Tivic Health Systems, Inc.

Welcome to Tivic Health Systems year-end 2024 financial results and operational update conference call. This call has been pre-recorded and the questions you have submitted in advance will be answered following the prior 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 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 risk and uncertainties that could cause actual results or outcomes to differ materially from those indicated by our forward-looking statements. Please read the safe harbor statement contained in the press release we issued today, as well as those contained in typical health filings with the SEC, including its annual report on Form 10-K of the year end December 31st, 2024. to be filed with the SEC on or about March 21st, 2024, under the heading Risk Factors, as well as the company's other filings with the SEC. On today's call with Tivic Health's Chief Executive Officer, Jennifer Ernst, and Interim Chief Financial Officer, Lisa Wolf. Now, let me turn the call over to Jennifer.

Thank you for that introduction. I am Jennifer Ernst, the CEO of Tivic Health, and welcome to our 2024 year-end corporate update. Now, while this is formally a look back at 2024, I have to say that much of what we did in 2024 has culminated in the last few weeks and considerably reshaped the company. We have advanced our vagus nerve stimulation program, and in February of 2025, we announced that we've acquired worldwide exclusive rights to a phase three immunomodulatory drug candidate. So I'd like to spend a portion of this, this front end, I'll tell you more about the drug candidate itself. We'll talk with you a little bit more about the Vegas Nerve work and how this represents a very, very different company than CIVIC has been over the last year and a half. Now, to say that we reshaped the company in the last several weeks really is quite an understatement. We announced that we've acquired worldwide exclusive rights to a Phase 3 immunomodulatory drug candidate. Over 140 million has previously been invested in the candidate. This is a toll-like receptor. We'll go into a little bit more about what the toll or agonist is about. It's an immunotherapy drug candidate called Entelamod. And we acquired a license for this clinical asset from Statera Biopharma. With this license, we not only got exclusive rights to the first indication for Entelamod, but also to five additional indications and to an additional molecular structure called Entelasta. So we now have two drug candidates in the pipeline in addition to the vagus nerve stimulation work that you've heard me talk about before. By adding a newly licensed TLR5 agonist to the pipeline, This gives us a late stage drug candidate for treating acute radiation syndrome. It's also called ARS. But importantly, we believe that this lays the foundation for building a biopharmaceutical capacity within TIVIC. And that is what I am tremendously excited about to talk with you about today. We are creating a robust pipeline that combines both biologic and bioelectronic medicine to focus on immune dysregulation. So the pharmaceutical component we've licensed is an excellent complement to our work on non-invasive vagus nerve stimulation. We've moved to that work forward throughout the year, and we are seeing increasingly positive signals that we can regulate immune and autonomic system functions with a non-invasive neurostimulation device. So between the progress we've made internally and the comprehensive agreement we've entered with Statera Biopharma, we are aggressively accelerating the strategic transformation of this company into a diversified therapeutics company, a diversified company with multiple shots on goal. So let me spend a little bit of time now to explain what we licensed and how it positions TIVIC going forward. We all know our immune system is our body's defense system. And one part of our immune system are these toll-like receptors. They're basically like security sensors that are part of that body's defense system. PLR5 in particular recognizes a specific enemy of the flag called flagella and the protein that's found in many bacteria. And when the receptor detects that flag, it triggers an immune response to fight off an invading bacteria. Now, how is that helpful to us? Entolimod is a TLR5, a Toll Receptor 5 agonist. It activates the same mechanism as that bacteria would in order to boost the immune system as a protective measure. Now, Entolimod was originally developed as a radioprotective drug for acute radiation syndrome. That occurs when high-dose radiation exposure occurs. So, think of nuclear accidents or attacks or dirty bombs. Obviously, defense agencies have been a major proponent in this. There are limited FDA-approved options for acute radiation syndrome, and they don't treat all of the factors that are associated with the condition. IntelliMod is positioned to fill a critical gap and provide several potential advantages over the existing treatments. For example, IntelliMod only requires one dose to become highly active. Other drugs that are approved today require multiple doses. It also has shown improvements in the GI tract function, something that none of the other drugs that are in market today have done. And there is shown the potential to be used prophylactically as a means to prevent radiation damage rather than just repair it. So, IntelliMod was funded extensively by the U.S. government through agencies like BARDA and the Department of Defense. As I mentioned before, the original developer spent over $140 million in its development with significant support from those agencies. With the development of Entelamod, those types of agencies are likely to be the key potential customers. This is the type of drug that nation states as well as military defense agencies will stockpile and keep on hand to have for emergency situations. Entelamod has already been tested extensively for acute radiation syndrome. As I said earlier, phase three drug, all we have to face into now is the validation and manufacturing. So what is ARS? Acute radiation syndrome is the name for a cluster of pathologies that develop soon after exposure to toxic doses of ionizing radiation. Radiation disrupts the DNA, destroys rapidly dividing cells like those that are found in the bone marrow and in the intestines, and it triggers massive inflammation. So the effects that you see depend on the dose, they depend on the duration, but generally within minutes to hours, symptoms like nausea, vomiting, diarrhea, headache, and fatigue begin developing. Those are the first signs of the cellular level of damage that is occurring in response to the radiation. In hours to days following, there may appear to be an improvement but the overall cell damage continues to spread. It's often fatal then due to the immune collapse, to organ failure, and to radiation-induced infection because the entire immune system begins to shut down and the body has no way to protect itself. Acute radiation syndrome can be lethal within hours or days. So, emergency treatments like Entelamod aims to be to protect those critical tissues and improve survival rates. Entelamon has been shown to have a 3X increase in survival rates when tested in animal models. The drugs that are available today, like Neupogen and Elasta, have been approved for treatment of ARS due to their ability to support the bone marrow repair. But studies of Entelamon have shown an improvement in both the bone marrow and the GI tract, And again, as I said, potentially being used as a standalone treatment, not necessarily requiring the additional medical support, but can be improved if used in conjunction with existing drugs. So, these are the types of studies that we will continue to advance and demonstrate in addition to the ARS application for which this drug is ready to move into manufacturing. So, the phase three studies have been completed for Entelemod. There are no human studies remaining for us to do for Entelemod. Our next step is to move into manufacturing validation. And for that, we will require wrapping up the manufacturing, a certain amount of biological testing in animals, and then into a BLA application or biologics license application with the FDA. This particular asset has been significantly de-risked. Minitivic will be able to capitalize on it a much less capital-intensive pathway than if we were attempting to, for example, develop a drug from scratch. ARS, though, is only one indication. Immune system dysregulation, an area we have been familiar with because of our history of working with the immune system through both the sinus nasal passages and through the VNS work we've been doing. Now, immune system dysregulation is a very common issue for patients that undergo medical radiation treatments. That is part of the area where we see expansion opportunity. So our next steps in telemod, what you'll hear about through the course of this year, is to commence the validation of the manufacturing process. It includes the first lot manufacturing, bioequivalency testing, and then we will file and make a request to the FDA to market a biologic product in the United States, typically expected to take approximately 18 months. The FDA will use the information we provide, the testing results we present from the manufacturing, what we present in the BLA to ensure that the biologic processes meet rigorous safety, purity, and potency standards. We expect or hope to be able to then begin marketing the biologic compound in the United States if and when the FDA issues the biologics license. This means if all goes as planned, we may be seeing first orders within about two years. So prior to FDA approval, we may also have some opportunities to market Entelemon for emergency use in other parts of the world. So this represents, as a drug candidate, a significant revenue opportunity within a relatively short window compared to other drug candidates. Now, we are also seeing a number of exciting opportunities to potentially expand our pipeline to adjacent indications. Some of the indications related to chronic radiation toxicity and, again, immune system dysregulation, I think they're seen in aging populations. They're seen among those individuals who are receiving radiation treatments and even among healthcare professionals that administer those radiation treatments. So, listen through the year for words like immunosenescence. This is a gradual age-related decline in our immune system function. Intelinod is being tested in a randomized control trial for age-related immune system dysfunction at the Mayo Clinic. Neutropenia and lymphocyte exhaustion. Now, neutropenia is a condition characterized by abnormally low numbers of neutrophils or white blood cells. That can result from chemotherapy, radiation, bone marrow disorders, and certain autoimmune conditions. And lymphocyte exhaustion similarly is a condition that occurs when immune cells, or particularly T-cells, become less effective after being exposed to infection, to cancer, or to cancer treatment. So Entelamod has been tested on humans and demonstrated utility in healthy patients and cancer patients for the treatment of neutropenia and lymphocyte exhaustion. Finally, chronic radiation syndrome. So the types of cases where conditions that are caused by the long-term exposure to low levels of radiation, and that's what we would see in the medical treatment area people that run x-rays, that run CT scans, people that work around nuclear residue or may experience occupational exposure. To treat long-term chronic syndrome, we have a second compound. We would advance the second licensed compound, Entelasta, through the clinical and regulatory trials. So leading the ramp-up of this biopharma activity within TIVIC, I am thrilled to have brought on board Michael K. Handley. Mike is a former chief executive officer, president, and chairman of Statera Biopharma, where Nthalamad was previously held. He has been absolutely instrumental in the launch of 17 drug candidates and has had access to multiple strategic buyers. Mike has joined PIVIC as our chief operating officer. That brings his experience in neuromodulation and in drug development to the table. He's also then headed the president, he is the president of Civic Biopharma, as we begin to build that program out. So, I believe, we believe that Mike is the perfect leader to head up this newly formed area. So, he'll be tasked with leading IntelliMod through the remaining steps toward the potential regulatory approval and commercialization, and will also direct future biotech pipeline development activities. whether that is through continued organic development licensing or additional inorganic opportunities that we are able to identify. The work we will be pursuing in this new biopharma capability is an ideal complement to our current focus in bioelectronics. So where we are developing this, so I want to segue now to talk a little bit more about the non-invasive vagus nerve stimulation work that we are doing. We are developing a non-invasive Cervical, that means the neck stimulation device for vagus nerve activation. This is a device that we expect will be able to treat key indications that affect large populations who are impacted by overactive immune systems. Earlier I said entolamide, entolasta, and the biologics we have licensed have a powerful effect on activating an immune system that is underactive. But there are a number of conditions such as heart diseases, neurologic diseases, and autoimmune diseases in which the immune system is overactive, opposite direction. So with the complement of both the biologic and the bioelectronic approaches, we have the ability to bring the immune system into homeostasis whether it is underactive or overactive. So each of these two programs together will work to address illnesses that are caused by the immune and autonomic system dysregulation, one through the neural stimulation pathways and one through the body's molecular pathways. I believe that we are highly, highly unique in being able to bring both solutions together as either individual candidates or in concert with each other over time to be able to address the serious disease conditions that the world faces today. So to say a little bit more then about the NCVNS program. I've mentioned before, there are surgically approved implants. These are open up the neck, stick in an implant, stimulate the vagus nerve. These have been approved for or are approaching approval for diseases like epilepsy, depression, rheumatoid arthritis. Our goal, though, is to replace the need for that surgical approach with a non-invasive approach. We're focused on vagus nerve treatments that can be done without having to put an implant in the body, but be able to deliver equal or superior in efficacy compared to the existing treatments. So, in previous studies, earlier this year, we announced results of our heart rate variability studies with the Feinstein Institute, showing that we were demonstrating significant changes in heart rate variability, in the brainwave function, and in autonomic system function. Compared to the implants, we had data that was right on par with the implant, or in some cases, better. Certainly better than most anyone has seen from a non-invasive device. Now, we currently are going through an optimization program with Feinstein, with the Feinstein Institute. So just two weeks ago, We shared that the Feinstein Institute for Medical Research presented the first layer of the data that is coming out of that optimization study. Our data showed that personalizing the vagus nerve stimulation, personalizing it, not just going at it with one frequency, but personalizing the stimulation to the individual offered a 400% increase in the effects that we saw So between having demonstrated already incredibly compelling results earlier in the year and then continuing the work in the optimization area, we are seeing an opportunity here for a profound effect with a non-invasive treatment. We believe that this data is significant because it signals a strong likelihood that we can better treat inflammatory, cardiac, and neurologic disorders without the need for invasive surgeries. Most importantly, we believe that the study strongly validates our strategy of developing these personalized neuromodulation devices, non-implantable devices, and following some of the leaders that have already informed and educated the market on VNS stimulation who have educated the market on VNS with an implanted device. And we hope to be able to then demonstrate that we can replace those implanted devices with non-invasive approaches, broadening the market, reducing the risk to patients, and opening up new therapeutic categories. Now, we expect to complete the data gathering phase of this optimization work with the Feinstein Institute sometime in the next month or two, and I would expect to be reporting that data further out in the course of this year, in Q2. Progress during the last several weeks also included expanding our U.S. and international IP portfolio. that we filed on these new novel modalities of stimulation, including the personalization, adding additional IP on a state-of-the-art method of personalizing the vagus nerve stimulation that is received. With the growing clinical data showing that tailoring key stimulation parameters to each study subject results in meaningfully improved effect on the measures of the autonomic system, we believe that this combo is a key differentiator for introducing the new vagus nerve stimulation. So I have been a bit vague about exactly where we intend to apply these. We have completed and are working through the data from work we engaged Fletcher Spate in Q3 and Q4 to do as we prioritize the selection of the first indication. So we've been looking with confidence, looking at all of the market applications for VMS, using that data about reimbursement, about physician receptiveness, patient receptiveness, our confidence continues to grow as we work through that and prepare to move into the disease-specific clinical trials. So in the short term, in the short term, we will be prioritizing the advancement of IntelliMod towards revenue. I also expect, though, that we will begin entering these disease-specific trials for the vagus nerve stimulation device later in 2025. So as we are securing our intellectual property on a global scale, today we have 16 issued patents and 11 patents pending. We also now have exclusively licensed over 60 patents as part of our agreements with Statera Biopharma. This combination of a biologic and bioelectronic immunotherapy pipeline represents a truly, truly transformational opportunity for the company. And it's an incredible opportunity and moment in time for our investors. I just want to highlight that a compelling aspect of the clinical pipeline we've created is its comparative cost effectiveness. In the world of therapeutics, for a typical non-invasive VNS device, the cost to advance a treatment through U.S. FDA approval is substantially lower than what it is to do so with a surgical implanted device. companies that have developed the implanted therapeutics have been funded to the tune of hundreds of millions of dollars. However, because of this non-invasive approach, and then take a look at the significant prior investment that has already been made for IntelliMod, the fact that there are no remaining human trials between here and revenue for the first indication, Antivic has secured the option to license five additional indications for Entelemod and its second-generation drug, Entelasta. This is an incredible moment for the company. We are a completely different company than we were six months ago. Which finally brings me to a couple of other updates important for investors. As we previously communicated, we received the notices last year from NanoStick of a bid price deficiency. In February, we presented our compliance plan to the NASDAQ hearings panel, and subsequently we received approval of the compliance plan and extension of our review. I am pleased to say, as of today, as of today, we have traded above $1 for 10 consecutive days, and we fully expect to be hearing from NASDAQ soon that we are in compliance with continued listing requirements. This morning, we also announced So we have closed an equity line of credit in the amount of $25 million. An equity line of credit, we don't take it all at once. This gives us a very flexible tool, though, for funding the company through the stages of development. If we were able to fully utilize even a portion of that line, we believe we have the commercialization of IntelliMod fully funded. And as we move forward, we can strategically finance the rest of our programs. So I started this call saying this is a transformational year for TiVoC. And a lot of what we have worked on is coming to fruition right now. We started 2024 as a single product company with an OTC product directed to consumers. We now have a highly robust immunotherapy pipeline, and I would encourage any investor who might be looking at TIVIC to go look at comparable companies in the market today who are doing immunotherapeutics and the type of valuations that are present when you have this kind of pipeline. So with that, yes, we now go to our 2024 numbers. But for me, what is most exciting about TIVIC today is looking forward to 2025 and the foundation we have created now. So let me turn now the call over to Lisa to report on a year-end balance sheet and our P&L data points.

Thank you, Jennifer. For ease of listening, all of the financial metrics I'll be reporting today compare the year ended December 31, 2024 to the prior year ended December 31, 2023, unless otherwise stated. Revenue net of returns totaled $0.8 million compared to $1.2 million a year ago. The decline was primarily due to a decrease in unit sales of 41% associated with reductions in our overall marketing spend. Cost of sales decreased 12% to 0.8 million from 0.9 million in the prior year, primarily due to a 41% decrease in unit sales. Cost of sales in 2024 included an inventory reserve of 354,000 compared with 32,000 in reserves for 2023. Disposal costs of $21,000 were incurred in 2024 related to the move to a new logistics provider. The change in logistics providers in August 2024 has resulted in cost savings and improved margins on a recurring basis. We're exploring new opportunities to increase cash flow generated by the ClearUp business. We deployed a new e-commerce web infrastructure for ClearUp, improving user experience and also upgraded the TIVIC Health Investor Relations website. Gross profit was 2,000 compared with 287,000 for the prior year. The lower gross profit in 2024 was primarily due to the 354,000 in inventory reserves recorded in 2024 compared to 32,000 in 2023. Total operating expenses were 5.7 million compared to 8.5 million for 2023. 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 Intolamod and Intolasta. Net loss for the year decreased to $5.7 million from $8.2 million for 2023. Cash and cash equivalents at December 31, 2024, totaled $2 million compared with $3.4 million at December 31, 2023. The company had working capital of $2.4 million at December 31, 2024. We have no debt as of year-end 2024 or 2023. We recently affected a reverse stock split. One of the greatest challenges of drug and device development is the need for constant capital infusions over time until full commercialization occurs. We've taken preemptive actions to solidify a promising future for TIVIC and its shareholders, which included the shareholders' approval of a 17-for-1 reverse stock split, which went into effect on March 7th. The objective of this action is to gain compliance with exchange listing requirements by potentially increasing the market price of TIVIC's common stock and making it more attractive to investors. We feel confident that with the progress we've made on meeting NASDAQ requirements, and reshaping the company to become a more diversified organization, we are well positioned for growth opportunities ahead. Now, let me turn the call back to Jennifer for closing remarks.

Thank you, Lisa. Now, as we start 2025, PIVX is a completely different company than we were a year ago. I look forward to this year more than I have any other year in the company's history. We continue with a determined focus on achieving the upcoming key milestones, those associated with the IntelliMod commercialization and with advancing our VNS programs in particular. And we view 2025 as a year of growth and progress that will continue to reshape Kivic. We will continue to move the company closer to securing regulatory approvals for what we expect will be life-changing treatments for patients in need. And on a final note, I invite you to visit our newly updated investor website, webpages where we have updated our clinical pipeline and investor deck to capture the broadened opportunities for product development and expansion. While there, you can also sign up to receive company news and filing alerts that will help you stay informed of the exciting progress that is ahead of us in real time. So I look forward to communicating with you very soon as we come back for the next earnings call. And thank you so much. I want to offer my thanks to our team, to our investors, and also to Kraft Capital, who brought this incredible opportunity to us to help us build this company going forward. So I want to thank all of our collaborators across this process of a transformation and turning Tivic now into a diversified therapeutics company.

Thank you. And with that, that does conclude today's teleconference. We thank you for your participation. You may disconnect your lines at this