EPI Übernahme - Wir halten zusammen
mad-jay : EPI Übernahme - Wir halten zusammen
Bitte dazu einfach nur die Menge kommentieren, ich sammel die Daten und gebe Regelmäßige Zwischenstände ab.
Hier bitte keine weiterführende Diskussion.
% Anteil 6,54
keinGeldmehr : Fazit
keinGeldmehr : Jep Nwolf
Hauptsache der Preis stimmt.
Mogli3 : Kgm
Guru51 : nwolf
du sinngemäß: " glaube nicht, dass sich balaton mit der TK zufrieden gibt ".
hast du die aussage ( sinngemäß ) " wir haben unterstützung durch die großinvestoren " nicht vernommen.
Horscht Börse : Nein die jährliche
Ziel ist es doch nahezu alle Leute zu screenen um den Darmkrebs nahezu auszumerzen. Dann muss man auch den höchstmöglichen Standard zum Screening bringen und das ist diese Variante "the goldstandard", den CMS ignoriert.
Und die 2- Jahres-Variante bringt auch bessere Ergebnisse als 74/90.
Wie oft sollte ein Test der 74/90 (den es die nächsten 5 Jahre nicht gibt) bringt angewendet werden mit welchen signifikant besseren Ergebnissen?
keinGeldmehr : Mogli
2/3 Jahre für Version 2.0 find ich äußerst gewagt...4?5 sind realistisch.
nwolf : @Guru
Die Luft ist dabei noch dünner als letztes Jahr November, wo das Geld auch mal wieder ausging. Aber da haben sich noch ein paar Investoren erbahmt. Wenn auch Heino nur die Hälfte gezeichnet hat.
Dieses Jahr wird auch das nichts mehr werden...
keinGeldmehr : Nwolf
Die 2-3 Euro die in der Frage des Calls an Greg genannt werden, werden aus meiner Sicht kein Kaufpreis sein. Die Risiken sind zu hoch und man kauft ein Unternehmen das im Jahr ca 12 Mio verbrennt.?
3? wären um 130 Mio ? trotz der ?CMS Pleite? fänd ich 3? günstig für den Käufer.
namgni : Guru
Nwolf war wohl noch ganz beseelt von der Antwort die ihm Greg gab...
clourac : blöde Frage
konnte leider beim Call nicht dabei sein.
Was hat GH ausgestrahlt?
neutro : Meine Wahrnehmung ist die
Ich persönlich bin da etwas skeptisch.
philojoephus : Transcript 'Preliminary CMS decision' Teil 1
Hier noch einmal zum Nachlesen für alle.
Ladies and gentlemen, hello, and welcome to Epigenomics AG conference call regarding preliminary CMS decision. [Operator Instructions] Let me now turn floor over to your host, Mr. Frederic Hilke.
Thank you very much, Elena. Hello, and welcome to Epigenomics investor conference call. My name is Frederic Hilke. I'm Investor Relations Manager for Epigenomics. With me on phone is CEO of Epigenomics AG, Greg Hamilton; and President and CFO, Dr. Jorge Garces.
On today's call, we will be discussing CMS proposed NCD and preliminary Q3 results. This call is being webcast for anyone who would like to follow presentation. The link can be found on the Epigenomics website in the financial calendar. Before I hand over the presentation to Greg, let me point out some of the usual legal information.
The following presentation will contain expressly or implicitly certain forward-looking statements concerning Epigenomics AG and its business. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of Epigenomics AG to be materially different from any future results performance or achievements expressed or implied by such forward-looking statements. Please find some of these factors described in the safe harbor statement.
And now I would like to hand you over to CEO, Greg Hamilton, who will continue with the presentation.
Thanks, Frederic. Good morning, everyone, and thank you for joining our call. Obviously, the past 72 hours have been incredibly frustrating and disappointing for all of us. On Friday, CMS issued the proposed NCD for blood-based screening that includes a noncoverage decision for Epi proColon. We are appalled and vehemently disagree with this proposed decision as the proposed criteria is in direct conflict with the goal of CRC screening and scientific evidence.
Epigenomics is in agreement with CMS that the goal of a screening program is to reduce the mortality associated with the cancer. However, we are shocked that CMS has recommended to set arbitrary sensitivity and specificity point estimates with a 3-year interval as a key criteria for coverage.
The main rationale behind the proposed decision is CMS claims there's no direct or indirect evidence that a blood test will decrease the mortality of cancer. Hence, they proposed arbitrary selecting the sensitivity of FIT at 74%, the specificity of Cologuard at 90%, along with a 3-year interval and inferring mortality reduction based solely on these factors.
It is incomprehensible that CMS claims there is no evidence of mortality with Epi proColon when, in fact, that exact data was published in August of this year by the Sisnet Group within their sister agency of the National Cancer Institute. As a backdrop, it is important to understand that it is impossible for any new technology to have direct evidence that it reduces the mortality of colon cancer.
Direct evidence requires a long-term study, typically 10 years or more to prove the test reduces mortality over time. Thus, the only evidence for reduced mortality by a new technology is through indirect evidence. To date, the only methods that have such direct evidence are long-term fit and flexible sigmoidoscopy studies that have been conducted by governments, such as the United States and Great Britain. As such, the National Cancer Institute created the Sisnet Group to develop, validate and publish sophisticated models to understand and evaluate cancer control interventions.
These models are considered the industry gold standard in determining incidence and mortality reduction for all new screening strategies. These models have been developed and validated over the last 2 decades, utilizing the direct evidence from the long-term studies just mentioned. As the gold standard, these models are utilized as the basis for both the USPSTF and the American Cancer Society guidelines. In August of this year, the Sisnet authors published a Miscan model that included Septin9.
As you can see from the graph above, annual testing with Septin9 reduces the mortality of CRC more than annual FIT testing and Cologuard performed every 3 years. It is incomprehensible to us how CMS can claim that no evidence of mortality reduction exists when the gold standard, NCI-sponsored Sisnet Group has published such data only a couple of months ago.
In fact, the publication is listed in the bibliography of the proposed NCD, but it is not referenced once in the entire 69 pages of the proposed decision. In addition to the Sisnet publication in August, the Harvard Medical School also published a peer-reviewed microsimulation model with similar outcomes.
CMS ignored the Holy grail of clinical evidence in -- of CRC screening, which is a validated mortality reduction outcome data analysis tool used by all the experts in the field. Instead of utilizing the gold standard, CMS is proposing to arbitrarily select various test parameters and interval from FIT and Cologuard with an inference that it will lead to greater mortality reduction.
We don't have access to the Sisnet model, but an analysis with the Harvard model using the proposed nonexistent CMS test of 74 90 every 3 years will ironically result in less death averted than annual Septin9 testing, annual FIT or Cologuard every 3 years. We believe that the test proposed at a 3-year interval would lead to inferior outcomes as compared to annual Epi proColon.
It is not rational to cherry-pick point estimates at an interval from various tests and hope it reduces cancer while ignoring validated and published data analysis methods available.
What's next for Epigenomics? First, we will comment on and challenge the proposed NCD. And we will urge others to do the same. There has been precedent for CMS making substantial changes between a proposed decision memo and the final NCD. For example, CAR-T cell therapy proposed decision memo only would cover CAR-T cell therapy through coverage with evidence development. That is the therapy would only be covered if the patient is enrolled in a CMS approved clinical study or registry.
In the final NCD, there was a major shift to broadly cover CAR-T therapy when used for medically accepted indications. As CMS has already communicated to us, this is only a proposed decision, and they are looking for feedback. We will continue our interaction with CMS and utilize the 30-day public comment period to influence all stakeholders. While this will be challenging, in the end, we know that the clinical and scientific evidence is on our side. Second, as we have disclosed on our previous investor calls, we need to raise capital as our current cash balance of EUR 6.6 million at the end of Q3, coupled with the cost-saving measures we have implemented, give us liquidity through Q1 2021.
The proposed NCD has put the company in a difficult position. As such, Epigenomics is forced to explore all strategic alternatives at this time. It is too early to get into specifics. However, based upon the current situation, we need to explore all value creation activities.
In order to discuss our 9-month liquidity, we are also presenting our 9-month preliminary financial results. Revenue for 9 months 2020 was approximately EUR 0.5 million compared to EUR 0.8 million for the 9 months in 2019. The preliminary adjusted EBITDA for 9 months is approximately negative EUR 8.2 million. And as mentioned, our liquid assets at the end of September 2020 were EUR 6.6 million.
It pains us greatly to be having this call today as we expected a very different result from the proposed NCD. We will fight the proposed decision with all of our efforts and resources. As shareholders, we all deserve a better outcome and so to Medicare beneficiaries. I will now open the call to questions.
Der Frage & Antworteil folgt.
philojoephus : Transcript 'Preliminary CMS decision' Teil 2
[Operator Instructions] And the first question comes from Mr. Dennis Berzhanin from Pareto Securities.
Dennis Berzhanin from Pareto Securities. Just a couple of questions from me. Number one, could you provide some color why CMS did not consider the microsimulation models despite the expectation that it would? Have they provided any feedback as of the rationale? And why they haven't looked at the adherence at all?
And then also, it looks like one of CMS requirements is for inclusion into professional society or guidelines. Is this something that you would still have to do? Or is there a possibility to avoid this requirement?
Okay. Yes, we have discussed this issue with CMS in regards to why did they ignore all of the microsimulation model data when that is the gold standard there -- where we're at is they acknowledge that, and that will be a major talking point during the comment period. We can't go into any more detail about it. But clearly, that is just an underlying theme that is a major, major driver in our goal to, in essence, turn this around and get coverage.
Because at the end of the day, the clinical data is there, and it needs to be part of the conversation. So we are doing everything possible to make that happen. In regards to the guideline requirement, this is something that is inconsistent with previous approval. So Cologuard was when it was approved, it was not required to be in a guideline nor was it in a guideline when it was approved. So that is something else we will discuss with CMS.
The reality is that in the latest version of the NCCN guideline, we were included in there for patients who refuse other screening modalities, and that is aligned with our FDA label. So we do believe we meet a requirement of a professional guideline. The language needs to be tweaked in the NCD for that, but we do believe we meet that. And then in addition, we believe with the microsimulation data published by the Sisnet Group, that is the input for all future guidelines, so the next USPSTF decisions utilize those models. That's how they make their decisions. So we also feel confident about upcoming guidelines as well.
Okay. Just a quick follow-up. Could you just talk a little bit more about the process? What are some of the steps there? And historically speaking, how often have these appeals been successful?
Well, in general, Dennis, just so you know, most NCDs are positive anyways. It's actually pretty rare to getting negative NCD. So in the end, I mean, we still got to get to the final NCD. This is only proposed. So for example, as we discussed in the presentation, the CAR-T proposed NCD was considered negative by most people. And that coverage would only be given to patients who enrolled in a CMS approved study.
So basically, people would be denied therapy unless they enrolled in a trial. That was a major shift at the end to -- basically, they covered that therapy for all patients with that medical indication. So we do believe we have a fighting chance to get the switch. Now once it goes final, if it's still negative, then there is an appeal process. The first is a departmental appeal process. And then the second is a formal appeal process, what's called reconsideration. That reconsideration process takes longer. Typically, you can be looking at time lines of about a year for appeal.
People who have been shareholders for a long time will remember, in essence, we had to do the same appeal process for the rate. We initially were given a rate of $83 from CMS. We went through the appeal process and ultimately one and got a rate of $192. It took a while, but in the end, we were successful. So as we want to be realistic with everyone, the NCD process in this 90 days is challenging. But at the end of the day, we feel that the evidence is on our side and that it is inappropriate for Medicare to ignore the gold standard on that evidence. And if we think if we can get over that hurdle, it changes the entire complexion of the conversation.
The next question comes from Mr. Simon Scholes from First Berland.
So -- I mean my information is that CMS used microsimulation studies to evaluate FIT, Cologuard and CT colonography. So -- and I share your astonishment that they haven't -- they don't deem it a FIT method for use with Epi proColon. I mean did CMS give any indication of their aversion to microsimulation studies with regard to Epi proColon when you met them in March for the consultation?
I mean, absolutely not. I mean, that's why we're in shock. And I mean the reality is CMS has commissioned microsimulation to do various analysis for CRC screening methods. So actually, members of that group are authors on microsimulation model papers. So it's again incomprehensible. It's been a very, very challenging 72 hours as we've digested this NCD. Because at the end of the day, Cologuard did not have any direct or indirect outcome data when it got approved. We actually haven't we actually have data that shows Epi proColon reduces mortality in an independent, scientifically validated peer-reviewed publication. That day didn't even exist for Cologuard and Cologuard got approval. And we are currently recommended for noncoverage.
So like I said, we are not going to stand on the sidelines here. We are going to challenge this with everything we have. And at the end of the day, we believe we will be successful. It will be challenging. The process is not one that is transparent as anyone would like. But it's one that we just have to follow.
Okay. And I mean, presumably, you'll make your response to CMS public.
Yes, we will do a response in the public comment period, but we are also encouraging all supporters of evidence-based decisions to comment as well in the public comment period on the CMS website.
Okay. And I mean, you said that -- you said just now that by far the majority of NCDs are positive. I know you mentioned this CAR-T case. I mean, is that the only -- I mean, how many cases have been -- how many negative decisions have there been?
I mean I don't know the specific number, but they're pretty rare. I mean you got to remember, for them to even accept and open the NCD, they have to believe there's a reasonable amount of evidence for coverage. So that's the criteria for them to even accept it and open it. So again, it's hard for us to express how shocked we were not only based on the strong body of evidence that we do have. But our interactions previously with CMS and walking them through the data, I mean, we -- they are fully aware of the Harvard data. The NCI data came out, obviously, very late in the process. It came out in August. So maybe that's one of the reasons why it wasn't in the proposed, but hopefully...
I mean, they also say that they only consider documents up to February.
Yes. I mean, they said that, but for some reason, they listed the JNCI paper from August in the But again, did not reference it anywhere in the decision. So it's challenging for us to rationalize how that could happen, but it's our job right now to try and get that fixed.
Yes. As I said thing is that they seem to gage their methodology, and they use microsims for all the other tests, but not for you?
Hello, can you hear me?
Yes, Jorge, we can hear you.
Yes, this is Jorge. I just want to clarify. So the NCD proposal is actually positive and that they say they will cover blood-based CRC screening. However, the criteria that they set in order for them to cover the blood test, led to noncoverage for our test of Epi proColon. So we're not trying to flip a negative NCD to a positive. We're trying to modify the criteria so that Epi proColon can get coverage. So it's a positive NCD, and we're pushing to change the criteria so that it would lead to coverage of Epi proColon. So I just want to make sure everybody is clear on that.
The next question comes from Hogan Mulally from Encode IDS.
You obviously have some powerful competition out there with Exact Sciences, Freenome and Guardant. This sort of arbitrary 74% sensitivity, 90% specificity that CMS has put in the proposed decision memo. To the best of your knowledge of your competitors out there, can any of them achieve this sensitivity, specificity bar based on the liquid biopsy data they've generated thus far?
Hogan, it's unknown. The data that's been presented so far by Freenome and Guardant has all been kind of case-control data that, as we know, can vary pretty substantially between that and prospective trial data. So so we don't know. I mean, their initial data that they presented, yes, clearly would meet these hurdles. But also got to remember that those tests are designed on sequencing machines and are going to be very, very expensive. So they need a 3-year interval. So the only way that they actually can work is if they have a sensitivity level and a specificity level that would justify a 3-year interval.
So meaning, the key to this disease state is the sensitivity, specificity interval, all work together to, in essence, determine whether a -- the assay works. So for lower sensitivity assays, they're extremely effective, but the interval needs to be more frequent, hence, FIT is every year. The optimal interval for our test in both the Harvard and the NCI papers a year, right? And both of those show that each of our tests is more effective FIT and Septin9 is more effective, for example, than Cologuard at a 92% sensitivity because Cologuard is 3-year interval.
So again, we are encouraging CMS not to issue an incredibly dangerous precedent of just cherry picking random numbers from various tests and inferring it somehow that's going to lead to reduced mortality. So in the end, they need to make decisions based upon evidence, not upon cherry picking.
Right. I guess I'm just sort of curious -- sorry, go ahead, Jorge.
No. If we could refer to Slide 6 in the presentation where we look at the number of deaths, Greg, I don't know if you could project that. Yes. So Hogan, if you can look at the slide, I want to make sure the message wasn't missed. So the orange bar would be kind of the -- a test with the performance that Medicare is suggesting is acceptable. So 74% sensitivity, 90% specificity done every 3 years. And here, the number of deaths that are averted with -- would would be averted with such it has. One bar above it is Epi proColon done every year. And you can see that our tests with our clinical performance parameters performed every year is expected to do much, much better at averting a lot more deaths for patients.
In fact, Cologuard and FIT every year would be better than that test. So they're proposing actually a task that would be inferior in terms of outcomes, even though it's 74% sensitive, 90% specific. So again, the clinical performance alone does not measure what the clinical outcomes are going to be. So as Greg said, this is a dangerous precedent because they're pushing for an inferior outcome for patients over what Epi proColon could provide.
Right. I guess where I would start leading with this is that the -- it almost seems like CMS is foreshadowing a test that they want to approve as opposed to looking at the evidence in its totality for Epi proColon. It almost looks like the large muscular competitors out there have created a bar or influenced a bar, which is rather arbitrary. I know that's a leading question. I won't ask you to sort of opine on that per se, but it certainly is a decision by CMS and it just looks like the bigger players here have had some influence as far as the levels of sensitivity, specificity that are thrown out by CMS.
Yes, Hogan, I mean, obviously, that would be challenging for us to confirm or not. I mean -- so all we can go on is what they've written in the proposed NCD. And clearly, what they've written, we just know to be categorically false. So we just have to move forward with what's in front of us and bring enough eyeballs and people to the table to for CMS to make decisions based upon clinical and scientific evidence. And to your point, not some theoretical assay that doesn't exist, and quite honestly, clearly wouldn't even work.
Next question comes from Mr. Bruce Jackson from The Benchmark Mark Company.
So you're still FDA approved. You've done a fair amount of work with HMOs like Geisinger. Is there anything to prevent in HMO or a commercial plan from running the Septin9 test as part of a colon cancer screening option?
Bruce, yes, no, there's not. I mean -- but the realistic challenge here is that Medicare is the dominant payer in this space, about 40% of the available population is Medicare. So what you've seen historically is all of the other payers, commercial, et cetera, look to Medicare to be the first mover. So if you look at Cologuard, I mean Cologuard was launched successfully because they got FDA approval and 2 months later, they got Medicare approval.
And then after that, then the commercial payer started lining up. And that took a bit of time after Medicare did it. But if you look at the initial days of Cologuard. I mean, I think they announced that typically, they were like 60% to 65% of their samples in their first couple of years were Medicare simple. So it is challenging for commercial payers to lead in this space when Medicare is the dominant player. And ultimately, they're seen as the leader because the average onset of this disease is actually at 67. So when patients are Medicare age.
So Medicare is more incentivized than anybody to increase screening rates and reduce the burden of this disease. So that's why they play such an important role. And this NCD is -- that's why it's so critical to us to get it because it really then is the launching pad to commercialize then across the entire payer spectrum.
The next question is Mr. Randy Baron from Pinnacle.
You mentioned that you spoke to Medicare. I'd be curious to get a little more color on the conversation that they had in terms of what seems to the previous questioner's point about arbitrary kind of picking and choosing is it? And then by them referencing the that August study, did they just come out and say we didn't consider? I just want to get a little more color on the conversation. And then in terms of the open comment period, I mean, this has a lot of ramifications almost beyond CRC. Do you think you'll get more open comments in this next month than you did in the initial ones?
Well, Randy, I mean, first of all, in the comment period, I mean, the initial comment period, I mean, even CMS and the proposed decision acknowledged that a vast, vast majority of the comments were positive. And so we are fully expecting a very active comment period because, yes, we are in agreement with you that the precedent that CMS is setting here could be very dangerous. And so we are highly encouraging people to get involved and to support the clinical and scientific evidence. And so we do believe that there is an opportunity to get this moved. I mean CMS made it very clear to us. This is only a proposal. And I think the more attention we can bring to the fact that they just made an absolute statement that no direct or indirect evidence exists for the reduction in mortality of the disease is just completely false.
Now if CMS says they want to ultimately ignore that data for some reason, then they should have to come out and justify why that is that they will now want to ignore microsimulation modeling data when they've used that as a standard throughout their history. So we believe that it's going to be a very active 90 days. And ultimately, we do believe there's a path forward for us to get the positive decision.
Now that said, we are realistic that it is going to be challenging, right, that it is -- this is not easy. But again, at the end of the day, we feel confident that it is very hard to ignore the -- one of the graphs we showed on this presentation from the NCI experts that says Epi proColon works, and it works really well.
Yes. There's no doubt, this is not a logical decision. What is the exact date for 90 days out? And then related to that, let's just drill into the strategic review a little bit. Obviously, you have less than a year of cash. I just love a little more color into timing when you think kind of the next potential strategic decision could be? Is it going to be before that 90 days? Is it -- to a previous questioner, it certainly seems like some of the bigger players in the space through some political weight around? You have basically the future of testing. So what happens if they come and knock on the door at a high level?
Yes. So Randy, I mean, we have to face the reality that we are a micro-cap company who is basically banging down the door of a space that is dominated by only companies that are worth billions of dollars and have raised either billions or hundreds of millions to be into this space. And so in regards to the strategic options, we can't go into too many details other than the fact of the matter is that our balance sheet requires us to do that right now.
We have to create as much value for shareholders as possible. And the fact of the matter is that we do not have the balance sheet to withstand, go through and potentially a negative final decision and then go through an appeal. We don't have enough cash to last that long. So this negative decision or proposed decision forces us to look at all strategic alternatives.
Now ultimately, we want to flip this and in 90 days, get a positive coverage decision for Epi proColon. And then the outcome can be very different, but we have to look at all strategic alternatives right now.
I totally agree with that. But as a shareholder, I would just encourage you if this ends up being some sort of negotiating ploy by one of the bigger players to at least carve out some sort of contingent value right, so that if you do a strategic decision in the next 89 days, existing shareholders benefit as well from the overturning of an decision?
Yes. No. And Randy, we are in complete alignment that we are going to look at doing whatever we can to maximize the shareholder value for all of us.
[Operator Instructions] So the next question comes from Mr. Dennis Berzhanin from Pareto Securities.
Greg, just a couple of follow-up questions. I want to ask, given all the challenges with Epi proColon, I know you've had some other tests in the pipeline to just deliver cancer test. Is it possible to given some of the positive data in the past, maybe focus on of your efforts of getting that? And then also, I appreciate the situation, the clarity about the funding situation. It appears to me that you won't actually have enough funding to get you through the entire the appeal process and so forth. So could you just confirm when exactly you actually need to raise cash by when?
Yes. Thank you, Dennis. So first off, what I would say is we've been very clear that we have enough liquidity to get through Q1 2021. So as we evaluate all strategic alternatives, capital -- raising capital is part of those strategic alternatives because we need to look at that as well. So hopefully, that answers the question.
And then what was the other part of your question, Dennis?
Yes. Just wondering if it was possible at all to -- given challenges Epi proColon to maybe focus or rejuvenate your efforts again with the other tests in the pipeline such as the deliver cancer test, given the positive data you had in the past?
Yes. So right -- so the reality is that we don't feel any of the value of our pipeline is reflected in our stock nor the 300 granted or applied for patents we have in epigenetic markers, et cetera. And considering liquid biopsy is such a hot space, we have a lot of IP in this area. So the challenge is that, clearly, we do not have the capital resources to take those those assays that we have in development to the next level. They're there. The data looks very promising, as we've talked about and have published to date, and we have other publications that we believe are coming out, hopefully, in the near future.
But as you know, publications are hard to estimate when they come out. So ultimately, there is additional value, we believe in the organization that is not reflected in our stock price at this time. But as we look at strategic alternatives, part of is to, in essence, unlock that value so that shareholders can realize that value.
philojoephus : Transcript 'Preliminary CMS decision' Teil 3
The next question comes from Mr. Ulrich [Operator Instructions] So the next question comes from Mr. Niklas Wolf, who is a private investor.
Greg, I just was wondering how you can execute a capital increase in your current position because the share price, as we know, is below EUR 1? And can you maybe give more details on that how you're going to execute, yes, capital increase -- capital increase, for example?
I appreciate the question. The reality is that it is too early for us to discuss in detail strategic alternatives and how we would execute those and all the various strategic alternatives we are looking at. But we felt it was important today to get on a call with investors and let you know that we are not standing still and that we appreciate, and we are so incredibly disappointed by the proposed decision, but we understand the reality that it puts us in. So therefore, we have to look at multiple strategic alternatives. Increasing capital is just one of those.
So it's just a reality we have to look at how we would execute it would tie into our overall strategic analysis on the alternatives for the company. So as we are able to provide more clarity later on, we will. But for right now, that's as much as we can say.
We have now Mr. Ulrich from Advisory company.
Thank you for explaining the current situation. I was wondering where the factors outside the pure medical aspects, in your opinion, may have played a role in the negative decision. Specifically, I'm wondering about 2 events or aspects. One being the upcoming U.S. election. And more precisely, I guess, the question is, do you get any sense that the election, which is due to take place early November may have had an influence on how the authorities have decided here and that they're basically delaying a decision until after the election date?
And second of all, I was wondering whether you get any sense that's being incorporated as a German company, you may be playing on an uneven playing field vis-à-vis, specifically the U.S. competitors? And as an addendum to the second question, do you feel that you could use the support, let's say, political support of German experts vis-à-vis the U.S. decision-makers?
Thank you very much for the question. We do not believe the upcoming election has had an influence on CMS and this proposed NCD. At the end of the day, that group is supposed to be making determinations based upon the evidence, which actually called an evidence review. That said, political influence is one of the areas that all companies look at when they are trying to get their products, either FDA-approved or covered by Medicare. So those are avenues that we work with actively to try and get to the right decision-makers and influencers.
In regards to experts, I mean, we look to experts all over the world to provide input. I mean, quite honestly, the Sisnet model that was published in August, a couple of key members are from the Netherlands. And they are considered worldwide experts in colon cancer analysis and modeling. So we take expertise from wherever we can get it because at the end of the day, colon cancer is colon cancer. It doesn't matter if you get it in Germany or you get it in the U.S., the reality is that the disease that shouldn't exist and one that we can prevent.
The next question comes from Mr. Dieter Nowak, who is a private investor.
As we all shocked, I think the another big investor is shocked as well. I'm talking about Did you have any contact to until now, what did say? What's their stand or what's their position right now? Do they say, "Oh, we are leaving or do they say okay, we support you in any way? Do you have any information about that?
So I mean, yes, our large institutional investors have been extremely supportive of the company and remains supportive of the company. They are all shocked by the decision as well. I think between Balaton and some of the other large U.S. funds that are backing Epigenomics, you'll see that many of them are experts in health care to have a tremendous expertise in understanding the market, the FDA, CMS, and even they are very, very shocked.
So we know that our large key investors are behind us. In addition, I would add that last year at the AGM -- or sorry, this year at the AGM, as you know, we've added a member of the Supervisory Board who is with Balaton. So there is a strong link and support as Balaton being our largest shareholder.
And ultimately, it is our goal as a management team to create as much value for our shareholders, Balaton, you, myself and everyone else. And so our goal is to maximize the value as much as possible. And to do everything in our power to overcome this initial proposed negative NCD and flip it to a positive.
Okay. And then you say you do everything to raise money, for example, I think there's a plan B in your pocket or plan C or whatever. And I think you can't speak about it. But can you give us a hint in which direction at least? Is it maybe some -- as another person asked before about the liver test that it might be in the foreground and not be backed up a little bit and do a little bit more like, okay, our second leg is not only the number one is Epi proColon, but we have HCC, which is very proposing. So we bring it in the public. Is there any idea of doing that? Or did I understood
So we've currently published on HCC. Sorry, go ahead, Jorge.
Yes, this is Jorge. Yes. So we have a publication that is now under review by a major journal on our liver work, and we're waiting for acceptance of that manuscript to be able to unveil the data. But yes, obviously, with the data published, we will -- which we anticipate before year-end, we will then unveil that data.
Okay. I mean the other part is very much important. And I know that. And let me just give you one-off sentence from me personally because, in Germany, we all have very, very hot discussions about Epi and what you're doing. And especially, what is not done, which means we are missing sometimes more, how would we say more and more action more, more press release, more data to the public that Epi is in the mouse of everybody. So everybody speaks about this, for example. Epi should be more known everywhere. Yes. Do you know what I mean up to?
Yes. No, listen, we understand and appreciate that. And regretfully, as an undercapitalized company, we have to make tough choices on where we spend our money. I mean, if you -- the reality is, we have -- we ended Q3 with EUR 6.6 million. The next closest competitor -- the lowest cash balance of our next closest competitor trying to enter the colon cancer screen space with blood is Freno, and they just raised $270 million in cash.
But Greg, in Germany, we have is a cancer organization. I don't know if you know them, and especially, they have the colonoscopy test in their portfolio. They are -- newspaper brings stuff like that. And they already now Epi, but as said, we don't work with them because nobody knows it really. We are -- our test business test and we hang up to this. Is there any chance to bring Epi, for example, the proColon more close to those organizations who are up to colonoscopy already, which I think cost very much
Yes. I mean, again, we're exploring all options at this point. So -- but the reality is we have a resources, and we need to focus on the things that we think can provide the greatest amount of value in the shortest amount of time. But we -- listen, I acknowledge what you're saying. I agree that we want to do more and we are doing everything in our power to try and make this company as successful as possible.
And we have one last question that comes from Mr. Yohanna who is a private investor.
I have actually three. Number one, I still haven't understood what really happened. I mean, you had been quite convinced that there will be a positive NCD positive for the company. What [Audio Gap] this outcome was the one that we now have? That is question number one.
You said several times that you explore all strategic options. I heard the capital raise and maybe selling some of the pipeline. Can you maybe tell us a few more options you are at least thinking about? And then the last question is there was a very, very high trading volume yesterday. About half of the shares of the companies were traded. Do you have any information, any guess who has been buying those shares?
Thank you. I'll answer the last question first. We do not have great visibility into who was buying the shares. Yesterday, we know there was a tremendously high-volume of shares traded yesterday, but that's not surprising on a major move that we saw from the NCD. So we will continue to monitor that.
In regards to strategic options, again, as we've said, we can't really discuss that in great detail. We think it's important to get on the call today and be transparent with investors that we are looking at strategic alternatives to create as much shareholder value as possible. And I think we have to leave the discussion there. And as we're able to provide more clarity to investors later on, we will.
And then your first question is to CMS, I mean, again, yes, we are incredibly surprised, but not only are we surprised, but I think everybody in the entire industry is surprised by the proposed NCD from CMS. So it is challenging for us to give anyone a rational explanation as to why they issued a positive coverage decision for blood test, but a negative coverage decision for Epi proColon based upon arbitrary criteria.
I can't give you on why you've done that. I think we've shown today that the actual justification in the [Audio Gap] CAR-T was a good example of a proposed NCD that came out, and people were just shocked that Medicare's initial recommendation. And ultimately, through the 90-day period, they -- it was able to be flipped to cover that therapy.
So we, in essence, are trying to accomplish the same goal.
We have one more question from Mr. Astegan from
I do have 2 questions -- I have 2 questions. First question is, when is the deadline of the 90 days, which day is that? First' question. Second question is, if you're talking about a strategic option, and you talked about that you saw less capitalized. And you're talking about the big companies where EUR 200 million, you mentioned your smallest competitor. Why are you not have the product portfolio, which is even wider, and you can't bring it to the market don't -- because you don't have the cash. Why you're not considering a sale of the whole company to try to get an offer, let's say, at EUR 3, EUR 4, EUR 5 per share, and do it together with a big boy?
So when we say we're exploring all strategic alternatives, that includes all strategic alternatives. So hopefully, that answers your question. And then the first part of your question, again, was
January -- I think it's either January 14 or 15, I don't remember what on the CMS website, but it's one of those 2 days.
Okay. So strategic outlook is as well find a big boy and get umbrella.
Yes, the date is January 14 -- January 14, 2020.
There are no more questions, Mr. Hamilton.
Horscht Börse : Hab mal
Epigenomics stimmt mit dem CMS darin überein, dass das Ziel eines Früherkennungsprogramms darin besteht, die mit dem Krebs verbundene Sterblichkeit zu reduzieren. Wir sind jedoch schockiert, dass die CMS empfohlen hat, willkürliche Sensitivitäts- und Spezifizitätspunkt-Schätzungen mit einem 3-Jahres-Intervall als Schlüsselkriterium für die Abdeckung festzulegen.
Der Hauptgrund für die vorgeschlagene Entscheidung liegt darin, dass die CMS behauptet, es gebe keinen direkten oder indirekten Beweis dafür, dass ein Bluttest die Mortalität von Krebs verringert. Daher schlugen sie vor, die Sensitivität von FIT mit 74% und die Spezifität von Cologuard mit 90% willkürlich zu wählen, zusammen mit einem 3-Jahres-Intervall und der Ableitung einer Mortalitätsreduktion allein auf der Grundlage dieser Faktoren.
Es ist unverständlich, dass die CMS behauptet, es gebe keinen Beweis für die Mortalität mit Epi proColon, obwohl die genauen Daten im August dieses Jahres von der Sisnet-Gruppe innerhalb ihrer Schwesteragentur des National Cancer Institute veröffentlicht wurden. Vor diesem Hintergrund ist es wichtig zu verstehen, dass es für jede neue Technologie unmöglich ist, direkte Beweise dafür zu haben, dass sie die Sterblichkeit bei Dickdarmkrebs senkt.
Direkte Beweise erfordern eine Langzeitstudie, in der Regel 10 Jahre oder mehr, um zu beweisen, dass der Test die Sterblichkeit mit der Zeit reduziert. Daher ist der einzige Beweis für eine reduzierte Mortalität durch eine neue Technologie der indirekte Nachweis. Bisher sind die einzigen Methoden, die eine solche direkte Evidenz haben, langfristige Studien zur Eignung und Flexibilität der Sigmoidoskopie, die von Regierungen wie den Vereinigten Staaten und Grossbritannien durchgeführt wurden. Daher hat das National Cancer Institute die Sisnet-Gruppe ins Leben gerufen, um anspruchsvolle Modelle zum Verständnis und zur Bewertung von Krebsbekämpfungsmassnahmen zu entwickeln, zu validieren und zu veröffentlichen.
Diese Modelle gelten in der Branche als Goldstandard bei der Bestimmung der Inzidenz- und Mortalitätsreduktion für alle neuen Früherkennungsstrategien. Diese Modelle wurden in den letzten zwei Jahrzehnten entwickelt und validiert, wobei die direkte Evidenz aus den gerade erwähnten Langzeitstudien genutzt wurde. Als Goldstandard werden diese Modelle als Grundlage sowohl für die USPSTF- als auch für die Leitlinien der American Cancer Society verwendet. Im August dieses Jahres veröffentlichten die Sisnet-Autoren ein Miscan-Modell, das Septin9 einschloss.
Wie Sie aus der obigen Grafik ersehen können, reduziert die jährliche Testung mit Septin9 die Sterblichkeit bei CRC mehr als die jährliche FIT-Testung und die alle 3 Jahre durchgeführte Cologuard-Testung. Es ist für uns unverständlich, wie ein CMS behaupten kann, dass es keine Beweise für eine Mortalitätsreduktion gibt, wenn der Goldstandard, die vom NCI gesponserte Sisnet-Gruppe, solche Daten erst vor ein paar Monaten veröffentlicht hat.
Tatsächlich ist die Publikation in der Bibliographie des vorgeschlagenen NCD aufgeführt, aber sie wird auf den gesamten 69 Seiten des Entscheidungsvorschlags nicht einmal erwähnt. Zusätzlich zu der Sisnet-Publikation im August veröffentlichte die Harvard Medical School auch ein von Fachkollegen begutachtetes Mikrosimulationsmodell mit ähnlichen Ergebnissen.
Das CMS ignorierte den Heiligen Gral der klinischen Evidenz im -- des CRC-Screenings, das ein validiertes Datenanalyse-Tool für die Ergebnisse der Mortalitätsreduktion ist, das von allen Experten auf diesem Gebiet verwendet wird. Statt den Goldstandard zu verwenden, schlägt die CMS vor, verschiedene Testparameter und Intervalle von FIT und Cologuard willkürlich auszuwählen, mit der Schlussfolgerung, dass dies zu einer größeren Mortalitätsreduktion führen wird.
Wir haben keinen Zugang zum Sisnet-Modell, aber eine Analyse mit dem Harvard-Modell unter Verwendung des vorgeschlagenen nicht existierenden CMS-Tests von 74 90 alle 3 Jahre wird ironischerweise zu weniger abgewandten Todesfällen führen als jährliche Septin9-Tests, jährliche FIT oder Cologuard alle 3 Jahre. Wir glauben, dass der vorgeschlagene Test in einem 3-Jahres-Intervall zu schlechteren Ergebnissen führen würde als der jährliche Epi proColon-Test.
Es ist nicht vernünftig, in einem Intervall von verschiedenen Tests nach dem Cherry-Pick-Point-Prinzip zu schätzen und zu hoffen, dass dadurch der Krebs reduziert wird, während man die verfügbaren validierten und veröffentlichten Datenanalysemethoden ignoriert.
Was ist das Nächste für Epigenomics? Zunächst werden wir die vorgeschlagene NCD kommentieren und in Frage stellen. Und wir werden andere auffordern, das Gleiche zu tun. Es hat Präzedenzfälle gegeben, in denen das CMS wesentliche Änderungen zwischen einem vorgeschlagenen Entscheidungs-Memo und dem endgültigen NCD vorgenommen hat. So würde z.B. das vorgeschlagene Entscheidungs-Memo zur CAR-T-Zelltherapie nur die CAR-T-Zelltherapie abdecken, und zwar durch Abdeckung mit der Entwicklung von Evidenz. Das heißt, die Therapie wäre nur dann abgedeckt, wenn der Patient in eine vom CMS genehmigte klinische Studie oder ein Register aufgenommen wird.
In der endgültigen NCD gab es eine wesentliche Verschiebung hin zu einer breiten Abdeckung der CAR-T-Therapie, wenn sie für medizinisch akzeptierte Indikationen eingesetzt wird. Wie uns die CMS bereits mitgeteilt hat, handelt es sich hierbei nur um einen Entscheidungsvorschlag, und sie bitten um Feedback. Wir werden unsere Interaktion mit dem CMS fortsetzen und die 30-Tage
Gardiun : Gute Fragen....
Referent : CMS
Dies wären zweifellos die Zielwerte 74/90 gewesen. In einem Antrag ist dies i.d.R. aus der Zusammenfassung der letzten Seite erkennbar. Mir stellt sich eben die Frage, wie so ein Verfahren 3 Monate dauern kann und dann nochmals um 6 Wochen überzogen wird, wenn der 1. Prüfpunkt schon eine Rückweisung erfordert. Für mich war dies reine Behördenwillkür, die ganz erhebliche Zeit und Geldmittel verbrauchte. Wenn evtl. dieser Zielwert infolge dieses Präzedenzfalles erst gefunden werden musste, kann sich diese Sofortentscheidung evtl. etwas verzögern, aber sicherlich nicht so lange. Nachdem EPi mit dem CMS – wie mir mitgeteilt wurde - in ständigem Austausch war, hätte wohl dieser Zielwert vorrangig angesprochen werden müssen. Dass die MS sowie die fast allesamt positiven Stellungnahmen aus der Erörterung unberücksichtigt, setzt dem Ganzen wohl den Deckel auf.
Alternativ wäre wohl möglich gewesen, den Test in jetziger Qualität zeitlich begrenzt zu übernehmen, bis eine verbesserte Variante 2.0 durch ist. Damit wäre zumindest das Überleben von Patienten und auch von Epigenomics gesichert gewesen.
HFreezer : Nun denn
Herr Hamilton hofft, dass Spiel bis zum 14. Januar noch drehen zu können
Er setzt sehr auf die nun anstehende 30-tägige Kommentierungsphase und die Evidenz (Mikrosimulation und und und...) die eindeutig für ProColon sprechen
„Die CMS haben uns mitgeteilt, die „Nichterstattung“ sei ja erst mal nur ein Vorschlag und man warte nun die öffentlichen Kommentare ab“
„Wir bleiben im Austausch mit CMS“
Bezüglich der möglichen strategischen Optionen lässt er sich nicht in die Karten schauen und wehrt Nachfragen hierzu ab
„Wir werden es weiter nachverfolgen, wer möglicherweise gestern bei dem extrem hohen Umsatz Aktien erworben hat“
Laßt uns schauen, ob bis Freitag Stimmrechtsmitteilungen eintrudeln
Wir werden ja sehen, ob jemand die 20% oder 25%-Schwelle genommen hat......
Dann dürfte es klar sein, wohin die Reise geht!!!!!
1 Z.B. EXACT Sciences legt ein Angebot für Epi vor
2. Gleichzeitig wird an einer Wende zur positiven NCD gearbeitet
3. (EXACT hat Informationen bzgl guter HCC-Daten)
4. EPI geht an Exact
5. Die CMS befürwortet Mitte Januar 2021 plötzlich doch noch die ProColon-Erstattung (is ja jetzt in amerikanischer Hand)
6 Ende gut alles gut......
keinGeldmehr : Referenz
Jeder Blutdarmtest muss nun 74/90 haben um erstattet zu werden.
Mogli3 : Ref
Michaelwelzelbln : Das ganze
Irgendwie hat man das Gefühl, dass EPI immer wieder Brocken in den Weg gelegt wurden, es aber auch immer wieder geschafft wurde, diese zu beseitigen. Irgendwie habe ich das Gefühl, dass das Ganze bis zur Erstattung sich noch 1,5 Jahre hinzieht, diese dann aber vielleicht.... kommt
Mogli3 : Cms
Horscht Börse : Hat der fit Test nicht nur
Michaelwelzelbln : Mogli
keinGeldmehr : Einspruchsverfahren...
Ich hoffe, dass der Laden vorher zwischen 3?4 Euro verkauft wird.
1 Nutzer wurde vom Verfasser von der Diskussion ausgeschlossen: vielsurfer