Processa Pharmaceuticals Inc Aktie

Thank you for standing by. My name is Demi, and I'll be your conference operator today. At this time, I would like to welcome everyone to the Processa Pharmaceuticals' announced acquisition of Vidya Therapeutics. [Operator Instructions]

I would now like to turn the conference over to George Ng, CEO. You may begin.

Good morning, everyone, and thank you for joining us for our announcement of Processa's acquisition of Vidya Therapeutics and the concurrent private placement financing.

I'm George Ng, CEO of Processa, and I'm delighted to introduce Sheila Gujrathi of Vidya Therapeutics, who, in connection with the transaction, has joined Processa's Board of Directors. She will present details on Vidya and its focus on advancing BTK inhibitor therapies for immune-mediated diseases. You can access the press release issued this morning on the Investor Relations page of our website at www.processappharma.com (sic) [ www.processapharmaceuticals.com ].

Before we jump into the strategic details, I'll direct your attention to the safe harbor slide currently on your screen. I'll 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 31, 2025, and quarterly report on Form 10-Q for the quarter ended March 31, 2026.

With that, I will now turn the call over to Sheila.

Thank you, George, and thank you to everyone for joining us today. I'm Sheila Gujrathi, Founder of Vidya and newly appointed Director of Processa. Vidya is a clinical-stage biotechnology company focused on immune system and central nervous system diseases.

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 nonvoting convertible preferred stock. As George mentioned, we entered into a definitive agreement for a private placement financing expected to result 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 nonvoting convertible preferred stock into common stock is expected in the fourth quarter of 2026.

Vidya is a clinical-stage biotechnology company focused on immune system and central nervous system diseases. We're 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's a single differentiated optimized molecule driving 3 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're excited to advance all 3 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 we have a pipeline and a product optionality across several immune-mediated diseases with the potential to expand into additional indications over time.

Food allergy and chronic spontaneous urticaria are our 2 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're pursuing multiple sclerosis. Our initial study is in relapsing MS, but it will be including progressive MS patients. We're staggering the start of that study into the first half of 2027 with data expected in the second half of 2028. So 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. So the mechanism is well validated, and it's a space that's 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, PMN 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 neuro-inflammatory diseases.

The unmet medical 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. And across MS populations, patients continue to experience irreversible disability and disease progression, independent of relapse activity despite treatment and desperately need additional therapeutic options. Any one of these indications will 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 2 adverse events of special interest that have been observed with other compounds in this class, liver and bleeding risk, and 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.

So why is BTK such a compelling target in the first place? BTK is a validated node in B-cell activation, mast cell signaling and innate immune function, implicating it across autoimmune, allergic and neuro-inflammatory diseases. BTK is a central node that links the 2 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's required both for the production of pathogenic antibodies and for mediating the effects of these antibodies on other cells. That's how a single molecule can address disease through multiple mechanisms at once and works so well across a breadth of indications in peripheral systemic conditions and in the CNS 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 a differentiated package that gave us the confidence to take it into the clinic.

Here's how we designed our first-in-human study. Our Phase I was a standard single and multiple ascending dose study with a key objective of assessing safety and tolerability, determining our pharmacokinetic 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 milligrams and escalated to 60 milligrams, all generally well tolerated and then tested a much lower 5-milligram dose since we already observed consistent maximal inhibition of the target at these low doses. The multiple ascending dose study was once-daily dosing for 7 days in duration. We built in extra measurements along the way, target BTK receptor occupancy and functional inhibition in the blood, through the spinal fluid sampling 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 provided 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 evaluated up to 60 milligrams 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 III event was arm pain from repeated blood draws in the multiple dose group, which wasn't related to the drug. And there were 2 mild headaches that resolved on their own. And 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 PK 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 6 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, that gave 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 receptor occupancy, 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 on to and for how long. After a single dose on the left side of the slide, every dose we tested from 5 to 60 milligrams gave near-complete occupancy for 24 hours and was durable, lasting beyond 24 hours out to 72 hours, shown here on the slide. At the lowest dose of 5 milligrams, the occupancy stayed above 95% after 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 would 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 this. If you look across this slide, it all comes together, validated biology and a differentiated molecule, a favorable safety profile with no dose-limiting toxicities 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 a low once-daily oral pill. 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 treatment.

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 multibillion-dollar estimated market opportunities. This transaction gives us the capital to advance all 3 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 Vidya and VT-7208 as part of Processa, and we look forward to keeping you updated as we advance all 3 programs through Phase II studies and towards several near-term milestones.

I also want to sincerely thank George and the Processa team. We're glad to be taking this next step together. Our contact information is on the screen, and we welcome any follow-up. Thank you again for your time, and have a great day.

Ladies and gentlemen, that concludes today's call. Thank you all for joining. You may now disconnect.