05/04/2021 | Press release | Distributed by Public on 05/04/2021 14:10
SAN DIEGO, May 04, 2021 (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 first quarter ended March 31, 2021 and provided pipeline updates.
'We look forward to advancing imsidolimab into a Phase 3 trial for GPP following our recent end-of-Phase 2 meeting with the FDA,' said Hamza Suria, president and chief executive officer of AnaptysBio. 'AnaptysBio continues to pursue a capital-efficient business model where partnership revenues continue to support advancement of our wholly-owned pipeline poised to generate multiple clinical data catalysts through 2021 and 2022.'
Imsidolimab (Anti-IL-36 Receptor) Program
ANB030 (Anti-PD-1 Agonist) Program
ANB032 (Anti-BTLA Modulator) Program
GSK Partnered Programs
First Quarter Financial Results
Financial Guidance
AnaptysBio expects its net cash burn in 2021 will be close to $100 million. We anticipate that our cash, cash equivalents and anticipated revenues will fund our current operating plan at least into 2024.
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 imsidolimab, its anti-IL-36R antibody, previously referred to as ANB019, for the treatment of dermatological inflammatory diseases, including generalized pustular psoriasis, or GPP, EGFRi skin toxicity, ichthyosis, hidradenitis suppurativa and acne; its anti-PD-1 agonist program, ANB030, for treatment of certain autoimmune diseases where immune checkpoint receptors are insufficiently activated; and its BTLA modulator program, ANB032, which is broadly applicable to human inflammatory diseases associated with lymphoid and myeloid immune cell dysregulation. 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 GSK, including an anti-PD-1 antagonist antibody (JEMPERLI (dostarlimab-gxly)), an anti-TIM-3 antagonist antibody (cobolimab, GSK4069889) 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 trials in EGFRi, ichthyosis, hidradenitis suppurativa and acne, ANB030's Phase 2 clinical trials in alopecia areata and vitiligo, and ANB032's healthy volunteer Phase 1 trial; the timing of announcement of key aspects of imsidolimab's GPP Phase 3 clinical trial design and initiation of the trial; the milestones and royalty payments to be received under the GSK collaboration; and our projected 2021 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
[email protected]
AnaptysBio, Inc.
Consolidated Balance Sheets
(in thousands, except par value data)
(unaudited)
March 31, 2021 | December 31, 2020 | ||||||
ASSETS | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 284,148 | $ | 250,456 | |||
Receivable from collaborative partners | 1,247 | - | |||||
Short-term investments | 96,212 | 143,197 | |||||
Prepaid expenses and other current assets | 5,464 | 2,908 | |||||
Restricted cash | 60 | - | |||||
Total current assets | 387,131 | 396,561 | |||||
Property and equipment, net | 1,754 | 1,783 | |||||
Long-term investments | 7,056 | 17,546 | |||||
Other long-term assets | 477 | 602 | |||||
Restricted cash | - | 60 | |||||
Total assets | $ | 396,418 | $ | 416,552 | |||
LIABILITIES AND STOCKHOLDERS' EQUITY | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 2,452 | $ | 4,217 | |||
Accrued expenses | 11,826 | 15,262 | |||||
Other current liabilities | 197 | 342 | |||||
Total current liabilities | 14,475 | 19,821 | |||||
Stockholders' equity: | |||||||
Preferred stock, $0.001 par value, 10,000 shares authorized and no shares, issued or outstanding at March 31, 2021 and December 31, 2020, respectively | - | - | |||||
Common stock, $0.001 par value, 500,000 shares authorized, 27,367 shares and 27,356 shares issued and outstanding at March 31, 2021 and December 31, 2020, respectively | 27 | 27 | |||||
Additional paid in capital | 664,147 | 660,665 | |||||
Accumulated other comprehensive loss | (111 | ) | (4 | ) | |||
Accumulated deficit | (282,120 | ) | (263,957 | ) | |||
Total stockholders' equity | 381,943 | 396,731 | |||||
Total liabilities and stockholders' equity | $ | 396,418 | $ | 416,552 |
AnaptysBio, Inc.
Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except per share data)
(unaudited)
Three Months Ended March 31, |
|||||||
2021 | 2020 | ||||||
Collaboration revenue | $ | 11,247 | $ | 15,000 | |||
Operating expenses: | |||||||
Research and development | 24,185 | 20,968 | |||||
General and administrative | 5,423 | 4,285 | |||||
Total operating expenses | 29,608 | 25,253 | |||||
Loss from operations | (18,361 | ) | (10,253 | ) | |||
Other income, net: | |||||||
Interest income | 195 | 1,897 | |||||
Other income, net | 3 | 94 | |||||
Total other income, net | 198 | 1,991 | |||||
Net loss | (18,163 | ) | (8,262 | ) | |||
Unrealized (loss) income on available for sale securities | (107 | ) | 807 | ||||
Comprehensive loss | $ | (18,270 | ) | $ | (7,455 | ) | |
Net loss per common share: | |||||||
Basic and diluted | $ | (0.66 | ) | $ | (0.30 | ) | |
Weighted-average number of shares outstanding: | |||||||
Basic and diluted | 27,361 | 27,264 |
Source: AnaptysBio, Inc.