On May 11, 2023 AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics, reported its operating results for the first quarter ended March 31, 2023 and provided pipeline updates (Press release, AnaptysBio, MAY 11, 2023, View Source [SID1234631483]).

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"We’re excited about our progress as we continue to develop best-in-class antibodies across a number of high-value immune cell modulatory targets. We have initiated our global Phase 2b trial in moderate-to-severe atopic dermatitis (AD) for ANB032, our BTLA agonist, and will host a virtual R&D event on May 25th to highlight the biologic and mechanistic rationale for developing a BTLA agonist in AD," said Daniel Faga, interim president and chief executive officer of AnaptysBio. "We believe our checkpoint agonists, rosnilimab and ANB032, as well as our CD122 antagonist, ANB033, have the potential to treat a broad range of autoimmune and inflammatory disorders by directly acting on immune cells that mediate disease pathology, and we remain well capitalized to execute on our broad development plan."

Updates on Wholly Owned Immune Cell Modulator Pipeline

Rosnilimab (PD-1 agonist antibody)

Anticipate initiation in Q3 2023 of a global Phase 2b trial in moderate-to-severe rheumatoid arthritis (RA)
Multi-hundred patient placebo-controlled trial assessing three dose levels of subcutaneously administered rosnilimab for up to 6 months on well-established endpoints including ACR20/50/70 and DAS28
Top-line interim data anticipated by mid-year 2025
Plan to initiate second global Phase 2 trial, in an indication to be announced, by year-end 2023
ANB032 (BTLA agonist antibody)

Initiated a global Phase 2b trial in moderate-to-severe AD
160 patient placebo-controlled trial assessing three dose levels of subcutaneously administered ANB032 (randomized 1:1:1:1) for a 14-week treatment duration on well-established endpoints, including EASI75 and IGA 0/1
Top-line interim data anticipated by year-end 2024
Presented poster on Phase 1 data for ANB032, a BTLA agonist for the treatment of moderate-to-severe AD, at International Societies for Investigative Dermatology (ISID) Annual Meeting, May 11, 2023, in Japan
Planning to host a virtual BTLA Agonist (ANB032) R&D Event on Thursday, May 25, 2023 at 1:15pm PT / 4:15pm ET
Management will host the event via conference call and webcast, with an accompanying slide presentation
The live audio webcast, as well as a replay of the presentation, will be available on the investor section of the AnaptysBio website at View Source
ANB033 (anti-CD122 antagonist antibody)

Plan to submit an Investigational New Drug (IND) application in H1 2024
Updates on Legacy Clinical-Stage Cytokine Antagonist Programs Available for Out-Licensing

Announced publication of Phase 2 GALLOP data for imsidolimab, an investigational, wholly owned, anti-IL-36R antagonist IgG4 antibody in generalized pustular psoriasis (GPP) in The British Journal of Dermatology on April 30, 2023

Anticipate top-line data from the ongoing GEMINI-1 Phase 3 trial in Q4 2023
Plan to out-license imsidolimab prior to potential FDA approval
GSK Immuno-Oncology Financial Collaboration

GSK announced publication of RUBY Phase 3 clinical data for JEMPERLI (dostarlimab-gxly), an anti-PD-1 antagonist antibody discovered at AnaptysBio and licensed to GSK, in The New England Journal of Medicine and presented simultaneously at ESMO (Free ESMO Whitepaper) Virtual Plenary and SGO Annual Meeting in March 2023
JEMPERLI has the potential for a first-in-class approval in primary advanced or recurrent endometrial cancer after meeting the primary endpoint in the pivotal RUBY Phase 3 trial demonstrating JEMPERLI plus chemotherapy significantly improved PFS versus chemotherapy plus placebo
GSK plans regulatory submissions in H1 2023
GSK anticipates top-line data from the ongoing FIRST Phase 3 trial, a randomized, double-blind, comparison of platinum-based therapy with dostarlimab and niraparib versus standard of care platinum-based therapy as first-line treatment of Stage III or IV nonmucinous epithelial ovarian cancer, in H2 2023
GSK anticipates top-line data from the ongoing COSTAR Lung Phase 3 trial, a randomized, open label 3-arm trial comparing cobolimab plus dostarlimab plus docetaxel to dostarlimab plus docetaxel to docetaxel alone in patients with advanced NSCLC who have progressed on prior anti-PD-(L)1 therapy and chemotherapy, in 2024
Stock Repurchase Program and Year-End Cash Guidance

Completed Stock Repurchase Program, authorized in January 2023, of $50.0 million of the Company’s outstanding common stock
Reiterating cash runway through year-end 2026 with expected year-end 2023 cash and investments of $370 – $385 million
First Quarter Financial Results

Cash, cash equivalents and investments totaled $526.1 million as of March 31, 2023, compared to $584.2 million as of December 31, 2022, for a decrease of $58.1 million. The decrease relates primarily to cash used for the stock repurchase program and operating activities.

Collaboration revenue was $1.4 million for the three months ended March 31, 2023, compared to $1.0 million for the three months ended March 31, 2022. The change is due to increased royalties recognized for sales of JEMPERLI and Zejula in the first quarter of 2023.

Research and development expenses were $35.0 million for the three months ended March 31, 2023, compared to $22.5 million for the three months ended March 31, 2022. The increase was due primarily to manufacturing and development costs for imsidolimab, rosnilimab, ANB032 and ANB033. The R&D non-cash, stock-based compensation expense was $2.8 million for the three months ended March 31, 2023 as compared to $1.7 million in the same period in 2022.

General and administrative expenses were $10.8 million for the three months ended March 31, 2023, compared to $10.2 million for the three months ended March 31, 2022. The G&A non-cash, stock-based compensation expense was $6.1 million for the three months ended March 31, 2023 and 2022.

Net loss was $44.3 million for the three months ended March 31, 2023, or a net loss per share of $1.58, compared to a net loss of $36.3 million for the three months ended March 31, 2022, or a net loss per share of $1.31.