Tivic Health Systems, Inc.

and the questions you have submitted in advance will be answered following the prepared remarks. This call is being webcast, and the replay will be available on the IR section of the company's website for three months. Before we begin, let me remind you that during today's call, management will make various forward-looking statements. Investors are questioned 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, Terrific Health issued today, as well as the risk factors contained in Terrific 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 report to be filed with the SEC today, as well as other companies' SEC filings. On today's call, we have Trivik Health's Chief Executive Officer, Jennifer Earnest, Interim Chief Financial Officer, Lisa Wolf, and Chief Operating Officer and President of Trivik Biopharma, Michael Hanley. Now let me turn the call over to Jennifer Earnest.

Thank you to the operator for that introduction, and welcome to both the investors that are listening today and to those that are listening at another time. I'm Jennifer Ernst, CEO of Tivic Health, and it is my absolute pleasure to be here with you today to share some of the perspectives on our first quarter of 2025. There's really no doubt in my mind that this will be one of the defining moments in Tivic's history. In recent months, we have catalyzed an aggressive reinvention of Tivic, It's tempting to point to a single event or a quarter, but really what we're reporting on today is the culmination of work undertaken and hard-fought battles we've had along the way that brought us to a point where we could transform the company. Last year, we were a single-product company, selling over-the-counter into a crowded direct-to-consumer marketplace. Today, and going forward, we are a diversified immunotherapeutics company. We are building on our history in immunology with a clinical pipeline and product candidates that focus on diseases where immune system dysregulation plays a central role. In lay terms, when the immune system isn't functioning properly, health suffers, and we have ways to address both the overactive and underactive immune systems. In February, we secured exclusive worldwide rights to a late-stage immunomodulatory drug candidate called Entelamod. We also secured options on rights to its derivative, Entelasta. Today, I'm joined by Michael Handley, our new Chief Operating Officer and President of Tific Biopharma. Mike joined us from Cetera Biopharma and has previously launched 17 new drugs, including those that we hope Entelamod and Entelasta will supplant. So surely I'll be asking him to provide more details about the licensed compounds, showcasing the value creation opportunity that these represent for TIVIC investors. We have rapidly begun advancing IntelliMog along its commercialization pathway. For clarity, phase three trials are already complete under the FDA's animal pathway rules, meaning that we believe we are poised to move this rapidly forward. Just this week, we announced that we have entered into a manufacturing validation agreement for GMP production and scale-up. With Intalamod fully validated for treatment of acute radiation syndrome, the first indication that we'll be pursuing, entering GMP manufacturing is an inflection point that represents the transition from clinical to commercialization phase. It is also the necessary first step in preparing the application to the FDA. So today, the licensing agreement will be our focus, but it's not the only focus for the company. The immunomodulatory effects of entolamide and entolaster are highly complementary to the work we are advancing in non-in-Vegas vagus nerve stimulation. I expect to hear or share more about the vagus nerve stimulation program next quarter. We now have, as a company, the scientific foundation that we believe will enable us to seize opportunities to address diseases caused by either under or overactive immune systems. Importantly, in this context, we've also signed an $8.4 million tranche funding agreement that is designed to infuse capital at critical inflection points while allowing the company to build market value. Structurally, we've taken an approach that offers investors less dilution while we continue to accelerate the transformation of the company into high-value markets. Shortly, I will turn this call over to Lisa Wolfe, our interim CFO, to review our Q1 financial performance. But before doing so, just a few more comments on how we have navigated a significant strategic transition. Our priority has been on enhancing shareholder value and utilizing our resources to prioritize the assets that hold the greatest potential to deliver substantial returns. That meant in Q1, we invested in securing and operationalizing the biopharmaceutical assets and supporting the clinical research in non-invasive vagus nerve stimulation. In order to manage our resources, our board of directors and the leadership of CIVIC made the strategic choice to significantly reduce advertising into our D2C product, ClearUp. At the time we were under NASDAQ review and the world at large is facing high economic uncertainty, we believe this was the right decision. It allowed us to set the transformation in motion without taking in capital under onerous terms. Decreasing advertising spend, though, did have a commensurate impact on revenue. Investors should expect that we will continue to endeavor to manage the capital of the company in ways that offer the best opportunities for return. And with that, I'd like to hand the next section over to Lisa.

Thank you, Jennifer. For ease of listening, all of the financial metrics I'll be reporting compare the first quarter ended March 31, 2025 to the prior year quarter ended March 31, 2024, unless otherwise stated. Revenue net of returns totaled 70,000 compared to 334,000 in the year-ago quarter. The decline was primarily due to a decrease in unit sales of 81% associated with reductions in our overall marketing spend. We intentionally reduced our advertising spend by 92% in order to focus our capital resources into this Daterra licensing agreement. Cost of sales decreased to $20,000 from $167,000 in the year-ago quarter, primarily due to the 81% decrease in unit sales. Gross margins increased from 50% to 72% as we reduced our product support and fulfillment costs. Operating expenses remain flat at $1.6 million for the first quarter of 2025, compared with the same period in 2024. We plan to increase our research and development investments in our vagus nerve platform and clinical applications, and to advance the development of TIVX-licensed TLR5 agonist programs, specifically in Intelamod and Intelasta. Net loss for the quarter remained flat at $1.5 million for the first quarter of 2025 compared with the first quarter of 2024. At March 31, 2025, cash and cash equivalents totaled $669,000 compared with $2 million at December 31, 2024. The company had working capital of $520,000 at March 31, 2025. We have no debt as of the end of the first quarter of 2025. Subsequent to the end of the quarter, we raised net proceeds of $1.7 million pursuant to the Equity Distribution Agreement, or ATM, program. In March, we secured a $25 million equity line of credit. Our first drawdown is expected to take place in the second quarter. Generally, the funds will be used to support advancing TIVX clinical and pre-commercial activities. On May 9th, we entered into an $8.4 million strategic financing with an investor that provides the critical funds needed to support the company's transformation. We believe these funds, along with the other sources of capital currently available, such as the equity line of credit, will be sufficient to fund the company through GMP manufacturing validation for Intolamod, a key value inflection point. With that, I will turn the call back over to Jennifer. Thank you, Lisa.