Regulus(RGLS) - 2021 Q2 - Earnings Call Transcript

Financial Data and Key Metrics Changes - As of June 30, 2021, cash and cash equivalents totaled approximately $41.4 million, an increase of about $9.8 million from $31.6 million at the end of March 31, 2021 [12] - Net loss for Q2 2021 was $6 million, compared to a net loss of $6.9 million for the same period in 2020, with basic and diluted net loss per share of $0.08 compared to $0.23 in Q2 2020 [13] Business Line Data and Key Metrics Changes - Research and development expenses for Q2 2021 totaled $4.2 million, consistent with the same period in 2020 [12] - General and administrative expenses for Q2 2021 were $2.5 million, up from $2.3 million in Q2 2020 [13] Company Strategy and Development Direction - The company is focused on advancing its ADPKD program, with a Type A meeting requested with the FDA to discuss the modeling requirements and safety margins [5][18] - The company has nominated a new clinical candidate, RGLS8429, with GMP manufacturing underway and an IND anticipated in Q1 next year [10] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the FDA meeting, hoping for positive feedback that could lead to the removal of remaining hold requirements [32] - The company is exploring the potential of RGLS8429 as a fixed-dose approach with an auto-injector, which could provide a different market positioning compared to RGLS4326 [40] Other Important Information - The company reported that RGLS4326 was well tolerated in the first cohort of patients, with no serious adverse events [8] - Enrollment for the second cohort of the Phase 1b clinical study has been completed, with top-line data expected in Q4 2021 [9] Q&A Session Summary Question: Regarding the FDA meeting, will the discussion focus on the model or clinical data? - The objectives are to get feedback on the model predicting exposure and the safety margins required for dosing [18] Question: When can feedback from the FDA be expected after the meeting? - Draft feedback may be received within 48 hours, with formal meeting minutes typically available within a month [27] Question: Has the company completed all required tests by the FDA? - Yes, the company has built a model to predict exposure and is seeking FDA feedback on its robustness and predictive capability [31]