BioRestorative Therapies Q1 2024 Business Update

BioRestorative Therapies, Inc. (BioRestorative, BRTX), a clinical-stage company specializing in stem cell-based therapies, recently shared an update on its business progress. CEO Lance Alstodt highlighted the company's significant strides in advancing its primary clinical program, BRTX-100, and expanding its preclinical program, ThermoStem®. BioRestorative is also preparing to launch its BioCosmeceuticals business, expecting substantial revenue generation this year. The company’s financial stability is bolstered by $16.4 million in cash, equivalents, and marketable securities as of Q1 2024.

BioRestorative's Disc/Spine Program saw notable advancements with the presentation of preliminary data from its ongoing Phase 2 clinical trial of BRTX-100 for chronic lumbar disc disease (cLDD) at the Orthopaedic Research Society's 2024 Annual Meeting. The trial data showed promising patient outcomes with no significant safety issues. The company also enhanced its manufacturing and clinical processes, tripling its monthly trial capacity. Additionally, BioRestorative partnered with Galen Patient Recruitment, Inc. to support the completion of patient enrollment for the Phase 2 BRTX-100 study by the end of 2024. An important FDA-approved amendment to the Phase 2 study protocol was announced, replacing the saline injection in the control arm with a sham injection.

In its Metabolic Program, BioRestorative revealed the development of a new exosome-based biologic targeting obesity. Using its ThermoStem® platform, the new therapeutic candidate could complement existing FDA-approved weight loss drugs. The company plans to initiate the FDA process for this candidate by filing a Drug Master File (DMF) in Q3 2024 and aims to begin first-in-human clinical trials by year-end.

On the commercial front, BioRestorative entered into a five-year exclusive agreement with Cartessa Aesthetics, LLC in late April. Under this agreement, BioRestorative will supply Cartessa with specified quantities of a proprietary cell-based biologic serum annually, which will be marketed under Cartessa’s Chronos ExoCR brand. This partnership positions BioRestorative for potential rapid growth in the biocosmeceuticals sector.

BioRestorative’s core development programs include the Disc/Spine Program (brtxDISC™) and the Metabolic Program (ThermoStem®). The brtxDISC™ program focuses on BRTX-100, a cell therapy product derived from a patient’s own cultured mesenchymal stem cells. This therapy aims to treat painful lumbosacral disc disorders non-surgically or as an adjunct to surgical procedures. The BRTX-100 production process involves collecting, isolating, and culturing stem cells from the patient’s bone marrow, which are then cryopreserved. The cells are injected into the patient’s damaged disc in an outpatient procedure, intended for patients whose pain isn't relieved by non-invasive treatments and who might otherwise face surgery. A Phase 2 clinical trial is underway to treat chronic lower back pain from degenerative disc disease.

The ThermoStem® program develops cell-based therapies to tackle obesity and metabolic disorders using brown adipose-derived stem cells (BADSC) to create brown adipose tissue (BAT) and exosomes secreted by BADSC. BAT mimics brown fat depots in humans that regulate metabolic homeostasis. Initial research shows that more brown fat in animals can lead to higher caloric burning and reduced glucose and lipid levels. People with more brown fat may have a lower risk of obesity and diabetes. BADSC exosomes could also contribute to weight loss.

BioRestorative also operates a commercial BioCosmeceutical platform. Their current product, manufactured in an ISO-7 certified clean room, is a cell-based secretome containing exosomes, proteins, and growth factors. This serum aims to reduce fine lines and wrinkles and improve other cosmetic areas. The company plans to expand its product line to include a broader range of cell-based aesthetic products and therapeutics, seeking FDA approval for these emerging BioCosmeceuticals.