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EX - 99.1 2 q32021 earningsrelease.htm EX - 99.1 • • AnaptysBio Announces Third Quarter 2021 Financial Results and Provides Pipeline Updates Imsidolimab GPP GALLOP Phase 2 16 - week data presented at 2021 EADV Congress and GEMINI - 1 Phase 3 trial initiated subsequent to FDA end - of - Phase 2 meeting Top - line data from ongoing imsidolimab ACORN Phase 2 trial in moderate - to - severe acne anticipated in H1 2022 and HARP Phase 2 trial in moderate - to - severe hidradenitis suppurativa in H2 2022 Rosnilimab Phase 1 healthy volunteer top - line data and initiation of AZURE Phase 2 trial in alopecia areata anticipated in Q4 2021 JEMPERLI ( dostarlimab ) was approved for mismatch repair deficient ( dMMR ) recurrent or advanced solid tumors in the US , earning $ 20 million cash milestone during Q3 2021 JEMPERLI royalty monetization transaction signed with Sagard Healthcare Royalty Partners for $ 250 million upfront payment in exchange for capped return on royalties and certain milestones below $ 1 billion in annual sales Expect to end 2021 with approximately $ 600 million in cash and will continue to operate in a capital - efficient manner SAN DIEGO , November 4 , 2021 - AnaptysBio , Inc. ( Nasdaq : ANAB ) , a clinical - stage biotechnology company developing first - in - class antibody product candidates focused on emerging immune control mechanisms applicable to inflammation and immuno - oncology indications , today reported operating results for the third quarter ended September 30 , 2021 and provided pipeline updates . " Our wholly - owned pipeline continues to make progress with the recent initiation of our imsidolimab GEMINI - 1 Phase 3 trial in GPP and anticipated initiation of our rosnilimab AZURE alopecia areata Phase 2 trial during the remainder of 2021 , " said Hamza Suria , president and chief executive officer of AnaptysBio . “ We believe the recent royalty monetization transaction with Sagard validates the future revenue stream anticipated from JEMPERLI sales and further supports AnaptysBio's capital- efficient business model . " Imsidolimab ( Anti - IL - 36 Receptor ) Program . • Following an end - of - Phase 2 meeting with the FDA in Q2 2021 , we publicly disclosed Phase 3 trial designs for imsidolimab in generalized pustular psoriasis ( GPP ) , GEMINI - 1 and GEMINI - 2 . The primary endpoint of our GEMINI - 1 Phase 3 trial is the proportion of patients achieving a score of clear ( 0 ) or almost clear ( 1 ) skin on the Generalized Pustular Psoriasis Physician's Global Assessment ( GPPPGA ) at week 4 in 45 patients randomized against placebo . GEMINI - 2 will assess 6 months of monthly subcutaneous dosing and safety follow - up of those same patients . GEMINI - 1 was initiated in Q3 2021 . Full data from the Phase 2 GALLOP trial in GPP , including efficacy and safety of imsidolimab treatment through week 16 , was disclosed in an oral presentation by Dr. Johann Gudjonsson , professor of Dermatology at the University of Michigan , at the European Academy of Dermatology and Venereology ( EADV ) Congress on October 2nd , 2021 . Imsidolimab demonstrated rapid and sustained efficacy with 6 of 8 ( 75 % ) GPP patients achieving the primary endpoint at week 4 and 16. We also observed early reduction of erythema with pustules by 60 % at week 1 , 94 % reduction at week 4 , 98 % reduction at week 16 , each versus baseline . We anticipate top - line data from the ACORN Phase 2 trial of imsidolimab in moderate - to - severe acne in H1 2022 and from the HARP Phase 2 trial in moderate - to - severe hidradenitis suppurativa in H2 2022 .