---
title: "Oragenics advances ONP-002 Phase IIa in Australia, $6.1M cash and LOI for CNS device"
type: "News"
locale: "en"
url: "https://longbridge.com/en/news/286915159.md"
description: "Oragenics has initiated Phase IIa dosing of ONP-002 in Australia, with a cash balance of $6.1M and a Letter of Intent for a CNS device. The trial involves 40 patients and focuses on safety and feasibility, with no serious adverse events reported. The company plans to request an FDA Type C meeting in Q2 2026 and aims for a full IND submission by the end of 2026. R&D expenses have increased by 89% to $0.6M, and an annual meeting is scheduled for June 29, 2026."
datetime: "2026-05-19T12:43:01.000Z"
locales:
  - [zh-CN](https://longbridge.com/zh-CN/news/286915159.md)
  - [en](https://longbridge.com/en/news/286915159.md)
  - [zh-HK](https://longbridge.com/zh-HK/news/286915159.md)
---

# Oragenics advances ONP-002 Phase IIa in Australia, $6.1M cash and LOI for CNS device

**Oragenics reported active Phase IIa dosing of ONP-002 in Australia, a $6.1M cash balance and an LOI for a complementary CNS device.**

**Key Highlights:**

-   Phase IIa in Australia active: Mackay site activated and first patient dosed; Alfred screening; Adelaide pending final approval.
-   Trial design: 40-patient randomized, placebo-controlled study focusing on safety, tolerability and feasibility with 30-day follow-up.
-   No serious adverse events reported to date across active sites, CRO operations managed by Southern Star Research.
-   Regulatory path: targeting FDA Type C meeting request in Q2 2026 and full IND submission by end of 2026 to enable U.S. trials.
-   Financials and corporate: $6.1M cash at March 31, 2026; R&D up 89% to $0.6M; ATM facility active and annual meeting set for June 29, 2026.

Original SEC Filing: ORAGENICS INC \[ OGEN \] - 8-K - May. 19, 2026

**Disclaimer**

This is an AI-powered summary. It may contain inaccuracies. Consider verifying important information with the source. Please note this summary is solely based on documents filed with the SEC.

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