Tonix Pharmaceuticals Holding Corp.

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

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

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