On May 4, 2022 AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company developing first-in-class antibodies focused on emerging immune control mechanisms applicable to inflammation and immuno-oncology indications, reported operating results for the first quarter ended March 31, 2022 and provided pipeline updates (Press release, AnaptysBio, MAY 4, 2022, View Source [SID1234613525]).
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"We are excited with our recently released Phase 1 trial results of ANB032, our anti-BTLA agonist, and the potential to broadly treat T and B-cell driven inflammatory diseases. Our recently initiated strategic portfolio review will define the path forward across a breadth of clinical development options of potential inflammation-focused indications that could be pursued for each of our clinical and preclinical therapeutic antibody programs," said Daniel Faga, interim president and chief executive officer of AnaptysBio. "We look forward to continuing to execute on our ongoing clinical trials with multiple readouts throughout the next 18 months."
Imsidolimab (Anti-IL-36 receptor) Program
•Imsidolimab, our investigational wholly owned anti-IL-36R therapeutic antibody, is in Phase 3 trials in generalized pustular psoriasis (GPP), and we anticipate top-line data from the GEMINI-1 Phase 3 clinical trial in Q4 2023.
•We anticipate top-line data from the HARP Phase 2 trial in moderate-to-severe hidradenitis suppurativa in Q3 2022.
Rosnilimab (Anti-PD-1 agonist) Program
•Rosnilimab, our investigational wholly owned anti-PD-1 agonist therapeutic antibody, previously known as ANB030, is in the AZURE Phase 2 clinical trial in moderate-to-severe alopecia areata, and we anticipate top-line data in H1 2023.
ANB032 (Anti-BTLA agonist) Program
•Announced positive top-line phase 1 data in April 2022 of ANB032, our investigational wholly owned anti-BTLA agonist antibody, demonstrating favorable safety and tolerability with no dose limiting toxicities were observed and no serious adverse events (SAEs) reported.
•ANB032 pharmacokinetic analyses demonstrated a favorable profile including an approximate two-week half-life and Full BTLA receptor occupancy rapidly within hours and was maintained for greater than 30 days.
•ANB032 also demonstrated rapid and sustained target engagement on both T cells and B cells.
•We are advancing ANB032 with an IND filing for a Phase 2 clinical trial anticipated in H2 2022.
First Quarter Financial Results
•Cash, cash equivalents and investments totaled $596.8 million as of March 31, 2022, compared to $615.2 million as of December 31, 2021, for a decrease of $18.4 million. The decrease relates primarily to cash used for operating activities offset by cash received from stock option exercises.
•Collaboration revenue was $1.0 million for the three months ended March 31, 2022, compared to $11.2 million for the three months ended March 31, 2021. The decrease relates primarily to one milestone achieved for JEMPERLI in the first quarter of 2021 for $10.0 million, and no milestones achieved in the first quarter of 2022.
•Research and development expenses were $22.5 million for the three months ended March 31, 2022, compared to $24.2 million for the three months ended March 31, 2021. The decrease was due primarily to reduced imsidolimab manufacturing costs offset by increased costs for the Company’s clinical programs. The R&D non-cash, stock-based compensation expense was $1.7 million for the three months ended March 31, 2022 as compared to $1.2 million in the same period in 2021.
•General and administrative expenses were $10.2 million for the three months ended March 31, 2022, compared to $5.4 million for the three months ended March 31, 2021. The increase was due primarily to $3.8 million of costs incurred for our former President and CEO’s resignation in the first quarter of 2022. The G&A non-cash, stock-based compensation expense was $6.1 million for the three months ended March 31, 2022 which includes $3.2 million of the $3.8 million one-time costs described earlier as compared to $2.1 million in the same period in 2021.
•Net loss was $36.3 million for the three months ended March 31, 2022, or a net loss per share of $1.31, compared to a net loss of $18.2 million for the three months ended March 31, 2021, or a net loss per share of $0.66.