Tonix Pharmaceuticals Holding Corp. 12th Annual Cantor Fitzgerald Global Healthcare Conference

Great. First of all, thank you very much for having us at the conference and for doing this fireside chat. I'm Seth Lederman, the CEO of Tonix, and we are a fully integrated biotech company, where we've taken a product from concept through development, FDA approval, and now launch all on our own. The product is TONMYA, for the treatment of fibromyalgia in adults. In addition to that, we have a pipeline of programs, several phase II or phase II-ready programs, that present, I think, also a very exciting opportunity for investors and for patients. The ones I'd call out quickly are we have a prophylactic long-acting monoclonal antibody for Lyme disease. In addition to that, we have an antibody, an anti-CD40 ligand antibody, for transplant rejection and treating autoimmunity.

Thank you. I think the launch of TONMYA is really first and foremost on our minds and as a value creator for Tonix. We've now had two full quarters of launch under our belts. The first quarter of 2026, we had $3.7 million of net sales, and in the second quarter, we had $11 million, which is a 3x increase Q2 over Q1. It's not a small undertaking for a small company to build out a whole commercial infrastructure, but I think we're doing a good job of it. We now have 150 reps in the field, where we had 100 and we've just gone up to 150.

We have also been successful on managed care access, where we have two out of the three big PBM GPOs signed up under contract on the commercial side, and we have one of the big three on the managed Medicare side. The managed Medicare contract will come in in January of 2027, at which point we will have about 46% of Americans covered.

Fibromyalgia is an enigma. I was a professor at Columbia University, and I spent several years in the division of rheumatology, and I can tell you fibromyalgia is hard to understand, even for rheumatologists. First, without falling back into being a professor too much, the term rheumatism is the parent term for rheumatology. Fibromyalgia, rheumatism is the archaic term for fibromyalgia, so in a way, we are studying the most ancient and prevalent rheumatology condition in fibromyalgia. But 50 years ago, it was said by one of the thought leaders that among rheumatologists, half of rheumatologists say they never see fibromyalgia, and the other half said it is the most common condition they see.

I think in today's term, you would call that ascertainment bias and confirmation bias, but there is still a big lack of understanding, even among prescribers, about what fibromyalgia is, what it takes to diagnose it, and other issues. I think that there are about 3 million diagnosed and treated fibromyalgia patients, so those are our kind of low-hanging fruit from the commercial side. But then there is about 7 million that are not yet diagnosed, and that is going to be our big upside. Some of the very big changes that have happened in fibromyalgia recently, all of which are wind at our backs. One is that the new criteria in 2016 very specifically say it is not a diagnosis of exclusion, and that fibromyalgia can be diagnosed in the setting of many other conditions, even conditions that cause similar symptoms.

The second is that now tender points are not part of the diagnosis, so I think that that makes it more straightforward to diagnose. I think that understanding fibromyalgia is so important. I should say one of the other big thing that's happened is in 2017, the International Association for the Study of Pain, the IASP, recognized nociplastic pain, and fibromyalgia is the prototype of nociplastic pain. There are three primary types of pain, kind of like there are three primary colors, yellow, blue, and red. There are three primary types of pain, nociceptive, neuropathic, and now nociplastic, and fibromyalgia is the prototype of nociplastic pain. These are messages we have to get out there and have to explain the potential for using a new FDA-approved medicine for this indication.

Great. First of all, like all of the other programs at Tonix, it's first in class. The existing medicines, LYRICA was approved in 2007, Cymbalta in 2008, Savella in 2009. Two of them are SNRIs, and the other is a gabapentinoid. And they have their own mechanisms, but ours targets the disturbed sleep in fibromyalgia. So there's no other product that has our mechanism. I think that that's a very unique aspect to it. It's an every night bedtime medicine that's designed and FDA approved for long-term use. Now, we have not done any comparative head-to-head studies with the other products. And it's a little bit hard to compare also because we enrolled patients with the 2016 criteria in our studies, and the earlier drugs enrolled patients by the 1990 criteria, which required tender points.

I generally think that the earlier products, those studies probably enrolled more severe patients, and we enrolled the patients that you would currently call fibromyalgia today. Another thing is that those products were studied before the FDA required the modern treatment for missing data. And we did our approvals under modern standards. So it's hard to compare the data, but I think that ours is probably as effective. But the important thing is that I think that we have big advantages in tolerability.

Thank you. TONMYA, in the clinical studies, and we did three phase III studies, was generally well-tolerated. The most common adverse event in the studies was an oral experience that some people called tongue numbness, some people called abnormal taste. Some people had other words for it. But in practice, we are finding that that is not an obstacle to people initiating or staying on therapy by and large. Obviously, we don't have the same kind of data from real-world evidence that you would have in a controlled study. But we're very pleased with the way the product is being accepted in practice. We're still early in the game as we bring in new patients. But we'll have to see as time plays out about refill rates, persistence, and things like that. I think it's too early to have quantitative information.