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 Immunon's second 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 on your phone to ask a question. You may press star one. Apologies. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. Please keep in mind, if you are using a speakerphone, you must release your mute function to allow the signal to reach your 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 Golodetz. Please go ahead.

Thank you, and good morning, everyone. This is Kim Golodetz with LHA. Welcome to Immunon's 2023 Second 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 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, August 10th, 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.

Thank you, Kim, and good morning, everyone. Today, joining me is Jeffrey Church, our Chief Financial Officer. In addition, Dr. Kirshid Anver, our Chief Science Officer, will be available during the Q&A session at the end of our prepared remarks. As I have discussed during previous calls, insurance growth and development is dependent on four pillars. The one I'd like to spend most of our time on today is the development of our Placine prophylactic vaccines modality as an out-licensing and partnership opportunity. Placine is our proprietary mono or multisystemic non-viral and synthetic DNA technology for the expression of pathogen antigens. It is currently being evaluated in preclinical studies for the development of next generation vaccines. We have made exceptional progress advancing this technology as a prophetic vaccine modality with important features both as a commercial product platform and as a potential solution to addressing the next pathogens of interest. I will review some of our most recent clinical data with the vaccine which suggests this asset has been the risk and is performing as we anticipated. During the quarter, Dr. Enver presented results from pre-gable studies in a vaccine COVID-19 vaccine at the Vaccine Technology and the 2023 Virus and Cells Golden Research Conference in Barcelona that demonstrated characteristics that address the limitations of current commercial vaccines by offering enhanced breadth of protection to emerging variants, Persistence and robust cellular immunity as well as stability at workable temperatures. Importantly, humoral immune responses specific to SARS-CoV-2 spike antigen were persistent over a 14-month post-vaccination period, while the T-cell responses from classic COVID-19 vaccines after 14 months were higher than a commercial mRNA vaccine. In another mouse study, the humoral response to a single dose of the commercial mRNA vaccine plateaued within 14 days after vaccination, while the response continued to increase over time with the plasmin vaccine, demonstrating improved durability. We believe that our DNA plasmid vaccine may provide greater protection against reinfection, hospitalization, or death. More recently, we have shown that Lecithin is stable for at least 12 months at refrigerated temperatures and for at least one month at room temperature. I can't emphasize enough how important these attributes are to a commercial vaccine product, especially as many new pathogens 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. Beyond the development of a next-generation COVID-19 booster vaccine, which I will come back to in a minute, we at Immunon are interested in developing the placebo therapy across many pathogens of interest, like filoviruses or RNA viruses, where a DNA-based approach may be beneficial To date, the US and global public health policy and commercial vaccine manufacturers continue to play catch up with the reoccurrence of existing infectious disease threats and new emerging pathogens. Emerging fevers, which are caused by viruses like Lassa or Marburg or Ebola, are prime examples and are among the most serious threats to public health, both in the endemic regions of West Africa and worldwide, due to high mobility and mortality rates. These viruses cause lethal hemorrhagic fevers in several cases and are classified as risk approaches which need to be handled in biosafety levels for facilities. There are also potential biodefense threats if used as biological weapons against civilians. turn to IMNN's 101, our first clinical vaccine designed as the next generation COVID-19 booster. All the preclinical studies in mice and NHPs have supported the development of a pre-IND package that we submitted earlier this year to the FDA. We have just received the written response from the FDA, and I am pleased to tell you that the FDA provided encouraging feedback on our data and clinical development plans. which gives us comfort that we are well on track to submit an IND in the first quarter of 2024 and enter the clinic soon thereafter. The IND will be for a proposed Phase 1-2 program, which is designed to provide proof of principle in humans. The FDA also confirmed that the plug-and-play strategy for our platform was acceptable. So this confirms the flexibility and the versatility of our modality, which allows for the rapid production and development of any vaccine by simply changing the antigen coding cassette. MNN101 is a monovalent COVID-19 vaccine candidate of the Omicron XBB15 variant, as per the FDA's recommendation. You remember that the FDA's VIAFAC, the Vaccines and Related Biology Products Advisory Committee, met on June 15 this year to discuss and make recommendations for SARS-CoV-2 strains for updated COVID-19 vaccines for use in the United States beginning in the fall of 2023. So the plug and play model using the plasmid DNA backbone has shown excellent results, not only in COVID-19 strains, but our early work also suggests a plasmid vaccine would could be useful in multi-parks, known also as MParks. Initial data appear to confirm the validity of Plessin as a platform with broad applicability. You know, mice immunized at the zero and 14 with an MParks vaccine, and this is it, three separate immunological responses associated with the virus. And we also have generated immunological responses against flu and flu viruses in pre-table work. Last quarter, I mentioned that we are developing tumor modalities as a logical extension 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 TRIP2 and NYSO1 tumor-associated antigen cancer vaccine in melanoma, which we call IMNN201. This new modality is based on antigen selection and optimization, along with the option to include a potent immune modifier on a single nucleic acid vector. This represents a promising strategy to induce a specific and long-lasting immune response against tumor antigens. We have completed our initial proof of concept study looking in a mouse melanoma model at the potential prophylactic benefits of monovalent TRIP2 and bivalent TRIP2-NYSO1 vaccines. We are very happy with the results as the fixed-class vaccination followed by a tumor challenge delayed the tumor growth and improved survival. Now, the therapeutic studies Evaluating the therapeutic benefits of our vaccines and consisting of a tumor challenge followed by vaccination are ongoing and will be completed in the second half of the year. And we are also in early discovery of our fourth modality in the past for personalized neoantigen cancer vaccines. I'd like now to touch on IMNN001, our DNA-based immunotherapy for the localized treatment of advanced ovarian cancer currently in Phase II development. Recall that last September, we reached full enrollment of 110 patients, and we expect to report an additional set of interim more mature data in the second half of 2023. Enrollment with our A study with breakthrough cancer is now open at MD Anderson, and the Breakthrough Cancer Foundation is working to add more sites. This study, as you remember, is looking at MNN001 in combination with a vaccine. As part of our strategy to reduce reliance on outsourced manufacturers, In June, we unveiled our new CGMP clinical materials production facility on the Hudsville, Alabama campus of the Hudson-Alpha Institute of Biotechnology. The facility will support RNA efficiencies and lower development costs for infectious disease and cancer vaccines and non-viral DNA-based immuno-oncology therapies. This new capability complements our existing CGMP quality control facility for testing clinical products at the Huntsville site. We have designed and built our own manufacturing capabilities to produce GMP-grade plasmid DNA and DNA-facilitating agents to support Phase I clinical studies with our plasmid infectious disease modality and our IndiPlus and FixPlus cancer vaccine modalities. The PSP DNA and DNA satiating agents are key components of the final vaccine formulation with GMP fill and finish carried out at the CDMO partner site. Our scientists can now select any protein from the human or pathogen proteomes to be engineered. Our existing labs also have the ability to conduct testing and run experiments in a variety of animal disease models. These internal capabilities will allow us to control both the cost and the process. I will turn the call over to Jeff Church now, who will discuss our financial results. Then I'll come back and provide a review of upcoming milestones and activities. Jeff?