Hi, everyone. Thank you for joining us here at our 46th Annual Healthcare Conference. I am Vishwa Shah, one of, a part of the biotechnology team here at TD Cowen. I work with analyst Stacy Ku. It is my pleasure today to introduce Seth Lederman from the CEO of Tonix Pharmaceuticals to give us a presentation.
Thank you very much for that introduction, and thanks, everyone, for coming. We're grateful to be included in the conference. I'm Seth Lederman, CEO of Tonix. Tonix trades on Nasdaq under the ticker TNXP. I will be making forward-looking statements, and this is our standard safe harbor. Here's Tonix in one slide. We're a fully integrated pharmaceutical company. Most of the focus this year is on the launch of Tonmya. That's a new treatment for fibromyalgia that was conceived, developed, approved, and launched by Tonix on our own. We also have two migraine drugs, Tosymra and Zembrace, I'll describe a little bit. We work in a number of different therapeutic areas. We like to consider ourselves as opportunity-focused.
Now with our success in taking something from concept to approval, we have been able to in-license some programs. We believe we can add value along all the different steps of the development cycle. One of the programs I'll talk about today is a Lyme preventative program that we licensed from University of Massachusetts last summer. Snapshot, we had $208 million at the end of last year. We have no debt. We have a simple balance sheet, but we also have a simple cap structure where we have all common equity and common shares and a few pre-funded warrants. Finally, we have partnerships with a number of leading institutions around the world for our programs, which we believe are all best in class.
I'm gonna spend most of the presentation on Tonmya, which is sublingual cyclobenzaprine tablets. It was approved last summer in August for the treatment of fibromyalgia in adults. Tonmya is a first-in-class, first-line medicine. It's a unique sublingual transmucosal product for fibromyalgia. It's taken every night at bedtime, and it is designed to target the disturbed sleep quality in fibromyalgia, so it's first-in-class. There's never been a drug designed to target the disturbed sleep of fibromyalgia. Fibromyalgia has a high unmet need. The epidemiology says there are about 10 million adults in the United States with fibromyalgia. There are three previously approved drugs. Ours is the fourth, but there's still a very high unmet need. There's a lot of dissatisfaction with the existing products. Tonmya has a distinct mechanism.
As I said, it's taken at bedtime to target the disrupted sleep to break this vicious cycle of bad sleep, worse pain, bad sleep. It's a large market, and we have 100% share of voice. The other products are either generic or no longer promoted, and that's both a challenge and an opportunity. It's a challenge because we're out there having to remind people, prescribers, the general public, about fibromyalgia. But it's an opportunity because clearly it's a good business opportunity not to have anyone promoting against you. And fibromyalgia, which I'll describe a little bit later, is a complex condition, and a lot has changed in the understanding of fibromyalgia since the three previous drugs were approved more than 15 years ago. Here's Tonmya.
We had just a stub of sales in the last year since it launched on November 17th. We have reported in our flash financials that we had $1.4 million of net sales last year. More importantly, we have a great commercial team that's assembled actively out there, and I'll describe in detail later what we're doing. We've had 90 reps in the field since October, and we're focusing on the 5% of prescribers who write 70% of fibromyalgia prescriptions. We have a data-driven approach to identifying these prescribers, we're not doing a strategy where we're just marketing to rheumatologists, we're writing to a number of different subspecialties based on whether people diagnose and treat fibromyalgia. Tonmya's been added to existing contracts with wholesalers and specialty pharmacies.
We have robust patient access programs in place, including a savings card, co-pay assistance, prior authorization support, and all of this is intended to reduce the barriers to access during early commercialization. We're working on our managed care strategy. We've been in discussions with managed care for over a year now, starting with the pre-approval information requests and now going on into more detailed discussions about our value proposition. Fibromyalgia is a pain condition. It's a chronic pain condition that affects mostly women. It's widespread pain, which means that the pain is all over the body, not localized in one place. It often begins with a regional pain condition, but then over time, the pain generalizes. Fibromyalgia is a pain disorder, but it also has two other core symptoms. One is non-restorative sleep, and the other is fatigue.
That triad of chronic widespread pain, non-restorative sleep, and fatigue are the core features of fibromyalgia. They are also now increasingly viewed as the core features of nociplastic pain, where nociplastic pain for the past 10 years has been recognized by the International Association for the Study of Pain and other major groups as the third primary type of pain. The other types of pain are nociceptive pain and neuropathic pain, but it's very often the case that patients will present with a pain syndrome that is a mixture of some of these three primary types of pain. A lot of very interesting research going on in rheumatology and other fields about some condition and fibromyalgia. Now there's a lot of research about lupus and fibromyalgia, rheumatoid arthritis and fibromyalgia, osteoarthritis and fibromyalgia, breast cancer and fibromyalgia. There's.
That was previously sometimes called secondary fibromyalgia, but is clearly considered fibromyalgia. There's a lot of interesting work going on so that people don't chase the symptoms, for example, of lupus when, in fact, there's an exacerbation of fibromyalgia, which requires very different kinds of treatments. Because fibromyalgia is a pain condition, our drug is an analgesic. It's a painkiller. Because it's not an opioid, it is a non-opioid analgesic. This is a very high priority for the United States healthcare system and systems around the world to work on new ways to treat chronic pain, because chronic pain is really one of the main drivers of the opioid crisis and also a lot of unhappiness. There are, as I said before, we entered the market in November, there were three approved drugs.
Lyrica, that was approved from Pfizer in 2007. Cymbalta, which was approved from Lilly in 2008. Savella, which is now sold by AbbVie. Savella is still under patent. Lyrica and Cymbalta have lost their patent protection. In their day, Lyrica was Pfizer's largest drug product, and Cymbalta was Lilly's largest product. These were both blockbusters in their day, and I think it speaks to the potential of providing treatment to fibromyalgia patients. These drugs are not cures, and in fact, patients cycle between the drugs. Many patients that are diagnosed with fibromyalgia have already been on these other drugs, and are looking for new options. The market is large. The epidemiology says there are at least 10 million American adults with fibromyalgia.
Those numbers come from before the COVID epidemic. In fact, now there may be 20 or 30 million long COVID patients. We've presented some data about claims analysis that it could be that as many as half of long COVID patients can be diagnosed with fibromyalgia appropriately. The National Academy of Sciences in June of 2024 came out with a very important piece on statement on the definition of long COVID. They made the important conclusion that fibromyalgia is a diagnosable condition in long COVID patients. We'll see how many of these 20 or 30 million long COVID patients ultimately are diagnosed with fibromyalgia, which would make them eligible to potentially try Tonmya. Of these 10 million patients from the pre-COVID epidemiology, only about three million are currently diagnosed and treated.
There's a missing seven million patients, and hopefully, we and maybe others could increase education about that. This is the low-hanging fruit for our marketing efforts, the three million patients that are already diagnosed and treated. That's how we've used data to target the prescribers. Fibromyalgia is very frustrating for patients and also for prescribers. That's unfortunately led to misunderstanding and some frustration. You can see that patients feel isolated, embarrassed, et cetera. Big problems with validation. People say, "Fibromyalgia has stolen my life from me." Others may be more articulately will say, "It's stolen my life roles. I wanna go back to being a spouse, a parent, an employee." Doctors are also very frustrated.
They don't have good medicines to treat fibromyalgia patients, and often, they don't maybe take the time to listen to all of the many problems that manifest with fibromyalgia. There's a lot of underdiagnosis and not only under-treatment, but a lot of prescribers unfortunately use kind of a Whac-A-Mole approach to treating fibromyalgia instead of a holistic approach. One of the dangerous ways that prescribers treat, or in some cases mistreat, fibromyalgia is this Whac-A-Mole approach of treating pain, sleep, and fatigue separately. Pain, remember fibromyalgia is a pain condition, and this is a claims data analysis that we commissioned, and it's a look -back, a 18-month look -back on what kind of treatments, what kind of prescription drugs did fibromyalgia patients get in the United States.
The results are not only disappointing, I think they're appalling because one thing that pain experts and fibromyalgia experts would agree on is opioids should not be used. Fibromyalgia is not the kind of pain that should be treated with opioids. opioids just cause problems, side effects, and also serious problems like addiction, dependency, et cetera. You can see here that, you know, in this list of top prescribed drugs, you see hydrocodone, an opioid, oxycodone, an opioid, tramadol, an opioid. Widely prescribed in the United States and yet not believed to be, well, not indicated, and actually most doctors think they should not be used in fibromyalgia patients. In fact, when we speak to experts or doctors treating fibromyalgia, experts, fibromyalgia, I mean, it's known from medical school and training not to do this.
No one takes credit for it, here it is. These are prescriptions in the system. Somehow someone is writing these prescriptions. Let's look at the things that are used. The most widely used drug, gabapentin, off-label. I think there's a lot of pushback now on gabapentin, the overuse of that. Here's pregabalin, which is approved, which is all the way down here on the list. The most valuable and most widely prescribed medicine that's on-label is duloxetine. That's the former Lilly, Cymbalta. You can see here that, you know, that it's all over the place. What we're gonna do with our education is target doctors and improve their knowledge and also tell them about Tonmya. We're targeting 5% of these 470,000 prescribers. That's roughly 25,000 prescribers.
We're doing it with an omni-channel approach, a lot of social media, other kind of outreach to them. A key thing is that we do have 90 reps in the field, so about 9,000 of the prescribers will be targeted by an in-person field force. We already have in place robust access programs, co-pay assistant, prior auth assistants, things like this. This is already ongoing. Our WAC we announced after approval, is $1,860 a month. That's for adults 18 to 64, two tablets a night, long-term. Tonmya is indicated for long-term daily use. Before we launched Tonmya, we bought two marketed migraine products. These are, you know, great products. We think Tosymra is a sumatriptan nasal spray.
Zembrace is a sumatriptan injection. They're both indicated for the acute treatment of headache in adults. We thought it was a good entry into the market because this is a pain syndrome. Migraine affects mostly women. Migraine is more common in fibromyalgia patients than non-fibromyalgia, and fibromyalgia is more common in migraine patients than non-fibro patients. Nonetheless, while these are both on patent and very interesting and elegant products, we are not using our sales force to promote these, or we're gradually decreasing our promotion of these products. Let me tell you a little bit more about the science of fibromyalgia and Tonmya. Cyclobenzaprine, the active ingredient of Tonmya, was actually the first medicine ever studied in fibromyalgia. Merck did a large 6-month study, and it failed, and Merck killed the program.
That's because it was a swallowed medicine. We looked at that and said, "You know, glass is half full. It worked for a month, and then it stopped working." What we did was we re-engineered it to improve the durability of the response. Fibromyalgia is a chronic pain condition. In order to treat it, you need a drug that works over long periods of time. We made a sublingual tablet. This is the active ingredient, cyclobenzaprine, a tricyclic. What we did with a lot of formulation technology to actually get it transmucosally absorbed. Many products that are sublingual or buccal or something, they're actually meant to be taken without water in the middle of the day at work or something, but they're actually swallowed. This is a relatively unique product that is sublingual and designed for transmucosal absorption.
To do that, we had to add a basic excipient that basically creates the freebase that pushes freebase cyclobenzaprine across the mucosal membrane. It bypasses the liver, and for reasons I'll explain later, if you bypass the liver, then you, we believed, we hypothesized that we could get durable responses. There is another level of technology that was required because if you just add a base to cyclobenzaprine, the base attacks the cyclobenzaprine, the tablets fall apart in a day at room temperature. We came up with a very intriguing formulation called a eutectic formulation, and this is where two crystals co-penetrate each other. It's a novel form of matter so that the interactions are at the angstrom level. The eutectic actually protects the cyclobenzaprine against attack from the base.
If you see here, this is what our formulation looks like in a cartoon, that the eutectic is stable in a tablet, and we have 4-year stability on our tablet. We have very good shelf life with our tablet, and yet it has all of the desirable properties of a sublingual tablet, rapidly disintegrates, rapidly dissolves, rapidly delivers cyclobenzaprine freebase into the bloodstream. This is hard to read, but these are all from the label. This is the bottle that Tonmya comes in. By the way, it's instructed that pharmacists are not supposed to divide this into amber bottles. The patient gets bottles that look like this. It's a 60-count bottle for adults. And that's because to get the 4-year stability, there's a foil top that is easy to peel off.
Here's the efficacy data in the package insert. As you can see, this is pain on the Y-axis, this is number of weeks on the X-axis. You can see that Tonmya, the bottom line, these patients had a significant reduction in pain that started early in the study and was durable throughout the trial. That's the difference between sublingual cyclobenzaprine with transmucosal absorption and the swallowed cyclobenzaprine from 30 years ago that didn't work. These graphs are a little bit hard to understand, but this is the number of 30% responders in the Tonmya group on top and the placebo group in the bottom. You can see it's 46% 30% responders on drug versus 20%, 27% on placebo in the second trial.
This is important because this is what the experts have determined is a clinically meaningful response. We have a statistically significant improvement in pain, and we also have a clinically meaningful improvement of pain. Like every prescription drug, Tonmya has side effects. The most common adverse effects were related to oral experiences. Remember, this is a drug that's designed to rapidly disintegrate, dissolve, in the mouth, under the tongue. A number of different things were reported in as many as 25% of patients in our trials, but they were mostly mild and rarely led to discontinuation. Very importantly, weight and blood pressure did not change in the Tonmya group. This is important because these are problems in some of the other drugs that are approved for fibromyalgia.
There were no reports of cognitive dysfunction or sexual dysfunction, no evidence of abuse potential. It's recommended or advised against for pregnant women or women intending to become pregnant. There are a number of drugs like MAO inhibitors, SNRIs, et cetera, that are contraindicated. We're very excited about Tonmya. You know, we've been marketing it for 12 weeks, I think. Each week, the number of scripts are growing. The new prescriptions are growing each week. We're excited about many of the dynamics of the launch that we're seeing. Let me quickly take you through our clinical pipeline. These are all programs that are either in or about to go into phase II trialss. They're already phase II or phase II-ready.
A Lyme prophylactic, a treatment for organ transplant, treatment for Prader-Willi, and then two, call it line extensions for the product that is called TNX-102 SL outside of fibromyalgia. We call it Tonmya inside of fibromyalgia. I said before, as a fully integrated pharmaceutical company, we can add value, you know, throughout the entire development chain. That's why we, I think we're selected to develop this very exciting Lyme prophylactic that was developed by the University of Massachusetts. When we licensed it, they already had compelling phase one data showing a 70-day half-life. This is designed to be administered in the spring and to provide protection against Lyme through the Lyme season in the continental United States. It's a long-acting monoclonal antibody. It's directed against OspA.
OspA is the same target that's being targeted by Pfizer/Valneva, by Moderna with their with their mRNA program, and also was the target of an earlier vaccine called LYMErix from SmithKline Beecham that was taken off the market. It's a very interesting program. The OspA is expressed in the midgut of the tick. That's where this drug has its activity. Our monoclonal has its activity. When the tick bites someone, it sucks in the blood, it sucks in the antibody with the blood, and in the midgut of the tick, the Borrelia is killed. In primate challenge studies, we had 95% protection against a challenge. We're doing a similar challenge or we're planning a similar challenge study in humans, which is a novel development plan.
No one has done a CHIM study in humans before with Lyme, but we're, you know, busy setting this up to potentially start in 2027. It's one shot a year, so it's an annual protective dose, and we think it's a better solution than a vaccine because the vaccines in development require three different doses to get the titers up, but they also require annual boosters, at least the way they're being developed. TNX-102 SL we're developing for two other indications pretty actively. This major depressive study will start in the middle of the year, and it's a novel approach to depression, so it's basically targeting the disturbed sleep of depression. Depression is obviously a very important market.
In two of our previous studies, one in PTSD and one in fibromyalgia, we had secondary exploratory endpoints using the Beck and the MADRS, and we had very promising data. We're encouraged about this study. Acute stress disorder is a precursor to post-traumatic stress disorder, and we are working with the University of North Carolina on a study in acute stress disorder. This is funded by the United States Department of Defense, because this is a protective measure against potentially developing PTSD. The second to last phase II study I'll talk about is 1500. We're going into a phase II study in kidney transplant, with MGH, that we say will start in the middle of this year. This is internally developed start to finish.
It's a monoclonal antibody against CD40 ligand, and we've modified the Fc region so that it doesn't interact with CD32A or FcγRIIa , which is a sign of toxicity associated with toxicity in earlier versions of CD40 ligand. It's a very active target around the world. Biogen is in their second phase III for lupus. Amgen has a program in Sjogren's. Sanofi has a program in multiple sclerosis. For a number of reasons I can't get into, we believe ours is best in class. Finally, we have a Prader-Willi program. This is a intranasal oxytocin program. In animal models, oxytocin has profound effects on the mouse model of Prader-Willi, the knockout model. We intend to start this study, it's in the first quarter of 2027.
We have a unique formulation which contains magnesium, and you can see here magnesium is right between in the interaction of oxytocin and the oxytocin receptor. These are some of the accomplishments. August, FDA approval of Tonmya. November, commercial launch of Tonmya. A lot of different activities coming up in 2026 and 2027. Importantly, in the start of 2027, we'll have the Lyme program, CHIM, Controlled Human Infection Model, and also the field trial study. To wrap it up, we plan to and are delivering a best-in-class launch. We've got an exciting midstage pipeline, and we're poised to provide long-term growth. Thank you very much.