Tonix Pharmaceuticals Q3 2026 Earnings Call Transcript

Tonix Pharmaceuticals (NASDAQ:TNXP) reported third-quarter financial results on Monday. The transcript from the company’s third-quarter earnings call has been provided below.

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Summary

Tonix Pharmaceuticals reported third quarter net sales of approximately $15 million for Tonmya, representing a 37% increase quarter-over-quarter, attributed to expanded sales force and payer agreements.

The company is advancing three key R&D programs: TNX-102 SL for major depressive disorder, TNX-4800 for Lyme disease prevention, and TNX-1500 for kidney transplant rejection.

Tonix received a patent challenge from Dr. Reddy’s Laboratories for Tonmya and plans to vigorously defend its intellectual property rights.

The company ended the quarter with $162.8 million in cash, projecting sufficient resources into early Q3 2027, with ongoing efforts to manage expenses and explore partnership opportunities.

Management is focused on expanding market access for Tonmya, with coverage now reaching 53% of covered lives in the U.S., and emphasizes growth through increased prescriber reach and patient awareness.

Full Transcript

OPERATOR

Good morning and welcome to Tonix Pharmaceuticals’ third 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 hand the call over to Deborah Elson, Head of Investor Relations at Tonix Pharmaceuticals. Please go ahead.

Deborah Elson (Head of Investor Relations)

Thank you, operator, and good morning everyone. Thank you for joining us to discuss Tonix Pharmaceuticals’ third quarter 2026 financial results and operational highlights. Before we begin, I would like to refer you to the forward-looking statements disclaimers on Slide 2. 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 factors include, but are not limited to, risks related to the failure to successfully launch and commercialize Tonmya and any of our approved products, uncertainties of patent protection and litigation, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations, risks related to the timing and progress of clinical development of our product candidates, our need for additional financing, uncertainties of government or third-party payer reimbursement, limited research and development efforts and dependence upon third parties, and substantial competition.

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 31, 2025 and our subsequent quarterly reports on Form 10-Q. Tonix 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, Chief Commercial Officer, and Bradley Saenger, Chief Financial Officer. Following our prepared remarks, we will open the call for questions. With that, I will turn the call over to Seth. Seth.

Seth Lederman (Chief Executive Officer)

Thank you, Deborah, and good morning everyone. Today we are reporting our third quarter financial results and operational highlights. Slide 3 outlines our progress in advancing Tonmya’s commercial business and priority clinical programs. Tonmya third quarter net sales totaled approximately 15 million, increasing 37% quarter over quarter. Previously signed payer agreements contributed to third quarter sales. We have also begun to see promising performance growth since our expanded sales force entered the field on September 1st. These positive trends are continuing into the fourth quarter. We remain encouraged by Tonmya’s trajectory. With our larger sales force and growing sales, we believe we’re well positioned to create value by improving the treatment of fibromyalgia and reinvigorating the market.

On October 1, 2026 we received notice from Dr. Reddy’s Laboratories that it had filed an abbreviated new drug application, or ANDA, paragraph IV patent certification for Tonmya. Generic challenges are common in the life cycle of an approved drug. We will vigorously defend and enforce our Tonmya intellectual property rights against infringement. As we prioritize Tonmya’s growth, we are also advancing key research and development programs. These include three programs. First, the potential pivotal Phase 2 HORIZON study of TNX-102 SL for the treatment of major depressive disorder, or MDD, which could serve as a potential label expansion for Tonmya. Second, the Phase 2 adaptive study of TNX-4800 for the prevention of Lyme disease, and third, the initiation of the Phase 2 investigator-initiated study of TNX-1500, also known by its proposed name, Mosta Prubart, to prevent kidney transplant rejection.

I will now turn the call over to Tom Englese, our Chief Commercial Officer, to discuss the Tonmya launch. Tom.

Thomas Englese (Chief Commercial Officer)

Thank you, Seth, and good morning everyone. I’m honored to serve as Tonix’s first Chief Commercial Officer and I’m grateful to our team for their hard work. On Slide 4, net sales of Tonmya were approximately 15 million in the third quarter, representing 37% quarter-over-quarter growth. Key contributors included pull-through from the two commercial payer agreements signed in May and June, more favorable gross-to-net adjustments than expected, and execution of our launch strategy. We continue to expect gross-to-net fluctuations early in the launch despite expected summer seasonality. Tonmya prescriptions grew by 28% in the third quarter and outperformed other FDA-approved fibromyalgia-indicated products in the third quarter, which were generally flat in the same period.

Turning to our key performance metrics, third quarter prescriptions totaled 16,375, up 28% from the second quarter. Bridge scripts declined quarter over quarter, consistent with significantly more patients moving to covered paid scripts. New prescriptions grew 17% quarter over quarter and refill prescriptions grew 56% quarter over quarter. Our September 1st expansion to 150 sales reps has strengthened the Tonmya business. Total prescriptions, new prescriptions, refills, new writers, and total writers have all meaningfully increased since September 1st compared to the first two months of the third quarter.

More field activity, broader, deeper prescriber reach, and sampling are driving the stronger performance. We view these early trends as promising indicators of future performance and are focused on deepening them. Now turning to market access on Slide 5, Tonmya coverage now reaches approximately 53% of covered lives in the U.S., and we continue to focus on expanding access. We have prioritized access early in the launch to help patients obtain insurance coverage before significantly increasing demand. We signed multiple commercial and government payer agreements in 2026, including two managed Medicare agreements. In the third quarter, our team is engaging downstream plans under existing agreements and pursuing contracts with additional payers.

Since the end of the second quarter, our total prescription approval rate among commercially insured patients has increased and our bridge prescriptions via BlinkRx, our digital specialty pharmacy, have decreased. Both trends are consistent with expanding coverage and we expect continued progress. Additionally, prior authorization submission and approval rates remain strong. We recently added third-party field access managers to support further progress.

Finally, we added multiple new Tonmya distributors in the third quarter and continue to see stable and consistent days on hand at the large wholesalers. Now looking at marketing, prescriber feedback remains positive. Our latest market research survey of top prescribers shows growing Tonmya awareness. Since February, unaided awareness of Tonmya has doubled and more than 80% of healthcare providers surveyed recognized Tonmya when prompted. Intent to prescribe is also encouraging. Our direct-to-consumer, or DTC, initiatives are evolving. We sponsored a segment this morning on Good Morning America to help people learn about fibromyalgia, engage with our MoveFibro Forward digital assets, and talk to their providers.

On the branded side, in the third quarter we conducted a media tour with a leading fibromyalgia key opinion leader and paid spokesperson for Tonix. Twenty interviews were broadcast across major U.S. markets. On the branded side for HCPs, from September to early November we generated high-touch engagements through our booth presence and symposia at 13 congresses. KOLs also hosted more than 130 peer-to-peer sessions in the quarter. I will now turn the call back to Seth to discuss medical affairs and our pipeline. Seth.

Seth Lederman (Chief Executive Officer)

Thank you, Tom. Our medical affairs organization is focused on building awareness of the Tonmya data that supported FDA approval through participation in key medical meetings. The team is also educating providers about the current diagnostic criteria for fibromyalgia. The 2016 revised criteria state that fibromyalgia is not a diagnosis of exclusion. The National Academy of Sciences, Engineering, and Medicine has stated that fibromyalgia is a diagnosable condition in long COVID.

We believe broader understanding of these criteria could meaningfully grow the diagnosed population and help patients get treated earlier. Now I will move to our priority clinical development programs. On slide 6, we are enrolling participants into HORIZON, a Phase 2 potentially pivotal study of TNX102 SL as a first-line monotherapy in adults with MDD. TNX102 SL targets the disturbed sleep of depression through antagonism at four neuronal receptors, which we believe represents a novel approach. Despite FDA-approved treatments, MDD continues to impose a substantial burden on patients and leave room for better options.

Moving to slide 7, we’re advancing TNX4800, our long-acting monoclonal for the prevention of Lyme disease in the U.S., towards the initiation of an adaptive Phase 2 field study which will be called TRAIL in the first quarter of 2027. We believe the study has the potential to demonstrate efficacy and, if positive, support registration. In August, we received FDA minutes from our Type C meeting confirming overall agreement on the randomized, placebo-controlled adaptive field study design.

In the third quarter we also submitted the study protocol to the FDA for their review. We are manufacturing investigational product and remain on track to deliver it to study sites in the first quarter of 2027. Additionally, we have selected our CRO partner and are evaluating potential study sites. We are pleased that our study has generated strong interest so far from potential sites. As a reminder, we expect to enroll approximately 33 adults 18 and older from Lyme-endemic areas in the United States who engage in activities that increase their risk of deer tick bites.

We plan to enroll this study over two Lyme seasons, starting with a lead-in cohort of approximately 500 participants starting in the first quarter of 2027 that will address safety in addition to efficacy. After the second dose, a data safety monitoring board, or DSMB, is expected to review unblinded safety data. If cleared to proceed, we expect to enroll the balance of the efficacy cohort in the 2028 Lyme season. As you can see on slide 8, the ideal participant will have meaningful outdoor exposure, understand the risk of Lyme disease, and be motivated to prevent infection. We expect to screen for exposure to endemic areas, age profile, willingness to prevent infection, risk perception, and lifestyle.

Turning to slide 9, an initial third-party commercial assessment conducted by Trinity Market Research in the third quarter supports TNX4800’s significant market opportunity. First, this assessment estimates that approximately 118 million United States adults may be at risk of Lyme disease because they live, work, or travel in high-risk endemic areas. This population could grow over time as tick habitats expand. Second, providers and payers cited high public awareness and concern about Lyme disease as reasons for their interest in TNX4800.

Additionally, they are enthused about TNX4800’s potential clinical differentiation, target population, Phase 1 safety results, potential efficacy, and potential rapid onset and duration of protection. They also cited Lyme prevention as the most significant unmet need for this condition. Finally, on slide 10, an investigator-initiated Phase 2 study of TNX1500, our anti-CD40 ligand monoclonal antibody to prevent kidney transplant rejection, is expected to begin at Massachusetts General Hospital in the first quarter of 2027. CD40 ligand is also called CD154. The study is expected to enroll five patients. We believe TNX1500 is a differentiated third-generation anti-CD40 ligand program. We engineered TNX1500 to improve safety and tolerability relative to first-generation anti-CD40 ligand monoclonal antibodies while preserving the durable half-life and certain effector functions associated with the Fc, or crystallizable fragment.

In this Phase 2 study, the dose of conventional immunosuppressive drugs will be significantly reduced. Long-term use of conventional immunosuppressive drugs is associated with infection, cancer, cardiovascular side effects, and metabolic syndrome. With that, I will turn the call over to Bradley Saenger, our Chief Financial Officer, to review our financial results. Bradley.

Bradley Saenger (Chief Financial Officer)

Thank you, Seth, and good morning, everyone. On slide 11, I’ll review our financial results for the third quarter ended September 30, 2026. Net product revenue for the third quarter of 2026 was approximately 17.2 million, which consists of approximately 15 million from Tonmya and 2.2 million from Zembrace SymTouch and Tosymra products. This compares to 3.3 million for the same period in 2025, which consisted only of Zembrace and Tosymra, as Tonmya launched in November 2025.

Cost of sales for the third quarter was approximately 1.3 million compared to 1.4 million for the same period in 2025. The decrease was driven by a change in product mix. Research and development expenses were approximately 25.8 million compared to 9.3 million for the same period in 2025. The increase was primarily driven by higher manufacturing expenses of 9.8 million, clinical expenses of 3.6 million, and non-clinical expenses of 1.1 million as we advance our prioritized pipeline, as well as higher employee-related costs of 1.5 million due to increased headcount.

Selling, general, and administrative expenses were approximately 45.6 million compared to 25.7 million for the same period in 2025. The increase was primarily driven by higher sales and marketing expenses of 13.5 million, employee-related expenses of 4.1 million, and professional expenses of 1.5 million, all in connection with the launch of Tonmya. Turning to the balance sheet, we ended the quarter with approximately 162.8 million in cash and cash equivalents as of September 30, 2026, compared to approximately 207.6 million as of December 31, 2025. We believe our cash resources as of September 30, 2026, together with the net proceeds raised from the equity offerings after quarter end, will meet our operating and capital expenditure requirements into early third quarter of 2027. With that, I will turn the call back to Seth for closing remarks.

Seth Lederman (Chief Executive Officer)

Thank you, Bradley. Looking at slide 12, our third quarter results demonstrate Tonmya’s potential to create value and help the fibromyalgia community. We are dedicated to growing the Tonmya business and we believe we are well positioned for a strong fourth quarter and 2027. We are also advancing TNX102 SL in MDD, TNX4800 to prevent Lyme disease, and TNX1500 to prevent kidney transplant rejection, which we believe could make a difference for patients facing these chronic conditions.

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 11. If your question has been answered and you’d like to remove yourself from the queue, press star 11. Again, our first question comes from Stacy Ku with TD Cowen. Your line is open.

Stacy Ku (Analyst)

Thanks so much for taking your questions. We have a couple. Sorry about that, my AirPods are logging in, so thanks so much. Tom, I have a couple for you. You disclosed some encouraging result metrics, but first can you maybe comment on the anecdotal durability of the product from patients taking Tonmya from last winter? So that’s the first comment as we look to kind of Tonmya to next year, and then maybe further discuss your confidence and expectations for what will drive growth next quarter and year.

Are the prescribers broadening? Are they going deeper? What kind of outreach are you expecting to see with kind of a fully formed 150-person sales force? To us it doesn’t seem like you need any more than modest, steady, month-over-month growth that could hit consensus for next year. So that’s the second question. And then third, we appreciate your comments on the recent ANDA filing. It does suggest Tonmya is growing nicely and catching folks’ attention. So just remind us the timelines here—so it will be the normal course of updates—and of course your current patent protection. And then last, as we kind of look at the company prep for 4800 and Lyme, as we await the FDA response on study design, what kind of feedback would you expect, and would you be willing to provide more detail on study sites and learnings from other programs?

Thanks so much.

Thomas Englese (Chief Commercial Officer)

Yeah. So I’ll start, since you started with questions for me—it’s Tom. Thank you for the question, Stacy. So, moving from the feedback that we’re getting on the durability and what we’re seeing in terms of the persistence and number of prescriptions that we’re getting from patients who started early but have also continued to start, anecdotally what we’re hearing is what we expected, which is good efficacy, a very strong tolerability profile. What we’re seeing in the data is we’re seeing a greater number of prescriptions coming after the first couple of fills as we move forward, as evidenced by the refills.

So the feedback has been patients are on it; they’re seeing a benefit. You know, some doctors have given us the feedback that their patients view it as life-changing versus what they were taking. And we think we’ll continue to see that increased refills, persistence, and durability as we move forward. In terms of growth, which obviously is, you know, the thing we’re really laser locked in on, the 150-person sales force with the recent expansion—since that started on September 1—we are seeing an increase in the rate across the board. So we are seeing more new prescribers, we are seeing greater depth, we are seeing more new prescriptions, obviously the refills, as you noted. So I think it’s really a broad-based growth that we’re going to be seeing as we move through Q4 through 2027.

And, you know, I believe you made a comment about the, you know, consistent growth. That’s exactly what we anticipate. Our progress with the payers will obviously add a little bit to that as coverage increases. But we believe that we are on a really good path right now. And the conversations with those payers with the immediate impact that we’re seeing from the sales force expansion, I think those are going to be the real growth levers as we move forward into 2027.

I believe the next question was more about the ANDA, so maybe I’ll pass that over to Seth.

Seth Lederman (Chief Executive Officer)

Okay, thank you, Tom, and thank you, Stacy, for these questions. The ANDA filing—the process for responding to an ANDA certification—is laid out in the Hatch-Waxman Act, and we’re in that process. Since this is litigation, we don’t really comment on details about it, but we are committed to vigorously defending our intellectual property with respect to the term of our core patent. They, as granted right now, provide protection into 2034, and they relate to aspects such as the eutectic formulation technology and other unique characteristics of our product.

And then finally, with respect to 4800, we had a meeting with the FDA in mid-July and had favorable minutes—positive minutes—from that meeting about our plans for the Phase 2 study, the upcoming Phase 2 field study, and we submitted a protocol based on the conversation we had with FDA. So we don’t expect significant changes, but we can’t give a timeline in terms of when exactly we’ll have a completely finalized protocol. But we believe we have great confidence that we’ll be able to begin enrolling in the Phase 2 study in the first half of 2027 in order to catch the first part—to catch the Lyme season—of 2027.

And as we laid out in the presentation, the first season will be focused on enrolling about 500 participants; it would be 1-to-1 randomized, 4800 and placebo, with the idea of getting at least 200 patients through two doses and their safety assessment. So we are very confident about beginning the study in 2027.

Stacy Ku (Analyst)

Thank you so much.

OPERATOR

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

Tiago Fath (Analyst)

Great. Thanks for taking the question. Just thinking about—so revenue growth outpaced prescription growth this quarter. So I’m just trying to understand: a lot of that reflects improved bridge-to-pay conversion, the gross-to-net, and the payer mix, right? So I’m wondering if you can quantify any of those factors. And again, as coverage expands, how should we expect that relationship to continue tracking over time? When can we reach a steady state on a net revenue per script basis, for example?

And then one on the Lyme program—just to think specifically what you can learn from the 2027 cohort that can improve your confidence in getting to the right number of cases without extending a trial in 2029. I know most of the enrollment is planned for 2028, so just how much flexibility is there to adjust either number of sites, number of patients, depending on what you see in terms of event rates in the first season? Thank you.

Seth Lederman (Chief Executive Officer)

Thank you, Tiago. Tom, why don’t you take the first part on Tonmya, and then I’ll do Lyme.

Thomas Englese (Chief Commercial Officer)

Yep, that sounds great. Thanks for the question. Yes, so we are seeing, obviously, strong revenue and prescription growth. In terms of the mix of what’s contributing to that—obviously you mentioned gross-to-net—that is one component of it. We are seeing a better mix as we progress through the launch in terms of the 60-count bottle versus a 30-count bottle, so the average price continues to climb up every quarter, which is driving some of that growth as well.

In terms of the payer mix, obviously that has an impact in terms of where the prescriptions are coming from. As we continue, we continue to see more prescriptions—even from payers with whom we do not have formal coverage yet—get approved through the prior authorization process that they may have set up for a newly launched drug. And obviously those have a very strong gross-to-net profile, being that they’re coming from a payer that we’re not necessarily paying rebates for.

The really encouraging thing is, as we progress, we are seeing the number of approvals go up; we are seeing the amount we’re contributing in copay buy-downs go down, which is exactly the trend that you want. So I think we’re going to continue to see that as we progress. Those trends have been multiple quarters now, so I would anticipate that we’re going to see continued improvement on the copay buy-downs and also on the approval rates as we move forward.

So all of that really is contributing to that excess revenue growth.

Seth Lederman (Chief Executive Officer)

Thanks, John. And then, Tiago, thanks for your question about Lyme. In 2027, the 500-volunteer lead-in cohort is mostly focused on safety. Nonetheless, in 2027 we expect to learn a lot about how to enroll intelligently in 2028. So our idea is, when we have the safety clearance from DSMB—to expect by the end of the second quarter or early in the third quarter—then we can go into 2028 at full speed enrolling. But that means that in 2027 we’re going to be on the ground talking to sites, looking at epidemiology, and using lots of techniques—established techniques, including some techniques that rely on artificial intelligence—to identify sites and potential participants who are likely to get bitten by deer ticks.

So I don’t think that the cohort that we’re enrolling in 2027 will be large enough to be instructive about attack rate and how to find people at risk, but I think the other work that we’ll be doing in 2027 will be very illustrative on how to make the 2028 year the most productive as possible. Thank you.

Tiago Fath (Analyst)

Yeah, perfect. Thank you so much.

OPERATOR

Thank you. Our next question comes from Gary Nockman with Canaccord Genuity. Your line is open.

Gary Nockman (Analyst)

Thanks. Good morning. So on Tonmya, again, just as coverage improves and awareness improves, is it being used more as second line, third line? Any cases where it can be used first line, potentially? And what about combo use with other fibro drugs? Just give us a sense of how you think the drug is being used and how that’s going to be trending going forward. And then with the additional 50 reps—yeah, if you could just quantify how many more physicians you’re targeting. So how many new writers have there been? And I guess what your goal is there with that 150-person salesforce going forward. And then I have one follow-up.

Seth Lederman (Chief Executive Officer)

Sure. Thank you, Gary. Well, let me take—Tom, let me take the first part of that on Tonmya—first line, second line—and then you take 50 reps, if that’s okay. So, Gary, I’m coming to you from the ACR Conference, the American College of Rheumatology Conference in Orlando, where I can report an anecdotal but pretty compelling sea change in the acceptance of fibromyalgia among rheumatologists. And rheumatologists divide fibromyalgia into primary fibromyalgia and then often something called concomitant fibromyalgia. And concomitant fibromyalgia means in the context of other conditions. And I think the whole field is waking up to the idea that fibromyalgia is a parallel but distinct condition that needs separate treatment.

So, for example, in many different autoimmune conditions like rheumatoid arthritis, there’s a group called difficult-to-treat rheumatoid arthritis, and there’s the growing conception that that difficult-to-treat means that they have concomitant fibromyalgia. In lupus, there’s a specific type of lupus that people are now recognizing is concomitant fibromyalgia. There’s a lot of excitement here about the Sjogren’s drugs—new Sjogren’s drugs in development from Amgen, BMS, and Novartis. And while they have compelling immunological data, there’s still not a lot of response—or not enough response—on the symptoms that patients complain of the most, which people are increasingly recognizing are fibromyalgia symptoms. In Sjogren’s, the mix of fibromyalgia relative to the immunological condition is possibly greater than the other two.

And I could go on and on, but I think the key thing is the recognition of fibromyalgia and the recognition that fibromyalgia needs to be treated separately from the associated rheumatological diseases is gaining great acceptance. And this all comes on the heels of the recognition of nociplastic pain by the International Pain Society in 2017 and the widespread acknowledgement that fibromyalgia is the prototypic nociplastic syndrome. So I think there’s been a tremendous sea change in utility. So in terms of fibromyalgia, our label and our studies all studied it as monotherapy for fibromyalgia. And as far as I know, I think that’s how it’s being used. But since fibromyalgia is concurrent with many other conditions, then doctors evaluate the safety of using two drugs together. But I think that this could be good for the healthcare system, because many times people who have a flare or an exacerbation of an autoimmune disease are chased with steroids and biologics, when in fact the flare might be just fibromyalgia.

Fibromyalgia is a serious condition defined by the FDA, but the idea that people sometimes are chasing the fibromyalgia flare as a flare of their autoimmune disease is something that I think will make a big improvement in the care of autoimmune patients. Tom, do you want to talk about the 50 reps?

Thomas Englese (Chief Commercial Officer)

Sure. Thanks for the question, Gary. Yes, so, you know, as we’ve laid out before, there’s about 25,000 HCPs who are really diagnosing and treating these fibromyalgia patients. With the new salesforce expansion that we have, we’ve moved to now basically seeing—roughly targeting—roughly 70% of these adopters, you know, probably greater than the, call it, 40% or so pre-expansion that we were targeting. We are targeting all 25,000, obviously, with our digital assets and direct-to-HCP reach-out via the marketing team.

Since the expansion, the new writers and total writers have increased at a much greater rate than pre-expansion. We’ve been seeing increases every single week, but that rate has definitely stepped up as we’ve—you know, post the September 1st expansion, we continue that. We continue to believe that’s going to keep going. As we’ve already moved, you know, one month into the fourth quarter here, we have seen that trend continue. So more total—more new—writers will lead to more new patients, and with the durability that I spoke of earlier, we anticipate that we’ll continue to see strong refills on those new patients.

So hopefully that helped give an answer to your question.

Gary Nockman (Analyst)

Yeah, no, thanks for all that color. And then just quickly, just on 4800—given the timing of starting with Phase 2—just give us a sense of how we should think about the spending for that next year, how that’s going to ramp up, and just more generally your options for extending the cash runway. So how much left on the ATM? Will you scale back at any places on spending at all? And would you consider potentially out-licensing any of maybe the non-core pipeline programs?

Bradley Saenger (Chief Financial Officer)

Yeah, Gary, thank you. So first of all, we’ve guided that we have runway into Q3 of next year. We are looking at, you know, all our expenses critically as we go forward and focusing on the key programs that we mentioned in the introductory comments. But we’re always looking for partnerships, and we’re in various levels of discussion with potential partners. We have a group right now at Bio Europe. We’re in touch with potential partners all the time.

The timing of that is uncertain, so we don’t give any updates on any particular dialogues. But the first 500 patients of TNX-4800, I think, will be very value-creating for that program because there will be a lot of de-risking of that program. So in the beginning of Q3 next year, you know, we expect to have the safety completed and to have investigational product and to be in a position to really give clarity about what is going to happen in 2028. So the cost from now until this clarity is—you know, call it seven or eight months—you know, is a much smaller number than the cost of 2028, when we’ll be doing the big efficacy portion of the Phase 2 study.

So we are monitoring everything as we go forward, but we believe we’re creating very significant value with the programs that we’re focusing on.

Gary Nockman (Analyst)

Great. Thank you so much.

OPERATOR

Thank you. Our next question comes from James Malloy with Alliance Global Partners. Your line is open.

James Malloy (Analyst)

Hey guys, good morning. Thank you very much for taking my questions. I had a question. Seth, you touched on the Dr. Reddy’s timeline. Obviously the litigation, you can’t comment a lot on it. But as outsiders looking in, any suggestions on sort of cut points that we should be watching for of upcoming events as this litigation proceeds through and obviously, and obviously that would be potential next generation new and improved Tonmya to extend patent life.

Anything you can comment on along those lines.

Seth Lederman (Chief Executive Officer)

Thank you. Jim. Two great questions. Unfortunately, two questions for which I can’t give you a lot of clarity. As I said, the Dr. Reddy’s Paragraph IV certification goes along the clock set forth in the Hatch-Waxman Act and we’re involved in it, but it’s hard to comment on litigation ongoing. But I’m sure you’re familiar with the ideas of after the certification there’s 45 days to respond and a 30-month stay, et cetera. And I don’t know when in the course of that there’ll be public updates.

With respect to follow-on programs, the answer is yes. We see ourselves as the leader in understanding the relationship of non-restorative sleep to widespread pain and particularly to how widespread pain manifests in fibromyalgia and other chronic overlapping pain conditions. And that includes things like ME/CFS, chronic fatigue syndrome, chronic Lyme, post-treatment Lyme disease syndrome. So an enormously large group of adults in America are suffering from these conditions.

And I think that the insights that we’ve gotten from developing Tonmya put us in a very unusual leadership position in exploiting next-generation products. So we do have some very early work underway, but it doesn’t cost enough to be something that we would materially comment on relative to the expensive clinical development of our major depression, major depressive disorder study, which would be a label expansion of Tonmya. But we also think that we have time to introduce, test, and hopefully get approval for next-gen products that target non-restorative sleep.

James Malloy (Analyst)

Good, great. Two last questions on 1500 and 1300. 1500, the Phase 2 starting first quarter next year, five patients. It’s an IST. These are notoriously challenging, I guess, to—it’s out of your control with the ISTs running the trial. Any thoughts on timing on that to get that going, get that wrapped up to come to data? And on 1300, I believe last guidance was expectations for an FDA meeting for next steps. Is that still ongoing?

Seth Lederman (Chief Executive Officer)

Yes, Jim, and thank you for following us. Yeah. The 1500 study that is starting at Mass General pretty imminently, we’re guiding for first quarter. The primary endpoint is 18 months, but there will be, you know, interim looks at earlier time points. But I think it will be a big change in the valuation and importance of that program once we accumulate this Phase 2 data. We believe that looking at all the factors together, potency in terms of modulating the immune system, PK, how long the product lasts in the bloodstream, and other features—we think putting all of those together, we believe we have the best-in-class anti-CD40 ligand products.

And I’m sure many of you are aware that it’s a very exciting area. So that’s a lot to say, but we think that breaking the ground and getting it into a Phase 2 study and collecting this kind of information will be very important in its development. And yes, with respect to 1300, we did have that FDA meeting and we are awaiting a response from FDA, but we remain very interested in that program. But we’re kind of at an impasse with clinical development that we’re trying to straighten out with FDA, where we believe the path forward is to seek an approval based on lab studies only. But we’re waiting to see if FDA will agree with that approach. But there is no other treatment out there for cocaine intoxication, and ours is fundamentally a cocaine antidote.

So it’s an important program to us, but until we reach agreement with FDA on a path forward, we really don’t have much to comment on.

James Malloy (Analyst)

Thank you for taking the questions.

OPERATOR

Thank you, Joe. Thank you. Our next question comes from David Botts with Zacks Small-Cap Research. Your line is open.

David Botts (Analyst)

Hey, good morning, everyone. Thanks for taking the questions. So one more for you, Tom, about the launch. I was wondering if you could tell us, if you have this data available, what percentage of the third quarter prescriptions were bridge prescriptions versus commercially reimbursed? And then maybe more importantly, how has that percentage changed from the second quarter to the third quarter?

Thomas Englese (Chief Commercial Officer)

Yeah, yeah, thanks for the question. Absolutely. So, looking to get into the specific percentages, what I can tell you is this. First, we have a very good conversion rate on bridge prescriptions that are through BlinkRx. As I mentioned earlier in the discussion, that rate of percentage of bridge scripts as a total percentage has consistently come down as coverage has come up. I would anticipate that we would continue to see this quarter over quarter, month over month, continue to be a smaller percentage of our total prescriptions as this coverage comes on.

Once that script comes in, if they’re covered, there is no bridge required. So the change has been a strong change in the positive direction. And that coincides with the approval rate I mentioned earlier and the continued progress that we’re making on the payer front. And those discussions, I tell you, happen every week with multiple payers and downstream plans. And we feel like we’re making really good progress. And I would say the bridge scripts have been a great lever to start, but they are slowly becoming a less meaningful part of the total prescriptions, and that will continue as we move forward.

David Botts (Analyst)

Okay, great. Appreciate that. Now, as far as the HORIZON study goes, does management have any expectations for when enrollment could be completed or top-line results might be reported?

Seth Lederman (Chief Executive Officer)

Yeah, thank you, David. We’re not guiding to that yet. It’s still early on in the enrollment period, so we don’t have a clear trajectory and we’re certainly not at steady state yet in terms of the enrollment of participants. But I will say that this is a very standard six-week depression study, very similar to other depression studies that multiple other sponsors have run. So we are hoping to enroll it quickly, but we will provide guidance hopefully sometime soon when we believe that the run rate has become more predictable.

David Botts (Analyst)

Okay, and last two for Bradley. On the financial side, I was wondering if you could tell us how much of the 45 million in SG&A this quarter was for, say, recurring commercial infrastructure versus non-recurring launch expenses. And then with the sales force now presumably fully expanded, how should we think about SG&A, say in the fourth quarter and then going into 2027?

Bradley Saenger (Chief Financial Officer)

Great. Thank you, David. So as you point out in our 10-Q, which was filed today, a significant amount of that 45 million was due to the sales force. Obviously, as we continue to launch Tonmya and grow the program, I would expect that to be, again, a significant piece of our SG&A.

David Botts (Analyst)

All right, thanks for taking the questions.

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. Mr. Lederman?

Seth Lederman (Chief Executive Officer)

Yes, I’m sorry, I was fumbling for the right buttons here. Well, thank you, operator. And thank you all for joining us. I would like to thank our entire team for their dedication to Tonix’s mission and to patients. Have a good day.

OPERATOR

Thank you for your participation. This does conclude the program. You may now disconnect.

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