FibroBiologics Reports $11.161 Million Net Loss for Fiscal Year 2024, Improved from Previous Year

FibroBiologics, Inc., a clinical-stage biotechnology company, reported a net loss of $11.161 million for the fiscal year ended December 31, 2024, compared to a net loss of $16.485 million in 2023. This represents a $5.324 million improvement. Total operating expenses decreased from $8.889 million in 2023 to $13.737 million in 2024, primarily due to increased research and development and general and administrative expenses related to preparing for clinical trials and operating as a public company. The company attributes the overall net loss improvement to gains related to changes in fair value of warrant and convertible debt liabilities, partially offset by increased operating expenses.

Significant changes in financial performance are largely attributable to the company's transition to a public company and increased investment in research and development. Research and development expenses increased by $2.1 million to $4.5 million in 2024, driven by increased drug product and CRO expenses, personnel costs, research supplies, and facility depreciation. General, administrative, and other expenses rose by $2.7 million to $9.2 million, primarily due to increased personnel costs, insurance expenses, and expenses related to the direct listing and public company operations. The company also notes gains and losses related to various liability instruments, including warrants and convertible debt.

Strategic developments during the fiscal year included the completion of pre-clinical studies for CYWC628, a wound-healing therapy, showing statistically significant acceleration in wound closure in diabetic mice. The company plans to initiate a Phase 1/2 clinical trial for CYWC628 in Australia during the second half of 2025. A Phase 1 safety study of CYMS101, a multiple sclerosis treatment, was completed in Mexico, showing no treatment-related adverse events. Further research is underway to characterize the mode of action, with plans to file an IND application for a Phase 1/2 U.S. clinical trial. Pre-clinical studies for CYPS317, a psoriasis treatment, are ongoing, with a projected completion date in the fourth quarter of 2025.

Operational developments include the company's thirteen full-time employees as of December 31, 2024, with seven holding medical or doctoral degrees and nine engaged in research and development. The company contracted with a CDMO for the production of master and working cell banks for CYWC628 and CybroCell™. As of December 31, 2024, the company held 92 issued patents and 154 pending patent applications. The company also notes that it is currently not involved in any material legal proceedings.

FibroBiologics' outlook is contingent upon securing additional funding to support ongoing operations and the advancement of its product candidates through clinical trials and regulatory approval. The company acknowledges substantial doubt about its ability to continue as a going concern, emphasizing its reliance on future capital raises and successful product development to achieve profitability. The company's financial statements are prepared on a going-concern basis, and no adjustments are included to reflect the potential inability to continue operations.