NeOnc (NTHI) updates 24-patient NEO100 astrocytoma data

Q: What did NeOnc Technologies Holdings (NTHI) announce in this 8-K?

Updated clinical results for intranasal NEO100 from ongoing Phase 1/2a and compassionate care studies in a 24-patient IDH1‑mutant astrocytoma cohort.

Q: What exhibits were included in NTHI’s filing?

Exhibit 99.1 (press release), 99.2 (investor presentation), 99.3 (call transcript), and 104 (cover page Inline XBRL).

Q: Was the information in the 8-K filed or furnished?

It was furnished under Item 7.01 and is not deemed filed or subject to Section 18 liabilities.

Q: Did NTHI hold an event to discuss the results?

Yes. The company hosted an investor conference call to discuss the results on November 12, 2025.

Q: Which indication is NEO100 being studied for?

Recurrent WHO Grade III/IV IDH1‑mutant astrocytoma in a 24-patient cohort.

Q: What is the development stage of NEO100?

NEO100 is investigational and being evaluated in Phase 1/2a and compassionate care settings.

Accepted by SEC EDGAR 11/12/2025 - 05:06 PM EST

Filing Impact

(Moderate)

Filing Sentiment

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Form Type

8-K

Rhea-AI Filing Summary

NeOnc Technologies Holdings (NTHI) furnished a Reg FD update announcing updated clinical results from ongoing Phase 1/2a and compassionate care studies of its investigational intranasal agent NEO100 in a 24-patient cohort with recurrent WHO Grade III/IV IDH1‑mutant astrocytoma.

The company also hosted an investor call to discuss the results and provided supporting materials. The press release, investor presentation, and call transcript are furnished as Exhibits 99.1, 99.2, and 99.3. The information under Item 7.01 is furnished, not filed, and is not subject to Section 18 liabilities or incorporation by reference except as specifically stated.

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 NeOnc Technologies Holdings (NTHI) announce in this 8-K?

Updated clinical results for intranasal NEO100 from ongoing Phase 1/2a and compassionate care studies in a 24-patient IDH1‑mutant astrocytoma cohort.

What exhibits were included in NTHI’s filing?

Exhibit 99.1 (press release), 99.2 (investor presentation), 99.3 (call transcript), and 104 (cover page Inline XBRL).

Was the information in the 8-K filed or furnished?

It was furnished under Item 7.01 and is not deemed filed or subject to Section 18 liabilities.

Did NTHI hold an event to discuss the results?

Yes. The company hosted an investor conference call to discuss the results on November 12, 2025.

Which indication is NEO100 being studied for?

Recurrent WHO Grade III/IV IDH1‑mutant astrocytoma in a 24-patient cohort.

What is the development stage of NEO100?

NEO100 is investigational and being evaluated in Phase 1/2a and compassionate care settings.

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

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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):

November 12, 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 November 12, 2025, NeOnc Technologies Holdings, Inc. (the “Company”) issued a press release announcing updated clinical results from its current Phase 1/2a and compassionate care studies involving a cohort of 24 patients with recurrent WHO Grade III/IV isocitrate dehydrogenase 1 (IDH1)–mutant astrocytoma treated with its investigational intranasal agent, NEO100 (the “Results”). A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

On November 12, 2025, the Company hosted an investor conference call to discuss the Results. Furnished as Exhibit 99.2 and Exhibit 99.3 hereto are the investor presentation that the Company used in connection with its presentation at the investor conference call and a transcript of the investor conference call, respectively.

The information in this Item 7.01, Exhibit 99.1, Exhibit 99.2 and Exhibit 99.3 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 November 12, 2025
99.2		Investor Presentation
99.3		Transcript
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: November 12, 2025	NeOnc Technologies Holdings, Inc.

	By:	/s/ Amir Heshmatpour
		Name:	Amir Heshmatpour
		Title:	Chief Executive Officer, President and Executive Chairman

Source: View Original Filing on SEC EDGAR