CVM and Multikine; Rating and Confidence ReaffirmedDisclaimer
I am long $CVM to the tune of X0,000 shares (and growing). I genuinely believe, as a scientist, biochemist, and analyst, in Cel-Sci Corporation's Multikine. This article serves as the thesis that $CVM deserves that I have given to other stocks. As always buy shares, options are dangerous and are often used to manipulate the stock.
Now that we have gotten through that:
This is in no way, shape or form, fluid and function, an analytical, qualitative or intelligent compte rendu. There is absolutely no financial advice here because the only financial advice I can give is to research, research, and research. The purpose of this analysis is to serve as an example of an investigation into a company's background, fundamentals, and assets through various lenses to determine if it is a good potential investment for you. The function of this write up is to serve as an educational resource for investors looking to understand how to find good investments. So read and learn some things about a company that cured cancer, yeah, the big C.
Thesis
It is upon rare occasion that one must look towards the past for moving into the future. Then certainly we are led here, a company starting it's preclinical scientific journey in the 1980s. A relic of a flare in a field few thought held value, immunology. Now, it is one of the fastest growing fields in medicine and science, where immunotherapies are quickly becoming the next generation of cancer treatments. Where others have come, and shown promise, Multikine has been here, for decades, toiling in the dark, fighting off bankruptcy, manipulative media and share attacks, and snobby scientists and doctors. Cel Sci Corp stand on victory, their quest coming to an end, and the market coming to the beginning of their own: How much is a drug that safely cures cancer worth?
Keytruda, itself an inhibitor of the immunoblockade, brings in nearly $15 billion in revenue per year over the last 3, with some estimates that this is early rather than late. Keytruda's therapeutic effects limited to an average of 6 to 8 months of survival time depending on cancer, Immunotherapies quickly became the sensation despite "limited" clinical benefits. Molecularly speaking- that is under the hood- Keytruda's true glory served as a limited toxic drug. Standard chemotherapeutics rely on a simple principle: do as much damage to quickly dividing cells, as much so to cancerous cells. This damage is not specific to the cancer cells: normal, happy, healthy cells get damaged too, often leading to them dying. But sometimes they don't die, they carry that damage on and then become a cancer cell later on. Sometimes that which doesn't kill you, makes you stronger, and sometimes it makes something inside you stronger that then kills you. Cisplatin, itself a platinum based drug that binds to the DNA, RNA and proteins in a cell causing them to clump up, get degraded, fixed if possible, leading to massive chromosomal damage (the genetic code). Normal cells take up the Cisplatin to a similar degree to the cancer cells (in fact cancer cells can make more of a special drug pump, then pump all of the drug out of the cancer cell to be consumed by the healthy cells, thus helping it grow), except normal cells have special checkpoints in place to look out for damaged DNA to fix it, or if unfixable, destroy it. 99.9% of the time, the damage gets fixed, or the cell dies, and 99.9% of those times where the cell continues on and becomes cancerous, the immune system finds it and kills it as it identifies it shouldn't be there. Cisplatin has an extremely high rate of cancer reoccurrence, keeping patients alive through cancer round 1, but often failing in round 2 or 3, but also being the cause of round 2 and 3.
Cel-Sci Corporation's Multikine, a mix of interleukins and cytokines used to communicate between the working immune system that an issue is there and needs to be addressed, showed excellent promise in Phase 1 and 2 clinical trials. However, clinical trials have been difficult and slow for a multitude of reasons; the immune system is extremely complex, and until recently there was no technology available to easily study the system in the true depth necessary. Pre-clinical research could not be done on standard laboratory animals as their immune systems are nearly completely defective. From there, a biochemical understanding of the nature of treatment itself impossible until recently, clinicians had little to no idea on what therapeutic response should look like, or what it could look like. Perhaps in some medieval notion, doctors might have considered activating the immune system to fight cancer would be similar to fighting a virus; shakes, shivers, fevers, sickness. When none of these effects, or even no side effects occurred, perhaps there was a considerable amount of white coats in large rooms shaking their heads assuming the project dead.
Through nearly 10 years of a Phase 3 in Head and Neck cancer, starting with a criminal and negligent CRO leading to a successful trial and large monetary recuperation, and ending with a stock-collapsing headline of " 14% increased 5 year survival over Surgery and Radiation alone, less than 10% increased 5 year survival over Surgery, Radiation and Cisplatin ". Perhaps in some small way, Cel-Sci Corporation never had a chance of an easy time, starting from the uphill battle through Ivy Tower elite scientists, ego-heavy medical doctors without a degree in immunology, manipulative short sellers and evil hedge funds reminiscent of the vile Michael Milken; through 3+ decades of pushing the entire medical field forward, paving the way through doctrine and dogma, leading to a breakthrough therapy with no significant side effects through hundreds of people, and an impressive long term survival rate in a cancer that has had no medical breakthroughs in just as long.
Previous articles by this author and others have suggested that the Cisplatin arm of head and neck cancer patients is likely at or below 62%, which is Multikine's 5 year survival topline result. However, the numbers drop from there, and the specifics of that population look even worse. Cisplatin has an extremely low disease free survival/cured rate (where cure is defined as 5 years without cancer), and high secondary tumour incidence. That isn't to say that if given a choice between death and Cisplatin by the oncologist, the patient should absolutely chose Cisplatin, but very soon, they won't have to. Oncologist's will be able to choose a treatment profile in waves, where the first wave is safe therapies, specifically those with low death/suffering rate, such as surgery, radiation, and perhaps a side effect free drug that activates the immune system leading to a long term immune response capable of suppressing the immuno-evasion of the tumour cells right through to 5+ years of healthy life. Patient's from the Phase 2 trial of Multikine had a significant shrinkage of tumour, composite loss of pain, regained freedom of movement in tongue, etc; the drug was an absolute success. In fact the muted response from the clinical results from the trial paper is astounding. While the world must wait for the Phase 3 results to be published in a peer-reviewed journal, a critical step in validating and diffusing the data, the door to the FDA is coming closer and closer. Within the next several weeks or months, a pre-BLA meeting is expected between the FDA and CVM, where they will discuss the next steps and review keynotes of the data organizing it for the final submission and drug review process through the hands of dozens of scientists and medical professionals. Here, the FDA will see as any scientific or medical eye will find, Multikine is a breakthrough drug that will revolutionize cancer treatments.
Emulating Keytruda's path from rich to uber-rich, Multikine will seek for, and gain, approval for Head and Neck cancer with an open label allowance for other indicated cancers. Keytruda went from seeking approval, to nearly complete market approval in a matter of 6 months. While Cel-Sci Corporation does not have the wealth and power to force such a keystone move on the FDA, following historical precedent and medical need, Multikine will be in cancer patients across the spectrum as long as they have a working immune system by the end of 2022, just as Keytruda was in the same position at the same time scale. There is nothing exclamatory or insane about this statement, it has been this way for every disease and every drug that has gone through the FDA; a standard of care exists, experimental drugs better than SOC come along, the new SOC is formed through years of main-stream drug use showing wide market agreement with the clinical trials. Even in Keytruda's own question, failure of all primary or secondary endpoints has not stopped it from getting added to the therapeutic regiment for nearly every cancer, and ultimate approval for said cancer by the FDA.
Multikine's lack of additional clinical response with Cisplatin was a scientific inevitability. Cisplatin damages fast growing cells, the immune system being one of the fastest. Cisplatin often leaves patient's immune system naïve, leading to a need for a geriatric round of childhood vaccines! However, the scientific team at Cel-Sci realized this pre-Phase 3, leading to the establishment of the clinical trial arm without Cisplatin. While bear's might call this part out as evidence of CVM's failure, it is specifically opposite. Cel-Sci Corporation's leadership strong-armed the FDA to allow this branch of the trial, and because of it, have illustrated multiple paramount issues;
Immunotherapies take a long time to work in cancer, but they do work.
Immunotherapies do not work with mainstream chemotherapeutics that have the potential to inhibit and mute their effects.
Cisplatin is a bad drug that kills people and is only used because sometimes it kills the cancer before killing the person.
In this thread, CVM's true long term worth comes in the clinical lessons learned, not just the lives saved. And Multikine does save lives. If only indicated for the current population, head and neck cancer without cisplatin treatment, an estimated 12,000 people a year will be saved by getting Multikine too. Financially speaking, that is a lot of dough. If given to all available patients in the 144,000 group and sitting at Keytruda costs per year of $150k, Multikine could see revenues of $21.6 billion within 3 years. Any deviation in patient population upwards, as is expected, could lead to the most economically impressive drug of all time, and a metric %&#@ of lives saved.
While the current price action is little more than the chaotic meandering of algorithms, market makers, and maleficent hedge funds trying to prevent a massive squeeze from decades of phantom shares being sold, the inevitable trajectory is upwards. This author will leave the curious investor's mind to wander through previous articles and historical acquisition deals of similar scope, but there has never been a drug with more active therapeutic potential than Multikine. When collective cancer research was losing it's mind over Keytruda/PD-L1/PD-1/CAR-T cells, etc, there was only pre-clinical evidence and all early clinical evidence was looking rough. Multikine is out of Phase 3s with a perfect safety record, a massive amount of therapeutic evidence showing a massive clinical benefit, 14% 5 year survival rate in Head and Neck cancer patients leading to a similar short term, and much better longer (>5yrs) term survival rates than Cisplatin. While the catalysts are in full scope for $CVM from today's $11, to a potential $X00, the most important element is this:
Fuck cancer.
Trading Beta
TradingView will enjoy my use of the term Beta with their new rock climbing theme.
The chart shows current price valuations across bear, bull and base case estimates.
From a basic standpoint, this author continues to buy shares, especially as the price continues to be pummeled by the banks and large hedge funds offloading their puts and getting in more calls. Ultimately, a short squeeze/retail interest/increased volume should yield a $50-75 bear price, where appropriate dissemination and understanding of the clinical data and therapeutic implications could lead to an initial bull run to $150-200 giving the company a market capitalization around $5-7 billion (a measly sum considering $OCGN's worth given vaccine uncertainty and $SAVA with pre-clinical data issues and a drug early on in a lengthy and competitive clinical process).
Reasonably speaking, the goal is to amass a large sum of shares, never sell, use leverage and margin to build up secondary positions as $CVM's long term success is guaranteed. Current and future short sellers will force smart moves, but appropriate risk management practices leave this as the primary goal.
Secondarily, amassing large quantities of shares and selling monthly covered calls at critical price points as a way to create sustaining, secondary income and a forward momentum/pressure on the stock promises some level of efficacy.
Tertiarily, options around impulse waves while keeping my own position stable and growing yields more favourable derivative outcomes. Cel-Sci Corporation no longer needs to be acquired to achieve maximum market capitalization, and in some ways, may best achieve shareholder value by utilizing their new manufacturing space to continue on their smaller scale, guaranteeing current investor access to a double digit billions in yearly revenue within 3-5 years.
Links to Previous articles
Links to other highly qualified articles
There are many more articles than this, I just tried to choose a few from the various mixed media sources. I absolutely encourage any investor to see what others have written on the matter, but do not, under any circumstance, believe any single person, including me, without doing your own research and confirming or denying any and every thing. It is absolutely imperative to double check, triple check any and everything.
www.cvmresearch.com
seekingalpha.com
www.sciencetimes.com
seekingalpha.com
finance.yahoo.com
biotechhealthx.com
Disclaimer
Thank you for reading, please review all links, articles, press briefings and scientific data. If ever any questions, please comment, message me, or find me on twitter.
