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spk06: Please stand by. Good morning. My name is Nick and I will be your operator today. At this time, I would like to welcome you to the Immunon first 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. You may press star 1 on your phone to ask a question at that time. 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 Golodets. Please go ahead.
spk04: Thank you, and good morning, everyone. This is Kim Golodets with LHA. Welcome to WIMUNO's first 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 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 13, 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 Michael Tarduno, Immunon's Executive Chairman. Michael?
spk09: Thank you, Kim, and good morning, everyone. And let me also thank you for joining us for this, a particularly important call. I want to start by welcoming Stacey Lindborg, your new chief executive and president, to her first call with the investment community and our supporters. Dr. Lindborg and I are joined by Jeff Church, our chief financial officer, who will provide remarks on our financials, Krishid Anwar, our chief science officer, and Dr. Sebastian Hazard, our chief medical officer, are also on the line. Both will be available for the question and answer period. But first, Dr. Lindborg. For those of you who have read last week's press announcement, you know much of what I'm going to tell you. That Stacey comes to Immunon well-equipped for the task. For many years in our industry, we've seen to that. She accounts among her employment history some of the most storied company's in the pharma and biotech world, including Eli Lilly, Biogen, and most recently, his co-CEO of Brainstorm Cell Therapeutics, where her deep conviction in their clinical stage product led her to present a compelling case to FDA at an adcom for continued development following a Phase III study that missed its primary endpoint. Now, if you followed this adcom as I did, you know that the argument that Stacey made was very impressive. It's clear. that as an experienced biostatistician, Dr. Lindvord's academic focus has provided the regulatory world with innovative approaches to clinical stage product evaluation. Frankly, her career is a history of accomplishment and a record of success that perfectly complements the challenges facing Immunon as we seek to find solutions to some of the most devastating diseases facing modern oncology and medicine. Virtually everyone who has worked with her knows that her skills are not confined, however, to technology and product development. She has a deep and abiding commitment to the people of an organization and to people generally. I witnessed her passion, up front and personally, for an organizational culture of dignity, respect, transparency, and an atmosphere where everyone has a voice. Dr. Stacey Lindborg is someone I have come to know and admire. Her work over the past three years as a member of our board of directors has helped us, and me personally, to evaluate Immunon's priorities and drive our critically important development strategies. I look forward with confidence to Stacey's leadership and the value she will bring to our mission and to you, our shareholders. Stacey, would you like to make a few comments, please?
spk03: Thank you, Michael, for those kind words, and I really couldn't be more delighted to join this call in my new capacity as president and CEO of Immunon. Perhaps it would help to reflect on my reasons for joining Immunon at this exciting time, of which there were three drivers, science, people, and opportunity. Let me expand on each. Starting with science, we have the potential to do great things for patients, most immediately women fighting ovarian cancer, with our lead investigational immunotherapy. In fact, we may have in our hands the first immunotherapy program effective for the treatment of ovarian cancer. This cancer is a terrible disease that in the US leads to about 20,000 new diagnoses every year, and in the same timeframe, about 13,000 deaths. When we look globally, there are nearly a quarter million women living with the disease. The second driver is people. At Immunon, we have a focused and dedicated staff who bring great purpose to our work, leveraging a phenomenal depth from scientific and operational perspectives. We have a core group of employees with tenure that rivals companies known for staff stability. The third driver is opportunity. In TheraPlas and Plaxane, we have two cutting-edge DNA-based technology platforms that provide bountiful opportunity in clinical development. Both of these technologies have important readouts this year. First up being the Phase 2 trial, which we call Ovation 2, with our TheraPlas Interleukin-12 immunotherapy, and a first in human trial with Immunon 101 to demonstrate proof of contact with Plasine. Both technologies hold great potential, and the near-term timing of these events make my joining the company at this time ideal from my perspective. As Michael just shared, I bring to the table close to three decades of pharmaceutical and biotech industry experience with a particular focus on R&D, regulatory affairs, executive management, and strategy development. My most recent years have included senior leadership roles in the biotech sector with the first 20 years of my career spent in pharma. Across a range of companies, I've had the opportunity to work on multiple modalities and assume a diverse set of roles, providing a broad view of our business. This included the opportunity to study R&D productivity as head of R&D strategy at Lilly, which led to two publications in the journal Nature. I think we can all appreciate that as with any R&D endeavor, there are risks and uncertainties But from my vantage point, we have an amazing opportunity in front of us at Immunon. And what you can expect from me is to be wholly committed to advancing our two key technology platforms, which are aimed at delivering value to patients, and to run our business in a manner that is in the best interest of our shareholders and employees. Our future is bright, and as a company, we are full of hope that we will have meaningful impact on patients' lives and create shareholder value. I'm grateful for the trust Michael and the board have put in me as we execute our plans. I'll now turn it back to Michael.
spk09: Thank you, Stacey. On behalf of our shareholders and employees, welcome. We look forward to your leadership in this challenging and exciting world of BioNTech. Now to you, our shareholders and listening audience, I want to assure you that during our management transition, we remain wholly committed to advancing our two key platforms, as Stacey mentioned, TheraPlas and Plasene. As you know, it's a particularly important time as we look forward to reporting top-line results from our Phase II study of Immunon 001 in advanced ovarian cancer. And as we reported this morning, that enrollment has begun, as promised, in our Phase 1 vaccine study of Immunon 101, a proof-of-concept trial to evaluate immunization of patients against COVID-19 with our DNA-based, let me say we believe our mRNA-better technology. I also want to emphasize that during the transition, we will not lose focus on our overall strategy for continued development of these product candidates and our technologies, as we will discuss. We fully expect to report top-line results from the Phase 2 Ovation 2 study in mid-2024. As you know, Immuno-001 is our DNA-based IL-12 immunotherapy. Ovation 2 is evaluating 001 for the perioperative treatment of patients newly diagnosed with ovarian cancer. It's being tested in combination with the standard of care chemotherapy. In September 2022, we reached full enrollment of 113 patients. And a year later, we reported interim data showing promising progression-free survival, or PFS, and overall survival, or OS. So, Dr. Anwar, Krishid, can I ask you to give us some rationale for our optimism and the supporting data for our study?
spk10: Of course, Michael. This is Krishid. I mean, that's a great question. I think every team... should have that developing any product. So clearly for iminon-001, there are good reasons for the team to be optimistic about the drug, which is based on our data that we have available so far over the last several years. First of all, ovarian cancer is a local disease. An effective concentration at local site is important. In both human and animal studies, we have seen OO1 distribution primarily local in the cavity of the peritoneum, and that is a site of the disease. So that's an important pharmacological aspect that drug is there where it's supposed to be. Second, iminon OO1 makes IL-12. There's evidence that there is production of IL-12, the biological molecule that we are delivering to the gene therapy approach. And then also there's level of interferon gamma that's the potent mediator of IL-12 action. So you've got this Pharmacology there, there's also pharmacokinetic where these agents or cytokines last for several days after single injection. So there's a continuous pressure on tumor of these cytokines to build an immune response against cancer. Then these levels also translate into biological activity. That's an important point. You may have the levels, but what does it mean downstream? So we have seen innovation one. the tumor microenvironment in ovarian cancer is very immunosuppressive, and that's where the disease progresses. And we have seen a shift in the balance between immunostimulatory cells and immunosuppressive, favoring the immunostimulation. So creating an environment in ovarian cancer that would be conducive to an anti-tumor effect. So having seen these pharmacokinetic and pharmacodynamic of 001, together with the clinical benefits we have seen in PFS, I think there's good reason to be optimistic about this trial and future results, Michael.
spk09: Thank you, Krishit. So if the interim data are confirmed, the observed PFS benefit would represent a clinically meaningful outcome. By September, we reported PFS and OS data suggesting an approximate 30% delay in disease progression and death among patients in the treatment arm compared with patients in the control arm. The hazard ratio, in fact, nears the study objective. Preliminary OS data followed a similar trend, showing an approximate nine-month improvement in the treatment arm over the control arm. Subgroup analyses suggest patients treated with a PARP inhibitor as a maintenance therapy had longer PFS and OS if they were treated with immunon-001 versus patients treated with neoadjuvant chemotherapy only. We note that when the Ovation 2 study began, PARP inhibitors had not yet been approved for first-line maintenance treatment for a study population. Since then, for patients with certain genetic characteristics, PARP inhibitor forms an important part of the patient's treatment plan. For a subgroup, let me say this is a non-prespecified subgroup. For a subgroup analysis of patients who receive PARP inhibitor maintenance therapy Trends suggest that even a larger clinical benefit exists or has the potential. In this subgroup, the median PFS in the control arm was 15.7 months versus 23.7 months in the treatment arm, or eight months longer. In addition, the median OS in the control arm was 45.6 months, and yet had not been reached in the treatment arm. All those data are post hoc and, again, non-pre-specified. They represent a small number of patients. They are intriguing nonetheless and encouraging, I would suggest. So we have a second study. It's not been talked about much, but it's starting to attract quite a bit of interest from the medical community. It's a second study of OO1 in advanced ovarian cancer. It's ongoing, principally funded by the Breakthrough Cancer Foundation. And although the funding is from Breakthrough Cancer Foundation, the data belongs to the company, belongs to Immunon. I want to reassure you of that. MD Anderson Cancer Center at the University of Texas is the lead clinical site. The trial is expected to enroll 50 patients with stage 3-4 ovarian cancer. Patients treated for frontline neoadjuvant therapy will be randomized one-to-one and will receive standard chemotherapy plus Avastin, that's the differentiator, so the treatment arm will be standard chemotherapy plus Avastin, I'm sorry, the control arm, standard chemotherapy plus Avastin, while the treatment arm is standard chemotherapy plus Avastin plus Immunon 001. So I'm happy to report that the acceptance of our abstract for this trial describing the study designed for presentation at a poster at the ASCO conference this year at its annual meeting in Chicago during the week of May 31st through June 4th. I'd suggest again that this reflects the medical community's interest in our study and its potential for a new therapeutic option for women with advanced ovarian cancer. Also, I just want to point out the trial's primary endpoint is the detection of minimal residual disease The acronym is MRD, minimal residual disease, by second look laparoscopy. This is a novel endpoint that will be assessed following adjuvant treatment, approximately three months following adjuvant treatment. The secondary endpoint is PFS. The trial will also provide a wealth of translational endpoints aimed at understanding the clonal evolution in immunogenomic features of the MRD phase of ovarian cancer that is currently undetectable by imaging or tumor markers. In February 2024, Memorial Sloan Kettering, that's MSK Cancer Center, joined MD Anderson in enrolling patients in this trial. We expect two more sites to be up and running in the near future. We'll keep you posted as sites are added and this trial progresses. Assuming success in either or both of these studies, we believe O01, that's immunon O01, will be the first immunotherapy, as Stacey pointed out, that's proven effective for the treatment of advanced ovarian cancer and will demonstrate our TheraPlas platform. This is key. We'll demonstrate the platform may have a place in medicine to treat a range of intraperitoneal cancers. So now I'll turn my focus to the infectious disease program. Last month we announced acceptance by the FDA, just last month, acceptance by the FDA of our Phase I protocol for a seasonal COVID-19 booster. As we announced this morning, if you read our press release, enrollment has begun already. Initiated our clinical trial center in Philadelphia. Second center, Beth Israel in Boston, should be up and running very soon. This first phase of the study is a 24-hour subject proof-of-concept trial. The primary objectives in this study of healthy adults are to evaluate the vaccine candidate's safety and tolerability. Secondary objectives are are to evaluate neutralizing antibody response, cellular response, and their durability, which we expect to be among the key advantages of our DNA-based formula. Based on preclinical data, durability is expected to be substantially superior to published mRNA vaccine data. So this trial is a little bit complex, and I'm not sure I covered it properly. Sebastian, could you describe the study in a little bit more detail for us?
spk01: Absolutely, Michael, and good morning, everyone. So, yes, this Phase 1 study, the main objective is to really understand, you know, what those to use in Phase 2. So there will be... three cohorts escalating doses, three cohorts of eight participants, and together with independent data monitoring committee, we look at this data to determine what would be the best dose for phase two. We'll also, as Michael mentioned, dedicate a lot of attention to the safety and tolerability of the product. That will be another very important objective of the study. And then, of course, we look at the efficacy. First, the neutralizing antibody response. This is what we'll get the sooner after participants are enrolled. But also cellular response. and its durability, and the durability of post-responses may be, we hope, based on preclinical data, something that will differentiate this product from RNA vaccine. Michael?
spk09: Thank you, Sebastian. So if we're successful in the first 24 patients, then what?
spk01: So, you know, we have the protocol already states that we will be ready to enroll into a phase two of approximately 50 patients using the recommended phase two dose. And that will further establish the tolerability and the safety, but most importantly, provide a robust proof of concept on the efficacy.
spk09: Thank you. Thank you very much, Sébastien. So now, based on compelling preclinical data for this vaccine candidate, we expect immunogenicity and protection greater than 95%. Superior shelf life of at least 12 months at refrigerator temperatures. Recall that messenger RNA vaccines have to be stored at minus 7 degrees centigrade. And we expect also stability for at least one month at 90 degrees Fahrenheit. The stability profile suggests superior commercial handling. and distribution properties compared with mRNA vaccines, as well as a greater manufacturing flexibility. Compared with viral or other DNA vaccines or protein vaccines, we expect our DNA vaccine will have advantages in T-cell responses, in safety, in delivery compliance, and manufacturing flexibility. Assuming successful Phase I and assuming imidon-001 performs as expected, we look to partner this program out for further development to expand the platform and to expand the platform. So I want to make crystal clear, this is a Phase I study. It is a proof-of-concept study to demonstrate the superior characteristics of our vaccine candidate. SARS-CoV-2 is a relevant virus to demonstrate this product's comparative benefits and its potential application for a host of other infectious diseases. Once demonstrated, the superiority of our vaccine technology demonstrates has the potential to be vitally important to the government and the medical community as a means to address rapidly evolving and newly emerging viral pathogens with pandemic potential on a global basis. So now with that, I'll turn the call over to Jeffrey Church for his always lively discussion of our financial results.
spk07: Jeff? Thank you, Michael. Details of Immunon's first quarter 2024 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. As of March 31, 2024, Immunon had $9.8 million in cash and investment. Use of cash was $5.9 million in the first quarter of 2024, compared with $4 million for the comparable prior year period. This increase was primarily due to the final payment of CRO costs associated with the Phase 3 Optimist Study. In March 2024, we received $1.3 million in net proceeds from the sale of approximately $1.4 million of our unused New Jersey net operating losses. These NOL sales cover the tax year 2022 and is non-dilutive funding further strengthening the company's balance sheets. As we have in the past, we will continue to focus on strong cash management. We have taken proactive steps to evaluate and prioritize our spending with a focus on our two clinical stage product candidates. With a minimal level of financing through the continued sale of our New Jersey NOLs and the opportunistic use of our at-the-market facility, we expect our cash runway to extend into the first quarter of 2025. Let me now turn to a review of our financial results. Immunon reported a net loss for the first quarter of 2024 of $4.9 million, or 52 cents per share. This compares with the net loss for the first quarter of last year of $5.6 million, or 68 cents per share. Operating expenses were $5 million in the current quarter, a decrease of $700,000, or 12% from the first quarter of 2023. Let me break down the operating expenses by line item. Research and development expenses were $3.3 million in the first quarter of 2024. That was an increase of $700,000 from the $2.6 million we reported last year. More specifically, R&D costs associated with development of Immunon 001 to support the Ovation 2 study, as well as development of Plastine DNA vaccine technology platform were $1.6 million for Q1 2024 compared with $1.4 million in the same period a year ago. Costs associated with the Ovation 2 study were $300,000 for the first quarters in both 2024 and 2023. As Michael indicated, the enrollment of this study was completed in September of 2022. CMC costs, manufacturing costs, were $300,000 in the first quarter of 2024, which compares to $600,000 in the first quarter of 2023. This was due to the development of in-house pilot manufacturing capabilities for DNA plasmids and nanoparticle delivery systems in 2023. General and administrative expenses were $1.7 million in the first quarter of 2024. This compares to $3.1 million in the year-ago first quarter. This $1.4 million decrease in G&A expenses was primarily attributable to lower non-cash compensation expense, lower employee-related costs, lower consulting and legal fees, as well as lower premiums on our D&O, our director and officer's insurance. Other non-operating income was $100,000 for the first quarter of 2024, largely unchanged from the previous year's first quarter. With that financial review, I'll turn the call back to Michael.
spk09: Thank you, Jeff. As always, a great overview of financials. And Jeff made a point, you know, we spent some money on pilot manufacturing. We probably don't make enough of this, but the company has the ability to produce its plasmids, the underlying structure for our DNA therapeutics and vaccines. in a fraction, probably an order of magnitude lower cost than if we were to outsource them. It bodes very well for the future expenses of the company, and frankly, producing our own product internally, particularly these precursors, bodes very well for our ability to be able to control product and cost going forward. So unappreciated yet, part of our development program, but certainly as we advance our programs, will be a very important strength that your company has. Also point out, I think as you heard through the course of this conversation, we have some exciting events coming up in the next few months that will inform the future of the company and the decisions that we will make. In the meantime, we have taken steps to conserve capital. I think we pointed that out in our last conference call. Our goal is to ensure that we have cash sufficient to read out our two clinical trials. We're keeping a close eye on funding conditions for microcap companies in this very challenging capital market. And I want to conclude our prepared remarks with just, again, the appointment of Stacey Lindberg. We're looking forward to her leadership of a deep and capable management team. Together, I believe, we believe, the Board and I believe that we have the potential to create significant value for patients and shareholders alike under Dr. Lindberg's leadership. So with that, operator, I'd like to open the call to questions. Operator?
spk06: 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 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. The first question comes from Emily Bodnar with HC Rainwright. Please go ahead.
spk05: Good morning, Emily. Hi, thanks for, hello, good morning. Thanks for taking the questions and congrats on the new role, Stacey, and welcome to the team. Just a few questions for me. First few on the COVID study. I noted you're intending to look at three different doses. So can you maybe comment on if you're looking to start with a dose that you believe would be effective in producing neutralizing antibodies based on your preclinical work. And then kind of just talk about your internal goals for that study in terms of durability and neutralizing antibody response, given you're kind of looking at a different variant than the other COVID vaccines studied initially. And then the last question for the Ovation 2 study, are you planning to have a corporate event to announce the top line results there? And how soon do you think you'd be able to initiate a Phase 3 study if the Ovation 2 study was positive? Thanks.
spk09: Okay. Can I... Let me start with the first question, and I believe it was related to are we starting with a dose in the phase one study of the vaccine trial that we believe to have immunogenic, I mean, effective vaccine properties? So I'm going to turn that question over to Krishit Anwar. Krishit, the first dose, do you believe it has some efficacy as it relates to protection?
spk10: Yes. So Emily, good to have you on the call. We did an NHP study where we did look at a couple of doses, and we had seen the elicitation of binding antibodies, utilizing antibodies, and as you probably remember, almost complete protection of the challenge to the virus comparable to mRNA. So the doses that we have used in human trials are overlaps with the doses we have seen in non-human primates. So we have good confidence that we should be able to get, you know, good immunicity based on the critical data in non-human primates. These doses are overlapping.
spk09: Yeah, and before we finish with the answer to that question, Sebastian, would you add anything more to that?
spk01: No, I think that summarizes very well, Michael. I don't have anything in particular to add to this.
spk09: Thank you. Emily, does that cover it for you?
spk05: Yeah, it does, I think.
spk09: I think your second question is... related to Ovation 2 and our plan with regards to announcing it at a corporate event? Yeah, I think so. I mean, this is a relatively – it's a very, very new approach to recruiting the immune system using IL-12. We're very proud of this technology developed under Dr. Anwar's capable leadership. We know that IL-12 has been a subject of discussion a potential therapeutic since the late 1980s in Dr. Rosenberg's laboratory at the NIH. And it's been really put on the shelf largely because the safety profile of a direct administration of recombinant IL-12 has been the subject of concern. So, you know, in addition to announcing the results, I think this platform, this product capability, assuming we're successful, would make a very interesting candidate for a range of interperitoneal cancers. But yes, I think not only given the results, but the potential of the platform, I think we'd find a means to be able to share this information along with the perspectives of the KOLs involved in the study with the investment community. And I think the third question was related to when would we be able to start a phase three. So we already have some ideas here on the construct of the phase three. Dr. Hazard has been actively evaluating a number of approaches. But I suspect based on the last interim data in the The top line data that we'll see in the next few months, we'll be able to assemble the appropriate group of KOLs and investigators to finalize the study protocol. You know, the most difficult part of forecasting when is the interaction with the agency. But our internal goal would be to have a phase three study up and running in the first quarter of next year.
spk05: All right. Just to follow up on that, are you planning to have, like, an end-of-Phase II meeting with the FDA following the study?
spk09: Yeah, I think that would be required. Yeah, of course.
spk05: Okay. Thanks.
spk09: Thank you.
spk06: The next question comes from Kemp Dolliver with Brookline Capital Markets. Please go ahead. Hello, Kemp.
spk02: Hello. Thank you, and welcome on board, Dr. Lindborg. Since we have a biostatistician on the call, I do want to ask about how we should think about the parameters in a Phase III study, assuming you have success. And I understand these are going to be broad brush at this juncture, but I would like to hear your insights on this.
spk03: So this trial, as we've been sharing in the past, and I've had the benefit of seeing as a board member the design and really how the trial is being received and, of course, the early readouts, we know that the trial is not powered to present a significant p-value, but really was planned to give us confidence to design the next trial. we're really expecting that we will learn what we need to design this next trial. And the most important thing that we'll need to consider as we read out the final results, the interim looks always give you perspective on the trial, but until you really get to the end of the trial and you have all of the events, so we planned this to have 80 events, We'll need to step back and understand the evolving treatment landscape, as Michael spoke about in the prepared remarks, the emergence of PARP inhibitors, what that brings in terms of insights into the relationship of what we can see the treatment effect is on top of the standard of care, influence of those PARP inhibitors, how they're spread across the trial, you know, other important genetic information, BRCA positive, how that influences the results. And, you know, and then we'll work closely with the medical community, not only to make sure we harness the complexity of our trial and our data, but with this disease and the emerging insights that we can bring. So as Michael has already shared, there's been a lot of thought already given to what that trial design could look like, but the real kind of sharpening of the pencil begins when we have the final data. And I think anything before that is premature.
spk02: Thank you. Yes, thank you.
spk06: The next question comes from James Malloy of Alliance Global Partners. Please go ahead. Morning, James.
spk08: Hey, guys. Thank you for taking the question, and congratulations to Dr. Lindborg on your appointment as CEO. I'd love to hear your thoughts. When you're joining in to Immunon and looking at sort of the two sets of trials ongoing, what gave you sort of the most interest or which was sort of between the vaccine or the immunotherapy, sort of maybe the highest sort of level of confidence. So this is, you know, this is the move you want to make to come on, aiming on. And then can you talk a little bit about, we look at this Ovation 2 data, could you help us sort of game out what good, bad, or equivocal data might be coming here in NID24? And it almost seems like maybe the PARP inhibitors, you know, maybe left this Ovation 2 behind, or is there still going to be room for
spk03: Both very interesting questions, and I think on your first, you asked the question really between the two studies. To be honest, the trials give us insights into technology, and what was certainly very exciting to me goes beyond just what these trials will provide. they give us an insight into what really is a broad array of trials that can come and really ultimately then we hope approvals. So I think what was very exciting for me was to see very tangible ways that we can test the technology, that we can seek a path towards a first approval But then beyond that, knowing that this is really, I think the word I used in my prepared remarks were a bountiful set of opportunities, and to me that's the most exciting thing that we can have as a company is to know that we'll be able to expand directly. Your second question, remind me. Oh, yes. So absolutely, the emergency. You know, frankly, any company, and we certainly, when we look at what these women are fighting, we want to see standard of care progress, and we want to see effective treatments emerging. And from the interim data, specifically in this trial, we see that, in fact, at the last interim, we actually see stronger results in women who were receiving PARP inhibitors on top of OO1 our novel therapy. So in no way does it invalidate the treatment. In fact, we're seeing that there appears to be a synergistic and an additive effect. So we're pleased to see what's evolving, and that's just part of our business. We have to build upon any progress that's made.
spk09: And let me add also, Jim, that the PARP inhibitors are currently indicated for a Patients with a certain genomic signature, they have to be HRD positive or BRCA positive. And that represents only about 45%, or a little bit less, of the neoadjuvant. Patients who are indicated for neoadjuvant treatment. So, you know, the synergistic effect is very encouraging in those patients treated with PARP inhibitors. And also... I mean, on O01, we expect to deliver some advantages to patients who are treated or not indicated for PARP inhibitors. So, I mean, that's our point of view.
spk08: Excellent. In the thinking, I know it's waiting for the date, obviously, but looking at the Phase III, would PARP inhibitors be in the Phase III in some respect, or any thoughts on what that trial design might look like? Again, presuming good data here, mid-'24.
spk09: So that's all a subject of discussion. You know, I think it's always going to be dependent upon the data. Assuming we'd like to not eliminate either of the two groups in our current study, it could very well be that this trial includes both populations stratified for each And, yeah, it could be a very interesting approach. And probably, I mean, if I were a betting person, that's probably the direction we'll take. But, again, it's going to be based on the strength of the data. One of the unfortunate parts about oncology trials is sometimes you continue to narrow the population so much to get a positive result, so much so that you exclude a lot of individuals who will benefit. And I find that to be a regulatory strategy that's anathema to the goal of companies like ours. We're looking to develop therapeutics that have broad application, but unfortunately the way the regulatory world has designed success or outlined success, unfortunately sometimes we narrow the study populations to a small percentage of those who, potentially could benefit. So if we do have the opportunity, and if our vetting person, as I'll say it again, to include the intent to treat population that was currently enrolled in our study, we'll do that, but we'll do that with an eye to making sure that we're able to evaluate the effect of O01 on both groups. Make sense?
spk08: Indeed, absolutely. Well, thank you for that. And then maybe a couple of follow-up questions, then I'll be done. The Phase 1-2 of 0-1 plus Updivo and Yervoy, expectations on getting that trial up and started? And then over the vaccine side, when do you anticipate top-line data from the 1-0-1 SARS-CoV-2 trial? And is there an update on the 1-0-2 for an IND filing? Thank you.
spk09: Yes, so I don't know if I misspoke or you did, but we're combining 001 with Avastin, not Yervoy, in the MRD study. Is that the one you're talking about?
spk08: That's right. I had in my notes that you guys are going to look to start a combo with Avdiv and Yervoy as well. I know you have the Avastin up and running.
spk09: Oh, I'm sorry. So, you know, I think we indicated in some earlier conversations that we thought the checkpoint inhibitor combination might be a very interesting approach. You know, we're stuck in this conserved capital kind of world right now, Jim, so we're not focused to it. But I think as we consider the future for these therapeutics, that would be a very interesting combination. I don't know if Dr. Sebastian, if you'd like to comment on that.
spk01: No, yes, absolutely. I think this is a project that I've been looking into in terms of synergy and to help really immunotherapy be really active in ovarian cancer. That could be a very nice opportunity. So as Michael said, provided we get the resources, that would be an excellent project to initiate.
spk09: I'm sorry, could you repeat the second part of your question?
spk08: Yes, thank you. The 101 data expectation, roughly, which we anticipate that phase one data to come out, and then is 102 kind of, again, the capital preservation, is that a little bit on the back burner?
spk09: Yes, I can say that unequivocally. So we've narrowed our focus to when we believe these platforms have, A great deal of potential, but we've narrowed our immediate focus to the programs that we've just talked about. With regards to data from the vaccine proof of concept, so we expect top-line data before the end of the year. We certainly won't have the durability information that we think is key. We won't know where the nadir is for that. But we'll certainly be able to report progress both on the immunogenicity and the durability of the vaccine's response. So, yes, before the end of the year.
spk08: Great. Thank you for taking the questions.
spk09: Thank you.
spk06: This concludes our question and answer session. I would like to turn the conference back over to management for any closing remarks.
spk09: Let me first finish by saying thank you very much, particularly for the questions and allowing us the opportunity to expand a little bit more on the work that we're doing that we're so very proud of. We're focusing in an area of technology that has been explored by many companies. I think under Dr. Anwar's leadership and with the support of this management team, we've been able to unlock the potential of DNA as a as a therapeutic and potentially as a vaccine. And so, you know, the future for us under, as I said, under Dr. Limbaugh's leadership is very, very exciting. I want to thank all of you for participating in this call. Again, underscoring the potential of our proprietary technologies is something that, you know, is probably a One of the joys that I have is the executive chairman of the company. As our work in providing options to women in ovarian cancer progresses and the population's exposure to potential pandemic increases, we remain committed, excited, and prepared to report to you the progress that we're making in the coming months. So we look forward to keeping you informed, and on behalf of all of us here and on the call, we And our employees here at Immunon, we wish you a very safe and nice afternoon. Thank you very much.
spk06: The conference is now concluded. Thank you for attending today's presentation. You may now disconnect.
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