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Thank You for your following thoughts:
"And I’m a big believer in taking responsibility for your decisions. I do with this. No one forced me to buy and or to hold and there is no grand scheme to deceive and bilk me. I invested. Sometimes it works and sometimes it doesn’t."
100% Totally Absolutely correct ... for Everybody who invested.
Hello, "Without a revenue stream or a commercial release date for initial products and services, there is no way to estimate future cash requirements."
100% correct. About the only thing we know about "future cash requirements" is that they will more and more of it not only for current trials but also a couple of new trials slated for 2023.
"Is the published data from Baylor and MarkerT, in fact, reliable?"
Although without me being divine, so can never be positive, I would have to answer Yes to that.
"If the data is reliable and the underlying technology is sound, is it sufficiently differentiated from their competition [genetic engineering, 'fast' & scalable manufacturing, perhaps lower cost] to provide competitive advantage?
That would be another 100% correct. I believe it is WAY MORE than sufficiently differentiated.
10 times cheaper, 10 times faster, NO Cytokine Release Syndrome reported at all (CAR-T does and has killed patients), the Big Advantage of Epitope Spreading, Disease targeted antigens, has shown good success even in the "active" (worse) group, etc..
But Please, don't listen to me, I'm already down about 125k in MRKR.
Thank You for the info.
I don't think that anybody but short sellers like the results since the merger. The only thing is if there was no merger, we would be at 0 cents instead of 47 cents. I say that because everything TPIV is no longer in the pipeline basically because none of it panned out. So instead of us holding nothing, we now hold a ton of lost money with a wee bit of hope to cling on to. I got no choice but to cling, I'm not selling at this kind of loss.
I agree on hoping for some kind of good data on the 9 day patients before dilution, but even with the active patients, any "good" results should be viewed as GREAT results simply because they ARE so hard to treat. The question is will the buyers with the real money see that the same way I do.
About 12% up, that's good, now all I need is for it to go up about another ONE THOUSAND percent and I'll be close to a profit.
"The Company believes that its existing cash, cash equivalents and restricted cash will fund its operating expenses and capital expenditure requirements into the first quarter of 2023."
Question is can they hold out on doing a dilution and hope for good data readout before the end of 2022?
At least if that happens, they can at least do a dilution at hopefully a much higher price.
From Investor Village:
"Post Clinical Update Clarification
After the company update last month, I reached out to Marker directly to try to get some clarification on a few things as well as try to get a little more insight into how they view all of their recent decisions. I have a lot of mixed feelings right now, but I’ll start with saying as much as the share price has been beaten down this company has more going for it now than it ever has. We just have to hope they can execute now.
They’ve spent a lot of time and energy on improving their manufacturing process over the last couple of years. These process improvements were always a large goal of the company. According to them, and they’re right, as a cell therapy company process is everything. Obviously, we need results but those won’t come if they don’t have their process locked down. As such, a lot of their focus has been getting their process to the point where they want it and feel comfortable that they’ll be able to get the results they need moving forward. The potency measure is six times better with the new manufacturing process and is capable of killing 4x the amount of tumor that the equivalent dose can kill with current process. You can’t argue that that shouldn’t work in the company’s favor. All of this remains to be seen but they should be done with the process improvements for the time being, aside from maybe mixing and matching different antigen targets, and should now be able to focus solely on the trials.
I was originally very frustrated with the adjustments to the PI AML trial as they are obviously causing a delay that we don’t need right now. With no real explanation as to why the trial design was adjusted it just left a lot of room for speculation. Mainly that the trial was failing, and they needed to figure out a way to fix it. I’m actually quite pleased with the clarification I received although it still doesn’t change the fact that this delay will probably cause us some pain short term. Basically, this is the original trial design they always wanted to have. Their intention from the beginning was to have the active group split into the two arms with one being frank relapse and the other being MRD+. When they were originally designing the trial, they had met with several key opinion leaders (KOLs). They all said, at the time, treating MRD+ patients would be damn near impossible due to the manufacturing timeline of the BCM process (36 days) as the window to treat these patients is fairly short. They got that manufacturing time down to 20 days which is most likely how they were able to turn the MRD+ patient MRD- which they weren’t actually trying to do in that safety lead in. With the new process being 9 days, they think they have an even better chance at treating these patients. As they should since this means the patients are being treated earlier in an already very short window. The reason this is so important is that if you can prevent post-transplant relapse the patient has a much better chance at success moving forward. An MRD+ patient is basically on their way to relapse but not quite there so by turning MRD- they essentially prevented that relapse from ever happening in the first place. That’s pretty big considering how difficult it is to treat patients with active disease.
The company seems to be very excited at the possibility to treat MRD+ patients. The following link is to a journal abstract from July of last year: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8268140/. It just gives an overview of the challenges MRD brings when treating AML.
A search on clinicaltrials.gov for “measurable residual disease” and “minimal residual disease” turned up two active pharma company sponsored trials in MRD+ AML.
Novartis: PIb/II
https://clinicaltrials.gov/ct2/show/NCT04623216?cond=measurable+residual+disease&draw=2&rank=4
AMGEN: PI
https://clinicaltrials.gov/ct2/show/NCT02520427?cond=minimal+residual+disease+AML&draw=2&rank=30
This was just a brief search on my part, and I’m certainly no expert, but it does seem like there is not currently much competition when focusing on MRD in AML and there could be some validity to the company’s focus on these MRD+ patients as they are almost guaranteed to relapse if they receive no further treatment.
I’d love to hear anyone’s thoughts on this.
It seems like from his post there, the line that stands out is:
"We just have to hope they can execute now."
Theory #1, people woke up and realized that even now, MRKR should be worth about 125 million, not 30 million.
Theory #2, the Baker Brothers are buying back in on the cheap.
Theory #3, currently behind the scenes, Merck and Abbvie are in a bidding war to see who will pay the most for an AML partnership.
Theory #4, MRKR made it to the top of the Forbes list of most undervalued stock in America.
Theory #5, somebody knows something.
Honestly, I would have no problem with a partner for AML. Actually, I would prefer that to a PC partner (why a bit latter). Give away the majority (80%?) of the potential AML profits, and intentionally bargain for BELOW normal milestone payments in exchange for a HIGHER than normal upfront payment that will at least get the PC trial through phase 2 (?).
I don't want to sound like an A--H--- but I invest to make $. Everybody and their brother is working on AML. Pancreatic from what I understand is a much tougher nut to crack. If MRKR can have success with PC and then other solid tumors, the lost/given away profits from AML will pale in comparison.
At this point I just want Marker to have a chance to go forward so they can PROVE that they either CAN or CAN NOT do what they say they (think) they can do .......... Without just giving everything away in a total buyout (screws investors), or a sick raise money/dilution at sick prices that would REALLY screw investors.
There are people on this board who have been with TPIV?MRKR for a LONG time and have invested A TON of money. Gatta-git-it and Hanscott and many others deserve a chance to see this out with at least a wee bit of hope going forward.
I guess really all we can do is type this kind of stuff that means nothing, wait and see, and hope for the best.
Howdy Phantom, I'd like to say something about "partnership", and if you haven't read it yet, maybe your opinion on my post # 31959.
A few decades ago, I remember several very small biotechs that were going with (let's call it) plan B, which was NOT doing it by themselves.
One company that stands out in my mind is Seattle Genetics (SGEN). I remember looking at their very early pipeline and they had like 6 or 8 different trials going, all were early Phase 1 trials, and Every One of them had a partnership deal with different players involved. That was their gimmick, pay for as little as possible with our own money.
Yes they made less profit, but all those much smaller profits that added up to something was paid for (mostly) by someone else.
It may not be the most common thing in the world, but you really don't have to wait until you are 90% through your Phase 3 trial before you can get a partnership deal.
If raising more money at these low prices suck.
And a complete buyout at these low prices suck.
A partnership seems to be the only thing that makes sense.
Concerning our being below $1 for Nasdaq rules. I do not believe that is even close to being one of major problems. This below $1 problem can be easily solved.
And before I say it, YES, I KNOW, "most times" after a reverse split, the stock price continues down.
BUT, a reverse split like 1 for 10 is (math/value wise) for the investor, neutral and longer term, an added benefit.
Neutral because (in theory), you lose NO value, instead of you owning 10 shares at 0.30, you now own 1 share at 3.00, no value lost, Nasdaq problem solved.
An added benefit is because now, down the road there are 10 times LESS shares available for the SHORTS to screw with.
Our 2 real problems are buyout versus partnership.
I have been clear on my positions on those.
A Buyout ANYTHING CLOSE TO THIS CRAZY INSANE SICK LOW VALUE is ... and should continue to be ... OUT OF THE QUESTION.
WE NEED a partnership with a big biopharma firm ... PERIOD.
And YES, I want James Allison to get off his ass and use his fame and notability, to pick up the damn phone and TRY HIS BEST to get us a deal. (and Juan Vera and Ann Leen and others also).
P.S. Phantom, feel free to forward a copy of this post to your connections at Marker.
No, nothing to see over here, pay no attention to the shiny object, I'm sure it is just a coincidence. Right (sigh)!
I also thought the same thing, not only did insiders invest at 1.75 ... BUT No business leader with a working brain would devote THAT MUCH money to a new factory if they weren't like 99% positive that they would have a profitable use for it??????????
That was one of the reasons I kept buying more at 1.22 and .85 and .65, because insiders recently bought in at I think it was 1.75 not too long ago. I figured they must know something long term.
Our market cap is 34 million, after we just got a 13 million grant. OK
"The Company has 180 calendar days, or until August 15, 2022, to regain compliance with the minimum bid price requirement."
It MIGHT be possible, maybe, if there is good news and NOT a dilution before then?
"additional 180-calendar day compliance period"
Maybe, if there is good news and NOT a dilution before then?
Only hope is some type of partnership with big pharma on a drug candidate with normal upfront payment, which brings up well above $1 ... then dilute when needed.
They may be just not trying to show their hand, sometimes it's better not to volunteer information. If they looked for bio markers in cured, they might not disclose that. ?
PETER HOANG WAS CORRECT ... I remember a time back, I think it was shortly after our TPIV/MRKR merger, that Peter was asked about the low share price.
He said something like: "I know the share price is down, but it won't be for long".
He was correct, the share price did not stay down,
it went ... WAYYYYYYYYYYYYY ... DOWNNNNNNNNNNNNNN.
I guess I just misinterpreted his meaning.
Foolish me, I thought Peter meant up.
OK, "No. This was one of the first people dosed in the safety lead in."
SO, unless I'm crazy, results in the future, using the "9 day 4 X better" should produce MUCH BETTER outcomes.
"Yes. It does seem that way."
Ok, like you and Hanscott said, makes sense, seems reasonable, it's just that the timing and share price suck, but may be better in the long run (if we can make it there).
"The patients they are treating have already failed multiple lines of treatment. I think in the PI it was 4-10 prior lines of therapy failed.
The active patients are running out of options and nothing is working.
The chance of curing them is small."
Then God I hope the FDA isn't expecting miracles, if it helps some people, then it helps some people, that beats the hell out of NOTHING. WTF?
P.S. Thanks again for your responses.
OK, like my head is going to explode, they, delayed the adjuvant group, changed the active group design.
I am sorry for questions, but I will ask.
SPECIFICALLY talking about one thing: "The new nine-day manufacturing process enables increased antigen specificity and diversity, the new process produces a patient product that is four times more potent, with the potential to greatly improve tumor killing."
OK, in relation to that Statement;
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"?
I added your info in your post to my answer to Hanscott, ie: upcoming data for active, not adjuvant.
Also, I was NOT even aware that they delayed the adjuvant trial, I can't recall reading that. that sucks.
Hello hanscott. On expanding the antigen mix, I also wondered why as it just made sense to me that different cancers would have different "optimal" antigen candidates. I think they went with the original because they just wanted to run with what they had at the time. A bird in the hand is better than 2 in the bush.
From everything I got from Phantom, the adjuvant should do like 100 times better than the active, for obvious reasons.
I think the active AML data that was supposed to be Q1 is now Q2, so by June? P.S. Phantom just informed me "No adjuvant data this year. The data that was upcoming was from the active group. Adjuvant data is likely a ways off. Especially now that they delayed the trial"
On institutional holdings, I would love to see that myself. Is NEA still in? Others?
On clinical enrollment, I have asked MANY TIMES, if the technology was so great, like most of believe it is, then WHY are not Doctors referring their patients to Marker in droves? WHY is it taking so long to get to full enrollment?
Good Luck my Friend. All my Best Wishes to you and your family.
"Now we can be sure that the financing will be at record lows {RECORD LOWS} and damn near completely wipe out any current shareholder value unless they have some miracle news lined up which is highly unlikely."
That is what I was afraid of. Suspected it, kind of knew it, but was still hoping against it.
Raise $'s at 30 cents versus raise $'s at $2.50, have to issue more than 8 times the amount of shares, JUST GREAT.
So I guess the only hope/dream I am left with goes like this:
James Allison goes to big pharma and says "Hi, I won the Nobel Prize, I am not stupid, please partner with Marker on X, Y, or Z, so that maybe they could hold off on sick low dilution until the share price goes BACK UP.
Yeah, I know, keep dreaming, I agree, I think we are Screwed.
Hello Phantom, you said you had a call for next week where you may be able to ask some questions.
I guess Q1/Q2 means AML adjuvant data by end of June 2022, (and maybe some more active arm data)??
The PR said "Three patients were treated with MT-401 using the legacy reagent and three additional patients were treated with MT 401 using the new reagent."
If you think it would be meaningful, can you ask if the MRD+ to MRD- patient got the "legacy" or "new" reagent?
But mainly, we need clarification on one major issue from the PR.
We know they said "but beginning any additional clinical trial is subject to the receipt of additional funding".
OK, we KNOW that that applies to ALL of the following:
Off-the-shelf (OTS) product candidates.
The Company expects to expand OTS clinical trials in other hematological malignancies and solid tumors
Preclinical / development activities
Analyzing potential of a 12-antigen product
Assessing potential of combination therapies for MT-401 and MT-601
BUT, does the sentence "but beginning any additional clinical trial is subject to the receipt of but beginning any additional clinical trial is subject to the receipt of additional funding", ALSO apply to the Pancreatic and Lymphoma that they said they were starting?
OR do those 2 trials NOT go forward without "the receipt of additional funding" ??
Thank You
Getting hard to keep the faith. There was once a no safety rope cliff climber. Well, he fell and out of good fortune he happened to grab on to a large dead branch that was sticking out the side of the cliff face. There he was, just hanging there in midair, not a hand hold or foot hold to be found anywhere.
All he could do was hang on, so he started yelling "HELP HELP can Anybody Help Me" ...
"HELP HELP can Anybody Help Me" ... all of a sudden, a booming voice came down from the heavens ...
"Yes my son, I will help you, just have faith and let go of the branch".
Upon hearing this, he thought about it for a bit ... and then yelled out,
"Can ANYBODY Else Help Me".
But in the end, if this doesn't work out, I will look at it like this.
Every month for many years, money is automatically deducted out of my checking account for Saint Jude Childrens Hospital and other charities.
This will just be a case of ... oh well, I donated 150K+ to try to cure cancer with Marker, but it just didn't work out.
I would rather watch the towel burn to ashes ... before I throw in it.
Stubborn? Stupid? Either? Both?
It looks like all of the TPIV legacy programs are history. Not a single one left on the pipeline chart and I doubt a penny is going towards them. So everything TPIV was nothing but a big fat ZERO.
So for all TPIV investors who said at the beginning ... "I know I will have to wait 4 to 6 years before this will do anything big".
We are all back to square one with 4 to 6 years, and A LOT of money wasted, now we have MRKR in phase 1 pancreatic and this and that pre-clinical wannabes, and once again, let's wait 4 to 6 years to see how this new improved plan turns out.
Great, just great.
...---...
...---...
...---...
Agree, NO DILUTION near term. Need a partnership, good AML readout, share price up MUCH from here, THEN dilute if need be.
P.S. the term "Frank" in medicine means unmistakable, manifest, clinically evident, as in an unmistakable relapse.
OK, my honest estimation. First impression is ... it doesn't sound like a company that plans on going out of business anytime soon.
YES, I know, at this point, it is still just talk and hot air, but you have to admit, a lot of it sure sounded good.
"No dose limiting toxicities, cytokine release syndrome or neurotoxicity were observed. The results were consistent with the safety data observed in more than 150 patients treated in the Phase 1/2 studies at the Baylor College of Medicine.
1 MRD+ patient became MRD- after infusion with MT-401.
Immuno-monitoring data indicates the evidence of epitope spreading after infusion of MT-401 in the patient who converted from MRD+ to MRD-."
...........SOUNDS GOOD.
"The new nine-day manufacturing process enables increased antigen specificity and diversity, which has exhibited a strong linear correlation to anti-tumor activity in vitro. The new process produces a patient product that is four times more potent, with the potential to greatly improve tumor killing."
............SOUNDS GREAT
"Mr. Hoang continued: “Further, we are pleased to announce a planned expansion of our pipeline into pancreatic cancer, our first Company-sponsored trial evaluating MultiTAA cell therapy for the treatment of solid tumors, and a Company-sponsored Phase 1 trial in lymphoma."
..........BUT BUT BUT .... "but beginning any additional clinical trial is subject to the receipt of additional funding:"
ALSO IN THE FUTURE:
"Patient-specific product candidates
MT-601, a six-antigen product, for the treatment of pancreatic cancer and lymphoma
The Company intends to file Investigational New Drug applications (INDs) for MT-601 in pancreatic cancer and lymphoma in 2022 and expects to initiate these trials in 2023
Off-the-shelf (OTS) product candidates
Patients will be dosed using “banked” products based on human leukocyte antigen (HLA) matching
The OTS platform is designed to eliminate manufacturing wait time and patient product can be shipped to patients immediately
High scalability where one donor has the potential to provide more than 100 patient products
An OTS program in AML is already approved under the Company’s current Phase 2 AML IND. The Company is currently in the process of developing its patient cell bank inventory and expects to dose the first patient in 2023.
The Company expects to expand OTS clinical trials in other hematological malignancies and solid tumors
Preclinical / development activities
Analyzing potential of a 12-antigen product
Assessing potential of combination therapies for MT-401 and MT-601"
............."but beginning any additional clinical trial is subject to the receipt of additional funding:"
"but beginning any additional clinical trial is subject to the receipt of additional funding:"
Most sounded good to me but also sounded like they will need a lot more $"s to do what they just said.
Any dilution or sale anywhere near this sick low price valuation will kill investors.
Need to with a partner on one trial so the upfront payment part can help fund the beginnings of the future plans. The milestone payments will come later and help later, but for now, no dilution.
On the good side, nothing has been leaked in advance (yet). I guess they learned that lesson. I am hoping for good news because if they are going to have a PR in March anyway, why announce something now if it weren't good news.
But then again, I have been wrong about that the last dozen times, soo ....
Just curious if anybody knows ... does Donor Lymphocyte Infusions (DLIs) have a problem with cytokines and cytokine release syndrome similar to the cytokine problem that (I believe) CAR-T had? Thanks
So there's no chance of something along the lines of ....
"the FDA said we are doing so great curing patients in our AML trial that they will let us forgo phase 3 and will let us file for an NDA New Drug Application"
Yeah, I know, but I can still dream.
Well being that every other time there is an announcement the share price goes down, I just say that out of desperation hoping for a different result this time.
This better be FREAKIN GREAT news!!!!!!!!!!!!!!!!!!
Thank You Very Much Phantom. So, I am reading this:
CAR-T works SOMETIMES in SOME cancers, but also sometimes KILLS people, but (as far as I know) Multi-TAA has killed no one.
CAR-T kills B cells so CAR-T patients "require regular infusions of antibodies in the form of immunoglobulin infusions."
Both CAR-T and Multi-TAA both utilize CD4 and CD8 to fight cancer in similar ways.
CAR-T has little to none Epitope spreading, but Epitope spreading is a MAJOR benefit of Multi-TAA.
So having said all that, why is not everybody beating a path to the door of Marker and Multi-TAA.
I guess they are just waiting for more trial data.
Hope it comes soon and continues to be very positive.
I think most of our share price problem is that most of the medical community has never even heard of Multi-TAA.
My Doctor (an internist), and his daughter (an oncologist) never did until I gave them some info on it.
THANKS AGAIN, I always understand better when you translate into plain English.
Hi Phantom. I just read the following (published Wednesday):
https://www.msn.com/en-us/health/medical/a-cancer-treatment-makes-leukemia-vanish-but-creates-more-mysteries/ar-AATpelW?ocid=msedgdhp&pc=U531
In the article they say: “Now we can finally say the word ‘cure’ with CAR T cells,”. But after using the word "cure", they add
"Although most patients will not do as well"
and "The therapy has helped many with blood cancers, and has proved particularly effective in patients with acute leukemias and other blood cancers." and "The CAR T treatment has also caused serious side effects in some patients like high fevers, comas, dangerously low blood pressure and even death" and "It has not yet worked in people with the solid tumors found in conditions like breast and prostate cancer."
OK, we knew most of that, but I don't quite understand this part:
"The result, if the treatment succeeded, would be to destroy every B cell in the body. Patients would be left with no B cells. But also no cancer."
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?
I know I'm a pain with all the questions and understand if you don't address them all.
Thank You