BioRestorative Therapies, Inc. (NASDAQ: BRTX), a regenerative medicine company focused on stem cell-based therapies, reported significant financial improvements and clinical advancements for the year ended December 31, 2024.
The company achieved a 175% increase in total revenue, reaching $401,000 compared to $146,000 in 2023. This growth was primarily driven by $300,000 in revenue from its BioCosmeceuticals platform. BioRestorative also demonstrated improved operational efficiency, reducing its loss from operations by 24% to $11.6 million from $15.2 million in the previous year.
"2024 was a transformative year for BioRestorative, highlighted by significantly improved financial performance and meaningful clinical program advancement," said Lance Alstodt, BioRestorative's Chief Executive Officer.
BRTX-100 Shows Promise in Chronic Disc Disease Treatment
The company's lead therapeutic candidate, BRTX-100, continues to demonstrate positive results in its Phase 2 clinical trial for chronic lumbar disc disease (cLDD). At the 2025 Orthopaedic Research Society Annual Meeting in February, BioRestorative presented blinded data from the first 15 patients enrolled in the trial, showing encouraging safety and efficacy trends at 26-52 weeks post-injection.
No serious adverse events were reported, and preliminary Visual Analog Scale (VAS) and Oswestry Disability Index (ODI) data showed positive trends compared to baseline. Notably, 52-week MRI comparisons revealed potential disc microenvironment remodeling, including increased hydration, decreased protrusion size, and resolution of annular tears.
Following these promising results, the U.S. Food and Drug Administration (FDA) granted Fast Track designation to the BRTX-100 program for cLDD treatment. This designation could lead to Priority Review and Accelerated Biologics License Application approval, potentially expediting the therapy's path to market.
Expanded Clinical Pipeline
In a significant development for the company's disc/spine program, the FDA cleared BioRestorative's Investigational New Drug application for BRTX-100 for the treatment of chronic cervical discogenic pain (cCDP) in February. This clearance expands the company's advanced clinical pipeline to include treatments for both chronic lower back and neck pain.
BRTX-100 is formulated from a patient's own (autologous) cultured mesenchymal stem cells collected from bone marrow. The treatment involves injecting these cells into damaged discs in an outpatient procedure, targeting patients whose pain has not responded to non-invasive procedures and who may otherwise face surgery.
Metabolic Program and Regulatory Advancements
BioRestorative continues to explore opportunities for its ThermoStem® metabolic platform technology, which targets obesity and metabolic disorders using brown adipose-derived stem cells. The company reported ongoing discussions with an undisclosed commercial-stage regenerative medicine company regarding potential licensing of this intellectual property, though no agreement has been finalized.
In November, BioRestorative received a provisional license from the New York State Department of Health for processing allogeneic (non-autologous) donor tissue material. This expanded capability allows for the isolation, expansion, and cryopreservation of various cell types, including stem cells, for medical research, building upon its previous authorization for autologous processing only.
Financial Position
BioRestorative ended 2024 in a strong financial position with $10.7 million in cash, cash equivalents, and investments held in marketable securities, with no outstanding debt. The company's net loss improved by 14% to $9.0 million ($1.16 per share) from $10.4 million ($2.47 per share) in 2023, while cash used in operating activities totaled $8.2 million.
BioCosmeceuticals Platform
The company's commercial BioCosmeceutical platform contributed $300,000 in revenue for 2024. BioRestorative's current commercial product is a cell-based secretome containing exosomes, proteins, and growth factors, engineered to reduce the appearance of fine lines and wrinkles. The company plans to explore expanding its commercial offerings to include a broader family of cell-based biologic aesthetic products and therapeutics through IND-enabling studies.
Future Outlook
BioRestorative's management remains focused on executing its growth strategy, with particular emphasis on advancing its clinical programs for BRTX-100 in both lumbar and cervical applications. The company's improved financial performance, expanded regulatory clearances, and promising clinical data position it well for continued progress in the regenerative medicine space.
"Looking ahead, we remain focused on aggressively executing our growth strategy, and very much look forward to updating investors as we progress," added Alstodt.
The company's dual focus on therapeutic applications for disc/spine disease and metabolic disorders, complemented by its commercial BioCosmeceuticals platform, provides multiple potential pathways for growth in the evolving regenerative medicine market.
