# EDGAR Filing Document

**Accession Number:** 0001979414
**File Stem:** 0001829126-25-007323
**Filing Date:** 2025-9
**Character Count:** 10190
**Document Hash:** d9a3fa22c60817f54ae7a0ec8e158ab2
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001829126-25-007323.hdr.sgml**: 20250911

**ACCESSION NUMBER**: 0001829126-25-007323

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 13

**CONFORMED PERIOD OF REPORT**: 20250910

**ITEM INFORMATION**: Regulation FD Disclosure

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20250911

**DATE AS OF CHANGE**: 20250911

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** NEONC TECHNOLOGIES HOLDINGS, INC.
- **CENTRAL INDEX KEY:** 0001979414
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 921954864
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-42567
- **FILM NUMBER:** 251309187

**BUSINESS ADDRESS:**
- **STREET 1:** 23975 PARK SORRENTO
- **STREET 2:** SUITE 205
- **CITY:** CALABASAS
- **STATE:** CA
- **ZIP:** 91302
- **BUSINESS PHONE:** 310 663 7831

**MAIL ADDRESS:**
- **STREET 1:** 23975 PARK SORRENTO
- **STREET 2:** SUITE 205
- **CITY:** CALABASAS
- **STATE:** CA
- **ZIP:** 91302

?xml version='1.0' encoding='ASCII'?

**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

**<u>NEONC TECHNOLOGIES HOLDINGS, INC.</u>**

(Exact Name of Registrant as Specified in Its Charter)

**Delaware**

(State or Other Jurisdiction of Incorporation)

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| | |
|:---|:---|
| **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) |

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**(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:

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| | | |
|:---|:---|:---|
| **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. ☐

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| | |
|:---|:---|
| **Item 7.01.** | **Regulation FD Disclosure.** |

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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.*

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| | |
|:---|:---|
| **Item 9.01.** | **Financial Statements and Exhibits.** |

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(d) Exhibits

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| | |
|:---|:---|
| **Exhibit No.** | **Description** |
| 99.1 | [Press Release, dated September 10, 2025](neonctechnologies_ex99-1.htm) |
| 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.

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

---

## Exhibit 99.1

**Exhibit 99.1**

**NeOnc Technologies Receives FDA Authorization to Proceed with Phase II Clinical Trial of NEO212 – A<br> First-in-Class Oral Chemical Conjugated Chemotherapy Candidate for Brain Cancer**

CALABASAS, Calif., Sept. 10, 2025 -- NeOnc Technologies Holdings, Inc. (NASDAQ: NTHI) ("NeOnc" or the "Company"), a multi-Phase 2 clinical-stage biopharmaceutical company pioneering therapies for central nervous system (CNS) cancers, today announced 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.

The FDA's decision follows the successful completion of the Phase I dose-escalation study, which demonstrated that NEO212 could be safely administered at doses up to 810 mg daily on Days 1–5 of a 28-day cycle. Independent review of the recommended Phase II dose is ongoing, with patient enrollment expected to begin before the end of 2025.

**A Next-Generation Standard of Care Candidate**

NEO212 is NeOnc's first oral chemical conjugated chemotherapy drug, uniquely combining Temozolomide (TMZ) – the current standard of care for glioblastoma and other brain cancers (marketed as Temodar®) – with NEO100 (a proprietary form of perillyl alcohol (POH), which is owned and patented by NeOnc). This proprietary conjugation is designed to overcome the limitations of TMZ, including resistance and limited efficacy, by enhancing blood-brain barrier penetration and antitumor activity.

NeOnc believes NEO212 has the potential to replace TMZ as the future standard of care for all brain cancers, representing a transformative leap forward in therapeutic options for patients facing glioblastoma, astrocytoma, and other aggressive CNS malignancies.

**Phase II Clinical Development Strategy**

The NEO212-01 Phase II trial will expand patient enrollment across leading U.S. cancer centers, building on four currently approved and active trial sites:

● NextGen Oncology – Kumar Sankhala, MD

● Northwest Medical Specialties (NWMS) – Jorge Chaves, MD

● Oncology Physician's Network – Vu Phan, MD

● University of Southern California (USC) – Frances Chow, MD

In anticipation of expanded Phase II enrollment, NeOnc is preparing activation at a broad network of premier cancer institutions, including:

Baylor Scott & White ● Beverly Hills Cancer Center ● Cancer Specialists of North Florida ● Cleveland Clinic ● Duke University ● Inova (Virginia) ● New York University Langone ● Providence St. John's ● RecioMed (Florida) ● Sutter Health ● Tampa General Hospital ● Vanderbilt University Medical Center ● University of Texas Southwestern ● University of California, San Francisco

**Leadership Commentary**

"Receiving FDA authorization to advance NEO212 into Phase II is a defining milestone for NeOnc Technologies," said Amir Heshmatpour, Executive Chairman and President of NeOnc Technologies Holdings, Inc. "This program represents years of innovation combining our proprietary molecule NEO100 with the current standard Temozolomide into a powerful conjugated therapy that we believe can redefine treatment outcomes for brain cancer patients. Our Phase II strategy will expand across the country's leading cancer centers and position NEO212 as the first real replacement for Temozolomide in decades."

Dr. Thomas Chen, Chief Executive Officer and Founder of NeOnc Technologies, added:

"From the beginning, our mission has been to give brain cancer patients and their families real hope where few options exist. NEO212 embodies that vision – it is science and compassion fused together. Moving into Phase II is not just a regulatory step forward; it is a step toward changing the future of brain cancer care worldwide."

**About NeOnc Technologies Holdings, Inc.**

NeOnc Technologies Holdings, Inc. (NASDAQ: NTHI) is a multi-Phase II clinical-stage biopharmaceutical company pioneering novel therapies for central nervous system cancers and other hard-to-treat malignancies. The Company's portfolio includes NEO100 and NEO212, with proprietary intellectual property and clinical programs designed to deliver transformative outcomes for patients worldwide.

**Forward-Looking Statements**

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the potential of NEO212 to become the new standard of care for brain cancer, anticipated patient enrollment timelines, and future clinical trial sites. These statements involve risks and uncertainties that could cause actual results to differ materially, including but not limited to clinical development risks, regulatory review processes, patient enrollment variability, and financial resource availability. NeOnc undertakes no obligation to update any forward-looking statements contained herein.

Company Contact:

info@neonc.com

Investor Contact:

James Carbonara

Hayden IR

(646)-755-7412

James@haydenir.com