BioRestorative Therapies(BRTX) - 2025 Q2 - Earnings Call Transcript

Financial Data and Key Metrics Changes - In Q2 2025, revenues increased to $303,000 from $89,000 in the same period last year, representing a 240% increase primarily due to a contract manufacturing agreement on BioCosaceuticals [8] - The loss from operations for Q2 2025 was $3.3 million, compared to $2.5 million for the same period in 2024 [9] - The net loss for Q2 2025 was $2.7 million or $0.30 per share, compared to a net loss of $4 million or $0.50 per share for 2024 [9] - The company ended the quarter with cash, cash equivalents, and marketable securities of $7.4 million and no outstanding debt [9][20] Business Line Data and Key Metrics Changes - The lead clinical stage candidate, BRTX-100, is in a Phase 2 trial for chronic lumbar disc disease (CLDD), with promising preliminary data showing over 74% of subjects achieving greater than 50% improvement in function and over 72% reporting greater than 50% reduction in pain by 52 weeks [12][13] - The enrollment for the BRTX-100 trial is progressing well, with more than halfway through the goal of 99 subjects [14] - The core preclinical metabolic program, THERMACEM, is focused on developing cell-based therapies for obesity and metabolic disorders, with ongoing discussions for potential licensing agreements [15][16] Market Data and Key Metrics Changes - The company is in advanced discussions with key partners to accelerate the growth of its regenerative biologic secretone products [17] - The market for secretone products is significant, and the company aims to achieve high margins in this business [30] Company Strategy and Development Direction - The company is focused on advancing its two core clinical development programs, BRTX-100 and ThermoStem, while ramping up commercial opportunities in regenerative biologics [17] - There is a strategic emphasis on obtaining FDA approval for BRTX-100 and exploring various indications for future trials [22] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the regulatory environment and the progress of the BRTX-100 trial, highlighting a strong safety profile and encouraging trends in efficacy [19][41] - The company is committed to efficiently managing cash reserves while executing strategic goals, with expectations of a potential reduction in SG&A expenses as enrollment stabilizes [28][20] Other Important Information - The company has been methodically building a comprehensive portfolio of issued patents to protect its metabolic disease programs [15] - Management noted that the FDA's support for stem cell therapies could facilitate an expedited regulatory pathway for BRTX-100 [37] Q&A Session Summary Question: Timing for the start of the CCDT trial and its size - The company did not comment on the cervical trial but emphasized the focus on the lumbar trial and its progression towards a BLA [22] Question: Revenue growth expectations for Cosmoceutical - Management indicated that while growth is expected, it is difficult to predict exact quarterly performance due to the nature of the growing business [24] Question: SG&A expense trends - Management confirmed that SG&A expenses are expected to follow a similar trend as last year, with heavier expenses in the first quarter and lighter in subsequent quarters [26] Question: Recent interactions with the FDA regarding expedited pathways - Management noted anecdotal support from the FDA for an accelerated pathway but did not disclose any new designations beyond the fast track designation [38] Question: Comparison of Phase 2 trial results to placebo - The primary endpoint is safety, with a minimum requirement of 30% improvement in pain and function compared to baseline and a control group [40][41] Question: Potential for unblinded interim data - Management suggested that discussions with the FDA could shape the regulatory strategy, potentially allowing for an interim analysis [43]