Imunon Q4 2023 Earnings Call Transcript

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Provided by Quartr
March 28, 2024

There are 9 speakers on the call.

Operator

Good morning. My name is Dave, and I will be your operator today. At this time, I would like to welcome you to the Immune 2023 Financial Results Conference Call. All lines have been placed on mute to prevent any background noise. Following the speakers' prepared remarks, there will be a question and answer session.

Operator

I would now like to turn the call over to Kim Golodetz. Please go ahead.

Speaker 1

Thank you, and good morning, everyone. This is Kim Golodetz with LHA. Welcome to Immunon's 23 financial results and business update conference call. During today's call, management will be making forward looking statements regarding ImmuneOn'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.

Speaker 1

These statements are based on current expectations and are subject to a number of risks and uncertainties, including those set forth in the company's periodic filings with the Securities and Exchange Commission. No forward looking statements can be guaranteed and actual results may differ materially from such statements. I also caution that the content of this conference call is accurate only as of the date of the live broadcast, March 28, 2024. Immunon undertakes no obligation to revise or update comments made during this call, except as required by law. With that said, I would like to turn the call over to Michael Tordugno, Immuneon's Executive Chairman.

Speaker 2

Michael? Thank you, Kim,

Speaker 3

and good morning, everyone. It's good to be here with all of you. Joining me today are Jeffrey Church, our Chief Financial Officer and Sebastian Hassard, our Chief Medical Officer. Doctor. Hassard will speak about immunon001 or IL-twelve immunotherapy and its anticipated place in the treatment of advanced ovarian cancer.

Speaker 3

In addition, Doctor. Khurshid Anwar, our Chief Science Officer, who joins us from the HudsonAlpha Institute in Huntsville, Alabama, where our research center is. Doctor. Anwar will be available during the Q and A session at the end of our prepared remarks. But first, I'm sure you're all aware of the departure of Corinne Lagoff earlier this month to pursue other business opportunities.

Speaker 3

We wish her well and are grateful for her leadership and her contributions that she made to immunon during her tenure. 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 2 key technology platforms, that's Theraplas and Placine. We remain on track to complete our Phase 2 OVATION II study with IMMUN001, which is based on the TheraPlas platform and to initiate our Phase 1 study of IMMUN101, our seasonal COVID-nineteen vaccine concept based on our Placine technology. Our strategy for the development of these product platforms remains unchanged as well. From the OVATION II study, we expect to report top line data in mid-twenty 24.

Speaker 3

Based on our interim data and preliminary conversations with FDA, Doctor. Hassart will be drafting the protocol for the Phase 3 study soon. He'll be speaking more about this in a minute. 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 1 study in the Q2 of this year.

Speaker 3

And we're ready to go. We have 2 sites identified. The 2 sites identified, that's Beth Israel in Boston and DM Clinical Research in Philadelphia. Both institutions have submitted to the IRB, our protocol. They've been conditionally approved pending FDA acceptance.

Speaker 3

The biological safety committees at both institutions have approved the protocol and our contracts in place are in process. We're ready to go. 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 Doctor. Hassard.

Speaker 3

Sebastien?

Speaker 2

Thank you very much, Michael. Hello, everyone. Before I discuss our vision for 1, 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, O01 is our DNA based IL-twelve immunotherapy. OVATION 2 is a randomized study evaluating OVATION 1 for the perioperative treatment of newly diagnosed advanced ovarian cancer patients.

Speaker 2

It's being tested in combination with standard of care chemotherapy. September 'twenty two, we reached full enrollment of 113 patients. And a year later, in September 'twenty three, we reported a set of interim data showing promising progression free survival and overall survival. In the intent to treat population, the data showed a delay in disease progression of death in the treatment arm of more than 3 months. And preliminary overall survival data followed a similar trend, showing an approximate 9 months improvement in the treatment arm over the control arm.

Speaker 2

This data, particularly OS, still need 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 OVATION II study, PARP inhibitors were not yet part of the first line maintenance treatment in ovarian cancer. 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 suggest an even larger clinical benefit.

Speaker 2

In this subgroup, the median progression for survival was 23.7 months in the arm with 1 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 not reached in the O01 arm. Although these data are from a small number of patients, they are intriguing. Safety analysis continue to show good tolerability of O1 in this setting. So here are our thoughts on this program right now.

Speaker 2

We think we may very well have in our hands the 1st immunotherapy effective for treatment of ovarian cancer. This is made possible by the TheraPlas technology allowing the durable production of IL-twelve by the tumor microenvironment, as shown in our Phase I OVATION I study. So far, the clinical data with O1 from Ovation 1 to the preliminary data of Ovation 2 confirm O1's activity. We believe that the positioning of O1 in the perioperative treatment of ovarian cancer patients is very important. In addition, the lack of the 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 microenvironment.

Speaker 2

Assuming enough maturity on the PFS data around midyear and similar efficacy results, the next step is to submit our registration study plans to the FDA. Several considerations are in 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 the patients. And these patients were excluded from OVATION 2. 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.

Speaker 2

This is important as it may allow 1 to offer even more clinical benefit in synergy with angiogenic. It would also help with the study enrollment by making the trial more attractive to sites using bevacizumab for most of their patients. Another consideration is a focus on the tumor with homologous recombinant deficiencies, or HRD, who are the most likely to be exposed to PARP inhibitors 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. Now enrollment in our 2nd Phase II study in collaboration with Breakthrough Cancer Foundation is ongoing.

Speaker 2

The first four patients have been treated at the University of Texas MD Anderson Cancer Center. And in the Q1 of 'twenty four, we announced that Memorial Sloan Kettering has joined the study. This study is evaluating 1 in combination with bevacizumab, rivastine, is expected to enroll 50 patients in Stage IIIIV ovarian 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 2nd loop laparoscopy, and the secondary endpoint is progression free survival.

Speaker 2

Initial second look laparoscopy data are expected within a year following completion of enrollment, and final PFS data are expected approximately 3 years following enrollment completion. This trial will include translational endpoints to better understand the impact of O1 combined with bevacizumab on the tumor microenvironment and assess other methods like ctDNA to measure MRD, an important trial to better understand the somewhat under evaluated new adjuvant stage of ovarian cancer. We will keep you updated as sites continue to be added. So with that review of our ovarian cancer program, I turn the call back over to Michael. Thank you, Sebastian.

Speaker 2

I just want

Speaker 3

to say for the record, Doctor. Hassard has joined us recently and he brings with him a wealth of experience in clinical research, ovarian cancer, in regulatory affairs that's beginning to show a great deal of promise. We are delighted. I can't say enough for the impact that you've had in your very short period of time. And I'm sure the company and our shareholders will benefit from your expertise.

Speaker 2

Thank you.

Speaker 3

Thank you, Suvaj. So I want to talk a little bit more about the durability. You're going to hear that through the course of our conversation this morning. 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 immunon001, as illustrated by Doctor.

Speaker 3

Hassard. This allows the prolonged exposure of the tumor microenvironment to IL-twelve. And 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 6 months that is provided by the mRNA vaccine platforms. So with that, I'm not the expert here. So Doctor.

Speaker 3

Anwar, 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?

Speaker 4

Sure, Michael. This is Krishid. 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-twelve, a persistent local level at 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.

Speaker 4

The same is true for vaccine. The only difference is that in 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-twelve product or a pathogen antigen in our vaccine product is addressing the bioavailability and persistent challenges. 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. 2nd, the DNA unlike protein or mRNA has longer residence time in the cell, and hence the production of protein antigen or therapeutics last longer.

Speaker 4

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 cell through the use of DNA. Really those two key aspects are part of the mechanism.

Speaker 3

Thank you, Krishid. Doctor. Anwar will be on the line to answer questions at the end of our prepared remarks. So now let's continue our discussion of Placine, our proprietary vaccine based on a DNA plasmid that promotes the expression of pathogen antigens delivered in our proprietary non viral synthetic delivery system that Doctor. Anwar just spoke about.

Speaker 3

We are delighted to report that the filing of an NDA for 101 with the FDA, we are proposing a Phase 1 clinical trial as a seasonal COVID-nineteen booster vaccine. This 24 subject proof of concept study is expected to begin enrollment in the Q2 of 2024 following acceptance by the FDA, which we are hopeful will be quite soon. The dialogue between Doctor. Hassard and the agency has been robust. Our responses to their questions have been very timely.

Speaker 3

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 response and durability, a key characteristic. The second objectives are to evaluate the ability of IMUEN-one hundred and one to elicit the antibody immunoglobulin G or IgG as it's referred to in T cell activity and their durability. Based on preclinical data, durability of immune expression is expected to be superior over published mRNA vaccine data.

Speaker 3

101 for this study has been designed to protect against omicron XBB1 5 variant of SARS CoV-two in accordance with the FDA's guidance published in June 2023. As you may recall, we've generated some compelling preclinical data on the attributes of this vaccine, most importantly immunogenicity and better protection than 95 percent protection better than 95%. We also demonstrated superior shelf life at 12 months at refrigerated temperatures and at least 1 month at 90 degrees Fahrenheit from 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, plasine vaccines have the advantage in T cell responses, safety, delivery compliance or manufacturing flexibility.

Speaker 3

So I'm going to turn back to you, Doctor. Anwar. And why are we so confident about the stability of our product? Can you give us a little bit of contrast and compare with messenger RNA?

Speaker 4

Yes, sure. I mean, we all know that when mRNA vaccines came out, very strict storage conditions requirement actually at minus 70 degree freezers, you have to keep it there in pharmacies during transportation, you have to use minus 70 degree. That's extreme cold temperature and the country, even developing countries, much less the underdeveloped countries, just not equipped with that kind of temperature provision. So it's a problem disseminating the vaccine. So relative to mRNA, the DNA is more stable and it could last at working temperature.

Speaker 4

There's a refrigerated temperature, which almost every pharmacy has for a very protective delivery system also provides 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 synthetic delivery system that provides limits the degradation of DNA. That really keeps distinguishing feature of our vaccine over mRNA in terms of temperature stability. And actually, even at 37 degree, we have seen for a month stability. Stability.

Speaker 4

So imagine that pharmacy nurses take it out or delivery people, they don't have to worry about putting it discarding it after a couple of hours if it's not if the duration goes beyond 2 hours. So I think we feel confident in that sense we have addressed that critical issue in vaccine distribution and storage.

Speaker 3

Thank you, Krishit. Again, Krishit used the 37 degrees centigrade, and I was talking about 90 degrees Fahrenheit, both are equivalent for handling for at least 1 month. And that really makes the vaccine stable during its preparation for administration to patients at temperatures that are very realistic in some of the particularly in some of the more demanding third world countries. Again, Doctor. Unmall will be available for questions at the end of our prepared remarks.

Speaker 3

Following the Phase 1 study and assuming 101 performs as expected, we have no reason to believe it won't. 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 financials. Jeff?

Speaker 5

Thank you, Michael. Details of Immunon's 2023 financial results are included in the press release we issued this morning and in our Form 10 ks, which we filed before the market opened. Invenon ended the year with $15,700,000 in cash and investments. Net cash used for operating activities was $18,900,000 for 2023. This compares to $23,100,000 in the prior year.

Speaker 5

This decrease is primarily due to a one time payment of $4,500,000 in interest expense in the Q1 of 2022, resulting from the sale and subsequent redemption of $30,000,000 of convertible preferred stock. Cash used in financing activities was $3,800,000 this year. That resulted from the payoff of the Silicon Valley Bank loan, which amounted to $6,400,000 offset by sales under the company's at the market equity facility of $2,600,000 dollars 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. Aimmune reported a net loss for 2023 of $19,500,000 $2.16 per share and this compares with a net loss of $35,900,000 or $5.03 per share last year.

Speaker 5

Operating expenses were $21,000,000 for 2023, a decrease of $4,400,000 or 17% from 2022. Now breaking down these operating expenses by major line item, research and development expenses were 11,300,000 dollars very consistent with the levels we reported last year. More specifically, R and D cost associated with the development of 1 to support the OVATION II study as well as the development of the plastine DNA vaccine technology platform were $6,000,000 in 2023 and that compared to $6,100,000 for 2022. Costs associated with the OVATION II study, the clinical development costs, were 1,200,000 dollars this year. That's down from $1,500,000 in the prior year.

Speaker 5

And this decline was due to the completion of enrollment, as Doctor. Hassard indicated, in September of 2022. CMC costs, manufacturing costs increased to 2,200,000 dollars for 2023 from $1,200,000 for 2022 due to the development of in house pilot manufacturing capabilities for DNA plasmids and nanoparticle delivery systems this year. Costs associated with the Phase 3 OPTIMA study were de minimis this year compared to $1,000,000 in 2022. Our clinical and regulatory costs were $1,800,000 this year compared to 1.9 dollars for 2022.

Speaker 5

General and administrative expenses were $9,700,000 for 2023 compared to $13,700,000 for 2022. This $4,000,000 decrease was primarily attributable to lower non cash stock compensation expense, lower employee related costs, primarily lower legal costs as we've resolved many of the issues that had arisen with the Phase 3 trial with ThermoDox. Lower costs for D and O insurance also contributed to this decrease. Subsequent to the end of the year, we announced that we had received $1,300,000 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.

Speaker 5

Other non operating income this year was $200,000 That compares to other non operating expenses in 2022 of $12,500,000 Investment income this year from our short term investments was $1,200,000 compared to $500,000 last year. As I mentioned earlier, in June of 2020 one, we had entered into a loan facility with Silicon Valley Bank. 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 compared to $500,000 in 2022. In the second quarter of 2023, we terminated and paid off the Silicon Valley bank loan facility.

Speaker 5

We had to pay some early termination and end of term fees and we recognized a $300,000 loss on the debt extinguishment. I think more importantly, the big driver in last year's non operating expense was an impairment charge of $13,400,000 that we took in writing off some in process assets or in process R and D assets and offsetting that was a non cash gain of $5,400,000 due to the write off of a earn out milestone liability because the requirements had not been achieved. And then lastly, as I mentioned earlier, we had a one time $4,500,000 interest in offering expenses results from the sale and then subsequent redemption of the preferred stock. Our cash utilization for 2024 is approximately $18,000,000 providing us with a runway that takes us pretty much through 2024 time period. With that financial review, I'll now turn

Speaker 3

the call back to Michael. Thank you, Jeff. As always, a lively discussion of our financials. As you know, 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 testing the market, Immunon, like virtually all other nonrevenue microcap biotechs, was presented with terms that we felt were unacceptable and unfair to our shareholders.

Speaker 3

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, 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 just discussed milestone readouts of our 2 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.

Speaker 3

In closing 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 call to your questions. Operator?

Operator

Our first question comes from James Molloy with Alliance Global Partners. Please go ahead.

Speaker 3

Good morning, James.

Speaker 6

This is Laura, for the Phase onetwo trial that you're conducting for 1 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?

Speaker 3

I'm going to start by answering that question and maybe I can turn the balance over to Doctor. Hussar. So this is a very important study. It's hypothesis generating in many ways. 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.

Speaker 3

So this idea of second look laparoscopy to evaluate for any minimal residual disease is a proposal that if we're successful here, it could change the course of treatment of patients. 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, Harvard, Dana Farber. So we have 2 institutions now enrolling. Two more institutions will be joining the study quite soon. I think we have a number of patients on trial.

Speaker 2

Sebastian? Yes, we have 4 patients on trial. And based on the first sites open at MD Anderson, As I mentioned, we have a second one who just opened and we expect 2 more, one being John Hopkins and the second one being Oklahoma University. And so based on these 4 large sites, we expect that enrollment will pick up. But the point I would like to make here also is that there are 2 main objectives for this study.

Speaker 2

1 is, of course, proof of concept on 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 Phase III study, the safety data on the combination will be very useful.

Speaker 3

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 this study.

Speaker 6

Got it. Thank you for the clarity. And then also in regards to your vaccine and your other vaccine candidates, how may you describe the current partnership environment and maybe any of your ongoing potential partnership discussions that you might have held?

Speaker 3

I think, well, we haven't arrived at any partnerships specifically yet. Of the institutions that have expressed an interest are waiting for some clinical data, which is not far off. And you can expect that. I mean, immunon is new to this vaccine environment. Our technology is novel.

Speaker 3

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 probably for me though, however, the most exciting potential collaborators are some of the agencies of the government. What I don't know if we've talked too much about this, but pandemics, whether they're organic or otherwise, I mean, they have the potential to be 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.

Speaker 3

So those partnerships, again, once we have some preliminary clinical data, I expect to mature.

Speaker 6

Understood. Thank you for taking the question.

Speaker 3

Thank you.

Operator

The next question comes from David Boss with Zacks Small Cap. Please go ahead.

Speaker 7

Hey, good morning, everyone. Thanks for the update this morning. So I kind of want to start it off with keying off your discussion of durability from earlier in the call. Curious in regards to actually both programs going on, 1 and plastine. Are you measuring for 1, are you measuring IL-twelve expression as these patients move through treatment?

Speaker 7

And then for the vaccine program, will you be looking at kind of longitudinal expression of the spike protein in those healthy volunteers in that Phase 1 study?

Speaker 3

That's a great question. And Doctor. Anwar, Krashid, are you still on the line?

Speaker 4

Yes, I am, Michael. So David, that's a good question. For IL-twelve, we have in previous clinical trials, major IL-twelve after the repeated administration of the product. As you may recall, 1 is given once every week for several weeks. So we have in multiple studies examined IL-twelve levels after the treatment and quantified that increases over baseline.

Speaker 4

With respect to the spike protein, we have in animal models, we have done western blot analysis to ensure that protein is properly molecular weight, but most of our quantification is mRNA based.

Speaker 7

Is the FDA going to require you to look at the levels of expression of the spike protein in the study or is that something that they're interested in?

Speaker 4

No, in human clinical trials, no, it's not required. FDA does not require that due to 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 the antigen production. So, no, it's not required to quantify the spike protein in the clinical trial.

Speaker 7

Okay, great. So switching gears a little bit, I'm sure you saw the news this morning about Gilead, their partnership for an IL-twelve asset. I'm just kind of curious if you've seen any interest in 1 or partnering discussions how those are going for that product?

Speaker 2

Look, I mean, as you know, we are on the verge of having our Phase II data with this asset. We have already very promising clinical data. I can tell you that there are some potential that would be interested in looking at our data when we have confirmation. And so, of course, this is a possibility that we develop partnerships on this asset.

Speaker 3

To answer that, 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.

Speaker 7

Okay. And then lastly, for the 1 study,

Speaker 3

I guess, I just kind of

Speaker 7

want to clear up what exactly is going to be considered positive data readout as we look forward to this data coming up in the middle of this year. I know you've discussed kind of the study set up to show a 33% increase in PFS. But I guess what is there kind of a gono go level? What should we be expecting there?

Speaker 3

Yes. I'm going to start this conversation and maybe Doctor. Hazard can jump in. So during the course of this trial, we've seen an evolution of the treatment of cancer patients, ovarian cancer patients. So when we started the trial, the data was not yet in from the Avastin program.

Speaker 3

So Avastin was not included as one of the treatment options for newly diagnosed patients. And subsequent to the Avastin approval, we saw PARP inhibitors make their way in for the HRD population. Again, neither of those adjuvant treatments or combination treatments were considered in 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. 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.

Speaker 3

And so we're not particularly stratified to do a the kind of typical analysis. 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 Doctor. Hassard alluded to, to see if there's a subgroup here that would make sense to include in a larger pre specified to include in a larger study. But I think what we're seeing in the response that we're getting for the medical community at 3 to 4 month improvement in PFS is clinically relevant, whether or not that's an 85%, 86%, 87% hazard ratio is probably not the material issue. The last point I'll make and this is I think can be verified by any clinician treating cancer patients.

Speaker 3

Immunotherapies for the most part have a much better OS benefit than is indicated by PFS. So and 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 3 study going forward. You think I got that, Doctor. Herzog? Yes, absolutely.

Speaker 3

I have nothing else to add to this. So, frankly, we're excited with the data that we're seeing so far. And as we look at this is a novel treatment in the newly diagnosed patients with a standard of care, that 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 standard ways.

Speaker 7

Okay. Sounds good. Appreciate you taking the questions this morning.

Speaker 2

Thank you.

Operator

The next question comes from Kempe D'oliver with Brookline Capital Markets. Please go ahead.

Speaker 3

Good morning, Ken.

Speaker 8

Good morning. Thank you for taking my questions. First, just for clarification,

Speaker 3

is an institution that's primarily set up to evaluate the 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 of them, you can find them online, a well regarded high quality clinical research focused institution and recommended to us by the way by the

Speaker 2

Israel people.

Speaker 8

Great. Thank you. The second question relates to your commentary around partnering and particularly with government. So what is the state of your of that part of the process? Because BARDA and DoD can move very slowly and presumably you would have other part potential partners involved who would be in a position to move faster once you have data that everyone can evaluate?

Speaker 3

Yes. And that's a good question. I typically don't include the government in any kind of my thinking about development of products, even though they are the biggest consumer in many ways. Because of just as you pointed out, I mean, the decision process is low and there's always this competitive element that may or may not include a good old boys network. And I apologize for saying it that way, but that's I mean, that's the reality of it.

Speaker 3

We will not assuming good data, we will not delay any ongoing development of our products pending a financing or interest from the government. Although my expectation is that good data will bring in interest from the big guys. We've had multiple, I mean, important people in the government. We've had multiple conversations. Doctor.

Speaker 3

Le Goff especially found this opportunity with the government to be very compelling. I agree with her completely. But in the meantime, the platform makes sense for other vaccine focused pharma 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.

Speaker 3

I would suspect that pharma will be as they have said in our we have a TPP, a targeted product profile that's generated continued ongoing interest. And in this environment, it's not like the heavy days of a number of years ago. But in this environment, there's a little more patience 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 on 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.

Speaker 8

Great. Thank you.

Speaker 3

Thank you.

Operator

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

Speaker 3

Well, first, let me thank everyone for joining us. I don't think we could be in a better position. Your company on the fundamentals, we have seen quite a bit of progress in our 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.

Speaker 3

We believe in our proprietary technologies on a preliminary basis in preclinical studies and in early Phase 1 study for 1, for example. We are showing the potential that in the technologies. We know these technologies. This O-one, for example, we know it works in stimulating recruiting, let me say, the entirety of the immune system. So our technologies hold excellent promise in immuno oncology and the potential as a next generation protection against virulent pathogens, our work in providing options to women with ovarian cancer and the general public's exposure to potential pandemics progresses.

Speaker 3

And I hope you see, as we have indicated, to you 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. And we will remain very excited about reporting data from our clinical trials in the coming months. So again, thank you for your attendance.

Speaker 3

We look forward to keeping you informed in 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.

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Earnings Conference Call
Imunon Q4 2023
00:00 / 00:00