Tonix Pharmaceuticals Holding Corp. (TNXP) November 10, 2026 Conference Transcript

Thanks so much, everyone, for joining us this year for the Guggenheim Healthcare Innovation Conference. I'm Vamo Devon, one of the biopharma analysts here. Next up here in this room, we have Tonics Pharmaceuticals, and I'm joined by Seth Liederman, the CEO of the company. Thanks again for joining us. So maybe I'll turn it to you first. I know you guys just reported earnings yesterday morning, and I'm keeping my days straight here. Maybe just the key takeaways that you're highlighting from the results you shared.

First of all, thank you very much for including us in the conference and for interviewing me. We did report yesterday our earnings, and I think the headline was that our launch of Tanmaya for treating fibromyalgia is on track. We had growth in... Net sales, all of our KPIs, net sales, TRX, NRX, refills, MBIX, et cetera, MBRX. So we're really on track for what we think is going to be a very important product in fibromyalgia. You know, there hasn't been a product in fibromyalgia, a new product, in more than 15 years. So we've had to come in and recreate, breathe life into this category, which is a challenge. But on the other hand, there's really wind at our back because there's a lot of science that's happened in the past 15 years and a lot of interest in fibromyalgia.

Okay. And so you touched on this briefly, but what are the key metrics that you're looking at? What should investors be focused on as we track this launch?

Yeah, well, the main thing is net sales. So we had 15 million of net sales last quarter, and that was over 11 million of net sales in Q2s. That was a 37% increase. TRX grew significantly, 27%, and all the way down. But in addition to that, behind that, we had wins in access. In Q2, we got two of the big three payers in commercial, and then in Q3, we got two of the big three in managed Medicare. So as we sit here today, we have 53% of covered lives in the United States, And we believe that contributed to Q3 sales, but we expect going forward that that will be further wind at our back. Another important change is over the summer, we recruited and trained 50 new sales representatives who were in the field on September 1st. So our sales force has grown from 100 to 150. So, our commercial operation is... I'm running on all cylinders, and yesterday we sponsored an unbranded segment on Good Morning America to raise awareness of fibromyalgia, so both on the unbranded and the branded piece and all over, I think that we're having wins and successes in fibromyalgia.

Okay. And you mentioned the access that you have now, I think you said 166 million lives covered? A couple of questions from there. What do you think is, what's next here? What's the sort of steady state you hope to get to in terms of covered lives? And then what is the level of access? Are there step-throughs? Or what do patients have to do to actually get on the product?

Yeah, so I think the same reasons that the current payers have signed on Are the same reasons why new payers will sign on? Meaning, I think a typical experience is that a plan will see that they are paying for... Prescriptions, and they're not getting a rebate, so that is usually something that brings people to the table, and from the launch, from the very beginning of the launch, actually almost a year ago today, we've had very good rates on prior auth submissions and prior auth approvals, so I think that that's what's really driving our success. Where do I hope it gets to? Well, you know, I think that we still have one of the big three to get in commercial and one of the big three to get in managed Medicare. And then there are some other plans that are not part of the big three, but together a lot of lives. I can't guide, and obviously we can't drag anyone to the table, but we're having a lot of productive conversations, and our managed access team is running all over the country, not just focused on the top plans, but also the subplans now, because once you get the top plan, you still have to get the subplans to buy on. In terms of the steps, we have not focused on getting coverage without steps. It just hasn't been a priority for us. So typically, our contracts would have one or two steps, and it's usually a list of the three approved medicines and then maybe one or two off-label medicines that are commonly used. But we don't see that as an obstacle to our product being used. Part of that is it's just the way of life today in the industry. But the other thing is that fibromyalgia patients, particularly the group of fibromyalgia patients who are already diagnosed, typically have already been on and failed one of the existing products. So we're getting a lot of people showing up to the doctors, and they already qualify for, you know, for trying a new medicine.

Okay. And then one other thing you mentioned yesterday with the earnings was the gross net, and you saw some fluctuations in the quarter. It was a similar sort of question in terms of how do you expect that to settle when you get to more of a steady state with the product?

Yeah, that's, you know, early on in the launch of a product, gross to net definitely fluctuates. We think that at equilibrium, when we're, you know, at steady state, I don't know if that's, you know, year two or year three, we think it'll be 50% or better, meaning or more favorable. But so far, we've been pleasantly surprised by our gross to net, and I think that part of that is the mix that before you have contracts, you're not paying rebates, and that tends to make the gross to nets favorable. But not where we want to be to have a very successful launch. So we're at it every day, and we think that this is going to be a very important product.

Okay. Maybe the last one on this topic, just in terms of the uptake from the prescriber side. Maybe you can comment a little more detail in terms of what you're seeing in terms of breadth and the depth of the prescribing out there.

Yeah, well, we, you know, we had 100 patients going into the, 100 reps going into the summer, and now we have 150, and we've, you know, our sales team has alternated between first going for breadth, and then in Q2, the focus was depth, getting more prescriptions per rider, and now with 150 reps, we're focused on both, and I think that we're making progress in both categories. I just came from the American College of Rheumatology meeting in Orlando, and my feedback will be anecdotal and maybe biased because people are talking to me because they're interested in fibromyalgia, but I've been talking about fibromyalgia for more than 30 years, and I've never seen so much interest. So I think that the biggest group of writers are rheumatologists. And, you know, we knew that going into it, and that's, you know, That's been, that's proven true, but the rheumatologists are very interested in this because there's a real recognition now that fibromyalgia is not a diagnosis of exclusion, and in fact, fibromyalgia typically occurs in the setting of other conditions. So in rheumatology, there's a certain group of rheumatoid arthritis patients who are called difficult-to-treat, and now more and more people realize that means they also have fibromyalgia. In psoriatic arthritis and spondyloarthritis, there's the concept of persistent pain, and now they realize that's fibromyalgia. So fibromyalgia and rheumatology is emerging as the thing that's left when the biologic has controlled the inflammation. And it just seems to be, I think our moment has arrived in terms of the recognition of this aspect and what our product might do.

Okay, all right, great. So maybe we can shift now to more of the pipeline, because we have several interesting programs to talk about there for 102 in MDD. You know, just kind of how you see that asset differentiating, and I know you're, one of the things you've talked about is sort of the benefits around sleep, or, so how are you, what's the patient population you're looking to enroll, and how do you sort of, you know, show the differentiation here for this asset?

Yeah, thank you. So we have an ongoing potential pivotal phase 2 study in MDD, major depressive disorder, and this is exactly the same product that we have approved in fibromyalgia. In fibromyalgia, it's called Tanmaya, but in depression where it's not approved, we call it TNX-102SL, and it's well known that depression patients have sleep problems. So our targeting of depression by trying to improve their sleep quality, I think it's really a novel idea. And we have de-risked this to some extent because from a pivotal trial in fibromyalgia, we actually had a nominal p-value in improving depression by what's called the Beck, the Beck Depression Inventory. And in a PTSD study, we had a nominal p-value, improving depression by the Madras, and the Madras is the primary endpoint of this study. So we have not enrolled prospectively patients with MDD and looked at their depression, but... From two large registration quality studies, we believe there's a signal in there, so we're very excited. This would obviously be a line extension or a label expansion of the product in depression, and depression, as you know, is a much more accepted and big market, so we're very excited, and unsatisfied market, despite the many products that are out there.

And so now the Horizon, maybe the last, what's the latest around the Horizon trials that you're running? What are the next steps to look out for?

Yeah, we started enrolling in June. We haven't given an update. We're generally pleased with how it's going, but we don't feel we can guide to top line yet until the enrollment hits steady state. But I think it will not be long before we can guide to top line in that study. But it's a very traditional six-week depression study that... All the latest drugs and depression have done pretty much the same protocol. It's not particularly hard to enroll or operate. I mean, every study, you have to focus on every detail. But I'm saying there's nothing novel about this study. So I think that this is more blocking and tackling. But we're very excited about the idea of expanding this into an entirely new category.

Okay. And then last question on 102. Beyond MDD, do you see potential to expand this further into other indications?

We do, and we are very excited because poor sleep plays roles in so many indications. There's actually a very interesting news article in Nature Medicine over the summer that was triggered by our work, but also some of the new orexin drugs. And we're excited that we're not alone in targeting disturbed sleep as a mechanism. Most people think of a molecular target when they talk about targets, but as a therapeutic target, improving sleep quality could have a lot of broad applications. And, you know, we think fibromyalgia and depression are just the tip of the iceberg.

Okay. So let's shift gears into 4800, obviously in development for Lyme. So, you have the... Trail, trial, which I like the name there. So maybe just, what is the proposed dosing regimen here for this program?

Yeah, so our TNX4800 is a long-acting monoclonal antibody that provides passive immunity to the OSP-A protein on Borrelia. So it functions like a vaccine, but it's not a vaccine. It's a long-acting monoclonal antibody that delivers passive immunity. So what we're competing against, so to speak, there are no products on the market, but obviously Pfizer-Valneva has a vaccine that elicits active immunity to the same antigen. And so comparing it to we have, you know, we have much faster. We have onset to protection, because if you get our antibody, in theory, it's in development, we don't know, but in monkeys, in experimental challenge studies with Borrelia-infected ticks, we have onset very rapidly, so call it two days, whereas the vaccine takes several months for the first season, and then there's another booster after a year. So we think that that's probably the biggest advantage is the speed of onset. But except for that, the study that we're doing that we plan to start in 2027 is very similar to the Pfizer study in terms of being a field study. Looking, the primary endpoint is decreased number of Lyme disease cases, very similar statistical analysis, very similar in just about every way. One of the things that makes it easier for us is we can start getting efficacy the first season, whereas in the vaccine trials like Pfizer, the primary efficacy surveillance period was after that one-year boost. So it's a little bit faster for us to get there.

So two questions on this program. So you take the antibody and it's a one time.

Oh, I'm sorry. I didn't answer your question. We believe based on the serum levels of the antibody, it's a long acting antibody. It's the Y, the LS, you know, type of long acting antibody. And we believe that one dose will have protected levels for three months. So our protocol is to get a booster, if that's the right word, or a second dose, three months later. So imagine someone, you know, starts, you know, gets the first shot in April in the Northeast, let's say, and then, you know, May, July, July, they get the second one, and they protect it all summer. But, you know, that's the protocol we're testing, and that's really for people who live in endemic areas. But we also envision that there could be another market, more of a traveler's vaccine market, for someone who lives in a non-endemic area, but then goes and spends two weeks on the Cape, Martha's Vineyard, East Hampton, wherever, you know, they go into the belly of the beast, so to speak, you know, where there's, you know, very high rates of Lyme. So that they would probably only need the one dose.

Okay. So a couple of other questions that I have on the trial itself. So one, what age range are you studying in terms of the population?

That's a very important question because Pfizer studied five and up. And, you know, at some point we would love to study the pediatric population, but right now we're focusing on adults. So our population will be 18 and older, and at some point we'll go back to the pediatrics. But one of the advantages of studying adults is particularly if you look at the population 55 and older, there's almost a doubling of incidence of Lyme. So, that's one of the ways where we think we can address some of the case accumulation issues that have plagued other studies.

Okay. And then you mentioned this trial, you know, wanting to see the impact, you know, the sort of proposed patient profile. I need people who could be at risk of getting Lyme. So, how are you executing the trial to make sure the patients you enroll are actually sort of at risk for getting it so you can see an impact from your therapy?

But one of the big advantages we have is all of the work that Pfizer's already done. So they've already put out literature about risk factors, you know, and all the things. So we're, you know, we're following, we're following in their footsteps, following the footsteps of giants. So and, you know, we were going to do everything that they did, so to speak. We have the advantage of the adult thing and loading up on, you know, potentially people 55 and above. But generally speaking, it's the same things that they were looking at. People who spend time outdoors, hikers, golfers, gardeners, etc. I mean, and similar to them, we are going to focus on, you know, people in areas where, you know, you can do, call it geotargeting, and, you know, find people in areas where the deer ticks are now advancing into that area, because those are areas where people are more likely to get Lyme.

Okay. And then we can talk just a little bit about how you're seeing the commercial opportunity, obviously, still a little bit ways off, but in terms of... Yeah. What patients do you think or what people do you think would be likely to receive this antibody? What do you envision the cost would be? Is this something you think would be covered by insurance or be more of an out-of-pocket?

Well, first of all, we've done some primary research. We commissioned a third-party firm to do primary research, some of which is in our materials on the web. But the interest in a product that protects against Lyme is extremely high. I mean, there's just a lot of paranoia about Lyme. I mean, obviously, I think Lyme is the most common tick-borne disease, but I think it's the most terrifying tick-borne disease because between 10% and 20% of people get long-term symptoms. And I think, you know, I live in New York and vacation, you know, essentially on the Cape. So I'm, you know, I'm adjacent to a community that's very appropriately scared of getting it. Because it can really derail someone's life. It's a very significant problem for adults. For children, it can change the trajectory of their life. So, I mean, I think that this Borrelia bacteria is a terrible nuisance. And I think that that really drives the high level of, I don't want to use the word paranoia, because it sounds like I'm not treating it respectfully, The high level of fear about contracting Lyme, because you really don't know if you're going to be part of that unlucky 10% to 20% who's going to wind up with long-term symptoms. We haven't gotten to the cost yet. You know, just on the surface, though, this is a full monoclonal antibody, so it's not going to probably, it will be more expensive than a vaccine. But it is amazing what's happening now in terms of the manufacturing efficiencies and consequently lower costs of monoclonal antibodies. So, I mean, if all goes well, you know, this product has the potential, well, top line could be, you know, Q1 2029 or first half 2029. You know, if all went well and we got favorable reviews from everything, the product could potentially be approved in 2031. And so I think we have time to get there. But by that time, I think that the cost of antibodies would astound all of us, given all of the advances that are going on in terms of manufacturing. So I don't have a number in mind, but I don't think it would be out of pocket. But I think that, you know, it would be covered by insurance. And the previous one, Limerick's, which was approved in 1998, was covered by insurance and got, you know, recommendations from the vaccine group. So I'm pretty clear that I'm pretty sure that this would be recognized as providing significant benefits. Okay.

Maybe let's quickly touch on your TNX-1500. And I guess a couple quick questions I have here. So obviously CD40 by GAN for kidney transplant rejection. There's an investigator-initiated trial starting next year. What are you hoping to learn from that trial? And then maybe the broader question is going to, from that, what's the path to try and get this into registrational type work? There's obviously Elodon's in this space, too. And is it something you'd follow sort of a non-inferiority sort of pathway, or are you looking at it differently?

Yeah, thank you very much. I think you know this, but maybe the audience doesn't. But I've been working on CD40 ligand for more than 30 years. So as a young assistant professor, I discovered the CD40 ligand and worked for many years with Biogen on the first-generation product called Riplozumab. So I've been working on this for a long time. We followed the other products. And I think that the two most exciting products out there are ours, which is a long-acting, well, it's an antibody, not long-acting, but it has a half-life of more than 30 days, and the Amgen product, which is actually, it came from, you know, Horizon, Viello, Metamune, and that one has very interesting data in Sjogren's syndrome. So, and then there's Tegoprubart from Elodon, and there's also Sanofi has Frexalumab that they're developing. So it's a crowded space, but, and by the way, Biogen's product is in its second phase three for lupus, and that was actually developed under our original Columbia patent, under a license warrant patent, and yet it's about to be approved, well, about to, pending phase three data. So I'm very excited that the field is advancing. And I just came from ACR. And, you know, Amgen and Sjogren's is very exciting. The Biogen data in lupus, in the United States, Biogen has it. In Europe, it's UCB. But so these, I'm delighted that CD40 ligands come to the service. I don't have time to go through all of the comparisons, but I believe from a number of different studies, and by the way, not head-to-head comparisons, but from all the data I've seen, I believe ours is the most potent. And I believe that it has the longest half-life. It's kind of the same as the Sanofi's Frexalamab. And those two factors together, I think, you know, we believe we've got a best in class. So when you ask about what's our plan, well, we're starting with kidney transplant because kidney transplant is a very stringent test of the potency of an anti-CD40 ligand. For example, the Biogen antibody that I'm very proud of, my role in it indirectly 30 years later. That does not... So modulate cell-mediated immunity. That's limited to humoral immunity, and that's why I think it's so exciting for lupus, which is mostly a humoral immunity condition. But then going into things like transplant, you know, if we get what we're hoping to get, I think that that would open the door to many immunological conditions. You know, there's something about, back in that day, you know, the early days of therapeutic monoclonal antibodies, something about low-hanging fruit. Modulating CD40 ligand is a very potent modulator of the immune system. You know, now it's taken time for the subtleties of IL-17 and some other things to be monster successes, but anti-CD40 ligand has tremendous potential to modulate the And I think that I know this is a line from Johnson & Johnson when they bought their FCRN, but I really believe this is a pipeline and a product opportunity.

Okay. And maybe just last quick question is just around your cash position and the runway.

Yeah, thank you. We reported, you know, our Q3 cash was $163 million, and we have no debt. And in the three quarters so far of 2026, our cash burn has been 41, 41, and 43. But nonetheless, we're guiding that we have cash to get into Q3. So, you know, but the fact that we have no debt, and I think we have reasonable access to cash. And I think that our story just keeps getting better and better. Every week, we get Tanmayo sales, and there are a number of other milestones that we feel are coming up.

Okay. All right, great. Thanks so much again for joining us. Congrats on the progress, and we'll look forward to seeing how things progress from here.

Thank you very much. Thank you.