Structure Therapeutics (GPCR) investor relations material

Key insights from ADA and obesity market trends

• Recent ADA data and a Nature Medicine publication highlighted a best-in-class efficacy profile, with up to 16% weight loss shown, surpassing competitors in the oral obesity pill space.

• Oral obesity medications have rapidly gained market share, now representing 14% of the market within five months, with significant growth driven by patient demand for alternatives to injectables.

• Patient segmentation and combination therapies (e.g., GLP-1 with amylin or other agents) are expected to become increasingly important over the next 5-10 years.

• The amylin program demonstrated a unique 60-hour half-life in non-human primates, with phase I human data expected next quarter.

• Oral small molecules offer pricing advantages due to lower cost of goods compared to oral peptides, supporting broader accessibility.

Phase III program design and regulatory alignment

• Phase III for aleniglipron will start in Q3, following FDA guidance for 52 weeks on maintenance dose, 4,500 participants, and a focus on long-term weight maintenance.

• The starting dose will be 2.5 mg, with three dose levels (low, medium, high) and four-week titration steps, based on improved tolerability and efficacy findings from phase II.

• Patient-friendly titration and flexibility are prioritized, allowing for dose adjustments and down-titration to enhance adherence and minimize discontinuations.

• Open-label extension in phase II showed 86% of participants opted to continue, supporting strategies to reduce placebo arm dropouts.

• The company is focused on chronic weight management as the primary indication, with potential for strategic partnerships to expand into adjacent indications like type 2 diabetes and fatty liver disease.

Amylin and combination therapy development

• Amylin program (ACCG-2671) showed significant weight loss in non-human primates and a long half-life, with phase I human data and phase IIa planned for next quarter.

• Combination studies with GLP-1 and amylin will begin in Q4, aiming to determine optimal dosing balance and maximize efficacy and tolerability.

• The company is advancing both DACRA and SARA small molecule amylins, leveraging a robust IP strategy and manufacturing capabilities for global accessibility.

• Safety, once-daily dosing, combinability, and affordability are key target product profile features for future amylin therapies.

• Cash reserves of $1.5 billion are expected to fund the registrational phase III and key pipeline programs through 2028.