FDA Alignment on CMC a Welcome Signpost on the Road to Late-Stage Development

研报英文原文证据摘录

FDA Alignment on CMC a Welcome Signpost on the Road to Late-Stage Development

Investment Thesis

NeOnc is focused on improving the treatment of brain tumors. The company is taking a multipronged approach by improving CNS

delivery of agents that are known to be active against CNS tumors such as temozolomide (TMZ) and also by developing novel agents

active against hard-to-treat CNS tumors (including metastases). Key catalysts for the stock are incremental data sets supporting

activity of the two lead drugs in difficult-to-treat CNS tumor patients expected in later 2026 and 2027. The key ingredient in NeOnc's

efforts is the natural product Perillyl Alcohol (POH) that is itself active as an anti-cancer agent via multiple validated pathways

(including the induction of ER-stress) and also helps other agents cross the blood brain barrier (BBB) to reach the CNS.BIOTECHNOLOGY Upcoming Catalysts Price Performance

August 2026 - P2 trial for NEO100 interim update. $13

$12

2H26 - P2/3 trial of NEO212 starts in recurrent GBM and possibly metastatic brain $11

$10EQUITY tumors.

$9

$8

$7

$6

Base Case Assumptions: $15 Price Target $5

$4

P2 trial for NEO100 updates in 2H26 to show continued signs of treatment effects in $3RESEARCH IDH1-mutated astrocytoma. Aug-25 Sep-25 Oct-25 Nov-25 Dec-25 Jan-26 Feb-26 Mar-26 Apr-26 May-26 Jun-26 Jul-26

NEO-100 for recurrent gliomas - 40% PoS, 2030 market entry, 60% peak penetration NTHI

in malignant gliomas in temozolomide resistant brain tumors with an IDH1 mutation, Source:S&PFactSet500 (rebased)

$15k per year

NEO-212 for glioblastoma - 50% PoS, 2030 market entry, 60% peak penetration in Company Description

malignant glioblastomas in temozolomide resistant brain tumors, $15k per year

NeOnc is a clinical-stage biopharma