Delaware | 001-37985 | 20-3828755 |
(State or Other Jurisdiction of Incorporation) | (Commission File Number) | (IRS Employer Identification No.) |
10421 Pacific Center Court, Suite 200 San Diego, CA | 92121 | |
(Address of Principal Executive Offices) | (Zip Code) |
• | Multiple Top-line Phase 2 Clinical Efficacy Readouts from Wholly-owned Pipeline Anticipated in 2019 |
• | Etokimab Phase 2b Eosinophilic Asthma Trial Initiation Anticipated in 4Q19 |
• | IND Filing for Company’s Third Wholly-Owned Program, ANB030, an anti-PD-1 Agonist, Expected in 4Q19 |
• | Recognized $5.0 million milestone for advancement of dostarlimab, an anti-PD-1 antagonist antibody partnered with GSK, into Phase 3 for a second indication |
• | In June 2019, AnaptysBio presented full data from its Phase 2a proof-of-concept clinical trial of etokimab in adult patients with severe eosinophilic asthma at the 2019 European Academy of Allergy and Clinical Immunology (EAACI) Congress. Data showed that a single dose of etokimab resulted in rapid and sustained lung function improvement as measured using Forced Expiratory Volume in One Second, or FEV1, patient reported outcomes associated with asthma symptoms, as measured using the Asthma Control Questionnaire 5, and biomarker levels as measured using blood eosinophils. The Company believes these data support continued development of etokimab in eosinophilic asthma and plans to initiate a multi-dose Phase 2b randomized, double-blinded, placebo-controlled trial in 300-400 eosinophilic asthma patients in the fourth quarter of 2019. |
• | The Company is also conducting its ATLAS trial, a Phase 2b randomized, double-blinded, placebo-controlled, multi-dose study in approximately 300 adult patients with moderate-to-severe atopic dermatitis. The study is designed to assess different dose levels and dosing frequencies of subcutaneously-administered etokimab, with top-line data expected in the fourth quarter of 2019. |
• | 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 interim top-line data from the ECLIPSE trial in the fourth quarter of 2019. |
• | The Company is conducting a single arm, open-label Phase 2 trial of ANB019 in up to 10 patients with generalized pustular psoriasis, or GPP, also known as the GALLOP trial, with interim top-line data expected in mid-2019. |
• | The Company is 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 top-line data anticipated in the first half of 2020. |
• | 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 and anticipates filing an Investigational New Drug Application (IND) in the fourth quarter of 2019. Preclinical data from the ANB030 was presented in June at the 2019 FOCIS Annual Meeting. |
• | Cash, cash equivalents and investments totaled $467.9 million as of June 30, 2019 compared to $500.2 million as of December 31, 2018, for a decrease of $32.3 million. The decrease relates primarily to cash used for operating activities. |
• | Collaboration revenue was $5.0 million for the three and six months ended June 30, 2019, which related to a milestone for initiation of a Phase 3 trial in a second indication for dostarlimab, the anti-PD-1 antagonist antibody partnered with TESARO, a GlaxoSmithKline (GSK) company, compared to no revenue for the three and six months ended June 30, 2018. |
• | Research and development expenses were $27.4 million and $48.0 million for the three and six months ended June 30, 2019, compared to $10.6 million and $22.4 million for the three and six months ended June 30, 2018. The increase was due primarily to continued advancement of the Company’s etokimab and ANB019 clinical programs and additional personnel-related expenses, including share-based compensation. |
• | General and administrative expenses were $4.3 million and $8.4 million for the three and six months ended June 30, 2019, compared to $3.8 million and $7.8 million for the three and six months ended June 30, 2018. The increase was due primarily to additional personnel-related expenses, including share-based compensation. |
• | Net loss was $24.0 million and $46.0 million for the three and six months ended June 30, 2019, or a net loss per share of $0.89 and $1.70, compared to a net loss of $13.6 million and $28.7 million for the three and six months ended June 30, 2018, or a net loss per share of $0.57 and $1.20. |
June 30, 2019 | December 31, 2018 | ||||||
(unaudited) | |||||||
ASSETS | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 146,552 | $ | 113,596 | |||
Receivable from collaborative partners | 5,000 | — | |||||
Australian tax incentive receivable | — | 174 | |||||
Short-term investments | 275,664 | 313,486 | |||||
Prepaid expenses and other current assets | 3,772 | 6,960 | |||||
Total current assets | 430,988 | 434,216 | |||||
Property and equipment, net | 1,481 | 1,445 | |||||
Long-term investments | 45,707 | 73,128 | |||||
Other long-term assets | 1,913 | 148 | |||||
Restricted cash | 60 | 60 | |||||
Total assets | $ | 480,149 | $ | 508,997 | |||
LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 10,921 | $ | 5,443 | |||
Accrued expenses | 14,102 | 8,761 | |||||
Notes payable, current portion | 4,781 | 7,574 | |||||
Other current liabilities | 819 | 58 | |||||
Total current liabilities | 30,623 | 21,836 | |||||
Other long-term liabilities | 1,105 | 796 | |||||
Stockholders’ equity: | |||||||
Preferred stock, $0.001 par value, 10,000 shares authorized and no shares, issued or outstanding at June 30, 2019 and December 31, 2018, respectively | — | — | |||||
Common stock, $0.001 par value, 500,000 shares authorized, 27,045 shares and 26,922 shares issued and outstanding at June 30, 2019 and December 31, 2018, respectively | 27 | 27 | |||||
Additional paid in capital | 640,550 | 633,251 | |||||
Accumulated other comprehensive income (loss) | 574 | (223 | ) | ||||
Accumulated deficit | (192,730 | ) | (146,690 | ) | |||
Total stockholders’ equity | 448,421 | 486,365 | |||||
Total liabilities and stockholders’ equity | $ | 480,149 | $ | 508,997 |
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||
2019 | 2018 | 2019 | 2018 | ||||||||||||
Collaboration revenue | $ | 5,000 | $ | — | $ | 5,000 | $ | — | |||||||
Operating expenses: | |||||||||||||||
Research and development | 27,350 | 10,583 | 47,981 | 22,393 | |||||||||||
General and administrative | 4,307 | 3,832 | 8,448 | 7,779 | |||||||||||
Total operating expenses | 31,657 | 14,415 | 56,429 | 30,172 | |||||||||||
Loss from operations | (26,657 | ) | (14,415 | ) | (51,429 | ) | (30,172 | ) | |||||||
Other income (expense), net: | |||||||||||||||
Interest expense | (281 | ) | (436 | ) | (601 | ) | (887 | ) | |||||||
Interest income | 2,957 | 1,297 | 5,945 | 2,482 | |||||||||||
Other income (expense), net | (41 | ) | (64 | ) | (34 | ) | (127 | ) | |||||||
Total other income (expense), net | 2,635 | 797 | 5,310 | 1,468 | |||||||||||
Loss before income taxes | (24,022 | ) | (13,618 | ) | (46,119 | ) | (28,704 | ) | |||||||
Provision for income taxes | 60 | — | 79 | — | |||||||||||
Net loss | (23,962 | ) | (13,618 | ) | (46,040 | ) | (28,704 | ) | |||||||
Other comprehensive income (loss): | |||||||||||||||
Unrealized income (loss) on available for sale securities, net of tax of $99, $0, $214 and $0, respectively | 370 | 124 | 797 | (250 | ) | ||||||||||
Other comprehensive income (loss), net of tax | $ | 370 | $ | 124 | $ | 797 | $ | (250 | ) | ||||||
Net loss per common share: | |||||||||||||||
Basic and diluted | $ | (0.89 | ) | $ | (0.57 | ) | $ | (1.70 | ) | $ | (1.20 | ) | |||
Weighted-average number of shares outstanding: | |||||||||||||||
Basic and diluted | 27,026 | 23,932 | 27,004 | 23,867 |