Oragenics, Inc. Provides Shareholder Update on Strategic Progress and Announces Janet Huffman as Interim CEO

Core Viewpoint - Oragenics, Inc. has made significant strategic advancements since its $4 million capital raise in September 2024, including leadership changes and preparations for clinical trials, while focusing on innovative treatments for brain-related health conditions [1][2][5]. Leadership Transition - Janet Huffman has been appointed as the interim Chief Executive Officer, bringing extensive experience in capital raising, mergers and acquisitions, and financial planning [2][4]. - The Board of Directors expressed confidence in Ms. Huffman's leadership, highlighting her strategic capabilities and understanding of the company's operations [4]. Financial Overview - The company has strategically allocated resources since the capital raise to enhance operational efficiency [5]. Strategic Progress and Upcoming Milestones - Improvements have been made to the formulation and intranasal delivery device for ONP-002, with steps taken to secure intellectual property [6]. - The company is finalizing site agreements for Phase II clinical trials in Australia, aiming to dose the first patient by the end of Q1 2025 or early Q2 2025 [6][11]. - Completion of the spray-dry campaign is expected to ensure sufficient drug-device units for upcoming trials [6]. - Prototyping for an automated intranasal device for patients with altered states of consciousness has been completed [6]. - The company is on track for the closure of the Phase I clinical trial and submission of data for investigational new drug (IND) and investigator's brochure (IB) approval [6]. Future Outlook - The company is optimistic about 2025, focusing on advancing ONP-002 and laying the groundwork for future growth [8]. - Goals include the submission of the IB package by Q1 2025 for Australia Phase II clinical trials and formalizing strategic partnerships in Australia [11].