On July 31, 2026 FibroBiologics, Inc. (Nasdaq: FBLG) ("FibroBiologics"), a clinical-stage biotechnology company with 270+ patents issued and pending with a focus on the development of therapeutics and potential cures for chronic diseases using fibroblasts and fibroblast-derived materials, reported financial results for the second quarter ended June 30, 2026, and provided a corporate update.

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Recent Highlights:

Clinical Updates:

Initiation of patient dosing in the Company’s Phase 1/2 clinical trial evaluating CYWC628 for the treatment of diabetic foot ulcers (DFUs).
Completed manufacturing of three batches of the CYWC628 drug product in accordance with FDA’s Good Manufacturing Practices (cGMP). Two of these batches have been released and the third batch will be released after it successfully passes all required safety and quality testing.
Financing:

Strengthened financial position through completion of a $9.0 million private placement with $3.0 million upfront and up to approximately $6.0 million of potential additional gross proceeds upon the exercise in full of warrants. Additionally, closed a $3.0 million public offering.
Preclinical Progress:

Reported preclinical results suggesting that topical treatment with human dermal fibroblast (HDF) spheroids may reprogram the burn wound environment by dampening harmful inflammation, reshaping immune cell behavior, and reducing markers of scar-forming activity, within just eight days of injury.
Patent Portfolio:

Received a notice of an allowance for a patent with the U.S. Patent and Trademark Office (USPTO) covering methods of treating and accelerating the healing of wounds by topically administering a composition comprising 3D spheroid fibroblasts together or with one or more fibroblast-derived materials.
Filed a provisional patent application with the USPTO covering oral delivery systems designed to protect fibroblast-based therapeutics through the stomach and enable targeted release in the gastrointestinal tract.
Conference Presentations:

Presented poster presentations on the novel thymus organoid platform at the Keystone Symposia on Aging and Immunity; and preclinical data from its CYPS317 program for psoriasis at the Society for Investigative Dermatology 2026 Annual Meeting.
Presented its proprietary thymus organoid technology to reboot the immune system and extend human life at the Alliance for Longevity Initiatives H-Span Summit in Washington DC.
Upcoming Milestones

Wound Healing:

Phase 1/2 clinical trial evaluating fibroblast-based spheroids product candidate, CYWC628, in DFU patients:
Expects to report interim results in the second half of 2026.
Anticipates completion and disclosure of primary safety and efficacy results by the end of 2026.
Psoriasis:

Anticipates IND clearance for the treatment of psoriasis with CYPS317, the Company’s fibroblast spheroid product candidate, in the fourth quarter of 2026.
Multiple Sclerosis:

Plans to submit an IND application with the U.S. Food & Drug Administration (FDA) for the treatment of multiple sclerosis with FibroBiologics’ fibroblast spheroid product candidate, CYMS101, in the fourth quarter of 2026.
Degenerative Disc Disease:

Plans to amend the IND clearance with the FDA to replace single-cell fibroblasts with fibroblast-derived chondrocyte spheroids derived from the CYWC628 master cell bank.
Pete O’Heeron, CEO and Founder of FibroBiologics, said, "With the first patient dosed in our CYWC628 trial, FibroBiologics has entered an important stretch as a clinical-stage company. Every milestone ahead builds on this one, and every data point will speak to what fibroblasts can do for patients. We are positioned for the catalysts ahead and eager to share our initial findings this year."

Financial Highlights for the Quarter Ended June 30, 2026

Research and development expenses were approximately $1.7 million for the three months ended June 30, 2026, compared to approximately $2.0 million for the same period in 2025. The decrease was primarily due to decreased CRO costs of $0.3 million as clinical validation changed to manufacturing, and certain costs were capitalized to research and development supplies.
General and administrative expenses were approximately $2.4 million for both the three months ended June 30, 2026 and 2025. The primary areas of net change are decreased personnel expenses of $0.2 million; increased professional fees of $0.1 million for accounting, legal and marketing expenses; decreased facilities expenses of $0.1 million; and increased listing expenses of $0.1 million.
For the three months ended June 30, 2026, FibroBiologics reported a net loss of approximately $4.1 million. The net loss for the three months ended June 30, 2026, was primarily due to research and development expenses and general and administrative expenses discussed above.

Cash and cash equivalents totaled approximately $3.5 million at June 30, 2026.

(Press release, FibroBiologics, JUL 31, 2026, View Source [SID1234669585])