Anixa Biosciences details final Phase 1 breast cancer vaccine data

Anixa Biosciences, Inc. reported that it and The Cleveland Clinic Foundation presented final data from a Phase 1 clinical trial of Anixa’s investigational breast cancer vaccine.

Rhea-AI Filing Summary

Anixa Biosciences, Inc. reported that it and The Cleveland Clinic Foundation presented final data from a Phase 1 clinical trial of Anixa’s investigational breast cancer vaccine. The data were shared in a presentation by Justin Johnson, Ph.D., a program manager at Cleveland Clinic and co-inventor of the vaccine technology, and were followed by a company press release. The 8-K primarily alerts investors to the completion and public disclosure of this early-stage clinical trial dataset, with additional details contained in the attached press release and presentation exhibits.

Insights

Biotech and clinical development analyst

Anixa highlights final Phase 1 data disclosure for its breast cancer vaccine.

Anixa Biosciences announced that final data from its Phase 1 clinical trial of an investigational breast cancer vaccine have been presented jointly with The Cleveland Clinic Foundation. Phase 1 studies typically focus on safety and immune response rather than proving full effectiveness, so this marks an early step in the clinical path rather than a definitive efficacy result. The filing emphasizes that details are contained in a press release and a presentation abstract.

The disclosure underlines the importance of the collaboration with Cleveland Clinic and the involvement of co-inventor Justin Johnson, Ph.D., in presenting the results. The company also reiterates standard forward-looking statement cautions, referencing risks described in its annual and quarterly reports, which signals that future progress will depend on subsequent trial phases and regulatory steps beyond this initial study.

8-K Event Classification

2 items: 7.01, 9.01

2 items

Item 7.01 Regulation FD Disclosure Disclosure

Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, or exhibit attachments filed with this report.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Anixa Biosciences (ANIX) announce in this 8-K?

Anixa Biosciences announced that it and The Cleveland Clinic Foundation presented final data from a Phase 1 clinical trial of Anixa’s investigational breast cancer vaccine, and it furnished a related press release and presentation abstract as exhibits.

What stage is Anixa Biosciences' breast cancer vaccine in?

The breast cancer vaccine is in the Phase 1 clinical trial stage, and this filing notes that final data from that Phase 1 study have been presented.

Who presented the Phase 1 breast cancer vaccine data for Anixa (ANIX)?

The data were presented by Justin Johnson, Ph.D., Program Manager at The Cleveland Clinic Foundation and co-inventor of the breast cancer vaccine technology.

What exhibits are included with this Anixa Biosciences 8-K?

The 8-K includes a press release as Exhibit 99.1, a presentation abstract as Exhibit 99.2, and the Cover Page Interactive Data File as Exhibit 104.

Does this Anixa (ANIX) filing provide detailed clinical results?

The filing itself mainly announces that final Phase 1 data were presented; detailed information is contained in the attached press release and the presentation abstract exhibits.

What cautionary language does Anixa Biosciences include with this announcement?

Anixa states that non-historical statements are forward-looking, highlights risks and uncertainties related to its clinical trials, and refers to the risk factors in its most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Accepted by SEC EDGAR 12/11/2025 - 06:34 PM Learn about SEC filing dates

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or Section 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): December 11, 2025

ANIXA BIOSCIENCES, INC.

(Exact name of registrant as specified in its charter)

Delaware		001-37492		11-2622630
(State or other jurisdiction of incorporation)		(Commission File Number)		(IRS Employer Identification No.)

3150 Almaden Expressway, Suite 250 San Jose, CA		95118
(Address of principal executive offices)		(Zip Code)

Registrant’s telephone number, including area code: (408) 708-9808

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation to 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, par value $0.01 per share		ANIX		The NASDAQ Stock Market LLC

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 11, 2025, Anixa Biosciences, Inc. (“we,” “us,” “our,” or the “Company”) issued a press release announcing that the Company and The Cleveland Clinic Foundation (“Cleveland Clinic”) presented final data from the Phase 1 clinical trial of its investigational breast cancer vaccine. The press release, which is furnished as Exhibit 99.1 hereto, was issued following a presentation made by Justin Johnson, Ph.D., Program Manager at Cleveland Clinic and co-inventor of the breast cancer vaccine technology. Furnished hereto as Exhibit 99.2 is the presentation abstract utilized by Dr. Johnson for the presentation.

Statements that are not historical fact may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not statements of historical facts, but rather reflect our current expectations concerning future events and results. We generally use the words “believes,” “expects,” “intends,” “plans,” “anticipates,” “likely,” “will” and similar expressions to identify forward-looking statements. Such forward-looking statements, including those concerning our clinical trials, involve risks, uncertainties and other factors, some of which are beyond our control, which may cause our actual results, performance or achievements, or industry results, to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements. These risks, uncertainties and factors include, but are not limited to, those factors set forth in “Item 1A - Risk Factors” and other sections of our most recent Annual Report on Form 10-K as well as in our Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. You are cautioned not to unduly rely on such forward-looking statements when evaluating the information presented in this Current Report.

Item 9.01. Financial Statements and Exhibits

(d) Exhibits

The following exhibits are filed with this Current Report on Form 8-K:

Exhibit No.		Description
99.1		Press Release
99.2		Presentation
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.

Dated: December 11, 2025

	ANIXA BIOSCIENCES, INC.
	By:	/s/ Michael J. Catelani
	Name:	Michael J. Catelani
	Title:	President, Chief Operating Officer and Chief Financial Officer