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.

Jeff? Thank you, Corinne. Details of Immunon'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. Immunon entered 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 30th 2022 indian reported a net loss of 6.1 million dollars or 87 cents per share this compares with a net loss of 5.4 million or 94 cents 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 $2.4 million, down slightly from the $2.5 million a year ago. Research and development costs associated with the development of the Placine 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 Opto Phase III study were $0.1 million in the current quarter, which represented expenses associated with closing out this discontinued study. Other clinical, CMC, and regulatory costs were $0.8 million in the third quarter of this year, compared with $1 million for the comparable period in 2021. General and administrative expenses were $3.9 million for the third quarter of 2022 compared to $2.7 million in the third quarter of 2021. This $1.2 million increase was primarily attributable to higher legal costs to defend various lawsuits filed after the announcement of the Optima Phase III study results in 2020 and higher compensation expenses resulting from the CEA secession plan announced in July 2022. Offsetting these higher G&A expenses were lower non-cash stock compensation expenses. We had non-operating income of $26,000 in the third quarter. This compared to non-operating expense of $300,000 a year ago. This improvement largely was attributable to lower interest expense under our loan facility with Silicon Valley Bank and higher income from invested capital in the current quarter. On a year-to-date basis, Net cash used for operating activities was $18.1 million, and this compares to $11.4 million in the same period of 2021. This increase was primarily due to the one-time payment of $4.5 million in interest expense related to the sale and subsequent redemption of $30 million of Series A and B convertible redeemable preferred stock in the first quarter of 2022, and another $100,000 in costs related to the special meeting of shareholders held in February 2022. This special meeting of shareholders was necessary to ensure that the company had an adequate number of authorized shares to continue funding our R&D initiatives. Excluding these one-time expenditures, cash used in operation was $13.5 million in the first nine months of 2022, which is in line with our projections. Cash provided by financing activities of $6.3 million from the first nine months of 2022 was a result of a registered direct offering in April 2022 that was priced at the market with no warrants. We also received net proceeds of $1.4 million from the sale of NLLs in February 2022. That projected cash utilization for the balance of 2022 is approximately $5 million for the fourth quarter of 2022. I will now turn the call back to Corinne.

Thanks, Jeff. In closing, I want to mention that since I joined Immunon 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 medicines 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. To ask a question, you may press star then 1 on your touchtone phone. If you're using a speakerphone, please pick up the handset before pressing the keys. At any time, If your question has been addressed and you would like to withdraw your question, please press star then two. At this time, we'll pause momentarily to assemble our roster. Thank you. And our first question comes from Emily Bodnar from H.G. Wainwright. Please, Emily, go ahead.

Hi, good morning, and thanks for taking the questions. 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 a 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 Moderna variant? vaccine boosters, or are you kind of waiting to see if a 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 this question. 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, right? 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, will have the conversation with the FDA about the kind of variants they want to look at, what could be of interest moving forward. So that's the discussions we're going to have with them. Krishan, you might want to add a few things.

Yeah, no, exactly. Karine, as you know, the new variants are emerging. They are BQ.1, BQ.1.1, XBB on 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 yourself?

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

Okay. Maybe the last question. Could you just discuss the ACUTUS agreement a bit more and how you're kind of planning to utilize their LMP delivery system, would you use utilize that in your COVID program? Or are you kind of looking to do that more on the cancer side?

Thanks. If you want to comment on this one?

Sure. Yes. So, Emily, as we've said earlier, that we have very impressive data with the current formulation that we have with SARS-CoV-2. On the basis of these encouraging data, we 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're proposing to go forward for SARS-CoV-2 as we know today, but clearly LNP will give us a little bit more breadth and further potential for either route of delivery or different pathogens to have that under our belt. It's mostly a platform sort of expansion.

Okay, got it. Thanks so much.

You're welcome.

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

Hey, guys. Thanks for taking my questions. I had a question on the Equitas Therapeutics Agreement you guys originally signed. Any monetary considerations that go back and forth between the two of you or any sort of hard and fast lockups on the deal? No.

So right now, Jim, the agreement with them is more of an 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 systems. At this stage, it's more 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 if that works well with plasma DNA as well. So very exploratory at this stage.

Understood. Thank you. And could you characterize how the partnership environment looks For the Placine DNA, is there, and perhaps, you know, lay out the landscape a little bit. Who's sort of the closest competitor for anyone to you guys in the DNA space? And who's, you know, seems to be most interested or potentially could be most interested or would be ideal for you guys to sign up as a partner for Placine going forward if things progress as you hope they will?

Yeah, Gene, that's a very good question. You know, I think... And maybe I can convey the discussions we had with BARDA the other day last week, because I believe that we have made a lot of progress in the name of DNA. And they were quite impressed with our results in terms of delivery and gene expression. And that opens the door to a completely new class of medicines, starting with prophylactic vaccines for sure, as we showed to them, you know, that was the purpose of our conversation with them was to show them the potential of the Smith DNA in the fight 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.

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

Absolutely, couldn't agree more. Thank you for taking the questions. You're welcome.

At this time, I'd just like to remind you, if you would like to pose a question, press star 1. And we now have a question from David Botts from Zach Small Cap Research. David, please go ahead.

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

Yeah.

Yes, Kirshen, 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 in 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 bisestronic or bivalent vaccine, we have seen activity, effective vaccination against both variants, but with the commercial vaccine, the IgG levels or neutralizing antibodies are not as effective against a mutated variant, because those vaccines are for a wild-type virus. And clearance-wise, similar clearance, as Corinne had said in the remarks in her statement, that 95 to 99% So we compare head-to-head in NHB with commercial mRNA. Clearance is very comparable or similar. In terms of the duration, that's an important point. We have initiated a durability study where we're looking at neutralizing antibody responses following placene. 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 month duration. It's an ongoing study, so we hope to collect data beyond that. And just to add a little bit more about an RNA comparison, as you kind of pointed out, The stability study also that's ongoing, six-month data shows that stable at four degree, and that, you know, it's advantageous of an mRNA vaccine. So, yes, we are making some comparisons, and that's the results so far, and we hope to have more characterization of our responses with Plessy.

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. Boris to comment. But as you know, it's a one-to-one randomized open trial, so we have some data cuts that we can discuss when the time is right and when the data is mature enough.

Yeah, 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, you know, 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 the 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 LeGoff 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 Elias Global Partners virtual conference on November 30th and December 1st. 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 J.P. Morgan Healthcare Conference during the second week of January. Please contact our IR firm, LHJ, to schedule a 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.