Annual General Meeting Transcript - FBLG 2026-09-17

Operator

Good morning, or good afternoon, and welcome to the Fibrobiologics Special Meeting of Stockholders. I would now like to turn the conference over to Pete O'Heron. Please go ahead.

Pete O’Heeron, CEO

Good morning. I'm Pete O'Heron, the founder, chairman, and chief executive officer of Fibrobiologics, and I'll be presiding at this meeting. Welcome to this special meeting of stockholders. Before I call the meeting to order, I'd like to introduce you to the other members of Fibrobiologics Board of Directors. They're Rich Cilento, Robert Hoffman, Victoria Nicholas, Kate Rubins, and Lee Steinberg. Also present today is Dr. Hamid Koja, our Chief Scientific Officer, Jason Davis, our Chief Financial Officer, and Ruben Garcia, our General Counsel and Secretary. Ruben will serve as Secretary of this meeting. I would now like to call this meeting to order. We will proceed with the formal business of the meeting as set forth in your notice of special meeting and proxy statement. After the formal part of our meeting, we'll provide you with a corporate update and an opportunity to ask questions. Please note that the meeting is being recorded and a webcast replay will be available online following today's meeting. Will the Secretary please report at this time with respect to the mailing of the notice of the meeting?

Ruben A. Garcia, General Counsel

I have an affidavit from Broadridge certifying that on July 31, 2026, a notice of the special meeting of stockholders of fiberbiologics was deposited in the U.S. mail to stockholders of record at the close of business on July 20, 2026. In accordance with Delaware law, a complete list of stockholders entitled to vote at this meeting has been made available for examination by stockholders for at least 10 days prior to this meeting.

Pete O’Heeron, CEO

At this time, I'm appointing our Secretary, Ruben Garcia, to act as Inspector of Elections at this meeting. Mr. Garcia has taken the customary oath of office to execute his duties with strict impartiality we will file this oath with the records of this meeting this function is to decide upon the qualification of voters accept their votes and when balloting on all matters is completed to tally the final votes will the secretary please report at this time with respect to the existence of a quorum proxies have been received from holders of shares of our common stock and series c preferred stocks outstanding on the record date that represents 3,423,980 of the 8,283,193 votes available to be cast at this

Ruben A. Garcia, General Counsel

meeting, which represents approximately 41% of the total number of votes available to be cast on the record date. This constitutes a quorum for the meeting today, and we may now carry out the official business of the meeting. Thank you. The Secretary will now open the polls and describe the voting procedures. The time is 11.02 a.m. Central on September 17, 2026, and the polls are now open for voting on all matters to be presented. If you already submitted your proxy card, you should not vote again unless you would like to change your vote. If you have not already voted by proxy, please mark the appropriate box on the screen, which will then be submitted for tallying. Each share of common stock is entitled to one vote, and and each share of Series C preferred stock is entitled to 13,000 votes. The polls will be closed to voting after we go through the matters to be voted on.

Pete O’Heeron, CEO

Thank you. There's one proposal to be considered by the stockholders at this meeting. The proposal is more fully described in our proxy statement filed with the SEC on July 31, 2026. The sole item of business to approve is the issuance of 8,163,266 shares of common stock issuable upon the exercise of outstanding common warrants issued pursuant to the Security Purchase Agreement dated June 25, 2026, and up to 285,714 shares of common stock issuable upon the exercise of outstanding common warrants issued pursuant to our engagement letter with HC Wainwright. The Board recommends you vote for this proposal. No other proposals have been properly submitted pursuant to our bylaws or the rules of the SEC, so no other proposals are being considered. The Secretary will now close the polls.

Ruben A. Garcia, General Counsel

The time is 11.04 a.m. Central on September 17, 2026, and the polls are now closed for voting.

Pete O’Heeron, CEO

May we have the results of the voting?

Ruben A. Garcia, General Counsel

The preliminary results for the proposal presented at this meeting are as follows. The issuance of up to 8,163,266 shares of common stock upon the exercise of outstanding common warrants issued pursuant to the securities purchase agreement, dated June 25, 2026, and up to 285,714 shares of common stock upon the exercise of outstanding common warrants issued pursuant to the engagement letter is approved. We expect to report our preliminary voting results, or if available to us on a timely basis, our final voting results on a current report on Form 8-K to be filed with the SEC within the next four business days.

Pete O’Heeron, CEO

This includes a formal portion of today's meeting, and the meeting is now adjourned. Thank you all for joining us. We will now provide a company update. I want to start with a simple message. Fiberbiologics is in a stronger place today than at any point in our history, and I could not be more excited about where we're headed. This past year tested us. Being a young public company in a difficult market, it's not for the faint of heart. We faced those challenges head-on. We made hard decisions, we stayed focused on the science, and we kept our promises. We weathered the storm, and we're coming out of it stronger, sharper, and a more determined company. Every company that builds something meaningful goes through storms. We take the long view. If you're willing to completely focus on the product and the science, you can build something that lasts for decades. That's exactly what we're doing. And look at what we've accomplished along the way. Our Phase 1-2 wound care trial is underway, and we're enrolling and dosing patients. We filed our IND with the FDA for psoriasis, and we added DEF to our board with two new remarkable members, Kate Rubins and Lee Steinberg. None of that happens alone. We owe it to you, our shareholders who believed in us, to our dedicated employees who show up every day with passion and purpose, to our management team, and to supportive board of directors that stood with us through every step. We thank you. The stem cell revolution didn't begin in a billion-dollar lab. It began with fibroblasts, nature's quiet architects of healing. At FibroBiologics, we believe the next era of medicine will be defined by regeneration, generation by restoring balance, by treating chronic disease at its roots. Our corporate update will be followed by the opportunity to ask questions about Fiber Biologics business. There's a Q&A button on your screen that you can use to submit your questions at any time. Before we begin, I'd like to note that our corporate update and responses to questions may include forward-looking statements. Actual results could differ materially from those contemplated by our forward-looking statements. Please take a look at the slides being presented at this meeting and at our filings with the SEC for discussion of the factors that could cause results to differ. Also note that any forward looking statements are based on information available to us as of today's date and we disclaim any obligation to update such statements except as required by law. Let me start with the big picture. There's four things I want every shareholder 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 are enrolling and dosing patients in our phase one, two trial in diabetic foot ulcers, and we've submitted our IND for phase 1-2 trial in psoriasis. Both programs come from the same fibroblast platform. Third, we built a patent fortress. More than 270 issued and pending patents protect the platform that can reach across many therapeutic areas. And fourth, the opportunity is massive. Chronic disease represents a $4 trillion market. That gives FibroBiologic 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 what's not going to change patients will always want to heal faster they'll always want to live longer and suffer fewer side effects we're building this company around things that will never change here's a bold statement despite decades of pharmaceutical innovation chronic diseases remain uncured 60 of americans live with a chronic disease and 90% of America's $4 trillion in annual health care costs is driven by chronic disease. Traditional drugs tend to manage symptoms. They suppress, they block, they inhibit. But biology is not a switch to be flipped. It's a system 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. And 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 extraordinary things. They drive wound healing and repair. They modulate the immune system, calming an overactive response without dangerous suppression. And they regenerate tissue by secreting the proteins and signals that rebuild damage at the cellular level. On top of that, they're practical. They're allergenic. so one donor can treat many patients their immune privilege which means they have low rejection risk we have validated library of commercial use fibroblasts low manufacturing costs a 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, and it's versatile and scalable. Start 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 types at scale, each with its own therapeutic property. Then delivery. Three, fibroblasts target the disease source where they get to work on tissue repair and appropriate immune modulation. And 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 that platform translates into a pipeline please note we've reviewed revised our pipeline format to better illustrate the different strengths of fibroblasts in wound healing CYWC 628 is 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, bed sores, and even surgical wounds. In autoimmune and immune modulation, we have CYMS-101 for multiple sclerosis, CYPS-317 for psoriasis, and CYTER-915, which aims to restore thymus function and push back against the effects of aging on the immune system. In tissue regeneration, we have CyberCell for degenerative disc disease and CYAPO913, an insulin-producing artificial pancreatic organoid for diabetes. And in oncology, TCB190 is exploring fibroblasts for cancer immunotherapy. Each of these programs draws on the same core strengths, immune modulation and tissue repair. It 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 a foot ulcer. These are not minor complications. They are life-altering events. 40% of these ulcers come back within a year and 70% within three 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 and there's a real shortage of FDA-approved therapies designed to heal them and keep them from coming 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 also validate the power of our fibroblast platform. So how does CYWC628 work? Well, instead of single cells, we use spheroids. Each spheroid is a small sphere containing between 1 and 3,000 individual fibroblasts. Once applied, these spheroids attach to the chronic wound surface and migrate onto the wound surface. We place the fibroblasts directly into the fight where they release their 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 six hours after administration, the spheroids are already attaching and spreading across the womb. It is a predictable, time-released biologic that keeps working on target. This is the data that gave us confidence to move into the clinic. In animal models, we compared multiple doses of our fibroblast spheroids against Graphics, an FDA-approved product, and against a control group. By day 19, our spheroids achieved 83.8% average closure rate compared to 66% for graphics and 51.2% for control. Our spheroids beat control with statistical significance at every dose. And by the third and fourth doses, they're also statistically superior to graphics. That's exciting data, and it's real hope for patients. Dr. Koja, our chief scientific officer, will now walk us through our CYWC-628 clinical trial design and provide an overview of our psoriasis program.

Hamid Khoja, Other

Thank you very much, Pete. The milestone we have worked so hard to achieve is here. Our CYWC628 Phase I, II clinical trial is underway. This is a randomized controlled trial of up to 120 patients across three arms. Standard of care alone, standard of care plus a low dose CYWC628, and standard of care plus high dose. Patients are randomized in a one-to-one-to-one ratio. We are 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 six months of follow-up. Our primary endpoint is safety, intolerability, and the proportion of patients with complete wound closure at 12 weeks, and percent area reduction within 12 weeks. As secondary endpoints, we will assess recurrence rates through six months and improvement in blood flow. We expect interim primary outcome data at six weeks. Testing two doses levels also sets us up to select the right dose for phase three. 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 six-week interim results support this approach. Our second clinical program targets psoriasis. Psoriasis affects 123 million people worldwide and 7.5 million here in the United States. It carries a heavy lifestyle and psychological toll. It can progress from mild to severe and is associated with considerable comorbidities. There is no disease-modifying treatment currently available. Current therapeutics often fail to provide long-term relief and can bring unwanted side Our approach is different. We use allogenic human dermal fibroblasts to recalibrate the immune system to homeostasis, not psilocyte. That distinction matters, and I'm thrilled to share that we have filed our IND with the FDA for a Phase I-II trial in psoriasis.

Hamid Khoja, Other

Here's why we are so encouraged.

Hamid Khoja, Other

In a chronic relapse annual model of psoriasis, a single administration of our fibroblasts delivered lasting benefits. 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. That durability from one treatment is exactly what patients are missing today. We also looked at what was happening inside the skin lesions. Our fibroblasts reduced three key inflammatory signals, IL-23, PNF-alpha, and IL-12 P70. Why does that matter? These are the same varied targets of the Blockbuster Monocola antibody drugs on the market today, including Humira, Inabril, Filara, Kyrizi, and Trampia. These drugs each go after one or two targets. Our fibroblast-based potential therapeutic reduces all three. This slide brings it all together. We compared CYPS-317 against the leading class of psoriasis drugs on five criteria, disease modifying potential, breath of cytokine targeting, true immune restoration, dosing frequency, and scalable, cost-efficient manufacturing. CYPS-317 checks every box. We aim to offer a durable immune reset with limited treatment instead of chronic injections. in a manufacturing model that can scale. We believe that Physician CYPS317 is a truly transformative platform-level self-therapy for psoriasis. Keith will now walk us through our other projects.

Pete O’Heeron, CEO

Thanks, Amid. Beyond our clinical programs, our platform keeps opening new doors. In multiple sclerosis, we have fully characterized fibroblast subtypes that have demonstrated significant remyelination and immune balance in animal models. In degenerative disc disease, our fibroblasts reduced inflammation and helped replace damaged cartilage. That's a high-value orthopedic market with very few regenerative options. In human longevity, we're developing fibroblast-based artificial thymic organoids. By age 60, most of our thymus function is gone, and that decline is linked to cancer, infection, chronic inflammation, and reduced response to vaccination. Restoring it could be truly transformative. In cancer, we're exploring how fibroblasts shape the tumor environment and support immune oncology. It's early, but the long-term potential is significant. Behind every breakthrough is a team willing to take on the hard road of development. Our leadership team brings more than 60 years of combined experience in medical innovation, product development, finance, and capital markets. Dr. Amit Koj, our chief scientific officer, brings more than two decades of research leadership from Chiron, Novartis Vaccines, and Eli Lilly. Jason Davis, our chief financial officer, brings more than two decades of public company finance, capital markets, and SEC experience. Biotech demands resilience, adaptability, and relentless execution. This team has lived it the past year and delivered, and I'm proud to work alongside them. we're also fortunate to have an outstanding board of directors and this year it got even stronger please join me in welcoming our two newest directors dr kate rubens she's a retired nasa astronaut microbiologist and genomics scientist kate has been a valued member of our scientific advisory board since 2022 and her firsthand knowledge of how the human body adapts and heals in extreme environments makes her a natural fit for our board lee steinberg is wildly regarded as the most influential sports agent of his generation. He brings five decades of deal-making experience, and he's been pioneering champion of brain health and human longevity for decades. His network across sports, medicine, business, and media is second to none. Kate and Lee join Rich Cilento, Victoria Nicholas, Robert Hoffman, and myself on a board with broad biotech, biopharma, and operational leadership experience. Their guidance and oversight have been invaluable especially this past year our scientific advisory board includes world-class experts from UCLA Cedar Sinai Dell Medical School at UT and MD Anderson Cancer Center they'll help us move quickly and wisely as our science advances think of them as our co-pilots keeping every decision pointed towards our goal of curing chronic disease before we open it up for questions let me say this we've met the challenges of being a public company with diligence and perseverance in this business you have to be stubborn on the vision and flexible in the details. Our vision is never wavered. How we get there, well, we refine that every single day. Our wound care trial is underway, our psoriasis IND is filed, and our best days are ahead of us. Thank you again to our shareholders, our employees, our management team, and our board of directors. Your support made all of this possible. I will now pause to see if there's any questions. Please refer to the rules of conduct and procedures posted on our virtual meeting page to see the types of questions we will not answer for additional investor information you can reach russo partners at the contact shown on the screen being no questions we want to thank you all for being here today and we look forward to sharing more progress with you soon the conference is now concluded thank you for attending today's annual meeting special meeting you may now

Operator

No disconnect.