Participants

Kim Golodetz; IR; Lippert/Heilshorn & Associates Inc

Michael Tardugno; Executive Chairman of the Board; Imunon Inc

Stacy Lindborg; President, Chief Executive Officer; Imunon Inc

Khursheed Anwer; Executive Vice President, Chief Scientific Officer; Imunon Inc

Sebastien Hazard; Executive Vice President, Chief Medical Officer; Imunon Inc

Jeffrey Church; Chief Financial Officer, Executive Vice President; Imunon Inc

Emily Bodnar; Analyst; H.C. Wainwright & Co, LLC

Kemp Dolliver; Analyst; Brookline Capital Markets

James Molloy; Analyst; Alliance Global Partners

Presentation

Operator

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 Imunon first quarter 2024 financial results conference call. (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 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 contents 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. 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 in our supporters.
Dr. Lindborg and I are joined by Jeff Church, our Chief Financial Officer, will provide remarks on our financials. Khursheed Anwer, 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 Stacy comes to Imunon well equipped for the test for many years in our industry is seen to that. She counts among her employment history, some of the most storied companies in the pharma and biotech world, including Eli Lilly, Biogen and most recently his Co-CEO, brainstorm Cell Therapeutics. For our deep conviction in their clinical stage product letter 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 follow this AdCom, as I did, you know that the arguments that Stacy, maybe was very impressive. It's clear that as an experienced credit statistician, Dr. Lindborg's academic focus has provided the regulatory world with innovative approaches to clinical stage product evaluation.
Frankly, her career as 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 conveying, 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 post, upfront and personally. For an organizational culture of dignity, respect, transparency and atmosphere where everyone has a voice.
Dr. Stacey Lindborg is someone I've come to know and admire. The 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 value 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 the 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 have -- we may have in our hands the first immunotherapy effective for the treatment of ovarian cancer. The 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 drivers 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 perspective. We have a core group of employees with tenure that rivals companies known for staff stability.
The third driver is opportunity. In their place and flexing, 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 innovation to with our TheraPlas Interleukin 12 immunotherapy. In a first-in-human trial with IMNN-101 to demonstrate proof of concept with PlaCCine, Both technologies hold great potential.
In the near term timing of these events make my joining the company at this time, I feel 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 including the opportunity to study R&D productivity as head of R&D strategy at Lilly, which lead to 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 has put in me as we execute our plans, and I'll turn it back to Michael.

Michael Tardugno

Thank you, Stacy. On behalf of our shareholders and employees. Welcome look forward to your leadership in this challenging and exciting world of biotech. Now that you are shareholders and listening audience, I want to assure you that during our management transition, we remain fully 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 the IMNN-001 in advanced ovarian cancer. And as we reported this morning, enrollment has begun as promised in our Phase 1 vaccine study of immunized 101. A proof-of-concept trial to evaluate the immunization of patients against COVID-19 with our DNA based - let me say, we believe our mRNA better technology.
We 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 peri-operative 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 a diaphragm, our Khursheed, can I ask you to give us some rationale for our optimism in the supporting data for a study?

Khursheed Anwer

Of course, Michael. This is Khursheed. I mean that's a great question. I think you have the team, I 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, wherein 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 supposed to be.
Second, IMNN-001 makes IL-12. There's evidence that there is production of IL-12, the biological molecules that we are delivering the gene therapy approach. And then also there's levels of interferon gamma that's a potent mediator of IL-12 action. So you've got this pharmacology there.
There's also from a kinetic where these agents are cytokine last for several days after simple injections is the continuous pressure on tumor of this cytokine is 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 OVATION 1. 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 imunon stimulation. So creating an environment in ovarian cancer that will be conducive to an anti-tumor effect. So having seen this 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?

Michael Tardugno

Thank you. Khursheed. So if the interim data confirm the observed, PFS benefit would represent a clinically meaningful outcome. Last September 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 approximately nine month improvement in the treatment arm over the control arm. Subgroup analyses suggest patients treated with a PARP inhibitor is 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's treatment plan.
First subgroup, we say this is a non prespecified subgroup. For subgroup analysis of patients who receive PARP inhibitors may -- Park 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, not prespecified. It represented a small number of patients. They are intriguing nonetheless, and encouraging, I would suggest.
So you have a second study has not been talked about much, when starting to get quite a bit of -- attract quite a bit of interest from the medical community to second study of 001 in advanced ovarian cancer. It's ongoing, principally funded by the breakthrough Cancer Foundation. Now that the funding is from breakthrough Cancer Foundation, the data belongs to the company, belongs to Imunon and want to reassure you of that.
MD Anderson, Cancer Center at the University of Texas is the lead clinical site. The trial's expected to enroll 50 patients with stage 3 for 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 for the -- I'm sorry, control arm standard chemotherapy plus Avastin. For the treatment arm and 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 design 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 that 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 treatments.
The secondary endpoint is PFS. The trial will also provide a wealth of translational endpoints aimed at understanding the clonal evolution in immunogenic features of the MRD phase of ovarian cancer that is currently undetectable by imaging for marker, tumor markers. In February 2024, Memorial Sloan Kettering, that's MSK, cancer center join 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 during 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. We'll demonstrate the platform may have placed 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 and 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 -- in this study of healthy adults are to evaluate the vaccine candidate, safety and tolerability.
Secondary objectives are to evaluate neutralizing antibody response, cellular response in 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 properly, Sebastian, but could you describe the study in a little bit more detail for us.

Sebastien Hazard

Absolutely, Michael and Anwer. Good morning, everyone. So you have this Phase 1 study. The main objective is to really understand what were those to use in Phase 2. So there will be a three cohorts escalating doses, three course of eight participants. And together with the independent data monitoring committee, we look at this 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, but that will be another very important objective of the strategy.
And then of course, we look at the efficacy. First, the neutralizing antibody response. This is what will get the sooner after patients from participants have enrolled, but cellular response and it's durability and durability, of course, responsives may be. We hope based on preclinical data, something it will differentiate this product from mRNA vaccine. Michael?

Michael Tardugno

Thank you, Sebastian. 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 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, Sebastian. So now based on compelling preclinical data for this vaccine candidate, we expect immune -- immunogenicity and protection greater than 95%. Superior shelf life of at least 12 months at refrigerator temperatures, recall and messenger RNA vaccines have to be stored at minus 7 degrees centigrade.
And we expect also stability it 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 greater manufacturing flexibility. Compared with viral load or other DNA vaccines or protein vaccines, we expect our DNA vaccine will have advantages in T cell responses, in safety and 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. This is a proof of concept study to demonstrate the superior characteristics of our vaccine candidate. So as COVID 2 is a relevant virus for them -- to demonstrate this product's comparative benefits in 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 in the medical community. It 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?

Jeffrey 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 investments. 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 NOLs 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 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. 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. And 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 IIMNN-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 Mike -- Michael indicated, the enrollment of this study was completed in March -- 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, and it's also a great overview of financials. And just make a point here and we spent some money on pilot manufacturing, I just -- we are 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 for a fraction probably an order of magnitude lower cost than if we were to outsource them. That bodes very well for the future expenses as a company and frankly, producing our own product internally particularly these precursors bodes very well for our ability to be able to control product costs going forward.
So on appreciated yet part of our development program, but certainly as we advance our programs will be a very important strength that the company -- your company has. 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.
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 while keeping a close eye on funding conditions for microcap companies in this very challenging capital market.
And I just want to conclude our prepared remarks with just again the appointment of Stacy Lindborg, we're looking forward to a 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 from the Dr. Lindborg's leadership.
So with that, operator, I'd like to open the call to questions. Operator?

Question and Answer Session

Operator

Thank you. We will now begin the question and answer session (Operator Instructions)
Emily Bodnar, H.C. Wainwright.

Michael Tardugno

Good morning, Emily.

Emily Bodnar

Hello, good morning and thanks for taking the questions and congrats on the new role, Stacey, and welcome to the team. Just a few questions for me. Firstly, on the COVID study, I know that 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, let's 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 vaccine studied initially.
And then last question, as for the OVATION 2 study, are you going to have a corporate event to announce the top line results there. How soon do you think you'd be able to initiate a Phase 3 study if the OVATION 2 study was positive? Thanks.

Michael Tardugno

Okay. How can they -- 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 the immunogenic. I mean that yeah, I mean, the vaccine -- effective vaccine properties. So I'm going to turn that question over to Khursheed Anwer. Khursheed, the first dose, you believe it has some efficacy as it relates to protection?

Khursheed Anwer

Yes, So Emily, good to have you on the call. We did NHP study, where we did look at a couple of doses and we have seen the illustration of binding antibodies, floating antibody. 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 [minimum] could even be in a city based on the preclinical data in non-human primate doses that over lapping.

Michael Tardugno

And to before we finish with the answer to their question, Sebastian, would you add anything more to that?

Sebastien Hazard

No. I think it -- that summarizes very well, Michael. I don't have anything in particular to add to this.

Michael Tardugno

Thank you. Emily does that cover your point?

Emily Bodnar

Yeah, does. Thanks.

Michael Tardugno

Your second question is related to OVATION 2 on our plan with regard to announcing it at a corporate event? Yeah, I think so. I mean, this is relatively -- it's a very, very new approach to our recruiting the immune system using IL-12. We're very proud of this technology and developed under Dr. Anwer's capable leadership. We know that IL-12 has been a subject of potential therapeutics since the late 1980s and Dr. Rosenberg's laboratory at the NAH, and it's been really put on the shelf largely because of the safety profile of a direct administration of recombinant IL-12 has not been -- has been a subject of concern.
So in addition to announcing the results, I think this platform is product capability, assuming we're successful with 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're fine and it means to be able to share this information along with the perspectives of the KOLs involved in this 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 into 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 this study protocol. The always 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

I think that would be required, of course.

Emily Bodnar

Okay. Thanks.

Operator

Kemp Dolliver, Brookline Capital Markets.

Michael Tardugno

Hello, Kemp.

Kemp Dolliver

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 of the Phase 3 study, assuming you have success and I understand, is it going to be broad brush at this juncture, but we'd like to hear your insights on this.

Stacy Lindborg

So the trial 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.
So we're really expecting that we will learn what we need to design this next trial and the most important thing that will need to consider as we read out the final results that 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 in the prepared remarks, the emergence of prep 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 the PARP inhibitors, how they're spread across the trial, other important genetic information, a positive how that influences the results.
And 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 it's premature.

Kemp Dolliver

Yeah. Thank you.

Michael Tardugno

Yeah. Thank you.

Operator

James Molloy, Alliance Global Partners.

Michael Tardugno

Good morning, James.

James Molloy

Hi, guys. Thank you for taking the question and congratulations, Dr. Lindborg on your appointment as CEO. I'd love to hear your thoughts, when you joining in to Imunon and looking at the sort of the two sets of trials ongoing, what gave you the sort of the most interest or so, which was sort of the between the vaccine or the immunotherapy? sort of gave you the highest level of confidence that this is mostly on the move you want to make and to come on Imunon?
And then can you talk a little bit about we look at this division to data, could you help us sort of a game out what are good bad or equivocal data might be coming here in mid '24, and it almost seems like maybe the PARP, at the PARP inhibitors, maybe left us OVATION 2 behind or is there still going to be room for 001?

Stacy Lindborg

It's very interesting questions. And I think on your first and 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 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 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 and directly.
Your second question remind me.

James Molloy

PARP inhibitors .

Stacy Lindborg

Yes. So absolutely at the emergence, frankly any company, and we certainly when we look at what these women are fighting, we want to see standard of care in progress, and we want to see effective treatments. Emerging from the interim data specifically in this trial, we see that in fact, the West Central and we actually see stronger results and women who were receiving pump inhibitors on top of it on top of oh one, our novel therapy.
So in no way, does it invalidate the treatment in fact, we're seeing that there appears to be synergistic and additive effect. So we're pleased to see what's evolving, and that's that's just part of our business. We have to we have to build upon any progress that's made.

Michael Tardugno

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 bracket positive, and that represents only about 45% or a little bit less of the neoadjuvant. Patients are indicated for neoadjuvant treatment.
So I mean, so the synergistic effect in 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 a PARP inhibitors. So that's our point of view.

James Molloy

Thanks. I think -- I know it's a ways of the data, obviously because looking at the Phase 3, we would have PARP inhibitors, in the Phase 3 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 in the assuming, we would like to not to eliminate any of -- either of the two groups in our current study and I could very well, be that this trial includes both populations stratified for each in the -- yeah, it could 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 kind of, again, it's going to be based on the strength of the data.
One of the unfortunate parts about oncology trial is you can -- sometimes you continue to narrow, the population, so much just to get a positive result so much or that you exclude a lot of individuals who benefit. And I find that to be a regulatory strategy that I now come on to the goal of companies like ours, and we're looking to develop therapeutics that have a broad, broad application. But unfortunately, the way the deal regulatory world is designed successor -- online success, unfortunately, sometimes we narrowed the study populations too, and a small percentage of those who potentially could benefit.
So if we do have the opportunity, then I if I were a betting person is, I'll say it again to include the intent-to-treat population that's currently being and that was currently enrolled in our study. We'll do that, but we'll do that with an eye to making sure that we are able to evaluate the effect of 001 on both groups. Makes sense?

James Molloy

Indeed. Absolutely. Thank you for that. And then a couple of questions. And I'll be done on the Phase 1, Phase 2 of 001 plus OPDIVO 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 101 SARS CoV 2 trials? And what's the update on the 102 for an I&D filing. Thank you.

Michael Tardugno

So I don't know if I misspoke or you just or you did, but that we're combining 001 with Avastin, that YERVOY in the MRD study is that when you're talking about?

James Molloy

That's all I had in my notes that you guys are going to look to start a combo with OPDIVO and YERVOY as well. I know you have the Avastin up and running.

Michael Tardugno

I'm sorry. So I think we indicated in some earlier conversations that we thought a checkpoint inhibitor might combination. It might be a very interesting approach. We're stuck in this conserve capital kind of world right now. So -- a lot of focus to it. But I I think as we consider the future for these therapeutics that the a very interesting combination. I don't know Dr. Sebastien, if you'd like to comment on that.

Sebastien Hazard

No, yes, absolutely. I think is a project that I been looking into and in terms of synergy and to help really immunotherapy, we are really, really active in ovarian cancer, that could be a very nice opportunity. So as Michael said, I 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

Yeah. Thank you. The 101 data expectation roughly which we anticipate that Phase 1 data to come out and then any is one or two kind of again of the capital preservation? Is that a little bit in the back burner?

Michael Tardugno

Yes, I can say that unequivocally. So we've narrowed our focus to I mean, 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. And with regards to a data from the fact seeing proof of concept, so are 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 nader 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. Thanks 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

So let me first say 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 still very proud of. Where we're focusing in an area of technology that has been explored by many companies. I think under Dr. Anwer 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 on all 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 the -- 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 look forward to keeping you informed and we on behalf of all of us here and on the call, we have our employees here that we wish you a very safe and nice afternoon. Thank you very much.

Operator

The conference is now concluded. Thank you for attending today's presentation. You may now disconnect.