BioRestorative Therapies(BRTX) - 2025 Q1 - Earnings Call Transcript

Financial Data and Key Metrics Changes - For Q1 2025, revenues were $25,000, down from $35,000 in the same period last year, indicating a decrease of approximately 29% [7] - Deferred revenues for Q1 2025 were $150,000 compared to nil in Q1 2024, reflecting a timing difference in revenue recognition [7] - The loss from operations for Q1 2025 was $4,800,000, compared to $4,100,000 for Q1 2024, showing an increase in operational losses [8] - The net loss for Q1 2025 was $5,300,000 or $0.64 per share, compared to a net loss of $2,200,000 or $0.33 per share in Q1 2024, primarily due to a gain on the exchange of warrants in the previous year [8] Business Line Data and Key Metrics Changes - The lead clinical stage candidate, BRTX-100, is being evaluated in a Phase II trial for chronic lumbar disc disease (CLDD) with positive preliminary data trends observed [10][12] - The company is also developing ThermoStem, a cell-based therapy targeting obesity and metabolic disorders, with ongoing efforts to protect its intellectual property [14][15] Market Data and Key Metrics Changes - The FDA granted Fast Track designation for BRTX-100, facilitating development and review processes for serious conditions [13] - BRTX-100 is now the first and only stem cell-based product candidate cleared by the FDA for evaluation in cervical degeneration disc disease [14] Company Strategy and Development Direction - The company is focused on advancing its two core clinical development programs, BRTX-100 and ThermoStem, while managing resources efficiently [17][19] - There are ongoing discussions regarding potential licensing agreements for ThermoStem metabolic disease programs [16] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the ongoing Phase II trial for BRTX-100, with expectations that data will continue to trend positively [17] - The company is actively engaging with the FDA to discuss endpoints and regulatory processes as they progress towards potential BLA approval [38][46] Other Important Information - The company ended Q1 2025 with cash, cash equivalents, and marketable securities totaling $9,100,000 and no outstanding debt, indicating a strong financial position [9][19] Q&A Session Summary Question: Clarification on efficacy endpoint - Management confirmed that the primary endpoint is safety, with a secondary efficacy endpoint of a 30% improvement, and the term "preliminary" indicates it is not the primary focus [21][22] Question: Interim analysis status - Management stated that an interim analysis is still a potential option but has not been determined yet, as it could impact long-term development [23][24] Question: Enrollment pace and characteristics - Management indicated that enrollment is picking up due to new recruitment strategies and that they expect to counteract any typical summer slowdown [36][37] Question: Morphological changes observed - Management provided details on encouraging morphological changes observed in patients, including increased hydration and decreased protrusion in some cases [42][44]