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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):
April 1, 2026
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 2.02. |
Results of Operations and Financial Condition. |
On April 1, 2026, NeOnc Technologies Holdings, Inc. (the “Company”) issued a press release reporting financial results for the fourth quarter and year ended December 31, 2025. A copy of the press release is attached hereto as Exhibit 99.1 and the information therein is incorporated herein by reference.
The information contained in this Item 2.02 and in the accompanying Exhibit 99.1 shall not be deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by reference in any filing under the Exchange Act or the Securities Act of 1933, as amended (the “Securities Act”), except as shall be expressly set forth by specific reference in such filing.
| Item 7.01. |
Regulation FD Disclosure. |
The information under Item 2.02, above, is incorporated herein by reference.
The information reported under Items 2.02 and 7.01 in this Current Report on Form 8-K, including Exhibit 99.1 attached hereto, shall not be deemed filed for purposes of Section 18 of 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 or the Exchange Act, regardless of any general incorporation language in such filing.
| Item 9.01. |
Financial Statements and Exhibits. |
| Exhibit No. |
|
Description |
| 99.1 |
|
Press Release, dated April 1, 2026 |
| 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: April 3, 2026 |
NeOnc Technologies Holdings, Inc. |
| |
|
|
| |
By: |
/s/ Amir Heshmatpour |
| |
|
Name: |
Amir Heshmatpour |
| |
|
Title: |
Chief Executive Officer, President and Executive Chairman |
Exhibit
99.1
NeOnc
Provides Business Update and Reports Q4 2025 Financial Results
CALABASAS,
Calif., April 01, 2026 -- NeOnc Technologies Holdings, Inc. (Nasdaq: NTHI) (“NeOnc” or the “Company”),
a multi-Phase 2 clinical-stage biopharmaceutical company developing novel therapies for central nervous system (CNS) cancers, today
announced financial results for the quarter and year ended December 31, 2025, and provided an update on recent operational
achievements and upcoming milestones.
Amir
Heshmatpour, Chief Executive Officer, Executive Chairman, and President, commented:
“Q4
2025 and early 2026 marked important inflection points for NeOnc. We completed NEO212’s Phase 1 dose escalation and established
a recommended Phase 2 dose of 610 mg, with early signs of possible anti-tumor activity in heavily pretreated patients.
In
parallel, the NEO100 Phase 2a study in recurrent IDH1-mutant high-grade glioma is fully enrolled. Updated Phase 1/2a data suggested
a 24% radiographic remission rate, 44% six-month progression-free survival, and no significant toxicity.
We
also strengthened the balance sheet through a PIPE financing anchored by Cinctive Capital’s $10 million commitment, expanded
the leadership team, and advanced our Middle East strategy through NuroMENA.
Looking
ahead, we plan to hold a Type B End-of-Phase 1 FDA meeting for NEO212. We also expect a preliminary NEO100 Phase 2a data readout
in approximately five months. We believe these near-term catalysts position NeOnc to deliver value-creating milestones for shareholders
in the months ahead.”
Fourth
Quarter and Recent Highlights
Clinical
Milestones & Data
|
● |
NEO212
— Phase 1 Complete, RP2D Set at 610 mg: |
|
○ |
Early
signs of possible clinical efficacy, including potential durable disease control in heavily pretreated recurrent GBM and
brain metastasis patients, observed even within the safety-focused phase |
|
○ |
The
company intends to request a Type B End-of-Phase 1 FDA meeting to align on a potential pivotal, registrational Phase 2 study |
|
○ |
Exploring
an Accelerated Approval pathway |
|
○ |
First
oral bio-conjugated temozolomide asset is mechanistically differentiated by its potential ability to overcome MGMT-mediated
TMZ resistance. |
|
● |
NEO100
— Phase 2a Fully Enrolled: Completed enrollment in the NEO100 Phase 2a trial for IDH-1 mutant recurrent high-grade
glioma, with an interim data readout expected in ~5 months (approximately August 2026). |
|
● |
Updated
NEO100 Clinical Results Show Possible Durable Efficacy in Recurrent IDH1-Mutant Gliomas: |
|
○ |
Expanded
25-patient cohort from Phase 1/2a and compassionate-use experience, intranasal NEO100 |
|
○ |
Suggested
a 24% radiographic remission rate (6/25)—3× the ~8% historically seen with salvage therapies |
|
○ |
44%
six-month progression-free survival (vs. 21–31% historical benchmarks) |
|
○ |
36%
of patients (9/25) alive ≥18 months post-treatment initiation |
|
○ |
No
significant toxicity even under prolonged chronic dosing |
|
○ |
Reinforces
NEO100’s potential as a first-in-class, CNS-penetrant metabolic therapy for recurrent WHO Grade III/IV IDH1-mutant astrocytoma. |
|
● |
NEO100
& Ultrasound: Announced AI-driven findings demonstrating that ultrasound may enhance the potency of NEO100 against
primary and metastatic brain tumors, pointing toward a potential combination approach.
|
Middle
East Expansion (NuroMENA)
|
● |
Executive
Chairmanship: His Highness Sheikh Nahyan bin Zayed Al Nahyan assumed the role of Executive Chairman of NuroMENA,
NeOnc’s UAE-based subsidiary, to advance a UAE-US partnership in brain cancer treatment. |
|
● |
Operational
Agreements: NuroMENA executed a Master Services Agreement with M42’s IROS and expanded its Board of Directors.
|
Strengthening
Leadership & Securing Growth Capital
|
● |
PIPE
Financing: Raised a PIPE investment anchored by a $10 million commitment from Cinctive Capital Management, strengthening
the balance sheet to advance clinical priorities. |
|
● |
Chief
Executive Officer: Named Amir Heshmatpour as CEO to lead the company’s next phase of clinical and corporate development. |
|
● |
Chief
Accounting Officer: Appointed David Choi as CAO to oversee the Company’s accounting, financial reporting,
internal controls, and corporate governance functions. |
|
● |
Scientific
Advisory Board Expansion: Added two leading neuro-oncologists — Dr. David M. Ashley, Director of Duke’s
Preston Robert Tisch Brain Tumor Center, and Dr. Alexandra M. Miller, Chief of Neuro-Oncology at NYU Langone’s Perlmutter
Cancer Center — deepening the company’s scientific bench.
|
Investor
& Media Engagement
|
● |
Broadcast
Exposure: Featured across multiple New to The Street segments on Bloomberg Television (U.S., MENA, and Latin America)
and Fox Business, increasing visibility among retail and institutional audiences. |
|
● |
Investor
Events & KOL Calls: Hosted multiple investor and key opinion leader conference calls presenting clinical data
updates and participated in the New to The Street Accredited Investor Event at Hudson Yards, New York.
|
Financial
Results for Q4 2025
|
● |
G&A
expenses: $4,818k vs. $1,680k in Q4 2024, reflecting expanded marketing, rent, travel, and Middle East partnership-related
costs. |
|
● |
R&D
expenses: $3,638k vs. $3,045k in Q4 2024, driven by active management of NEO100 trial sites, recruitment for NEO212, initiation
of NEO100-3, and overall patient recruitment activity. |
|
● |
Net
loss: $62.1 million or $3.20 per diluted share, compared to $11.9 million or $0.69 per diluted share in Q4 2024, primarily
due to increased general and administrative expenses, as well as stock-based compensation expenses.
|
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 https://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.
Please
refer to the “Risk Factors” section of our Quarterly and annual reports on Form 10-Q and 10-K as filed with the Securities
and Exchange Commission, along with other cautionary language in that report and risk factors and other cautionary language in
our subsequent filings with the Securities and Exchange Commission, 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 fact that
results of preclinical studies and early clinical trials may not be predictive of results of future clinical trials, announced
or published data from our clinical trials may change as more patient data become available and are subject to audit and verification
procedures that could result in material changes in the final data and our product candidates are in preclinical and clinical stages
of development, are not approved for commercial sale and might never receive regulatory approval or become commercially viable.
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
