8-K - Neonc Technologies Holdings, Inc. | StockGist

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NeOnc Technologies Holdings, Inc. announced Phase 1 dose-escalation results for NEO212, determining Maximum Tolerated Dose at 810 mg (Cohort 5) and Recommended Phase 2 Dose at 610 mg (Cohort 4), with promising efficacy signals in recurrent GBM and brain metastases patients. The company plans a Type B FDA meeting to discuss Phase 2 design and potential accelerated approval.

Key Takeaways

1Phase 1/2 NEO212-01 trial reached MTD at Cohort 5 (810 mg, Days 1–5, 28-day cycle) after second Dose-Limiting Toxicity

2RP2D set at 610 mg (Cohort 4); Phase 2a metastasis cohort starts at 400 mg (Cohort 3)

3Promising efficacy: partial response in recurrent IDH1 wild-type MGMT-methylated GBM patient stable 21 months post-recurrence

4Stable disease in squamous NSCLC-to-brain metastasis patient on Cycle 16 after 55 months since diagnosis

5No clinically meaningful myelosuppression, hepatic, or renal toxicity observed across 14 patients

6Plans Type B FDA meeting to review RP2D, Phase 2 design, and accelerated approval pathway

Current Report Details

Event Type

Regulation Fd

Disclosure

Voluntary

Variant

8-K

Items Reported

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

Regulation Fd

9.01

. Financial Statements and Exhibits. (d) Exhibits Exhibit No. Description 99.1 Press Release, dated March 4, 2026 99.2 Investor Presentation 99.3 Transcript 104

Exhibits Only

Exhibits (4)

8-K

99.1

EXHIBIT 99.1

99.2

EXHIBIT 99.2

99.3

EXHIBIT 99.3