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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):
October 4, 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 1.01. |
Entry into a Material Definitive Agreement |
On October 4, 2025, NeOnc Technologies Holdings,
Inc. (the “Company”) entered into a Master Services Agreement (the “MSA”) with Insights Pharmaceutical
Research LLC (“IROS”), a contract research organization based in the United Arab Emirates and an affiliate of Group 42
Holding Ltd. and Mubadala Investment Company PJSC. The MSA establishes the terms and conditions under which IROS will provide clinical
research services to in support of the Company’s clinical development programs in the UAE. The MSA will be transferred to the Company’s
controlled UAE subsidiary (NuroCure) once its incorporation is complete.
Under the MSA, IROS will serve as the Company’s
contract research organization for clinical trials conducted in the UAE and will be responsible for regulatory submissions, site selection
and management, clinical monitoring, data management, and trial reporting activities, in accordance with Good Clinical Practice guidelines
and applicable UAE and FDA regulations. Each specific project or study will be governed by a separate work order under the MSA.
The first work order to be executed under the
MSA covers a multi-site, randomized Phase 2b/3 study titled A Multi-Site, Randomized, Phase 2b/3 Study Evaluating Overall Survival
of Intranasal NEO100 in Patients with Progressive or Recurrent Grade III Astrocytomas and Glioblastoma Multiforme (GBM), Stratified by
IDH1 Mutation Status, Compared to Best Standard of Care. The initial work order has an estimated budget of approximately $2.4
million in service fees and $0.1 million in pass-through costs, payable in four milestone-based installments through study
completion. The Company retains all rights to clinical data, intellectual property, and regulatory filings arising from the studies performed
under the MSA.
The MSA sets out the general terms on which all
projects will be conducted. In addition to performance commitments and payment terms, it includes customary provisions relating to confidentiality,
indemnification and liability, insurance, audit and inspection, data protection, termination rights, compliance with applicable laws and
dispute resolution. The agreement is governed by the laws of the Abu Dhabi Global Market.
The
foregoing description of the MSA does not purport to be complete and is qualified in its entirety by reference to the full text of the
MSA, which is filed as Exhibit 10.1 to this Current Report on Form 8-K and is incorporated herein by reference.
| Item 7.01. |
Regulation FD Disclosure. |
On October 9, 2025, the Company issued a press
release announcing two major strategic developments that solidify its expansion into the Middle East. 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. |
| Exhibit No. |
|
Description |
| 10.1 |
|
Master Services Agreement, dated October 4, 2025 |
| 99.1 |
|
Press Release, dated October 9, 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: October 9, 2025 |
NeOnc Technologies Holdings, Inc. |
| |
|
|
| |
By: |
/s/ Amir Heshmatpour |
| |
|
Name: |
Amir Heshmatpour |
| |
|
Title: |
President and Executive Chairman |
