Business
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
About this update from Anaptysbio, Inc.
[{"type":"text","content":"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 meetingTop-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 2022Rosnilimab Phase 1 healthy volunteer top-line data and initiation of AZURE Phase 2 trial in alopecia areata anticipated in Q4 2021JEMPERLI (dostarlimab) was approved for mismatch repair deficient (dMMR) recurrent or advanced solid tumors in the US, earning $20 million cash milestone during Q3 2021JEMPERLI 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 salesExpect to end 2021 with approximately $600 million in cash and will continue to operate in a capital-efficient manner SAN DIEGO, Nov. 04, 2021 (GLOBE NEWSWIRE) -- 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 p...