BioRestorative Therapies(BRTX) - 2024 Q4 - Earnings Call Transcript

Financial Data and Key Metrics Changes - For the 12-month period ending December 31, 2024, BioRestorative's revenue grew 175% year-over-year to $401,000 [10] - The company's loss from operations was $11.6 million, a 24% improvement from the $15.2 million loss for 2023 [10] - The net loss for 2024 was $9 million, or $1.16 per share, a 14% improvement from a net loss of $10.4 million, or $2.47 per share, for 2023 [10] - Cash used in operating activities in 2024 was $8.2 million, with the company ending the year with cash, cash equivalents, and marketable securities of $10.7 million and no outstanding debt [10] Business Line Data and Key Metrics Changes - The lead clinical stage candidate, BRTX-100, is being evaluated in a Phase 2 study for chronic lumbar disc disease, with positive preliminary data showing no serious adverse events and promising trends in patient outcomes [12][14][15] - The FDA granted Fast Track designation for BRTX-100, facilitating development and review processes [16] - The company is also advancing its ThermoStem program, targeting obesity and metabolic disorders, with promising preclinical data indicating significant weight loss and blood glucose level reductions [19][20] Market Data and Key Metrics Changes - The company is leveraging its data from the lumbar trial to expedite the regulatory pathway for cervical disc disease, potentially saving time and costs associated with preclinical studies [18][39] - The ThermoStem program is expanding its intellectual property portfolio to ensure long-term market exclusivity [21] Company Strategy and Development Direction - The company is focused on advancing its two clinical development programs, BRTX-100 and ThermoStem, while managing resources efficiently [23] - There is a strategic intent to expand BRTX-100 beyond lumbar and cervical applications to other musculoskeletal indications [37][41] - The company aims to build a comprehensive patent portfolio to protect its innovations and attract potential licensing partners [21] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the company's financial performance and projected growth plans, indicating a pathway to reduced dependence on capital markets [26] - The management team highlighted the importance of FDA interactions and the potential for accelerated regulatory approvals [25][43] Other Important Information - The company is in discussions with a commercial-stage regenerative medicine company regarding potential licensing agreements for its ThermoStem programs [22] - The company is exploring regulatory opportunities to potentially shorten the trial duration for BRTX-100 [51] Q&A Session Questions and Answers Question: Regarding the resolution of annular tears and decreased protrusion size - Management indicated that such improvements are not expected to happen spontaneously, especially in cases of degenerative disease [33][34] Question: Expansion of BRTX-100 to cervical indications - Management confirmed that the cervical space was strategically chosen, and they aim to leverage lumbar data to facilitate regulatory processes [36][39] Question: Enrollment update in the lumbar trial and cash burn estimation for 2025 - Management stated that enrollment is progressing well and cash burn in 2025 is expected to be similar to 2024, with potential reductions in future years [48][49] Question: Future revenues from Cartessa - Management expects revenues to become more consistent as the commercial relationship develops, while also exploring additional commercial opportunities [58][62]