NeOnc Technologies Announces FDA End of Phase 1 Meeting for NEO212

A Phase 2 dose has been selected, but the individual patient outcomes still need confirmation in larger studies.

Rhea-AI Summary

NeOnc Technologies (NTHI) will meet the FDA on November 17, 2026, to discuss development of investigational cancer drug NEO212. NeOnc plans to seek feedback on the proposed patient population, Phase 2 trial design, endpoints, dose and evidence for a future marketing application. FDA authorized the Phase 2a and Phase 2b portions of NEO212-01 in September 2025; scheduling this meeting does not establish FDA agreement on a trial design or accelerated approval pathway.

Phase 1 dose escalation stopped after a dose-limiting toxicity at 810 mg, given once daily on Days 1 through 5 of a 28-day cycle. The recommended Phase 2 dose is 610 mg. One patient with recurrent glioblastoma had a partial response, including an approximately 60% reduction in tumor size, followed by disease control lasting 21 treatment months. A second patient with lung cancer metastatic to the brain had stable disease for approximately 16 months. These individual outcomes do not establish efficacy.

Positive

• FDA authorized Phase 2a and Phase 2b portions of NEO212-01 in September 2025.

Market Context

The Jun 16 NEO212 UAE IND clearance followed Phase 1 completion and selection of a 610 mg dose, prov...

Analysis

The Jun 16 NEO212 UAE IND clearance followed Phase 1 completion and selection of a 610 mg dose, providing a same-program progression comparator for this FDA meeting; NTHI's recorded -4.5% 24-hour move does not establish causation.

Key Figures

FDA meeting date: November 17, 2026 FDA Phase 2 authorization: September 2025 Dose associated with dose-limiting toxicity: 810 mg +4 more

FDA meeting date

November 17, 2026

End-of-Phase 1 Type B meeting for NEO212

FDA Phase 2 authorization

September 2025

Authorization to proceed with NEO212-01 Phase 2a and Phase 2b portions

Dose associated with dose-limiting toxicity

810 mg

Once daily on Days 1 through 5 of a 28-day cycle

Recommended Phase 2 dose

610 mg

Selected for NEO212

Tumor-size reduction

Approximately 60%

Partial response in one patient with recurrent GBM

Disease control duration

21 treatment months

Following the partial response in one patient with recurrent GBM

Stable disease duration

Approximately 16 months

In one patient with lung cancer metastatic to the brain

Previous Clinical trial Reports

1 past event · Latest: Jun 16

Same Type 1 event

1. Jun 16

   IND authorization

   24h Move

   +14.9%

   NEO212 received UAE IND clearance after Phase 1 dose escalation and selection of its recommended Phase 2 dose.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

end-of-phase 1 type b meeting, dose-limiting toxicity, partial response, immune checkpoint inhibitors, +2 more

6 terms

end-of-phase 1 type b meeting regulatory

"an in-person End-of-Phase 1 Type B meeting concerning NEO212"

A U.S. Food and Drug Administration (FDA) "end-of-Phase 1" Type B meeting is a formal, scheduled discussion between a drug developer and regulators held after initial human safety testing (Phase 1). It focuses on the Phase 1 results, safety issues, and the design and data expectations for the next stage of development (Phase 2), serving like a checkpoint where the regulator and sponsor agree on what evidence is needed to move forward. This matters to investors because the meeting’s outcome can clarify timelines, required studies, and regulatory risk for a drug program.

dose-limiting toxicity medical

"dose escalation was discontinued following a dose-limiting toxicity"

Dose-limiting toxicity is a serious, treatment-related side effect observed in clinical trials that prevents researchers from safely increasing a drug’s dose. It matters to investors because these toxic effects set the maximum tolerated dose, influence whether a drug can reach levels that are effective, and therefore affect development timelines, costs, and the chance of regulatory approval — like a safety speed limit on how far a drug program can go.

partial response medical

"resulted in a partial response, including an approximately 60% reduction"

A partial response is a clinical outcome where a treatment produces a clear, measurable improvement in a disease — for example a substantial shrinkage of a tumor or reduction in symptom measures — but does not eliminate the disease entirely. For investors it signals meaningful efficacy that can support regulatory progress, further trials, or commercial potential, like seeing a product gain market traction even though it hasn’t achieved a complete cure.

immune checkpoint inhibitors medical

"including immune checkpoint inhibitors"

Drugs that release the immune system’s natural “brakes,” allowing immune cells to recognize and attack cancer cells; imagine taking the safety off a guard dog so it can chase intruders. They matter to investors because they can become high-value treatments with large sales potential, but their commercial success depends on clinical trial results, regulatory approval, competition and side-effect management, which all affect a company’s valuation.

accelerated approval pathway regulatory

"whether a proposed trial design could support a potential accelerated approval pathway"

The accelerated approval pathway is a process that allows new medicines to be approved more quickly based on early evidence that they may be effective, rather than waiting for full proof. This can help patients access promising treatments faster, but it also means ongoing studies are needed to confirm the benefits. For investors, it highlights potential faster market entry and earlier revenue opportunities, along with some uncertainty about long-term outcomes.

investigational new drug application regulatory

"developed under an FDA investigational new drug application"

An investigational new drug application is a formal request made to regulatory authorities to begin testing a new medication in humans. It is a critical step in the drug development process, as approval indicates the drug has passed initial safety checks and can be studied further. For investors, this signals that a potential new treatment is progressing through its early testing stages, which can impact the company's future growth prospects.

AI-generated analysis. How Rhea-AI works. Not financial advice.

See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google

Add on Google Not now

November 17 meeting will address Phase 2 study design and potential regulatory pathways

CALABASAS, Calif., Sept. 28, 2026 (GLOBE NEWSWIRE) -- 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 is scheduled to meet with the U.S. Food and Drug Administration (FDA) on November 17, 2026, for an in-person End-of-Phase 1 Type B meeting concerning NEO212. The meeting is scheduled to take place at FDA’s White Oak campus in Silver Spring, Maryland.

The Company plans to seek FDA feedback on its NEO212 clinical development program, including an update to its proposed patient population, trial design, endpoints, dose selection and evidence needed to support a future marketing application. The meeting provides an opportunity for discussion; its scheduling does not establish FDA agreement on a trial design, an accelerated approval pathway or eventual approval of NEO212.

In September 2025, FDA authorized the Company to proceed with the Phase 2a and Phase 2b portions of NEO212-01.

This meeting follows completion of the Phase 1 dose-escalation portion of the NEO212-01 Phase 1/2 clinical trial. NeOnc previously reported that dose escalation was discontinued following a dose-limiting toxicity at 810 mg, administered once daily on Days 1 through 5 of a 28-day cycle, and that 610 mg was selected as the recommended Phase 2 dose.

NeOnc also reported encouraging clinical activity observed during the Phase 1 portion of the trial. In one patient with recurrent IDH1 wild-type, MGMT-methylated glioblastoma (GBM), treatment with NEO212 resulted in a partial response, including an approximately 60% reduction in tumor size, followed by prolonged disease control lasting 21 treatment months. This duration of disease control is notable in the setting of recurrent GBM, where outcomes following recurrence have historically been limited.

In a second patient with lung cancer metastatic to the brain who had previously received and progressed following multiple lines of therapy, including immune checkpoint inhibitors, treatment with NEO212 was associated with stable disease lasting approximately 16 months. Patients with brain metastases from lung cancer who have progressed following multiple prior systemic therapies represent a population with substantial unmet medical need and historically limited treatment options.

While these individual patient outcomes do not establish efficacy and require confirmation in larger studies, the durability of responses observed during Phase 1, together with the established recommended Phase 2 dose, provides the clinical rationale for further evaluation of NEO212 in the Phase 2 portions of the NEO212-01 trial. Building on these findings, NeOnc intends to discuss its potential registrational development strategy and to seek FDA feedback on whether a proposed trial design could support a potential accelerated approval pathway.

“We have completed dose escalation and selected a recommended Phase 2 dose for NEO212,” said Amir Heshmatpour, Executive Chairman, President and Chief Executive Officer of NeOnc. “This meeting will help us understand FDA’s feedback on the population, study design and endpoints for the next stage of development. We may update our plans after evaluating the agency’s feedback.”

About High-Grade Glioma

High-grade gliomas, including glioblastoma, are serious brain cancers with substantial unmet medical need. Treatment may include surgery, radiation and drug therapy, but recurrence is common.

About NEO212

NEO212 is an investigational oral conjugate of temozolomide and NEO100. It is being studied for CNS cancers, including recurrent glioblastoma. Preclinical studies support further evaluation of its potential activity and delivery characteristics; clinical efficacy and safety have not been established. NEO212 is being developed under an FDA investigational new drug application.

About NeOnc Technologies Holdings, Inc.

NeOnc Technologies Holdings, Inc. is a clinical-stage biopharmaceutical company developing therapies for CNS cancers. Its investigational programs include intranasal NEO100 and oral NEO212. Neither product is approved by FDA for commercial use. The Company has licensed intellectual property from the University of Southern California relating to its development programs.

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

Forward-Looking Statements

This press release contains forward-looking statements, including statements regarding the anticipated date and format of the FDA meeting, the topics to be discussed, future clinical trial design, a potential registrational development strategy, possible accelerated approval, and the clinical potential of NEO212. These statements reflect current expectations and involve risks and uncertainties. FDA feedback may differ from the Company’s proposals; the meeting may be rescheduled or its format changed; additional clinical, nonclinical or manufacturing work may be required; 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

This press release was published by a CLEAR® Verified individual.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What will NeOnc Technologies discuss with the FDA about NEO212?

At its November 17, 2026, meeting, NeOnc plans to seek FDA feedback on the proposed patient population, Phase 2 trial design, endpoints, dose selection and evidence needed for a future marketing application. The company also intends to discuss whether a proposed trial design could support a potential accelerated approval pathway.

What did NeOnc Technologies report from the NEO212 Phase 1 trial?

NeOnc reported a partial response in one patient with recurrent glioblastoma, including an approximately 60% reduction in tumor size and disease control lasting 21 treatment months. A second patient with lung cancer metastatic to the brain had stable disease for approximately 16 months. These individual outcomes do not establish efficacy.

What is NeOnc Technologies' NEO212 drug being discussed with the FDA?

NEO212 is an investigational oral conjugate of temozolomide and NEO100 being studied for central nervous system cancers, including recurrent glioblastoma. It is not approved by the FDA for commercial use.