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Date: March 2, 2020
/s/ Eric Loumeau
Name: Eric Loumeau
Title: Interim Chief Financial Officer and General Counsel
Interim Top-Line Data From Etokimab ECLIPSE Phase 2 Trial in Chronic Rhinosinusitis with Nasal Polyps Anticipated in First Half of 2020
Reported Positive Topline Data from Interim Analysis of GALLOP Phase 2 Clinical Trial of ANB019 Monotherapy in Moderate-to-Severe Generalized Pustular Psoriasis and Anticipate Additional Clinical Data and Regulatory Update During 2020
Phase 1 Trial of Company’s Third Wholly-Owned Program, ANB030, an anti-PD-1 Agonist Antibody, Anticipated in First Half of 2020 Following IND Submission in Q4 2019
GlaxoSmithKline (GSK) Announced BLA Submission of Dostarlimab, a PD-1 Antagonist Antibody Partnered With AnaptysBio, in Endometrial Cancer
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 half of 2020.
The Company previously announced 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 has discontinued development of etokimab in moderate-to-severe atopic dermatitis.
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 results are available from the ECLIPSE trial.
In September, AnaptysBio announced positive topline data from an interim analysis of its Phase 2 clinical trial of ANB019 monotherapy in moderate-to-severe generalized pustular psoriasis, or GPP, also known as the GALLOP trial. In this interim analysis, both patients achieved the primary endpoint of disease score improvement at Day 29 and Day 113 without requiring rescue therapy, demonstrated rapid and sustained mJDA score improvement, with reduction of 58% at Day 8 and 63% at Day 113, and showed complete clearance of skin pustules by Day 8 and through Day 113, with CRP levels decreasing to nearly normal. Enrollment is ongoing in the GALLOP study, and the Company anticipates additional clinical data and a regulatory strategy update for the development of ANB019 in GPP during 2020.
The Company is also conducting a randomized, placebo-controlled, multi-dose Phase 2 trial in 50 patients with palmoplantar pustulosis, or PPP, also known as the POPLAR trial, with topline data anticipated in the second half of 2020.
AnaptysBio has taken steps to enhance enrollment in the GALLOP and POPLAR trials, including expansion of clinical trial sites and countries.
ANB030 is a wholly-owned antibody that binds PD-1 in an agonistic manner, leading to reduced T cell activity and anti-inflammatory effects in vivo. Genetic mutations in the PD-1 pathway are associated with increased susceptibility to various inflammatory conditions and we believe ANB030 has the potential to suppress inflammatory diseases by restoring insufficient PD-1-mediated negative signaling on activated T cells. The Company plans to focus future clinical development of ANB030 on certain autoimmune diseases where PD-1 checkpoint receptor function may be under-represented, submitted an Investigational New Drug Application (IND) in the fourth quarter of 2019 and plans to initiate a Phase 1 clinical trial in the first half of 2020. Preclinical data from the ANB030 was presented in June at the 2019 FOCIS Annual Meeting.
Our fourth wholly-owned program is an anti-BTLA modulator antibody, known as ANB032, which is broadly applicable to human inflammatory diseases associated with lymphoid and myeloid immune cell dysregulation. Mutations in the BTLA signaling pathway are associated with human inflammatory disease and we believe ANB032 silences pro-inflammatory signaling by modulating BTLA binding to HVEM. We anticipate filing an IND for ANB032 in the second half of 2020.
GSK has recently announced that a first BLA filing for dostarlimab, an AnaptysBio-generated PD-1 antagonist antibody under partnership with TESARO, a GSK company, occurred in the fourth quarter of 2019 for the treatment of endometrial cancer. AnaptysBio anticipates receiving a $10.0 million cash milestone payment upon acceptance of this BLA filing and a $20.0 million cash milestone upon first FDA approval of dostarlimab. Including additional cash milestones due upon future development and commercialization of dostarlimab, TSR-022, an AnaptysBio-generated TIM-3 antibody, and TSR-033, an AnaptysBio-generated LAG-3 antibody, AnaptysBio can potentially receive a total of $1.1 billion in aggregate milestone payments under this GSK partnership. In addition, AnaptysBio is due a 4% to 8% royalty from GSK, tiered upon global sales, for each of the aforementioned programs.
In September, the Company appointed Laura J. Hamill to its board of directors. Most recently, Ms. Hamill served as Executive Vice President, Worldwide Commercial Operations, for Gilead Sciences, where she was involved in the strategic direction and long-term planning of the organization. Previously, Ms. Hamill held a number of US and international executive roles at Amgen, culminating with Senior Vice President and General Manager where she led ~$20B in U.S. commercial operations.
Cash, cash equivalents and investments totaled $428.5 million as of December 31, 2019 compared to $500.2 million as of December 31, 2018, for a decrease of $71.7 million. The decrease relates primarily to cash used for operating activities.
Collaboration revenue was $3.0 million and $8.0 million for the three months and year ended December 31, 2019, which related to a milestone for initiation of a Phase 2 trial for TSR-033, the anti-LAG-3 antibody partnered with TESARO, a GlaxoSmithKline (GSK) company, compared to zero and $5.0 million for the three and year ended December 31, 2018.
Research and development expenses were $21.4 million and $99.3 million for the three months and year ended December 31, 2019, compared to $15.9 million and $56.2 million for the three months and year
General and administrative expenses were $3.8 million and $16.1 million for the three months and year ended December 31, 2019, compared to $3.7 million and $15.5 million for the three months and year ended December 31, 2018. The increase was due primarily to personnel-related expenses, including share-based compensation.
Net loss was $20.3 million and $97.3 million for the three months and year ended December 31, 2019, or a net loss per share of $0.75 and $3.60, compared to a net loss of $17.0 million and $61.7 million for the three months and year ended December 31, 2018, or a net loss per share of $0.64 and $2.50.
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Preferred stock, $0.001 par value, 10,000 shares authorized and no shares, issued or outstanding at December 31, 2019 and December 31, 2018, respectively
Common stock, $0.001 par value, 500,000 shares authorized, 27,255 shares and 26,922 shares issued and outstanding at December 31, 2019 and December 31, 2018, respectively
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Unrealized income (loss) on available for sale securities, net of tax of ($36), $55, $153, and $55, respectively
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