Durect reports Q2 EPS (46c), consensus (51c)

Reports Q2 revenue $2.1M, consensus $2.94M. At June 30, the company’s cash, cash equivalents and investments were $34.9M, compared to $43.6M at December 31, 2022. The company said, “We are pleased to have completed enrollment in our Phase 2b AHFIRM trial in June and remain on track to report topline data in the fourth quarter of 2023. Assuming a positive outcome from AHFIRM, we plan to review the results with the U.S. Food and Drug Administration (FDA) in the first quarter of 2024. If approved, larsucosterol would be the first FDA-approved treatment for alcohol-associated hepatitis (AH). We are also excited to announce the expansion of our epigenetic modulator platform into oncology. In conjunction with teams of experienced chemists and biologists, our research and development team have designed new chemical entities (NCE) that are now in preclinical development for multiple oncology indications…Building on our knowledge of epigenetic modulation, DURECT has internally developed multiple novel small molecule DNMT inhibitors that exhibit broad spectrum activity against multiple hematologic and solid tumor types. These compounds display unique and desirable physiochemical properties and pharmacokinetic profiles, as well as favorable tolerability. We intend to select a product candidate by the end of 2023 to advance into clinical trials in cancer patients. Our goal is to be prepared to initiate clinical trials for this product candidate by the end of 2024.”