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spk02: Hello everyone. Good morning. My name is Mello and I will be your operator today. At this time, I would like to welcome you to Immunon's third quarter 2024 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 might press star and one 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, let's start and want to ask a question during the Q&A session. I would now like to turn the call over to Kim Golodetz. Please go ahead.
spk01: Thank you and good morning, everyone. This is Kim Golodetz with Alliance Advisors IR. Welcome to Immunon's third quarter 2024 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, 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. Sorry. I also caution that the content of this conference call is accurate only as of the date of the live broadcast, November 7th, 2024. 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. Stacey Lindborg, Immunon's President and Chief Executive Officer. Stacey?
spk07: Thank you, Kim, and good morning, everybody. I'd like to begin by noting that Michael Tardigno, the Executive Chairman of our Board, and Krishid Anwar, our Chief Scientific Officer, are both on the line and will be available for Q&A. David Gallero, our Interim Chief Financial Officer, will review our financial results following my remarks. Let me start with a punchline and a groundbreaking milestone for Immunon. On July 30th, we announced the results from our large randomized phase two study, Ovation 2, which has the potential to set a new standard in cancer research. This large randomized study involving 112 newly diagnosed patients with advanced ovarian cancer not only exceeds expectations, but also marks an unprecedented achievement in oncology. An improvement in median overall survival 11.1 months, nearly a year compared to the standard of care, a clinically meaningful and unprecedented improvement in first-line treatment. For women who were administered PARP inhibitors in the Immunon arm, the median overall survival was not yet reached at data lock, indicating that more than half of the patients in the Immunon arm are still with us, with some women approaching the five-year mark since trial initiation. Importantly for those receiving at least 20% of the planned Immunon 001 doses, survival increased by a remarkable 17 months. These outcomes are particularly significant in a patient population that has not witnessed an advancement in frontline therapy, which extends patients' lives for over 25 years. More crucially, Ovation 2 is the first study ever to demonstrate an improvement in overall survival in this context. For a deeper dive and to better understand these outcomes, I encourage you to visit our Ovarian Cancer R&D Day presentation from September 18th. which is available on our website under the News and Investors tab and then Scientific Presentations. This R&D day features insights from studies, principal investigators, esteemed thought leaders, and distinguished Harvard statistics professor and a former NIH and National Cancer Institute IL-12 researcher. Their endorsements are compelling, and a testament to the significance of the Ovation 2 results. You can listen to the entire program or target specific talks, and I promise it will be well worth your attention. We also announced today the presentation of additional data from Ovation 2 study at the Society for Immunotherapy of Cancer, or CITC, the 39th annual meeting taking place in Houston, Texas. The Ovation 2 results were so compelling that they accepted our presentation as a late-breaking poster at the meeting after the deadline had passed. Results are being presented at the meeting tomorrow by Dr. Jennifer Scalise from Emory University of Medicine, the School of Medicine. This is an exceptional opportunity to build awareness and broader awareness of Immuno-01 and our Phase II trial results. among peers and experts in the oncology field. Drilling into the data further, we observed consistent benefits in the trial across multiple study endpoints. This includes an early treatment effect as shown by progression-free survival, chemotherapy response scores, surgical response scores, and most importantly, in a sustained way through overall survival. These data are all in the intent to treat population of 112 patients. We expect to report supportive translational data from the trial shortly. In summary, the clinically meaningful results with Immunona 01 are truly remarkable and consistent. Furthermore, the safety profile has been consistently benign and easily managed. The unmet patient need is very high. This is a terrible and difficult to treat cancer, with more than a quarter million women diagnosed with the disease globally each year. In the U.S., there are more than 20,000 new diagnoses and about 13,000 deaths every year. Ovation 2 accomplished the desired outcome, and we know the data were sufficiently strong that our scientific advisory board unequivocally recommends proceeding to a registration phase three trial. with the dose studied in phase two. The support of the scientific advisor award was unanimous and unwavering. On a commercial note, our prospective product pricing assumptions suggest a U.S. market opportunity for ovarian cancer that exceeds 1.6 billion annually, which is far greater as we consider other geographies and clearly in blockbuster territory. We've been saying all along that the Phase II outcome was not unexpected. Ovation 1, a Phase I study in the same population, demonstrated unambiguously through translational data that our TheraPlas technology works. The trial showed immunodriven increases in anti-cancer cytokine levels, such as IL-12 and interferon gamma, and decreases in immunosuppressant biomarkers. such as FOXP3, PD-1, PD-1L, and IDO1. In fact, the breadth of translational data from this trial is more than I can highlight given our time today, and I would encourage you to explore them further through the Ovation 1 manuscript. In short, Ovation 1 provides evidence that TheraPlas works by effectively recruiting the patient's own immune system to fight cancer. Ovation 1 also provides a dose-dependent trend in clinical improvement and an acceptable Immunon safety profile with virtually no overlapping toxicity with chemotherapy treatments. For those who follow Immunon closely, you know that what makes Immunon-001 unique is the THERAPLUS technology. Immunon-001 is a non-viral gene therapy which delivers IL-12 directly into the microtumor environment, causing multiple fold increases. and interferon gamma and those of other important cytokines. And furthermore, producing never yet before seen overall survival data. The gene delivery at the tumor site minimizes the toxicity that others have seen with systemic IL-12 injections. And our approach has unlocked the door to new treatment frontiers with IL-12 and is generating new hope for patients with ovarian cancer. Turning to the concept of statistical significance, I want to highlight for just a moment the presentation at our R&D day by Dr. L.J. Wei of Harvard University. Dr. Wei pioneered a statistical approach that combines information across study endpoints for a more comprehensive evaluation of our treatment. He published this method in journals such as New England Journal of Medicine and JAMA, specifically with the methodology applied to oncology studies. If you're short on time, I suggest you prioritize Dr. Wei's presentation. He independently analyzed Ovation 2 data, combining information from two Kaplan-Meier curves, progression-free survival and overall survival, calculating the area under the curve and generating the average time lost due to both undesirable events, ovarian cancer, which would be cancer progression and death. Dr. Wei's approach has also been successfully used in cardiology and other additional cancer studies. And the end result of his analysis showed that iminona O1 had a reduction in the area under the curve with a significant p-value of 0.0375. His analysis provided statistical evidence that the effect observed in ovation 2 is likely to be driven by true treatment effect. His analysis gives us added confidence in the ability to replicate Ovation 2 findings in Phase 3. So where are we with respect to advancing the development of Immunon-001? Interactions with FDA are proceeding well, and we have asked the agency for an end of Phase 2 meeting and will meet with them before the end of the month. Assuming an agreement with the agency, we remain on track to begin our Phase III registration trial in the first quarter of 2025, and we are carefully identifying the requisite capabilities. As we are planning it, we expect that the Phase III trial will enroll approximately 500 women with advanced ovarian cancer and will evaluate iminon-001 in the study design that's very similar to Phase II. Inclusion criteria are likely to include newly diagnosed patients of at least 18 years of age that are candidates for neoadjuvant chemotherapy with histological evidence of epithelial, ovarian, fallopian tube, or primary peritoneal carcinoma with stage 3C and 4, and a performance score of 0, 1, or 2 by Eastern Cooperative Group, or ECOG, criteria. The primary endpoint is expected to be overall survival, but of course, the final protocol will be finalized with guidance from the FDA. Now to the ongoing MRD study, which is principally funded by the Breakthrough Cancer Foundation. The study is evaluating iminon-001's potential to eliminate minimal residual disease, or MRD, as determined by second look laparoscopy. We're studying this when iminon O1 is administered in combination with bioequivalent Avastin and NA-CT in subjects newly diagnosed with advanced ovarian, flipping tube, or primary peritoneal cancer. MRD is prognostic for cancer recurrence and as an endpoint may be able to determine the impact of treatment early in the disease. An update on the study was provided by the study principal investigator, Dr. Amir Jazari, of MD Anderson Cancer Center at our recent ovarian cancer R&D day. The study recently added additional clinical trial sites including Memorial Sloan Kettering Cancer Center and Johns Hopkins University. And as the first few patients have now reached second look laparoscopy, Dr. Daziri will conduct a pilot study to test circulating tumor DNA levels in plasma and peritoneal fluid following treatment using a next generation DNA assay. The goal is to determine the impact of both iminon and bioequivalent Avastin on MRD, understanding that positive MRD patients have worse outcomes. Switching topics, let's now turn to the phase one proof of concept study for iminon 101, which utilizes our Placine platform as a seasonal COVID-19 booster vaccine. During the second quarter of 2024, we began enrolling participants in the study, which is now fully enrolled and all treatments completed. We believe the anticipated immunogenicity data, along with superior handling logistics of the Plastine platform, differentiate our vaccine. And we are on track to complete phase one and report data before the end of the year. We've kicked off BD activities and will actively seek a partner to continue development. Recall this trial was not intended to move forward a vaccine in COVID, but instead to serve as a vehicle to efficiently demonstrate proof of concept on this platform. With more than 80 new pathogenic viruses discovered since the 1980s, for the right partner, this is an exciting product that can proceed in a multitude of strategic directions. As we gear up for our phase three trial with Immunon 001 and report top line data from Immunon 101, we've made two strategic hires to fortify our capabilities. These appointments have been meticulously considered to address critical needs at this crucial juncture for Immunon. We hired Kristen Longabardi as Senior Vice President of Strategic Operations. Kristen joins us with over two decades of exceptional experience in enhancing business processes and operations across the biotech and pharmaceutical sectors. Most recently, she served as Vice President of R&D Quality Operations and Performance at Biogen. We expect Kristin to play a vital role in planning the conduct of the phase three study, making sure it stays on track and on budget. In addition, we hired Susan Aulog. As general counsel and corporate secretary, Susan brings a depth of legal acumen to our team with a background that includes senior counsel at Science 37 and various other senior legal roles. Our goals include partnering some of our products, for example, Immunon 101, and as in-house legal counsel, Susan will play an important role in ensuring the soundness of any agreement we enter into, while also reducing the extraordinary legal cost burden typically incurred in the biotech industry. And now I'd like to turn over the call to Dave Gallero, to review our financial results for the third quarter and year to date. Dave?
spk00: Thank you, Stacey. Details of Immunon's third quarter 2024 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. As of September 30th, 2024, Immunon had $10.3 million in cash and cash equivalents. With our continued focus on strategically managing our cash while continuing to advance our programs, we expect our capital resources to fund operations into the third quarter of 2025. Research and development expenses were $3.3 million for the third quarter of 2024, compared with $2 million for the third quarter of 2023. The increase was driven primarily by increased clinical spend related to Ovation 2 and the Placidine trial. General and administrative expenses were $1.7 million in the third quarter of 2024, as compared with $1.9 million in the third quarter of 2023. Our net loss was $4.9 million, or $0.34 per share, for the third quarter of 2024, as compared with a net loss of $3.5 million, or $0.37 per share, for the third quarter of 2023. Turning briefly to financial results for the first nine months of 2024, research and development expenses were $9.4 million for the first nine months of 2024, compared with $7.7 million for the first nine months of 2023. The increase was driven primarily by increased clinical spend related to Ovation 2 and the Placine trial. General and administrative expenses were $5.6 million for the first nine months of 2024, as compared with $7.3 million for the first nine months of 2023. The decrease in G&A expenses in the first nine months of 2024 compared with the first nine months of 2023 was primarily driven by decreased employee related expenses and decreased professional fees. Our net loss was $14.6 million or $1.39 per share for the first nine months of 2024 as compared with a net loss of $14.6 million or $1.64 per share for the first nine months of 2023. With that financial review, I'll turn the call back to Stacey.
spk07: Thank you, Dave. As I mentioned during our last quarterly call, we've taken a number of steps to conserve cash and align our critical needs with available capital. The pace of phase three will depend on several factors, including access to capital and patient recruitment. But at this point, we are targeting a regulatory readout by the end of 2029. Financing the company is necessary to achieve success. At this junction, and as Dave pointed out, our cash runway accounting for costs associated with starting the trial in Q1 extends into Q3 of 2025. We are able to raise funds from our ATM facility and would look for a more substantial raise with investors who see the value of Immunon 001 in ovarian cancer. Our seasonal COVID-19 vaccine trial is on track to read out before the end of the year, and we are actively pursuing acquisition, license, or partnership for this asset to provide non-dilutive funding. Our TheraPlas technology underpins Immunon-001, and this may, likely, may have an application to other oncology indications, such as pancreatic and colon cancers. These remain interesting areas to pursue should we have the financial resources to do so. Before I open the call to your questions, I want to remind you of the power of our technology. Immunon-001 allows durable, therapeutic, and dose-dependent production and release of IL-12 into the tumor microenvironment. The lack of toxicity shows its advantages over other approaches to IL-12. such that the ability of iminon-001 to achieve well-tolerated and durable dose levels of IL-12, along with other anti-cancer cytokines, could usher in the first immuno-based gene therapy for ovarian cancer. I want to leave you with the following thoughts. We may have in our hands the first and only immunotherapy that's effective for the treatment of ovarian cancer. We've reported favorable and clinically meaningful top-line results for Ovation 2 in patients with newly diagnosed ovarian cancer. We're on track to begin our pivotal Ovation 3 trial in Q1 2025, and we have internal GMP manufacturing capability in place in Huntsville, Alabama, which will allow us to produce quality product at an order of magnitude lower cost. compared to an external CDMO. Ovarian cancer represents a multi-billion dollar unmet market and medical need. And our product has been granted fast track designation by FDA and orphan drug status has been established in the US and Europe, thus providing additional protected commercial runway. A second phase two study in advanced ovarian cancer is underway. with Immunon 101 plus Avastin evaluating MRD through second look laparoscopy. This is largely funded by the Breakthrough Cancer Foundation and will give insights into combination treatment with Avastin, biosimilar Avastin, or Bevacizumab. Our proof of concept study is nearing completion with the Placine platform in SARS-CoV-2. And while we wait on the data, recall Immunon 101 has demonstrated a robust immune response in preclinical platform trials. And our technology offers multiple advantages over current vaccines. We believe these attributes will be attractive to potential partners. Before opening the call to questions, I'd like to ask Michael, our executive chairman, if he has any questions. Michael? Michael, your phone may be muted.
spk04: I'm sorry, it is muted.
spk07: There we go, we hear you.
spk04: I don't have any questions, but I do have just a short comment here. And first, thanks for sharing a remarkable and very optimistic update. In this short tenure of yours at the company, we've seen the The organization be laser-focused, streamlined, and delivering results that by any standard or measure suggest a significant investment opportunity. I believe that we can all agree that the future of Immunon is bright and that together with our shareholders, Immunon will deliver on its mission to have a meaningful impact on patients' lives. So with that, I'll return it back to the operator who can open it up for questions.
spk02: Thank you. 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 hands and 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 comes from David Bouts from Dex. Your line is open.
spk06: Hey, good morning, everyone. Stacy, thanks for the overview this morning. It was very helpful. My first question is about the Phase III study upcoming. What percentage of advanced ovarian cancer patients are on PARP inhibitors? And are you going to try to match that percentage in the study? And I guess kind of a second part to that question would be, are there any other treatments that you're going to be looking at in combination with your therapy?
spk07: David, great to hear from you. Thank you for the question. And as you reflect on the data that we've shared even on this call about patients with PARP inhibitors, We think that the Phase 2 trial shows very similar to what we can expect in the general community, so the practicing community, as well as what we'll see in Phase 3. So we saw about 40% of patients receiving PARP inhibitors in our trial. We think that could go up as high as 50%. In phase two, the trial worked very well in terms of balance and randomization, but this is something that we are carefully thinking about from a design perspective. Women that have HR deficiency, which includes BRCA mutation, have been shown to benefit from PARP inhibitors. And that is a component that we will discuss with FDA and plan to bring into our design so that we can ensure there's balance. It is a group that had differentiated efficacy. And right now, that is the plan for treatment. Your second part to the question was, are there other treatments that we're considering? We are going to have this very explicitly included in our protocol. And again, we'll discuss this with FDA. and we'll get their feedback on our protocol.
spk06: Okay. As far as financing the study, so you're ready to launch with the capital that you have right now, is this going to kind of be a finance as you go? Are there thoughts to do a huge financing? How are you kind of thinking about that right now?
spk07: That's right, and you heard very correctly. Our cash runway includes fully burdened with launching the trial, everything that's required to get the trial up and running, and with a good pace of patients enrolling. And in terms of fundraising, the goal is to fund the trial in full. And we want to do this with investors that are aligned with the long-term impact for patients and our strategy. We know this will take time, and we're currently looking at the best and investor-friendly means to fully fund the study.
spk06: Okay. Sounds good. Appreciate you taking the questions.
spk07: Thank you, David.
spk02: Thank you. Our next question comes from Kemp Dolliver from Brookline Capital Markets. Your line is open.
spk03: Great. Good morning, and thank you for taking the questions. I'm going to have two questions. First, on 101, you mentioned you've started BD activities. Are you at a point where you've had their CDAs in place, or are you still in the... very early steps.
spk07: Yes, so it's premature to offer in-depth comments around the partnership opportunities that we are pursuing. But as you would expect us to do, we have appropriate feelers out. We're working with some very professional people in this regard. And we're awaiting our data from the proof of concept study. And I guess one point I really want to make is that we're very intent on ensuring that any partnership or deal really reflects the value of our product and the platform, and we do not intend to sell it for a bargain.
spk03: Great. Thank you for that. And the second question relates to the phase three trial and your previous comments that you're expecting you'll have, you know, some interim readouts. Is that still going to be the case?
spk07: Yes, we are. We've given a lot of thought. We've very carefully designed the phase three trial with seeking, you know, expertise outside the company. Part of having a thoughtful design is really looking to maximize the likelihood of success for a registration trial, assuming that it is effective, which we believe we have very strong confidence based on our data. It's also to allow a thoughtful design, I think, in phase three where you have a fatal illness is to allow early reads on data that could allow for an early submission. for a subgroup and also for the overall trial. So we have given a lot of thought to this. We have very sophisticated input from statisticians that know this field very well, and we will be talking about these design components with FDA. But it would very much allow us to align interim decisions for the trial that are really in the best interest of the product. and patience long-term, but also with investors that we're talking with.
spk03: Great. And obviously, you're finalizing the details, but fair to say that the $50 million cost estimate you've given previously is pretty reliable at this point?
spk07: Yeah, we've done really very thorough top to bottom, you know, estimates and continue to come back with what we think is, you know, a really imminently fundable trial and a number that is very attractive when you compare to other trials of this magnitude, you know, in the oncology world. So, yes, we remain very confident in our estimates.
spk03: Great. Thank you so much.
spk02: Thank you. Thank you. As a reminder, if you have a question, please press star, then one on your telephone. Our next question comes from James Malloy from Allianz Global Partners. Go ahead.
spk05: Hey, guys. Good morning. Thank you for taking my questions. I wonder if you walk through sort of your expectations coming out of the end of Phase 2 meeting and what sort of be a good, bad, or equivocal meeting with the FDA. And then any thoughts you can share with us in advance of that of where you hope or expect the phase three trial design to look like, sort of enrollment timelines and potential interim cut points that we could be looking for. And then the last question would be, would you be able to characterize the partnership environment for either Placine or perhaps even for Immunon-001? I imagine you're getting interest from a larger pharma for that asset as well. Thank you.
spk07: Yeah, thank you, James, for the questions. Let me see if I can tick through them. So expectations for the end of Phase 2 meeting, as is common in the industry, of course, we'll plan to go through our Ovation 2 data, which is really the foundation of our Phase 3 trial. And one of the key goals is to discuss the proposal for Phase 3. As I described earlier, there's been a lot of thought that's gone into our proposal that we've shared with them. We've chosen to select the definitive endpoint of our primary endpoint, overall survival, and we expect that will be the endpoint of the trial. But we, of course, will come out of that discussion really seeking their advice and input The inclusion criteria that kind of ticked through a little bit in the prepared remarks are very similar to Phase 2. And, you know, we really do look forward to a constructive conversation with them. Your second question, I guess, was related to timing. So you can clarify if you had something else in mind, but we are planning by having the end of phase two in this month. We're intending to have the protocol pulled together by the end of the year and everything that is between that and the first patient enrolled occurring in Q1 of next year. So we've done a lot of work in advance to allow for successful activation of the study and to be able to move quickly The last was characterizing partnership, the partnership environment. And I, you know, we've been very intentional to not get ahead of ourselves, given that we know that these discussions, the data that will come out of the 101 trial will be very important, and we do not yet have that in our hands. So it's a little premature to talk about the environment. We've really been engaging with people who would be key with making or furthering conversations, you know, that we think will be the most fruitful for us. And we share your view on that these are likely to also lead to their plus as well as discussions. And remain open-minded, you know, to continue to think about, you know, the best investor-friendly means to propel our company forward.
spk05: Great. Thank you for taking the questions.
spk07: Thank you, James.
spk02: Thank you. This concludes our question and answer session. I would like to turn the conference back over to the management for any closing remarks.
spk07: Thank you for your questions, guys. And as we work in providing new treatment options for women with ovarian cancer and this progresses, And we seek an opportunity to partner and further the development of our vaccine platform. We remain very excited about reporting data from our ongoing clinical studies in the coming months. And we look forward to keeping you appraised of our progress. Thank you for joining us today and for your interest in Immunon. Have a great day.
spk02: Thank you. The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.
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