Q4 2023 Imunon Inc Earnings Call

Operator: Please. Good morning. My name is Dave, and I will be your operator today. At this time, I would like to welcome you to the Imunon 2023 Financial Results Conference Call. All lines have been placed on mute to prevent any background noise.

Please.

Dave: Good morning, My day, My name is Dave and I will be your operator today.

Dave: This time I would like to welcome you to immuno on 2023 financial results conference call. 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 at that time, you May Press Star and then one on your phone to ask your question.

Operator: Following the speaker's prepared remarks, there will be a question and answer session. At that time, you may press star and then one on your phone to ask a question. Please keep in mind that if you're using a speakerphone, you must release your mute function to allow the signal to reach our equipment.

Dave: Please keep in mind, if you're using a speaker phone he must release your mute function to allow the signal to reach our equipment.

Operator: Again, that's star number one to ask a question during the Q&A session. I would now like to turn the call over to Kim Golodetz. Please go ahead.

Dave: Again, that's star wanted to ask a question during the Q&A session.

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

Kim Sutton Golodetz: Thank you and good morning everyone. This is Kim Golodetz with LHA. Welcome to Imunon's 2023 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.

Thank you and good morning, everyone. This is Kim Collins with L. H, a welcome to you and me and 2023 financial results and business update conference call.

Kim Collins: During today's call management will be making forward looking statements regarding <unk> expectations and projections about future events in general looking statements can be identified by words, such as expects anticipates believes or other similar expressions. These statements are based on current expectations.

Kim Sutton Golodetz: 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 litigation with the Securities and Exchange Commission. No forward-looking statements can be guaranteed, and actual results may differ materially from such statements. I also caution that the content of this conference call is accurate only as of the date of the live broadcast, March 28, 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 Tordugno, Imunon's Executive Chairman. Thank you, Kim. And good morning, everyone.

Kim Collins: Subject to a number of risks and uncertainties, including those set forth in the company's periodic filings with the Securities and Exchange Commission no forward looking statements can be guaranteed and actual results may differ materially from such statements.

I also caution that the content of this conference call is accurate only as of the date of the live broadcast March 28, 2020 for immune on 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 Mike I'll try to do it now.

Mike: I'm the executive Chairman Michael.

Mike: Thank you Kim.

Mike: Good morning, everyone. It's good to be here with all of you.

Michael Tordugno: It's good to be here with all of you. Joining me today are Jeffrey Church, our Chief Financial Officer, and Sebastian Hazard, our Chief Medical Officer. Dr. Hazard will speak about Imunon OLA-1 or IL-12 immunotherapy and its anticipated place in the treatment of advanced ovarian cancer. In addition, Dr. Khursheed Anwer, our Chief Science Officer, who joins us from the Hudson Alpha Institute in Huntsville, Alabama, where our research center is. Dr. Anwer will be available during the Q&A session at the end of our prepared remarks. But first, I'm sure you're all aware of Corinne Le Goff's departure earlier this month to pursue other business opportunities. We wish her well and are grateful for her leadership and the contributions that she made to Imunon during her tenure.

Michael: Joining me today are Jeffrey Church, our Chief Financial Officer and.

Michael: Sebastian Lazard, our Chief Medical Officer, Dr. <unk> will speak about immune on or one or IL 12 immunotherapy in its anticipated place in the treatment of advanced ovarian cancer. In addition, Dr. Chris <unk>, Our Chief Science Officer, who joins us from the Hudson Institute in Huntsville.

Michael: Bama wore a research centers.

Michael: Doctor Ardmore will be available during the Q&A session at the end of our prepared remarks.

Michael: But first I'm sure you're all aware of the departure of Chrysler golf earlier this month to pursue other business opportunities.

I wish you well and are grateful for her leadership on our contributions that you've maintained during her tenure.

Michael Tordugno: I just want to reassure you, however, that her departure in no way impacts our plans for growth, and we remain wholly committed to advancing our two key technology platforms, that is, TheraPlas and Plasene. We remain on track to complete our Phase 2 Ovation 2 study with Imunon-001, which is based on the Theraplast platform, and to initiate our Phase 1 study of Imunon 101, our seasonal CO Our strategy for the development of these product platforms also remains unchanged.

Michael: I just want to reassure you however that her departure in no way impacts our plans for growth.

Michael: We remain wholly committed to advancing our two key technology platforms, that's there of Plas and Pliocene.

Michael: We remain on track to complete our phase II ovation, two study with <unk> or one which is based on the therapist platform and to initiate our phase one study of immuno on one on one.

Michael: She did all COVID-19 vaccine concept based on our <unk> technology.

Michael: Our strategy for the development of these product platforms remains unchanged as well.

Michael Tordugno: From the Ovation 2 study, we expect to report top-line data in mid-2024. Based on our interim data and preliminary conversations with FDA, Dr. Hazart will be drafting the protocol for the Phase 3 study soon. He'll be speaking more about this in a minute.

Michael: From the ovation two study we expect to report topline data in mid 2024 based on our interim data in preliminary conversations with F. D. A doctor his art will be drafting the protocol for the phase III studies soon.

None: Are you speaking more about this in a minute.

Michael Tordugno: Meanwhile, this past month, we announced the submission of an IND application with the FDA for 101. Following acceptance by the agency, we expect to begin enrolling patients in this phase one study in the second quarter of this year. And we're ready to go.

None: Meanwhile, this past month, we announced the submission of an Anda application with the FDA for 101.

None: Following acceptance by the agency, we expect to begin enrolling patients in this phase one study in the second quarter of this year and we're ready to go we have two sites identified they the two sites identified that's fun to Israel in Boston and D. M clinical research in Philadelphia, both institutions have.

Michael Tordugno: We have two sites identified, Beth Israel in Boston and DM Clinical Research in Philadelphia. Both institutions have submitted their protocols to the IRB, and they've been conditionally approved pending FDA acceptance. The biological safety committees at both institutions have approved the protocols. Our contracts are in place or in process. We're ready to go.

None: Amid the eye to the I R V. Our protocol they've been conditionally approved pending FDA acceptance.

None: Biological safety committees at both institutions have approved the protocol are contracts in place or in process.

None: We're ready to go.

Michael Tordugno: So we look forward to the agency's agreement with the IND submission and look forward to initiating the study. I'll talk some more about the vaccine program, but first I'd like to turn the call over to Dr. Hazard. Sebastian?

None: So we look forward to the agency's agreement with the.

None: With the <unk> submission and are and look forward to initiating the study.

Sebastian Herzog: I'll talk some more about the vaccine program, but first I'd like to turn the call over to Doctor Herzog Sebastian. Thank you very much Michael Hello, everyone.

Sebastian Hazard: Thank you very much, Michael. Hello, everyone. Before I discuss our vision for 001, I want to review some of the interim data we've generated and share some considerations on what a pivotal trial could look like should the Phase II data hold up. As you know, OO1 is our DNA-based IL-12 immunotherapy. Probation 2 is a randomized study evaluating 001 for the perioperative treatment of newly diagnosed advanced ovarian cancer patients.

Sebastian Herzog: Before I discuss our vision for one I want to review some of the debt that we've generated.

Sebastian Herzog: And she has some considerations on what a pivotal trial could look like should the phase two that the hold up.

Herzog Sebastian: As you know one is old G&A base 12 immunotherapy.

Herzog Sebastian: Ovation two is your own device study.

Herzog Sebastian: Oh, one for the failure palliative treatment of newly diagnosed advanced ovarian cancer patients.

Sebastian Hazard: It's being tested in combination with standard-of-care chemotherapy. On September 22, we reached full enrollment of 113 patients, and a year later, on September 23, we reported a set of interim data showing promising progression, free survival, and overall survival. In the intent-to-treat population, the data show a delay in disease progression or death in the treatment arm for more than three months. Early overall survival data followed a similar trend, showing an approximate nine month improvement in the treatment arm over the control arm. However, this data, particularly OS, still needs to mature to confirm this robust efficacy signal. We also reported, for the first time, data on a subset of patients treated with PARP inhibitors. When we began the Ovation 2 study, PARP inhibitors were not yet part of the first-line maintenance treatment in ovarian cancer.

Herzog Sebastian: It's being tested in combination we started off cash chemotherapy.

Herzog Sebastian: September 22, we reached full enrollment of 110 patients on a yearly two in September 23, we bought you just set of enjoying the desktop showing promising.

Herzog Sebastian: Progression free survival and overall survival.

And do you intend to treat population did that that showed the delay disease progression or death.

Treatment for more than three months.

Herzog Sebastian: Preliminary overall survival desktop followed a similar trend showing that the approximate nine months improvement in their treatment, although they won't hold up.

Herzog Sebastian: Does that that particularly O S T need to mature from this robust she gets she said no.

Herzog Sebastian: We also reported for the first time that that on a subset of patients treated to respond to any of yours. When we began the ovation two study.

Herzog Sebastian: Well not yet passed them to first line maintenance treatment in Nevada.

No they form an important part of the patient's treatment.

Sebastian Hazard: Now they form an important part of the patient's treatment plan. A subgroup analysis of patients who received post-chemo maintenance therapy with PARP inhibitors suggests an even larger clinical benefit. In this subgroup, the median progression through survival was 23.7 months in the arm with 001 versus 15.7 months in the control arm, or 8 months longer. In addition, the median overall survival in the control arm was 45.6 months and was not reached in the 001 arm. Also, the data from a small number of patients are intriguing. Safety analysis continues to show good tolerability of OO1 in this setting. So, your thoughts on this program right now.

Herzog Sebastian: So group and that I see some patients who received <unk> plus chemo mountain stop responding would be curious suggest an even larger scale could benefit your subgroup. The median progression free survival was $23 seven months.

Herzog Sebastian: Oh, one versus 15 seven months in the control arm or eight months younger.

Herzog Sebastian: In addition, the median overall survival in the control arm was 45 six months on nuts reached either one.

Herzog Sebastian: Or is that out from a small number of patients they are intriguing.

Herzog Sebastian: 60, and that actually has continued to show good Tony IBD cheerful one in the city.

None: So yeah. So it's on this call gone right now.

Sebastian Hazard: We think we may very well have in our hands the first immunotherapy effective for the treatment of ovarian cancer. This is made possible by the THERAPLAST technology, allowing the durable production of IL-12 by the tumor microenvironment, as shown in our Phase 1 Ovation 1 study. So far, the clinical data with O1, from Ovation 1 to the preliminary data of Ovation 2, confirm this for one second. We believe that OO1's positioning in the perioperative treatment of ovarian cancer patients is very important.

None: We think we may very well.

None: The first immunotherapy.

None: Treatment of ovarian cancer.

None: She's made pushy ballroom betaseron plastic noted G, allowing them to durable production of IL 12.

None: The tumor microenvironment as Sean you know phase one ovation one study.

None: So far the clinical that Oh, one from ovation, one to the preliminary that observation to.

None: Confirm.

Who runs like T G.

None: We believe that the positioning or wanting to Philly about these treatment of ovarian cancer patients is very important.

Sebastian Hazard: In addition, the lack of new options for these patients. This is the stage of the disease when a locally administered immunotherapy can have the most impact by harnessing the local immune system in the tumor microinvertebrates. Assuming enough maturity in the PFS data around mid-year and similar efficacy results, the next step is to submit our registration study plans to the FDA. Several considerations are under discussion internally. One being the inclusion of patients receiving Bevacizumab during the perioperative setting. Bevacizumab, as you know, is frequently used in the perioperative setting in about approximately 50% of patients. And these patients were excluded from ovation 2.

In addition, the lack of new options for the especially for these patients.

None: This is the stage of the disease. When you locally administered immunotherapy can have the most impact by harnessing the liquidity means Houston Macaroni grill.

None: As you mean me enough maturity on the PFS data around midyear.

None: Similarly, she gets you research. The next step is to submit a registration study plans to give here.

None: She won't considerations are in discussion you've done.

None: One being the inclusion of patients receiving bevacizumab during the period that is sitting.

None: Yes, you bet.

None: As you know is frequently used in the PR you felt you said Gee.

None: Approximately 50% of the patients.

None: And these patients were excluded from ovation too.

Sebastian Hazard: The combination of Bevacizumab and O1 has also shown synergistic efficacy in preclinical experiments, and the ongoing Phase II study done with Breakthrough Cancer Foundation will provide safety data on the combination. This is important as it may allow 001 to offer even more clinical benefit in synergy with you. It would also help with study enrollment by making the trial more attractive to sites using Bevacizumab for most of their patients. Another consideration is a focus on tumors with homologous recombinant deficiencies, or HRD, who are the most likely to be exposed to a PARP inhibitor in maintenance. We may introduce in the study design the possibility to test O1 efficacy in this subpopulation, representing around 40% of the newly diagnosed ovarian cancer patients.

None: The combination of divestitures you bet on one.

None: Also shown she now just stick she said she clicking toward experiments.

None: The ongoing phase two studies done with breakthrough cancer Foundation will provide 50 that don't do combination.

None: She seemed goffstown I think may allow or one to offer even more it could be the sheep in GB.

None: I'm sure it will.

None: Also helped with the study enrollment by making the trial more attractive to sites using the vessels, but for most of their patients.

None: And I definitely see duration.

None: Okay. So on the Chimera was promoted goes what can be done deficiencies H O G.

None: While the most likely to be exposed to a puppy need be chosen methods.

None: We may introduce in the study design the pushy to test one if you could see in your Sip population.

None: Representing around 40% of the newly diagnosed ovarian cancer patients.

None: Oh and one of them you know second phase III study in collaboration with breakthrough cancer Foundation is ongoing.

Sebastian Hazard: Enrollment in our second Phase II study in collaboration with Breakthrough Cancer Foundation is ongoing, and the first four patients have been treated at the University of Texas MD Anderson Cancer Center. And in the first quarter of 2024, we announced that Memorial Sloan Kettering has joined the study. This study is evaluating O1 in combination with Bevacizumab or Avastin. It is expected to enroll 50 patients in stage 3-4 brain cancer at several sites. Initially, this randomized study will allow to confirm the safety of the combination of O1 with Bevacizumab and later provide proof of concept for this combination. The trial's primary endpoint is detection of minimal residual disease, or MRD, by second loop laparoscopy, and the secondary endpoint is progression-free survival. Initial second look laparoscopy data are expected within a year following completion of enrolment, and final PFS data are expected approximately three years following enrolment completion.

None: First four patients have been treated at the University of success M D Anderson cancer Center.

None: And in the first quarter of 'twenty, four we announced at Memorial Sloan Kettering is trying to study.

None: These studies evaluating one in combination with Bevacizumab or Avastin, if you'd expect 250 patients stage default Ryan can sell single sites.

None: Initially it was flooded my study, we don't know to confirm the safety of the combination of old when we'd be able to see as you may have on later provide proof of concept for this combination.

None: The trial's primary endpoint detection of minimal residual disease, all MLD bicycling look like that was competing in the secondary and buggies portion free survival.

None: Yeah sure so you're going to look like I always keep your debt that I expected. It was in the euro falling condition of one word months on final PFS that I expected that proximity three years fully undrawn upon completion.

Sebastian Hazard: This trial will include translational endpoints to better understand the impact of O1 combined with BVCgmab on the tumor microenvironment and assess other methods, like ctDNA to measure MRG. An Important Trial to Better Understand the Somewhat Under-Evaluated New Adjuvant Stage of Orion Cancer We will keep you updated as sites continue to be added. Now, with that review of our ovarian cancer program, I turn the call back over to Michael. Thank you, Sebastian. You know, I just want to say, for the record, Dr. Hazard has joined us recently, and he brings with him a wealth of experience.

None: This trial will include transnational endpoints to better understand the impact of one combining these babies you met on the tumor microenvironment.

None: Other methods like CTG and niche, we Miss you I imagine.

None: And then thoughts on trial to better understand is somewhat and they'll evaluate new adjuvant stage ovarian cancer.

None: We will keep you updated our sites continue to be high did indeed, so we definitely view.

None: Al or Brian can support program I turn the call back over to Michael Thank.

Michael: Thank you Sebastian and I, just want to say for the record. The Doctor has art has joined US recently and he brings with him a wealth of experience in clinical research ovarian cancer and regulatory affairs, that's beginning to show a great deal of promise.

Michael Tordugno: Clinical Research, Ovarian Cancer, and Regulatory Affairs that's beginning to show a great deal of promise. We are delighted. I can't say enough about the impact that you've had in your very short period of time.

Michael: We are we are at the light it I can't say enough for the impact that you had in your very short period of time and I'm sure the company and our shareholders will benefit from your expertise.

Michael Tordugno: And I'm sure the company and our shareholders will benefit from your expertise. Thank you. So I want to talk a little bit more about durability. You'll hear that through the course of our conversation this morning.

None: Thank you so much.

So I want to talk a little bit more about the durability, you're going to hear that through the course.

Of course of the conversation this morning.

Michael Tordugno: Durability is a key characteristic and an advantage of our technology over similar product candidates. Our technology allows for the durable production of a protein in the body. For example, for Imunon, 001.

None: Durability is a key characteristic and an advantage of our technology over similar product candidates.

None: Our technology allows for the durable production of a protein in the body for them in on or one.

Michael Tordugno: As illustrated by Dr. Hazard, this allows the prolonged exposure of the tumor microenvironment to IL-12 for a vaccine against a pathogen. This durability allows sustained production of the target antigens that we expect will provide protection from the pathogen well beyond the approximate six months that are provided by the mRNA vaccine platform. So with that, I'm not the expert here, so Dr. Anwer, you're on the line. Could you tell us a little bit more about the mechanism and our experience so far with this durability characteristic? Sure, Michael. This is Khursheed.

None: As illustrated by a Doctor has art. This allows the prolonged exposure of the tumor microenvironment to IL 12.

None: For a vaccine against the pathogen.

None: Durability lot of sustained production of the target antigens that we expect will provide protection from the pathogen well beyond the approximate six months that is provided by the mrna vaccine.

None: Platforms.

None: So with that I'm not the expert here so a doctor on while you're on the line would you could you tell us a little bit more about the mechanism and our experience so far with our.

None: This start durability characteristic.

Koschei: Sure. Michael This is cause sheet Hello, as you said, Michael the durability of an agent whether a therapeutic or a vaccine is an important attribute of a drug for oncology drugs, such as IL 12, the persistent local level of tumor site as imperative to keep the pressure on the tumor and that is determined by the <unk>.

Khursheed Anwer: Hello. As you said, Michael, the durability of an agent, whether a therapeutic or a vaccine, is an important attribute of a drug. For oncology drugs such as IL-12, a persistent local level at the tumor site is imperative to keep the pressure on the tumor, and that is determined by the stability of the drug after injection and persistence after cell entry. The same is true for vaccines. The only difference is that in the vaccine setting, your product is a pathogen antigen. Now, to answer your question, the mechanism of our approach for durable expression of a therapeutic molecule in our IL-12 product or a pathogen antigen in our vaccine product addresses bioavailability and persistent challenge. The first mechanism that addresses product stability after administration is the use of our proprietary delivery system that protects the DNA from degradation so there's higher bioavailability. Second, DNA, unlike protein or mRNA, has longer residence time in the cell, and hence the production of protein antigens or therapeutics last longer.

Koschei: The ability of the drug after injection and persistence after sell entry. The same is true for vaccine. The only difference is that in vaccine setting you practice opinion antigen.

Koschei:

Koschei: To answer your question the mechanism of our approach for durable expression of therapeutic molecules out of IL 12 product order patented antigens in our vaccine product is addressing the bioavailability and persistent challenges.

Koschei: First mechanism that addresses the product stability. After administration is the use of our proprietary delivery system that protects the DNA from degradation. So there's higher bioavailability second the DNA. Unlike protein our mrna has longer residence time in the cell and hence the production of.

Koschei: Protein antigen or therapeutics last longer so in a nutshell, our mechanism of durability, rather a therapeutic or a vaccine is increasing the bioavailability through the delivery system and longer read this residence time in sell through the use of DNA really the two those two key aspects that are part of the mechanism.

Khursheed Anwer: So in a nutshell, our mechanism of durability, whether a therapeutic or a vaccine, is increasing the bioavailability through the delivery system and longer residence time in the cell through the use of DNA. Really, those two key aspects are part of the mechanism. Thank you, Khursheed.

None: Thank you Chris shade, a doctor on where I'll be on the line to answer questions at the end of our prepared remarks.

Michael Tordugno: Dr. Anwer will be on the line to answer questions at the end of our prepared remarks. So now, let's continue our discussion of Placene, our proprietary vaccine based on DNA plasmid that promotes the expression of pathogen antigens delivered in our proprietary non-viral synthetic delivery system that Dr. Anwer just spoke about. We're delighted to report that we are proposing a phase one clinical trial as a seasonal COVID-19 booster vaccine. This 24-subject proof-of-concept study is expected to begin enrollment in the second quarter of 2024 following acceptance by the FDA, which we are hopeful will be quite soon. The dialogue... between Dr. Hazard and the agency has been robust.

None: So now let's continue our discussion of Pliocene, our proprietary vaccine based on DNA.

None: DNA plasmids that promotes the expression of pathogen antigens are delivering and our proprietary non viral synthetic delivery system.

None: That the doctor on or just spoke about.

None: We're delighted to report that the filing of an NDA for a one on one with the F. D. A we're proposing a phase one clinical trial as he sees it all COVID-19 booster vaccine.

None: There's 24 subject proof of concept study is expected to begin enrollment in the second quarter of 'twenty 'twenty four following acceptance by the F. D. A which we are hopeful will be will become quite soon.

None: Dialogue a b.

None: Between our Doctor Hazara and the agency has been robust our responses to their questions had been very timely so.

Michael Tordugno: Our responses to their questions have been very timely, so things are moving quite well. The primary objective of this study in healthy adults is to evaluate the vaccine's safety, tolerability, and neutralizing antibody response. We will also evaluate the durability of the response and durability, a key characteristic.

None: Things are moving quite well.

None: The primary objective of this study is in healthy adults is to evaluate the vaccine's safety Tolerability and neutralizing antibody response.

Also evaluate the durability of response and durability.

None: Key characteristic the second objectives are to evaluate the ability of M. U N 101 to elicit the antibody immuno globulin G. R. I G. G. As it's referred to in T cell activity and their durability.

Michael Tordugno: The second objective is to evaluate the ability of Imunon-101 to elicit the antibody immunoglobulin G, or IgG as it's referred to, and T cell activity and their durability. Based on preclinical data, durability of immune expression is expected to be superior over published mRNA vaccine data. The one-on-one vaccine for this study has been designed to protect against the Omicron XBB1-5 variant of SARS-CoV-2 in accordance with the FDA's guidance published in June 2023. As you may recall, we've generated some compelling pre-clinical data on the attributes of this vaccine. Most importantly, immunogenicity and better protection than 95%. I'm sorry, protection better than 95%. We also demonstrated superior shelf life at 12 months at refrigerated temperatures and at least one month at 90 degrees Fahrenheit, or body temperature. These characteristics suggest superior commercial handling and distribution properties when compared with the more fragile messenger RNA vaccines, as well as greater manufacturing flexibility. Compared with viral or other DNA vaccines or protein vaccines, placin vaccines have the advantage in T cell responses, safety, delivery compliance, or manufacturing flexibility.

None: Based on preclinical data durability of immune expression is expected to be superior over published mrna vaccine data.

None: 101 for this study has been designed to protect against all Mcright X B B one five variant.

None: Sars Covid two in accordance with the Fda's guidance published in June 2023.

None: As you May recall, we've generated some compelling preclinical data on the attributes of this vaccine, most importantly, immunogenicity and better protection than 595%.

None: I'm, sorry protection better than 95%, we also demonstrated superior shelf life of 12 months at refrigerated temperatures.

And at least one month at 90 degrees Fahrenheit for.

Her body temperature. These characteristics suggests superior commercial handling and distribution properties when compared with the more fragile messenger RNA vaccines as well as greater manufacturing flexibility.

None: Compared with the viral or other DNA vaccines or protein vaccines Pliocene vaccines have the advantage in T cell responses safety delivery compliance or manufacturing flexibility.

None: Flexibility.

None: So I'm going to turn it back to you Doctor on war why why are we so confident about the stability of our product can you give us a little bit of a compressing contrast, and compare with the messenger RNA.

Khursheed Anwer: So I'm going to turn back to you, Dr. Anwer, and why are we so confident about the stability of our product? Can you give us a little bit of a contrast and compare it with messenger RNA? Yeah, sure. We all know that the mRNA vaccines came out, very strict storage conditions requirements, actually, at minus 70 degrees freezers, you have to keep them there in pharmacies, during transportation, you have to use minus 70 degrees, that's an extreme cold temperature, and the countries, even developing countries, much less the underdeveloped countries, just aren't equipped with that kind of temperature provision. So it's a problem. Disseminating the vaccine. Relative to mRNA, DNA is more stable, and it could last at working temperatures.

None: Yeah sure I mean, we all know that the minute marinade vaccines came out a very strict storage conditions requirement actually at minus 70 degree freezers you have to keep it there and pharmacies. During transportation you have to use minus 70 degree that's extreme cold temperature and the cut.

Tree, even developing countries much less the underdeveloped countries just not eclipse, that's got that kind of temperature.

None: Provision so it's a problem.

None: Disseminating the vaccine so.

None: Relative to MRO name the DNA is a more stable and it could last year at working temperature does a refrigerated temperature, which almost every pharmacy has for a very long period of time, because it's it's more stable than mrna and plus as a as I had mentioned before the use of it.

Khursheed Anwer: There's a refrigerated temperature, which almost every pharmacy has for a very long period of time because it's more stable than mRNA. And plus, as I mentioned before, the use of a protective delivery system also provides more stability. So it's just the intrinsic nature of DNA versus mRNA and the use of a synthetic delivery system that limits the degradation of DNA that really keeps a distinguishing feature of our vaccine over mRNA in terms of temperature stability. And actually, even at 37 degrees, we have seen for a month stability.

None: <unk> delivery system also provides more stability. So it just the intrinsic nature of DNA versus mrna and the use of synthetic delivery system that provides limits the degradation of DNA that really keeps a distinguishing feature of our vaccine or mrna in terms of temperature stability.

None: Yeah.

None: And actually even at 37 degrees, we have seen for months stable with decent imagine that pharmacy nurse to stick it out or delivery people and they don't have to worry about you know putting it.

Khursheed Anwer: So imagine that pharmacy nurses take it out, or delivery people; they don't have to worry about, you know, putting it, discarding it after a couple of hours if it's not, you know, if it's temperature, if the duration goes beyond two hours. So I think we feel confident in that sense. We have addressed that critical issue in vaccine distribution. Thank you, Khursheed. Again, Khursheed used 37 degrees centigrade, and I was talking about 90 degrees Fahrenheit.

None: Starting it after a couple of hours if it's not you know if its temperature.

The duration goes beyond two hours. So I think we feel confident in that sense. We have addressed that critical you shouldn't vaccine distribution and storage.

None: Thank you Christie got Krish it.

None: Again, Chris Crocheted used 37 degrees centigrade.

None: And I was talking about 90 degrees Fahrenheit both are equivalent.

Michael Tordugno: Both are equivalent for handling for at least one month. And that really makes the vaccine stable during its preparation for administration to patients at temperatures that are very realistic, some of the, and particularly in some of the more demanding third world countries. Again, Dr. Anwer will be available for questions at the end of our prepared remarks, following the phase one study and assuming 101 performs as expected. We have no reason to believe it won't.

None: For handling for at least one month and that really makes the.

None: Vaccine are stable.

None: During its preparation for.

None: For administration to patients had temperatures that are very realistic.

None: Some of the and particularly in some of the more demanding a third world countries.

None: Oh, I've got again, a doctor on where I'll be available for questions at the end of our prepared remarks.

Following the phase one study and assuming a one on one performs as expected.

None: And we have no reason to believe it won't.

Michael Tordugno: We'll look to partner out this program for further development and to expand on the platform. For those of you who may be concerned that we are a little bit late to the party, I'd also like to add, assuming success in the clinic... As we are pointing out, the superiority of this technology has the potential to be vitally important to the government, the defense agencies, in particular, and, of course, to the medical community as a means to address rapidly evolving and newly emerging viral pathogens with pandemic potential. So with that, I'll turn the call over to Jeffrey Church for a discussion of our finances. Jeff.

None: Well look the partner off this program for further development and to expand on the platform.

None: For those who may be concerned that we are a little bit late to the party I I'd also like to add assuming success in the clinic.

None: As we were pointing out the superiority of this technology has the potential to be vitally important to the government. The defense agencies in particular and of course to the medical community as a means to address rapidly evolving and newly emerging viral pathogens with pandemic potential.

None: So with that I'll turn the call over to Jeffrey Church for a discussion of our financials Jeff.

Jeffrey W. Church: Thank you, Michael. Details of Imunon's 2023 financial results are included in the press release we issued this morning and in our Form 10-K, which we filed before the market opened. Imunon ended the year with $15.7 million in cash and investments.

Jeffrey W. Church: Thank you Michael details of Immunized 2023 financial results are included in the press release, we issued this morning and in our Form 10-K, which we filed before the market opened EMEA and ended the year with $15.7 million in cash and investments net cash used for operating activities was $18 9 million for 2023.

Jeffrey W. Church: Net cash used for operating activities was $18.9 million in 2023, compared to $23.1 million in the prior year. This decrease is primarily due to a one-time payment of $4.5 million in interest expense in the first quarter of 2022, resulting from the sale and subsequent redemption of $30 million of convertible preferred stock. Cash used in financing activities was $3.8 million this year.

Jeffrey W. Church: This compares to $23 1 million in the prior year. This decrease was primarily due to a onetime payment of four and a half million dollars in interest expense in the first quarter of 2022.

Jeffrey W. Church: <unk> from the sale and the subsequent redemption of $30 million of convertible preferred stock.

Jeffrey W. Church: Cash used in financing activities was $3 $8 million. This year that resulted from the pay off of the Silicon Valley Bank alone, which amounted to $6 $4 million.

Jeffrey W. Church: That resulted from the payoff of the Silicon Valley Bank loan, which amounted to $6.4 million, offset by sales under the companies at the market equity facility of $2.6 million. As we have in the past, we will continue to focus on strong cash management. Let me now turn to a review of our financial results. Imunon reported a net loss for 2023 of $19.5 million, $2.16 per share, and this compares with a net loss of $35.9 million, or $5.03 per share, last year.

Jeffrey W. Church: Offset by sales under the company's at the market equity facility of $2 6 million as we Havent passed we will continue to focus on strong cash management.

Jeffrey W. Church: Now turning to a review of our financial results <unk> reported a net loss for 2023 of $19 5 million.

Jeffrey W. Church: 16, $2 16 per share and this compares.

Jeffrey W. Church: With a net loss of <unk> 30.

Jeffrey W. Church: $35 9 million or $5 three per share last year.

Jeffrey W. Church: Operating expenses were $21 million for 2023, a decrease of $4 4 million or 17% from 2022 now.

Jeffrey W. Church: Now breaking down these operating expenses by major line items, our research and development expenses were $11 3 million.

Jeffrey W. Church: Operating expenses were $21 million in 2023, a decrease of $4.4 million, or 17% from 2022. Now, breaking down these operating expenses by major line item, research and development expenses were $11.3 million, very consistent with the levels we reported last year. More specifically, R&D costs associated with the development of 001 to support the Ovation 2 study, as well as the development of the Placene DNA vaccine technology platform, were $6 million in 2023, and that compared to $6.1 million for 2022. Costs associated with the Ovation 2 study, the clinical development costs, were $1.2 million this year, that's down from $1.5 million in the prior year, and this decline was due to the Hazard indicated in September of 2022. CMC costs, manufacturing costs, increased $2.2 million for 2023 from $1.2 million for 2022 due to the development of in-house pilot manufacturing capabilities for DNA plasmids and nanoparticle delivery systems this year.

Jeffrey W. Church: Very consistent with the levels, we reported last year.

Jeffrey W. Church: More specifically R&D cost associated with the development of a one.

Jeffrey W. Church: To support the ovation two study as well as the development of the plastic DNA vaccine technology platform were $6 million in 2023 and that compared to $6 1 million for 2022.

Jeffrey W. Church: Costs associated with the ovation two study the clinical development costs.

Jeffrey W. Church: We're 1.2 million this year, that's down from $1 5 million the prior year and this decline was due to the completion of enrollment as a doctor hazard indicated in September of 2022.

Jeffrey W. Church: C M C cost manufacturing cost increased $2 2 million for 2023 from $1 2 million for 2022.

Jeffrey W. Church: Element in house pilot manufacturing capabilities for DNA, plasmids, and nano particle delivery systems. This year.

Jeffrey W. Church: Our costs associated with the phase III Optima study work were de Minimis this year compared to $1 million in 2022, a clinical and regulatory costs were 1.8 million. This year compared to 1.9 for 2022 general and administrative expenses were $9 7 million for 2023 compared to <unk>.

Jeffrey W. Church: $1 7 million for 2022, this $4 million decrease was primarily attributable to lower noncash stock compensation expense lower employee related costs, primarily lower legal cost as we've.

Jeffrey W. Church: Costs associated with the Phase 3 Optimist Study were de minimis this year compared to $1 million in 2022. Our clinical and regulatory costs were $1.8 million this year compared to $1.9 million for 2022. General administrative expenses were $9.7 million for 2023 compared to $13.7 million for 2022.

Jeffrey W. Church: Resolved many of the issues that come.

Jeffrey W. Church: With the phase III trial with Thermodox lower costs for D&O insurance also contributed to this decrease subsequent to the end of the year, we announced that we had received $1 $3 million in net cash proceeds from the sale of our unused New Jersey.

Jeffrey W. Church: The operating losses are these NOL sales are a very nice non dilutive funding source, which further strengthens the company's balance sheet.

Jeffrey W. Church: Other non operating income this year was $200000 and that compares to other non operating expenses in 2022 of $12 5 million.

Jeffrey W. Church: This $4 million decrease was primarily attributable to lower non-cash stock compensation expense, lower employee-related costs, and primarily lower legal costs as we've resolved many of the issues that had arisen with the Phase 3 trial with Thermadox. Lower costs for D&O insurance also contributed to this decrease. Subsequent to the end of the year, we announced that we had received $1.3 million in net cash proceeds from the sale of our unused New Jersey net operating losses. These NOL sales are a very nice non-dilutive funding source, which further strengthens the company's balance sheet. Other non-operating income this year was $200,000.

Jeffrey W. Church: Investment income this year from our short term investments was $1 2 million compared to half a million dollars last year.

Jeffrey W. Church: As I mentioned earlier in June of 2021 we had entered into a loan facility with silicon and Silicon Valley Bank, we use the proceeds from that facility to retire our previous loan facility.

Jeffrey W. Church: With Hudson Technology Finance Corporation in connection with the a S. P. B loan facility, we incurred $200000 of interest expense in 2023 that compared to 500000 in 2022 in the second quarter of 2023, we terminated and.

Jeffrey W. Church: That compares to other non-operating expenses of $12.5 million. Investment income this year from our short-term investments was $1.2 million, compared to half a million dollars last year. As I mentioned earlier, in June of 2021, we entered into a loan facility with Silicon Valley Bank, and we used the proceeds from that facility to retire a previous loan facility with Hudson Technology Finance Corporation. In connection with the SVB loan facility, we incurred $200,000 of interest expense in 2023.

Jeffrey W. Church: And paid off the Silicon Valley Bank loan facility, we had pay some early termination and end of term fees and we recognized a 300000 dollar loss on the debt.

Jeffrey W. Church: Debt extinguishment.

Jeffrey W. Church: I think more importantly show you that the big driver in last year's.

Jeffrey W. Church: Operating expense was a impairment charge of $13 4 million that we took and writing off some in process assets are in in process R&D assets.

Jeffrey W. Church: Offsetting that was a noncash gain of $5 4 million due to the write off of a earn out milestone.

Jeffrey W. Church: Milestone liability because of the requirements had not been achieved and then lastly, as I mentioned earlier, we had a one time four and a half million dollar.

Jeffrey W. Church: That compared to $500,000 in 2022. In the second quarter of 2023, we terminated and paid off the Silicon Valley Bank loan facility. We had to pay some early termination and end-of-term fees, and we recognized a $300,000 loss on the debt extinguishment.

Interest and offering expenses resulted from the sale.

Jeffrey W. Church: And then subsequent redemption of the preferred stock.

Jeffrey W. Church: Our cash utilization for 2024 is approximately $18 million, providing us with a runway that takes us pretty much through.

Jeffrey W. Church: The 'twenty 'twenty four time period.

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

Michael: Thank you Jeff has always a lively discussion of our financials.

Jeffrey W. Church: I think more importantly, the big driver of last year's non-operating expense was a payment charge of $13.4 million that we took in writing off some in-process R&D assets. Offsetting that was a non-cash gain of $5.4 million due to the write-off of an earn-out milestone liability because the requirements had not been achieved. Lastly, as I mentioned earlier, we had a one-time $4.5 million interest in offering expenses resulting from the sale, and then subsequent redemption of the preferred stock. Our cash utilization for 2024 is approximately $18 million, providing us with a runway that takes us pretty much through the 2024 time period. With that financial review, I'll now turn the call back to Michael. Thank you, Jeff.

Michael: Right as you know as you know.

Michael: We filed an S. One in January of this year, the goal of which was to raise capital in support of our ongoing research programs in <unk>.

Michael: Testing the market immune unlike virtually all other non revenue micro cap biotechs was.

Michael: Presented with terms that we felt were unacceptable and unfair to our shareholders.

Michael: So consequently, we have chosen to divert differ financing until there are more favorable market conditions for the company.

Michael: Doing so however is not without a plan we have taken a responsible steps to implement a cash conservation program.

Michael: Deferring some of our non essential programs and reducing our head count footprint just makes sense. So our goal is to ensure that we have cash.

Michael: Through the just discussed.

Michael Tordugno: As always, a lively discussion of our financials. As you know, we filed an S-1 in January of this year, the goal of which was to raise capital in support of our ongoing research program. Competing in the market, Immunon, like virtually all other non-revenue micro-cap biotechs, was presented with terms that we felt were unacceptable and unfair to our shareholders. So, consequently, we have chosen to defer financing until there are more favorable market conditions for the company. Doing so, however, is not without a plan. We have taken a responsible step to implement a cash conservation program.

Michael: A milestone readouts of our two clinical trials I Trust that you will agree that we have been and are acting in the best interests of our shareholders.

Michael: Our employees and our commitment to medical research.

Michael: In closing my prepared remarks, I want to emphasize that your company has a deep and capable management team is keenly focused on harnessing the power of the immune system. Our goal is to provide more potent and durable immunity for millions of people with cancer or infectious diseases, while creating significant value for our shareholders.

Michael: In a place of work that our employees can be.

Michael: Proud of.

With that I'll open up to questions open up the call to your questions operator.

None: We will now begin the question and answer session.

Michael Tordugno: Deferring some of our non-essential programs and reducing our headcount footprint just makes sense. So our goal is to ensure that we have cash through the methods we just discussed. Milestone readouts of our two clinical trials. I trust that you will agree that we have been and are acting in the best interests of our shareholders, our employees, and our commitment to medical research. In closing, in my prepared remarks, I want to emphasize that your company has a deep and capable management team that is keenly focused on harnessing the power of the immune system. Our goal is to provide more potent and durable immunity for millions of people with cancer or infectious diseases, while creating significant value for our shareholders in a place of work that our employees can be very proud of. With that, I'll open up the questions, uh, open up the call to your questions. Operator? We will now begin the question and answer session. To ask a question, you may press star, then 1 on your touchtone phone. If you're using a speakerphone, please pick up your handset before pressing the keys.

None: Ask a question you May press Star then one on your Touchtone phone.

None: Youre using a speakerphone please pick up your handset before pressing the keys that any time. Your question has been addressed and you would like to withdraw your question. Please press Star and then two.

None: Our first question comes from James Molloy with Alliance Global Partners. Please go ahead.

James Francis Molloy: Good morning, James.

James Francis Molloy: Hello, This is actually Laura Sorel on for Jim.

James Francis Molloy: Right.

James Francis Molloy: Laura.

But let's say once you try that you're conducting for L. One in combination with Avastin. When do you think you'll complete patient enrollment as lot was obtained.

First look or an interim result.

James Francis Molloy: John.

John: I'm going to start answering that question and maybe I can turn the balance over to a doctor who's or.

None: So you know this is a very important study it's hypothesis generating in many ways. The the primary end point is one of great interest to the Ah.

None: Individual researchers who are both associated with the program you know evaluating the extent to which patients have been in the cancer has been eliminated from patients there's been a difficult thing to do so this idea of second look laparoscopy.

Operator: If at any time your question has been addressed, and you would like to withdraw your question, please press star and then 2. Our first question comes from James Molloy with Alliance Global Partners. Please go ahead. Good morning, James.

None: To evaluate for minimal residual disease.

Unknown Executive: Hello, this is actually Laura Surrealon on Jim's behalf. Thank you for taking our question. For the Phase 1-2 trial that you're conducting for OO1 in combination with Avastin, when do you think you'll complete patient enrollment as well as obtain a first look or an interim result readout for this trial? I'm going to stop answering that question, and maybe I can turn the balance over to Dr. Hazart.

None: Is a proposal that if if 60, if we're successful here it could change the course of treatment of patients.

So using our R. R product candidate in combination with a vast and under the.

None: Watchful control of.

None: One of the premier institutions in the country.

None: Including M D Anderson Johns Hopkins.

None: Memorial Sloan Kettering.

None:

None: Bird.

Bird: Yeah, Yeah, Dana Farber yeah.

Bird: So we have two institutions now enrolling.

Michael Tordugno: So, you know, this is a very important study. In many ways, its hypothesis generating, the primary endpoint is one of great interest to the individual researchers who are associated with the program. Evaluating the extent to which patients have been, the cancer has been eliminated from patients has been a difficult thing to do. So this idea of second look laparoscopy to evaluate for any minimal residual disease is a proposal that, if we're successful here, could change the course of treatment for patients.

Bird: Two more institutions will be joining the study are quite soon I think we have a number of patients on trial, yeah, yeah cause Sebastian yes, we have for patients on trial.

Bird: Based on the the first site open.

Bird: Anderson as.

Bird: As I mentioned, we have a second one just opened and we expect to more one being a joined up keeps on the second one being Oklahoma University onshore based on these four large sites, we expect that's wrong enrollment will pick up.

Michael Tordugno: So using our product candidate in combination with Avastin under the watchful control of some of the premier institutions in the country, including MD Anderson, Johns Hopkins, Memorial Sloan-Kettering, Hartford, and yeah, Dana Farber.

Bird: The point I would like to make here also is that you know there are two main objectives for the study when he's of course proof of concept on efficacy on this would take a little bit of time to look at the PFS a disciplined one is the safety of the combination because if we are able to start a phase three study.

Michael Tordugno: So we have two institutions now enrolling patients. Two more institutions will be joining the study quite soon. I think we have a number of patients on trial. Yeah, Sebastian?

These safety data on the combination would be very useful.

None: So on just to the answers question specifically. The addition of the second two sites and by the way this has been a a.

Sebastian Hazard: Yes, we have four patients on trial. And based on the first site open, MD Anderson, as I mentioned, we have a second one just opened, and we expect two more, one being John Hopkins and the second one being Oklahoma University.

None: Our longer enrollment period for the sites than we anticipated and largely because of the novelty of the approach to establishing it as the primary endpoint among other things.

None: Once the once those sites are on board, we're expecting a possibly by the end of next year, but they have all 50 patients in this study.

Sebastian Hazard: And so, based on these four large sites, we expect that enrollment will pick up. The point I would like to make here also is that, you know, there are two main objectives for this study. One is, of course, proof of concept for efficacy, and this will take a little bit of time to look at the PFS. The second one is the safety of the combination, because if we are able to start a phase three study, the safety data on the combination will be very useful.

None: Okay.

None: Got it. Thank you for the clarity and then Austin regards here <unk> seen in your other vaccine candidates how many either.

None: Scribe the current partnership environment, and maybe any you know any of your ongoing potential partnership discussions that you might have out.

None: You know I think I'm well, we haven't arrived at any partnerships. Specifically you had most of most of the institutions that have expressed an interest are waiting for some clinical data, which is not far off and you can expect that.

Sebastian Hazard: So just to answer your question specifically, the addition of the second two sites, and by the way, this has been a longer enrollment period for the sites than we anticipated, largely because of the novelty of the approach to establishing this primary endpoint, among other things. Once those sites are on board, we're expecting, possibly by the end of next year, to have all 50 patients in the study.

None: Imminent is new to this vaccine environment, our technology is novel the superiority the potential that we've talked about in this.

None: In this call. This morning, I think is reckitt well recognized by each and every institution that we've talked to.

None: But there are a handful of big pharma companies that are on the sidelines right now are asking for continued updates and we are engaging with them I think probably for me, though however, the most exciting potential collaborators or are some of the agencies of the government.

Michael Tordugno: Thank you for the clarification. And then also, in regard to your plaque scene and your other vaccine candidates, how may you describe the current partnership environment and maybe any, you know, any of your ongoing potential partnership discussions that you might have held? You know, I think we haven't arrived at any partnership specifically yet. Most of the institutions that have expressed an interest are waiting for some clinical data, which is not far off. You can expect that. I mean, Imunon is new to this vaccine environment. Our technology is novel.

None: What well.

None: I don't know if we've talked too much about this but you know the pandemic whether there are.

None: Organic or otherwise I mean, they have the potential to be there.

None: The compromise not only patients, but economies and and and got even if even governments.

None: So the idea that having a an effective means to be able to quickly respond with a potent vaccine to emerging newly emerging or viruses that are evolving in a more virulent way Ah is a is a critical objective of our of the D. O D. For example.

Michael Tordugno: The superiority, the potential that we talked about in this call this morning, I think is well recognized by each and every institution that we've talked to. But there are a handful of big pharma companies that are on the sidelines right now asking for continued updates, and we are engaging with them. I think, for me, though, the most exciting potential collaborators are some of the agencies of the government.

Simple and BARDA.

None: So those partnerships are.

Again with once we have some up some preliminary clinical data I expect to mature.

None: Yeah.

None: Okay.

None: Thank you.

None: The next question comes from David bonds with Zacks small cap. Please go ahead.

David Bautz: Hey, good morning, everyone. Thanks for the update this morning.

David Bautz: So I kind of want it started off with the King of your discussion of the durability from earlier in the call I'm curious in regards to actually both programs going on over one and placebo.

Michael Tordugno: I don't know if we've talked too much about this, but, you know, the pandemics, whether they're organic or otherwise, have the potential to compromise not only patients but economies and even governments. So the idea that having an effective means to be able to quickly respond with a potent vaccine to emerging, newly emerging, or viruses that are evolving in a more virulent way is a critical objective of the DoD, for example, and BARDA. So those partnerships will mature again once we have some preliminary clinical data. understood.

David Bautz: Are you measuring Oh wonder you're measuring IL 12 expression.

David Bautz: As these patients move through treatment and then for the vaccine program will you be looking at kind of longitudinal expression of the spike protein in.

David Bautz: And those healthy volunteers in that phase one study.

Oh, that's so it's a great question and then a doctor on wire crocheted are you.

None: Still on the line.

Yes, I am Michael So David that's a good question for IL 12, we have in in previous clinical trials major IL 12 mm. After the repeated administration of the product as you may recall, Oh, one it's given once every week.

Unknown Executive: Thank you for taking the question. Thank you. The next question comes from David Bautz with Zach's Small Cap. Please go ahead. Hey, good morning, everyone.

David Bautz: Thanks for the update this morning. So I kind of want to start it off with kicking off your discussion of durability from earlier in the call. I'm curious in regards to actually both programs going on, O1 and Placene.

Michael: For several weeks. So we have an end in multiple studies examine the IL 12 levels. After the yeah, the treatment quantified that increases over baseline with.

David Bautz: Are you measuring, for 001, IL-12 expression as these patients move through treatment? And then for the vaccine program, will you be looking at kind of longitudinal expression of the spike protein and Healthy Volunteers in that Phase 1 study? Oh, that's a great question. And Dr. Anwer, Khursheed, are you still on the line?

Michael: With respect to the Spike protein we have in animal models, we have than western blot analysis to ensure that the protein is.

Michael Tordugno: Yes, I am, Michael. So, David, that's a good question. For IL-12, we have, in previous clinical trials, shown major IL-12 production after the repeated administration of the product, as you may recall. OR1 is given once every week for several weeks. So, we have, in multiple studies, examined IL-12 levels after the treatment and quantified that increase over baseline. With respect to the spike protein, in animal models, we have done Western blot analysis to ensure that the protein is the proper molecular weight.

Michael: Properly molecular weight like most of our quantification is mrna based C. D mrna for Spike and begins to produce but you know characterization of protein size on our western blot that we have done that as well.

Michael: Is the is that you are going to require you to look at the levels they've expression of the spike protein in this study no something whether it's you know in human clinical.

Michael: Trials are you know its not required FDA does not require that you two major.

Michael: The protein spike levels and that is it's been pretty consistent in the literature. I mean are there other trials as well you demonstration of the antibody response is reflective of the engine production. So no it's not required to quantify the spike protein in their clinical trials.

Khursheed Anwer: But most of our quantification is mRNA-based to see if the mRNA for spike antigen is produced. But characterization of protein size on a Western blot, we have done that. Is the FDA going to require you to look at the levels, say, of expression of the spike protein in the study, or is that not something that they're interested in? No, in human clinical trials, you know, it's not required. FDA does not require that you measure the protein spike levels, and that has been pretty consistent in the literature. I mean, other trials as well, you, demonstration of the antibody response is reflective of antigen production. So, no, it's not required to quantify spike protein in clinical trials.

None: Okay, great. So switching gears, a little bit a truce on the news this morning around Gilead their partnership for an IL 12, as it I'm just kind of curious if you've seen any interests.

None: One we're partnering discussions around how those are going for that product.

None: Look I mean, you know as you know we all are the verge of I.

None: Oh phase two that are vis vis asset.

Khursheed Anwer: Okay, great. So switching gears a little bit, I'm sure you saw the news this morning about Gilead and their partnership for an IL-12 asset. I'm just kind of curious if you've seen any interest in O1 or partnering discussions, how those are going for that product. Look, I mean, as you know, we are on the verge of having our phase two data with this asset. We already have very promising clinical data. I can tell you that there are some potential third parties that would be interested in looking at our data when we have confirmation. And so, of course, this is a possibility that we will develop partnerships on this asset. And on statute, I mean specifically for Gilead, I have to say that we have not been contacted by us as yet. They are on the list to do so.

None: We have already very promising clinical data at all.

None: I can tell you that there are some potential short about he said he'd be interested in looking at all that when we have confirmation.

None: And so of course this is a possibility that.

None: If you look at the ships on this asset.

None: Instead to it I mean, specifically for Gilead I have to say that they have not been contacted by us as yet they are on the list to do so.

None: Okay.

None: And then lastly for.

None: For the for the old one study.

None: Yes, I, just kind of want to clear up what exactly is gonna be considered a positive data readout.

None: But as we look forward to this data coming up in the middle of this year I know you've discussed.

Michael Tordugno: Okay, and then lastly, for the OO1 study, I guess I just kind of want to clear up what exactly is going to be considered a positive data readout as we look forward to this data coming out in the middle of this year. I know you've discussed the kind of study set up to show a 33% increase in PFS, but I guess, What, what, is there kind of a go, no-go level, like, what should we be expecting there? I'm going to start this conversation, and maybe Dr. Hazard can jump in.

None: The study is set up to show a 33% increase and PFS are but I guess.

None: What what is there kind of a go no go level like what should we be expecting there.

None: Yeah, I'm going to start this conversation and maybe Doctor Azad can jump in so as you know during the course of this trial.

None: Evolution of the treatment of cancer patients ovarian cancer patients. So when we started the trial of the data was not yet in from the Avastin program. So vast and was not included as a as one of the treatment options for newly diagnosed patients.

And subsequent to the Avastin approval, we saw PARP inhibitors make their way and for the HRD population.

Michael Tordugno: So, you know, during the course of this trial, we've seen an evolution in the treatment of cancer patients, ovarian cancer patients. When we started the trial, the data was not yet in from the Avastin program, so Avastin was not included as one of the treatment options for newly diagnosed patients. Subsequent to Avastin's approval, we saw PARP inhibitors make their way into the HRD population. However, again, neither of those adjuvant treatments or combination treatments were considered.

None: Again, neither of those adjuvant treatments or combination treatments were considered.

None: In the design of the trial. So the ITT population, we still believe a 33% improvement the 80% powered to show that improvement is.

None: He is an important milestone to achieve or very close.

None: It means that some of our assumptions to achieve that objective.

None: I've changed with the addition of I mean, obviously these patients are.

None: Who are in our study ethically I've been included and some maintenance programs of these.

Michael Tordugno: In the design of the trial, so the ITT population, we still believe a 33% improvement, 80% power to show that improvement is an important milestone to achieve or very close to achieving. I mean, some of our assumptions to achieve that objective have changed with the addition of, I mean, obviously, these patients who are in our study ethically have been included in some maintenance programs of these drugs that were recently approved. And so we're not particularly stratified to do the kind of typical analysis.

None: Drugs that are <unk>.

None: The recently approved and so we're not particularly stratified groups.

None: Two to do a the the kind of a typical analysis, but.

None: Oh, you know what we think we have every right and reason to look at the data parse it out a little bit more.

None: Specifically to see is is doctors aren't alluded too to see if there's a.

Michael Tordugno: But we think we have every right and reason to look at the data, parse it out a little bit more specifically to see, as Dr. Hazard alluded to, if there's a subgroup here that would make sense to include in a larger, you know, pre-specified study. But, you know, I think what we're seeing in the response that we're getting from the medical community, at three to four months improvement in PFS, is clinically relevant. Whether or not that's an 85, 86, 87 percent hazard ratio is probably not the material issue.

A subgroup here that would make sense to include in our larger you know prespecified to include an a.

None: A larger study.

None: But you know I think what we're seeing in the response that we're getting from the medical community at three to four month improvement in PFS is clinically relevant whether or not that's an 80 580, 687% hazard ratio.

None: There's probably not a material issue.

None: The last point I'll make and this is.

None: I think can be verified by any clinicians treating cancer patients.

None: Immuno therapies for the most part.

Michael Tordugno: The last point I'll make, and this is, I think, can be verified by any clinician treating cancer patients, immunotherapies for the most part, have a much better OS benefit than is indicated by PFS. With that knowledge, we feel very comfortable in being able to look holistically at the data coming from this trial and to make decisions that reduce the risk, frankly, of failure to make decisions on the construct of a Phase III study going forward. So, frankly, we're excited with the data that we're seeing so far, and as we look at, you know, this is a novel treatment in a newly diagnosed patient with a standard of care, and an evolving standard of care. So that gives us a little bit more, I don't want to call it uncertainty, but a little bit more opportunity to evaluate the data in some, I think, some appropriate, but typically non-appropriate ways. Standard Waste.

None: Have a much better OS benefit then as indicated by PFS.

None: So with that with that knowledge, we feel very comfortable in being able to look holistically at the data coming from this trial and to make decisions that are reduced the risk frankly, our failure to make decisions on the construct of a phase III study going forward.

None: I think I got that the Doctor is that yeah.

None: Yeah.

None: I have nothing to it.

None: [noise] so yeah.

None: Yeah.

None: And we're frankly, we're excited with the data that we're seeing so far and as we look at you know this is a novel treatment in newly diagnosed patients where the standard of care.

None: And and an evolving standard of care, so that gives us a little bit more I.

None: I don't want to call it uncertainty, but a little bit more opportunity to.

None: To evaluate the data in some I think some appropriate but typically not.

David Bautz: Okay, sounds good. Appreciate you taking the questions this morning. Thank you. The next question comes from Kemp Dolliver with Brookline Capital Markets. Please go ahead.

None: Standard ways.

None: Okay. It sounds good appreciate you taking the questions. This morning. Thank.

None: Thank you.

None: The next question comes from Ken Oliver with Brookline Capital markets. Please go ahead.

Brian Kemp Dolliver: [inaudible] Good morning. Thank you for taking my questions. First, just for clarification, you mentioned the two sites for 101. One was Beth Israel.

Ken Oliver: Good morning, Ken.

Ken Oliver: Good morning.

Ken Oliver: Thank you for taking my questions.

Ken Oliver: First just for clarification, you mentioned, the two sites or 1011 was Beth Israel.

Michael Tordugno: And the second site in Philadelphia is which institution? This is an institution that's primarily set up to evaluate vaccine programs. It's DM Clinical Research in Philadelphia. And it's been relied upon by all of the major vaccine companies for enrollment. They are geared specifically to bring patients, healthy patients, into a study like this to administer the vaccine and for follow-up. I mean, if you're curious about them, you can find them online.

Ken Oliver: The second site in Philadelphia, which institution.

Ken Oliver: Oh. This is an institution, that's primarily set up to evaluate the vaccine programs.

None: It's T M clinical research in Philadelphia.

None: And it's been relied upon by all of the the May.

None: The major vaccine companies for enrollment.

None: They are geared specifically to bring patients in healthy patients and two a study like this to.

To you know administer the vaccine and for poor follow up there I mean, if you're curious of them you could you could.

None: Find them online.

Michael Tordugno: A well-regarded, high-quality Clinical Research Focus Institution. And recommended to us, by the way, by the Israeli people. Great, thank you.

None: Well regarded high high quality.

None: Ah clinical research focused institution.

None: And recommended to us by the way by the but Israel people.

None: Great. Thank you.

None: The second question relates to.

Michael Tordugno: The second question relates to your commentary around partnering and, particularly, with government. So what is the state of that part of the process? Because BARDA and DOD, you can move very slowly, and presumably, you would have other potential partners involved who would be in a position to move faster once you have data that everyone can evaluate. Yeah, and I think that's a good question. I, you know, I, I... You know, I typically don't include the government in any kind of my thinking about the development of products. Even though they are the biggest consumer in many ways, just as you pointed out, the decision process is low, and there's always this competitive element that may or may not include a good old Boys Network.

None: Your commentary around partnering and particularly with government. So.

None: What is the state of your part.

None: Part of the process, because you know Florida.

None: And U D O D.

None: If we move very very slowly and presumably you would have other part potential partners involved you would be in a position to move faster.

None: Once you have data that everyone can evaluate.

None: Yeah, that's a good question.

None: Yeah.

None: Yeah.

None: I typically don't include the government and any kind of my thinking about the development of products.

None: Even though they are the biggest consumer of no anyway. So the.

None: Because of the just as you've pointed out I mean, the decision process is low and as I've always this competitor development that may or may not include a good old boys that work.

Michael Tordugno: And I apologize for saying it that way, but that's the reality of it. We will not, assuming good data, we will not delay any ongoing development of our products pending financing or interest from the government, although, you know, my expectation is that good data will bring in interest from the big guys. We've had multiple meetings with, you know, important people in the government.

None: And I apologize for saying it that way, but that's I mean, that's the reality of it.

None: We will not.

None: Assuming good data, we will not delay any oh.

None: The ongoing development of our products pending a.

None: Financing or interest from the government. Although my expectation is that good data will bring in interests from the big guys. We've had multiple I mean important people in the government and we've had multiple conversations with doctor on the golf, especially found this opportunity with the government to be very compelling I agree with her completely.

Michael Tordugno: We've had multiple conversations, but in the meantime, the platform makes sense for other vaccine-focused pharmaceutical companies. And as well, I hope for the investment community. I mean, if we can demonstrate the kind of superiority, the kind of characteristics that make this vaccine not only unique but at least as potent with a stronger capability to provide protection over time. I would suspect that pharma will be, as they have said, in our, you know, we have a TPP, Targeted Product Profile, that's generated, you know, continuing and ongoing interest. You know, and in this environment, it's not like the heady days of a number of years ago, but in this environment, the environment is a little more...

None: <unk>.

None: But in the meantime, the platform makes sense for our other vaccine focused pharma companies and.

And as well I hope for for the investment community I mean, if we can demonstrate the kind of superiority.

None: What kind of characteristics that make this a vaccine not only unique but at least as potent with a stronger.

None: Capability to provide protection over time.

None: I would suspect that Oh pharma will be as they have set and in our you know we have a T. P T.

None: Target product profile.

None: That's jeb generated a continuing ongoing interest.

None: And in this environment its not like the heady days of.

None: A number of years ago, but it isn't a survivor the environment, there's a little more.

Michael Tordugno: Patients for Wait-and-See. So we hope we'll continue to get support from the investment community as we make our way forward. And if we're right, the payoff for that patience and continued investment in the company, if we're right, I have every reason to believe we'll have major returns for our investors. Great, thank you.

None: Ah patients for wait and see so.

None: We are we are hopeful will continue to get support from the investment community as we make our way forward.

None: And that and if we're right the pay off on that patience and continued investment in the company.

None: If we're right I have every reason to believe we'll have major returns for our investors.

None: Okay.

None: Great. Thank you.

Brian Kemp Dolliver: Thank you. This concludes our question and answer session. I would like to turn the conference back over to Michael Tardarno for any closing remarks. Well, first, let me thank everyone for joining us. I don't think we could be in a better position.

None: Thank you.

None: This concludes our question and answer session I would like to turn the conference back over to Michael Gardner.

Michael Gardner: For any closing remarks.

Michael Gardner: Well first let me thank everyone for joining us.

Michael Gardner: I don't think we could be in a better position your company on the fundamentals we have.

Michael Tordugno: Your company On the fundamentals, we have seen quite a bit of progress in all of our programs. We have a very excited group of scientists and researchers. We continue to add the kind of complement of intellectual talent that's important to our success. We believe in our proprietary technology. On a preliminary basis, in preclinical studies and in early phase one studies for O01, for example, we are showing the potential that these technologies, we know these technologies, this O01, for example, works, stimulating recruitment of, let me say, the entirety of the immune system. So, our technologies hold excellent promise in immuno-oncology and the potential as next-generation protection against virulent pathogens. Our work in providing options for women with ovarian cancer and the general public's exposure to potential pandemics is progressing, and I hope you see, as we have indicated to you, it is progressing quite well. We're focused on making sure that our cash is being used very efficiently. Jeff Church will, with his sharp pencil, make sure that it is.

Michael Gardner: <unk> seen quite a bit of progress in our all of our programs we have a very excited.

Michael Gardner: A group of scientists and researchers are.

Michael Gardner: We continue to add the kind of complement our intellectual talent that's important to our success.

Michael Gardner: Believe in our proprietary technologies on a preliminary basis.

Michael Gardner: Preclinical studies and in early the early phase one study for Oh. One for example, we are showing the potential that are that are in the technologies. We know these technologies. This oh one for example, we know it works.

Michael Gardner: Stimulating recruiting let me say the entirety of the immune system.

Michael Gardner: So our technology is hold excellent promise in immuno oncology and the potential as a next generation protection against very very old pathogens are work in providing options to women with ovarian cancer and the general public's exposure to potential Pandemics progresses, and I hope you see as we have indicated.

Michael Gardner: You've progressed quite progressing quite well, we're focused on making sure that our cash is being used very efficiently.

Michael Gardner: Jeff Church will with a sharp pencil and make sure that it is.

Operator: And we will remain very excited about reporting data from our clinical trials in the coming months. So, again, thank you for your attendance. We look forward to keeping you informed of our progress and wish you a very nice afternoon and, for those celebrating the holiday weekend, a great and wonderful holiday weekend. And that concludes our remarks, Operator. The conference is now concluded. You may disconnect.

And we will remain very excited about reporting data from our clinical trials in the coming months.

None: So again, thank you for your attendance. So we look forward to keeping you informed of our progress and wish you a very odd.

None: Nice afternoon, and for those who are celebrating the holiday weekend, a great and wonderful holiday weekend.

None: And that concludes our remarks operator.

None: The conference has now concluded.

None: You may disconnect.