HOUSTON - FibroBiologics, Inc. (NASDAQ:FBLG) has announced a partnership with Charles River Laboratories to produce a cell-based therapy for an upcoming diabetic foot ulcer (DFU) clinical trial. The master services agreement between the two companies will focus on the development and manufacturing of FibroBiologics' therapeutic cell products, including a master cell bank and fibroblast-based spheroids, known as CYWC628.
The clinical-stage biotechnology firm, FibroBiologics, holds over 160 issued and pending patents for treatments using fibroblasts and fibroblast-derived materials, targeting chronic diseases such as multiple sclerosis, degenerative disc disease, psoriasis, and cancer. Their research emphasizes the immunomodulatory and regenerative properties of fibroblasts.
Charles River Laboratories will act as the contract development and manufacturing organization (CDMO) for FibroBiologics, following successful technology transfer and feasibility studies that confirmed the viability of the proprietary cell manufacturing processes. The collaboration aims to streamline complex supply chains and meet the rising demand for advanced therapy services, including plasmid DNA, viral vector, and cell therapy.
Kerstin Dolph, Corporate Senior Vice President of Global Manufacturing at Charles River, expressed enthusiasm for the partnership, highlighting the potential of CYWC628 to significantly improve the treatment of diabetic foot wounds. Pete O’Heeron, CEO of FibroBiologics, noted that working with Charles River would enable innovation through global reach and scalability.
The clinical trial for CYWC628 is set to commence in 2025, marking a critical step towards introducing new treatments to the market. The partnership is part of a broader commitment by Charles River to support regenerative medicine and the development of innovative therapies.
This collaboration announcement is based on a press release statement and contains forward-looking statements, which involve risks and uncertainties. These include the maintenance of the master services agreement, the company's liquidity, and the unpredictable nature of R&D translating into successful clinical trials. FibroBiologics has made no guarantees of future performance and cautions against undue reliance on these statements.
In other recent news, FibroBiologics has been granted a European patent for a novel cancer treatment method using modified fibroblasts. The biotechnology firm also reported unregistered sales of equity securities, totaling $3,887,000 in gross proceeds to GEM Global Yield LLC SCS. EF Hutton gave FibroBiologics a Buy rating based on promising pre-clinical data and positive outcomes from a Phase 1 study.
FibroBiologics has made amendments to its Articles of Incorporation and bylaws, which have received stockholder approval. The company has submitted a patent application for a new fibroblast cell-based technology aimed at wound healing bandages, and secured an Australian patent for a method to regenerate cartilage cells.
FibroBiologics is planning a larger Phase 1/2 trial for Diabetic Foot Ulcer with 120 participants in Australia. The firm is also exploring treatments for Degenerative Disc Disease, with a proof-of-concept study in the pipeline. Lastly, FibroBiologics has developed an artificial thymus organoid, demonstrating its ability to restore immune function.
InvestingPro Insights
As FibroBiologics (NASDAQ:FBLG) embarks on this promising partnership with Charles River Laboratories, investors should consider some key financial metrics and insights provided by InvestingPro.
Despite the positive news, FBLG's financial health presents some challenges. According to InvestingPro data, the company's market capitalization stands at $117.06 million, reflecting its current valuation in the biotech sector. However, the company is not profitable over the last twelve months, with an adjusted operating income of -$11.21 million.
InvestingPro Tips highlight that FBLG suffers from weak gross profit margins and that short-term obligations exceed liquid assets. These factors may impact the company's ability to fund its ambitious clinical trial plans without additional capital raises.
On a more positive note, FBLG has seen a significant return over the last week, with a 27.69% price increase. This recent uptick could be attributed to investor optimism surrounding the Charles River partnership announcement. However, it's important to note that the stock has experienced substantial volatility, with a 69.85% price decline over the past six months.
For investors considering FBLG's long-term potential, it's worth noting that analysts do not anticipate the company will be profitable this year, as per another InvestingPro Tip. This aligns with the typical trajectory of clinical-stage biotech firms, which often prioritize R&D investments over near-term profitability.
InvestingPro offers additional insights, with 10 more tips available for FBLG, providing a more comprehensive analysis for those interested in delving deeper into the company's prospects.
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