On February 27, 2024 Pliant Therapeutics, Inc. (Nasdaq: PLRX), a clinical-stage biotechnology company and leader in the discovery and development of novel therapeutics for the treatment of fibrotic diseases, reported a corporate update and provided fourth quarter 2023 financial results (Press release, Pliant Therapeutics, FEB 27, 2024, View Source [SID1234640527]).

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"The progress made by our teams during the fourth quarter of 2023 position us well for executing upon our 2024 milestones including the recent positive data from the INTEGRIS-PSC trial that support the late-stage development of bexotegrast in this important indication," said Bernard Coulie, M.D., Ph.D., President and Chief Executive Officer of Pliant Therapeutics. "In 2024, our focus will be on the advancement the BEACON-IPF late-stage program, gathering clarity on next steps for a late-stage PSC program and providing updates to our early-stage portfolio including from our oncology and muscular dystrophy programs."

Fourth Quarter and Recent Highlights
Bexotegrast Highlights
•Positive safety and efficacy data from 320 mg dose cohort of INTEGRIS-PSC Phase 2a trial in patients with primary sclerosing cholangitis (PSC). At a once-daily dose of 320 mg, bexotegrast was well tolerated over 12 weeks of treatment with no drug-related severe or serious adverse events. At the 320 mg dose, bexotegrast reduced both Enhanced Liver Fibrosis (ELF) scores and PRO-C3 levels and showed improvements in hepatocyte function and bile flow by contrast MRI imaging relative to placebo at Week 12. Twenty-four-week data from the 320 mg dose group is expected in mid-2024.
•Enrollment continues in BEACON-IPF, a Phase 2b trial of bexotegrast in patients with idiopathic pulmonary fibrosis (IPF). BEACON-IPF is a 52-week, multinational, randomized, dose-ranging, double-blind, placebo-controlled trial evaluating bexotegrast at once-daily doses of 160 mg or 320 mg. BEACON-IPF is expected to enroll approximately 270 patients with IPF.
Pipeline Programs
•Phase 1 trial of PLN-101095 in solid tumors is enrolling. This is a Phase 1 open label trial of PLN-101095, an oral, small molecule, dual selective inhibitor of αvβ8 and αvβ1 integrins designed to block TGF-β activation in the tumor microenvironment. The trial is currently dosing the third of five planned dose cohorts in a Phase 1 open label dose-escalation trial of PLN-101095 as monotherapy and in combination with pembrolizumab in patients with solid tumors that are resistant to immune checkpoint inhibitors. Preliminary data is expected in late 2024.
•Muscular dystrophy program on track for regulatory filing in the first quarter of 2024. PLN-101325 is a monoclonal antibody designed to act as an allosteric agonist of integrin α7β1. Filing for first-in-human clinical studies in Duchenne muscular dystrophy (DMD) is expected in the first quarter of 2024.

Fourth Quarter 2023 Financial Results
•Research and development expenses were $33.2 million, as compared to $25.1 million for the prior-year quarter. The increase was due primarily to higher employee-related expenses and increased clinical and manufacturing-related costs associated with our lead program, bexotegrast.
•General and administrative expenses were $13.9 million, as compared to $14.3 million for the prior-year quarter. The decrease was primarily due to a decrease in stock-based compensation as we achieved a clinical development milestone in the fourth quarter of 2022 that triggered the vesting of certain performance based awards.
•Net loss was $41.1 million as compared to $35.1 million for the prior-year quarter. The increase was due to higher operating expenses coupled with a decrease in collaboration revenues under the Novartis collaboration during the quarter.
•As of December 31, 2023, the Company had cash, cash equivalents and short-term investments of $495.7 million which the Company expects, together with funds available under the Oxford Loan Agreement, to be sufficient to fund operations into the second half of 2026.