On March 7, 2022 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, reported operating results for the fourth quarter and year ended December 31, 2021 and provided pipeline updates (Press release, AnaptysBio, MAR 7, 2022, View Source [SID1234609594]).
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"We advanced our wholly-owned antibody product pipeline and completed a $250 million royalty monetization transaction during 2021," said Hamza Suria, president and chief executive officer of AnaptysBio. "We look forward to multiple clinical data readouts during 2022 and remain focused on developing first-in-class therapeutic antibodies using a capital-efficient business model."
Imsidolimab (Anti-IL-36 Receptor) Program
Following an end-of-Phase 2 meeting with the FDA, we initiated our GEMINI-1 Phase 3 trial of imsidolimab in generalized pustular psoriasis (GPP) where the primary endpoint 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 placebo. These same patients will subsequently be enrolled into GEMINI-2, which will assess 6 months of monthly subcutaneous dosing and safety follow-up.
We anticipate top-line data from the ACORN Phase 2 trial of imsidolimab in moderate-to-severe acne in H1 2022 and from the HARP Phase 2 trial in moderate-to-severe hidradenitis suppurativa in H2 2022.
Rosnilimab (Anti-PD-1 Agonist) Program
We announced positive top-line data from a randomized placebo-controlled healthy volunteer single and multiple ascending dose Phase 1 trial of rosnilimab, our investigational wholly-owned anti-PD-1 agonist therapeutic antibody, previously known as ANB030. Top-line data demonstrated favorable safety, pharmacokinetics and pharmacodynamic results, which supported initiation of our Phase 2 AZURE clinical trial of rosnilimab in alopecia areata.
ANB032 (Anti-BTLA Modulator) Program
We are advancing ANB032, our wholly-owned BTLA modulator antibody, in a healthy volunteer Phase 1 single and multiple ascending dose clinical trial where top-line data is anticipated during the first half of 2022.
GSK Partnered Programs
We completed a royalty monetization agreement with Sagard Healthcare Royalty Partners where AnaptysBio received a $250 million payment in exchange for JEMPERLI royalties due to AnaptysBio on annual commercial sales below $1 billion and certain future milestones starting October 2021. The aggregate JEMPERLI royalties and milestones to be received by Sagard under this Agreement is capped at certain fixed multiples of the upfront payment.
Fourth Quarter Financial Results
Cash, cash equivalents and investments totaled $615.2 million as of December 31, 2021, compared to $411.2 million as of December 31, 2020, for an increase of $204.0 million. The increase relates primarily to cash received from the royalty monetization transaction with Sagard Healthcare Partners offset by cash used for operating activities.
Collaboration revenue was $1.0 million and $63.2 million for the three and twelve months ended December 31, 2021. The $1.0 million earned during the fourth quarter primarily relates to royalty revenue earned for sales of JEMPERLI (dostarlimab) and Zejula by GSK, compared to $60.0 million and $75 million of milestone revenue for the three and twelve months ended December 31, 2020.
Research and development expenses were $26.8 million and $98.5 million for the three and twelve months ended December 31, 2021, compared to $21.6 million and $80.0 million for the three and twelve months ended December 31, 2020. The increase was due primarily to continued advancement of the Company’s clinical programs.
General and administrative expenses were $5.4 million and $21.5 million for the three and twelve months ended December 31, 2021, compared to $5.1 million and $18.9 million for the three and twelve months ended December 31, 2020. The increase was due primarily to personnel-related expenses, including share-based compensation.
Net loss was $32.5 million and $57.8 million for the three and twelve months ended December 31, 2021, or a net loss per share of $1.18, and $2.11, compared to net income of $33.6 million for the three months ended December 31, 2020 or net income per share of $1.23 and a net loss of $19.9 million for the twelve months ended December 31, 2020, or net loss per share of $0.73.