Summary of 89Bio (ETNB) Conference Call - September 03, 2025 Company Overview - **Company**: 89Bio (ETNB) - **Industry**: Biopharmaceuticals, specifically focusing on NASH (Non-Alcoholic Steatohepatitis) treatment Key Points and Arguments NASH Market Dynamics - The NASH space is experiencing significant growth due to the approval of two drugs: Resdiffera and SEMA, addressing a substantial unmet need in the market [4][5] - There are millions of undiagnosed NASH patients, presenting a large opportunity for market expansion as awareness and diagnosis improve [5][6] - The next generation of products, particularly potent anti-fibrotic agents like pegosofirmin, is expected to further enhance treatment options and market growth [7][8] Current Treatment Landscape - GLP-1 drugs are being utilized but do not directly target liver fibrosis, leading to continued disease progression in many patients [10][11] - Despite the presence of GLP-1s, there remains a significant market for liver-directed therapies, as many patients still have advanced fibrosis [12][13] Clinical Trials and Study Updates - The ENLIGHTEN studies for pegosofirmin are progressing well, with high enthusiasm from clinical sites and a large number of patients being screened [15][16] - The studies are global, involving over 250 sites across 20+ countries, indicating a robust initiative to address the unmet need in cirrhosis [17][18] Differentiation and Competitive Advantage - Physicians recognize the difference between current metabolic drugs and more potent anti-fibrotic agents, with excitement around the potential of FGF21s and pegosofirmin in treating advanced fibrosis [19][20] - Pegosofirmin shows promising data in combination with GLP-1s, indicating potential synergistic effects on liver fibrosis and metabolic markers [21][22][24] Safety and Tolerability - Safety and tolerability are critical factors for long-term patient compliance, especially in chronic conditions like NASH [40][53] - Pegosofirmin has demonstrated lower rates of gastrointestinal events compared to competitors, which is crucial for maintaining patient adherence [42][53] Future Directions and Potential Indications - Beyond NASH, there is potential for pegosofirmin in other fibrotic conditions, including liver cirrhosis from various etiologies, renal fibrosis, and cardiac fibrosis [71][72] - The company is considering partnerships to explore these additional indications while preserving capital for NASH and SHTG (Severe Hypertriglyceridemia) studies [73][75] Commercial Strategy - The potential for co-formulation with GLP-1s is seen as a significant opportunity for differentiation in the market, providing convenience for patients [45][47] - Pricing strategies for combination therapies will depend on the strength of clinical data and market dynamics [50][76] Additional Important Insights - The company is focused on executing its Phase III studies effectively, with a keen eye on the evolving landscape of NASH treatments and patient needs [17][18] - There is a recognition of the importance of long-term weight management and glycemic control in impacting fibrosis outcomes, emphasizing the chronic nature of NASH [29][30] This summary encapsulates the key discussions and insights from the conference call, highlighting the strategic positioning of 89Bio in the evolving NASH treatment landscape.

Core Viewpoint - Switzerland has ranked first in the global innovation index for 13 consecutive years since 2011, making it a significant innovation hub and China's first strategic partner in innovation [1] Group 1: Company Overview - Tandem Therapeutics, founded in 2023, focuses on developing novel peptide-drug conjugates specifically targeting fibrotic matrices to provide new precision treatment options for fibrosis and fibrotic cancers [2][4] - The company is a spin-off from ETH Zurich, co-founded by Mamta Chabria, Viola Vogel, and Martin Behe, who have extensive backgrounds in biology and biophysics [2][6] Group 2: Technology and Research - Tandem's technology is based on over 15 years of research from ETH Zurich and the Paul Scherrer Institute, utilizing a comprehensive understanding of matrix mechanobiology to develop treatments for fibrosis [6][7] - The company aims to target the mechanical changes in fibrotic extracellular matrices, which are critical drivers of fibrosis progression, using peptide-drug conjugates that offer non-immunogenicity and cost-effectiveness compared to antibodies [8] Group 3: Market Potential and Development - Fibrosis is a significant medical challenge, accounting for over 45% of mortality in developed countries, with current treatments unable to fully halt or reverse the condition [4] - Tandem's lead project focuses on progressive pulmonary fibrosis, with preclinical efficacy being validated in mouse and human lung fibrosis models [8] - The company has received CHF 150,000 in funding from Venture Kick and joined the Wyss Zurich Translational Center to advance its research and development efforts [8]

Summary of RAIN Therapeutics Conference Call Company Overview - RAIN Therapeutics, following a reverse merger with Aleron Therapeutics in October 2023, is focused on developing first-in-class treatments for orphan pulmonary conditions, particularly fibrosis indications [2][4]. Key Products and Clinical Trials - **Lead Asset: LTI-03** - Targeting idiopathic pulmonary fibrosis (IPF), currently moving into a Phase 2 trial [3]. - Demonstrated safety and tolerability in Phase 1 studies, with promising biomarker results [3][24]. - Unique mechanism with both anti-fibrotic and regenerative functions [3][16]. - **Second Asset: LTI-01** - Aimed at treating loculated pleural effusion, a condition affecting approximately 60,000 people in the US annually [4]. - No current FDA-approved pharmacologic solutions exist for this condition [4][33]. Market Potential - The global market for IPF treatments is estimated to reach nearly $12 billion by 2031, with current leading drugs (e.g., Nintedanib) generating around $3.6 billion in 2023 [11][12]. - LTI-01 has a potential market of $400 million in the US and Europe, based on pricing comparable to off-label drugs [33]. Mechanism of Action - LTI-03 operates through a peptide that mimics the Cav1 protein, which is downregulated in fibrotic states [15][37]. - The drug is delivered via dry powder inhalation, targeting lung tissue directly [16][24]. Clinical Study Insights - Phase 1b study showed significant reductions in key biomarker proteins associated with IPF, indicating effective drug delivery to fibrotic lung tissue [25][26]. - The upcoming Phase 2 trial will assess lung function metrics (FVC, FEV1) over 24 weeks, with expectations of positive outcomes based on previous studies [30][31]. Competitive Landscape - Current approved treatments for IPF only slow disease progression and are poorly tolerated, highlighting a significant unmet need in the market [10][12]. - RAIN Therapeutics aims to differentiate itself by offering a safer, more effective treatment option with fewer side effects [18][46]. Future Outlook - Anticipation of Phase 2 trial initiation and data release within the next year, with hopes of demonstrating significant lung function improvements [29][51]. - Ongoing partnership with Taiho Pharmaceutical for commercialization rights in Japan for LTI-01 [33]. Additional Considerations - The regenerative potential of LTI-03 could lead to greater benefits in lung function compared to existing therapies, which primarily focus on slowing decline [44][46]. - The company is optimistic about enrollment for the upcoming trials, aiming for a global reach to capture a diverse patient population [50].