FDA clears NeOnc Technologies (NTHI) to advance NEO212-01 into Phase IIa/IIb

Rhea-AI Filing Summary

NeOnc Technologies Holdings, Inc. filed a current report describing a regulatory milestone for its lead program. The company announced that the U.S. Food and Drug Administration has authorized it to proceed with Phase IIa/IIb of its NEO212-01 clinical trial, indicating clearance to advance this investigational therapy into the next stage of human testing. The update was communicated through a press release furnished as an exhibit to the report rather than filed for liability purposes under the securities laws.

Insights

Biotech and regulatory strategy analyst

FDA authorization lets NeOnc advance NEO212-01 into Phase IIa/IIb, marking a key development step for its pipeline.

The report states that the U.S. Food and Drug Administration has authorized NeOnc Technologies Holdings, Inc. to proceed with Phase IIa/IIb of its NEO212-01 clinical trial. This means the company has met the necessary regulatory conditions to move beyond earlier-phase work and begin a more advanced study of its investigational product in patients.

Progression into Phase IIa/IIb is typically associated with gathering more detailed data on safety and early signs of effectiveness, which can be important for future development decisions and potential partnerships. The update is furnished via a press release attached as Exhibit 99.1, so future disclosures about trial design, endpoints, and timing would be expected in that document or subsequent filings.

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, and exhibit attachments filed with this report.

Understanding 8-K Material Events →

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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):

September 10, 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 September 10, 2025, NeOnc Technologies Holdings, Inc. (the “Company”) issued a press release announcing that the U.S. Food and Drug Administration (FDA) has authorized the Company to proceed with Phase IIa/IIb of its NEO212-01 clinical trial. 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 September 10, 2025
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

1

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: September 11, 2025	NeOnc Technologies Holdings, Inc.
	By:	/s/ Amir Heshmatpour
		Name:	Amir Heshmatpour
		Title:	President and Executive Chairman

2

FAQ

What did NeOnc Technologies Holdings, Inc. (NTHI) announce in this 8-K?

The company announced that the U.S. Food and Drug Administration (FDA) has authorized it to proceed with Phase IIa/IIb of its NEO212-01 clinical trial, as described in a press release furnished with the report.

Which NeOnc Technologies (NTHI) program is affected by the FDA decision?

The FDA authorization applies to the company’s NEO212-01 clinical trial, allowing NeOnc Technologies to advance this investigational therapy into Phase IIa/IIb testing.

How did NeOnc Technologies (NTHI) communicate the FDA authorization to investors?

NeOnc Technologies furnished a press release as Exhibit 99.1 to the report, describing the FDA’s authorization to proceed with Phase IIa/IIb of the NEO212-01 clinical trial.

Is the NeOnc Technologies (NTHI) press release considered filed for liability purposes?

No. The company states that the information in Item 7.01 and Exhibit 99.1 is furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 or otherwise subject to that section’s liabilities.

When did the FDA authorization and NeOnc (NTHI) announcement occur?

The report notes that on September 10, 2025, NeOnc Technologies issued a press release announcing that the FDA had authorized the company to proceed with Phase IIa/IIb of its NEO212-01 clinical trial.