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FibroBiologics CEO Issues Letter to Shareholders
Globenewswire· 2026-01-07 13:30
Core Insights - FibroBiologics is focused on developing fibroblast-based therapies for chronic diseases, emphasizing innovation and patient impact in 2025 [2][3] Company Progress - The company expanded its laboratory in Houston to over 10,000 square feet, enhancing its R&D capabilities and in-house manufacturing [3] - FibroBiologics raised significant capital through multiple registered direct offerings, totaling $7.2 million in late 2025, and eliminated all outstanding debt [3] - Jason D. Davis was appointed as CFO, bringing extensive experience in corporate finance and capital markets [3] - The company actively presented its research at various conferences, enhancing its visibility in the biotech community [3] Clinical Trials and Milestones - FibroBiologics completed the CYWC628 master and working cell banks, which are crucial for its wound healing program [4] - The company received HREC approval for a Phase 1/2 trial in Australia for CYWC628, targeting diabetic foot ulcers with a study of 120 patients [4] - Positive IND-enabling data for CYPS317 indicated efficacy comparable to biologics, leading to a new IND filing on December 30, 2025 [4] - Progress was made on CYMS101 for multiple sclerosis, with plans for an IND submission [4] Scientific Advancements - The company confirmed remyelination in brain tissue repair models, supporting its approach for treating demyelinating diseases [5] - Advances in the bone marrow organoid platform showed potential in reducing tumor sizes and addressing age-related immune decline [5] Intellectual Property - FibroBiologics holds over 270 patents issued and pending, covering various therapeutic areas including wound healing and human longevity [6] - Recent patent filings include methods for generating multipotent cells from fibroblasts and a fibroblast-based chondrocyte spheroid platform for musculoskeletal conditions [6] Financial Overview - The company reported disciplined execution in its quarterly reports, with R&D expenses focused on lab expansion and cell bank development [7] - Financing efforts included closing two tranches of a $25 million financing round [7] Future Outlook - The company aims to execute clinical trials, submit INDs, and strengthen its financial position in 2026 [8] - Challenges such as regulatory hurdles and funding are acknowledged, but the company expresses confidence in overcoming these obstacles [8]
FibroBiologics(FBLG) - Prospectus
2025-12-23 21:02
As filed with the Securities and Exchange Commission on December 23, 2025. Registration No. 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) (I.R.S. Employer Identification Number) 455 E. Medical Center Blvd. Suite 300 Houston, Texas 77598 (281) 671-5150 Delaware 2834 86-3329066 (Prim ...
FibroBiologics Announces Payoff of Outstanding Debt
Globenewswire· 2025-11-26 13:30
Core Viewpoint - FibroBiologics has successfully repaid all outstanding convertible promissory notes, strengthening its balance sheet and eliminating further dilution from conversions [1][2][3] Financial Developments - The company has paid off the convertible promissory notes issued to Yorkville, which were part of a Standby Equity Purchase Agreement (SEPA) allowing the sale of up to $25 million in common stock [1][2] - The first $15 million was advanced in three equal tranches, and with the repayment, there will be no further conversions into shares [2] - The SEPA remains active until December 20, 2026, permitting the company to sell an additional $10 million of its common stock under certain conditions [2] Strategic Focus - The repayment of convertible debt allows the company to concentrate on advancing its clinical programs, particularly the initiation of first-in-human trials [3] - The company is preparing to start a Phase 1/2 clinical trial for its fibroblast-based product candidate CYWC628 in diabetic foot ulcer patients in early 2026 [4] - Additionally, the company plans to submit Investigational New Drug applications for treatments targeting psoriasis and multiple sclerosis [4] Company Overview - FibroBiologics is a clinical-stage biotechnology company based in Houston, focusing on developing therapeutics for chronic diseases using fibroblast cells [8] - The company holds over 270 patents issued and pending, covering various clinical pathways including wound healing, multiple sclerosis, and cancer [8]
FibroBiologics Reports Third Quarter 2025 Financial Results and Provides Corporate Update
Globenewswire· 2025-10-31 20:30
Core Insights - FibroBiologics is advancing preparations for the manufacturing of its fibroblast-based spheroids product candidate, CYWC628, for a Phase 1/2 clinical trial targeting diabetic foot ulcers (DFU) patients [1] - The company is also preparing to submit Investigational New Drug (IND) applications for treatments of psoriasis with CYPS317 and multiple sclerosis with CYMS101 [1] Recent Highlights - The CEO emphasized the strategic focus on moving advanced product candidates towards clinical trials while establishing fibroblasts as a scalable platform [4] - Positive updates from the psoriasis research program indicate the potential of human dermal fibroblast spheroids as a novel therapeutic approach [6] - The Bone Marrow Organoid platform has been advanced, presenting new treatment options for hematopoietic cancers and age-related immune decline [6] Financial Highlights - Research and development expenses for the nine months ended September 30, 2025, were approximately $6.6 million, up from $3.1 million in the same period of 2024, primarily due to increased contract research costs and personnel-related expenses [5] - General and administrative expenses were approximately $7.4 million for the same period, compared to $6.9 million in 2024, driven by increased personnel and professional fees [10] - The net loss for the nine months ended September 30, 2025, was approximately $15.4 million, compared to a net loss of $8.1 million in 2024 [10] Upcoming Milestones - The company plans to complete manufacturing training runs for CYWC628 and confirm the sterility of the manufacturing process by the end of 2025 [6] - The initiation of the Phase 1/2 clinical trial in Australia for CYWC628 is expected in the first quarter of 2026, with completion anticipated in the third quarter of 2026 [6] - Pre-clinical IND-enabling studies for psoriasis and multiple sclerosis treatments are also set to be completed, with IND submissions planned [6]
FibroBiologics(FBLG) - Prospectus
2024-06-18 20:12
As filed with the Securities and Exchange Commission on June 18, 2024. Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 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) FORM S-1 REGISTRATION STATEMENT UNDER 455 E. Medical Center ...
FibroBiologics(FBLG) - Prospectus(update)
2024-06-04 18:36
As filed with the Securities and Exchange Commission on June 4, 2024. Delaware 2834 86-3329066 Registration No. 333-278938 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 (Primary Standard Industrial (I.R.S. Employer Identification Number) 455 E. Medical Center Blvd. Suite 300 Houston, Texas 775 ...
FibroBiologics(FBLG) - Prospectus(update)
2024-05-15 20:27
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 ...
FibroBiologics(FBLG) - Prospectus
2024-04-25 23:24
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 ...
FibroBiologics(FBLG) - Prospectus(update)
2024-03-26 21:28
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 ...
FibroBiologics(FBLG) - Prospectus(update)
2024-03-15 20:09
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 ...