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I said miscommunication and misunderstanding in my last post. They should not have said "receive regulatory approval" because I think any normal person would assume that means the FDA needs to give the green light before they can proceed. From the response I received I believe what they meant by approval was more of an unofficial confirmation from the FDA that their submitted documents looked good even though it's technically not required.
While I can kind of piece together where I think they were coming from I still think it's dumb not to just PR the information given how crucial the facility is.
The company didn't release any news regarding the facility so I sent an email in to see if I could get any updates. Response is paraphrased below:
The facility is ready to provide patient material for the clinical trials, as it has been operating for six months conducting engineering and process development runs. They can technically start producing for patients immediately after submitting the facility qualification package to FDA, which they have done, but they are giving the FDA a 30 day period to comment on the package. I can only assume that this is because if the FDA has any comments they want to know about them before they begin producing for the trial. If they don't provide any response within 30 days I would guess they assume the qualification package was well received and there should be no issues moving forward. This is just my assumption. There has been a bit of miscommunication or just misunderstanding in that there is no “approval” from FDA needed on this. As such it wasn't something "material" that needed a PR. As of now they plan to update on the status of the facility on the quarterly update mid August. The company still believes they are tracking to all of their publicly announced milestones.
I still don't see the reason not to give an update on the facility now given how essential it is to the PII trial and the future of the company. It is what it is though and I can't control their PR.
I believe they were all dosed from BCM.
I don't know that a hold would be placed on the trial if they don't get immediate approval for the facility. I believe they can still manufacture product at BCM. The issue would be the pivotal status of the trial. To gain approval from the pivotal PII "most" of the product used in the trial needs to come from the facility that will manufacture the final approved product. This is one of the main reasons they chose to build out their own facility to begin with. The longer they go without approval there is a higher chance for delays in the trial because their facility is instrumental in gaining approval.
You're right. I shouldn't have said will be as it is never a given. I meant to say anticipated but didn't choose my words properly. Regardless, this is all irrelevant to the main point. The news was definitely expected. They said a week before the end of the quarter that they were still anticipating the completion by the end of the quarter. There is no reason not to expect today's news from the company's statements.
Technically the Q1 milestone was "initiate" the tech transfer from BCM which they did and announced in their Q1 report. I highly doubt there will be any issues with any of this as they seem to have a decent relationship with BCM but like you said it's not a huge deal considering they are still waiting on facility approval. I was 100% viewing the manufacturing facility approval the same way I view the safety lead in in that since they decided to say they still anticipate receiving approval by the end of the quarter so close to the end of the quarter that they did have it. The caveat here is that the FDA seems do be stepping on it's dick with the timing of things recently. I'd hate to be relying on them for anything right now.
That being said, with today's news I am backtracking a bit. I don't see why they wouldn't announce the facility approval at the same time if they did indeed have it. I set a timeline of this Friday for both pieces of news to come out before I assume they messed up. I don't see why they would split the news up but I'll stick to the timeline I set before I get pissed off. If we don't see news regarding the facility approval by this Friday my confidence level in them having actually been given the approval will significantly drop.
I guess I forgot you have access to the EDC and can monitor the enrollment status of the trial!
Looking at the company’s track record on this trial
This news was expected. Positive or not there isn't going to be a ton of buying on news that literally everyone knew was on the way.
Today was the final day of the Russell reconstitution. MRKR was on the preliminary list to be deleted from the Russell indexes. Could be index funds reallocating.
Technically they provided an "update" on the pancreatic trial during the Oppenheimer webcast Q&A back in March. At this point there isn't going to be much to report as they are just monitoring survival. Either the patients are alive or they are not. The other thing you need to keep in mind is that this trial is sponsored by BCM and I believe any official updates need to be approved by them. That being said I don't think BCM is intentionally blocking anything but if there is going to be a presentation of any new data it is going to by by the principal investigator which has changed since Dr. Smaglo left BCM. I would imagine that may have complicated things slightly. Regardless, the main point is that there is just no new information to share.
The next we hear on the pancreatic trial is when they decide to advance it into further trials. I believe this will be sometime by the end of this year or early next year.
There was some previous discussion a while back when the pancreatic data originally came out that they might be able to optimize the antigen mix as there are certain antigens that are expressed in pancreatic patients that they would be able to specifically target. As of right now it sounds like they will not optimize but move forward with the current mix of target antigens with the expectation that they will continue to see epitope spreading to the various other antigens that are over expressed in pancreatic cancer.
The safety lead in is still tracking to be complete by the end of this month. Most of the trial sites should be online by next month and they are looking to have 20 of the 40 patients enrolled in the active arm between then and Q1 of next year. Full 40 enrolled by the middle of next year. The adjuvant arm is larger so will inevitably take longer to enroll.
I have no information on the regulatory approval of the manufacturing facility but assume it should still be good to go as this is pertinent to gaining approval. No approval of the facility would more than likely mean a big delay for the trial.
I would be very surprised if there is any meaningful pancreatic update right now. During the Oppenheimer conference someone asked a question about the pancreatic trial and, IIRC, the answer was somewhere along the lines of they are still monitoring the trial and seeing good results but please be patient as the company is fully focused on getting the AML trial up and running. I did reach out to the company about a week ago and was given some information on where the pancreatic trial might be headed. Right now BCM is in complete control of the current trial. To move forward I was given two options. This is not to say one of these will definitely be the route the company takes just that they are options.
Option 1: With the data they currently have they move the trial straight into a pivotal PII. This would involve enrolling somewhere around 400 patients. The bar for approval should be low given how deadly pancreatic caner is but a 400 patient trial would obviously be a big undertaking currently.
Option 2: Partner up on the trial. I've said before that the pancreatic trial would make a lot of sense to partner on and I still believe that. If I had to guess right now I would say this is ultimately the route the company takes provided they can find a partner. The one drawback to this is that, from what I was told, BP usually has a minimum number of patients treated that they want to see when they look to partner on these trials. Somewhere around 25. Currently the pancreatic trial has 13. If 13 patients is not enough for any BP then the company would need to initiate a new PI trial to mirror the BCM trial but enroll at least 25 patients to attract a BP partner.
One other tidbit I received was that with the AML trial soon to be fully up and running the company is looking into where to next advance the pipeline. We could be getting this update by the end of this year or early next year. The obvious candidates are lymphoma and pancreatic. This should help add value as it provides the company with multiple chances at approval.
I really think all the TPIV trials will be terminated eventually. That's just my guess. Once they complete the AML trial the focus will still be MultiTAA just in other indications. I do know, or at least was told previously, that they are continuing to monitor all BCM MultTAA trials to eventually decide which indication to move forward next.
I don't have any other updates on the pancreatic trial. It's probably time for a check in though to see if I can get anymore info. I'll probably shoot an email off next week if they don't provide any further details on this trial during the conference call.
I can almost guarantee the merger was never about the peptide vaccines. They just came along for the ride. The merger was definitely easier, cheaper, and quicker than going the traditional IPO route but it does come at a cost as I'm pretty sure they would have been able to achieve a much higher valuation had they gone the IPO route. An example being AlloVir which almost had the chance of being part of the Marker merger. That being said the original Marker holders definitely knew the valuation would be lower than it could be going the route they did and they still chose to do it. In addition to the merger being easier the original Marker shareholders also wanted Peter as CEO. This is coming from the filings where it's detailed out that they approached him to become CEO of AlloVir (ViraCyte) before they ultimately decided to merge Marker with Tapimmune.
I wouldn't say the peptide vaccines are worthless but I don't expect them to be of any focus right now. If they are to be of any value I believe it will be in combination with other therapies. PolyStart I see as a wild card and could go either way. There was a trademark application filed in the middle of last year for it. When I reached out to the company about any potential updates I was told that with the focus on the AML trial there are no planned updates on PolyStart until there is something meaningful to report. I was able to speak with Peter
back in January of this year and he mentioned that during the last half of last year Marker's lab techs had the chance to work with PolyStart and they found some "intriguing applications." I'd take all of this with a grain of salt because it is still very minimal information with no established timeline for results. It's possible they find a use for it but I also wouldn't be surprised to see it fall out of favor if MultiTAA continues to produce results.
When forming a valuation I would think the safe way to go about it would be to ignore the peptide vaccines. That's not to say they have no value but with resources focused elsewhere their full potential may not be realized in the near future if ever.
Marker shareholders got a public company and the CEO that they clearly wanted running things. They most certainly did not merge with Tapimmune for their peptide vaccines if that's what you are trying to imply. I think the writing is on the wall that all the company sponsored peptide vaccine trials have a good shot at being terminated. There is only one left. Just read the annual report. When discussing MultiTAA it's all about reviewing BCM's studies to decide which indication will be the next candidate for future trials and when talking about the peptide vaccines it literally says "we are in the process of evaluating the programs to determine the future strategy and proper allocation of resources to improve shareholder value. In conjunction with this evaluation process we may de-emphasize or terminate certain vaccine therapeutic products or programs."
I just don't see many people reading that and coming to the conclusion that the peptide vaccines are of much importance right now. The last thing we heard straight from the company about the vaccines was the suspension of the company sponsored ovarian trial of TPIV200 for "not meeting the threshold for probability of clinical benefit." As far as I'm concerned the only real shot for the vaccines is with the Mayo sponsored, DoD funded trials. Even then it will just be an added bonus if things pan out. Not the main driver to shareholder value.
It doesn't really matter what any of us want to believe. The company has made it pretty clear in their actions that their focus is on MultITAA, not the peptide vaccines. As such it is completely logical that anyone who wants to start DD here should begin with the merger and MultiTAA. Not Tapimmune and the peptide vaccines.
100% agree.
I'm not trying to change the facts but pointing out past "failures" from 2012-2014 is most certainly irrelevant. Please tell me what bearing those have on the company as it stands today? I would argue that no one needs to do any DD prior to the merger as the direction the company is going has clearly shifted. There isn't a single person in management right now that was around back then. You can't seriously think that what Tapimmune was doing in 2012 has any relevance to what Marker is doing today, can you?
I mentioned the PolyStart application but wasn't around in 2014 to see their pre clinical infectious disease indication. Clearly it did not go anywhere. I would hardly conclude from that that they ever had a focus on infectious diseases. Regardless, it's completely irrelevant.
Following on and off since 2015. When did they have an infectious disease program?
How so? It never has been in the past so no reason it will be now.
I don't recall them ever having an infectious disease program other than PolyStart being mostly applicable to infectious diseases. If they did it was well before my time here so the shift to the peptide vaccines seems a bit irrelevant. At least to me. The merged with Marker and gained a new technology. One that has a lot more promise than their peptide vaccines. On top of that the vaccines failed to show significant results in two of three company sponsored trials. It makes complete sense for them to shift their focus to MultiTAA. Even with that they continue to "support" Mayo in their trials using the vaccines so even with the company sponsored trials for the vaccines shutting down that doesn't necessarily mean they are dead yet.
As for the manufacturing, that goes hand in hand with the MultiTAA technology. Ever since they announced the merger and started discussing MultiTAA the manufacturing process has always been a part of those discussions. It's not new. What is new are the improvements they made to the manufacturing process post merger. I'm down for any manufacturing improvements they can make, robots or not, as it only allows for a superior product and should give a better chance at the trials, and company as a whole, ultimately meeting or exceeding expectations.
As much as people don't want to believe it the shift away from the peptide vaccines to MultiTAA (which includes the manufacturing of MultiTAA) is what gives Marker a chance at ultimately succeeding.
I'm going to assume you're being sarcastic and not waste my time with an actual response.
This is definitely not the reason insiders purchased shares. That's the TPIV 200 trial in TNBC HERE. I don't know how many times it needs to be said but this trial is clearly not one of focus for the company right now. They completely deleted it from their website, along with all other trials using the peptide vaccines, and it's the last remaining company sponsored trial of any of the peptide vaccines. The last two were stopped as they did not see statistically significant results. While I hope that isn't the case with this one and data is good I'm not holding out hope that we will see much come of this. The company has made it pretty obvious their focus is on MultiTAA. Not the peptide vaccines.
Most of the people here have been following the company for a while and more or less know what to expect barring any surprise news. At this point in time there is nothing to be inquisitive about. Even if there was, it's most likely nothing that can be substantiated so it's not worth speculating on.
I get what you are saying but the legal definition of insider trading is the only one that ultimately matters. We'll disagree here and hopefully in the end none of this will even matter.
I think the only milestone we can count on is the data in Q1 of 2020 from the PII AML trial. Having the manufacturing facility completely up and running will be great but I doubt it will do much for the share price. Who knows. Other than those two things I would like an update on the pancreatic trial but I'm not expecting it. My hope is that the company continues to attend conferences through the end of the year to help garner more attention now that they are close to meaningful data.
I think people are vastly overestimating the company's ability to get favorable terms for that financing. The SP was stagnant for a while and everyone knew they would run short of cash by Q1 of next year. There is no way their lack of cash wasn't a factor in the suppression of the SP. These offerings are usually priced based on a discount to market close after the offering is announced. So, offering is announced. Price inevitably goes down, although this is not always the case. In our case we closed at $1.94. The offering is then priced, again, at a discount to the closing price. In our case that discount was ~9% which is not abnormal. Doesn’t matter that prior to the announcement the closing price was $2.51. I know that’s what everyone looks at but that’s just how these offerings work. Again, every scenario is different. I’ve seen some barley close lower after the announcement of the offering and never trade below the offering price. That’s currently our situation although it has only been two weeks. That’s not to say SP doesn’t slip below $1.75 but again, every scenario is different. While I would have preferred everything went down differently I see nothing shady here.
What I know or don't know about the company has nothing to do with the recent insider purchases and if they are kosher or not. You are certainly entitled to your opinion but there isn't a debate as to what constitutes "insider trading." Unless they have material non-public information, which I think is fair to say they don’t, it is not illegal so they will face no legal ramifications. Do you honestly think they would put their reputations on the line just to purchase a few shares? Wilson and Vera already owned a sizable position in the company and have a lot more at stake than you or I. You can believe what you want but you have not provided any evidence to support your view. The law doesn’t care what you personally consider to be insider trading as it is already defined. Like it or not they were allowed to take part in that offering. I would have preferred they made their purchases on the open market, but it is what it is. From my understanding they had to provide their dollar amount commitment prior to the pricing so they did not know what they would be paying when they made their commitment. I can say with almost 100% confidence that everything was on the up and up. We’ll agree to disagree though.
I think it has been very clear that the MultiTAA is the future of the company. I don't disagree with that but it would be nice to hear directly that they have no plans to further progress the vaccines. I don't think it will have any effect in the end as, while there might have been value to the vaccines, focusing resources on MultiTAA is the right call.
New website looks pretty fresh. They seemed to have completely wiped any trace of the TPIV vaccines and trials though.
You look way too far into things. None of those things are unusual. Leen selling at $3 has nothing to do with the offering at $1.75. Neither do the analyst initiating coverage.
Obviously it wouldn't look good if Leen sold all of her shares but she hasn't done that so there is no point in discussing it.
The numbers reported on the form 4s aren't technically inaccurate. The way websites aggregate them is the issue. No one bothers to read the actual filings though. Either way, I don't doubt people showed up due to the insider buying. A lot of them just think there was a lot more than there actually was.
Those numbers are inaccurate. If there are more eyes on MRKR because of that it's because people aren't reading the actual filings.
How is her selling shares at $3 unusual? She can sell wherever she wants.
Again, I still don't buy it without some proof directly pointing to it. I'm not saying you are wrong, just that I need more evidence for me to personally believe it.
I have no idea where the volume came from and have no thoughts other than it seems like too much to be day traders churning shares. They would have had to buy and sell the entire float multiple times over and I'm just not buying it. The idiots on Stocktwits are definitely a minority.
Listen Jeff. That guy over there who bought in last Friday and now all of a sudden knows that there are TONS of catalysts coming up before the end of the year definitely knows what he is talking about /s. Your thoughts are too logical for them. I spent too much time trying to explain how insiders didn't just buy 60M shares even though there are filings that directly contradict that. I take solace in knowing that they will all be gone soon enough. If it does tank the price I will be waiting to buy again. I really don't think the volume over the past couple of days was all short term traders though.
CPXX at the time it went from $1.30's to $24 had announced positive PIII trial results and then were bought out at ~$30/share a few months later. Totally different scenario. However, the volume here the past few days is definitely interesting.
~11.7M shares total for about $20.5M. The CEO bought ~142K shares, the chief development officer bought ~570K shares, John Wilson, a director, bought ~1.7M shares, Aisling Capital bought ~1.1M shares that were reported under Steve Elms on a form 4 as he is a director of Marker and managing partner at Aisling, and NEA bought ~5.7M shares. That brings NEA's total ownership over 10% so all their partners who have indirect ownership filed form 4s. All the form 4's that were just filed claiming 5.7M shares are reporting indirect ownership of the same shares. They are not separate individual purchases of 5.7M shares each.
There is no way this is approved in 90 days. That is not how any of this works. They need to run the trial, submit the BLA, and wait for FDA review. The FDA isn't just going to approve a therapy that literally just started a PII trial. This is one of the craziest things I have heard said on this board.
If you are referring to the lymphoma data published in the Journal of Clinical Oncology that was not new data. It is the PI data that they have already presented. It was not an abstract submitted anywhere. You are saying abstract because the link the was posted to this board was an abstract of the journal. No the whole journal article.
No explanation on reason for build out of Manu facility
An unneeded secondary (at a price that was manufactured to be low)...Yes, manufactured to stay low so they could proceed with secondary for the benefit of insiders.
With accelerated approval in 2021, there was NO NEED for the secondary.