Good morning. My name is Marliese, and I will be your operator today. At this time, I would like to welcome you to Imunon's Third Quarter 2022 Financial Results Conference Call. All lines have been placed on mute to prevent any background noise. Following the speakers' prepared remarks, there will be a question-and-answer session. [Operator Instructions] I would now like to turn the call over to Kim Golodetz Investor Relations representative. Please go ahead.

Thank you, and good morning, everyone. This is Kim Golodetz with LHA. Welcome to Imunon's Third Quarter 2022 Financial Results and Business Update Conference Call. As has been Imunon'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 Imunon'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 Imunon'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 14, 2022. 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, 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. Khursheed Anwer, our Chief Scientific Officer; and Dr. Nicholas Borys, our Chief Medical Officer, will be available during the Q&A session to answer your questions regarding our development programs with PLACCINE or prophylactic vaccine modality and GEN-1, our IL-12 immunotherapy for the treatment of advanced ovarian cancer. Today, I am going to spend most of my time speaking about PLACCINE. As our recent progress in developing this modality has been extraordinarily robust. PLACCINE is one of Imunon’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 the pathogen or multiple variants of the same antigen. Imunon has produced a family of DNA vaccine vectors expressing one of more SARS-CoV-2 surface antigens, and we have demonstrated expression of the uncoated genes. This promising vaccine approach has brought 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…

Thank you, Corrine. Details of Imunon's third quarter 2022 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 third quarter of 2022 with $43.4 million in cash, investments restricted cash and accrued interest receivable, along with future planned sales of the company's state of New Jersey net operating losses, we believe we have sufficient capital resources to fund our operations into early 2025 at our current spending rate. Over the past four years and without any dilution to our shareholders, we have raised over $16 million from NOL sales, and we have a further $3.5 million of unused NOLs available for sale over the 2022 to 2024 time period. We are in an exit position with respect to liquidity to support operations through several important value-creating milestones. Let me now turn to our third quarter and year-to-date financial results. For the quarter ended September 30, 2022, Imunon reported a net loss of $6.1 million or $0.87 per share. This compares with a net loss of $5.4 million or $0.94 per share for the third quarter of 2021. Operating expenses were $6.3 million for the third quarter of 2022, which is up $1.1 million or 21% from the third quarter last year. Breaking this down by line item. Research and development expenses were up $2.4 million, down slightly from the $2.5 million a year ago. Research and development costs associated with the development of the plasmid DNA vaccine platform as well as the GEN-1 OVATION 2 study increased to $1.5 million for the current quarter, up slightly from the $1.3 million a year ago. Costs associated with the OPTIMA Phase III study were $0.1 million in the current quarter, which represented expenses…

Thanks, Jeff. In closing, I want to mention that since I joined Imunon back in the summer, I have been so highly impressed by the commitment of our talented scientists, clinicians and staff to bring a new class of medicine to patients and the medical community. In doing so, we will also create great value for our shareholders. So with that overview of our business and our recent financial results, we are ready to open the call to your questions. Operator?

Thank you very much. We will now begin the question-and-answer session. [Operator Instructions] Thank you. And our first question comes from Emily Bodnar from H.C. Wainwright. Please Emily, go ahead.

Hi, good morning and thanks for taking my question. I have a couple. So I want to talk about the COVID program, and you kind of mentioned your plans to evaluate the vaccine and the new booster. So can you just discuss if you need to show proof-of-concept in one of the established variants first prior to doing a clinical study for a booster program? And are you kind of looking to evaluate an Omicron variant similar to the Pfizer and the Moderna vaccine boosters – or are you kind of waiting to see some new variant approaches? And are you still planning to seek a partner for this program? Or are you kind of at this point looking to evaluate it yourself?

Thank you, Emily, for these questions. So as I mentioned, we now have, we believe, a modality that is strong enough to stop thinking about an IND for COVID booster, which seems obviously logical because most of the world population has either been vaccinated or had the infection – so that's our focus and potentially another IND for another pathogen. Now what we want to do, obviously, is to have a pre-IND meeting with the FDA. And that will drive how we go about developing this booster strategy. But what you mentioned is correct. We also obviously, we have the conversation with the FDA about the kind of variance they want to look at what could be of interest moving forward. So that's the discussions we're going to have with them. Khursheed, you might want to add a few things.

Yes. No exactly, Corinne. As you know the new variants are emerging. They are the BQ.1, BQ1.1, XBB on horizon. So clearly, we will be getting some feedback from FDA on what's more – what makes sense in terms of combination. We do have Omicron combination with Delta, preclinical studies ongoing with BA.1. But clearly, as Corinne said, we need some feedback from FDA on that. But our research is ready to plug in any variant that would be of interest to go forward as a booster.

Got it. Okay. And are you still seeking a partner for the COVID program? Or do you think you would move forward yourselves?

Yes. So yes, we definitely would like to seek partnerships in the future for [indiscernible] developments simply because, as you know, developing a vaccine clinically takes resources in many patients. We now feel that we have enough data from our PLACCINE modality so that we can seek partnerships. As I mentioned, our NHP study is still ongoing. So we'll have the final results by the end of the year.

Okay. And maybe a last question. Could you just discuss the Acuitas agreement a bit more and how you're kind of planning to utilize their LNP delivery system? Would you utilize that in your COVID program? Or are you kind of looking to do that more on the cancer side? Thanks.

Khursheed, if you want to comment on this one?

Sure. Yes. So Emily, as we have said earlier that we have a very impressive data with the current formulation that we have with SARS-COV-2 on the basis of these encouraging data, we're really considering expanding our platform and maybe different routes of delivery. So that's why we want to expand our portfolio, not letting any stone unturned. So LNP, as you know, there's a commercial vaccine. So right now, this is more of a platform enrichment approach to see what we can do with LNP with plasmid DNA. But currently, our formulation, we are proposing to go forward for SARS-COV-2 we know today. But clearly, LNP will give us a little bit more breadth and further potential for either the delivery or different pathogens to have that under our belt. It's mostly a platform sort of expansion.

Perfect. Got it. Thanks so much.

And we have a question now from James Molloy from Alliance Global Partners. Jim, please go ahead.

Hey guys. Thanks for taking my questions. I had a question on the Acuitas Therapeutics agreement side, any monetary considerations that go back and forth between interior or any sort of hard and fast lockups on the deal?

Khursheed, do you want to comment to that?

Yes, sure. Of course. So right now, Jim, the agreement with them is more exploratory. So we will be looking at their technology for fit with plasmid DNA. As you know, there's a lot more information of LNP and mRNA-based system. So at this stage, it's more of to see if that's valuable for us in an exploratory model and setting an agreement. And if there's attractive data, then we can discuss other terms such as monetary as you said. But right now, it's very much to see how that works well with plasma DNA as well. It's very exploratory at this stage.

Understood. Thank you. And could you characterize how the partnership environment looks for the PLACCINE DNA? And perhaps the landscape a little bit to sort of the closest competitor, if anyone to you guys in the DNA space, and who's the most interest or potentially could be most interested? Or will be a deal for you guys to sign up as a partner for PLACCINE going forward if things progress as you hope they will?

Jim, that's a very good question. I think and maybe I can convey the discussions we had with BARDA the other day last week because I believe that we are – we have made a lot of progress in the name of DNA, right. And they were quite impressed with our results in terms of delivery of gene expression. And that opens the door to a completely new class of medicines, starting with prophylactic vaccine for sure as we show to them, that's what the purpose of our conversation with them was to show them the potential of plasmid DNA in the site of new pathogens. So yes, there is great interest from BARDA, but also from other players in looking at new technologies that will address the changing world of pathogens going forward.

Yes. If I may add, so the current DNA landscape, Jim, is device-based and for vaccine, of course, prophylactic vaccine, it's very hard to have a masses with some sort of devices with some – not as good compliance. There's one approved device based vaccine in India as there are viral vectors to deliver DNA vaccine that has its own complications viral based. So our approach is devoid of our independent devices and viral vector. So yes, I think it's getting great it's attractive because of not having device or viruses. So that's the landscape device and vital base and here we are with more safer and better compliant approach. So I think that's – we hope to get more traction in terms of partnership where there's more need for more safer and better compliant delivery of DNA vaccine?

Absolutely. I couldn't agree more. Thank you for taking the questions

Welcome.

[Operator Instructions] And we now have a question from David Bautz from Zacks Small-Cap Research. David, please go ahead.

Hey, good morning everyone. I have a couple of questions on PLACCINE. How did the antibody and T cell responses compare between the PLACCINE vaccinated animals and the mRNA vaccinated animals. And I'm also curious if you have any data for how long animals immunized with PLACCINE were still making antigen. Basically, I'm trying to see how long that the vaccine stays active following immunization. Thanks.

Yes.

Yes. Khursheed, please go ahead.

Thank you, David. Good. Very important questions. So we have done a side-by-side comparison with the commercial mRNA vaccine, both in rodents and non-human primates in preclinical studies. In rodents, we have seen very comparable IgG levels and T cell responses. The benefit we have seen is with our biosystronic or bivalent vaccine, we have seen activity effective vaccination against both variants. But with the commercial vaccine, the IgG levels of neutralizing antibodies are not as effective against a mutated variant because those vaccines for wild-type virus. And clearance-wise, similar clearance, as Corinne had said in the remarks in our statement that 95% to 99% clearance. So we compare head-to-head in NHP with commercial mRNA, clearance is very comparable or similar. In terms of the duration, that's important point, we have initiated durability study where we're looking at neutralizing antibody responses following PLACCINE. And we've been testing two single antigen vectors and one bivalent vector, and we are into eight months now, and we have not seen any significant drop in neutralizing antibodies at eight months duration, its ongoing studies, so we hope to collect data beyond that. And just to add a little bit more about mRNA comparison, as you kind of pointed out, the stability study also that's ongoing six-month data shows at stable at four degree and that is advantageous over mRNA vaccine. So yes, we are making some comparisons and that's the result so far, and we hope to have more characterization of our responses with PLACCINE.

Okay. Great. And a quick question on the OVATION 2 study. What updates, if any, should we expect between now and the release of the data on the primary outcome?

Thank you, David, I'll ask Dr. Borys to comment. But as you know, it's a one-to-one randomized, open trial. So we have some data costs that we can discuss when the client is right and when the data is mature enough.

Yes. Thank you for that question on the OVATION 2. So as Corinne announced today, we had an interim analysis of our data. We're at about midpoint in terms of our data collection, about 50% of our primary endpoint was collected. And as Corinne announced, we're seeing good activity, and it gives us confidence to move forward in the studies that she mentioned. Moving forward, again, she announced that we expect the final data. Our statisticians project in around the middle of 2024. And we will be doing data cuts meanwhile. So we haven't made an announcement yet on when our next data cut will be, but we will share that as soon as that's been established.

Okay. Thanks for taking my questions.

Thank you, David.

Thank you. And this concludes our question-and-answer session. I would like to turn the conference back over to Corinne Le Goff for any closing remarks.

Thank you. Thank you all for your time this morning. I trust we conveyed our excitement about the potential for our platform technologies. We look forward to keeping you informed of our progress. Please note that we will be participating in ELIA's Global Virtual Conference on November 30 and December 1. Please contact AGP, if you would like a one-on-one meeting, and we hope to see some of you in San Francisco as we prepare to hold one-on-one meetings concurrent with the JPMorgan Healthcare Conference during the second week of January. Please contact our IR firm, LHA, to a scheduled meeting. We will speak with you again when we report our 2022 fourth quarter financial results in March. Have a very nice rest of the day. Thank you.

And the conference has now concluded. Thank you for attending today's presentation. You may now disconnect.