Q4 2023 Imunon Inc Earnings Call
Participants
Kim Golodetz; IR; Lippert/Heilshorn & Associates, Inc.
Michael Tardugno; Executive Chairman, Director; Imunon Inc
Sebastien Hazard; Executive Vice President, Chief Medical Officer; Imunon Inc
Khursheed Anwer; Executive Vice President, Chief Scientific Officer; Imunon Inc
Jeffrey Church; CFO, Executive VP & Corporate Secretary; Imunon Inc
Laura Suriel; Analyst; Alliance Global Partners
David Bautz; Analyst; Zacks Small-Cap Research
Kemp Dolliver; Analyst; Brookline Capital Markets
Presentation
Operator
Good morning my day. My name is Dave, and I will be your operator today. At this time, I would like to welcome you to ImmunoGen 2023 financial results conference call. (Operator Instructions) I would now like to turn the call over to Kim Golodetz. Please go ahead.
Kim Golodetz
Thank you, and good morning, everyone. This is Kim Golodetz with LHA. Welcome to ImmunoGen's 2023 financial results and business update conference call. During today's call, management will be making forward-looking statements regarding immunome expectations and projections about future events. In general, forward-looking statements can be identified by words such as expect, anticipates, believes or other similar expressions.
These statements are based on current expectations and are subject to a number of risks and uncertainties, including those set forth in the Company's periodic filings with the Securities and Exchange Commission. No forward-looking statements can be guaranteed, and actual results may differ materially from such statements. I also caution that the contents of this conference call is accurate only as of the date of the live broadcast March 28, 2024. Immunovia undertakes no obligation to revise or update comments made during this call except as required by law.
With that said, I would like to turn the call over to Michael Tardugno, immunology, Executive Chairman. Michael?
Michael Tardugno
Thank you, Kim, 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 Sebastien Hazard our Chief Medical Officer; Dr. Hazard will speak about the immunome or one of our 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 centers, Dr. Anwar, 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 the departure of Crenlo golf earlier this month to pursue other business opportunities. We wish her well and are grateful for her leadership and her contributions that you've made to immunize 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 two key technology platforms that's TheraPlas and Plessey.
We remain on track to complete our Phase two OVATION two study with immunoSEQ or one, which is based on the TheraPlas platform and to initiate our Phase one study of immunology one oh one, our seasonal COVID-19 vaccine concept based on our place in technology, our strategy for the development of these product platforms remains unchanged as well. From the OVATION two study, we expect to report top line data in mid 2024 based on our interim data and preliminary conversations with FDA Dr. Hazard will be drafting the protocol for the Phase three study soon. We'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 one-on-one 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 the two sites identified as Beth Israel in Boston and DM clinical research in Philadelphia.
Both institutions have submitted the IRE to the IRB or protocol. They've been conditionally approved, pending FDA acceptance. The biological safety committees at both institutions have approved the protocol, our contracts in place or in process, we're ready to go. So we look forward to the agency's agreement with the 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?
Sebastien Hazard
Thank you very much, Michael, and hello, everyone.
Before I discuss our vision for four one, I wanted to review some of the interim data we generated and share some considerations on what a pivotal trial could look like. Should the Phase two data hold up. As you know, oh one is our DNA-based IL-12 immunotherapy. Provation two is a randomized study evaluating all one for the variability of treatment of newly diagnosed advanced ovarian cancer patients being tested in combination with standard of care chemotherapy, September 22, we reached full enrollment of 113 patients and a year later in 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 showed the delay in disease progression or death in the treatment arm more than three months on preliminary overall survival data followed a similar trend showing an approximate nine months improvement in the treatment arm over the control arm. These data, particularly OS. still need to mature to confirm this robust efficacy signal. We also reported that for the first time data on the subset of patients treated with Spark inhibitors.
When we began OVATION two Study past inhibitors, we are not yet part of the first-line maintenance treatment in ovarian cancer now form an important part of the patient's treatment plan. A subgroup analysis of patients who received post chemo maintenance therapy response inhibitors suggest an even larger clinical benefit in this subgroup. The median progression-free survival was 23.7 months in the arm with or one 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 on not switched into one arm. Although these data from a small number of patients. They are intriguing. 50 analysis continue to show good tolerability of all when the city. So our thoughts on this program right now, 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 TheraPlas technology, allowing the durable production of IL-12 by the tumor microenvironment. As shown in our Phase 1 OVATION one study so far, the clinical data we all run from revision one to the preliminary data observation to confirm for one's activity.
We believe that the positioning of all one in the peri operative treatment of ovarian cancer patients is very important. In addition, the lack of new options for the especially 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 general macro environment, assuming enough maturity on the PFS data around midyear and similar efficacy results.
The next step is to submit our registration study plans to visit similar considerations are in discussion internally, one being the inclusion of patients receiving bevacizumab during the perioperative setting and is the MAB, as, is frequently used in the period (inaudible) to about approximately 50% of the patients.
And these patients were excluded from revision to the combination of bevacizumab on or one has also shown synergistic efficacy in preclinical experiments. And the ongoing Phase two study done with breakthrough Cancer Foundation will provide safety data on the combination. This is important as it may allow or one tool for even lockdown could benefit in synergy. We control unique. It will also help with the study enrollment by making the trial more attractive to sites using the best smartphone most of their patients.
Another consideration is the focus on the tumor with homologous recombination deficiencies of HRG. who have the most likely to be exposed to above inhibitors in maintenance, we may introduce in the study design the possibility to test one efficacy in this subpopulation, representing around 40% of the newly diagnosed ovarian cancer patients. Enrollment in our second Phase two study in collaboration with breakthrough Cancer Foundation is ongoing.
The first four patients have been treated at the University of Texas, MD Anderson Cancer Center. And in the first quarter of '24, we announced that Memorial Sloan Kettering has joined the study. The study is evaluating one in combination with bevacizumab or Avastin is expected to enroll 50 patients in stage before line consortium sites. Initially, this randomized study will allow to confirm the safety of the combination of oh one 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 SecondLook laparoscopy. And the secondary endpoint is progression free survival. Initial second, look laparoscopy data expected within a year following conditional one one months on final PFS data, I expected approximately three years following enrollment completion. This trial will include translational endpoints to better understand the impact of all one combined with bevacizumab on the tumor microenvironment and assess other metals like CTG. and A. to measure and monitor an important trial to better understand somewhat under evaluated new adjuvant stage or in cancer. We will keep you updated as sites continue to be added to it.
So with that review of our income support program. I turn the call back over to Michael.
Michael Tardugno
Thank you, Sebastian. And I just want to say for the record that Dr. Hazard 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. And we are we are delighted. 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.
Sebastien Hazard
Thank you.
Michael Tardugno
So I want to talk a little bit more about the durability. You're going to hear that through the course of the conversation this morning, a 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 immunology oh one is illustrated by Dr. resort which allows the prolonged exposure of the tumor microenvironment to IL. 12. If our vaccine against the pathogen, this durability low 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 platforms.
So with that, I'm not the expert here. So Dr. Anwer, you're on the line, would you could you tell us a little bit more about the mechanism and our experience so far with this start durability characteristics?
Khursheed Anwer
Sure, Michael, this is Khursheed. 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 that persistent local level of 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 vaccine. The only difference is that in vaccine setting, the product is a pathogen antigen.
Now to answer your question, the mechanism of our approach for durable expression of therapeutic molecule in our IL-12 product or a pathogen antigen in our vaccine product is addressing the bioavailability and persistent challenges. First mechanism that addresses the product's stability after administration is the use of our proprietary delivery system that protects the DNA from degradation. So there's higher bioavailability. Second DENA, unlike protein or mRNA, has longer residence time in the cell and hence, the production of protein antigen or therapeutics last longer. So in a nutshell, our mechanism of durability, whether a therapeutic or a vaccine is increasing the bioavailability to the delivery system and longer register residence time in cell through the use of DNA. Really the two those two key aspects are part of that.
Michael Tardugno
Thank you, Khursheed doctor and well beyond the line to answer questions at the end of our prepared remarks. So now let's continue our discussion of placing our proprietary vaccine based on high DNA plasmids that promotes the expression of pathogen antigens delivered in our proprietary nonviral synthetic delivery system that Dr. Anwar just spoke about. We're delighted to report that the filing of an NDA for our one oh one with the FDA we are proposing a Phase 1 clinical trial is 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 we will be quite soon, are the dialogue now between Dr. HYZAAR and the agency has been robust.
Our responses to their questions have been very timely. So things are moving quite well are the primary objective of this study is in healthy adults is to evaluate the vaccine, safety, tolerability and neutralizing antibody response will also evaluate the durability of response and durability, a key characteristic.
The second objectives are to evaluate the ability of Immunicon one-on-one 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, one a one for this study has been designed to protect against all McCranie XBB. one five variants of SARS-CoV-2 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 5D 95% at times, sorry, protection better than 95%. We also demonstrated superior shelf life for 12 months at refrigerated temperatures in at least one 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 the viral or other DNA vaccines or protein vaccines, placing vaccines, you have the advantage in T cell responses, safety delivery, compliance or manufacturing flexibility. So I'm going to turn it back to you, Dr. Anwar, why and why are we so confident about the stability of our product. Can you give us a little bit of a compressed can contrast and compare with the messenger RNA?
Khursheed Anwer
Yes, sure I mean, we all know that the 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 under development countries, just not a clip, it does get that kind of temperature and provision. So it's a problem of disseminating the vaccine.
So relative to mRNA, the DNA is more stable. And it could last at working temperature, does the 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 had 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 synthetic delivery system that provides limit the degradation of DNA that really keeps a distinguishing feature of our vaccine, our mRNA in terms of temperature stability and actually even at 37 degree, we have seen for a month stability.
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 hours, if it's not if it temperature if the duration goes beyond two hours. So I think we feel confident in that sense, we have address that critical issue in vaccine distribution and storage.
Michael Tardugno
Thank you, Khursheed, again Khursheed, you used the 37 degrees centigrade high and I was talking about 90 degrees Fahrenheit, both the equivalent of four handling out for at least one month. And that really makes the the vaccine on stable during its preparation for administration to patients at temperatures that are very realistic in some of the in particular, in some of the more demanding of third world countries are got again, a doctor and will be available for questions at the end of our prepared remarks, following the Phase one study and assuming one performs as expected, we have no reason to believe it won't if we look to partner out this program for from further development and to expand on a platform for those 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 and defense agencies in particular and of course, to the medical community as a means to address rapidly evolving and new 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?
Jeffrey Church
Thank you, Michael. For 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. Immunogen ended the year with $15.7 million in cash and investments. Net cash used for operating activities was $18.9 million for 2023.
This compares 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. That resulted from the payoff of the Silicon Valley Bank loan, which amounted to $6.4 million, offset by sales under the company's 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. Mem reported a net loss for 2023 of $19.5 million -- or $2.16 per share. And this compares with a net loss of $35.9 million or $5.3 per share last year. Operating expenses were $21 million for 2023, a decrease of $4.4 million or 17% from 2022.
Now breaking down these operating expenses by major line items of 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 oh one to support the OVATION two study as well as the development of the placing DNA vaccine technology platform were $6 million in 2023, and that compared to $6.1 million for 2022 costs associated with the OVATION two 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 completion of enrollment. As Dr. hazard indicated, in September of 2022, our CMC costs manufacturing costs increased to $2.2 million for 2023 from $1.2 million for 2022 due to the development in house pilot manufacturing capabilities for DNA plasmids and nano particle delivery systems of this year. Costs associated with the Phase 3 OPTIMA study work were diminimus 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. This $4 million decrease was primarily attributable to lower non-cash stock compensation expense, lower employee related costs, primarily a lower legal costs. As we've done have resolved many of the issues that come had arisen with the Phase 3 trial with ThermoDox, lower costs for D&O insurance and also contributed to this decrease subsequent to the end of the year, we announced that we had received $1.3 million 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. That compares to other non-operating expenses in 2022 of $12.5 million of investment income this year from our short-term investments was $1.2 million compared to half $1 million last year.
As I mentioned earlier, in June of 2021, we had entered into a loan facility with Silicon 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 ISPB. loan facility, we incurred $200,000 of interest expense in 2023 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. And I think more importantly, show you the the big driver in last year's on Jan, I'm operating expense was a impairment charge of $13.4 million that we took in writing off some in-process assets are in in-process R&D assets and offsetting that was a non-cash gain of $5.4 million due to the write-off of eight earn-out of Milestone liability because the requirements had not been achieved.
And then lastly, as I mentioned earlier, we had a one-time $4.5 million of 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 was us with a runway that takes us pretty much through each of the 2024 time period about with that financial review I'll now turn the call back to Michael.
Michael Tardugno
Thank you, Jeff. As always, a lively discussion of our financials. As you know, 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 programs and testing the market. The immunome, unlike virtually all other non-revenue microcap biotechs, was presented with terms that we felt were unacceptable and unfair to our shareholders. So consequently, we have chosen to divert deferred 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 nonessential programs and reducing our headcount footprint just makes sense. So our goal is to ensure that we have cash through the just discuss the 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 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 to questions and open up the call to your questions. Operator?
Question and Answer Session
Operator
(Operator Instructions) James Molloy, Alliance Global Partners.
Michael Tardugno
Morning, James.
Laura Suriel
This is actually Laura Suriel on for Jim. Thank you.
For taking my question of loss of momentum for the Phase one two trial that you're conducting for oh one in combination with Avastin on when do you think you'll complete patient enrollment as well as obtain a first look an interim result readout for the strong?
Michael Tardugno
I'm going to start to answer that question and maybe I can throw the barrels over to Dr. reserves. So you know, this is a very important study is hypothesis-generating in many ways. The primary endpoint is one of great interest to the 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 has been a difficult thing to do.
So this idea of SecondLook lap from Skippy is to evaluate for any minimal residual disease is the proposal that is 64 successful here could change the course of treatment of patients. So using our product candidate in combination with Avastin under the see a watch for control of some of the premier institutions in the country and not including MD Anderson, Johns Hopkins, Memorial Sloan Kettering, Hartford?
Yes,, Dana-Farber, yes. So we have two institutions now enrolling our two more institutions will be joining the study quite soon. I think we have a number of patients on trial. Sebastien?
Sebastien Hazard
And yes, we have four patients on trial. And based on the the first sites open at MD Anderson, as I mentioned, we have a second one just opened and we expect two more one being John Hopkins on the second one being Oklahoma University. And so based on these four large sites, we expect that long enrollment will pick up.
And the point I would like to make here also is that, you know, there are two main objectives for the study. One is, of course, proof of concept on efficacy. And this will take a little bit of time to look at the PFS. And 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.
Michael Tardugno
So and 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 and largely because of the novelty of the approach to establishing it as the primary endpoint among other things once once those sites are on board, we're expecting our possibly by the end of next year by the half of 50 patients in this study.
Laura Suriel
Got it.
Thank you for the clarity and then also in regard to your complex theme and your other vaccine candidates on how you describe the current partnership environment and maybe any, you know, any of your ongoing potential partnership discussions that you might have helped and I think come what we haven't arrived at any partnerships specifically and 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 them medium in immunology is new to this vaccine environment.
Our technology is novel to superiority. The potential that we've talked about in this in this call this morning, I think is really 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 are asking for continued updates and we are engaging with them.
I think probably for me though, however, the most exciting of potential collaborators are some of the agencies of the government, but I don't know if we've talked too much about this, but the pandemics, whether they're organic or otherwise, I mean, have the potential to be compromised, not only patients but economies and and got even be even governments in US.
So the idea that having a an effective means to be able to quickly respond with a potent vaccine to emerging newly emerging or on viruses that are evolving in a more virulent way is a disease, a critical objective of the DOD, for example, and part of also the those partnerships of our again, once we have some some preliminary clinical data, I expect to mature.
And I said, thank you for taking the questions.
Michael Tardugno
Thank you.
Operator
(Operator Instructions) David Bautz, Zacks Small-Cap.
David Bautz
Hey, good morning, everyone, and thanks for the update this morning. So I kind of want to start it off with backing off your discussion of durability from earlier in the call. I'm curious in regards to actually both programs going on oh one and Plessey and are you measuring for oh one, are you measuring IL-12 expression commonly 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 those healthy volunteers in that Phase one study?
Michael Tardugno
Well, that's a great question. And Dr. Anwar, Khursheed, are you still on the line?
Khursheed Anwer
Yes, I am Michael So, David, that's a good question for IL. 12, and we have in previous metal Thailand's major iOS 12 and after the repeated administration of the product, as you may recall, or one is given once every week for several weeks. So we have and multiple studies examined IL-12 levels after the and the treatment quantified that increases over baseline with respect to the spike protein we have in animal models, we have done Western blot analysis to ensure that the protein is properly molecular weight, but most of our quantification is mRNA-based to see the mRNA for spike. And again, this produce, but no characterization of protein size on a Western blot, we have done that as well.
David Bautz
Is the FDA going to require you to look at the levels of expression of the spike protein in the study, you know, something there and show?
Khursheed Anwer
In human clinical trials, you know, it's not required.
FDA does not require that you too major and the protein spike levels, and that has been pretty consistent in the literature. I mean, other other trials as well, demonstration of the antibody response is reflective of the antigen production. So no sort of required to quantify the spike protein in the clinical trial.
David Bautz
Okay, great. So switching gears a little bit curious on the news this morning, on Gilead on their partnership for an IL. 12 asset. I'm just kind of curious, have you seen any interest in one or partnering discussions, how those are going for that product.
Sebastien Hazard
So look, I mean, you know, as you know, we are on the verge of having our Phase 2 data with this asset, and we have already very promising clinical data and 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 develop partnerships on this asset instead to roaming specifically for Gilead, I have to say that, sir, they have not been contacted by us as yet. They are on the list to do so.
David Bautz
Okay and then lastly, for the for the oh one study, I guess I just kind of want to clear up what exactly is going to be considered a positive data readout as I look forward to this data coming up in the middle of this year, I know you've discussed and the study is set up to show a 33% increase in PFS. I guess what is there kind of a go no-go level? What should we be expecting there?
Michael Tardugno
And I'm going to start this conversation and maybe a doctor has our consumption certainly during the course of this trial in an evolution of the treatment of cancer patients, ovarian cancer patients. When we started the trial of the data was not yet in from the Avastin program.
So Avastin was not included at Zynga has one of the treatment options for newly diagnosed patients are in subsequent to the Avastin approval or we saw partner inhibitors make their way in for the HRD population need. Neither of those adjuvant treatments or combination treatments were considered and in design of the trial.
So the ITT population, we still believe a 33% improvement, 80% powered to show that improvement is an important milestone to achieve or very close on the means and some of our assumptions to achieve that objective of change with the addition of the obviously these patients that were in our study, it typically had been included in some maintenance programs of these two drugs that were recently approved.
And so we're not particularly stratified groups to do a the kind of typical analysis. But so we think we have every right in reason to look at the data, parse it out a little bit more on specifically to see is Dr. Zang alluded to to see if there's a subgroup here that would make sense to include in a larger prespecified to include in a larger study.
But I think 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 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 by immunotherapies. For the most part, I have a much better OS. benefit than is indicated by our PFS.
So and 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. It does reduce the risk, frankly of failure to make decisions on the construct of a Phase 3 study going forward.
I think I said a doctor who's out your facility?
Sebastien Hazard
I and I have nothing else to it.
Michael Tardugno
Yes.
David Bautz
So okay.
Michael Tardugno
And we're frankly, we're excited with the data that we're seeing so far. And as we look at this is a novel treatment in a newly diagnosed patients with the standard of care that and in an evolving standard of care. So that gives us a little bit more. I don't want to call it uncertainty, but have a little bit more opportunity to to evaluate the data in some, I think some appropriate, but typically none our standard ways.
David Bautz
Okay, sounds good. I appreciate you taking the questions for next quarter.
Michael Tardugno
Thank you.
Operator
(Operator Instructions) Kemp Dolliver, Brookline Capital Markets.
Michael Tardugno
Good morning Kemp.
Kemp Dolliver
Thank you for taking my questions. First, just for clarification. The you mentioned the two sites or one oh one one was Beth Israel and the second site in Philadelphia that would show some institutions.
Michael Tardugno
And this 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 or they are geared specifically to bring patients and healthy patients in to a study like this to administer the vaccine.
And for for follow up, I mean, there, I mean, if you're curious of them, you could you can find them online a well regarded the high quality of our clinical research focused institution and recommended to us, by the way, by the Israel people.
Kemp Dolliver
Great. Thank you. The second question relates to your commentary around partnering and particularly with government. So lastly, what is the state of your that part of the process? Because Barta and DoD, your move very slowly very slowly. And presumably you would have other partners, potential partners involved to would be in a position to move faster once you have data that everyone can evaluate.
Michael Tardugno
Yes, that's a good question. I and I typically don't include the government and any kind of my thinking about development of products. Our even though they are the biggest consumer in many ways of the because of the just as you pointed out, I mean, the decision process is low and there's always this competitor development that may or may not include a good old voice network and I apologize for saying it that way. But that I mean, that's the reality of it.
We will not assuming good data. We will not delay any of the ongoing development of our products pending a final financing or interest from the government, although and my expectation is that good data will bring in our interest from the big guys. We've had multiple, I mean, important people in the government, and we've had multiple conversations. So Dr. McGrath, especially from this opportunity with the government to be very compelling. I agree with you completely.
But in the meantime, the platform makes sense for other vaccine focused pharma companies and as well, I hope both for for the investment community I mean, if we can demonstrate the kind of superiority that kind of characteristics that make this our vaccine, not only unique, but the at least as potent with a stronger capability to provide protection over time. I would suspect that and pharma will be as they have said in our we have a TPP. at the targeted product profile that's generated a continuing ongoing interest in IT. 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 patience for wait-and-see.
So we are, we hope, will continue to get support from the investment community as we make our way forward in that. 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 investors.
Kemp Dolliver
Great thank you.
Michael Tardugno
Thank you.
Operator
This concludes our question and answer session. I would like to turn the conference back over to Michael Tardugno for any closing remarks.
Michael Tardugno
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 our 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 technologies on a preliminary basis, I preclinical studies and in early the early Phase 1 study for oh one, for example, we are showing the potential that that in technologies we know these technologies, this of one, for example, we know it works and 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 very virulent pathogens, our 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 to you progress quite progressing very well. We're focused on making sure that our cash is being used the very efficiently. Jeff Church was with a sharp pencil to 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, and we look forward to keeping you informed on 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.
Operator
The conference is now concluded. You may disconnect.
