NeOnc Technologies (NTHI) details new intranasal NEO100 data in recurrent astrocytoma

Rhea-AI Filing Summary

NeOnc Technologies Holdings, Inc. reported that it has released updated clinical results for its investigational therapy NEO100. The update covers an ongoing Phase 1/2a study and compassionate-use experience using intranasal NEO100 in patients with recurrent WHO Grade III/IV IDH1-mutant astrocytoma, a form of aggressive brain cancer. These details are provided in a press release dated December 15, 2025, which is included as an exhibit to the report.

The company furnished this information under a Regulation FD disclosure so that all investors receive the clinical update at the same time. The press release itself contains the specific clinical data and outcomes related to NEO100 in this patient group.

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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):

December 15, 2025

NEONC TECHNOLOGIES HOLDINGS, INC.

(Exact Name of Registrant as Specified in Its Charter)

Delaware

(State or Other Jurisdiction of Incorporation)

001-42567		92-1954864
(Commission File Number)		(IRS Employer Identification No.)

23975 Park Sorrento, Suite 205 Calabasas, CA		91302
(Address of Principal Executive Offices)		(Zip Code)

(818) 570-6844

(Registrant’s Telephone Number, Including Area Code)

N/A

(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 of the registrant under any of the following provisions (see General Instruction A.2. below):

☐ 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 Symbols		Name of each exchange on which registered
Common Stock, par value $0.0001		NTHI		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 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).

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 15, 2025, NeOnc Technologies Holdings, Inc. (the “Company”) issued a press release announcing updated clinical results from its ongoing Phase 1/2a and compassionate-use experience evaluating intranasal NEO100 in patients with recurrent WHO Grade III/IV IDH1-mutant astrocytoma. 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 7.01 and Exhibit 99.1 furnished hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (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, as amended, 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 December 15, 2025
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

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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 17, 2025	NeOnc Technologies Holdings, Inc.
	By:	/s/ Amir Heshmatpour
		Name:	Amir Heshmatpour
		Title:	Chief Executive Officer, President and Executive Chairman

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FAQ

What did NeOnc Technologies Holdings (NTHI) disclose in this report?

NeOnc Technologies Holdings disclosed that it issued a press release with updated clinical results from its ongoing Phase 1/2a study and compassionate-use experience of intranasal NEO100 in patients with recurrent WHO Grade III/IV IDH1-mutant astrocytoma.

What is NEO100 and in which patients is it being studied by NeOnc Technologies (NTHI)?

NEO100 is an investigational therapy administered intranasally. It is being evaluated in patients with recurrent WHO Grade III/IV IDH1-mutant astrocytoma, according to the company’s update.

What is the stage of the NEO100 clinical program mentioned by NeOnc Technologies (NTHI)?

The company’s update relates to an ongoing Phase 1/2a clinical study along with a compassionate-use experience for intranasal NEO100 in the specified astrocytoma patient population.

How did NeOnc Technologies (NTHI) provide the updated NEO100 clinical results to investors?

The company provided the updated clinical results through a press release dated December 15, 2025, which is furnished as Exhibit 99.1 to the report under a Regulation FD disclosure item.

Are the NEO100 clinical results considered filed financial information for NeOnc Technologies (NTHI)?

No. The company states that the information in Item 7.01 and Exhibit 99.1 is furnished and not deemed "filed" for purposes of Section 18 of the Exchange Act or incorporated by reference into other securities law filings, unless specifically referenced.

Who signed this NeOnc Technologies (NTHI) report related to the NEO100 update?

The report was signed on behalf of NeOnc Technologies Holdings, Inc. by Amir Heshmatpour, who is the company’s Chief Executive Officer, President and Executive Chairman.