BioRestorative Therapies, Inc. Q3 FY2024 earnings call

• Lance introduced Francisco to present BRTX-100 preliminary Phase 2 data.
• BRTX-100 is a cell-based therapeutic targeting low blood flow/oxygen areas. Ongoing Phase 2 trial for chronic lumbar disc disease.
• Early data from 10 patients at 26 weeks: 70% improved in pain and function (VAS/ODI). Strong safety signals with no severe adverse events.
• Contemplating 26-week interim efficacy analysis and expansion to cervical indications.
• Ended Q3 with strong financial position, $13.1M in cash, no debt, on path to profitability.

No detailed product segment financial breakdown was provided. The focus was on the BRTX-100 cell therapy program and the company's financial position with $13.1 million in cash, cash equivalents, and marketable securities at the end of the third quarter with no outstanding debt.

• Continue enrolling in Phase 2 trial, expect to complete enrollment by end of 2024.
• Anticipate more data, including 52-week results, in January/February 2025.
• Considering BRTX-100 data for potential accelerated approval based on FDA's more supportive view of cell therapies.

• Uncertainties in clinical trial outcomes, including placebo effects and maintaining trial blind.
• Potential delays or issues with FDA approval processes affecting timeline for commercialization.

Q: How many patients are enrolled thus far?

A: Considerably more than 10, with enrollment to continue and expected to complete by end of 2024.

Q: When will the first unblinded data be seen?

A: Likely in early 2025, specifically the first half, but subject to trial integrity.

Q: How long will $13 million last?

A: No immediate need for financing, as cash is sufficient to achieve strategic goals within the trial.

Q: Magnitude of response for 52-week data patients?

A: Trend continues with some patients showing greater than 60% improvement, while one patient had ~30% improvement.

Q: Could BRTX-100 be eligible for accelerated approval?

A: Yes, given encouraging data and FDA's more supportive view of cell therapies, potential to use data for pivotal and accelerate commercialization.

Q: Co-primary endpoints and responder criteria?

A: Both pain (VAS) and function (ODI) must improve by at least 30% to be a responder; protocol includes radiographic endpoints for additional evidence.