Imunon, Inc.

Good morning. My name is Dave and I will be your operator today. At this time, I would like to welcome you to Immunon 2023 Financial Results Conference Call. All lines have been placed on mute to prevent any background noise. Following the speaker's prepared remarks, there will be a question and answer session. At that time, you may press star and then 1 on your phone to ask a question. Please keep in mind if you are using a speakerphone, you must release your mute function to allow the signal to reach our equipment. Again, that's star one to ask a question during the Q&A session. I would now like to turn the call over to Kim Golodets. Please go ahead.

Thank you, and good morning, everyone. This is Kim Golodets with LHA. Welcome to Immunon's 2023 Financial Results and Business Update Conference Call. During today's call, management will be making forward-looking statements regarding Immunon's expectations and projections about future events. In general, forward-looking statements can be identified by words such as expects, anticipates, believes, or other similar expressions. These statements are based on current expectations and are subject to a number of risks and uncertainties, including those set forth in the company's periodic filings with the Securities and Exchange Commission. No forward-looking statements can be guaranteed, and actual results may differ materially from such statements. I also caution that the content of this conference call is accurate only as of the date of the live broadcast, March 28, 2024. Immunon undertakes no obligation to revise or update comments made during this call, except as required by law. With that said, I would like to turn the call over to Michael Tordugno, Immunon's Executive Chairman. Michael?

Thank you, Kim, and good morning, everyone. It's good to be here with all of you. Joining me today are Jeffrey Church, our Chief Financial Officer, and Sebastian Hazard, our Chief Medical Officer. Dr. Hazard will speak about Immunon 001, or IL-12 immunotherapy and its anticipated place in the treatment of advanced ovarian cancer. In addition, Dr. Krishid Anwar, our Chief Science Officer, who joins us from the Hudson Alpha Institute in Huntsville, Alabama, where our research center is. Dr. Anwar will be available during the Q&A session at the end of our prepared remarks. But first, I'm sure you're all aware of the departure of Corinne Le Goff earlier this month to pursue other business opportunities. We wish her well and are grateful for her leadership and her contributions that she made to Immunon during her tenure. I just want to reassure you, however, that her departure in no way impacts our plans for growth, and we remain wholly committed to advancing our two key technology platforms, that's TheraPlas and Placine. We remain on track to complete our Phase 2 Ovation 2 study with Immunon 001, which is based on the TheraPlas platform, and to initiate our Phase 1 study of Immunon 101, our seasonal COVID-19 vaccine concept, based on our Placine technology. Our strategy for the development of these product platforms remains unchanged as well. From the Ovation 2 study, we expect to report top-line data in mid-2024. Based on our interim data and preliminary conversations with FDA, Dr. Hazard will be drafting the protocol for the Phase 3 study soon. He'll be speaking more about this in a minute. Meanwhile, this past month, we announced the submission of an IND application with the FDA for 101. Following acceptance by the agency, we expect to begin enrolling patients in this phase one study in the second quarter of this year. And we're ready to go. We have two sites identified. The two sites identified, that's Beth Israel in Boston and DM Clinical Research in Philadelphia. Both institutions have submitted to the IRB our protocol. They've been conditionally approved pending FDA acceptance. The biological safety committees at both institutions have approved the protocol. Our contracts are in place or in process. We're ready to go. So we look forward to the agency's agreement with the IND submission and look forward to initiating the study. I'll talk some more about the vaccine program, but first I'd like to turn the call over to Dr. Hazard. Sebastian?