Item 1. Business FibroBiologics is a clinical-stage cell therapy company developing fibroblast-based therapies for chronic diseases and life extension applications [Overview](index=5&type=section&id=Overview) FibroBiologics, formed in April 2021, is a clinical-stage cell therapy company developing fibroblast-based therapies for chronic diseases and life extension applications - FibroBiologics is a clinical-stage cell therapy company developing fibroblast-based therapies for chronic diseases including degenerative disc disease, multiple sclerosis, wound healing, and certain cancers, with potential for life extension applications[17](index=17&type=chunk) - The company was formed in April 2021 as a spinout from FibroGenesis, acquiring rights to certain intellectual property through patent assignment and cross-licensing agreements[18](index=18&type=chunk) [Fibroblasts Technology Platform](index=5&type=section&id=Fibroblasts%20Technology%20Platform) FibroBiologics leverages fibroblasts as a cell therapy platform, highlighting their regenerative capabilities, immune-privileged nature, and cost-effectiveness - Fibroblasts are considered favorable over stem cells for cell therapy due to several advantages[21](index=21&type=chunk) - Can be non-invasively harvested from skin donors - Have a faster doubling time in culture than stem cells - Possess superior immune modulatory activity compared with stem cells - Exhibit enhanced ability to produce regenerative cytokines and growth factors compared with stem cells - Are more economical to isolate, culture and expand compared with stem cells because fibroblasts do not require the use of expensive tissue culture media - Allogeneic fibroblasts are immune-privileged and do not provoke an immune response, allowing for off-the-shelf treatments - The company plans to build its own cGMP manufacturing facility to source allogeneic fibroblast cells for clinical testing and commercial sales[21](index=21&type=chunk) [Our Strategy](index=6&type=section&id=Our%20Strategy) FibroBiologics aims to become a world leader in regenerative medicine by prioritizing clinical development, investing in manufacturing, and protecting intellectual property - Key strategic pillars include[23](index=23&type=chunk) - Attract and retain skilled scientists for preclinical and clinical studies - Prioritize clinical development on product candidates with significant unmet needs, lower risk, and market potential - Partner with Clinical Research Organizations (CROs) for successful clinical trial execution - Invest in critical capabilities for fibroblast production and supply for clinical trials and initial commercialization - Protect, expand, and defend the intellectual property portfolio around fibroblasts - Expand development efforts for product candidates with longer timelines and greater risk as funding allows - Available Capital and Planned R&D Funding (as of Dec 31, 2023) | Metric | Amount (approx.) | | :------------------------------------------------ | :----------------- | | Cash and cash equivalents (Dec 31, 2023) | $9.2 million | | **Expected R&D Initiatives (next 12 months):** | | | Capital expenditures for lab equipment | $0.1 - $0.2 million| | Acquire clinical skin samples | $0.3 - $0.4 million| | Tissue and fibroblast cell characterization/optimization | $0.2 - $0.3 million| | Develop master cell bank | $0.2 - $0.4 million| | Develop working cell bank | $0.1 - $0.3 million| | Develop processes for transfer to CDMO | $0.1 - $0.3 million| | Submit IND for CYWC628 (wound healing) | $0.1 million | | Complete preclinical animal study for CYMS101 (MS) | $0.2 - $0.3 million| | Initiate preclinical animal study for CYTER915 (thymic involution) | $0.1 million | [Our People](index=7&type=section&id=Our%20People) FibroBiologics has an experienced executive leadership team and a scientific advisory board guiding its research and development efforts - The executive leadership team has successful track records in startup entrepreneurial companies and the life sciences industry[27](index=27&type=chunk) - A scientific advisory board of world-renowned scientists guides the company's research and development efforts[27](index=27&type=chunk) [Our Current Pipeline](index=7&type=section&id=Our%20Current%20Pipeline) FibroBiologics has a pipeline of fibroblast-based product candidates in various development stages, targeting degenerative disc disease, multiple sclerosis, wound healing, and early-stage research for other conditions - The company's pipeline includes product candidates for degenerative disc disease, multiple sclerosis, wound healing, and early-stage research for extension of life, psoriasis, and certain cancers[28](index=28&type=chunk)[52](index=52&type=chunk)[69](index=69&type=chunk)[80](index=80&type=chunk)[89](index=89&type=chunk)[92](index=92&type=chunk) [CybroCell for Degenerative Disc Disease](index=7&type=section&id=CybroCellfor%20Degenerative%20Disc%20Disease) CybroCell is an allogeneic fibroblast cell-based therapy for degenerative disc disease, with IND clearance for a Phase 1/2 study in the US - CybroCell™ is an allogeneic fibroblast cell-based therapy for degenerative disc disease, aiming to repair intervertebral disc cartilage[44](index=44&type=chunk) - The therapy uses Human Dermal Fibroblasts (HDFs) forced to differentiate into chondrocyte-like cells in vivo[44](index=44&type=chunk) - Received IND clearance from the FDA on November 7, 2018 (IND number 18151) for a Phase 1/2 study in the US, conditional on master cell bank approval[44](index=44&type=chunk)[49](index=49&type=chunk) - Preclinical animal studies demonstrated positive outcomes[47](index=47&type=chunk)[48](index=48&type=chunk) - **10% increase in disk height index** after eight weeks with nHDFs (p<.05) - Reduced expression of inflammatory markers - Higher ratio of collagen type II over collagen type I gene expression - Increased proteoglycan contents [CYMS101 for Multiple Sclerosis](index=12&type=section&id=CYMS101%20for%20Multiple%20Sclerosis) CYMS101 is an allogeneic fibroblast cell-based therapy for Multiple Sclerosis, with a completed Phase 1 study in Mexico showing no adverse effects - CYMS101 is an allogeneic fibroblast cell-based therapy under development for Multiple Sclerosis (MS)[63](index=63&type=chunk) - A completed Phase 1 study in Mexico (5 participants) showed no adverse effects and general improvement in PASAT score (cognitive function) and Nine-Hole Peg Test completion time (upper extremity function)[63](index=63&type=chunk)[64](index=64&type=chunk) - No general improvement or deterioration was noted with the Timed 25-Foot Walk Test or EDSS test in the Phase 1 study[65](index=65&type=chunk)[66](index=66&type=chunk) - The company is conducting further research to determine the mode of action of fibroblasts in oligodendrocyte expansion and plans to file an IND application for a Phase 2 clinical trial in the US[67](index=67&type=chunk) - The company may seek a strategic partner for CYMS101 development before or after the Phase 2 study[67](index=67&type=chunk) [CYWC628 for Wound Healing](index=15&type=section&id=CYWC628%20for%20Wound%20Healing) CYWC628 is an early-stage allogeneic fibroblast cell-based therapy for wound healing, with an IND application planned for 2024 - CYWC628 is an early-stage allogeneic fibroblast cell-based therapy for wound healing[77](index=77&type=chunk) - Current studies focus on using fibroblasts and fibroblast-derived cells to treat wounds in diabetic mice and rats[77](index=77&type=chunk) - An IND submission with the FDA for wound healing is planned as early as **2024**, based on achieved results[77](index=77&type=chunk) [Our Early-Stage Research](index=17&type=section&id=Our%20Early-Stage%20Research) FibroBiologics is conducting early-stage research on CYTER915 for life extension, CYPS317 for psoriasis, and TCB190 for certain cancers - CYTER915 research aims to regenerate or reinvigorate the thymus and/or spleen using activated or inactivated fibroblasts, potentially combined with nucleic acids, cytokines, growth factors, and hormones[86](index=86&type=chunk) - Preclinical studies are planned to demonstrate thymic or splenic involution reversal in animal models[86](index=86&type=chunk) - CYPS317 is being developed for psoriasis, utilizing fibroblasts' immunomodulatory and anti-inflammatory properties, offering a scalable and cost-effective alternative to mesenchymal stem cells (MSCs)[91](index=91&type=chunk) - Early-stage research is also underway for TCB190 for the treatment of certain cancers[92](index=92&type=chunk) [Manufacturing and Supply](index=18&type=section&id=Manufacturing%20and%20Supply) FibroBiologics currently produces cell therapy candidates in its Houston lab and is contracting with a CDMO for cell bank production to support clinical trials - Cell therapy product candidates are currently produced at the company's Houston laboratory facility[93](index=93&type=chunk) - The company is contracting with a CDMO for the transfer of its experimental cell bank to produce master and working cell banks for clinical trials[93](index=93&type=chunk) - Future manufacturing for commercial sales will either be in-house (cGMP facility) or outsourced to a CDMO[93](index=93&type=chunk) [Intellectual Property](index=18&type=section&id=Intellectual%20Property) FibroBiologics' IP portfolio includes 48 issued patents and 109 pending applications, with exclusive rights in spinal diseases, certain cancers, orthopedic diseases, and multiple sclerosis - The company's IP portfolio includes **48 issued patents** and **109 pending patent applications**, with patent protections generally expiring from **2027 to 2043**[97](index=97&type=chunk) - Exclusive rights for fibroblast development are granted in fields including spinal diseases, certain cancers, orthopedic diseases, and multiple sclerosis[95](index=95&type=chunk)[96](index=96&type=chunk) - CybroCell™ does not have composition of matter patents due to patent ineligibility laws, but patents related to its production exist[99](index=99&type=chunk)