Tonix Pharmaceuticals Holding Corp. (NASDAQ:TNXP)

Tonix is developing a drug called cyclobenzaprine for treating fibromyalgia. This drug has been used orally for more than 40 years, so its effects are well known and characterized. Tonix, however, has re-formulated the drug using its delivery technology so that it can be absorbed sublingually, bypassing the digestive tract. This avoids first pass metabolism, reducing creation of active metabolites and off target effects and helps promote rapid absorption of the drug.

Tonix has had a rocky road in developing this drug, which it calls TNX-102. Past trials have failed to show statistical improvement in pain relief when compared to placebo, but the experience has helped the company fine tune its dosing and trial protocols, along with interaction with the FDA.

Right now, the company is running a Phase 3 for TNX-102 in fibromyalgia, and very soon the company expects the trial will produce data. Interim data are expected by the end of September, and topline data by December.

If data are good, showing that TNX-102 works to help treat fibromyalgia, it could be a big boon for TNXP shares, boosting them to a multiple of where they are today. Strong trial results will enable the Tonix to submit a new drug application with the FDA and, if approved, begin marketing the drug.

But there’s a great deal more going on at Tonix. TNX-102 is is in Phase 3 trials for post-traumatic stress disorder (PTSD) and ready to enter Phase 2 trials for Alzheimer’s agitation and alcohol use disorder. The company has a different drug, TNX-1300 in Phase 2 for cocaine intoxication, and TNX-601 in Phase 1 for depression, PTSD, and neurocognitive dysfunction from corticosteroids.

On top the the company’s central nervous system portfolio, there is a robust immunological pipeline including three different COVID-19 vaccines, two smallpox preventing vaccines, an organ transplant rejection and autoimmune condition vaccine, a gastric and pancreatic cancer vaccine, and a vaccine designed to protect against radiation damage. The company expects animal data from its COVID-19 programs to read out at the end of this year.

Success in any of these other programs could boost TNXP’s price well beyond where it is today, but the main event right now is the imminent Phase 3 readout from the company’s lead drug in fibromyalgia. Tonix reports $55 million as of its last quarterly filing, exclusive of a $9.6 million capital raise in July. That’s plenty of cash to get to an interim analysis later this month, as well as a final readout by the end of the year.

As noted, the market for fibromyalgia is potentially in the multibillion dollar range. Accessing that market successfully starts with a positive Phase 3 readout. Hitting that goal means Tonix would potentially be worth hundreds of percentage points higher than it is today.

A holding company that holds nothing but heartache...