Financial Data and Key Metrics Changes - As of June 30, 2020, the company reported $21.6 million in cash, cash equivalents, and marketable securities, having used $4.7 million in cash during Q2 2020 [31] - The net loss for Q2 2020 was $5.1 million, compared to $3.7 million for Q2 2019, attributed to decreased revenue and a $1 million accrual for future milestone payments [32][33] - Revenue recognized in Q2 2020 was $600,000, down from $2.6 million in the same period in 2019, primarily due to the conclusion of prior clinical studies [33][35] - R&D expenses totaled $2.7 million in Q2 2020, down from $4.2 million in Q2 2019, reflecting the completion of earlier studies [36] - G&A expenses increased to $3 million in Q2 2020 from $1.3 million in Q2 2019, mainly due to higher public company operating costs [37] Business Line Data and Key Metrics Changes - The company achieved several milestones for its lead asset, sofpironium bromide, including the completion of a 12-month Phase III open label safety study in the US and positive Phase III results from its partner Kaken Pharmaceuticals in Japan [9][10] - The Phase III pivotal study in Japan met all primary and secondary efficacy endpoints, demonstrating significant improvements in hyperhidrosis symptoms [15][16] Market Data and Key Metrics Changes - Kaken Pharmaceuticals is expected to receive a regulatory decision on their NDA for sofpironium bromide gel 5% in Japan as early as Q4 2020, with Brickell entitled to milestone payments and royalties from sales [23][24] Company Strategy and Development Direction - The company plans to initiate a Phase III pivotal program for sofpironium bromide in the US in Q4 2020, consisting of two trials with approximately 350 subjects each [25][26] - The strategy includes focusing on the safety and efficacy of a 15% concentration of sofpironium bromide gel [27] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ability to conduct the upcoming studies despite potential COVID-19 impacts, citing the short duration of patient engagement in the studies [51][53] - There is cautious optimism regarding Kaken's regulatory interactions in Japan, with expectations for a typical 12-month approval timeline [56] Other Important Information - The company completed a public offering in June 2020, raising net proceeds of $18.7 million to support the advancement of its clinical programs [28] Q&A Session Summary Question: What does a 2-point reduction on the primary endpoint mean for patients? - A 2-point shift on the HDSM-Ax scale indicates a move from severe to mild or moderate hyperhidrosis, significantly improving quality of life for patients [40][42] Question: How does the PRO scale compare to Qbrexza? - The HDSM-Ax scale is a multi-domain 5-point scale requiring a 2-point shift, while Qbrexza uses an 11-point scale requiring a 4-point shift, indicating different measurement approaches [45] Question: How dependent is the study initiation on COVID-19? - The timeline is somewhat dependent on COVID-19, but there is confidence in the ability to start the study due to the short duration and geographic variance of study sites [51][53] Question: Is the second study initiation gated by enrollment pace in the first study? - The focus is currently on starting the first study, with no guidance provided on the second study's initiation at this time [54] Question: How is Kaken's regulatory dialogue with authorities? - Kaken has had regular interactions with regulatory authorities in Japan, and the process appears to be proceeding according to plan [56]
Fresh Tracks Therapeutics(FRTX) - 2020 Q2 - Earnings Call Transcript