AGMB-447, our second clinical-stage product candidate, is an inhaled small molecule inhibitor of ALK5, or TGFβR1, in development for the treatment of idiopathic pulmonary fibrosis, or IPF. IPF is a rare progressive fibrotic lung disease that has a poor prognosis for patients with a median life expectancy of less than five years. IPF affects approximately 240,000 people in the United States, Japan, the United Kingdom, and the four largest European markets (France, Germany, Spain, and Italy), with 30,000 to 40,000 new cases being diagnosed each year in the United States alone.

AGMB-447 is designed to have a high local exposure in the lung tissue, and then upon absorption into the bloodstream, AGMB-447 is hydrolyzed and substantially inactivated in order to avoid potential toxicities associated with systemic inhibition of ALK5 signaling. Direct delivery to the lung through inhalation and subsequent lung restriction are designed to confer high efficacy and a favorable safety profile for AGMB-447. We believe AGMB-447 also has the potential to demonstrate a low potential for drug-drug interactions that could make it well-suited for use as a single-agent and in combination with current standard of care therapies.

AGMB-447 is currently being investigated in a Phase I Study to Assess Safety, Tolerability, PK and PD of AGMB-447 in Healthy Participants and Participants with IPF (NCT06181370).

We completed an interim analysis of the SAD and MAD B1-6 stages in 108 healthy participants where we observed positive topline interim results. We expect to report data from IPF patients in the second half of 2026.

AGMB-447 has received U.S. FDA Orphan Drug Designation, a status granted by the FDA to promising treatments in development for rare diseases.