Q1 2024 Imunon Inc Earnings Call

Nick: 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.

Please standby good morning, My name is Nick and I will be your operator today at this time I would like to welcome you to the immuno first quarter 'twenty 'twenty four financial results conference call.

Nick: 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 Golodetz. Please go ahead.

Nick: All lines have been placed on mute to prevent any background noise. Following the speakers' prepared remarks there'll be a question and answer session. You May press star one on your phone to ask a question at that time.

Please keep in mind, if you're using a speakerphone you must release your mute function to allow the signal to reach our equipment again, that's star one to ask a question during the Q&A session.

Nick: I'd now like to turn the call over to Kim Golar. That's please go ahead.

Kim Golodetz: Thank you and good morning everyone. This is Kim Golodetz with LHA.

Kim Golodetz: Thank you and good morning, everyone. This is Kim gala, that's what they're like Jay welcome to them, you announced first quarter 2024 financial results and business update conference call.

Kim Golodetz: 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.

Kim Golodetz: During today's call management will be making forward looking statements regarding immuno <unk> 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 companys periodic filings with the Securities and Exchange Commission.

Kim Golodetz: 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.

Kim Golodetz: No forward looking statements can be guaranteed and actual results may differ materially from such statements.

Kim Golodetz: I also caution that the content of this conference call is accurate only as of the date of the live broadcast May 13, 2024, immuno <unk> undertakes no obligation to revise or update comments made during this call except as required by law, but that said I would like to turn the call over to Michael Junior.

Michael H. Tardugno: Immuno wants executive Chairman Michael.

Michael H. Tardugno: Thank you, Kim, and good morning, everyone. And let me also thank you for joining us on 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 will provide remarks on our financials. Khursheed 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.

Michael H. Tardugno: Thank you Kim and good morning, everyone.

Michael H. Tardugno: Let me also thank you for joining us for this a particularly important call I want to start with.

Michael H. Tardugno: Welcoming Stacy Lindbergh, your new Chief Executive and President to her first call with the investment community and our supporters.

Lindbergh and I are joined by Jeff Church.

Jeffrey W. Church: Chief Financial Officer, who will provide remarks on our financials.

Jeffrey W. Church: Hershey on where our Chief Science Officer, and Doctor Sebastian Hazara Chief Medical Officer are also on the line.

Jeffrey W. Church: It will be available for the question and answer period.

Michael H. Tardugno: 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, we've seen to that.

Jeffrey W. Church: But first the Doctor Lindbergh for those of you have read last week's press announcement.

Jeffrey W. Church: Even though much of what I'm going to tell you that.

Jeffrey W. Church: Stacey comes Damian on well equipped for the task for many years in our industry has seen to that.

Michael H. Tardugno: 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, co-CEO of Brainstorm Cell Therapeutics, for her deep conviction in their clinical stage product letter to present a compelling case to FDA at an advertising conference for continued development following a Phase III study that missed its primary endpoint. Now, if you followed this EDCOM as I did, you know that the argument that Stacy made was very impressive. It's clear.

Jeffrey W. Church: She accounts among her employment history some of the most storied companies in the pharma and biotech world, including Eli Lilly Biogen and most recently.

Jeffrey W. Church: As co CEO brainstorm cell therapeutics or.

Jeffrey W. Church: Our deep conviction in their clinical stage product letter to present, a compelling case to F D a to Nat cat.

Jeffrey W. Church: Continued development following a phase III study that missed its primary endpoint.

Jeffrey W. Church: Followed the satcom as I did you know that the.

Jeffrey W. Church: The argument that Stacey made was very impressive it's clear.

Michael H. Tardugno: 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.

So it is an experienced biostatistician Dr. Linda Rhodes academic focus has provided the regulatory world with innovative approach innovative approaches to clinical stage product evaluation.

Jeffrey W. Church: Frankly, our careers at history of accomplishment and our record of success that perfectly complements the challenges facing imminent 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.

Jeffrey W. Church: All of them she has a deep and abiding commitment to the people of an organization into people generally.

Michael H. Tardugno: She has a deep and abiding commitment to the people of an organization and to people generally. I witnessed her passion up close, up front, and in person for an Organizational Culture of Indignity, respect, transparency, and an atmosphere where everyone has a voice. Dr. Stacey Lindborg is someone I have come to know and admire, for her work over the past three years as a member of our board of directors has helped us, and me personally, to evaluate immunized priorities and drive our critically important development strategy. I look forward with confidence to Stacy'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?

Jeffrey W. Church: Why wouldn't a surpassing our posts upfront and personally for organizational culture.

Any risk.

Jeffrey W. Church: Respect transparency and atmosphere, where everyone has a voice.

Speaker Change: Doctor Stacy Lindbergh and someone I've come to know and admire.

Speaker Change: The work over the past three years as a member of our board of Directors has helped US and me personally.

Speaker Change: Oh wait immunized priorities and drag our critically important development strategies I look forward with confidence to states. His leadership from the value she will bring to our mission and to you our shareholders.

Speaker Change: Would you like to make a few comments place. Thank you Michael for those kind words, and I really couldnt be more delighted to join this call in my new capacity as president and CEO with I mean on.

Stacey 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.

Speaker Change: Perhaps it would help to reflect on my reasons for joining immune on at this exciting time of which there were three drivers.

Speaker Change: People an opportunity.

Stacey Lindborg: Starting with science, we have the potential to do great things for patients, most immediately for 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 a quarter million women living with the disease. The second driver is people.

Speaker Change: Let me expand on it.

Speaker Change: Starting with fire.

Speaker Change: We have the potential to do great things for patients most immediately women fighting ovarian cancer with our lead investigational immunotherapy.

Speaker Change: In fact, we have we may have in our hands the first.

Therapy effective for the treatment of ovarian cancer.

Speaker Change: This cancer is a terrible disease that in the U S leads to about 20000, new diagnoses every year and then the same timeframe about 13000 deaths.

Speaker Change: When we look globally, there are nearly a quarter million women living with the disease.

Speaker Change: The second driver is people.

Stacey Lindborg: At Imunon, we have a focused and dedicated staff who bring great purpose to our work, leveraging 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.

Speaker Change: And you know and we have a focused and dedicated staff, who bring great purpose to our work leveraging a phenomenal depth from scientific and operational perspective.

Speaker Change: We have a core group of employees with tenure that rivals companies known for stop stability.

Speaker Change: The third driver is opportunity.

Stacey Lindborg: In Theraplas and Plaxene, we have two cutting-edge DNA-based technology platforms that provide bountiful opportunities for clinical development. Both of these technologies have important readouts this year, with the first up being the Phase 2 trial, which we call Ovation 2, with our therapeutic interleukin 12 immunotherapy, and a first in human trial with Imunon 101 to demonstrate proof of contact with Plaxene.

Surplus and flexing, we have two cutting edge DNA based technology platforms that provide bountiful opportunity in clinical development.

Speaker Change: Both of these technologies have important readouts this year.

Speaker Change: First stop being the phase two trial, which we call ovation two with our therapy class interleukin 12 immunotherapy.

Speaker Change: And our first in human trial with I mean on 101 to demonstrate proof of concept with that with passing.

Stacey Lindborg: Both technologies hold great potential, and the near-term timing of these events makes 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 pharmaceuticals.

Speaker Change: Both technologies hold great potential in the near term timing of these events make my joining the company at this time ideal from my perspective.

Speaker Change: 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.

Speaker Change: My most recent years have included senior leadership roles in the biotech sector.

Speaker Change: With the first 20 years of my career spent in pharma.

Stacey Lindborg: 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.

Speaker Change: 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.

Speaker Change: 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.

Speaker Change: I think we can all appreciate that as with any R&D endeavor, there are risks and uncertainties.

Speaker Change: But from my Vantage point, we have an amazing opportunity in front of us at Amin on.

Stacey Lindborg: 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 interests of our shareholders and employees. Our future is bright. And as a company, we are full of hope that we will have a 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.

Speaker Change: 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.

Speaker Change: And to run our business in a manner that is in the best interest of our shareholders and employees.

Speaker Change: 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.

Speaker Change: I'm grateful for the Trust, Michael and the board have put in me as we execute our plans.

Speaker Change: Now I'll turn it back to Michael Thank you Stacey.

Michael H. Tardugno: Thank you, Stacey. 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 Stacey mentioned, Theraplast and Placene. As you know, it's a particularly important time as we look forward to reporting top-line results from our Phase 2 study of Imunon-001 in advanced ovarian cancer, and as we reported this morning, enrollment has begun as promised in our Phase 1 Vaccine Study of Imunon 101.

Michael H. Tardugno: On behalf of our shareholders and employees welcome.

Michael H. Tardugno: We look forward to your leadership in this challenging and exciting world of biotech.

Michael H. Tardugno: None of you our 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, there are plus and policy.

Michael H. Tardugno: As you know, it's a particularly important time as we look forward to reporting topline results from our phase two study of immune on over one.

Michael H. Tardugno: In advanced ovarian cancer and as we reported this morning.

Michael H. Tardugno: Enrollment has begun as promised in our phase one vaccine study of it on 101.

Michael H. Tardugno: 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 technology. We fully expect to report top-line results from the Phase 2 Ovation 2 study, which is evaluating O-O-1 for the perioperative treatment of patients newly diagnosed with ovarian cancer, in mid-2024.

Michael H. Tardugno: Concept trial to evaluate immunization of patients against COVID-19, with our DNA based let me say, we believe our mrna better technology.

Michael H. Tardugno: We also wanted to show is that during the transition we will not lose focus on our overall strategy for continued development of these product candidates.

And our technologies.

Speaker Change: I will discuss.

Speaker Change: We fully expect to report topline results from the phase II ovation two study in mid 'twenty 'twenty four as you know.

Speaker Change: You mean on over one.

Speaker Change: Our DNA based IL 12, immunotherapy ovation two is evaluating <unk> for the perioperative treatment of patients newly diagnosed with ovarian cancer.

Michael H. Tardugno: 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. Anwer, Khursheed, can I ask you... to give us some rationale for our optimism and the supporting data for our study. And, of course, my...

Speaker Change: It's being tested in combination with the standard of care chemotherapy.

Speaker Change: Timber 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 for all of us.

Speaker Change: So that's where I work because she can I can I ask you.

Speaker Change: To give us some rationale for our optimism in the supporting data for our study.

Khursheed Anwer: Of course, Michael, this is Khursheed. I mean, that's a great question. I think every team should have that when developing any products. So clearly, for Imunon, 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 a local site is important.

Of course, Michael This is Christian.

Michael H. Tardugno: Good question I think a routine.

Christian: I should have that develop.

Speaker Change: Any products, so clearly for us I mean on one.

Christian: There are good reasons for the team to be optimistic about the drug.

Christian: Which is based on our data that we have available so far with lots of them use supposed to fall our way didn't cancer with local disease.

Christian: And effective concentration at local site, it's important in both human and animal studies, we have seen one distribution, primarily local b cavity of the peritoneum.

Khursheed Anwer: In both human and animal studies, we have seen OO1 distribution primarily local in the cavity of the peritoneum, and that is the site of the disease. So that's an important pharmacological aspect; the drug is there where it's supposed to be. Second, Imunon-01 makes IL-12. There's evidence that there is production of IL-12, the biological molecule that we are delivering through the gene therapy approach. And then also there's a level of interfering gamma that's the potent mediator of IL-12 action.

Christian: That is the site of the disease. So that's important pharmacological aspect of drug is there they're supposed to be.

Christian: Second you may not know one makes IL 12, there's evidence that there is production of IL 12.

Christian: Biological molecule that we're delivering to the gene therapy approach and then also there's level offering different gama. That's important mediator file collection. So you've got this pharmacology. There. There's also some other kinetic where these agents are cytokines last for several days off of school injections as the continuous pressure on tumor of these cytokines.

Khursheed Anwer: So you've got this pharmacology there, and there's also pharmacokinetics where these agents or cytokines last for several days after simple injections. So there's a continuous pressure on the tumor from 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 that mean downstream?

Christian: To build an immune response against cancer.

Christian: And these levels also translate into biological activity. That's what point you may have the levels, but what does it mean downstream. So we have seen innovation one.

Khursheed Anwer: 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 cells, favoring 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 O01, 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.

Christian: The tumor microenvironment in ovarian cancer as theory.

Christian: But that's where the disease progresses and we have.

Christian: He was a shift in the balance between immuno stimulatory.

Christian: Immuno suppressive.

Christian: The union of stimulation, so, creating an environment and they didn't cancel that'll be conducive to an anti tumor effect so having seen these.

Speaker Change: A Connecticut Pharmacodynamic Oh, one together with the clinical benefits, we have seen in PFS Oh I think there's good reason to be optimistic to think about this trial and future results Michael.

Michael H. Tardugno: Thank you appreciate it.

Khursheed Anwer: 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, nearly approaches the study objective.

Speaker Change: So if the interim data are confirmed the observed PFS benefit would represent a clinically meaningful outcome.

Speaker Change: Last September we reported PFS and OS data, suggesting an approximate 30% delaying disease progression and death among patients in the treatment arm compared with patients in the control arm.

Speaker Change: Dessert ratio in fact nearest the study objective.

Khursheed Anwer: Preliminary OS data followed a similar trend, showing an approximately nine-month improvement in the treatment arm over the control arm. Subgroup analysis suggests that patients treated with a PARP inhibitor as a maintenance therapy had longer PFS and OS if they were treated with Imunon 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 in the 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-pre-specified subgroup.

Speaker Change: Preliminary O S data followed a similar trend showing an approximate nine month improvement in the treatment arm over the control arm.

Speaker Change: Subgroup analyses suggest page.

Speaker Change: Patients treated with a PARP inhibitor as a maintenance therapy had longer PFS and OS if they were treated with imminent or one person.

Speaker Change: Versus patients treated with neo adjuvant chemotherapy only.

Speaker Change: We know that when the ovation two study begin PARP inhibitors had not yet been approved for first line maintenance treatment for a study population.

Speaker Change: It's just that for patients with certain genetic characteristics PARP inhibitor forms an important part of the patient treatment plan.

Speaker Change: For a subgroup.

Speaker Change: Well, let me say this is a not a prespecified subgroup.

Khursheed Anwer: 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 not pre-specified.

Speaker Change: For subgroup.

Speaker Change: All sorts of patients who received PARP inhibitors may PARP inhibitor maintenance therapy trends suggest that even a larger clinical benefit.

Speaker Change: Whereas as the potential in this subgroup the median PFS in the control arm was $15 seven months versus 23 seven months in the treatment arm or eight much longer.

Speaker Change: In addition, the median OS in the control arm was 45 six months.

Speaker Change: And yet had not been reached in the treatment or all those theaters are post hoc and again not pre specified.

Khursheed Anwer: They represent a small number of patients there but are treating them nonetheless and encouraging them. 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 001 in advanced ovarian cancer. It's ongoing, and principally funded by the Breakthrough Cancer Foundation. And although the funding is from Breakthrough Cancer Foundation, the data belongs to the company, and it belongs to Imunon. I want to reassure you of that.

Speaker Change: They represent a small number of patients they are intriguing nonetheless.

Encouraging I would suggest.

Speaker Change: Well, we have a second study is up and talked about much but its starting to get quite a bit of attract quite a bit of interest from the medical community.

Speaker Change: The second study of all one in advanced ovarian cancer, it's ongoing principally funded by the breakthrough.

Speaker Change: Cancer Foundation.

Speaker Change: And all of the funding is from breakthrough cancer Foundation. The data belongs to the company belongs to immune I want to reassure you about that.

Khursheed Anwer: 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 front-line neoadjuvant therapy will be randomized one-to-one and will receive standard chemotherapy plus a VASD. That's the differentiator.

Speaker Change: Well M D. Anderson cancer Center at the University of Texas is the lead clinical site. The trial is expected to enroll 50 patients with stage three or four ovarian cancer patients treated for frontline Neo adjuvant therapy will be randomized one to one.

Speaker Change: C standard chemotherapy plus avastin, that's the differentiator.

Khursheed Anwer: So the treatment arm will be standard chemotherapy plus a vest. We're in the, I'm sorry, the control arm, standard chemotherapy, post-advanced, or the treatment arm at Standard Chemotherapy plus Sebastian plus Imunon 001. So I'm happy to report the acceptance of our abstract for this trial describing the study designed for presentation as a poster at the ASCO conference this year at its annual meeting in Chicago during the week of May 31st through June 4th.

Speaker Change: So the treatment arm will be standard chemotherapy plus avastin.

Speaker Change: And I'm sure the controller standard chemotherapy, plus avastin for the treatment arm at standard chemotherapy, plus avastin plus immune on over one.

Speaker Change: Okay.

Speaker Change: 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 Astro Conference this year.

Speaker Change: <unk> annual meeting in Chicago during the week of May 31 through June four.

Khursheed Anwer: I'd suggest again that this reflects the medical community's interest in our study and its potential as 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.

Speaker Change: I guess it suggests 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.

Speaker Change: Also I just wanted to point out the trials. The trials primary endpoint is the detection of minimal residual disease. The acronym is M D minimal residual disease by second look laparoscopy.

Speaker Change: As a novel endpoint that will be assessed following adjuvant treatment.

Speaker Change: Approximately three months following edge retrieval.

Speaker Change: The secondary endpoint is PFS. The trial will also provide a wealth of translational endpoints aimed at understanding the clonal evolution and immuno genomic features of the M. R. D face of ovarian cancer that is currently under detectable by imaging or mark or tumor markers.

Khursheed Anwer: 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 marker. In February 2024, Memorial Sloan-Kettering, that's MSK Cancer Center, joined MD Anderson and Rowling patients in this trial. We expect two more sites to be up and running in the near future.

Speaker Change: In February 2024.

Speaker Change: Oriel Sloan Kettering that's M. S. K cancer center join M. D. Anderson enrolling patients in this trial, we expect two more sites to be up and running in the near future. We will keep you posted as sites are added in this trial progresses well.

Khursheed Anwer: 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 Imunon 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 theraplast platform, this is key, will demonstrate the platform may have a place in medicine to treat a range So now I'll turn my focus to the Infectious Disease Program.

Speaker Change: Assuming success in either or both of these studies, we believe all one that Tim had an old one will be the first immunotherapy as Stacy pointed out that's proven effective for the treatment of advanced ovarian cancer and will demonstrate our third plus platform. This is Kate will demonstrate the platform. They have placed a place in medicine that treat.

Speaker Change: A range of intraperitoneal cancers.

Speaker Change: So now I'll turn my focus to the infectious disease program last month, we announced the acceptance by the FDA just last month.

Khursheed Anwer: Last month we announced acceptance by the FDA, just last month, of our phase one protocol for a seasonal COVID-19 booster. As we announced this morning, if you read our press release, enrollment has begun already. We initiated our clinical trial center in Philadelphia. Second center, Beth Israel in Boston, should be up and running very soon.

Speaker Change: Exceptions, but the F D a of our phase one protocol for seasonal COVID-19 booster.

Speaker Change: As we announced this morning, if you read our press release and a woman has begun already initiated a clinical trial center in Philadelphia Second Center Beth Israel in Boston should be up and running very soon.

Sebastien Hazard: This first phase of the study is a 24-subject proof-of-concept trial. The primary objectives of this study of healthy adults are to evaluate the vaccine candidate's safety and tolerability. Secondary objectives 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?

The first phase of this study is a 24 subject proof of concept trial. The primary objectives. In this study are in the study of healthy adult start to evaluate the vaccine candidates safety and Tolerability secondary objectives are to evaluate neutralizing antibody response shows a response or durability.

Speaker Change: Which we expect to be among the key advantages of our DNA based formula.

Speaker Change: Based on preclinical data durability.

Speaker Change: Is expected to be substantially superior to published mrna vaccine data. So this trial is a little bit complex that I am not sure I covered it properly Sebastian but could you describe the study it a little bit more detail for us.

Sebastien Hazard: Absolutely Michael and good morning everyone. So, this Phase 1 study, the main objective is to really understand what those to use in Phase 2, so there will be three cohorts with escalating doses, three cohorts of eight participants. And together with the Independent Data Monitoring Committee, we will look at this data to determine what would be the best dose for phase 2. And we'll also, as Michael mentioned, devote a lot of attention to the safety and tolerability of the product.

Sebastien Hazard: Absolutely Mike Good morning, everyone. So this phase one study our main objective is to really understand what wed do is to use in phase two so there will be.

Sebastien Hazard: Threep cool is kidney disease.

Speaker Change: <unk> three cools off.

Speaker Change: Lots of stuff.

Sebastien Hazard: And together.

Sebastien Hazard: Independent of them.

Sebastien Hazard: The monitoring committee.

Sebastien Hazard: I just did that to determine what we do today.

Sebastien Hazard: For phase two.

Sebastien Hazard: So as my good months.

Did you keep a lot of attention to the safety to log in to Q2, I'm going to predict that we'd be up another very important too because you've moved just a year and then of course, we look at these kits.

Sebastien Hazard: So 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 patients and participants have enrolled. But also the cellular response and its durability and the durability of both responses may be, we hope, based on preclinical data, something that will differentiate this product from the RNA vaccine.

Sebastien Hazard: Neutralizing antibody response, and this is what we would get to due to snow I still patients.

Sebastien Hazard: But those who are sitting in our response.

Sebastien Hazard: And as Joe alluded to you on that.

Sebastien Hazard: July was weak.

As supposed to meet.

Sebastien Hazard: We hope based on preclinical that doesn't appear to be filling shapes.

Sebastien Hazard: These products from our neighbors.

Michael H. Tardugno: Michael?

Sebastien Hazard: Michael.

Sebastien Hazard: Thank you, Sebastien. So if we're successful in the first 24 patients, then what?

Michael H. Tardugno: Thank you Sebastian so if if we're successful in the first 24 patients than what.

Sebastien Hazard: So we have the protocol already states that we will be ready to enroll into 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 for the efficacy.

Sebastien Hazard: So you know we have the protocol or would you state that to where we would be ready to go into a phase two or a couple of weeks makes me 50 patients you seem to go on these phase two dose and then further.

Further establish do tend to see is cheap, but most of it goes down.

Sebastien Hazard: It provides the oldest proof of concept on these kits.

Sebastien Hazard: Yeah.

Michael H. Tardugno: Thank you. Thank you very much, Sebastien. Now, based on compelling preclinical data for this vaccine candidate, we expect immunogenicity and protection greater than 95 percent and 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 also expect stability for at least one month at 90 degrees Fahrenheit.

Speaker Change: Thank you. Thank you very much Sebastian.

Speaker Change: So not based on compelling preclinical data for this vaccine candidate, we expect EMU immunogenicity and protection greater than 95%.

Speaker Change: Superior shelf life of at least 12 months have refrigerator temperatures.

Speaker Change: Call that messenger RNA vaccines have to be sorted minus seven degrees centigrade.

And we expect also stability for at least one month at 90 degrees Fahrenheit.

Michael H. Tardugno: The stability profile suggests superior commercial handling and distribution properties compared with mRNA vaccines, as well as 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. Safety and Delivery Compliance and Manufacturing Flexibility.

Speaker Change: This 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.

Speaker Change: Expect our DNA vaccine will have advantages and T cell responses in safety and delivery compliance and manufacturing flexibility.

Michael H. Tardugno: Assuming a successful Phase 1 and assuming Imunon-001 performs as expected, we look to partner this program out for further development to expand the platform. So, I want to make crystal clear that this is a Phase 1 study; this 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.

Assuming successful phase, one and assuming all of it.

Speaker Change: Oh, one performs as expected we look to partner this program out for further development to expand the platform.

Speaker Change: And to expand the platform. So I want to make crystal clear. This is a phase one study as a proof of concept studies to demonstrate the superior characteristics or a vaccine candidate.

Speaker Change: As koby to as a relevant virus for Devon to demonstrate this product 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 as it means to address rapidly evolving.

Michael H. Tardugno: Once demonstrated, the superiority of our vaccine technology 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, I'll turn the call over to Jeffrey Church for his always lively discussion of our financial results. Jeff.

Speaker Change: And newly emerging viral pathogens with pandemic potential on a global basis.

Jeffrey W. 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 Optimist study.

Speaker Change: So with that I'll turn the call over to Jeffrey Church for as always lively discussion of our financial results, Jeff. Thank you Michael.

Jeffrey W. Church: Retails are immunized 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.

Jeffrey W. Church: As of March 31, 2020 for me not had $9.8 million in cash and investment and 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 III Optima study.

Jeffrey W. Church: In March 2024, we received $1 $3 million in net proceeds from the sale of approximately $1 4 million of our unused.

Jeffrey W. Church: New Jersey net operating losses. These NOL sale cover the tax year 2022, and is non dilutive funding further strengthening the company's balance sheet.

Jeffrey W. Church: As we have in the past we would 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.

Jeffrey W. Church: With a minimal level of financing through the continued sale of our New Jersey, Nols and the opportunistic use of air 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. You mean on reported a net loss for the first quarter of 2024.

Jeffrey W. Church: 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. 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.

Jeffrey W. Church: $4 $9 million or <unk> 52 cents per share. This compares with a 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 $700000 or 12% from the first quarter of 2023.

Jeffrey W. Church: 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 $700,000 from the $2.6 million we reported last year.

Jeffrey W. Church: Let me break down the operating expenses by line item research and development expenses were $3 3 million in the first quarter of 2024, there was an increase of 300000 or $700000 from the $2 6 million, we reported last year.

Jeffrey W. Church: More specifically, R&D costs associated with the development of Imunon-001 to support the Ovation 2 study, as well as the development of the Plastine DNA vaccine technology platform were $1.6 million for Q1 2024, compared with $1.4 million in the same period a year ago. Additionally, costs associated with the Ovation 2 study were $300,000 for the first quarters in both 2024 and 2023. As Michael indicated, enrollment in this study was completed in September of 2022.

More specifically R&D costs associated with development of immuno and over one to support the ovation two study as well as development of passing DNA vaccine technology platform were $1.6 million for Q1, 2024, compared with $1 4 million in the same period a year ago cost.

Jeffrey W. Church: Associated with your patient to study with $300000 for the first quarters in both 2024 and 2023. That's my micro indicated the enrolment of this study was completed in March and September of 2022, Sam.

Jeffrey W. Church: 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 GNA 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 DNO, 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.

Jeffrey W. Church: CMC costs manufacturing costs were $300000 in the first quarter of 'twenty 'twenty, four which compares to 600000.

Jeffrey W. Church: The first quarter of 2023.

Jeffrey W. Church: This was due to the development of in house pilot manufacturing capabilities for DNA plasmids and nanoparticle delivery system.

Jeffrey W. Church: 23 general and administrative expenses were $1 $7 million from the first quarter of 2024. This compares to $3 1 million in the year ago first quarter. This $1 4 million dollar decrease in G&A expenses was primarily attributable to lower <unk>.

Jeffrey W. Church: Noncash compensation expense lower employee related costs, a lower consulting and legal fees as well as lower premiums on air D N, Our director and officer insurance.

Other non operating income was $100000 for the first quarter of 2024, largely unchanged from the previous year's first quarter.

Michael H. Tardugno: With that financial review, I'll turn the call back to Michael. Thank you, Jeff. As always, a great overview of our financials. And Jeff made a point, you know; 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 product and costs going forward.

Jeffrey W. Church: With that financial review I'll turn the call back to Michael.

Thank you Jeff is always a great overview of our financials.

Jeff: And just made a point you know we spent some money on pilot manufacturing I just we.

Michael H. Tardugno: We we probably don't make enough of this but the company has the ability to produce it's a plasmid the underlying structure for our DNA.

Michael H. Tardugno: Therapeutics and vaccines, but a fraction probably an order of magnitude lower cost than if we were to outsource them.

Michael H. Tardugno: That bodes very well for the future expenses of the company frankly.

Michael H. Tardugno: <unk>, our own product internally, particularly these precursors.

Michael H. Tardugno: Bodes very well for our ability to be able to control the product and cost won't fall. So unappreciated, yet a part of our development program.

Michael H. Tardugno: 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. 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.

Michael H. Tardugno: Certainly as we advance our programs and to be a very important strength that the company Your company has.

Michael H. Tardugno: Also point out and I think as you heard through the day.

Michael H. Tardugno: We of course have 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 the.

Michael H. Tardugno: Meantime, we have taken steps to conserve capital.

Michael H. Tardugno: Pointed that out in our last conference call. Our goal is to ensure that we have cash sufficient.

Michael H. Tardugno: 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.

Michael H. Tardugno: And I just want to conclude our prepared remarks with once again the appointment of Stacey Lindbergh. We're looking forward to the leadership of a deep and capable management team. Together, I 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?

Michael H. Tardugno: And just I want to conclude our prepared remarks, just again the appointment of Stacy Lindbergh.

Michael H. Tardugno: Well, we're looking forward to her leadership of a deep and capable management team together.

Michael H. Tardugno: Together I believe we believe Gordon and I believe that we have.

Michael H. Tardugno: Total well to create significant value for patients and shareholders alike.

Michael H. Tardugno: The Doctor Lindbergh leadership.

Speaker Change: So with that operator, I'd like to open the call to questions operator.

Nick: Thank you. We will now begin the question and answer session. To ask a question, you may press star, then one on your telephone keypad. If you are using a speakerphone, please pick up your handset before pressing the keypad. To withdraw your question, please press star again. At this time, we will pause momentarily to assemble our roster. The first question comes from Emily Bodnar with HC Rainwright. Please go ahead.

Speaker Change: Thank you.

Speaker Change: We will now begin the question and answer session to ask a question you May Press Star then one on your telephone keypad, if youre using a speakerphone. Please pick up your handset before pressing the keys to withdraw your question. Please press Star then two at.

Speaker Change: At this time, we will pause momentarily to assemble our roster.

Speaker Change: The first question comes from Emily Podnar with H C. Wainwright. Please go ahead.

Emily Claudia Bodnar: Hi, 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.

Emily Claudia Bodnar: Good morning, I wanted to thank Sir Hello. Good morning, Thanks for taking my questions and congrats on the new role Stacie and welcome to the team.

Emily Claudia Bodnar: 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 soon do you think you'd be able to initiate a Phase 3 study if the Ovation 2 study was positive? Thanks.

Emily Claudia Bodnar: Two question for me.

Firstly on the Cobra study I noted you you're intending to look at three different doses. So can you maybe comment on if you're looking to start with it does that you believe would be effective in producing neutralizing antibodies based on your preclinical work.

Emily Claudia Bodnar: And then.

Emily Claudia Bodnar: Oh, let's talk about your internal goals for for that study in terms of durability on neutralizing antibody response, and you're kind of looking at the different variants and other COVID-19 vaccine study initially.

Speaker Change: And then last question.

Speaker Change: For the ovation. Two study are you planning to have a corporate about to announce the topline results there and.

Speaker Change: How soon do you think you'd be able to initiate a phase three study the ovation two study was positive.

Speaker Change: Okay, how about kidney failure.

Michael H. Tardugno: Okay, I'm not kidding either. 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, vaccine, effective vaccine properties? So, I'm going to turn that question over to Khursheed Anwer. Khursheed, the first dose, do you believe it has some efficacy as it relates to protection?

Speaker Change: Paul Let me start with the.

Paul: First question I believe it was related to or we are we starting with a dose in the phase one study of the vaccine trial that we believe to have the immunogenic I mean, yeah.

Paul: Yeah, I mean, a vaccine a effective vaccine properties.

Paul: So I'm going to turn that question over to Chris Shean on more.

Chris Shean: Chris Schade.

Chris Shean: First dose do 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 MHP study where we looked at a couple of doses and we saw the elicitation of binding antibodies, using 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 in overlap with the doses we have seen in non-human primates, so we have good confidence that we should be able to get good immunogenicity based on the clinical data in non-human primates.

Chris Shean: Yes, Emily good to have you, we did and it should be.

Chris Shean: B study, we did look at a couple of doses.

Chris Shean: And we had seen.

Chris Shean: The limitation of binding antibodies.

Chris Shean: Body then.

Chris Shean: Remember almost gonna be protection.

Chris Shean: The challenge to the wider comparable.

Chris Shean: The doses that we have used in human trials.

Chris Shean: Or wasn't lapses.

Chris Shean: Seen in nonhuman primates. So you have good confidence that you should be able to.

Chris Shean: Good.

Chris Shean: Could you didn't do the city based on the preclinical data in nonhuman primates do we do that we're lapping.

Chris Shean: Okay.

Sebastien Hazard: And before we finish with the answer to that question, Sebastien, would you add anything more to that?

Chris Shean: Yeah, and the shouldn't before we finish with the answer the question. The Sebastian would you add anything more to that.

Sebastien Hazard: I think that summarizes it very well, Michael. I don't have anything in particular to add to that.

Sebastien Hazard: No I think it's that's summarized it fairly well.

Sebastien Hazard: I just don't have anything particular to.

Sebastien Hazard: To add to this.

Michael H. Tardugno: Thank you. Emily, does that cover it for you?

Speaker Change: Thank you not only does that cover reported.

Emily Claudia Bodnar: Yeah, it does.

Speaker Change: Yeah. It does.

Michael H. Tardugno: I think your second question is related to Ovation 2 and our plan with regard to announcing it at a corporate event. Yeah, I think so.

Speaker Change: Your second question is.

Related to our ovation, two or a plan with regards to announcing a corporate event.

Michael H. Tardugno: I mean, you know, this is a relatively 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 concern 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.

Speaker Change: Yeah, I think so I mean that there's you know this is a relatively it's a very very new approach to.

Speaker Change: Oh recruiting the immune system using IL 12, and we're very proud of this technology.

Speaker Change: Developed under a doctor on wars are capable leadership.

Speaker Change: We know that the IL 12 has been a subject of.

Speaker Change: But there is a potential therapeutics since the late 19 navies and Dr. Rosenberg laboratory at the NIH.

Speaker Change: And it's been really put on the shelf largely because of the.

Speaker Change: Safety.

Speaker Change: I'll file.

Direct administration of recombinant IL 12 is not.

Speaker Change: It has been the subject of concern.

Michael H. Tardugno: So, you know, in addition to announcing the results, I think this platform..., product capability, assuming we're successful, would make a very interesting candidate for a range of interperitoneal cancers. 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 we would be able to start Phase 3. So, we already have some ideas here on the construct of Phase 3. Dr.

So you know in addition to announcing the results I think there's this platform.

Speaker Change: Product capability, assuming we're successful.

Speaker Change: What would make a very interesting candidate for a range of intraperitoneal cancers.

Speaker Change: Yes.

Speaker Change: I think not only given the results, but the potential of the platform I think we'd find them.

Speaker Change: It means to be able to share this information along with the.

Speaker Change: Perspectives of the Kols involved in the study.

Speaker Change: With the investment community.

Speaker Change: And I think the third question was related.

Speaker Change: Related to one would we be able to start a phase three.

Speaker Change: So all we already have some ideas here.

Speaker Change: The construct of the phase III.

Michael H. Tardugno: Hazard has been actively evaluating a number of approaches. But I suspect, based on the last interim data and the top-line data that we'll see in the next few months, we'll be able to assemble the appropriate group of key opinion leaders and investigators to finalize the study protocol. You know, the most difficult part of forecasting when is the interaction with the agents. But our internal goal would be to have a Phase III study up and running in the first quarter of next year.

Speaker Change: Doctor Azad has been actively evaluating a number of approaches.

Speaker Change: But I I suspect based study based into the last interim data in the.

Speaker Change: That's the top line data that we'll see in the next few months, we'll be able to assemble.

Speaker Change: The appropriate.

Speaker Change: Group a K a.

Speaker Change: The walls and investigators to finalize the study protocol.

Speaker Change: You know they always the most difficult part of forecasting when is.

Speaker Change: Does the interaction with the agency.

Speaker Change: But our internal goal would be to have a phase III study up and running in the first quarter of next year.

Speaker Change: Okay.

Michael H. Tardugno: Alright, just a follow-up on that. Are you planning to have an end of phase two meeting with the FDA following this study? Yeah, I think that would be required, of course.

Speaker Change: Just a follow up on that are you I think to have like an end of phase two meeting with the FDA. Following this study.

Speaker Change: Yeah, I think that would be required of course.

Speaker Change:

Michael H. Tardugno: and Sallie Permar. Okay, thanks. Thank you. The next question comes from Kemp Dolliver with Brookline Capital Markets. Please go ahead.

Speaker Change: Okay.

Speaker Change: Thank you.

Speaker Change: Yeah.

Speaker Change: The next question comes from Tempt Oliver with Brookline capital markets. Please go ahead.

Brian Kemp Dolliver: Low-cap. Hello, thank you, and welcome on board.

Tempt Oliver: Look up.

Hello.

Tempt Oliver: Thank you and welcome on Board Dr. Lindbergh.

We have as well as the statistician on the call.

Tempt Oliver: Just wanted to ask about how we should think about the parameters in our phase III study, assuming you have succession.

Speaker Change: Your stand.

Dr. Lindbergh: We're gonna be broad brush at this juncture, but we'd.

Dr. Lindbergh: We'd like to hear your insights on this.

Stacey Lindborg: So this trial, as we've been hearing 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 was really planned to give us confidence to design the next trial. So, you know, we're really expecting that we will learn what we need to design this next trial.

Speaker Change: So let's.

Speaker Change: It's trial.

Speaker Change: In the past and I've had the benefit of thing as a board member the design and and really how the trial is being received and of course the early read out.

Speaker Change: We know that the trial is not powered them to present, a a significant P value, but really was planned to give us confidence to design. The next trials. So you know we're really expecting that we will learn what we need to to design. This next trial and the most important thing.

Stacey Lindborg: And the most important thing that we'll need to consider as we read out the final results is that the interim results 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 his prepared remarks, the emergence of PARP inhibitors, what that brings in terms of insights into the relationship between what we can see as treatment effective 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.

Speaker Change: That will need to consider as we read out the final results that the Enron interim looks always give you a perspective on the trial that until you really get to the end of the trial and you have them all of the event. So we planned this to have a D and then will need to step back.

And understand the evolving treatment landscape as Michael spoke about in the in the prepared remarks, the emergence of PARP inhibitors, and 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.

Speaker Change: Influence of those PARP inhibitors, how they're spread across the trial.

Speaker Change: You know other important genetic information for BRCA positive how that influences our results and you know and then well well well work closely with the medical community not only to make sure. We harnessed the complexity of our trial and our data with the disease and the emerging.

Stacey Lindborg: 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 also with this disease and the emerging insights that we can bring. 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.

Speaker Change: And insights that we can bring so.

Speaker Change: As a as Michael has already shared theres been a lot of thought already given to what that trial design could look like but.

Speaker Change: The real kind of sharpening of the pencil begins when we have the final the final data and I think anything before that is it's just premature.

Speaker Change: Okay.

Speaker Change: All right.

Speaker Change: Yes. Thank you.

James Francis Molloy: The next question comes from James Molloy of Alliance Global Partners. Please go ahead.

Speaker Change: The next question comes from James Molloy of Alliance Global Partners. Please go ahead.

Stacey Lindborg: Hey guys, thank you for taking the question and congratulations to Dr. Lindborg on your appointment as CEO. I'd love to get your thoughts, when you joined Imunon and looked at sort of the two sets of trials ongoing, what gave you the most interest or which was sort of between the vaccine or the immunotherapy, sort of maybe the highest sort of level of confidence? What's the move you want to make to come to Imunon?

James Francis Molloy: Good morning, James Hey, guys. Thank you for taking the question and congratulations on Lindbergh on your appointment as CEO.

Speaker Change: Your thoughts when you are.

James Francis Molloy: Turning it into immuno on and looking at sort of the two are.

James Francis Molloy: Two sets of trials ongoing.

Speaker Change: We gave you the sort of the the most interest or.

Speaker Change: Which was sort of the between the vaccine or the.

Speaker Change: Immunotherapy.

Speaker Change: I gave you the highest sort of level of confidence that this is mostly on the move you want to make it.

Speaker Change: Come on.

Speaker Change: And then.

Stacey Lindborg: Can you talk a little bit about, when we look at the Salvation 2 data, can you help us sort of game out what good, bad, or equivocal data might be coming here in mid-24? And it almost seems like maybe the PARP inhibitors. (Inaudible)

Speaker Change: Can you talk a little bit about we look at this our vision two data could you help us sort of a game out what a good bad or equivocal data.

Might be coming here in mid 'twenty Ford and it almost seems like maybe the apartment of the PARP inhibitors.

Speaker Change: Well you know maybe leftist lift this ovation two behind or is there still going to be room for well for Oh one.

Stacey Lindborg: Both very interesting questions, and I think on the first one, you asked the question really about the two studies. You know, 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 toward a first approval, but then beyond that, knowing that this is really, I think the word I used in my prepared remarks was a bountiful set of opportunities, Your second question, remind me. Oh, yes.

That's very interesting questions and I think on your your first you asked the question really between the two studies you know to be honest the child's 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 approval. 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 of <unk>.

Speaker Change: But then beyond that knowing that this is really.

Speaker Change: 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 we can have us as a company.

Speaker Change: Is to know that we'll be able to expand them directly.

Speaker Change: Your second question remind me PARP inhibitors, Oh, yes, so absolutely it the emergence.

Stacey Lindborg: So, absolutely, the emergence of new treatments, 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 001, our novel therapy. So, in no way does it invalidate the treatment.

Speaker Change: Frankly, any any company and and we certainly when we look at what these women are fighting we want to see standard of care progressed somebody wanted to see effective treatments.

Speaker Change: Our emerging and from the interim data specifically in this trial, we see that in fact that the the last interim we actually see stronger results and women, who were receiving PARP inhibitors on top of them on top of Oh, one and our novel therapy. So in no way does it.

Speaker Change: Validate the treatment in fact, we're seeing that there appears to be center, just thinking a additive effect. So.

Stacey Lindborg: 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.

Speaker Change: Where we're pleased to see what what's evolving and and that's that's just part of our business. We have to we have to build upon them any progress that's made.

Michael H. 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 percent, or a little bit less, of the 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, Imunon-001, we expect to deliver some advantages to patients who are treated with or not indicated for PARP inhibitors. So that's our point of view.

Speaker Change: And Mike Let me add also.

Mike: And also a gymnast.

Mike: Nevertheless, his inhibitors are currently indicated for Ya.

Mike: Patients with a certain genomic signature they have to be HRD positive or a BRCA positive and that represents only about 45% or a little bit less.

Mike: Of the Neo adjuvant patients who are indicated for neo adjuvant treatment.

Mike: Yeah.

Mike: So I'm sure you know the.

The synergistic effect and that is it is very encouraging and those patients treated with PARP inhibitors.

Mike: Also.

Mike: No one we expect to deliver some advantages to patients who are treated or not are indicated for a PARP inhibitors.

So that's our point of view.

Michael H. Tardugno: Excellent. In the thinking, I know it's waiting for the data, obviously, but looking at phase three, would apartment inhibitors be in phase three in some respect or any thoughts on what that trial design might look like? Again, presuming good data here mid-24.

Speaker Change: Excellent and the thinking and I know you're waiting for the data, obviously, but looking at the phase III.

Speaker Change: With a PARP inhibitor to be in the in the phase III in some respect or any thoughts on what that trial design might look like again presuming good data here mid 'twenty four.

Michael H. Tardugno: So that's all a subject of discussion. I, you know, I think it's always going to be dependent upon the data, you know, the assumption that we'd like to know... 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. 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.

Speaker Change: So.

Speaker Change: So that's all a subject of discussion.

Speaker Change: I you know I think it's always going to be dependent upon the data.

Speaker Change: Assuming.

We would like to now.

Speaker Change: Not eliminate any either of the two groups are in our current study.

It could very well be that this.

Speaker Change: This trial includes.

Speaker Change: Both populations.

Speaker Change: Stratified for each.

Speaker Change: And.

Speaker Change: 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 will take but it's kind of again, it's gonna be there based on the strength of the data.

Michael H. Tardugno: But it's going to, again, be based on the strength of the data. I mean, one of the unfortunate parts about oncology trials is that 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.

Speaker Change: The unfortunate parts about our oncology trials is because sometimes you continue to narrow the population.

Speaker Change: So much to get a positive result, so much or that you exclude a lot of.

Speaker Change: Individuals' will benefit.

I find that to be a regulatory strategy that and they have come out to the golar for companies like ours.

Michael H. Tardugno: I mean, we're looking to develop therapeutics that have broad applications, but unfortunately, the way the regulatory world has defined success... 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 were a betting 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 it.

Speaker Change: We're looking to develop therapeutics that have.

Speaker Change: Brought broad application.

Speaker Change: Unfortunately, the way the a D a.

Speaker Change: Regulatory World has designed success or.

Speaker Change: All lines success of <unk>.

Speaker Change: Sometimes we narrowed the study populations too.

Speaker Change: A small percentage of those who potentially could benefit. So if we do have the opportunity and I. If I were a betting person is I'll say it again.

Speaker Change: They include the intent to treat population. That's currently thinking there 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.

Speaker Change: Evaluate the effect of all one on both groups makes.

Speaker Change: It makes sense.

James Francis Molloy: Indeed, absolutely. Well, thank you for that.

Speaker Change: Indeed, absolutely well. Thank you for that and then maybe a couple of follow up questions. Then I'll be done the phase one two although one plus opdivo in your voice expectations on getting that trial up and started.

Speaker Change: And then.

Michael H. Tardugno: And then maybe a couple of follow-up questions, then I'll be done. The Phase I-II of O1 plus Obdivo and Urovoi, expectations for getting that trial up and started, and then... And then on the vaccine side, when do you anticipate top-line data from the 101 SARS-CoV-2 trial, and is there an update on the 102 for an IND filing? Thank you.

And then over the vaccine side when do you anticipate.

Offline data from 101.

Speaker Change: Sars Covid two trial.

What's the is there an update on the one O to O for an IND filing.

Michael H. Tardugno: Yes, so I don't know if I misspoke or you did, but we're combining 001 with Vaston. Not your voice? In the MRD study, is that the one you're talking about?

Speaker Change: Yeah, So I I don't know, if I misspoke or or with just what.

Speaker Change: Well you did but.

Where we're combining all one with avastin.

Speaker Change: Your boy.

Speaker Change: The <unk> study is that the one you're talking about.

James Francis Molloy: I apologize; I had in my notes that you guys are going to look to start a combo with Abdi when you're a boy as well. I know you have Avastin up and running.

Speaker Change: I apologize I had in my notes that you guys are gonna look to start a combo with opdivo in your voice as well I know you have the avast and up and running.

Michael H. Tardugno: Oh, I'm sorry. So, you know, I think we indicated in some earlier conversations that we thought the checkpoint inhibitor plus 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 getting a lot of focus on 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. Hazard or Sebastian, if you'd like to comment on that,

Speaker Change: Oh I'm sorry, So you know I think we indicated then some earlier conversations than we thought.

Speaker Change: Checkpoint inhibitor might might a combination might be a very interesting approach at all where we're stuck in this conserve capital kind of world right now so all of them.

Speaker Change: All of this to it but I think as is as we consider the future for these therapeutics are that's a very interesting combination I don't know if the Doctor Oh, sorry, Sebastian if you'd like to comment on that.

Sebastien Hazard: 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, really active in ovarian cancer. That could be a very nice opportunity. So as Michael said, you know, provided we get the resources, that would be an excellent project to initiate.

No yes, absolutely I think the huge this is a project that are been looking into.

Down the synergy I'm on to help you do that.

Michael H. Tardugno: I'm sorry, could you repeat the second part of your question?

Speaker Change:

Sebastien Hazard: We are keeping in mind can show that could be very nice for Boston. So as Michael said, you know what value do we get the resource Munich center projects to initiate.

Sebastien Hazard: Yeah.

Speaker Change: I'm, sorry could you repeat the second part of your question.

James Francis Molloy: Yes, thank you for clarifying. Data, Expectation, roughly how we anticipate that phase one data to come out, and then any is 102 kind of again, capital preservation is that a little bit on the back burner.

Speaker Change: Yeah.

Speaker Change: Yeah the 101.

Speaker Change: Theta expectation roughly what should we anticipate the phase one data to come out and then.

And it is 102 kind of again to the capital preservation is that a little bit on the backburner.

Michael H. 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 regard 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 before the end of the year.

Speaker Change: Yes, I can say that unequivocally, yes, so we've narrowed our focus to them. When we believe these platforms have a great deal of potential we've narrowed our immediate focus to the programs that we've just talked about.

Speaker Change: With regards to data from.

Speaker Change: Uh huh.

Speaker Change: In fact seeing proof of concept.

Speaker Change: So oh.

Speaker Change: We expect top line data before the end of the year.

Speaker Change: Well, we certainly won't have the durability information that we think is key.

Speaker Change: We'll have we won't know where the nadir is for that.

Speaker Change: But we'll certainly be able to report progress both on the Immunogenicity in the ER and the durability of the vaccines response, so yes, yes before the end of the year.

James Francis Molloy: Great, thank you for taking the questions.

Speaker Change: Great. Thanks for taking the questions.

Speaker Change: In Q.

Speaker Change: Yeah.

Nick: This concludes our question and answer session. I would like to turn the conference back over to management for any closing remarks.

Speaker Change: This concludes our question and answer session I would like to turn the conference back over to management for any closing remarks.

Michael H. Tardugno: 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. Well, we're focusing on 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.

Speaker Change: So let me first by finish by saying Thank you very much.

Particularly for the questions and allowing us the opportunity to.

Speaker Change: Expand a little bit more on the work that we're doing that we're still very proud of.

Speaker Change: Well, we're focusing in an area of technology that has been explored by many companies.

Speaker Change: I think under a doctor on where his leadership and with the support of this management team, we've been able to unlock the potential of DNA as a.

Speaker Change: As a therapeutic and potentially as a vaccine.

Michael H. Tardugno: And so, you know, the future for us, as I said, under Dr. Lindborg's leadership is very, very exciting. I want to thank all of you for participating in this call and again underscoring the potential of our proprietary technologies. Something that, you know, probably one of the choices that I have is the executive chairman of the company.

Speaker Change: And so.

Speaker Change: The future for us under as I said other Oh, sorry can learn board's leadership right.

Speaker Change: So very very exciting.

Speaker Change: I want to thank all of you for participating in this call.

Speaker Change: Again, underscoring the potential of our proprietary proprietary technologies is something that.

Speaker Change: Probably one of the.

Speaker Change: Joyce that I have as the executive chairman of the company.

Michael H. Tardugno: As our work in providing options to women with ovarian cancer progresses and the population's exposure to potential pandemics 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 on behalf of all of us here and on the call, we and our employees here at Imunon, we wish you a very safe and pleasant afternoon. Thank you very much.

Speaker Change: But as our work in providing options to women in ovarian cancer progresses in the population's exposure to potential pandemic increases we remain.

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

unknown: https://www.youtube.com.uk

Speaker Change: Committed are excited and prepared to report to you on the progress that we're making in the coming months.

Speaker Change: So we look forward to keeping you informed and we are on behalf of all of US here on the call we are in.

Speaker Change: Sure we wish you a very safe and.

Speaker Change: Nice afternoon, Thank you very much.

Speaker Change: The conference has now concluded. Thank you for attending today's presentation you may now disconnect.

Speaker Change: Okay.

Speaker Change: Yeah.

Speaker Change:

Speaker Change: Yeah.

Yeah.

Speaker Change: [music].