UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amendment No. 1 to FORM S-1 REGISTRATION STATEMENT FibroBiologics, Inc. (Exact name of registrant as specified in its charter) As filed with the Securities and Exchange Commission on May 15, 2024. Registration No. 333-278938 UNDER THE SECURITIES ACT OF 1933 (State or other jurisdiction of (Primary Standard Industrial Delaware 2834 86-3329066 (I.R.S. Employer Identification Number) 455 E. Medical Center Blvd. Suite 300 Houston, Texas 775 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024. or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-41934 FibroBiologics, Inc. (Exact name of registrant as specified in its charter) Delaware 86-3329066 (State or other jurisdic ...

As filed with the Securities and Exchange Commission on April 25, 2024. Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 FibroBiologics, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Delaware 2834 86-3329066 (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification Number) 455 E. Medical Cente ...

As filed with the Securities and Exchange Commission on March 26, 2024. Registration No. 333-277019 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amendment No. 2 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 FibroBiologics, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Delaware 2834 86-3329066 (I.R.S. Employer Identification Num ...

As filed with the Securities and Exchange Commission on March 15, 2024. UNITED STATES SECURITIES AND EXCHANGE COMMISSION Registration No. 333-277019 Washington, D.C. 20549 Amendment No. 1 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 FibroBiologics, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Delaware 2834 86-3329066 (I.R.S. Employer Identification Num ...

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)

As filed with the Securities and Exchange Commission on February 12, 2024. Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 FibroBiologics, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Delaware 2834 86-3329066 (I.R.S. Employer Identification Number) 455 E. Medical Ce ...

As filed with the Securities and Exchange Commission on January 24, 2024. Registration No. 333-275361 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amendment No. 8 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 FibroBiologics, Inc. (Exact name of registrant as specified in its charter) (Primary Standard Industrial Delaware 2834 86-3329066 (I.R.S. Employer Identification Number) 455 E. Medical Center Blvd. Suite 300 Houston, Texas 77598 (281) 671-5150 (Address, ...

As filed with the Securities and Exchange Commission on January 23, 2024. Registration No. 333-275361 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amendment No. 7 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 FibroBiologics, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of (Primary Standard Industrial Delaware 2834 86-3329066 (I.R.S. Employer Identification Number) 455 E. Medical Center Blvd. Suite 300 Houston, Texas ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Amendment No. 6 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 FibroBiologics, Inc. As filed with the Securities and Exchange Commission on January 22, 2024. Registration No. 333-275361 Delaware 2834 86-3329066 (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) (I.R.S. Employer Identification Number) 455 E. Medical Center Blvd. Suite 300 Houston, T ...