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You are correct. This is for the TPIV peptide vaccines. Officially those are now gone and its probably a long time coming given the results they generated. I looked over the license agreement and it doesn't look like there is any monetary loss to Marker here and it would more than likely have been disclosed if there was. Its really a non event unless people thought the peptide vaccine program was somehow holding the company back.
They should be able to get financing either way. I've touched on it before but they have other options internally to explore before they need to go to a secondary offering. If they do go to a secondary offering they still shouldn't have an issue and it certainly isn't hinging on data from 6 patients. Especially since they got interest from the FDA via the orphan product grant based on their early MRD data. They have more trials set to start which should garner more interest than the AML trial. What you need to worry about is the terms of a secondary offering. They have cash out to August of next year. The closer they get to that point without obtaining more cash the worse any terms from a secondary offering are going to be. Think larger discount to market and the potential need to add more incentives like additional warrants to the deal.
The only real positive here is that, if what I was told is accurate, they are trying to get to a point where they have lymphoma data by the end of next year and in the PI trials that was by far the best data. The expectation being that the data would provide a large enough lift to the share price to do a larger offering. The cash needed to make it to the end of next year is ~$10M-$15M. If they can't get that through other means and do need a secondary offering it should be minimal although it will probably be more than they technically need. That being said any raise at these levels will severely dilute existing shareholders
I wish I could be as optimistic as you but they haven't had enough data in the AML active disease setting, outside of the focus on MRD positivity, for me to have a ton of faith. With such a small data set so far its too easy to point to certain variables that leave enough cause for hesitation to believe it will have much success.
Long term and in other indications I still believe they have a good shot to be successful but the active (frank relapse) AML setting has produced their least convincing data so far. The bar for approval should be relatively low but they are cutting it very close.
Its either incompetence or its dishonesty. Neither of which is a good option. I personally don't think it has anything to do with the share price decline though. The share price was already down and volume, outside of when they announced the lymphoma IND acceptance, has been pretty much nonexistent. They need news and data to move the needle.
This matches with what I was told as well. One thing that sticks out is the topline readout done in the Q2 update. He also mentioned to me that data was released in the Q2 update after I pointed out it was missed. I just more or less ignored the comment as I thought I must have missed it or it was very limited. Now with you getting the same response I am almost certain that whoever prepares the press releases was checked out when the Q2 results PR was done up.
We already know that there was an error with the date of the next available results but now it looks like there was a fumbling of the "data release". Below is the text from the PR regarding the AML data:
Marker has enrolled 13 evaluable patients in total, including 6 in the Safety Lead-in cohorts.
5 patients have been treated with MT-401 manufactured by a revised process and have completed dose-limiting toxicity (DLT) periods with no DLTs reported.
One additional MRD+ patient was treated and became MRD- at 8 weeks after the first infusion.
Nowhere in that excerpt does it mention that there were 6 more frank relapse patients who showed no response. It can definitely be assumed (13 evaluable patients, subtract the 6 safety lead in to get 7, then subtract 1 more as they disclosed they had another MRD+ patient turn MRD-, which leaves 6 remaining patients). They really shouldn't be leaving everyone to assume though. Lets hope the new manufacturing process produces better results.
For anyone who is curious I've recapped all available active AML data below:
PI: 8 patients treated, 1PR & 1CR (The PR patient saw enough of a reduction to allow a second cell transplant)
PII: 11 frank relapse patients treated, 0CR
2 MRD+ patients treated, 2 CR MRD-
They're seeing responses but just need more data. I hope to see at least one CR in the next data for frank relapse patients but it seems pretty clear the best path forward in an active setting is with MRD.
It's not that I am against a merger, its that I just don't think it makes sense at this current point in time and there are a ton of variables standing in the way of this even happening. They already discussed merging Marker and ViraCyte (AlloVir) together and bringing them public at the same time. It didn't workout that way so they took the two companies public in separate deals. Marker via the merger with Tapimmune and AlloVir via an IPO. If they wanted to merge the companies together it should have done right away.
Prior to AlloVir going public they made a deal to join ElevateBio. ElevateBio basically just has a portfolio of companies in the cell and gene therapy industry. Currently the original owners of Marker and AlloVir own a very small percentage of AlloVir. As far as I can tell John Wilson is completely removed from the company, Ann Leen is their CMO and Juan Vera still sits on the board. I doubt any of them have much pull over there anymore. Regardless, they all made bank on the deal and probably should have took Marker in that direction.
Part of ElevateBio's business model is that they have one large facility where all of their companies have access to research and manufacture product. While Marker's facility could more than likely be used for AlloVir as the manufacturing process is probably still very similar AlloVir has no use for it.
Of course the company is working for the shareholders. The CEO is a shareholder, the COO is a shareholder, multiple directors own shares. You think they have no incentive to move this along? If the company isn't working on behalf of the shareholders who do you think they are working for?
Which is exactly what Marker is doing so what's your point?
While cancer is deadly it's relatively rare compared to other medical conditions. An actual cure would be ridiculously valuable but you ultimately still have a limit to the amount of patients you can treat which obviously limits the amount of money to be made. There is a reason the FDA has orphan designation and fast track designation. There needs to be some incentive for companies to to develop therapies for these rarer diseases.
DICE went public in September of last year. Obviously they aren't going to have any splits. While we have the pending R/S that will probably happen by February of next year you can't really take any of Marker's history prior to 2018 into account. So Marker essentially has no splits in it current form either. If you are going to make comparisons between two completely different companies at least try to make them in good faith.
We all know management matters but it doesn't matter who is in management if data is good. DICE didn't increase over 100% because their management team is a bunch of saints. They release positive data and reported that they are advancing trials into the next phase. That is the only reason for the increase. Stop trying to pretend otherwise unless you can provide real examples to prove your point.
I'm not going to be able to address all of your concerns and I also share your frustration. I've said previously that Marker's issue is they don't have enough new data. They made all these manufacturing adjustments and process changes but have yet to get any real data from it. I know the new data is coming but that still takes time. I get that these process improvements were necessary for them to dial in and they hopefully help long term but it put them in a bad position short term by delaying their one relevant trial.
I know absolutely nothing about DICE but the market seemed to react to their data. Doesn't matter that it was PI they still had data to support their efforts. Upon release the SP is up ~90%. As a comparison I would look to what happened with MRKR (TPIV) when the merger was first announced. While Marker had already released PI data this merger announcement was the first time the broader market could invest in it. Upon that merger announcement SP went from ~$3 to ~$10. That's ~233% increase. Since that point MRKR hasn't really released much new data other than the new focus on MRD positivity. They can sit in their fancy new facility tweaking their process all they want but until they get it into trials and get meaningful data it means nothing.
I know you are pointing to DICE because of the recent price movement but there really isn't a fair comparison between them and MRKR. The psoriasis market was ~$27B this year and expected to rise to ~$51B by 2030 (SOURCE) while the AML market was ~$1B this year and expected to rise to ~$2.5B in 2030 (SOURCE). That's a major difference. Emotionally, you shouldn't find many people who think the need for a psoriasis treatment outweighs the need for an AML treatment but the reality is the market for psoriasis is 20x the AML market so DICE can currently support a larger market cap than Marker based on the relatively minimal data they each have.
Non issue because while they are operating without a named "CFO" the responsibilities will more than likely just be shared among other officers. From the last 10Q (HERE), "On August 10, 2022, our board of directors appointed Michael Loiacono to serve as our principal financial and accounting officer, effective upon [Kim's] Separation Date." Prior to Tony Kim joining the company Michael Loiacano was serving as CFO & Chief Accounting Officer so they are more or less just reverting back to that.
I'm not convinced this will save them enough money to matter though which, unless there was something going on behind the scenes, was the whole point of this separation.
This first patient went MRD- at week 32.
I gotcha. But those aren't multiple large stakeholders. It's one large stakeholder.
Those aren't individual purchases. Those are, or were at the time of purchase, partners at NEA. They are reporting indirect ownership of the same lot of shares. NEA owns the shares but as partners all individuals need to file reports showing that they have control over the shares that NEA owns.
I guess anything is possible but board members are generally not appointed to provide a strategic relationship between two companies. They need to remain unbiased and act in the best interest of the shareholders. If Knobil was appointed for the sole purpose of facilitating a future relationship between Marker and Agilent it would be a major conflict of interest. It's not uncommon for officers of one company to serve on the BoD of other companies. Marker is not the only company that Knobil is a director for as is the case for most members of Marker's board.
Aside from all of this Marker doesn't really need Agilent to scale up their production unless they decide to completely change their process. That would probably be a mistake at this point in time. Their manufacturing process is already scalable and they built their facility with expansion already in mind. They will have capacity for their existing and future trials as well as commercialization of any approved products.
Again, anything is possible but I personally don't see much of a useful relationship between Agilent and Marker.
I don't know much about Agilent but I'm not sure they would have much interest in investing in MRKR. Or, I should say I'm not sure Marker has anything to offer them. From what I can tell a lot of their business is software and diagnostic testing, and lab supplies for medical companies. Again, I don't know much of anything about them. The reason I singled out Bio-Techne is due to their clear relationship with Wilson Wolf and the fact that they are directly involved in cell and gene therapy development and manufacturing. Which is where Marker has invested a good amount of time and resources. I'm not entirely sure that all fits with Agilent's business model. If Marker has been able to develop a top of the line manufacturing process and facility like they claim, and Wilson Wolf took note, and Bio-Techne likes Wilson Wolf enough to sign an agreement for a potential future purchase, then maybe Marker has something to offer Bio-Techne. For a price of course.
Disclaimer: This is information I was able to gather while doing DD. I have sprinkled some of my own opinion into this post. None of this is an endorsement to buy or sell MRKR. I hate that I even have to say that, but I have had people recently get pissy with me because I posted information and my own opinion, but the share price continues to lag. Like that’s somehow my fault. I can’t do anything about the share price although I really wish I could. Now that this is out of the way…
As I previously posted the Q3 data readout listed in the last PR on August 11th was supposed to say Q4. IR made an error and it was not caught. Still unacceptable but I’d rather the incompetence be in missing this error than them just not being able to appropriately time their trial. This data should be on roughly 6 patients but will be with the new manufacturing process. The dose level is 200m cells which is the highest dose so far. There were no CRs from the safety lead in patients so the hope is that with the new manufacturing process and higher dose they will see some by the data release, Q4 now. If they still don’t see any response in frank relapse, then they will have to evaluate where they want to go in terms of increasing the dose again. They will need approval w/ FDA to do so but apparently the FDA has been very accommodating with them on the dose level changes and manufacturing improvements. All this being said I don’t expect earth shattering results from this next set of data. It’s a small sample size in a heavily pre-treated patient population still experiencing active disease. The AML adjuvant setting has always shown more promise but that data is a little further out.
MRD+ patients are a big focus for the FDA as AML patients see a median survival of about 4.5 months. Turning MRD+ patients MRD- should extend patients overall survival and increase their quality of life. These two things are taken into account by the FDA. Remember that MRD+ patients are almost guaranteed to turn into frank relapse patients so preventing that is a big deal. From my understanding the early MRD patient data, while only 2 patients, is the main reason MRKR received the FDA grant. They need to continue turning MRD+ patients MRD-.
They have apparently made a big push to get the lymphoma trial up and running. The money from the Wilson Wolf deal is what allowed them to move this forward quicker. Remember the IND was original supposed to be filed Q4 but was filed and approved by the beginning of August. They have high hopes for this lymphoma trial as that was by far the best early data from BCM. The path forward just wasn’t there initially back in 2018-2019 with the recent approvals of Yescarta and Kymriah because it is unethical for doctors to refer patients to a trial when they are eligible for an approved therapy. Now that some time has passed, they do have a path forward for lymphoma. The biggest group of patients here will be the CAR refractory patients, i.e., patients who failed CAR-T treatment, but they will also be able to treat patients who are CAR ineligible. They want to have a lymphoma readout by the end of next year. If this is going to happen, then they need to get patients dosed ASAP. It’s possible we get some more lymphoma trial news in the near future. The lymphoma IND acceptance is the last news that brought in huge volume even though the share price increase wasn’t sustained.
Their cash runway will reach into mid-August of next year. They should get more funds from their CPRIT grant soon that is going toward funding the AML trial. They would probably need an additional $10M-$15M cash to get them to the end of 2023 where they are wanting to have a lymphoma readout. If they have to go to the secondary market, they will but they are still exploring other options. I can’t remember if I posted this here or not but Anthony Kim, before he left the company, gave an interview where he talked about what they were looking at in terms of the next financing and he mentioned they are looking internally to their BoD. (HERE) is the interview posted to the company twitter on 8/8/2022. He talks about financing at minute 1:38. The only board members I can personally see providing access to capital are John Wilson, either by himself or through Wilson Wolf again, or Steve Elms through Aisling Capital who is already one of the largest shareholders. I’m going to perform some mental gymnastics here so just bear with me. The third intriguing board member is David Eansor. Up until February of this year he was with Bio-Techne. I don’t think he will personally provide any capital but there might be a link. In the PR from April announcing the deal with Wilson Wolf (HERE) I noticed a part under about Wilson Wolf that says, “In 2020, Wilson Wolf formed a joint venture with Bio-Techne and Fresenius-Kabi called ScaleReady…” At the time I looked into it out of curiosty and found (THIS) PR from 12/14/2021 detailing a future purchase agreement of Wilson Wolf by Bio-Techne. Basically, if certain milestones are met Bio-Techne will have the option to fully acquire Wilson Wolf. Clearly there is a relationship between Wilson Wolf and Bio-Techne. If the company was actually looking internally at board members to provide additional capital, I have to think that John Wilson would be the leading candidate. With Bio-Techne looking to potentially purchase Wilson Wolf they must have some sort of relationship with John Wilson. Bio-Techne is currently a $12B company with $700M to $800M in annual revenue. If Wilson Wolf was impressed enough with Marker’s manufacturing facility and process to the point they gave Marker $8M “for services relating to Marker’s expertise in the manufacture of cell therapies” then maybe they can convince Bio-Techne to pony up some cash for some of that expertise. Thank you for coming to my TED Talk. With that out of the way it does look like they are trying to get the next tranche of cash in an efficient manner that is the least dilutive to current investors, but given the main goal is to keep the company operating if they have to dilute current investors they obviously will.
Again, this is just information I was able to gather. Believe it or don’t but don’t blame me if you act upon this information and results aren’t as you hope. My DD is not a substitute for your own DD.
I hate to be the only one getting responses but I did get one. I did send my email out a lot earlier though. The answer was that it was an error in the August PR and instead of stating data in Q3 it should have said Q4. The delay in getting the data is because the rest of the patients, should be around 6 of them, are being treated with product using the new manufacturing process. So while they were enrolled last year they waited to dose them until they had the FDA approval to use the new process.
I still don't think the error was acceptable and I would honestly be ok at this point with them not giving any timelines and just releasing it when it is ready.
I have more information on other matters that I will work up a post on.
Looks like they will miss their own timeline for releasing the data for the third time. I can't imagine there is enough of us or that it will do anything but I think we should tell them how unacceptable that is.
Peter Hoang, Chief Executive Officer: phoang@markertherapeutics.com
Juan Vera, Chief Operating Officer & Chief Scientific Officer: jvera@markertherapeutics.com
Mythili Koneru, Chief Medical Officer: mkoneru@markertherapeutics.com
Neda Safarzadeh, Head of IR, PR, & Marketing: nsafarzadeh@markertherapeutics.com
Even if the data ends up being good, although I'm not sure there is enough currently to be very meaningful, missing your own timeline this many times is unacceptable.
November 10, 2021: Q3 2021 Update PR (HERE)
“Topline readout of Group 2 active disease anticipated in Q1 2022
March 17, 2022: YE 2021 Update PR (HERE)
“Topline readout of Group 2 active disease anticipated in Q2 2022”
May 13, 2022: Q1 2022 Update PR (HERE)
“Topline readout of Group 2 active disease is anticipated in Q2 2022”
August 11, 2022: Q2 2022 Update PR (HERE)
“We expect to provide a topline readout of active disease patients in Q3 2022”
I sure hope they don't miss their release date for a third time but they have not instilled a lot of confidence with this. Not only have they missed their stated release of data twice already they have not even acknowledged it. The least they can do is provide an explanation for the continued delay of the data. Delay could be good or bad but by not acknowledging it one way or the other they leave everyone to think the worst.
I still believe in the science as I have since the beginning but this is just poor business practice no matter how you look at it.
AlloVir and Marker were founded by the same people. I have to assume if there were any synergies to find they would have. They literally use the same technology with one expanding virus specific T cells and targeting viral infections and one expanding tumor specific T cells and targeting cancer. They had the opportunity to combine the companies and take them public together but chose not to. Combining the companies via a buyout of Marker by AlloVir at this point in makes absolutely no sense for either party. AlloVir gains more expenses, which they don't need right now as they are already losing ~$40M per quarter, and Marker's shareholders lose the entire company for pennies on the dollar. Not to mention, major holders of Marker sit on the board of directors and I can almost guarantee they will not approve any buyout at these levels.
None of this matters. To sell the company you need a buyer. If they had a legitimate buyer that gave a legitimate offer I would have to think the company would have been sold by now. Even if there was a buyer it would be stupid to consider a sale prior to having more data. That's also probably the reason they don't have a buyer. They aren't going to go bankrupt because they will be able to raise more cash. I'm not going to speculate on the future of the company because the fact is we just don't know how things will play out. No reason to discuss any sale of the company. Just doesn't make sense right now.
The problem there is Marker would never let the company go for 50 cents a share. Nor should they. That would screw damn near every shareholder. They would have to merge in some way that is fair for everyone and at this point it really wouldn't make sense.
They each have specific licenses and patents that they have rights to from BCM. In simple terms, AlloVir has the license to virus specific T cell therapies and Marker has the license to tumor associated antigen therapies. They can't infringe on each other. It really is a moot point though because the two companies were founded by the same people. They are, for the most part, all still affiliated with both companies so one won't be infringing on the other. At this point Baylor has no say outside of what they already agreed to in the license agreements. Any agreement now would need to be negotiated between AlloVir and Marker and that is highly unlikely at this point. It was a possibility back in 2018 but that ship has sailed.
I mean, the company has been doing a very good job at taking themselves out. It's been four years and they really don't have much more data than they did back then. For BP to want to buyout or partner they want to see data. MRKR doesn't have enough right now. The PII trial has been delayed quite a bit, while most of the delays were beyond their control, the fact remains that they have backed themselves into a corner here. If they can get this AML trial back on track and get the lymphoma and pancreatic trials up and running this should all change but short term they have not put themselves in the best position.
I just have a hard time believing anyone who has the means to hold that entire position, or a large portion of it, actually would. You are probably right that it was most likely initiated at a higher price but at what point do you take your win and call it a day? The share price seems to have bottomed out. I have to believe the chances of this rising 50% are better than it falling another 50%. Even if I'm wrong I don't see many smart investors still taking that gamble. It makes no sense to continue holding it and if it's not retail I would have thought those entities are smarter than that. Ultimately we will never know. I don't think it's an issue either way though as I don't believe the short position large enough to sink us further or cause a squeeze in the other direction. It just exists.
You can hold a short position through a reverse split. Would probably just be a better idea to short right after though. In Marker's case they still have enough gas in the tank to make a push to regain compliance and avoid the reverse split. It's a tall task and like I previously mentioned I have my doubts that they can actually do it but if they can closely string together the news it's possible SP rises over $1. Would suck to be holding a short position if they were able to regain compliance. Like you said though, they probably aren't shorting right now. I doubt anyone that matters is shorting this at these levels. The short interest has remained relatively small anyways. As of 8/31 it was 1.3M shares. It's hovered around that number for the past year. Unless it's a few "large" positions I would assume it's just a bunch of retail folks making peanuts thinking they are smart shorting a $0.40 stock. The reward compared to the risk is nowhere near good enough for someone who knows what they are doing. Short at $2+ with no major news on the horizon? Sure. Short at $0.40 with news on the way? You're just asking to be burned.
For the entities that hold warrants and no shares, yes. Still doesn't make sense for them to short down here because the warrants are priced at $5 so even if they act as a hedge that's still a pretty big loss for them should it play out that way. The point I was getting at is a lot of the warrants are held by NEA, John Wilson, Juan Vera. They are not allowed to short. The other major holders of the warrants are Perceptive Advisors and Baker Brothers. I don't believe those entities are usually known to short a lot. Not that they can't, just that I don't think they generally do. Ann Lean, co founder of MRKR owns a bunch, like hell she is going to short the company she founded. Regardless, the short position on MRKR is relatively small and generally always has been.
Care to elaborate on how it doesn't work that way?
No stipulation saying they can't short. That being said, the largest warrant positions are with people that aren't going to short as they are long term holders.
I hate warrants too. A lot of the outstanding warrants are in the hands of entities who have proven themselves to be very short term holders. I'd have to assume if we did reach the exercise price they would damn near immediately be dumped on the market. We don't need more shares added to the float. We need them held by long term investors.
I hope they don't make a deal to lower the exercise price because, if I remember correctly, the last time they did that they issued new warrants as part of the deal. Don't need anymore warrants out there.
I have no idea if they can extend the expiration or not. They can issue new warrants to the existing holders after the current ones expire I guess. Can't imagine they would do that though as that's not really how warrants work.
That last price jump is almost meaningless as it was not sustained. Even on the massive volume. No reason price should have dropped back down immediately. Its a little concerning to me. It's also a little weird because we knew that news was eventually coming. Just like we'll end up with basically the same news regarding the pancreatic trial sometime in the near future. Either way, until these moves are sustained they won't help. To regain compliance with the Nasdaq minimum listing requirements we need the share price over $1 for ten consecutive trading days. Couldn't even keep the price over $0.40 for ten days on over 100M share volume. That's not giving me a whole lot of confidence right now.
I am also not an expert when it comes to MM activity but I don't buy for one minute that they are trying to control this. It's not worth their time and energy for such a tiny company.
The company has no business doubling the share count right now but you are right. They just don't have enough funds to do anything at this point and that's what it would take for them to get enough funds to stretch the cash runway another year. Its pathetic and I honestly hope they are serious about looking for more non dilutive means of financing. Not holding my breath on that one though. They have a ton of warrants expiring next year. ~5M at $2.99 and ~13M at $5. Maybe they can work some miracles or black magic voodoo to get the share price over $5 long enough for those to be exercised. Its still dilutive but at least those have already taken into account. Wouldn't hold my breath on that one either though, lol. Just grasping at straws.
Can't say I disagree with you. They just need more data to attract BP and they seem to be doing everything they can at this point to avoid getting that data.
It's difficult to make a price prediction with a pending reverse split out there. If they are able to get the share price over $1 by February I don't think it will be by much. I'm hesitant to believe they will even be able to do it at all since we pretty much have a clear picture of all the news that will be coming between now and then. The IND acceptance for the lymphoma trial brought in some huge volume and a decent price surge, albeit very short lived, so maybe when the pancreatic IND is accepted we will see similar, hopefully sustained, results.
I can't see any reason why the market cap should be below $100M right now. The little data we should be getting this month might help some and then hopefully the AML trial enrollment reopening under the new manufacturing process, the completion of the cell inventory for the off the shelf program, and the pancreatic IND acceptance can get us the rest of the way there if not higher. I would like this target hit very short term. Preferably before February. That would be a share price of ~$1.20.
If they have the AML trial enrollment reopened this quarter like planned then I would expect some data from the active group by middle of next year. The MRD patients are going to be what moves the needle in the active arm and even though the sample of MRD patients we have data for now is very small it does seem promising. They just need a larger sample size. If the results remain consistent and the MRD+ continue to turn MRD-, coupled with the initiation of the pancreatic and lymphoma trials, I'd put the market cap somewhere between $300M and $500M. So a share price between ~$3.60 and $6 sometime in Q3 of 2023.
Depending on how quick they enroll the active group its possible they can have a BLA filed sometime Q4 of next year or early 2024. I'd lean closer to early 2024. This is based on the timeline I was given from the company prior to the pause on the trial enrollment. I've mentioned it in previous posts. If they can get the BLA filed within this time frame its possible to have an approval decision on the active group by the end of 2024. By then we should also have had some data from the adjuvant group of the AML, lymphoma, and pancreatic trials. If this all plays out I'll say market cap should approach $1B. Share price of ~$12.
One wild card in all of this is a potential partner for the pancreatic trial. I've mentioned in the past I believe they will attempt to partner up for a PII pancreatic trial. If they can attract a partner for this that should bring some additional validation. If this happens I'd adjust my end of 2024 target closer to somewhere between $1.5B and $2B. Share price between ~$18 and $24.
The share prices are all based on the current outstanding share count and assume for no reverse split which I have my doubts about them avoiding. They will soon be in dire need of funding so unless they can come up with a substantial amount of non-dilutive funding those share prices will be lower. Before their CFO left he gave a short interview where he detailed what they were looking at in terms of financing. He mentioned they were looking into grant opportunities, which just came to fruition, as well as looking internally at board members to provide access to additional capital. It would be a big win if they can make this happen without diluting the hell out of all of us. My fingers are crossed but I'm not holding out hope.
Obviously they need a lot of things to happen, and happen right, to come anywhere near these numbers I've posted. At this point I'll be happy if the share price reaches my breakeven point, lol.
The FDA grant is for the whole trial not just the active disease group. Marker paused enrollment in the trial at the beginning of the year so they can implement their new manufacturing process and adjust the trial design to include MRD+ patients. They did also state that enrollment would be reopened this quarter with the goal of enrolling 10 more patients by the end of Q4. With the information we have available to us the current state of the trial looks like this:
Adjuvant Group: 120 patients, 60 will receive SOC (observation) and 60 will receive MT401. Time frame on this group is up to 24 months.
Active Group: 60 patients (this is up from the original 40), 30 will be frank relapse and 30 will be MRD+. Time frame on this group is up to 12 months for CR or MRD- and up to 24 months to measure the duration of CR.
They previously stated they would have 20 patients enrolled by the end of last year. Per the PR from August 11th they say they have 13 evaluable patients including 6 from the safety lead in. That would mean, if they did indeed enroll 20 patients last year, that 7 of them were into the active group and 13 of them were into the adjuvant group. So unless they somehow enrolled more patients I am assuming the data we should be getting by the end of this month will be on these 7 active patients.
Something they have not been very clear on are the two cohorts they are running with the new manufacturing process. In total there are 6 patients split between these two cohorts. It's possible, and hopefully they clarify when they release the data, that these are part of the 13 evaluable patients. If that's the case then the 20 patients enrolled in 2021 were pretty much all in the adjuvant group.
Either way, we should be getting data on at least 7 patients by the end of the quarter.
Trial will cost about $25M. They now have $15M in grants total to run the trial. That's VERY good.