Phase 2Data readout

ONP-002

Traumatic brain injury

OGENOragenics, Inc.

Expected catalystDecember 31, 2026Company guidance: Dec 31, 2026

Catalyst overview

Event details

Drug or asset: ONP-002
Development stage: Phase 2
Event type: Data readout
Indication: Traumatic brain injury

Research summary

What is being tracked?

This catalyst tracks a Phase 2 data readout for ONP-002 in Traumatic brain injury. The expected timing is based on the latest available company guidance and may change.

Development notes

10/8/24- Completed key FDA-recognized study. 1/21/25- Dose first patient in Australia by the end of Q1 2025, or early Q2. 4/9/25- Submitted a clinical trial protocol for regulatory review. 5/12/25- Host management update webinar on May 20, 2025. 5/13/25- Received approval to initiate Ph2 trial, to begin enrollment in Q2 2025. 03/12/26:- First Ph2a Australia site initiated; two sites in final RGO review; enrollment and dosing expected soon. 03/17/26:- HREC approval obtained; first Phase 2a Australian site initiated. Enrollment, dosing and IND filing planned in 2026. 04/13/26:- First patient dosed in Ph2a. IND submission targeted Q4 2026. 04/20/26:- Two patients dosed in Ph2a; Alfred Hospital onboarding planned April 2026. 05/05/26:- Two sites enrolling; four dosed. Phase 2a data readout expected before year-end 2026. IND planned Dec 31, 2026. 07/07/26:- All 3 Ph2a sites active/enrolling; no SAEs. Type B meeting requested; Ph2a data readout still Q4 2026.

Verification

Primary source

Confirm timing and program details against the company announcement or filing.

Open source

What is being tracked?

This catalyst tracks a Phase 2 data readout for ONP-002 in Traumatic brain injury. The expected timing is based on the latest available company guidance and may change.