Form 8-K

8-K — CITIUS ONCOLOGY, INC.

Accession: 0001213900-26-049347

Filed: 2026-04-29

Period: 2026-04-29

CIK: 0001851484

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Other Events

Item: Financial Statements and Exhibits

Documents

8-K — ea0288202-8k_citius.htm (Primary)

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2026-04-29

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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) April 29, 2026

Citius Oncology, Inc.

(Exact

name of registrant as specified in its charter)

Delaware

(State

or other jurisdiction of incorporation)

001-41534

99-4362660

(Commission

File Number)

(IRS

Employer

Identification No.)

11 Commerce Drive, 1st Floor, Cranford, NJ

07016

(Address

of principal executive offices)

(Zip

Code)

Registrant’s

telephone number, including area code (908) 967-6677

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:

Title

of each class

Trading

Symbol(s)

Name

of each exchange on which registered

Common Stock

CTOR

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 ☒

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

8.01 Other Events.

April 29, 2026, Citius Oncology, Inc. issued a press release announcing the initial shipment of LYMPHIR™ (denileukin diftitox-cxdl)

to Europe through one of its regional distribution partners. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated

herein by reference.

Item

9.01. Financial Statements and Exhibits.

(d)

Exhibits

Exhibit

No.

Description

99.1

Press release, dated April 29, 2026.

104

Cover

Page Interactive Data File, formatted in Inline Extensible Business Reporting Language (iXBRL).

SIGNATURES

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

ONCOLOGY, INC.

Date:

April 29, 2026

/s/

Leonard Mazur

Leonard

Mazur

Chairman

and Chief Executive Officer

EX-99.1 — PRESS RELEASE, DATED APRIL 29, 2026

EX-99.1

Filename: ea028820201ex99-1.htm · Sequence: 2

Exhibit 99.1

Citius Oncology Ships First International Order

of LYMPHIR™ to Europe

Order fulfilment expands international patient

access to LYMPHIR following initial U.S. launch

Distribution by regional partners through Named

Patient Programs in specific international markets

CRANFORD, N.J., April 29, 2026 –

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)

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

Risk Summary

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

Risk Summary

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.

Pregnancy Testing

Verify the pregnancy status of females of reproductive

potential prior to initiating LYMPHIR.

Contraception

Females

Advise females of reproductive potential to use

effective contraception during treatment with LYMPHIR and for 7 days after the last dose.

Infertility

Males

Based on findings in rats, male fertility may

be compromised by treatment with LYMPHIR. The reversibility of the effect on fertility is unknown.

Pediatric Use

Safety and effectiveness of LYMPHIR in pediatric

patients have not been established.

Geriatric Use

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.

Investor Contact:

Ilanit Allen

ir@citiuspharma.com

908-967-6677 x113

Media Contact:

STiR-communications

Greg Salsburg

Greg@STiR-communications.com

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-Section 425

+ Details

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