FBRX - 1Q26; Fast-Track Designation Granted For CeD; Phase Ib Vitiligo Topline Readout Expected Shortly; Phase II CeD & Phase Ib Alopecia Areata Topline Remain Slated for 2026

研报英文原文证据摘录

FBRX - 1Q26; Fast-Track Designation Granted For CeD; Phase Ib Vitiligo Topline Readout Expected Shortly; Phase II CeD & Phase Ib Alopecia Areata Topline Remain Slated for 2026

May 11, 2026

Yatin Suneja yatin.suneja@guggenheimpartners.com FBRX - 1Q26; Fast-Track Designation Granted For

212 518 9565 CeD; Phase Ib Vitiligo Topline Readout Expected

Min Lee, Ph.D.

min.lee@guggenheimpartners.com Shortly; Phase II CeD & Phase Ib Alopecia Areata

212 823 6744 Topline Remain Slated for 2026 Iris Gao, Ph.D.

iris.gao@guggenheimpartners.com

212 518 9013 Key Message: Key takeaways from the 1Q26 earnings print are: (1) Phase II Celiac

Eddie Hickman, Ph.D. Disease (CeD) study continued to progress, with topline results remaining slated for 2026.

eddie.hickman@guggenheimpartners.com FBRX announced thatFB102 (anti-CD122 mAb) was granted Fast Track Designation

212 518 9904 (FTD) for CeD, which reflects the promising nature of FB102 for CeD treatment. FBRX

Delma Caiati, M.D., Ph.D. mgmt emphasized that enrollment in the Phase II (n=100) CeD study is going

delma.caiati@guggenheimpartners.com well and there is a "lot of excitement" from the physicians in the study. We note

617 859 4606 that TEVA also received FTD for their anti-IL-15 mAb for CeD in May 2025, further

underscoring FDA's alignment in recognition of CeD as a disease with urgent unmet

need; (2) Phase Ib vitiligo study (n~32)is ongoing to evaluate the safety & efficacy (F-

VASI) of FB102, with topline data anticipated shortly. Our base-case assumes that

FBRX BUY FB102'swould be24-weeklooking fordataan comeabsolutein-lineF-VASIwith 75INCY'sresponderOpzelura'srate in12-weekthe 12-15%efficacy,rangeand(Seewe

Forte Biosciences, Inc. Fig 1 for our scenario analysis). Any improvement in efficacy from week 12 to week 24