Celsion Corporation (NASDAQ:CLSN) Q2 2022 Earnings Conference Call August 15, 2022 11:00 AM ET
Company Participants
Monique Kosse – IR, LifeSci Advisors
Michael Tardugno – Executive Chairman
Corinne Le Goff – President & CEO
Jeffrey Church – CFO
Nicholas Borys – CMO
Khursheed Anwer – Chief Science Officer
Conference Call Participants
Emily Bodnar – H.C. Wainwright
Kumar Raja – Brookline Capital Markets
David Bautz – Zacks Small-Cap Research
Operator
Good morning, and welcome to Celsion’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 Kosse of LifeSci Advisors. Please go ahead.
Monique Kosse
Thank you, operator, and good morning, everyone. Welcome to Celsion’s second quarter 2022 earnings call.
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 & Investors tab.
With us today are Michael Tardugno, Executive Chairman of the Board of Celsion; Corinne Le Goff, President and Chief Executive Officer; and members of Celsion’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 Celsion’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 Celsion’s 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. Celsion 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 Tardugno, Executive Chairman of the Board. Michael?
Michael Tardugno
Thank you, Monique. Good morning, everyone.
I’m extraordinarily pleased to be here today with Dr. Corinne Le Goff, Celsion’s new President and Chief Executive Officer. I’m also here with Jeffrey Church, our Chief Financial Officer; Dr. Nicholas Borys, our Chief Medical Officer; and Dr. Khursheed Anwer, 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 Dr. Borys and Anwer for updates and by Jeffrey Church for a review of our second quarter financials.
For the past 24 months, the 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 the short period of time, and I’d say a nanosecond in a biotech quo, 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 Celsion is on a runway well into 2025.
Now showing promise with impressive technology platforms and an outstanding and committed group of employees. The capstone 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 unapproachable 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?
Corinne Le Goff
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 Celsion recent developments in immuno-oncology and vaccines.
I want to spend a few minutes to share with you why I decided to join Celsion 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 ThermoDox Phase 3 program in liver cancer to focus on the development of a very promising plasma 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 knowhow and expertise of our scientists and with the focus, the dedication and passion of all our employees.
Second, Celsion is a platform company with a unique and very innovative plasma DNA technology platform. I can imagine that over a long-term horizon, we will create a new category of medicines based on our plasma DNA technology across the broad array of human diseases. We are studying in immune-oncology and infectious diseases, and we will continue to invest to fully characterize the platform and to advance the technological frontier of plasma 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, Celsion has an available cash position to pursue diligently the current development programs and at the current forecast of spending the company’s operating runway 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 Celsion 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 our observations to-date and put into perspective through the lens of my extensive professional carrier, the potential that I foresee for technological platform. Ahead of doing so, I want to highlight that my 30 years and for the success of Celsion 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 immuno-oncology and vaccines.
I believe that Celsion has a very differentiated DNA plasma technology with proprietary, synthetic, non-viral delivery systems that are engineered for gene-based therapies that’s the TheraPlas platform or for the expression of multiple pathogen antigens in vaccines and that’s a PLACCINE 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. Borys will share with you in a few minutes, the progress of the GEN-1 program in ovarian cancer.
As you know, in preclinical and Phase 1 studies GEN-1 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 Celsion has demonstrated a way to enlist the power of IL-12 to create a potent immune tumor micro environment 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 could 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 a registrational trial in this HRD, BRCA negative population.
We are also evaluating strategy combination therapies with GEN-1. We are planning to start a study to evaluate GEN-1 in combination with dual immune checkpoint inhibitors Yervoy and Opdivo in patients with recurrence 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’re 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 to 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 drug 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 R&D 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 plasma DNA platform because Celsion 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 clean catch up with the latest variant, and that can be shipped and stored around the world without requiring deep freeze temperature.
Our technology might be the answer. Khursheed with the ability on the PLACCINE 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 variant. 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 at our GMP compliance, so that we can meet the requirements of let’s face clinical trials.
We are obviously planning for success and we are putting our future in our own hands with a 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 aphorism. Celsion 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 Borys, who will review recent progress around our GEN-1 immuno-oncology product. Nick?
Nicholas Borys
Thanks very much Corinne. You’re joining Celsion 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 BRCA or HRD signature mutations do very well when they are given at relatively new drug called the 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 their 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 GEN-1 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 GEN-1 with dual checkpoint 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 1/2 study evaluating GEN-1 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.
Corinne Le Goff
Thank you, Nick.
Our progress with our proof of concept vaccine development program has been equally impressive. I’d like to invite Khursheed to make a few comments in this regard. Khursheed?
Khursheed Anwer
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 PLACCINE 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 — PLACCINE vector containing the spike antigen of SARS-CoV-2 Alpha or Delta variant, or a combination of Alpha and Delta variant elicited strong IgG and T-cell responses upon intramuscular administration. The neutralizing activity of the IgG response was verified in a pseudo lentivirus 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 vital 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 titer persist for at least five months, the study in progress and additional time points to be collected in the future.
A three-month stability study shows the neutralizing activity of our PLACCINE 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 cynomolgus 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 adjutancy are in progress in an effort to continually improve our vaccine platform.
Corinne?
Corinne Le Goff
Thank you, Khursheed for that very thorough overview.
I’d like to turn the call over to Jeff Church who will review our second quarter financial results. Jeff?
Jeffrey Church
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.
Celsion ended the quarter with $48.1 million in cash, investments, and interest receivable as of June 30, 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 their 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 used in 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. For the second quarter ended June 30, 2022, Celsion reported 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 the support the OVATION 2 program, as well as preclinical development activities around our PLACCINE 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 3 trial and 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 2020 of the OPTIMA Phase 3 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 debt indebtedness with Horizon, which carry a much higher interest rate.
With that, I’ll now turn the call back to Corinne.
Corinne Le Goff
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.
Question-and-Answer Session
Operator
[Operator Instructions].
We’ll take our first question from Emily Bodnar with H.C. Wainwright.
Emily Bodnar
Hi, thanks for taking my questions and welcome to the team, Corinne. Maybe I’ll start with a question for you and then I have a few follow-ups. But as the new CEO maybe discussed, 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.
Corinne Le Goff
Well, thank you very much, Emily. Yes. So as I said, 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 recent remarks, I’m very enthusiastic about the plasmid DNA platform and what it has to offer both in immuno-oncology and in vaccine development. So we definitely — we wait for the data to turn out obviously both in — with the ovarian cancer program and the COVID-19 proof of concept program, but more to come in the next quarters for sure, Emily.
Emily Bodnar
Okay, Corinne. And then, just a follow-up, could you maybe discuss if you’re going to have any other data updates on the OVATION 2 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 COVID 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.
Corinne Le Goff
Okay. Yes. Thank you for that great questions. Maybe I’ll comment on the last one first on vaccine, and then I’ll ask Khursheed to add to what I’m saying. On the vaccine boosters program, yes, obviously, as you know, we are seeking a proof of concept with our PLACCINE COVID-19 program, right? So we do not intend at the moment to compete with the mRNA vaccines that are currently marketed. But maybe Khursheed you want to add to what I’m saying here?
Khursheed Anwer
Yes. I mean, I agree Corinne that this platform is for proof of concept and we are 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 although, 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 the commercial players are also going after SARS strategy and hypothesis has been pretty much consistent with how the vaccine field is slowing. But clearly as Corinne said, we’re developing platform technology using SARS-CoV-2 no intently compete, however, down the road if we do intend to use as a booster we don’t rule that out for SARS-CoV-2.
Corinne Le Goff
Absolutely. Thank you, Khursheed. And on your first question, Emily, I’ll ask Nick to comment on the availability of new data for the GEN-1 program.
Nicholas Borys
Yes. Thanks very much for that question. As we mentioned in our prepared remarks, 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 altogether 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.
Operator
Go to our next question from Kumar Raja with Brookline Capital Markets.
Kumar Raja
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 expectation in terms of the safety profile with the combination? Thank you.
Corinne Le Goff
Kumar, these are two really great questions. Thank you. I’ll ask Nick to answer both of them, please.
Nicholas Borys
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 a 110 by the end of this month, within the next few weeks. And depending on the enrollment rate reaching a 130, which would give us a much more robust data platform to look at that would take perhaps another three months or so, and 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 the 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 will escalate the dosing according to the safety signals and hopefully announce a safe dose early next year after we start the trial.
Kumar Raja
Okay. I mean in terms of the safety profile with Avastin what’s the expectation there? Thank you.
Nicholas Borys
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 intraperitoneally, 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, 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.
Operator
[Operator Instructions].
We’ll take our next question from David Bautz with Zacks Small-Cap Research.
David Bautz
Hey, good morning, everyone, and thanks for the update this morning. So I’ve got two questions about the PLACCINE 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 are the other indications is the company considering for applying the PLACCINE technology to?
Corinne Le Goff
Thank you very much, David, for your question. So I’m going to ask Khursheed to comment on both of your questions. But let me — before I let Khursheed answer, let me say a few things about the development of the platform.
Obviously, we are developing the PLACCINE technology as a platform. COVID-19 is a proof of concept. So you are right to ask questions about possible other antigens besides COVID-19. Khursheed, would you like to take the questions, please?
Khursheed Anwer
Yes. Thank you, David for your question. I mean, NHP 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 a very solid mouse data. There’s also evidence in so far from this NHP study that vaccine is immunogenic. We would like to further and also is — 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 NHP studies are kind of stepping a 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 degree centigrade, and also durability in — from our mouse study complementary to NHP 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 pick 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 epitopes, immune epitopes will be perhaps more important than just an antigen.
Monkeypox is another pathogen that we could test our technology that’s being developed with SARS-CoV-2 to go against some of those pathogens. And it depends how the — I mean, 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, every year we have four variants of flu vaccine. And so that’s an ideal candidate for putting multiple variants for flu vaccine to single vaccine that’s also potential target.
Corinne Le Goff
So David, if I can comment further, you hear that obviously sky’s limit potentially, but what we are doing first and 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, right? As I said in my remarks, we are trying to develop what could be the future of vaccines.
David Bautz
All right. Great. I appreciate your taking the questions this morning.
Corinne Le Goff
Thank you.
Operator
As there are no further questions at this time, I’ll turn the call back to the company for any closing comments.
Michael Tardugno
Thank you. I’ll closeout this call. I hope all of you on the line found to be very informative. It certainly represents as you can see the commitment to our research, I call it probable. 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.
Operator
This concludes today’s call. Thank you for your participation. You may now disconnect.
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