FibroBiologics, Inc.

FibroBiologics, Inc. announced that the first patients have been dosed in its Phase 1/2 clinical trial evaluating CYWC628 for the treatment of diabetic foot ulcers (DFUs). This marks a significant transition from laboratory science to clinical application for the investigational allogeneic fibroblast cell-based therapy. Concurrently, the company is advancing its manufacturing operations, having released drug product from its second good manufacturing practice (GMP) run and completed the first two batches of its third GMP run to support ongoing trial activity.

FibroBiologics announced positive preclinical data for its CYPS317 program for psoriasis at the Society for Investigative Dermatology 2026 Annual Meeting. The data showed that HDF spheroids reduced disease severity in mouse models, offered a favorable systemic safety profile, and sustained therapeutic efficacy with booster dosing. CYPS317 also demonstrated significant reductions in PASI scores and protected against hallmarks of psoriatic disease, indicating targeted immunomodulation.

FibroBiologics, Inc. announced a strategic expansion of its fibroblast-based platform to target Hantavirus pulmonary syndrome (HPS). This initiative builds on existing preclinical work in treating acute respiratory distress syndrome (ARDS), which shares similar terminal lung damage and inflammatory cascades with HPS. HPS is a rare but severe respiratory illness with high mortality rates and no approved antiviral therapies. The company's fibroblast platform is designed to modulate uncontrolled inflammatory responses and promote tissue repair, and FibroBiologics is now evaluating its platform in Hantavirus disease models with plans for regulatory discussions.

FibroBiologics, Inc. announced an increase in its At The Market (ATM) offering program, raising the maximum aggregate offering price to up to $7,500,000. This ATM offering, established on May 1, 2026, allows the company to sell common stock through H.C. Wainwright & Co., LLC. To date, 71,830 shares have been sold under the agreement.

FibroBiologics, Inc. granted stock options to its Chief Executive Officer, Chief Financial Officer, Chief Scientific Officer, and General Counsel on May 4, 2026. CEO Pete O R Heeron received options for 92,410 shares, while Jason D. Davis (CFO), Hamid Khoja (CSO), and Ruben A. Garcia (General Counsel) each received options for 61,607 shares. The options are exercisable at $1.38 per share and vest over four years, with the first quarter vesting on the one-year anniversary and the rest monthly thereafter.

FibroBiologics, Inc. announced its Annual Meeting of Stockholders will be held virtually on June 22, 2026. Stockholders will vote on the election of Pete O’Heeron as a Class III director, the ratification of WithumSmith+Brown, PC as the independent auditor, and the approval of a stock issuance of up to 2,272,728 common shares from the March SPA and 159,091 shares from the Engagement Letter. Additionally, approval for the 2026 Equity and Incentive Compensation Plan will be sought. Pete O’Heeron's Series C Preferred Stock, subject to an irrevocable proxy to the Board, accounts for 1,625,000 votes, or approximately 24% of the total votes.

FibroBiologics, Inc. announced compelling preclinical results for its topical human dermal fibroblast (HDF) spheroids in treating burn wounds. The study showed that daily HDF spheroid treatments significantly reduced inflammation, reshaped immune cell behavior, and decreased markers of scar-forming activity within eight days of injury. These findings suggest a fundamental shift in the wound's immunological programming, potentially leading to cleaner healing with less permanent tissue remodeling, and validate the company's strategy to expand its wound care platform to include burn injuries.

FibroBiologics, Inc. announced the release of the first batch of its CYWC628 drug product, which will support its Phase 1/2 clinical trial for patients with diabetic foot ulcers (DFUs). The product was manufactured under cGMP and successfully passed all required safety and quality testing, enabling patient enrollment. This marks a significant step in evaluating the safety, tolerability, and preliminary efficacy of CYWC628, an investigational fibroblast-based therapy.

FibroBiologics, Inc. has entered into an At The Market Offering Agreement with H.C. Wainwright & Co., LLC, allowing the company to sell up to $6,150,000 of its common stock. The company intends to use any net proceeds from the offering for working capital and general corporate purposes. H.C. Wainwright & Co., LLC will receive a commission of 3.0% of the gross proceeds from sales, along with reimbursements for legal and due diligence-related expenses.

FibroBiologics, Inc. reported a net loss of approximately $5.0 million for the first quarter ended March 31, 2026. The company made significant progress in its clinical pipeline, completing cGMP manufacturing and site onboarding for its Phase 1/2 clinical trial for diabetic foot ulcers (DFUs), with the first patient expected to be dosed in Q2 2026. Additionally, FibroBiologics raised $3M through a direct offering, regained Nasdaq compliance, and reported positive preclinical results for its burn and degenerative disc disease programs.