Fulcrum Therapeutics(FULC) - 2020 Q3 - Earnings Call Transcript

Financial Data and Key Metrics Changes - The company ended Q3 2020 with $127 million in cash, cash equivalents, and marketable securities, which is expected to support operations into Q2 2022 [24] - Research and development expenses increased to $15.6 million in Q3 2020 from $13.5 million in Q3 2019, primarily due to costs associated with ongoing clinical trials and personnel [25] - General and administrative expenses rose to $5.3 million in Q3 2020 from $3.5 million in Q3 2019, attributed to costs related to operating as a public company and personnel [26] - The net loss for Q3 2020 was $19 million, compared to a net loss of $16.5 million in Q3 2019 [26] Business Line Data and Key Metrics Changes - The company made significant progress in its clinical development programs, particularly with Losmapimod for FSHD and FTX-6058 for sickle cell disease [6][11] - The Phase 3 trial for Losmapimod (LOSVID) was initiated for COVID-19 treatment, with patient enrollment progressing despite some delays [12][13] Market Data and Key Metrics Changes - Sickle cell disease affects an estimated 100,000 patients in the U.S. and millions worldwide, highlighting the market potential for FTX-6058 [18] Company Strategy and Development Direction - The company aims to improve the lives of patients with genetically defined rare diseases, focusing on areas with high unmet medical needs [6] - The strategy includes advancing clinical trials for Losmapimod and FTX-6058 while expanding discovery efforts through collaborations [7][22] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the progress in clinical programs and the potential of Losmapimod and FTX-6058 to address significant medical needs [6][20] - The company plans to report full data from the ReDUX4 trial in FSHD in Q2 2021 and expects to begin dosing in the Phase 1 trial for FTX-6058 in healthy volunteers [27] Other Important Information - The company announced key appointments to its management team, including a new general counsel and a clinical advisor [13][14] - The proprietary Fulcrum Seek database has grown significantly, aiding in the identification of druggable targets and advancing discovery programs [22] Q&A Session Summary Question: Updates on LOSVID and ReDUX timing - Management indicated that a comprehensive assessment of Losmapimod will be provided with full data, rather than topline results, to better evaluate its potential benefits [30] Question: Development plans for FTX-6058 - The company is considering evaluating FTX-6058 in beta thalassemia and in combination with hydroxyurea, with plans to move into sickle cell disease patients after Phase 1 [42][43]