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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 7, 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 7, 2025, NeOnc Technologies Holdings, Inc. (the “Company”) issued a press release announcing that it will host an investor conference call and webcast on Wednesday, November 12, 2025, at 9:00 a.m. Eastern Time to present data updates from ongoing Phase 1/2a NEO100-1 clinical trial and compassionate use program. 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 November 7, 2025 | |
| 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 10, 2025 | NeOnc Technologies Holdings, Inc. | ||
| By: | /s/ Amir Heshmatpour | ||
| Name: | Amir Heshmatpour | ||
| Title: | Chief Executive Officer, President and Executive Chairman |
||
Exhibit 99.1
NeOnc
Technologies (Nasdaq: NTHI) to Host Investor Conference Call to Present Data Updates from
Ongoing NEO100-1 Phase 1/2a Clinical Trial
and Compassionate Use Program
CALABASAS, Calif., Nov. 07, 2025 -- NeOnc Technologies Holdings, Inc. (NTHI) (“NeOnc” or the “Company”), a clinical-stage biopharmaceutical company developing novel brain-penetrant therapeutics for patients with malignant brain tumors and central nervous system (CNS) disorders, today announced that it will host an investor conference call and webcast on Wednesday, November 12, 2025, at 6:00 a.m. Pacific Time / 9:00 a.m. Eastern Time (prior to market open).
During the call, members of the NTHI management team and independent members of the company’s Scientific Advisory Board (SAB) will present data updates from the Company’s ongoing Phase 1/2a NEO100-1 clinical trial and compassionate use program, evaluating intranasal delivery of NEO100 (high-purity perillyl alcohol) in patients with recurrent high grade malignant glioma.
The discussion will highlight MRI-based radiographic response data, progression-free survival (PFS), and overall survival (OS) trends observed to date, providing important insights into long-term clinical outcomes for patients treated with NEO100.
Featured Participants:
Dr. Henry S. Friedman, MD – Deputy Director, Preston Robert Tisch Brain Tumor Center, Duke University; Independent Member, NTHI Scientific Advisory Board
Dr. Alexandra Miller, MD – Chief Neuro-oncology, Brain Tumor Program, NYU Langone Health; Independent Member, NTHI Scientific Advisory Board
NTHI Management Team:
Amir Heshmatpour – Chief Executive Officer, Executive Chairman and President
Dr. Thomas C. Chen, MD, PhD – Chief Medical Officer and Chief Scientific Officer
Dr. Josh Neman, PhD – Chief Clinical Officer
Keith Garnett – Chief Financial Officer
Conference Call Details:
Date: Wednesday, November 12, 2025
Time: 6:00 a.m. PT / 9:00 a.m. ET
Webcast: A live webcast can be accessed at https://www.webcaster5.com/Webcast/Page/3151/53234 or by visiting https://investors.neonc.com
ABOUT NEONC TECHNOLOGIES HOLDINGS, INC.
NeOnc Technologies Holdings, Inc. is a clinical-stage life sciences company focused on the development and commercialization of central nervous system therapeutics that are designed to address the persistent challenges in overcoming the blood-brain barrier. The company’s NEO™ drug development platform has produced a portfolio of novel drug candidates and delivery methods with patent protections extending to 2038. These proprietary chemotherapy agents have demonstrated positive effects in laboratory tests on various types of cancers and in clinical trials treating malignant gliomas. NeOnc’s NEO100™ and NEO212™ therapeutics are in Phase II human clinical trials and are advancing under FDA Fast-Track and Investigational New Drug (IND) status. The company has exclusively licensed an extensive worldwide patent portfolio from the University of Southern California consisting of issued patents and pending applications related to NEO100, NEO212, and other products from the NeOnc patent family for multiple uses, including oncological and neurological conditions.
For more about NeOnc and its pioneering technology, visit neonc.com.
Important Cautions Regarding Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements can be identified by terminology such as “may,” “will,” “should,” “intend,” “expect,” “plan,” “budget,” “forecast,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue,” “evaluating,” or similar words. Statements that contain these words should be read carefully, as they discuss our future expectations, projections of future results of operations or financial condition, or other forward-looking information.
Examples of forward-looking statements include, among others, statements regarding whether a definitive agreement will be reached with Quazar. These statements reflect our current expectations based on information available at this time, but future events may differ materially from those anticipated.
The “Risk Factors” section of our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, along with other cautionary language in that report or in our subsequent filings, outlines important risks and uncertainties. These may cause our actual results to differ materially from the forward-looking statements herein, including but not limited to the failure to finalize the agreement with Quazar, modifications to its terms, or alternative uses of proceeds.
We assume no obligation to revise or update any forward-looking statements, whether as a result of new information, future developments, or otherwise, except as required by applicable securities laws and regulations.
“NEO100” and NEO “212” are registered trademarks of NeOnc Technologies Holdings, Inc.
Company Contact:
info@neonc.com
Investor Contact:
James Carbonara
Hayden IR
(646)-755-7412
James@haydenir.com