If you're not a millionaire now but would like to become one, there's a well-worn path to get there. Just buy pieces of small businesses that become much larger. 

Aspiring millionaires have been drawn to Tonix Pharmaceuticals (TNXP -9.57%), a small clinical-stage biotech with some potential new drugs in development that could be worth billions.

Can this company's potential new treatments for fibromyalgia and COVID-19 make millionaires out of bold new investors? To answer this burning question, let's start with this clinical-stage company's lead candidate.

Pharmaceutical sales meeting.

Image source: Getty Images.

Lots of good news

Tonix Pharmaceuticals doesn't have any revenue-generating assets yet, but that could change if its lead candidate, TNX-102, can earn approval to treat fibromyalgia. This chronic nerve-pain condition affects millions of American adults, and a new and improved treatment could generate billions in annual revenues.

In a phase 3 trial, fibromyalgia patients given TNX-102 achieved significant pain reductions compared to those given a placebo. Sleep disturbance is a serious issue for fibromyalgia patients, so investigators measured for this outcome as well. On the sleep quality front, TNX-102 knocked it out of the park.

Tonix also turned a lot of heads this March with positive data from its COVID-19 vaccine program. The company's lead vaccine candidate, TNX-1800, knocked it out of the park on a pre-clinical challenge study. All four subjects given TNX-1800 were protected from infection, while all four subjects given the placebo tested positive for COVID-19.

Let's get serious

As far as companies like Tonix Pharmaceuticals are concerned, Operation Warp Speed is over and done. This company will not be receiving bucketloads of cash from the U.S. government to develop TNX-1800 or any new COVID-19 vaccine.

The Tonix Pharmaceuticals lost $50 million last year, and there's no telling when the bleeding is going to stop because we still don't know if TNX-1800 has a shot at earning FDA approval. The company still hasn't injected its vaccine candidate into humans. 

Moreover, TNX-1800 uses a drug delivery method that will invite extra scrutiny from the FDA. Tonix Pharmaceuticals is using the hollowed-out husk of another virus, horsepox, to deliver genetic blueprints that should coax human cells into producing a portion of the virus responsible for COVID-19. If this sounds familiar, it's because vaccines from AstraZeneca (AZN 0.04%) and Johnson & Johnson (JNJ 1.11%) rely on similar technology. 

Coronavirus vaccines from AstraZeneca and Johnson & Johnson are the first viral-vector vaccines to be used beyond clinical trials, and so far, it's not going well. Before the FDA allows injections of TNX-1800 to reach millions of healthy people, it will be run through a much longer development process than investors are probably prepared for.

Sublingual cyclobenzaprine

Tonix Pharmaceuticals' most advanced new drug candidate, TNX-102, is essentially cyclobenzaprine in a new package. Cyclobenzaprine earned its first FDA approval in 1977, and it comes from a powerful class of drugs used extensively to treat depression and other chronic conditions. 

These days, the use of cyclobenzaprine is limited to short-term relief from muscle spasms. This is because physicians need to carefully monitor patients who take cyclobenzaprine for signs of abuse and unintentional overdosage that can be fatal.

While TNX-102 is in late-stage trials now, Tonix is facing a long uphill battle ahead. TNX-102 was designed to be held under the tongue to boost its efficacy, but that will also boost the FDA's concerns about its potential for abuse. 

Keep looking

Tonix Pharmaceuticals hasn't provided evidence that sublingual TNX-102 is an acceptable treatment option for chronic conditions that require long-term dosing. That makes its eventual approval for fibromyalgia extremely unlikely without successful results from a long-term safety study that addresses addiction. 

Tonix Pharmaceuticals has gotten its shareholders into a long slog uphill that you don't want any part of. More misguided enthusiasm could quickly drive it higher, but investors would do well to look for better biotech stocks to buy.