Enlivex Therapeutics Stock Forecast: The term “cytokine storm” sounds like a weather event, but it has nothing to do with atmospheric conditions. Instead, it’s a dramatic immune system response that happens when the body is too good at fighting off infections.
Also known as Cytokine Release Syndrome (CRS), this condition can be deadly. It’s responsible for situations in which healthy adults die of the flu, and it is one of the biggest challenges that patients face during treatment of sepsis, complications from blood marrow transplants, and solid tumors.
To date, no biopharmaceutical company has solved the cytokine storm dilemma, but Enlivex Therapeutics says it is close. If so, there could be tremendous opportunity for investors. But is Enlivex really on track with a therapy to combat CRS?
The Basics of Cytokine Storms
The human immune system is extraordinary. At the first sign of infectious intruders, it swings into action, releasing a variety of specialized cells that identify and destroy foreign material.
White blood cells called macrophages can differentiate unwelcome visitors from the body’s own cells, and they go on the attack – often swallowing viral, bacterial, and fungal cells whole.
B-cells release protein antibodies that attach to the invaders, marking them as dangerous so T-cells can find and destroy them, and a variety of other chemicals, proteins, and cells offer backup.
All of this activity is coordinated by proteins that serve as messengers between members of the immune system’s army. These proteins are cytokines, and they are responsible for encouraging the body to ramp up immune system response. Of course, things don’t always go smoothly.
In some cases, the body produces too many immune cells in response to signals from cytokines. That increases the number of cytokines as well, which means more pressure on the body to produce immune cells.
It turns into a loop of cytokine creation, and the cytokine number grow out of control. A “cytokine storm” takes over, and the immune system starts to run amok. Organs are damaged, particularly the lungs and kidneys, and they begin to fail. If the cycle continues, entire systems shut down, and eventually, the patient will die.
Treating this condition is complicated, because the only way to mute the immune response is to suppress the entire immune system. That gives the original infection free reign to destroy everything in its path. It’s nearly impossible to balance the two with the therapies currently available, and the bottom line is that many patients die from complications of this condition.
Enlivex says it has a solution, and it is hard at work attracting investors so it can move through clinical trials and bring its drug candidate to market. Is this a good opportunity for investors, or has Enlivex promised more than it can deliver? In short, is Enlivex a buy? What is the Enlivex Therapeutics stock forecast?
Is Enlivex Therapeutics Close To Success?
Enlivex Therapeutics [NASDAQ: ENLV] says it “puts out storms”, and indeed that is the company’s primary area of focus.
Enlivex is working on solutions to stop the cycle that leads to cytokine storm, calming the immune system and returning it to normal, balanced function.
Balanced is the key word here.
The treatment is intended to solve the cytokine storming issue without completely suppressing the immune system. For patients, that means they can still fight off the original infection.
Enlivex Therapeutics [NASDAQ: ENLV] has developed a product candidate Allocetra, which is well into clinical trials.
It is an immunotherapy drug that calms life-threatening hyperactivity of the immune system by harnessing the power of the immune system’s own naturally occurring regulation mechanisms.
Allocetra connects with macrophages and dendritic cells to prevent and protect against extreme proliferation of immune response cells, while still allowing these infection-fighting tools to get their job done.
The company is targeting three major areas in its initial application of the drug. First, testing is underway to determine Allocetra’s effectiveness when patients experience graft versus host disease as a result of bone marrow transplants. This condition is responsible for many post-transplant deaths, and available therapies are quite limited.
For the moment, physicians have little more than steroids to combat complications from graft versus host disease, and all too often, the steroids simply can’t solve the problem.
The next trial phase is scheduled to begin during the first quarter of 2020. If the drug is successful through remaining trials and eventually approved , the addressable global market for bone marrow transplant recipients is approximately $3 billion.
Enlivex Therapeutics Market Opportunity
Sepsis is the second major target for Allocetra.
This condition occurs when the body’s response to infection is overwhelming, and healthy tissue is killed along with diseased tissue.
More than 1.7 million American adults are diagnosed with sepsis each year, and research shows that one out of every three patients who die in a hospital setting has this condition.
Sepsis causes more approximately 270,000 deaths per year in the United States alone.
Preliminary data from a small initial study show that when patients are treated with Allocetra early, they have a high likelihood of surviving sepsis. Because the condition is so prevalent, the total addressable market is enormous.
In the United States and European Union alone, the market exceeds $33 billion. Allocetra is already well into clinical trials, and the company is expecting to report top line results soon. If successful, this drug could be a game-changer for one of the most difficult – and deadly – health issues facing patients today.
Enlivex Therapeutics Is Attacking Cancer
Finally, Enlivex is exploring applications for using its product to fight solid tumors. This area of research is in early stages, but there are promising signs that the company may eventually offer a new weapon in the fight against cancer.
If successful, the total addressable market for this application is massive. After all, cancer is the second leading cause of death in the United States. Only heart disease claims more lives.
All of this sounds good on paper. After all, if Enlivex Therapeutics [NASDAQ: ENLV] is able to solve even one of these thorny medical problems, sales revenue will come pouring in. Does that make Enlivex a buy?
Is Enlivex Therapeutics a Buy?
The biggest problem with Enlivex Therapeutics [NASDAQ: ENLV] is the same one that faces every biotech firm. Failure is far more likely than success.
Every company has experienced the heartbreak of a drug failure in late-stage trials, even when preliminary results were excellent. Investing in any of these companies is a big risk. They rarely make money along the way, and if product candidates don’t get regulatory approval, investors stand to lose every penny.
Enlivex Therapeutics is in a more precarious situation than some of its better-established peers. The company has no revenue to speak of, and it is going through cash at a rapid rate.
Enlivex Therapeutics Stock Forecast
Now, both of these issues are normal and expected for early-stage biotechs. There won’t be any revenue until the company has a product to sell, and the spending is necessary to bring that product to market.
Nonetheless, this is an uncomfortable financial position from an investor’s perspective, so this stock may be best suited for the very boldest buyers. Those with any qualms about owning high-risk stocks would be better off steering clear of this one.
Learn more about the risks and rewards of investing in biotechs from the experts at Financhill – where many of the world’s smartest investors go for information.
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