Summary of Pliant Therapeutics (PLRX) FY Conference Call - January 10, 2023 Company Overview - **Company**: Pliant Therapeutics - **Focus**: Development of novel treatments for fibrotic diseases with an industry-leading fibrosis platform [2][3] Key Programs and Developments 1. **Bexotogast (formerly PLN74809)** - Currently in Phase 2A trials for Idiopathic Pulmonary Fibrosis (IPF) and Primary Sclerosing Cholangitis (PSC) [3][4] - Phase 2A data showed it was well tolerated with a clear anti-fibrotic effect, evidenced by an 80% reduction in FVC decline [23][24] - Expected interim data for 12-week treatment in early Q1 2023 and final data in Q2 2023 [7][31] 2. **PLN101095** - A potential first-in-class selective integrin small molecule inhibitor targeting immune checkpoint inhibitor resistance [4] - IND submitted late last year, with Phase I trials expected to start in Q2 2023 [4][39] 3. **PLN101325** - An allosteric activator aimed at muscle diseases and fibrosis, with an IND filing expected by the end of 2023 [5][6] 4. **PLN1474** - Focused on treating NASH-associated liver fibrosis, owned by Novartis, entering Phase II testing [6] Financial Position - **Cash Position**: $360 million at the end of Q3 2022, including $230 million from a follow-on financing [5] Market Landscape and Competitive Positioning - Current IPF market dominated by Asbriet and OFEV, generating over $3 billion in revenue in 2020 [9] - Asbriet went generic in 2022, and OFEV will lose exclusivity in 2025, creating a significant opportunity for new treatments [9] - Bexotogast offers advantages such as: - Direct anti-fibrotic effect through TGF beta inhibition [10] - Once-daily dosing compared to multiple daily doses for existing treatments [10] - Better tolerability with no GI side effects reported [10][28] Clinical Data Highlights - Bexotogast demonstrated a 15 mL decrease in FVC decline compared to placebo, with a notable improvement in the 80 mg dose group [24][25] - Safety profile showed no significant adverse events or discontinuations due to the drug [22][23] - The drug's mechanism involves blocking integrins selectively upregulated in fibrotic tissue, leading to reduced pro-fibrotic gene expression [13][14] Upcoming Milestones - Anticipated data releases for bexotogast in both IPF and PSC throughout 2023 [7][33] - Phase IIb study for bexotogast expected to start mid-2023, with a focus on both monotherapy and combination therapy [58][61] Regulatory Considerations - Ongoing discussions with the FDA regarding the design of the Phase IIb study, which will include a significant portion of patients not on standard care [58][61] - The potential for using validated biomarkers as co-primary endpoints in PSC trials, given the challenges of histological assessments [66][68] Conclusion - Pliant Therapeutics is well-positioned in the fibrotic disease market with promising clinical data and a strong financial foundation, aiming to address significant unmet needs in IPF and PSC treatments [2][5][9]