Form 8-K

8-K — CITIUS ONCOLOGY, INC.

Accession: 0001213900-26-112477

Filed: 2026-10-26

Period: 2026-10-26

CIK: 0001851484

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Results of Operations and Financial Condition

Item: Financial Statements and Exhibits

Documents

8-K — ea0309347-8k_citius.htm (Primary)

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8-K — CURRENT REPORT

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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) October 26, 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

2.02. Results of Operations and Financial Condition.

October 26, 2026, Citius Oncology, Inc. issued a press release announcing preliminary, unaudited LYMPHIR® (denileukin

diftitox-cxdl) unit sales to U.S. wholesalers and institutional vial orders for the fiscal fourth quarter ended September 30, 2026. A

copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

The

information in this Item 2.02 (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

9.01 Financial Statements and Exhibits.

(d)

Exhibits

Exhibit

No.

Description

99.1

Press Release, dated October 26, 2026.

104

Cover

Page Interactive Data File (embedded within the Inline XBRL document).

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: October 26, 2026

/s/ Leonard

Mazur

Leonard Mazur

Chairman and Chief Executive Officer

EX-99.1 — PRESS RELEASE, DATED OCTOBER 26, 2026

EX-99.1

Filename: ea030934701ex99-1.htm · Sequence: 2

Exhibit 99.1

Citius

Oncology Reports Continued Institutional Demand and 120% Growth in

Shipments of LYMPHIR® Units to U.S. Wholesalers During the Fiscal

Fourth Quarter of 2026

CRANFORD,

N.J., October 26, 2026 - Citius Oncology, Inc. (“Citius Oncology” or the “Company”) (Nasdaq: CTOR), an oncology-focused

biopharmaceutical company and majority-owned subsidiary of Citius Pharmaceuticals, Inc. (“Citius Pharma”) (Nasdaq: CTXR),

today announced preliminary, unaudited LYMPHIR® (denileukin diftitox-cxdl) unit sales to U.S. wholesalers and institutional

vial orders for the fiscal fourth quarter ended September 30, 2026.

“The

fiscal fourth quarter showed continued institutional demand for LYMPHIR. Unit sales to wholesalers more than doubled as our expanded

commercial team reached nationwide coverage in August,” said Leonard Mazur, Chairman and Chief Executive Officer of Citius Oncology.

“We are now more than halfway to our goal of having LYMPHIR on formulary at 100 priority institutions by calendar year-end. As

we enter fiscal 2027, we expect the momentum we built in the fourth quarter to carry forward, with growing institutional demand, deeper

penetration into academic and community treatment centers, and continued sales growth as LYMPHIR becomes further established in CTCL.”

Preliminary

Fiscal Fourth Quarter 2026 Highlights (unaudited)

● 792

units purchased by U.S. wholesalers for the three months ended September 30, 2026, compared

to 360 units for the three months ended June 30, 2026, an increase of 120%;

● 950

LYMPHIR vials ordered by prescribing centers from wholesalers during the fiscal fourth quarter,

compared to 926 for the fiscal third quarter; and

● As

of the date of this release, 54 institutions have now ordered LYMPHIR, compared to 44 as

of August 14, 2026, as last reported.

The

unit information in this release is preliminary and unaudited, is based on management’s current estimates, and is subject to completion

of the Company’s year-end closing procedures and the audit of its fiscal 2026 financial statements. Actual results may differ,

and the Company’s independent registered public accounting firm has not audited, reviewed or performed any procedures on these

preliminary figures. The Company recognizes revenue when wholesaler orders are fulfilled. Accordingly, the Company's revenue is based

on LYMPHIR units sold to wholesalers, net of estimated gross-to-net adjustments, rather than on institutional vial orders from wholesalers

by institutions. Citius Oncology expects to report complete fiscal fourth quarter and fiscal year 2026 results in December 2026 with

the filing of its Annual Report on Form 10-K.

About

LYMPHIR® (denileukin diftitox-cxdl)

LYMPHIR

is a targeted immunotherapy 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 DT fragments that have entered cells

to inhibit protein synthesis, resulting in cell death. Denileukin diftitox-cxdl has demonstrated the ability to deplete immunosuppressive

regulatory T lymphocytes (Tregs) and antitumor activity through a direct cytocidal action on IL-2R-expressing tumors. LYMPHIR 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 after 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.

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 is the majority owner 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 contains “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 include: the possibility that the preliminary,

unaudited unit information in this press release may differ from our final results upon completion of year-end closing procedures and

the audit of our financial statements; quarterly shipments may fluctuate based on wholesaler purchasing patterns and inventory levels;

we may not achieve our goal of having LYMPHIR on formulary at 100 priority institutions by calendar year-end; 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; the estimated markets for LYMPHIR and our product candidates and the acceptance thereof by any market; physician

and patient acceptance of LYMPHIR in a competitive treatment landscape; our ability to obtain, perform under, and maintain third-party

agreements and relationships, including obtaining a new bulk drug substance supplier; 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; our ability to secure and maintain strategic partnerships and expand international

access to LYMPHIR; risks relating to the results of research and development activities; 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. 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 Quarterly Report on Form 10-Q for the quarter ended June 30, 2026, filed with the SEC on August 14, 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, except as required by law.

Contacts

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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