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Seroclinix & UTAK - December 09 VIEW RECORDING - 22 mins (No highlights): https://fathom.video/share/ziLfsyWqGM-CVxrCB9fFp7DP_7hxNgLZ --- 0:00 - Meryssa Valdivia-Lopez Good morning. Appreciate you guys joining. 0:06 - Andrew Hartmann (UTAK Laboratories) Happy to help. 0:09 - Nicole Miller I've come up with a list of questions to run down for them, so. Rapid fire. I just try to be prepared and also efficient with people's time. 0:20 - Andrew Hartmann (UTAK Laboratories) Yeah. 0:22 - Nicole Miller Well, it's nothing worse than, like, we're trying to find information live on a call. I try to be as prepared as possible to have, like, everything open so that any question that can be asked, I just have to, like, navigate to that open tab, not have to, like, track it down. Same. I've got the quotes open. 0:39 - Andrew Hartmann (UTAK Laboratories) My list of questions is Excel. So hopefully it'll be a pretty quick just kind of run through on some design. And I want to kind of chat about a couple of different pricing options and figure out if you're looking to buy all these as one thing now or if the idea is just getting pricing and we're still just going to do, like, trial order of one, you know, one of the. Sunsets of these parts, and that kind of thing. Yeah, makes sense. 1:09 - Nicole Miller Where are they located at? New York. Okay. 1:17 - Andrew Hartmann (UTAK Laboratories) All right, Howard is here. Hey, Howard, welcome. If you can hear us, we can not hear you. Can you hear us, Howard? Yes, yes, I can hear you. 1:56 - Howard Lee (Seroclinix) Awesome. Is Jarek with you? 1:59 - Andrew Hartmann (UTAK Laboratories) They're waiting for Jarek, right? right? Yes. Okay, no problems. 2:05 - Howard Lee (Seroclinix) Are you guys having the cold snap up in New York right now? Okay, sorry. Yeah, can you hear me okay? I can, yes. 2:28 - Andrew Hartmann (UTAK Laboratories) Okay, perfect, yes. 2:28 - Howard Lee (Seroclinix) It's a bit faint there. Got it. Okay. 2:38 - Andrew Hartmann (UTAK Laboratories) How cold is it up in New York right now? Oh, it's pretty cold. It's minus a few degrees. We're having a heat wave right now in Missouri. It's 50 today, which is significantly warmer than it's going to be tomorrow. I think we drop into the 20s overnight. Oh, my gosh. Yeah, yeah, yeah. 2:56 - Howard Lee (Seroclinix) Yeah, yeah. yeah. Yeah, yeah. 2:59 - Andrew Hartmann (UTAK Laboratories) I'm Marissa. They're balmy 65 right now, I assume. 3:03 - Nicole Miller Yeah, 70 is a nice warm 85 this last weekend. 3:07 - Andrew Hartmann (UTAK Laboratories) Oh, wow. It's amazing how much the weather changes across the country. 3:14 - Nicole Miller Hey, Jarek, welcome. Hi. Hi, good morning. 3:16 - Andrew Hartmann (UTAK Laboratories) How are you? Doing pretty good. were just kind of – you guys appear to be freezing. We're moderate, and Nicole is warm. Our temperature is staying across the country. 3:26 - Jarek Flanders (seroclinixlabs.com) Single digits to teens. I mean, it was one last night, so. 3:30 - Nicole Miller Whew. Yeah. It's early. 3:32 - Jarek Flanders (seroclinixlabs.com) I know where I live, though, so. You're supposed to have that Arctic blast or whatever coming through, I think, this weekend. Yeah, as long as ski town, ski country gets it, then I'm happy, so. 3:46 - Andrew Hartmann (UTAK Laboratories) Awesome. Well, just to kind of jump right in, had a couple of sort of general questions as well as some specific questions as far as the design. I know pricing has been a concern for us on these. It's – it looks like there's one. one. Nanolite more than all of the rest that are really driving the cost of this control. It's that leukocyte esterase. Yeah, yeah, you brought that. 4:09 - Jarek Flanders (seroclinixlabs.com) We all agreed on that in the beginning that that would definitely be something more new and harder to source and more expensive. So that was very clear from the beginning and we assumed that too, but it is important to us. But if that's a make or break, then I don't know how that will work out for us. Right. Howard, Ali is more of a necessity, right? 4:37 - Howard Lee (Seroclinix) I think he's talking to multiple people, but Ali has done the, I think he's on multiple calls right now, but Ali, we all know would be harder to source. 4:45 - Jarek Flanders (seroclinixlabs.com) Not as much material on the market. 4:47 - Andrew Hartmann (UTAK Laboratories) We understand that. Yeah, I'm just kind of curious, you know, how necessary it is for you or if you'd want to see an option with it removed. It's very important, but if, I mean, depending on how much that is driving up the cost. 5:00 - Jarek Flanders (seroclinixlabs.com) Yeah. Yeah. What would be the cost if we took it out, Jarek? Like, what do you guys think if we took it out? 5:07 - Howard Lee (Seroclinix) Marissa, would you have any kind of ballpark on that? 5:11 - Andrew Hartmann (UTAK Laboratories) Let me see. 5:15 - Meryssa Valdivia-Lopez I can give a ballpark on it. 5:17 - Nicole Miller I think, like, $1,500 per level. That's for the quantity of two-pack in synthetic urine is the one I'm looking at right now. So, goes from $2,500 per pack to about $1,500 per pack. So, a significant savings there. Oh, wow. Okay. Overall, like, 40% cheaper in that range? 5:43 - Jarek Flanders (seroclinixlabs.com) 30, 40% just for moving out late? 5:47 - Nicole Miller Yes. For that specific level, it might be different for quantity breaks, but just, like, general ballpark for that one. Okay. Okay. Yeah, that makes a big difference. 5:57 - Jarek Flanders (seroclinixlabs.com) Yeah, because, like, what we were looking at this morning... Like, just regular urine with those numbers, I mean, up to a liter, that's $302 each mil, the cost. mean, that's a lot. Just for us to try and make this reasonable to work with the rest of our products. Right. That's why I was hoping if we could expand the catalog decals and controls to at least be able to meet your minimum requirements for at least this first time. Because, again, the goal was to consolidate how many items we do use for our customers' total panel, with LE being pretty important. I had a question about that minimum order size in your comment there. 6:39 - Andrew Hartmann (UTAK Laboratories) So, it's 50 ml per level and, like, per product. Per product, If we're looking at, like, the linearities, you know, each of those levels, one through five, we've got to make 50 ml of each of those levels. 50 ml. So, there's not a way to split it, like, you know, five. Yeah. 6:56 - Jarek Flanders (seroclinixlabs.com) We were hoping if we expanded that into the other. Two items, calibrators, or controls that overall it could get our cost per mil down. Because we would use more than, like a calibrator would probably use like 10 mils per customer where linearity is only one. 7:14 - Andrew Hartmann (UTAK Laboratories) Yeah, think it's definitely worth looking at like pricing this as a whole as well and seeing if, you know, if you're ordering all of these products, you know, if there's an additional discount, we could tie into it. So that was kind of my next question is for your first order, would you be just wanting to order like one of these sections of products to try it out? Or are you going to be looking to order, you know, a set of everything, a linearity, a cal, a QC? 7:41 - Jarek Flanders (seroclinixlabs.com) Howard? 7:43 - Howard Lee (Seroclinix) I think we want to order at least one set of each one, like just a small batch to test first to make sure we can look at stability, you know, open like once you thaw and use it for 510. We'd have probably have to do that as well. And I think for the calibrators, Jarek, don't we need to have, like, three levels for every test? Not for a minimum of two, like a zero? 8:08 - Jarek Flanders (seroclinixlabs.com) A lot of them are zero and just a cal. So it looks like one, two, three, four of them are only, three of them are only a blank and one a cal. Okay. Sorry, there's a bench right above my head right now, if you can hear that. Since it's cold, it keeps kicking on. Like, an example, if you look at the calibrator section, are, some of them go high, like Euro, all the way up to five calibrators. But, I mean, some of them don't have as much. Okay. I know, but the LEs and everything, which is what's going to drive the cost of it. Right, right. 8:50 - Howard Lee (Seroclinix) Okay, so we just do the eight, right, Jarek? Like, just the eight, right? Not, not, and we take an LE. Take out LE? 9:02 - Jarek Flanders (seroclinixlabs.com) Do you think our current source for that will be pretty dependable on to get this long-term? yeah. Okay. I think so. So we're going to sell it down to eight analytes with switching to UTAK then? Yeah, yeah. 9:19 - Howard Lee (Seroclinix) And we can quote out those just to see how it works out. 9:22 - Andrew Hartmann (UTAK Laboratories) So we'll quote an option with the LE in for the CALS and QCs and the linearity and then we'll quote an option with it out. Okay. Okay. Just so we can get pricing and kind of figure out what's going to be best for you. 9:35 - Jarek Flanders (seroclinixlabs.com) Yeah, because if we're not sure on the LE stability too, we don't want to get burned on that. So I think THAAD, as long as we can get at least two weeks, which we'll do our own studies and follow up with you, because I know you'll want that info too, then that would really meet our minimum requirements. A thought to LE stability, which we would know as soon as we try your products. 9:58 - Andrew Hartmann (UTAK Laboratories) Okay. As far As as getting some pricing tiered out, so the controls, we're going to do a 10 mil fill size per vial. We can quote you at a minimum order size just for like a trial order, but what other volumes would you be interested in seeing for that? 10:14 - Jarek Flanders (seroclinixlabs.com) I guess for calibrators, 1 and 5 mils, and controls, 5 and 10. You're talking fill size there? 10:26 - Andrew Hartmann (UTAK Laboratories) Yeah, fill size, yeah. 10:34 - Howard Lee (Seroclinix) And then, Jarek, so we can't add pH, specific gravity, or microal, because you already have microal, right? 10:44 - Andrew Hartmann (UTAK Laboratories) What's that? 10:45 - Jarek Flanders (seroclinixlabs.com) Microal, because we already have microal? 10:47 - Howard Lee (Seroclinix) No, because we talked about this before. 10:50 - Jarek Flanders (seroclinixlabs.com) The manufacturer of the microalbumin says that it detects albumin, and the manufacturer of microprotein says it. It detects albumin in both those statements. Okay. I mean, if it's cheaper, then we could just do a control or a calibrator of just microalbumin, because that cal set we use is pretty expensive. Will we have enough to replace the barrad QCs then in this stuff we're doing? 11:20 - Howard Lee (Seroclinix) It'd be everything but microalbumin. 11:23 - Jarek Flanders (seroclinixlabs.com) Oh, so the microalcal, we stayed with that. Yeah, unless they wanted to make something small, something on the side. So they would do an element on its own. Yeah. No, let's just leave it the way it is. 11:36 - Howard Lee (Seroclinix) Otherwise, you know, it's too hard to change these people. Yeah. 11:40 - Jarek Flanders (seroclinixlabs.com) Exactly. They're already using the multipoint cal, which means they don't need the linearity. Okay. 11:45 - Howard Lee (Seroclinix) So then that would mean that we would have lucaside on its own, microal, and then pH is specific gravity on its own. Okay. That's fine. That's fine. 11:55 - Jarek Flanders (seroclinixlabs.com) Yep. Yep. Yep. 11:57 - Howard Lee (Seroclinix) Okay. I think that's good. So we have a. Plus 4 standalone, which still reduces their bottles by, you know, 20, 20, 30 bottles. 12:04 - Jarek Flanders (seroclinixlabs.com) That's good. A lot, a lot. Yep. 12:07 - Andrew Hartmann (UTAK Laboratories) As far as total quantity for the QC, we'll quote you a 50 ml minimum, but what kind of, you know, like, realistic projections do you have on, like, you know, if this goes forward, what volumes would we be ordering so we can get you some tiered pricing, kind of like we did on the linearity sets? So, Howard, how many sites a month do you think? 12:28 - Jarek Flanders (seroclinixlabs.com) 20? 12:30 - Howard Lee (Seroclinix) If everything goes as planned, I think we're looking at about 35 to 50 sites a month ordering, let's say, so the 10 ml QC, is that going to last two weeks or four weeks? 12:43 - Jarek Flanders (seroclinixlabs.com) If they don't use it all, hopefully four, depends how messy they get. 12:49 - Howard Lee (Seroclinix) Okay, so do you think two five mils would last four weeks? Yeah. 12:53 - Jarek Flanders (seroclinixlabs.com) If they keep it, if they transfer it and keep it in, say, a tube and not just keep using transfer pets. If they're safe with it, then, yeah, too. So 10 ml, say, for 35 sites, so 350 mils, too. 13:13 - Howard Lee (Seroclinix) Yeah, and we'd have to have a bit of stock, so probably looking at about 500 mils, and then for calibrators… Yeah, 500 mils for QC, yeah. Yeah, calibrators, could we do like 2 or 3 mils per sec, because they'll use that just once, right, like once per week? Oh, no, it depends on the asset. 13:29 - Jarek Flanders (seroclinixlabs.com) Unless something happens, they're instrument twice, so. Okay, so twice per week, and then… Twice per cat, twice per cat. So once or less. Once or, okay. Like, 2 mils a site? 2 mils times per week, right, Jerk? 13:51 - Andrew Hartmann (UTAK Laboratories) 2 mil per week? 13:54 - Jarek Flanders (seroclinixlabs.com) Yeah, well, twice, so 4 mil. Okay, so 4 mil, and… 14:00 - Howard Lee (Seroclinix) That's eight, so each kit is going to have four, four. So each kit will have 12. The QC will do 10 plus, if we're doing five mil vials, you know, maybe we do like three weeks' worth, so 15 mils. Yeah. 14:24 - Jarek Flanders (seroclinixlabs.com) 15 mil for QC. Yeah. And two, two mils for QC, so four total. 14:35 - Howard Lee (Seroclinix) For two weeks or three weeks? Well, they should thaw it, use it, keep it, and hopefully not have to calibrate again until the next kit. 14:43 - Jarek Flanders (seroclinixlabs.com) So there's the second one, two mil. Okay, got it. Okay. 14:47 - Howard Lee (Seroclinix) So then that times, like, you know, between 35 searches, let's say about 35 sites, some stock. 14:54 - Jarek Flanders (seroclinixlabs.com) So it'll be 50 sites. 14:58 - Howard Lee (Seroclinix) I think I can use these numbers. numbers. We're of to kind of work up a couple of quantities. 15:02 - Andrew Hartmann (UTAK Laboratories) So similar to that linearity quote, we'll quote you guys a couple of different quantities there just to kind of get an idea with pricing. And we'll quote you with and without the LE so we can see what pricing difference including that makes. Regarding the QCs, that was pretty straightforward. So a couple of them we do have blocked out. If we're using real human urine, my assumption is that some of these are going to be endogenous. So I'm just kind of curious how that would affect QC3. If it's not in here, sort of how you'd want to proceed with that. Okay. 15:38 - Jarek Flanders (seroclinixlabs.com) We would use our baseline that we would send to you probably. Okay. So just baseline. 15:44 - Andrew Hartmann (UTAK Laboratories) Yeah. 15:44 - Jarek Flanders (seroclinixlabs.com) And then I guess on the instrument I'll I guess build up an equation to automatically remove it. Or if they're not testing for it in that control, it doesn't matter anyways. They shouldn't like that one right there. They shouldn't be testing micro. Micro. Protein on QC3 anyways, so. Okay. And then kind of a similar question. 16:07 - Andrew Hartmann (UTAK Laboratories) They're looking for something they don't need to look for then, so. 16:11 - Jarek Flanders (seroclinixlabs.com) Similar question on calibrators. 16:13 - Andrew Hartmann (UTAK Laboratories) we have calibrator 6 with nothing in there. Is that going to be just endogenous? Is that another 0? 16:19 - Jarek Flanders (seroclinixlabs.com) that was left on my part because the microalbumin was on there and it uses 6. So that can all be blocked out. That's gone. Because the calibrator 1 is our 0, so 6 is kind of gone now that microalbumin is gone. Perfect. 16:39 - Andrew Hartmann (UTAK Laboratories) So we'll have a 0, we'll have these, and then 3, 4, and 5 are just partial panels where in the real human, we'll just go with baseline, and then the SMX, we'll assume it's a negative. Yeah. 16:52 - Nicole Miller Also, that calibrator 1 then with the 0s, if we are in real urine, is that a true 0? Is that also baseline value then? Yeah. Do you have a suggestion on that? 17:06 - Jarek Flanders (seroclinixlabs.com) If you have any customers that may be using, we may just have to change that to a water blank then. Yeah, so that's an option. 17:15 - Nicole Miller Yeah, or just synthetic urine for Calibrator 1 regardless is also an option that we can do. If we're not, even if want urine for the other levels, we could just do SMX for that one. 17:25 - Jarek Flanders (seroclinixlabs.com) Because your SMX only has glucose and creatinine in it, correct? 17:30 - Nicole Miller I forget off the top of my head which one's in it. But I mean, we could do it as zero for those ones also if you wanted them at true zero. Okay. 17:38 - Jarek Flanders (seroclinixlabs.com) Maybe we just get a small donor of that one just to be sure on our end. And then we'll use that for the Cal 1, which is all zero. 17:48 - Andrew Hartmann (UTAK Laboratories) So we'll do SMX without the glucose and creatinine controlled it too instead of DI water. Yeah. 17:57 - Jarek Flanders (seroclinixlabs.com) Okay. Yeah, Howard, the zero really should be more reflective of the matrix than just being a water blank. Oh, so you're kind of like how euros, one is the same matrix as an example. Okay, okay. The ones I've been doing with bilirubin, I've been using that negative, that true negative, which is not a water blank as another example. Okay, okay. 18:28 - Howard Lee (Seroclinix) So, Jarek, I just noticed some of the QC values are the same values as a calibrator. Shouldn't they be off, like, slightly different? Which ones are you looking at? Okay, you've got bilirubin. So you've got bilirubin at 2 and 5 QC, and your calibrator's at 2 and 5. Okay. 18:48 - Jarek Flanders (seroclinixlabs.com) All right. Hemoglobin. Yeah, this is before we were working with. 0.5 of 2. 18:55 - Andrew Hartmann (UTAK Laboratories) Okay, yeah. You may want to just go through that, just to make sure we have the proper QC set. Let's I'll 19:01 - Howard Lee (Seroclinix) Yeah, it would be the same analyte in each one. 19:07 - Jarek Flanders (seroclinixlabs.com) We'll just double-check the concentrations. Yeah, take the values. that's fine. Yeah, but it all looks good. 19:14 - Howard Lee (Seroclinix) Yeah, the HEMO one should be what we're doing right now with the nano, 100 and 500, and then the 50 and 150. 19:23 - Jarek Flanders (seroclinixlabs.com) Okay, we'll give the QC a second shot and send that over. Yeah, yeah. Perfect. 19:28 - Howard Lee (Seroclinix) I'll wait until I get that one before I formally submit it, but I think I have the rest of the design info that I need. 19:34 - Andrew Hartmann (UTAK Laboratories) So for QC, we'll probably switch from a 10ml fill to a 5ml fill, because it sounds like that smaller fill is probably going to be ideal, at least just to get us in ballpark on pricing so we don't have to throw out too many options here. Same thing with the calibrators. We'll switch it from a 5ml to a 1ml fill, and we'll put together, you know, several different volume purchasing options, and we'll quote with and without LE just to see the pricing difference there. We'll go ahead. Oh We'll kind of figure out what ballparks we're in, and then whichever design we decide to move forward with, we can, you know, tailor it in, change the volume, anything like that that you guys want to, but just to avoid us quoting, you know, 100 different options. 20:13 - Jarek Flanders (seroclinixlabs.com) Yeah, yeah, yeah, do irrelevant stuff, and yeah, we've already thrown a lot since last Thursday or maybe Wednesday last week, so. So, but it's just, it's just, we want this to be a really good product to move forward if we were to, you know, move forward with, forward with the 510k clearance with all this, because all our clients are doing LDTs right now with a lot of products. So, it's just kind of, it's putting all the capital together to try and get this to work out, to have every site transferred to this, too. So, there's a lot more than just the upfront cost. Yeah, and I'll work with our team on the back end to see if there's anything we can do pricing-wise. 20:48 - Andrew Hartmann (UTAK Laboratories) You know, maybe if you guys are buying all of this in one thing, we can possibly work out a discount or something like that, and, you know, I'll lean on Marissa here for any kind of insight as far as what's driving up any costs. So, we'll kind We'll of work internally and see what we can come up with and reconnect with you if we have any other follow-up questions before we quote. Okay. 21:08 - Jarek Flanders (seroclinixlabs.com) Perfect. So we'll wait for that update from you, and then from there I'll be able to get everything else going. 21:14 - Andrew Hartmann (UTAK Laboratories) Yep. 21:14 - Jarek Flanders (seroclinixlabs.com) I'll double-check the concentrations, and then I'll send that to you in a little bit. Awesome. 21:19 - Andrew Hartmann (UTAK Laboratories) Well, appreciate the time and connecting. Any other questions while we're all here? No, no, no. I appreciate you talking to us today. 21:24 - Jarek Flanders (seroclinixlabs.com) Yeah, thank you very much, guys. Thank you. 21:27 - Howard Lee (Seroclinix) Have a good one. 21:27 - Andrew Hartmann (UTAK Laboratories) Stay warm. All right. You as well. Take care. Bye-bye. Bye. Bye. Bye. Bye.