OpGen - Spezialist gegen antibiotikaresistente Infektionen (Seite 27)

[MikeCashCow]

Antwort auf Beitrag Nr.: 63.165.742 von haowenshan am 29.03.20 10:45:26

Curetis bekommt 18 Prozent, Altaktionaere von OpGen 7 Prozent. Was ist mit den restlichen Prozenten bzw. Aktien?

[Stefan1655]

Welche Vorteile ergeben sich durch die Fusion für OpGen?

[haowenshan]

Antwort auf Beitrag Nr.: 63.165.316 von MikeCashCow am 29.03.20 09:33:33

ja der CEO von curetis übernimmt. ich glaube auch, dass der neue aufsichtsratsvorsitzende der bisherige aufsichtsratsvorsitzende von curetis wird.

formal ist es ein kauf von curetis durch opgn, aber de fakto ist es umgekehrt. curetis war an einer nasdaq notierung interessiert. die curetis aktionäre hätten ursprünglich ~ 72% an opgn erhalten sollen, also klar die mehrheit, durch die zwischenzeitlichen finanzierungsrunden bleiben ihnen aber nur mehr ca 18% während die ursprünglichen opgn aktionäre etwa 7% an der "neuen" opgn halten werden.

[MikeCashCow]

Wird es einen neuen CEO geben nach der Fusion?

[Growth2012]

Antwort auf Beitrag Nr.: 63.141.439 von haowenshan am 26.03.20 15:56:58

Hat Bosch ein Test für Pneumonia (Lungenentzündung/schwer/mittel/mild) auch laufen?

...Nein! OPGN schon. Amerika steht parat- als Absatzmarkt- erobert zu werden
(straight after the ink on the soon pending fusion contract has dried )

[haowenshan]

so weils mir gerade zufällig untergekommen ist:

Bosch entwickelt Coronavirus-Schnelltest
Der Test liefert ein Ergebnis in 2,5 Stunden. Er soll ab April in Deutschland verfügbar sein.

https://futurezone.at/science/bosch-entwickelt-coronavirus-s…

(curetis, ein teil der opgn group , hat ähnliche testgeräte entwickelt, https://www.curetisusa.com/unyvero-system/ (sie überlegen, ob/wie sie diese mit corona-virus tests ergänzen sollen) und hat zusätzlich zugang zu den testkits)

[haowenshan]

Antibiotic resistance: the hidden threat lurking behind Covid-19

https://www.statnews.com/2020/03/23/antibiotic-resistance-hi…

[Plomo_o_plata]

Antwort auf Beitrag Nr.: 63.121.648 von haowenshan am 25.03.20 07:43:01

Willkommen

Auf Seeking Alpha auch zum nachhören. https://seekingalpha.com/article/4334006-opgen-inc-opgn-ceo-…

Werde später bei Gelegenheit nachkaufen drüben.

[haowenshan]

aus der Q&Q des gestrigen earning calls (bevors wieder hinter der paywall verschwindet):

Oliver Schacht

Okay. Perfect. Thanks, Yi. Look, the BGI test kit is a standard PCR plate-based assay. It works on an ABI, so it’s a Thermo Fisher platform, ABI 7500; fairly simple reagent kit. It works with any standard RNA extraction protocol. They have specified or recommend the QIAGEN one, but we also know it works with other RNA perhaps. In terms of volume of shipments, it’s really early days as Evan pointed out. Literally last week we received our very first shipment. We’ve gone from let’s say low single digit thousands. Our second order which we received yesterday is the first five digit number of tests. We’re processing orders daily. What I can say is we have shipped several thousand tests in these past 48 hours and quite literally by the hour there is expressions of interest. We just got to work through and figure out how to best and most efficiently and effectively leverage our existing European distribution network. Because as you remember, we at Curetis no longer have a direct sales and end customer presence in the European market. We work through various distributions such as Menarini, Axon Labs, [indiscernible] and others. So that’s our primary goal. That said, we’ve also been – I won’t say inundated, but we’ve also been receiving a lot of inbound calls and requests from hospitals existing Unyvero customers across Germany, France, Benelux where we’re of course also willing to stand by and provide these kits to anybody who has an ABI 7500 system. In terms of the accounting, it’s fairly straightforward. We purchased these kits at an agreed upon transfer price from BGI. They ship to our warehouse here in Germany and we then sell them at a transfer price to our distribution partners. We’ve not guided to any specific pricing, but – and I’d say it’s fair to assume that we’re working off of standard molecular diagnostic industry distribution margins, so somewhere in the call it 20% to 40% range. So there’s definitely a positive gross margin. And again we as of today have no direct end customer channel here. This is all buying in bulk from BGI and then reselling to our distribution network to make sure these tests get straight into the hands of the labs and doctors who need them most urgently across initially Europe, but we’ve also been given the green light from BGI to expand beyond the strict boundaries of the European Union and we have inbound requests as Evan pointed out from a number of countries across the Northern African, Middle Eastern and Asia-Pacific regions of the world as well.

Yi Chen

Thank you. Could you also comment on the additional synergy, if there’s any, between using both the BGI COVID-19 test and the Unyvero test system? Thanks.

Oliver Schacht

Absolutely. If you look at some recent data that’s come out of China, there has been a retrospective study of about 200 patients showing very clearly that in intensive care unit patients you have a prevalence of about 15% to 20% of patients also getting a bacterial pneumonia co-infection. If you look at the mortality cases, almost half, 50%, of all of deaths in the COVID crisis have been attributable to bacterial pneumonia. So while of course it is critical initially to triage patients and diagnose them for coronavirus, as soon as you have them in an intensive care unit and especially ventilated, it’s also critical to make sure you get a rapid diagnosis of all the potential pathogens and that’s really the core of our product portfolio and pipeline at Curetis with the pneumonia and lower respiratory panels in Europe and the U.S. So being able to detect 20 different pathogens and 10 different resistant markers in the U.S., 19 of them have been cleared in Europe, clearly also gives doctors the ability to then select the best antibiotic treatment. Of course, the good news is as opposed to a virus, we do have effective drugs for bacterial pneumonia. We just got to make sure we pick the right ones for these critical care patients.

Oliver Schacht

Sure. I’ll let Evan comment on the supply chain. In Europe, what I can so far, knock on wood, on the Curetis side have not been impacted by any immediate supply chain issues. That of course can change going forward. But we have supply of instruments, we have supply of any components, plastics as well as reagents we need to manufacture our cartridges. So, so far so good. In terms of the structured programs, you’re obviously facing a very interesting conundrum. On the one hand there is significant inbound interest from hospitals to bring in additional Unyvero systems for what I outlined earlier, this parallel testing for bacterial pneumonia. On the other hand, there’s virtually no way physically to send anybody into these hospitals, be it Northern Italy, Austria, the borders are closed across Europe, even inside Germany frankly with a lot of the travel restrictions, it’s literally impossible. So part of the programs we’ve been working on with our distribution partners but also with some of our former direct end clients is sort of virtual video-based Skype and WhatsApp-based video tutorials where we have staff virtually standing by and assisting in the installation, training. And again, it goes to show how easy the Unyvero platform is to use. It doesn’t take necessarily somebody onsite as much as you’d like to be there for the first installation and initial training. That’s just part of the programs. We’ve also offered to our European partner Menarini an increase – we have a pool defined across Europe in all the 11 countries that they serve for us, we have a pool of Unyvero instrument systems which we have agreed to potentially increase in size, make additional units available in a very uncomplicated fashion. And again, we’ve received several additional installation requests in Italy, in Southern Europe in places like Greece. Again, right now the key challenges that Menarini being headquartered in Northern Italy is effectively quarantined as a company, nobody able to go from A to B, so we’re trying to figure out smart ways of working through that. We’ll have some of the – just the hands-on real world challenges that we’re facing, but we’re going to find smart solutions to those.

(..)

Maxim Jacobs

Hi, guys. Thanks for taking my questions. My first one is just – I understand that the testing landscape for COVID-19 is rather fluid, but I was wondering if you can give us a sense of where the Curetis COVID-19 test stands compared to others that are available in that?

(...)

Got it, okay, understood. Sure. Look, the one thing to realize is as you said it’s a very fluid, very dramatic situation. There’s a substantial universe of opportunities for COVID-19 testing, be it almost home testing for antigens. There’s more and more tests coming out that way all the way through the ultra-high throughput Roche, Covis platforms which honestly those types of platforms are likely going to take the bulk of the sheer volumes when you look at central labs processing thousands, if not tens of thousands of tests in a very short order. Where the BGI test kit fits in is really in that middle segment. The Thermo Fisher ABI 7500 is really a workhorse of the PCR landscape. It’s a well established, widely distributed platform both in Europe and the United States, but in Europe it’s been around for a long time. It’s got a lot of fans, a lot of labs. They’re sort of in the lower to medium volume, but it’s a simple platform; doesn’t require the capital outlay if you go farther out into Eastern Europe or Southeastern Europe, they have fewer and fewer labs that have sort of the latest and greatest Roche, Covis [indiscernible] platforms but they do often have these ABI 7500 workhorse platforms. So we’re playing in this let’s call it medium volume throughput, again, standard 96 well plate. So it’s not onesies and twosies, but it’s also not designed to do 10,000 tests in a single shift. So in that mid range and again that’s the sweet spot and that’s really where the focus is getting those tests in the hands of all of those labs who have the platform readily available. If you look at the PAC insert and the instructions for use and you look at it from a technical standpoint, frankly there’s also no reason to believe these reagent kits and this is true for the BGI kit but also many others that are out on generic PCR equipment would not also work on many other PCR platforms, but of course this being a regulated CE Mark diagnostic, it has been validated on the ABI 7500. Now if folks are looking at this from – getting cute and looking at other PCR platforms, I would not be too surprised if it works equally well on a bunch of other platforms. We know it works on other Thermo Fisher platforms as we have some of those in our own labs. We’re not promoting it actively for those, but it’s certainly something that as things evolve can be looked at in terms of expanding the universe of instruments this can run on.

Maxim Jacobs

Great, that was very helpful. I was just wondering what’s the prospect of developing a test for the U.S. market?

Oliver Schacht

Well, the BGI test kit has been FDA cleared under the Emergency Use Authorization. Given our longstanding strategic partnership with BGI, is this a conversation we’re having with them? Absolutely. Now BGI also has its own direct commercial channels in the U.S., so no decisions have been made there. But the test is, in principle, available in the United States by now. Where they are in terms of inventory, I have visibility on their European operations because their European affiliate is in Germany and in Denmark, so we have good visibility on this. The bulk volume that’s coming through there out of China, I don’t have that visibility on any available test kits in the United States, as in are they physically available there today. But from a regulatory standpoint, as of last week, this has been emergency use authorized by the FDA.

Evan Jones

Max, Evan here. Just wanted to add that on the script earlier, we talked about the potential of adding the coronavirus test to the Unyvero LRT Panel. If that goes forward, that could be moved into the North American market under the Emergency Use Authorization fairly quickly. And then we’re also looking at other opportunities, but one thing we don’t want to do is just duplicate some of the activities that have already been done by others. So I think we’d look to the company to make smart strategic moves here while it capitalizes on its position on the two products that I just mentioned.

Maxim Jacobs

Wonderful. That was extremely helpful. My last question is kind of minor one for Tim. I was just wondering, so after the amendment that was filed last week, how much is left under the ATM right now?

Tim Dec

Sure. There’s a significant amount left, in excess of 11 million.

(...)


Bruce Jackson

Hi. Good afternoon and thank you for taking my questions. I wanted to start off with the 510(k) for the Acuitas device. Can you give us a sense of what types of questions the FDA is asking? Are they questions that are easy to address or are these questions that might take some time to work on?

Evan Jones

Bruce, thanks for the question. Even Jones here. I’ll answer that one. First, let me just say that the near-term delays are primarily a function of the State of Maryland having shutdown all nonessentials businesses. And so even though the FDA is capable and is working remotely, that’s causing anticipated understandable near-term delay there. In terms of the remaining questions, without getting into a lot of details I can tell you that they’re the type of questions that are related to product labeling and things like that.

Bruce Jackson

Okay, great. That’s really helpful. And then in terms of the supply of the BGI SARS-2 test, you said you’ve got some visibility. Do you have any type of relationship in place where if you get – if they get supply constrained, you get preferred status and the product can continue to flow to your customers?

Oliver Schacht

That’s a very good question. I would like to believe so. Is it contractual in writing? No. But I’ve been dealing with Chinese partners for many, many years. We were the first ones they called in January in Europe. We were the first ones they offered the commercial partnership opportunity too? No. Understandably they’re not relying on Curetis alone here in Europe. So we are one of several partners. But we have a very close dialogue with the European representatives and we also have a direct communication channel to corporate headquarters in Shenzhen in China. So far they’ve been very good. They give us heads up on volumes inbound. They proactively ask, what’s your next week’s take? If only I knew. I can tell you literally we’ve been in a mold these last 48 hours where we’ve been short selling products. I’ve sold kits that I knew we were going to get and we did actually receive them this morning, but I sold some of those kits last Friday. So, so far – again, they have made us a preferred partner. We hope that stays that way and we obviously do our utmost to justify that trust in that relationship by getting those kits in the hands of distribution partners and into the market as quickly as possible. What I can see from – again, it’s only been a week the first shipment. The second shipment was 10x the size of the first one. It’s a safe assumption that the next shipment we’re getting is yet again going to be larger. So we’re definitely getting a feel for what’s the weekly volume that we can safely put into our channels, and that number is likely going to be increasing. And so yes, I think we will continue to benefit from this personal but also corporate relationship between Curetis and BGI as things get even crazier and even more hectic here.

[MikeCashCow]

Antwort auf Beitrag Nr.: 63.119.671 von Plomo_o_plata am 24.03.20 21:15:59

Was hat das zu bedeuten?
"Das Unternehmen geht davon aus, den Unternehmenszusammenschluss nach seiner Genehmigung auf der Sonderversammlung bis Anfang April 2020 abzuschließen. Der erwartete kurzfristige Abschluss dieser Kombination folgt auf die erfolgreiche Hinzufügung von 22 USD."