Clinical Trials and Research - Imsidolimab achieved a primary endpoint improvement in the clinical global impression scale (CGI) for 6 of 8 (75%) patients in the GALLOP clinical trial[75]. - The modified Japanese Dermatology Association Severity Index (mJDA-SI) score decreased by an average of 29% on Day 8 and 54% on Day 29 in the GALLOP clinical trial[75]. - The company plans to initiate Phase 3 registrational trials for imsidolimab for GPP, called GEMINI-1 and GEMINI-2, in Q3 2021[76]. - The RADIANCE study is a global registry of GPP patients aimed at improving understanding of the patient journey and assisting in future clinical trial enrollment[77]. - A Phase 2 clinical trial of imsidolimab for moderate-to-severe acne (ACORN) will involve 120 patients, with top-line data expected in H1 2022[78]. - A Phase 2 clinical trial of imsidolimab for hidradenitis suppurativa (HARP) will also involve 120 patients, with top-line data anticipated in H2 2022[79]. Financial Performance and Revenue - The company has received approximately $205.3 million in cash receipts from collaborations, including a $20.0 million milestone payment for the FDA approval of JEMPERLI[84]. - JEMPERLI is projected to have peak year annual sales estimates of £1-£2 billion according to GSK[84]. - The company amended its collaboration with GSK to increase royalties on global net sales of JEMPERLI to 8% on sales below $1 billion and 12-25% on sales above $1 billion[84]. - The company anticipates additional milestone payments of $15.0 million and $165.0 million upon achieving certain regulatory and commercial milestones for JEMPERLI[84]. - Collaboration revenue for Q2 2021 was $30.0 million, compared to $0 million in Q2 2020, primarily from milestone payments related to JEMPERLI[97]. - Milestone revenue for the six months ended June 30, 2021, was $40.0 million, compared to $15.0 million in the same period of 2020[97]. Expenses and Cash Flow - Research and development expenses increased to $25.3 million in Q2 2021 from $17.9 million in Q2 2020, driven by a $4.5 million rise in clinical expenses[98]. - Total research and development expenses for the six months ended June 30, 2021, were $49.5 million, up from $38.9 million in the same period of 2020, reflecting a $10.6 million increase[98]. - General and administrative expenses rose to $5.2 million in Q2 2021 from $4.7 million in Q2 2020, mainly due to increased personnel costs[100]. - Interest income decreased to $0.1 million in Q2 2021 from $1.1 million in Q2 2020, attributed to lower interest rates and reduced investment balances[101]. - As of June 30, 2021, the company had $396.3 million in cash, cash equivalents, and investments[103]. - Net cash used in operating activities for the six months ended June 30, 2021, was $13.6 million, compared to $34.7 million for the same period in 2020[107]. - Net cash provided by investing activities during the six months ended June 30, 2021, was $94.7 million, an increase from $86.1 million in 2020[110]. - The net cash provided by financing activities during the six months ended June 30, 2021, was $0.7 million, related to the issuance of common stock upon the exercise of stock options[111]. - Net cash used in operating activities was primarily due to a net loss of $18.6 million for the six months ended June 30, 2021[107]. Future Outlook and Financing - The company expects research and development expenses to remain high as it advances product candidates into larger clinical trials[91]. - The company anticipates an increase in general and administrative expenses due to costs associated with being a publicly traded company[100]. - The company expects its existing cash resources to fund its current operating plan at least into 2024[106]. - The company may seek additional financing through equity or debt financings or collaborations in the future[106]. - There have been no material changes in market risk, including interest rate risk and foreign currency exchange risk, as of June 30, 2021[115]. - The company has contractual obligations with vendors for goods and services, which may require payments for cancellation or early termination[112].

Product Development and Commercialization - The company has no products approved for commercial sale and has not generated any revenue or profit from sales of its product candidates[163]. - The company is currently conducting clinical trials for imsidolimab, ANB030, and ANB032, but has a limited history of clinical trials and no history of commercializing biotechnology products[163]. - The company has limited data regarding the safety profile of its wholly-owned product candidates when dosed in humans, which may inhibit regulatory approval[176]. - The company has not established effective sales or marketing capabilities, which may hinder its ability to generate product revenue[163]. - The company’s ability to commercialize product candidates depends on obtaining necessary regulatory approvals, which can be lengthy and uncertain[182]. - The company is currently only in the clinical development stages for its most advanced product candidates and may never generate significant revenues[215]. - The company plans to seek Orphan Drug Designation for imsidolimab, which could provide market exclusivity if granted[254]. - The commercialization of product candidates is heavily dependent on third-party reimbursement practices and pricing regulations, which can significantly impact sales revenue[257]. - The inability to establish adequate reimbursement could adversely affect the adoption and sales revenue of approved product candidates[264]. Financial Performance and Capital Requirements - The company has limited operating revenue and a history of operational losses, requiring additional capital to finance operations[163]. - The company has incurred significant operating losses since inception, with a net loss of $19.9 million for the year ended December 31, 2020, and an accumulated deficit of $264.0 million[212]. - The company expects to continue incurring significant expenses and increasing operating losses for the foreseeable future[213]. - The company believes its existing cash, cash equivalents, and investments will fund its current operating plan at least into 2024[217]. - The company may need to raise additional funds or obtain funding through collaboration agreements to continue the development of its product candidates[217]. - Future funding requirements will depend on various factors, including the costs and results of clinical trials and regulatory approvals[219]. - The company may seek additional capital through various means, which could result in dilution of existing stockholders' interests[221]. Competition and Market Risks - The company faces significant competition, and if competitors develop more effective or less expensive products, its commercial opportunities may be negatively impacted[163]. - The company faces significant competition from established pharmaceutical and biotechnology companies with greater resources and experience[194]. - Competitors for GPP and PPP include therapies such as secukinumab (Cosentyx) and ustekinumab (Stelara), among others[195]. - For hidradenitis suppurativa, adalimumab (Humira) is a key competitor approved for moderate to severe cases[196]. - The company’s ability to compete may be affected by competitors obtaining regulatory approval more rapidly and establishing a strong market position before the company can enter the market[200]. Clinical Trials and Regulatory Challenges - Clinical trials for product candidates may be delayed or halted due to various factors, including safety concerns and regulatory holds[185]. - The average time for product candidates to be developed from discovery to approval is estimated to be 10 to 15 years[185]. - Regulatory authorities may impose conditions that could delay or prevent marketing approval for product candidates[187]. - The company may incur additional costs or experience delays if clinical trials fail to demonstrate safety and efficacy[180]. - One patient dropped out of the GALLOP Phase 2 clinical trial for imsidolimab due to a serious adverse event, which was deemed possibly drug-related[179]. Manufacturing and Supply Chain Risks - The company relies on third-party manufacturers for production, and any difficulties they encounter could delay the supply of product candidates[163]. - The company is dependent on third-party manufacturers for the production of biologics, which is complex and subject to multiple risks, including contamination and compliance with regulations[208]. - Manufacturing biotechnology products is complex, and any difficulties in production could delay the availability of product candidates for clinical trials[225]. - The company outsources the manufacturing of its product candidates and lacks internal manufacturing capabilities, which poses risks of supply disruptions[243]. - The company depends on a small number of suppliers for key raw materials, and any loss of these suppliers could materially affect its business[246]. Intellectual Property and Legal Risks - The company has filed numerous patent applications, but the patent prosecution process is expensive and may not result in the desired patent rights[283]. - The patent position of biotechnology companies is uncertain, and pending applications may not result in patents that effectively protect the company's technology[284]. - The company may face challenges in protecting its intellectual property rights globally, with potential high costs and varying enforcement levels in different jurisdictions[289]. - The company may face legal proceedings alleging infringement of intellectual property rights, which could adversely affect business success[311]. - The company relies on trade secrets and non-disclosure agreements to protect proprietary information, but breaches could lead to significant costs and competitive disadvantages[315]. Regulatory Compliance and Legal Obligations - The company is subject to various health care laws and regulations, including the federal Anti-Kickback Statute, which prohibits remuneration to induce referrals for services covered by federal health care programs[275]. - The company faces potential civil and criminal penalties under the federal False Claims Act for presenting false claims for payment to the federal government[276]. - Compliance with state laws requires biotechnology companies to report marketing expenditures and payments to health care providers, which can be time-consuming and costly[277]. - The General Data Protection Regulation (GDPR) imposes fines of up to €20 million or 4% of worldwide revenue for non-compliance, increasing the company's liability regarding personal data processing[279]. - The company may incur substantial costs to ensure compliance with health care laws and regulations, which could adversely affect its business operations[279]. Market and Economic Conditions - The market price of the company's stock has been volatile, posing a risk of investment loss[163]. - The stock price of the company has been volatile, influenced by factors such as competitive product success and regulatory actions, which could lead to significant investment losses[317]. - Legislative reforms, such as the Affordable Care Act, have significantly impacted the pharmaceutical industry, including changes to Medicaid rebates and pricing methodologies[267]. - Ongoing healthcare reform measures may limit government payments for healthcare products, resulting in reduced demand and additional pricing pressures[273]. - International operations face extensive governmental price controls, with prices in many countries being substantially lower than in the U.S., which may affect revenue generation[260]. Employee and Operational Risks - The company must attract and retain highly skilled employees to succeed in its business[163]. - The company expects to experience growth in operations and employee numbers, which may lead to significant costs and require effective management to avoid disruptions[231]. - The company faces intense competition for qualified personnel, which is critical for its success in product development and commercialization[223]. - Employee misconduct, including noncompliance with regulatory standards, poses a risk that could lead to significant fines or sanctions against the company[280].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ Quarterly Report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the quarterly period ended September 30, 2020 OR ☐ Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from to . Commission File Number: 001-37985 ANAPTYSBIO, INC. (Exact name of registrant as specified in its charter) Delaware 20-3828755 (State or other jurisdiction of in ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 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 FORM 10-Q ☒ Quarterly Report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the quarterly period ended June 30, 2020 OR ☐ Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from to . Commission File Numbe ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 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 Non-accelerated Filer ☐ Smaller Reporting Company ☐ Emerging Growth Company ☐ FORM 10-Q ☒ Quarterly Report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the quarterly period ended March 31, 2020 OR ☐ Transition report pursuant to Section 13 or 15(d) of the Securities ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ______________________________________ FORM 10-K ______________________________________ ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2019 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number: 001-37985 ______________________________________ ANAPTYSBIO, INC. (Ex ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 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 Non-accelerated Filer ☐ Smaller Reporting Company ☐ Emerging Growth Company ☐ FORM 10-Q ☒ Quarterly Report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the quarterly period ended September 30, 2019 OR ☐ Transition report pursuant to Section 13 or 15(d) of the Securi ...