Imunon (IMNN) provided a comprehensive update on its financial status and clinical trial advancements during its 2023 earnings call. The biotech company is moving forward with its Phase 2 OVATION 2 study for IMNN-001, an immunotherapy for advanced ovarian cancer, and is preparing for a Phase 3 study.
A Phase 1 study for IMNN-001 as a COVID-19 vaccine is also planned. Imunon has filed an NDA for a PlaCCine vaccine and expects to begin Phase 1 trial enrollment in Q2 2024. Financially, the company reported a reduced net loss of $19.5 million for 2023 and ended the year with $15.7 million in cash and investments, implementing a cash conservation strategy amid challenging market conditions.
Key Takeaways
- Imunon is advancing its TheraPlas and PlaCCine technology platforms.
- Phase 2 OVATION 2 study for IMNN-001 is on track, with a Phase 3 study in preparation.
- A Phase 1 study for IMNN-001 as a COVID-19 vaccine is planned for Q2 2024.
- An NDA for the PlaCCine vaccine has been filed, with superior durability expected compared to mRNA vaccines.
- The company reported a net loss of $19.5 million for 2023, with $15.7 million in cash and investments.
- Imunon has implemented a cash conservation program, deferring financing and reducing headcount.
Company Outlook
- Imunon is preparing for the top-line data report for OVATION 2 in mid-2024.
- The company is confident in the efficacy and durability of its technology platforms.
Bearish Highlights
- Imunon reported a substantial net loss, although reduced from the previous year.
- The company is deferring financing due to unfavorable market conditions.
Bullish Highlights
- The PlaCCine vaccine demonstrates stability and ease of distribution, especially beneficial for developing countries.
- Imunon is exploring potential partnerships with government agencies for its vaccine candidates.
Misses
- The company has had to implement a cash conservation program, including reducing headcount and deferring non-essential programs.
Q&A Highlights
- Imunon expects to complete patient enrollment for its Phase 1/2 trial for 001 in combination with Avastin by the end of next year.
- The company is aiming for a 33% improvement in progression-free survival in the 001 study.
- Discussions with government figures are ongoing, and the company is optimistic about the potential for government partnerships.
- Imunon is not delaying development for government financing or interest and is confident that good data will attract larger pharmaceutical companies.
Imunon's earnings call highlighted both the progress and challenges faced by the biotech company. With clinical trials moving forward and a focus on cash conservation, Imunon is navigating the complexities of biotech development and finance. The company's advancements in its technology platforms and the potential for partnerships offer a glimpse into its strategic direction for the coming years.
InvestingPro Insights
Imunon (IMNN) presents a mixed financial landscape as it progresses through crucial phases of clinical trials and vaccine development. With a market capitalization of $15.42 million and an adjusted P/E ratio of -0.8 for the last twelve months as of Q4 2023, the company's valuation reflects the challenges typical of the biotech sector, where profitability is often long-term and contingent on the success of product development.
The stock's recent performance has been notably strong, with a one-week total return of 82.24% and a three-month total return of 141.18%. This surge in stock price may be related to optimism surrounding their clinical trials and technological advancements. However, it's important to consider that the company's RSI suggests the stock is in overbought territory, which could indicate a potential pullback in the near future. Additionally, analysts do not anticipate the company will be profitable this year, emphasizing the speculative nature of investing in IMNN.
InvestingPro Tips for Imunon also highlight that the company holds more cash than debt on its balance sheet, which is a positive sign for financial stability. This could provide some reassurance to investors concerned about the company's ability to fund its ongoing trials. On the downside, Imunon is quickly burning through cash, which is a common occurrence in the biotech industry due to the high costs of research and development.
For investors looking for more detailed analysis and additional insights, there are 16 more InvestingPro Tips available for Imunon at https://www.investing.com/pro/IMNN. Use coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription, which can provide further guidance on whether Imunon's current financial trajectory aligns with your investment strategy.
Full transcript - Celsion Corp. (NASDAQ:IMNN) Q4 2023:
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. [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 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, 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. 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: 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 then Sebastien Hazard, our Chief Medical Officer. Dr. Hazard will speak about Imunon-001, IL-12 immunotherapy and its anticipated place in the treatment of advanced ovarian cancer. In addition, Dr. Kursheed Anwer, our Chief Science Officer, who joins us from the HudsonAlpha Institute in Huntsville, Alabama, where our research center is. Dr. Anwer will be available during the Q&A session at the end of our prepared remarks. But first, I'm sure you're all aware of 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 Imunon 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 PlaCCine. We remain on track to complete our Phase 2 OVATION 2 study with IMNN-001, which is based on the TheraPlas platform, and to initiate our Phase 1 study of IMNN-001, our seasonal COVID-19 vaccine concept, based on our PlaCCine 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 1 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 and our contracts 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. Sebastien?
Sebastien Hazard: Thank you very much, Michael. Hello, everyone. Before I discuss our vision for 001, I want to review some of the interim data we 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. 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 the delay in disease progression or death in the treatment arm for 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. This data, particularly OS, still needs to mature to confirm this robust efficacy signal. We also reported, for the first time, data on a subset of patients treated with PARP inhibitors. When we began 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 patient 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 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 are 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 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 the 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 midyear and similar efficacy results, the next step is to submit a 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 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 [Technical Difficulty], 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 who are the most likely to be exposed to a PARP inhibitor in maintenance. We may introduce in the study design the possibility to test 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. And 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 allow to confirm the safety of the combination of 001 with bevacizumab and later provide proof-of-concept for this combinations. The trial's primary endpoint is detection of minimal residual disease or MRD, 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 PFS data are expected approximately three years following 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 MRD. 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: 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, and 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.
Sebastien Hazard: Thank you.
Michael Tardugno: 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. 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 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. Would you -- could you tell us a little bit more about the mechanism and our experience so far with this durability characteristic?
Kursheed Anwer: Sure, Michael. This is Kursheed, 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. Second, 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.
Michael Tardugno: 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, 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 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'll also evaluate the durability of response and durability, 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 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 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, PlaCCine vaccines have the advantage in T cell responses, safety, delivery compliance, or 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: 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 degrees. That's extreme cold temperature and the country, even developing countries, much less the under developing 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 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, you know, putting it -- discarding it after a couple of hours if its not, you know, if the temperature -- if the duration goes beyond two hours. So I think we feel confident in that sense. We have addressed that critical issue in vaccine distribution and storage.
Michael Tardugno: 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, and particularly in some of the more demanding third world countries. Again, Dr. Anwer will be available for questions at the end of our prepared remarks. Following the Phase 1 study in 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 is 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?
Jeffrey Church: Thank you, Michael. Details of Imunon’s 2023 financial results are included in the press release we issued this morning and in our Form 10-K, which we filed before the market opened. Imunon ended the year with $15.7 million in cash and investments. 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. Imunon 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 PlaCCine DNA vaccine technology platform, were $6 million in 2023, and that compared to up $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. Our 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 3 OPTIMA study were de minimis this year, compared to a million dollars in 2022. Our clinical and regulatory costs were $1.8 million this year, compared to $1.9 for 2022. General administrative expenses were up $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 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 (NYSE:HUD) 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, so 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 a earn-out milestone liability, because the requirements had not been achieved. And then lastly, as I mentioned earlier, we had a one-time $4.5 million interest in offering expenses resulting in 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.
Michael Tardugno: Thank you, Jeff. As always, a lively discussion of our financials. As you know, we filed an S1 in January of this year, the goal of which was to raise capital in support of our ongoing research programs. In testing the market Imunon 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 non-essential programs and reducing our headcount footprint just makes sense. So our goal is to ensure that we have cash through the just discussed milestone readouts of our 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?
Operator: We will now begin the question-and-answer session. [Operator Instructions] Our first question comes from James Molloy with Alliance Global Partners (NYSE:GLP). Please go ahead.
Michael Tardugno: Good morning, James.
Laura Suriel: Hello, this is actually Laura Suriel on for Jim. Thank you, you know, 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: 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, who are associated with the program. Evaluating the extent to which patients have been, the cancer has been eliminated from patients, has been a difficult thing to do. So this idea of second look laparoscopy to evaluate for any minimal residual disease is a proposal that if we're successful here, it could change the course of treatment of patients. So 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, Dana-Farber. 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. Yes, Sebastian?
Sebastien Hazard: Yes, we have four patients on trial. And based on the first site open MD Anderson, as I mentioned, we have a second one just opened and we expect two more, one being Johns 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 Phase 3 study, the safety data on the combination will be very useful.
Michael Tardugno: 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: Got it. Thank you for the clarity. And then also in regards to your PlaCCine and your other vaccine candidates, how may you describe the current partnership environment and maybe any of your ongoing potential partnership discussions that you might have helped?
Michael Tardugno: 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, 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 however, 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 you know, pandemics, whether they're organic or otherwise, I mean, they have the potential to compromise not only patients, but economies and even in governments. So the idea that having an effective means to be able to quickly respond with a potent vaccine to emerging -- newly emerging or viruses that are evolving in a more virulent way is a critical objective of the DoD, for example, and BARDA. So those partnerships, again, once we have some preliminary clinical data, I expect to mature.
Laura Suriel: Understood. Thank you for taking the question.
Michael Tardugno: Thank you.
Operator: The next question comes from David Bautz with Zacks Small-Cap. Please go ahead.
David Bautz: Hey, good morning, everyone. And 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 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: Oh, that's a great question. Dr. Anwer Kursheed, are you still on the line?
Kursheed Anwer: 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, 001 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.
David Bautz: 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: No, 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. You -- demonstration of the antibody response is reflective of the antigen production. So, no, it's not required to quantify the spike protein in the clinical trials.
David Bautz: Okay, great. So, switching gears a little bit, I’m sure you saw the news this morning about Gilead (NASDAQ:GILD), their partnership for an IL-12 asset. I'm just kind of curious if you've seen any interest in 001 or partnering discussions, how those are going for that product?
Sebastien Hazard: 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, this is a possibility that we develop partnerships on this asset.
Michael Tardugno: [Indiscernible] 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: 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, kind of, the studies set up to show a 33% increase in PFS, but I guess what is there, kind of, a go no-go level? What should we be expecting there?
Michael Tardugno: Yes, I'm going to start this conversation, and maybe Dr. Hazard can jump in. So, you know, during the course of this trial, we've seen an evolution of the treatment of cancer patients, ovarian cancer patients. So when we started the trial, the data was not yet in from the Avastin program, 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 (NYSE:ITT) population, we still believe, a 33% improvement, 80% power to show that improvement is an important milestone to achieve or very close. I mean, some of our assumptions to achieve that objective have changed with the addition of, 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 a -- the kind of typical analysis, but we think we have every right and reason to look at the data, parse it out a little bit more specifically to see, as 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 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. 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 3 study going forward. Do you think I got that, Dr. Hazard?
Sebastien Hazard: Yes, absolutely. I have nothing else to add to this.
Michael Tardugno: 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 patients with a standard-of-care that -- an evolving standard-of-care. So that gives us a little bit more, I don't want to call it uncertainty, but a little bit more opportunity to evaluate the data in some, I think, some appropriate, but typically non-standard ways.
David Bautz: Okay, sounds good. Appreciate you taking the questions this morning.
Michael Tardugno: Thank you.
Operator: The next question comes from Kemp Dolliver with Brookline Capital Markets. Please go ahead.
Michael Tardugno: Good morning, Kemp.
Kemp Dolliver: 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?
Michael Tardugno: 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, into a study like this to, you know, administer the vaccine and for follow-up. I mean, they're -- I mean, if you're curious of them, you could find them online, a well-regarded high-quality 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 what is the state of your -- of that part of the process? Because BARDA and DoD can move very slowly and presumably you would have other potential partners involved, who would be in a position to move faster once you have data that everyone can evaluate?
Michael Tardugno: Yes, and that's a good question. I typically don't include the government in any kind of my thinking about development of products, even though they are the biggest consumer in many ways, because of, just as you pointed out, I mean, the decision process is low and there's always this competitive development 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 financing or interest from the government. Although my expectation is that good data will bring in interest from the big guys. We've had multiple, I mean important people in the government, we've had multiple conversations. Dr. Le Goff especially found this opportunity with the government to be very compelling. I agree with her completely. But in the meantime, the platform makes sense for other vaccine-focused pharma companies. And as well, I hope for the investment community, I mean, if we can demonstrate the kind of superiority, the kind of characteristics that make this vaccine not only unique, but at least as potent with a stronger capability to provide protection over time. I would suspect that pharma will be -- as they have said, in our, you know, we have a TPP that’s a 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 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 our 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 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 in preclinical studies. And in early Phase 1 study for 001, for example, we are showing the potential that in the technologies, we know these technologies, this 001, for example, we know it works in stimulating, recruiting, let me say the entirety of the immune system. So our technologies hold excellent promise in immuno-oncology and the potential as a next generation protection against virulent pathogens. Our work in providing options to women with ovarian cancer, and the general public's exposure to potential pandemics progresses. 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 in our progress and wish you a very nice afternoon and for those celebrating the holiday weekend, a great and wonderful holiday weekend. And that concludes our remarks, operator.
Operator: The conference is now concluded. You may disconnect.
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