Form 8-K

8-K — NEONC TECHNOLOGIES HOLDINGS, INC.

Accession: 0001829126-26-011446

Filed: 2026-10-22

Period: 2026-10-16

CIK: 0001979414

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

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)

EX-99.2 — EXHIBIT 99.2 (neonctechnologies_ex99-2.htm)

EX-99.3 — EXHIBIT 99.3 (neonctechnologies_ex99-3.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):

October 16, 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 7.01.

Regulation FD Disclosure.

On October 16, 2026, NeOnc Technologies Holdings,

Inc. (the “Company”) issued a press release announcing early clinical improvement in its first patient treated in Abu Dhabi,

United Arab Emirates, with investigational intranasal NEO100 through the Company’s Compassionate Care program. A copy of the press release

is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

On October 21, 2026, the Company issued a press

release announcing that it has signed a Memorandum of Understanding (MoU) with the Department of Health – Abu Dhabi (DoH) to cooperate

on the development of research and clinical capability in oncology and central nervous system therapeutics in the Emirate of Abu Dhabi.

A copy of the press release is furnished as Exhibit 99.2 to this Current Report on Form 8-K.

On October 22, 2026, the Company issued a press

release announcing that it will be featured on Health Uncensored with Dr. Drew, a national health television series hosted by Dr. Drew

Pinsky, in a segment on non-invasive approaches to delivering investigational therapies to brain tumors. A copy of the press release is

furnished as Exhibit 99.3 to this Current Report on Form 8-K.

The information in this Item 7.01,

Exhibit 99.1, Exhibit 99.2, and Exhibit 99.3 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 October 16, 2026

99.2

Press

Release, dated October 21, 2026

99.3

Press

Release, dated October 22, 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: October 22, 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 Reports Early Clinical Improvement in First Child Treated with NEO100 Under Compassionate Use in Abu Dhabi

Treating physicians report that a critically ill three-year-old boy is breathing independently and showing renewed movement following initiation of investigational treatment

CALABASAS, Calif., Oct. 16, 2026 – NeOnc Technologies Holdings, Inc. (Nasdaq: NTHI) (“NeOnc” or the “Company”), a clinical-stage biopharmaceutical company developing therapies for central nervous system (CNS) cancers, today announced early clinical improvement in its first patient treated in Abu Dhabi, United Arab Emirates, with investigational intranasal NEO100 through the Company’s Compassionate Care program. According to his treating physicians, the patient, a critically ill three-year-old boy with an aggressive brain tumor, is now breathing independently without ventilator support and beginning to move his legs following initiation of treatment. These early observations involve one patient receiving compassionate-use treatment and do not establish that NEO100 caused the improvement or predict outcomes in other patients.

“Hearing that this little boy is breathing on his own and beginning to move his legs is profoundly moving. For his family, every sign of progress matters,” said Amir F. Heshmatpour, Executive Chairman, President and Chief Executive Officer of NeOnc. “We remain cautious about these early observations and deeply grateful to his physicians and our partner, the Department of Health – Abu Dhabi, for making access to treatment possible.”

The treatment reflects coordination between NeOnc, the child’s treating physicians and the Department of Health – Abu Dhabi to provide access to investigational NEO100. The patient did not meet the eligibility criteria for the Company’s NEO100-03 pediatric clinical trial and is receiving treatment outside that trial through NeOnc’s Compassionate Care program. The program provides access to NEO100 for patients with serious or life-threatening conditions who have no comparable or satisfactory treatment alternatives.

“The improvements reported by this child’s treating physicians are encouraging, and continued clinical observation is essential to understand his progress,” said Thomas Chen, MD, PhD, Founder, Chief Medical Officer and Chief Scientific Officer of NeOnc. “This individual experience does not establish safety or efficacy. Our pediatric clinical program is designed to evaluate NEO100 systematically in children with serious brain tumors.”

NEO100 is a highly purified form of perillyl alcohol administered intranasally. Its delivery approach is designed to provide a non-invasive route to the brain. NEO100 remains investigational, and its safety and efficacy in pediatric patients have not been established.

The treatment builds on NeOnc’s expanding development activities in Abu Dhabi. In June 2026, the Company announced that the Department of Health – Abu Dhabi had granted IND authorization for NEO100 across its NEO100-01, NEO100-02 and NEO100-03 protocols, encompassing adult Phase 1 through Phase 2 studies and a pediatric Phase 1 and Phase 1b pathway pending further protocol review. In March 2025, NeOnc announced that the U.S. Food and Drug Administration had granted Rare Pediatric Disease Designation to NEO100 for pediatric-type diffuse high-grade gliomas. These authorizations and designations do not constitute approval for commercial use.

About NeOnc Technologies Holdings, Inc.

NeOnc Technologies Holdings, Inc. is a clinical-stage biopharmaceutical company developing therapies for central nervous system cancers. Its investigational programs include intranasal NEO100 and oral NEO212. NEO212 has completed Phase 1 dose escalation and is advancing toward Phase 2 development. NeOnc exclusively licenses a worldwide portfolio of issued patents and pending applications from the University of Southern California related to NEO100, NEO212 and other drug candidates and delivery approaches.

For more information, visit https://neonc.com.

Forward-Looking Statements

This press release contains forward-looking statements, including statements regarding the continued treatment of pediatric patients in Abu Dhabi through the Company’s Compassionate Care program, the Company’s clinical development activities in the United Arab Emirates, and the clinical potential of NEO100. These statements reflect current expectations and involve risks and uncertainties. Patients may not be treated or respond as expected, and treatment remains subject to applicable clinical, regulatory and institutional requirements; experience with individual patients treated through compassionate use may not be predictive of results in clinical trials; future studies may not demonstrate safety or efficacy; and no regulatory pathway or marketing approval is assured. Actual results may differ materially. Readers should consider the risk factors described in the Company’s most recent filings with the Securities and Exchange Commission. These statements speak only as of the date of this release.

The Company undertakes no obligation to update forward-looking statements except as required by law.

“NEO100” and “NEO212” are registered trademarks of NeOnc Technologies Holdings, Inc.

Contacts

Company Contact:

info@neonc.com

Investor Contact:

Jon Nugent

Jon Nugent Communications

jon@jonnugent.com

205-566-3026

EX-99.2 — EXHIBIT 99.2

EX-99.2

Filename: neonctechnologies_ex99-2.htm · Sequence: 3

Exhibit 99.2

NeOnc Technologies and

the Department of Health – Abu Dhabi Sign MoU to Advance Brain Cancer Research and

Proposed Clinical Collaboration

Proposed collaboration covers scientific exchange, specialist training and real-world evidence, alongside assessment of clinical trial opportunities and a potential regional presence for NeOnc in Abu Dhabi

Two children in Abu Dhabi are receiving investigational NEO100 through NeOnc’s Compassionate Care program, with a third expected this week

CALABASAS, Calif. and ABU DHABI, United Arab Emirates, Oct. 21, 2026 – NeOnc Technologies Holdings, Inc. (Nasdaq: NTHI) (“NeOnc” or the “Company”), a clinical-stage biopharmaceutical company developing therapies for central nervous system (CNS) cancers, today announced that it has signed a Memorandum of Understanding (MoU) with the Department of Health – Abu Dhabi (DoH) to cooperate on the development of research and clinical capability in oncology and central nervous system therapeutics in the Emirate of Abu Dhabi. The MoU was signed on the sidelines of the Abu Dhabi Future Health Summit (ADFHS) 2026.

Amir F. Heshmatpour, Executive Chairman, President and Chief Executive Officer of NeOnc Technologies Holdings, Inc., said: “For families facing brain cancer, access to investigational treatments and clinical research opportunities matters deeply. This proposed collaboration creates a framework to bring NeOnc’s development expertise together with Abu Dhabi’s clinical capabilities, with the goal of advancing research and expanding opportunities for patients closer to home. We are grateful to the Department of Health – Abu Dhabi for its commitment to addressing the needs of patients with complex and rare CNS cancers, including children.”

H.E. Dr. Noura Khamis Al Ghaithi, Undersecretary of the Department of Health – Abu Dhabi (DoH), said: “For patients and families facing complex CNS cancers, every advance in research offers hope for more effective care and better quality of life. Our proposed collaboration with NeOnc connects international expertise with Abu Dhabi’s clinical capabilities to strengthen the evidence and skills needed to evaluate new approaches responsibly. By developing specialist knowledge and a deeper understanding of these critical conditions, we aim to support care that responds more closely to each patient’s needs, reflecting our commitment to bringing scientific advances closer to our community and beyond.”

The MoU builds on NeOnc’s existing activity in the Emirate, where DoH is the government entity responsible for regulating the health sector. In June 2026, DoH granted Investigational New Drug (IND) status for NEO100, covering the Company’s NEO100-01, NEO100-02 and NEO100-03 protocols across Phase 1, Phase 1b and Phase 2 studies in adults with progressive or recurrent Grade III or IV gliomas, together with pediatric studies authorized for Phase 1 and Phase 1b pending further protocol review. That authorization followed DoH’s IND clearance for NEO212, also announced in June 2026. The DoH clearances apply to the conduct of clinical research and do not constitute marketing authorization, and NeOnc must satisfy additional conditions, including separate DoH Institutional Review Board approval, before patient enrollment in the UAE. Two children in Abu Dhabi are currently receiving investigational NEO100 through NeOnc’s Compassionate Care program. A third child is expected to be onboarded from India this week. Building on that experience and on the Company’s existing DoH clearances, NeOnc is working to open a Phase 1 study of NEO100 in the Emirate.

Under the MoU, the parties will exchange scientific and clinical knowledge and expertise in CNS oncology and in the development and translation of therapeutics for rare, pediatric and high-unmet-need conditions; exchange expertise on clinical development methodologies, including trial design, endpoint selection and response assessment criteria, in support of strengthening clinical development capability in the Emirate; and cooperate on the generation and exchange of real-world evidence and clinical insights relating to CNS tumors in Abu Dhabi, including epidemiological and outcomes data, in accordance with applicable data protection legislation and subject to the required approvals.

The parties will also collaborate on training, capacity-building and professional development initiatives for investigators, clinical research coordinators and allied healthcare professionals, including in clinical trial conduct, neuro-oncology imaging assessment methodologies and molecular diagnostics relevant to CNS tumors, and on the development of Abu Dhabi’s life sciences ecosystem.

The MoU further provides for cooperation on the advancement of clinical research in CNS oncology, including studies of NeOnc’s investigational programs, subject to a separate agreement between the parties and to all applicable regulatory requirements and approvals. Subject to a separate agreement and to all applicable laws, regulations and approvals, the parties will also explore the potential establishment of a regional presence and manufacturing, supply or distribution activities by NeOnc in the Emirate, and the positioning of Abu Dhabi as a potential regional platform for NeOnc’s future development activities. These potential activities remain subject to further assessment, applicable approvals and any necessary definitive agreements.

The MoU is not a binding contract on either party. It takes effect upon signature by representatives of both parties and remains in effect for two years, unless either party gives at least three months’ notice of its wish to terminate. The MoU does not restrict either party from entering into similar arrangements with other institutions.

About the Department of Health – Abu Dhabi (DoH)

The Department of Health – Abu Dhabi is the regulator of the healthcare sector in the Emirate of Abu Dhabi. Committed to ensuring excellence in healthcare, DoH monitors the health status of the population while shaping the regulatory framework for the health system. This includes inspecting against regulations, enforcing standards and encouraging the adoption of world-class best practices and performance targets by all healthcare providers in the Emirate. Abu Dhabi remains dedicated to shaping the future of healthcare by establishing an intelligent and sustainable ecosystem that prioritizes health, longevity and quality of life for all community members. Leveraging state-of-the-art infrastructure and cutting-edge capabilities, DoH continues to develop and implement initiatives and programs in line with its strategic focus areas, Healthy Population, Best-in-Class Care and Resilience and Innovation. These efforts reflect DoH’s unwavering commitment to predicting, preventing and personalizing healthcare for every individual.

For further information on DoH, visit https://www.doh.gov.ae/ and follow on X, Instagram, Facebook, LinkedIn and YouTube.

About NeOnc Technologies Holdings, Inc.

Forward-Looking Statements

This press release contains forward-looking statements, including statements regarding the Company’s proposed collaboration with the Department of Health – Abu Dhabi, the Company’s clinical development activities in the United Arab Emirates, and the potential establishment of a regional presence in the Emirate. These statements reflect current expectations and involve risks and uncertainties. The Memorandum of Understanding is not binding and may not result in any definitive agreement; activities contemplated by the parties remain subject to separate agreement and to applicable regulatory, institutional and other approvals; future studies may not demonstrate safety or efficacy; and no regulatory pathway or marketing approval is assured. Actual results may differ materially. Readers should consider the risk factors described in the Company’s most recent filings with the Securities and Exchange Commission. These statements speak only as of the date of this release.

The Company undertakes no obligation to update forward-looking statements except as required by law.

“NEO100” and “NEO212” are registered trademarks of NeOnc Technologies Holdings, Inc.

Contacts

DoH Media Contact:

Mariam Al Marzooqi

msalmarzooqi@doh.gov.ae

+971 50 536 6660

NeOnc Company Contact:

info@neonc.com

NeOnc Investor Contact:

Jon Nugent

Jon Nugent Communications

jon@jonnugent.com

205-566-3026

EX-99.3 — EXHIBIT 99.3

EX-99.3

Filename: neonctechnologies_ex99-3.htm · Sequence: 4

Exhibit 99.3

NeOnc Technologies to Be Featured on Health Uncensored with Dr. Drew to Discuss Reaching Brain Tumors

Without Surgery or Systemic Chemotherapy

Segment to air Sunday, October 25, at 5:30 p.m. ET on Fox Business Network

CALABASAS, Calif., October 22, 2026 -- NeOnc Technologies Holdings, Inc. (Nasdaq: NTHI) (“NeOnc” or the “Company”), a clinical-stage biopharmaceutical company developing therapies for central nervous system (CNS) cancers, today announced that it will be featured on Health Uncensored with Dr. Drew, a national health television series hosted by Dr. Drew Pinsky, in a segment on non-invasive approaches to delivering investigational therapies to brain tumors.

Fox Business Network will carry the segment on Sunday, October 25, 2026, at 5:30 p.m. ET / 2:30 p.m. PT. Air dates and times are subject to change.

Amir F. Heshmatpour, Executive Chairman, President and Chief Executive Officer, and Thomas Chen, MD, PhD, Founder, Chief Medical Officer and Chief Scientific Officer of NeOnc, join Dr. Drew to discuss how NeOnc’s intranasal approach is designed to reach brain tumors directly, without the limitations of surgery and systemic chemotherapy.

During the segment, Mr. Heshmatpour describes brain cancer as a growing problem and discusses the Company’s investigational intranasal NEO100 program, which is in clinical development in both adults and children. Speaking about what the program could mean for patients, he says: “We believe that we will make a significant impact in the standard of care for adults and kids suffering with brain cancer.”

Additionally, in the segment, Dr. Chen explains how the same mechanism meant to protect the brain actually makes brain tumors so difficult to treat with traditional approaches, and how NeOnc is working to overcome that challenge.

About Health Uncensored with Dr. Drew

Health Uncensored with Dr. Drew is a health and wellness program hosted by Dr. Drew Pinsky, a board-certified physician in Internal and Addiction Medicine, as well as a television host, author and public speaker. Dr. Drew engages with a range of experts, thought leaders, celebrities and everyday people to provide viewers with practical advice, evidence-based information and discussions about wellness, mental health and the importance of proactive health management.

About NeOnc Technologies Holdings, Inc.

For more information, visit https://neonc.com.

Forward-Looking Statements

This press release contains forward-looking statements, including statements regarding the Company’s clinical development programs and the clinical potential of NEO100. These statements reflect current expectations and involve risks and uncertainties. NEO100 is investigational and has not been approved by any regulatory authority; future studies may not demonstrate safety or efficacy; clinical development remains subject to applicable clinical, regulatory and institutional requirements; and no regulatory pathway or marketing approval is assured. Actual results may differ materially. Readers should consider the risk factors described in the Company’s most recent filings with the Securities and Exchange Commission. These statements speak only as of the date of this release.

The Company undertakes no obligation to update forward-looking statements except as required by law.

“NEO100” and “NEO212” are registered trademarks of NeOnc Technologies Holdings, Inc.

Contacts

Company Contact:

info@neonc.com

Investor Contact:

Jon Nugent

Jon Nugent Communications

jon@jonnugent.com

205-566-3026

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-Number 240

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Name of the Exchange on which a security is registered.

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Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection d1-1

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Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act.

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Reference 1: http://www.xbrl.org/2003/role/presentationRef

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Trading symbol of an instrument as listed on an exchange.

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Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.

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Reference 1: http://www.xbrl.org/2003/role/presentationRef

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-Name Securities Act

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