Slide 1: Topline Results for Phase 3 EFZO-FIT Study of Efzofitimod in Pulmonary Sarcoidosis
A New Approach to Interstitial Lung Disease Topline Results for Phase 3 EFZO-FIT™ Study of Efzofitimod in Pulmonary Sarcoidosis September 15, 2025 Exhibit 99.1
Slide 2: Forward Looking Statements
Forward Looking Statements The following slides and any accompanying oral presentation contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. The use of words such as “may,” “might,” “will,” “should,” “expect,”
Slide 3: Summary of Key Findings
Summary of Key Findings Study did not meet primary endpoint in change from baseline in mean daily OCS dose at week 48 52.6% of patients treated with 5.0 mg/kg efzofitimod achieved complete steroid withdrawal at week 48 vs 40.2% on placebo (p=0.0919) Clinical improvement in KSQ-Lung score at week 48
Slide 4: Global Phase 3 Trial in Pulmonary Sarcoidosis
Global Phase 3 Trial in Pulmonary Sarcoidosis Population: moderate to severe pulmonary sarcoidosis Diagnosis of pulmonary sarcoidosis for ≥ 6 months Stable treatment with ≥ 7.5 and ≤ 25 mg/day OCS Extent of fibrosis < 20% Symptomatic with KSQ-Lung score ≤ 70 Steroid Taper Protocol Guidelines Based o
Slide 5: Steroid Reduction
Steroid Reduction 1Missing patients considered non-responders; 2Adjusted percentage; Tables 14.2.1.2.1, 14.2.2.2.1; rounded to closest first decimal Week 48 Placebo N=90 Efzofitimod 3 mg/kg N=86 Efzofitimod 5 mg/kg N=88 N 81 77 83 LS mean dose at week 48 (mg) 3.5 3.5 2.8 LS mean change from baseline
Slide 6: King's Sarcoidosis Questionnaire (KSQ)-Lung and Composites
King’s Sarcoidosis Questionnaire (KSQ)-Lung and Composites 1stable = >-3; 2missing patients treated as non-responders; 3adjusted percentage; 4improved = ≥8; 5raw percentage; Source: Tables 14.2.6.3, 14.2.3.1, Draft output for steroid free and improved; rounded to closest first decimal Week 48 Placeb
Slide 7: Forced Vital Capacity (FVC)
Forced Vital Capacity (FVC) 1GLI global; Tables 14.2.4.2.1, Draft output for FVC % predicted; rounded to closest first decimal Week 48 Placebo N=90 Efzofitimod 3 mg/kg N=86 Efzofitimod 5 mg/kg N=88 N 74 67 74 FVC (mL), LS mean 3380.4 3369.7 3395.4 LS mean change from baseline (mL) Difference in LS m
Slide 8: Safety and Tolerability
Safety and Tolerability Efzofitimod was generally well-tolerated at both the 3.0 mg/kg and 5.0 mg/kg doses, consistent with a previously observed safety profile in all trials conducted to date Adverse events (AEs) were mostly mild or moderate in severity and generally assessed as unrelated to the st
Slide 9: Key Takeaways and Next Steps
Key Takeaways and Next Steps Evidence of drug activity observed for 5.0 mg/kg efzofitimod across multiple clinically relevant efficacy endpoints Clinical improvement in quality of life as measured by the KSQ-Lung for 5.0 mg/kg efzofitimod vs placebo Preservation of lung function with efzofitimod 5.0
Slide 10: KOL Commentary
KOL Commentary Robert P. Baughman, M.D. Emeritus Professor of Medicine, University of Cincinnati Editor, Sarcoidosis, Vasculitis, and Diffuse Lung Disease Editor, Current Opinion in Pulmonary Medicine Past President, World Association of Sarcoidosis and Other Granulomatous Disorders (WASOG) Member,
Slide 11: Q&A
Q&A