ANB020 Top-Line Phase 2a Readouts Anticipated For Peanut Allergy in March 2018 and Eosinophilic Asthma in Second Quarter 2018
ANB019 GPP and PPP Phase 2 Studies to be Initiated During 2018
SAN DIEGO, March 05, 2018 (GLOBE NEWSWIRE) -- AnaptysBio, Inc. (Nasdaq:ANAB), a clinical-stage biotechnology company developing first-in-class antibody product candidates focused on unmet medical needs in inflammation, today reported operating results for the fourth quarter and year ended December 31, 2017 and anticipated 2018 pipeline milestones.
“AnaptysBio made significant progress on multiple program and corporate milestones during 2017,” said Hamza Suria, president and chief executive officer of AnaptysBio. “We are poised to continue advancing our ANB020 and ANB019 programs with additional clinical data readouts in serious inflammatory conditions during 2018. We are on-track to report top-line data on ANB020 as a treatment for both severe adult peanut allergy in March 2018 and severe adult eosinophilic asthma during the second quarter of 2018. We plan to initiate a Phase 2b study of ANB020 in moderate-to-severe adult atopic dermatitis during the first half of 2018, as well as Phase 2 studies of ANB019 in generalized pustular psoriasis, or GPP and palmo-plantar pustular psoriasis, or PPP, during 2018. These milestones are significant for the company, and important steps forward in bringing our novel treatments to patients with severe inflammatory diseases.”
ANB020 (Anti-IL-33 Program)
ANB019 (Anti-IL-36 Receptor Program)
Corporate Highlights
Fourth Quarter and Year-End 2017 Financial Results
2018 Financial Guidance
AnaptysBio expects that its cash, cash equivalents and investments will fund its current operating plan through the end of 2019.
About AnaptysBio
AnaptysBio is a clinical-stage biotechnology company developing first-in-class antibody product candidates focused on unmet medical needs in inflammation. The company’s proprietary anti-inflammatory pipeline includes its anti-IL-33 antibody (ANB020) for the treatment of moderate-to-severe adult atopic dermatitis, severe adult peanut allergy and severe adult eosinophilic asthma; its anti-IL-36R antibody (ANB019) for the treatment of rare inflammatory diseases, including generalized pustular psoriasis and palmo-plantar pustular psoriasis; and a portfolio of checkpoint receptor agonist antibodies for the treatment of certain autoimmune diseases where immune checkpoint receptors are insufficiently activated, which have demonstrated efficacy in an animal model of graft-versus-host disease. AnaptysBio’s antibody pipeline has been developed using its proprietary somatic hypermutation (SHM) platform, which uses in vitro SHM for antibody discovery and is designed to replicate key features of the human immune system to overcome the limitations of competing antibody discovery technologies. AnaptysBio has also developed multiple therapeutic antibodies in an immuno-oncology partnership with TESARO and an inflammation partnership with Celgene, including an anti-PD-1 antagonist antibody (TSR-042), an anti-TIM-3 antagonist antibody (TSR-022) and an anti-LAG-3 antagonist antibody (TSR-033), which are currently under clinical development with TESARO, and an anti-PD-1 checkpoint agonist antibody (CC-90006) currently in the clinic with Celgene.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to: the timing of the release of data from our clinical trials, including ANB020’s Phase 2a trials in severe adult peanut allergy patients and severe adult eosinophilic asthma patients, and Phase 2b clinical trial in moderate-to-severe adult atopic dermatitis patients; our ability to launch a Phase 2b clinical trial of ANB020 in moderate-to-severe adult atopic dermatitis patients and Phase 2 clinical trials of ANB019 in GPP and PPP; and the success of our partnership with TESARO and Celgene. Statements including words such as “plan,” “continue,” “expect,” or “ongoing” and statements in the future tense are forward-looking statements. These forward-looking statements involve risks and uncertainties, as well as assumptions, which, if they do not fully materialize or prove incorrect, could cause our results to differ materially from those expressed or implied by such forward-looking statements. Forward-looking statements are subject to risks and uncertainties that may cause the company’s actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to the company’s ability to advance its product candidates, obtain regulatory approval of and ultimately commercialize its product candidates, the timing and results of preclinical and clinical trials, the company’s ability to fund development activities and achieve development goals, the company’s ability to protect intellectual property and other risks and uncertainties described under the heading “Risk Factors” in documents the company files from time to time with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and the company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof.
Contact:
Chelcie Lister
THRUST Investor Relations
910.777.3049
chelcie@thrustir.com
ANAPTYSBIO, INC. | |||||||
CONSOLIDATED BALANCE SHEETS | |||||||
(in thousands, except par value data) | |||||||
December 31, 2017 | December 31, 2016 | ||||||
ASSETS | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 81,189 | $ | 51,232 | |||
Receivable from collaborative partners | — | 1,225 | |||||
Australian tax incentive receivable | 1,601 | 4,118 | |||||
Short-term investments | 167,218 | — | |||||
Prepaid expenses and other current assets | 2,688 | 1,633 | |||||
Total current assets | 252,696 | 58,208 | |||||
Property and equipment, net | 665 | 471 | |||||
Long-term investments | 75,897 | — | |||||
Long-term vendor deposits | 46 | — | |||||
Restricted cash | 60 | 60 | |||||
Deferred financing costs | — | 3,441 | |||||
Total assets | $ | 329,364 | $ | 62,180 | |||
LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY (DEFICIT) | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 2,323 | $ | 2,278 | |||
Accrued expenses | 4,875 | 3,429 | |||||
Notes payable, current portion | 6,875 | — | |||||
Other current liabilities | 17 | 1 | |||||
Total current liabilities | 14,090 | 5,708 | |||||
Notes payable, net of current portion | 7,553 | 13,809 | |||||
Deferred rent | 140 | 154 | |||||
Preferred stock warrant liabilities | — | 3,241 | |||||
Commitments and contingencies | |||||||
Series B convertible preferred stock, $0.001 par value, no shares and 3,963 authorized, issued and outstanding at December 31, 2017 and December 31, 2016, respectively | — | 28,220 | |||||
Series C convertible preferred stock, $0.001 par value, no shares and 1,887 shares authorized, no shares and 1,593 shares issued and outstanding at December 31, 2017 and December 31, 2016, respectively | — | 6,452 | |||||
Series C-1 convertible preferred stock, $0.001 par value, no shares and 474 shares authorized, issued and outstanding at December 31, 2017 and December 31, 2016, respectively | — | 2,156 | |||||
Series D convertible preferred stock, $0.001 par value, no shares and 5,491 shares authorized, issued and outstanding at December 31, 2017 and December 31, 2016, respectively | — | 40,688 | |||||
Stockholders’ equity (deficit): | |||||||
Preferred stock, $0.001 par value, 10,000 shares and no shares authorized, issued or outstanding at December 31, 2017 and December 31, 2016, respectively | — | — | |||||
Common stock, $0.001 par value, 500,000 and 17,214 authorized, 23,791 shares and 2,651 shares issued and outstanding at December 31, 2017 and December 31, 2016, respectively | 24 | 3 | |||||
Additional paid in capital | 393,017 | 16,672 | |||||
Accumulated other comprehensive loss | (426 | ) | — | ||||
Accumulated deficit | (85,034 | ) | (54,923 | ) | |||
Total stockholders’ equity (deficit) | 307,581 | (38,248 | ) | ||||
Total liabilities, convertible preferred stock and stockholders’ equity (deficit) | $ | 329,364 | $ | 62,180 | |||
ANAPTYSBIO, INC. | |||||||||||||||
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | |||||||||||||||
(in thousands, except per share data) | |||||||||||||||
Three Months Ended December 31, | Year Ended December 31, | ||||||||||||||
2017 | 2016 | 2017 | 2016 | ||||||||||||
Collaboration revenue | $ | 3,000 | $ | 2,754 | $ | 10,000 | $ | 16,684 | |||||||
Operating expenses: | |||||||||||||||
Research and development | 7,606 | 5,016 | 29,443 | 15,419 | |||||||||||
General and administrative | 2,545 | 912 | 9,338 | 4,290 | |||||||||||
Total operating expenses | 10,151 | 5,928 | 38,781 | 19,709 | |||||||||||
Loss from operations | (7,151 | ) | (3,174 | ) | (28,781 | ) | (3,025 | ) | |||||||
Other income (expense), net | |||||||||||||||
Interest expense | (456 | ) | (111 | ) | (1,775 | ) | (458 | ) | |||||||
Change in fair value of liability for preferred stock warrants | — | (1,091 | ) | (1,366 | ) | (756 | ) | ||||||||
Interest income | 862 | 29 | 1,623 | 127 | |||||||||||
Other income (expense), net | (116 | ) | (231 | ) | 229 | (147 | ) | ||||||||
Total other income (expense), net | 290 | (1,404 | ) | (1,289 | ) | (1,234 | ) | ||||||||
Net loss | (6,861 | ) | (4,578 | ) | (30,070 | ) | (4,259 | ) | |||||||
Unrealized loss on available for sale securities | (383 | ) | — | (426 | ) | — | |||||||||
Other comprehensive loss | (383 | ) | — | (426 | ) | — | |||||||||
Comprehensive loss | $ | (7,244 | ) | $ | (4,578 | ) | $ | (30,496 | ) | $ | (4,259 | ) | |||
Net loss per common share: | |||||||||||||||
Basic and diluted | $ | (0.30 | ) | $ | (1.73 | ) | $ | (1.52 | ) | $ | (1.62 | ) | |||
Weighted-average number of shares outstanding: | |||||||||||||||
Basic and diluted | 23,089 | 2,647 | 19,782 | 2,637 | |||||||||||