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EX - 99.1 2 q12021earningsrelease.htm EX - 99.1 • • • • • AnaptysBio Announces First Quarter 2021 Financial Results and Provides Pipeline Updates Imsidolimab Phase 3 GPP trial anticipated to commence in mid - 2021 following FDA end - of - Phase 2 meeting held during Q2 2021 JEMPERLI ( dostarlimab ) , our PD - 1 antagonist antibody partnered with GlaxoSmithKline ( GSK ) , was approved for endometrial cancer in the US and EU during Q2 2021 , earning $ 30 million in cash milestones and 8-25 % royalties , plus Zejula ( niraparib ) 1 % royalty revenue earned starting January 2021 Expanded imsidolimab clinical development program with initiation of Phase 2 trials in acne and hidradenitis suppurativa , with top - line data readouts anticipated in H1 2022 and H2 2022 , respectively Top - line data from POPLAR phase 2 clinical trial of imsidolimab monotherapy in palmoplantar pustulosis ( PPP ) , disclosed in Q1 2021 , failed to meet primary endpoint Ongoing healthy volunteer Phase 1 trial with ANB030 , with top - line data anticipated in H2 2021 and initiation of Phase 2 clinical trials in alopecia areata and vitiligo in Q4 2021 Achievement of first - in - human dosing of ANB032 with healthy volunteer Phase 1 top - line data anticipated in H1 2022 SAN DIEGO , May 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 first quarter ended March 31 , 2021 and provided pipeline updates . " We look forward to advancing imsidolimab into a Phase 3 trial for GPP following our recent end - of - Phase 2 meeting with the FDA , " said Hamza Suria , president and chief executive officer of AnaptysBio . “ AnaptysBio continues to pursue a capital- efficient business model where partnership revenues continue to support advancement of our wholly - owned pipeline poised to generate multiple clinical data catalysts through 2021 and 2022. " Imsidolimab ( Anti - IL - 36 Receptor ) Program We held an end - of - Phase 2 meeting with the FDA during Q2 2021 to review an orphan disease Phase 3 development plan for imsidolimab for the treatment of GPP and anticipate announcing key aspects of our Phase 3 trial design upon its initiation in mid - 2021 . Our worldwide registry of GPP patients , named RADIANCE , is ongoing , and we expect that this study will improve our understanding of the patient journey and support enrollment of our Phase 3 clinical trial . While initial GPP epidemiology studies suggested at least 3,000 GPP patients in the United States , medical claims analyses 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 , by a physician between 2017 and 2019 using the International Classification of Diseases 10th Revision ( ICD - 10 ) billing code pertaining to GPP ( L40.1 ) . We initiated a Phase 2 clinical trial of imsidolimab in hidradenitis suppurativa , named HARP , where 120 - patients are randomized equally between two dose levels of imsidolimab and placebo , and top - line data is anticipated in H2 2022 . We also commenced an imsidolimab Phase 2 trial in moderate - to - severe acne , named ACORN , where 120 - patients are randomized equally between two dose levels of imsidolimab and placebo , and top - line data is anticipated in H1 2022. We continue to anticipate top - line data at the end of 2021 from our EMERGE Phase 2 trial of imsidolimab in EGFR / MEK - mediated skin toxicities and top - line data from our Phase 2 INSPIRE trial in ichthyosis during 2022 . We announced in Q1 2021 top - line data from our POPLAR phase 2 clinical trial of imsidolimab monotherapy in PPP , which failed to meet the trial's primary endpoint . While we continue to review