Monogram Technologies Inc.

Hello, everyone. Welcome to the Q2 2024 update call with Monogram. We look forward to reviewing our quarter with you. We've got a lot of great news to go over with you and look forward to your questions at the end of the call. Let me just read through this legal disclaimer so we get it on record and then we'll get into the meat of the matter. This presentation by Monogram Orthopedics may include forward-looking statements to the extent that the information presented in this presentation discusses financial projections, information or expectations about Monogram, business plans, results of operations, products or markets, or otherwise make statements about future events. Such statements are forward-looking. Such forward-looking statements can be identified by... the use of words such as should, may, intends, anticipates, believes, estimates, projects, forecasts, expects, plans, goal, target, and proposes. Although Monogram believes that the expectations reflected in this presentation are based on reasonable assumptions, there are a number of risks and uncertainties that could cause actual results to differ materially from such forward-looking statements. Thank you for letting me go through that. Okay, this is just a brief summary of the agenda for today. We're gonna give you the brief summary of the financial information for the quarter and year to date. And then Ben's gonna go over the recent milestone accomplishments, next steps in our evolution, and then we're gonna open it up to questions. So just short and sweet. Okay, so in line with how we've previously reported, Our cash position at the end of June 30th, 2024 is $7.3 million. And we have a operating cash flow of 6.4, almost $6.5 million over the six months ended June 30th, 2024. Our average monthly cash burn, as we've stated in the past and we've stuck to, is a little over $1 million a month. We've been really tight on marshaling our resources to stay at that level, and we've succeeded in that goal. It's important to note that we have 27 full-time employees and a highly variable cost structure. We still have no traditional debt and no warrant obligations at this time. A portion of our spend was related to the verification and validation phase that was ongoing through June, and that's coming to an end. So we will be able to reduce our contract labor, which is a big part of our variable cost structure, to a degree going into the third quarter. So we're comfortable where we are, and we're ready to execute the next phase of our development. So with that, I'll hand it over to Ben and he'll go through the recent milestones.

Thanks. Sure. Thanks, Noel. And thanks, everybody, for joining you for our Q2 2024 business update. As Noel said, we hit some pretty major milestones that we're quite excited about. So the first, not the least of which, is we successfully submitted our 510K application to the FDA for our embossed TKA system. The application was submitted on July 19th. It has passed administrative review. So the FDA has gone through it and it is a complete application. And now we're in what's called the primary substantial review phase, which should last approximately 60 days. So we expect to hear from the FDA on or around September 17th. So that's going to be here before we know it. Just in terms of this is not guidance, but this is from the FDA's website. The goal in 2024 for the average time to a decision is about 124 days right now. So we. are pretty excited about where we are. We are looking through this fundraiser that we're currently running and some of the other initiatives to be in a spot where we can push forward. And we are not currently expecting a clinical trial request, but as I'm gonna get into with the next key milestone, we're ready for one if that becomes necessary based on the FDA's feedback. So again, we're pretty confident with the application. We're pretty confident with the substantial equivalence of our system to the claims predicate. And we look forward to interacting with the FDA around that submission. The next major critical milestone, we have alluded to this for some time, but we were able to announce our strategic clinical trial collaboration with Shalvi. Shalvi, we're very proud to be partnering with them on the clinical trial in India. We see a lot of strategic potential kind of in the intermediate term to post-approval launch OUS. We see them as a potential partner that could be very helpful for that. They are one of the largest orthopedic hospital networks in the world. We think it's pretty validating that they like our system. We are really excited to get it into their surgeons' hands. We are going to be working with six surgeons on the clinical trial. We anticipate there's going to be a pretty, pretty quick trial. It's 102 patients is the target patient population with three month follow up. And we anticipate that we will be submitting our system for regulatory clearance in India very as soon as possible. So we're kind of on track with those timelines. The plan right now is to leverage the clinical data from outside the U.S. for post-launch marketing in the United States, as well as for launching internationally where we think we can scale quite rapidly with less working capital constraints. So it's pretty exciting to be talking to various distributors. Actually in January of next year, we're gonna be attending a major international trade show in Dubai. where we hope to continue to explore commercialization opportunities outside of the United States as we anticipate hopefully a clearance. And obviously in the United States, we also continue to look at ways to leverage our technology. And with that, I want to highlight the key upcoming milestones that we see. So We anticipate submitting the application for regulatory clearance in India. We expect at some point to obtain hopefully clearance for the emboss system here in the United States or to have a decision. If the decision requires clinical data, we hope to be in a position where we're ready to provide that. And we are... working very quickly towards our first live inpatient, uh, surgeries, which of course is, uh, really why we're here and what this is about. So with that, I want to open up the opportunity for, for questions from investors. Uh, if you do have a question for Noel or myself, uh, please feel free to, uh, to write it in. And, uh, with that on the right-hand side, you'll see a, uh, a chat. I'll just, uh, Let me see if I'm not seeing any chat. Let me see if folks can now chat. Perfect. So on the right there, you can see if you want to leave a question for Nolari to respond to, you can type it to the chat. The first question comes from Tom Kerr. Let me put that here. So this release says FDA decision is expected within 90 days of initial submission, but you said previously six to nine months. Are those two different timeframes? Can you clarify the FDA submission timeframe expectations? Sure. So we do not expect a decision from the FDA within 90 days. The way it works is we're right now in the substantive review period, so that takes 60 days. And how it works with the FDA is that it's like playing chess where whoever's turn it is, that's their clock. So right now we're on the FDA's clock. So they have 60 days. Then when they come back to us with questions, they stop the clock and they hand the clock to us. it's our job to respond to those questions as quickly as we can and address anything that they raise attention to. And then we provide those responses back and the clock goes back to them. So the time that they review the application, they try and have that done within 90 days. And the average, the target that they have right now per the FDA is about 128 days. So hopefully that's helpful.

Okay.