Good morning. My name is Alan. I will be your operator today. At this time, I would like to welcome you to Imunon’s Q2 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 one 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 Imunon’s 2023 Q2 financial results and business update conference call. During today's call, management will be making forward-looking statements regarding Imunon’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 10, 2023. Imunon 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 Le Goff, Imunon’s President and Chief Executive Officer. Corinne? Thank you, Kim, and good morning, everyone. Today, joining me is Jeffrey Church, our Chief Financial Officer. In addition, Dr. Khursheed Anwer, our Chief Scientific Officer, will be available during the Q&A session at the end of our prepared remarks. As I have discussed during previous calls, Imunon’s 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 PlaCCine prophylactic vaccines modality as an out-licensing and partnership opportunity. PlaCCine is our proprietary mono- or multicistronic, non-viral, and synthetic DNA technology for the expression of pathogenic genes. 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 prophylactic 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 preclinical data with PlaCCine, which suggest this asset has been de-risked and is performing as we anticipated. During the quarter, Dr. Anwer presented results from preclinical studies in a PlaCCine COVID-19 vaccine at the Vaccine Technology Boston and the 2023 Viruses and Cells Gordon 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 PlaCCine 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 a PlaCCine 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 PlaCCine 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 Imunon are interested in developing the PlaCCine modality across many pathogens of interest, such as filoviruses or arenaviruses, where a DNA-based approach may be beneficial. To date, the U.S. and global public health policymakers and commercial vaccine manufacturers continue to play catch-up with the reoccurrence of existing infectious disease threats and new emerging pathogens. Hemorrhagic fevers, which are caused by viruses like Lassa, 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 morbidity and mortality rates. These viruses cause lethal hemorrhagic fevers in severe cases and are classified as Risk Group agents, which need to be handled in biosafety level 4 facilities. They are also potential biodefense threats if used as biological weapons against civilians. Let's now turn to IMNN-101, our first clinical vaccine, designed as the next-generation COVID-19 booster. All the preclinical studies in mice and NHP 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 plan, which gives us comfort that we are well on track to submit an IND in the Q1 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. 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. IMNN-101 is a monovalent COVID-19 vaccine candidate of the Omicron XBB.1.5 variant, as per the FDA's recommendation. You remember that the FDA VRBPAC, the Vaccines and Related Biological Products Advisory Committee, may 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. 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 could be useful in mpox. Initial data appear to confirm the validity of plasmid DNA as a platform with broad applicability. You know, mice immunized at day 0 and 14 with an mpox vaccine, elicited three separate immunological responses associated with the virus. We also have generated immunological responses against influenza and enteroviruses in preclinical work. Last quarter, I mentioned that we are developing two more modalities as a logical extension of our prophylactic vaccine modality. Six last 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 TRP-2 and NY-ESO-1 tumor-associated antigen cancer vaccine in melanoma, which we call IMNN-201. 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 TRP-2 and bivalent TRP-2/NY-ESO-1 vaccines. We are very happy with the results, as the fixed last vaccination followed by a tumor challenge, delayed the tumor growth and improved survival. 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 H2 of the year. 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 IMNN-001, 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 H2 2023. Enrollment with our study with breast cancer is now open at MD Anderson, and the Breast Cancer Foundation is working to add more sites. This study, as you remember, is looking at IMNN-001 in combination with Avastin. As part of our strategy to reduce reliance on outsourced manufacturers, in June, we unveiled our new cGMP-compliant clinical materials production facility on the Huntsville, Alabama, campus of the HudsonAlpha Institute for Biotechnology. The facility will support R&D 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-compliant quality control facility for testing clinical products at the Huntsville site. We have designed and built our own manufacturing capabilities to produce GMP-grade DNA plasmid and DNA-facilitating agents to support Phase I clinical studies with our PlaCCine infectious disease modality and our IndiPlas and FixPlas cancer vaccine modalities. The DNA plasmid and DNA-facilitating 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. I'll come back and provide a review of upcoming milestones and activities. Jeff? Thank you, Corinne. Details of Imunon’s Q2 2023 financial results are included in the press release we issued this morning and in our Form 10-Q, which we filed today before the market opened. Imunon ended the Q2 with $24.1 million in cash investments and accrued interest receivable. Our cash or net cash usage for operating activities was $6.8 million in the Q2 2023, up from $5.4 million from the prior year period. The increase was primarily due to the cash settlement in April 2023, along with related legal costs for arbitration with a former contract manufacturer for ThermoDox. Cash used by financing activities of $6.2 million during the Q2 2023 resulted from the early repayment of the company's loan facility with Silicon Valley Bank. This was offset by equity sales under the at-the-market equity facility. Combined with the $1.8 million in planned future sales of Imunon’s State of New Jersey net operating losses, we believe we have sufficient capital resources to fund the company's operation through 2024. Let me now turn to a review of our financial results. Imunon reported a net loss for the Q2 2023 of $5.6 million or $0.61 per share. This compares with a net loss of $6 million or $0.87 per share in the Q2 of 2022. Operating expenses were $5.5 million in the Q2 2023. That was down about 10% from the $6.1 million that we reported in the Q2 2022. Let me break down each one of these line items. Research and development expenses were $3.1 million in the Q2 2023, a decrease of about $100,000 from the prior year's Q2. More specifically, research and development costs associated with our PlaCCine DNA vaccine modality increased to $1.3 million from increased from $1.3 million from $600,000 a year ago. R&D costs support the OVATION study as well as the Phase III OPTIMA program, decreased to $0.3 million from $0.8 million in the Q2 of 2022. R&D costs associated with the preclinical development of IMNN-001 decreased to $0.4 million in the Q2, compared to $0.8 million in the same period of 2022. Other clinical and regulatory costs were $0.4 million this year, compared to $0.7 million in the prior year. CMC or manufacturing costs increased $0.7 million this year from $0.3 million, reflecting the development of the in-house pilot manufacturing capability, which Corinne referred to earlier, for DNA plasmids and nanoparticle delivery systems. General and administrative expenses were $2.3 million in the Q2 2023, compared to $2.9 million for the comparable prior year period. This decrease was primarily attributable to lower non-cash stock compensation and lower professional fees, including legal fees, offset by higher compensation expenses related to the CEO succession plan, which we announced in mid-2022. Other non-operating expenses were $85,000 in the Q2 2023. That compared to $65,000 in the prior year period. The company incurred an early debt extinguishment expense of $300,000 on its loan facility with Silicon Valley Bank, which was offset by higher investment income from short-term investments due to the higher returns we're seeing on these investments. Recall that in April 2023, we repaid the loan to First Citizens Bank, which is previously Silicon Valley Bank, for a total of $6.4 million, which included principal interest, prepayment fees, and end of term fees. The $6 million collateral account, which we classified as restricted cash, was released and utilized to pay off the loan. Investment income from the company's short-term investments increased by $300,000 for the Q2 compared to the prior year, due to higher returns on these investments. Take a just a brief look at the first half of the year, both first and Q2. For the six months ended, we reported a net loss of $11.2 million. That compares to $16.5 million. In the same period of 2022. Operating expenses were $11.2 million in the H1 2023, which was an 8% decrease from the $12.1 million that we reported in the same period last year. Net cash used for operating activities was $10.8 million for the first six months of 2023, compared to $13.4 million for the same period in 2022. This decrease was primarily related to a one-time payment of $4.5 million in interest expense and related costs, resulting from the sale and subsequent redemption of $30 million of Series A, Series B convertible redeemable preferred stock in the year ago period. Cash used by the financing activities of $3.7 million during the first six months of 2023 resulted from, as I mentioned earlier, the earlier repayment of our loan facility with Silicon Valley Bank, offset by $2.7 million of sales of equity under or at the market facility. We also received net proceeds of $1.4 million from the sale of unused State of New Jersey net operating losses in the Q1 2023. Our projected cash utilization for the balance of 2023 is approximately $4.5 million per quarter. The majority of expenses are related to the development of our PlaCCine modality. We will now turn the call back over to Corinne. Thank you, Jeff. Imunon 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 the non-viral DNA will be a key driver of the future of global medicines. We are very excited about the potential at Imunon to improve the health of millions, if not billions, of people, while creating significant value for our shareholders. Among our achievements, we have de-risked our PlaCCine modality across several pathogens of interest by demonstrating the immunogenicity and safety of our vaccines. We have generated compelling data in SARS-CoV-2 and IMNN-101, the next generation COVID-19 signal booster will be in the clinic in Q1 next year. We also have generated excellent immunological response for vaccines against pathogen of concern, especially mpox, influenza, Lassa virus and Marburg virus. We unveiled a state-of-the-art manufacturing site in Huntsville to reduce our reliance on others. We entered into collaborations designed to advance our technology. We're actively building capabilities for the development of cancer vaccines. Looking forward, we expect to reach several value-creating milestones over the next six to 18 months. Among them are reporting additional interim data on IMNN-001 for our OVATION 2 study and the combination study with bevacizumab in advanced ovarian cancer, and reporting top line data from the OVATION 2 study. Filing also the IND for SARS-CoV-2 vaccine and announcing proof of concept vaccine data as well for another virus program. We are very excited to tell you about our programs in more detail in an R&D day that we plan to hold this fall. We will have several key opinion leaders discussing our work during this virtual program, so please keep an eye out for more details in the coming weeks. With that, I open up the call to your questions. Operator? We will now begin the question-and-answer session. To ask a question, you may press star, then one on your touchtone phone. If you are using a speakerphone, please pick up your handset before pressing the keys. To withdraw your question, please press star then two. At this time, we will pause momentarily to assemble our roster. Our first question comes from Emily Bodnar of H.C. Wainwright. Go ahead. Hi, thanks for taking the questions. I guess two on the COVID program. First, can you touch on the remaining steps and studies that you might need before you could submit the IND in the Q1? Do you plan to have the Phase I/II study just be in general healthy volunteers, or do you think you might focus development on either, like, elderly or immunocompromised patients? Just clarifying timelines for OVATION 2. I think you previously talked about interim data in the third quarter. Is that still happening, top- line data still on track for the H1 of next year? Thank you. Thank you, Emily. I'll, I'll start with the timelines on OVATION. Yes, I confirm that we should have additional interim data in the Q3. For the top- lines, we're still planning on, on having the top lines at the end of this Q2 2024. To your question on COVID. I'll ask Dr. Khursheed Anwer to complete my answers. Yeah, we'll be ready to submit our IND in the Q1. What we are, are working on at the moment is the production of the clinical vector. You know, we are, you know, pretty much set and very much on track for, for this submission of IND. When it comes to the Phase I/II trial design, we'll be looking at generally healthy volunteers. I think your, your question on, on looking at, immunocompromised patients actually is an interesting one, or, more elderly patients. That's something that we actually will address with our advisors. That could be a subsequent study. Krusheed, do you want to, to add to what I just said? Yeah, sure. I think you've covered it well. Emily, at least two sets of studies that are IND-enabling are currently in progress. One is to look at the safety of animals. That's a safety toxicology study. It's due to start soon, and a biodistribution study where the plan is made and the delivery system goes, and how long it takes to clear. Those are the two fundamental IND-enabling studies that will complete the submission of the IND. As Corinne said, early phase I study will be healthy volunteers, but clearly for Phase II part, we could look into some stratification. As Corinne said, maybe some elderly with morbidity, but discussion with our advisors definitely on our part. Okay, great. That's very helpful. Thank you. Thank you. You're welcome. Our next question comes from David Bautz of, from Zacks. Go ahead. Hey, good morning, everyone. Thanks for taking the questions. First one's on the PlaCCine technology. Do we have any idea right now about how long the antigen is going to be expressed in someone who gets immunized with PlaCCine? Are we talking days, or weeks, or months? Do you have any clue right now? Hi, David. Yes, we certainly do. Please, Khrusheed, can you please answer the question? Yeah. Yeah, of course. David, you know, compared to mRNA or protein, the DNA stays for longer period of time, especially in skeletal muscle. With other genes, such as the reporter gene, we have seen the expression for several weeks. I anticipate the expression of the antigen will last several weeks after a single injection or even months. Is there any concern about tolerance development or even an allergic reaction with such long expression of the antigen? The, the levels of the antigen are, are not high or super, you know, maxed to be able to cause any intolerance issue. That generally happens if you have an antigen or protein bolus given over time, you know, physiological levels, then you see intolerance. These are levels that are enough to initiate immune responses. I don't anticipate intolerance, but again, we haven't specifically looked for that. Okay. What I'd like to add as well, David, we believe that, the, increased expression of the antigen or longer expression of the antigen is, in fact, a, a benefit, because it gives time to, your immune system, to build memory cells. Right? That's, maybe the concern a little bit with mRNA is that, you know, memory cells are not always present. Okay. That sounds good. Then, as far as the Phase I study goes, I guess, how do you determine which, which variant you're going to target for that? Then can you change which variant you target between going from, say, the Phase I to the Phase II? That's a great question. I, mentioned that the FDA, every year, will tell manufacturers which variant to go after. They're going to use the same principle as they do for the influenza vaccines, right? They met, the VRBPAC, back in, on 2015, they said then what the manufacturer needs to put into production is Omicron XBB.1.5, which is what we did. They, they agreed that that was the right thing for us. We'll do a Phase I/II, which means that, as soon as we start the Phase I, when we get the safe dose from the Phase I, we'll go immediately into a Phase II program with the same variant. Okay. Is this system being set up kind of like the influenza vaccine is, where you're not going to have to basically do animal studies again every year with a different variant, you're just going to be able to plug it in and, and use... Correct. that, whichever variant. Okay. That's, what I mentioned, you know, that's why we're so pleased that the FDA confirmed what we call our plug-and-play strategy. Then you don't have to redo your toxicology studies in animals when you change the cassette. Okay, great. Thanks for taking the questions. The next question comes from Kemp Dolliver, from Brookline Capital Markets. Go ahead. Great. Thank you. Just to continue on with the vaccine discussion. Do you expect you would have Phase I data in the H2 2024, given the timing of the IND filing? I believe so. Yeah, that's what we are planning to do. Bye, Kemp. Okay. All right, thank you. You had originally hoped to file the IND by the end of the year. You know, we're not talking about a significant change in the timeline, but I'm curious, does the change in the timeline reflect the timing of FDA feedback or reflect the pre-IND functions that or the IND enabling functions that you're doing now? Right. No, thank you. Yes, we, we thought we could be a bit faster with our pre-IND, with our IND filing, you're correct. I think the shift in the timelines reflect the fact that we wanted to hear, to make sure that we would pursue a variant that is the one recommended by the FDA. We wanted to wait for the June 16, VRBPAC meeting. Then, of course, you know, the FDA feedback on our pre-IND package was a bit delayed compared to what we had thought as well. That's the reason. Great. Thank you very much. Once again, if you have a question, please press star, then one. Our next question comes from James Molloy of Alliance Global Partners. Go ahead. Hi, good morning. Thank you for taking my question. Most of them answered, but I had a question on the combo with Avastin, Phase I/II, underway. What's the expectation for the, for a potential interim look for that and moving into the Phase II portion of that trial? Good morning, James. As I mentioned, this trial is under the sponsorship of the Break Through Cancer. We're supposed to have four centers enrolling patients in this clinical trial. The first center in MD Anderson is up and running. They have not enrolled the patients yet, but they, they are definitely up and running, and we are expecting the other centers to join the study in Q3, or in, yeah, I mean, maybe September- October timeframe, this year. It's a Phase I/II, which means that the first phase of this trial is really to evaluate the, you know, the dose that we need to administer to patients in combination with Avastin, and then the Phase II will come after. It's a bit difficult at the moment to give you exactly when that, when we can get first, some first data. But certainly, you know, in the course of 2024, we'll have more certainty as the new, the new centers evolve. Khrusheed, do you want to add anything to what I said? I, I know you've been talking with the investigator as well. Sure. No, you're right. I mean, the initial part, as Corinne said, is to demonstrate safety in combination with the Avastin and chemo. Once the four sites that we have targeted come on board, the Phase I portion should not take much. I don't want to put a date or time, but I think it's just starting now. Phase I portion should not take a longer time before we get into Phase II. September- October timeframe, we anticipate all sites to be on board. So another matter of perhaps, I would say, you know, three to four months after that. Okay, great. Thank you. I have sort of in my model, expectations for maybe another combo at some point with Opdivo. Is that something that you guys are still looking at for epithelial ovarian cancer? Hi, James. Yeah. I think I, I would say in theory, I believe that, you know, there is a lot of value in testing IL-12 in combination, because mechanistically, that makes a lot of sense to add, you know, an IL-12 with a checkpoint inhibitor, for instance, right? Because it's, it's all about modulating the tumor microenvironment. We might, we might think about this. I mean, you know, we do one, one thing, one, one thing at a time, right? The reason why we engaged in a combination trial with Avastin now is because we had very compelling synergistic data, in a preclinical model in mice. You know, it's not out of the question to think that a combination with a checkpoint inhibitor could be, could be an interesting trial as well. Absolutely. I know you have limited resources, as everyone does. Actually, on that point, has there been any discussion to, to the effect of, any larger pharma partners just coming in to, to partner to help, with, with the R&D? On the IL-12 program, you're asking specifically? Really, IL-12 or really across the board. Right, yes. Looking at the technology, and that's pretty good, we want to get in on that. Yes, I mean, collaboration and partnership is, will be key to our operating model. We'll certainly will, we'll seek partnerships. That's why we are so eager to get into a Phase I program with our vaccine modality, so that we can get to this proof of principle in humans. Then I'm sure that this will open doors for collaborations after that. Outstanding. Thank you for taking the questions. Thank you. This concludes our question and answer session. I would like now to turn the conference back over to Dr. Corinne Le Goff for any closing remarks. Thank you very much. As you know, we've have been using the phrase "vaccine of the future" to describe our work, and this is exactly what our vision is. It's to be the provider of safe and effective vaccines that are superior to current vaccines in terms of durability and virtual protection, that are stable at workable temperatures, that can be manufactured rapidly to respond to evolving pathogens, and offer better compliance for mass immunization with no need for a device or virus. We also believe our technology holds excellent promise in immuno-oncology. We look forward to keeping you informed of our progress for joining us, and we look forward to speaking with you again at our upcoming R&D Day event. Have a very nice day. The conference is now concluded. Thank you for attending today's presentation. You may now disconnect.