Protagonist Therapeutics (PTGX) Update / Briefing Transcript

Protagonist Therapeutics (PTGX) Conference Call Summary Company Overview - Company: Protagonist Therapeutics (PTGX) - Date of Call: June 30, 2025 - Key Speakers: - Dr. Dinesh Patel, President and CEO - Dr. Newman Yielding, Chief Scientific Officer - Asif Ali, CFO - Dr. Sam Sachs, Clinical Development Advisor - Dr. Kirk Waze, Clinical Advisor on obesity program Core Industry and Product Focus - Industry: Biotechnology, specifically focusing on obesity treatment - Product: PN-477, a novel triple receptor agonist for obesity treatment targeting GLP, GIP, and GCG receptors Key Points and Arguments 1. Product Development: PN-477 is a triple agonist with high potency against GLP, GIP, and GCG receptors, designed for both oral and subcutaneous administration [6][10][29] 2. Obesity Epidemic: Nearly 75% of the U.S. population is overweight or obese, with 40% qualifying as obese (BMI ≥ 30). Current injectable treatments only reach about 2% of eligible patients, indicating significant unmet needs [7][8] 3. Market Opportunity: The current market is dominated by injectable drugs (semaglutide and tirzepatide), which have limitations in accessibility and patient compliance. An oral option is highly desirable [8][9] 4. Clinical Development Strategy: Protagonist plans to develop both oral and subcutaneous formulations of PN-477 to maximize treatment options for patients and healthcare providers [11][32] 5. Preclinical Data: PN-477 demonstrated up to 50% weight loss in diet-induced obesity (DIO) mouse models, showing superior efficacy compared to existing treatments [18][30] 6. Pharmacokinetics: Oral dosing in monkeys resulted in sustained weight loss of up to 11% even after treatment cessation, indicating potential for long-term efficacy [24][25] 7. Safety Profile: The design of PN-477 aims to minimize gastrointestinal tolerability issues, which are common with current obesity treatments [10][68] 8. Market Positioning: PN-477 is positioned as a best-in-class agent with the flexibility of both oral and injectable forms, catering to diverse patient preferences [32][79] Additional Important Insights 1. Long Half-Life: Anticipated longer half-lives in humans based on preclinical data suggest potential for less frequent dosing, which could improve patient adherence [35][38] 2. Bioavailability: The focus is on achieving effective bioavailability for chronic therapy, with confidence in the oral formulation based on preclinical results [40][41] 3. Regulatory Pathway: Protagonist is preparing for IND enabling studies and aims to initiate clinical trials in the following year [31][32] 4. Market Competition: PN-477 is expected to compete with existing therapies like tirzepatide and retatrutide, with a focus on providing a more convenient and effective treatment option [75][78] Conclusion Protagonist Therapeutics is advancing its obesity treatment candidate PN-477, which offers a promising alternative to current injectable therapies. The dual formulation strategy, combined with strong preclinical data and a focus on patient compliance, positions the company well in the growing obesity treatment market. The upcoming clinical trials will be crucial in validating the efficacy and safety of PN-477.