Regulus Therapeutics Inc.

As of September 30, 2022, cash, cash equivalents and short-term investments were approximately $45.3 million, and management said the cash runway should extend through 2023. Third-quarter 2022 R&D expense was $5.3 million, down from $5.9 million a year ago; G&A expense was $2.3 million, down from $2.5 million. Net loss was $7.6 million versus $8.6 million in Q3 2021, and basic and diluted net loss per share was $0.50 versus $0.99. During the quarter, the company sold and settled about 2.2 million shares under its ATM for net proceeds of $4.5 million. For guidance, management now expects first-cohort MAD data in mid-2023, second-cohort data in the second half of 2023, and cash runway through 2023.

Jay Hagan’s message was focused on execution in ADPKD, especially progress with the next-generation candidate RGLS8429. He emphasized the positive early clinical profile, saying the drug was well tolerated and that the PK looked similar to the first-generation asset, which supports their expectation of similar biological effects. His tone was cautiously optimistic, but he repeatedly framed timelines and enrollment as dependent on operational progress.

Crispina Calsada highlighted a relatively lean quarterly spend profile and the company’s improved liquidity position. She reported Q3 2022 R&D of $5.3 million and G&A of $2.3 million, both lower than the prior-year quarter, with net loss narrowing to $7.6 million from $8.6 million and EPS improving to a $0.50 loss from $0.99. She also cited $45.3 million in cash, cash equivalents and short-term investments at September 30, 2022, and said the runway is expected to extend through 2023.

Analysts focused on what the mid-2023 data readout might look like, asking whether longer dosing in animals should inform expectations for the clinical readout. Management pointed to prior first-generation data showing statistically significant increases of about 60% and 40% in Polysystem 1 and 2 at the 1 mg/kg dose, and said similar effects are anticipated given the similar PK of the next-gen compound. Questions also centered on the timing shift from first half 2023 to mid-2023; Jay Hagan said the update reflects real-world enrollment timing, with 6 active sites, 2 patients in study, and 12 targeted for the first cohort, and added that the second cohort is still expected in the second half of 2023.