LYT-100 in Patients With Idiopathic Pulmonary Fibrosis (IPF)

Key Inclusion Criteria:

• Treatment naïve patients or those with <6 months of exposure to nintedanib withphysician diagnosed IPF based on ATS/ERS/JRS/ALAT 2018 guidelines

• Idiopathic Pulmonary Fibrosis on HRCT, performed within 12 months of Visit 1 asconfirmed by central readers

• DLCO corrected for Hemoglobin (Hb) [visit 1] ≥ 30% and ≤90% of predicted of normal

• FVC ≥ 45% of predicted normal

Key Exclusion Criteria:

• Primary obstructive airway physiology (pre-bronchodilator FEV1/FVC < 0.7 at Visit 1)

• Known explanation for interstitial lung disease, including but not limited toradiation, sarcoidosis, hypersensitivity pneumonitis, bronchiolitis obliteransorganizing pneumonia, human immunodeficiency virus (HIV), viral hepatitis, andcancer

• Diagnosis of any connective tissue disease, including but not limited toscleroderma/systemic sclerosis, polymyositis/dermatomyositis, systemic lupuserythematosus, and rheumatoid arthritis

• Major extrapulmonary physiological restriction (e.g., chest wall abnormality, largepleural effusion)

• Cardiovascular diseases, any of the following:

• Uncontrolled hypertension, within 3 months of Visit 1

• Myocardial infarction within 6 months of Visit 1

• Unstable cardiac angina within 6 months of Visit 1

• Prior hospitalization for confirmed COVID-19, acute exacerbation of IPF or any lowerrespiratory tract infection within 3-months of Visit 1