DoctorFaustus

CVM; The End is Nigh and the Reaper is coming to collect someone

Long
AMEX:CVM   Cel-Sci Corporation
As always, I am not an analyst in any shape, form or capacity, except for shapes, forms and capacities. I am a complete stranger on the internet spewing absolute nonsense, please double check everything I post (I will add links when I have enough reputation).

Ok, with the formalities out of the way, let us get down to business. I am going to follow procedure by not following procedure and talk about the play first. The science is cool behind this, and I can talk about it in a fun way down below, but I happen to think the deal needs to be addressed at the top.

The Play
The play is this: CVM has been around for 33 years and has this one, singular drug. This drug just went through phase 3 clinical trials in the US after 9.5 years. If the drug succeeds, then it is possible this goes full vertical in multiple ways. If the drug fails, expect a bankruptcy announcement and your stock to become worthless instantly. Every single dollar you put into it is gone, poof, nada. You want to be rich, you put your savings in 20k, the play went the wrong way and now you have 0. If this scares you, good, that is what this bet is. I am not putting my life savings on this, as I don't think anyone should ever do.

Sometime very soon, official phase 3 results will be announced for Multikine, CVM's golden egg. As an independent contractor is performing the final data analysis, CVM nor anyone else knows what the end results are going to be. However, in the trial end conditions, they decided to wait for 298 deaths (just about a third of the total trial participants). They finished entering people into the trial in 2016, announced in may 2020 the final death. In the setup, they set the standard order of care at 55% for 3 year survival. Assuming 55% survival at 3 years, the control group would have 443 deaths. On top of that, this suggests Multikine has a 70%+ survival rate (some of the deaths will be removed from the trial such as car accident, stabbing, shooting, deaths absolutely having nothing to do with the drug). That is a homerun hit. Pulling some stats straight from cancerresearchuk.org & cancer.gov; 5 year survival % for all head and neck cancers is 27-30%, with 4% of all cancers being head and neck. If this drug does 70% @ 3 year, this becomes the standard of care, and the best part is, this is an additive. Multikine is pre- everything else, so no matter what other drugs get developed, it is likely Multikine will remain SoC.

Multikine has a huge short interest. Turns out Citadel and Susquehana went to town shorting this baby lately, with their shorts alone being more than what most institutional investors own, with a total 15% short interest. Sure, this isn't massive, but the low float combined with a sudden buying demand for a biotech-king to be or an acquisition by a bigger fish, there is a solid base for momentum upwards. Again, with that, its always possible Citadel and Susquehana know insider information and are going to make a lot of money off of this. Remember this is the definition of risky.

Everyone of those small biotechs with the potential breakout hit, most of them don't even make it this far into phase 3, let alone on the precipice. CVM is going to get the news soon, and it will be the catalyst for the moment we wait years for on these biotech gambles.

The Science
Multikine is a combination of human cytokines, which are the chemicals and proteins in your body that activate the immune system. Each one has it's own pathway, with it's own effects and results, so combining them like this is somewhat novel for me. I kinda like it. I believe that the recent failures of PD-L1 and other immune checkpoint blockade programs have been a great indicator on how 1-leg strategies targeting the cancer immune system is a waste of time. On top of that, Interleukins, which are cytokines and a component of this drug, have been tried for decades and decades in clinical trials for cancers. All of them have had weak results, always with the glimmer of hope, but somehow never panning out despite trial after trial. My personal hypothesis is that the trial setup has been all wrong on these for decades, combinatorial therapies should have been tested long ago. I have no idea if Multikine is what CVM says it is, I am not an immunologist and my basic understanding of this aspect of biology is weak and limited to RNA defense stuff. Summarily, I won't be surprised if this works.

Cancer and the immune system is the trillion dollar question right now. There have been some brilliant people investigating this for longer than I have been alive. There just may be brilliant people investigating this for longer than I will be alive. I can't answer specifics, especially specifics we don't know, but I can give you this: the way cancer uses and abuses the immune system varies over time, over need and over tissue type, the specifics are messy and will bog you down, all to boil down to this: the immune system has lost it's ability to identify or fight against a foreign and maligned organism (the cancer cell). By activating the immune system in every single way, the way Multikine hypothetically does, might just overload all the different defense mechanisms the cancer has to evade or trick the immune system.

One of the neat things about Interleukins and the research on them, is this stall effect they cause on cells that has been shown to lead to healthier and longer proliferation. The idea behind this being that the cell senses a problem, Interleukin is literally a red letter screaming problem across the cell, and the cell stops trying to proliferate, it does a check on everything. This has the possibility of causing a brief replication pause in the cancer cell, giving the immune system time to identify the cancer cell when it is unable to perform some of its tricks (a replication halt in G2/M phase should stop most transcriptome changes, some that might be very important in immune system evasion). Now the bad thing is sometimes cancer likes the pause, and depending on the length of time between a replication halt from a cytokine storm, and chemotherapies or radiation therapies; this has the potential to impact potential treatments in various cancer backgrounds.

Nothing in the science of Multikine is specific to head and neck cancers, so if CVM get this for head and neck, expect a massive push into other cancers, especially those without a reasonable standard of care.

The Company & The Financials
Don't even look here, it doesn't matter. The company is nothing without Multikine. They have a few preclinical programs, but if Multikine fails the game is over. Financials wise, it has 40M cash and nothing of interest.

I believe ownership % is important. The top institutional owners are Blackrock, Vanguard and State Street, all with just over 6 million shares combined. 30% institutional ownership, 38 million float, >15% short interest.

I cannot speak to the quality of the company and executives, but if you go to yahoo finance, key execs for CVM are mostly scientists. This is super bullish for me. Science should lead science, not business.

The History
I think it is important to note, and at the very least make you aware of the following:
A subreddit dedicated to CVM
Various communities with some strong opinions on shorts (google kill the shorts cvm)

With that said, I did not read through those locales, if you are interested in this stock, you might want to so you can be aware of what is going on in the periphery.

The End
As always, do your own due diligence and research. I know nothing. Please leave feedback, criticisms, suggestions. Thanks.
Comment:
6/25/2021: Multikine works! www.businesswire.com...e/20210628005472/en/
Disclaimer

The information and publications are not meant to be, and do not constitute, financial, investment, trading, or other types of advice or recommendations supplied or endorsed by TradingView. Read more in the Terms of Use.