Hello, and welcome to Virtual Investor Conferences. On behalf of the Life Science Investor Forum and our co-host, Small Cap Research, we are very pleased you have joined us for our quarterly conference. Our next presentation is from Tivic. Please note you may submit questions for the presenter in the box to the left of the slides. You can also view a company's availability for a one-on-one meeting by clicking "Book Meeting" in the top toolbar. At this point, I'm very pleased to introduce the Chief Executive Officer of Tivic, which trades on the NASDAQ under the symbol TIVC. Welcome, Jennifer. Thank you, and thank you for this opportunity to, for many people, reintroduce Tivic. For those of you that haven't heard of us before, this is a company that has been in a transformation process over the last year, and I hope what you hear today shows that we are at a very interesting point for investment. First of all, thank you to everyone. Tivic is a focused late-stage diversified immunotherapeutics company. What I mean by that is we're harnessing the power of the immune system to fight disease, to restore health, and hopefully to save lives. That is really our mission, to drive forward on the immune system's function. All of you have probably seen such a safe harbor statement before. Let me move into telling you now a little bit more about the company. I'm one of the, as I noted, I'm the CEO and one of the co-founders of the company. If we were talking last year, I would have told you that we were a single-product company with a product in treating allergies, sinus, cold, and breast pain. At this point in time, we have now significantly diversified our portfolio and began to move out of the consumer product space. In May of last year, I started a program in vagus nerve stimulation that has generated tremendous results. In February, just a short four months ago, I licensed a phase III immunotherapy program. It consists of two molecules, one of which has been the subject of over $140 million invested by agencies such as DARPA, DoD, BARDA, in developing an acute radiation syndrome treatment that also has applications then in oncology and hematology. Two molecules, six different indications we've structured our license around, and post phase III for acute radiation syndrome. All necessary clinical testing has been completed for phase III. We are in the process already of manufacturing validation and scale-up. In February, we licensed a new molecule. March 31, the end of the quarter, we regained our NASDAQ minimum bid compliance, and on May 14, entered a GMP Manufacturing Agreement. That's four months from the time we licensed the product to the point we were into a GMP Manufacturing Agreement that will begin to support the BLA filing for these assets. I will tell you objectively, I don't think the market has fully absorbed yet what we have brought into the company. This newly licensed portfolio complements an internally developed portfolio in non-invasive vagus nerve stimulation, which I'll show you a bit more about as we go through here. This now positions the company squarely in a $183 billion market segment with multiple commercial and clinical catalysts now in the next 18 months. Why we are different in the immunotherapeutics market is that we're looking at an interdisciplinary approach. We're thinking about patient first, what is the problem we need to solve, and the different methodologies to solve it. I think we are probably unique today in having a bioelectronic and biologic portfolio. The bioelectronic, if you look at this holistically, the big idea is that the body is an electrochemical system, and yet our pharmaceutical products treat the chemical compounds, but not the electrical signals. The bioelectronic process treats the electrical signals on the electrical signals, particularly important as we've discovered more and more linkages between the nervous system and the immune system of the body in maintaining health. This is a very unique portfolio in which our bioelectronic work today downregulates the overactive immune system, and our biologic work upregulates an underactive immune system to be able to come at it from two sides of the coin. This has given us a very broad and diverse portfolio, as I mentioned earlier, six separate indications, and also including the acute and chronic versions of several of those indications. As we are developing the platform, we have previously commercialized a product that we're in the process of looking at strategic alternatives for at the moment. Our platform in our VNS stimulation, our non-invasive VNS, has potential applications in neurologic and psychiatric disorders, particularly those that have a root neurologic underpinning, and our cardiac and autonomic system diseases. I'm going to spend most of my time at this point focusing on the phase three asset, the TLR5 program, the newly licensed asset for us with products called Intelamod and Entalasta. These are biologic drugs. They're engineered to activate a specific receptor on basically the sensory system of the body, the immune system. This receptor activates a very sophisticated pathway for fighting off invaders, for fighting off attackers in the system, activates the immune system and the white blood cell production in particular. Significant prior funding, significant number of trials that it's undergone, and the first indication for acute radiation syndrome is very far along. In fact, within weeks of having licensed this compound, we were able to start taking meetings at the White House and at the FDA, furthering conversations about opportunities for accelerated pathways for this to market. Now, Intelamod already has an FDA grant for fast-track designation. This is considered a stockpile drug, and this is one reason I want to mention this for investors, is this is not a case where you are looking to get something newly adopted or factored into a physician workflow. Once a product is available, once a stockpile agent is available and meets a particularly critical need, which I'll speak more about, I'll speak more to, the governments can begin ordering. Now, the U.S. government will require a GMP product, and so we have kicked off the GMP process and an FDA approval, possibly may accept product under an emergency use directive, an emergency use authorization. Outside of the U.S., though, there are other countries that are in desperate need of treatments for acute radiation syndrome, ones that have nuclear reactors that are under attack from foreign powers, ones that are facing dirty bombs in their streets. In those cases, countries such as that are potentially willing to take product even before the GMP process is completed, as long as we can do the purity validation. We do have multiple paths to market at the moment for, again, a recently in-licensed product. We began our GMP manufacturing at a site in Texas. The validation process began May 2024, so just last month. Now, BARDA, to give you a taste of the type of clinical data that has come out with a single dose of Intelamod, this is a lethal dose administered to mice, 70% lethal. A single dose of Intelamod administered 25 hours after radiation increased survival by threefold. Now, the drugs that are available in market right now require multiple doses, and they only treat for one factor of the damage. When we look at acute radiation syndrome or radiation damage, there are two systems that get damaged, are the dominant cause of death associated with treatment. One of them is the bone marrow gets damaged. The second is that the GI tract gets damaged, the fast replicating cells. In this case, with the mouse trials, and this is the only kind of trial required for FDA approval of this indication, the animals received no other supportive care. A single dose was able to do it, and we have evidence, very strong evidence of protecting both the GI tract and the bone marrow. We are aware of no other compound that has both protective properties. As we look at clinical milestones that are upcoming, the milestones that are upcoming, February, we licensed the product. In April, we were meeting with the White House with senior executives. In May, we kicked off our GMP manufacturing partially in response to the solid support and interest we received at those meetings. That leads us to a series of milestones. One commercial pathway is the standard pathway and the one that runs along the bottom. First GMP law, about a year of bioequivalency stability and testing, filing of the BLA grant, and then those familiar with life sciences know approximately the timeline around from the grant, what can be expected from an application filed to a grant with a fast track, with a reminder that we do have a fast track already approved or already granted. The FDA has expressed interest potentially in an emergency use application for us. This provides a potential expedited pathway in the U.S., and as I indicated earlier, the FDA, full FDA approval may not be required for sales outside the U.S. Now, the acute radiation syndrome is a beautiful indication to help fund a company because it is a stockpiling application. When we talk about a stockpile order, we could be talking anywhere from a starting order of $25 million to a starting order of $250 million. This is an indication that can help us truly build a war chest, but it may or may not be the largest indication in the portfolio. Neutropenia today, excuse me, is forecast, it's today approximately a $10 billion market. It's forecasted to be a $20 billion plus market by 2032. Neutropenia is the low white blood cell count. Now, you see this, there are autoimmune conditions that can cause it. There are certainly genetic issues. However, the most common cause of seeing neutropenia is chemotherapy and radiation, the radiation treatment that is used in cancer treatment itself. You will also see it sometimes among workers who use, who are exposed to radiation, whether through X-rays or nuclear power plant exposures in their work processes. The largest portion of the growth and the largest portion right now is expected to come from the radiation treatments that are being used in cancer treatment. I would like to look out with you why we think this application is so, the application of Intelamod in this area is so compelling. The currently approved drugs, this is a category of G-CSF drugs. You know them under brand names like Neupogen, Neulasta, M-Plate. Around G-CSF, Neupogen, Neulasta, and the biosimilars. Just saw a question come in, and I'll be happy to address some of that at the end. Bone marrow, the G-CSF drugs that are in market today only treat the bone marrow. They can be used after exposure. They are basically this blue track that you see up above here. Treat after exposure because there is not anything in this pathway and this mechanism of pathway that would provide protective solutions. Multiple doses are required, and they are approved with additional supportive care. Now, if we look at Intelamod, this TLR5 agonist addresses, starts much, much earlier, uses the NF- k B pathway. It covers the same pathway, the same G-CSF pathway. If I follow the trails here, covers the same G-CSF pathway as the current drugs do. However, it also activates a number of other protective pathways that help prevent, help with the restoration and the prevention of damage to the bone marrow and to the GI tract. That can be done with a single dose. It is well tolerated. It can be used over repeat doses, but a single dose kicks off the same pathway and is what was used in the data I showed earlier. No adjunctive care. Today, the G-CSF market is a $7.2 billion market, expected to grow to be about $14.5 billion. It means it's about two-thirds of that neutropenia market we were talking about. This is a very real opportunity for us to either bring to market or work with people who already have the channel into the G-CSF, the people that are competing tooth and nail on the G-CSF drugs to be able to partner with a company in that class. I was asked in the question box, can you provide any more color on the license? Who owns the IP and do you have global rights? Yes. Let me say a little bit more. The license is structured, it is a worldwide exclusive license. The license is structured such that we have the outright rights right now to acute radiation syndrome and to acute neutropenia. The company, Statera Biopharma, that owns the rights at the moment or owns the patents at the moment, has reserved for us exclusively the right to extend that option into these additional areas with no time limitation, no required commitments. The only commitment is that when we do take something on, we need to immediately begin development on it. There is an opportunity here for us to be very flexible in how we fund the portfolio and how we drive this commercial license forward. That license also includes a buyout clause for us. At any point during the course of our development, when cash feels appropriate, we can, in cash or equity, buy out the license and have all of the ownership of all intellectual property, the 60-plus patents that are part of this portfolio. I mentioned earlier that there are two candidates, two drugs in this. Intelamod is very, very suitable for acute treatment syndromes. If you were to take Intelamod on a regular basis, closely spaced doses on a regular basis, there is some immunogenicity that tends to develop. Entalasta, the second molecule in this, the proteins have been removed, excuse me, the proteins have been removed that cause that immunogenicity. Entalasta should be able to be used on any kind of long-lived state. That particularly becomes of interest with something like immunosenescence, and that is also covered in the Entalasta category. In the immunosenescence area, more and more we are finding that the activation of the immune system, and particularly the activation of the white blood cells, is a critical component in aging and longevity. Many of the age-related diseases we see have a root cause that stems back to dysfunction or dysregulation in the immune system. Some of them are dysregulation of the kind we're talking about underactive, and some of those aging are overactive immune systems that have gotten stuck in a hyperdrive state. You will see with aging, sometimes a disease state that you're stuck in a hyperactive state, which is where our bioelectronic portfolio comes in, and the underactive state then comes out of the fatigue of the system over time. Okay, let me, I'm going to pick up a couple of the other questions that have come in after I go through the bioelectronics, because that'll give me an ability to talk to a more complete solution. These, as I was speaking earlier, G-CSF drugs are the primary class used today, a primary class of drugs, well-researched, well-characterized. The TLR5, Intelamod, is a new class. It would be a class of TLR5 agonist being introduced that operates upstream from the G-CSF. I hope that addresses one of the questions I'm seeing. Last, I just want to mention our few minutes on our bioelectronic portfolio. It was about 25 years ago that it was discovered that the vagus nerve plays a critical role in the immune system. The vagus nerve, largest autonomic nerve in the body, it runs from the brain through to the stomach and touches every major organ in between. It is considered a very, very high-value target. Since the time of the discovery of the connection point, a number of solutions have come out in stimulation of the vagus nerve that require implanted technologies. Almost all of the medically tested, medically proven technologies that use VNS stimulation require something like implanting a pacemaker and attaching wires into the vagus nerve. We have been working on an internally developed program for which we own all of the intellectual property, and clinically testing it with the Feinstein Institutes for Medical Research at Northwell Health. These are considered the leaders in a field called bioelectronic medicine. It began emerging out of that discovery in the neurostim and the neuromodulation space that modulating the signals of the vagus nerve can control the immune system responses. What we have demonstrated so far with a medical-grade non-invasive VNS is that we have driven heart rate increases, heart rate variability increases. This is a very good marker. Healthy hearts have a lot of variability to them. We have improved heart rate variability with a 20-minute treatment over 2X, and among our responder population, that was a 2.7X. We have not seen any other non-invasive device that comes anything close to that. That is the kind of increase in heart rate variability that you see with someone who has spent a year improving their diet, exercise routines, taken extreme care, and started meditation. This is a profound movement of the heart rate, heart rate variability. We also saw a 60% decrease in gamma waves. We saw a 20% increase in theta waves, over 20% increase in theta waves. The gamma waves being the decrease in the gamma waves inducing that sense of calm, theta waves inducing a sense of focus. Right now we are in clinical studies with Feinstein Institutes for Medical Research working on optimization of the stimulation parameters. We used a fairly complex dosing regimen across the first trial. We are now going through and identifying the key properties to which the autonomic system responds most strongly so that we can continue to advance and improve those numbers, reduce the timeframes, and develop very personalized. What we're finding right now is that we will be able to develop very personalized stimulation devices using this non-invasive approach that at this time are showing improvements in biologic measures that are as good as or better than the implanted devices. That's a very exciting position when we look at what has happened in the market. The dominant approach, as I mentioned, is surgically implanted devices. Look at a company like LivaNova. It's a multi-billion, several billion dollar company with a stimulator approved for epilepsy and depression, and yet they only are cornering about 1-2% of the market, about 2% in epilepsy, about 1% in depression. That's because of the surgical requirement. It's a piece, it's a last resort. SetPoint and Galvani are both moving forward devices through approval for rheumatoid arthritis. SetPoint is very close to approved being an implanted device for rheumatoid arthritis. Yet they are only doing stimulation for one minute per day. At one minute per day, a non-invasive device would be a very compelling alternative to a surgical solution. Finally, if I look at MicroTransponder, they've had approved an implantable device for stroke rehabilitation. It's approved for six months for use, six months after a stroke, in part because you need the patient to stabilize after the stroke before you can do a surgical intervention. While the doctors that are using it are thrilled with the results they're getting, they would love to be able to get a device onto a VNS device, a proven, clinically proven and validated VNS device onto a patient within a few weeks rather than waiting months. All of this taken together, we see a very strong opportunity to move the devices we're doing into these medical-grade applications. They are much lower cost to develop than pharmaceutical products. As we look at rounding out the portfolio, we can create an extremely capital-efficient approach. We're picking up a very late-stage asset, filling the pipeline in, and then bringing along the vagus nerve stimulation to begin complementing the rest of that immunotherapeutic function that we can target. Let me address just a couple of questions that are here. Let me move to this. I'll go back. A couple of questions in here. I think I've addressed the competing alternatives to neutropenia. That's primarily the G-CSF drugs. The solutions, all of the acute radiation syndrome trials were—sorry, the question was, where are you currently undergoing medical trials for the solutions in your portfolio? The acute radiation syndrome, all of the trials have been completed for that. We are looking at starting up some new trials in the area, particularly of the neutropenia. Those will be at, those have not been yet disclosed for where we're working. The Feinstein Institutes for Medical Research at Northwell Health is running our trials for our VNS, our vagus nerve stimulation device. Previously, when we ran our sinus pain and congestion studies, they were run at Stanford University at the U.S. Center for Allergy and Sinus Research and Allergy Associates. In terms of revenue projections for ClearUp, it has actually been a somewhat lackluster performing product for us. At the moment, we found that we're actually getting better return on investment for our investors and for building out to be focusing on developing the next part of the pathway and working on, we're now working on some commercial alternatives for the ClearUp product. Not forecasting revenue at this time on that particular product line. Good product needs a real commercial marketing engine behind it. From a, okay, last thing I'll just touch on here with the cap is our cap table structure. I did mention that earlier this year we went through one of the standard micro cap problems of bid price compliance. We were through the bid price compliance and we've maintained fairly stable after that, after all of that was done. That was March 31, 2023, that we regained compliance after reverse split. Our cap table has been kept quite clean. We have no debt. We have good trading volumes, plain vanilla warrants. We do have some warrants sitting out there at about $18.44. The Series A convertible preferred shares you see here are held by Statera Biopharma, the licensor and the assignees within that. Those are people who have a shared goal to see this company very much appreciated value. In addition to what is on the cap table, as I expected for June 30th, we have a shareholder meeting on June 30th to approve the financings that have already been announced. These have already been priced into the share. We have the financing of $8.4 million that has been signed and will be tranched out over the course of the coming months. We do have an active ELOC at the moment with MassTel. All in all, the cap table, the financing structure, and the design of the cap table has been such that we are protecting the cap table as we go forward without having large blocks of shares that are suddenly subject to some form of volatility. With that, I am happy to take any final questions, the final questions that you have. Okay, at this point, thank you so much for taking the time with me today. Again, I'm Jennifer Ernst, CEO of Tivic Health. I am actually going to be a bit out of office for a bit, for a little bit after this conference. The best way to reach right now is ir@tivichealth.com. They know that I'm speaking here today and they will be planning if there's any follow-up interest to reach out and help coordinate a follow-up time for us to speak. Thank you so much for your attention. I hope you are as excited about what we have at Tivic today as I am.