Tonix Pharmaceuticals Q2 2026 Earnings Report

Tonix Pharmaceuticals EPS Results

• Actual EPS: -$2.44
• Consensus EPS: -$2.64
• Beat/Miss: Beat by +$0.20
• One Year Ago EPS: N/A

Tonix Pharmaceuticals Revenue Results

• Actual Revenue: $13.54 million
• Expected Revenue: $7.72 million
• Beat/Miss: Beat by +$5.82 million
• YoY Revenue Growth: N/A

Tonix Pharmaceuticals Announcement Details

• Quarter: Q2 2026
• Date: 8/10/2026
• Time: Before Market Opens
• Conference Call Date: Monday, August 10, 2026
• Conference Call Time: 8:30AM ET

Tonix Pharmaceuticals (NASDAQ:TNXP) is a clinical-stage biotechnology company focused on developing therapeutics for central nervous system disorders, immunology and rare diseases. The company’s pipeline includes small-molecule and biologic product candidates designed to address conditions such as fibromyalgia, post-traumatic stress disorder (PTSD) and other chronic pain syndromes, as well as vaccines for potential viral and biothreat agents.

Among Tonix’s lead programs is TNX-102 SL, a sublingual formulation of cyclobenzaprine being evaluated for the treatment of fibromyalgia and PTSD. The company is conducting late-stage clinical trials to assess safety and efficacy in people who experience chronic pain and disrupted sleep due to these conditions. In addition to its CNS portfolio, Tonix is advancing live-virus vaccine candidates against orthopoxviruses, including those that could be used for smallpox or monkeypox, and is exploring development of vaccines against other biothreat agents.

Headquartered in New York, Tonix Pharmaceuticals leverages in-house research and collaborations with academic institutions and government agencies to advance its pipeline. The company was co-founded and is led by Seth H. Lederman, M.D., who serves as President and Chief Executive Officer. Under Dr. Lederman’s direction, Tonix continues to progress multiple programs through clinical development while maintaining a focus on unmet medical needs in both therapeutic and vaccine arenas.

Tonix Pharmaceuticals Q2 2026 Earnings Call Transcript

Key Takeaways

• TONMYA sales accelerated: Second-quarter net sales reached approximately $11 million, up 197% quarter over quarter, while prescriptions, new patient starts, and refills all increased. Management attributed the momentum to positive prescriber feedback, tolerability, and strong refill activity.
• Market access and commercial expansion are progressing: TONMYA coverage currently reaches about 136 million U.S. lives, with coverage expected to rise to approximately 145 million on January 1, 2027. Tonix is adding 50 sales representatives, bringing the field force to roughly 150 by September, to support broader geographic and prescriber coverage.
• Gross-to-net remains variable: Favorable retail and specialty distribution mix and lower copay assistance costs supported second-quarter results, but management expects continued quarterly fluctuations as new payer agreements generate downstream effects. Wholesaler inventory days remained consistent, with no reported incremental inventory buildup.
• Pipeline programs advanced: Tonix randomized the first patient in the phase II HORIZON study of TNX-102 SL for major depressive disorder and expects to begin enrollment of an adaptive phase II study of TNX-4800 for Lyme disease prevention in the first quarter of 2027. Management believes the Lyme study could potentially provide pivotal efficacy evidence if enough infections occur in the placebo group.
• Operating expenses and funding needs increased: Second-quarter R&D expense rose to approximately $19.4 million and SG&A to $36 million, largely due to clinical development and TONMYA commercial investments. Cash and equivalents declined to $176.2 million at quarter-end, with current resources and subsequent equity proceeds expected to fund operations into early second quarter 2027.

Presentation

[Operator]

Welcome to Tonix 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 Tonix Pharmaceuticals. Please go ahead.

[Deborah Elson, Head of Investor Relations at Tonix Pharmaceuticals]

Thank you, operator. Good morning, everyone. We appreciate you joining us today to discuss Tonix 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 filings with 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. Tonix undertakes no obligation to update or revise any forward-looking statements except as required by law.

[Deborah Elson, Head of Investor Relations at Tonix Pharmaceuticals]

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?

[Seth Lederman, CEO at Tonix Pharmaceuticals]

Thank you, Deborah. Good morning, everyone. We are pleased to welcome you to Tonix's 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 Tonmya is progressing well, supported by growing sales, improvement across launch metrics, and patient access wins. Tonmya was invented, developed, tested, and launched in-house by the Tonix team. Tonmya 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.

[Seth Lederman, CEO at Tonix Pharmaceuticals]

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 Tonmya sales. We believe our second quarter and cumulative launch performance underscore Tonmya's compelling value proposition and differentiated profile. Historically, fibromyalgia patients and their healthcare providers, or HCPs, have been dissatisfied with limited treatment options. Now, we are pleased to offer Tonmya as an effective and generally well-tolerated treatment option. Tonmya is a non-opioid analgesic that improves fibromyalgia pain, the core symptom of the disease. Tonmya 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.

[Seth Lederman, CEO at Tonix Pharmaceuticals]

In the second quarter of 2026, we achieved approximately $11 million in net sales for Tonmya, representing 197% quarter-over-quarter growth. That is approximately triple the net 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 Tonmya and to our strategic focus and execution. We also had early wins in managed access. We do not believe these wins contributed significantly to Tonmya sales in Q2. However, we are beginning to see their effects in Q3. Currently, Tonmya 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 U.S.

[Seth Lederman, CEO at Tonix Pharmaceuticals]

On January 1st, 2027, when our managed Medicare GPO coverage agreement becomes effective, Tonmya coverage will represent approximately 145 million covered lives or approximately 46% of the covered lives in the U.S. 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 sales-force 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. Tonix's 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.

[Seth Lederman, CEO at Tonix Pharmaceuticals]

In 2026, we have focused our resources primarily on TNX-102 SL, which is sublingual cyclobenzaprine tablets, which is a potential new indication for Tonmya 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 headway on both programs. For TNX-102 SL in MDD, we randomized the first patient in the second quarter. For TNX-4800 in Lyme disease prevention, we held a constructive Type C FDA meeting and received positive final minutes on our planned adaptive Phase II 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 Tonmya launch. Tom?

[Thomas Englese, EVP of Commercial Operations at Tonix Pharmaceuticals]

Thank you, Seth, and good morning, everyone. Today, I will review our second-quarter sales performance for Tonmya. I will cover our launch strategy. We are pleased to offer Tonmya as a treatment to adults fibromyalgia patients. Looking at slide four, we are encouraged to see net sales of $11 million for Tonmya 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 Tonmya. 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 co-pay buydowns related to stronger-than-expected-prior authorization approvals.

[Thomas Englese, EVP of Commercial Operations at Tonix Pharmaceuticals]

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. We'll look at our key performance indicators for Tonmya. 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. 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 Tonmya and our patient support program. We will walk you through our strategy regarding market access, sales, and marketing on slide five. We've already reached major market access coverage milestones, which we believe speaks to the value of Tonmya.

[Thomas Englese, EVP of Commercial Operations at Tonix Pharmaceuticals]

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 nine million Medicare lives beginning January 1st, 2027. Tonmya 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 co-pay assistance and savings programs in the commercial population.

[Thomas Englese, EVP of Commercial Operations at Tonix Pharmaceuticals]

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 Tonmya and do not support any other company or product. Over time, we expect to bring high-performing reps in-house to Tonix. The entire sales force management team has recently been brought in-house at Tonix. We are committed to quality and consistency of tactical execution.

[Thomas Englese, EVP of Commercial Operations at Tonix Pharmaceuticals]

As a reminder, we are initially targeting the 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 Tonmya is a welcome new treatment option for their patients. 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. We are excited to further advance the launch of Tonmya. I will now turn the call back to Seth to discuss medical affairs. Seth?

[Seth Lederman, CEO at Tonix Pharmaceuticals]

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. 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. These other diagnoses should not exclude the diagnosis of fibromyalgia.

[Seth Lederman, CEO at Tonix Pharmaceuticals]

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. I now want to update you on the pipeline. We are advancing our development pipeline. I will focus on TNX-102 SL and TNX-4800. On slide six, TNX-102 SL for the treatment of MDD could potentially serve as a label expansion for Tonmya. 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.

[Seth Lederman, CEO at Tonix Pharmaceuticals]

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 MADRS total score at week six. Secondary endpoints include global impression scores, anxiety ratings, and measures of sleep quality. We are evaluating TNX-102 SL for MDD based on initial signals observed in previous Tonix phase II and III studies, in which TNX-102 SL nominally improved depression symptoms in fibromyalgia patients and PTSD patients. TNX-102 SL was designed to target the disturbed sleep in fibromyalgia. If TNX-102 SL has effects on depression, 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 Tonmya label extension is acute stress disorder and acute stress reaction.

[Seth Lederman, CEO at Tonix Pharmaceuticals]

An investigator-initiated phase II 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, for which we expect to report top-line data in mid-2027. I'll move to slide seven to discuss TNX-4800, 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 II 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 TNX-4800 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 burgdorferi, causes 99.9% of Lyme disease cases in the U.S.

[Seth Lederman, CEO at Tonix Pharmaceuticals]

TNX-4800 is designed to act in the midgut of the Borrelia-infected deer tick. If someone is treated with TNX-4800 before getting bitten by the tick, then the tick sucks 4800-containing blood into its midgut. TNX-4800 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. OspA is a validated target for antibodies. TNX-4800 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 TNX-4800 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 that take three or four separate immunizations over at least six months to provide protection. TNX-4800 does not require a host immune response like vaccines.

[Seth Lederman, CEO at Tonix Pharmaceuticals]

That means it doesn't depend on the host's immune system, which is known to be less active in older people and people with certain conditions. After reporting phase I data earlier this year and meeting with the FDA in early Q3, we now have a clear view of our planned phase II 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, aged 18 and older, will be recruited from Lyme-endemic areas in the U.S. and selected for their engagement in 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.

[Seth Lederman, CEO at Tonix Pharmaceuticals]

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 TNX-4800 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 TNX-4800, 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 TNX-4800, 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?

[Bradley Saenger, CFO at Tonix Pharmaceuticals]

Thank you, Seth, and good morning, everyone. On slide eight, I will review the 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 Tonmya and $2.5 million from Zembrace SymTouch and Tosymra, which are our migraine products. This compares to $2 million for the same period in 2025, which consisted only of Zembrace and Tosymra. Tonmya was approved last August and launched in November, and the second quarter of 2026 was Tonmya'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.

[Bradley Saenger, CFO at Tonix Pharmaceuticals]

Research and development expenses were approximately $19.4 million, compared to $10.8 million for the same period in 2025. The increase was primarily 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 Tonmyaand our migraine products, together with higher employee-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 30th, 2026, compared to approximately $207.6 million as of December 31st, 2025.

[Bradley Saenger, CFO at Tonix Pharmaceuticals]

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 and capital expenditure requirements into early second quarter of 2027. With that, I will turn the call back to Seth for closing remarks. Seth?

[Seth Lederman, CEO at Tonix Pharmaceuticals]

Thank you, Bradley. We'll move to slide nine. In the second quarter, we delivered progress on the launch of Tonmya and on the development of two of our mid-stage clinical development programs, TNX-102SL for the treatment of MDD and TNX-4800 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 Tonmya, 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 Tonmya, we remain focused on driving growth across net sales and KPIs, working to secure patient access and deploying our expanded sales force. For TNX-102SL, we will continue to execute on the enrollment of the potentially pivotal phase II study in MDD.

[Seth Lederman, CEO at Tonix Pharmaceuticals]

For TNX-4800, we are manufacturing the investigational product in 2026 to begin the adaptive phase II field study in preventing Lyme disease in the first quarter of 2027. With that, we will now open the call for questions. Operator? Operator?

[Operator]

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

[Stacy Ku, Analyst at TD Cowen]

Hey, good morning. Congratulations on a great quarter, thanks so much for taking our questions. We do have a few. First one is for Tom and Seth. Given the Tonmya 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 Tonmya's efficacy and the early durability signals, giving encouraging refill dynamics? That's the first on Tonmya. As we look to TNX-4800 and Lyme, it's been great to get the FDA interaction minutes. 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.

[Stacy Ku, Analyst at TD Cowen]

Second, do you believe the phase II has the potential to be pivotal in Lyme given the patient study size of around 3,300? Thanks so much. Actually before I let you guys answer the questions, just some really quick quarterly clarifications for Tonmya. One, what gross-to-net range would you expect for Q3 and Q4 given the favorable mix we saw in Q2? Kind of the same question, but what kind of inventory nuances we should consider for Q2? Thanks so much.

[Seth Lederman, CEO at Tonix Pharmaceuticals]

Thank you very much, Stacy. There are three parts to your question. Tom, would you please address the question about Tonmya's launch-

[Thomas Englese, EVP of Commercial Operations at Tonix Pharmaceuticals]

Sure

[Seth Lederman, CEO at Tonix Pharmaceuticals]

and the early clinical feedback?

[Thomas Englese, EVP of Commercial Operations at Tonix Pharmaceuticals]

Absolutely. Thanks very much. The early feedback we have received from HCPs is that Tonmya 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. The feedback has been positive. We're going to continue obviously to target over time with our sales force those key riders as I mentioned. We're excited for the additional reps because we can increase our breadth and depth. All in all, signs have been very positive and the durability and refill signals have been positive as well.

[Seth Lederman, CEO at Tonix Pharmaceuticals]

Great. Thank you, Tom. 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 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, we do believe that this phase II study can provide evidence of efficacy, if positive, could be a pivotal study supporting approval of the product.

[Seth Lederman, CEO at Tonix Pharmaceuticals]

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. Now let me turn the third part over about the quarterly gross-to-net back to Tom. This quarterly gross-to-net, and also about inventory-

[Thomas Englese, EVP of Commercial Operations at Tonix Pharmaceuticals]

Yep

[Seth Lederman, CEO at Tonix Pharmaceuticals]

of Tonmya to Tom.

[Thomas Englese, EVP of Commercial Operations at Tonix Pharmaceuticals]

Great. Thanks again. Yeah. 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-to-net positively being impacted by our mix in our channel. The prior authorization submissions and approval rates have been strong as well, and we obviously have new coverage that's coming online. I would anticipate a gross-to-net in the range similar to what we've seen 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. There's been really no incremental inventory build at our wholesaler and distributor partners. I think that was probably where you were going with the inventory question. Thank you for that.

[Stacy Ku, Analyst at TD Cowen]

Thank you so much.

[Seth Lederman, CEO at Tonix Pharmaceuticals]

Stacy, are there follow-up questions or?

[Stacy Ku, Analyst at TD Cowen]

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

[Seth Lederman, CEO at Tonix Pharmaceuticals]

Thank you.

[Operator]

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

[Tiago Fauth, Analyst at Raymond James]

Great. Thanks for the good question, and congrats on the progress. I have one for Tonmya, one for TNX-4800. On TNX-4800, just to hone in on the sample size 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're seeing a surprisingly low rate of infections in VALOR. Can you just talk about that dynamic as we're thinking about both powering of the study and also the site selection and enrichment to ensure that you can accrue enough events? On Tonmya, 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.

[Seth Lederman, CEO at Tonix Pharmaceuticals]

Thank you, Tiago. I'll take the first part about TNX-4800, and then I'll ask Tom to answer the question about step edits. With the TNX-4800 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. In that study, they had an attack rate of 0.8 in one group and 1.2% another group that was the main efficacy group. Since then, Lyme has increased significantly in the U.S., at least threefold increase in Lyme-endemic areas. We think that the attack rate that's 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.

[Seth Lederman, CEO at Tonix Pharmaceuticals]

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. Let me turn it over to Tom for the discussion about step edits on Tonmya.

[Thomas Englese, EVP of Commercial Operations at Tonix Pharmaceuticals]

Thank you very much. Obviously, first let me note that our target patient population is around 3 million patients who were previously diagnosed and treated for fibromyalgia. It's important to understand that 80%, roughly 80% of these patients have been already or are on multiple therapies for fibromyalgia. In our discussions with the payers and our, since pre-launch even and post-launch, pre-launch in the pre-information exchange and post-launch in 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.

[Tiago Fauth, Analyst at Raymond James]

Right. Fantastic. Thanks again for taking the questions.

[Seth Lederman, CEO at Tonix Pharmaceuticals]

Thank you, Tiago.

[Operator]

Thank you. Our next question comes from James Molloy with A.G.P. Your line is open.

[James Molloy, Analyst at A.G.P.]

Hey, guys. Thank you very much for taking my questions. I know that looking at the Tonmya 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. 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?

[Seth Lederman, CEO at Tonix Pharmaceuticals]

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

[Thomas Englese, EVP of Commercial Operations at Tonix Pharmaceuticals]

Yep. Thanks, James. Look, in Q2, obviously we said we had favorable dynamics that attributed to the gross-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 down streams come online. Moving forward, I would expect continued fluctuations in the range of what we've seen thus far for Q1 and Q2. Then, at some point, obviously once we get all the coverage pretty much locked down, we should see a more stabilization moving forward.

[James Molloy, Analyst at A.G.P.]

Okay, great. Then staying with Tom on the launch, you had some anecdotal comments already that 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, or when do you sort of anticipate them getting to that point? Also looking at the overall gross margin, looks 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?

[Seth Lederman, CEO at Tonix Pharmaceuticals]

Tom?

[Thomas Englese, EVP of Commercial Operations at Tonix Pharmaceuticals]

Yeah. Great. Yeah, we're excited about the performance of the reps so far. Obviously in launch, you're in a very focused ramp period and focused targeting and calling on specific doctors that you believe are seeing and treating most of those patients, which obviously we have great data on. Over time, as we add these 50 incremental reps who will be boots on the ground September, they're already in training. We're going to be expanding 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, et cetera. We're excited about it. We're looking forward to getting to even more doctors with Tonmya and patients.

[Thomas Englese, EVP of Commercial Operations at Tonix Pharmaceuticals]

Seth, would you like to go to Bradley on the gross margin question?

[Seth Lederman, CEO at Tonix Pharmaceuticals]

Bradley?

[Bradley Saenger, CFO at Tonix Pharmaceuticals]

Okay, great. Thanks for the question. Obviously, as we mentioned, we do have certainly a product mix that's shifting over time. Obviously we don't guide to exactly what our numbers would be. I would expect, again, a little fluctuation as we try to solidify various levels. I think that's where we'll be for at least the next quarter or two. Hopefully once things have stabilized, we will be able to have a more regular gross-to-net as well as margins as well.

[James Molloy, Analyst at A.G.P.]

Okay. Final question then, if I could please, on TNX-4800, the study starting up. Could you sort of compare or 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 getting infected. How you can best try to work around that in the TNX-4800 study.

[Seth Lederman, CEO at Tonix Pharmaceuticals]

Thank you, James. 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 with evaluating a vaccine product, it took about a year to develop immunity, and then they were looking at protection after the immunity. Whereas our product, we believe it would provide protection within two days of the first dose. A much simpler product to get and for people to understand, and the engagement with volunteers is shorter. I think that several characteristics of our study are different. The U.S. 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.

[Seth Lederman, CEO at Tonix Pharmaceuticals]

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.

[James Molloy, Analyst at A.G.P.]

Thank you very much for taking the questions.

[Seth Lederman, CEO at Tonix Pharmaceuticals]

Thank you, James.

[Operator]

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.

[Seth Lederman, CEO at Tonix Pharmaceuticals]

We're very grateful to everyone who participated and particularly those who asked questions. We are excited about the success of Tonmya 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. 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.

[Operator]

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

Participants

Executives

• Deborah Elson, Head of Investor Relations
• Seth Lederman, CEO
• Thomas Englese, EVP of Commercial Operations
• Bradley Saenger, CFO

Analysts

• Stacy Ku, Analyst at TD Cowen
• Tiago Fauth, Analyst at Raymond James
• James Molloy, Analyst at A.G.P.