Oragenics Provides Update On Strategic Progress Since $4M Capital Raise In September 2024, Including Phase II Prep And Device Enhancements; Appoints Janet Huffman As Interim CEO

Oragenics, Inc. (NYSE:OGEN), a biotechnology company advancing innovative treatments for brain-related health conditions, today provided an update on its strategic progress since its last capital raise in September 2024. The Company also announced the appointment of Janet Huffman as its new interim Chief Executive Officer.

Strategic Progress Since Capital Raise

Following the Company's $4 million capital raise in September 2024, the Company has made significant advancements, including:

• Formulation and Device Enhancements: The Company has improved the formulation and intranasal delivery device for ONP-002 and in connection therewith has taken significant steps with the goal of securing its intellectual property for such formulations and devices.
• Advancing Phase II Preparations: The Company has vetted clinical research organizations (CROs) and hospital partners in Australia and is in the process of finalizing site agreements for its Phase II clinical trials in Australia. The goal remains to dose the first patient in Australia by the end of Q1 2025, or early Q2.
• Supply Chain Preparedness: Completion of the spray-dry campaign is expected to ensure sufficient drug-device units for the upcoming trials, with all units validated and prepared for shipment.
• Prototyping for Enhanced Accessibility: Prototyping for an automated intranasal device, designed for patients with altered states of consciousness, has been completed.
• Regulatory Milestones: Closure of the Phase I clinical trial and submission of data for investigational new drug (IND) and investigator's brochure (IB) approval remain on track.
  
   

Leadership Transition

The Company is also pleased to announce the appointment of Janet Huffman as interim Chief Executive Officer. Since joining Oragenics, Ms. Huffman has played a pivotal role in driving the Company's strategy, leveraging her extensive experience in capital raising, mergers and acquisitions, and financial planning.

Before her tenure at Oragenics, she served as Chief Financial Officer for TRxADE HEALTH, Inc., a company focused on health services IT for retail pharmacies. In 2019, Ms. Huffman was a founding member of Banyan Pediatric Care Centers, where she served as CFO and played a critical role in its merger with Assisted 4 Living, Inc., later renamed Arboreta Healthcare Inc. She also held financial leadership roles at Signature HomeNow, Infinity Homecare, and Family Home Health Services.