information available to us as of the date of this presentation . While we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information . Factors that could cause actual results to differ from those discussed in the forward - looking statements include, but are not limited to : 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, including covering the costs of licensing payments, product manufacturing and other third - party goods and services, through our majority - owned subsidiary and any of our other product candidates that may be approved by the FDA ; our ability to obtain, perform under and maintain financing and strategic agreements and relationships ; our ability to maintain compliance with Nasdaq's continued listing requirements ; risks relating to the results of research and development activities, including those from our existing and any new pipeline assets ; risks related to research using our assets but conducted by third parties ; the estimated markets for our product candidates and the acceptance thereof by any market ; the ability of our product candidates to impact the quality of life of our target patient populations ; our dependence on third - party suppliers ; our ability to procure cGMP commercial - scale supply ; uncertainties relating to preclinical and clinical testing ; the early stage of products under development ; 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 ; competition ; and other assumptions described in this presentation underlying or relating to any forward - looking statements Investors are strongly encouraged to carefully review the Company's SEC filings for a listing of the risks that could cause actual results to differ from these forward - looking statements . These forward - looking statements speak only as of the date of this presentation and should not be construed as statements of facts . As a matter of course, we do not make public projections as to our expected sales or profitability due to, among other reasons, the inherent uncertainty of the underlying assumptions and estimates . Similarly, as a matter of course, we do not comment on ongoing or potential partnership discussions, the expected timing of future financial raises or potential long - term strategic plans .

![](ex99-1_003.jpg)

INVESTMENT HIGHLIGHTS Biopharmaceutical company with multiple advanced development programs • LYMPHIR (denileukin diftitox - cxdl) • LAUNCHED December 2025 for the treatment of adult patients with relapsed or refractory Stage I - III cutaneous T - cell lymphoma (CTCL) after at least one prior systemic therapy • Spun - off into Citius Oncology, Inc. (NASDAQ: CTOR) in August 2024 • Mino - Lok® • Only treatment designed to salvage infected catheters causing CLABSI • Phase 3 trial completed in 2024 • Positive Topline data – met primary and secondary endpoints • Halo - Lido • Only Rx therapy under development for hemorrhoids • Phase 2b trial completed NASDAQ: CTXR 3

![](ex99-1_004.jpg)

NASDAQ: CTXR ABOUT CITIUS ONCOLOGY, INC. 4 1. Internal estimates based on IQVIA market research. Biopharmaceutical company focused on developing and commercializing innovative targeted oncology therapies • NASDAQ: CTOR \| Stand - alone public company since August 2024 • Majority - owned (~79%) subsidiary of Citius Pharmaceuticals (NASDAQ: CTXR) • Shared management services agreement with CTXR for operational efficiency • LYMPHIR : First commercial product launched December 2025 • $400M+ est. addressable U.S. market with strong growth opportunities 1 • Rights to all markets except India, Japan and certain parts of Asia • Mission: Deliver innovative, targeted oncology therapies that transform patient outcomes

![](ex99-1_005.jpg)

LYMPHIR NOW COMMERCIALLY AVAILABLE IN THE U.S. INDICATION: LYMPHIR is an IL2 - receptor - directed cytotoxin indicated for the treatment of adult patients with relapsed or refractory Stage I - III cutaneous T - cell lymphoma (CTCL) after at least one prior systemic therapy • First marketed product by Citius Oncology • Commercial supply shipped to national wholesalers • Accessible to providers and patients across the U.S. NASDAQ: CTXR 5

![](ex99-1_006.jpg)

EXPERIENCED MANAGEMENT TEAM LEONARD MAZUR CHAIRMAN & CEO JAIME BARTUSHAK EVP, CFO & CBO DR. MYRON CZUCZMAN EVP, CHIEF MEDICAL OFFICER OMAR LANSARI DIR, MARKETING MICHAEL MCGUIRE VP, COMMERCIAL MYRON HOLUBIAK EXECUTIVE VICE CHAIRMAN Shared management services agreement with Citius Pharmaceuticals mitigates execution risk, maximizes capital efficiency and leverages industry expertise NASDAQ: CTXR 6

![](ex99-1_007.jpg)

NASDAQ: CTXR 7 WHAT IS CUTANEOUS T - CELL LYMPHOMA (CTCL)? • Orphan cancer • Severe quality - of - life impact: pain, pruritus, skin lesions • Patients with persistent or recurrent CTCL require systemic therapy • Limited systemic treatment options CTCL is a general term for T - cell lymphoma that involves the skin, but may also involve the blood, lymph nodes, and internal organs CTCL accounts for approximately 4% of all non - Hodgkin lymphoma (NHL) 1 More prevalent in men than women and usually appears in patients in their 50s and 60s 60% 3 - 5% 37% CTCL Prevalence by Subtype 2,3,4 Mycosis Fungoides Sezary Syndrome Other CTCL J Hematol. 2019;94(9):1027 - 1041. 1. Dummer R, et al. Nat Rev Dis Primers. 2021;7(1):61. 2. Rangoonwala, HI and Cascella M. 2022, StatPearls Publishing: Treasure Island, FL. 3. Cleveland Clinic. Cutaneous T - Cell Lymphoma . 2023. Available from: https0://my.clevelandclinic.org/health/diseases/17940 - cutaneous - t - cel l - l ymphoma 4. Hristov AC, et al. Am Considered to be incurable, CTCL is a Subgroup of Non - Hodgkin Lymphomas (NHL) that can be Indolent or Aggressive and is Driven by Malignant T Cells

![](ex99-1_008.jpg)

CTCL PATIENTS HAVE A HIGH DISEASE BURDEN T1 T4 Sézary cell T2 T3 Zackheim. J Am Acad Dermatol. 1999;40:418. Slide credit: clinicaloptions.com NASDAQ: CTXR 8

![](ex99-1_009.jpg)

DIFFERENTIATED MECHANISM OF ACTION (MOA) LYMPHIR targets the IL - 2 receptor, working both as a targeted therapy against malignant T - cells AND as an immunotherapy against Tregs IL - 2 receptor offers a unique treatment opportunity in CTCL Malignant T - cells and Tregs share a common marker: the IL - 2 receptor Targets Malignant Cells Binds to IL - 2 receptors to deliver diphtheria toxin, killing tumor cells directly NASDAQ: CTXR 9 Eliminates Immunosuppressive Tregs Reduces number of Treg cells, subsequently enhancing anti - tumor immunity

![](ex99-1_010.jpg)

COMPETITIVE LANDSCAPE Today's CTCL treatments are non - curative LYMPHIR excels where current therapies are limited • Requires CD30+ biomarker • Peripheral neuropathy may limit use • Most effective in SS subsegment of CTCL (<5%) • Acts on blood disease rather than skin disease • ORR 21% in MF • Use limited by cumulative bone marrow toxicity • Quality of life issues • No biomarker needed • Broad label • No cumulative toxicity • Skin relief • Rapid response • No cumulative toxicity • No cumulative toxicity • Refined patient profile Limitations NASDAQ: CTXR 10

![](ex99-1_011.jpg)

VERY CONCENTRATED PRESCRIBER BASE 10% of Providers (Physicians) Treat ≥3 Patients 90 17 7 15 12 0 10 20 30 40 50 60 70 Number of Accounts 80 90 100 20 - 40 41 - 60 61 - 80 81 - 120 121 - 475 Number of Patients Accounts by Number of Diagnosed Patients 3928, 90% 427, 10% Providers treating at least 1 patient Providers treating at least 3 patients Source: IQVIA Medical (Dx) & Pharmacy (Rx) Claims Data; IQVIA Citius CTCL HCP Targeting Report – September 2022 Copyright© 2022 IQVIA. All rights reserved. Patients may be double counted if treated by multiple providers. Accounts include institutions with multiple prescribing physicians or centers of care. NASDAQ: CTXR 11 141 Accounts Diagnose ≥20 Patients

![](ex99-1_012.jpg)

![](ex99-1_013.jpg)

NASDAQ: CTXR DISTRIBUTION READINESS AND CHANNEL ACCESS Patient - Centric Distribution Strategy aims to provide timely product availability for eligible CTCL patients across all care settings, reinforcing Citius' commitment to access • Nationwide U.S. distribution network established • All major distribution agreements operational • Citius Oncology has executed agreements with Cencora, Cardinal Health, and McKesson to support U.S. distribution of LYMPHIR • These partnerships ensure nationwide coverage across academic centers and community clinics • Commercial - ready inventory with a 60 - month shelf life is in place to meet projected demand 12 – 18 months post - launch • Ex - U.S. strategy to leverage country - specific Named Patient Programs • Exclusive distribution agreement with Integris Pharma S.A. (Oct 2025) • Establishes coverage for 12 markets: Greece, Cyprus, Malta, Bulgaria, Romania, Croatia, Serbia, Albania, Bosnia Herzegovina, Kosovo, Montenegro and North Macedonia • Citius Pharma is in active discussions with multiple additional prospective distribution partners across several European Union member states, in South America, and in select Middle Eastern territories 13

![](ex99-1_014.jpg)

NASDAQ: CTXR PROVIDER & PATIENT SUPPORT Citius Oncology Access & Education Tools • HCP portal: www.lymphirhcp.com • Reimbursement and prior authorization support • Patient assistance via Citius Advantage program • Comprehensive education & prescribing tools 14 NASDAQ: CTOR \|

![](ex99-1_015.jpg)

OPPORTUNITIES FOR GROWTH BEYOND CTCL • University of Pittsburgh: an investigator - initiated trial is underway to evaluate LYMPHIR for potential use as an immuno - oncology therapy in combination with KEYTRUDA® in patients with recurrent or metastatic solid tumors (NCT05200559) • Encouraging preliminary results of interim analysis: • 15 evaluable patients showed 27% ORR; 33% Clinical Benefit Rate; median Progression Free Survival of 57 weeks (for patients that achieved a clinical benefit) • The data supports further evaluation of this combination across a broader range of solid tumor types • Phase 1 Preliminary study data (n=25) anticipated Q1 2026 • University of Minnesota: LYMPHIR in combination with CAR T therapies (NCT04855253) • Phase 1 study to evaluate the potential benefit of LYMPHIR given prior to CAR T therapy in patients with high risk relapsed/refractory B - cell lymphomas • Preliminary study results anticipated Q1 2026 • Logical label expansion potential in PTCL where there is a high unmet need and no curative therapies Phase III Phase II Phase I Preclinical Investigational Indication Program data published Prelim Interim p C OMBINATION WITH PD - 1 I NHIBITOR (K EYTRUDA®) 1 UNIVERSITY OF PITTSBURG MEDICAL CENTER, HILLMAN CANCER CENTER C OMBINATION WITH CAR - T (K YMRIAH) 1 UNIVERSITY OF MINNESOTA, MASONIC CANCER CENTER P ERIPHERAL T - C ELL L YMPHOMA LYMPHIR - P NASDAQ: CTXR KEYTRUDA is a registered trademark of Merck & Co., Inc. KYMRIAH is a registered trademark of Novartis Pharmaceuticals Corporation. 15

![](ex99-1_016.jpg)

LYMPHIR IS COMPETITIVELY POSITIONED • Differentiated MOA targeting the IL - 2 receptor reinforces rationale for inclusion among the current core therapeutic options in the U.S. market • CTCL treatments are non - curative , often have a limited duration of response and/or are discontinued early • Patients are put on multiple alternate therapies and cycle to 2nd line treatments within 5 months , on average • Key growth drivers expected to increase overall market size and facilitate market penetration • Evolving treatment paradigm; incremental therapeutic option for pre - treated patients • Historically, market growth has followed introduction of new therapeutics • Competitively priced • No new therapy approved since 2018 Clinical profile and market dynamics supports market entry NASDAQ: CTXR 16

![](ex99-1_017.jpg)

MINO - LOK NASDAQ: CTXR 17 Phase 3 Trial Completed: Positive Topline Data

![](ex99-1_018.jpg)

NASDAQ: CTXR MINO - LOK OVERVIEW Achieved primary and secondary endpoints of Phase 3 Trial x Time to catheter failure exceeded expectations x Majority of patients in the Mino - Lok group achieved overall treatment success x Well tolerated with no drug - related serious adverse events A novel antibiotic lock solution designed to salvage catheters in patients with catheter - related bloodstream infections Mino - Lok addresses the complications, discomfort and cost of catheter removal and replacement No drugs currently approved to salvage catheters in patients with central - line associated bloodstream infections (CLABSI) or catheter - related bloodstream infections (CRBSI) Phase 3 Trial completed: multi - center, randomized, open label, blinded assessor, active control superiority study Estimated global market expected to exceed $2 billion 1 18 1. Market.us. Catheter - Related Bloodstream Infection Market Report. Retrieved from https://market.us/report/catheter - related - bloodstream - infection - market/

![](ex99-1_019.jpg)

CENTRAL VENOUS CATHETERS NASDAQ: CTXR 19 Central Venous Catheters (CVCs), Peripherally Inserted Central Catheter (PICCs), and Hemodialysis Central Venous Catheter PICC Hemodialysis

![](ex99-1_020.jpg)

BIOFILM FORMATION PROTECTS COLONIES • Pathogens attach to the surface of the lumen in a central venous catheter and form colonies. • Colonies grow and exude a fibrous glycocalyx that protects the organisms from antibiotics, even when shown to be sensitive in vitro NASDAQ: CTXR 20

![](ex99-1_021.jpg)

MARKET POTENTIAL: $1B+ IN US AND $2B+ GLOBALLY High incidence of catheter - related infections support need for effective treatment options ~500,000 CRBSI/CLABSI infections annually in the U.S.\*\* 12 - 25% CRBSI/CLABSI associated mortality & morbidity\*\* \* Shah H., Bosch W., Hellinger W. C., Thompson K. M. (2013). Intravascular catheter - related bloodstream infection. Neurohospitalist 3, 144 – 151. doi: 10.1177/1941874413476043. \*\* Antoňáková Němčíková A, Bednárovská E. Catheter - related bloodstream infections: do we know all of it? Klin Onkol. 2017;30(6):405 – 411. doi: 10.14735/amko2017405. NASDAQ: CTXR 21 4 million Long - term CVCs (>1 month) in the U.S.\* 7 million Central Venus Catheters (CVCs) used annually in the U.S.\*

![](ex99-1_022.jpg)

POTENTIAL TO CHANGE STANDARD OF CARE Mino - Lok addresses the complications, discomfort and cost of CVC removal and replacement salvage existing catheters Limited duration IV therapy designed to eradicate bacterial colonization with a short 2 - hour dwell time Limits disruption of infusion therapy allowing continued use of the catheter for intended treatments Ease of Administration: Locking a catheter is a well - known standard operating procedure Non - invasive and adjunct to systemic therapy Lowers risks to patient Lower cost alternative: significantly less than removal and replacement NASDAQ: CTXR 22

![](ex99-1_023.jpg)

MINO - LOK PHASE 3 TRIAL TOPLINE RESULTS NASDAQ: CTXR 23 Mino - Lok significantly outperforms hospital - specific anti - infective lock solutions • Kaplan Meier Analysis demonstrated clear separation between Mino - Lok and control arms, illustrating Mino - Lok's superiority in extending time to catheter failure Control arm: 33 days Mino - Lok arm: exceeded the trial period (6 weeks) (p - value = 0.0006) Primary Endpoint: Median Time to Failure A greater percentage of patients in the Mino - Lok arm achieved overall treatment success compared to the control arm (p - value = 0.0025) Key Secondary Endpoint: Overall Treatment Success Mino - Lok was well - tolerated with no drug - related serious adverse events Comparable adverse events between Mino - Lok (45.1%) and control (46.1%) arms, as expected in very ill patients Mino - Lok is instilled into the catheter and never enters the patient Safety Profile

![](ex99-1_024.jpg)

HALO - LIDO NASDAQ: CTXR 24 Halobetasol/Lidocaine

![](ex99-1_025.jpg)

NASDAQ: CTXR • 10+ Million patients report symptoms of hemorrhoidal disease; 1/3 seek physician treatment 1 • A cream formulation containing halobetasol propionate (highly potent steroid) and Lidocaine HCl • Phase 2b enrollment completed • 5 cohorts of 60 subjects each • Primary endpoint: reduction in hemorrhoidal symptoms • Subject self - reported using proprietary mobile app (PRO) • Positive Phase 2b results • Meaningful reduction in symptom severity when compared to individual components alone • Dose for Phase 3 trial selected • Trial validates Patient Reported Outcome (PRO) instrument developed to support a pivotal Phase 3 study • Ongoing FDA engagement regarding next steps over the coming months • Citius anticipates monetizing the value of this asset with a strategic or financial partner HALO - LIDO OVERVIEW Potentially the first FDA - approved prescription product to treat hemorrhoids 1. Source: https: //www.mayoclinic.org/medical - professionals/digestive - diseases/news/hemorrhoidal - disease - diagnosis - and - management/mac - 20430067 25

![](ex99-1_026.jpg)

SUMMARY NASDAQ: CTXR 26

![](ex99-1_027.jpg)

WHY INVEST? WHY NOW? NASDAQ: CTXR 27 Diversified late - stage biopharmaceutical company with first commercialized product launched Q4 2025 • LYMPHIR launched December 2025 • $400+M est. addressable market with multiple opportunities for growth • First new systemic CTCL therapy since 2018 • 12 - year BLA exclusivity • Pipeline of additional late - stage assets • Management and shareholder alignment • $26.5 M invested by founders • Successful pharma/biotech track record • Attractive investor entry points

![](ex99-1_028.jpg)

NASDAQ: CTXR Citius Pharmaceuticals, Inc. (NASDAQ: CTXR) Investor Inquiries ir@citiuspharma.com

## Exhibit 99.2

**Exhibit 99.2**

![](ex99-2_001.jpg)

**Citius Oncology Announces U.S. Commercial Launch of LYMPHIR™, a Novel Cancer Immunotherapy for Cutaneous T-Cell Lymphoma (CTCL)**

*LYMPHIR now available nationwide*

**CRANFORD, N.J.**, December 1, 2025 – Citius Oncology, Inc. ("Citius Oncology") (Nasdaq: CTOR), the oncology-focused subsidiary of Citius Pharmaceuticals, Inc. ("Citius Pharma") (Nasdaq: CTXR), today announced the commercial launch of LYMPHIR™ (denileukin diftitox-cxdl). LYMPHIR is a novel IL-2 receptor-directed fusion protein approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory (r/r) Stage I–III cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy.

![](ex99-2_002.jpg)

"LYMPHIR is an important new treatment option for the CTCL community, and its launch marks the beginning of a new chapter for Citius Oncology. With a median time to response of 1.4 months in the Phase 3 trial, we believe LYMPHIR may offer rapid skin relief, among other benefits, to patients suffering from severe and debilitating itching common with the disease," said Leonard Mazur, Chairman and CEO of Citius Oncology and Citius Pharmaceuticals. "This is our first marketed product and the culmination of years of development work and commercial preparation. LYMPHIR addresses a clear clinical need in a disease with limited treatment options. Ultimately, we expect LYMPHIR to be a meaningful addition to the treatment paradigm for CTCL and a value-driving catalyst for Citius Oncology shareholders. We estimate that LYMPHIR is entering a growing U.S. market valued at over $400 million, with further upside opportunities through international market access and potential expanded indications in the future. Our focus now is on execution to ensure that LYMPHIR reaches the patients who need it," added Mazur.

The FDA approval of LYMPHIR was based on data from Pivotal Study 302 (NCT01871727), which evaluated the efficacy and safety of LYMPHIR in patients with Stage I–III CTCL who had received at least one prior systemic treatment. The study demonstrated an Objective Response Rate (ORR) of 36.2%, with 84% of evaluable patients experiencing a reduction in skin tumor burden. Moreover, LYMPHIR demonstrated meaningful activity on severe pruritus (itchiness), a significant quality of life issue for CTCL patients. Median time to response was 1.4 months. Importantly, LYMPHIR was not associated with cumulative toxicity.

"LYMPHIR is an important new tool in the fight against CTCL. It is the only FDA-approved systemic therapy for CTCL in more than seven years," said Dr. Myron Czuczman, Executive Vice President and Chief Medical Officer of Citius Oncology and Citius Pharma. "LYMPHIR's direct tumoricidal activity and transient T-regulatory cell depletion offer a powerful new approach to disease control without cumulative toxicity. As such, LYMPHIR's clinical profile makes it a compelling treatment option for physicians and patients facing the burden of relapsed or refractory CTCL."

**Commercial Access and Distribution**

LYMPHIR is now available in the U.S. through specialty distributors nationwide. Healthcare providers can access treatment resources and prescribing information via the dedicated portal: www.lymphirhcp.com. The product has been assigned a permanent J-code (J9161), effective April 1, 2025, to facilitate reimbursement and streamline claims processing.

The launch is supported by medical education and payer access programs, alongside a field engagement strategy. LYMPHIR has also been included in the National Comprehensive Cancer Network (NCCN) Guidelines<sup>®</sup> for CTCL with a Category 2A recommendation.

Outside the U.S., Citius Oncology holds exclusive rights to develop and commercialize LYMPHIR in all global markets except India, Japan, and certain parts of Asia. The company recently announced a distribution agreement with Integris Pharma S.A. to initiate named-patient access programs in Greece, Cyprus, and other Southern European and Balkan countries. This partnership marks the first pillar in Citius Oncology's international strategy and supports efforts to provide patients worldwide with access to LYMPHIR.

**Patient and Provider Resources**

To support informed treatment decisions and facilitate access to care, Citius Oncology has developed clinical, administrative and educational resources for healthcare providers, available at www.lymphirhcp.com. The site includes prescribing information, reimbursement support materials, and product ordering guidance. Additionally, the site features information about Citius Advantage, a dedicated patient assistance program that includes reimbursement and benefits support, prior authorization assistance, and coordination with specialty pharmacies for eligible patients to help reduce out-of-pocket costs and improve access to treatment.

**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 in August 2024.

**About Cutaneous T-cell Lymphoma**

Cutaneous 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 Citius Oncology, Inc.**

Citius Oncology, Inc. (Nasdaq: CTOR) is a platform to develop and commercialize novel targeted oncology therapies. In August 2024, its primary asset, LYMPHIR, was 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. In August 2024, the FDA approved LYMPHIR, a targeted immunotherapy for an initial indication in 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<sup>®</sup>, 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. Citius Pharma owns 79% of Citius Oncology. For more information, please visit www.citiuspharma.com.

**INDICATION**

LYMPHIR 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 SYNDROME**

**Capillary 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 Syndrome**

LYMPHIR 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 <3 g/dL. These symptoms were not required to occur simultaneously to be characterized as capillary leak syndrome.

As defined, CLS occurred in 27% of patients in the pooled population across 3 clinical trials, including 8% with Grade 3. There was one (0.8%) fatal occurrence of CLS. Of the patients with CLS, 22% had recurrence. The majority of CLS events (81%) occurred within the first 2 cycles of treatment. The median time to onset from Cycle 1, Day 1 was 6.5 days (range: 1 to 77), the median duration of CLS was 14 days (range: 2 to 40), and 75% of patients had resolution. The most common symptoms included edema, hypoalbuminemia, and hypotension. Pleural effusion, pericardial effusion, and dehydration also occurred.

Regularly assess patients for weight gain, new onset or worsening of edema, dyspnea, and hypotension (including orthostatic changes). Monitor serum albumin levels prior to the initiation of each cycle of therapy and more often as clinically indicated.

Withhold, reduce dose, or permanently discontinue based on severity. If LYMPHIR is withheld, resume LYMPHIR following resolution of CLS and when serum albumin is greater than or equal to 3 g/dL.

**Visual Impairment** 

LYMPHIR can cause serious visual impairment, including changes in visual acuity and color vision. In the pooled population across 3 clinical trials, visual impairment occurred in 9%, with Grade 1 in 8% and Grade 2 in 1%. The most commonly reported symptom was blurred vision. Of the patients with visual impairment, 67% had resolution of their visual impairment.

Perform baseline ophthalmic examination and monitor as clinically indicated. If patients experience symptoms of visual impairment, such as changes in visual acuity, changes in color vision, or blurred vision, refer for ophthalmologic evaluation.

Withhold LYMPHIR until visual impairment resolves or permanently discontinue based on severity.

**Infusion-Related Reactions** 

LYMPHIR can cause serious infusion-related reactions. Infusion-related reactions were reported in 69% of patients in the pooled population across 3 clinical trials of patients who received LYMPHIR, with Grade 3 infusion-related reactions in 3.4%. Eighty-three percent of infusion-related reactions occurred in Cycles 1 and 2. The most common symptoms included nausea, fatigue, chills, musculoskeletal pain, vomiting, fever, and arthralgia.

Premedicate patients for the first three cycles prior to starting a LYMPHIR infusion. Monitor patients frequently during infusion. For Grade 2 or higher infusion reactions, premedicate at least 30 minutes prior to each subsequent infusion with a systemic steroid for at least 3 cycles.

Interrupt or discontinue LYMPHIR based on severity. Institute appropriate medical management.

**Hepatotoxicity**

LYMPHIR can cause hepatotoxicity. In the pooled safety population, elevated ALT occurred in 70% of patients, with Grade 3 ALT occurring in 22%; elevated AST occurred in 64% of patients, with Grade 3 AST elevation occurring in 9%. For Grade 3 events, median time to onset was 8 days (range: 1 to 15 days); median time to resolution was 15 days (range: 7 to 50 days); all cases of Grade 3 ALT or AST elevations resolved. Elevated total bilirubin occurred in 5% of patients, with Grade 3 occurring in 0.9%.

Monitor liver enzymes and bilirubin at baseline and during treatment as clinically indicated. Withhold, reduce dose, or permanently discontinue LYMPHIR based on severity.

**Embryo-Fetal Toxicity**

Based on its mechanism of action, LYMPHIR can cause fetal harm when administered to a pregnant woman. Verify the pregnancy status of females of reproductive potential prior to the initiation of LYMPHIR. Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment and for 7 days following the last dose of LYMPHIR.

**ADVERSE REACTIONS** 

The most common adverse reactions (≥20%), including laboratory abnormalities, are increased transaminases, albumin decreased, nausea, edema, hemoglobin decreased, fatigue, musculoskeletal pain, rash, chills, constipation, pyrexia, and capillary leak syndrome.

**USE IN SPECIFIC POPULATIONS**

**Pregnancy**

<u>Risk Summary</u>

Based on its mechanism of action, LYMPHIR can cause fetal harm when administered to a pregnant woman. There are no available data on the use of LYMPHIR in pregnant women to evaluate for a drug-associated risk. No animal reproductive and developmental toxicity studies have been conducted with denileukin diftitox.

Denileukin diftitox-cxdl causes depletion of regulatory T lymphocytes (Treg), immune activation, and capillary leak syndrome, compromising pregnancy maintenance. Advise pregnant women of the potential risk to a fetus.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies are 2-4% and 15-20%, respectively.

**Lactation**

<u>Risk Summary</u>

No data are available regarding the presence of denileukin diftitox-cxdl in human milk, the effects on the breastfed child, or on milk production. Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment with LYMPHIR and for 7 days after the last dose.

**Females and Males of Reproductive Potential** 

Based on its mechanism of action, LYMPHIR can cause fetal harm when administered to a pregnant woman.

<u>Pregnancy Testing</u> 

Verify the pregnancy status of females of reproductive potential prior to initiating LYMPHIR.

<u>Contraception</u>

 

*Females* 

Advise females of reproductive potential to use effective contraception during treatment with LYMPHIR and for 7 days after the last dose.

<u>Infertility</u>

 

*Males*

Based on findings in rats, male fertility may be compromised by treatment with LYMPHIR. The reversibility of the effect on fertility is unknown.

<u>Pediatric Use</u>

Safety and effectiveness of LYMPHIR in pediatric patients have not been established.

<u>Geriatric Use</u>

Of the 69 patients with Stage I-III r/r CTCL who received LYMPHIR, 34 patients (49%) were 65 years of age and older and 10 patients (14%) were 75 years of age and older. Clinical studies of LYMPHIR did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients.

**You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Citius Oncology at 1-844-459-6744.**

Please read Important Safety Information and full Prescribing Information, including Boxed WARNING, for LYMPHIR.

**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, 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; 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; our ability to secure strategic partnerships and expand international access to LYMPHIR; our ability to use the latest technology to support our commercialization efforts; the estimated markets for LYMPHIR and our product candidates and the acceptance thereof by any market; 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; our ability to maintain Nasdaq's continued listing standards; 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, 2024, filed with the SEC on December 27, 2024, as amended on January 27, 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@citiuspharma.com

908-967-6677 x113

**Media Contact:**

STiR-communications

Greg Salsburg

Greg@STiR-communications.com