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EX - 99.1 2 q22021 earningsrelease.htm EX - 99.1 • • • AnaptysBio Announces Second Quarter 2021 Financial Results and Provides Pipeline Updates Imsidolimab GPP GEMINI - 1 Phase 3 trial anticipated to initiate in Q3 2021 following recent FDA end - of - Phase 2 Meeting Imsidolimab GALLOP GPP Phase 2 trial 16 - week data to be orally presented at the EADV Congress on October 2nd , 2021 Imsidolimab Phase 2 trials ongoing in acne , hidradenitis suppurativa , EGFR - mediated skin toxicity and ichthyosis , with multiple top - line data readouts anticipated in 2022 Rosnilimab , previously referred to as ANB030 , Phase 1 healthy volunteer top - line data and initiation of a Phase 2 trial in alopecia areata anticipated in Q4 2021 JEMPERLI ( dostarlimab ) , our PD - 1 antagonist antibody , which our partner GlaxoSmithKline ( GSK ) anticipates to reach peak annual sales of £ 1- £ 2 billion , was approved for endometrial cancer in the US and EU , earning $ 30 million in cash milestones in Q2 2021 and 8-25 % royalties on global net sales of JEMPERLI going forward SAN DIEGO , August 9 , 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 second quarter ended June 30 , 2021 and provided pipeline updates . " We continue to make progress in advancing our wholly - owned pipeline and look forward to multiple clinical data readouts over the upcoming 18 months ” said Hamza Suria , president and chief executive officer of AnaptysBio . “ The recent approval of JEMPERLI , which is the first AnaptysBio - generated antibody to be approved in the US and EU , validates AnaptysBio's antibody discovery platform and provides additional revenues to support our capital - efficient business model . ” Imsidolimab ( Anti - IL - 36 Receptor ) Program • • Following an end - of - Phase 2 meeting with the FDA in Q2 , we publicly disclosed trial designs for our imsidolimab generalized pustular psoriasis ( GPP ) Phase 3 trials , called GEMINI - 1 and GEMINI - 2 . We anticipate initiating GEMINI - 1 in Q3 2021. The primary endpoint of our Phase 3 program is the proportion of patients achieving clear or almost clear skin as determined by a Generalized Pustular Psoriasis Physician's Global Assessment ( GPPPGA ) score of zero or 1 at week 4 of GEMINI - 1 , while GEMINI - 2 is designed for 6 months of safety follow - up assessment . We continue to enroll GPP patients in our worldwide registry of GPP patients , called RADIANCE , which is designed to improve our understanding of GPP patient journeys and support enrollment of our GEMINI Phase 3 trials . Medical claims analyses recently conducted by IQVIA indicate approximately 37,000 unique patients were diagnosed with GPP at least once , and approximately 15,000 unique patients were diagnosed with GPP at least twice , in the United States by a physician between 2017 and 2019 using the International Classification of Diseases 10th Revision ( ICD- 10 ) billing code pertaining to GPP ( L40.1 ) . Full data from our completed Phase 2 GALLOP trial of imsidolimab in GPP , including efficacy and safety of imsidolimab treatment through week 16 , will be disclosed in an oral presentation at the European Academy of Dermatology and Venereology ( EADV ) Congress on October 2nd , 2021 . We are continuing to advance imsidolimab through Phase 2 clinical trials in multiple additional indications associated with IL - 36 signaling dysfunction . Our 120 - patient placebo - controlled ACORN Phase 2 trial of imsidolimab in moderate - to - severe acne is anticipated to read out top - line data in the first half of 2022. Imsidolimab is also being tested versus placebo in hidradenitis suppurativa , where our 120 - patient HARP trial is anticipated to generate top - line data in the second half of 2022. We continue to enroll our 45 - patient