Form 8-K

8-K — Citius Pharmaceuticals, Inc.

Accession: 0001213900-26-112478

Filed: 2026-10-26

Period: 2026-10-26

CIK: 0001506251

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Results of Operations and Financial Condition

Item: Financial Statements and Exhibits

Documents

8-K — ea0309345-8k_citius.htm (Primary)

EX-99.1 — PRESS RELEASE, DATED OCTOBER 26, 2026 (ea030934501ex99-1.htm)

GRAPHIC (ea030934501_ex99-1img1.jpg)

XML — IDEA: XBRL DOCUMENT (R1.htm)

8-K — CURRENT REPORT

8-K (Primary)

Filename: ea0309345-8k_citius.htm · Sequence: 1

false

0001506251

2026-10-26

iso4217:USD

xbrli:shares

iso4217:USD

xbrli:shares

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 Pharmaceuticals, Inc.

(Exact name of registrant as specified in its charter)

Nevada

(State or other jurisdiction of incorporation)

001-38174

27-3425913

(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, $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 2.02. Results of Operations

and Financial Condition.

On October 26, 2026, our wholly-owned

subsidiary, 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, 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.

Date: October 26, 2026

CITIUS PHARMACEUTICALS, INC.

By:

/s/ Leonard Mazur

Leonard Mazur

Chairman and Chief Executive Officer

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

EX-99.1

Filename: ea030934501ex99-1.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

GRAPHIC

Filename: ea030934501_ex99-1img1.jpg · Sequence: 3

Binary file (14689 bytes)

Download ea030934501_ex99-1img1.jpg

XML — IDEA: XBRL DOCUMENT

XML

Filename: R1.htm · Sequence: 8

v3.26.3

Cover

Oct. 26, 2026

Cover [Abstract]

Document Type

8-K

Amendment Flag

false

Document Period End Date

Oct. 26, 2026

Entity File Number

001-38174

Entity Registrant Name

Citius Pharmaceuticals, Inc.

Entity Central Index Key

0001506251

Entity Tax Identification Number

27-3425913

Entity Incorporation, State or Country Code

Entity Address, Address Line One

11 Commerce Drive

Entity Address, Address Line Two

1st Floor

Entity Address, City or Town

Cranford

Entity Address, State or Province

Entity Address, Postal Zip Code

07016

City Area Code

908

Local Phone Number

967-6677

Written Communications

false

Soliciting Material

false

Pre-commencement Tender Offer

false

Pre-commencement Issuer Tender Offer

false

Title of 12(b) Security

Common stock, $0.001 par value

Trading Symbol

CTXR

Security Exchange Name

NASDAQ

Entity Emerging Growth Company

false

- Definition

Boolean flag that is true when the XBRL content amends previously-filed or accepted submission.

+ References

No definition available.

+ Details

Name:

dei_AmendmentFlag

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration

- Definition

Area code of city

+ References

No definition available.

+ Details

Name:

dei_CityAreaCode

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

Period Type:

duration

- Definition

Cover page.

+ References

No definition available.

+ Details

Name:

dei_CoverAbstract

Namespace Prefix:

dei_

Data Type:

xbrli:stringItemType

Balance Type:

Period Type:

duration

- Definition

For the EDGAR submission types of Form 8-K: the date of the report, the date of the earliest event reported; for the EDGAR submission types of Form N-1A: the filing date; for all other submission types: the end of the reporting or transition period. The format of the date is YYYY-MM-DD.

+ References

No definition available.

+ Details

Name:

dei_DocumentPeriodEndDate

Namespace Prefix:

dei_

Data Type:

xbrli:dateItemType

Balance Type:

Period Type:

duration

- Definition

The type of document being provided (such as 10-K, 10-Q, 485BPOS, etc). The document type is limited to the same value as the supporting SEC submission type, or the word 'Other'.

+ References

No definition available.

+ Details

Name:

dei_DocumentType

Namespace Prefix:

dei_

Data Type:

dei:submissionTypeItemType

Balance Type:

Period Type:

duration

- Definition

Address Line 1 such as Attn, Building Name, Street Name

+ References

No definition available.

+ Details

Name:

dei_EntityAddressAddressLine1

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

Period Type:

duration

- Definition

Address Line 2 such as Street or Suite number

+ References

No definition available.

+ Details

Name:

dei_EntityAddressAddressLine2

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

Period Type:

duration

- Definition

Name of the City or Town

+ References

No definition available.

+ Details

Name:

dei_EntityAddressCityOrTown

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

Period Type:

duration

- Definition

Code for the postal or zip code

+ References

No definition available.

+ Details

Name:

dei_EntityAddressPostalZipCode

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

Period Type:

duration

- Definition

Name of the state or province.

+ References

No definition available.

+ Details

Name:

dei_EntityAddressStateOrProvince

Namespace Prefix:

dei_

Data Type:

dei:stateOrProvinceItemType

Balance Type:

Period Type:

duration

- Definition

A unique 10-digit SEC-issued value to identify entities that have filed disclosures with the SEC. It is commonly abbreviated as CIK.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b-2

+ Details

Name:

dei_EntityCentralIndexKey

Namespace Prefix:

dei_

Data Type:

dei:centralIndexKeyItemType

Balance Type:

Period Type:

duration

- Definition

Indicate if registrant meets the emerging growth company criteria.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b-2

+ Details

Name:

dei_EntityEmergingGrowthCompany

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration

- Definition

Commission file number. The field allows up to 17 characters. The prefix may contain 1-3 digits, the sequence number may contain 1-8 digits, the optional suffix may contain 1-4 characters, and the fields are separated with a hyphen.

+ References

No definition available.

+ Details

Name:

dei_EntityFileNumber

Namespace Prefix:

dei_

Data Type:

dei:fileNumberItemType

Balance Type:

Period Type:

duration

- Definition

Two-character EDGAR code representing the state or country of incorporation.

+ References

No definition available.

+ Details

Name:

dei_EntityIncorporationStateCountryCode

Namespace Prefix:

dei_

Data Type:

dei:edgarStateCountryItemType

Balance Type:

Period Type:

duration

- Definition

The exact name of the entity filing the report as specified in its charter, which is required by forms filed with the SEC.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b-2

+ Details

Name:

dei_EntityRegistrantName

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

Period Type:

duration

- Definition

The Tax Identification Number (TIN), also known as an Employer Identification Number (EIN), is a unique 9-digit value assigned by the IRS.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b-2

+ Details

Name:

dei_EntityTaxIdentificationNumber

Namespace Prefix:

dei_

Data Type:

dei:employerIdItemType

Balance Type:

Period Type:

duration

- Definition

Local phone number for entity.

+ References

No definition available.

+ Details

Name:

dei_LocalPhoneNumber

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

Period Type:

duration

- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 13e

-Subsection 4c

+ Details

Name:

dei_PreCommencementIssuerTenderOffer

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration

- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 14d

-Subsection 2b

+ Details

Name:

dei_PreCommencementTenderOffer

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration

- Definition

Title of a 12(b) registered security.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b

+ Details

Name:

dei_Security12bTitle

Namespace Prefix:

dei_

Data Type:

dei:securityTitleItemType

Balance Type:

Period Type:

duration

- Definition

Name of the Exchange on which a security is registered.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection d1-1

+ Details

Name:

dei_SecurityExchangeName

Namespace Prefix:

dei_

Data Type:

dei:edgarExchangeCodeItemType

Balance Type:

Period Type:

duration

- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 14a

-Subsection 12

+ Details

Name:

dei_SolicitingMaterial

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration

- Definition

Trading symbol of an instrument as listed on an exchange.

+ References

No definition available.

+ Details

Name:

dei_TradingSymbol

Namespace Prefix:

dei_

Data Type:

dei:tradingSymbolItemType

Balance Type:

Period Type:

duration

- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Securities Act

-Number 230

-Section 425

+ Details

Name:

dei_WrittenCommunications

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration