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. [Operator Instructions] 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-K 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 second quarter 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, while seeing a return to pre-pandemic case volumes for a new quarterly record of 249 procedures covered, 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 four-pillar growth strategy. Danilo? Danilo D’Alessandro: Thank you, Joe, and thank you all for joining us today. Looking at the second quarter 2021 results, total revenue was $3.4 million for the three months ended June 30, 2021 and $2.5 million for the three months ended June 30, 2020 which represents an increase in revenue of $0.9 million, or 38%. Our revenue is made of three components; functional neurosurgery navigation therapy, biologics and drug delivery and capital equipment. Functional neurosurgery navigation therapy revenue consists of disposable products sales related to cases utilizing the ClearPoint system. This revenue segment increase 74% to $1.9 million for the three months ended June 30, 201 from $1.1 million for the same period in 2020. This increase reflects the resumptions in the three months ended June 30, 2021 of elective surgical procedures, which were postponed or canceled during the same…

Thank you, Danilo. As mentioned earlier, our clinical specialist team enjoyed a record quarter for procedures supported. We added multiple new biologics partners and new services to our active list and portfolio and two exciting new partnerships with Blackrock Neurotech and adeor 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 four growth pillars. First, 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 the 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 have communicated that elective procedures may once again be put on hold due to the COVID Delta variant. And the number -- 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 communications 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 first quarter 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 2021 and remain…

Thank you. And at this time, we will be conducting our question-and-answer session. [Operator Instructions] Our first question comes from Frank Takkinen 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 can give us a little bit more color on the drivers to drive the sequential growth through the back half of the year?

Yeah, I’m happy to. 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 pick up in the third quarter. 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 two weeks of June. So a lot of those replenishment orders took place in the first two 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 that a portion of those? Is it more than 60? Just trying to get a feel for the opportunity to sell into the established market right now?

Yeah. 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 because 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 to the 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 Microelectric Recording or MER in the operating room. So what I mean by that is the 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-AADC and European market, but I wanted to say that they also may have pushed out the US BLA submission. So could you just update us on this partner one if that's the correct partner and two 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 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 in 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 seen. 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 that 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. So the first question for me is about Europe. Just curious how things are progressing from a site activation or the ability to get into sites from a sales and marketing standpoint faster? I just 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 potentially 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. Now 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 three 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 two or three additional installations take place as we prepare not only to do laser ablation procedures or potentially deep brain stimulation procedures, but also prepare 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 the first in their city to be able to participate in this kind of exciting new procedure.

Okay. Great context. Thank you very much for that. Last question is just related to the direct-to-patient marketing potential for the asleep DBS procedure in the MRI suite. 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 was an article just published this week out of the Brigham and Women's Institute that talks about the accuracy of asleep DBS placement. 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 a fashion 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. Thanks for taking all my questions. Congrats on the progress and good luck going forward.

Okay. Thanks Andrew.

Our next question comes from Bjorn Ng with 10x 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 adeor Medical and it's definitely great news. Could you share with us on how you feel this will be complementary to ClearPoint 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 Bjorn. 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. So -- and 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 fixed skulls and certain disorders actually generally lend themselves to thicker 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 -- 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 under the skull. So in some clinical trials you can imagine you're not only doing two holes you could be doing four you could be doing six, you might even want to do more than that. So the thought…

All right. Thank you. 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 five 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 makeup for any potential impact, due to the COVID Delta variant? Thanks, Joe.

Yeah, I'm happy to. I think we enjoyed a very nice pace, here in, I'll say the second quarter, but I'm including sort of the recent news from this week. So it's really the month of July as well. I think Voyager made an announcement today, where 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 subtraction. So if we think about what took place in the last three to four months, effectively we added about seven partners, and then, subtracted two, relative to the Voyager and Neurocrine departure from this space. It was a net of five. 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 bring on seven new partners in just three or four months. But I think maintaining a pace of about one a month or one every two 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 one or two 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 the new journey with ClearPoint. Thank you for all the hard work to you and your team. And have a great day ahead.

Okay. Thank you, Bjorn.

[Operator Instructions] Our next question comes from J. H. Tan with JH Capital.

Hey Joe, 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.

Okay.

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 expansion 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 three to four months. So the message of going to these customers, who had always been sort of interested in ClearPoint, but simply wanted to do their pre-clinical work and their clinical work sort of on their home turf across Europe and the U.K. 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 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 thin, but it wouldn't surprise me in the next 12 to 18 months that you would see one to two 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 have already resumed the trials? And do you see any new clinical trials being initiated? And if there is any advancement on existing clinical trials that you see? Thank you.

Sure. Thanks. Yes. So the vast majority of hospitals have absolutely resumed work as a result of COVID. Now as I mentioned, there's five or six 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 in 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 from my side. And I would just want to say that I'm confident that ClearPoint can be an even bigger company than it is today under your leadership. And as a shareholder, I'm looking forward to being on this journey with you. Have a great day.

Okay. Thank you, J.H.

Thank you. There are no further questions at this time. I'll turn it back to management for closing remarks. Thank you.

All right. Well, 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 patient and their family first, as we take on greater and greater responsibility for their treatment across our entire portfolio. Thank you and have a good night.

Thank you. This concludes today's conference. All parties may disconnect. Have a great night.