Phantom……would love you comments on this please…..Burr
Seeking Alpha article posted this morning…….
Since I covered Marker Therapeutics (NASDAQ:MRKR) in April, the stock is down 30%. The stock has a bit of a following, the outlook is mostly positive, and the short interest, too, is a nondescript 2%. And yet the stock has stayed depressed since 2018 - what gives?
Marker is a developer of a kind of T cell therapy which does not need to be engineered, simply expanded. Contrast that to a CAR-T, where the T in a CAR-T is genetically reengineered. So it acts like a foreign body, an antigen, generating an immune response. Therefore this requires lymphodepletion to suppress the immune response; even then, CAR-T treatment can cause severe cytokine storms, endangering the patient.
The MultiTAA technology developed by Marker simply expands the T cells and does not reengineer them. Therefore they behave just like any other autologous T cell, do not produce an immune response and do not require lymphodepletion. Yet they are able to recognize multiple tumor associated antigens across the solid and heme space, and kill tumor cells expressing those antigens. Not only is the therapy easier to manufacture, but it is also overwhelmingly cheaper. Lack of genetic modification also reduces the risk of malignant mutagenesis. All this makes MultiTAA a much better option, in theory. And in practice, Marker says that they have not come across a single serious adverse event, or SAE, in the over 150 patients they have treated so far. This is not something you will hear about CAR-T.
As I noted in my previous coverage:
In various trials in over 150 patients across 7 indications in Phase I/II trials at Baylor College of Medicine, Marker's therapies have shown complete response rates similar to CAR-T results. They have differed from CAR-T in that these CRs have exhibited strong durability. The therapy has shown no evidence of cytokine release syndrome, neurotoxicity or dose limiting toxicities. The therapy costs less than $8000 to manufacture, comparing positively to the million-dollar price tag of CAR-Ts. It can also be given in an outpatient setting in a 10 minute infusion, with 3 infusions over 2-4 weeks.
The company's pipeline looks like this:
Source
The problem with this scenario is that there are 8 trials running, 6 of these in phase 1 and 2 in phase 2, and of these 8, 7 are being undertaken by the Baylor College. That leaves Marker with just one phase 2 trial in AML, which is supposed to come out with data in mid 2022. AML is usually an exploratory indication for cancer therapies and does not evoke a lot of interest in the early stage. Basically, therefore, Marker has a technology of some theoretical promise but nothing they have proven in the clinic. This is precisely the reason the stock is trading sideways for months now:
Source
If we are looking for more reasons and want to get technical, the phase 2 AML study is an open label study. There are three arms in this trial, an adjuvant arm, meaning therapy is given to people after their HSCT, where there has been no relapse observed; the control arm, which provides for no intervention after HSCT; and an active disease arm, where disease has relapsed. The problem, as I see it, with this approach is that data would probably have been better understood if there had been a control arm for each intervention setting. Clearly, a larger clinical trial will aim to address one of these two exploratory arms, the one where data is more robust. I remain confused how the two arms will be differentiated among themselves if they are being compared to the same undifferentiated control arm.
Let us say you want to compare the level of fermentation of two sugary drinks after one week of setting. What is the ideal comparator here? I would think it would be each sugary drink that has been refrigerated to prevent fermentation. Instead, you mix both sugary drinks and refrigerate them, and provide just a single statistic for the mixture. How are you going to compare the level of fermentation of each drink? There are basically two separate trials here, apparently put together for convenience, but for the sake of convenience, important parameters are being lost. This trial is just aimed at being indicative, and a future trial will be required to arrive at more conclusive conclusions. Until then, there can be no defined positive conclusion to be made about MRKR, and therefore, the stock will not find momentum.
The company, in June, completed the six-patient safety part of the phase 2 trial. Patient enrollment is ongoing. There will be 120 patients in the adjuvant setting and 40 more in the active disease portion. Enrollment will be over by Q4. Top line data from the active portion is expected by Q1.
Financials
MRKR has a market cap of $127mn and till June 30, 2021, Marker had cash and cash equivalents of $57.2 million, which it thinks will last till 2023. The company recently received a $13mn award to support the development of MT-401, so that adds to its cash reserve. Including that, they have around $70mn in cash. Research and development expenses were $7.4 million for the quarter ended June 30, 2021, and SG&A expenses were around $3.6mn. So they have around 7 quarters of cash at this rate. The company also did a $56.5 public offering in Q1.
There is moderate interest from funds and institutions. Key holders are:
Source
There have been no new purchases since my April article, except one.
Bottom Line
This article, such as it is, resulted from a question by TPT members about the continued stagnation of the stock. Frankly, there's not much to work with here to answer that question. They were in a data desert, and they are still in a data desert. There are minor updates but that is all that is - and those haven't moved the stock. I am continuing to avoid the stock for now, although, given the theoretical promise of the technology, I will keep watching it closely.
