TNXP

Image source: The Motley Fool. Monday, Aug. 10, 2026 at 8:30 a.m. ET Head of Investor Relations - Deborah Elson Chief Executive Officer - Seth Lederman Executive Vice President of Commercial Operations - Thomas Englese Chief Financial Officer - Bradley Saenger Operator: Good morning, and welcome to the Tonix Pharmaceuticals Second Quarter 2026 Financial Results and Business Update Conference Call. [Operator Instructions] As a reminder, this call is being recorded. I would now like to turn the call over to Deborah Elson, Head of Investor Relations at Tonix Pharmaceuticals. Please go ahead. Deborah Elson: Thank you, Operator, and 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 2 that any statements made on today's call that are not historical facts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are based on management's current expectations and are subject to risks and uncertainties that could cause actual results to differ materially from those projected. These risks are described more fully in our filing with the Securities and Exchange Commission, including our annual report on Form 10-K for the year ended December 31, 2025, and our subsequent periodic reports. Tonix undertakes no obligation to update or revise any forward statements, except as required by law. Joining me on today's call are Dr. Seth Lederman, Chief Executive Officer; Thomas Englese, Executive Vice President of Commercial Operations; and Bradley Saenger, Chief Financial Officer. With that, I will turn the call over to Seth. Seth? Seth Lederman: Thank you, Deborah, and good morning, everyone. We're 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 2, 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. 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 underscored TONMYA's compelling value proposition and differentiated profile. Historically, fibromyalgia patients and their healthcare providers, or HCPs, have been dissatisfied with limited treatment options. 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 set to improve the lives of patients and simultaneously creating long-term value for shareholders. In the second quarter of 2026, we achieved approximately $11 million in net sales for 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 United States. On January 1, 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 United States. We believe this broad coverage lays the foundation for growth in patient access and net sales for the rest of the year and beyond. This coverage led us to activate our planned 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 targeting large therapeutic or preventative areas of unmet need. Each of these agents are potentially first-in-class or best-in-class. In 2026, we have focused our resources primarily on TNX-102 SL, which is sublingual cyclobenzaprine sublingual 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 and MDD, we randomized the first patient in the second quarter. For TNX-4800 and 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: Thank you, Seth, and good morning, everyone. Today, I will review our second quarter sales performance for TONMYA, and then I will cover our launch strategy. We are pleased to offer TONMYA as a treatment to adult fibromyalgia patients. Looking at Slide 4, 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. We are seeing proactive patient and prescriber hand raisers interested in TONMYA, and we're gaining traction with our HCP target list. Second, gross-to-net in both Q1 and Q2 have been driven by a favorable mix between the retail and specialty distribution channels and lower co-pay buy-downs related to stronger-than-expected prior authorization approvals. We've historically shared that we expect fluctuations quarter-over-quarter, as is common early in commercial launches. We expect continued fluctuations for gross-to-net in both Q3 and Q4. Now, we'll look at our key performance indicators for 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 and refills increased 207% quarter-over-quarter. We continue to see increases in the number of prescriptions per patient, which we attribute to the benefits and tolerability of TONMYA and our patient support program. We will now walk you through our strategy regarding market access, sales, and marketing on Slide 5. First, we've already reached major market access coverage milestones, which we believe speaks to the value of TONMYA. We signed commercial payer agreements with two leading GPOs. These agreements, which went into effect on May 1 and June 1, 2026, cover 52 million lives. We also signed a major managed Medicare agreement, which will cover approximately 9 million Medicare lives beginning January 1, 2027. 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. 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. 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. Moving to marketing, our efforts have focused on an unbranded digital disease awareness campaign called Move Fibro Forward, DTC social advertising, influencer programs, and peer-to-peer KOL speaker programs. Highlights in Q2 include programs such as our KOL speaker bureau, a Reddit Ask Me Anything program, influencer ads, and a digital HCP webcast. Looking ahead, we are excited to further advance the launch of TONMYA. I will now turn the call back to Seth to discuss medical affairs. Seth? Seth Lederman: 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. First, a diagnosis of exclusion was an unreasonable standard because no amount of lab tests or imaging can prove a negative. Second, the medical community now recognizes that fibromyalgia commonly occurs in the context of other conditions, including long COVID, chronic Lyme, systemic lupus, rheumatoid arthritis, and cancer. This means that these other diagnoses should not exclude the diagnosis of fibromyalgia. We believe broader understanding of the current diagnostic criteria could meaningfully grow the addressable fibromyalgia patient population and help patients get diagnosed and treated earlier in the course of their condition. It currently takes on average over 6 years for patients to be diagnosed with fibromyalgia. Moving on from medical affairs, I now want to update you on the pipeline. We are advancing our development pipeline. Today, I will focus on TNX-102 SL and TNX-4800. Moving to Slide 6, 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. Participants are being randomized to receive TNX-102 SL 5.6 milligrams taken sublingually at bedtime or matching placebo. The primary endpoint of the study is the change from baseline in MADRS total score at week 6. 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, then we believe targeting sleep would be a novel mechanism. 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. 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, and for which we expect to report top-line data in mid-2027. Now, I'll move to Slide 7 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, Borrelia burgdorferi, causes 99.9% of Lyme disease cases in the United States. 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 2 days after 1 dose, compared to a prior vaccine or a vaccine in development that takes 3 or 4 separate immunizations over at least 6 months to provide protection. Also, TNX-4800 does not require a host immune response like vaccines. 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, age 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 2-season study and expect to enroll the majority of participants in 2028. If the attack rate is lower than planned, enrollment could potentially extend into 2029. The primary efficacy endpoint will be Lyme disease prevention through 6 months after the first dose, and a key secondary efficacy endpoint will be prevention through 3 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 1-to-1 to receive either placebo or TNX-4800 dosing 450 milligrams sub-Q in the spring, and another dose approximately 3 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: Thank you, Seth. And good morning, everyone. On Slide 8, I will review financial results for the second quarter ended June 30, 2026. Net product revenue for the second quarter of 2026 was approximately $13.5 million, which consists 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 was approximately $0.7 million compared to $3.3 million for the same period in 2025. The decrease in the cost of sales was predominantly driven by a change in product mix and a write-off of migraine products in 2025. Research and development expenses were approximately $19.4 million compared to $10.8 million for the same period in 2025. The increase was 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 TONMYA and 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 30, 2026, compared to approximately $207.6 million as of December 31, 2025. We expect our cash resources as of June 30, 2026, together with net proceeds from equity offerings subsequent to June 30, 2026, to fund our planned operating and capital expenditure requirements into the early second quarter of 2027. With that, I will turn the call back to Seth for closing remarks. Seth? Seth Lederman: Thank you, Bradley. We'll move to Slide 9. 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-102 SL 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-102 SL, we will continue to execute on the enrollment of the potentially pivotal Phase II study in MDD. 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 Instructions] Our first question comes from Stacy Ku with TD Cowen. Your line is open. Stacy Ku: Congratulations on a great quarter and thanks so much for taking our questions. We do have a few. First one is for Tom and Seth. Given that 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, given encouraging refill dynamics? That's the first on TONMYA. And then as we look to 4800 and Lyme, it's been great to get the FDA interaction minutes. So first, can you discuss in more detail why you believe the majority of infections will be collected in the first season? Maybe discuss how you're identifying the right sites. And then second, do you believe the Phase II has the potential to be pivotal in Lyme given the patient study size of around 3,300? And then actually before 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? And kind of the same question, but what kind of inventory nuances we should consider for Q2? Seth Lederman: So there are three parts to your question. Let me -- Tom, would you please address the question about TONMYA's launch and the clinical feedback? Thomas Englese: Yes, absolutely. Thanks very much. Yes, so the early feedback we have received from HCPs is that TONMYA is, you know, like I said, a welcome addition, a 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, you know, the effectiveness of the product and the tolerability of the product especially. So the feedback has been positive. We're going to continue, obviously, to target over time with our sales force, those key writers, as I mentioned. And we're excited for the additional reps because we can increase our breadth and depth. So all in all, signs have been very positive and the durability and refill signals have been positive as well. Seth Lederman: Great. Thank you, Tom. And Stacy, to follow up on your question about Lyme. First of all, now that we have the final FDA minutes, we've gone back to the CROs in the process of bid defense and the rest of it. And we're actively working on identifying sites and characteristics of people at risk for deer ticks and Lyme disease. With respect to your question about whether we think it could provide evidence of efficacy, we have stated that in a press release and in our comments today. And we do believe that this Phase II study can provide evidence of efficacy, and if positive, could be a pivotal study supporting approval of the product. The study will be conducted as a potential registrational study. The key question will be whether we accumulate enough events, which is mostly driven by Lyme disease cases in the placebo group in our observation period. So now let me turn the third part over about the quarterly gross-to-net back to Tom, this quarterly gross-to-net and also about inventory on TONMYA to Tom. Thomas Englese: Great. Thanks again. Yes. So, you know, as we mentioned, we don't disclose specifics about our gross-to-net. What I can say is that we've seen a good, as I mentioned earlier, we've seen the gross-to-net positive being impacted by our mix in our channel. The prior approval submissions and approval rates have been strong as well. And we obviously have new coverage that's coming online. So, you know, I would anticipate a gross-to-net in the range similar to what we've seen, you know, in Q1 and Q2. In terms of inventory -- I'm assuming we're talking about the inventory at the wholesalers. We track that, and we have seen a consistent days on hand as demand has increased. So there's been really no incremental inventory build at our wholesaler and distributor partners. So I think that was probably where you were going with the inventory question. So thank you for that. Seth Lederman: Stacy, are there follow-up questions? Stacy Ku: No, I think we're all set. Operator: Our next question comes from Tiago Fauth with Raymond James. Tiago Fauth: Great. Thanks for the good question and congrats on the progress. I have one for TONMYA, one for the 4800. For the 4800, just to hone in on the sample size and to your comment related to infection rates on the placebo arm. If you look at the older studies, you see a slightly higher rate. We've seen a surprisingly low rate of infections in VALOR. So can I just talk about that dynamic as we're thinking about both powering of the study and also the site selection enrichment to ensure that you can accrue enough events? And also 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? Seth Lederman: I'll take the first part about 4800 then I'm going to ask Tom to answer the question about step edits. So 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. And in that study, they had an attack rate of 0.8% in 1 group and 1.2% in another group that was the main efficacy group. And since then, Lyme has increased significantly in the United States, at least threefold increase in Lyme endemic areas. So we think that the attack rate, you know, that is supported by the epidemiology supports that we could get enough events with 3,300 participants that we've announced we're targeting. How we're targeting them and the specifics of the clinical trial, are to some extent proprietary, but we're certainly working with experts in the field and clinical experts in areas where Lyme is growing rapidly to select patients who are at risk for contracting getting deer tick bites and in areas where the deer ticks have a significant rate of Borrelia infection. So let me turn it over to Tom for the discussion about step edits on TONMYA. Thomas Englese: Yep. Thank you very much. Yes, so obviously first let me note that our target patient population is around 3 million patients who were previously diagnosed and treated for fibromyalgia. And it's important to understand that 80% -- roughly 80% of these patients have been already or are on multiple therapies for fibromyalgia. So in our discussions with the payers and our, you know, pre-launch even and post-launch, pre-launch in the pre-approval 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: All right, fantastic. Operator: Thank you. Our next question comes from James Molloy with AGP. Your line is open. James Molloy: 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. Is this lower level, do you anticipate this lower level being more typical, or do you think it's more likely to fluctuate back towards sort of the second quarter of launch, where it's almost a 50% gross-to-net discount? Seth Lederman: Thank you very much for the question, Jim. Let me turn that over to Tom. Thomas Englese: Yes. Thanks, Jim. So, 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 downstreams come online. Moving forward, I would expect continued fluctuations, you know, in the range of what we've seen thus far for Q1 and Q2. And then at some point, obviously, once we get all the coverage pretty much locked down, we should see a more stabilization moving forward. James Molloy: Okay, great. And then stay with TONMYA on the launch. You had some anecdotal comments already. I saw the launch is going well. Could you walk through sort of on the sales reps, what percentage of the reps or what number of the reps are sort of covering their own costs currently? When do you sort of anticipate them getting to that point? And also looking at the overall gross margin was quite good, 5% cost of goods in the quarter. Is that a number we should anticipate going forward now that sort of you've got production up to a scale and running at a higher level? Seth Lederman: Tom? Thomas Englese: Yes, so great. Yes, so we're excited about the performance of the reps so far. Obviously in launch you're in a very, you know, focused ramp period and focused targeting and calling on specific doctors that you believe are seeing and treating most of those patients, which obviously we have great data on. So 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. So we're excited about it. We're looking forward to getting even more doctors with TONMYA and patients. And then, Seth, would you like to go to Bradley on the gross margin question? Seth Lederman: Bradley? Bradley Saenger: Great. Thanks for the question. So obviously, as we mentioned, we do have a, you know, certainly a product mix that's shifting, you know, over time. So obviously we don't guide to exactly what our, you know, numbers would be, but, you know, I would expect, again, a little fluctuation as we try to solidify various levels. And so I think that's where we will be for at least the next quarter or 2. And hopefully once things have stabilized, we will be able to have a more regular, you know, gross-to-net as well as margins as well. James Molloy: Okay, final question then, if I could, please. On 4800, the study's starting up. Could you sort of compare, contrast any learnings you may have got from Pfizer's VALOR study, which just missed significance? I think they didn't have quite enough people get infected, and how to sort of -- how you can best try to work around that in the 4800 study. Seth Lederman: Thank you, Jim. I'll take that. The Pfizer study was very different from the study that we're planning. They had a very significant proportion of their patients were enrolled from Europe and we're planning a U.S.-only study evaluating a vaccine product that took about a year to develop immunity and then they were looking at immunity after the, you know -- at protection after the immunity, whereas our product, we believe it would provide protection within 2 days of the first dose. So a much easier product to get and for people to understand and the engagement with volunteers is shorter. So 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. And I think that we have confidence that we can do a better job of identifying people at higher risk of Lyme than was seen in that study, although our ability to understand all the details of that study are limited. Operator: 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: Well, 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. So with that I want to thank everyone on the call, particularly the management team. And thank you very much. This is the end of the call. Operator: Thank you for your participation. You may now disconnect. Good day. Before you buy stock in Tonix Pharmaceuticals, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Tonix Pharmaceuticals wasn’t one of them. The 10 stocks that made the cut are built for long-term growth and could produce monster returns in the coming years. 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Interested in Tonix Pharmaceuticals Holding Corp.? Here are five stocks we like better. Tonmya drove strong commercial growth: Second-quarter net product revenue reached approximately $13.5 million, including $11 million from Tonmya, whose sales rose 197% sequentially. Prescriptions doubled from the prior quarter, supported by increasing refills and expanding payer coverage. Tonix is expanding access and its sales force: Tonmya coverage currently spans about 136 million U.S. lives, with coverage expected to rise to roughly 145 million by January 2027. The company is adding 50 representatives, bringing its field force to approximately 150. Pipeline programs advanced amid higher spending: Tonix began its Phase II HORIZON trial of TNX-102 SL in major depressive disorder and plans to start a Phase II Lyme disease prevention study of TNX-4800 in early 2027. Cash totaled $176.2 million at quarter-end, with funding expected to support operations into early Q2 2027. Pharma Frenzy: Volatility Ignites Biotech Sector Tonix Pharmaceuticals (NASDAQ:TNXP) reported second-quarter 2026 net product revenue of approximately $13.5 million, led by $11 million in sales of fibromyalgia treatment Tonmya. The company said Tonmya sales rose 197% from the first quarter, its second full quarter of commercial sales following the product’s November launch. Revenue also included approximately $2.5 million from migraine products Zembrace SymTouch and Tosymra, compared with $2 million in total product revenue in the prior-year period, when revenue consisted solely of the migraine products. → MarketBeat Week in Review – 08/03 - 08/07 Is Tonix Pharmaceuticals the Next Biotech Breakout? Chief Executive Officer Seth Lederman said the company is pursuing commercial expansion for Tonmya while prioritizing development of TNX-102 SL for major depressive disorder and TNX-4800, a long-acting monoclonal antibody being developed to prevent Lyme disease. Tonix said Tonmya, a once-daily, non-opioid analgesic taken at bedtime, is the first FDA-approved medicine for adult fibromyalgia in more than 15 years. The company said it is initially targeting nearly 3 million diagnosed and treated patients within an estimated U.S. adult fibromyalgia population of more than 10 million. → Quantum Earnings Week: Winners and Losers Are Finally Emerging During the second quarter, prescriptions totaled 12,592, up 100% sequentially. New patient prescriptions increased 36% from the first quarter, while refills rose 207%, according to Executive Vice President of Commercial Operations Thomas Englese. Englese attributed the sales performance to growing interest from patients and prescribers, traction with the company’s targeted healthcare-provider list, and favorable early gross-to-net dynamics. He said the company expects gross-to-net results to continue fluctuating in the third and fourth quarters as additional payer coverage becomes active. → Take-Two’s Q1 Results Leave GTA 6 Bulls Stuck in the Fog of War Tonix said Tonmya coverage across commercial insurance, managed Medicare and Medicaid currently represents about 136 million covered lives, or 43% of approximately 314 million U.S. covered lives. The company expects coverage to reach roughly 145 million lives, or 46%, when a managed Medicare group purchasing organization agreement takes effect on Jan. 1, 2027. The company has signed commercial payer agreements with two group purchasing organizations covering 52 million lives, which became effective May 1 and June 1. Tonix expects downstream benefits from those agreements to begin materializing during the third and fourth quarters. Following its market-access progress, Tonix is adding 50 sales representatives and expects them to be in the field by September. The field force is expected to total roughly 150 representatives, primarily working through a contract partner. Englese said the company is focusing initially on 25,000 healthcare providers responsible for approximately 70% of fibromyalgia treatment prescriptions. Management said prior-authorization submissions and approvals have been favorable, while many patients have already received or are receiving multiple therapies for fibromyalgia. Englese said payers have generally required one or two steps through treatment options rather than mandating use of a specific product. In June, Tonix randomized the first patient in HORIZON, a potentially pivotal Phase II study of TNX-102 SL as a first-line monotherapy for adults with major depressive disorder. The study is targeting enrollment of approximately 360 U.S. patients experiencing moderate-to-severe major depressive episodes. Participants will receive either 5.6 milligrams of TNX-102 SL sublingually at bedtime or placebo. The primary endpoint is change from baseline in Montgomery-Åsberg Depression Rating Scale total score at week six. Secondary measures include global impression scores, anxiety ratings and sleep-quality measures. Lederman said Tonix is evaluating the candidate for depression based on signals from prior company studies in fibromyalgia and post-traumatic stress disorder patients. The company also cited an investigator-initiated Phase II study, called OASIS, evaluating TNX-102 SL in acute stress disorder and acute stress reaction. Tonix expects top-line data from that study in mid-2027. For TNX-4800, Tonix said it received final minutes from a Type C meeting with the FDA that supported key elements of a planned adaptive Phase II field study in Lyme disease prevention. Subject to agreement on the final protocol, the company expects to begin enrollment in the first quarter of 2027. The planned randomized, placebo-controlled study is expected to enroll approximately 3,300 adults from Lyme-endemic U.S. areas who participate in activities that increase their exposure to deer ticks. Tonix expects the trial to span two seasons, with most participants enrolled in 2028. Enrollment could extend into 2029 if the Lyme disease attack rate is lower than planned. The primary endpoint will assess prevention of Lyme disease through six months following the first dose, with prevention through three months as a key secondary endpoint. Lederman said the company believes a positive Phase II study could provide evidence of efficacy and potentially serve as a pivotal study supporting approval. Second-quarter cost of sales was approximately $700,000, compared with $3.3 million a year earlier. Chief Financial Officer Bradley Saenger said the decline primarily reflected product mix and a 2025 write-off of migraine products. Research and development expense rose to approximately $19.4 million from $10.8 million in the prior-year quarter, driven by higher manufacturing and clinical costs related to pipeline prioritization and increased employee-related expenses. Selling, general and administrative expense increased to approximately $36 million from $16.2 million, reflecting sales and marketing investment behind Tonmya and the migraine portfolio, as well as higher employee and professional expenses. Tonix ended June 30 with approximately $176.2 million in cash and cash equivalents, down from $207.6 million at the end of 2025. Saenger said the company expects its June 30 cash resources, together with net proceeds from equity offerings completed after quarter-end, to fund planned operating and capital expenditure requirements into early in the second quarter of 2027. Tonix Pharmaceuticals 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. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Tonix Pharmaceuticals Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

This article first appeared on GuruFocus. Net Product Revenue: Approximately $13.5 million in Q2 2026, up from $2 million in Q2 2025. TONMYA Net Sales: Approximately $11 million in Q2 2026, representing 197% quarter-over-quarter growth. Migraine Product Revenue: Approximately $2.5 million from Zembrace, Simtouch, and Tesimra in Q2 2026. Cost of Sales: Approximately $0.7 million in Q2 2026, down from $3.3 million in Q2 2025. Research and Development Expenses: Approximately $19.4 million in Q2 2026, up from $10.8 million in Q2 2025. Selling, General, and Administrative Expenses: Approximately $36 million in Q2 2026, up from $16.2 million in Q2 2025. Cash and Cash Equivalents: Approximately $176.2 million as of June 30, 2026, down from $207.6 million as of December 31, 2025. TONMYA Prescriptions: Totaled 12,592 in Q2 2026, a 100% quarter-over-quarter increase. New Patient Prescriptions: Increased 36% quarter-over-quarter in Q2 2026. Refills: Increased 207% quarter-over-quarter in Q2 2026. Warning! GuruFocus has detected 2 Warning Signs with TNXP. Is TNXP fairly valued? Test your thesis with our free DCF calculator. Release Date: August 10, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. TONMYA net sales reached $11 million in Q2 2026, a 197% quarter-over-quarter increase, demonstrating strong commercial momentum. Prescriptions for TONMYA totaled 12,592 in Q2, a 100% quarter-over-quarter increase, with refills up 207%, indicating strong patient adherence and durability. Market access coverage expanded to 136 million covered lives (43% of the U.S.), with agreements expected to increase coverage to 145 million lives by January 2027. The company plans to expand its sales force to 150 reps by September 2026, enhancing its ability to target high-prescribing HCPs and drive further growth. TNX-102SL for major depressive disorder (MDD) advanced with the first patient randomized in the potentially pivotal Phase 2 HORIZON study, and TNX-4800 for Lyme disease prevention received positive FDA feedback on its Phase 2 study design. The company's cash position decreased to $176.2 million as of June 30, 2026, from $207.6 million at the end of 2025, with funding only expected to last into early Q2 2027. Selling, general, and administrative expenses increased significantly to $36 million in Q2 2026, up from $16.2 million in Q2 2025, driven by launch-related costs. Research and development expenses rose to $19.4 million in Q2 2026, up from $10.8 million in Q2 2025, reflecting increased pipeline investment. Gross-to-net fluctuations are expected in Q3 and Q4, which could impact net sales and profitability. The TNX-4800 Phase 2 study for Lyme disease prevention is large and complex, with enrollment of approximately 3,300 participants and a potential extension into 2029 if attack rates are lower than expected. Q: Given that TONMYA's launch is going well, can you discuss current learnings and strategies to drive patient adoption, early clinical feedback on efficacy, and durability signals given encouraging refill dynamics? Also, for TNX-4800, why do you believe the majority of infections will be collected in the first season, and do you believe the Phase 2 study has the potential to be pivotal?A: Tom Inglese (EVP, Commercial Operations) stated that early feedback from HCPs is that TONMYA is a welcome addition to a space with no new products in 15 years. Durability signals are very good, with a high rate of refills attributed to the product's effectiveness and tolerability. Seth Lederman (CEO) added that for TNX-4800, the company has gone back to CROs for bid defense and is actively identifying sites with high deer tick risk. He confirmed the Phase 2 study could provide evidence of efficacy and, if positive, could be a pivotal study supporting approval, with the key question being whether enough Lyme disease events accumulate in the placebo group. Q: Can you discuss the sample size for the TNX-4800 study and the dynamic of infection rates in the placebo arm, given the surprisingly low rate of infections seen in Pfizer's VALOR study? Also, how should we characterize the ease of access for TONMYA policies relative to step edits?A: Seth Lederman (CEO) explained that the reference study for Lyme prevention is the LYMErix vaccine study from 1998, which had attack rates of 0.8% and 1.2%. Since then, Lyme disease has increased at least threefold in endemic areas, supporting the ability to get enough events with 3,300 participants. He noted the site selection strategy is proprietary but involves working with experts in high-risk areas. Tom Inglese (EVP, Commercial Operations) addressed step edits, noting that roughly 80% of the target 3 million patients are already on multiple fibromyalgia therapies. Payers have shown a tendency to require one or two steps through multiple products, but no mandatory steps through any specific product, which the company finds manageable based on early prior authorization submission and approval rates. Q: The gross-to-net came down quite a bit in the quarter. Is this lower level more typical, or should we expect it to fluctuate back towards the almost 50% gross-to-net discount seen in the second quarter of launch?A: Tom Inglese (EVP, Commercial Operations) stated that Q2 had favorable dynamics contributing to the gross-to-net, but it will continue to fluctuate, especially as coverage from the two recently signed commercial contracts comes online. He expects continued fluctuations in the range seen in Q1 and Q2, with stabilization expected once all coverage is locked down. Q: What percentage of sales reps are currently covering their own costs, and when do you anticipate them getting to that point? Also, is the 5% cost of goods in the quarter a number to anticipate going forward?A: Tom Inglese (EVP, Commercial Operations) said the company is excited about rep performance so far, and as they add 50 incremental reps by September, they anticipate a good portion of reps will cover their costs over the course of 2027. Bradley Saenger (CFO) noted that the product mix is shifting over time, and while they don't guide to exact numbers, fluctuations are expected for at least the next quarter or two before margins stabilize. Q: Can you compare and contrast any learnings from Pfizer's VALOR study, which missed significance, and how you plan to work around that in the TNX-4800 study?A: Seth Lederman (CEO) highlighted key differences: Pfizer's study enrolled a significant proportion of patients from Europe, while Tonix's study is U.S.-only. Pfizer's vaccine took about a year to develop immunity, whereas TNX-4800 provides protection within two days of the first dose. The company is speaking with experts and clinicians who see a lot of Lyme in the U.S. and is confident they can identify people at higher risk of Lyme better than the VALOR study did. Q: What were the key drivers of TONMYA's 197% quarter-over-quarter net sales growth in Q2, and what is the current market access coverage?A: Seth Lederman (CEO) reported Q2 net sales of approximately $11 million for TONMYA, nearly triple Q1. Tom Inglese (EVP, Commercial Operations) attributed growth to proactive patient and prescriber interest, traction with the HCP target list, and favorable gross-to-net driven by channel mix and lower copay buydowns due to stronger-than-expected prior authorization approvals. Coverage currently represents approximately 136 million covered lives (43% of U.S.), expanding to 145 million (46%) on January 1, 2027, when the managed Medicare GPO agreement becomes effective. Q: What are the key performance indicators for TONMYA in Q2, and how is the sales force expansion progressing?A: Tom Inglese (EVP, Commercial Operations) reported total prescriptions of 12,592 in Q2, up 100% quarter-over-quarter. New patient prescriptions increased 36%, and refills increased 207% quarter-over-quarter. The company is adding 50 sales reps, bringing the field force to roughly 150 reps by September, all exclusively dedicated to TONMYA. The sales force management team has been brought in-house, and the company is targeting the 25,000 HCPs who write approximately 70% of fibromyalgia treatment prescriptions. Q: What is the status of the TNX-102SL program for major depressive disorder (MDD), and what is the study design?A: Seth Lederman (CEO) announced that the first patient was randomized in June in the HORIZON study, a potentially pivotal Phase 2 trial evaluating TNX-102SL 5.6 mg as first-line monotherapy in adults with moderate to severe MDD. The study targets approximately 360 patients in the U.S., with the primary endpoint being change from baseline in MADRS total score at week 6. Secondary endpoints include global impression scores, anxiety ratings, and measures of sleep quality. The program is based on initial signals from previous Phase 2 and 3 studies where TNX-102SL nominally improved depression symptoms in fibromyalgia and PTSD patients. Q: What is the status of the TNX-4800 program for Lyme disease prevention, and what are the For the complete transcript of the earnings call, please refer to the full earnings call transcript.

BERKELEY HEIGHTS, N.J., July 27, 2026 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully integrated, commercial-stage biotechnology company, today announced that it will host a conference call and webcast to report second quarter 2026 financial results and operational highlights on Monday, August 10, 2026, at 8:30 a.m. ET. To listen to the conference call, register at this link. To view the webcast, register at this link. A replay will be available under “IR Events” in the Investors section of the Company’s website at https://ir.tonixpharma.com/news-events/ir-events. Tonix Pharmaceuticals Holding Corp.Tonix Pharmaceuticals* is a fully integrated, commercial-stage biotechnology company focused on central nervous system (CNS) disorders, infectious diseases, immunology conditions, and rare diseases where there exists high unmet medical need. TONMYA® (cyclobenzaprine HCl sublingual tablets 2.8mg), the Company’s flagship internally conceived and developed medicine, is the first treatment for fibromyalgia in more than 15 years. Tonix’s CNS commercial infrastructure supports its marketed products, including its acute migraine products, Zembrace® SymTouch® (sumatriptan injection 3 mg) and Tosymra® (sumatriptan nasal spray 10 mg). Tonix is extending the science behind TONMYA in Phase 2 clinical studies to evaluate the potential of TNX-102 SL in major depressive disorder and acute stress disorder/acute stress reaction. Tonix is also advancing a pipeline of infectious disease programs, including monoclonal antibody TNX-4800 (anti-OspA mAb) for Lyme disease prevention in the U.S. and TNX-801 (horsepox, live virus vaccine), a vaccine in development for the prevention of mpox and smallpox. Within immunology, Tonix is developing TNX-1500 (anti-CD40L mAb), a third-generation CD40 ligand inhibitor for the prevention of kidney transplant rejection. Finally, the Company’s rare disease portfolio includes TNX-2900 for the treatment of Prader-Willi syndrome. To learn more, visit www.tonixpharma.com. *Tonix’s product development candidates, including TNX-102 SL for new, unapproved indications, are investigational new drugs or biologics. Their efficacy and safety have not been established and have not been approved for any indication. Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. TONMYA is a registered trademark of Tonix Pharma Limited. All other marks are property of their respective owners. Forward Looking Statements Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995 including those relating to the completion of the offering, the satisfaction of customary closing conditions, the intended use of proceeds from the offering and other statements that are predictive in nature. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. 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; 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 patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, as filed with the SEC on March 12, 2026, and periodic reports filed with the SEC on or after the date thereof. Tonix does not undertake an obligation to update or revise any forward-looking statement. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof. ContactsDeborah Elson (Investors/Media)Tonix [email protected]@tonixpharma.com Brian Korb (Investors)astr partners(917) [email protected] Andrea Cohen (Media)Sam Brown Inc.(917) [email protected]

In the first full quarter since launch, 2,145 healthcare providers prescribed TONMYA®, 3,588 patients initiated treatment, and ~5,400 prescriptions were filled Agreement signed in May with leading group purchasing organization (GPO) that provides access to TONMYA for approximately 35 million U.S. commercial lives Expect to initiate adaptive Phase 2 field study for the prevention of Lyme disease in the U.S. in the first half of 2027 for TNX-4800, pending FDA agreement Approximately $185.5 million in cash and cash equivalents as of March 31, 2026 BERKELEY HEIGHTS, N.J., May 11, 2026 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) ("Tonix" or the "Company"), a fully integrated, commercial biotechnology company, today announced financial results for the quarter ended March 31, 2026, and provided an overview of recent operational highlights. “TONMYA is the first new fibromyalgia medicine in 15 years," said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “TONMYA is a non-opioid analgesic designed for bedtime administration and long-term use by adults. Since launch in November 2025, TONMYA has shown growth in prescriptions, new writers, refills, and patient access. Our first managed care partnership was announced in May, providing access to approximately 35 million U.S. commercial lives. We will continue engagement with commercial and government payers to expand patient access. Our focus remains on operational excellence across sales, marketing, medical affairs, and market access to educate and deliver on TONMYA’s differentiated potential.” Dr. Lederman continued, “We also continue to meaningfully advance our mid-stage clinical programs and our earlier-stage pipeline. For TNX-4800, our investigational long-acting borreliacidal, human monoclonal antibody targeting OspA on Borrelia burgdorferi, which causes the majority of Lyme disease in the U.S., we announced positive Phase 1 data and plans for an adaptive Phase 2 field study in 2027, pending FDA agreement. We look forward to our scheduled Type C meeting with the FDA early in the third quarter of 2026 to discuss the study. We believe TNX-4800 offers several advantages over vaccines in development, including onset of protection within two days and a simpler two-dose regimen with a second booster dose two months after the first. We also expect to begin our Phase 2 study of TONMYA for the treatment of Major Depressive Disorder (MDD) mid-year. Our other programs across CNS, infectious disease, immunology, and rare disease remain well positioned for near-term milestones.” Commercial Updates TONMYA (cyclobenzaprine HCl sublingual tablets): a centrally acting, non-opioid analgesic for the treatment of fibromyalgia in adults On November 17, 2025, TONMYA became commercially available, following U.S. FDA approval in August 2025 for the treatment of fibromyalgia in adults. TONMYA is the first new prescription medicine approved for fibromyalgia in more than 15 years. The approval was based on two double-blind, randomized, placebo-controlled Phase 3 clinical studies of nearly 1,000 patients that demonstrated durable and statistically significant reduction in daily pain scores compared to placebo. There are now approximately 100 TONMYA sales reps in the field. In the first quarter of 2026, the first full quarter since launch, key metrics include: 2,145 unique healthcare providers prescribed TONMYA to patients. 3,588 unique patients initiated treatment with TONMYA. Approximately 5,400 prescriptions were filled. This includes bridge prescriptions that are facilitated through the Company's specialty pharmacy channel. Bridge prescriptions represent initial patient fills provided while coverage determinations are pending and do not immediately generate net product revenue. For the period beginning November 17, 2025, through April 24, 2026, cumulative key metrics include: More than 2,700 unique healthcare providers have prescribed TONMYA to patients. Approximately 5,618 unique patients have initiated treatment with TONMYA. For the period beginning November 17, 2025, through May 1, 2026, cumulative key metrics include: Approximately 11,016 prescriptions were filled. This includes bridge prescriptions that are facilitated through the Company's specialty pharmacy channel. Repeat prescriber and patient refill trends are encouraging. The Company is prioritizing engagement with commercial payers, Medicare, and Medicaid to increase access: In May 2026, Tonix secured commercial payer coverage with its first managed care partnership agreement with a leading GPO, which will provide access for approximately 35 million U.S. patients (20% of ~177 million commercial lives in the U.S.) To date, TONMYA is covered under Medicaid in 38 states, for approximately 55 million lives, representing 73% of the roughly 75 million Medicaid lives. Tonix has a robust patient access program and support services in place, including a TONMYA savings card, copay assistance, and prior authorization support, intended to reduce access barriers during early commercialization. To educate healthcare providers (HCPs), the Company held a multidisciplinary dialogue about TONMYA via a national webcast. Tonix also launched a national speaker training program with approximately 100 HCPs to maximize peer-to-peer speaker programs expected to occur across target specialties and regions this year. As part of a commitment to continued clinical evidence generation and education, Tonix presented clinical data on TONMYA at the 8th International Congress on Controversies in Fibromyalgia, 2026 American Academy of Pain Medicine (AAPM) PainConnect Annual Meeting, and 2026 Non-Opioid Pain Therapeutics Summit. The Company also published two articles in the peer-reviewed journal, Clinical Pharmacology in Drug Development. Key Product Pipeline Candidates: Recent Highlights Central Nervous System (CNS) Pipeline TNX-102 SL (cyclobenzaprine HCl sublingual tablets): in Phase 2 development for MDD; remains on track to initiate mid-year 2026 In November 2025, the FDA cleared the IND for TNX-102 SL 5.6 mg for the treatment of MDD in adults. The IND clearance enables Tonix to proceed with the HORIZON study, a potentially pivotal Phase 2, 6-week, randomized, double-blind, placebo-controlled study of TNX-102 SL as a first-line monotherapy in adults with MDD. About 360 patients will be enrolled at approximately 30 U.S. sites, with the primary endpoint being the MADRS total score change from baseline at Week 6. Tonix plans to initiate enrollment in mid-2026. TNX-102 SL in Phase 2 development for the treatment of acute stress disorder (ASD) and acute stress reaction (ASR) The U.S. Department of Defense-funded Optimizing Acute Stress Reaction Interventions (OASIS) study is being conducted by the University of North Carolina under an investigator-initiated IND. The OASIS study examines the safety and efficacy of TNX-102 SL to reduce adverse posttraumatic neuropsychiatric sequelae among patients in the emergency department after a motor vehicle collision. Topline data is expected to be reported in the second half of 2026. TNX-1300 (double-mutant cocaine esterase) for cocaine intoxication; Phase 2-program has Breakthrough Therapy designation from the FDA, with no products on the market for this indication The Company plans to meet with the FDA in 2026 to inform the clinical design of the next Phase 2 study (a Phase 2a study has been completed). TNX-1900 (intranasal potentiated oxytocin): in development for several CNS disorders TNX-1900 is currently being studied in four Phase 2 and one Phase 1 investigator-initiated studies. The Phase 2 investigator-initiated studies include binge-eating disorder (Massachusetts General Hospital, “MGH”), adolescent obesity (MGH), bone health in autism (MGH and University of Virgina), and arginine vasopressin deficiency (MGH). In March 2026, Tonix announced the dosing of the first participant in a Phase 1 investigator-initiated pharmacodynamic study with Erasmus University of TNX-1900 in healthy female volunteers, using capsaicin and electrical stimulation to model trigeminal neurovascular reactivity. Infectious Disease Pipeline TNX-4800 (anti-OspA mAb): Phase 2-ready long-acting human monoclonal antibody in development for the seasonal prevention of Lyme disease in the U.S., which has no FDA-approved vaccines or prophylactics In March 2026, Tonix presented Phase 1 data at the World Vaccine Congress Washington 2026 and announced plans to initiate an adaptive Phase 2 field study in the first half of 2027, pending FDA agreement. The Company also presented Phase 1 data in April 2026 at the 4th Annual Ticks and Tickborne Diseases Symposium at Johns Hopkins University. TNX-4800 demonstrated encouraging safety, tolerability, pharmacokinetics, and immunogenicity, with serum TNX-4800 measurable at the earlier sampling time of 48 hours and no significant clinical or laboratory safety signals. The Phase 1 study was conducted by a team at UMass Chan Medical School led by Mark S. Klempner, MD, Professor of Medicine at UMass Chan and an inventor of TNX-4800. In April 2026, the Company announced it expects to lead a randomized, double-blind, placebo-controlled, adaptive Phase 2 field study to evaluate the efficacy of a two-dose regimen of TNX-4800 subcutaneous (SC) in preventing the first occurrence of confirmed Lyme disease during the primary efficacy surveillance period (Day 3 through Month 6 following administration). Each fixed dose is expected to provide exposures comparable to the 5 mg/kg dose evaluated in Phase 1. The first dose will be administered in the Spring and the second booster dose will be administered two months later. Participants will include adolescents and adults 16 years of age and older in Lyme-endemic areas in the U.S. The primary endpoint will be the prevention of Lyme disease for six months (comparison of TNX-4800 group and placebo group) following the initial dose. In April 2026, the Company announced it has scheduled a Type C meeting with the FDA early in the third quarter of 2026 to discuss the planned adaptive Phase 2 field study design. The Company expects to have GMP investigational product available for clinical testing in early 2027. TNX-801 (recombinant horsepox virus): attenuated, pre-clinical live orthopoxvirus vaccine candidate for the prevention of smallpox and mpox In March 2026, Tonix presented animal and in vitro data on TNX-801 at the World Vaccine Congress Washington 2026. TNX-801 is expected to enter a Phase 1 study in 2027 pending FDA clearance of the Investigational New Drug (IND) application. TNX-4200 (small molecule): broad spectrum anti-viral to protect against viral diseases TNX-4200 is a small molecule broad-spectrum antiviral agent targeting CD45 for the prevention or treatment of high lethality infections to improve the medical readiness of military personnel in biological threat environments. The TNX-4200 program is supported by an up to $34 million contract over five years from the Department of Defense’s Defense Threat Reduction Agency (DTRA). In the first quarter of 2026, the Company received confirmation that the project was cleared to enter the next budgetary and developmental phase. Immunology Pipeline TNX-1500 (dimeric Fc modified anti-CD40L, humanized mAb): Phase 2-ready third generation anti-CD40L for prophylaxis of kidney transplant rejection and treatment of autoimmune disorders In November 2025, Tonix announced a collaboration with MGH to advance a Phase 2, open-label, investigator-initiated clinical study of TNX-1500 in kidney transplant recipients, planned for initiation mid-year 2026, pending FDA clearance of the IND. The study is expected to enroll five adult kidney transplant recipients. Rare Disease Pipeline TNX-2900 (intranasal potentiated oxytocin): in development for Prader-Willi syndrome, with Orphan Drug designation as well as Rare Pediatric Disease designation that could make Tonix eligible for a Priority Review Voucher upon approval In September 2025, Tonix announced plans to initiate a Phase 2, randomized, double-blind, placebo-controlled study in children and adolescents with Prader-Willi syndrome. The study is expected to initiate in the first quarter of 2027. Immuno-oncology Pipeline TNX-1700 (TFF2-albumin fusion protein): in preclinical development for gastric and colorectal cancer In March 2026, Tonix presented preclinical data at the American Association for Cancer Research (AACR) Annual Meeting 2026. Data presented in an oral presentation showed how TNX-1700 reversed aging-associated gastric inflammation and significantly attenuated tumor progression in an aged gastric microenvironment in preclinical models. Data in a poster presentation demonstrated TNX-1700 exhibited dose-independent, linear pharmacokinetics in animals. TNX-4700 (human anti-BTLA mAb): in preclinical development for immuno-oncology indications In March 2026, Tonix presented preclinical data in a poster presentation at the AACR Annual Meeting 2026 demonstrating TNX-4700 demonstrated potent, high-affinity binding and functional antagonism. The mAb technology was licensed from Curia. Financial: Recent Highlights Tonix had approximately $185.5 million of cash and cash equivalents as of March 31, 2026, compared to approximately $207.6 million as of March 31, 2025. Net cash used in operations was approximately $42.3 million for the first quarter ended March 31, 2026, compared to $16.6 million for the same period in 2025. Subsequent to quarter-end, the Company has raised $22.6 million proceeds using its at-the-market (ATM) facility. The Company believes that its cash resources as of March 31, 2026, together with the net proceeds that it raised from equity offerings in the second quarter of 2026, will fund its planned operating and capital expenditure requirements into early second quarter of 2027. As of May 8, 2026, the Company had 15,940,601 shares of common stock outstanding. First Quarter 2026 Financial Results Net product revenue for the first quarter 2026 was approximately $6.9 million, compared to $2.4 million for the same period in 2025, and consisted of combined net sales of TONMYA, Zembrace® SymTouch®, and Tosymra®. Net revenue from sales of TONMYA for the first quarter was approximately $3.7 million. TONMYA was launched in November 2025. Net revenue from sales of TONMYA for the period from November 17, 2025, to December 31, 2025, was approximately $1.4 million. Net revenue from sales of Zembrace® SymTouch® and Tosymra® for the was approximately $3.2 million compared to $2.4 million for the same quarter in 2025. Cost of sales for the first quarter 2026 was approximately $1.6 million, compared to $0.9 million for the same period in 2025. Research and development expenses for the first quarter 2026 were approximately $18.2 million, compared to $7.4 million for the same period in 2025. This increase is predominately due to pipeline prioritization period over period, and increased headcount. Selling, general, and administrative expenses for the first quarter 2026 were $28.6 million, compared to $10.1 million for the same period in 2025. The increase is predominately due to spending on sales and marketing related to TONMYA, as well as increased headcount. Net loss available to common stockholders was $40.2 million, or $2.93 per basic and diluted share, for the first quarter 2026, compared to net loss available to common stockholders of $16.8 million, or $2.84 per basic and diluted share, for the same period in 2025. The basic and diluted weighted average common shares outstanding for the first quarter 2026 was 13,707,104 compared to 5,927,231 shares for the same period in 2025. Tonix Pharmaceuticals Holding Corp. Tonix Pharmaceuticals* is a fully integrated, commercial-stage biotechnology company focused on central nervous system (CNS) disorders, infectious diseases, immunology conditions, and rare diseases where there exists high unmet medical need. TONMYA® (cyclobenzaprine HCl sublingual tablets 2.8mg), the Company’s recently approved flagship medicine, is the first new treatment for fibromyalgia in more than 15 years. Tonix’s CNS commercial infrastructure supports its marketed products, including its acute migraine products, Zembrace® SymTouch® and Tosymra®. Tonix is maximizing the science behind TONMYA in Phase 2 clinical studies to evaluate its potential in major depressive disorder and acute stress disorder/acute stress reaction. Tonix is also advancing a pipeline of infectious disease programs, including monoclonal antibody TNX-4800 for Lyme disease prevention in the U.S. and TNX-801, a vaccine in development for the prevention of mpox and smallpox. Within immunology, Tonix is developing TNX-1500, a third-generation CD40 ligand inhibitor for the prevention of kidney transplant rejection. Finally, the Company’s rare disease portfolio includes TNX-2900, which is Phase 2 ready for the treatment of Prader-Willi syndrome. To learn more, visit www.tonixpharma.com. *Tonix's product development candidates are investigational new drugs or biologics; their efficacy and safety have not been established and have not been approved for any indication. Zembrace® SymTouch® and Tosymra® are registered trademarks of Tonix Medicines. TONMYA® is a registered trademark of Tonix Pharma Limited. All other marks are property of their respective owners. Forward Looking Statements Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995 including those relating to the completion of the offering, the satisfaction of customary closing conditions, the intended use of proceeds from the offering and other statements that are predictive in nature. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix's current expectations and actual results could differ materially as a result of a number of factors, including the ability of the Company to satisfy the conditions to the closing of the offering and the timing thereof, as well as those described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, as filed with the SEC on March 12, 2026, and periodic reports filed with the SEC on or after the date thereof. Tonix does not undertake an obligation to update or revise any forward-looking statement. All of Tonix's forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof. Investor ContactsJessica MorrisTonix Pharmaceuticals(862) [email protected] Brian Korbastr partners(917) [email protected] Media ContactsDeborah ElsonTonix [email protected] Ray JordanPutnam [email protected]

TONMYA™ (cyclobenzaprine HCl sublingual tablets) launched November 17, 2025, for the treatment of fibromyalgia; through February 27, 2026, more than 1,500 healthcare providers have prescribed TONMYA to patients, approximately 2,500 patients have initiated treatment with TONMYA, and cumulative prescriptions totaled approximately 4,200 Expect to initiate U.S. field study in 2027 for TNX-4800 for seasonal prevention of Lyme disease pending FDA clearance Completed $20.0 million registered direct offering with Point72 on December 29, 2025 Approximately $207.6 million in cash and cash equivalents as of December 31, 2025 BERKELEY HEIGHTS, N.J., March 12, 2026 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) ("Tonix" or the "Company"), a fully integrated, commercial biotechnology company, today announced financial results for the fourth quarter and full year ended December 31, 2025, and provided an overview of recent operational highlights. “2025 was transformational for Tonix as we achieved FDA approval and began the U.S. commercial launch of TONMYA, our first fully in-house developed product and the first new medicine approved for fibromyalgia in more than 15 years,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “TONMYA is a non-opioid analgesic designed for long-term, once-daily bedtime dosing. We believe TONMYA now provides an alternative medicine for the approximately 10 million adults in the U.S. who suffer from fibromyalgia. We have the capabilities to engage healthcare providers and patients, having launched the product and an approximately 90-member salesforce. Early prescription trends reflect favorable prescriber uptake and repeat utilization consistent with our internal launch expectations. Our experienced commercial team is committed to growing awareness and adoption, facilitating patient access, and obtaining payer coverage as we strive to improve the fibromyalgia journey for patients and healthcare providers.” Dr. Lederman continued, “We also meaningfully advanced our robust clinical pipeline in 2025. Tonix in-licensed TNX-4800, a long-acting human monoclonal antibody for the seasonal prevention of Lyme disease, for which there are no FDA-approved vaccines or prophylactics. This program, developed by researchers at UMass Chan Medical School, anchors our clinical-stage infectious disease pipeline, and we plan to discuss Phase 2/3 development with the FDA this year. An additional highlight includes FDA clearance of the Investigational New Drug application (IND) for HORIZON, a potentially pivotal Phase 2 study of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) in major depressive disorder, which is expected to initiate enrollment in mid-2026. Looking ahead, our priorities are clear. We are driven to continue our momentum in 2026 as we focus on the successful commercialization of TONMYA, pipeline progress, and sustainable long-term value for patients and shareholders.” Commercial Updates TONMYA (cyclobenzaprine HCl sublingual tablets): a centrally acting, non-opioid analgesic for the treatment of fibromyalgia in adults In August 2025, the U.S. FDA approved TONMYA for the treatment of fibromyalgia in adults, making it the first new prescription medicine approved for this indication in more than 15 years. The approval was based on two double-blind, randomized, placebo-controlled Phase 3 clinical trials of nearly 1,000 patients that demonstrated statistically significant reduction in daily pain scores compared to placebo. On November 17, 2025, TONMYA became commercially available at pharmacies by prescription in the U.S. Approximately 90 sales representatives were deployed in the field in advance of the launch. Early prescription trends reflect favorable adoption rates by prescribers and patients, with prescription volumes increasing each full month post launch. Launch metrics for the period November 17, 2025–February 27, 2026 (launch-to-date), are as follows: More than 1,500 healthcare providers have prescribed TONMYA to patients. Approximately 2,500 patients have initiated treatment with TONMYA. Cumulative prescriptions totaled approximately 4,200. This includes bridge prescriptions that are facilitated through the Company’s specialty pharmacy channel. Bridge prescriptions represent initial patient fills provided while coverage determinations are pending and do not immediately generate net product revenue. The Company has contracted with existing wholesalers and specialty pharmacies for distribution and with companies to assist with prescription fulfillment and patient access. Tonix also has a robust patient access program and support services in place, including TONMYA savings card, copay assistance, and prior authorization support, intended to reduce access barriers during early commercialization. The Company is prioritizing expanding payer engagement and establishing contracts with commercial payers, while also progressing discussions with Medicare and Medicaid. Key Product Pipeline Candidates: Recent Highlights Infectious Disease Pipeline TNX-4800 (anti-OspA mAb): long-acting human monoclonal antibody in development for the seasonal prevention of Lyme disease, which has no FDA-approved vaccines or prophylactics In December 2025, Tonix announced plans to meet with the FDA in 2026 to explore Phase 2/3 development options, including a Phase 2 field study and a Phase 2 controlled human infection model (CHIM) study, which is also called a human challenge study. The Company expects to have GMP investigational product available for clinical testing in early 2027. Pending FDA clearances, the field study is expected to initiate enrollment in 2027 and the CHIM study in 2028. Central Nervous System (CNS) Pipeline TNX-102 SL (cyclobenzaprine HCl sublingual tablets): in development for major depressive disorder (MDD) In November 2025, the FDA cleared the IND for TNX-102 SL 5.6 mg for the treatment of MDD in adults. The IND clearance enables Tonix to proceed with the HORIZON study, a potentially pivotal Phase 2, 6-week, randomized, double-blind, placebo-controlled study of TNX-102 SL as a first-line monotherapy in adults with MDD. About 360 patients will be enrolled at approximately 30 U.S. sites, with the primary endpoint being the MADRS total score change from baseline at Week 6. Tonix plans to initiate enrollment in mid-2026. Prior studies of TNX-102 SL in fibromyalgia and post-traumatic stress disorder (PTSD) showed promising signals for improvement of depressive symptoms. TNX-102 SL treatment has been associated with a low incidence of side effects common with traditional antidepressants, including weight gain, blood pressure changes, sexual dysfunction, and cognitive issues. TNX-102 SL for the treatment of acute stress reaction (ASR) and acute stress disorder (ASD), and prophylaxis against development of PTSD The U.S. Department of Defense-funded Optimizing Acute Stress Reaction Interventions (OASIS) trial is being conducted by the University of North Carolina under an investigator-initiated IND application. The OASIS trial examines the safety and efficacy of TNX-102 SL to reduce adverse posttraumatic neuropsychiatric sequelae among patients in the emergency department after a motor vehicle collision. Topline data is expected to be reported in the second half of 2026. Immunology Pipeline TNX-1500 (dimeric Fc modified anti-CD40L, humanized monoclonal antibody): third generation anti-CD40L for prophylaxis of kidney transplant rejection and treatment of autoimmune disorders In November 2025, Tonix announced a collaboration with Massachusetts General Hospital to advance a Phase 2 open-label, investigator-initiated clinical trial of TNX-1500 in kidney transplant recipients, planned for initiation mid-year 2026 pending FDA clearance of the IND. The study is expected to enroll five adult kidney transplant recipients. In October 2025, Tonix presented an update at the Japan Society for Transplantation annual congress, highlighting Phase 1 safety and pharmacokinetic and pharmacodynamic results and outlining next steps toward Phase 2 evaluation in allogenic kidney transplantation. Rare Disease Pipeline TNX-2900 (intranasal potentiated oxytocin): in development for Prader-Willi syndrome, with Orphan Drug designation as well as Rare Pediatric Disease designation that could make Tonix eligible for a Priority Review Voucher upon approval In September 2025, Tonix announced plans to initiate a Phase 2, randomized, double-blind, placebo-controlled trial in children and adolescents with Prader-Willi syndrome. The study is expected to initiate in the first quarter of 2027. Financial: Recent Highlights Tonix had approximately $207.6 million of cash and cash equivalents as of December 31, 2025, compared to approximately $98.8 million as of December 31, 2024. Net cash used in operations was approximately $99.8 million for the full year ended December 31, 2025, compared to $60.9 million for the same period in 2024. Cash paid for capital expenditures for the full year ended December 31, 2025, were approximately $3.4 million compared to $0.1 million for the same period in 2024. In December 2025, Tonix completed a $20.0 million registered direct offering with Point72 Asset Management. The net proceeds are being used to fund commercialization of marketed products, pipeline development, and general working capital. TD Cowen acted as sole placement agent for the offering. A.G.P./Alliance Global Partners acted as a financial advisor. Subsequent to year-end, the Company has raised $8.6 million proceeds using its at-the-market (ATM) facility. The Company believes that its cash resources at December 31, 2025, will meet its planned operating and capital expenditure requirements into the first quarter of 2027. As of March 11, 2026, the Company had 13,405,401 shares of common stock outstanding. Full Year 2025 Financial Results Net product revenue for the full year 2025 was approximately $13.1 million, compared to $10.1 million in 2024. Net revenue from sales of Zembrace®, SymTouch®, and Tosymra® for the full year 2025 was approximately $11.7 million, compared to $10.1 million in 2024. Net revenue from sales of TONMYA for the period from launch on November 17, 2025, to December 31, 2025, was approximately $1.4 million. Cost of sales for the full year 2025 was approximately $6.6 million, compared to $7.8 million in 2024. Research and development expenses for the full year 2025 were approximately $44.5 million, compared to $40.0 million in 2024. This increase is predominately due to pipeline prioritization period over period, and increased headcount. Selling, general, and administrative expenses for the full year 2025 were $87.7 million, compared to $40.1 million in 2024. The increase is predominately due to spending on sales and marketing related to TONMYA as well as increased headcount. Net loss available to common stockholders was approximately $124.0 million, or $14.57 per basic and diluted share, for the full year 2025, compared to net loss available to common stockholders of $130.0 million, or $176.60 per basic and diluted share, in 2024. The basic and diluted weighted average common shares outstanding for the full year 2025 was 8,511,318 compared to 736,339 shares for 2024. Fourth Quarter 2025 Financial Results Net product revenue for the fourth quarter 2025 was approximately $5.4 million, compared to $2.6 million for the same period in 2024, and consisted of combined net sales of TONMYA™, Zembrace® SymTouch®, and Tosymra®. Cost of sales for the fourth quarter 2025 was approximately $1.1 million, compared to $1.2 million for the same period in 2024. Research and development expenses for the fourth quarter 2025 were approximately $16.9 million, compared to $8.3 million for the same period in 2024. This increase is predominately due to pipeline prioritization period over period and increased headcount. Selling, general, and administrative expenses for the fourth quarter 2025 were $35.7 million, compared to $15.6 million for the same period in 2024. The increase is predominately due to spending on sales and marketing related to TONMYA and increased headcount. Net loss available to common stockholders was $46.9 million, or $3.98 per basic and diluted share, for the fourth quarter 2025, compared to net loss available to common stockholders of $22.1 million, or $9.77 per basic and diluted share, for the same period in 2024. The basic and diluted weighted average common shares outstanding for the fourth quarter 2025 was 11,798,945 compared to 2,263,535 shares for the same period in 2024. Tonix Pharmaceuticals Holding Corp. Tonix Pharmaceuticals* is a fully-integrated, commercial-stage biotechnology company focused on central nervous system (CNS) and immunology treatments in areas of high unmet medical need. TONMYATM (cyclobenzaprine HCl sublingual tablets 2.8mg), the Company’s recently approved flagship medicine, is the first new treatment for fibromyalgia in more than 15 years. Tonix’s CNS commercial infrastructure supports its marketed products, including its acute migraine products, Zembrace® SymTouch® and Tosymra®. Tonix is maximizing the science behind TONMYA in Phase 2 clinical trials to evaluate its potential in major depressive disorder and acute stress disorder. In addition, the Company’s CNS portfolio includes TNX-2900, which is Phase 2 ready for the treatment of Prader-Willi syndrome, a rare disease. Tonix is also advancing a pipeline of immunology programs, including monoclonal antibody TNX-4800 for Lyme disease prophylaxis and TNX-1500, a third-generation CD40 ligand inhibitor for the prevention of kidney transplant rejection. To learn more, visit www.tonixpharma.com and follow the Company on LinkedIn and X. *Tonix’s product development candidates are investigational new drugs or biologics; their efficacy and safety have not been established and have not been approved for any indication. Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. TONMYA is a trademark of Tonix Pharma Limited. All other marks are property of their respective owners. Forward Looking Statements Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995 including those relating to the completion of the offering, the satisfaction of customary closing conditions, the intended use of proceeds from the offering and other statements that are predictive in nature. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix's current expectations and actual results could differ materially as a result of a number of factors, including the ability of the Company to satisfy the conditions to the closing of the offering and the timing thereof, as well as those described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, as filed with the SEC on March 12, 2026, and periodic reports filed with the SEC on or after the date thereof. Tonix does not undertake an obligation to update or revise any forward-looking statement. All of Tonix's forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof. Investor Contacts Jessica Morris Tonix Pharmaceuticals (862) 799-8599 [email protected] Brian Korb astr partners (917) 653-5122 [email protected] Media Contacts Deborah Elson Tonix Pharmaceuticals [email protected] Ray Jordan Putnam Insights [email protected] INDICATION TONMYA is indicated for the treatment of fibromyalgia in adults. CONTRAINDICATIONS TONMYA is contraindicated: In patients with hypersensitivity to cyclobenzaprine or any inactive ingredient in TONMYA. Hypersensitivity reactions may manifest as an anaphylactic reaction, urticaria, facial and/or tongue swelling, or pruritus. Discontinue TONMYA if a hypersensitivity reaction is suspected. With concomitant use of monoamine oxidase (MAO) inhibitors or within 14 days after discontinuation of an MAO inhibitor. Hyperpyretic crisis seizures and deaths have occurred in patients who received cyclobenzaprine (or structurally similar tricyclic antidepressants) concomitantly with MAO inhibitors drugs. During the acute recovery phase of myocardial infarction, and in patients with arrhythmias, heart block or conduction disturbances, or congestive heart failure. In patients with hyperthyroidism. WARNINGS AND PRECAUTIONS Embryofetal toxicity: Based on animal data, TONMYA may cause neural tube defects when used two weeks prior to conception and during the first trimester of pregnancy. Advise females of reproductive potential of the potential risk and to use effective contraception during treatment and for two weeks after the final dose. Perform a pregnancy test prior to initiation of treatment with TONMYA to exclude use of TONMYA during the first trimester of pregnancy. Serotonin syndrome: Concomitant use of TONMYA with selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, tramadol, bupropion, meperidine, verapamil, or MAO inhibitors increases the risk of serotonin syndrome, a potentially life-threatening condition. Serotonin syndrome symptoms may include mental status changes, autonomic instability, neuromuscular abnormalities, and/or gastrointestinal symptoms. Treatment with TONMYA and any concomitant serotonergic agent should be discontinued immediately if serotonin syndrome symptoms occur and supportive symptomatic treatment should be initiated. If concomitant treatment with TONMYA and other serotonergic drugs is clinically warranted, careful observation is advised, particularly during treatment initiation or dosage increases. Tricyclic antidepressant-like adverse reactions: Cyclobenzaprine is structurally related to TCAs. TCAs have been reported to produce arrhythmias, sinus tachycardia, prolongation of the conduction time leading to myocardial infarction and stroke. If clinically significant central nervous system (CNS) symptoms develop, consider discontinuation of TONMYA. Caution should be used when TCAs are given to patients with a history of seizure disorder, because TCAs may lower the seizure threshold. Patients with a history of seizures should be monitored during TCA use to identify recurrence of seizures or an increase in the frequency of seizures. Atropine-like effects: Use with caution in patients with a history of urinary retention, angle-closure glaucoma, increased intraocular pressure, and in patients taking anticholinergic drugs. CNS depression and risk of operating a motor vehicle or hazardous machinery: TONMYA monotherapy may cause CNS depression. Concomitant use of TONMYA with alcohol, barbiturates, or other CNS depressants may increase the risk of CNS depression. Advise patients not to operate a motor vehicle or dangerous machinery until they are reasonably certain that TONMYA therapy will not adversely affect their ability to engage in such activities. Oral mucosal adverse reactions: In clinical studies with TONMYA, oral mucosal adverse reactions occurred more frequently in patients treated with TONMYA compared to placebo. Advise patients to moisten the mouth with sips of water before administration of TONMYA to reduce the risk of oral sensory changes (hypoesthesia). Consider discontinuation of TONMYA if severe reactions occur. ADVERSE REACTIONS The most common adverse reactions (incidence ≥2% and at a higher incidence in TONMYA-treated patients compared to placebo-treated patients) were oral hypoesthesia, oral discomfort, abnormal product taste, somnolence, oral paresthesia, oral pain, fatigue, dry mouth, and aphthous ulcer. DRUG INTERACTIONS MAO inhibitors: Life-threatening interactions may occur. Other serotonergic drugs: Serotonin syndrome has been reported. CNS depressants: CNS depressant effects of alcohol, barbiturates, and other CNS depressants may be enhanced. Tramadol: Seizure risk may be enhanced. Guanethidine or other similar acting drugs: The antihypertensive action of these drugs may be blocked. USE IN SPECIFIC POPULATIONS Pregnancy: Based on animal data, TONMYA may cause fetal harm when administered to a pregnant woman. The limited amount of available observational data on oral cyclobenzaprine use in pregnancy is of insufficient quality to inform a TONMYA-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Advise pregnant women about the potential risk to the fetus with maternal exposure to TONMYA and to avoid use of TONMYA two weeks prior to conception and through the first trimester of pregnancy. Report pregnancies to the Tonix Medicines, Inc., adverse-event reporting line at 1-888-869-7633 (1-888-TNXPMED). Lactation: A small number of published cases report the transfer of cyclobenzaprine into human milk in low amounts, but these data cannot be confirmed. There are no data on the effects of cyclobenzaprine on a breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for TONMYA and any potential adverse effects on the breastfed child from TONMYA or from the underlying maternal condition. Pediatric use: The safety and effectiveness of TONMYA have not been established. Geriatric patients: Of the total number of TONMYA-treated patients in the clinical trials in adult patients with fibromyalgia, none were 65 years of age and older. Clinical trials of TONMYA did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients. Hepatic impairment: The recommended dosage of TONMYA in patients with mild hepatic impairment (HI) (Child Pugh A) is 2.8 mg once daily at bedtime, lower than the recommended dosage in patients with normal hepatic function. The use of TONMYA is not recommended in patients with moderate HI (Child Pugh B) or severe HI (Child Pugh C). Cyclobenzaprine exposure (AUC) was increased in patients with mild HI and moderate HI compared to subjects with normal hepatic function, which may increase the risk of TONMYA-associated adverse reactions. Please see additional safety information in the full Prescribing Information. To report suspected adverse reactions, contact Tonix Medicines, Inc. at 1-888-869-7633, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Indication and Usage Zembrace® SymTouch® (sumatriptan succinate) injection (Zembrace) and Tosymra® (sumatriptan) nasal spray are prescription medicines used to treat acute migraine headaches with or without aura in adults who have been diagnosed with migraine. Zembrace and Tosymra are not used to prevent migraines. It is not known if Zembrace or Tosymra are safe and effective in children under 18 years of age. Important Safety Information Zembrace and Tosymra can cause serious side effects, including heart attack and other heart problems, which may lead to death. Stop use and get emergency help if you have any signs of a heart attack: discomfort in the center of your chest that lasts for more than a few minutes or goes away and comes back severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw pain or discomfort in your arms, back, neck, jaw or stomach shortness of breath with or without chest discomfort breaking out in a cold sweat nausea or vomiting feeling lightheaded Zembrace and Tosymra are not for people with risk factors for heart disease (high blood pressure or cholesterol, smoking, overweight, diabetes, family history of heart disease) unless a heart exam shows no problem. Do not use Zembrace or Tosymra if you have: history of heart problems narrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease) uncontrolled high blood pressure hemiplegic or basilar migraines. If you are not sure if you have these, ask your provider. had a stroke, transient ischemic attacks (TIAs), or problems with blood circulation severe liver problems taken any of the following medicines in the last 24 hours: almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, ergotamines, or dihydroergotamine. Ask your provider for a list of these medicines if you are not sure. are taking certain antidepressants, known as monoamine oxidase (MAO)-A inhibitors or it has been 2 weeks or less since you stopped taking a MAO-A inhibitor. Ask your provider for a list of these medicines if you are not sure. an allergy to sumatriptan or any of the components of Zembrace or Tosymra Tell your provider about all of your medical conditions and medicines you take, including vitamins and supplements. Zembrace and Tosymra can cause dizziness, weakness, or drowsiness. If so, do not drive a car, use machinery, or do anything where you need to be alert. Zembrace and Tosymra may cause serious side effects including: changes in color or sensation in your fingers and toes sudden or severe stomach pain, stomach pain after meals, weight loss, nausea or vomiting, constipation or diarrhea, bloody diarrhea, fever cramping and pain in your legs or hips; feeling of heaviness or tightness in your leg muscles; burning or aching pain in your feet or toes while resting; numbness, tingling, or weakness in your legs; cold feeling or color changes in one or both legs or feet increased blood pressure including a sudden severe increase even if you have no history of high blood pressure medication overuse headaches from using migraine medicine for 10 or more days each month. If your headaches get worse, call your provider. serotonin syndrome, a rare but serious problem that can happen in people using Zembrace or Tosymra, especially when used with anti-depressant medicines called SSRIs or SNRIs. Call your provider right away if you have: mental changes such as seeing things that are not there (hallucinations), agitation, or coma; fast heartbeat; changes in blood pressure; high body temperature; tight muscles; or trouble walking. hives (itchy bumps); swelling of your tongue, mouth, or throat seizures even in people who have never had seizures before The most common side effects of Zembrace and Tosymra include: pain and redness at injection site (Zembrace only); tingling or numbness in your fingers or toes; dizziness; warm, hot, burning feeling to your face (flushing); discomfort or stiffness in your neck; feeling weak, drowsy, or tired; application site (nasal) reactions (Tosymra only) and throat irritation (Tosymra only). Tell your provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of Zembrace and Tosymra. For more information, ask your provider. This is the most important information to know about Zembrace and Tosymra but is not comprehensive. For more information, talk to your provider and read the Patient Information and Instructions for Use. You can also visit https://www.tonixpharma.com or call 1-888-869-7633. You are encouraged to report adverse effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Tonmya™ (cyclobenzaprine HCl sublingual tablets) for the treatment of fibromyalgia set to launch in November Tonmya is the first new FDA-approved medicine for fibromyalgia in more than 15 years Cash and cash equivalents of $190.1 million reported as of September 30, 2025; current cash runway expected to fund operations into the first quarter of 2027 CHATHAM, N.J., Nov. 10, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully-integrated commercial biotechnology company today announced financial results for the third quarter ended September 30, 2025, and provided an overview of recent operational highlights. “Following U.S. Food and Drug Administration (FDA) approval of Tonmya™, we are focused on execution of the U.S. launch later this month to bring the first new treatment option for fibromyalgia to patients and clinicians in more than 15 years,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “We have built the commercial infrastructure, market access capabilities, and brand awareness to position Tonmya for a strong launch and sustainable market presence.” Dr. Lederman continued, “Turning to our pipeline, we were excited to in-license TNX-4800, a Phase 2-ready, long-acting human monoclonal antibody for the seasonal prevention of Lyme disease, and to announce a collaboration with Massachusetts General Hospital to conduct an investigator-initiated Phase 2 study of TNX-1500 for the prevention of kidney transplant rejection. Our priorities are clear: launch Tonmya successfully, advance our pipeline strategically, and drive sustainable growth that benefits patients and shareholders.” Commercial Updates Tonmya (cyclobenzaprine HCl sublingual tablets) 2.8 mg: a centrally acting, non-opioid analgesic for the treatment of fibromyalgia in adults In August, the FDA approved Tonmya, the first new fibromyalgia therapy in more than 15 years. In September, the Company established the wholesale acquisition cost (WAC) for Tonmya. In October, Tonix announced the commercial launch of Tonmya will commence before the end of November. 90 Tonmya sales representatives have been in the field for over a month, in preparation for the November launch. Tonix has contracted with its existing wholesalers and specialty pharmacies for the distribution of Tommya. Tonix has also contracted with companies to assist with prescription fulfillment and patient access. The Company strengthened its commercial organization with the appointment of Ganesh Kamath as Head of Market Access to lead pricing, payer strategy, and reimbursement for the Tonmya launch. Tosymra® (sumatriptan nasal spray) 10 mg: approved treatment of acute migraine in adults Effective January 1, 2026, Tosymra has preferred exclusive placement on a payer formulary representing approximately 16 million covered lives. Pipeline Updates TNX-102 SL (cyclobenzaprine HCl sublingual tablets) 2.8 mg: in development for major depressive disorder (MDD) In August, Tonix held a positive Type B Pre-Investigational New Drug (IND) meeting with the FDA regarding TNX-102 SL for MDD. In October, the Company filed the IND, and, upon receiving IND clearance, Tonix intends to initiate a Phase 2 study mid-year 2026. TNX-1500 (dimeric Fc modified anti-CD40L, humanized monoclonal antibody [mAb]): third generation anti-CD40L under investigation for prophylaxis of kidney transplant rejection, with the potential to also be a treatment for autoimmune disorders. In October, Tonix presented an update at the Japan Society for Transplantation annual congress, highlighting Phase 1 safety and biomarker results and outlining next steps toward Phase 2 evaluation in allo-transplantation. In November, Tonix announced a collaboration with Massachusetts General Hospital to advance a Phase 2 open-label, investigator-initiated, clinical trial of TNX-1500 in kidney transplant recipients in 1H 2026. TNX-4800 (anti-OspA mAb): long-acting human mAb in development for the prevention of Lyme disease In September, Tonix announced in-licensing worldwide rights to TNX-4800, from UMass Chan Medical School. TNX-4800 is a fully human mAb that targets and kills Borrelia burgdorferi inside infected deer ticks when they have bitten treated animals and ingested their blood. Adaptive Phase 2/3 study will test whether TNX-4800 protects humans by killing B. burgdorferi inside infected deer ticks when they have bitten treated humans and ingested their blood. There are currently no FDA-approved vaccines or prophylactics to protect against Lyme Disease. Tonix plans to initiate the adaptive Phase 2/3 study during tick season in 2027. TNX-2900 (intranasal potentiated oxytocin): in development for Prader-Willi syndrome In September, Tonix announced plans to initiate a Phase 2, randomized, double-blind, placebo-controlled trial in 2H 2026 in children and adolescents. TNX-2900 has Orphan Drug designation as well as Rare Pediatric Disease designation that could make Tonix eligible for a Priority Review Voucher upon approval. Financials As of September 30, 2025, Tonix had $190.1 million in cash and cash equivalents, compared with $98.8 million as of December 31, 2024. Net cash used in operations was approximately $60.2 million for the nine months ended September 30, 2025, compared to $46.3 million for the same period in 2024. Based on its current operating plan, the Company believes its cash on hand as of September 30, 2025, together with $34.7 million in net proceeds received from equity offerings during the fourth quarter 2025, will fund planned operating and capital expenditures into the first quarter of 2027. Third Quarter 2025 Financial Results Net product revenue for the three months ended September 30, 2025 was approximately $3.3 million, compared to $2.8 million for the same period in 2024; revenue reflected combined net sales of Zembrace® SymTouch® (sumatriptan injection) and Tosymra® (sumatriptan nasal spray). Cost of sales for the three months ended September 30, 2025 was approximately $1.4 million, compared to $1.6 million for the same period in 2024. Research and development expenses for the three months ended September 30, 2025 were $9.3 million, compared to $9.1 million for the same period in 2024. The increase was predominately due to increased manufacturing expenses of $2.3 million, offset by a reduction in clinical expenses of $2.1 million, as a result of pipeline prioritization period over period. Selling, general and administrative expenses for the three months ended September 30, 2025 were $25.7 million, compared to $7.7 million in 2024. The increase is predominately due to spending on sales and marketing relating to Tonmya. Net loss available to common stockholders was $32.0 million, or $3.59 per share (basic and diluted), for the third quarter 2025, compared to a net loss of $14.2 million, or $22.68 per share, for the same period in 2024. The basic and diluted weighted-average common shares outstanding for the third quarter 2025 were 8,922,792, compared to 626,669 for the same period in 2024. Tonix Pharmaceuticals Holding Corp.* Tonix Pharmaceuticals is a fully-integrated biotechnology company with marketed products and a pipeline of development candidates. Tonix has received FDA approval for TonmyaTM, a first-in-class, non-opioid analgesic medicine for the treatment of fibromyalgia, a chronic pain condition that affects millions of adults. This marks the first approval for a new prescription medicine for fibromyalgia in more than 15 years. Tonix also markets two treatments for acute migraine in adults: Zembrace® SymTouch® and Tosymra®. Tonix’s development portfolio is focused on central nervous system (CNS) disorders, immunology, immuno-oncology, rare disease and infectious disease. TNX-102 SL is being developed to treat acute stress reaction and acute stress disorder under an Investigator-Initiated IND at the University of North Carolina in the OASIS study funded by the U.S. Department of Defense (DoD). TNX-102 SL is also in development for major depressive disorder. Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is an Fc-modified humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix’s rare disease portfolio includes TNX-2900, intranasal oxytocin potentiated with magnesium, in development for Prader-Willi syndrome. Tonix’s infectious disease portfolio includes TNX-801, a vaccine in development for mpox and smallpox, as well as TNX-4800, a monoclonal antibody for the seasonal prevention of Lyme Disease. Finally, TNX-4200 for which Tonix has a contract with the U.S. DoD’s Defense Threat Reduction Agency (DTRA) for up to $34 million over five years, is a small molecule broad-spectrum antiviral agent targeting CD45 for the prevention or treatment of high lethality infections to improve the medical readiness of military personnel in biological threat environments. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, Md. * Tonix’s product development candidates are investigational new drugs or biologics; their efficacy and safety have not been established and have not been approved for any indication. This press release and further information about Tonix can be found at www.tonixpharma.com. Forward Looking Statements Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. 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; 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 patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the Securities and Exchange Commission (the “SEC”) on March 18, 2025, and periodic reports filed with the SEC on or after the date thereof. All of Tonix's forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof. 1The condensed consolidated balance sheet for the year ended December 31, 2024 has been derived from the audited financial statements but do not include all of the information and footnotes required by accounting principles generally accepted in the United States for complete financial statements. Investor Contacts Jessica Morris Tonix Pharmaceuticals [email protected] (862) 799-8599 Brian Korb astr partners (917) 653-5122 [email protected] Media Contacts Mary Ann Ondish Tonix Pharmaceuticals [email protected] Ray Jordan Putnam Insights [email protected] INDICATION TONMYA is indicated for the treatment of fibromyalgia in adults. CONTRAINDICATIONS TONMYA is contraindicated: In patients with hypersensitivity to cyclobenzaprine or any inactive ingredient in TONMYA. Hypersensitivity reactions may manifest as an anaphylactic reaction, urticaria, facial and/or tongue swelling, or pruritus. Discontinue TONMYA if a hypersensitivity reaction is suspected. With concomitant use of monoamine oxidase (MAO) inhibitors or within 14 days after discontinuation of an MAO inhibitor. Hyperpyretic crisis seizures and deaths have occurred in patients who received cyclobenzaprine (or structurally similar tricyclic antidepressants) concomitantly with MAO inhibitors drugs. During the acute recovery phase of myocardial infarction, and in patients with arrhythmias, heart block or conduction disturbances, or congestive heart failure. In patients with hyperthyroidism. WARNINGS AND PRECAUTIONS Embryofetal toxicity: Based on animal data, TONMYA may cause neural tube defects when used two weeks prior to conception and during the first trimester of pregnancy. Advise females of reproductive potential of the potential risk and to use effective contraception during treatment and for two weeks after the final dose. Perform a pregnancy test prior to initiation of treatment with TONMYA to exclude use of TONMYA during the first trimester of pregnancy. Serotonin syndrome: Concomitant use of TONMYA with selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, tramadol, bupropion, meperidine, verapamil, or MAO inhibitors increases the risk of serotonin syndrome, a potentially life-threatening condition. Serotonin syndrome symptoms may include mental status changes, autonomic instability, neuromuscular abnormalities, and/or gastrointestinal symptoms. Treatment with TONMYA and any concomitant serotonergic agent should be discontinued immediately if serotonin syndrome symptoms occur and supportive symptomatic treatment should be initiated. If concomitant treatment with TONMYA and other serotonergic drugs is clinically warranted, careful observation is advised, particularly during treatment initiation or dosage increases. Tricyclic antidepressant-like adverse reactions: Cyclobenzaprine is structurally related to TCAs. TCAs have been reported to produce arrhythmias, sinus tachycardia, prolongation of the conduction time leading to myocardial infarction and stroke. If clinically significant central nervous system (CNS) symptoms develop, consider discontinuation of TONMYA. Caution should be used when TCAs are given to patients with a history of seizure disorder, because TCAs may lower the seizure threshold. Patients with a history of seizures should be monitored during TCA use to identify recurrence of seizures or an increase in the frequency of seizures. Atropine-like effects: Use with caution in patients with a history of urinary retention, angle-closure glaucoma, increased intraocular pressure, and in patients taking anticholinergic drugs. CNS depression and risk of operating a motor vehicle or hazardous machinery: TONMYA monotherapy may cause CNS depression. Concomitant use of TONMYA with alcohol, barbiturates, or other CNS depressants may increase the risk of CNS depression. Advise patients not to operate a motor vehicle or dangerous machinery until they are reasonably certain that TONMYA therapy will not adversely affect their ability to engage in such activities. Oral mucosal adverse reactions: In clinical studies with TONMYA, oral mucosal adverse reactions occurred more frequently in patients treated with TONMYA compared to placebo. Advise patients to moisten the mouth with sips of water before administration of TONMYA to reduce the risk of oral sensory changes (hypoesthesia). Consider discontinuation of TONMYA if severe reactions occur. ADVERSE REACTIONS The most common adverse reactions (incidence ≥2% and at a higher incidence in TONMYA-treated patients compared to placebo-treated patients) were oral hypoesthesia, oral discomfort, abnormal product taste, somnolence, oral paresthesia, oral pain, fatigue, dry mouth, and aphthous ulcer. DRUG INTERACTIONS MAO inhibitors: Life-threatening interactions may occur. Other serotonergic drugs: Serotonin syndrome has been reported. CNS depressants: CNS depressant effects of alcohol, barbiturates, and other CNS depressants may be enhanced. Tramadol: Seizure risk may be enhanced. Guanethidine or other similar acting drugs: The antihypertensive action of these drugs may be blocked. USE IN SPECIFIC POPULATIONS Pregnancy: Based on animal data, TONMYA may cause fetal harm when administered to a pregnant woman. The limited amount of available observational data on oral cyclobenzaprine use in pregnancy is of insufficient quality to inform a TONMYA-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Advise pregnant women about the potential risk to the fetus with maternal exposure to TONMYA and to avoid use of TONMYA two weeks prior to conception and through the first trimester of pregnancy. Report pregnancies to the Tonix Medicines, Inc., adverse-event reporting line at 1-888-869-7633 (1-888-TNXPMED). Lactation: A small number of published cases report the transfer of cyclobenzaprine into human milk in low amounts, but these data cannot be confirmed. There are no data on the effects of cyclobenzaprine on a breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for TONMYA and any potential adverse effects on the breastfed child from TONMYA or from the underlying maternal condition. Pediatric use: The safety and effectiveness of TONMYA have not been established. Geriatric patients: Of the total number of TONMYA-treated patients in the clinical trials in adult patients with fibromyalgia, none were 65 years of age and older. Clinical trials of TONMYA did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients. Hepatic impairment: The recommended dosage of TONMYA in patients with mild hepatic impairment (HI) (Child Pugh A) is 2.8 mg once daily at bedtime, lower than the recommended dosage in patients with normal hepatic function. The use of TONMYA is not recommended in patients with moderate HI (Child Pugh B) or severe HI (Child Pugh C). Cyclobenzaprine exposure (AUC) was increased in patients with mild HI and moderate HI compared to subjects with normal hepatic function, which may increase the risk of TONMYA-associated adverse reactions. Please see additional safety information in the full Prescribing Information. To report suspected adverse reactions, contact Tonix Medicines, Inc. at 1-888-869-7633, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Indication and Usage Zembrace® SymTouch® (sumatriptan succinate) injection (Zembrace) and Tosymra® (sumatriptan) nasal spray are prescription medicines used to treat acute migraine headaches with or without aura in adults who have been diagnosed with migraine. Zembrace and Tosymra are not used to prevent migraines. It is not known if Zembrace or Tosymra are safe and effective in children under 18 years of age. Important Safety Information Zembrace and Tosymra can cause serious side effects, including heart attack and other heart problems, which may lead to death. Stop use and get emergency help if you have any signs of a heart attack: discomfort in the center of your chest that lasts for more than a few minutes or goes away and comes back severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw pain or discomfort in your arms, back, neck, jaw or stomach shortness of breath with or without chest discomfort breaking out in a cold sweat nausea or vomiting feeling lightheaded Zembrace and Tosymra are not for people with risk factors for heart disease (high blood pressure or cholesterol, smoking, overweight, diabetes, family history of heart disease) unless a heart exam shows no problem. Do not use Zembrace or Tosymra if you have: history of heart problems narrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease) uncontrolled high blood pressure hemiplegic or basilar migraines. If you are not sure if you have these, ask your provider. had a stroke, transient ischemic attacks (TIAs), or problems with blood circulation severe liver problems taken any of the following medicines in the last 24 hours: almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, ergotamines, or dihydroergotamine. Ask your provider for a list of these medicines if you are not sure. are taking certain antidepressants, known as monoamine oxidase (MAO)-A inhibitors or it has been 2 weeks or less since you stopped taking a MAO-A inhibitor. Ask your provider for a list of these medicines if you are not sure. an allergy to sumatriptan or any of the components of Zembrace or Tosymra Tell your provider about all of your medical conditions and medicines you take, including vitamins and supplements. Zembrace and Tosymra can cause dizziness, weakness, or drowsiness. If so, do not drive a car, use machinery, or do anything where you need to be alert. Zembrace and Tosymra may cause serious side effects including: changes in color or sensation in your fingers and toes sudden or severe stomach pain, stomach pain after meals, weight loss, nausea or vomiting, constipation or diarrhea, bloody diarrhea, fever cramping and pain in your legs or hips; feeling of heaviness or tightness in your leg muscles; burning or aching pain in your feet or toes while resting; numbness, tingling, or weakness in your legs; cold feeling or color changes in one or both legs or feet increased blood pressure including a sudden severe increase even if you have no history of high blood pressure medication overuse headaches from using migraine medicine for 10 or more days each month. If your headaches get worse, call your provider. serotonin syndrome, a rare but serious problem that can happen in people using Zembrace or Tosymra, especially when used with anti-depressant medicines called SSRIs or SNRIs. Call your provider right away if you have: mental changes such as seeing things that are not there (hallucinations), agitation, or coma; fast heartbeat; changes in blood pressure; high body temperature; tight muscles; or trouble walking. hives (itchy bumps); swelling of your tongue, mouth, or throat seizures even in people who have never had seizures before The most common side effects of Zembrace and Tosymra include: pain and redness at injection site (Zembrace only); tingling or numbness in your fingers or toes; dizziness; warm, hot, burning feeling to your face (flushing); discomfort or stiffness in your neck; feeling weak, drowsy, or tired; application site (nasal) reactions (Tosymra only) and throat irritation (Tosymra only). Tell your provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of Zembrace and Tosymra. For more information, ask your provider. This is the most important information to know about Zembrace and Tosymra but is not comprehensive. For more information, talk to your provider and read the Patient Information and Instructions for Use. You can also visit https://www.tonixpharma.com or call 1-888-869-7633. You are encouraged to report adverse effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

FDA PDUFA goal date of August 15, 2025, for TNX‑102 SL for fibromyalgia: if approved by FDA, TNX‑102 SL would be the first new drug for fibromyalgia in more than 16 years In June 2025, the Company was added to the Russell 3000® and Russell 2000® Indexes following the annual reconstitution Phase 3 RESILIENT results published in peer-reviewed journal, Pain Medicine, including statistically significant reduction in fibromyalgia pain with once‑nightly TNX‑102 SL; generally well tolerated Cash and cash equivalents of $125.3 million reported as of June 30, 2025; current cash runway expected to fund operations into the third quarter of 2026 CHATHAM, N.J., Aug. 11, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully-integrated biotechnology company with marketed products and a pipeline of development candidates, today announced financial results for the second quarter ended June 30, 2025, and provided an overview of recent operational highlights. “With the U.S. Food and Drug Administration (FDA) Prescription Drug User Fee Act (PDUFA) goal date of August 15, for TNX-102 SL (cyclobenzaprine HCl sublingual tablets) for fibromyalgia, we are excited about the potential to make this important new therapy available to patients in the fourth quarter of this year,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “FDA considers fibromyalgia a serious condition and awarded TNX-102 SL Fast Track designation last year. There has been no new treatment for this debilitating condition approved in over 16 years. Additionally, our RESILIENT Phase 3 study results were recently published in the peer-reviewed journal, Pain Medicine.” Dr. Lederman continued, “Our pipeline momentum remains strong. In the second quarter, we dosed the first patient in the U.S. Department of Defense (DoD)-funded, investigator-initiated, OASIS trial of TNX-102 SL for acute stress reaction. We also presented new data for our live-virus vaccine, TNX-801, which demonstrated durable single-dose protection against mpox and rabbitpox in animal models. We previously reported positive Phase 1 safety and pharmacokinetic data for TNX-1500, advancing this next-generation anti-CD40L antibody toward a Phase 2 kidney-transplant study. We are well-positioned to translate these milestones into meaningful value for patients and shareholders alike.” Central Nervous System (CNS) Pipeline TNX-102 SL (cyclobenzaprine HCl sublingual tablets 2.8 mg): two tablets (5.6 mg), once-daily at bedtime for fibromyalgia (FM) – a centrally-acting, non-opioid analgesic. In June 2025, Tonix presented a poster at the European Congress of Rheumatology (EULAR 2025) demonstrating that TNX‑102 SL produced statistically significant, durable (14‑week) pain reduction across two Phase 3 trials. In July 2025, Tonix announced online publication of full results from the confirmatory Phase 3 RESILIENT trial of TNX‑102 SL in the peer-reviewed journal Pain Medicine, showing once‑nightly 5.6 mg achieved a statistically significant reduction in fibromyalgia pain versus placebo and was well tolerated; the data confirm the earlier RELIEF study and support the ongoing New Drug Application (NDA) review with an August 15, 2025 PDUFA goal date. TNX-102 SL in development for the treatment of acute stress reaction (ASR) and acute stress disorder (ASD), and prophylaxis against development of posttraumatic stress disorder (PTSD) In May 2025, the first patient was dosed in the Phase 2 investigator initiated OASIS trial evaluating a two week course of TNX102 SL 5.6 mg to reduce the severity of acute stress reaction (ASR) and the frequency of acute stress disorder (ASD); the study is sponsored by the University of North Carolina and supported by a $3 million U.S. Department of Defense grant, with topline results expected in the second half of 2026. TNX-1500 (anti-CD40L Fc-modified humanized monoclonal antibody): third generation anti-CD40L monoclonal antibody under investigation for prophylaxis for organ transplant rejection and treatment of autoimmune disorders In May 2025, Tonix reported positive topline data from a Phase 1 single‑ascending‑dose study in healthy volunteers: TNX‑1500 met all safety, pharmacokinetic and pharmacodynamic goals, blocked primary and secondary antibody responses at 10 mg/kg and 30 mg/kg doses with intravenous (i.v.) administration, and showed a 34–38‑day mean half‑life that supports monthly i.v. dosing—supporting the path for a planned Phase 2 study to evaluate TNX-1500 for prevention of rejection in kidney allogeneic transplant. TNX-801 (recombinant horsepox virus, minimally replicative live-virus vaccine): potential vaccine to protect against mpox and smallpox. In April 2025, Tonix presented new preclinical data on TNX-801 at the World Vaccine Congress Washington 2025 showing a single subcutaneous (s.c.) dose protected animals from mpox and rabbitpox for at least six months, remained well tolerated even in immunocompromised models, and met key attributes in the WHO’s preferred target product profile for mpox vaccines. In May 2025, Tonix appointed Joseph Hand, Esq. as General Counsel and Executive Vice President of Operations, adding more than two decades of legal and operational expertise as the Company prepares for potential TNX‑102 SL commercialization. In June 2025, Tonix announced that commercial veteran James Hunter joined its Board of Directors, bringing forty years of go‑to‑market experience to strengthen strategy and governance ahead of the expected TNX‑102 SL launch. In June 2025, the Company was added to the Russell 3000® and Russell 2000® Indexes following the annual reconstitution, broadening visibility among institutional investors as Tonix approaches key regulatory milestones. As of June 30, 2025, Tonix had $125.3 million in cash and cash equivalents, compared with $98.8 million as of December 31, 2024. Net cash used in operations was approximately $31.4 million for the six months ended June 30, 2025, compared to $27.5 million for the same period in 2024. The Company believes that, based on its current operating plan, its cash on hand at June 30, 2025, together with $51.5 million in net proceeds received from equity offerings during the third quarter 2025, will fund planned operating and capital expenditures into the third quarter of 2026. Second Quarter 2025 Financial Results Net product revenue for the three months ended June 30, 2025 was approximately $2.0 million, compared to $2.2 million for the same period in 2024; revenue again reflected combined net sales of Zembrace® SymTouch® and Tosymra®. Cost of sales for the three months ended June 30, 2025 was approximately $3.3 million, compared to $3.4 million for the same period in 2024. Research and development expenses for the three months ended June 30, 2025 were $10.8 million, compared to $9.7 million for the same period in 2024. The increase was predominately due to increased clinical expenses, nonclinical expenses and manufacturing expenses, reflecting spend on pipeline priorities. Selling, general and administrative expenses for the three months ended June 30, 2025 were $16.2 million, compared to $7.5 million in 2024. The increase is predominately due to spend on sales and marketing to progress pre-launch activities related to the potential FDA approval of TNX-102 SL for fibromyalgia. Net loss available to common stockholders was $28.3 million, or $3.86 per share (basic and diluted), for the second quarter 2025, compared to a net loss of $78.8 million, or $1,920.85 per share, for the same period in 2024. The basic and diluted weighted-average common shares outstanding for the second quarter 2025 were 7,327,257 compared to 41,011 for the same period in 2024. Tonix Pharmaceuticals Holding Corp.* Tonix is a fully-integrated biotechnology company focused on transforming therapies for pain management and vaccines for public health challenges. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to advance TNX-102 SL, a product candidate for fibromyalgia, for which an NDA was submitted based on two statistically significant Phase 3 studies for fibromyalgia and for which a PDUFA goal date of August 15, 2025 has been assigned for a decision on marketing authorization. The FDA had also granted Fast Track designation to TNX-102 SL for fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction and acute stress disorder under a Physician-Initiated IND at the University of North Carolina in the OASIS study funded by the U.S. Department of Defense (DoD). Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is an Fc-modified humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix’s infectious disease portfolio includes TNX-801, a vaccine in development for mpox and smallpox, as well as TNX-4200 for which Tonix has a contract with the U.S. DoD’s Defense Threat Reduction Agency (DTRA) for up to $34 million over five years. TNX-4200 is a small molecule broad-spectrum antiviral agent targeting CD45 for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, Md. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults. * Tonix’s product development candidates are investigational new drugs or biologics; their efficacy and safety have not been established and have not been approved for any indication. Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are property of their respective owners. This press release and further information about Tonix can be found at www.tonixpharma.com. Forward Looking Statements Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the Securities and Exchange Commission (the “SEC”) on March 18, 2025, and periodic reports filed with the SEC on or after the date thereof. All of Tonix's forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof. 1The condensed consolidated balance sheet for the year ended December 31, 2024 has been derived from the audited financial statements but do not include all of the information and footnotes required by accounting principles generally accepted in the United States for complete financial statements. Investor Contact Jessica Morris Tonix Pharmaceuticals [email protected] (862) 799-8599 Brian Korb astr partners (917) 653-5122 [email protected] Media Contact Ray Jordan Putnam Insights [email protected] (949) 245-5432 Indication and Usage Zembrace® SymTouch® (sumatriptan succinate) injection (Zembrace) and Tosymra® (sumatriptan) nasal spray are prescription medicines used to treat acute migraine headaches with or without aura in adults who have been diagnosed with migraine. Zembrace and Tosymra are not used to prevent migraines. It is not known if Zembrace or Tosymra are safe and effective in children under 18 years of age. Important Safety Information Zembrace and Tosymra can cause serious side effects, including heart attack and other heart problems, which may lead to death. Stop use and get emergency help if you have any signs of a heart attack: discomfort in the center of your chest that lasts for more than a few minutes or goes away and comes back severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw pain or discomfort in your arms, back, neck, jaw or stomach shortness of breath with or without chest discomfort breaking out in a cold sweat nausea or vomiting feeling lightheaded Zembrace and Tosymra are not for people with risk factors for heart disease (high blood pressure or cholesterol, smoking, overweight, diabetes, family history of heart disease) unless a heart exam shows no problem. Do not use Zembrace or Tosymra if you have: history of heart problems narrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease) uncontrolled high blood pressure hemiplegic or basilar migraines. If you are not sure if you have these, ask your provider. had a stroke, transient ischemic attacks (TIAs), or problems with blood circulation severe liver problems taken any of the following medicines in the last 24 hours: almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, ergotamines, or dihydroergotamine. Ask your provider for a list of these medicines if you are not sure. are taking certain antidepressants, known as monoamine oxidase (MAO)-A inhibitors or it has been 2 weeks or less since you stopped taking a MAO-A inhibitor. Ask your provider for a list of these medicines if you are not sure. an allergy to sumatriptan or any of the components of Zembrace or Tosymra Tell your provider about all of your medical conditions and medicines you take, including vitamins and supplements. Zembrace and Tosymra can cause dizziness, weakness, or drowsiness. If so, do not drive a car, use machinery, or do anything where you need to be alert. Zembrace and Tosymra may cause serious side effects including: changes in color or sensation in your fingers and toes sudden or severe stomach pain, stomach pain after meals, weight loss, nausea or vomiting, constipation or diarrhea, bloody diarrhea, fever cramping and pain in your legs or hips; feeling of heaviness or tightness in your leg muscles; burning or aching pain in your feet or toes while resting; numbness, tingling, or weakness in your legs; cold feeling or color changes in one or both legs or feet increased blood pressure including a sudden severe increase even if you have no history of high blood pressure medication overuse headaches from using migraine medicine for 10 or more days each month. If your headaches get worse, call your provider. serotonin syndrome, a rare but serious problem that can happen in people using Zembrace or Tosymra, especially when used with anti-depressant medicines called SSRIs or SNRIs. Call your provider right away if you have: mental changes such as seeing things that are not there (hallucinations), agitation, or coma; fast heartbeat; changes in blood pressure; high body temperature; tight muscles; or trouble walking. hives (itchy bumps); swelling of your tongue, mouth, or throat seizures even in people who have never had seizures before The most common side effects of Zembrace and Tosymra include: pain and redness at injection site (Zembrace only); tingling or numbness in your fingers or toes; dizziness; warm, hot, burning feeling to your face (flushing); discomfort or stiffness in your neck; feeling weak, drowsy, or tired; application site (nasal) reactions (Tosymra only) and throat irritation (Tosymra only). Tell your provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of Zembrace and Tosymra. For more information, ask your provider. This is the most important information to know about Zembrace and Tosymra but is not comprehensive. For more information, talk to your provider and read the Patient Information and Instructions for Use. You can also visit https://www.tonixpharma.com or call 1-888-869-7633. You are encouraged to report adverse effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

The previously disclosed and now published RESILIENT data show that once-nightly TNX-102 SL achieved statistically significant improvement in the primary endpoint of reducing fibromyalgia pain versus placebo, and was generally well tolerated These results confirm findings from the previously published RELIEF phase 3 trial, which also demonstrated a statistically significant reduction in fibromyalgia pain FDA target PDUFA date for TNX-102 SL is August 15, 2025 and, if approved, would be the first new drug for treating fibromyalgia in more than 15 years CHATHAM, N.J., July 09, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP), a clinical-stage biopharmaceutical company, today announced that full results from its confirmatory Phase 3 RESILIENT trial of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) for the management of fibromyalgia have been published online in the peer reviewed Pain Medicine, the official journal of the American Academy of Pain Medicine. The publication is titled, “Pain Relief by Targeting Nonrestorative Sleep in Fibromyalgia: A Phase 3 Randomized Trial of Bedtime Sublingual Cyclobenzaprine” and is available here. “The RESILIENT data that are now published on-line in Pain Medicine underscores the therapeutic promise of TNX-102 SL, our non-opioid, centrally-acting analgesic in development for reducing fibromyalgia pain,” said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. “RESILIENT confirms the pain improvement data previously reported from our RELIEF study. Based on these two statistically significant Phase 3 studies, we submitted a New Drug Application (NDA) which has been granted a Prescription Drug User Fee Act (PDUFA) target date of August 15 for a decision on marketing authorization.” RESILIENT was a randomized, double-blind, placebo-controlled trial that enrolled 457 adults with fibromyalgia across 33 United States sites. Participants received TNX-102 SL 2.8 mg for two weeks followed by 5.6 mg for twelve weeks, or matching placebo, with efficacy assessed over fourteen weeks. Treatment with TNX-102 SL produced a least-squares mean reduction of 1.8 points on the eleven-point daily pain numeric rating scale compared with a 1.2-point reduction for placebo, achieving the primary endpoint with high statistical significance. Statistically significant improvements were also observed across all six prespecified key secondary endpoints, including Patient Global Impression of Change responder analysis, Fibromyalgia Impact Questionnaire – Revised (FIQR) Symptoms and Function domains, and the PROMIS Sleep Disturbance and Fatigue instruments. TNX-102 SL was generally well tolerated. The most common treatment-emergent adverse events were oral tingling/numbness and bitter or noticeable aftertaste, which were typically mild, transient lasting less than an hour, and self-limiting. No drug-related serious adverse events or deaths were reported. These safety and efficacy findings underscore TNX-102 SL’s favorable risk-benefit profile and its potential to address the unmet needs of people living with fibromyalgia. About Fibromyalgia Fibromyalgia is a chronic pain disorder that is understood to result from amplified sensory and pain signaling within the central nervous system. Fibromyalgia afflicts an estimated 6-12 million adults in the U.S., approximately 90% of whom are women. Symptoms of fibromyalgia include chronic widespread pain, nonrestorative sleep, fatigue, and morning stiffness. Other associated symptoms include cognitive dysfunction and mood disturbances, including anxiety and depression. Individuals suffering from fibromyalgia struggle with their daily activities, have impaired quality of life, and frequently are disabled. Physicians and patients report common dissatisfaction with currently marketed products. About TNX-102 SL TNX-102 SL is a patented sublingual tablet formulation of cyclobenzaprine hydrochloride which provides rapid transmucosal absorption and reduced production of a long half-life active metabolite, norcyclobenzaprine, due to bypass of first-pass hepatic metabolism. As a multifunctional agent with potent binding and antagonist activities at the 5-HT2Aserotonergic, α1-adrenergic, H1-histaminergic, and M1-muscarinic receptors, TNX-102 SL is in development as a daily bedtime treatment for fibromyalgia, acute stress reaction (ASR)/acute stress disorder (ASD), Long COVID (formally known as post-acute sequelae of COVID-19 [PASC]), alcohol use disorder (AUD) and agitation in Alzheimer’s disease (AAD). The United States Patent and Trademark Office (USPTO) issued United States Patent No. 9636408 in May 2017, Patent No. 9956188 in May 2018, Patent No. 10117936 in November 2018, Patent No. 10,357,465 in July 2019, and Patent No.10736859 in August 2020. The Protectic™ protective eutectic and Angstro-Technology™ formulation claimed in the patent are important elements of Tonix’s proprietary TNX-102 SL composition. These patents are expected to provide TNX-102 SL, upon NDA approval, with U.S. market exclusivity until 2034/2035. About the Phase 3 RESILIENT Study The RESILIENT study is a double-blind, randomized, placebo-controlled trial designed to evaluate the efficacy and safety of TNX-102 SL (cyclobenzaprine HCl sublingual tablets) in the management of fibromyalgia. The two-arm trial enrolled 457 adults with fibromyalgia across 33 United States sites. The first two weeks of treatment consist of a run-in period in which participants start on TNX-102 SL 2.8 mg (1 tablet) or placebo. Thereafter, all participants increase their dose to TNX-102 SL 5.6 mg (2 x 2.8 mg tablets) or two placebo tablets for the remaining 12 weeks. The primary endpoint is the daily diary pain severity score change (TNX-102 SL 5.6 mg vs. placebo) from baseline to Week 14 (using the weekly averages of the daily numerical rating scale scores), analyzed by mixed model repeated measures with multiple imputation. For more information, see ClinicalTrials.gov Identifier: NCT05273749. Tonix Pharmaceuticals Holding Corp.* Tonix is a fully-integrated biotech company focused on transforming therapies for pain management and vaccines for public health challenges. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to advance TNX-102 SL, a product candidate for the management of fibromyalgia, for which an NDA was submitted based on two statistically significant Phase 3 studies for the management of fibromyalgia and for which a PDUFA (Prescription Drug User Fee act) goal date of August 15, 2025 has been assigned for a decision on marketing authorization. The FDA has also granted Fast Track designation to TNX-102 SL for the management of fibromyalgia. TNX-102 SL is also being developed to treat ASR and ASR, Long COVID, AUD and AAD. A phase 2 study of ASR/ASD is ongoing under a Physician-Initiated IND at the University of North Carolina in the OASIS study funded by the U.S. Department of Defense (DoD). Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is an Fc-modified humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix’s infectious disease portfolio includes TNX-801, a vaccine in development for mpox and smallpox, as well as TNX-4200 for which Tonix has a contract with the U.S. DoD’s Defense Threat Reduction Agency (DTRA) for up to $34 million over five years. TNX-4200 is a small molecule broad-spectrum antiviral agent targeting CD45 for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, Md. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults. * Tonix’s product development candidates are investigational new drugs or biologics; their efficacy and safety have not been established and have not been approved for any indication. Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. All other marks are property of their respective owners. This press release and further information about Tonix can be found at www.tonixpharma.com. Forward Looking Statements Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the Securities and Exchange Commission (the “SEC”) on March 18, 2025, and periodic reports filed with the SEC on or after the date thereof. All of Tonix's forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof. Investor Contact Jessica Morris Tonix Pharmaceuticals [email protected] (862) 799-8599 Brian Korb astr partners (917) 653-5122 [email protected] Media Contact Ray Jordan Putnam Insights [email protected] Indication and Usage Zembrace® SymTouch® (sumatriptan succinate) injection (Zembrace) and Tosymra® (sumatriptan) nasal spray are prescription medicines used to treat acute migraine headaches with or without aura in adults who have been diagnosed with migraine. Zembrace and Tosymra are not used to prevent migraines. It is not known if Zembrace or Tosymra are safe and effective in children under 18 years of age. Important Safety Information Zembrace and Tosymra can cause serious side effects, including heart attack and other heart problems, which may lead to death. Stop use and get emergency help if you have any signs of a heart attack: discomfort in the center of your chest that lasts for more than a few minutes or goes away and comes back severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw pain or discomfort in your arms, back, neck, jaw or stomach shortness of breath with or without chest discomfort breaking out in a cold sweat nausea or vomiting feeling lightheaded Zembrace and Tosymra are not for people with risk factors for heart disease (high blood pressure or cholesterol, smoking, overweight, diabetes, family history of heart disease) unless a heart exam shows no problem Do not use Zembrace or Tosymra if you have: history of heart problems narrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease) uncontrolled high blood pressure hemiplegic or basilar migraines. If you are not sure if you have these, ask your provider. had a stroke, transient ischemic attacks (TIAs), or problems with blood circulation severe liver problems taken any of the following medicines in the last 24 hours: almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, ergotamines, or dihydroergotamine. Ask your provider for a list of these medicines if you are not sure. are taking certain antidepressants, known as monoamine oxidase (MAO)-A inhibitors or it has been 2 weeks or less since you stopped taking a MAO-A inhibitor. Ask your provider for a list of these medicines if you are not sure. an allergy to sumatriptan or any of the components of Zembrace or Tosymra Tell your provider about all of your medical conditions and medicines you take, including vitamins and supplements. Zembrace and Tosymra can cause dizziness, weakness, or drowsiness. If so, do not drive a car, use machinery, or do anything where you need to be alert. Zembrace and Tosymra may cause serious side effects including: changes in color or sensation in your fingers and toes sudden or severe stomach pain, stomach pain after meals, weight loss, nausea or vomiting, constipation or diarrhea, bloody diarrhea, fever cramping and pain in your legs or hips; feeling of heaviness or tightness in your leg muscles; burning or aching pain in your feet or toes while resting; numbness, tingling, or weakness in your legs; cold feeling or color changes in one or both legs or feet increased blood pressure including a sudden severe increase even if you have no history of high blood pressure medication overuse headaches from using migraine medicine for 10 or more days each month. If your headaches get worse, call your provider. serotonin syndrome, a rare but serious problem that can happen in people using Zembrace or Tosymra, especially when used with anti-depressant medicines called SSRIs or SNRIs. Call your provider right away if you have: mental changes such as seeing things that are not there (hallucinations), agitation, or coma; fast heartbeat; changes in blood pressure; high body temperature; tight muscles; or trouble walking. hives (itchy bumps); swelling of your tongue, mouth, or throat seizures even in people who have never had seizures before The most common side effects of Zembrace and Tosymra include: pain and redness at injection site (Zembrace only); tingling or numbness in your fingers or toes; dizziness; warm, hot, burning feeling to your face (flushing); discomfort or stiffness in your neck; feeling weak, drowsy, or tired; application site (nasal) reactions (Tosymra only) and throat irritation (Tosymra only). Tell your provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of Zembrace and Tosymra. For more information, ask your provider. This is the most important information to know about Zembrace and Tosymra but is not comprehensive. For more information, talk to your provider and read the Patient Information and Instructions for Use. You can also visit https://www.tonixpharma.com or call 1-888-869-7633. You are encouraged to report adverse effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

FDA PDUFA goal date of August 15, 2025, for TNX-102 SL for the management of fibromyalgia; if approved, TNX-102 SL would become the first new drug for treating fibromyalgia in more than 15 years Announced positive topline results from Phase 1 study of TNX-1500, a next generation anti-CD40L mAb candidate in development for prevention of kidney transplant rejection and treatment of autoimmune disorders Cash and cash equivalents of $131.7 million reported as of March 31, 2025; Current cash sufficient to fund operations into the second quarter of 2026 CHATHAM, N.J., May 12, 2025 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a fully-integrated biopharmaceutical company with marketed products and a pipeline of development candidates, today announced financial results for the first quarter ended March 31, 2025, and provided an overview of recent operational highlights. “We believe TNX-102 SL (cyclobenzaprine HCl sublingual tablets)* is on track to become a new therapeutic option for patients suffering with fibromyalgia,” said Seth Lederman, M.D., Chief Executive Officer of Tonix. “TNX-102 SL would be the first member of a new class of FDA approved drugs for fibromyalgia. TNX-102 SL is a non-opioid analgesic that targets fibromyalgia’s characteristic disturbed sleep to improve the widespread pain of fibromyalgia, while also being well tolerated. Our focus continues to be on the upcoming U.S. Food and Drug Administration (FDA) Prescription Drug User Fee Act (PDUFA) goal date of August 15, 2025, for a decision on the market authorization on TNX-102 SL for the management of fibromyalgia. We are building out our commercial team for the anticipated product launch in the fourth quarter of this year. Tonix believes it has sufficient cash to fund operations beyond these key milestones.” Dr. Lederman continued, “Beyond TNX-102 SL for fibromyalgia, we are encouraged by the continued achievements in our pipeline, including positive Phase 1 results for TNX-1500, a next generation anti-CD40L Fc-modified humanized monoclonal antibody (mAb) in development for prevention of kidney transplant rejection and pre-clinical results for TNX-801, a live-virus vaccine in development for preventing mpox and smallpox. We look forward to providing additional updates to each of these promising programs in 2025.” Key Investigational Product Candidates* -- Recent Highlights Central Nervous System (CNS) Pipeline TNX-102 SL (cyclobenzaprine HCl sublingual tablets): 5.6 mg, once-daily at bedtime small molecule for the management of fibromyalgia (FM) – a centrally-acting, non-opioid analgesic. In March 2025, Tonix announced that FDA will not require an Advisory Committee meeting to discuss the Company’s New Drug Application (NDA) for TNX-102 SL for the management of fibromyalgia. The FDA previously granted Fast Track designation to TNX-102 SL for the management of fibromyalgia in 2024, a designation intended to expedite FDA review of important new drugs to treat serious conditions and fill an unmet medical need. In December 2024, the NDA for TNX-102 SL for fibromyalgia was accepted by FDA with a PDUFA goal date of August 15, 2025. The NDA was based upon two Phase 3 studies of TNX-102 SL in fibromyalgia that showed statically significant reduction in the chronic, widespread pain associated with fibromyalgia. TNX-102 SL was generally well tolerated and has no known addictive properties. If approved by the FDA, TNX-102 SL would be the first member of a new class of tertiary amine tricyclic (TAT) non-opioid analgesic drugs for fibromyalgia and the first new drug available for treating fibromyalgia in more than 15 years. Fibromyalgia affects more than 10 million adults in the U.S., most of whom are women. In April 2025, Tonix presented data and analyses of TNX-102 SL treatment and effects on fibromyalgia at the American Academy of Pain Medicine (AAPM) 2025 Annual Meeting, held in Austin, Texas, in a poster presentation titled, “Sublingual Cyclobenzaprine (TNX-102 SL) for Fibromyalgia: Efficacy and Safety in Two Randomized, Placebo-Controlled Trials.” In March 2025, the Company presented data and analyses of TNX-102 SL treatment and effects on fibromyalgia at the 7th International Congress on Controversies in Fibromyalgia, held in Vienna, Austria, in an oral presentation titled, “Transmucosal Sublingual Cyclobenzaprine (TNX-102 SL) Treatment of Fibromyalgia at Bedtime to Target Non-Restorative Sleep Showed Durable Pain Reduction in Two Double-Blind Randomized Phase 3 Studies.” TNX-102 SL in development for the treatment of acute stress reaction (ASR) and acute stress disorder (ASD), and prophylaxis against development of posttraumatic stress disorder (PTSD) The U.S. Department of Defense-funded Optimizing Acute Stress Reaction Interventions (OASIS) trial will be conducted by the University of North Carolina under an investigator-initiated investigational new drug (IND) application. The OASIS trial will examine the safety and efficacy of TNX-102 SL to reduce adverse posttraumatic neuropsychiatric sequelae among patients in the emergency department (ED) after a motor vehicle collision. Fourteen days of bedtime TNX-102 SL will be dosed and tested in the immediate aftermath of motor vehicle collision. The study will test the potential for TNX-102 SL to target trauma-related sleep disturbance and its ability to facilitate recovery from ASR and to prevent PTSD. The program has the potential to provide military personnel with a new treatment option that improves warfighter performance and resilience when administered in the early aftermath of traumatic events in the war theater. The study is expected to be initiated in the second quarter of 2025. TNX-1300 (recombinant double mutant cocaine esterase): under investigation for biologic for cocaine intoxication The National Institutes of Health (NIH)'s National Institute of Drug Abuse (NIDA) previously awarded Tonix a Cooperative Agreement grant for approximately $5 million to support development of TNX-1300. TNX-1300 has been granted Breakthrough Therapy designation by the FDA. The Company discontinued enrollment and terminated the Phase 2 CATALYST study of its TNX-1300 double-mutant cocaine esterase 200 mg, i.v. solution product candidate for the treatment of cocaine intoxication because enrollment in this emergency department-based study was slower than projected. The Company is evaluating new study designs and new endpoints for further development of TNX-1300. The CATALYST study was not discontinued for safety or efficacy reasons. Immunology Pipeline TNX-1500 (anti-CD40L Fc-modified humanized monoclonal antibody): third generation anti-CD40L monoclonal antibody under investigation for prophylaxis for organ transplant rejection and treatment of autoimmune disorders. In February 2025, Tonix announced positive topline results from its Phase 1, single ascending dose (SAD) first-in-human trial of TNX-1500 in healthy participants. The objectives of the Phase 1 trial were to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of intravenous TNX-1500, as well as to support dosing in a planned Phase 2 trial in kidney transplant recipients, pending alignment with the FDA. All objectives were met and support proceeding to a Phase 2 trial. TNX-1500 blocked the primary and secondary antibody responses to a test antigen at the 10 mg/kg and 30 mg/kg i.v. doses, showed mean half-life of 34-38 days for the 10 mg/kg and 30 mg/kg doses (supporting monthly dosing for future efficacy trials) and was generally well-tolerated with a favorable safety profile. The first proposed indication for TNX-1500 is prophylaxis of organ rejection in adult patients receiving a kidney transplant; but multiple additional indications are possible, including the treatment of autoimmune diseases. Preclinical studies have shown that TNX-1500 maintains the activity of first-generation monoclonal antibodies (mAbs), yet with reduced risk of thrombotic complications. Pharmacokinetic data support a monthly i.v. dosing regimen. This analysis together with TNX-1500’s activity and tolerability in animal models, suggests that the protein engineering of TNX-1500’s Fc region has achieved its design goals. Infectious Disease Pipeline TNX-801 (recombinant horsepox virus, minimally replicative live vaccine): potential vaccine to protect against mpox and smallpox. In April 2025, the company presented data on TNX-801 in an oral presentation at the World Vaccine Congress Washington 2025, held in Washington, D.C. The presentation titled “A Novel Single-Dose, Attenuated Live, Minimally Replicative Mpox Vaccine” highlighted positive preclinical efficacy data, demonstrating that TNX-801 protected animals from mpox and rabbitpox and was well tolerated, even in immunocompromised animals. Durable protection of rabbits from lethal rabbitpox infection was present six months after vaccination. In September 2024, Tonix announced that the WHO’s preferred target product profile (TPP), released at the WHO sponsored Mpox Research and Innovation Scientific Conference, aligns with the characteristics of TNX-801. In March 2025, Tonix announced it was awarded a grant from the Medical CBRN Defense Consortium (MCDC) to support the development of TNX-801. The grant will allow Tonix to develop a commercialization plan for TNX-801. Corporate and Partnerships – Recent Highlights* In April 2025, the Company announced it has entered into a collaborative research agreement with Makana Therapeutics, a global leader in the field of xenotransplantation, to study Tonix’s anti-CD40L (CD40 ligand, also called CD154) monoclonal antibody candidate, TNX-1500, in combination with Makana’s human-compatible pig organs and cells for the treatment of organ failure. TNX-1500 is an investigational, humanized Fc-modified IgG4 anti-CD40L antibody with high affinity for CD40L. The preclinical research and development collaboration has the potential to span multiple Makana programs including kidney, heart and islet cell xenotransplant. In April 2025, Tonix announced the launch of TONIX ONE™, a fully-integrated digital platform designed to provide resources to help patients better understand and manage their migraine condition. TONIX ONE provides an intuitive, comprehensive journey for patients by offering educational resources about migraine and the limitations of oral medications which can sometimes lead to delayed or ineffective symptom relief. The platform also connects patients directly to independent migraine specialists via telehealth services and e-prescription requests, simplifying and accelerating access to treatment. During the first quarter of 2025, the Company announced the promotion of Siobhan Fogarty to Chief Technical Officer and the appointment of Gary Ainsworth as its new Vice President, Market Access. Financial - Recent Highlight As of March 31, 2025, Tonix had $131.7 million of cash and cash equivalents, compared to $98.8 million as of December 31, 2024. Net cash used in operations was approximately $16.6 million for first quarter 2025, compared to net cash used in operations of $17.6 for the same period in 2024. On July 30, 2024, the Company entered into a Sales Agreement with AGP pursuant to which the Company may issue and sell, from time to time, shares of the Company’s common stock having an aggregate offering price of up to $250.0 million in at-the-market sales. During the three months ended March 31, 2025, the Company sold approximately 2.7 million shares of common stock for net proceeds of approximately $59.8 million. Subsequent to March 31, 2025, the Company sold 0.6 million shares of common stock under the Sales Agreement, for net proceeds of approximately $9.9 million. The Company believes that its cash resources at March 31, 2025, along with the net proceeds of $9.9 million raised from equity offerings in the second quarter of 2025, will meet its planned operating and capital expenditure requirements into the second quarter of 2026. Subsequent to March 31, 2025, the Company repurchased 150,000 of its shares of common stock outstanding under a share repurchase program, for a gross aggregate cost of approximately $2.9 million. First Quarter 2025 Financial Results Net product revenue for the first quarter 2025 was approximately $2.4 million compared to $2.5 million for the same period in 2024. Net product revenue consisted of combined net sales of Zembrace® SymTouch® and Tosymra®. Cost of Sales for the first quarter 2025 was approximately $0.9 million compared to $1.7 million for the same period in 2024. Research and development expenses for the first quarter 2025 were $7.4 million, compared to $12.9 million for the same period in 2024. This decrease is predominantly due to decreased clinical, non-clinical, manufacturing and employee-related expenses. Selling, general and administrative expenses for the first quarter 2025 were $10.1 million, compared to $9.3 for the same period in 2024. The increase was primarily due to an increase in sales and marketing expenses offset by a decrease in employee-related expenses resulting from a reduction in workforce in earlier 2024. Net loss available to common stockholders was $16.8 million, or $2.84 per share, basic and diluted, for the first quarter 2025, compared to net loss of $14.9 million, or $535.72 per share, basic and diluted, for the same period in 2024. The basic and diluted weighted average common shares outstanding for the first quarter 2025 was 5,927,231 compared to 27,886 shares for the same period in 2024. About Tonix Pharmaceuticals Holding Corp.* Tonix is a fully integrated biopharmaceutical company focused on transforming therapies for pain management and vaccines for public health challenges. Tonix’s development portfolio is focused on central nervous system (CNS) disorders. Tonix’s priority is to advance TNX-102 SL, a product candidate for the management of fibromyalgia, for which an NDA was submitted based on two statistically significant Phase 3 studies for the management of fibromyalgia and for which a PDUFA (Prescription Drug User Fee act) goal date of August 15, 2025 has been assigned for a decision on marketing authorization. In March 2025 the FDA guided that no Advisory Committee Meeting will be required for this NDA. The FDA has also granted Fast Track designation to TNX-102 SL for the management of fibromyalgia. TNX-102 SL is also being developed to treat acute stress reaction and acute stress disorder under a Physician-Initiated IND at the University of North Carolina in the OASIS study funded by the U.S. Department of Defense (DoD). Tonix’s immunology development portfolio consists of biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is an Fc-modified humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft rejection and for the treatment of autoimmune diseases. Tonix’s infectious disease portfolio includes TNX-801, a vaccine in development for mpox and smallpox, as well as TNX-4200 for which Tonix has a contract with the U.S. Department of Defense’s (DoD’s) Defense Threat Reduction Agency (DTRA) for up to $34 million over five years. TNX-4200 is a small molecule broad-spectrum antiviral agent targeting CD45 for the prevention or treatment of infections to improve the medical readiness of military personnel in biological threat environments. Tonix owns and operates a state-of-the art infectious disease research facility in Frederick, Md. Tonix Medicines, our commercial subsidiary, markets Zembrace® SymTouch® (sumatriptan injection) 3 mg and Tosymra® (sumatriptan nasal spray) 10 mg for the treatment of acute migraine with or without aura in adults. * Tonix’s product development candidates are investigational new drugs or biologics. Their efficacy and safety have not been established and have not been approved for any indication. Zembrace SymTouch, Tosymra and TONIX ONE are trademarks of Tonix Medicines. All other marks are property of their respective owners. This press release and further information about Tonix can be found at www.tonixpharma.com. Forward Looking Statements Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the failure to successfully market any of our products; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the Securities and Exchange Commission (the “SEC”) on March 18, 2025, and periodic reports filed with the SEC on or after the date thereof. All of Tonix's forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof. 1The condensed consolidated balance sheet for the year ended December 31, 2024 has been derived from the audited financial statements but do not include all of the information and footnotes required by accounting principles generally accepted in the United States for complete financial statements. Investor Contact Jessica Morris Tonix Pharmaceuticals [email protected] (862) 799-8599 Peter Vozzo ICR Healthcare [email protected] (443) 213-0505 Media Contact Ray Jordan Putnam Insights [email protected] (949) 245-5432 About Zembrace SymTouch and Tosymra Indication and Usage Zembrace® SymTouch® (sumatriptan succinate) injection (Zembrace) and Tosymra® (sumatriptan) nasal spray are prescription medicines used to treat acute migraine headaches with or without aura in adults who have been diagnosed with migraine. Zembrace and Tosymra are not used to prevent migraines. It is not known if Zembrace or Tosymra are safe and effective in children under 18 years of age. Important Safety Information Zembrace and Tosymra can cause serious side effects, including heart attack and other heart problems, which may lead to death. Stop use and get emergency help if you have any signs of a heart attack: discomfort in the center of your chest that lasts for more than a few minutes or goes away and comes back severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw pain or discomfort in your arms, back, neck, jaw or stomach shortness of breath with or without chest discomfort breaking out in a cold sweat nausea or vomiting feeling lightheaded Zembrace and Tosymra are not for people with risk factors for heart disease (high blood pressure or cholesterol, smoking, overweight, diabetes, family history of heart disease) unless a heart exam shows no problem. Do not use Zembrace or Tosymra if you have: history of heart problems narrowing of blood vessels to your legs, arms, stomach, or kidney (peripheral vascular disease) uncontrolled high blood pressure hemiplegic or basilar migraines. If you are not sure if you have these, ask your provider. had a stroke, transient ischemic attacks (TIAs), or problems with blood circulation severe liver problems taken any of the following medicines in the last 24 hours: almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, ergotamines, or dihydroergotamine. Ask your provider for a list of these medicines if you are not sure. are taking certain antidepressants, known as monoamine oxidase (MAO)-A inhibitors or it has been 2 weeks or less since you stopped taking a MAO-A inhibitor. Ask your provider for a list of these medicines if you are not sure. an allergy to sumatriptan or any of the components of Zembrace or Tosymra Tell your provider about all of your medical conditions and medicines you take, including vitamins and supplements. Zembrace and Tosymra can cause dizziness, weakness, or drowsiness. If so, do not drive a car, use machinery, or do anything where you need to be alert. Zembrace and Tosymra may cause serious side effects including: changes in color or sensation in your fingers and toes sudden or severe stomach pain, stomach pain after meals, weight loss, nausea or vomiting, constipation or diarrhea, bloody diarrhea, fever cramping and pain in your legs or hips; feeling of heaviness or tightness in your leg muscles; burning or aching pain in your feet or toes while resting; numbness, tingling, or weakness in your legs; cold feeling or color changes in one or both legs or feet increased blood pressure including a sudden severe increase even if you have no history of high blood pressure medication overuse headaches from using migraine medicine for 10 or more days each month. If your headaches get worse, call your provider. serotonin syndrome, a rare but serious problem that can happen in people using Zembrace or Tosymra, especially when used with anti-depressant medicines called SSRIs or SNRIs. Call your provider right away if you have: mental changes such as seeing things that are not there (hallucinations), agitation, or coma; fast heartbeat; changes in blood pressure; high body temperature; tight muscles; or trouble walking. hives (itchy bumps); swelling of your tongue, mouth, or throat seizures even in people who have never had seizures before The most common side effects of Zembrace and Tosymra include: pain and redness at injection site (Zembrace only); tingling or numbness in your fingers or toes; dizziness; warm, hot, burning feeling to your face (flushing); discomfort or stiffness in your neck; feeling weak, drowsy, or tired; application site (nasal) reactions (Tosymra only) and throat irritation (Tosymra only). Tell your provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of Zembrace and Tosymra. For more information, ask your provider. This is the most important information to know about Zembrace and Tosymra but is not comprehensive. For more information, talk to your provider and read the Patient Information and Instructions for Use. You can also visit https://www.tonixpharma.com or call 1-888-869-7633. You are encouraged to report adverse effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.