$PLRX reports Q4 results, positive data from Phase 2a trial, and upcoming clinical catalysts.
Mar 9th 2023, 9:12 pm
Analyst Summary: Pliant Therapeutics, Inc. (Nasdaq: PLRX) has reported their financial results for the fourth quarter of 2022, with a total revenue of $24.5 million. The company has recently completed a $287.5 million equity financing which extends their runway into the second half of 2026. The company also announced positive interim data from their Phase 2a INTEGRIS-IPF trial where their bexotegrast was reported to have a favorable safety profile and outperformed all lower dose cohorts on exploratory efficacy endpoints. Pliant is expected to deliver multiple clinical catalysts in 2023, including a final 24-week data readout for the INTEGRIS-IPF Phase 2a trial from the bexotegrast 320 mg dose group in Q2 2023. Furthermore, the company has completed enrollment for the INTEGRIS-PSC trial with the topline Phase 2a data expected in Q3 2023. Additional data readouts and portfolio milestones are also expected throughout the remainder of this year. Management stated that Bexotegrast has received Fast Track Designation and Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) in IPF and PSC with the company receiving EMA Orphan Drug designation for bexotegrast in IPF. The company's muscular dystrophy program is expected to progress through IND enabling activities with the IND submission expected in 2023. There are also other milestones to look out for, such as the initiation of a Phase 1 trial of PLN-101095 in patients with solid tumors resistant to immune checkpoint inhibitors in Q2 2023. To fund their ongoing and future preclinical and clinical programs, further develop their integrin targeting platform, and for other general corporate purposes, Pliant intends to use the net proceeds from the most recent offering alongside their existing cash, cash equivalents, and investments. Forward-looking statements include plans for the initiation of a Phase 2b trial of bexotegrast in patients with IPF in mid-2023, as well as the topline data from the 40, 80, and 160 mg dose groups of the INTEGRIS-PSC Phase 2a trial in Q3 2023. The company provided certain risks and uncertainties regarding the development and commercialization of its product candidates, including delays in ongoing or planned preclinical or clinical trials and the impact of the ongoing COVID-19 pandemic on their business, operations, clinical supply, and plans.