Greetings. Welcome to the ClearPoint Neuro Second Quarter 2021 Financial Results Conference Call. At this time, all participants are in a listen only mode. A question and answer session will follow the formal presentation. Please note this conference is being recorded.
Comments made on this call may include statements that are forward looking within the meaning of securities laws. These forward looking statements may include, without limitation, Statements related to anticipated industry trends, the company's plans, prospects and strategies, both preliminary and projected and management's expectations, beliefs, estimates or projections regarding future results of operations. Actual results or trends could differ materially. The company undertakes no obligation to revise forward looking statements for new information or future events. For more information, please refer to the company's annual report on Form 10 ks for the year ended December 31, 2020, and the company's quarterly report on Form 10 Q for the quarter ended March 31, 2021, both of which have been filed with the Securities and Exchange Commission and the company's quarterly report on Form 10 Q for the quarter ended June 30, 2021, which the company intends to file with the Securities and Exchange Commission on or before August 16, 2021.
All the company's filings may be obtained from the SEC or the company's website at www.clearpointneuro.com. I will now turn the conference over to your host, Joe Burnett, Chief Executive Officer. Thank you. You may begin.
Thank you, Diego, and thank you to all of the investors and analysts on today's call for being a part of the ClearPoint vision and journey. We are here to help restore quality of life to patients and their families who are suffering from some of the most debilitating neurological disorders imaginable. In the Q2 of 2021, we made substantial progress across all four of our pillars of growth, including functional neurosurgery navigation, Biologics and Drug Delivery, ClearPoint Therapeutic Products and Achieving Global Scale. Importantly, we made this progress as well as adding multiple new biologics partners to our active list, bringing our total from 30 to approximately 35 today. I will now turn the call over to Danilo, our CFO, to review our financial performance in the quarter, after which I will add some detail to our 4 pillar growth strategy.
Danilo?
Thank you, Joe, and thank you all for joining us today. Looking at the Q2 2021 results, Total revenue was $3,400,000 for the 3 months ended June 30, 2021 and $2,500,000 for the 3 months ended June 30, 2020, which represents an increase in revenue of $900,000 or 38%. Our revenue is made up of 3 components: Functional Neurosurgery Navigation and Therapy, Biologics and Drug Delivery and Capital Equipment. Functional Neurosurgery Navigation revenue consists of disposable product Sales related to cases utilizing the ClearPoint system. This revenue segment increased 74 percent to $1,900,000 for the 3 months ended June 30, 2021 from $1,100,000 for the same period in 2020.
This increase reflects the resumptions in the 3 months ended June 30, 2021 of elective surgical procedures, which were postponed or canceled during the same period in 2020 due to the COVID-nineteen pandemic. Biologics and Drug Delivery revenue includes sales of products of disposable products and services related to customer sponsored clinical trials utilizing our products. Biologics and Drug Delivery sales increased 19 percent to $1,400,000 for the 3 months ended June 30, 2021 from $1,200,000 for the same period in This increase is attributable to increases in both biologic and drug delivery product revenue and service revenue as our biologic and drug delivery customers reestablish their estimated timelines for initiation or resumption of their clinical trials. Capital equipment and software revenue consisting of sales of ClearPoint Reusable Hardware and Software and of related services were $200,000 for each of the 3 month periods ended June 30, 2021 2020. Revenue from this product line historically has varied from quarter While interest in the ClearPoint system remains strong, capital headwinds and delayed evaluations due to COVID and IT ransomware concerns continue to slow new site activations.
Gross margin for the 3 months ended June 30, 2021 was 67% compared to 68% for the same period in 2020. This decrease was due primarily to a decreased contribution in the Q2 of 2021 to total sales of service revenue, which bear higher gross margins in comparison to other to our product lines. This decrease was substantially offset by an increased contribution from functional neurosurgery navigation disposable Product sales which carry a higher gross margin relative to other product lines. Research and development costs were $2,100,000 for the 3 months ended June 30, 20 compared to $800,000 for the same period in 2020, an increase of $1,300,000 or 177 percent. Sales and marketing expenses were $1,600,000 for the 3 months ended June 30, 2021, compared to $1,100,000 for the same period in 2020, an increase of $500,000 or 42%.
Both these increases reflect additions in key areas to our team as we invest in expanding our product line, launch indications and comply with global standards as installations take place around the world. General and administrative expenses were $2,000,000 for the 3 months ended June 30, 2021, compared to $1,200,000 for the same period in 2020, an increase of $800,000 or 63%. This increase was due primarily to increases in state franchise taxes, insurance expenses, occupancy costs and share based compensation. As a benefit of our last rounds of financing, we have hired 50 new employees across the organization since the beginning of the year order to accelerate product development efforts, commercial support and global expansion. At June 30, 2021, we had cash and cash equivalents totaling $61,500,000 as compared to $20,100,000 at December 31, 2020, with the increase resulting primarily from the completion of a public offering of our common stock in February of this year.
I would like to turn now the call back to Joe.
Thank you, Danilo. As mentioned earlier, And 2 exciting new partnerships with BlackRock Neurotech and Adior were announced, showing our progress in reaching further and further into the operating room to complement our MRI guidance strategy. Let's break down that progress into our 4 growth pillars. 1st, Functional neurosurgery navigation continued to rebound with 249 cases covered by our specialist team in the quarter versus 126 a year ago during COVID, a growth of about 98%. We had previously communicated that we believe case volume would return to these levels in the second half of 2022.
So on the positive side, we see that this return happened about a few months early. We are not fully out of the woods yet, however, As we are aware of a number of hospitals in states like Texas, Kansas, Louisiana, Florida and Georgia that elective procedures may once again be put on hold due to the COVID delta variant and the growing number of hospitalizations. At this point, at least one hospital has halted elective procedures and one hospital has limited them. All other communication to this point has been a warning so far. From a development standpoint, we continued progress across our portfolio and solidified budgets, schedules and team members using the significant capital infusion in the Q1 of this year.
As mentioned on the last call, we did receive FDA clearance for the SmartFrame array, which is meant to streamline workflows and help ClearPoint to cross over into the operating room. We will continue our limited market release through the second half of twenty twenty one and remain on track for a full market release in the first half of twenty twenty two. We have continued development across the rest of our pipeline as well, including the 2.1 ClearPoint software, the Maestro Brain model, the Orchestra multi trajectory headframe, Our co developed MER system in collaboration with BlackRock and our robotic assisted system called ClearPoint Revolution in partnership with D&K Engineering. We feel that we have an exciting cadence of new and improved products over the next few years, which will continue to demonstrate ClearPoint as one of the true innovative companies in the neurosurgery space. All of our previous timelines remain intact And after completing our first clinical cases with SmartFrame Array, which was accomplished in the Q2, we continue to expect first cases of ClearPoint 2.1 and Maestro in 2022 and Orchestra, MER and Revolution in 2023.
Our recent announcement to enter the Brain Computer Interface Navigation segment with BlackRock Neurotech is a very exciting one. There is tremendous potential around the future of BCIs, both for medical and communication purposes, as you can tell by the significant investment taking place in this space. BlackRock is one of the first and most experienced BCI implant companies with 29 cortical impacts completed to date in human subjects. Their recent infusion of capital is designed to accelerate the clinical and commercial launches of their pipeline of BCI tools. Under this agreement, we are leveraging our existing ClearPoint platform to build a custom SmartFrame solution and software to make the BCI implantation faster, more precise and more repeatable across multiple surgeons and hospital sites.
I think of this partnership as very similar to the work we do with our pharma partners, where we provide a system, disposables and clinical support during the infusion of a drug. In this example, we are placing the BCI as a target instead of the infusion cannula, but the business relationship is very similar. Our intention is to sell this navigation system directly to hospitals through our commercial channel and see this as another disposable spoke on the ClearPoint hub platform. Importantly, while MRI images are used for many, if not all, BCI applications, the surgery itself is designed to take place in the operating room. So this is another application that we are focused on that is not reliant on MRI access, but rather an additional crossover technology for ClearPoint into the operating room.
We also just announced yesterday an agreement with Adior, a leader in surgical drill solutions based in Germany. This partnership has 2 important elements. 1st, a distribution agreement allowing ClearPoint to sell and support the Adeor portfolio of power drills designed for the operating room here in the United States. This is an impressive portfolio of products that has been quite successful across Europe and just recently gained FDA clearance. We expect training and limited market release activities to begin in the Q4 of 2021 with a full market release in the first half of twenty twenty two.
The second element of our agreement with Adeore is that Adeore will build an MRI conditional device Based on their current Velocity Alpha design and upon the successful development, ClearPoint will be the worldwide exclusive distributor of the MRI conditional drill. This drill is an important addition to our portfolio as it is designed to eliminate the need for a slower hand twist drill and could save anywhere from 15 minutes to more than an hour of surgical time during each procedure depending on the numbers of trajectories. This is especially relevant for our drug delivery partners as multiple trajectories and infusions are quite common. Like in the BlackRock agreement, This also provides yet another crossover technology for ClearPoint to help penetrate the operating room as well. 2nd, our biologics and drug delivery team continued to add additional partners and services in the second quarter.
We currently have As a reminder, it is common that each customer or partner has a drug platform of their own, meaning they are not planning to use their drug or vector for only one indication. Our decision to expand into Europe has already helped us win additional European based pharma business and academic researchers. We plan to continue adding partners and still believe that an initial commercial gene therapy approval for neuro could take place in the year 2022. As you've likely seen from recent press releases, the enrollment of patients into these trials has restarted after COVID and we fully expect multiple partners to continue enrollment and initiate new trials here in the second half of twenty twenty one. It is also important to note that the majority of our investment into the navigation system mentioned in Pillar 1 applies also to Biologics and Drug Delivery.
That is the beauty of our platform strategy as much of the investment is applied across many indications in both Biologics and medical device navigation. This is crucial from a training standpoint as well. Every biopsy case, laser ablation case Our deep brain stimulation case the hospital does with ClearPoint today is in fact training and preparing them to do biologics cases in the future. For our 3rd pillar, therapeutic devices, we have continued our development progress and remain on schedule for our previously communicated timeline. The ClearPoint exclusive laser ablation system that is in development with CLS in Sweden and IGT in France continues to make progress and collect data and we are still planning for a submission in the second half of twenty twenty one to the FDA despite some COVID related delays.
We did announce an installation and clinical partnership in Paris at Rothschild Hospital a couple of weeks ago. The primary clinical data that will be collected will be on pediatric tumors using the complete ClearPoint CLS IGT laser solution with the expectation of the first patients be enrolled in the first half of twenty twenty two. Our biopsy platform similarly is planned for first human cases in 2022 and remains on track today. Finally, our 4th pillar of achieving global scale has made progress as well. Our quality system has been successfully updated to be compliant with the new European MDR rules that went into effect in May of this year.
This is not a small task and has been daunting enough to some companies that they have decided not to sell certain products in Europe under these new regulations. Although compliance is challenging, we believe our investment is the right one and the simple fact that we have one of our clinical specialists present at our procedures helps us with that compliance and market surveillance. We have also relocated key personnel to Europe and are preparing to do additional installations like the one that was just announced in Paris later this year. Based on the Q2 results, we are continuing to stand by our prior forecast of between $16,000,000 $17,500,000 in revenue for the year and a range of 900 to 1000 cases covered by our clinical team. The last comment I would like to make is about our team.
We have successfully added about 15 exceptional team members across clinical, development, Quality, legal, finance and production over the past 6 months, and I want to make sure I underline how special this team is. We have a vision of where we want to go. We are well capitalized and we have a motivated and very capable team that knows these patients and their families are depending on us. In my experience, this has always been a recipe for success. With that, I would like to open up the call to any questions.
Thank you.
Our first question comes from Frank Tackanan with Lake Street Capital Markets. Please state your question.
Hey guys, thanks for taking my questions. I wanted to first ask on the fiscal year 2021 guidance reaffirmed. Where should we expect the reacceleration to come to drive the sequential growth through year end? With the report here, it's modeled in to be growing through the end of the year. So I was just hoping you could give us a little bit more color on the drivers to drive the sequential growth through the back half of the year.
Yes, I'm happy to. So and thanks for the question, Frank. So as you mentioned, we have reiterated our forecast And obviously, that does imply that the second half of this year has significantly more revenue than the first half. So we are expecting to see that and see that Pickup in the Q3. Again, when you're growing things off of a smaller revenue base, even a week of a delay of a delivery to a biologics customer Or for example, we had a very large number of cases in the last 2 weeks of June.
So a lot of those replenishment orders took place in the 1st 2 weeks of July. So really just timing at where the quarter happened to end, I think maybe brought the revenue numbers for Q2 down, but it's certainly been replenished here in Q3. And in fact, to date, July has been our most successful month ever from a biologics and from a Case volume standpoint, so we do expect that acceleration to start back up in Q3 here.
Got it. That's helpful. Thank you. Moving over to Array, maybe speak to the opportunity you guys see with this product in your 60 established sites. Do you feel this is something All 60 sites would benefit from implementing at their practice.
Is it a portion of those? Is it more than 60? Just trying to get a feel for the opportunity to sell in the established market right now.
Yes, I do believe, I believe it is an opportunity for not only existing customers, but maybe even more for new customers that would like to use some of ClearPoint's technology, especially when our laser is available and our MER system is available, but simply can't do that today We're still waiting for that solution. But I do think it's something that applies broadly. I don't think it's specific to a hospital and I think it becomes more specific Timing to an indication. So what I mean by that is if you're doing a laser ablation procedure, using the array system makes a lot of sense because it's faster, it's simpler, it's a little bit easier to make adjustments. And If you're doing multiple trajectories in the same patients, which is very common for tumors, it makes that workflow a little bit simpler.
So I think the adoption of Array into laser procedures will be sooner. If you wanted to use the Array for a procedure like a deep brain stimulation case. This is really required to use something like microelectrical recording or MER in the operating room. So what I mean by that is that timing of array adoption for deep brain stimulation might have to wait until our MER system is available closer to 2023. So it really depends on what it is the site is looking to use our technology for.
Got it. Okay. And then last one for me. I wanted to ask on I heard your commentary about you still are expecting your first biologic Approval this year that is using the ClearPoint system. Can you speak to this approval?
I want to say it's PTC, See AADC in the European market, but I want to say that they also may have pushed out the U. S. BLA submission. So could you just update us on this partner, 1, if that's the correct partner and 2, their latest development timeline that they're expecting? Yes.
So I believe what they've communicated is that they're still expecting to submit their BLA here in 2021 with a potential approval in 2022. So I do believe that commentary from PTC is effectively what we're presenting here today. There is the potential for a European commercial approval to take place sooner than 2022 or sooner than the United States. But whether it happens at the second half of this year or the first half of this year or the first half of next year, I think it kind of remains to be We need to remember that it's going to be a very significant milestone whenever it takes place because it will be the very first gene therapy approved for a neuro indication. However, being the first is always challenging when the FDA notified bodies are continuing to work through all of those different requirements.
We know many of the challenging requirements have been taking place related to manufacturing and replication of the drugs themselves since many of these facilities are set up for the first time, but we're still we'll be ready whenever that clearance is available. One other thing I'd build on that comment, However, is that there are also some other opportunities for orphan disorders that could take place in 2022 as well. So while PTC is one of the partners we work with where we've announced the name and we're doing a lot of pre launch activities and planning for them, It does not mean that that's necessarily always going to be the first one. There are other opportunities in 2022.
Got it. Okay. That's helpful. That's all for me. Thanks for taking my questions.
All right.
Thanks, Frank.
Our next question comes from Andrew D'Silva with B. Riley Securities, please state your question.
Hey, good afternoon. Thanks for taking my questions. Apologies if you answered any of these. I was jumping between calls. Okay.
So, first question from me is about Europe. Just curious how things are progressing from a site activation This ability to get into sites from the sales and marketing standpoint faster. I did see a couple of installs year to date, which looks good, but obviously Europe seems like it could be approved from a commercial standpoint first and the majority of the navigation footprint for y'all is domestic. So I'm just trying to get a sense of how support there from ClearPoint will look once approvals and launches start happening.
Okay. Thanks for the question, Andrew. And yes, so Europe is starting to open up again. However, there's obviously some additional challenges worldwide with the Delta variant that we're seeing. However, the installation process seems to have resumed.
As I think you pointed out, we've had 3 installations in Europe that have taken place so far this year in Denmark, in Poland and in France. I would say by the end of the year, we expect to have at least 2 or 3 additional installations take place as we prepare not only to do laser ablation procedures or Potentially deep brain stimulation procedures, but also prepared to do some of the drug delivery cases either under some sort of commercial approval as you pointed out or as we extend into clinical trials with some of our partners that are starting to enroll in European sites. So I think It's the ability to have some support from the pharmaceutical side of things for clinical trials to get our equipment in Certainly helps us to accelerate the process of installation because we generally have a champion at each one of these centers that's really, really interested in being the first in their country or certainly
Last question is just related to direct to patient marketing potential for the Aselete DBS procedure In MRI, sweet, just where are we on that or what should we think about as next steps?
Yes, I think we're actually making quite a bit of progress there. In fact, there And some of the materials from different DBS companies are starting to indicate more and more usage of Really leaving it up to the physician as to whether the patient should be awake or asleep for these procedures. We continue to gather this data and organize it in and expect to start doing some basic education directly with neurologists as well as physician providers on some techniques on how the ClearPoint procedure is used and again, whether that patient needs to be awake or asleep for those procedures at the physician's discretion. So I think things are absolutely looking positive there.
Great. Hey, thank you very much for taking my questions. Congrats on the progress and good luck going forward.
Okay. Thanks, Andrew.
Thank you. Our next question comes from Dijon Nguyen with 10 Times Capital. Please go ahead.
Hey, Joe. We have been following the progress of ClearPoint and it's really exciting to see how the story is unfolding. And I continue to be a strong supporter of what you do. So I just want to touch on the recent partnership that ClearPoint formed with Adeo Medical and it's definitely great news. Could you share with us on how you feel this will be complement complemental to ClearPoint's existing solutions?
And how would this partnership Value add to ClearPoint's current offering as well as for both the functional neurosurgery and the biologics and drug delivery partners. Thank you.
Thanks for the question, Jordan. And I'll cover the part the second part first, which is really the strategic rationale for this, which heavily relies on our ambition in the biologics and drug delivery space. We truly want to be a leader there and continue to be a leader and Not relinquish that lead once we have it. So what the drill solution will allow us to do, the one that is currently in development is it will allow us to replace our Twist drill, which is currently in our kit and is used during these clinical trials. So if you can imagine the difference of drilling inside of an MRI environment.
So remember, you can't have any heavy metals there. You have to use titanium drill bits and things like that. So the primary solution that's used in that MRI environment today for these drug delivery cases is putting a hand drill, so effectively like moving your arm in a circle to actually rotate the drill bit and drill through the Skull. And if you have kind of middle aged patients with very sick skulls and certain disorders Generally lend themselves to bigger skulls as well. Every single one of those drill holes can take you 15 to 20 minutes And you could actually have to do what's called as described as bone work at the end to make sure you don't push into the skull itself, but be able to scrape around the holes and give yourself a clean entry or a clean purchase onto the skull.
So in some clinical trials, you can imagine you're not only doing 2 holes, you could be doing 4, You could be doing 6, you might even want to do more than that. So the thought of 10 to 15 minutes for each one of those holes can be a pretty daunting one. It can also be Tyresym for the surgical team that's doing the procedure. So having an automated version that's similar to the ones available in the operating room today, You could effectively do that same exact work in less than a minute for each one of those holes. So anything we can do to shorten the procedure time to take up less Time in the MRI magnet itself and to ensure that when the patient is asleep under general anesthesia, we're not keeping them under anesthesia too long.
These are crucial, crucial elements to all of our drug and pharma partners. So it's a very, very important project and we feel we've partnering with the best company to kind of deliver on this ambition. So that's the strategic part of the development partnership. The first part, which is the more immediate opportunity, is the U. S.
Opportunity to distribute this offer the Velocity Alpha, which is the high end precision surgical drill that Adeore makes and distributes throughout Europe. So this is Atul, it's an existing $200 plus 1,000,000 market here in the United States. If you look across all the indications, including orthopedics and spine and Cranial, intracranial for neuro, dentistry and things like that. Obviously, our channel is not focused on things like dentistry today, But our presence in the hospital and the intimate relationship we have with the neurosurgery community certainly gives us a chance to go after cranial and spine immediately And actually potentially play in Orthopedics as well. So our focus is going to be on the customers that we know and the relationships that we have today.
However, we are going to explore the ability to expand into some of these new markets as well. But even if you just look at the existing U. S. Market for cranial and spine. So the neurosurgery applications that our customers are using today, that's at least a $50,000,000 opportunity from the data that we
Right. Thanks, Joe. That sounds really exciting. So I just got one more question relating to our biologics and drug delivery partners. It's great to hear that we added another 5 partners in this quarter.
So do you expect that we will continue adding partners at a similar pace? And could you share with us some color on how our biologics and drug delivery business will make up for any potential impact due to the COVID delta variant? Thanks, Joe.
Yes, I'm happy to. I think we enjoyed a very nice pace here in, I'll say the Q2, but I'm including sort of the recent news from this week, so really the month of July as well. I think Voyager made an announcement They were discontinuing their surgical approach relative to their drug delivery platform. So obviously, that's the subtraction of one of those partners, at least temporarily. It still remains to be seen if they're interested or willing to sell off that asset to another partner and Restart some of the clinical work, but the way that we think about counting these partners is there's some addition that takes place and there's also some attraction.
If we think about what took place in the last 3 to 4 months, effectively, we added about 7 partners and then subtracted 2 relative to the Voyager and Neurocrine sort of departure from this space. So it was a net of 5 and that's how we continue to make this count. I would say that that's more on the high end of what I would expect to kind of bring on 7 new partners in just 3 or 4 months. But I think maintaining a pace of about 1 a month or 1 every 2 months is certainly something that's available. We still believe there's another 100 Partners out there across intracranial and spine that would benefit from ClearPoint Technology.
And I'd say we have active conversations with 20 to 30 of them at this point, but they haven't matured to the point where we would say, okay, that's an official partner at this point. So similar to the way we think about capital equipment placements where we've got a funnel of potential customers and then we look to install 1 or 2 a quarter. Similarly, on the pharma side of things, we're trying to do the same thing. We're starting with a very large base of potential users that would benefit from ClearPoint and looking to convert them into formal partners on a steady cadence.
All right. Thanks a lot, Joe. It's a privilege to be your shareholder and to be on this journey with ClearPoint. Thank you for all the hard work to you and your team and have a great day ahead.
Thank you, Barn.
Our next question comes from J. H. Tan with J. H. Capital.
Please state your question.
Hey, Juve. I would like to also congratulate you on the quarter, and I'm really happy to see how ClearPoint has been progressing so far under your leadership. So the first question I would like to ask about is the global expansion. So in terms of Europe, We have seen trials such as PTC and also the recent announcement with the Hospital Foundation Rothschild in Paris. So do you see any interest, accelerate the interest in terms of new partnerships in the pipeline?
And if possible, can you also walk me through how you are planning to scale up your global expansion to cater to this pipeline? Thank you.
It's a great question, J. H, and thank you for your support as well. The global We have focused on initially has been in Europe. And to answer your question directly, we absolutely, As a result of this investment and this communication and not just communication, but achievements of starting these installations, we have already been able to win Multiple European based pharmaceutical partners, which we saw added here over the past 3 to 4 months. So the message of Going to these customers who had always been sort of interested in ClearPoint, but simply wanted to do their preclinical work and their clinical work sort of on their home turf across Europe and the UK.
For them to now have the opportunity to work with ClearPoint, It's something that absolutely is opening the doors. And that combined with our very broad indication for not just our navigation system, but for our SmartFlow cannula On the delivery of fluids to the brain gives quite a bit of confidence into our partners to say, hey, I'm thrilled to be using the SmartFlow and the ClearPoint system Because it's been tried and tested through thousands of cases at this point, it's by no means purely experimental. So I think that's been very positive and We've certainly seen that in Europe. We have also generated interest from partners in Asia as well, and we are looking at evaluating the right partnerships and ways to pursue there. Again, we don't want to spread ourselves too thin and we also recognize that the technical complexity and the The benefit of having a ClearPoint personnel in the room for the procedure is certainly something we don't want to walk away from just yet.
It's something that we want to continue to build on. So we're going to be very careful as to how far we spread ourselves in, but it wouldn't surprise me in the next 12 months to 18 months that you would see 1 to 2 installations in Europe for that same reason of being able to help Asia based pharmaceutical companies install closer to home.
Okay. Okay. And Thank you for that. That was really insightful. And I have just one last question for you.
It's good to see that The elective procedures are starting to rebound. Can I just ask how many partners or hospitals are you seeing that And do you see any new clinical trials being initiated? And if there is any advancement on at the distinct clinic press Charles that you see? Thank you.
Sure thing. Yes. So the vast majority of hospitals have absolutely resumed work as a result of COVID. Now, as I mentioned, there's 5 or 6 states here in the United States that are struggling with the delta variant more and have issued warnings. So if they are sites that would be enrolling clinical patients, it's possible that Trials would be impacted.
However, generally trials that are being performed here in the United States are spread across multiple sites. So even if a site in Texas, for example, had to pause for a period of time to deal with COVID, I don't know that that same issue is present the Northeast or in California necessarily where a lot of these other patients would be initiated. So whereas I could see Some slowdown potentially in trial enrollment in some areas. I don't see the same halt in trials like we saw over the past 18 months. So That's I think one thing to think about.
Further, I do expect, if I were to tell you based on what I know today looking across the 35 active relationships that we have, I would say that at present, the schedules I've seen involve us continuing enrollment and initiating patients in the second half of this year across Phase 1, Phase 2 and Phase 3 trials. So there's quite a bit of demand. A lot of these no one wants to go faster than our biotech partners want to go. They're absolutely Moving as quickly as they possibly can because their incentives are to do that as well to get these patients enrolled and show the benefit of their therapy. So, like I said, we're trying to be there for each one of our partners and make sure we're ready as soon as they and the hospital are as well.
Okay, okay. Thanks a lot, Joe. So I have no more questions on my side. And I would just want to say that I'm confident that TailPoint can be an even bigger company than it is today under your leadership. And as a shareholder,
Thank you. There are no further questions at this time. I'll turn it back to management for closing remarks. Thank you.
All right. Once again, thank you to everyone interested in being a part of this team's story here at ClearPoint. We believe that we are doing very important work and will continue to put the
Thank you. This concludes today's conference. All parties may disconnect. Have a great night.