BioRestorative Therapies, Inc. Q1 FY2024 earnings call

Lance Alstodt welcomed everyone to the inaugural quarterly call. Francisco Silva provided an update on business lines, including the BRTX-100 Phase 2 trial for chronic lumbar disc disease, the ThermoStem preclinical metabolic program with a new exosome-based therapeutic candidate for obesity, and the commercial agreement with Cartessa in the bio BioCosmeceuticals markets. Lance Alstodt highlighted the positive momentum, including preliminary clinical data for BRTX-100, the FDA clearing an amendment to the study protocol, progress in the ThermoStem program, and the strategic agreement with Cartessa.

Anticipates completing enrollment in the BRTX-100 Phase 2 trial before the end of 2024, plans to initiate first in human clinical studies for the ThermoStem-based therapeutic candidate before the end of the year, and expects the commercial agreement with Cartessa to provide financial flexibility.

Q: Discuss advantages of exosome based product for obesity program vs implantable brown adipose tissue stem cells.

A: Exosomes avoid encapsulation, no known immune responses, cheaper to make.

Q: Mechanistic differences between brown adipose derived platform and existing obesity therapies.

A: GLP-1 interacts with brown fat, ThermoStem can act as adjuvant to lower GLP-1 dosage and reduce negative effects.

Q: Thoughts on duration for larger blinded read in BRTX-100 Phase 2.

A: Six months or longer makes sense, with sham injection in control arm helping get cleaner results.

Q: Purchase minimums with clients and funding for Phase 2 data.

A: Significant revenue line with pharma-like margin, providing financial flexibility.

Q: Northwell enrollment start and fraction of sites.

A: Northwell has started enrolling, they are one of 16 sites.

Q: Galen partnership and enrollment pace.

A: Proactively reached out to Galen to accelerate recruitment, hoping to match lab output with recruitment input.