Welcome to Tivic Health Systems Second Quarter 2025 Financial Results and Operational Update Conference Call. This call has been prerecorded. This call is being webcast, and the replay will be available on the IR section of the company's website for 3 months. Before we begin, let me remind you that during today's call, management will make various forward-looking statements. Investors are cautioned that these forward-looking statements are based on current expectations and are subject to risks and uncertainties that could cause actual results or outcomes to differ materially from those indicated in our forward-looking statements. Please read the safe harbor statement contained in the press release that Tivic Health issued today as well as the risk factors contained in Tivic Health's filings with the SEC, including its annual report on Form 10-K of the year-end December 31, 2024, and the Form 10-Q to be filed with the SEC today as well as other company's SEC filings. On today's call, we have Tivic Health's Chief Executive Officer, Jennifer Ernst; and Chief Financial Officer, Lisa Wolf. Now let me turn the call over to Jennifer Ernst.

Thank you, and welcome to those of you who are joining us today. Before we cover the financial portion of the earnings call, I want to lay the groundwork for those who may have just begun to follow Tivic. Over the course of the last 6 months, we have reshaped the company by expanding Tivic into the biopharmaceutical sector. We've also been advancing ongoing work with our next-generation of vagus nerve stimulation devices. This combination of assets makes Tivic unique in having the ability to treat disease by addressing both the body's biochemical and bioelectronic systems that regulate immune responses. We believe we now have quite a robust set of opportunities in the pipeline and ones that are able to generate a significant return on investment. In this context, our expansion into drug development with our exclusive licensing of Statera Biopharma's portfolio, a portfolio of TLR5 agonist assets, provides Tivic a late-stage, highly derisked Phase III drug candidate and multiple additional indications. Specifically, Entolimod, the first commercial opportunity of the TLR5 portfolio was developed as a military countermeasure to lethal levels of ionizing radiation. Most governments maintain a national stockpile of emergency use quantities of treatments for ARS to be accessed in the instance of a nuclear event. Now in addition to that, in addition to the strategic national stockpile, U.S. defense agencies maintain ARS treatments to protect active duty personnel. This includes, for example, the nearly 0.25 million military and civilians deployed overseas. Because of the volume and because of these stockpile opportunities, a single contract for ARS has the potential to total several hundred million dollars. During the second quarter and in recent weeks, we have made additional progress in validating the U.S. government's interest in Entolimod for ARS. Most recently, we met with key decision-makers at the…

Thank you, Jennifer. For ease of listening, all of the financial metrics I will be reporting compare the second quarter ended June 30, 2025, to the prior year quarter ended June 30, 2024, and the 6 months ended June 30, 2025, to the 6 months ended June 30, 2024, unless otherwise stated. Financial results for the second quarter and the first half of the year reflect our transition as a company with our focus towards the biopharmaceutical market and away from the consumer device market. Revenue net of returns totaled $86,000 for the quarter compared to $140,000 in the year ago quarter. Revenue net of returns totaled $156,000 for the first half of 2025 compared to $474,000 for the first half of 2024. The decline was due to decreased unit sales of ClearUP, which were a result of reductions in our overall marketing expenditures. We have intentionally reduced our advertising expenses in order to focus our capital resources into the advancement of our TLR5 program. Cost of sales decreased to $32,000 from $110,000 in the year ago quarter and to $52,000 from $277,000 for the 6-month period. The decreases were primarily due to the decreases in unit sales and the restructuring of our supply chain with new partners that was completed in August 2024. Gross margins have increased to 63% for the second quarter compared to 21% a year ago and increased to 67% from 42% for the first half of 2025 compared to 2024. The increases were due to reductions of our product support and fulfillment costs. Operating expenses were $2 million for the second quarter of 2025 compared with $1.3 million for the same period in 2024. Operating expenses for the first half of 2025 were $3.5 million compared to $3 million for the first half of 2025. The increases were primarily due to increased research and development investments in our biologics programs, offset by reductions in sales and marketing costs for ClearUP. Net loss was $1.9 million for the second quarter of 2025 compared with $1.3 million for the second quarter of 2024. Net loss for the first half of 2025 was $3.4 million compared with $2.7 million for the first half of 2024. At June 30, 2025, cash and cash equivalents totaled $1.2 million compared with $2 million at December 31, 2024. Subsequent to the quarter's end, we raised gross proceeds of $0.9 million through utilization of our equity line of credit and the sale of Series B preferred stock pursuant to our preferred purchase agreement. The company has no debt on its balance sheet. We believe these funds, along with the $7 million in remaining planned tranches of our preferred purchase agreement will allow us to make meaningful progress toward GMP manufacturing validation for Entolimod, which is a key value inflection point for the company and will provide a strong signal of our potential to achieve commercialization. With that, I'll turn the call back over to Jennifer.

Thank you, Lisa. Let me finish my prepared remarks by highlighting a few other areas of important progress that we achieved during the quarter. We made important adjustments to our staff to align the team more closely with our newly defined focus. One of those changes included having Lisa join us now as our CFO from her previous role as Interim CFO. And Lisa, let me congratulate you on that move. We also made important investments in talent to advance the Entolimod program. To support our clinical work and create a government relations capacity, we hired key team members from Statera that include a Head of Regulatory and Quality, Clinical Operations and a new business development lead. We're very pleased to have this infusion of talent, and I'm looking forward to working with these new team members and to their contributions in advancing our clinical and commercial opportunities. Blake Gurfein stepped down as our Chief Scientific Officer, but stays on as a consultant to support advancing our VNS program as we continue to refine the focus of that program. Looking ahead, our next milestones include completing the transfer of existing INDs from Statera to Tivic, completing the cell line verification, completing our first batch of GMP materials, validating bioequivalence, which we can commence working on upon receipt of those materials, reporting out the study results of our VNS trial and meeting with the FDA for the previously mentioned Type B meeting on Entolimod. We will, of course, be providing updates to our shareholders as each of those milestones are completed. I look forward to reporting to you as we move the company increasingly into these new clinical areas and delivering what we expect will be life-changing treatments for patients in need and strong value creation for shareholders. And with that, I'd like to say thank you for the time you've taken today and have a very good rest of the day.

Thank you. This will conclude today's conference. You may disconnect your lines at this time, and thank you for your participation.