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They'll announce a call if there is going to be one. I believe their call schedule is Q2 and Q4 so there should be one. They usually release results sometime between the 8th and the 15th. I would assume if they don't release anything today they'll announce Thursday or Friday that the call will be early next week. No one really knows.
Always possible but CAR-Ts and MultiTAA work in completely different ways. There is nothing to indicate that people who fail CAR-T therapy or are not eligible for it will fail MultiTAA.
The dilution will be an issue regardless.
CAR-Ts are already approved. Rarely, if ever, do you get to run a cancer trial in which the therapy being studied is given priority over already approved therapies. Doctors are going to recommend approved treatments until they don't work and then they'll recommend participation in an experimental trial. Have to remember that just because the PI trial showed promise doesn't mean the results will be the same in a PII. This also makes the path to approval easier. When they chose AML as their first indication, even though lymphoma had the better results, the main reason given was because there was a lot more competition in the lymphoma space and the path to an AML approval would be easier. With the lymphoma trial being specifically for patients who have failed, or are not eligible, for CAR-T the path to approval becomes easier as they are not competing with the CAR-Ts.
To address your other post, CD-19 is expressed in all B cells. This includes the healthy B cells. So when you target CD19 you are not only killing the cancer cells you are also killing healthy cells. Hence the toxicity with CAR-Ts. I would assume this is the reason CD19 is not included as a target in MultiTAA. The antigens Marker is targeting are specifically overexpressed in cancer cells, not healthy cells. This is just my understanding.
I agree. I only know that as my email was responded to. They knew the whole time thale plan would be to release results during the Q2 conference call. They should have just said that up front instead of just saying Q2. At best it's an oversight on their end. At worst it's deceptive.
They're going to provide the data update on the Q2 conference call. It will probably be sometime in mid to late August. I don't know why they didn't just say that to begin with.
I caught that too when the PR came out. Since the PR was announcing Q1 results I believe when they said data released next quarter they were still referring to Q2 even though the PR was released in May. Hence the reason further down in the PR they say data will be released end of Q2.
The data in the active group was never going to be as good as the data in the adjuvant group. So far the active data we have seen, the 6 safety lead in patients, has tracked with the initial results from BCM so I would expect that to remain the same but don't expect improved results other than the addition of the MRD positive patients turning MRD negative. If active data stayed on track with the BCM data there was a chance they could still receive approval for it but the approach has now switched to MRD and turning the positive patients negative which will only lead to an increased chance of approval if they can prove their therapy is what is causing the change. That's what I'll be looking for in the data but it will still be a very small sample size. I believe it will be less than 10 patients reported on. They need the damn trial back up and running so they can have more data.
The adjuvant data is going to take longer because once the patients are dosed, they need to wait at least a year, if I remember correctly, to be evaluated. It’s possible we get some interim data prior to that point but I wouldn’t count on it. I would assume that the year timeline before evaluation is why the company has not given an estimate yet on when to expect data. We might get a small data release sometime end of this year or beginning of next year on the patients that have already been enrolled, somewhere around 10 patients, but the rest won’t be until end of next year with the delay to the current trial so long as they get it started back up again on their stated timeline.
For someone like yourself who has done zero DD more DD is always warranted. You hold no position here and clearly don't ever intend to so I find it quite odd, and frankly pathetic, that you post so often.
If you just look at the conversations that have been happening on the board recently it should be pretty obvious that no one actually cares about having an honest discussion about the science. They just want to complain about how they made a poor investment decision and are down a bunch of money. Why would I want to post anything here when no one else wants to actually engage in any discussion other than, "management bad"? Or my favorite, "the IP must not be solid. I'll do some DD and report back." And over a year later still no DD done. The board went downhill very quick to the point there are like two people left actually trying to have engaging discussions and are constantly met with the same responses I was. The board has become worthless to everyone and just a place for people to piss and moan.
I honestly don't really know what to think until more trial news starts to roll in. They need cash and the last time I brought it up with the company they seemed to think the upcoming data would be enough to lift the SP and would allow them to raise cash at higher levels than where we currently are now. They are preparing for the need to do a reverse split and the writing on the wall does seem to indicate it will happen but I will just point out that come August 15th if SP has not gotten over $1 they can apply for a 180 day extension which the Nasdaq almost always grants. This would take the date to reach $1 out to February 11th of next year. As of right now there is zero reason to effect the RS and I don't expect it to happen until December or January if necessary. It makes complete sense to vote on it at the upcoming shareholder meeting because if they don't and SP stays below $1 come the end of the year or early next year they would need to call a special vote specifically for approval of the RS and that would not look good.
The bio market has been beaten down over the past year which, whether you believe it or not, has contributed in part to MRKRs fall. Hopefully it turns around and we get a little lift because right now there isn't much going on here other than the upcoming AML active group data. I expect that data to be positive but I don't expect it will be received very well by the market as this is being driven by retail and retail's expectations are too high. Especially considering the patient population MRKR is targeting for the active group of the trial. The data that was presented in February was better than the PI data from the BCM trial and look how the market reacted. This is going to take institutional money to make a decent run and unfortunately the big money isn't in biotech right now. It will come back though. It's just a matter of time and if MRKR will benefit.
Man I love living rent free in some random nobody's head. Glad to see you're still thinking about me.
I love you too.
If the pancreatic trial is what determines partnership then everyone should sell this
Get on the road and do not return without a vote of confidence from those who matter.
I get it. Everyone always wants a partnership or buyout when in reality that's not as common as everyone makes it out to be. I've said it for the longest time that the best chance at a partnership here is going to be in pancreatic or other solid tumor indications. The company sponsored trial in pancreatic will be what dictates if a partnership materializes in the future. Feel free to disagree with me.
Sure, Marker could run out and beg BP for a partnership right now and while it would be nice I wouldn't hold out hope for that. I can almost guarantee that most bio companies would rather build their company into the next BP rather than sell out so early on. The reality is that if they can produce the goods someone will come knocking soon enough.
To facilitate any partnership or buyout the company needs to produce data. No one is going to bring up front cash without it. They don't have enough data right now to warrant a buyout unless you want it to be for peanuts.
They did get non dilutive funding for the current trial. Literally just over half of the trial is funded via non dilutive money.
Turn it around like what, like they did TapImmune?
Again, management makes great salaries (top 1%) with great perks (cheap options) and lots of other trimmings. They can become millionaires for managing research in a failed company
when the CEO foolishly doesn't even acknowledge his shareholders, you can guess where his head is at.
I suspect many here would disagree with you on the incompetence part.
Are you confident they'll rise too? I'm not. Not without better communication and press.
the "board leader" always taking the side of management instead of retail. Always an encyclopedic knowledge of the company but hardly any care for retail
I think it's easier to ask the right questions here and have investors with the information at their fingertips share it, rather than have to go through endless filings.
I thought these boards were about that...Sharing information and observations??
LOL. I'll reply to this because it is one of the dumbest things I've ever heard.
If it was truly planned they should've included existing shareholders with some rewards program
Just an FYI, these options are issued every year around this time. That's part of the compensation plan. I get that everyone here likes, or needs, to find something to complain about but this ain't it.
Is THAT the "medicine/treatment" that was given to the one MRD positive patient and five frank relapse patients in the safety lead-in stage of the Marker Phase 2 AML trial?
Did they delay the adjuvant group because they want to use the new "9 day, 4 times more potent" medicine/treatment in further adjuvant procedures?
And also, if the 5 frank relapse patients, the way I read it, were "frank" when they were given to us, as in they had ALREADY relapsed BEFORE MT-401 who knows how many times and from who knows how many different drugs and treatments, and therefore (I assume) must have been sick for a long time ... in other words, weren't the chances for "curing" very sick, already relapsed patients very small to start with?
How many already relapsed frank patients have others "cured"?
They changed the active group design and want to use their new manufacturing process and are running small dose escalation groups before they proceed. If everything works out these could be good improvements but they chose a horrible time to do it. Long term this should provide better results in the trial but short term they seem to have screwed us all.
I won't ignore that they ran into some unfortunate events in the past that were really beyond their control. Plenty of things were attributed to poor management that really should not have been and I still stand by this. I had sympathy for them because it could not have been easy given they were trying to get everything running basically from scratch.
This presentation was an actual miscue that I won't forgive unless they have a damn good explanation. Their plan moving forward better be iron clad and they better execute it to perfection. I know this is probably too much to ask but they can't make any more excuses.
No adjuvant data this year. The data that was upcoming was from the active group. Adjuvant data is likely a ways off. Especially no that they delayed the trial.
None of the news they presented was bad. None of the news should lead people to sell if they are in this long term and believe in the science. The need for funding might scare some people away but as I've mentioned before it should have been no surprise to anyone when they raise cash in the next few months. These people most likely would have already sold or not bought in to begin with. My main issue is their timing of everything. They announce a pause on their only trial. They are disclosing new trials that they don't even intend to initiate until next year. That is beyond stupid. I knew they were going to announce new trials but was under the impression that they would announce when they were ready to begin. We now know they have absolutely no news coming for the rest of the year. Why would anyone want to invest now when they no there is nothing coming for yet another year at the very least? All of this coming at a time when they NEED TO RAISE CASH! They better have a plan for this because right now they look like a bunch of idiots.
if the MRD+ to MRD- patient got the "legacy" or "new" reagent
but beginning any additional clinical trial is subject to the receipt of additional funding
They said absolutely nothing about that but did update the slide deck to Q1/Q2. That definitely means Q2 now. How far into Q2 is anyone's guess.
I've got a call scheduled next week with the company to get some clarification. I will hold off on giving my detailed thoughts right now other than I'm pissed and that call was a complete disaster. I knew what they were going to announce, and posted as such here previously, but their plan of execution seems awful. I hope they have some answers and valid reasoning for how they are handling things but at this point it is looking like complete incompetence on their end.
What do you want from me?
Lol. I did say Q4 call with EXTRA UPDATES. Those extra updates are obviously going to be clinical like I already said they would be previously regarding new trial initiations. Regardless, anyone expecting anything groundbreaking is most likely setting themselves up for disappointment.
Tell me I'm wrong all you want but I can guarantee I know more than you do on this matter.
For the record, I really do hope I'm wrong and we get earth shattering news. I've just been around long enough to not expect that from this company.
The call tomorrow is most likely just going to be a Q4 results call with some extra updates. 10Q should be released after close today. The PR that will come in March will be for data. The two are independent of each other so I would avoid going down the path of "if they are going to have a PR in March anyway, why announce something now if it weren't good news."
It is going to be dependent on how the market reacts obviously. I am personally a little fearful that people's expectations are too high, given that this will just be interim data from the active group, which could lead to some selling when the data is good but people still want more.
We've been in trouble with SP plummeting but I'm not really going to worry about it until something fundamentally changes with the company.
I'm keeping my expectations low for this upcoming readout which I expect to come closer to the end of March. No reason to rush it unless the data are just completely unexpected and way better than anticipated. On one hand it will be the first readout from a PII trial which is exciting and a step in the right direction but on the other hand it's interim data from the active group and as we all know the best data so far has come in the adjuvant setting.
The active group is a lot harder to treat as evidenced by the PI data. In 8 patients (technically 6 but 2 were dosed twice) there was only 1 complete response and 1 partial response. All of these patients failed multiple lines of therapy. I believe the lowest number of prior therapies failed was 4. These particular patients are clearly running out of options. The CR is obviously positive but this is such a small data set that it is hard to use it as an effective measure of how the PII is going to go. That being said I personally believe that if the PII results can match the PI results we should be ok.
I've touched on this in the past but will just recap a little since the data readout is closer now. This therapy needs to be compared to Donor Lymphocyte Infusions (DLIs). DLIs are given after relapse post stem cell transplant. So the same space Marker is running this PII trial in. They are typically only used for patients who are in very good shape, all else considered, but are very toxic and very expensive. The ORR for DLIs is anywhere between 5%-10%. The main issue with a DLI is Graft vs Host Disease (GvHD) where the donor cells attack the recipient’s healthy cells. The incidence of GvHD in these patients ranges from 40%-60% with 20%-35% being grade 3 or 4.
Even if MultiTAA can just match the response rates of DLIs, ~10% on the high end, it should be approvable based on the extremely favorable safety profile. Not only would it then be a better option for those that would be eligible for a DLI it should also be an option for those that would not have been eligible for a DLI.
The PI CR rate was ~12%. Again, this was based of of 8 patients so we can't really assume those results will carry forward into the PII. However, if they do we would expect to see at least 5 CRs out of the total 40 patients. The upcoming readout will be on 20 patients so it would be nice to see 2 or 3 CRs but I will hold judgement for the full data readout which could come in the middle of the year. I would guess beginning of Q3.
One last note. They are continuing to make manufacturing improvements. They cut the manufacturing time down 50% over the original BCM process and are working towards reducing it another 50% for a total of 75% reduction in manufacturing time. Along with the other improvements they made we should hopefully see improved results in the PII. They are also looking into developing an off the shelf therapy which could be a big step forward if they can manage it. I don't expect it to come soon but it's something to keep an eye out for.
Hell yea!
Well I wish you the best of luck. I'm just saying as someone who has been around a while there most likely won't be anything ground breaking presented during this call that literally lines up with when Q4 results are due. Doesn't matter that they didn't call it a quarterly conference call. That's basically what it is with the addition of them announcing new trials and updates on their manufacturing process. I know they are wanting to be able to get their treatment to be an off the shelf product and that would be HUGE news but I don't think they are there yet.
If you jump in for a trade and get no movement during the call they should be releasing interim PII data towards the end of next month which should be a better catalyst.
Good luck.
You seem pretty confident for someone who clearly hasn't reviewed the PRs. Maybe next time you tell someone to go do something you make sure you've done it first.
https://ir.markertherapeutics.com/news-releases/news-release-details/marker-therapeutics-provides-business-and-clinical-update
https://ir.markertherapeutics.com/news-releases/news-release-details/marker-therapeutics-host-conference-call-and-webcast-review
Regardless of this, you can think what you want but if you have been following this company you should know exactly what to expect.
"Clinical program update"
They are going to announce new trials as has been discussed here in the past and the company eluded to themselves earlier last month.
This is not the first time they have provided a company update via conference call that was not a quarterly call. That being said, the date of this lines up with the deadline to release Q4 results. It's basically a quarterly call without calling it a quarterly call.
When you say current trials you should really say current trial. Marker really only has the one PII AML trial currently running. The BCM PI trials will not move the needle as they have basically done what they intended. Support the advancement of MultiTAA into future later stage trials. They stated in the past that their plan was to focus on getting the AML trial up and running before moving the pipeline forward because at the time of the merger that was their best shot at an approval. The only thing wrong with that is that now they only have one trial and should any of the results be worse than expected there is nothing else to fall back on. With the initiation of more trials they will now have multiple shots on goal which should help limit any further fall in SP should the AML data be received poorly by the market. Regardless of any of this it is never a bad thing to have multiple trials up and running. I mean, how many bio companies make it with just one trial?
Marker is paying for this trial as they will for any future trials. You can't expect them to just sit on their hands and wait for a SP rebound before they take any action to add value to the company. More trials = more value. Obviously that means an increase in expenses but that's just how things work. Remember that the full PII AML trial will cost just shy of $25M to run the whole thing. On top of that CPRIT gave them a grant of $13M for the AML trial effectively freeing up $12M for Marker to allocate elsewhere. This pancreatic trial is only going to be 25 patients. The cost should be very minimal in the grand scheme of things and the data that comes from it should help them gain a partner and move it into a pivotal PII. People have been wanting a BP partnership for a while and what BP wants is a promising treatment for solid tumors.
This will more than likely just be a brief Q4 update as the call is the day after Q4 results are due and the announcement of the new pancreatic trial. There is a small possibility they announce another trial as well but I can only be sure of the pancreatic trial. Sounds like they have some manufacturing process updates too. I know they were working on cutting down the manufacturing process time by another 50%. If this is the case that would be a 75% reduction in the original processing time which is pretty big considering it will allow them to dose patients sooner. We'll see what they say come next week but I wouldn't expect much more than this.
Admittedly, I don't know everything about CAR-Ts. While I do my own DD I am bound at some point to misinterpret something and it will most likely be on the science side of things. This is just my disclaimer that I am not a scientist so only have a basic understanding of some of this.
CAR-T kills every B cell???
I thought T cells and B cells and NK cells were beneficial because they fight disease?
Does Multi TAA also kill every B cell?
It also sounds like they use CAR-T to "train or activate" CD8 and CD4 to kill the cancer.
Isn't that what ALLOVIR is doing with their Virus-Specific T Cells?
"Viral Infection Activates and Expands Endogenous Helper (CD4+) and Cytotoxic (CD8+) T Cells"
Does Multi TAA activate CD8 and CD4 cells?
We talked about an added benefit of Multi TAA was Epitope spreading. Do you know if Epitope spreading is a by function of CAR-T?
Not that it needs clarifying but my $500M figure did not come from what's his nuts as much as he might want to believe so. I respect nothing he posts.
I'm saying that there is no reason the company shouldn't currently be trading at a market cap of $500M. I have no idea what a buyout value would be but it's not worth discussing right now with the SP where it is. Unless some random BP company wanted to pay a ridiculous valuation I don't think Marker would even entertain the idea.
Nothing prevented them to launch a $500 Mil subscription. This would have afforded them to populate their studies on a global scale and increase their research with new pipelines with more staffing and with multiple BP partners.
I wish Marker had surrounded themselves with world class pharma CEO who understands both science and the dynamics of public listings
Kite pharma did it the right way : they raised $641 Mil in JUN2014