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, 2023 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 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, 2023 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 incorpo ...

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 March 31, 2023 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 incorp ...

Product Development and Clinical Trials - The company is developing therapeutic antibodies, including rosnilimab and ANB032, which are currently in clinical development stages[83]. - The company reported that the initial Phase 2a clinical trial results for etokimab were not representative of later Phase 2b trial results, leading to the discontinuation of its development[83]. - The company has commenced clinical trials for imsidolimab in GPP, with plans for Phase 3 trials enrolling approximately 45 moderate-to-severe GPP patients[87]. - Product candidates typically take 10 to 15 years from discovery to approval, with numerous potential delays due to regulatory, manufacturing, and clinical trial challenges[89]. - The company has limited experience in conducting pivotal Phase 3 clinical trials and commercializing biotechnology products, which may hinder future viability[93]. - The company may face delays in obtaining required regulatory approvals, which would impair its ability to commercialize and generate revenue from its product candidates[87]. - The development of product candidates requires substantial investment in clinical trials, regulatory approvals, and marketing efforts before generating revenue[92]. - The company may not successfully expand its pipeline of product candidates, which could adversely affect future revenue and business prospects[92]. - Competitors may achieve faster regulatory approval, establishing a strong market position before the company can enter the market[96]. - The company may face delays in obtaining marketing approval due to insufficient data or regulatory requirements, impacting the commercialization timeline[90]. - The company outsources the manufacturing of its product candidates and any unexpected loss of supply could lead to significant delays in clinical trials[119]. Financial Performance and Capital Requirements - The company has no products approved for commercial sale and has not generated any revenue or profit from sales of its product candidates[81]. - For the year ended December 31, 2022, collaboration revenue was $10.3 million, and the net loss was $128.7 million, with an accumulated deficit of $450.5 million[102]. - The company has a history of operational losses and may not achieve or sustain profitability without additional capital[81]. - The company expects to continue incurring significant expenses and increasing operating losses for the foreseeable future[103]. - Additional capital will be required to finance operations, and failure to secure funding could lead to significant delays or discontinuation of product development[104]. - The company anticipates that existing cash and investments will fund operations for at least the next 12 months, but rapid capital consumption may occur[105]. - The company has financed operations primarily through public offerings and royalty monetization agreements, indicating reliance on external funding sources[103]. Competition and Market Risks - The company faces significant competition, and if competitors develop more effective or safer products, it could negatively impact commercial opportunities[81]. - Significant competition exists in the biotechnology industry, with competitors having greater financial and technical resources, potentially impacting commercial opportunities[95]. - The market acceptance of approved product candidates is uncertain and depends on factors such as efficacy, safety, timing of introduction, and reimbursement availability[97]. - If product candidates do not achieve adequate market acceptance, the company may not generate sufficient revenue to remain profitable[98]. - The company faces significant competition for skilled personnel, which is critical for the success of product development and commercialization efforts[108]. Regulatory and Compliance Challenges - The company has limited data regarding the safety profile of its product candidates when dosed in humans, which may affect regulatory approval[85]. - Regulatory approvals will require ongoing compliance and could impose significant post-marketing requirements, affecting the company's operations[122]. - The company must navigate complex healthcare laws and regulations that could expose it to criminal sanctions and civil penalties, impacting profitability[131]. - The company is subject to extensive federal and state health care laws, including the federal False Claims Act, which imposes penalties for presenting false claims to the government[132]. - The company may incur substantial civil and criminal penalties due to violations of advertising and promotion regulations, with fines exceeding $1.0 billion in past cases[125]. - The company may face challenges in obtaining timely foreign regulatory approvals, which could diminish the commercial prospects of its product candidates[125]. - Legislative reforms, such as the IRA, may impose price negotiations and penalties for price increases, affecting the company's pricing strategies[129]. Intellectual Property and Legal Risks - The company has filed numerous patent applications, but the patent prosecution process is expensive and time-consuming, with no guarantee of obtaining desired patent rights[136]. - The company may face challenges in protecting its intellectual property rights, which could impact its competitive position in the market[136]. - The lifespan of patents is generally 20 years from the earliest filing date, which may not provide sufficient protection against competition from generics or biosimilars[136]. - Changes in patent law, such as the transition to a "first-to-file" system, could increase uncertainties and costs related to patent applications and enforcement[140]. - Legal proceedings to enforce intellectual property rights can be costly and time-consuming, with the risk of unfavorable outcomes impacting business operations[144]. - The company relies on trade secrets and non-disclosure agreements to protect its proprietary information, but breaches could lead to significant costs and distractions[151]. Operational and Supply Chain Risks - The company depends on a small number of suppliers for key raw materials, and any loss of these suppliers could materially affect its business[120]. - Risks associated with large-scale manufacturing could severely impact the company's ability to meet clinical trial and commercialization needs[100]. - The reliance on third parties for clinical trials and studies may lead to delays and adversely affect the company's business prospects[117]. - The company relies on third parties for the commercialization of its product candidates, and any failure to establish collaborations could adversely affect future product revenue[114]. Stockholder and Market Considerations - The stock price of the company has been volatile, influenced by various factors including competitive products and regulatory actions[154]. - The company has broad discretion in using net proceeds from public offerings, which may not enhance stockholder value[156]. - The company does not intend to pay dividends, limiting returns to stock appreciation[163]. - Provisions in the company's bylaws may discourage changes in control, potentially depressing stock price[164]. - The company is classified as a "smaller reporting company," which may result in reduced disclosure obligations, potentially making its stock less attractive to investors[169].

Pipeline and Catalysts - AnaptysBio's rapid antibody R&D engine has advanced 7 internally-generated antibodies to clinical development since 2016[4, 6, 8, 57] - Imsidolimab (ANB019, anti-IL-36R) GALLOP GPP Phase 2 Trial FDA End-Of-Phase 2 meeting is anticipated in Q4 2020[10, 59] - Imsidolimab (ANB019, anti-IL-36R) POPLAR PPP Phase 2 Trial top-line data is anticipated in Q1 2021[10, 59] - Imsidolimab (ANB019, anti-IL-36R) EGFRi Mediated Skin Toxicity Phase 2 Trial Phase 2 trial initiation in Q4 2020[10, 59] - Imsidolimab (ANB019, anti-IL-36R) Ichthyosis Phase 2 Trial Phase 2 trial initiation in Q4 2020[10, 59] - Etokimab (ANB020, anti-IL-33) ECLIPSE Adult Chronic Rhinosinusitis with Nasal Polyps Phase 2 Trial complete data is expected by year-end 2020[10, 59] - ANB030 (anti-PD-1 Agonist) Healthy Volunteer Phase 1 Trial top-line data is anticipated in mid-2021[10, 59] - ANB032 (anti-BTLA Modulator) IND Filing is anticipated in Q4 2020[10, 59] Financial Status - AnaptysBio has approximately $160 million in partnership revenues to date, with an additional $75 million in milestones anticipated in the upcoming 18 months, plus royalties[4, 53] - The company anticipates cash and existing partnerships to extend runway into 2023, with ~$375 million in cash (end Q3 2020) and a projected 2020 net burn close to breakeven[4]

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 ...

PART I. FINANCIAL INFORMATION [Item 1. Consolidated Financial Statements (unaudited)](index=4&type=section&id=Item%201.%20Consolidated%20Financial%20Statements%20%28unaudited%29) The unaudited consolidated financial statements present the company's financial position, results of operations, and cash flows for the periods ended June 30, 2020, and December 31, 2019 [Consolidated Balance Sheets](index=4&type=section&id=Consolidated%20Balance%20Sheets) As of June 30, 2020, total assets decreased to **$401.7 million** from **$435.2 million** at December 31, 2019, primarily due to a decrease in investments Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2020 (unaudited) | December 31, 2019 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $221,172 | $171,017 | | Total current assets | $384,516 | $377,733 | | Total assets | $401,746 | $435,197 | | **Liabilities & Equity** | | | | Total current liabilities | $20,130 | $29,535 | | Total liabilities | $20,310 | $30,189 | | Accumulated deficit | $(273,836) | $(244,026) | | Total stockholders' equity | $381,436 | $405,008 | [Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) For the six months ended June 30, 2020, net loss decreased to **$29.8 million** from **$46.0 million** year-over-year, driven by higher collaboration revenue and lower R&D expenses Statement of Operations Highlights (in thousands, except per share data) | Metric | Three Months Ended June 30, 2020 | Three Months Ended June 30, 2019 | Six Months Ended June 30, 2020 | Six Months Ended June 30, 2019 | | :--- | :--- | :--- | :--- | :--- | | Collaboration revenue | $0 | $5,000 | $15,000 | $5,000 | | Research and development | $17,948 | $27,350 | $38,916 | $47,981 | | General and administrative | $4,687 | $4,307 | $8,972 | $8,448 | | Loss from operations | $(22,635) | $(26,657) | $(32,888) | $(51,429) | | Net loss | $(21,548) | $(23,962) | $(29,810) | $(46,040) | | Net loss per share (basic and diluted) | $(0.79) | $(0.89) | $(1.09) | $(1.70) | [Consolidated Statements of Stockholders' Equity](index=6&type=section&id=Consolidated%20Statements%20of%20Stockholders%27%20Equity) Total stockholders' equity decreased to **$381.4 million** at June 30, 2020, primarily due to a net loss of **$29.8 million** for the six-month period - The accumulated deficit increased from **$244.0 million** at the end of 2019 to **$273.8 million** by June 30, 2020, reflecting ongoing net losses from operations[9](index=9&type=chunk) [Consolidated Statements of Cash Flows](index=8&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) For the six months ended June 30, 2020, net cash used in operating activities was **$34.7 million**, while net cash provided by investing activities was **$86.1 million** Cash Flow Summary (in thousands) | Activity | Six Months Ended June 30, 2020 | Six Months Ended June 30, 2019 | | :--- | :--- | :--- | | Net cash used in operating activities | $(34,722) | $(31,616) | | Net cash provided by investing activities | $86,145 | $67,533 | | Net cash used in financing activities | $(1,268) | $(2,961) | | **Net increase in cash, cash equivalents, and restricted cash** | **$50,155** | **$32,956** | [Notes to the Unaudited Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20the%20Unaudited%20Consolidated%20Financial%20Statements) The notes detail the company's business as a clinical-stage biotechnology firm, its accounting policies, and the significant impact of COVID-19 on operations - The company is a clinical-stage biotechnology firm focused on first-in-class immunology therapeutic product candidates, developing its pipeline using a proprietary antibody discovery platform based on somatic hypermutation (SHM)[14](index=14&type=chunk) - Under the GSK collaboration, the company earned and recognized two clinical milestones totaling **$15.0 million** during the six months ended June 30, 2020, related to the filing of an NDA and MAA for dostarlimab[25](index=25&type=chunk)[26](index=26&type=chunk)[27](index=27&type=chunk) - No revenue was recognized under the BMS agreement during the three and six months ended June 30, 2020 and 2019[29](index=29&type=chunk) - On May 4, 2020, the company entered into a new 124-month lease for approximately **45,000 square feet** of space, with the term beginning on March 1, 2021[51](index=51&type=chunk) - A putative securities class action lawsuit was filed against the company on March 25, 2020, alleging material misrepresentations regarding the etokimab drug, which the company believes are without merit[52](index=52&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=26&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's focus on developing immunology therapeutic candidates, the impact of COVID-19, and its financial position, including **$392.2 million** in cash and investments as of June 30, 2020 [Overview and Pipeline](index=26&type=section&id=Overview%20and%20Pipeline) AnaptysBio is a clinical-stage biotech company focused on immunology, with lead candidates imsidolimab and etokimab, and partnered programs like dostarlimab with GSK - Imsidolimab (anti-IL-36R) is in a Phase 2 trial (GALLOP) for GPP with a regulatory update expected in Q4 2020, and a Phase 2 trial (POPLAR) for PPP with top-line data expected in Q1 2021[64](index=64&type=chunk)[65](index=65&type=chunk)[66](index=66&type=chunk)[67](index=67&type=chunk) - Etokimab (anti-IL-33) is in a Phase 2 trial (ECLIPSE) for CRSwNP, with full 16-week data expected by year-end 2020 to determine next steps for the program[68](index=68&type=chunk) - Partnered program dostarlimab (anti-PD-1 with GSK) received FDA BLA acceptance and EMA MAA acceptance, triggering **$10.0 million** and **$5.0 million** milestone payments, respectively, with FDA approval anticipated in H2 2020[71](index=71&type=chunk) - The COVID-19 pandemic has caused the company to modify business practices, including remote work and curtailing travel, and has impacted clinical trial timelines, such as for the POPLAR trial[64](index=64&type=chunk)[74](index=74&type=chunk)[75](index=75&type=chunk) [Results of Operations](index=30&type=section&id=Results%20of%20Operations) For the six months ended June 30, 2020, collaboration revenue increased to **$15.0 million** due to GSK milestones, while R&D expenses decreased by **$9.1 million** - Collaboration revenue for the six months ended June 30, 2020, was **$15.0 million**, related to two milestone payments from GSK for the dostarlimab program (NDA and MAA filings), compared to **$5.0 million** in the same period of 2019[83](index=83&type=chunk) R&D Expenses by Program (Six Months Ended June 30, in thousands) | Program | 2020 | 2019 | Change | | :--- | :--- | :--- | :--- | | Etokimab | $11,891 | $19,163 | $(7,272) | | Imsidolimab | $8,816 | $10,165 | $(1,349) | | ANB030 | $1,639 | $4,977 | $(3,338) | | Preclinical and other unallocated | $7,997 | $4,147 | $3,850 | | **Total External Costs** | **$30,343** | **$38,452** | **$(8,109)** | | **Internal Costs** | **$8,573** | **$9,529** | **$(956)** | | **Total R&D Expenses** | **$38,916** | **$47,981** | **$(9,065)** | - General and administrative expenses increased by **$0.6 million** to **$9.0 million** for the six months ended June 30, 2020, primarily due to higher legal and insurance expenses[87](index=87&type=chunk) [Liquidity and Capital Resources](index=32&type=section&id=Liquidity%20and%20Capital%20Resources) As of June 30, 2020, the company had **$392.2 million** in cash, cash equivalents, and investments, which are expected to fund operations at least into 2023 - As of June 30, 2020, the company had **$392.2 million** in cash, cash equivalents and investments, which is expected to fund the current operating plan at least into 2023[92](index=92&type=chunk)[94](index=94&type=chunk) Cash Flow Summary (Six Months Ended June 30, in thousands) | Activity | 2020 | 2019 | | :--- | :--- | :--- | | Net cash used in operating activities | $(34,722) | $(31,616) | | Net cash provided by investing activities | $86,145 | $67,533 | | Net cash used in financing activities | $(1,268) | $(2,961) | - The company entered into a new lease agreement on May 4, 2020, for a 124-month term beginning March 1, 2021, for approximately **45,000 square feet** of space[102](index=102&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=36&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As of June 30, 2020, there have been no material changes to the company's market risk from the disclosures provided in its 2019 Form 10-K - There have been no material changes surrounding the company's market risk from the discussion provided in the Fiscal 2019 Form 10-K[110](index=110&type=chunk) [Item 4. Controls and Procedures](index=36&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were effective as of June 30, 2020, with no material changes in internal control over financial reporting during the quarter - Based on an evaluation as of June 30, 2020, the Chief Executive Officer and Interim Chief Financial Officer concluded that the company's disclosure controls and procedures were effective at a reasonable assurance level[111](index=111&type=chunk) - No changes in internal control over financial reporting occurred during the quarter ended June 30, 2020, that have materially affected, or are reasonably likely to materially affect, internal controls[113](index=113&type=chunk) PART II. OTHER INFORMATION [Item 1. Legal Proceedings](index=37&type=section&id=Item%201.%20Legal%20Proceedings) The company is facing a putative securities class action lawsuit filed on March 25, 2020, alleging material misrepresentations regarding the etokimab drug - A putative securities class action was filed on March 25, 2020, alleging material misrepresentations regarding the etokimab drug during the class period of October 10, 2017, to November 7, 2019[115](index=115&type=chunk) - The company believes the plaintiff's allegations are without merit and intends to vigorously defend against the claims, but cannot estimate a reasonably possible loss at this early stage[115](index=115&type=chunk) [Item 1A. Risk Factors](index=37&type=section&id=Item%201A.%20Risk%20Factors) The company outlines extensive risks including early-stage product development, potential clinical trial failures, COVID-19 impacts, financial needs, third-party reliance, regulatory challenges, and intellectual property protection - **Development Risk:** Product candidates are in early development stages and may fail or suffer delays; results from early trials may not be predictive of later, larger trials[117](index=117&type=chunk)[119](index=119&type=chunk)[121](index=121&type=chunk) - **COVID-19 Risk:** The pandemic has impacted business practices and could materially delay clinical trials, disrupt supply chains (CROs, CMOs), and affect patient enrollment[129](index=129&type=chunk)[131](index=131&type=chunk)[132](index=132&type=chunk) - **Financial Risk:** The company has a history of operating losses and will require additional capital to fund operations, which may cause dilution or require relinquishing rights to product candidates on unfavorable terms[178](index=178&type=chunk)[179](index=179&type=chunk)[184](index=184&type=chunk) - **Third-Party Reliance:** The business depends on collaborations with GSK and BMS and relies completely on third parties for manufacturing; failure or termination of these relationships could adversely affect development and commercialization[205](index=205&type=chunk)[212](index=212&type=chunk) - **Regulatory and Commercial Risk:** Obtaining regulatory approval is a lengthy and uncertain process, and even if approved, products face challenges with market acceptance, pricing pressure, and reimbursement from payors[142](index=142&type=chunk)[168](index=168&type=chunk)[226](index=226&type=chunk) - **Intellectual Property Risk:** Success depends on the ability to obtain and protect patents; the patent landscape is uncertain, and the company may become involved in expensive litigation to defend its IP rights[251](index=251&type=chunk)[253](index=253&type=chunk)[269](index=269&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=77&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This item is not applicable for the reporting period - Not applicable[303](index=303&type=chunk) [Item 3. Defaults Upon Senior Securities](index=77&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This item is not applicable for the reporting period - Not applicable[303](index=303&type=chunk) [Item 4. Mine Safety Disclosures](index=78&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable for the reporting period - Not applicable[305](index=305&type=chunk) [Item 5. Other Information](index=78&type=section&id=Item%205.%20Other%20Information) There is no other information to report for this period - None[305](index=305&type=chunk) [Item 6. Exhibits](index=78&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including CEO and CFO certifications - The report includes certifications from the Principal Executive Officer and Principal Financial Officer as required by the Sarbanes-Oxley Act of 2002[306](index=306&type=chunk)

Revenue and Collaboration - Collaboration revenue for Q1 2020 was $15.0 million, compared to $0.0 million in Q1 2019, driven by two milestones related to dostarlimab[91]. - The company has received approximately $100.0 million in cash receipts from collaborations to date[80]. - The company expects marketing approval for dostarlimab by the FDA for endometrial cancer during 2020[80]. Research and Development Expenses - Research and development expenses increased to $21.0 million in Q1 2020 from $20.6 million in Q1 2019, primarily due to a $0.5 million rise in clinical expenses[92]. - External costs for the etokimab program were $7.9 million in Q1 2020, up from $7.5 million in Q1 2019, reflecting an increase of $0.4 million[95]. - ANB019 external costs rose to $5.2 million in Q1 2020 from $5.0 million in Q1 2019, an increase of $0.2 million[95]. - ANB030 external costs decreased significantly to $0.7 million in Q1 2020 from $1.5 million in Q1 2019, a decrease of $0.8 million[95]. - Total external costs for the company were $16.4 million in Q1 2020, compared to $16.0 million in Q1 2019, reflecting a modest increase of $0.4 million[95]. - The company anticipates interim top-line data from the ECLIPSE trial of etokimab in Q3 2020[75]. Financial Performance - The ongoing COVID-19 pandemic may negatively impact the company's financial results and liquidity in fiscal 2020[82]. - General and administrative expenses increased to $4.3 million for Q1 2020 from $4.1 million in Q1 2019, primarily due to a $0.2 million rise in personnel costs and insurance expenses[96]. - Interest expense decreased to $0.0 million in Q1 2020 from $0.3 million in Q1 2019 due to the final payment on Term Loans[97]. - Interest income fell to $1.9 million in Q1 2020 from $3.0 million in Q1 2019, attributed to lower interest rates and decreased investment balances[98]. - Cash, cash equivalents, and investments totaled $412.7 million as of March 31, 2020, down from $428.5 million as of December 31, 2019[104]. - Net cash used in operating activities was $15.1 million in Q1 2020, compared to $16.1 million in Q1 2019, reflecting a reduced net loss[106]. - Net cash provided by investing activities was $10.8 million in Q1 2020, up from $9.7 million in Q1 2019, primarily due to investment maturity timing[107]. Future Financial Outlook - The company expects general and administrative expenses to rise due to costs associated with being publicly traded, including legal and compliance expenses[96]. - Future minimum annual obligations under non-cancellable operating lease commitments are $0.7 million for the remainder of fiscal years ending 2020 and 2021[110]. - The company has received an aggregate of $738.5 million since inception, with $412.7 million available as of March 31, 2020, to fund operations[100]. - The company may seek additional financing through equity or debt financings or collaborations, with uncertainty regarding the ability to obtain such financing on reasonable terms[102].

Part I [Business](index=5&type=section&id=Item%201.%20Business) AnaptysBio is a clinical-stage biotechnology company developing immunology therapeutics through its SHM platform, advancing its pipeline and collaborating with major pharmaceutical companies [Overview and Strategy](index=5&type=section&id=Overview%20and%20Strategy) The company's strategy focuses on advancing its wholly-owned product candidates to key clinical milestones and expanding its pipeline through strategic partnerships - The company's core strategy includes advancing its four wholly-owned programs to key 2020 milestones, such as Phase 2 data for etokimab and ANB019, Phase 1 initiation for ANB030, and an IND filing for ANB032[18](index=18&type=chunk) - AnaptysBio aims to expand its proprietary pipeline by using its SHM platform to generate new antibodies against novel immune-related targets[19](index=19&type=chunk) - The company plans to retain ownership of its pipeline programs through key data inflection points and seek strategic collaborations for later-stage development and commercialization[19](index=19&type=chunk) [Wholly-Owned Product Pipeline](index=8&type=section&id=Wholly-Owned%20Product%20Pipeline) The company's wholly-owned pipeline includes four candidates: etokimab, ANB019, ANB030, and ANB032, targeting various inflammatory and respiratory diseases Wholly-Owned Pipeline Status | Product Candidate | Target | Indication(s) | Development Stage | | :--- | :--- | :--- | :--- | | Etokimab | IL-33 | Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) | Phase 2 (ECLIPSE Trial) | | ANB019 | IL-36R | Generalized Pustular Psoriasis (GPP), Palmoplantar Pustulosis (PPP) | Phase 2 (GALLOP & POPLAR Trials) | | ANB030 | PD-1 (Agonist) | Inflammatory Diseases | Phase 1 initiation anticipated H1 2020 | | ANB032 | BTLA (Modulator) | Inflammatory Diseases | IND filing anticipated H2 2020 | - For ANB019 in GPP, interim Phase 2 data from the first two patients showed they achieved the primary endpoint of disease improvement at Day 29 and Day 113, with complete clearance of skin pustules from Day 8 through Day 113[13](index=13&type=chunk)[51](index=51&type=chunk) - The company has discontinued further clinical development of etokimab in atopic dermatitis following results from the Phase 2b ATLAS trial and has postponed a Phase 2b trial in eosinophilic asthma pending data from the CRSwNP trial[12](index=12&type=chunk) [SHM Antibody Discovery Platform](index=13&type=section&id=SHM%20Antibody%20Discovery%20Platform) The proprietary SHM antibody discovery platform replicates natural antibody generation in vitro, offering advantages in potency, functional selection, and manufacturability - The platform uses the activation-induced cytidine deaminase (AID) enzyme to replicate the natural SHM process in vitro, enabling the generation of a diverse library of antibodies[67](index=67&type=chunk)[68](index=68&type=chunk) - A key advantage is the mammalian cell system that simultaneously displays antibodies for selection and secretes them for functional assays, mitigating manufacturing risks early in the process[70](index=70&type=chunk)[73](index=73&type=chunk) - The platform is designed to overcome limitations of competing technologies, such as insufficient diversity, lack of functional selection, low potency, and unpredictable manufacturing properties[61](index=61&type=chunk) [Collaborations](index=16&type=section&id=Collaborations) The company maintains strategic collaborations with GSK and Bristol-Myers Squibb, providing non-dilutive funding through milestone payments and potential royalties - The collaboration with TESARO (GSK) covers antibodies targeting PD-1 (dostarlimab/TSR-042), TIM-3 (TSR-022), and LAG-3 (TSR-033); a Biologics License Application (BLA) for dostarlimab has been submitted by GSK[16](index=16&type=chunk)[74](index=74&type=chunk) - The collaboration with Celgene (BMS) is focused on inflammation, with two programs advancing, including an anti-PD-1 agonist antibody (CC-90006) in a Phase 1 trial[77](index=77&type=chunk) Collaboration Financials | Partner | Focus | Upfront Payments (in millions) | Potential Milestones (per target, in millions) | Royalties | | :--- | :--- | :--- | :--- | :--- | | TESARO (GSK) | Immuno-Oncology | $19.0 | Up to $273.0 | 4% to 8% tiered | | Celgene (BMS) | Inflammation | $6.0 | Up to $53.0 | Single-digit | [Intellectual Property](index=18&type=section&id=Intellectual%20Property) The company's intellectual property strategy focuses on patent protection for its platform and product candidates, supplemented by trade secrets - As of December 31, 2019, the company's patent portfolio included approximately **42 issued patents** and **158 pending patent applications**[89](index=89&type=chunk) Patent Protection Expiration Outlook | Product Candidate | Expected Patent Protection Until | | :--- | :--- | | Etokimab | September 2039 | | ANB019 | April 2036 | | ANB030 | June 2040 | | Platform Technology | May 2033 | - The company relies on trade secrets and confidentiality agreements with employees, consultants, and collaborators to protect proprietary information not covered by patents[100](index=100&type=chunk)[101](index=101&type=chunk) [Manufacturing, Competition, and Regulation](index=20&type=section&id=Manufacturing%2C%20Competition%2C%20and%20Regulation) The company relies on third-party manufacturing, faces intense competition, and operates under extensive government regulation for drug development and approval - AnaptysBio does not have internal cGMP manufacturing capabilities and relies on third-party contract manufacturers for all clinical and potential commercial drug production[104](index=104&type=chunk)[105](index=105&type=chunk) - Key competitors for etokimab in asthma and CRSwNP include approved biologics like Dupixent (Regeneron/Sanofi), Xolair (Roche), Nucala (GSK), and Fasenra (AstraZeneca)[110](index=110&type=chunk)[111](index=111&type=chunk) - Competitors for ANB019 in GPP and PPP include marketed therapies like Cosentyx (Novartis) and Stelara (Janssen), as well as an anti-IL-36 receptor antibody in development by Boehringer Ingelheim[112](index=112&type=chunk) - The company's products are regulated as biologics in the U.S., requiring a Biologics License Application (BLA) for marketing approval from the FDA, a process that is lengthy, expensive, and uncertain[115](index=115&type=chunk)[121](index=121&type=chunk) [Risk Factors](index=31&type=section&id=Item%201A.%20Risk%20Factors) The company faces substantial risks including clinical development failures, financial losses, reliance on third parties, intense competition, regulatory hurdles, and intellectual property challenges - All wholly-owned and partnered product candidates are in early stages of development and may fail or suffer delays; initial positive clinical results may not be replicated in later, larger trials[181](index=181&type=chunk)[183](index=183&type=chunk) - The company has a history of operational losses (**$97.3 million net loss in 2019**) and expects to incur significant expenses and increasing losses for the foreseeable future, with profitability dependent on successful commercialization[235](index=235&type=chunk)[236](index=236&type=chunk) - AnaptysBio relies completely on third parties for the complex and highly regulated manufacturing of its biologic product candidates, making it vulnerable to production difficulties, contamination, or supply disruptions[231](index=231&type=chunk)[272](index=272&type=chunk) - The company faces significant competition from major pharmaceutical companies with greater resources and established products in its target indications, which could negatively impact commercial opportunities[215](index=215&type=chunk) [Unresolved Staff Comments](index=64&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) The company reports no unresolved staff comments from the Securities and Exchange Commission - None[367](index=367&type=chunk) [Properties](index=64&type=section&id=Item%202.%20Properties) The company leases approximately **43,000 square feet** of office and laboratory space in San Diego, California, under leases expiring in 2021 - The company leases approximately **43,000 square feet** of office and lab space in San Diego, California, across two lease agreements set to expire in 2021[368](index=368&type=chunk) [Legal Proceedings](index=64&type=section&id=Item%203.%20Legal%20Proceedings) The company is not currently involved in any material legal proceedings that would adversely affect its business - As of the report date, AnaptysBio is not involved in any material legal proceedings[369](index=369&type=chunk) [Mine Safety Disclosures](index=64&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[370](index=370&type=chunk) Part II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=65&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company's common stock trades on Nasdaq under 'ANAB', has never paid dividends, and retains earnings for operations - The company's common stock trades on the Nasdaq Global Select Market under the symbol "ANAB"[372](index=372&type=chunk) - AnaptysBio has never declared or paid cash dividends and does not intend to in the foreseeable future[373](index=373&type=chunk) [Selected Consolidated Financial Data](index=66&type=section&id=Item%206.%20Selected%20Consolidated%20Financial%20Data) This section summarizes the company's consolidated financial data from 2015 to 2019, showing fluctuating revenue, increasing losses, and growing assets Selected Consolidated Financial Data (2017-2019) | (in thousands) | 2019 | 2018 | 2017 | | :--- | :--- | :--- | :--- | | Collaboration revenue | $8,000 | $5,000 | $10,000 | | Loss from operations | $(107,432) | $(66,722) | $(28,781) | | Net loss | $(97,336) | $(61,656) | $(30,070) | | **As of Year End** | | | | | Total assets | $435,197 | $508,997 | $329,364 | | Total stockholders' equity | $405,008 | $486,365 | $307,581 | [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=68&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses financial performance, noting increased collaboration revenue and R&D expenses, a **$97.3 million net loss** in 2019, and **$428.5 million** in cash expected to fund operations into 2023 [Results of Operations](index=74&type=section&id=Results%20of%20Operations) Collaboration revenue increased to **$8.0 million** in 2019, while R&D expenses surged by **$43.1 million** to **$99.3 million**, leading to a **$97.3 million net loss** Comparison of Operations (2019 vs. 2018) | (in thousands) | 2019 | 2018 | Change | | :--- | :--- | :--- | :--- | | Collaboration Revenue | $8,000 | $5,000 | $3,000 | | Research & Development Expenses | $99,338 | $56,196 | $43,142 | | General & Administrative Expenses | $16,094 | $15,526 | $568 | | Loss from Operations | $(107,432) | $(66,722) | $(40,710) | | Net Loss | $(97,336) | $(61,656) | $(35,680) | - The **$43.1 million** increase in R&D expenses was primarily driven by a **$20.9 million** increase in clinical expenses, a **$16.0 million** increase in preclinical and manufacturing services, and a **$5.4 million** increase in salaries and related expenses[427](index=427&type=chunk) [Liquidity and Capital Resources](index=76&type=section&id=Liquidity%20and%20Capital%20Resources) As of December 31, 2019, the company held **$428.5 million** in cash and investments, expected to fund operations into 2023, with primary uses for R&D and clinical trials - The company ended 2019 with **$428.5 million** in cash, cash equivalents, and investments, which is expected to fund operations at least into 2023[435](index=435&type=chunk)[441](index=441&type=chunk) Cash Flow Summary (in thousands) | Activity | 2019 | 2018 | | :--- | :--- | :--- | | Net cash used in operating activities | $(69,517) | $(48,506) | | Net cash provided by (used in) investing activities | $131,431 | $(142,451) | | Net cash (used in) provided by financing activities | $(4,493) | $223,364 | - As of December 31, 2019, total contractual obligations for notes payable and operating leases due within one year were approximately **$2.3 million**[447](index=447&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=78&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's market risk primarily stems from interest rate fluctuations on investments and debt, and foreign currency exchange rates, with no material impact expected from a 10% change - The primary market risks are interest rate fluctuations on its investment portfolio and variable-rate debt, and foreign currency exchange risk related to its Australian subsidiary and contracts denominated in foreign currencies[450](index=450&type=chunk)[454](index=454&type=chunk) - The company does not believe that a hypothetical **10% change** in interest rates or foreign currency exchange rates would materially impact its financial statements[452](index=452&type=chunk)[454](index=454&type=chunk) [Consolidated Financial Statements and Supplementary Data](index=80&type=section&id=Item%208.%20Consolidated%20Financial%20Statements%20and%20Supplementary%20Data) This section presents the audited consolidated financial statements and KPMG LLP's unqualified opinion, highlighting research and development costs as a critical audit matter - The independent auditor, KPMG LLP, issued an unqualified opinion on the consolidated financial statements and the effectiveness of internal control over financial reporting as of December 31, 2019[460](index=460&type=chunk)[461](index=461&type=chunk) - The critical audit matter identified by the auditor was the evaluation of research and development costs, highlighting the complexity and judgment required to estimate costs incurred with third-party vendors[464](index=464&type=chunk)[465](index=465&type=chunk) Consolidated Balance Sheet Highlights (as of Dec 31, 2019) | (in thousands) | Amount | | :--- | :--- | | Cash, cash equivalents, and investments | $428,532 | | Total Assets | $435,197 | | Total Liabilities | $30,189 | | Total Stockholders' Equity | $405,008 | [Changes in and Disagreements With Accountants on Accounting and Financial Disclosure](index=108&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20With%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) The company reports no changes in or disagreements with its accountants regarding accounting or financial disclosure matters - None[589](index=589&type=chunk) [Controls and Procedures](index=108&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management and KPMG LLP concluded that the company's disclosure controls and internal control over financial reporting were effective as of December 31, 2019 - Management concluded that the company's disclosure controls and procedures were effective as of December 31, 2019[589](index=589&type=chunk) - Management's report and the independent auditor's report both concluded that the company maintained effective internal control over financial reporting as of December 31, 2019[590](index=590&type=chunk)[594](index=594&type=chunk) [Other Information](index=111&type=section&id=Item%209B.%20Other%20Information) The company reports no other information for this item - None[600](index=600&type=chunk) Part III [Directors, Executive Officers and Corporate Governance](index=111&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) Information regarding directors, executive officers, and corporate governance is incorporated by reference from the forthcoming 2020 Proxy Statement - Information is incorporated by reference from the forthcoming 2020 Proxy Statement[601](index=601&type=chunk) [Executive Compensation](index=111&type=section&id=Item%2011.%20Executive%20Compensation) Information concerning executive compensation is incorporated by reference from the forthcoming 2020 Proxy Statement - Information is incorporated by reference from the forthcoming 2020 Proxy Statement[602](index=602&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=111&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) Information regarding security ownership and equity compensation plans is incorporated by reference from the forthcoming 2020 Proxy Statement - Information is incorporated by reference from the forthcoming 2020 Proxy Statement[603](index=603&type=chunk) [Certain Relationships and Related Transactions, and Director Independence](index=111&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) Information covering related party transactions and director independence is incorporated by reference from the forthcoming 2020 Proxy Statement - Information is incorporated by reference from the forthcoming 2020 Proxy Statement[604](index=604&type=chunk) [Principal Accounting Fees and Services](index=111&type=section&id=Item%2014.%20Principal%20Accounting%20Fees%20and%20Services) Information detailing fees paid to the principal accountant is incorporated by reference from the forthcoming 2020 Proxy Statement - Information is incorporated by reference from the forthcoming 2020 Proxy Statement[605](index=605&type=chunk) Part IV [Exhibits, Consolidated Financial Statement Schedules](index=112&type=section&id=Item%2015.%20Exhibits%2C%20Consolidated%20Financial%20Statement%20Schedules) This section lists all documents filed as part of the Form 10-K report, including consolidated financial statements and an index of exhibits - This item provides an index of all exhibits filed with the Annual Report, including corporate governance documents, material contracts, and SEC certifications[607](index=607&type=chunk)[608](index=608&type=chunk) [Form 10-K Summary](index=114&type=section&id=Item%2016.%20Form%2010-K%20Summary) The company indicates that no Form 10-K summary is provided - None[617](index=617&type=chunk)

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 ...