Anaptysbio, Inc 10-K, filed Mar 2, 2020

Anaptysbio, Inc (ANAB)

10-K 2020-03-02 For: 2019-12-31

Added on April 04, 2026

About this 10-K

Anaptysbio, Inc filed this 10-K on March 2, 2020, covering the fiscal year ended December 31, 2019.

Headline figures

Fiscal year ended December 31, 2019, as reported in this filing, compared with the same period a year earlier where the filing states it.

Revenue: $8M; up 60.0% from $5M a year earlier
Net loss: $97.34M; compared with a net loss of $61.66M a year earlier
Diluted EPS: -$3.60; compared with -$2.50 a year earlier

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Delaware		20-3828755
(State or other jurisdiction of incorporation or organization)		(I.R.S. Employer Identification Number)



Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common Stock, $0.001 par value	ANAB	The Nasdaq Stock Market LLC



Large Accelerated Filer	☒	Accelerated Filer	☐

Non-accelerated Filer	☐	Smaller Reporting Company	☐

		Emerging Growth Company	☐



		Page
PART I
Item 1.	Business	2
Item 1A.	Risk Factors	27
Item 1B.	Unresolved Staff Comments	59
Item 2.	Properties	59
Item 3.	Legal Proceedings	59
Item 4.	Mine Safety Disclosures	59

PART II
Item 5.	Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities	60
Item 6.	Selected Consolidated Financial Data	61
Item 7.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	63
Item 7A.	Quantitative and Qualitative Disclosures About Market Risk	72
Item 8.	Consolidated Financial Statements and Supplementary Data	74
Item 9.	Changes in and Disagreements With Accountants on Accounting and Financial Disclosure	101
Item 9A.	Controls and Procedures	101
Item 9B.	Other Information	103

PART III
Item 10.	Directors, Executive Officers and Corporate Governance	103
Item 11.	Executive Compensation	103
Item 12.	Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters	103
Item 13.	Certain Relationships and Related Transactions, and Director Independence	103
Item 14.	Principal Accounting Fees and Services	103

PART IV
Item 15.	Exhibits, Consolidated Financial Statement Schedules	104
Item 16.	Form 10-K Summary	106
	Signatures	107



	Year Ended December 31,
(in thousands)	2019			2018			2017			2016			2015
Collaboration revenue	$	8,000		$	5,000		$	10,000		$	16,684		$	17,571
Loss from operations	(107,432		)	(66,722		)	(28,781		)	(3,025		)	(3,322		)
Net loss	(97,336		)	(61,656		)	(30,070		)	(4,259		)	(5,405		)
Net loss attributed to common stockholders	(97,336		)	(61,656		)	(30,070		)	(4,259		)	(5,405		)
Net loss per common share: Basic and diluted	(3.60		)	(2.50		)	(1.52		)	(1.62		)	(2.12		)



☒	ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934



☐	TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934


•	the success, cost and timing of our product candidate development activities and ongoing and planned clinical trials;


•	our plans to develop and commercialize antibodies, including our lead product candidates: etokimab for patients with respiratory disorders and ANB019 for patients with generalized pustular psoriasis, or GPP, and palmoplantar pustulosis, or PPP;


•	the likelihood that the clinical data generated in any study we performed, are performing or plan to perform in a non-US jurisdiction will be subsequently accepted by the U.S. Food and Drug Administration, or FDA and/or by foreign regulatory authorities outside of the jurisdiction where the study was being performed;


•	the timing and ability of our collaborators to develop and commercialize our partnered product candidates;


•	the potential benefits and advantages of our product candidates and approaches versus those of our competitors;


•	our ability to execute on our strategy, including advancing our lead product candidates, identifying emerging opportunities in key therapeutic areas, continuing to expand our wholly-owned pipeline and retaining rights to strategic products in key commercial markets;


•	our ability to obtain funding for our operations, including funding necessary to complete further development and commercialization of our product candidates;


•	the timing of and our ability to obtain and maintain regulatory approvals for etokimab and ANB019 and our other product candidates;


•	our commercialization, marketing and manufacturing capabilities and strategy;


•	regulatory developments in the United States, the United Kingdom, Australia and other foreign countries;


•	the success of competing therapies that are or may become available;


•	our ability to attract and retain key scientific or management personnel;


•	the rate and degree of market acceptance and clinical utility of any approved product candidates;


•	the size and growth potential of the markets for any approved product candidates, and our ability to serve those markets;


•	our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates;


•	our ability to identify additional products or product candidates with significant commercial potential that are consistent with our commercial objectives; and


•	our estimates regarding expenses, future revenue, capital requirements and needs for additional financing.


•	Continuing to expand our proprietary pipeline by generating new product candidates using our technology platform. Using our proprietary SHM antibody generation platform, we are able to rapidly develop novel antibodies


•	Retaining rights to strategic products in key commercial markets. We intend to retain ownership and control of our pipeline programs to key preclinical and clinical data inflection points. For certain programs, we plan to seek strategic collaborations that provide us with funding, infrastructure and marketing resources to advance through development and commercialization.


•	Target Specificity. Due to the large size and complex nature of the antibody Fab domain, antibodies generally bind with high specificity to the desired therapeutic target and tend to exhibit less off-target binding to unrelated proteins, which lowers the risk of unintended biological side effects such as toxicity.


•	Pharmacokinetics and Dosing Frequency. As complex proteins, antibodies are metabolized and distributed differently than small molecules. Full length antibodies tend to exhibit serum half-lives of seven to 24 days in humans, leading to bi-weekly or monthly dosing as typical practice for therapeutic antibodies.


•	Potency and Dose Quantities. Antibodies are typically highly potent in binding to their desired target, with binding dissociation constants in the low nanomolar to picomolar range. Hence, antibodies tend to be dosed at low amounts (less than 1 gram quantities per course of therapy).


•	Lack of Functional Activity Selection. Competing technologies have not been able to drive antibody selection on the basis of functional activity. Even if antibodies are available against a certain target, they may not bind the correct region or epitope of the protein to achieve the intended functional therapeutic effects;


•	Low Potency. Antibodies from competing technologies tend to demonstrate low binding potencies against their targets. Such incomplete binding may not result in therapeutic effect that is sufficient to change disease outcomes, or require impractically high doses to convey therapeutic benefit; and


•	Unpredictable Manufacturing Properties. Using microbial display systems such as phage and yeast display libraries has resulted in unpredictable expression, stability and formulation when manufacturing is initiated using mammalian cells, thus leading to poor production yields and product stability.


•	Diversity against difficult targets. We are able to generate an unprecedented diversity of antibodies by applying SHM-based diversification outside of the constraints of an in vivo environment. This enables us to develop antibodies against human targets that we believe have not otherwise been accessible to prior technologies.


•	High potency. Because our platform generates highly-potent antibodies, we are potentially able to modulate every extracellular target associated with human disease, and believe only small therapeutic doses may be required to mediate therapeutic effect in vivo.


•	Functional activity selection. Our mammalian cell system simultaneously displays and secretes antibodies during the antibody discovery process, allowing us to incorporate functional assays throughout the process and focus on producing product candidates that are optimized for the desired therapeutic activity.


•	Speed. Our platform technology has enabled us to generate therapeutic-grade antibodies and initiate subsequent preclinical manufacturing and toxicology studies, typically in less than 12 months. We believe this timeline is significantly shorter than conventional approaches based upon mouse immunization and microbial display systems.


•	Manufacturability. By utilizing our mammalian cell display system, we believe our approach increases the probability of success in manufacturing and commercialization by mitigating the risks associated with antibody expression, formulation and stability during the antibody generation process.


•	a detailed summary of the protocol and study results and, if requested, case records or additional background data;


•	a description of the drug substance and drug product, including the components, formulation, specifications, and, if available, the bioavailability of the drug product;