Good morning, and welcome to the Imunon First Quarter 2023 Financial Results Conference Call. [Operator Instructions] Please note, this event is being recorded. I would now like to turn the conference over to Kim Golodetz. Please go ahead.

Thank you, and good morning, everyone. This is Kim Golodetz with LHA. Welcome to Imunon's 2023 First Quarter 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, May 11, 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. Joining me today 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. Today, I will provide an update on our development programs with places, 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. Imunon is tightly focused on harnessing the power of the immune system by developing novel DNA-based approaches in immuno-oncology and infectious disease. We believe that nonviral DNA will be a key driver of the future of global medicines. I say that because nonviral DNA has the potential to help create an unprecedented abundance and diversity of medicines that are currently beyond the reach of recovered and 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 nonviral 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…

Thank you, Corinne. Details of Imunon's first quarter 2023 financial results were 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 first quarter of 2023 with $37.3 million in cash and investments. Cash provided by financing activities of $2.5 billion during the quarter was from an equity sales under our at-the-market equity facility. We also received net proceeds of $1.6 million during the quarter from the sale of our 2021 New Jersey net operating losses, which leaves us with about $1.9 million remaining of these NOLs to sell later this year. Including these future planned NOL sales, the company believes it has sufficient capital to fund its operation into 2025, which will take us through several important value-creating milestones. The comments I delivered about the public equity markets during our fourth quarter conference call in late March are still relevant. Over the past few years, we have been opportunistic with respect to raising cash, and this leaves us in a much better position than many other development-stage biotech. That said, our long-term growth plans do include raising funds from both equity and nondilutive sources of capital, including the collaboration and partnerships Corinne mentioned earlier in this call. We continue to monitor the public equity markets with the hope that markets will begin to improve shortly. During the first quarter of 2023, we used $4.1 million in cash to fund operations -- this compares with $8 million in last year's first quarter. This decrease in the use of funds was primarily due to the onetime payment in the prior year quarter of $4.5 million in interest and operating expenses resulting from the sale and subsequent redemption of $30 million of convertible redeemable preferred stock. Let…

Thanks, Jeff. We have been using the phrase or vaccine of the future to describe our work, 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 breadth of protection, stability at workable temperatures, rapid manufacturing to respond to evolving pathogens and better compliance for mass immunization with no need for a device or a virus vector. I am delighted with our progress in support of this vision, which calls for the creation of a new category of medicines based on our nonviral plasmid DNA technology across a broad array of human diseases. We are starting in immuno-oncology and infectious diseases, and we will continue to invest to fully characterize the platform and to advance the technological frontier of plasmid DNA. We will leave large let a clinical trials to partners with the resources to contact them, and we will view each program with an eye toward a licensing transaction. In doing so, we will also expect to create considerable 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?

[Operator Instructions] Our first question is from Emily Bodnar with H.C. Wainwright.

I'm curious if the pre-IND meeting with the FDA was scheduled already? Or has that already occurred? And then maybe if you could just comment on how you think about the market opportunity for a seasonal COVID booster now that people aren't really getting vaccines as much. So curious how you think about long-term use of Covid vaccine. And then it sounds like based on your commentary, you could potentially initiate a Phase I study in early 2024. -- that time line unreasonable?

Thank you, Emily, for your question. So regarding the pre-IND meeting. So we said, as I mentioned, our preendpackage in March. We do not necessarily expect a meeting, we expect definitely a feedback from the FDA that will come this month, I believe, in May. As you know, the FDA does not grant a lot of pre-IND meetings anymore. So that's the expectation. And if everything is on schedule, then to go to your last question, yes, we would be in the position of filing an IND at the other end of the year, potentially starting the Phase I even this year, if possible or early next year. So that's our plan. You are asking also about the market opportunity for seasonal booster. So yes, there is a great demand from regulators, which has been expressed by the FDA early this year. You might remember that the FDA had a VPAC meeting in January. -- where they specifically requested that moving forward, that the COVID boosters be seasonal, so only once a year, not a boost every 4 to 6 months. And the process they propose is that in June, they would select the strain to be put into manufacturing for the vaccines, the boosters to be available for the fall and winter season. So in that context, there is obviously a market for COVID booster that is more durable than the current commercial vaccines. And you can imagine that specifically in certain population of patients namely the elderly population or the patients with -- that are Imunon compromised for some reason in the same way as the flu vaccine, a COVID vaccine will be necessary. I want to point out as well that as I mentioned, the fact that we are looking at developing a vaccine that would demonstrate good cellular immunity would be a plus in this population of patients.

[Operator Instructions] The next question is from James Molloy with Alliance Global Partners.

My question is on the fourth quarter next -- and final, is that a little light from what it had been previously? On the [indiscernible], the IND filing fourth quarter of this year. Is that on track? Or has that been delayed a little bit from previous...

Yes, it is in flex. It is.

And then when we're looking at the top line data coming out mid next year, how do you help us handicap what the [indiscernible] data, good data or bad data and would you anticipate seeing coming up next year?

So regarding the top line data for our OVATION 2 program, we'll see the results that we get. As you might remember, Jim, that we showed early cut of data that we did back in September. So again, it was very mature data because we only had 50% of the events, right, an event being a patient progressing, right? But what we showed at that point in time is that we actually showed good signals in terms of [indiscernible] rates and CRS 3 which is encouraging. But from those early data, you cannot conclude anything really. So we have another cut of data this year when we reach about 75% of the events. That's what we are planning to do, which should give us another bit more indications there as well.

Then you mentioned partnerships, how would you characterize the partnership environment currently?

The partnership environment, So we are I think the partnership environment, I don't think that I can characterize the environment of partnerships. I can only reflect on the interest that we get on our technology, right? And we've had the opportunity to present our data to BARDA, for instance, an example, back in November. Subsequent to this [indiscernible]meeting, we had further conversations with the agencies, the government agencies, even as recently as this week, in fact, -- and I can tell you that there is interest in this technology for the development of the next generation of vaccines because as I mentioned during the call, there's a number of features that are of interest in developing the future vaccine. So we see interest for sure. And the collaborative work that we have ongoing with the Wistar Institute is very productive. So we are quite pleased with the partnership that we have currently in place.

This concludes our question-and-answer session. I would like to turn the conference back over to Dr. 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. Have a very nice afternoon. Thank you.

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