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Regulus Therapeutics (RGLS) Investor Presentation - Slideshow
2021-08-13 20:28
REGULUS Corporate Presentation August 2021 Safe Harbor Statement Statements contained in this presentation regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements associated with the expected ability of Regulus to undertake certain activities and accomplish certain goals with respect to development, regulatory and other activities related to the RGLS4326 program in ADPKD, including the p ...
Regulus(RGLS) - 2021 Q2 - Earnings Call Transcript
2021-08-11 01:28
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]
Regulus(RGLS) - 2021 Q2 - Quarterly Report
2021-08-10 20:55
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED JUNE 30, 2021 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission file number: 001-35670 Regulus Therapeutics Inc. (Exact name of registrant as specified in its charter) Delaware 26-4738379 (State or Other Jurisd ...
Regulus(RGLS) - 2021 Q1 - Earnings Call Transcript
2021-05-14 01:16
Regulus Therapeutics Inc. (NASDAQ:RGLS) Q1 2021 Earnings Conference Call May 13, 2021 5:00 PM ET Company Participants Cris Calsada - Chief Financial Officer Jay Hagan - President & Chief Executive Officer Denis Drygin - Chief Scientific Officer Conference Call Participants Shveta Dighe - Wedbush Securities Yanan Zhu - Wells Fargo Operator Ladies and gentlemen, thank you for standing by and welcome to the Regulus Therapeutics 2021 Financial Results Conference Call. At this time, all participants are in a lis ...
Regulus(RGLS) - 2021 Q1 - Quarterly Report
2021-05-13 21:44
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED March 31, 2021 or TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission file number: 001-35670 Regulus Therapeutics Inc. (Exact name of registrant as specified in its charter) Delaware 26-4738379 (State or Other Jurisdi ...
Regulus(RGLS) - 2020 Q4 - Annual Report
2021-03-09 22:31
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE FISCAL YEAR ENDED DECEMBER 31, 2020 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission file number: 001-35670 Regulus Therapeutics Inc. (Exact name of registrant as specified in its charter) Delaware 26-4738379 (State ...
Regulus(RGLS) - 2020 Q3 - Quarterly Report
2020-11-05 21:43
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM10-Q (Mark One) 10628 Science Center Drive, Suite 225 92121 San Diego CA (Address of Principal Executive Offices) (Zip Code) 858-202-6300 ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED September 30, 2020 or TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission file number: 001-3567 ...
Regulus Therapeutics (RGLS) Presents at Wells Fargo Securities 2020 Virtual Healthcare Conference - Slideshow
2020-09-11 21:40
microRNA Therapeutics WELLS FARGO VIRTUAL HEALTHCARE CONFERENCE September 9-10 Corporate Presentation – September 2020 Safe Harbor Statement Statements contained in this presentation regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements associated with the expected ability of Regulus to undertake certain activities and accomplish certain goals with respect to development, regulatory an ...
Regulus(RGLS) - 2020 Q2 - Quarterly Report
2020-08-13 21:13
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM10-Q (Mark One) QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED June 30, 2020 or TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission file number: 001-35670 Regulus Therapeutics Inc. (Exact name of registrant as specified in its charter) (State or Other Jurisdiction of Incorporation ...
Regulus(RGLS) - 2020 Q1 - Quarterly Report
2020-05-14 20:36
or ¨ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED MARCH 31, 2020 FOR THE TRANSITION PERIOD FROM TO Commission file number: 001-35670 Regulus Therapeutics Inc. (Exact name of registrant as specified in its charter) Delaware 26-4738379 (State or Other Juri ...