iBio (IBIO) Study Update summary

Unmet needs in obesity and cardiometabolic disease treatment

• GLP-1 receptor agonists have transformed obesity care but are limited by side effects, muscle loss, and rapid weight regain after discontinuation.

• Up to 80% of lost weight can be regained within a year after stopping GLP-1 therapy, with fat returning faster than muscle.

• 30%-40% of weight lost on GLP-1s is from lean mass, raising concerns for older adults.

• There is a growing demand for therapies that preserve muscle, selectively target fat, and offer durable, well-tolerated results.

• Focus is on highly validated targets to preserve/build muscle mass and achieve fat-specific weight reduction, targeting both calorie intake and energy expenditure.

Platform and R&D strategy

• AI-enabled antibody discovery platform enables rapid, precise targeting of challenging proteins.

• Integrated optimization ensures high expression, stability, and manufacturability from early stages.

• R&D focuses on therapies complementing or following GLP-1s, validated targets, and rapid pipeline advancement.

• Pipeline includes programs targeting myostatin, activin E, and amylin receptors, with rapid optimization and development enabled by proprietary AI and screening platforms.

• Platform enables rapid optimization and development of multi-specific or co-formulated therapies.

IBIO-600: Anti-myostatin/GDF-11 antibody

• IND-enabling studies underway; IND filing targeted for Q1 2026 and first patient dosing in Q2 2026, subject to financing.

• Dual mechanism targets myostatin and GDF-11, aiming for broader efficacy and improved lean mass preservation.

• In aged, obese primates, a single dose increased muscle mass by ~8% and reduced fat by 12%-15% over 12 weeks.

• Projected human half-life of 74-130 days could allow twice-yearly dosing; NHP studies show 2-4x improved pharmacokinetics.

• Designed for scalable manufacturing and potential as monotherapy, combination, or maintenance therapy.