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spk04: Good morning and welcome to CELCION's second quarter 2022 earnings call. My name is Christina and I will be your operator today. At this time, I would like to remind everyone that this call is being recorded. I would now turn the call over to Monique Cossie of LifeSciAdvisors. Please go ahead.
spk08: Thank you, operator, and good morning, everyone. Welcome to CELCION's Second Quarter 2022 Earnings Call.
spk07: Earlier today, Celsion issued a press release announcing financial results for the second quarter ended June 30, 2022. You may access that release on the company's website under the News and Investors tab. With us today are Michael Tarduno, Executive Chairman of the Board of CELCION, Corinne Lagoff, President and Chief Executive Officer, and members of CELCION's Executive Management Team. Following management's prepared remarks, we will open the call for a question and answer session. During this call, management will be making forward-looking statements regarding CELCION's expectations and projections about future events. Generally, forward-looking statements can be identified by terminologies 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 statement can be guaranteed. and actual results may differ materially from such statements. In particular, there is significant uncertainty about the duration and impact of the ongoing COVID-19 pandemic, as well as the Russia-Ukraine conflict. This means results could change at any time, and the contemplated impact of these events on Celsius operations, financial results, and outlook is the best estimate based on the information for today's discussion. Also, the content of this conference call is accurate only as of the date of the live broadcast today, August 15, 2022. CELCION undertakes no obligation to revise or update comments made during this call, except as required by law. With that, I would like to now turn the call over to Michael Tarduno, Executive Chairman of the Board. Michael?
spk02: Thank you, Monique. Good morning, everyone. I'm extraordinarily pleased to be here today with Dr. Corinne Lagoff, CELCION's new president and chief executive officer. I'm also here with Jeffrey Church, our chief financial officer, Dr. Nicholas Morris, our chief medical officer, and Dr. Krishid Anwar, our chief science officer. I'd like to make a few opening remarks before handing the call over to Corinne who will be followed by Drs. Boris and Anwar for updates and by Jeffrey Church for a review of our second quarter financials. Over the past 24 months, your company has undertaken a major transformation. It's a testament to the quality and commitment of our management and our employees that literally on cue, we've been able to rapidly reposition our development focus on what many believe is the future of medicine. That's immunology and the related immuno-oncology and vaccinology areas of product development. During this short period of time, and I'd say a nanosecond in the biotech world, we have strengthened and expanded our technology platforms, strengthened and added depth to our research capabilities, and responsibly strengthened our balance sheet. With our transformational strategy now implemented, the new Celsius is on the runway well into 2025. Now showing promise with impressive technology platforms and an outstanding and committed group of employees. The capstone to all of this accomplishment was our announcement of a change in leadership last month. So without further ado, it is my great pleasure, and on behalf of the Board of Directors, and after a long and detailed search, to present to you our new Chief Executive and President, Dr. Corinne Le Goff. Corinne brings to the company an extraordinary sense of accomplishment, a stellar academic background, experience in both big pharma and biotech, and most importantly, and very important to the company, unreproachable values. We look forward to her vision, her strategy, her drive as she moves the company forward in this most exciting and transformational technology, immunology. Corinne?
spk09: Thank you very much, Michael. It is a great pleasure and a privilege for me to be talking to our investors and analysts today. I have spent all my career leading large pharmaceutical organizations, driving corporate strategy, and developing and prioritizing portfolios across many therapeutic areas, notably in oncology and immunology at companies like Roche and Amgen. Most recently, I was chief commercial officer at Moderna, where I led the deployment of commercial capabilities. My background gives me a good vantage point on Celsius recent developments in immunology and vaccines. I want to spend a few minutes to share with you why I decided to join Celsius at this present point of inflection for the company. There are three main reasons. First, it always starts with people. I am joining a savvy and senior executive team that has pivoted the company following the discontinuation last year of the Therpodocs Phase III program in liver cancer to focus on the development of a very promising plasmid DNA approach with broad applicability in immunology. In the last three weeks since I joined the company, I had a chance to meet the entire team, and I am impressed with the know-how and expertise of our scientists and with the focus, the dedication, and passion of all our employees. Second, Celsian is a platform company with a unique and very innovative plasmid DNA technology platform. I can imagine that over a long-term horizon, we will create a new category of medicines based on our plasmid DNA technology across a broad array of human diseases. We are starting in immunology and infectious diseases, and we will continue to invest to fully characterize the platform and to advance the technological frontier of Blasphemy DNA. At the same time, we will be investigating the addition of new cutting-edge modalities to increase the breadth and depth of our pipeline in immunological areas that are adjacent and complementary to our Gen 1 program. More to come on this topic in the coming quarters. Third, the company has maintained a strong balance sheet on investor-friendly terms, unique to many biotech companies today that are currently running low on cash. Celsius has an unviable cash position to pursue diligently the current development programs, and at the current forecast of spending, the company is operating one way, is projected to extend into 2025. It is a great position to be in, and Jeff will comment further on the strength of the balance sheet in a few minutes. So these are the three main criteria that convinced me that Celsius is the right place for me and has a lot of potential for growth. I now have been with the company for almost a month, and I took the time to review the programs and the key capabilities of the company. I first want to thank Michael, who has orchestrated a very smooth transition. I am very grateful for his generosity and for his keen attention to ensuring the continuity of activities currently underway. I also want to thank the entire executive team for their support. It is of course too early for me to talk about future strategic orientations, but I would like to share a few of my observations to date and put into perspective, through the lens of my extensive professional career, the potential that I foresee for our technological platform. Ahead of doing so, I want to highlight that my enthusiasm for the success of Celsius is grounded in my understanding of what it takes to develop a nucleic acid platform and in my knowledge of the clinical trends and therapeutic landscapes in immunology and vaccines. I believe that CELCION has a very differentiated DNA plasmid technology with proprietary synthetic non-viral delivery systems that are engineered for gene-based therapies, that's the TheraPlasm platform, or for the expression of multiple pathogen antigens in vaccines, and that's the Plasyn platform. Our DNA-based approach is designed to boost the immune response, and our delivery systems are being optimized to improve the stability of the plasmids, and to facilitate uptake and trafficking across cell membranes. And this is important. What this means practically is that no delivery device is needed. Our solution is therefore clearly differentiated from other DNA-based approaches, very patient-friendly, and commercially viable. The first application of the platform in immuno-oncology is very promising. Dr. Boris will share with you in a few minutes the progress of the GEN1 program in ovarian cancer. As you know, in preclinical and phase one studies, GEN1 has demonstrated proof of concept in terms of efficacy and tolerability. I have been watching this field for a long time while I was at Amgen and before at Roche. IL-12 was always seen as an ideal target for tumor immunotherapy because it is a pleiotropic cytokine that can activate both the innate and adaptive immune systems. But it was deemed undruggable because of its systemic toxicity and poor pharmacokinetics. It seems that Celsius has demonstrated a way to enlist the power of IL-12 to create a potent immune tumor macroenvironment by making the expression of IL-12 durable and local. And this is truly exciting, and I want to add that as a woman CEO, I am committed to making a difference in ovarian cancer, which remains one of the most lethal cancers. Based on the very early PFS data reported for Ovation 2, the potential for targeted therapy approach will need to be explored further. You know that women with ovarian cancer who test negative for HRD and BRCA mutations have very few options left. They are at risk for early progression, and PARP inhibitors are unlikely to work. In this population of patients, which represents about half of patients with high-grade serous ovarian cancer, demonstrating an advantage for Gen 1 would be game-changing. We will continue to monitor this subgroup, and Nick is looking at the possibility of expanding the current cohort of patients to better inform patients a registrational trial in this HRD BRCA-negative population. We are also evaluating strategic combinations therapies with Gen 1. We are planning to start a study to evaluate Gen 1 in combination with dual immune checkpoint inhibitors, Yervoy and Obdivo, in patients with recurrent or persistent ovarian cancer. Dr. Haider Mahdi from the University of Pittsburgh has done a lot of work on the modulation of the tumor environment. I talked to him last week, and he's very excited about this phase 1-2 trial, which we would like to start enrolling as early as Q1 next year. Another interesting combination possibility is with Avastin or Bevacizumab. We are looking to launch the MRD randomized phase 2 study. MRD stands for minimal residual disease or molecular residual disease. And we are looking at launching this study in patients this time with newly diagnosed advanced ovarian cancer where Avastin has shown no improvement in overall survival. We are hoping that we will be able to confirm in the clinic the benefits that Gen 1 has demonstrated in combination with Avastin in preclinical mice studies. MRD rate is potentially a very relevant and novel primary endpoint and will be determined at time of second-look laparoscopy. The surgically documented MRD rate has the potential to dramatically reduce timelines and costs for novel frontline therapies in ovarian cancer. The potential utility of MRD using ctDNA as an early point in clinical trials is included in FDA's draft guidance for early stage solid tumor drug development and will be investigated in this trial. The secondary endpoints are PFS, ORR, and surgical response. This study should be conducted in collaboration with the Breakthrough Cancer Foundation. It is designed to enroll 50 patients at four major cancer centers, MD Anderson, John Hopkins, Memorial Sloan-Kettering, and Dana-Farber. The protocol has already been approved by the FDA, and we will initiate the sites as soon as we receive our B approval. And we, of course, fully anticipate conducting the study, thanks to an equal partnership with the BTC Foundation. Switching gears to our vaccine platform. Here again, I believe in the potential of our plasmid DNA platform. because calcium synthetic polymeric DNA carrier has the potential to facilitate vaccine immunogenicity and can address the limitations that we see with mRNA vaccines. mRNA vaccines have saved countless lives and have demonstrated their superiority over traditional vaccines in this COVID-19 pandemic. But there is much more to be done. As we imagine the future of vaccines, and the looming threat of future pandemics, we need vaccines that offer durable immunogenicity against winning immunity. We need vaccines that offer broad protection to avoid playing catch-up with the latest variants, and that can be shipped and stored around the world without requiring deep-freeze temperature. Our technology might be the answer. Cursil will update you on the Placine program in COVID-19, where we are seeking to establish a proof of concept. We have very encouraging mouse challenge data that show neutralizing antibody titers at least comparable to mRNA vaccines and even greater against the Delta variants. And based on this data, we have begun immunization studies in non-human primates. We have evidence of immunogenicity. The immune response is not yet optimized, but is very informative. We now know that we have a viable program that gives us confidence that we can continue developing this program, but more work is needed. Finally, in the last month, I was also able to evaluate our capabilities, and I can see that the company has built solid foundations in all core areas of its business model, in discovery, early development, clinical development, in technical operations, and in CMC. And this is impressive for an organization of that size. Specifically, I want to point out that we are setting up in-house plasmid manufacturing capabilities that are GMP compliant so that we can meet the requirements of, let's say, clinical trials. We are obviously planning for success and we are putting our future in our own hands with the development of a cost-efficient and flexible supply chain. So I have shared with you my early views of the company, and I am sure that you can sense my enthusiasm. Celsius is in a great position, and I am thrilled to be leading the company into the next phase of growth. With that, let me turn the call over to Dr. Nicholas Boris, who will review recent progress around our Gen 1 immuno-oncology product. Nick?
spk03: Thanks very much, Corinne. You're joining CELCION at a very exciting time. Starting with our Ovation 2 study, which supplements standard chemotherapy and surgery with our Gen 1 immunotherapy in patients with newly diagnosed advanced ovarian cancer. This Phase 1-2 study will meet our initial target of enrolling 110 subjects by the end of this month. Currently, we are at 106 patients randomized from 20 centers throughout the United States and Canada. We will continue to enroll patients in order to make the data more robust. This is an important endpoint-driven study, which means that our final readout will be based on the study accumulating about 80 PFS events. In our case, an event is a patient who experiences a progression of their cancer. In these patients, progressions are typically seen around one year after being randomized. We hope that Gen 1 will prolong that considerably. At this time, about one-third of the PFS events have been reported. In newly diagnosed patients, time to cancer progression depends on genetic makeup of the patient and their cancers. Patients with a certain genetic makeup, such as a BRCA or HRD signature mutations, do very well when they are given a relatively new drug called a PARP inhibitor. However, as Corinne mentioned, only about one half of patients are eligible. Our work with Gen 1 is focused on the patients who do not get a great benefit from the PARP inhibitors. Thus far, with only 30% of the data reported, we are seeing the data favoring Gen 1. However, this is only 30% of the data and holds no statistical significance at this time. Gen 1 safety is continuously being evaluated and reported to our Data Safety Monitoring Board, and we are pleased that the patients are tolerating Gen 1 well. Most common toxicities related to Gen 1 are abdominal pain, nausea, fatigue, fever, vomiting, and diarrhea. Our next important milestones are to enroll about 130 patients in the trial, share the preliminary data with our medical advisors, which include the GOG partners, who are among the top opinion leaders in the field of gynecologic oncology. In addition to our work with GEN1 as a treatment in patients with newly diagnosed ovarian cancer, we have initiated two important collaborations with major institutions based on emerging science of immunotherapy and the role of IL-12. As Corinne has mentioned in her remarks, we are collaborating with Dr. Haider Mahdi of the University of Pittsburgh on combining GEN1 with dual-checkport inhibitors in patients with persistent or recurrent ovarian cancer. In other words, patients who failed first-line therapy. This is some very exciting science supporting this study, and we have three centers who have already committed to be a part of it. We have finalized another Phase I-II study evaluating GEN1 with Avastin. that will be executed in collaboration with several major cancer centers. The study has been approved by the FDA and we will be making an announcement in the near future on the details of the collaboration and the start date. In summary, we look forward to completing the Ovation 2 study this year and reviewing the initial findings with our advisors with the goal of moving into a registrational study. We also plan to initiate two key collaborations in combining Gen 1 with other immunotherapies to unlock Gen 1's full potential.
spk09: Thank you, Nick. Our progress with our proof of concept vaccine development program has been equally impressive. I'd like to invite Khurshid to make a few comments in this regard. Khurshid?
spk06: Thank you very much, Corinne. It is great to have you on board at these exciting times in the company. Now, regarding the vaccine program, we have been making steady progress in the development of our plasine technology that is based on a plasmid DNA vector containing multiple antigens of one or more pathogens with an optional immune modulating agent and a DNA delivery system and an adjuvant. This DNA-based multivalent vaccine that is administered without the aid of a device or a virus is potentially advantageous over current vaccines in several ways, including the breadth of immune response, flexibility of the vaccine design, durability of the immune response, shelf life, and manufacturing. In our preclinical studies, a single plasmid placine vector containing the spike antigen of SARS-CoV-2 alpha or delta variant, or a combination of alpha and delta variants, elicited strong IgG and T cell responses upon intramuscular administration. The neutralizing activity of the IgG response was verified in a pseudolentivirus cell-based assay. In a live viral challenge study in a mouse model of SARS-CoV-2, previously immunized with our alpha or Delta variant vaccine or the combination Alpha Delta variant vaccine was safe and reduced viral burden in lung tissue by over 90%, demonstrating a robust protection from the viral exposure, confirming our early results from a cell-based assay as mentioned above. The magnitude of IgG and neutralizing antibody response or T cell response to single or dual variant vaccines was comparable to a commercial mRNA vaccine. In pseudo lentivirus assay, the dual antigen vaccine was equally effective against both alpha and delta variants. However, in comparison, the commercial vaccine was less effective against the highly mutated delta variant. These results support our hypothesis that a dual variant vaccine has distinct advantages over a single variant vaccine. The durability studies in mice show the neutralizing antibody titers persist for at least five months. The study is in progress and additional time points to be collected in the future. A three-month stability study shows the neutralizing activity of Aplacene vaccine is maintained at four degrees centigrade. Additional time points for this ongoing study are being collected in future. Based on this encouraging mouse data, we have begun immunization studies in non-human primates. Immunization of sonomalgus monkeys with a single alpha variant vaccine administered as a single booster dose was safe and accompanied with IgG and neutralizing antibody responses that suggest our vaccine is working. At early time points, the IgG titers from alpha variant vaccine were lower than that of a commercial vaccine administered side by side. The NHP study is still in progress for collection of the immune response data after a second boost. In parallel, we are continuing to conduct additional optimization studies for vector design, delivery efficiency, and adjuvants are in progress in an effort to continually improve our vaccine platform. Corinne?
spk09: Thank you, Kershid, for that very thorough overview. I'd like to tell the call over to Jeff Church, who will review our second quarter financial results.
spk11: Jeff? Thank you, Corinne. Details of our second quarter 2022 financial results were included in the press release we issued this morning before the open and in our Form 10-Q, which we filed today before this call. Celsius ended the quarter with $48.1 million in cash investments and interest receivable as of June 30th, 2022. Adding to our cash position, we anticipate an additional $3.5 million from the sale of our New Jersey net operating losses in the 2022 to 2024 timeframe. In April 2022, we announced a $7 million registered direct offering, which was priced at the market with no warrant coverage. We have sufficient capital resources to fund our operations into 2025 at our current spending rate. Cash used in operations for the six months ended 2022 was $13.4 million, which compared to $7.3 million in the first six months of 2021. It is important to note that this increase was driven primarily by a one-time expenditure in the first quarter of 2022 for the following. interest expense of $4.5 million related to the sale and subsequent redemption of $30 million of Series A and B convertible redeemable preferred stock, and another $100,000 in costs related to the special meeting of shareholders held in February 2022. As discussed in our last earnings call, the special meeting of shareholders was necessary to ensure that the company had an adequate number of authorized shares to continue funding its R&D initiatives. An increase in the number of authorized shares requires a change to a company's articles of incorporation. This change requires at least 50% of total outstanding shares to vote in favor of this action. Due to recent changes in how large brokerage firms like Charles Schwab and TD Ameritrade vote discretionary shares held by them in various customer accounts, it has become extremely difficult, if not impossible, to secure this voting threshold. Many small cap largely retail stocks are facing this same issue. Excluding these one-time expenditures, cash use and operations was approximately $9 million in the first half of 2022 with projected cash utilization for the balance of 2022 estimated to be at $5 million per quarter. Let me now turn to a review of our quarterly financial results. the second quarter ended June 30, 2022, CELCION reported a net loss of $6 million compared to a net loss of $5.4 million in the comparable quarter in 2021. Operating expenses were $6.1 million for the second quarter of 2022, which represented a $900,000 or 19% increase from $5.2 million reported in 2021. Research and development expenses were $3.2 million in the second quarter of this year, a planned increase of $600,000 from the $2.6 million for the comparable period in 2021. The increase in research and development was primarily due to costs associated with the development of Gen 1 to support the Ovation 2 program, as well as preclinical development activities around our Placine DNA vaccine technology platform. which increased to $1.2 million in the second quarter of 2022 compared to $1.4 million in the same three-month period of 2021. Costs associated with the Optima study, that was our Phase III trial in primary liver cancer, were $500,000 in the second quarter, which represented expenses associated with closing out this trial, which was discontinued in the first quarter of 2021. Other clinical and regulatory costs were $1 million for both the second quarter of 2022 and 2021. General administrative expenses were $2.9 million in the second quarter of 2022, which compares to $2.6 million in the same period last year. The increase was primarily attributed to higher professional fees, largely legal fees to defend various suits filed after the announcement in July 2021. of the Optima Phase III clinical results and higher premiums for director and officer's insurance. These costs are being incurred for various opportunistic lawsuits, which we are aggressively defending and feel confident will be dismissed. Offsetting these higher expenses were lower non-cash stock compensation expense. Other non-operating expenses for the second quarter were $65,000 and this compared to $400,000 in the comparable prior year. This decrease was attributable to the payment of early termination and end-of-term charges to Horizon Technology Financial Corporation in June 2021, totaling $235,000. The company entered into a $10 million loan facility with Silicon Valley Bank in the second quarter of 2021 and used $6 million from this facility to retire all the outstanding indebtedness with Horizon, which carried a much higher interest rate. With that, I'll now turn the call back to Corinne.
spk09: Thank you, Jeff. In closing, I would like to thank everyone for joining us today, and I look forward to providing exciting updates in the quarters to come. With that, I would like now to open the call for Q&A.
spk04: If you'd like to ask a question, please signal by pressing star 1 on your telephone keypad. If you are using a speakerphone, please make sure your mute function is turned off to allow your signal to reach our equipment. Again, press star 1 to ask a question. We'll take our first question from Emily Bodner with HC Wainwright.
spk01: Hi, thanks for taking the questions and welcome to the team, Corinne. Maybe I'll start with a question for you and then I have a few follow-ups. As the new CEO, maybe discuss if you have any updated goals for the company and the pipeline, and if you plan to put more of a focus on vaccine development, given your background at Moderna. Thanks.
spk09: Well, thank you very much, Emily. Yes, so as I said, you know, for now, it's a bit too early for me to start talking about strategy and future plans for the company. But as you might have heard during my written remarks, You know, I'm very enthusiastic about the Plasmid DNA platform and what it has to offer, both in immunology and in vaccine development. So we definitely, you know, we wait for the data to turn out, obviously, both with the ovarian cancer program and the COVID-19 proof of concept program. But more to come in the next quarters for sure, Emily.
spk01: Okay, great. And then just a follow up. Could you maybe discuss this, you're going to have any other data updates on the ovation to study this year and what that might consist of. And then on the vaccine program. Obviously the major vaccine players are beginning to evaluate boosters with the newer coven variants like the Omicron variant. So maybe just talk about how you think your platform could compete with that and if you plan to evaluate newer variants in the clinic. Thanks.
spk09: Okay, yeah, thanks. These are great questions. Maybe I'll comment on the last one first on vaccines and then ask Kirshi to add to what I'm saying. On the vaccine boosters program, yes, obviously, you know, as you know, we are seeking a proof of concept with our Placid COVID-19 program. So we do not intend at the moment to compete with the mRNA vaccines that are currently marketed. But maybe, Khurshid, you want to add to what I'm saying here?
spk06: Yeah. I mean, I agree, Corinne, that this platform is for proof of concept and we're using SARS-CoV-2 for that purpose. Since reagents available, there's a regulatory path, but our intent is to develop a platform not to compete for SARS-CoV-2 vaccine. I would also like to mention a point that as you are following our vaccine program for about maybe just under two years or so, we have been talking about going after multiple variants from a single plasmid or multiple antigens. And now it's great to see that You know, the commercial players are also going after SARS strategy and hypothesis has been pretty much consistent with how the vaccine field is going. But clearly, as Corinne said, we're developing platform technology using SARS-CoV-2 and no intent to directly compete. However, down the road, if we do intend to use as a booster, you know, we don't rule that out for SARS-CoV-2.
spk09: Absolutely. Thank you, Kershid. And on your first question, Emily, I'll ask Nick to comment on the availability of new data for the Gen 1 program.
spk03: Yes, thanks very much for that question. As we mentioned in our prepared remarks, you know, we're currently collecting the data. We have about 30% of our primary endpoint data that's been collected. And our plan is to put that all together and analyze it in front of our GOG partners. And that we plan to do sometime in the fall. And once we get some direction from the partners, I think that the company may be interested in sharing that with the investors.
spk08: Okay, great. Thank you.
spk04: Let's go to our next question from Kumar Raja with Brookline Capital Markets.
spk05: Thanks for taking my questions, and congratulations, Corinne, on joining the team. So first with regard to the ovation trial, what should we expect in terms of the upper limit in terms of the number of patients that would be enrolled in the trial? Will you be stopping enrollment probably end of September or how should we think about that? And next with regard to the planned phase 1, 2 trials in combination with the checkpoint inhibitors, How should we think about sequencing there, and what are your expectations in terms of the safety profile with the combination? Thank you.
spk09: Kumar, these are two really great questions. Thank you. I'll ask Nick to answer both of them, please.
spk03: Yes, thank you again for those questions. In terms of when we hope to achieve meeting our 130 patient milestone that we're certainly setting, as I mentioned again in the prepared remarks, we hope to reach 110 by the end of this month, within the next few weeks. And depending on the enrollment rate, reaching 130, which would give us a much more robust data platform to look at, that would take perhaps another three months or so. Again, depending on the enrollment rate. Going on to your next question in regards to combining Gen 1 with immune checkpoint inhibitors. So this is a new area for Gen 1. The way this study is designed is that we're going to have a safety run-in of Gen 1 in combination with a standard dose of the checkpoint inhibitors that were found to be safe. and then we'll escalate the dosing according to the safety signals and hopefully announce a safe dose early next year after we start the trial.
spk05: Okay, and in terms of the safety profile with Avastin, what's the expectation there? Thank you.
spk03: In terms of a safety profile with Avastin, we do not anticipate any overlapping toxicities. As you know, with Avastin, you worry about blood pressure change in cardiovascular. Also, as we try to emphasize with the key advantage of Gen 1, this is a local regional applied treatment. So Avastin is IV. Gen 1 is given intrapartineally. So there's little drug-drug interaction to be anticipated. So again, we're following a very similar course as with our other studies. We're going to start off with a run-in, a safety run-in, to look at the initial patients from a DSMB point of view, establish a safe dose, and then continue the study from there.
spk05: Okay, great. Thanks so much.
spk04: And if you would like to ask a question, please press star 1 at this time. We'll take our next question from David Bouts with Small Cap Research.
spk10: Hey, good morning everyone and thanks for the update this morning. So I've got two questions about the Placine technology. For the first one, when do you anticipate the next results from the non-human primate study and what types of data should we expect at that time? And then, in addition to COVID, what other indications is the company considering for applying the Plastine technology to?
spk09: Thank you very much, David, for your question. So, I'm going to ask Kirshid to comment on both of your questions. But let me, before I let Kirshid answer, let me say a few things about the development of the platform. Obviously, we are developing the Placyn technology as a platform. COVID-19 is a proof of concept. So, you know, you are right to ask questions about possible other antigens besides COVID-19. COVID, would you like to take the questions, please?
spk06: Yes. Thank you, David, for your question. I mean, the NHB study is an investigational study, and we have two more cohorts to go. And clearly at the end of this study, which is somewhere around by the fourth quarter or so this year, we anticipate to establish immunogenicity of our vaccines in non-human primate. Certainly, we have very solid mouse data. There's also evidence so far from this NHP study that our vaccine is immunogenic. We would like to further, and also in terms of neutralizing antibody has been elicited, we would like to further show that it protects the animal against the vital challenge, life vital challenge. So evidence of immunogenicity, some durability data, protection against the virus, these are the things we would like to show. And as you know that NHB studies are kind of stepping stone towards human clinical trials And there would be enormous accomplishment to demonstrate that. Along the side in our preclinical level, we will be continuing to show stability shelf life at four degrees centigrade and also durability from our mouse study complementary to NHB study. And the second question was any additional pathogen Exactly. I mean, that's a great question because we're not married to SARS-CoV-2. It's a proof of concept pathogen we picked because of the pandemic. But clearly, since our vaccines are designed in a way that it can have different antigens, but also molecular boosters, molecular adjuvants, So certainly we could go after more difficult to handle pathogens such as HIV, RSV, where maybe additional component such as, you know, immunopitopes will be perhaps more important than just an antigen. Monkeypox is another pathogen that, you know, we could test our technology that's being developed with SARS-CoV-2 to go against some of those pathogens. And it depends, you know, how these days the pandemics would come, many epidemics. We will take a case-by-case basis, but certainly difficult to treat, difficult to develop vaccines such as RSV and HIV would be one of the target monkeypox. And flu, of course, you know, every year we have four variants of flu vaccine, and so that's an ideal candidate for putting multiple variants for flu vaccine into a single vaccine. That's also a potential target.
spk09: So, David, if I can comment further, you hear here that, you know, obviously sky's the limit potentially, but what we are doing first is that we continue to work on the formulation of the platform so that we can optimize the immunogenicity of the vector and the persistency. As I said in my remarks, we are trying to develop what could be the future of vaccines.
spk10: All right, great. I appreciate you taking the questions this morning. Thank you.
spk04: If there are no further questions at this time, I'll turn the call back to the company for any closing comments.
spk02: Thank you. I'll close out this call. I hope all of you on the line found it to be very informative. It certainly represents, as you can see, the commitment to our research. I call it palpable. I hope you feel it, too. I'll remind you that our fundamentals are strong, as Corinne pointed out, and getting stronger. Under her leadership, we expect the future to hold great promise for patients, for the medical community, for our shareholders. And we look forward, I look forward to participating in these calls with the management team. And my promise to you is that we will keep you informed on our future developments and the progress of the company in this very, very exciting transition to kind of what we believe is the future of medicine. under this terrific leadership. So I thank you all very much. I hope you have a wonderful day.
spk04: This concludes today's call. Thank you for your participation. You may now disconnect.
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