Welcome to Tivic Health Systems January 7 special conference call. This call has been pre-recorded. 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, I would like to 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 risk 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 for the year-end December 31, 2024, and subsequent company SEC filings. On today's call, we have Tivic's Chief Executive Officer, Jennifer Ernst. Now let me turn the call over to Jennifer Ernst. Thank you. First, let me say happy New Year for everyone who is joining us today. As always, thanks for your interest in Tivic. As you know, in 2025, we took Tivic through a significant transition from a consumer health tech company to a late-stage, vertically integrated immunotherapeutics company. It started with a licensing agreement in February and culminated in December with the acquisition of manufacturing and development assets to support commercialization of the drug product candidates we had licensed earlier. We have now added substantive development and manufacturing capabilities in-house and formed a new subsidiary, Velocity Bioworks, that will support both Tivic and third-party customers. 2025 is about transformation. 2026 is all about execution. Today my goal is to provide investors insight into the strategic impact of this move, particularly in the context of this overall transformation of the company. The acquisition dramatically strengthens our operational and execution capabilities. It increases our ability to successfully deliver not only Entolimod for indications around Acute Radiation Syndrome, but also to develop, test, and manufacture formulations of Entolimod and Entolasta for neutropenia and other indications. As we dive into this acquisition, what I'd like to go through, what basically is what it is, what has already been enabled, and what it means for Tivic and for Velocity Bioworks going forward. First, let me start with what we acquired and why. On December 11, we announced the acquisition of quote, "ready-to-scale cGMP manufacturing and development assets of Scorpius Holdings, Inc." For practical purposes, these are the assets of the biomanufacturing subsidiary. Throughout 2025, we have been working with the subsidiary, Scorpius BioManufacturing. Now together, we hit very important milestones, including our cell line verification. We completed our process development and a number of other internal milestones that have been necessary to move us into the current good manufacturing processes or cGMP that are required by the FDA. Having hit those milestones as we mapped out our next steps, it quickly became apparent that we were poised to become their largest customer. At the same time, I'll just say, like, let's call it, forces converged that created an economic opportunity for us. To get a little bit more context here, as we worked with Scorpius, we'd also looked at whether we should consider moving our cGMP processes to other out-of-house contract development and manufacturing organizations or CDMOs. Along that line, we were quoted $30 million-$32 million to complete the cGMP production needed for our BLA filing, and the lead times were ranging from anywhere from 12 months-24 months to get into the production queue. Now, that doesn't even count the time to work out the project, to negotiate contracts and such. As it worked out, we were able to acquire all process development, analytics, quality assessment, testing, manufacturing capabilities for microbial and mammalian production for approximately $16 million. At closing, we were able to immediately begin our engineering scale-up, the final step before moving to cGMP. That accelerated start led us to successfully completing a 200x scale-up that we announced this morning. Within weeks of closing, we demonstrated the final steps needed to achieve commercial scale, meeting all drug release requirements related to purity, potency, and yield. With the acquisition, Tivic went overnight from having no internal production or development capability to a company now able to produce tens of millions of doses per year of Entolimod just on the installed capacity. That means product for Acute Radiation Syndrome, for stockpiling, for neutropenia, and other indications of Entolimod and Entolasta. Overnight, able to produce tens of millions. With the development capability we added, we can accelerate every candidate in our clinical pipeline, essentially future-proofing the company. We have moved Tivic Health much, much, much closer to realizing the commercialization and licensing opportunities of Entolimod for Acute Radiation Syndrome and for our broader family of related assets. The other game-changing development in this story is the launch of Velocity Bioworks as a subsidiary. Velocity Bioworks serves two mission-critical purposes and functions. First, as you heard, our decision to bring development and manufacturing capabilities in-house allows us to dramatically lower costs for Entolimod and eventually for Entolasta. It also eliminated the incredibly long wait times we and other small development stage biotechs just like us will face when outsourcing manufacturing. I cannot emphasize enough that the speed and efficiency with which our team demonstrated the microbial expression of Entolimod at scale was truly remarkable, and it could not have been achieved without the acquisition. This acquisition is key to our ability to continue to achieve critical manufacturing milestones. This also puts us in such a strong position going into our meeting later this month with BARDA, the part of the U.S. government that is responsible for the Strategic National Stockpile. The San Antonio site can produce, store, and manage tens of millions of doses per year, making Entolimod readily available for response in a nuclear incident. The city of San Antonio itself is surrounded by five military bases and two major airports, and product can reach any site in the U.S. within hours. When it comes to treating Acute Radiation Syndrome, time is of the essence, and this is a particularly strong component that we now added into our arsenal. The other part of the opportunity, though, is the potential to generate meaningful revenue as a third-party CDMO in 2026. Now, we own a state-of-the-art CDMO built for fast, high-quality biologic production that can serve Tivic and third-party biotechs. Plans are already well underway to offer biomanufacturing services and unlock the potential for meaningful revenue through the operation and marketing of Velocity Bioworks. We continue to make strides in advancing our TLR5 agonist program with our lead candidate, Entolimod, progressing toward pivotal regulatory milestones. To accelerate our development timeline and strengthen our strategic position with government agencies, we were able to establish Velocity Bioworks. This is a wholly owned contract development and manufacturing organization. The vertical integration delivers transformative advantages for Tivic. Now, first, we have direct control of our manufacturing schedules. It eliminates the dependency on external CDMO capacity constraints. It moves us quickly forward, and it enables a rapid advancement of our next generation of TLR5 molecules. Just to put a little more color on that, what I mean is the additional formulations, the Entolasta products, the opportunities that we would not necessarily even be accelerating right now, we can do almost immediately within this site. This allows us a significant acceleration. We can respond immediately to clinical program needs without waiting for external manufacturing queues. Second, the ownership of a U.S.-based manufacturing capability significantly strengthens our position with the Department of Defense and BARDA. These agencies prioritize supply chain security and domestic manufacturing capability, particularly in the wake of the BIOSECURE Act, and particularly for medical countermeasures. Our ability to control our own supply chain addresses one of their core concerns and demonstrates our ability to deliver at scale during national emergencies. This revenue potential significantly strengthens our overall financial position and allows the CDMO to operate independently without drawing on corporate resources as we get it up to scale. The phase I and phase II biologics contract manufacturing segment represents one of the fastest-growing opportunities in the CDMO space, and Velocity is strategically positioned to capture significant market share. The biologic CDMO market is projected to reach approximately $145 billion by 2037 and is growing at a compound growth rate of over 15%. That's according to recent market analysis from Research Nester and Precedence Research. More importantly, the phase I and phase II segment is growing even faster at 17%-19% annually as over 1,200 biotechnology companies globally, over 1,200 biotech companies globally advance biologics through the early clinical development. These companies, just like Tivic, face a critical capacity gap. The large established CDMOs like Lonza, Samsung Biologics, and WuXi prioritize late-stage and commercial manufacturing due to higher margins and the longer contract durations. As a result, small to mid-sized technology companies, those that are often acquisition targets as well, face 18 month-24 month wait times for manufacturing slots, and particularly high pricing from tier one CDMOs often exceeds their budget. This creates a substantial underserved market that Velocity is designed to address. At 100% capacity utilization, our facilities could realize as much as $70 million in annual top-line revenue with serving 15-20 concurrent client programs. Several market drivers are fueling a rapid growth in biologics contract manufacturing. First, there is a rising demand for monoclonal antibodies and biosimilars. Monoclonal antibodies represent the largest therapeutic class with over 100 FDA-approved products and 500 more in clinical development. As blockbuster biologics lose patent protection over the next decade, representing over $150 billion in sales, biosimilar development is accelerating rapidly, and these biosimilar developers need CDMOs with analytical capabilities to demonstrate comparability and cost-efficient manufacturing to compete on price. Second, the growth in cell and gene therapies is creating unprecedented demand for specialized manufacturing. The FDA expects to approve 10-20 cell and gene therapy products annually by 2027, and plasmid DNA manufacturing capacity is severely constrained. While Velocity Bioworks's initial focus is on protein expression, our facility infrastructure provides a foundation for future expansions into plasmid DNA manufacturing. Third, the increasing prevalence of chronic and rare diseases is expanding addressable patient populations. The diabetes, cardiovascular disease, and neurodegenerative conditions affect hundreds of millions of patients globally, while over 7,000 rare diseases, 95% of which lack approved treatments, represent attractive opportunities for biotech investment. I'll note also that the aging population is driving sustained pharmaceutical demand growth. The number of people aged 65 and older will double from 761 million in 2021- 1.6 billion by 2015. This demographic alone accounts for 3x-5x higher pharmaceutical spending than younger cohorts. Velocity Bioworks was purpose-built as a manufacturing platform that emphasizes speed to final product for clinical testing. We recognize that there are meaningful opportunities to compress both the sales cycle and the actual production timeline through streamlined processes and advanced technologies. Our objective is to provide premium service to public biotech companies with early to mid-stage biologics and monoclonal antibodies with an unwavering focus on accelerating their path to clinical trials. Our vision for Velocity Bioworks extends beyond simply filling manufacturing capacity, though. I mean, we are building a strategic asset that serves multiple purposes. This is accelerating Tivic's proprietary TLR5 platform. We are strengthening our position with government agencies through demonstrated manufacturing capability and supply chain control. Now, taken in total, this move has established Tivic Health as a vertically integrated biopharmaceutical company with end-to-end capabilities from discovery through commercial scale manufacturing. The timing of this investment is also particularly strategic. We are entering the CDMO market at a point of structural transformation where outsourcing is accelerating, early-stage capacity is constrained, and emerging biotech companies are desperate for manufacturing partners that can move at their speed, and thus the name Velocity Bioworks. Velocity Bioworks is positioned to capture this wave of demand while building long-term strategic value for Tivic and its shareholders. Finally, I'd like to speak about the financing package that made this transaction and the rapid progress immediately thereafter possible. There are times when debt is the right move for a company. For example, in this case, acquiring significant capital assets. Now, 3i Group, a prior investor in Scorpius BioManufacturing, put forward a strong financing package that included financing the acquisition and $18 million of upfront new capital into Tivic immediately, buying out prior investors and providing access to a total of $75 million in preferred convertible equity as we move the company forward. Now on the revenue front, we anticipate that the acceleration of Entolimod to commercialization through agreements with BARDA, opportunities for emergency use outside the U.S., and the potential to generate revenue through third-party customers at Velocity Bioworks will be sufficient to service the debt obligations, particularly under the deferred payment structure. The equity agreement allows us to flexibly access capital as we need it while we execute on the 2026 strategy and beyond. We did take an opportunity for questions, and I'll go through a few of those, but before I go into the Q&A, I just want to highlight a recap here. The acquisition and financing we completed in December accelerates and de-risks our lead product candidate Entolimod. It provides cost savings and acceleration across the full drug development pipeline. It creates new short-term revenue opportunities independent of the drug product candidates. The financing package offers us flexible access to capital alongside the customer and revenue development opportunities. 2025 was about transformation. 2026 is all about execution. Since the close of the transaction, we've heard a few questions. Also appreciate the ones that were sent in ahead of time. There's a couple I'd like to tackle directly. Starting off with how much would a facility like the one you acquired cost to build from scratch? Roughly around what we acquired for $16 million, approximately $80 million-$100 million plus if viewers would try to build that from scratch. That capital expense is often what will underlie the CDMO expenses. Because we got into the capital position with it at such a low cost, it really does enable the cost savings for us and enable the operations. That actually feeds into the next question, which is, CDMOs are extensive operations. Given the expense of operating a CDMO, how is that translating to cost savings from the acquisition? Let me just start by saying that CDMO cost structures are largely driven by two factors. One is the CapEx for equipment, which we acquired at a steep discount already in place, ready to operate. There's some requalification work needed, but the second part of the cost structure is the personnel cost. Tivic would have needed to be hiring many of the same capabilities and skills whether we were setting up operations as a CDMO or setting up the company to be able to move the BLA process forward. When we ran the economics of outsourcing, hiring a third party, where we would be basically paying somebody else the money, we ran the economics of outsourcing versus the capital and operating expense of bringing the manufacturing in-house under the agreements we could secure. We found that between now and the time we get to filing a biologics application, we could expect to be saving on the order of about $10 million over that period. Those savings should be even greater when we look at the full product line of the life cycle of the family of drugs, including multiple oncology applications for both Entolimod and Entolasta. We are developing what very realistically could be a multi-billion-dollar drug. In that context, the time savings are every bit as important. Every day of delay is millions of dollars lost revenue potential, whether that's for us or an acquirer or licensee. In the big picture, as I mentioned earlier, queue times of 12 months-24 months, saving time is where the big payback is. I'll also note that given CDMO capacity is saturated, it's resulting in long queue times. This is increasingly a problem for biotech companies to meet their milestones. Having secured production capacity is now becoming a significant valuation driver for biotech companies. Next question was, you took on $60 million in debt. How do you plan to service the debt payments? I hope that what I've shared today has helped address this. Payments start 18 months from the signing. Velocity Bioworks itself is a new source of revenue and planned profit center. In addition, the acquisition accelerates our drug development and secures manufacturing capabilities for Entolimod. Having internal capacity at a facility designed initially for government security requirements should increase our likelihood of securing customer funding from the U.S. or from outside the U.S. governments and military operations that are seeking or assessing Entolimod as a radiation countermeasure. How much can you produce at Velocity Bioworks? Production capacity on what is installed today, the single reactor is over 20 million doses of Entolimod. Let me stop there and say 20 million doses of Entolimod is a $1.6 billion-$2 billion revenue potential. The site is provisioned to allow further expansion, including higher volume reactors that were part of the transaction. For example, our first cGMP batch is slated to be 200 liters. We also have now a 2,000-liter reactor that could be provisioned. Net takeaway, our access to manufacturing is a given. We have completely taken the constraint of outside manufacturing off the table. We are enabling at Velocity Bioworks with what is installed today, several billion dollars of revenue capacity. Are you planning to bring other customers into Velocity Bioworks? I mean, yes, we do plan to bring additional customers into Velocity Bioworks. Tivic is definitely the anchor customer. As we work with the team, which I've been talking about this being the pilot customer, the anchor customer. The immediate priority is getting our first materials produced under cGMP controls. Now, there is actually a lot more capacity at Velocity Bioworks than we ourselves are fully utilizing. It makes sense that that capacity selectively available, we can anticipate third-party revenue from Velocity Bioworks starting later in the year. What do you expect to come out of the BARDA meeting in January? I appreciate you getting this question because the meeting with BARDA is a TechWatch. It's not a meeting where orders are going to be taking place. It is a critical indicator of the agency's interest in Entolimod as part of our nation's defense. The TechWatch gets all the right stakeholders in the room at the same time to map a path forward. We'll be reviewing with them historical clinical data, the manufacturing capabilities U.S. government as a customer. Out of the meeting, what we are anticipating is indicators of interest and next steps to move us along that pathway. In closing, in only a year, Tivic has accomplished an extraordinary acceleration in revenue generating opportunities. In 2026, we will not take our eye off the prize. Entolimod is on track to complete the next manufacturing steps that will enable the filing of the BLA through the cGMP manufacturing process. This therapy has the potential to be the only therapy that can prevent as well as treat radiation-related damage to both human hematopoietic, or the blood cells, and gastrointestinal cells, and to do so with a single dose. In 2026, we can also accelerate the clinical and product development timelines across the oncology portfolio, unlocking the multi-billion-dollar opportunities for Entolimod. We have new revenue opportunities with Velocity Bioworks that are almost entirely accretive to the bottom line. This transformation that we took the company through has created, within the next 12 months, multiple value inflection points. I know you've heard it from me before, but I don't think the company has ever been in a stronger position to begin creating shareholder value with the combination of Entolimod and the secured assets that we brought in December. with that, I hope that this has provided investors a much deeper insight into why we undertook this transaction and what it means for the company going forward. Again, thank you for taking the time, and Happy New Year. Thank you. This will conclude today's conference. You may disconnect your lines at this time. Thank you for your participation.