Tonix Pharmaceuticals Holding Corp. Canaccord Genuity's 46th Annual Growth Conference

Great. Well, first of all, thank you all for coming. Thank you very much for having me and Tonix at the conference. It has been an exciting couple of days, an exciting 15 years.

Yeah. The company is really founded around the idea of finding a better way to treat fibromyalgia.

We have taken a product from concept through lots of stages of invention, development, testing, FDA approval, and now launch. We have done this all internally. What we have today is a product that was approved a year ago. It was launched in November, and now after two full quarters of launch, we have reported results yesterday where we had $11 million of net sales, which was approximately a triple over Q1. So we are getting good uptake from prescribers and patients, and it is very satisfying because we think that this is really going to has the potential to change the treatment of fibromyalgia. Tonix, to take a step back, over time, we have become a fully integrated company where we have things all the way from basic research through commercialization.

Our real focus on this year and next year is going to be the launch of TONMYA for fibromyalgia.

Great. First of all, let me back up and say I was a rheumatologist at Columbia Medical School back in a time when fibromyalgia was dismissed, denigrated, discounted by the faculty. I was training in a junior faculty.

Diagnosis by exclusion. Yeah, but worse If you could get to that point worse people said, "Fibromyalgia doesn't exist.

It's a made-up condition. It's just women complaining." There was a terrible framework of fibromyalgia rejection at that time. And something really brilliant was written by someone I'll get to in a minute, that there's a paradox of fibromyalgia, and this is in 1975, 51 years ago. Harvey Moldofsky wrote, "Half of rheumatologists say they never see it, and the other half say it's the most common condition they treat." I think today you would call that a affirmation bias or a confirmation bias, but clearly if you're looking with your eyes covered, you're not going to see something. It's always attractive to me to, it had this attraction of the elephant in the room or the hidden in clear sight. Because the patients were desperate, it was an unmet need, et cetera.

Big events in the history of fibromyalgia was in 2007, Lyrica was approved from Pfizer, and that became a $5 billion peak sales blockbuster. In 2008, Cymbalta was approved and became a $5 billion peak sale blockbuster. Those were big products and really opened up the field. But Lyrica works by basically kind of dulling the nerves. Fibromyalgia is a chronic pain condition, and Cymbalta is a little bit more refined because it does touch on this norepinephrine reuptake system, and there's an aspect of modulating pain that in fibromyalgia, where that's an important drug.

Our work came from Harvey Moldofsky, who in 1975 made a bold assertion. He wrote a paper, "I know you think that fibromyalgia is a pain disorder, but I believe it's a sleep disorder." He had a very provocative series of papers. One was a challenge study where he took undergraduates and sleep deprived them, and all the undergraduates except one developed widespread pain. He really turned the paradigm on its head, and the one that didn't was a cross-country athlete. Not only did he, in a sense, upend the apple cart or whatever of fibromyalgia, but he also understood the important connection of fibromyalgia and exercise, which I won't have time to get to today.

Basically, ours is the first product that targets the disturbed sleep in fibromyalgia. In that way, it's fundamentally different from the other ways that fibromyalgia has been treated. It's a little bit hard to compare our data versus Lyrica and Cymbalta, because in 2016, the diagnostic criteria were revised. Our product is the only one that has been tested with the modern revised criteria. In the old criteria, you needed 11 tender points, which were elicited by pressing in different points of the body. The modern definition does not have tender points. I think generally speaking, our group of patients that we studied would be generally milder or less severe than the patients that were treated with Lyrica and Cymbalta.

Another significant difference is that between when they were approved and when we were approved, the FDA has required a rigorous treatment for missing data. The missing data analysis that we used is the modern one, and I'm not sure whether Lyrica and Cymbalta would be approved on the data they collected with the modern criteria. It's impossible to tell without their actual data set. There was just a wonderful review of fibromyalgia in The New England Journal of Medicine, which shows how far we've come. I think it's the July 16th issue. The one thing that I think is not properly looked at is looking at our data relative to theirs in a head-to-head way, because when you have to account for missing data, it essentially is moving the hurdle higher and also treating the modern definition of fibromyalgia is moving the hurdle higher.