Earnings Call Transcript - IMNN Q4 2023

Operator, Operator

Good morning. My name is Dave, and I will be your operator today. At this time I would like to welcome you to Imunon 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. I would now like to turn the call over to Kim Golodetz. Please go ahead.

Kim Golodetz, LHA

Thank you and good morning everyone. This is Kim Golodetz with LHA. Welcome to Imunon's 2023 financial results and business update conference call. During today's call, management will be making forward-looking statements regarding Imunon's expectations and projections about future events. In general, forward-looking statements can be identified by words such as expect, anticipate, believe, 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. Imunon undertakes no obligation to revise or update comments made during this call except as required by law. With that said, I would like to turn the call over to Michael Tardugno, Imunon’s Executive Chairman. Michael?

Michael Tardugno, Executive Chairman

Thank you, Kim. Good morning, everyone. It's a pleasure to be here with you all. With me today are Jeffrey Church, our Chief Financial Officer, and Sebastien Hazard, our Chief Medical Officer. Dr. Hazard will discuss Imunon-001, IL-12 immunotherapy, and its expected role in treating advanced ovarian cancer. Also joining us is Dr. Kursheed Anwer, our Chief Science Officer, who is with us from the HudsonAlpha Institute in Huntsville, Alabama, where our research center is located. Dr. Anwer will be available for questions during the Q&A session following our prepared remarks. First, I want to acknowledge the recent departure of Corinne Le Goff, who has left to pursue other business opportunities. We wish her all the best and appreciate her leadership and contributions to Imunon during her time with us. I want to assure you that her departure will not affect our growth plans, and we are fully committed to advancing our two main technology platforms, TheraPlas and PlaCCine. We are on track to complete our Phase 2 OVATION 2 study with IMNN-001, which utilizes the TheraPlas platform, and to start our Phase 1 study of IMNN-001, our seasonal COVID-19 vaccine concept based on our PlaCCine technology. Our strategy for developing these product platforms remains unchanged. From the OVATION 2 study, we expect to report top-line data in mid-2024. Based on our interim data and initial discussions with the FDA, Dr. Hazard will soon draft the protocol for the Phase 3 study, which he will discuss shortly. Additionally, this past month, we submitted an IND application to the FDA for 101. Once accepted, we plan to begin enrolling patients in this Phase 1 study in the second quarter of this year. We have identified two sites for this study: Beth Israel in Boston and DM Clinical Research in Philadelphia. Both institutions have submitted our protocol to the IRB for conditional approval pending FDA acceptance. The biological safety committees at both sites have approved the protocol, and our contracts are either finalized or in progress. We are prepared to move forward and eagerly await the agency's response to the IND submission. I will share more about the vaccine program later, but for now, I would like to turn the call over to Dr. Hazard. Sebastien?

Sebastien Hazard, Chief Medical Officer

Thank you very much, Michael. Hello, everyone. Before I discuss our vision for 001, I want to review some of the interim data we generated and share some considerations on what a pivotal trial could look like should the Phase 2 data hold up. As you know, 001 is our DNA-based IL-12 immunotherapy. OVATION 2 is a randomized study evaluating 001 for the perioperative treatment of newly diagnosed, advanced ovarian cancer patients. It's being tested in combination with standard-of-care chemotherapy. On September 22, we reached full enrollment of 113 patients, and a year later, 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 show a delay in disease progression or death in the treatment arm for more than three months. Preliminary overall survival data followed a similar trend, showing an approximate nine-month improvement in the treatment arm over the control arm. This data, particularly overall survival, still needs to mature to confirm this robust efficacy signal. We also reported, for the first time, data on a subset of patients treated with PARP inhibitors. When we began the OVATION 2 study, PARP inhibitors were not yet part of the first-line maintenance treatment in ovarian cancer. 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-free survival was 23.7 months in the arm with 001 versus 15.7 months in the control arm, an eight-month difference. In addition, the median overall survival in the control arm was 45.6 months and has not been reached in the 001 arm. Although these data are from a small number of patients, they are intriguing. Safety analyses continue to show good tolerability of 001 in this setting. So here are our thoughts on this program right now. We believe we may 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 1 study. So far, the clinical data with 001, from OVATION 1 to the preliminary data of OVATION 2, confirm 001’s activity. We believe that the positioning of 001 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 locally administered immunotherapy can have the most impact by harnessing the local immune system in the tumor microenvironment. Assuming enough maturity on the progression-free survival data around midyear and similar efficacy results, the next step is to submit 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 approximately 50% of the patients. And these patients were excluded from OVATION 2. The combination of bevacizumab and 001 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 001 to offer even more clinical benefit in synergy with this treatment, and 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 the focus on the tumor with homologous recombinant deficiencies, or HRD, where patients are the most likely to be exposed to a PARP inhibitor in maintenance. We may introduce in the study design the possibility to test 001 efficacy in this subpopulation, representing around 40% of the newly diagnosed ovarian cancer patients. Now, enrollment in our second Phase 2 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. In the first quarter of ‘24, we announced that Memorial Sloan Kettering has joined the study. This study is evaluating 001 in combination with bevacizumab or Avastin. It is expected to enroll 50 patients in Stage 3/4 ovarian cancer at several sites. Initially, this randomized study will confirm the safety of the combination of 001 with bevacizumab and later provide proof-of-concept for this combination. The trial's primary endpoint is detection of minimal residual disease by second-look 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 progression-free survival data are expected approximately three years after enrollment completion. This trial will include translational endpoints to better understand the impact of 001 combined with bevacizumab on the tumor microenvironment and assess other methods like ctDNA to measure minimal residual disease. An important trial to better understand the somewhat under-evaluated neoadjuvant 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.

Michael Tardugno, Executive Chairman

Thank you, Sebastien. 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, and regulatory affairs that's beginning to show a great deal of promise. We’re 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, Sebastien. 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 IMNN-001, 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. Anwer, you're on the line. Could you tell us a little bit more about the mechanism and our experience so far with this durability characteristic?

Kursheed Anwer, Chief Science Officer

Sure, Michael. This is Kursheed. As you mentioned, the durability of an agent, whether it's a therapeutic or a vaccine, is a crucial characteristic of a drug. For oncology drugs like IL-12, maintaining a consistent local level at the tumor site is essential to effectively target the tumor, which relies on the drug's stability after injection and its persistence after entering cells. The same applies to vaccines, although in that case, the product is a pathogen antigen. To address your question, our approach to achieving durable expression of a therapeutic molecule in our IL-12 product or a pathogen antigen in our vaccine product focuses on addressing bioavailability and persistence challenges. The first mechanism we employ for enhancing product stability post-administration is our proprietary delivery system, which protects the DNA from degradation, resulting in higher bioavailability. Additionally, DNA has a longer residence time in the cell compared to proteins or mRNA, allowing for extended production of the protein antigen or therapeutics. In summary, our strategy for durability, whether in a therapeutic or a vaccine context, hinges on improving bioavailability through the delivery system and ensuring longer cell residence time with the use of DNA. These two key elements are fundamental to our mechanism.

Michael Tardugno, Executive Chairman

Thank you, Kursheed. Dr. Anwer will be on the line to answer questions at the end of our prepared remarks. So now let's continue our discussion of PlaCCine, our proprietary vaccine based on DNA plasmid that promotes the expression of pathogen antigens delivered in our proprietary non-viral synthetic delivery system that Dr. Anwer just spoke about. We're delighted to report that the filing of an NDA for 101 with the FDA is in progress. We are proposing a Phase 1 clinical trial as a seasonal COVID-19 booster vaccine. This 24-subject proof-of-concept study is expected to begin enrollment in the second quarter of 2024 following acceptance by the FDA, which we are hopeful will be quite soon. The dialogue between Dr. Hazard and the agency has been robust. Responses to their questions have been very timely, so things are moving quite well. The primary objective of this study in healthy adults is to evaluate the vaccine's safety, tolerability, and neutralizing antibody response. We'll also evaluate the durability of response, a key characteristic. The second objectives are to evaluate the ability of IMNN-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 the Omicron XBB1.5 variant of SARS-CoV-2 in accordance with the FDA's guidance published in June 2023. As you may recall, we've generated some compelling preclinical data on the attributes of this vaccine. Most importantly, immunogenicity shows better protection than 95%. We also demonstrated superior shelf life at 12 months at refrigerated temperatures and at least one month at 90 degrees Fahrenheit from body temperature. These characteristics suggest superior commercial handling and distribution properties compared with the more fragile messenger RNA vaccines, as well as greater manufacturing flexibility compared with viral or other DNA vaccines or protein vaccines. PlaCCine vaccines have the advantage in T cell responses, safety, delivery compliance, and manufacturing flexibility. So I'm going to turn back to you, Dr. Anwer. 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?

Kursheed Anwer, Chief Science Officer

Yes, sure. I mean, we all know that the mRNA vaccines came out with very strict storage conditions requirements, actually at minus 70 degrees Celsius. You have to keep it there in pharmacies during transportation. So, relative to mRNA, the DNA is more stable, and it could last at working temperature. There's refrigerated temperature, which almost every pharmacy has for a very long period, because it's more stable than mRNA. 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 us confident in the distinguishing feature of our vaccine over mRNA in terms of temperature stability. And actually, even at 37 degrees C, 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 temperature 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.

Michael Tardugno, Executive Chairman

Thank you, Kursheed. Again, Kursheed 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. Anwer will be available for questions at the end of our prepared remarks. Following the Phase 1 study, 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 government and 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?

Jeffrey Church, Chief Financial Officer

Thank you, Michael. Details of Imunon’s 2023 financial results are included in the press release we issued this morning and in our Form 10-K, which we filed before the market opened. Imunon ended the year with $15.7 million in cash and investments. 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, resulting 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. Imunon reported a net loss for 2023 of $19.5 million, or $2.16 per share. 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. R&D costs associated with the development of 001 to support the OVATION 2 study, as well as the development of the PlaCCine DNA vaccine technology platform, were $6 million in 2023, compared to $6.1 million for 2022. Costs associated with the OVATION 2 study, the clinical development costs, were $1.2 million this year, down from $1.5 million in the prior year. This decline was due to the completion of enrollment, as Dr. Hazard indicated in September of 2022. Our CMC costs, manufacturing costs, increased from $1.2 million for 2022 to $2.2 million for 2023 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 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 down to $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, and 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 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 $0.5 million 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 a 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. Lastly, 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 through the 2024 time period. With that financial review, I'll now turn the call back to Michael.

Michael Tardugno, Executive Chairman

Thank you, Jeff. As always, we had a lively discussion about our financials. As you know, we filed an S1 in January of this year to raise capital for our ongoing research programs. While testing the market, Imunon, like almost all other non-revenue micro-cap biotechs, encountered terms that we found unacceptable and unfair to our shareholders. Therefore, we decided to postpone financing until market conditions become more favorable. However, this decision comes with a strategy. We have taken vital steps to implement a cash conservation program, which includes deferring some non-essential programs and reducing our workforce. Our aim is to ensure we have sufficient cash to get us through the milestone readouts of our two clinical trials. I believe you will agree that we have been and continue to act in the best interests of our shareholders, employees, and our commitment to medical research. In closing my prepared remarks, I want to stress that your company has a strong and capable management team focused on leveraging the power of the immune system. Our goal is to deliver more effective and lasting immunity for millions facing cancer or infectious diseases, while also creating substantial value for our shareholders in a workplace our employees can be proud of. Now, I will open the call to your questions, operator.

Operator, Operator

We will now begin the question-and-answer session. Our first question comes from James Molloy with Alliance Global Partners. Please go ahead.

Michael Tardugno, Executive Chairman

Good morning, James.

Laura Suriel, Analyst

Hello, this is actually Laura Suriel on for Jim. Thank you for taking our questions. For the Phase 1/2 trial that you're conducting for 001 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?

Michael Tardugno, Executive Chairman

I'm going to start by answering that question and maybe I can turn the balance over to Dr. Hazard. 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 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, could change the course of treatment for patients. Using our product candidate in combination with the vast, and under the watchful control of some of the premier institutions in the country, including MD Anderson, Johns Hopkins, Memorial Sloan Kettering, Harvard, and Dana-Farber. 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. Yes, Sebastian?

Sebastien Hazard, Chief Medical Officer

Yes, we have four patients on trial. And based on the first site open, MD Anderson, as I mentioned, we have a second one just opened, and we expect two more, one being Johns Hopkins and the second one being Oklahoma University. Based on these four large sites, we expect that enrollment will pick up. The point I would like to make is that 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 the Phase 3 study, the safety data on the combination will be very useful.

Michael Tardugno, Executive Chairman

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 and 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.

Laura Suriel, Analyst

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

Michael Tardugno, Executive Chairman

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, Imunon 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, the most exciting potential collaborators are some of the agencies of the government. But I don't know if we've talked too much about this, but pandemics, whether they're organic or otherwise, have the potential to compromise not only patients but economies and even governments. So the idea that having an effective means to quickly respond with a potent vaccine to 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.

Laura Suriel, Analyst

Understood. Thank you for taking the question.

Michael Tardugno, Executive Chairman

Thank you.

David Bautz, Analyst

Hey, good morning, everyone. And thanks for the update this morning. So I want to start it off with, keying off your discussion of durability from earlier in the call. I'm curious regarding both programs going on 001 and PlaCCine. 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 1 study?

Michael Tardugno, Executive Chairman

Oh, that's a great question. Dr. Anwer Kursheed, are you still on the line?

Kursheed Anwer, Chief Science Officer

Yes, I am, Michael. So, David, that's a good question. For IL-12, we have measured IL-12 after the repeated administration of the product in previous clinical trials. As you may recall, 001 is given once every week for several weeks. So we have examined IL-12 levels after the treatment and quantified that increases over baseline. With respect to the spike protein, we have done Western blot analysis in animal models to ensure that the protein is of the proper molecular weight, but most of our quantification is mRNA-based to see if the mRNA for spike antigen is produced. However, we have done characterization of protein size on Western blot as well.

David Bautz, Analyst

Is the FDA going to require you to look at the levels, say, of expression of the spike protein in the study, or is that not something that they're interested in?

Kursheed Anwer, Chief Science Officer

No, in human clinical trials, it's not required. The FDA does not require that you measure the protein spike levels, and that has been consistent in the literature. 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.

David Bautz, Analyst

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 001 or partnership discussions, how those are going for that product?

Sebastien Hazard, Chief Medical Officer

Look, I mean, as you know, we are on the verge of having our Phase 2 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, it is a possibility that we develop partnerships on this asset.

Michael Tardugno, Executive Chairman

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.

David Bautz, Analyst

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 the setup for showing a 33% increase in PFS, but I guess, is there a go/no-go level? What should we be expecting there?

Michael Tardugno, Executive Chairman

Yes, 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, especially ovarian cancer patients. So when we started the trial, the data was not yet in from the Avastin program, so Avastin was not included as one of the treatment options for newly diagnosed patients. Subsequent to the Avastin approval, we've seen 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. The intent-to-treat population, we still believe, a 33% improvement, 80% power to show that improvement is an important milestone to achieve or get very close. Some of our assumptions to achieve that objective have changed with the addition of patients in our study, who have entered maintenance programs with these recently approved drugs. We're not particularly stratified to do a typical analysis, but we think we have every right and reason to look at the data, parse it out a little more specifically to see, as Dr. Hazard alluded to, if there's a subgroup that would make sense to include in a larger, pre-specified study. However, the response from the medical community is a three to four month improvement in PFS is clinically relevant. Whether or not that's an 85%, 86%, or 87% hazard ratio is probably not the material issue. The last point I'll make is that immunotherapies for the most part have a much better overall survival benefit than is indicated by PFS. With that knowledge, we feel very comfortable looking holistically at the data coming from this trial to make decisions that reduce the risk of failure and construct a Phase 3 study going forward. Did I capture that, Dr. Hazard?

Sebastien Hazard, Chief Medical Officer

Yes, absolutely. I have nothing else to add to this.

Michael Tardugno, Executive Chairman

We are genuinely enthusiastic about the data we have observed so far. As we consider this new treatment in patients who have just been diagnosed, along with a changing standard of care, we have more opportunity to analyze the data in some appropriate, albeit typically unconventional ways.

David Bautz, Analyst

Okay, sounds good. Appreciate you taking the questions this morning.

Michael Tardugno, Executive Chairman

Thank you.

Kemp Dolliver, Analyst

Good morning, and 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?

Michael Tardugno, Executive Chairman

This is an institution that's primarily set up to evaluate vaccine programs. It's DM Clinical Research in Philadelphia, and it's been relied upon by all of the major vaccine companies for enrollment. They are geared specifically to bring healthy patients into a study like this to administer the vaccine and for follow-up. If you're curious about them, you could find them online; they are a well-regarded, high-quality clinical research-focused institution, and they were recommended to us by the people at Beth Israel.

Kemp Dolliver, Analyst

Great, thank you. The second question relates to your commentary around partnering and particularly with the government. 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 who could move faster once you have data everyone can evaluate?

Michael Tardugno, Executive Chairman

Yes, that's a good question. I usually don't factor in the government when thinking about product development, despite them being a significant consumer, because the decision-making process is slow and often influenced by a network of established connections. I apologize for stating it that way, but that's the reality. We will not delay any ongoing product development due to pending financing or government interest, assuming we have good data. I believe good data will attract interest from major companies. We've had several discussions with key government figures, and Dr. Le Goff particularly sees this opportunity with the government as compelling, which I fully agree with. Meanwhile, the platform is also relevant for other vaccine-focused pharmaceutical companies. I hope we can attract interest from the investment community by showcasing the unique and powerful traits of this vaccine, which offers better long-term protection. I think big pharma, as they've indicated, will be interested in our Targeted Product Profile, which has been generating ongoing interest. The current environment may not be as exuberant as in previous years, but there is more patience for a wait-and-see approach. Therefore, we hope to gain support from the investment community as we proceed. If we're right, I believe we will deliver significant returns for our investors.

Kemp Dolliver, Analyst

Great. Thank you.

Michael Tardugno, Executive Chairman

Thank you.

Operator, 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, Executive Chairman

First, let me thank everyone for joining us. I don't think we could be in a better position. Your company on the fundamentals has made 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 complement of intellectual talent that's important to our success. We believe in our proprietary technologies on a preliminary basis, in preclinical studies, and in early Phase 1 study for 001, for example; we are showing the potential that we know these technologies work in stimulating, recruiting, let me say, the entirety of the immune system. Our technologies hold excellent promise in immuno-oncology and the potential as a next-generation protection against virulent pathogens. Our work is providing options to women with ovarian cancer and the general public's exposure to potential pandemics progresses. I hope you can see, as we have indicated to you, we are progressing quite well. We're focused on ensuring our cash is being used efficiently. Jeff Church will, with his sharp pencil, make sure of that. We remain excited about reporting data from our clinical trials in the coming months. So again, thank you for your attendance. We look forward to keeping you informed of our progress and wish you a very nice afternoon, and for those celebrating the holiday weekend, a great and wonderful holiday weekend. That concludes our remarks, operator.

Operator, Operator

The conference is now concluded. You may disconnect.