Imunon, Inc.

Good morning and welcome to the Immunon first quarter 2023 financial results conference call. All participants will be in listen only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your telephone keypad. To withdraw your question, please press star then two. Please note, this event is being recorded. I would now like to turn the conference over to Kim Golodets. Please go ahead.

Thank you, and good morning, everyone. This is Kim Golodets with LHA. Welcome to Immunon's 2023 First 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, May 11th, 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 Lagasse, 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. Kershid Enver, our Chief Scientific Officer, will be available during the Q&A session at the end of our prepared remarks. Today, I will provide an update on our development programs with Placine, our prophylactic vaccine modality, and with IMNN-001, which was previously known as Gen 1, which is our interleukin-12 immunotherapy for the treatment of advanced ovarian cancer. During our last conference call in March, I reminded investors of our key strategies in some detail. I'll do so again briefly today because I believe it is important for investors to understand where we are going as a company and our vision for the future. Then I'll provide an update on our various programs. Immunon is tightly focused on harnessing the power of the immune system by developing novel DNA-based approaches in immuno-oncology and infectious diseases. We believe that non-viral DNA will be a key driver of the future of global medicines. I say that because non-viral DNA has the potential to help create an unprecedented abundance and diversity of medicines that are currently beyond the reach of recombinant protein technology. Our platform does not require a device or a virus for facilitating DNA delivery. In addition, our medicines can be easily redosed, manufacturing is straightforward and scalable, and the administration to patients does not require painful electroporation. Our strategy is designed to deliver on the full scope of the non-viral DNA opportunity over the long term. Reaching patients with DNA medicines requires us to make several clear choices, including how much capital we devote to platform and modality development, drug development, and infrastructure, which programs we advance and how, whether we advance programs alone or with strategic collaborators, and which capabilities do we build internally and which do we outsource. To navigate these choices, we establish four strategic principles that guide our approach to creating value for patients and investors. First is our focus on immuno-oncology as an asset development opportunity. Our strategy is to pursue indications characterized by a high disease burden and substantive unmet medical need where an immunological approach can improve both the risk of progression and survival compared with the current standard of care. MNN001 is an example of one such asset. 001 is our first plasmid system developed from our TheraPlasmodality for the expression of proteins and cytokines. 001 expresses IL-12. IL-12, as you know, is a cytokine that potently stimulates both natural killer cells in the innate immune system and CD8 T cells in the adaptive immune system. The in situ expression of IL-12 activates tumor suppressing immune response with a good safety profile. 001 is currently in a phase two study in advanced ovarian cancer. This program is a clear example of how Immunon is pushing the boundaries of innovation in a difficult to treat tumor type. We are now developing a second modality for the development of personalized neoantigen cancer vaccines. 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. It represents a promising strategy to induce a specific and long-lasting immune response against tumor antigens. It also is a logical extension of our prophylactic vaccine modality. We just started a program in a melanoma model in mice, and we will keep you updated on our progress. Developing our Placine prophylactic vaccines modality as an out-licensing and partnership opportunity is the second prong to our business strategy. As I described last quarter, the need for new vaccine technologies is urgent, with fewer than 5% of pathogens having a commercially available vaccine. And we do discover new pathogen viruses every day. More than 80 pathogenic viruses were actually discovered since 1980. So clearly, the market for vaccines is enormous. Even before COVID, The global market for prophylactic vaccines was about $35 billion, and it's expected to reach $125 billion in 2028. The reason we are so excited about the Placine modality is because it has several characteristics that may address the shortcomings of current vaccine technologies. For example, Placine is engineered to be easily modified to create vaccines against a multitude of infectious diseases, with benefits that include durability and breadth of protection, transmission advantage, safety, and convenience, flexible manufacturing, and stability at standard refrigerated temperatures. These attributes are all sought by various global health authorities, and the efficiency of a plug-and-play strategy is extremely valuable against emerging pathogens. Our objective is to establish the safety and efficacy of our platform in a phase one human study and then seek to out-license this powerful technology and or to establish non-dilutive partnerships to develop vaccines for pathogens of interest. We've had productive conversations and we will continue to have conversations with various government agencies to ensure we are pursuing the most urgent and important pathogens. We are delighted with the reaction we have received from these agencies regarding our progress in making DNA vaccines more effective and more appealing. Our third strategic principle focuses on the vertical integration of the core elements of our business. Our goal here is to attract the interest of corporate partners while minimizing dependence on vendors so that we can control costs, timelines, and quality. Our range of capabilities is impressive. For example, our scientists can select any protein from the human or pathogen proteomes to be engineered. We have R&D laboratory testing capability to support product and method development. We have GMPQC laboratory to test raw materials, finished products, and to conduct our stability studies. And our labs also have the capacity and expertise to conduct testing and to run experiments in a variety of animal disease models. We also have developed in-house pilot scale manufacturing capabilities for DNA plasmids and nanoparticle facilitating systems. The next step in our vertical integration strategy is to build upon our pilot scale capabilities to produce phase one GMP materials to allow Immunon to control all aspects of product design, testing and manufacturing, meaning a complete bench to bedside capability. In addition, Owing to our strategic investment in transomic technologies, we are now able to construct vaccines against newer variants in just weeks using a comprehensive array of CRISPR, RNA, and gene expression tools and services. Our vertical integration strategy has allowed us to reduce costs and timelines by more than 75% while creating a reliable, high-quality, and predictable supply chain. Lastly, our fourth pillar, which is the bedrock of our long-term business model, concerns strategic collaborations. Joining forces with partners is a great way to expand our capabilities, accelerate the development of our programs, and obtain non-dilutive funding to execute our strategy. All these internal capabilities will allow us to control both the costs and development timelines in support of our goal to attract corporate partners. To that end, we have formed several important collaborations in recent months. In January, we signed our first collaborative research agreement with the Worcester Institute to develop new vaccine formulations for infectious diseases using our placebo modality. Worcester is a global leader in biomedical research and our agreement is with their vaccine and immunotherapy center. This builds upon our collaboration with the biotechnology company Acunitas Therapeutics, which is focused on developing delivery systems for nucleic acid vaccines and therapeutics based on lipid nanoparticles, an agreement we entered into in November 2022. We also formed an alliance with the Breakthrough Cancer Foundation that allows us to obtain non-durative funding to initiate new innovative clinical programs in niche indications like ovarian cancer. We expect the first patient to be enrolled in a few weeks in a 50-patient phase 1-2 study with IMNN001 in combination with Bevacizumab, otherwise known as Avastin, in advanced ovarian cancer. first at the University of Texas MD Anderson Cancer Center. Later, we expect additional participation at the Sydney Chemo Comprehensive Cancer Center at Johns Hopkins and at Memorial Sloan-Kettering Cancer Center. The Core Institute for Integrative Cancer Research at the MIT, Massachusetts Institute of Technology, will provide artificial intelligence services throughout the trial, including biomarker and genomic analysis, which is expected to expand the company's knowledge of the treatment paradigm. Breakthrough Cancer is partially funding the study. We were delighted that our work was presented at several important conferences during the first quarter. We presented very promising preclinical data for Placid Modality at the Vaccine Technology Summit 2023. Dr. Kershid Anvir, our chief scientific officer, reviewed the company's work in advancing our passing modality and the promising preclinical data generated to date. Among the topics presented was the ability of this multivalent technology to achieve broad-spectrum immunity from a single DNA plasmid with a synthetic delivery system. This ability is independent of virus, device, or liquid nanoparticle formulations. The preclinical data presented ticked the box on many desirable features that would characterize the next generation vaccines. Robust immunogenicity and protection in SARS-CoV-2 models. Comparable protection activity to a commercial mRNA vaccine in a booster dose comparison. durable cellular and neural responses detectable for more than 12 months. I want to point out that such a robust cellular response that goes out past a year is an important advantage. We have demonstrated that our vaccine creates memory cells that provide an additional layer of protective immunity and contributes to protection against severe disease. And lastly, superior immune quality versus the mRNA vaccine in a single dose comparison. In addition, the placebo modality had important distinguishing advantages for commercial vaccine, including a shelf life at four degrees for greater than nine months, and the ability for simple, rapid, and scalable manufacturing. Based on this compelling data, in March, we applied for a pre-IND consultation with the US FDA to receive guidance on our proposed program for seasonal COVID-19 booster vaccine. We expect to submit an IND application in the fourth quarter of this year. Again, our objective is to establish the safety and efficacy of our platform in a phase one human study, and then seek to license this powerful technology to pharmaceutical companies for the utilization of our platform in order to establish non-dilutive partnerships to develop vaccines for pathogens of interest. Subsequent to the end of the first quarter in April, Dr. Jean Boyer, Immunos vice president of preclinical research, presented a poster at the prestigious American Association for Cancer Research, AACR, conference. Dr. Boyer reported that IMNN001 demonstrated stimulation of the immune response in the ID8 ovarian tumor model. Of the three dosing regimens tested, the once-every-two-week regimen demonstrated comparability to the weekly regimen, while showing superiority to the once-every-three-week regimen, particularly with respect to mortality and tumor burden. Thus, exploring once every two week doses of 001 in human studies is warranted. It is an important step in developing the least cumbersome and best cancer treatment regimens to improve patient acceptability and compliance. Before I turn the call over to Jeff Church for his financial review, I want to outline several value-creating milestones we expect over the next six to 18 months. Building upon our compelling interim results with our Phase I-II Ovation II study in Stage III-IV ovarian cancer, which reached full enrollment of 110 patients last year, we expect to report an additional set of interim, more mature data in the second half of 2023. And then we expect to report top-line results by mid-2024. As a reminder, interim data for this study reported a year ago showed that in 46 patients who had undergone interval debulking surgery, those treated with 001 in combination with chemotherapy standard of care showed an improvement in R0 surgical resection rates and CRS3 chemotherapy response goals compared with the 41 patients in the control arm. Also in the second half of this year, we expect to file the IND for SARS-CoV-2 vaccine and announce proof of concept vaccine data for next pathogen. Moving to the first half of 2024, we'll be sharing press 1 results for SARS-CoV-2 study and interim results for the combination study of 001 and Bebas-Isibar. Now, I'll turn the call over to Jeff.