Marker Therapeutics Inc (MRKR)

[Phantom Lord]

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.