Good day, and thank you for standing by. Welcome to the Tonix Pharmaceuticals FDA Approval of Tonmya Presentation. At this time, all participants are in the listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press star one one on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star one one again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Jessica Morris, Chief Operating Officer. Please go ahead.
Thank you, and welcome to Tonix 's webcast and conference call to discuss the FDA approval of Tonmya for the treatment of fibromyalgia. Please note that a press release was issued on Friday, August 15, and can be found on the Investors section of our website. In addition, a copy of today's presentation is available, and a replay of today's call will be available on the Investors section of our website. On slide two, joining me today with prepared remarks are Dr. Seth Lederman, our CEO and Chairman, and Tom Englese, Executive Vice President, Commercial and President of Tonix Medicines. In addition to Dr. Lederman, Mr. Englese, and me, Dr. Gregory Sullivan, our Chief Medical Officer, will be available for Q&A following the prepared remarks portion of today's call. Turning to slide three, I'd like to remind everyone that this call includes forward-looking statements.
Each forward-looking statement on this call is subject to risks and uncertainties that could cause actual results to differ materially from those described in these statements. Additional information describing these risks is included in the press release that we issued on August 15, as well as in the Risk Factors and Management Discussion and Analysis section of our most recent annual report filed with the SEC. The forward-looking statements on this call speak only to the original date of this call, and except as required by law, we do not undertake any obligation to update or revise any of these statements. With that, I'd like to introduce and turn the call over to our CEO and Chairman, Dr. Seth Lederman..
Thank you, Jessica, and thank you all for joining us today. We're excited about the approval of Tonmya on slide four, which is sublingual cyclobenzaprine HCl tablets, now indicated for the treatment of fibromyalgia. We're here to share highlights of the label, outline our launch plans, and answer questions. Tonix was founded more than 15 years ago to discover and develop a new treatment for fibromyalgia. That concept has now been realized as the FDA-approved medicine, Tonmya. The Tonix team has taken Tonmya all the way from a concept to an FDA-approved product, and is now prepared to launch it commercially. Tonmya is a non-opioid analgesic developed and now FDA-approved for treating fibromyalgia, which is a common chronic pain condition. FDA granted Tonmya Fast Track designation, which recognizes fibromyalgia as both a serious condition and as an unmet need.
Healthcare providers, or HCPs, recognize that pain is a common complaint that leads patients to seek medical attention and an important determinant of whether they are satisfied with treatment. Fibromyalgia is a common pain condition. Employers, insurance companies, policymakers, and elected officials recognize fibromyalgia as a source of significant disability and economic burden. We believe that today is a landmark day for people living with fibromyalgia. I want to thank the patients who participated in our clinical trials and their families, caregivers, and supporters. Next, I want to thank the team at the U.S. FDA Division of Anesthesiology, Addiction Medicine, and Pain Medicine for their expert regulatory guidance and commitment to putting patients at the center of the drug development process. I'd like to note that this 15-year development process has spanned the terms of four directors of this division.
Today is also a landmark day for Tonix Pharmaceuticals . I would like to thank all of our current and former employees, board members, partners, investigators, and investors who have brought us to this moment. The journey to today underscores the difficulty in developing clinically meaningful new medicines for the high unmet need of fibromyalgia. Some of the hurdles are long trials, large numbers of patients involved, challenges of dose finding without an animal model, lack of a validated molecular target, the lack of objective endpoints, and the time and capital required. Fibromyalgia is a complex and invisible condition. It presents to drug developers and scientists the challenge of relieving pain with a non-addictive medicine. Our process has required gleaning insights from clinical observations and abstractions concerning pain processing in the central system. Tonmya targets non-restorative sleep. We hope that Tonmya
will provide relief to people living with fibromyalgia and will also lead to new medicines that also exploit the recognition that non-restorative sleep is an Achilles heel of the devastating condition that is fibromyalgia. On slide five, we mark that today is a major milestone for Tonix, but holds even greater significance for the more than 10 million adults in the U.S. living with fibromyalgia. Fibromyalgia has vexed physicians and patients for millennia. Our work on fibromyalgia has benefited from those who have gone before us. We stand on the shoulders of giants. Fibromyalgia was described in ancient Sanskrit lore from India. One such tale was adapted by Hans Christian Andersen as The Princess and the Pea. Many other legends and authors from all over the world have described fibromyalgia. From a medical perspective, a very modern description of fibromyalgia was put forth in 1642 by Dr.
Guillaume de Bayeux, who named it rheumatism. That clinical description stands pretty much unchanged today. Other names like neurasthenia and fibrositis have come and gone. Finally, the medical community and the FDA have coalesced around the term fibromyalgia, which is also used by the International Association for the Study of Pain. In 1975, 50 years ago, Dr. Harvey Moldofsky recognized the important role of non-restorative sleep in fibromyalgia. We believe the approval of fibromyalgia represents a major and long-awaited advancement. It is a first-in-class medicine and the first new medicine approved for fibromyalgia in more than 15 years. For the millions of Americans, predominantly women, who live with fibromyalgia, Tonmya represents new hope. The journey to today has been both deliberate and forward-looking. We've approached every step of this process with care and clarity of purpose, and we're ready for what comes next.
Moving to our balance sheet, as disclosed in our second quarter financial filing with the SEC, Tonix held approximately $125 million in cash at the end of the second quarter and has raised approximately $50 million in the third quarter. We have no debt. We believe this provides an expected runway into the third quarter of 2026, positioning us to support the upcoming launch of Tonmya. Later in today's call, you will hear from Tom Englese, the President of Tonix Medicines, who will highlight the commercial initiatives we are advancing to prepare for the Tonmya's launch next quarter. Slide six shows you some of the science. Sublingual Tonmya delivers cyclobenzaprine into the bloodstream in a way that bypasses first-pass liver metabolism. We believe that the reason why swallowed cyclobenzaprine does not work in fibromyalgia is because of liver metabolism, which converts cyclobenzaprine into norcyclobenzaprine.
The accumulation of norcyclobenzaprine is believed to block the effects of swallowed cyclobenzaprine on treating fibromyalgia. Swallowed cyclobenzaprine was studied for activity in fibromyalgia, and it does not work. Slide six shows how Tonmya is uniquely designed to be administered sublingually, meaning it dissolves under the tongue and releases soluble cyclobenzaprine into the saliva adjacent to the mucosal membrane. Free-base cyclobenzaprine crosses the mucosal membrane, enters the bloodstream directly, and thus bypasses first-pass metabolism in the liver. This is called transmucosal absorption. Tonmya's sublingual transmucosal route of delivery leads to direct absorption of cyclobenzaprine, lower levels of norcyclobenzaprine, and consistent, durable pain relief in fibromyalgia. Swallowed cyclobenzaprine is indicated for the treatment of muscle spasm and not fibromyalgia. Swallowed cyclobenzaprine is only indicated for acute treatment up to two weeks and not long-term treatment. In fact, the labels for the swallowed cyclobenzaprine products advise against long-term use.
In contrast to swallowed cyclobenzaprine products, Tonmya has been developed, tested, and FDA approved for treating fibromyalgia in a long-term treatment paradigm. Based on in vitro pharmacology studies, the mechanism of action of cyclobenzaprine is believed to relate to functionally blocking four neurotransmitter receptors: 5-HT2A serotonergic, Alpha-1 adrenergic, H1 histaminergic, and M1 muscarinic receptors. Turning to slide seven, fibromyalgia was specifically designed to treat fibromyalgia as a once-daily bedtime medicine. Tonmya is a first-in-class, first-line medicine for fibromyalgia. Two pivotal studies demonstrated durable reduction in fibromyalgia pain. In those studies, Tonmya was generally well tolerated. Tonmya is a non-opioid analgesic. Tonmya is not DEA scheduled. Relative to swallowed cyclobenzaprine products, Tonmya leads to reduced levels of norcyclobenzaprine, the major metabolite, which is believed to block the effectiveness of swallowed cyclobenzaprine in treating fibromyalgia.
Since we developed Tonmya internally, from concept to FDA approval, we own the unencumbered worldwide rights to the medicine with a strong intellectual property portfolio. Now let's turn to the prescribing information. As shown on slide eight, Tonmya is indicated for the treatment of fibromyalgia in adults. The recommended dose is 2.8 mg sublingually at bedtime for the first 14 days, followed by 5.6 mg once nightly thereafter. Tonmya comes in a 2.8 mg tablet. The run-in dose is one tablet per night. The long-term dose is two tablets per night. For geriatric patients or those with mild hepatic impairment, the recommended dose is 2.8 mg nightly. This equates to one tablet per night. Pregnancy testing is recommended in females of reproductive potential prior to initiating therapy with Tonmya.
The most common adverse reactions included oral hypoesthesia, oral discomfort, abnormal product taste, somnolence, oral paresthesia, oral pain, fatigue, dry mouth, and aphthous ulcer. Turning to slide nine, the FDA approval was based on efficacy from two double-blind, randomized, placebo-controlled phase III clinical trials of nearly 1,000 patients in total that evaluated Tonmya as a bedtime treatment for fibromyalgia. Across both phase III studies, Tonmya significantly reduced daily pain scores compared to placebo at 14 weeks, the primary endpoint. Pain was measured by an 11-point daily pain numeric rating scale. In trial one, the least squares mean change in pain from baseline to week 14 was a 1.9-point reduction for Tonmya compared to a 1.5-point reduction for placebo, representing a p-value of 0.01. In trial three, we saw a 1.8-point reduction for Tonmya
versus a 1.2-point reduction for placebo, representing a p-value of less than 0.001. Turning to slide 10, shown here are the graphs of the pain data that are included in the label. Patients experienced a sustained and consistent reduction in pain intensity that extended over the 14-week period. These pivotal studies demonstrate statistically significant improvements in pain measured by the mean change from baseline in weekly average of the daily 24-hour recall pain intensity scores at week 14. Turning to slide 11, are shown the pain reduction results from the trials shown as continuous responder graphs. On the x-axis is percent reduction in pain. On the y-axis is the percent of subjects who experienced this level of pain reduction. A 30% reduction in pain is regarded as clinically meaningful, and those patients are called responders.
As you can see, along the 30% responder vertical line in trial one, 47% of patients who Tonmya were responders. Likewise, on the 30% responder vertical line in trial three, about 46% Tonmya patients were responders. Turning to slide 12, in terms of safety and Tonmya performed well across all of our Tonmya was generally well tolerated. The most common adverse reactions are listed here, and we describe them on slide eight. For women who may become pregnant, healthcare providers are directed to obtain a pregnancy test prior to initiating treatment, and females should avoid the use Tonmya two weeks prior to conception and through the first trimester of pregnancy. In our clinical trials, there were no reports of cognitive dysfunction or sexual dysfunction.
Importantly, our clinical trials revealed no evidence of abuse potential. Cyclobenzaprine is not associated with addiction or dependence. We believe this profile will resonate with both patients and prescribers, especially against the backdrop of off-label opioid use that remains all too common in fibromyalgia management. On slide 13, provides the history of Tonix Medicines. In 2023, recognizing the strong potential of Tonmya, we formed Tonix Medicines to prepare launch Tonmya. to stand up its commercial capabilities, we acquired two FDA-approved prescription migraine products. This move allowed us to build our in-house commercial infrastructure and has prepared us for the imminent of Tonmya. from a financial and operational perspective, Tonix is well positioned.
With a clean balance sheet, a clean cap table, and a projected cash runway into the third quarter of 2026, we are capitalized to support a robust and comprehensive launch. I'll now turn it over to Tom Englese, EVP of Commercial and President of Tonix Medicines.
Thanks, Seth. It's great to be here as the approval Tonmya is a landmark moment not just for Tonix, but for the millions of people in the U.S. who have been living with fibromyalgia and searching for relief. For patients, this approval represents new hope, hope for improvement in fibromyalgia's core symptom of chronic widespread pain, with the medicine designed, tested, and FDA approved to treat this serious condition. As Seth mentioned, Tonix Medicines has been preparing to launch Tonmya. On slide 16, you can see we recruited an experienced leadership team with a strong track record in product launches across sales, marketing, commercial operations, and market access. These are professionals who know how to bring novel products to market and how to make them successful.
The acquisition of the two marketed migraine products provided us with immediate commercial infrastructure and gave us the systems, processes, and people that form the operational backbone of Tonix Medicines. This strategy has allowed us to stand up fully functioning and well-integrated commercial organizations. Tonix Medicines is now prepared and ready to launch Tonmya. As seen on slide 17, fibromyalgia represents both a significant unmet medical need and a compelling commercial opportunity. More than 10 million adults in the United States are affected by fibromyalgia. Only 2.7 million of these 10 million are diagnosed and treated each year. Despite the size of this patient population, treatment options remain limited, and fibromyalgia remains under-recognized, with approximately 75% of patients not being diagnosed or treated. Each year, roughly 15 million prescriptions are written for fibromyalgia. Still, dissatisfaction with current therapies is widespread.
Market research shows that first-line treatments fail in 85% of patients, most often due to the lack of efficacy or poor tolerability. Many patients cycle through different therapies in search of meaningful relief, including off-label opioids. Nearly 80% of patients end up on multiple prescription medications. We believe Tonmya is uniquely positioned to raise the standard of care in fibromyalgia and emerge as a market leader in a field long overdue for innovation. Through extensive market research, as shown on slide 18, we have gained deep insights into the fibromyalgia treatment journey from the patient and the healthcare professional, or HCP, perspective. What we heard was consistent and clear. Patients feel invalidated and isolated. Likewise, providers feel frustrated by the lack of well-tolerated, effective, and durable treatment options. This leads to many patients feeling dismissed by their providers.
This emotional layer of the condition and the feeling of being invisible are major drivers of dissatisfaction and therapy discontinuation. These findings directly informed our strategic launch approach, including messaging, branding, and support programs. As seen on slide 19, the widespread patient and provider dissatisfaction is reflected in real-world prescribing behavior. Our research revealed a surprising discrepancy between what prescribers know about the risks of opioids and fibromyalgia and what prescriptions are written for fibromyalgia patients. In our primary research, prescribers were well aware that opioids generally should not be prescribed for fibromyalgia. Yet, our claims data research revealed that off-label opioids are commonly prescribed within 18 months of fibromyalgia diagnosis. This includes drugs like oxycodone, hydrocodone, and tramadol, each of which is associated with known risks.
Many experts believe that opioids have no legitimate role in treating fibromyalgia, and some even believe that opioids have the potential to exacerbate fibromyalgia symptoms over time. Chronic opioids carry risks of abuse, dependence, and addiction. Opioid use in people with chronic pain is a major driver of our opioid crisis. In the absence of well-tolerated, effective, and durable options, many patients are placed on treatments not designed for fibromyalgia, including not only off-label opioids but also other off-label drugs with limited evidence supporting their utility and safety in with Tonmya, we have the opportunity to break the vicious cycle of opioid use and chronic pain and to provide a non-opioid analgesic medicine designed, tested, and FDA approved to treat fibromyalgia. As you see on slide 20, we've recently launched a disease awareness campaign called Move Fibro Forward.
This campaign is designed to bring awareness and to provide resources to individuals impacted by fibromyalgia. In just the first three weeks of launch, we saw close to 36,000 unique visitors with an average session duration over five minutes. About 15% of users downloaded a patient discussion guide or signed up for additional information. These early digital signals reinforce the opportunity ahead. On slide 21, we see that another important dynamic in the fibromyalgia marketplace is the concentration of high prescribers. We learned that roughly 5% of fibromyalgia diagnosed HCPs are responsible for writing approximately 70% of fibromyalgia prescriptions. This 5% represents approximately 25,000 HCPs. These insights will allow us to be strategic and efficient in our targeting approach, ensuring that we are directing resources to where they will have impact. Slide 22 demonstrates how we plan to capitalize on the concentrated prescribing pattern.
We are deploying a focused field force of approximately 90 sales representatives, supported by a telesales team. Initially, this group will include 10 existing internal representatives, and the remainder will be made up of a contract sales representative. All of the representatives will be utilizing our Tonix-owned commercial data and infrastructure. We will be moving judiciously and at our discretion in hiring contract representatives to become Tonix employees. Our ultimate objective is to have a sales force that is 100% Tonix employee-based. Our hybrid and internally coordinated team, in combination with our direct marketing efforts, will be responsible for reaching the top prescribers. These are the prescribers who are already making 70% of fibromyalgia diagnoses and writing 70% of fibromyalgia prescriptions. We expect them to be early adopters Tonmya.
Given that this space has seen no innovation for more than 15 years, there has been little to no direct sales or marketing aimed at these prescribers for some time. With no new medicines on the horizon, we expect our representatives will have a clear path to Tonmya to a receptive audience. To meet both patients and healthcare providers where they are, we are executing an omnichannel engagement strategy that complements in-person promotion with digital, social, and educational outreach. Slide 23 outlines our strategy. Our strategy is designed for us to build awareness and drive action across multiple points of contact. For HCPs, that strategy will include tailored digital advertising, email campaigns, interactive virtual tools, and direct engagement from our field force and telesales force.
For patients, some aspects of this strategy will include social media campaigns, paid search, and an educational website to help them understand their symptoms and treatment options. As slide 24 shows, our goal is to ensure broad patient access. We have been actively engaging payers, digital specialty pharmacies, and traditional retail pharmacy channel partners. We plan to implement robust programs to help reduce out-of-pocket costs and facilitate treatment initiation. As with any launch, we expect to reach key milestones over the coming quarters as we strive to Tonmya into a market leader. These milestones are highlighted on slide 25. Our phased and focused strategy enables us to execute with precision while staying agile as real-world feedback emerges. In the third quarter of 2025, we are laying the foundation for our launch. Our field team is being onboarded, trained, and aligned around key messaging and strategy.
HCP and patient education campaigns have begun and will continue to ramp up this quarter. We expect Tonmya to become commercially available next quarter. Our team will begin calling on and providing samples to the highest prescribing healthcare providers. They will be supported by a telesales team to expand reach and frequency. In the first quarter of 2026, we expect to see continued progress with payers, and our national speaker programs will ramp up as we engage key opinion leaders. By the second quarter of 2026, we expect coverage to solidify and awareness to grow. This is when we plan to activate broader direct consumer efforts across digital and social media platforms. This plan builds momentum, drives demand, expands access, and Tonmya as a transformative treatment for fibromyalgia. We are confident in our strategy and our ability to execute.
We look forward to launching Tonmya next quarter and sharing details of our progress in the months ahead. With that, I will now turn the call back to Seth.
Thank you, Tom. Moving to slide 26, Tonmya is a first-in-class medicine that was designed, tested, and is now FDA approved to treat fibromyalgia in a long-term treatment paradigm. Tonmya is a non-opioid analgesic that showed durable improvement in the chronic widespread pain and fibromyalgia in pivotal studies and was generally well tolerated. We believe Tonmya has the potential to transform how fibromyalgia is treated and improve the lives of those who live with it every day. As you've heard today, the approval of Tonmya marks a defining moment for Tonix and, more importantly, for the millions living with fibromyalgia who have waited far too long for new treatment options. To the millions with fibromyalgia who have felt unheard and invisible, we hear you, we see you, and we believe Tonmya will offer you better days ahead.
To the HCPs who treat fibromyalgia and are frustrated by the lack of options, we also hear you. We encourage you to facilitate a dialogue with your patients regarding this new medicine. As a company, we are entering this next important phase in stride and with strength. Our commercial team is prepared, our strategy is focused, and we are energized by the opportunity ahead. We look forward to making Tonmya available to patients next quarter and to continuing to build momentum in the quarters to come. I'd like to thank all of the participants on this call for their attention. Operator, please now open the line for questions.
Thank you. As a reminder, to ask a question, please press star one-one on your telephone and wait for your name to be announced. To withdraw your question, please press star one-one again. Our first question comes from the line of Benjamin Burnett with Wells Fargo. Your line is now open. Benjamin, your line is open. Please check your mute button. Our next question comes from the line of James Molloy with Alliance Global Partners. Your line is now open.
Hey, guys. Thank you for taking my questions. Congratulations. It's been quite a long journey. Congratulations on getting it across the finish line. Could you walk through the self-launch plans, the number of reps, and the onboarding process for that? I know that obviously you're set up for a self-launch. Have potential partnership conversations stepped up since the approval? I know it's only been the weekend. Thank you.
First of all, this is Seth Lederman. Thanks for the question. I'll take the second part of the question first. We're always in discussion with potential partners, but we're not in a position to discuss the progress of partnership talks. I don't have an update for you on that. I'll turn it over to Tom Englese to respond about the specifics of the launch and the details of reps.
Thank you. We will have at launch 90 reps, as mentioned, with 10 of them already being Tonix employees and roughly 80 contract sales reps. We've actually started this process a while ago, so we have most of those folks already onboarded through our contract sales partner, including all the management positions. That's what we'll be prepared to launch with at the beginning of Q4.
Can you talk a little bit about the counter detail versus the approved, the Lyricas, the Cymbaltas, and sort of the message that you'll be going out with the reps have been going out with to the providers? I mean, also, can you talk a little bit about any conversations with reimbursement and getting on payer plans?
Sure. Let me start with the messaging. The first thing to remember is that there's basically no counter messaging out there from the other fibromyalgia-approved products. None of the three approved products have sales reps in this space detailing. When it comes to Cymbaltas , it's a different product. It's been designed specifically for fibromyalgia. We're going to focus on the messaging that we've already been testing and the information and the attributes of the product that Seth laid out. We think that's going to be a winning message in the marketplace. Was there a second part around payers? Do you want to repeat that?
Yes, please. Yeah. Could you walk through how conversations with payers are going, please?
Yeah, we actually started talking to payers like roughly three, four months ago. We've had a lot of initial meetings during the pre-approval information exchange presentation, which is a medical presentation. Payers have been very receptive to the story Tonmya and the clinical data. We're going to continue to talk to those folks, obviously, now that we have approval. We look forward to working with them to make sure that there's broad access, as we said, to the product in the marketplace and for patients.
Great. Thank you for taking the questions.
Thank you. Our next question comes from the line of David Bautz with Zacks Small Cap Research. Your line is now open.
Hey, good morning, everyone, and congrats on the approval. I don't know if I had missed this, but is the company disclosing what the cost Tonmya is going to be? If not, maybe you can just discuss what some of the factors were that were going into determining what that cost is.
Thanks for the question. We are not yet in a position to announce the WAC. We're still doing research, and we are obviously in discussion with other stakeholders in that decision. We hope to be able to update you and the market in the near future, but we don't have that for you now.
Okay. Might be a little early, but what kind of sales metrics will the company be sharing later on? At any point in the future, is the company planning on giving revenue guidance?
Thanks for that question. We plan to announce, as a standard, net sales, gross to net, and the standard facts at the end of each quarter going forward. I'm sure everyone knows that these days with managed care and the PBMs and whatnot, launches don't go as quickly as they used to go. We anticipate that Q4 will be quite slow, but we're confident that by the summer of 2026, we'll be able to guide the market on the trajectory of the launch and the pull-through.
Okay. What do you see as some of the largest challenges to getting widespread uptake of the drug?
There are two parts of the market, and I'll leave it to Tom to explain. The first part is the diagnosed and treated people, which, as we said, is 2.7 million. Those are diagnosed and treated by doctors who are expert in fibromyalgia and who we expect might be the early adopters. One of the interesting aspects of the fibromyalgia market is that because of the dissatisfaction, patients cycle between different therapies. Basically, they get frustrated because of either lack of efficacy or tolerability issues with the existing medicines. We think that with the treated patients, we will have an opportunity to be tried by patients. We like that because that will give them an opportunity to Tonmya and see if it works for them and if it provides them with a favorable benefit-to-risk ratio.
The next challenge will be to try to penetrate the 75% of patients who we're told by epidemiology are out there, but who are not yet diagnosed and treated with fibromyalgia. For that, I'm going to turn it over to Tom.
Yeah. Thanks, Seth. Yeah. As Seth mentioned, the treated and diagnosed patients, they've been looking for something because, as I said, we've looked at the research, we've spoken to them. They've been waiting for a new medication and something that could potentially work for their symptoms and help treat fibromyalgia. As I also pointed out, we have a condensed HCP population that we're going to really be focusing on. That works in our favor. I completely agree, Seth. That first treated and diagnosed market is ripe right now with no other competitive counter detailing, as I mentioned. As we talked about, there are a lot of underdiagnosed and misdiagnosed and non-diagnosed patients with fibromyalgia. We have a medical team that's going to be out there educating physicians with clinical evidence about diagnosing and identifying these patients.
I kind of view that as the long-term growth lever for us as we continue to go. A market that is that underdiagnosed just gives us an entirely new opportunity on top of the 2.7 million patients that are already being treated and diagnosed. We're looking forward to it. I think it provides a great runway for us moving forward as we continue to launch and travel through the journey of Tonmya to the marketplace.
Yeah. Let me just add to what Tom said. From the bar chart we showed you about the prescriptions that patients get within 18 months of diagnosis in the United States, it's a great opportunity for us to come in and do some education because I think it's fair to say that the vast majority of fibromyalgia patients in the United States get prescriptions for off-label medicines. When we've been out in advisory committees and speaking with experts, there are serious doubts about whether these widely used off-label medicines actually offer benefit to fibromyalgia patients.
We're going to be armed with our real data from controlled clinical studies and in a position to discuss the relative value of controlled clinical data and an FDA approval against the kind of data that supports listing, for example, in a compendia, that when people fill up and look at it closely, may not be that compelling, particularly given the tolerability issues and the risks associated with some of these other products.
All right. Sounds good. Appreciate you taking the questions and congrats again.
Thank you.
Our next question comes from the line of Robert LeBoyer with Noble Capital Markets. Your line is now open.
Good morning, and congratulations to the entire team. This has been quite a journey, and this should be a nice breakthrough for the patients who have fibromyalgia. My question has to do with the actual market for the drug. You had mentioned 2.7 million patients. Are there any statistics or projections as to what these patients are currently spending on these medicines that they cycle through, or any expected market penetration in the first year or in the third to fifth years?
Oh, thank you very much for that question. We are trying to analyze this complex market, and we are working with a lot of consultants, health economists, effectiveness issues, things like this. Without getting into specifics, we can tell you that fibromyalgia patients are very expensive to the system. They have repeated doctor visits. They take lots of different prescription medicines. One study, the average fibromyalgia patient in the United States at any one time is on 2.7 prescription drugs for fibromyalgia. There's polypharmacy, cycling, and other things. There are also emergency room visits and other things like that. We're studying this. I think the top-line information I can give you is these are very expensive patients to the system. As you can imagine, once they move into the category of a chronic opiate patient with fibromyalgia, they become even more expensive because of the issues associated with opiates.
Even one of the approved medicines is now associated with falls and hip fractures and things like that. This is a very, very delicate population, one that's expensive to manage. That's why we think that our proposition of a well-tolerated medicine with a favorable risk-reward could really transform the system. One of the things that we've also learned in our research, and part of this is in published data, is on average, fibromyalgia patients go seven years without being diagnosed. This isn't a question of doctor education or their willingness to make it. There seems to be no call to action. There seems to be no reason in the minds of many of these doctors to make the diagnosis. That's one of the reasons why we think that with a better tolerated medicine, we might be used earlier in treatment.
We may actually find that earlier treatment has the potential to change the trajectory of fibromyalgia. This will take years of research, including years of outcome research. We really believe that this could be a transformational medicine for fibromyalgia patients.
I would agree with you on that. As a follow-up, are there any studies planned for the coming year on follow-up or post-marketing studies or anything like that that would examine the use or earlier use or any additional research there?
Yes, we're planning a number of studies, but we're not prepared to disclose them at this point. We think with a chronic condition like fibromyalgia and its complex overlap with other conditions, that there needs to be a lot of work done. Now, with an approved product, it will really facilitate us doing studies with academic leaders that can look at the kind of questions that you asked. It's just a new world for us in terms of these outcome studies to be doing them with an FDA-approved product.
Okay. One last question. You mentioned the trajectory of the condition. Are there any expected consequences or stages of fibromyalgia, as with other neurological conditions where there's a deterioration and the progression of disability? Is there anything comparable in fibromyalgia where there's an initial stage and then additional symptoms or additional severity where they might be in an early stage and then a progressing stage or anything? I'm thinking in comparison with something like MS or Alzheimer's or Parkinson's where you have a deterioration and accumulation of disability. Is fibromyalgia like that, or do symptoms shift from one type to another type? Any information on that?
Sure. It's a complex answer. First, let me say that I've been working on fibromyalgia for more than 30 years. Before I joined biotech, I was a professor at Columbia Medical School and spent over a decade in the Division of Rheumatology and had a rheumatology clinic. Fibromyalgia is a fascinating subject. Let me make some observations. First, it's not often discussed, but there are patients who have full-on fibromyalgia for a year or two and then get completely better. There is a potential for remission in fibromyalgia. The second is the general course of fibromyalgia. The most common patient is usually diagnosed, you know, between 40 and 50, but has already been suffering, as I said, for 7- 10 years.
The usual course is that it lasts for decades, for a few decades, but then it does tend to lessen and even go away, you know, in the elderly. There is, I guess you would call it a spontaneous rate of remission. Other people would just say that it burns out or whatever, but people certainly complain about it less later on. I think the important thing about our approval and the testing that we've done is that we are indicated for the treatment of fibromyalgia, and it's not limited to mild, moderate, or severe. I think that's important because it's still, although it's been described very precisely, there still is a lot of heterogeneity among fibromyalgia patients. We believe our drug is first-line monotherapy for all fibromyalgia patients.
As I said, there's the possibility that earlier treatment, a possibility that we hope to study, that earlier treatment could have more lasting benefits.
Okay, great. Thank you and congratulations again.
Thank you.
Thank you. Our next question comes from the line of Benjamin Burnett with Wells Fargo. Your line is now open.
Hey, thank you very much. I appreciate it. Apologies for the technical difficulties earlier. I wanted to ask a couple of questions. I guess first, just on the Move Fibro Forward program, your disease awareness campaign, I was wondering if you could maybe speak to that a little bit more. It looks like the math is sort of implying that maybe 5,000, 6,000 patients are sort of meaningfully engaging with that system. Are you able to, like, I guess, how do you convert those patients into scripts? Are you able to kind of see where they are and kind of who their healthcare providers are?
Yeah, that's a great question. I appreciate it. Obviously, that's a medical education program at start. That was started before, obviously, approval. It was not a branded sort of commercial program. That being said, yes, we first of all have a substantial amount of those patients have signed up for more information that they choose to do. Also, due to the, you know, through our partners and the digital infrastructure, there are ways that these types of programs can help us target patients and get crucial information Tonmya and also about fibromyalgia into their hands. As we progress, we have information, obviously, on the coverage levels that different payers have across the country, geographically, etc. We can then marry that up for where we're seeing some of these patients geographically come in and what their HCPs might be seeing when they come into those offices.
It is really a full circle and kind of enclosed operating ecosystem that enables us to do a lot of things when these people engage on any one of our platforms.
Okay. That's very helpful. I was wondering if you could maybe also just talk to your sort of IP runway and just like what you're thinking around sort of the exclusivity runway for Tonmya?
Thanks. I'll take that question. We have a group of issued United States patents that we call the eutectic patents that cover the composition of matter, which we believe is essential to making a sublingual transmucosal product. Eutectic is a novel structure of matter. It's very unique. You can't predict if something will form eutectic. We have a eutectic forming between cyclobenzaprine and mannitol. Those patents have been issued all over the world, which speaks to their strength and all of the data that go behind them. We have successfully defended interference brought on by a subsidiary of Sandoz in Europe, and we won on all claims. We think that the eutectic patents are strong. They've been road-tested by that interference, and we think they will stand in the United States. Those provide exclusivity into 2034 without taking into account patent term extensions.
In addition to those, we have a number of pending patent applications that we have confidence will issue. Although they represent a range of potential expiry dates, some of them go until 2044. The patent space is a moving target in terms of understanding it, but we think that we have solid grounds for expecting exclusivity into 2034 at least.
Okay. That's a great color. Thank you. Maybe if I could just squeeze in one more quick question. To what extent does your cash runway Tonmya sales?
Thank you very much for that question. We think it's a balanced projection in terms of the projected runway. That includes the burn from our full launch plans. Call that runway is fully burdened by the launch expenses. In our internal modeling, which reflects our cash runway, we are quite conservative about the sales that will garner, particularly in Q4 of 2025 and Q1 of 2026, because, as I said, these launches, there are so many hurdles to adoption, reimbursement, and other things. Our model does contemplate sales in the second quarter of 2026 and obviously growing in the third quarter of 2026, but we're not guiding on those sales.
Understood. Thanks so much. I appreciate it.
Thank you.
Thank you. This concludes the Q&A session. I would now like to turn the call back over to Seth Lederman for closing remarks.
First, I want to thank all of the participants in the call. I want to thank particularly the people who have asked questions. I want to thank our investors who have been with us over these years and believed in the products, and I want to thank the patients who have taken part in our clinical trials. As we said, this is a big moment for Tonix , the FDA of Tonmya. Tonix was founded more than 15 years ago specifically to develop this product, and we have now succeeded both in the design objectives of Tonmya product and in the clinical trials and the regulatory hurdles that lead us now to have the first new approved drug for fibromyalgia in more than 15 years. We are very excited about our next steps.
On the one hand, we're closing one chapter, but we're opening up another very exciting chapter of the commercial launch. We look forward to staying in close touch with our investors, the analysts on the call, and other stakeholders. Thank you very much.
This concludes today's conference call. Thank you for your participation. You may now disconnect.