initial public offerings (IPOs) trading on American exchanges

Friday, November 8, 2019

-==AnaptysBio (ANAB) : Etokimab ATLAS Phase 2b fails to meet primary endpoint

AnaptysBio misses by $0.06; Etokimab ATLAS Phase 2b fails to meet primary endpoint 
  • Reports Q3 (Sep) loss of $1.15 per share, $0.06 worse than the S&P Capital IQ Consensus of ($1.09).
  • Etokimab (ANB020 Anti-IL-33) Program
    • The Company today announced topline data from its ATLAS trial, a Phase 2b randomized, double-blinded, placebo-controlled, multi-dose study in approximately 300 adult patients treated with etokimab in moderate-to-severe atopic dermatitis. Each of the etokimab dosing arms failed to meet the primary endpoint of the trial, which was demonstration of statistically greater improvement in the Eczema Area and Severity Index (EASI) relative placebo at week 16.
    • AnaptysBio is conducting a randomized, placebo-controlled Phase 2 trial in approximately 100 adult patients with chronic rhinosinusitis with nasal polyps, also referred to as the ECLIPSE trial. Patients are being treated with two multi-dosing frequencies of subcutaneously-administered etokimab or placebo, each in combination with mometasone furoate nasal spray as background therapy. The Company anticipates topline data from an interim analysis of the ECLIPSE trial in the first quarter of 2020.
    • The Company has decided to postpone the initiation of its planned Phase 2b etokimab clinical trial in eosinophilic asthma, a multi-dose, randomized, double-blinded, placebo-controlled trial in 300-400 patients, until it has the opportunity to analyze the full data set from the ATLAS trial.
  • "While we are disappointed with the top-line results of our etokimab ATLAS trial, we intend to re-evaluate our etokimab development strategy following additional data from ATLAS and top-line results from ECLIPSE in the first quarter of 2020," said Hamza Suria, president and chief executive officer of AnaptysBio. "We look forward to advancing ANB019, ANB030 and additional preclinical programs in our wholly-owned pipeline."
  • AnaptysBio expects that its cash, cash equivalents and investments will fund its current operating plan, taking into account the adjustments to etokimab clinical development activities referenced above, at least into 2021. The Company expects to re-evaluate its current operating plan in light of the topline data from the ATLAS trial and to make adjustments as appropriate to manage the Company's available cash resources.

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