Oragenics gears up for Phase II trials, appoints new CEO

SARASOTA, Fla. - Oragenics, Inc. (NYSE American: OGEN), a biotechnology firm focusing on brain health and infectious diseases, with a current market capitalization of $3.44 million, today announced strategic advancements following its September 2024 capital raise and the appointment of Janet Huffman as the interim CEO. According to InvestingPro data, the company maintains a healthy cash position with more cash than debt on its balance sheet and a current ratio of 1.93. The company has made significant progress in the development of its ONP-002 treatment, including improvements to its formulation and intranasal delivery device, with an aim to protect its intellectual property.

The preparations for Phase II clinical trials are advancing, with clinical research organizations and hospital partners in Australia nearing final site agreements. The first patient dosing in Australia is targeted for the end of Q1 2025 or early Q2. Oragenics has completed a spray-dry campaign to ensure sufficient supply of drug-device units for the trials, with units validated and ready for shipment.

Additionally, the company has completed prototyping for an automated intranasal device intended for patients with altered states of consciousness. Regulatory milestones, including the closure of Phase I clinical trials and the submission of data for investigational new drug (IND) and investigator's brochure (IB) approvals, are reportedly on track.

Janet Huffman brings a wealth of experience to her new role as interim CEO, having previously served as CFO for various healthcare companies, including TRxADE HEALTH, Inc. (NASDAQ:MEDS). Her background includes key roles in capital raising, mergers and acquisitions, and financial planning. The Oragenics Board of Directors has expressed confidence in Huffman's ability to lead the company through its next phase of growth. InvestingPro analysis suggests the stock is currently undervalued, despite facing challenges with a 94% decline over the past year. Subscribers to InvestingPro can access detailed valuation metrics and eight additional exclusive insights about OGEN's financial health and market position.

Oragenics has strategically allocated resources from its recent capital raise towards drug and device formulation improvements, device prototyping, and Phase II clinical trial preparations. The company is also investing in the protection and acquisition of patents related to these advancements.

Looking ahead, Oragenics is focused on submitting the IB package for the Australian Phase II clinical trials by Q1 2025, formalizing strategic partnerships in Australia, and dosing the first patient in the Phase II clinical trial by early Q2 2025. While the company's overall financial health score is currently rated as WEAK by InvestingPro, analysts anticipate significant sales growth in the current year, potentially marking a turning point in the company's trajectory. Additionally, the submission of the IND package for Phase IIb clinical trials in the United States is targeted for Q3 of 2025.

Huffman expressed optimism about the company's direction and the potential impact of ONP-002 on patient outcomes and shareholder value. The company's efforts are aimed at advancing ONP-002 into its next developmental phase and laying the groundwork for future growth.

This news update is based on a press release statement from Oragenics, Inc.

In other recent news, Oragenics Inc (NYSE:OGEN). has undergone significant executive changes and completed the full exercise of Pre-Funded Warrants. The pharmaceutical company appointed Janet Huffman as Interim Chief Executive Officer following Bruce Cassidy's resignation. Huffman's base salary increased by 10% to $275,000 and she was awarded a discretionary cash bonus of $75,000.

Oragenics also announced the termination of its President's employment agreement, according to a regulatory filing with the Securities and Exchange Commission. In addition, the company entered into a sales agreement with Dawson James Securities Inc., potentially reaching up to $10,000,000 in aggregate sales of its common stock.

The company has seen progress in its operations, raising over $6 million in 2024, including a public offering that generated approximately $4.45 million. On the clinical front, Oragenics has made strides with ONP-002, a product candidate for the treatment of concussions, which has passed FDA-required cardiotoxicity tests. The company has also appointed Dr. William 'Frank' Peacock as Chief Clinical Officer and Dr. James 'Jim' Kelly as Chief Medical (TASE:PMCN) Officer to oversee the upcoming Phase II trial.

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