Imunon (ticker: IMNN) has announced its financial results and progress in clinical trials for the first quarter of 2024 during a recent earnings call. The biotechnology company, which specializes in developing immunotherapy treatments, introduced Stacy Lindborg as the new Chief Executive and President.
With a strong background in the pharma and biotech industry, Lindborg is leading the company's efforts in advancing their lead investigational immunotherapy, IMNN-001, currently in Phase 2 trials for ovarian cancer. Imunon expressed optimism about their technology platforms and their potential for treating ovarian cancer and seasonal COVID-19.
Key Takeaways
- Stacy Lindborg has been introduced as the new CEO and President of Imunon.
- Imunon is conducting Phase 2 trials for its lead immunotherapy, IMNN-001, targeting ovarian cancer.
- Preliminary data indicates IMNN-001 may delay disease progression and improve survival rates.
- The company's financial report shows a net loss of $4.9 million for Q1 2024 but has a cash runway extending into Q1 2025.
- A decrease in general and administrative expenses has been reported, along with the development of in-house manufacturing capabilities.
- Imunon plans to start a Phase 3 study in early 2025, pending successful Phase 2 trial results.
Company Outlook
- Imunon is focused on advancing the development of IMNN-001 and their other technology platforms.
- The company looks forward to upcoming events in the next few months that will inform future decisions.
- A Phase 3 study for IMNN-001 is planned for early 2025, subject to the success of the ongoing trials.
Bearish Highlights
- The company reported a net loss of $4.9 million for the first quarter of 2024.
- Despite in-house manufacturing capabilities, the focus on conserving capital remains a priority.
Bullish Highlights
- Imunon's preliminary data shows promising results in delaying ovarian cancer progression.
- The new CEO's experience in the pharma and biotech industry is expected to drive the company's success.
- The synergy of IMNN-001 with PARP inhibitors and potential combination with checkpoint inhibitors like OPDIVO indicates expansion opportunities.
Misses
- There were no specific misses reported during the earnings call.
Q&A Highlights
- The company discussed the potential of their vaccine candidate and expects to report top-line data from the trial before the year's end.
- Imunon is exploring therapeutic combinations, including one with OPDIVO, and is continuing work with Avastin.
- The focus on capital conservation was reiterated, along with the excitement for the proprietary technologies as both therapeutics and vaccines.
Imunon's commitment to developing treatments for ovarian cancer and addressing potential pandemics remains strong. With the anticipation of top-line data from their vaccine trial and the progress of IMNN-001, the company is poised to make significant strides in the biotech industry. Investors and patients alike are watching closely as Imunon continues to navigate the challenges and opportunities of their innovative research and development.
InvestingPro Insights
Imunon's (ticker: IMNN) recent earnings call has shed light on the company's financial health and future prospects. To provide a more comprehensive understanding of Imunon's position, here are some insights based on real-time data from InvestingPro.
InvestingPro Data metrics indicate that Imunon has a market capitalization of $13.91 million USD, reflecting its size and investor valuation in the market. Despite the challenges faced, the company has shown a significant return over the last three months, with a 202.04% increase. This impressive uptick could be a signal of growing investor confidence in Imunon's potential, particularly in the development of their immunotherapy treatments.
InvestingPro Tips highlight two key aspects of Imunon's financial strategy. Firstly, the company holds more cash than debt on its balance sheet, which is a positive indicator of financial stability and may provide flexibility for future R&D investments or to weather economic downturns. Secondly, Imunon's stock price movements have been quite volatile, which is important for investors to consider when evaluating the risk associated with investing in the company.
For readers interested in a deeper dive into Imunon's financials and additional InvestingPro Tips, there are 13 more tips available on the InvestingPro platform. These tips could provide valuable insights for making informed investment decisions. To access these insights and more, use coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription at InvestingPro.
Imunon's journey in the biotech industry is certainly one to watch, with its innovative approaches to treating challenging diseases and its financial strategies aimed at sustaining its growth and research initiatives.
Full transcript - Imunon Inc (IMNN) Q1 2024:
Operator: Good morning. My name is Nick and I will be your operator today. At this time, I would like to welcome you to the Imunon First Quarter 2024 Financial Results Conference Call. All lines have been placed on mute to prevent any background noise. Following the speakers prepared remarks there will be a question-and-answer session. [Operator Instructions] I would now like to turn the call over to Kim Golodetz. Please go ahead.
Kim Golodetz: Thank you and good morning everyone. This is Kim Golodetz with LHA. Welcome to Imunon’s first quarter 2024 financial results and business update conference call. During today's call, management will be making forward-looking statements regarding Imunon’s expectations and projections about future events. In general, forward-looking statements can be identified by words such as expects, anticipates, believes, or other similar expressions. These statements are based on current expectations and are subject to a number of risks and uncertainties, including those set forth in the company's periodic filings with the Securities and Exchange Commission. No forward-looking statements can be guaranteed, and actual results may differ materially from such statements. I also caution that the content of this conference call is accurate only as of the date of the live broadcast, May 13, 2024. Imunon undertakes no obligation to revise or update comments made during this call, except as required by law. With that said, I would like to turn the call over to Michael Tardugno, Imunon’s Executive Chairman. Michael?
Michael Tardugno: 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 Stacy 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. Kursheed Anwer, our Chief Science Officer, and Dr. Sebastien 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 Imunon well equipped for the test. For many years in our industry we've seen to that. She accounts among her employment history some of the most storied companies in the pharma and biotech world, including Eli Lilly (NYSE:LLY), Biogen (NASDAQ:BIIB), and most recently as 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 3 study that missed its primary endpoint. Now if you followed this adcom as I did, you know, that the argument that Stacy made was very impressive. It's clear that as an experienced biostatistician, Dr. Lindborg’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 Imunon 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've witnessed her passion, up front and personally, for an organizational culture of dignity, respect, transparency, and an atmosphere where everyone has a voice. Dr. Stacy 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 Imunon’s priorities and drive our critically important development strategies. I look forward with confidence to Stacy’s leadership and the values she will bring to our mission and to you, our shareholders. Stacy, would you like to make a few comments, please?
Stacy Lindborg: 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 Imunon. Perhaps it would help to reflect on my reasons for joining Imunon 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 effective for the treatment of ovarian cancer. This cancer is a terrible disease that in the U.S. leads to about 20,000 new diagnoses every year and in the same time frame about 13,000 deaths. When we look globally there are nearly 0.25 million women living with the disease. The second driver is people. At Imunon, 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 PlaCCine, 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 [Indiscernible] controlled immunotherapy. And a first-in-human trial with IMNN-101 to demonstrate proof-of-concept with PlaCCine. 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 Imunon. 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.
Michael Tardugno: Thank you, Stacy. On behalf of our shareholders and employees, welcome. We look forward to your leadership in this challenging and exciting world of biotech. 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 Stacy mentioned, TheraPlas and PlaCCine. As you know, it's a particularly important time as we look forward to reporting top line results from our Phase 2 study of IMNN-001 in advanced ovarian cancer and as we reported this morning, that enrollment has begun as promised in our Phase 1 vaccine study of Imunon 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, IMNN-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 in overall survival or OS. So, Dr. Anwer Kursheed, can I ask you to give us some rationale for our optimism and the supporting data for our study?
Kursheed Anwer: Of course, Michael. This is Kursheed. I mean, that's a great question. I think every team should have that developing any product. So clearly for IMNN-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 001 distribution primarily local in the cavity of the peritoneum, and that is a site of the disease. So that's important pharmacological aspect that drug is there where it's supposed to be. Second, IMNN-001 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 a 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 simple injections is the continuous pressure on tumor of the 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 1 the tumor micro environment 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 will 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 reason to be optimistic about this trial and future results, Michael.
Michael Tardugno: Thank you, Kursheed. So if the interim data are confirmed, the observed PFS benefit would represent a clinically meaningful outcome. Last 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 IMNN-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 treatment plan. For a subgroup, let me say this is a non-pre-specified subgroup. For 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. Well, we have a second study. It's not been talked about much, but it's starting to get quite a bit of -- attract quite a bit of interest from the medical community. It's a second study of 001 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 Imunon. 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 1:1 and will receive standard chemotherapy plus Avastin as the differentiator. So the treatment arm will be standard chemotherapy plus Avastin or the -- I'm sorry, the control arm, standard chemotherapy plus Avastin -- or the treatment arm on standard chemotherapy plus Avastin plus IMNN-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 31 through June 4. I 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 minimum residual disease, the economics 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 and its MSK, Cancer Center joint MD Anderson 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 001, that’s IMNN-001 will be the first immunotherapy as Stacy pointed out, that's proven effective for the treatment of advanced ovarian cancer and will demonstrate our TheraPlas platform. This is key, to 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 1 protocol for 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 this study is a 24 subject proof-of-concept trial. The primary objective in this study of healthy adults are to evaluate the vaccine candidate safety and tolerability. Secondary objectives hard 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. Sebastien, could you just strip the study in a little bit more detail for us?
Sebastien Hazard: Absolutely, Michael. And good morning, everyone. So yes, this Phase 1 study, the main objective is to really understand what dose 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’ll look at the data to determine what will be the best dose for Phase 2. 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 will get the sooner after patients participants have 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] (ph) vaccine. Michael?
Michael Tardugno: Thank you, Sebastien. So if we're successful in the first 24 patients then what?
Sebastien Hazard: So we have -- the protocol already states that we will be ready to enroll into a Phase 2 of approximately 50 patients using the recommended Phase 2 dose. And that will further establish the tolerability and the safety, but most importantly provide a robust proof-of-concept on the efficacy.
Michael Tardugno: Thank you. Thank you very much, Sebastien. So based on compelling preclinical data for this vaccine candidate, we expect immunogenicity and protection greater than 95%. Superior shop life of at least 12 months at refrigerator temperatures, recall that messenger RNA vaccines have to be stored at minus 70 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 1 and assuming IMNN-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 1 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 has the potential to be vitally important to the government and the medical community is 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. Jeff?
Jeff Church: Thank you, Michael. Details of Imunon'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, Imunon 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 OPTIMA 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 sheet. As we have in the past, we will continue to focus on strong cash management. We have taken proactive steps to evaluate and prioritize their 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 aftermarket 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. Imunon reported a net loss for the first quarter of 2024 of $4.9 million or $0.52 per share. This compares with a net loss for the first quarter of last year of $5.6 million or $0.68 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 $300,000 -- $700,000 from the $2.6 million we reported last year. More specifically, R&D costs associated with development of IMNN-001 to support the OVATION 2 study, as well as development of PlaCCine 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 the study was completed in March -- 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 Officers 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.
Michael Tardugno: Thank you, Jeff. As always, a great overview of our financials. And Jeff made a point, we spent some money on pilot manufacturing. I just -- 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 at 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 the product and cost going forward. So unappreciated yet. Part of our development program, but certainly, as we advance our programs it will be a very important strength that the company -- your company has. I'll also point out, and 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. Like, 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 micro-cap companies in this very challenging capital market. And just I want to quote our prepared remarks with just again the appointment of Stacy Lindborg. 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. Lindborg's leadership. So with that, operator, I'd like to open the call to questions. Operator?
Operator: Thank you. We will now begin the question-and-answer session. [Operator Instructions] The first question comes from Emily Bodnar with H.C. Wainwright. Please go ahead.
Michael Tardugno: Good morning, Emily.
Emily Bodnar: Hello, good morning. Thanks for taking the questions and congrats on the new role, Stacy, 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 can you just talk about your internal goals for that study in terms of durability neutralizing antibody response given and you're kind of looking at a different variant than the other COVID vaccine studied initially? And then last question for the OVATION 2 study. Are you planning to have a corporate event to announce the top line results there? And how can do you think you'd be able to initiate a Phase 3 study if the OVATION 2 study was positive? Thanks.
Michael Tardugno: 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 1 study of the vaccine trial that we believe to have immunogenic -- I mean vaccine effective vaccine properties. So I'm going to turn that question over to Kursheed Anwer. Kursheed, the first dose, you believe it has some efficacy as it relates to protection?
Khursheed Anwer: Yes, Emily. Good to have you on the call. We did an HP (NYSE:HPQ) study, where we did look at a couple of doses, and we had seen the illustration of binding antibodies, utilizing antibodies then 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 good immunicity based on the preclinical data in non-human primates doses were lapping.
Michael Tardugno: Yes. And before we finish with the answer to that question, Sebastien, would you add anything more to that?
Sebastien Hazard: No, I think that summarizes very well, Michael. I don't have anything in particular to add to this.
Michael Tardugno: Thank you. Emily, does that cover it for you?
Emily Bodnar: Yes, it does.
Michael Tardugno: Your second question is related to OVATION 2 and our plan with regards to announcing it in a corporate event. Yes, I think so. I mean there's -- this is a relatively -- it's a very, very new approach to recruiting the immune system using IL-12, and we're very proud of this technology. Developed under Dr. Anwer's capable leadership, we know that IL-12 has been a subject of -- but there's a potential therapeutic since the late 1980s and Dr. Rosenberg levered towards the NIH. And it's been really put on the shelf largely because of the safety profile of a direct administration of recombinant IL-12 is not -- has been the subject of concern. So 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 intraperitoneal cancers. Yes, I think not only given the results, but the potential of the platform, I think we'd find the means to be able to share this information along with 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 3. So we already have some ideas here on the construct in the Phase 3, Dr. Hazard has been actively evaluating a number of approaches. But I suspect, based on the last interim data in 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. They always take the most difficult part of forecasting when is the interaction with the agency. But our internal goal would be to have a Phase 3 study up and running in the first quarter of next year.
Emily Bodnar: All right. Just a follow-up on that. Are you planning to have like an end of Phase 2 meeting with the FDA following the study?
Michael Tardugno: Yes, I think that would be required -- of course.
Emily Bodnar: All right. Thanks.
Michael Tardugno: Thank you.
Operator: The next question comes from Kemp Dolliver with Brookline Capital Markets. Please go ahead.
Michael Tardugno: Hello, Kemp.
Kemp Dolliver: Hello, thank you and welcome on board, Dr. Lindborg. Since we have a supplier statistician on the call, I do want to ask about how we should think about the parameters in the Phase 3 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.
Stacy Lindborg: So this trial -- [Technical Difficulty] we have said in the past, and I've had the benefit of seeing as a Board member, the design and really how the trial 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. So 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 other important genetic information, BRCA positive, how that influences the results. 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 the 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.
Kemp Dolliver: Thank you. Yes, thank you.
Operator: The next question comes from James Molloy of Alliance Global Partners (NYSE:GLP). Please go ahead.
James Molloy: Congrats to Dr. Lindborg, your appointment as CEO. I'd love to get your thoughts when you joining into IMUNON and looking at sort of the two sets of trials ongoing. What will give you the 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 -- this is the move you want to make to come on Imunon? And then can you talk a little bit about -- we look at the OVATION 2 data. Could you help us sort of aim out what good bad or clinical data might be coming here in mid-'24. It almost seems like maybe the PARP inhibitors may be left this OVATION 2 behind? Or is there still going to be room for 001?
Stacy Lindborg: Both very interesting questions. And I think on your first, you asked the question really between the two studies. To be honest, 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 the first approval. But then beyond that knowing that this is really -- I think the word I used in my prepared remarks, we're 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. So absolutely, the emergence, frankly, any company, and we certainly -- when we look at what these women are fighting, we want to see standard of care progressing. 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 001, 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 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.
Michael Tardugno: And let me add also, Jim, that the PARP inhibitors are currently indicated for 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 -- the patients are indicated for neoadjuvant treatment. So I mean -- so the synergistic effect is it is very encouraging in those patients treated with PARP inhibitors. And also IMNN-001, we expect to deliver some advantages to patients who are treated or not indicated for PARP inhibitors. So that's our point of view.
James Molloy: And the thinking -- I know it's waiting for the data, obviously, but looking at the Phase III, would a PARP inhibitor 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?
Michael Tardugno: Yes. So that's all a subject of discussion. I think it's always going to be dependent upon the data. The -- assuming we would like to not eliminate any of -- either of the two groups in our current study. It could very well be that this trial includes both populations stratified for each. And 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 it's going to -- again, it's going to be based on the strength of the data. One of the unfortunate parts about oncology trials is you can -- sometimes you continue to narrow the population so much to get a positive results 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 outline 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 I'm a betting person, as I'll say it again, to include the intent-to-treat population that's currently being -- that was currently enrolled in our study. We'll do that, but we'll do that with a tie to making sure that we are able to evaluate the effect of 001 on both groups. It makes sense?
James Molloy: Indeed. Absolutely. And then maybe a couple of follow-up questions, then I'll be done. The Phase 1/2 of 001 plus, [Indiscernible] expectations on getting that trial up and started. And then over the vaccine side, when do you anticipate top line data from the 101 SARS-CoV-2 trial? And what's the -- is there an update on the 102 for an IND filing? Thanks.
Michael Tardugno: Yes. So I don't know if I misspoke or we -- or you did, but we're combining 001 with Avastin then Yervoy in the MRD study. Is that the one you're talking about?
James Molloy: I had in my notes that you guys are going to look to start a combo with OPDIVO and your voice. Well, I know you have the Avastin up and running.
Michael Tardugno: I'm sorry. So I think we indicated that in some earlier conversations that we thought a checkpoint inhibitor might combination -- might be a very interesting approach. We're stuck in this conserved capital kind of world right now, Jim. So a lot of focus to it. But I think as we consider the future for these therapeutics, that'd be a very interesting combination. I don't know if Dr. Anwer or Sebastien, if you'd like to comment on that?
Sebastien Hazard: No. Yes, absolutely. I think this is a project that I've been looking into in terms of synergy and to help really an immunotherapy fully active in ovarian cancer that could be a very nice opportunity. So as Michael said, provided we get the resources that will be an excellent project to initiate.
Michael Tardugno: I'm sorry, could you repeat the second part of your question?
James Molloy: The 101 data expectation, roughly, which we anticipate Phase I data to come out. And then is 102 kind of, again, the capital preservation is at a little bit on the back burner?
Michael Tardugno: Yes. I can say that unequivocally. So we've narrowed our focus to -- 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 effect seen, 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'll have -- we won't know where the nature is for that, but we'll certainly be able to report progress both on the immunogenicity and the durability of the vaccine response. So Yes, before the end of the year.
James Molloy: Great, thank you for taking the questions.
Michael Tardugno: Thank you.
Operator: This concludes our question-and-answer session. I would like to turn the conference back over to management for any closing remarks.
Michael Tardugno: Let me first finish by saying thank you very much. And 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. Anwer's leadership and with the support of this management team, we've been able to unlock the potential of DNA as a therapeutic and potentially as a vaccine. And so the future for us, and as I said, under Dr. Lindborg'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 is probably one of the choice 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 I look forward to keeping you informed and we -- on behalf of all of us here and on the call, we and our employees here IMUNON, we wish you a very safe and nice afternoon. Thank you very much.
Operator: The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.