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spk07: Good morning. My name is Dave and I will be your operator today. At this time, I would like to welcome you to Immunon 2023 Financial Results Conference Call. All lines have been placed on mute to prevent any background noise. Following the speaker's prepared remarks, there will be a question and answer session. At that time, you may press star and then 1 on your phone to ask a question. Please keep in mind if you are using a speakerphone, you must release your mute function to allow the signal to reach our equipment. Again, that's star one to ask a question during the Q&A session. I would now like to turn the call over to Kim Golodets. Please go ahead.
spk00: Thank you, and good morning, everyone. This is Kim Golodets with LHA. Welcome to Immunon's 2023 Financial Results and Business Update Conference Call. During today's call, management will be making forward-looking statements regarding Immunon's expectations and projections about future events. In general, forward-looking statements can be identified by words such as expects, anticipates, believes, or other similar expressions. These statements are based on current expectations and are subject to a number of risks and uncertainties, including those set forth in the company's periodic filings with the Securities and Exchange Commission. No forward-looking statements can be guaranteed, and actual results may differ materially from such statements. I also caution that the 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, Immunon's Executive Chairman. Michael?
spk04: 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 Sebastian Hazard, our Chief Medical Officer. Dr. Hazard will speak about Immunon 001, or IL-12 immunotherapy and its anticipated place in the treatment of advanced ovarian cancer. In addition, Dr. Krishid Anwar, our Chief Science Officer, who joins us from the Hudson Alpha Institute in Huntsville, Alabama, where our research center is. 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 Corinne Le Goff earlier this month to pursue other business opportunities. 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 two key technology platforms, that's TheraPlas and Placine. We remain on track to complete our Phase 2 Ovation 2 study with Immunon 001, which is based on the TheraPlas platform, and to initiate our Phase 1 study of Immunon 101, our seasonal COVID-19 vaccine concept, based on our Placine technology. Our strategy for the development of these product platforms remains unchanged as well. 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. Hazard 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 one study in the second quarter of this year. And we're ready to go. We have two sites identified. The two 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. The biological safety committees at both institutions have approved the protocol. Our contracts are in place or 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 Dr. Hazard. Sebastian?
spk03: Thank you very much, Michael. Hello, everyone. Before I discuss our vision for OO1, 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. Ovation 2 is a randomized study evaluating OO1 for the perioperative treatment of newly diagnosed advanced ovarian cancer patients. It's 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 a delay in disease progression or death in the treatment arm of more than three months. And 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, for the first time, data on a subset of patients treated with PARP inhibitors. When we began Ovation 2 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 suggests an even larger clinical benefit. In this subgroup, the median progression for survival was 23.7 months in the arm with 001 versus 15.7 months in the control arm or eight months longer. In addition, the median overall survival in the control arm was 45.6 months and not reached in the 001 arm. Although these data from a small number of patients, they are intriguing. Safety analysis continue to show good tolerability of 001 in this setting. So, here are our thoughts on this program right now. We think we may very well have in our hands the first immunotherapy effective for 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 1 study. So far, the clinical data with O1 from Ovation 1 to the preliminary data of Ovation 2 confirm We believe that the positioning of OO1 in the perioperative treatment of ovarian cancer patients is very important. In addition to 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 microenvironment. Assuming enough maturity on 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 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 OO1 has also shown synergistic efficacy in preclinical experiments. And the ongoing Phase 2 study done with Breakthrough Cancer Foundation will provide safety data on the combination. This is important as it may allow OO1 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. 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. This study is evaluating one in combination with Bevacizumab or Avastin, It is expected to involve 50 patients in stage 3-4 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 second-loop laparoscopy, and the secondary endpoint is progression-free survival. Initial second look laparoscopy data are expected within a year following completion of enrollment, and final PFS data are expected approximately three 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 neuroadjuvant 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.
spk04: Thank you, Sebastian. And I just want to say for the record, Dr. Hazard 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. Thank you. Thank you, Sebastian. So I want to talk a little bit more about 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 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 is provided by the mRNA vaccine platforms. So with that, I'm not the expert here, so Dr. 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?
spk01: 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-12, 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. 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-12 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. The DNA, 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 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.
spk04: Thank you, Krishi. Dr. 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 DNA plasmid that promotes the expression of pathogen antigens delivered in our proprietary non-viral synthetic delivery system that Dr. Anwar just spoke about. We're delighted to report that the filing of an NDA for a one-on-one with the FDA. 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, uh, which we are hopeful will be, uh, will be quite soon. Uh, the dialogue, uh, between Dr. Hazard and the agency has been robust. Our responses to their question 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 response. Durability, a key characteristic. The second objectives are to evaluate the ability of immunon 101 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. 101 for this study has been designed to protect against 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 preclinical data on the attributes of this vaccine. Most importantly, immunogenicity and better protection than 95%. 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 the viral or other DNA vaccines or protein vaccines. Placine vaccines have the advantage in T cell responses, safety, delivery compliance, or manufacturing flexibility. So I'm going to turn back to you, Dr. Anwar. Why are we so confident about the stability of our product? Can you give us a little bit of a contrast and compare with messenger RNA?
spk01: Yeah, 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. 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 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 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. So imagine that pharmacy nurses take it out or delivery people, they don't have to worry about discarding it after a couple of hours 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 and storage.
spk04: Thank you, Krishit. Again, Krishit used 37 degrees centigrade And I was talking about 90 degrees Fahrenheit, 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, particularly in some of the more demanding third world countries. Again, Dr. Onwar will be available for questions at the end of our prepared remarks. Following the phase one study and assuming 101 performs as expected, and we have no reason to believe it won't, we'll look to partner off 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? Thank you, Michael.
spk05: Details of Immunon'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. Immunon 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, results 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. Immunon reported a net loss for 2023 of $19.5 million, $2.16 per share. And this compares with the net loss of $35.9 million, or $5.03 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 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 Plastine 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 completion of enrollment, as Dr. 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. Costs associated with the Phase III Optimus 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. This $4 million 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 Thermadox. Lower costs for DNO 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. That compares to other non-operating expenses in 2022 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 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 SBB 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. I think more importantly, the big driver in last year's non-operating expense was in primer charge of $13.4 million that we took in writing off some in-process assets or in-process R&D assets and 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 And then 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.
spk04: Thank you, Jeff. 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 programs. In testing 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. 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 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, 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, open up the call to your questions. Operator?
spk07: 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. If at any time your question has been addressed and you would like to withdraw your question, please press star and then two. Our first question comes from James Molloy with Alliance Global Partners. Please go ahead.
spk04: James Molloy Good morning, James.
spk02: Hello, this is actually Laura Suriel on for Jim. Thank you for taking our question. For the phase one-two 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?
spk04: I'm going to start by answering that question and maybe I can turn the balance over to Dr. Hazard. So, you know, this is a very important study. It's hypothesis generating in many ways the The primary endpoint is one of great interest to the individual researchers who are associated with the program. Evaluating the extent to which 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, 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, Yeah, Dana Farber. Yeah. So we have two institutions now enrolling. Two more institutions will be joining the study quite soon. I think we have a number of patients on trial. Yeah.
spk03: Sebastian? Yes, we have four patients on trial. And based on the first site open at 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. 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 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 a phase three study, the safety data on the combination will be very useful.
spk04: 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.
spk02: Got it. Thank you for the clarity. And then also in regards to your Plexine 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?
spk04: You know, I think, well, we haven't arrived at any partnerships specifically yet. 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. I mean, Immunon is new to this vaccine environment. Our technology is novel. 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. I don't know if we've talked too much about this, but, you know, pandemics, whether they're organic or otherwise, I mean, they have the potential to compromise not only patients but economies and even governments, you know. 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, again, once we have some preliminary clinical data, I expect to mature.
spk02: Understood. Thank you for taking the question.
spk04: Thank you.
spk07: The next question comes from David Boz with Zacks Small Cap. Please go ahead.
spk06: 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. I'm curious in regards to actually both programs going on, 001 and Placine. Are you measuring for 001, are you measuring 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 in the healthy volunteers in that phase one study?
spk04: Oh, that's a great question. And Dr. Anwar, Krishit, are you still on the line?
spk01: Yes, I am, Michael. So, David, that's a good question. For IL-12, We have, in previous clinical trials, major IL-12 after the repeated administration of the product, as you may recall. One is given once every week for several weeks. So we have, in multiple studies, examined IL-12 levels after the treatment and 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 if the mRNA for spike antigen is produced. But characterization of protein size on a Western blot, we have done that as well.
spk06: Is the FDA going to require you to look at the level, say, of expression of the spike protein in the study? No.
spk01: In human clinical trials, no, it's not required. FDA does not require that you to measure the protein spike levels, and that has been pretty consistent in the literature. I mean, other trials as well, 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 trials.
spk06: Okay, great. So switching gears a little bit, I'm sure you saw the news this morning about Gilead, their partnership for an IL-12 asset. I'm just kind of curious, If you've seen any interest in one, we're partnering discussions how those are going for that product.
spk03: Look, I mean, as you know, we are on the verge of having our phase two data with this asset. We have already 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 develop partnerships on this asset.
spk04: I don't understand what 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.
spk06: Okay. And then lastly, for the 001 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 up in the middle of this year. I know you've discussed kind of the studies set up to show a 33% increase in PFS, but I guess Is there kind of a go, no-go level? What should we be expecting there?
spk04: I'm going to start this conversation, and maybe Dr. Hazard can jump in. During the course of this trial, we've seen an evolution of 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. 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 the design of the trial. So the ITT population, we still believe a 33 percent improvement, 80 percent 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. And so we're not particularly stratified to do the kind of typical analysis, but You know, 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, to see if there's a subgroup here that would make sense to include in a larger, you know, pre-specify it to include in a larger 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 month improvement in PFS is clinically relevant. Whether or not that's an 85, 86, 87 percent 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. immunotherapies, for the most part, have a much better OS benefit than is indicated by PFS. So 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. You think I got that, Doctor? Yes, absolutely. 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, 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 understanding 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.
spk06: Okay. Sounds good. Appreciate you taking the questions this morning.
spk04: Thank you.
spk07: The next question comes from Kemp Dolliver with Brookline Capital Markets. Please go ahead.
spk08: Morning, Kemp. Good morning. Thank you for taking my questions. First, just for clarification, you mentioned the two sites for 101. One was Beth Israel. And the second site in Philadelphia is which institution?
spk04: 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. They are geared specifically to bring patients, healthy patients, in to a study like this to, you know, administer the vaccine and for follow-up. I mean, if you're curious of them, you could find them online. A well-regarded, high-quality company. clinical research-focused institution and recommended to us, by the way, by the Israel people.
spk08: Great. Thank you. 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 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.
spk04: Yeah, and that's a good question. You know, 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, 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 the reality of it. We will not, assuming good data, we will not delay any ongoing development of our products pending a you know, 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, I mean, important people in the government. We've had multiple conversations. Dr. Lagoff 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, 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 continuing and ongoing interest. And in this environment, it's not like the heady 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.
spk08: Great. Thank you. Thank you.
spk07: This concludes our question and answer session. I would like to turn the conference back over to Michael Tardano for any closing remarks.
spk04: 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 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 study for O01, for example, we are showing the potential in the technologies. We know these technologies. This O01, 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, 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. 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. 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.
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