BioRestorative Therapies(BRTX) - 2024 Q2 - Earnings Call Transcript

Financial Data and Key Metrics Changes - Total revenues increased by 154% sequentially, from $35,000 in Q1 2024 to $89,000 in Q2 2024, driven by initial product revenue from the Cartessa agreement [6][7] - Loss from operations for Q2 2024 was $2.5 million, a 19% year-over-year improvement from the $3.1 million loss in Q2 2023, and a 39% sequential improvement from the $4.1 million loss in Q1 2024 [7][8] - Cash used in operating activities in Q2 2024 was $1.9 million, with the company ending the quarter with $14.7 million in cash, cash equivalents, and marketable securities, and no outstanding debt [8][20] Business Line Data and Key Metrics Changes - The company began to derive initial product revenue from its exclusive supply agreement with Cartessa, which is expected to grow materially in the future [6][7] - The BRTX-100 program is in a Phase II study targeting chronic lumbar disc disease, with 99 subjects being enrolled across 16 clinical sites [9][12] - The ThermoStem program is developing a cell-based therapy candidate targeting obesity and metabolic disorders, with promising preclinical data indicating significant weight loss potential [10][14] Market Data and Key Metrics Changes - The company is focusing on the BioCosmeceuticals market through its agreement with Cartessa, which is expected to validate its platform and drive revenue growth [19][39] - The company is exploring additional distribution opportunities outside the U.S. for its ExoCR product, indicating potential for market expansion [39] Company Strategy and Development Direction - The company aims to achieve sustainable profitability by managing resources effectively while advancing its clinical development programs and leveraging cash flow from the Cartessa agreement [18][20] - The company is committed to expanding its intellectual property portfolio to protect its technologies and facilitate future licensing opportunities [14][19] - The company is actively pursuing strategic licensing discussions for its ThermoStem metabolic disease program, indicating a focus on partnerships to enhance growth [15][19] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing Phase II study of BRTX-100 and expects full enrollment by the end of 2024, with optimism about the data being consistent with previous trends [18][19] - The company highlighted the importance of the FDA's protocol amendment for the Phase II study, which is expected to enhance patient safety and data integrity [12][18] - Management is optimistic about the potential for multiple licensing agreements related to the ThermoStem program, indicating a proactive approach to business development [36] Other Important Information - The company has entered into substantive discussions with a commercial-stage regenerative medicine company regarding a potential licensing agreement for the ThermoStem program [15] - The company plans to roll out new product lines in the BioCosmeceutical space in the fall of 2024, which could further enhance revenue [39] Q&A Session Summary Question: Are you seeing blinded data with a 2 to 1 split of activity similar to the previous 3 to 1 split? - Management confirmed that the first four patients had a 3 to 1 randomization, while subsequent patients are randomized 2 to 1, with early signs of improvement in pain reduction and function [21][22] Question: Can you provide details on the minimum Cartessa purchase quantities? - Management indicated that the agreement represents a low multimillion-dollar revenue contract over the first year, with a five-year exclusivity [22] Question: When is the 10-Q coming out? - Management confirmed that the 10-Q would be filed before the end of the day [24] Question: Will you proceed with the ThermoStem study regardless of a partnership? - Management stated that they would move forward with the DMS filing and first-in-human studies, regardless of a signed partnership [28] Question: How long will you be able to follow up with patients in the trial? - Management indicated that the primary efficacy endpoint is at the 52-week mark, which is when they expect to disclose data [29] Question: Is the DMF a rate-limiting step for potential agreements? - Management clarified that while the DMF is not a rate-limiting step, it is a key element for facilitating out-licensing opportunities [33][34] Question: Have you seen an acceleration in patient enrollment since the protocol amendment? - Management noted that the combination of the protocol change and hiring a marketing organization has positively impacted patient recruitment [35] Question: Are you considering multiple ThermoStem transactions? - Management acknowledged the possibility of multiple deals for different indications, particularly in obesity and metabolic syndrome [36] Question: Do you see opportunities to expand the commercial agreement with Cartessa? - Management expressed optimism about expanding the agreement and rolling out new products in the BioCosmeceutical space [39]