SAN DIEGO, Feb. 28, 2019 (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, 2018 and provided pipeline updates.

“We continued to advance the clinical development of our wholly-owned etokimab and ANB019 programs for severe inflammatory disease indications during 2018,” said Hamza Suria, president and chief executive officer of AnaptysBio. “Top-line data from our etokimab Phase 2a trial in severe adult eosinophilic asthma patients demonstrated rapid and sustained improvement in Forced Exhaled Volume In One Second versus placebo, with corresponding reduction in blood eosinophil levels. We look forward to announcing four Phase 2 top-line data readouts from ongoing clinical trials of etokimab and ANB019 during 2019 and expanding our pipeline with an IND filing for a new wholly-owned anti-inflammatory antibody program.”

Etokimab (ANB020 Anti-IL-33 Program)

ANB019 (Anti-IL-36 Receptor Program)

Corporate Highlights

Fourth Quarter and Full Year Financial Results

Financial Guidance

AnaptysBio expects that its cash, cash equivalents and investments will fund its current operating plan at least through the end of 2020.

About Etokimab

Etokimab, previously referred to as ANB020, is an antibody that potently binds and inhibits the activity of interleukin-33, or IL-33, a pro-inflammatory cytokine that multiple studies have indicated is a central mediator of atopic diseases, which AnaptysBio believes is broadly applicable to the treatment of atopic inflammatory disorders, such as atopic dermatitis, eosinophilic asthma, chronic rhinosinusitis with nasal polyps, or CRSwNP, and potentially other allergic conditions. Following completion of a healthy volunteer Phase 1 trial of etokimab, AnaptysBio continued clinical development of etokimab into a Phase 2a trial for moderate-to-severe adult atopic dermatitis and a placebo-controlled Phase 2a trial in severe adult eosinophilic asthma patients. AnaptysBio is conducting its ATLAS trial, a randomized, double-blinded, placebo-controlled multi-dose Phase 2b clinical trial of etokimab in 300 moderate-to-severe adult atopic dermatitis patients where top-line data is anticipated in the second half of 2019. The Company is conducting its ECLIPSE trial, a randomized, double-blinded, placebo-controlled Phase 2 trial of etokimab in approximately 100 adult patients with CRSwNP with top-line data anticipated in the second half of 2019. AnaptysBio also plans to initiate a randomized, double-blinded, placebo-controlled, multi-dose Phase 2b trial of etokimab in patients with eosinophilic asthma in 2019.

About ANB019

ANB019 is an antibody that inhibits the function of the interleukin-36-receptor, or IL-36R, which AnaptysBio plans to initially develop as a potential first-in-class therapy for patients suffering from generalized pustular psoriasis, or GPP, and palmoplantar pustulosis, or PPP.  AnaptysBio has previously presented data from this Phase 1 clinical trial, which demonstrated favorable safety, pharmacokinetics and pharmacodynamic properties that supported advancement of ANB019 into Phase 2 studies. AnaptysBio is conducting its GALLOP trial, a Phase 2 study of ANB019 in GPP where top-line data is anticipated in mid-2019, and its POPLAR trial, a Phase 2 study in PPP where top-line data is anticipated in the second half 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 etokimab, previously referred to as ANB020, for the treatment of moderate-to-severe atopic dermatitis, eosinophilic asthma, and adult chronic rhinosinusitis with nasal polyps, or CRSwNP; its anti-IL-36R antibody ANB019 for the treatment of rare inflammatory diseases, including generalized pustular psoriasis, or GPP and palmoplantar pustulosis, or PPP, previously referred to as palmo-plantar pustular psoriasis; and novel anti-inflammatory checkpoint receptor modulator antibodies for treatment of certain autoimmune diseases where immune checkpoint receptors are insufficiently activated. AnaptysBio’s antibody pipeline has been developed using its proprietary somatic hypermutation, or 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 (recently acquired by GlaxoSmithKline), 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), and an inflammation partnership with Celgene, including an anti-PD-1 checkpoint agonist antibody (CC-90006) currently in clinical development.

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 etokimab’s Phase 2a clinical trial in severe adult eosinophilic asthma patients,  etokimab’s Phase 2b clinical trial in moderate-to-severe adult atopic dermatitis patients, etokimab’s Phase 2 clinical trial in adult patients with chronic rhinosinusitis with nasal polys and ANB019’s Phase 2 clinical trials in GPP and PPP, the timing of and our ability to launch a Phase 2b clinical trial of etokimab in eosinophilic asthma patients, the timing of an IND filing for a new wholly-owned anti-inflammatory antibody program, and the success of our partnership with TESARO (recently acquired by GlaxoSmithKline) 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:
Dominic Piscitelli
AnaptysBio, Inc.
858.362.6348
dpiscitelli@anaptysbio.com

ANAPTYSBIO, INC.
CONSOLIDATED BALANCE SHEETS
(in thousands, except par value data)

 December 31, 2018 December 31, 2017
ASSETS
Current assets:   
Cash and cash equivalents$113,596  $81,189 
Australian tax incentive receivable174  1,601 
Short-term investments313,486  167,218 
Prepaid expenses and other current assets6,960  2,688 
Total current assets434,216  252,696 
Property and equipment, net1,445  665 
Long-term investments73,128  75,897 
Other long-term assets148  46 
Restricted cash60  60 
Total assets$508,997  $329,364 
LIABILITIES, PREFERRED STOCK AND
STOCKHOLDERS’ EQUITY
Current liabilities:   
Accounts payable$5,443  $2,323 
Accrued expenses8,761  4,875 
Notes payable, current portion7,574  6,875 
Other current liabilities58  17 
Total current liabilities21,836  14,090 
Notes payable, net of current portion625  7,553 
Deferred rent171  140 
Stockholders’ equity:   
Preferred stock, $0.001 par value, 10,000 shares authorized and no shares, issued or outstanding at December 31, 2018 and December 31, 2017, respectively—  — 
Common stock, $0.001 par value, 500,000 shares authorized, 26,922 shares and 23,791 shares issued and outstanding at December 31, 2018 and December 31, 2017, respectively27  24 
Additional paid in capital633,251  393,017 
Accumulated other comprehensive loss(223) (426)
Accumulated deficit(146,690) (85,034)
Total stockholders’ equity486,365  307,581 
Total liabilities, preferred stock and stockholders’ equity$508,997  $329,364 
        

ANAPTYSBIO, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(in thousands, except per share data)

 Three Months Ended
December 31,		 Year Ended
December 31,
 2018 2017 2018 2017
Collaboration revenue$—  $3,000  $5,000  $10,000 
Operating expenses:       
Research and development15,920  7,606  56,196  29,443 
General and administrative3,743  2,545  15,526  9,338 
Total operating expenses19,663  10,151  71,722  38,781 
Loss from operations(19,663) (7,151) (66,722) (28,781)
Other income (expense), net:       
Interest expense(365) (456) (1,652) (1,775)
Change in fair value of liability for preferred stock warrants—  —  —  (1,366)
Interest income2,834  862  6,685  1,623 
Other income (expense), net8  (116) (159) 229 
Total other income (expense), net2,477  290  4,874  (1,289)
Loss before income taxes(17,186) (6,861) (61,848) (30,070)
Provision for income taxes192  —  192  — 
Net loss(16,994) (6,861) (61,656) (30,070)
Other comprehensive income (loss):       
Unrealized income (loss) on available for sale securities373  (383) 258  (426)
Income tax expense related to other comprehensive income(55) —  (55) — 
Other comprehensive income (loss), net of tax318  (383) 203  (426)
Comprehensive loss$(16,676) $(7,244) $(61,453) $(30,496)
Net loss per common share:       
Basic and diluted$(0.64) $(0.30) $(2.50) $(1.52)
Weighted-average number of shares outstanding:       
Basic and diluted26,788  23,089  24,673  19,782