FibroBiologics, Inc. Common Stock Investor update

Thank you. He saved me the agony of reading my own forward-looking statements, so I'll just start. FibroBiologics is in a strong place today, stronger than we've ever had in our history. We couldn't be more excited about where we're heading. Every company that builds something meaningful goes through storms, and we take the long view. If you're willing to completely focus on a product and science, you can build something that lasts for decades. That's exactly what we're doing. Look what we've accomplished along the way. Our phase I/II wound care trial is underway. We're enrolling and dosing patients. We filed our IND with the FDA for psoriasis, and we've added depth to our board with two new remarkable directors, Kathleen Rubins and Leigh Steinberg. Let me start again. Let me start with the big picture. There's four things I want everyone to take away from today.

First, we're building an untapped differentiated cell therapy. Fibroblasts are the most abundant and architecturally central cell type in the body. They remodel tissue, regulate inflammation, and communicate across every organ system. For decades, the world overlooked them in favor of immune cells and stem cells. We did not. Second, we have real clinical momentum. We're enrolling and dosing patients in our phase I/II trial in diabetic foot ulcers, and we've submitted our IND for phase I/II trial in psoriasis. Both programs come from the same fibroblast platform. Third, we've built a patent fortress. More than 270-plus issued and pending patents protect a platform that can reach across many therapeutic areas. Fourth, the opportunity is massive. Chronic disease represents a $4 trillion market. That gives FibroBiologics a rare chance to build a diversified, durable business from a single biological engine.

Most people ask what's going to change over the next 10 years. We ask a different question. We ask what's not going to change. Patients will always want to heal faster, live longer, and suffer fewer side effects. We're building this company around those things that will never change. Here's a bold statement. Despite decades of pharmaceutical innovation, chronic diseases remain uncured. 60% of Americans live with chronic disease, and 90% of America's $4 trillion in annual healthcare costs is driven by chronic disease. Traditional drugs tend to manage symptoms. They suppress. They block. They inhibit. Biology is not a switch to be flipped, it's a system that has to be restored. We believe cures will come from cell therapy, gene therapy, and immunotherapy. These are approaches that work with biology, not against it. We believe fibroblasts are one of the most promising opportunities in that landscape.

Fibroblasts are the most prevalent cell type in the human body, and they do three things extraordinarily well. They drive wound care and repair. They modulate the immune system, calming an overactive response with dangerous suppression. They regenerate tissue by secreting proteins and signals that rebuild damage at the cellular level. On top of that, they're practical. They're allogenic, so one donor can treat many patients. They're immune privileged, which means the low rejection risk. We have a validated library of commercial use fibroblasts, low manufacturing costs, scalable spheroid delivery platform, and more than 30 years of peer-reviewed science behind us. Put simply, our approach guides the immune system back to balance and lets the body heal itself with the potential for durable treatment and significantly fewer side effects. This is our engine. It's versatile and scalable. It starts with cell sourcing.

We harvest allogenic fibroblasts from accessible tissue sources, giving us an abundant starting material with minimal invasiveness. Next is expansion. We grow disease-specific cell subtypes at scale, each with its own therapeutic properties. Then delivery. Fibroblasts target the disease source where they get to work on tissue repair and appropriate immune modulation. Finally, therapeutic action. Fibroblasts act as living factories, releasing cytokines, growth factors, and matrix proteins that can drive anti-inflammatory and regenerative outcomes. One platform, many diseases. That's the power of this model. Every program we advance teaches us more about fibroblasts. That knowledge makes the next program faster and less costly, and every success adds momentum to the entire platform. Here's how the platform translates into a pipeline. Please note we've revised our pipeline format to better illustrate the different strengths of fibroblasts.

In wound healing, CYWC628, it's our lead program for diabetic wound care, and it's in the clinic today. It's a platform technology with potential for treating DFUs, VLUs, bedsores, burn victims, and even surgical wounds. In autoimmune immune modulation, we have CYMS101 for multiple sclerosis, CYPS317 for psoriasis, and CYTER915, which aims to restore thymic function and pushes back the effects of aging on the immune system. In tissue regeneration, we have CybroCell for degenerative disc disease and CYAPO913, an insulin-producing artificial pancreatic organoid for diabetes. In oncology, TCB190 is exploring fibroblasts for cancer immunotherapy. Each of these programs draws on the same core strength, immune modulation and tissue repair. That gives us many shots on goal from a single foundation. Let's talk about why we chose diabetic foot ulcers as our lead indication. Globally, more than 33 million people with diabetes develop foot ulcer.

These aren't minor complications, they're life-altering events. 40% of these ulcers come back within a year, and 70% within 3 years. 60% become infected. 20% of patients require lower extremity amputation, and 10% die within one year of their first ulcer. DFUs are the leading cause of non-traumatic lower limb amputation in the world. There's a real shortage of FDA-approved therapies designed to heal them and keep them from coming back. That's a significant commercial opportunity and, more importantly, a deeply human one. If we can improve healing here, we can change lives, and we can validate the power of our fibroblast platform. How does CYWC628 work? Instead of single cells, we use spheroid. Each spheroid is a small sphere containing 1,000 to 3,000 individual fibroblasts.

Once applied, those spheroids attach to the chronic wound surface and migrate onto that wound surface. We place the fibroblasts directly into the fight, where they release the chemokines, cytokines, and growth factors the body needs to kickstart the healing process, and they act fast. As you can see in these images, just 6 hours after administration, the spheroids are already attaching and spreading across the wound. It's a predictable time-release biologic that keeps working on target. This is the data that gave us the confidence to move into the clinic. In animal models, we compared multiple doses of our fibroblast spheroids against GRAFIX, a Smith & Nephew FDA-approved product, and against a control group. By day 19, our spheroids achieved 83.8% average wound closure, compared with 66% for GRAFIX, which is the number one product in the market.

Our spheroids beat control with statistical significance at every dose, and by the third and fourth doses, they were statistically superior to GRAFIX. That's exciting data, and it's real hope for patients. Dr. Khoja, our Chief Scientific Officer, will now walk us through the CYWC628 clinical design and provide an overview of our psoriasis program.

Thank you very much, Pete. The milestone we've worked so hard to reach is here. Our CYWC628 phase I/II clinical trial is underway. This is a randomized control trial of up to 120 patients across 3 arms: standard of care alone, standard of care plus low dose of CYWC628, and standard of care plus a high dose. Patients are randomized in this trial in a one-to-one-to-one ratio. We're focused on refractory wounds, the hardest-to-treat patients, which make any success even more meaningful. Patients receive weekly treatment for up to 12 weeks, followed by a 6 months of follow-up visit. Our primary endpoint is safety and tolerability in the proportion of patients with complete wound closure at 12 weeks and percent area reduction within 12 weeks. As a secondary endpoint, we will assess recurrence rate through 6 months and improvement in the blood flow.

We expect interim primary outcome data at week 6. Testing 2 dose levels also sets us up to select the right dose for phase III. This is a well-designed trial, and we are proud to have it running. In fact, we are assessing the FDA's new guidance surrounding acceptance of a single trial to grant marketing authorization, and may pursue a BLA upon completion of the DFU trial without the need to conduct a phase III trial if the 6-week interim results support this approach. Our second program targets psoriasis. Psoriasis affects 123 million people worldwide and 7.5 million here in the U.S. It carries a heavy lifestyle and psychological toll. It can progress from mild to severe and is associated with considerable comorbidities. There's still no disease-modifying treatment. Current therapies often fail to provide long-term relief and can bring unwanted side effects.

Our approach is different. We use allogeneic human dermal fibroblasts to recalibrate the immune system back to homeostasis and not to silence it. That distinction matters, and I'm thrilled to share that we have filed our IND with the FDA for our phase I/II trial in psoriasis. Here's why we are encouraged. In a chronic relapse model of psoriasis in an animal model, a single administration of our fibroblasts delivered lasting benefit. During the first relapse, disease severity scores dropped 67% compared with control. During the second relapse, they were still 39% lower. Both results were statistically significant. The durability from one treatment is exactly what patients are missing today. We also looked at what's happening inside the lesions. Our fibroblasts reduced 3 key inflammatory signals, IL-23, TNF-alpha, and IL-12/p70. Why does this matter? These are the very same targets of blockbuster monoclonal antibody drugs on the market today, including COSENTYX, ENBREL, STELARA, SKYRIZI, and TREMFYA.