Good day, and welcome to the Capricor Therapeutics Inc. 2nd Quarter 2021 Earnings Call. Today's conference is being recorded. At this time, I would like to turn the conference over to A. J.
Bergman for the forward looking statement. Please go ahead, sir.
J. Bergman:] Thank you. Before we 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 an 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 or 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're cautioned not to place undue reliance on these forward looking statements, and we disclaim any obligation to update such statements. With that, I'll turn the call over to Linda Marban, CEO.
Thank you, A. J. This has been a busy quarter for Capricor with progress on all fronts. Today we will review the progress of our 2 clinical programs with our lead asset CAP-one thousand and two. The first program involves Duchenne muscular dystrophy or DMD and the second involves the treatment of the hyper immune response caused by COVID-nineteen.
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-one thousand and two and the exosome. This expansion will include enhancements to our research, clinical 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 OTAP, which is a division of CBER of the FDA, to see if there was a path to accelerated or full approval for CAP-one thousand and two in DMD based on the positive data from the HOPE-two clinical study. I am delighted to tell you for the first time after the final statistical analysis of the data in our HOPE-two clinical trial, we hit our primary efficacy endpoint of mid POLL 1.2, our secondary endpoint of the full POLL 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 Based on the strength of the clinical data, we had an end of phase meeting with OTAS.
And although it was a productive discussion, the consensus is that we should proceed to a Phase 3 clinical study. The principal thinking was that the size of the HOPE-two data set 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-two in which all patients are eligible to receive CAP-one thousand and two. In order to track progression of these patients and to enhance our safety database, we are using the POLL 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-two OLE patient before receiving CAPTAINO2 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 market improvement, including his visage, 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-one thousand and two. We are committed to getting CAP-one thousand and two to them as quickly as possible as we work towards potential registration.
Now let me briefly summarize the design of the HOPE-three trial. It will be a Phase 3 study with approximately 65 to 75 patients in a 1 to 1 randomization scheme. As is common, we are building in a pre specified interim analysis. The National Principal Investigator will again Doctor. 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 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 plan 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-one thousand and two 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-one thousand and two and DMD. Further, as we have previously stated, our plan is to secure a partner to take CAP-one thousand and two through commercialization. To that end, our discussions with potential partners have accelerated 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-nineteen. As you know, very few, if any of the therapies that have been tried to combat the active virus or its sequelae have 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-one thousand and two 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-one thousand and two'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-one thousand and two was helping in severe COVID-nineteen.
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'll be looking forward to seeing the impact CAP-one thousand and two 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-one thousand and two and COVID-nineteen has been in the data from a recently copublished 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-one thousand and two in COVID-nineteen. We have published that the mechanism of action of CAP-one thousand and two 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-one thousand and two For COVID in COVID and other indications of hyper immune activation. Now I'd like to provide an update on our exosome platform technology. A year ago, we announced that we would be expanding our portfolio of products to engineered exosome. As we realize the power of the exosomes derived from CAP-one thousand and two, 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 membrane, an area of active investigation and therapeutics for many years. We saw this as a great opportunity Capitalize on our knowledge of exosome, but not be harnessed by any particular feature of the exosome.
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 you have experience with engineering exosome, starting at the Vice President level, where we have recruited Doctor. Christy Elliott. Doctor.
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 facility. 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 Q2, we have advanced the clinical developments of our novel multivalent COVID-nineteen vaccine.
As seen in recent months, mutations in the spike protein on SARS CoV-two have resulted in highly contagious variants, specifically the Delta variant. These mutations and 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 may be necessary to continue to combat this virus globally.
As such, our hypothesis is that our vaccine may offer greater protection and less time for disease, we are planning for our COVID-nineteen 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 proteins.
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 the SARS CoV-two. 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 for 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 variance of COVID-nineteen.
IND enabling studies for our COVID-nineteen vaccines are underway we are on track to submit an IND in the Q4 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 request for 1 of the first exosome based vaccines to our knowledge that may be 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 are 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 may be 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 and 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 2 new exosome programs are underway with initial data expected in the Q4 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 and the advancement of our engineered exosome platform technology. We in addition, we recently added Kareema S. 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 of 2 1st in class vaccine and biotherapeutic And we look forward to our 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 Annual Cell and Gene Therapy Meeting on the MESA. We look forward to providing continuing updates on all of our programs. Thank you. Now I will turn the call over to A. J.
Bergman, our CFO, for an update on the financials. J. Bergman:] Thank you, Linda.
This afternoon's press release provided a summary of our Q2 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 will 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 $38,100,000 compared to approximately 32,700,000 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 twenty twenty one, our net cash used in operating activities was approximately $7,800,000 For the Q2 of 2021, excluding stock based compensation, our research and development expense was approximately $3,400,000 Compared to approximately $1,800,000 in Q2 2020. Again, excluding stock based compensation, our general and administrative expense was approximately $1,200,000 in Q2, twenty twenty one and approximately $1,000,000 in Q2, twenty twenty. Net loss for the first half of twenty twenty one was approximately $9,900,000 compared to a net loss of approximately $5,600,000 for the first half of twenty twenty. As Linda noted earlier, we continue to explore our business development opportunities with our CAP-one thousand and two program and are committed to the development of our exosome program. We will now open the line for questions.
We will take our first question from Emmanuella Brancheti 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 CAPT is moving forward, so congrats on that. And maybe you can share more details on the trial endpoints. So is the pool 2.0 the primary endpoint? And what about the cardiac measure?
Are we 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 POOL 2.0. As you know from the top line data and we'll see very soon from the published or presented data, the final data set from HOPE-two was very positive and very compelling. So we're very confident and the selection of the POLL 2.0 is the primary.
And yes, we're going to build in and have built in the cardiac secondary endpoints of ejection fraction and volume, also very significant in HOPE-two. The P value for ejection fraction in HOPE-two was 0.004. The P value for the POLL 2.0 and HOPE 2 with 0.04. So we're very excited, to take this into its pivotal trial.
Thank you for that. And you mentioned that the patient enrolling the HOPE-two Are you going to be eligible for moving forward to for moving forward to HOP3? Are all the patients that completed HOP2 eligible to address OPE-three directly, how is that going to work?
So they're not going to roll into OPE-three. The patients that were in hope to 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 OPE-two. They are currently receiving doses. Many of them are verbally reporting, feeling and seeing improvements since going back on to the cells. So we're 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 this. Can you share your estimate on the cost of the study?
I'm sorry, I didn't understand that last estimated The cost of the
study of the study. Yes.
Yes. So, we haven't disclosed that, but we're estimating that it will be around $15,000,000 Which sounds low for a Phase 3 clinical trial, but we've 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 the a little bit around the clinical development? Since this is a booster, subsequent to other vaccines, are there particular requirements that you have to meet for the IND approval and for moving forward?
I just I wanted to have your thoughts on that.
Yes. So we've been exploring that actively. We'll have more feedback once we file the IND. We had a pre IND meeting which we announced in the spring and we've been finishing up those IND enabling studies. Seems like it might have taken a long time, but the reality is that 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 And in terms of the acceptance of a booster strategy, well, I can't disclose exactly how we've 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 the work that we're doing to prepare for it. So we haven't completely baked in with the FDA and we won't, heed that huge cyber relief till we have the IND, but our current plan 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'll take our next question from Doctor. Mark Swain from Torrey Hills Capital. Your line is open. Please state your
Hi, Linda. Nice to hear from you and nice to hear the wonderful presentation. A couple of questions. As regards to your booster vaccine planning, what would be the proposed route of administration of that? I'm asking because does it mean administration IV of a modified CAP-one thousand and two type cell line or some other route of administration of prepared exosomes?
So it's a straight intramuscular injection. It's exactly the same if you've 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. All right. Does the company plan to, if the data are positive in the COVID-nineteen trial, to submit CAP-ten oh two for EUA?
Well, we're open to all possibilities. We 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'll see what this data set teaches us. Certainly, especially in this patient population where literally nothing has been successful, we'll work very carefully with FDA to see if we can move this forward as rapidly
can the epigenetic modification profile wielded by The CAPTILO2 exosomes, is it any good at suppressing IL-six expression? Has that been quantified or examined?
I mean, we've seen that in a lot of preclinical work that we've done. We've worked on CAP-one thousand and two for many, many years And it seems to suppress sort of the angry cytokines IL-one, IL-two, IL-six and augment IL-ten and 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 emergence 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 on ventilator for a while. We know now that those patients, as I mentioned, sadly don't do very well.
So we're really going to be able to look at the data in a very careful way from the study, and I hope you're 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 insights. Yes, I agree, totally. Changing subjects a little bit, It's been some time since we've talked, but the last interaction, I guess, I'd understood there to be a really avid gung ho plan to seek a kind of priority For preemptive authorization, Kapton-two and DMZ, and now I'm hearing the plan to pursue Phase 3. Are you doing is it a 2 pronged approach that you're 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 We're sitting on the edge of their seats waiting to see what happened. And basically FDA, OTAT, which is the Office of Tissue and Advanced Therapeutics at CBER have come down and said listen, this was really interesting data, but it was a small data set. We really need you to do this Phase 3 to validate what you've seen. And so we are rather than 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, A. J. Had mentioned $38,000,000 in 2 years of funding. Would that would the cost of this trial be subsumed?
But you've answered it in a different way. So thanks for that. That's all I have. Great hearing from you. Thank you very much.
Thank you for your time.
We'll take our next question from Alan Leung from BioWatch News. Your line is open. Please go ahead.
Wendy, A. J, congratulations on the San Diego expansion and for grabbing Doctor. Elliot out of Johns Hopkins along with her team. To me and I think to everyone, this is a major signpost. So congratulations.
Thank you. Thank you.
Yes, couple. Yes, I've actually been waiting for that shoe to drop and really happy. Good. I'm going to ask something about the pivotal trial. You mentioned the interim look.
Are they safety only or no go, no go signal? Or are they on the other extreme like Where you get a full peek at the ongoing endpoints?
For the HOPE-three trial, so we're in the process of How to pursue that interim now? We haven't disclosed that and we'll 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'll 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 or 18 month primary endpoint and early An early peek wouldn't move their hand for any early approval then.
Yes. So the primary is going to be 12 months. And the performance of the upper limb It's measuring shoulder, arm and hand function and then we've 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-one and HOPE-two. So we're very confident about the cardiac impact of CAP-one thousand and two as well as the skeletal muscle impact, we don't believe we need to go out to 18 months. FDA has said 12 months is representative of long term effectiveness.
Wonderful. I wanted to get your thoughts I was wondering if you will thoughts on the INSPIRE trial. It looks at treating severe COVID respiratory deterioration. Are you thinking about generalizing to respiratory deterioration overall requiring a CPAP? Several years ago, there several failed trials for respiratory recovery and frankly those companies have given their right arm for your results.
I can see for example military and you talked about they're using for General respiratory deterioration for trauma or is it for now just confined to So you're 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'll 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 distress syndrome.
Thanks. And just one more question, if I may. And I recognize this is an old question, but I'm getting lots of inquiries. Can you comment on the projected ease in relative terms, the ease of manufacturing costs and scalability Abexasone, there's a little bit of fear that this is actually more complicated than or as complicated as the 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 a scale up team. I'm 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 static exosome with a payload as opposed to trying to convince a natural cell to do exactly what you want it to do. I think when the field talks about the different difficulties in scaling up manufacturing, it's the people that are taking cells like CAP-one thousand and two 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 Lonza has an exosome manufacturing program now as well as many of the other global manufacturers. I have a lot of confidence in this space.
Well, congratulations, Linda and A. J. For Making the strategic turn and being able to carry it out. So I'm looking forward to your next year.
We'll take our next question from Brian Corday from Boer Partners. Your line is open. Please state your question.
Hi, Linda and A. J. Great job. Thanks for the updates. I had a question for you regarding the Program for Doctor.
McDonnel, where you said you're 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's In the past, you've told me there's people that really want to join this study. And will you be giving updates on enrollment throughout the next 3 to 6 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're not going to start the trial until we found a partner or have funding that's Come in, in a non dilutive fashion so that we can continue to build out this program efficiently. In terms of the wait list, yes, my e mail blows up every day more with patients and families that want CAP-ten zero two than even investors. And so I'm 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. We're working with sites that we've already had.
We're working with investigators that are very excited. And of course, we'll let you know sort of milestones along the way.
All right. In the San Diego edition where you're 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 And the last part of that is the total cost you think it's going to be?
So at least previously occupied lab space, I'm extremely excited to be moving into this really nice space. It's in Torrey Pines, San Diego. It allows us to expand our research and Development Group, which we needed to do. We already have 6 of them working for us full time. We anticipate adding about 4 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-one thousand and two.
We'd 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 cost or partnership with royalties, what are you envisioning?
So right now, I'm really excited by this program. I can't talk much about it. But we're actually working Exosome based vaccine technologies for other diseases besides COVID, my vision is that this would be something and we've been talking about this really since we started building out the Exosome platform that these are ripe and ready for licensing, right. So this particular partner or some combination of partners we'd be interested in licensing in the technology that we've built of using exosomes, loading it with mRNA or some other type of we are 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'm envisioning is showing that it works, that the strategy is effective, which I'm fully expecting, and then we'll provide more updates as we sort of flush out our plans with our potential partners.
Hi. Then the last question I have for you is any update on the peer reviewed journal?
Yes, it's still in review, which we think is a really good sign. It's at 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.
All right. Well, I appreciate it. Keep up the good work.
Thank you, Brian. We appreciate your time and attention.
It appears we have no further questions. I will hand I'll turn 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.