Thank you so much for joining us for the company overview of Processa Pharmaceuticals. My name is Sheila Gujrathi, and I am a member of the Processa board of directors and the founder of Vidya and former executive chair of Vidya Therapeutics. Before we jump into the strategic details, I will direct your attention to the safe harbor slide currently on your screen. I will remind listeners that our comments today will include forward-looking statements, which are subject to various risks and uncertainties detailed in our SEC filings, including our annual report on Form 10-K for the year ended December 31st, 2025, and quarterly report on Form 10-Q for the quarter ended June 30th, 2026. Processa merged with Vidya, and we are focused on advancing our lead program, VT-7208, which we believe is an excellent pipeline in a product. The acquisition is structured as a stock-for-stock transaction in which Processa acquired 100% of the outstanding equity interest of Vidya, which were exchanged based on a fixed exchange ratio for a combination of Processa common stock and newly created Series A non-voting convertible preferred stock. We entered into a definitive agreement for a private placement financing, resulting in gross proceeds of approximately $200 million from an excellent syndicate of new and existing investors, as outlined on this slide. The acquisition of Vidya brings BTK inhibitor VT-7208, Vidya's lead asset, into Processa's pipeline. The financing is expected to fund operations into the second half of 2029 and through multiple near-term clinical milestones. The shareholder vote to convert the non-voting convertible preferred stock into common stock is expected in the fourth quarter of 2026. We are advancing VT-7208, a potentially best-in-class oral once-daily BTK inhibitor designed to improve on the efficacy and safety of early-generation programs. What we believe makes this compelling is that it is a single differentiated, optimized molecule driving three parallel development programs: food allergy, chronic spontaneous urticaria, or CSU, and in neurology, relapsing multiple sclerosis, or RMS, where its CNS penetrant profile addresses an area of high unmet medical need. With the primary safety and dose escalation phases of the phase I study complete, we are excited to advance all three programs into phase II proof-of-concept studies, with initial data expected in 2027 and 2028. This transaction gives us the capital to evaluate VT-7208's potential across multiple indications in parallel rather than sequentially. From this single optimized molecule, we believe that we have a pipeline in a product optionality across several immune-mediated diseases, with the potential to expand into additional indications over time. Food allergy and CSU are our two leading programs on the peripheral systemic side. They have anticipated near-term readouts because they are fast, capital-efficient proof-of-concept studies that are easier to enroll, which lets us run multiple indications at once. Our goal is to get both trials off the ground in the second half of this year, with food allergy reading out in the second half of 2027 and CSU in the first half of 2028. In parallel, we are pursuing multiple sclerosis. Our initial study is in relapsing MS, but it will include progressive MS patients as well. We are staggering the start of that study into the first half of 2027, with data expected in the second half of 2028. We have a steady cadence of readouts across 2027 and 2028, each one with the potential and goal to validate the molecule in a new indication. Let me further frame this opportunity. BTK has become one of the most important targets in immunology, well beyond its original role in oncology. There are now regulatory approvals or demonstrated clinical proof of concept in at least 10 indications and growing outside of oncology. The mechanism is well-validated, and it is a space that is highly sought after. There are approvals in indications such as CSU, ITP, GVHD, and non-relapsing secondary progressive MS, and proof of concept in others, including relapsing forms of MS, food allergy, Sjögren's, HS, lupus, PMR, and others. Running food allergy, CSU, and relapsing MS in parallel gives us both near-term validation and long-term upside, with real room to expand into additional systemic and neuroinflammatory diseases. The unmet need in these markets is significant. In CSU, more than 1.7 million patients in the U.S. remain uncontrolled on antihistamines. In food allergy, roughly 14 million are left managing through avoidance or emergency rescue. Across MS populations, patients continue to experience irreversible disability and disease progression independent of relapse activity despite treatment, and desperately need new therapeutic options. Any one of these indications would be significant on its own. With so much activity in this space, what we think everyone is really looking for is a program that meets an optimized profile. The best possible efficacy from a BTK inhibitor, excellent safety and tolerability, and convenience. On safety, that means avoiding the two adverse events of special interest that has been observed with other compounds in this class, liver and bleeding risk. VT-7208 is designed to overcome these challenges. On convenience, it means delivering all of that in a once-daily low-dose pill. We believe that target profile is the value and the opportunity. Why is BTK such a compelling target in the first place? BTK is a validated node in B-cell biology, activation, mast cell signaling, and innate immune function, implicating it across autoimmune, allergic, and neuroinflammatory diseases. BTK is a central node that links the two arms of the immune system, the adaptive side driven by B cells, and innate immune function driven by myeloid and microglial cells. On the B-cell side, shown on the left, BTK drives B-cell proliferation, antigen presentation, and the production of disease-causing antibodies. On the myeloid side, it drives the activation of those cells by IgG Fc gamma receptor and IgE Fc epsilon receptor interactions. BTK is a uniquely convergent target because it is required both for the production of pathogenic antibodies and for mediating the effects of these antibodies on other cells. That is how a single molecule can address disease through multiple mechanisms at once and work so well across a breadth of indications in peripheral systemic conditions and the central nervous system. VT-7208 was rationally designed and optimized to overcome the limitations and liabilities of earlier BTK inhibitors. In our preclinical work, we observed that VT-7208 is a potent and highly selective compound, inhibiting BTK in both the periphery and the brain and has excellent CNS penetration and exposure, which is ideal for pursuing multiple sclerosis. VT-7208 also uses a differentiated, less reactive covalent warhead, which is a big part of what makes it safer than the earlier drugs. Across our in vitro testing and in vivo animal studies, we saw consistent, robust efficacy, a clean safety and toxicology profile with wide margins, and predictable PK, all at a low, once-daily oral dose. That's the differentiated package that gave us the confidence to take it into the clinic. Here's how we designed our first human study. Our phase I was a standard single and multiple ascending dose study with the key objectives of assessing safety and tolerability, determining our PK profile, and evaluating the drug's ability to fully engage the BTK target and hold that coverage for 24 hours or longer. For the single ascending dose study, we started at 20 mg and escalated to 60 mg, all generally well tolerated, and then tested a much lower 5 mg dose, since we already observed consistent maximal inhibition of the target at these low doses. The multiple ascending dose study was once oral daily dosing for seven days in duration. We built in extra measurements along the way. Target BTK receptor occupancy and functional inhibition in the blood cerebrospinal fluid to confirm our CNS exposure and a food effect cohort. It was an efficient design that enabled us to have confidence in a low once-daily dose and provide a comprehensive safety tolerability, systemic and CNS PK, and target engagement data package. The headline is that VT-7208 was generally well tolerated across every dose we studied, up to 60 mg a day. If you look at the table, what you mostly see are zeros, which is reassuring. There were no serious adverse events, and no one discontinued the study. The only grade three event was arm pain from repeated blood draws in the multiple dose group, which wasn't related to the drug, and there were two mild headaches that resolved on their own. Importantly for this class, we saw no liver or bleeding safety signals, which gives us confidence in the safety profile to move forward to the next stage of development. In phase I, VT-7208 showed a well-behaved, predictable, and consistent PK profile for both the SAD and MAD subject cohorts. Exposure went up in proportion to the dose. The half-life was about six hours, which is ideal for a covalent inhibitor, and we saw no accumulation of the drug with repeated dosing. We also observed nice exposure in the CSF, which we modeled would give us excellent exposure and target coverage in the brain. Now, this is a differentiated data set that got us the most excited. A measurement of BTK to receptor occupancy, which is a well-validated assay that is used to characterize the target engagement effects of covalent BTK inhibitors, which shows how much of the target the drug is locked onto and for how long. After a single dose on the left side of the slide, every dose we tested from 5 mg to 60 mg gave near complete occupancy for 24 hours and was durable, lasting beyond out to 72 hours, shown here on this slide. At the lowest dose of 5 mg, the occupancy stayed above 95% out to 48 hours and only dropped down to 90% at 72 hours. This profile supports once-a-day dosing, and if a patient misses a dose here and there, they will still be covered. For multiple doses on the right, the occupancy at these low once-daily doses were essentially maxed out and sustained, achieving near complete occupancy at steady state and lasting for several days beyond the cessation of dosing. In addition to measuring target occupancy, we also confirmed that we had functional inhibition of the target and shut down its signaling. In the multiple dose cohorts, we saw complete inhibition of phospho-BTK, which is a readout that tells us the pathway was switched off and it held for several days after the last dose. That's a durable effect, and it lines up with the sustained occupancy we just saw. Exactly what you'd expect from an irreversible inhibitor. These strong pharmacodynamic effects are occurring at once-daily doses that are quite low compared to the other BTK inhibitors. VT-7208 was designed to do what earlier BTK inhibitors couldn't: deliver potent selective inhibition in both the periphery and the CNS with a dosing and safety profile built for long-term use. We now have the phase I data in hand to confirm it. If you look across this slide, it all comes together. Validated biology and a differentiated molecule, a favorable safety profile with no dose-limiting toxicity seen to date, predictable PK and CNS exposure, and robust, durable target engagement and inhibition observed consistently at every low dose studied. Together, this data supports low once-daily oral pills, and that's a meaningful advantage for patients. A once-a-day pill regimen is easier to stay on than more frequent dosing regimens or injected treatments. On top of that, we have well-defined proof-of-concept studies with near-term data readouts, a capital-efficient plan to run them in parallel, and large multi-billion dollar estimated market opportunities. This transaction gives us the capital to advance all three indications and programs, food allergy, CSU, and relapsing MS, in parallel rather than sequentially with data expected in 2027 and 2028. Thank you so much for joining us today. We're excited about the road ahead for VT-7208 as part of Processa, and we look forward to keeping you updated as we advance all three programs through phase II and towards several near-term milestones. Thank you.
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