Pliant Therapeutics (PLRX) investor relations material

Clinical program updates

• 101095 is an oral, twice-daily integrin blocker targeting alpha-v beta-8 and beta-1, aiming to block TGF-beta activation and resensitize tumors refractory to checkpoint inhibitors.

• Phase I-A data showed a 30% overall response rate and 60% disease control rate, with notable durability including a cholangiocarcinoma patient in complete response for over 24 months.

• Phase I-B is ongoing with a 1g twice-daily dose, focusing on non-small cell lung cancer, renal cell carcinoma, and TMB-high tumors, with initial data expected in spring 2027.

• Biomarker analysis, including interferon gamma surges and ctDNA, is central to understanding monotherapy effects and patient selection.

• The study design includes a 14-day monotherapy run-in followed by pembrolizumab re-challenge, with scans every nine weeks.

Platform and preclinical development

• The integrin-targeting small molecule library comprises about 15,000 annotated compounds, enabling tissue-selective drug delivery.

• Preclinical siRNA delivery programs are advancing, with the muscle-targeting program in non-human primate studies and data disclosure anticipated this year.

• Small molecule-siRNA conjugates show promising tissue selectivity and long knockdown duration in mice, with potential advantages over peptide-based approaches.

• IND submission for the muscle program could occur by late 2027 or early 2028, with other tissue-specific programs progressing toward primate studies.

• The platform's flexibility may allow targeting of previously intractable tissues and genes, with ongoing evaluation of selectivity and safety.

Strategic and operational outlook

• The organization has undergone significant restructuring, reducing headcount from over 170 to about 40 while retaining core development capabilities.

• Sufficient cash reserves and a focused team position the company to advance oncology and platform programs.

• Key catalysts include oncology data in the next 12 months, siRNA platform data in 2026, and robust clinical data from expansion cohorts in 2027.

• The total enrollment for the ongoing phase I-B is expected to reach 108 patients across three cohorts.

• The company is prioritizing programs with clear competitive advantages and is open to pursuing novel targets beyond current competitors.