Good morning and welcome to Tonics Pharmaceuticals' second quarter 2026 Financial Results and Business Update conference call. At this time, all participants are in listen-only mode. Following management's prepared remarks, we will hold a question and answer session. As a reminder, this call is being recorded. I would like to turn the call over to Deborah Elson, Head of Investor Relations at Tonics Pharmaceuticals. Please go ahead.

Thank you, Operator, and good morning, everyone. We appreciate you joining us today to discuss Tonics Pharmaceuticals' second quarter 2026 financial results and operational highlights. Before we begin, I would like to remind everyone of the disclaimers on slide two that any statements made on today's call that are not historical facts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are based on management's current expectations and are subject to risks and uncertainties that could cause actual results to differ materially from those projected. These risks are described more fully in our filing, the Securities and Exchange Commission, including our annual report on Form 10-K for the year ended December 31st, 2025 and our subsequent periodic reports. Tonics undertakes no obligation to update or revise any forward-looking statements except as required by law. Joining me on today's call are Dr. Seth Lederman, Chief Executive Officer, Thomas Englese, Executive Vice President of Commercial Operations, and Bradley Saenger, Chief Financial Officer. With that, I will turn the call over to Seth. Seth?

Thank you, Deborah, and good morning, everyone. We're pleased to welcome you to Tonics' earnings call. Today we're reporting second quarter financial results and operational highlights that reflect strong execution in both our commercial business and advancing our development pipeline. We are focused on improving the care for patients with debilitating conditions or preventing illness before it happens. We believe each of the commercial products and the development candidates target major unmet medical needs. As you can see on slide two, the launch of TonMaya is progressing well, supported by growing sales, improvement across launch metrics, and patient access wins. TonMaya was invented, developed, tested, and launched in-house by the Tonics team. TonMaya is the first medicine for the treatment of fibromyalgia in adults approved by the FDA in over 15 years. More than 10 million adults in the U.S. suffer from fibromyalgia. We are initially targeting nearly 3 million patients who are currently diagnosed and treated. The second quarter of 2026 was the second full quarter of Tanmaya's sales. We believe our second quarter and cumulative launch performance underscored Tanmaya's compelling Thank you for joining us today. that improves fibromyalgia pain, the core symptom of the disease. Tonmia is a once-daily medicine taken at bedtime and indicated for long-term use by fibromyalgia patients. Commercially, Tonix has 100% share of voice as the only branded and marketed product for fibromyalgia. We are striving to improve the lives of patients and simultaneously creating long-term value for shareholders. In the second quarter of 2026, we achieved approximately $11 million in net sales for Tonmayo, representing 197% quarter over quarter growth. That is approximately triple the next sales of the first quarter. Additionally, we saw increases across other key metrics. We attribute these results to the patient and prescriber recognition of the value of Tonmaya and to our strategic focus and execution. We also had early wins in managed access. We do not believe these wins contributed significantly to Tonmaya sales in Q2. However, we are beginning to see their effects in Q3. Currently, Tonmaya coverage across commercial, managed Medicare, and Medicaid channels represents approximately 136 million covered lives, or 43% of the approximately 314 million covered lives in the United States. On January 1st, 2027, when our managed Medicare GPO coverage agreement becomes effective, Tonmaya coverage will represent approximately 145 million covered lives or approximately 46% of the covered lives in the United States. We believe this broad coverage lays the foundation for growth in patient access and Net Sales for the rest of the year and beyond. This coverage led us to activate our planned Salesforce expansion, which will be fully implemented by September. Tom will dive deeper into the field dynamics and expectations for the rest of the year. As we execute on our commercial launch, we are also strategically advancing certain development stage programs. Tonics' pipeline includes a carefully selected group of therapeutic and preventative development stage candidates, each targeting large therapeutic or preventative areas of unmet need. Each of these agents are potentially first in class or best in class. In 2026, we have focused our resources primarily on TNX-102SL, which is sublingual cyclobenzaprine tablets, which is a potential new indication for Tonmia for the treatment of major depressive disorder, or MDD, and TNX-4800, a long-acting monoclonal antibody for the prevention of Lyme disease. In the second quarter and early third quarter, we made substantial headline Headway on both programs. For TNX102SL and MDD, we randomized the first patient in the second quarter. For TNX4800 and Lyme disease prevention, we held a constructive type C FDA meeting and received positive final minutes on our planned adaptive phase two study, which we expect to begin enrolling in the first quarter of 2027. I will now turn the call over to Tom Englese, EVP Commercial Operations, to discuss the Tonmaya launch. Tom?

Thank you, Seth, and good morning, everyone. Today, I will review our second quarter sales performance for Tonmaya, and then I will cover our launch strategy. We are pleased to offer Tonmaya as a treatment to adult fibromyalgia patients. Looking at slide four, we are encouraged to see net sales of $11 million for Tonmaya in the second quarter. representing 197% quarter over quarter growth or nearly triple the first quarter. There are a few contributing factors to note. First, we are seeing proactive patient and prescriber hand raisers interested in Tamiya and we're gaining traction with our HCP target list. Second, gross to net in both Q1 and Q2 have been driven by a favorable mix between the retail and specialty distribution channels and lower copay buy downs related to stronger than expected prior authorization approvals. We have historically shared that we expect fluctuations quarter over quarter, as is common early in commercial launches. We expect continued fluctuations for gross to net in both Q3 and Q4. Now, we'll look at our key performance indicators for Tamiya. In the second quarter, we saw positive trends across prescriptions, new patient starts and refills. Prescriptions for the quarter totaled 12,592, increasing 100% quarter over quarter. New patient prescriptions increased 36% quarter over quarter, and refills increased 207% quarter over quarter. We continue to see increases in the number of prescriptions per patient, which we attribute to the benefits and tolerability of Tamiya and our patient support program. We will now walk you through our strategy regarding market access, sales, and marketing on slide five. First, we've already reached major market access coverage milestones, which we believe speaks to the value of Tamiya. We signed commercial pay agreements with two leading GPOs. These agreements, which went into effect on May 1st and June 1st, 2026, cover 52 million lives. We also signed a major managed Medicare agreement, which will cover approximately 9 million Medicare lives beginning January 1, 2027. TenMaya is also available under Medicaid in most states. We expect downstream pull-through from these agreements to begin to materialize in the third and fourth quarters of 2026. Our strategy has been to secure market access as early as possible so that the availability of insurance reimbursement could match patient demand. As our team brings these coverage agreements online, we expect patient access to become more robust. We have seen favorable rates of prior authorization submissions and approvals across commercial payers and Medicare, and strong usage of our copay assistance and savings programs in the commercial population. Altogether, we expect these trends to serve as the catalyst to unlock the next stages of the launch, which is sales and targeting. We've been planning to expand our sales force after securing coverage. Following the access wins, we are adding 50 sales reps who will be in the field by September. This expansion will enable us to increase our presence in previously uncovered geographies and increase our breadth and depth in existing dense geographies. By September, our field force will be roughly 150 reps, primarily engaged through our contract partner. Each of these contract reps is exclusively dedicated to Tamiya and do not support any other company or product. Over time, we expect to bring high-performing reps in-house to Tonics. The entire Salesforce management team has recently been brought in-house at Tonics. We are committed to quality and consistency of tactical execution. As a reminder, we are initially targeting at 25,000 HCPs who write approximately 70% of the fibromyalgia treatment prescriptions. We continue to focus on engaging priority HCPs and supporting prescribing for appropriate patients consistent with approved labeling. We are hearing supportive feedback from prescribers that Tenmaya is a welcome new treatment option for their patients. Moving to marketing, our efforts have focused on an unbranded digital disease awareness campaign called Move Fibro Forward, DTC social advertising, influencer programs, and peer-to-peer KOL speaker programs. Highlights in Q2 include programs such as our KOL Speaker Bureau, a Reddit Ask Me Anything program, influencer ads, and a digital HCP webcast. Looking ahead, we are excited to further advance the launch of TenMaya. I will now turn the call back to Seth to discuss medical affairs. Seth?

Thank you, Tom. Medical affairs is making headway with KOL engagements and education through conference symposia and data presentations. A key focus of our efforts has been on raising awareness among HCPs for the current fibromyalgia diagnostic criteria that state fibromyalgia is not a diagnosis of exclusion. The outdated conception that fibromyalgia was a diagnosis of exclusion created a barrier to diagnosis for two reasons. A diagnosis of exclusion was an unreasonable standard because no amount of lab tests or imaging can prove a negative. Second, the medical community now recognizes that fibromyalgia commonly occurs in the context of other conditions, including long COVID, chronic Lyme, systemic lupus, rheumatoid arthritis, and cancer. This means that these other diagnoses should not exclude the diagnosis of fibromyalgia. We believe broader understanding of the current diagnostic criteria could meaningfully grow the addressable fibromyalgia patient population and help patients get diagnosed and treated earlier in the course of their condition. It currently takes, on average, over six years for patients to be diagnosed with fibromyalgia. Moving on from medical affairs, I now want to update you on the pipeline. We are advancing our development pipeline. Today I will focus on TNX102SL and TNX4800. Moving to slide 6, TNX-102-SL for the treatment of MDD could potentially serve as a label expansion for Tonmaia. In June, we randomized the first patient in Horizon, a potentially pivotal Phase II study evaluating TNX-102-SL as first-line monotherapy in adults with MDD. We are targeting the enrollment of approximately 360 patients in the U.S. Eligible participants must be 18 years of age or older, currently experiencing a moderate to severe major depressive episode. Participants are being randomized to receive TNX-102-SL 5.6 mg taken sublingually at bedtime or matching placebo. The primary endpoint of the study is the change from baseline in Madras total score at week 6. Secondary endpoints include global impression scores, anxiety ratings, and measures of sleep quality. We are evaluating TNX102SL for MVD based on initial signals observed in previous tonics and three studies in which TNX102SL nominally improved depression symptoms in fibromyalgia patients and PTSD patients. TNX102SL was designed to target the disturbed sleep in fibromyalgia. If TNX102SL has effects on depression, then we believe targeting sleep would be a novel mechanism. The use of SSRIs and SNRIs for depression are frequently associated with treatment emergent insomnia. Another Tonmia label extension is acute stress disorder and acute stress reaction. An investigator initiated phase two study called OASIS is enrolling at the University of North Carolina funded by a United States Department of Defense grant to University of North Carolina. and for which we expect to report top line data in mid-2027. Now I'll move to slide seven to discuss TNX4800, our long-acting monoclonal antibody for the treatment of Lyme disease, for the prevention of Lyme disease. Positive FDA meeting minutes demonstrate alignment on the key elements of our adaptive phase two study design and Support Study Start in the first quarter of 2027. Currently, no FDA-approved vaccines or prophylactics for Lyme disease are available. We believe TNX4800 could potentially change the prevention paradigm. It targets the outer surface protein A, or OspA, on the Lyme-causing Borrelia bacteria. One type of Borrelia, Borrelia burgdorferi, causes 99.9% of Lyme disease cases in the United States. TNX4800 is designed to act in the midgut of the Borrelia infected deer tick. If someone is treated with TNX4800 before getting bitten by the tick, then the tick sucks 4800 containing blood into its midgut. TNX4800 either kills or blocks the maturation of Borrelia burgdorferi in the midgut of infected deer ticks while they are sucking the victim's blood. This mechanism blocks transmission and infection. OSP-A is a validated target for antibodies. TNX4800 is engineered for an extended half-life to provide a longer duration of protection after dosing relative to standard monoclonals. As a monoclonal antibody, we believe TNX4800 has important advantages over vaccines, namely that it provides protection within two days after one dose compared to a prior vaccine or a vaccine in development to take three or four separate immunizations over at least six months to provide protection. Also TNX4800 does not require a host immune response like vaccines. That means it doesn't depend on the host immune system, which is known to be less active in older people and people with certain conditions. After reporting Phase 1 data earlier this year and meeting with the FDA in early Q3, we now have a clear view of our planned Phase 2 study. Pending FDA agreement on the final study protocol, we plan to conduct a randomized placebo-controlled adaptive field study. We expect to enroll approximately 3,300 adult participants. These volunteers, age 18 and older, will be recruited from Lyme endemic areas in the U.S. and selected for their engagement and activities that increase their risk of deer tick bites. We expect this to be a two-season study and expect to enroll the majority of participants in 2028. If the attack rate is lower than planned, enrollment could potentially extend into 2029. The primary efficacy endpoint will be Lyme disease prevention through six months after the first dose, and a key secondary efficacy endpoint will be prevention through three months. Although it is a Phase II study, we believe it has the potential to demonstrate efficacy. The primary safety objective will be to evaluate the safety and tolerability of TNX4800 over a 52-week period after dosing. Participants in the planned Adaptive Phase II field study will be randomized one-to-one to receive either placebo or TNX4800 450 mg sub-Q in the spring and another dose approximately three months later. Our focus in 2026 has been on manufacturing investigational product for TNX4800. which is on track for delivery to study sites in the first quarter of 2027. With that, I will turn the call over to Bradley Saenger, our Chief Financial Officer to review our financial results. Bradley.

Thank you, Seth. And good morning, everyone. On slide eight, I will review financial results for the second quarter ended June 30th, 2026. Net product revenue for the second quarter of 2026 was approximately $13.5 million which consisted of approximately $11 million from Tonmaya and $2.5 million from Zembrace, Simtouch and Tesimra which are our migraine products. This compares to $2 million for the same period in 2025 which consisted only of Zembrace and Tesimra. Tonmaya was approved last August and launched in November and the second quarter of 2026 was Tonmaya's second full quarter of sales after launch. Cost of sales for the second quarter was approximately $0.7 million compared to $3.3 million for the same period in 2025. The decrease in the cost of sales was predominantly driven by a change in product mix and a write-off of migraine products in 2025. Research and development expenses were approximately $19.4 million compared to $10.8 million for the same period in 2025. The increase was preliminary driven by higher manufacturing and clinical expenses reflecting pipeline prioritization along with increased employee related costs from higher headcount. Selling, general and administrative expenses were approximately $36 million compared to $16.2 million for the same period in 2025. The increase was primarily driven by sales and marketing investment behind the launch of Tonmaier and our migraine products, together with higher employer-related and professional expenses. Turning to the balance sheet, we ended the quarter with approximately $176.2 million in cash and cash equivalents as of June 30, 2026. compared to approximately $207.6 million as of December 31st, 2025. We expect our cash resources as of June 30th, 2026 together with net proceeds from equity offerings subsequent to June 30th, 2026 to fund our planned operating capital expenditure requirements in the early second quarter of 2027. With that, I will turn the call back to Seth for closing remarks. Seth?

Thank you, Bradley. We'll move to slide nine. In the second quarter, we delivered progress on the launch of Tonmaya and on the development of two of our mid-stage clinical development programs, TNX102SL for the treatment of MDD and TNX4800 to prevent Lyme disease in the United States. We entered the second half of 2026 with meaningful momentum. Our strategic priorities are clear. Deliver on the promise of Tonmaya, advance the development of our mid-stage clinical programs, and drive sustainable growth to create value for all shareholders. Patients remain at the forefront of our work, and our team is dedicated to supporting them. For Tonmaya, we remain focused on driving growth across net sales and KPIs working to secure patient access and deploying our expanded sales force. For TNX102SL, we will continue to execute on the enrollment of the potentially pivotal phase two study in MDD. For TNX4800, we are manufacturing the investigational product in 2026 to begin the adaptive phase two field study in preventing Lyme disease in the first quarter of 2027. With that, we will now open the call for questions. Operator?

Operator?

Thank you. If you'd like to ask a question, please press star 1-1. If your question has been answered and you'd like to remove yourself from the queue, please press star 1-1 again. Our first question comes from Stacy Koo with TD Cowan. Your line is open.

Hey, good morning. Congratulations on a great quarter and thanks so much for taking our questions. We do have a few. First one is for Tom and Seth. Given the Tamiya launch is going pretty well, Can you talk about your current learnings and what strategies you're using to drive patient adoption in fibromyalgia? What has been the early clinical feedback on Tamiya's efficacy and the early durability signals, giving encouraging refill dynamics? That's the first on Tamiya. And then as we look to 4800 and Lyme, it's been great to get the FDA interaction minutes. So first, can you discuss in more detail Why you believe the majority of infections will be collected in the first season. Maybe discuss how you're identifying the right sites. And then second, do you believe the phase two has the potential to be pivotal in Lyme, given the patient study size of around 3,300? Thanks so much. And then actually before I let you guys answer the questions, just some really quick quarterly clarifications for Tamiya. One, what growth to net range would you expect for Q3 and Q4 given the favorable mix we saw in Q2? And kind of the same question, but what kind of inventory nuances we should consider for Q2? Thanks so much.

Thank you very much, Stacey. So there are three parts to your question. Tom, would you please address the question about Tom Myers' launch and the clinical feedback?

Yeah, absolutely. Thanks very much. Yeah, so the early feedback we have received from HCPs is that Tamiya is, like I said, a welcome addition and new product into the space. There hasn't been anything for 15 years. The durability thus far has been very good. We have seen, as you mentioned, a high rate of refills. I really attribute that to the effectiveness of the product. and the tolerability of the product, especially. So the feedback has been positive. We're gonna continue obviously to target over time with our Salesforce, those key writers, as I mentioned, and we're excited for the additional reps because we can increase our breadth and depth. So all in all, signs have been very positive and the durability and refill signals have been positive as well.

Great, thank you, Tom. And Stacy, to follow up on your question about Lyme, first of all, now that we have the final FDA minutes, we've gone back to the CROs in the process of bid defense and the rest of it. And we're actively working on identifying sites and and characteristics of people at risk for deer ticks and Lyme disease. With respect to your question about whether we think it could provide evidence of efficacy, we have stated that in a press release and in our comments today and we do believe that this phase two study can provide evidence of efficacy and if positive could B, a pivotal study supporting approval of the product. The study will be conducted as a potential registrational study, and the key question will be whether we accumulate enough events, which is mostly driven by Lyme disease cases in the placebo group. in our observation period. So now let me turn the third part over about the quarterly gross net back to Tom. This quarterly gross net and also that inventory on Maya to Tom.

Great. Thanks again. Yeah. So, you know, as we mentioned, we don't disclose specifics. about our gross to net. What I can say is that we've seen a good, as I mentioned earlier, we've seen the gross net positively being impacted by our mix in our channel. The prior approval submissions and approval rates have been strong as well. And we obviously have new coverage that's coming online. So, you know, I would anticipate a gross net in the range similar to what we've seen, you know, in Q1 and Q2. In terms of inventory, I'm assuming we're talking about the inventory at the wholesalers. We track that and we have seen a consistent days on hand as demand has increased. So there's been really no incremental inventory build at our, you know, wholesaler and distributor partners. So I think that was probably where you were going with the inventory question. So thank you for that.

Thank you so much.

Stacy, are there follow-up questions?

No, I think we're all set. Thank you so much.

Thank you.

Thank you. Our next question comes from Tiago Foss with Raymond James. Your line is open.

Great. Thanks for the good question, and congrats on the progress. I have one for Tamaya, one for the 800. On for the 800, just to hone in on the Simplify into your comment related to infection rates on the placebo arm. If you look at the older studies, you see a slightly higher rate. We've seen a surprisingly low rate of infections in Valor. So can you just talk about that dynamic as we're thinking about both powering of the study and also the site selection in Richmond to ensure that you can accrue enough events I just wanted to understand a little bit better how to characterize the access and ease of access of the policies that are in place relative to step edits. How cumbersome is the paperwork? How is that kind of evolving over time?

Thank you so much. Thank you, Tiago. I'll take the first part, about 4,800, and then I'll ask Tom to answer the question about step edits. So with the TNX4800 Lyme Preventative Program, the study that most people use as a reference is the study that was behind the approval of the Lymerix vaccine in 1998, which has subsequently been withdrawn. And in that study, they had an attack rate of but 0.8 in one group and 1.2% in another group that was the main efficacy group. And since then, Lyme has increased significantly in the United States, at least threefold increase in Lyme endemic areas. So we think that the attack rate that is supported by the epidemiology supports that we could get enough events with 3,300 participants that we've announced we're targeting. How we're targeting them and the specifics of the clinical trial are to some extent proprietary. but we're certainly working with experts in the field and clinical experts in areas where Lyme is growing rapidly to select patients who are at risk for contracting, getting deer tick bites and in areas where the deer ticks have a significant rate of Borrelia infection. So let me turn it over to Tom for the discussion about step edits. I'm Tom Maia.

Thank you very much. Yeah, so obviously, first let me note that our target patient population is around 3 million patients who were previously diagnosed and treated for fibromyalgia. And it's important to understand that 80%, roughly 80% of these patients have been already or are on multiple therapies for fibromyalgia. So in our discussions with the payers and our pre-launch even and post-launch, pre-launch in the pre-information exchange and post-launch and actual discussions about coverage, we've seen a tendency to require a step or two through one of multiple products, no mandatory steps through any specific product. Based on what we've already seen in the market and what we've already seen with our prior authorization submissions and approvals, early in launch. We're comfortable that this is a very manageable approach for both the patients and HCPs. Very fantastic.

Thanks again for taking the questions. Thank you, Tiago.

Thank you. Our next question comes from James Malloy with AGP. Your line is open.

Hey, guys. Thank you very much for taking my questions. I know that looking at the TonMaya launch, the gross to net came down quite a bit in the quarter. I know you suggested it's going to fluctuate. It seems like we see different numbers than you guys see when we look at our Symphony data. Is this lower level? Do you anticipate this lower level being more typical, or do you think it's more likely to fluctuate back towards sort of the second quarter of launch, where it's almost a 50% gross to net discount?

Thank you very much for the question, Jim. Let me turn that over to Tom.

Yep, thanks, Jim. So look, in Q2, obviously, we said, you know, we had favorable dynamics that attributed to the growth to net in Q2. It is going to fluctuate, as I mentioned, especially as the coverage comes online from the two commercial contracts that we have recently signed and the downstreams come online. Moving forward, I would expect continued fluctuations, you know, in the range of what we've seen thus far for Q1 and Q2. And then, you know, at some point, obviously, once we get all the coverage pretty much locked down, we should see a more stabilization moving forward.

Okay, great. And then stay with top of mind on the launch. You had some anecdotal comments already on the launch is going well. Could you walk through sort of on the sales reps? What percentage of the reps or what number of the reps are sort of covering their own costs currently? When do you sort of anticipate them getting to that point? And also looking at the overall gross margin was quite good, 5% cost of goods in the quarter. Is that a number we should anticipate going forward now that sort of you've got production up to a scale and running at a higher level?

Tom?

Yeah, so great. Yeah, so we're excited about the performance of the reps so far. Obviously, in launch, you're in a very, you know, focused ramp period and focused targeting and calling on specific doctors that, you know, you believe are seeing and treating most of those patients, which obviously we have great data on. So over time, as we add these, you know, 50 incremental reps who will be boots on the The geographies, but also the depth. I would anticipate that over the course of 2027, we'll see a good portion of those reps, all the reps, covering the cost of the reps and continuing to drive new patients, scripts, refills, etc. So we're excited about it. We're looking forward to getting even more doctors with Tamiya and patients. And then, Seth, would you like to go to Bradley on the gross margin question?

Bradley? Great. Thanks for the question. So obviously, as we mentioned, we do have certainly a product mix that's shifting over time. Thank you very much.

Final question then, if I could please, on 4800, the study starting up, could you sort of compare, contrast any learnings you may have got from Pfizer's Valor study, which just missed significance, I think they didn't have quite enough people get infected, and how to sort of, how you can best try to work around that in the 4800 study.

Thank you, Jim. I'll take that. The Pfizer study was very different from the study that we're planning. They had a very significant proportion of their patients enrolled from Europe, and we're planning a U.S.-only study. Their study was Evaluating a vaccine product that took about a year to develop immunity and then they were looking at immunity after the, you know, at protection after the immunity. Whereas our product, we believe it would provide protection within two days of the first dose. So a much simpler product to get and for people to understand and and the engagement with volunteers is shorter. So I think that several characteristics of our study are different. The US focus, the product that we're evaluating and also I think that we are speaking to experts and clinicians who see a lot of Lyme in the United States and I think that We have confidence that we can do a better job of identifying people at higher risk of Lyme than was seen in that study, although our ability to understand all the details of that study are limited.

Thank you very much for taking the questions.

Thank you, Jim.

Thank you. I'm showing no further questions at this time. I'd like to turn the call over to Seth Lederman for closing remarks.

Well, we're very grateful to everyone who participated, and particularly those who asked questions. We are excited about the success of Sonmaya so far and our clinical programs, and we look forward to keeping our investors and stakeholders engaged and updated as we make progress in 2026 and beyond. So with that, I want to thank everyone on the call, particularly the management team, and thank you very much. This is the end of the call.

Thank you for your participation. You may now disconnect. Good day.