Financial Data and Key Metrics Changes - The company reported cash and cash equivalents of $24.4 million as of June 30, 2021, with a subsequent equity capital raise of approximately $8.1 million [22][9] - Revenue for Q2 2021 was approximately $151,000, up from $17,000 in Q1 2021, but down from $600,000 in Q2 2020 [24] - R&D expenses increased to $8.8 million in Q2 2021 from $2.7 million in Q2 2020, primarily due to clinical trial costs [25] - G&A expenses totaled $2.9 million in Q2 2021, slightly down from $3 million in the same period last year [26] - The net loss for Q2 2021 was $11.1 million, compared to $5.1 million in Q2 2020, driven by increased R&D expenses [27] Business Line Data and Key Metrics Changes - The company is advancing sofpironium bromide through pivotal Phase 3 studies for primary axillary hyperhidrosis, with enrollment completed in both studies [8] - The last patient in the Cardigan I study has completed all scheduled visits, and the last patient in Cardigan II is expected to complete their final visit soon [8] Market Data and Key Metrics Changes - Kaken is in the early stages of launching ECCLOCK (sofpironium bromide gel 5%) in Japan, which is the first topical prescription product approved for primary axillary hyperhidrosis in the country [10] - Brickell receives royalties based on a percentage of net sales of ECCLOCK in Japan and is entitled to sales-based milestone payments [11] Company Strategy and Development Direction - The company aims to submit a New Drug Application (NDA) for sofpironium bromide gel 15% to the U.S. FDA in mid-2022, pending Phase 3 results [9][23] - Brickell is exploring potential business development opportunities to expand its pipeline with transformative therapies [29] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming Phase 3 readout and the potential advancement for the company and patients [28] - The company highlighted the resilience and resourcefulness of its team in achieving milestones during the pandemic [30] Other Important Information - The Phase 3 pivotal studies are expected to report top-line results in Q4 2021, which will inform the NDA submission process [17] Q&A Session Summary Question: Are there any significant items outstanding required for the NDA submission? - Management indicated that no additional clinical work is needed for the NDA submission, and they plan to meet with the FDA post-Phase 3 [34] Question: How does the company view indication expansion under Brickell? - Management expressed excitement about Kaken's Phase 1 study for palmoplantar hyperhidrosis and noted the unmet need in this area, indicating potential future opportunities [36]
Fresh Tracks Therapeutics(FRTX) - 2021 Q2 - Earnings Call Transcript