Imunon, Inc.

Good morning. My name is Marlies, and I will be your operator today. At this time, I would like to welcome you to Immunon's third quarter 2022 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 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 1 to ask a question during the Q&A session. I would now like to turn the call over to Kim Golodet. investor relations representative. Please, go ahead.

Thank you, and good morning, everyone. This is Kim Golodets with LHA. Welcome to Immunon's third quarter 2022 financial results and business update conference call. As has been Immunon's practice and as noted by the operator, prepared remarks will be followed by a question and answer session. 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 terminologies 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. In particular, there is significant uncertainty about the duration and impact of the COVID-19 pandemic. This means results could change at any time and the contemplated impact of COVID-19 on Immunon's operations, financial results, and outlook is the best estimate based on the information for today's discussion. I also caution that the content of this conference call is accurate only as of the date of the live broadcast, November 14th, 2022. 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, 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. Khurshid Enver, our Chief Scientific Officer, and Dr. Nicholas Boris, our Chief Medical Officer, will be available during the Q&A session to answer your questions regarding our development programs with Placine, our prophylactic vaccine modality, and GEN1, our IL-12 immunotherapy for the treatment of advanced ovarian cancer. Today, I am going to spend most of my time speaking about Placine, as our recent progress in developing this modality has been extraordinarily robust. Placine is one of Immunon's DNA-based platform technologies that relies on DNA delivery with novel synthetic delivery systems that are independent of viral vectors or devices. DNA vectors encompass molecular elements that are designed to improve the immune response by targeting multiple antigens of a pathogen or multiple variants of the same antigen. Immunon has produced a family of DNA vaccine vectors expressing one or more SARS-CoV-2 surface antigens, and we have demonstrated expression of the encoded genes. This promising vaccine approach has broad applicability in infectious diseases, and also in oncology. We have been conducting preclinical proof-of-concept studies on a DNA vaccine candidate targeting the SARS-CoV-2 virus in order to validate our modality. To date, we are delighted with the results, which bode well for our ability to broaden applications to other pathogens. But before I dive into the data, I want to start by telling you why I am excited about the potential of our DNA-based vaccine modality. First, the market opportunity is very large. Vaccines are the most powerful and cost-effective way to protect the health of billions of people around the world. Before COVID, the global market for preventive vaccines was about $35 billion. roughly shared between four key players, Sanofi, Merck, GSK, and Pfizer. The market grew to $61 billion in 2021 and is expected to reach $125 billion in 2028. And new viruses are being discovered all the time. In fact, over the past 40 years, 80 new pathogenic viruses have been discovered for an average of two new viruses per year. When it comes to the development of vaccines, if you consider all the viruses known to mankind from 100 years ago, commercial vaccines have been approved for only 4% of them. So clearly, there is a large addressable market providing significant room for new technologies. And that brings me to my second point. I believe that DNA has the potential to be an entirely new class of vaccines. In particular, our Placid modality has the potential to represent a viable alternative to current commercial vaccines. Current vaccine technologies, attenuated virus, protein-subunit mRNA, and viral DNA vector vaccines have shortcomings that we want to address. There are five important attributes that regulators and governments around the world want to see in the next generation of prophylactic vaccines, and we are addressing each with our technology. The first one, durability of protection. DNA antigen expression is more durable, longer lasting than mRNA, and induces a robust immunological response. Two, breadth of protection. Our multivalent vector increases the breadth of immune response and allows for combination vaccines. Three, transmission advantage. DNA has a greater capability to induce T cell activity against infected cells. We have the option in our vector for co-expression of immune modifiers to further strengthen the immune response and decrease the risk of viral shedding. Four, safety and convenience. Our synthetic delivery systems present no risk of genotoxicity. There is no virus involved. or risk of cytotoxicity. There also is no device needed, which improves treatment compliance and makes it very convenient to handle immunization campaigns with suitability for potential pandemic control. And five, flexible manufacturing. We are developing a truly versatile platform, enabling rapid response to changing pathogens, much better stability and shelf life than mRNA, at workable refrigerated temperatures versus deep-freeze temperatures, which simplifies handling and distribution. The data we have generated to date is extremely encouraging. In proof-of-concept mouse immunogenicity studies, we have demonstrated robust IgG, notarizing antibody, and T cell responses with our Placine vaccines. The data also demonstrated the ability of our Placine vaccines to protect a SARS-CoV-2 mouse model in a live viral challenge. In the study, mice were vaccinated with a Placine vaccine expressing the SARS-CoV-2 spike antigen from the D614G variant, the Delta variant, or a combination vaccine expressing both variants. All these vaccines were found to be safe and elicited IgG responses, and inhibited viral load by 90 to 95%. The key exciting finding is that our bivalent vaccine was equally effective against both variants of the SARS-CoV-2 virus we tested. The murine model data also suggests that our approach provides not only flexibility, but also the potential for efficacy that is at least comparable to benchmark mRNA commercial vaccines. with durability of protection expected to exceed six months. These encouraging results from the mouse study formed the basis of a non-human primate challenge study. The partial results from this ongoing study were reported last month. In the study, we are examining a single plasmid DNA vector containing the SARS-CoV-2 spike antigen from the D614G variant that is formulated with a synthetic DNA delivery system and administered by intramuscular injection. We vaccinated sinomolgus monkeys with either the Placine vaccine or a commercial mRNA vaccine three times over 84 days. Analysis of blood samples for IgG and neutralizing antibodies showed evidence of immunogenicity both in the Placine and mRNA vaccinated subjects. In a head-to-head comparison, the protection efficacy as measured by viral clearance following challenge with the SARS-CoV-2 virus was equivalent between Placine and the commercial mRNA vaccine. We look forward to the completion of this study and the final report by the end of this year. Also of importance, in an ongoing stability study, the physiochemical properties and immunogenicity of the Placine vaccine did not change during storage at four degrees Celsius for up to six months, it is a clear advantage of mRNA vaccines with respect to transport and flexibility. So what is next for Placine? Given the highly encouraging data to date and the potential for key commercial advantages of our existing vaccines, we have moved to broaden and strengthen the platform. and we entered into an agreement with Acritas Therapeutics to evaluate our placid nucleic acid constructs formulated with their proprietary lipid nanoparticle delivery system, or LNP. Acritas is known for its LNP systems for mRNA vaccines, having worked with Pfizer-BioNTech on their commercial vaccine. Our work with Acritas will focus on various LNP formulations for gene expression and immunogenicity in urine models. The combinations of our technologies will expand our delivery portfolio, thereby enabling us to pursue a broad spectrum of formulation capabilities and delivery modalities with greater potential to improve currently available vaccines against a multitude of pathogens and also to develop novel cancer vaccines. Now that our proof-of-concept studies using SARS-CoV-2 have yielded highly promising results, we are considering an option to developing a multivalent Plesin DNA vaccine as a SARS-CoV-2 booster vaccine and expanding Plesin vaccine to other pathogens. With respect to developing a SARS-CoV-2 booster vaccine and selecting the next pathogen for development, last week we held a tech watch with the Biomedical Advanced Research and Development Authority, BARDA, the division of HSS responsible for strategic preparedness and response. Our discussion with BARDA focused on the characteristics of blessing for developing the vaccines of the future. Our presentation was very well received. There was a clear reaction that Immunon has made real progress making classmate vaccines more effective. They were impressed with our ability to make DNA technology a potential strong contender in further vaccine development. While our near-term plan is to request a pre-IND meeting for a COVID booster based on the next variants of interest, we also plan to find a second IND for another pathogen. We are looking for Barbara's input on the vaccines of the future and hope to receive some non-dilutive funding from them to apply to our development programs. I have used the term vaccines of the future, and that is exactly what our vision is, to be the provider of safe and effective vaccines of the future that are superior to current vaccines in durability and breathable protection, stability at workable temperatures, speed in manufacturing process that allows for quick response to changing pathogens, and have better compliance for mass immunization by not requiring a device or virus. Now let's turn to our clinical oncology program, which utilizes Gen1, developed from our TheraPlas modality. As you know, Gen1 is a DNA plasmid that is administered into the abdomen of patients to induce cells to manufacture the potent natural immunomodulating agent interleukin-12, or IL-12. Our clinical studies have established that Gen1 produces IL-12 and is favorably impacting the tumor microenvironment. These data were published in the Journal of Cancer Clinical Research in 2021 and are the basis of the Ovation 2 study. The Ovation 2 study is designed to determine how safe and active Gen 1 is in patients with advanced ovarian cancer who will be undergoing neoadjuvant chemotherapy, or NACT. NA-CT is designed to shrink the tumors as much as possible for optimal surgical removal. Following surgery, another three cycles are administered to address any remaining tumor. In the Ovation 2 study, Gen 1 is added to standard NA-CT to boost the natural immune response to the cancer. Ovation 2 is a randomized Phase 2 study. that compares patients treated with standard neuroadjuvant chemotherapy against patients who get standard NACD plus Gen 1. The results of this study will help us determine the course of registration for Gen 1 in ovarian cancer. As previously announced, 110 patients from more than 20 centers in the U.S. and Canada have been enrolled in this study. It is important to note that since the Ovation 2 study was initiated several years ago, a new class of drugs called PARP inhibitors have been approved that benefit ovarian cancer patients who have a significant gene mutation called BRCA positive or HRD. In our study, when we focus on the BRCA negative patients who have not received PARP inhibitors, we can see that Gen 1 is providing a progression-free survival benefit. This data is interim and is not statistically significant, but it serves as a basis for interest in continuing evaluating BRCA-negative population and initiating combination studies with other therapies, such as Avastinol checkpoint inhibitors. The interim data has been reviewed by our independent data and safety monitoring board and experts in the field of ovarian cancer. They agree that the safety of Gen 1 is acceptable and that the data supports continuation of our clinical studies and exploration of combination regimens. We expect top-line data from the Ovation 2 study in mid-2024. This timing, however, depends on how quickly patients progress in their disease. As previously announced, we are working in partnership with the Breakthrough Cancer Foundation, with MD Anderson Cancer Center, and three other major centers to initiate a combination study of Gen 1 with Avastin in patients who are newly diagnosed with advanced ovarian cancer. The preclinical data supporting this combination is very exciting. and is being prepared for submission at an upcoming cancer conference in 2023. We hope to enroll our first patient in the first half of 2023. We are also preparing a Phase 1-2 study with Gen 1 in combination with checkpoint inhibitors, since the results of exciting preclinical data also should be published in the coming months. The FDA has accepted this protocol nevertheless, In consideration of the need to conserve capital, we might delay the start of this study. So as I have just described, we have a thoughtful and thorough plan for Gen 1 for the treatment of advanced ovarian cancer. Before I turn the call over to Jeff Church for his review of our very strong financial position, I want to impress upon you that our long-term vision called for the creation of a new category of medicines based on our plasmid DNA technology across a broad array of human diseases. We are studying inimmunology and infectious diseases, and we will continue to invest to fully characterize the platform and to advance the technological frontier of plasmid DNA. Now I will turn the call over to Jeff.