Forte Biosciences Reports Results From FB102 Double-Blind Placebo-Controlled Phase 1b Study In Vitiligo

Statistically Significant FB102 Benefit Observed By Day 64 and Continued through Week 24

FB102-Treated Subjects Continued Improving Through Week 24 After Completion of the 12-Week Treatment Period Supporting FB102 Mechanistic Modulation of Both IL-2– and IL-15–Dependent Pathogenic T-cell Biology while Preserving Regulatory T Cells

Forte will be Hosting a Conference Call to Discuss the Results at 8:30 am ET

Forte Biosciences, Inc. (www.fortebiorx.com) (NASDAQ:FBRX), a clinical-stage biopharmaceutical company focused on autoimmune and autoimmune-related diseases, today announced positive results from the FB102 double-blind placebo-controlled phase 1b study in vitiligo:

• FB102 achieved 29.6% mean FVASI improvement from baseline at week 24 (p-value = 0.020)
• Response to FB102 was observed early, with statistically significant improvements observed by the day 64 visit (p=0.023), continuing through week 24, after completion of the 12-week treatment period.
• FB102 achieved 43.2% mean FVASI improvement from baseline at week 24 (p-value = 0.006) in subjects with greater disease involvement having baseline FVASI ≥0.75 (approximately one-quarter of face depigmented), including:
  • FVASI50 = 58.8%
  • FVASI75 = 23.5%
• Responder endpoints in overall population achieved FVASI50 in 34.4% of FB102 treated subjects at week 24 with FVASI 75 achieved in 12.5% of FB102 treated subjects at week 24; this endpoint was impacted by one placebo FVASI75 responder, reinforcing the importance of randomized controlled studies and baseline severity when interpreting vitiligo responder endpoints.
• The majority of FB102 treated subjects continued to improve through week 24 after completion of the 12-week treatment period with an additional 8 percentage point FVASI improvement between week 12 and 24.
  • Among FB102-treated subjects with baseline FVASI ≥0.75 the mean FVASI improvement increased an additional 14 percentage points between week 12 and 24.
• 84% (27/32) of FB102 treated subjects improved from baseline to week 24 following the 12-week treatment period and 0% (0/32) worsened. 27% (3/11) of placebo subjects worsened during the 24 week period.
• FB102 continues to demonstrate a strong safety profile and compared favorably to placebo with only mild to moderate AEs.
• These independent centrally-reviewed, placebo-controlled data demonstrate statistically significant FB102 mean FVASI improvements from baseline, with progressive improvement and a strong responder profile through week 24 after completion of the 12-week treatment period.