Pliant Therapeutics Announces Q3 2024 Financial Results and Corporate Update

Pliant Therapeutics, a distinguished biotechnology firm specializing in advanced treatments for fibrotic diseases, shared significant corporate updates and financial results for the third quarter of 2024. A key achievement highlighted was the progress in the BEACON-IPF Phase 2b/3 trial, which is proceeding well and expected to complete enrollment by early 2025, with data release anticipated in mid-2026. This trial focuses on evaluating bexotegrast, a potential therapy for idiopathic pulmonary fibrosis (IPF).

Dr. Bernard Coulie, President and CEO of Pliant, expressed satisfaction with the community's engagement and the trial's progress. He emphasized the importance of their ongoing efforts to deliver new therapies to patients. The BEACON-IPF trial is a 52-week, multinational, randomized, double-blind, placebo-controlled study, aiming to enroll 360 IPF patients and assessing daily doses of 160 mg and 320 mg of bexotegrast.

The third quarter also saw the publication of positive results from a Phase 2a PET imaging trial in the American Journal of Respiratory and Critical Care Medicine, highlighting bexotegrast's efficacy in achieving dose-dependent integrin receptor occupancy in the lungs of IPF patients.

Pliant's pipeline includes PLN-101095, an oral, small molecule, dual inhibitor targeting αvβ8 and αvβ1 integrins to block TGF-β activation within the tumor microenvironment. The Phase 1 trial for PLN-101095, involving both monotherapy and combination therapy with pembrolizumab for patients with solid tumors resistant to immune checkpoint inhibitors, is in its third cohort, with preliminary data expected in early 2025.

Additionally, Pliant is exploring expanded applications for PLN-101325, a monoclonal antibody for muscular dystrophies, potentially broadening its scope before initiating Phase 1 trials.

Corporate advancements included the appointment of Dr. Gary Palmer as Senior Vice President of Medical Affairs. Dr. Palmer brings extensive experience from various biopharmaceutical companies and expertise across pulmonary medicine, immunology, and neurology.

Financially, Pliant reported research and development expenses of $47.8 million for the third quarter of 2024, up from $32.3 million the previous year, driven primarily by the BEACON-IPF trial. General and administrative expenses decreased slightly to $14.3 million from $15.3 million. The net loss for the quarter was $57.8 million, compared to $41.5 million the prior year, reflecting increased operating expenses. As of September 30, 2024, Pliant had $406.0 million in cash, cash equivalents, and short-term investments.

Pliant Therapeutics continues to position itself as a leader in developing novel treatments for fibrotic diseases. Bexotegrast, their lead product, has obtained Fast Track and Orphan Drug Designations from the FDA for IPF and PSC, as well as Orphan Drug Designation from the European Medicines Agency. The BEACON-IPF trial is a pivotal step in their mission to provide effective therapies for these challenging conditions. Additionally, the ongoing Phase 1 study of PLN-101095 for solid tumors and the potential expansion of PLN-101325's applications demonstrate Pliant's commitment to advancing its pipeline and addressing unmet medical needs in various therapeutic areas.