Form 8-K

8-K — NEONC TECHNOLOGIES HOLDINGS, INC.

Accession: 0001829126-26-003165

Filed: 2026-04-03

Period: 2026-04-01

CIK: 0001979414

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Results of Operations and Financial Condition

Item: Regulation FD Disclosure

Item: Financial Statements and Exhibits

Documents

8-K — neonctechnologies_8k.htm (Primary)

EX-99.1 — EXHIBIT 99.1 (neonctechnologies_ex99-1.htm)

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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.

(d)

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

EX-99.1 — EXHIBIT 99.1

EX-99.1

Filename: neonctechnologies_ex99-1.htm · Sequence: 2

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.

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.

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

○

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.

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

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