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spk03: 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.
spk02: 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?
spk00: 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.
spk04: Thank you, Corinne. Details of Immunon'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. Immunon ended the first quarter of 2023 with $37.3 million in cash and investments. Cash provided by financing activities of $2.5 million during the quarter was from equity sales 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 plan 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 biotechs. That said, our long-term growth plans do include raising funds from both equity and non-dilutive 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 operation. This compares with $8 million in last year's first quarter. This decrease in the use of funds was primarily due to the one-time payment in the prior year quarter of $4.5 million in interest and offering expenses resulting from the sale and subsequent redemption of $30 million of convertible redeemable preferred stock. Let me now turn to our financial results. For the first quarter of 2023, Immunon reported a net loss of $5.6 million or 68 cents per share. This compares with the net loss for the first quarter of 2022 of $10.5 million, or $1.82 per share. Operating expenses were $5.7 million in the first quarter of 2023, which is down 5% from $6 million in the first quarter of 2022. Breaking expenses down by line item, research and development expenses were $2.6 million in the first quarter of 2023, a decrease of a half a million dollars from the 3.1 million from the prior year's first quarter. More specifically, R&D costs associated with the development of the Plastine DNA vaccine technology platform, as well as the Ovation 2 study, decreased slightly to 1.7 million dollars compared to 1.9 million in the year ago. Other clinical and regulatory costs were 0.3 million dollars compared to 0.8 million in the prior year. CMC, or manufacturing costs, increased to $0.7 million from $0.3 million a year ago due to higher costs related to the development of in-house pilot manufacturing capabilities for DNA plasmids and nanoparticle delivery systems. General administrative expenses were $3.1 million in the first quarter of 2023, which compared to $2.9 million in the comparable prior year period. is primarily attributed to lower non-cash stock compensation expense offset by higher professional fees, including legal fees to defend various lawsuits filed after the announcement in July 2022 of the Optima Phase 3 study results, higher compensation expenses related to the CEO succession plan that we announced last July, and higher overall staffing costs. Other non-operating income was $93,000 in the first quarter of this year, which compared to other non-operating expenses of $4.6 million in the prior year period. In the first quarter of 2022, the company incurred one-time charges of $4.5 million, which I had mentioned related to the preferred stock offering that I talked about earlier. In addition, the company incurred higher interest expense on its loan facility with Silicon Valley Bank in the first quarter due to rising interest rates. This loan facility has since been assumed by First Citizens Bank under the same terms as the previous loan facility. On April 21, 2023, the company elected to repay this loan to First Citizens Bank for a total payment of $6.4 million, which included principal, interest, prepayment fees, and end-of-term payments. The $6 million collateral account, which we had classified on our balance sheet as restricted cash, was released and utilized to pay off the loan. Interest income from the company's short-term investments increased by $0.3 million in the first quarter of 2023 compared with the prior year, due to higher returns on our short-term investments. As I indicated last quarter, we continue to expect operating expenses for the year to be approximately $20 to $22 million for the full year of 2022, with the majority of expenses related to the development of our Placine next-generation vaccine modality. I will now turn the call back over to Corinne.
spk00: Thanks, Jeff. We have been using the phrase 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 non-viral plasmid DNA technology across a broad array of human diseases. We are starting in immunology 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 late-phase clinical trials to partners with the resources to conduct 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?
spk03: We will now begin the question and answer session. To ask a question, you may press star then 1 on your telephone keypad. If you are using a speakerphone, please pick up your handset before pressing the keys. To withdraw your question, please press star then 2. At this time, we will pause momentarily to assemble our roster. Our first question is from Emily Bodner with HC Wainwright. Please go ahead.
spk01: Hi there, thanks for taking the question. 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 vaccinated as much. So curious how you think about long-term use of a COVID vaccine. It sounds like based on your commentary, you could potentially initiate a phase one study in early 2024. Does that timeline sound reasonable? Thanks.
spk00: Thank you, Emily, for your questions. Regarding the pre-IND meetings, we sent, as I mentioned, our pre-IND package 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 questions, yes, we would be in the position of filing an IND at the very end of the year. potentially starting the phase one 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 VRPAC 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 four to six months. And the process they proposed is that in June, they would select the strain to be put into manufacturing for the vaccine's 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 it's specifically in certain population of patients, namely the elderly population or the patients that are immunocompromised 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.
spk03: Again, if you have a question, please press star then one. The next question is from James Molloy with Alliance Global Partners. Please go ahead.
spk05: Hi, Dr. O'Gough. Thank you for taking my question. My question is on the fourth quarter next and the final. Is that a little delayed from where it had been previously?
spk00: Tim, you're breaking up. I don't know if my colleagues could hear you better. Do you mind repeating?
spk05: I apologize. I'm on a cell phone. Can you hear me okay?
spk00: No, I can. Yes.
spk05: Thank you very much. Thank you. On the plasticine development, the IND filing fourth quarter of this year, is that on track or has that been delayed a little bit from previous?
spk00: It is on track. It is.
spk05: And then when looking at the top-line data coming out mid-next year, how do you help us handicap, you know, whether the equivocal data, good data or bad data? And will you anticipate seeing it coming out mid-next year?
spk00: So, regarding the top-line data for our Vision 2 program, you know, 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, an event being a patient progressing. But what we showed at that point in time is that we actually showed good signals in terms of R0 rates and CRS3, which is encouraging, but from those early data, you cannot conclude anything really. So we'll 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, a bit more indications there as well.
spk05: And you mentioned partnerships. How would you characterize the partnership environment currently?
spk00: 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. And we've had the opportunity to present our data to BARDA, for example, back in November. Subsequent to this TechWatch 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. We are quite pleased with the partnership that we have currently in place.
spk01: Great. Thank you for taking my question.
spk03: This concludes our question and answer session. I would like to turn the conference back over to Dr. Lagoff for any closing remarks.
spk00: Thank you. Thank you all for your time this morning. I trust we conveyed our excitement about the potential for platform technologies. We look forward to keeping you informed of our progress. Have a very nice afternoon. Thank you.
spk03: The conference is now concluded. Thank you for attending today's presentation. You may now disconnect.
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