Welcome to Tivic Health Systems First Quarter 2025 Financial Results and Operational Update Conference Call. This call has been prerecorded, 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 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 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 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 companies SEC filings. On today's call we have Tivic Health's Chief Executive Officer, Jennifer Ernst; Interim Chief Financial Officer, Lisa Wolf; and Chief Operating Officer and President of Tivic Biopharma Division, Michael Handley. Now let me turn the call over to Jennifer Ernst.

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 is 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 combination 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 Entolimod. We also secured options on rights to its derivative Entolasta. Today I'm joined by Michael Handley, our new Chief Operating Officer and President of Tivic Biopharma. Mike joined us from Statera Biopharma and has previously launched 17 new drugs, including those that we hope Entolimod and Entolasta will supplant. So shortly I'll be asking him to provide more details about the licensed compounds, showcasing the value creation opportunity that these represent for Tivic investors.…

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 the Statera 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 remained 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 Tivic's licensed TLR5 agonist programs, specifically Entolimod and Entolasta. 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 Tivic's clinical and pre-commercial activities. On May 9, 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 Entolimod, a key value inflection point. With that, I will turn the call back over to Jennifer.

Thank you, Lisa. And as I said earlier today, we are focused on sharing more information about the TLR5 biologic program that we have initiated through this licensing agreement with Statera Biopharma. This is a big move for the company. It's also an opportunity to dramatically accelerate the value creation. And for that reason, I want to provide investors more color and insight on the opportunity, the structure of the engagement with Statera and with our financing partners, as well as the commercial roadmap. As I turn this over to Michael in a few moments to provide more depth on the scientific perspective and Entolimod’s history. Briefly, we have licensed an asset that has had over $140 million invested previously by agencies such as the DOD, Department of Defense, DARPA, the Defense Advanced Research Program Agency, NASA and BARDA. The agency focused on countermeasures, among other threats, radiological and nuclear threats. It’s no wonder then that the senior officials at the White House and FDA welcomed our briefing a few weeks ago and showed positive indications to help this important drug candidate move forward for utilization by the U.S. and our allies. Now how this came to be, Tivic has been searching for an asset to bring into the company that would complement the emerging immunomodulatory effects that we are seeing from our VNS program one that would provide disproportionate value creation opportunity for our investors. At the same time, Statera Biopharma had been looking for a partner that had the requisite commercial infrastructure and experience, including the Nasdaq listing, to provide returns to shareholders. For clarity, Statera wasn’t simply looking for an exit strategy, but a partnership, a partnership that could provide long-term value creation for their shareholders. So it truly was one of those rare occasions when two…

Jennifer, thank you so much for your kind and warm introduction. I can't tell you how excited I am to be a part of the Tivic team and also to take part in the Tivic first quarter conference call. I am already engaged in advancing Tivic's newest clinical assets and I'm confidently anticipating the commercialization of Tivic's first TLR5 drug candidate, Entolimod, and I will walk us through the proposed steps today. First, some background. The Toll-like receptor-5 or TLR5 as we've been calling it, is a unique receptor that can be targeted by therapies to modulate the immune system. As we all know, the immune system has a broad range of effects on many diseases and if not working properly can result in patient sickness or death. In the case of radiation exposure, either medical radiation or treatment – for the treatment of cancer or nuclear radiation exposure, there are two cells in the bodies that are significantly affected by ionizing radiation. The first to be affected is the hematopoietic [ph] cells in your bone marrow. These are cells that produce your white blood cells to fend off infections. The second cells that are typically targeted by radiation are gastrointestinal cells that line your intestine. These are responsible for nutrient absorption. If either of these cells are damaged or destroyed, an individual will not be able to fight off infections or absorb nutrients, eventually resulting in the patient's death. This is where our TLR5 agonists in Entolimod and its next generation version Entolasta, both drugs that activate the TLR5 receptor. In turn activate several key pathways that protect and stimulate the hematopoietic cells in the bone marrow and also protect the GI endothelial cells from dying. On acute radiation syndrome, or ARS, as we've been calling it, which is…

Thank you, Michael. I truly hope that this last section you covered helps our investors understand the significant potential opportunity with the TLR5 program with entolimod and entolasta. I think it's important to also add that the FDA granted Fast Track status to entolimod and orphan drug status for ARS. We recently met with senior leadership at the FDA who confirms these opportunities and opportunities for additional accelerated pathways and potentially emergency use designations both in the U.S. and under export control outside the U.S. In terms of the progress you mentioned, yesterday we announced our GMP manufacturing validation for entolimod. And for clarity's sake, I want to underscore that the drug itself has already been validated in the type of studies that Michael went over. It's been validated for acute radiation syndrome through Phase 3 trials under the animal rule. Filing the biological licensing application of BLA with the FDA, however, requires us to also validate the manufacturing process itself, which is what we announced and are now undertaking. Given Scorpius' team's significant experience in biological manufacturing, we have a very high level of confidence in this collaboration and made successful outcomes. With the set context, once the manufacturing process is validated, we will then need to secure bioequivalency data and one-year of stability data before filing the complete BLA with the FDA. We will obviously be communicating as each of those milestones are completed. I did promise I would briefly speak to our VNS program. I don't want to give investors the impression that our VNS program is no longer a focus. While we have reduced investment in ClearUP, we are still deeply committed to the non-invasive VNS work that we have initiated. Our prior studies of our non-invasive vagus nerve stimulation methods have already shown exciting results…

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