FibroBiologics Inc 2024年度报告

A Letter From Our Founder, CEO and Chairman Dear Fellow Shareholders, When I founded FibroBiologics, it camefrom a deeply personal place—and a beliefthatwith the right team,the righttechnology, and the right focus, we couldmakea real difference in how chronicdiseases are treated. That belief has onlygrown stronger. Today, I’m proud to saywe’re turning that vision into measurableprogress. But at FibroBiologics, we know that realprogress is measured by outcomes. Ourmission has always been clear: to unlockthe power of fibroblasts—cells with uniqueimmune-modulatingandregenerativecapabilities—totackle chronic diseasesthat affect millions of people around theworld. That’s where our focus is. That’swhere we’re driving innovation. 2024 was a defining year for us. Our publicdebut on Nasdaq and our inclusion in theRussell2000Indexweren’tjustmilestones—theywere validation of thedisciplined,thoughtful approach we’vetakento building a company that’spositionedfor long-term impact.We’vealsoseen early recognition from theinvestmentcommunity,with three sell-sideanalysts initiating coverage,andstrong visibility from our national mediacampaign on CNBC and Fox Business. We’rebuildingsomethingenduring—powered by science, driven by purpose,and built to last. Strategic Horizons: 2025 & Beyond As we chart our course for the next few years, several strategic imperatives will guide ourwork: Platform Expansion Through Clinical Validation Our immediate focus, the diabetic foot ulcer trial, represents an entry point to validateour platform technology in the wound care space. With 33 million affected patientsworldwide and current treatments falling short (20% amputation rates and 70% three-year recurrence), this market presents both an unmet medical need and commercialopportunity. We are preparing to initiate a Phase 1/2 clinical trial in the second half of 2025 to evaluateour fibroblast-based spheroid product candidate, CYWC628, for the treatment of diabeticfoot ulcers. This trial aims to assess the safety and efficacy of CYWC628, focusing on thepercentageof wound closure within 12 weeks.To support this endeavor,we havepartnered with Charles River Laboratories, which will serve as the contract developmentand manufacturing organization (CDMO) to produce the necessary therapeutic cell banksand drug products under current good manufacturing practice conditions (cGMP). Upcoming near-term milestones for the diabetic foot ulcer trial include: Initiation of the clinical trial (2H 2025)First patient enrollment (Q3 2025)Interim efficacy data (Q4 2025)Completion of the clinical trial (Q4 2025) Pioneering Cellular Architectures Our work in spheroids and organoids represents the next frontier beyond single-celltherapies.Rather than replicating natural structures,we are engineering optimizedcellular compositions akin to naturally occurring cellular environments in the body, toprovide the lost functionality of the original organ. This approach has the potential to set us apart from single-cell therapies in three ways: Enhanced therapeutic potency through optimized cell-to-cell communication.Superior persistence in tissue environments.Potential for targeted delivery to specific organs andsystems. Strategic Disease Selection Ratherthan pursuing the most common conditions,we are strategically targetingindications where: Existing treatments fundamentally fail to address the root causes of chronic diseases.Cellular dysregulation plays a central role.Our fibroblast technology offers distinct advantages over alternative approaches,including stem cell therapies. This strategic disease selection supports our focus on multiple sclerosis (affecting 2.8million people globally), psoriasis (123 million people), degenerative disc disease, and ouremerging work in oncology. In each case, we are not trying to be marginally better thanexisting treatments; we are pursuing transformative outcomes. Intellectual Property Our intellectual property position continues to grow as we extend our world leadershipposition in the therapeutic use of fibroblasts. We are protecting our innovations in themanufacturing process, precise manipulation of the microcellular environment throughgenetic modification, and enhancing mitochondrial performance. Beyond Treatment to Regeneration Our most ambitious work, the artificial thymus organoid technology, moves beyonddisease treatment to fundamental regeneration of immune function. We have developedan innovative artificial thymus organoid composed of fibroblasts and thymus-derivedcells that is demonstrating significant potential in restoring immune function. In preclinical studies, these organoids persisted and functioned for over 60 days post-transplantation, achieving vascularization and generating a diverse array of mature Tcells, including CD4, CD8, T-regulatory, and gamma delta T cells. Notably, the organoidsproduced T cells with diverse TCR-beta chains, which enable the recognition of a broadspectrum of antigens