(State or Other Jurisdiction of Incorporation)
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(IRS Employer Identification No.)
Title of each class
Name of each exchange on which registered
Results of Operations and Financial Condition.
Description of Exhibit
Cover Page Interactive Data File (the cover page XBRL tags are embedded within the inline XBRL document).
Date: May 6, 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 Third Quarter of 2020, Decided to Over-Enroll Trial Due to COVID-19
Additional Topline Data from GALLOP Phase 2 Clinical Trial of ANB019 Monotherapy in Moderate-to-Severe Generalized Pustular Psoriasis on Track for Second Half of 2020
Topline Data from POPLAR Phase 2 Clinical Trial of ANB019 Monotherapy in Palmoplantar Pustulosis on Track for Second Half of 2020
IND Cleared For Company’s Third Wholly-Owned Program, ANB030, an anti-PD-1 Agonist Antibody, and Phase 1 Trial Initiation Anticipated in First Half of 2020
US BLA and EU MAA for Dostarlimab, Our PD-1 Antagonist Antibody Partnered With GlaxoSmithKline (GSK), in Endometrial Cancer Accepted by the FDA and the EMA, Respectively
AnaptysBio is conducting a randomized, placebo-controlled Phase 2 trial in 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. We have over-enrolled this trial beyond the first 100 patients to compensate for lost patient visits due to the COVID-19 pandemic, and hence anticipate interim top-line data from this trial to be available in the third quarter of 2020.
As previously announced, 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. The Company anticipates additional clinical data and a regulatory strategy update for the development of ANB019 in GPP during the second half of 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.
Enrollment of the GALLOP and POPLAR trials has been enhanced by expanding clinical sites and geographies involved. While the Company does not believe that the aforementioned timelines are materially impacted by the COVID-19 pandemic at this point, some of the sites involved in the GALLOP and POPLAR trials have been affected by the COVID-19 pandemic, and the Company will continue to monitor the situation over the upcoming months.
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. Our Investigational New Drug Application (IND) for ANB030 has been cleared by the FDA and we plan 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.
In the first quarter of 2020, the FDA accepted the first Biologics License Application (BLA) filing for dostarlimab, an AnaptysBio-generated PD-1 antagonist antibody under partnership with GSK, for the treatment of endometrial cancer. AnaptysBio received a $10.0 million cash milestone payment upon this acceptance, and anticipates an additional $20.0 million cash milestone upon first FDA approval of dostarlimab during 2020. Also in the first quarter of 2020, the EMA accepted GSK’s Marketing Authorization Application (MAA) for approval of dostarlimab in the EU for endometrial cancer, for which AnaptysBio has earned a $5.0 million milestone payment. 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.
Cash, cash equivalents and investments totaled $412.7 million as of March 31, 2020 compared to $428.5 million as of December 31, 2019, for a decrease of $15.8 million. The decrease relates primarily to cash used for operating activities.
Collaboration revenue was $15.0 million for the three months ended March 31, 2020, which related to milestone payments for successful BLA and MAA filings for dostarlimab, compared to zero for the three months ended March 31, 2019.
Research and development expenses were $21.0 for the three months ended March 31, 2020, compared to $20.6 million for the three months ended March 31, 2019. The increase was due primarily to continued advancement of the Company’s preclinical programs.
General and administrative expenses were $4.3 million for the three months ended March 31, 2020, compared to $4.1 million for the three months ended March 31, 2019. The increase was due primarily to personnel-related expenses, including share-based compensation.
Net loss was $8.3 million for the three months ended March 31, 2020, or a net loss per share of $0.30, compared to a net loss of $22.1 million for the three months ended March 31, 2019, or a net loss per share of $0.82.
March 31, 2020
December 31, 2019
Cash and cash equivalents
Receivable from collaborative partners
Prepaid expenses and other current assets
Total current assets
Property and equipment, net
Other long-term assets
LIABILITIES AND STOCKHOLDERS’ EQUITY
Notes payable, current portion
Other current liabilities
Total current liabilities
Other long-term liabilities
Preferred stock, $0.001 par value, 10,000 shares authorized and no shares, issued or outstanding at March 31, 2020 and December 31, 2019, respectively
Common stock, $0.001 par value, 500,000 shares authorized, 27,277 shares and 27,255 shares issued and outstanding at March 31, 2020 and December 31, 2019, respectively
Additional paid in capital
Accumulated other comprehensive income
Total stockholders’ equity
Total liabilities and stockholders’ equity
Three Months Ended
Research and development
General and administrative
Total operating expenses
Loss from operations
Other income (expense), net:
Other income, net
Total other income (expense), net
Loss before income taxes
Provision for income taxes
Other comprehensive income:
Unrealized income on available for sale securities, net of tax of $0 and $115, respectively
Net loss per common share:
Basic and diluted
Weighted-average number of shares outstanding:
Basic and diluted