Imunon, Inc.

Good morning. My name is Alan, and I will be your operator today. At this time, I would like to welcome you to the Immunon Third Quarter 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 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 1 to ask a question during the Q&A session. I would like now to turn the call over to Kim Golodets. Please go ahead.

Thank you. Good morning, everyone. This is Kim Golodets with LHA. Welcome to Immunon's 2023 Third Quarter 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 expect, anticipate, believe, 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, November 14th, 2023. 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 Dr. Corinne Lagoff, Immunon's President and Chief Executive Officer. Corinne?

Thank you, Kim, and good morning, everyone. Joining me today is Jeffrey Church, our Chief Financial Officer. In addition, Dr. Kirshen Enver, our Chief Science Officer, will be available during the Q&A session at the end of our prepared remarks. Immunose growth and development is dependent on four pillars. Last quarter, I spent the bulk of our time on the development of our placebo-prophylaxis vaccines modality as an out-licensing and partnership opportunity. While I will certainly update you on this modality, and we did have some interesting developments, first I'd like to highlight IMNN001, our DNA-based interleukin-12 immunotherapy for the localized first-line treatment of advanced ovarian cancer in combination with the standard of care chemotherapy, and it's currently in Phase II clinical development. Recall that in September 22, we reached full enrollment of 110 patients, And this year, in September 2023, we reported an additional set of interim more mature data showing promising progression-free survival and overall survival data. In the intent to treat population, we demonstrated a delay in disease progression in the treatment arm of approximately 33% or more than three months benefit. And preliminary overall survival data followed a similar trend, showing an approximate nine-month improvement in the treatment arm over the control arm. The hazard ratio of 0.78 approaches the protocol-defined value of 0.75, set at an 80% confidence interval for the ATT population. Since Ovation 2 is an exploratory study with a total, so control plus study arms, of only 110 patients, it was not powered to a P inferior to 0.05, and the current trend looks promising. Recall that this study is evaluating the dosing safety, efficacy, and biological activity of intraperitoneal IMNN001 in combination with neoadjuvant chemotherapy, or NACP. And this in patients newly diagnosed with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer. NACT is designed to shrink the tumors as much as possible for optimal surgical removal after three cycles of chemotherapy. And following NACT, patients undergo interval debulking surgery, followed by three additional cycles of chemotherapy to treat any residual tumor. And IMNN001 is administered weekly during the course of NACT. So we also reported for the first time data on new subset of patients treated with PARP inhibitors. When we began the Ovation 2 Phase 2 trial, the PARP inhibitors were not part of the first-line maintenance treatment in ovarian cancer. Now they form an important part of the patient's treatment plan. A subgroup analysis of patients who received IMNN001 and post-chemo maintenance therapy with PARP inhibitors versus PARP inhibitors alone in the control group shows positive impact. The median PSS in the PARP inhibitor plus NACT group was 15.7 months. Yet, PSS in the PARP inhibitors plus NACT plus IMNN001 group was 23.7 months or 8 months longer. In addition, the median OS in the PARP inhibitors plus NACT group was 14.6 months, and median OS, overall survival, has not yet been reached in the PAP inhibitor plus NSCT plus IMNN001 group. So although these data are from a small number of patients, they are intriguing. We also saw continued benefits in secondary endpoints, including a 20% higher R0 tumor resection score and a doubling of of the CRS3 chemotherapy response score to approximately 30% in treatment arm versus 14% in the control arm. A complete tumor resection or R0 is a microcosmically margin negative resection in which no growth of microscopic tumor remains in the tumor bed. Chemotherapy response score is considered a good prognostic indicator in ovarian cancer. So that's why those endpoints are important to look at. And safety analysis continue to show good tolerability of IMNN001 in this setting. Now, enrollment in our second Phase II study, which, if you remember, is done in collaboration with the Breast Cancer Foundation, has begun with the first patient treated at MD Anderson Cancer Center, LASMO. The study is evaluating MNN001 in combination with Bevacizumab. All in, the study is expected to enroll 50 patients with stage 3-4 ovarian cancer at several sites, including Memorial Sloan Kettering and Benef Arbor. The trial's primary endpoint is detection of minimal residual disease, or MRD, by second-look laparoscopy, and the secondary endpoint is PSS. Initial second-look laparoscopy data are expected within a year following the completion of enrollment, and final PSS data are expected approximately three years following enrollment completion. This trial would include a wealth of translational endpoints and that understanding the clonal evolution and immunogenomic features of the MRD phase of ovarian cancer. that is currently undetectable by imaging or tumor markers. We will keep you updated as sites are added. And as a reminder, much of this trial is being funded by Breaks Through Cancer. So we are now six to seven months away from seeing the final readout data of our Ovation 2 program. And this is an incredibly exciting time for immunology. If positive, this data would be transformational to the field and would confirm our hypothesis of IL-12 being a potent immunomodulator for cold, solid tumors. We will consult with the FDA on the potential regulatory path forward. Our small phase two is showing promising trends in the ITT population and a strong benefit to standard maintenance PARP inhibitors therapy, which could inform a registration study. PAP inhibitors are known to significantly increase PFS, but the improvement in overall survival is not yet established. And resistance to PAP inhibitor therapy is a concern, which warrants novel combination approaches, such as with the immune agent AMNN001. Let's now turn to Placine, a proprietary monovalent or multivalent DNA vaccine-based on a DNA plasmid that controls the expression of pathogen antigens and a non-viral synthetic DNA delivery system. Plastin is currently being evaluated for the development of next generation vaccines, or as we call them, the vaccines of the future. We continue to bolster our preclinical data set with Plastin, which suggests this asset has been de-risked and is performing as anticipated. Our first pressing product is IMNN 101, which is in final stages of preparation for an IND, Investigational New Drug Application, to the FDA. IMNN 101, which we view as a proof of concept, is designed to protect against SARS-CoV-2 Omicron XBB15 variant in accordance with the FDA's Vaccines and Related Biological Products Advisory Committee, the VRPAC committee, announcement that's been made in June, 2023, and that established a framework for updated COVID-19 doses. IMINON is targeting the first quarter of 2024 for submitting the IND and then enrolling the first subject in a phase one trial in April, 2024, with rapid advancement into phase two trial by mid-2024. So we are excited about the body of preclinical data, and we have been active in presenting this data at various conferences, both in the U.S. and Europe. For example, last month, Dr. Enver presented at the Third International Vaccines Congress, highlighting immunogenicity data and the development status of IMN 101. Dr. Enver's presentation described the multiple advantages of Placine over current commercial vaccine platforms, including more durable antigen expression and T-cell responses versus protein and mRNA vaccines. In addition, preclinical studies show that Placine elicits better antibody response kinetics following a single dose and demonstrates better shelf life of at least 12 months at 4 degrees Celsius and at least two weeks at very high temperatures of 37 degrees Celsius. These characteristics suggest superior commercial handling and distribution properties compared with mRNA vaccines, as well as greater manufacturing flexibility. Compared with viral or other DNA vaccines or protein vaccines, Placine vaccines have advantages in key cell responses, safety compliance, and manufacturing flexibility. Dr. Enver's presentation also describes the versatility of the Placine modality, demonstrating activity against Marburg and influenza viruses in collaboration with the Wister Institute, and activity against Lassa virus, which is being evaluated at the NIH NIH. I remind you that during the third quarter, we entered into a cooperative research and development agreement with the NIAID. This is a three-year agreement under which the NIAID will evaluate the immunogenicity and efficacy of two immuno-DNA-based Lassa virus vaccine candidates. The agency will assess the efficacy of placebo-DNA constructs against Lassa virus in the genetic and non-human primate disease models. including both prime and prime-boost vaccine strategies. We also announced our collaboration with WSTER in January of this year, and the WSTER Institute Vaccine and Immunotherapy Center is uniquely positioned to advance new vaccine formulations to facilitate further expansion and development of the vaccine. Collaboration with outside partners, particularly those that will provide some or all of the funding of the research, are a key pillar of our growth strategy. Now later today, Jean Boyer, our Vice President of Research and Development, will be presenting at the Vaccine Summit in Boston. Dr. Boyer's presentation describes preclinical T cell responses and notes that the induced immune response in vaccinated mice were persistent without decay for up to 14 months after vaccination. So as you might think, we are very pleased with the duration of response. So we believe that our placebo therapy is revealing itself as an important potential option in addressing not only pandemic response, but also a seasonal vaccine option. its stability at regular refrigerator temperatures of 12 months, room temperature stability of at least one month, and stability at high temperatures for at least two weeks, plus the immune response duration and the plug-and-play model using the plasmid DNA backbone has shown excellent preclinical results that are so important to a commercial vaccine product. And this is particularly important as many pathogens such as Lassa virus may arise in geographies where there are challenges with refrigeration storage and distribution networks. In addition, our ability to rapidly switch out antigens and load multiple antigens into the same vaccine should be instrumental in addressing the spread of disease. So in addition, our plasmid modality uses a DNA plasmid and a non-viral synthetic DNA delivery technology for the expression of pathogen antigens. And our DNA-based vaccines can be administered using a standard syringe and IM injection and are independent of viruses or specialized devices for delivery like electroporation. Last quarter, I touched on our work to develop tumor modalities as logical extensions of our prophylactic vaccine modality. Sixth class concerns the application of our DNA technology to produce universal cancer vaccines, also called tumor-associated antigen cancer vaccines. We have initiated preclinical work to develop a trip to an NYSO1 tumor-associated antigen cancer vaccine in melanoma, which we call AMNN201. This work is in a very early stage, and I look forward to admitting you as it progresses. We are also in early discovery of our fourth modality, INDIPLAS, for personalized neoantigen cancer vaccines, and we plan to enter into new collaborations that focus on developing AI-powered computational approaches and state-of-the-art cell sequencing technologies to identify tumor antigens in patient samples and create the next generation of personalized cancer vaccines. And as we stick flags, we'll update you as our development work progresses. Importantly, recall that we manufacture our vaccines at our own CGMP facility in Alabama. And our decision to manufacture in-house offers us many strategic benefits, but notably the control on costs, quality, and timelines. So now I will turn the call over to Jeff Church, who will discuss our financial results. Then I'll come back and provide a review of upcoming milestones and activities. Jeff?