Ladies and gentlemen, good day and welcome to the Capricor Therapeutics Inc. Second Quarter 2021 Earnings Call. Today’s conference is being recorded. At this time, I would like to turn the conference over to AJ Bergmann for the forward-looking statement. Please go ahead, sir..

Thank you. Before we start, I would like to state that we will be making certain forward-looking statements during today’s presentation.

These statements may include statements regarding, among other things, the efficacy, safety and intended utilization of our product candidates, our future research and development plans, including our anticipated conduct and timing of preclinical and clinical studies, our plans to present or report additional data, our plans regarding regulatory filings, potential regulatory developments involving our product candidates and our possible uses of existing cash and investment resources.

These forward-looking statements are based on current information, assumptions and expectations that are subject to change and involve a number of risks and uncertainties that may cause actual results to differ materially from those contained in the forward-looking statements.

These and other risks are described in our periodic filings made with the SEC, including our quarterly and annual reports. You are cautioned not to place undue reliance on these forward-looking statements and we disclaim any obligation to update such statements. With that, I will turn the call over to Linda Marbán, CEO..

Thank you, AJ. This has been a busy quarter for Capricor with progress on all fronts. Today, we will review the progress of our two clinical programs with our lead asset, CAP-1002. The first program involves Duchenne muscular dystrophy, or DMD, and the second involves the treatment of the hyperimmune response caused by COVID-19.

Then I will provide an update on our engineered exosome platform technology. Before I discuss our clinical updates, I would like to announce that we will be expanding our footprint to San Diego, California. We have selected a facility that will enable us to continue to build out our pipeline products, both CAP-1002 and the exosome.

This expansion will include enhancements to our research, political and executive teams. As we evaluated the talent landscape, we felt that San Diego area would provide more opportunity for us to continue this expansion. Now, let me start with DMD.

As we have been talking about for a while, we have been working with the Office of Advanced Tissue and Therapeutics, otherwise known as OTAT, which is a division of CBER of the FDA to see if there was a path to accelerated or full approval for CAP-1002 in DMD based on the positive data from the HOPE-2 clinical study.

I am delighted to tell you for the first time after the final statistical analysis of the data in our HOPE-2 clinical trial we hit our primary efficacy endpoint of mid-PUL 1.2, our secondary endpoint of the full PUL 2.0, and secondary cardiac endpoint of ejection fraction. The full dataset has been submitted for publication.

We have of course shared this data with FDA and will provide further updates on it after its publication or presentation at a scientific meeting. Based on the strength of the clinical data, we had an end-of-phase meeting with OTAT and although it was a productive discussion, the consensus was that we should proceed to a Phase 3 clinical study.

The principal thinking was that the size of the HOPE-2 dataset with 20 patients was relatively small. We now plan to move forward with a Phase 3 pivotal trial. Currently, we are treating patients in an open label extension study of HOPE-2, in which all patients are eligible to receive CAP-1002.

In order to track progression of these patients and to enhance our safety database, we are using the PUL 2.0 and a relatively new, but exciting measure of function called the DVA, or Duchenne video assessment tool.

Recently, at the Annual Parent Project for Muscular Dystrophy, or PPMD meeting, we showed a video of a HOPE-2-OLE patient before receiving CAP-1002 and after treatment, changing his position in his bed, which is targeted as one of the most important domains related to quality of life in Duchenne muscular dystrophy.

The video showed marked improvement, including his massage, which was more relaxed, as he more easily negotiated the task. This video is available on the PPMD conference website. This video has made its way through the DMD community. So, the patients are more excited than ever about CAP-1002.

We are committed to getting CAP-1002 to them as quickly as possible as we work towards potential registration. Now, let me briefly summarize the design of the HOPE-3 trial. It will be a Phase 3 study, with approximately 65 to 75 patients in a one-to-one randomization scheme. As is common, we are building in a pre-specified interim analysis.

The national principal investigator will again be Dr. Craig McDonald of UC Davis, who is one of the leading experts of DMD worldwide. Currently, we are planning on approximately 20 sites in the U.S. In terms of clinical readiness, we have begun engaging sites and securing clinical operations as our goal is to be ready to start the trial.

In terms of manufacturing, we continue to work with Lonza as we have previously discussed to have commercial ready clinical supply at the appropriate time. We plan on meeting with FDA to secure our CMC plant for commercialization.

As we are gearing up for the pivotal trial, we have also had multiple discussions with payers who have been positive in terms of the reimbursement potential for CAP-1002 for DMD. Their projected price target is in line with other cell and gene therapies for rare diseases.

This is instructive as we continue to evaluate the long-term value of CAP-1002 in DMD. Further, as we have previously stated, our plan is to secure a partner to take CAP-1002 through commercialization.

To that end, our discussions with potential partners have accelerated and we look forward to providing updates to the extent that they materialize into a definitive agreement. Now, let me turn my attention to INSPIRE, which is the clinical trial we are conducting in patients with COVID-19.

As you know, very few, if any of the therapies that have been tried to combat the active virus or a sequelae has been effective.

Based on a series of emergency use authorization cases, conducted by us in 2020 and published in a peer-reviewed journal, Basic Research in Cardiology, we decided to conduct a randomized, placebo-controlled double-blinded trial of CAP-1002 in these patients with severe, but not critical COVID.

Now what does that type of patient look like? They are in the hospital and are in need of oxygen supplementation, but are not on a ventilator. We carefully selected this particular patient population, because they were the most responsive to CAP-1002’s immunomodulatory properties in the emergency use series of patients.

Plus it is widely known that once patients are on a ventilator, the outcome is usually not positive, no matter which treatments have been utilized. The trial was designed to enroll up to 60 patients with a variety of exploratory endpoints, the purpose of which was to evaluate how CAP-1002 was helping in severe COVID-19.

We have been careful in patient selection at our sites, so that we will have the best dataset possible to move forward with.

Enrollment slowed for a while when COVID cases fell in the U.S., but now with the resurgence of the virus and the nature of the Delta variant, we are seeing increased enrollment and we will be looking forward to seeing the impact of CAP-1002 on severe COVID. At this time, based on our current plan, we anticipate top line data in the near future.

One of the reasons we are encouraged about the potential impact of CAP-1002 in COVID-19 has been in the data from a recently co-published paper with the United States Army Institute of Surgical Research.

The paper is called extracellular vesicles derived from cardiosphere-derived cells as a potential anti-shock therapeutic, the data from which supported our use of CAP-1002 in COVID-19. We have published that the mechanism of action of CAP-1002 is the exosomes that the cells release.

And this paper highlights that mechanism by showing the impact of CDC-EVs or exosomes on shock and trauma, the pathophysiology of which is similar to that seen in severe and critical COVID.

Taken together, we are enthusiastically waiting for the data from INSPIRE to evaluate the clinical potential of CAP-1002 in COVID and other indications of hyperimmune activation. Now, I’d like to provide an update on our exosomes platform technology. A year ago, we announced that we would be expanding our portfolio of products to engineered exosomes.

As we realized the power of the exosomes derived from CAP-1002, we also learned that they were nature’s communication device, able to deliver messages from cell to cell and furthermore, able to deliver payloads across the cell membranes, an area of active investigation and therapeutics for many years.

We saw this as a great opportunity to capitalize on our knowledge of exosomes, but not be harnessed by any particular feature of the exosomes. We envisioned a technology that would allow us to custom load the exosomes and deliver payloads of choice rather than happenstance.

We have spent the last year laying the groundwork for that exciting opportunity. First, we have recruited a team of people who have experience with engineering exosomes, starting at the Vice President level, where we have recruited Dr. Christy Elliott. Dr.

Elliott received her PhD from Johns Hopkins University and has more than a decade of experience in exosomes for therapeutic development and who has assembled a team of approximately 10 scientists working on our exosome platform technology. As I previously stated, this team will be primarily based in San Diego at our new research facilities.

This team is continuing to build out our vaccine program, while advancing our exosome-based therapeutic pipeline. The research and development efforts continue to yield results. And in the second quarter, we have advanced the clinical developments of our novel multivalent COVID-19 vaccine.

As seen in recent months, mutations in the spike protein on SARS-CoV-2 have resulted in highly contagious variants, specifically the Delta variant. These mutations in viral spike proteins may allow the virus to escape the immune response elicited by current vaccines.

Therefore, annual vaccines are likely to become necessary to protect against variants of the coronavirus. It is becoming clear that existing vaccines will therefore need boosters to enhance immunity. That leads to the concept that new innovative vaccine approaches maybe necessary to continue to combat this virus globally.

As such, our hypothesis is that our vaccine may offer greater protection and less toxicity. And we are planning for COVID-19 vaccine to be administered as a booster to any currently available vaccines in a Phase 1 clinical trial. Now, let me tell you what is different about our vaccine. First, our mRNA payload is delivered in an exosome.

Exosomes are nature’s delivery vehicle, which we believe may confer advantages to intracellular delivery of nucleic acids specifically and may lead to more natural antigen processing. Secondly, we have a multivalent construct of both the S and N protein.

The N is highly conserved, which means it doesn’t mutate as rapidly and in fact, it is what is measured in traditional antibody testing of coronavirus. Our hypothesis is that the addition of the N protein may confer longer lasting immunity to SARS-CoV-2.

Because the spike protein mutates rapidly, it may be more difficult to develop vaccines that protect against the rapidly mutating virus. It is important to mount both an antibody or B-cell response, which the current vaccines do very well. But for continued protection, it is important to have a T-cell or memory response as well.

We believe that by delivering multiple RNAs, which are processed intracellularly by natural processes. We may have a vaccine that could potentially offer stronger protection against the variants of COVID-19. IND-enabling studies for our COVID-19 vaccines are underway and we are on track to submit an IND in the fourth quarter of this year.

Although this timeline has been delayed from our original projections, we have worked through supply chain challenges and conducting multiple non-clinical CMC-related studies at FDA’s requests for one of the first exosome-based vaccines to our knowledge that maybe moving into the clinic.

Furthermore, this non-clinical work lays the groundwork for the development of exosome based pipeline as the basic platform is the same, which is an exosome loaded with a biologic molecule. I continue to believe that exosomes present an opportunity for other vaccines beyond COVID.

At this time, we were exploring the power of an exosome-based vaccine for other indications by conducting studies with a large pharmaceutical company with the hope that the data from such studies maybe used to support the overall efficacy of an exosome-based vaccine approach.

Finally, in addition, expansion of our exosome platform technology is ongoing. We have and are continuing to expand our R&D and product development teams to enable additional exosome-based programs. We are actively working to identify multiple indications over the next few quarters as part of our expanded exosome pipeline.

And some of these we plan to take into the clinic. We are investigating the use of both mRNA and siRNA as part of these therapeutic programs. Proof-of-concept studies for two new exosome programs are underway, with initial data expected in the fourth quarter of this year.

Taken together, it has indeed been a busy quarter for Capricor and we are anticipating finishing the year off strong with multiple clinical programs on the advancement of our engineered exosome platform technology.

In addition, we recently added Karimah Es Sabar to our Board who brings over 30 years of experience as a senior life sciences leader to our team. She successfully directed the global launch up to first-in-class vaccine and biotherapeutic products and we look forward to her guidance as we embark on Capricor’s next phase of growth.

Lastly, please stay tuned regarding the announcement of a new leader to our senior management team. In closing, we will be presenting at various banking and corporate conferences later this year as well as several leading scientific and medical conferences, including the Cantor Fitzgerald Global Healthcare Conference and the [Technical Difficulty].

Now, I will turn the call over to AJ Bergman, our CFO for an update on the financials..

Thank you, Linda. This afternoon’s press release provided a summary of our second quarter 2021 financials on a GAAP basis. You may also refer to our quarterly report on Form 10-Q, which we expect to become available in the next few days and be accessible on the SEC website as well as the financial section of our website.

As of June 30, 2021, the company’s cash and cash equivalents totaled approximately $38.1 million compared to approximately $32.7 million on December 31, 2020. Based on our current pipeline and operating plan, the company’s cash position is expected to be sufficient to support operations for at least 2 years.

Turning to the financials, in the first half of 2021, our net cash used in operating activities was approximately $7.8 million. For the second quarter of 2021, excluding stock-based compensation, our research and development expense was approximately $3.4 million compared to approximately $1.8 million in Q2 2020.

Again, excluding stock-based compensation, our general and administrative expense was approximately $1.2 million in Q2 2021 and approximately $1 million in Q2 2020. Net loss for the first half of 2021 was approximately $9.9 million compared to a net loss of approximately $5.6 million for the first half of 2020.

As Linda noted earlier, we continue to explore our business development opportunities with our CAP-1002 program and are committed to the development of our exosome program. We will now open the line for questions..

Thank you. [Operator Instructions] We will take our first question from Emanuela Branchetti from H.C. Wainwright. Your line is open, please go ahead..

Good afternoon, guys and thank you for taking my questions. It’s very exciting to hear that CAP-1002 is moving forward. So, congrats on that. And maybe you can share more details from the trial endpoints.

So, is the PUL 2.0 on primary endpoint and what about the target to measure, are you including those in the trial design as well?.

Yes, thank you for that question. Yes, the primary efficacy endpoint is going to be the PUL 2.0. As you know, from the top line data and we will see very soon from the published or presented data that the final dataset from HOPE-2 to was very positive and very compelling. So we are very confident in the selection of the PUL 2.0 as the primary.

And yes, we are going to build and have built in the cardiac secondary endpoints of ejection fraction and volume, also very significant in HOPE-2. The P value for ejection fraction in HOPE-2 was 0.004. The P value for the PUL 2.0 and HOPE-2 was 0.04. So we are very excited to take this into its pivotal trial..

Thank you for that. And you mentioned that the patients enrolled in the HOPE-2 are going to be eligible for moving forward to HOPE-3.

Are all the patients that completed HOPE-2 eligible to access HOPE-3 directly, how is that going to work?.

So they are not going to roll on to HOPE-3, the patients that were in HOPE-2 whether they received cells in the treated group or the placebo group and the patients still are blinded. So they don’t know what they received in the first iteration of the trial, are currently in the open label extension part of HOPE-2. They are currently receiving doses.

Many of them are verbally reporting, feeling and seeing improvement since going back on to the cell. So we are very excited at the patient reports and this also gives us a lot of energy moving into Phase 3..

Got it. Thank you for that.

And just last question about data, can you share your estimates on the cost of the study?.

So, I didn’t understand that last estimated....

The cost of the study for the HOPE-3, yes..

Yes. So we haven’t disclosed that, but we are estimating that it will be around $15 million, which sounds low for a Phase 3 clinical trial, but we have been really careful to make sure we’re only measuring what we need to take it through to registration.

We’ve worked with FDA on the Phase 3 protocol and feel very confident that it is a laser focused clinical effort to take this through registration..

Got it. Got it. Thank you.

And switching to the booster vaccine, I think that’s very smart strategy, but could you share your thoughts around a little bit around the clinical development, since this is a booster some sequence to other vaccines? Are there are particular requirements that you have to meet for the IND approval and for moving forward? I just wanted to have your thoughts on that?.

Yes, so we have been exploring it actively. We will have more feedback once we file the IND. We had a pre-IND meeting, which we announced in the spring and we have been finishing up those IND enabling studies.

It seems like it might have taken a long time but the reality is it sets the foundation for exosome based platform therapeutics both in the vaccinology space, but also in the therapeutic development space. So, it’s been a really good use of our research team’s time.

And in terms of the acceptance of a booster strategy, well I can’t disclose exactly how we have been working with the U.S. government on their perception of need for viral vaccine boosters and they seem supportive of this opportunity and the work that we are doing to prepare for it.

So we haven’t completely baked in with the FDA and we won’t heave that huge sigh of relief till we have the IND, but our current plan is to provide a booster to anybody that’s been vaccinated with any of the previously available vaccines..

Got it. Thank you very much and congrats on the progress..

Thank you..

We will take our next question from [indiscernible] Capital. Your line is open. Please state your question..

Hi, Linda. Nice to hear from you and nice to hear the wonderful presentation. Couple of questions.

With regard to your booster vaccine planning, what would be the proposed route of administration of that? I am asking, because does it mean the administration IV of a modified CAP-1002 type cell one or some of the route of administration of prepared exosomes?.

So, it’s a straight intramuscular injection, it’s exactly the same if you have been vaccinated with either the Pfizer or the Moderna vaccine, it would be the same type of thing, a quick shot in the arm that you don’t even know happens..

Okay, alright.

Does the company plan to if the data are positive in the COVID-19 trial, to submit CAP-1002 for EUA?.

Well, we are open to all possibilities. We have built that trial based on, as I said in my prepared remarks, the Emergency Use Authorization set of patients that we did way back at the beginning of the pandemic. And the data was very positive both in terms of preservation of life and also biomarkers.

And so we will see what this dataset teaches us, certainly, especially in this patient population, where literally nothing has been successful. We will work very carefully with FDA to see if we can move this forward as rapidly as possible should the data be positive..

Okay.

Can the epigenetic modification profile wielded by the CAP-1002 exosomes, is it any good at suppressing IL-6 expression, has that been quantified or examined?.

I mean, we have seen that in a lot of preclinical work that we have done. We have worked on CAP-1002 for many, many years. And it seems to suppress sort of the cytokines IL-1, IL-2, IL-6 and augments IL-10 in some of the inflammatory suppressing cytokines, but we haven’t seen it in this study, we are measuring it.

We did see some interesting data in the Emergency Use Authorization patients in terms of biomarkers. But in those days, let me emphasize, we were treating all-comers. And so a lot of the patients by the time we got to them, they had been in ventilator for a while we know now that those patients, as I mentioned, sadly don’t do very well.

So we are really going to be able to look at the data in a very careful way from the study. And I hope you are as excited as I am about it, because I think it could give us some really interesting clues on how to treat COVID..

And pathophysiology and so yes, I agree totally. Changing subjects a little bit, it’s been some time since we have talked, but I – the last interaction I guess I had understood there to be a really avid gung-ho plan to seek a kind of priority for pre-emptive authorization, CAP-1002 and VMZ. And now I am hearing the plan to pursue Phase 3.

Are you doing, is it a two-pronged approach that you are pursuing both or is it the plan just to primarily move ahead with Phase 3 now?.

So, we spent about a year working with FDA in multiple conversations. And I know, many of our investors as well as the Duchenne community were sitting on the edge of their seats waiting to see what happened.

And basically, FDA, it’s the OTAT which is the Office of Tissue and Advanced Therapeutics of CBER have come down and said, listen, this was really interesting data, but it was a small dataset, we really need you to do this Phase 3 to validate what you have seen.

And so we are rather than to continue to push the envelope and potentially keep fighting a battle that we might not win, I want to just jump right in, let’s get this trial done. And let’s get this product registered and commercialized.

And I will say, as I mentioned, but I want to highlight, we are going not going to start the study until we identify an appropriate partner to take it through with, we need to validate that we get the appropriate funding, and that we have a path all the way through to commercialization. So we’re ready to go and actively talking to partners now..

Yes, I was going to ask AJ had mentioned $38 million in 2 years of funding with that – with the cost of this trial be subsumed, but he answered it in a different way. So thanks for that. That’s all I have. It was great hearing from you. Thank you very much..

Thank you for your time..

We will take our next question from Alan Leong from BioWatch News. Your line is open. Please go ahead..

Linda and AJ, congratulations on the San Diego expansion and for grabbing Dr. Elliott out of Johns Hopkins along with her team. To me and I think, everyone this is a major signpost. So congratulations..

Thank you..

Thank you..

Yes, yes, a couple. Yes, it’s actually been waiting for that shoe to drop and really happy. Good. Yes. I am going to asking about the pivotal trial.

You mentioned that interim looks, are they safety only or going no-go signal are there any other extremely like, where you get a full peak at the ongoing endpoints?.

Good. Our HOPE-3 trial, so we are in the process of deciding how to pursue that interim now. We haven’t disclosed that. And we will give you more information as it becomes available. What we want to do is make sure that the trial is as airtight as possible for approval. And so we will follow the guidance of FDA on how to build that interim..

I see.

So, the FDA is pretty much wanting to look at the 12 months or 18 month primary endpoint, an early peak would move their hand for any early approval?.

Yes. So, the primary is going to be 12 months. And the performance of the upper limit is measuring shoulder, arm and hand function. And then we have built in some other measures of skeletal muscle performance as well as the cardiac muscle measurements in terms of function. And that will be similar to what we did in HOPE-1 and HOPE-2.

So, we are very confident about the cardiac impact of CAP-1002 as well as the skeletal muscle impact. We don’t believe we need to go out 18 months FDA, its 12 months is representative of long-term effectiveness..

Wonderful. I want to get your thoughts [indiscernible] thoughts on the INSPIRE trial. It looks that treating severe COVID respiratory deterioration, are you thinking about generalizing to respiratory deterioration overall, requiring a C-path? Several years ago, there were several failed trials for respiratory recovery.

And, frankly, those type of companies have given the right arm for your results. I can see for example, the military.

Can you talk about that using for general respiratory deterioration for trauma or is it now just confined to severe – you are thinking just confined and focus confined to severe COVID for now?.

So, COVID has done many terrible things globally, which none of us I think would argue against. But it really has opened the door in a large way to the expansion of biopharmaceuticals and the treatment of different diseases. And one of them is really this laser focus on respiratory distress.

And so once we get the data from the INSPIRE trial, we will be able to decide a path forward. And yes, we have absolutely not ruled out the possibility that this could be generalizable for many different types of respiratory disruptions..

Thanks. And just one more question, if I may. And I recognize this is an old question, but I am getting lots of inquiries.

Can you comment on the projected ease in relative terms, either manufacturing costs and scalability of exosomes, there is a little bit of fear that this is actually more complicated and/or is complicated as usual cell therapy manufacturing?.

We are in scale-up mode, we have, as I mentioned, built a new team of research and development. And part of that is the scale-up team. I am very confident that this is an engineering problem that can be solved.

One of the reasons we decided to move into engineered exosomes originally was because we felt that it would be much easier to manufacture synthetic exosome with a payload as opposed to trying to convince a natural cell to do exactly what you wanted to do.

I think when the field talks about the different difficulties and scaling up manufacturing, it’s the people that are taking cells like CAP-1002 and turning them into CDC exosomes, which is one of our products and one of the ones that we reserve for rare diseases, because they are harder to manufacture.

But we plan on building this out as a generalizable manufactured product. And I think the world is following along, I think long as to have exosome manufacturing program now as well as many of the other global manufacturers. So, I have a lot of confidence in this space..

Congratulations, Linda, and AJ, for making the strategic term and being able to carry it out. So, I am looking forward to your next year..

Thank you..

[Operator Instructions] We will take our next question from Brian Corde [indiscernible] Partners. Your line is open. Please state your question..

Hi Linda and AJ, great job. Thanks for the update. I had a question for you regarding the program for Dr. McDonald, where you said you are going to have 65 to 75 patients.

Are you planning? How many are you planning to enroll per month? Do you have several on the waiting list, because I know you told me that there is – in the past, you have told me there is people that really want to join this study.

And will you be giving updates on enrollment throughout the next three months to six months?.

Yes. Thanks and Brian, great to hear from you. So, we typically don’t provide enrollment updates. We are really moving quickly getting the sites up and running. As I mentioned, we are not going to start the trial until we found a partner or have funding that come in, in a non-diluted fashion so that we can continue to build out this program efficiently.

In terms of the wait list, yes, my email blows up every day, more with patients and families that want CAP-1002 and even investors. And so I am very confident that the field will meet this trial with great expectation. I will provide a cautionary tale that the clinical trial arena is quite complicated.

And a lot of times even amazing therapeutics take a long time to get up and running because sites are so slow. But we are working with sites that we have already had. We are working with investigators that are very excited. And of course, we will let you know sort of milestones along the way..

Alright.

And the San Diego addition where you are bringing in 10 scientists, are they going to be full-time for Capricor? Are they subbing out? And did you build the facility? Did you buy the facility? Are you leasing it? And the last part of that is the total cost you think it’s going to be?.

So, we leased previously occupied lab space. I am extremely excited to be moving into this really nice space, it’s important time San Diego, it allows us to expand our research and development group, which we needed to do. We already have six of them working for full-time.

We anticipate adding about four more full-time working for Capricor, primarily on our exosomes, but also on some of the late stage product work we need to do for CAP-1002. And we would encourage you to come visit us. We can go take a walk to the beach..

Good. Last question and I would like to come out there.

Question on the exosome platform when you said you were conducting talks with a large pharmaceutical company, what would be your ideal scenario to develop out of that full costs or partnership with royalties? What are you envisioning?.

So right now, I am really excited by this program. I can’t talk much about it. But we are actually working on exosome based vaccine technologies for other diseases besides COVID.

My vision is that this would be something and we have been talking about this, really, since we started building out the exosome platform, that these are ripe and ready for licensing, right that this particular partner, or some combination of partners, would be interested in licensing in the technology that we have built of using exosomes, loading it with mRNA, or some other type of way of eliciting an immune response and then driving vaccinology..

So, are you going to look at partnering for regions or selling off worldwide? How do you envision that?.

Yes. So, right now, what I am envisioning is showing that it works, that the strategy is effective, which I am fully expecting. And then we will provide more updates as we sort of flesh out our plans with our potential partners..

Alright.

And the last question I had for you is, any update on the peer reviewed journal?.

Yes, but it’s still in review, which we think is a really good sign [indiscernible] a very major, highly credible journal. And we expect to have that published either there or somewhere equally exciting over the next few months. In addition, we plan on presenting the data at a meeting in the near future..

Alright. Well, I appreciate it and keep up the good work..

Thank you, Brian. We appreciate your time and attention..

[Operator Instructions] It appears we have no further questions. I will hand over the call back to Linda for any additional closing remarks. Please go ahead..

Thank you for your time and attention today. We look forward to hopefully seeing you out and about in person or at the very least in Zoom meetings as the quarters roll forward, and please stay healthy and well during these very challenging times. Thank you very much..

That concludes today’s conference call. Thank you everyone for your participation. You may now disconnect..