SAN DIEGO, Nov. 04, 2020 (GLOBE NEWSWIRE) -- AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company developing first-in-class antibody product candidates focused on emerging immune control mechanisms applicable to inflammation and immuno-oncology indications, today reported operating results for the third quarter ended September 30, 2020 and provided pipeline updates.

“We are excited with the recent interim results from our GALLOP trial and look forward to engaging with regulatory authorities to progress imsidolimab into registration trials for the treatment of GPP,” said Hamza Suria, president and chief executive officer of AnaptysBio. “Under our amended immuno-oncology collaboration with GSK, we look forward to the anticipated first FDA approval of dostarlimab and its advancement for patients suffering with various oncological disorders.”   

Imsidolimab (Anti-IL-36 Receptor) Program

ANB030 (Anti-PD-1 Agonist) Program

ANB032 (Anti-BTLA Modulator) Program

Etokimab (ANB020 Anti-IL-33) Program

Dostarlimab (Anti-PD-1 Antagonist) Program Partnered with GSK

Third Quarter Financial Results

Cash, cash equivalents and investments totaled $374.5 million as of September 30, 2020 compared to $428.5 million as of December 31, 2019, for a decrease of $54.0 million. The decrease relates primarily to cash used for operating activities.

Collaboration revenue was zero and $15.0 million for the three and nine months ended September,30 2020, which related to milestone payments for successful BLA and MAA filings for dostarlimab by GSK, compared to zero and $5 million for the three and nine months ended September 30, 2019.

Research and development expenses were $19.5 million and $58.5 million for the three and nine months ended September 30, 2020, compared to $29.9 million and $77.9 million for the three and nine months ended September 30, 2019. The decrease was due primarily to reduced outside services for manufacturing and clinical expenses based on the timing of projects.

General and administrative expenses were $4.8 million and $13.8 million for the three and nine months ended September 30, 2020, compared to $3.8 million and $12.3 million for the three and nine months ended September 30, 2019. The increase was due primarily to increased legal and insurance expenses.

Net loss was $23.8 million and $53.6 million for the three and nine months ended September 30, 2020, or a net loss per share of $0.87 and $1.96, compared to a net loss of $31.0 million and $77.1 million for the three and nine months ended September 30, 2019, or a net loss per share of $1.15 and $2.85.

Financial Guidance
AnaptysBio expects its net cash burn in 2020 will be close to breakeven assuming the $20 million milestone payment upon first FDA approval of dostarlimab is received by year-end.  We anticipate that our cash, cash equivalents and anticipated revenues will fund our current operating plan at least into 2023.

About AnaptysBio
AnaptysBio is a clinical-stage biotechnology company developing first-in-class antibody product candidates focused on emerging immune control mechanisms applicable to inflammation and immuno-oncology indications. The Company’s proprietary anti-inflammatory pipeline includes its anti-IL-36R antibody imsidolimab, previously referred to as ANB019, for the treatment of rare inflammatory diseases, including generalized pustular psoriasis, or GPP, palmoplantar pustulosis, or PPP, EGFRi and ichthyosis; its anti-PD-1 agonist program, ANB030, for treatment of certain autoimmune diseases where immune checkpoint receptors are insufficiently activated; its BTLA modulator program, ANB032, which is broadly applicable to human inflammatory diseases associated with lymphoid and myeloid immune cell dysregulation; and its anti-IL-33 antibody etokimab, previously referred to as ANB020, for the treatment of chronic rhinosinusitis with nasal polyps, or CRSwNP, and eosinophilic asthma. 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 collaboration with GlaxoSmithKline, including an anti-PD-1 antagonist antibody (dostarlimab GSK4057190A), an anti-TIM-3 antagonist antibody (cobolimab, GSK4069889A) and an anti-LAG-3 antagonist antibody (GSK4074386), and an inflammation collaboration with Bristol-Myers Squibb, 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 imsidolimab’s Phase 2 clinical trial in PPP; the timing of initiation of imsidolimab’s Phase 2 clinical trials in EGFRi and ichthyosis; and etokimab’s week 16 data for the ECLIPSE Phase 2 clinical trial in chronic rhinosinusitis with nasal polyps; the timing of an end-of-Phase 2 meeting with the FDA for GPP; the timing of an IND filing for ANB032; the milestones and royalty payments to be received under the GSK collaboration; and our projected 2020 cash burn and cash runway. 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:
Dennis Mulroy
AnaptysBio, Inc.
858.732.0201
dmulroy@anaptysbio.com


AnaptysBio, Inc.
Consolidated Balance Sheets
(in thousands, except par value data)

 September 30, 2020 December 31, 2019
 (unaudited)  
ASSETS
Current assets:   
Cash and cash equivalents$209,154   $171,017  
Short-term investments129,192   203,210  
Prepaid expenses and other current assets7,468   3,506  
Total current assets345,814   377,733  
Property and equipment, net1,585   1,618  
Long-term investments36,177   54,305  
Other long-term assets1,114   1,481  
Restricted cash60   60  
Total assets$384,750   $435,197  
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:   
Accounts payable$5,484   $16,237  
Accrued expenses18,139   11,052  
Notes payable, current portion—   1,375  
Other current liabilities851   871  
Total current liabilities24,474   29,535  
Other long-term liabilities33   654  
Stockholders’ equity:   
Preferred stock, $0.001 par value, 10,000 shares authorized and no shares, issued or outstanding at September 30, 2020 and December 31, 2019, respectively—   —  
Common stock, $0.001 par value, 500,000 shares authorized, 27,346 shares and 27,255 shares issued and outstanding at September 30, 2020 and December 31, 2019, respectively27   27  
Additional paid-in capital657,560   648,669  
Accumulated other comprehensive income259   338  
Accumulated deficit(297,603) (244,026)
Total stockholders’ equity360,243   405,008  
Total liabilities and stockholders’ equity$384,750   $435,197  
        


AnaptysBio, Inc.
Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except per share data)
(unaudited)

 Three Months Ended
September 30,		 Nine Months Ended
September 30,
 2020 2019 2020 2019
Collaboration revenue$—  $—  $15,000  $5,000 
Operating expenses:       
Research and development19,542  29,931  58,458  77,912 
General and administrative4,794  3,814  13,766  12,262 
Total operating expenses24,336  33,745  72,224  90,174 
Loss from operations(24,336) (33,745) (57,224) (85,174)
Other income (expense), net:       
Interest expense—  (240) —  (841)
Interest income625  2,757  3,583  8,702 
Other (expense) income, net(56) 144  64  110 
Total other income (expense), net569  2,661  3,647  7,971 
Loss before income taxes(23,767) (31,084) (53,577) (77,203)
Provision for income taxes—  51  —  130 
Net loss(23,767) (31,033) (53,577) (77,073)
Other comprehensive (loss) income:       
Unrealized (loss) income on available for sale securities, net of tax of $0, ($25), $0 and $189, respectively(494) (94) (79) 703 
Comprehensive loss$(24,261) $(31,127) $(53,656) $(76,370)
Net loss per common share:       
Basic and diluted$(0.87) $(1.15) $(1.96) $(2.85)
Weighted-average number of shares outstanding:       
Basic and diluted27,316  27,058  27,286  27,022