BioRestorative Therapies(BRTX) - 2024 Q3 - Earnings Call Transcript

Financial Data and Key Metrics Changes - The company ended Q3 2024 with cash, cash equivalents, and investments held in marketable securities totaling $13.1 million, with no outstanding debt, indicating a strong financial position [24] Business Line Data and Key Metrics Changes - The preliminary Phase 2 BRTX-100 data showed that 70% of the first 10 patients treated reported improvements in both pain and function at the 26-week mark, with some patients achieving close to 90% improvement [16][22] Market Data and Key Metrics Changes - The ongoing Phase 2 clinical trial for BRTX-100 is evaluating its safety and efficacy in treating chronic lumbar disc disease, with a total of up to 99 eligible subjects to be enrolled across 16 clinical sites in the U.S. [11][12] Company Strategy and Development Direction - The company is contemplating a 26-week preliminary efficacy endpoint interim analysis and is looking to expand the product profile of BRTX-100 to include cervical indications [20] - The management expressed optimism about the potential for accelerated approval from the FDA based on the encouraging data from the trial [39][41] Management's Comments on Operating Environment and Future Outlook - Management highlighted the positive trends in patient-reported outcomes and expressed confidence in meeting efficacy endpoints for the Phase 2 trial, with plans to present more data in early 2025 [23][24] Other Important Information - The company has not experienced any severe adverse events or dose-limiting toxicity in the ongoing trial, which is a positive indicator for the safety of BRTX-100 [18] Q&A Session Summary Question: How many patients are enrolled thus far? - Management confirmed that the number of enrolled patients is considerably more than 10 but did not disclose the exact figure [27] Question: When will the first unblinded data be available? - The unblinded data is expected to be available after an interim analysis, likely in the first half of 2025 [30] Question: Could the data lead to accelerated approval from the FDA? - Management indicated that if the data continues to show positive effects, it could potentially be used for pivotal studies to accelerate commercialization [39][41] Question: Are pain and functional improvements co-primary endpoints? - Yes, both pain and function must improve by at least 30% for a patient to be labeled a responder [48]