SAN DIEGO, Jan. 31, 2024 (GLOBE NEWSWIRE) -- AnaptysBio, Inc. (NASDAQ:ANAB), a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics, today announced that Daniel Faga, president and chief executive officer, will present at Guggenheim's 6th Annual Biotechnology Conference. Investor Conference Details Event - Guggenheim's 6th Annual Biotechnology ConferenceFormat – Fireside chatDate and Time – Wednesday, Feb. 7, 2024 at 9:30am ET / 6:30am PT A live webcast of the firesi ...

Company Overview - AnaptysBio, Inc. is a clinical-stage biotechnology company focused on innovative immunology therapeutics [3] - The company is developing immune cell modulators, including two checkpoint agonists for autoimmune and inflammatory diseases: rosnilimab and ANB032 [3] - AnaptysBio has a preclinical immune cell modulator portfolio and has developed two cytokine antagonists available for out-licensing [3] Upcoming Event - Daniel Faga, president and CEO of AnaptysBio, will present at Guggenheim's 6th Annual Biotechnology Conference [1] - The event will take place on February 7, 2024, at 9:30 AM ET / 6:30 AM PT in a fireside chat format [2] - A live webcast of the presentation will be available on the investor section of AnaptysBio's website, with a replay accessible for at least 30 days [2]

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].

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[93] - The company has no approved products and has incurred significant operating losses every year since inception, except for fiscal year 2014[118] - The company expects to continue incurring significant expenses and increasing operating losses for the foreseeable future[118] - The company reported collaboration revenue of $63.2 million for the year ended December 31, 2021, with a net loss of $57.8 million, resulting in an accumulated deficit of $321.8 million[118] - The company anticipates that its research and development expenses will increase substantially as it continues to identify new clinical candidates and conduct clinical trials[119] - The company may require additional capital to finance operations, which may not be available on acceptable terms, potentially impacting product development and commercialization[119] - The company expects significant additional capital will be needed for planned operations, including clinical trials and commercialization efforts, which may lead to dilution of existing stockholders[177] - The company has approximately $293.4 million in federal net operating losses (NOLs) as of December 31, 2021, which can be carried forward to offset taxable income from 2028 to 2037[184] - The company does not intend to pay dividends on its common stock, limiting returns to stock appreciation[180] Clinical Development and Regulatory Challenges - The company has a limited history of conducting clinical trials and no history of commercializing biotechnology products, which may complicate future viability assessments[93] - The company has recently discontinued clinical development of imsidolimab for certain indications due to slower than anticipated patient enrollment[96] - The company currently has no marketing and sales force, which may hinder effective commercialization of its product candidates[93] - The company has only completed Phase 1 and Phase 2 clinical trials with imsidolimab, with ongoing trials for imsidolimab, rosnilimab, and ANB032[99] - The planned Phase 3 trials for imsidolimab will enroll approximately 45 moderate-to-severe GPP patients to demonstrate efficacy and safety[101] - Regulatory authorities may refuse to accept applications or require additional studies, potentially delaying or preventing marketing approval[103] - The company focuses on a limited number of internal product candidates due to financial and managerial resource constraints[104] - The company may forego or delay pursuing other product candidates that could have greater commercial potential due to current resource allocation decisions[104] - The company may encounter unfavorable third-party reimbursement practices, impacting the affordability of treatments for patients[143] - The company faces risks related to obtaining international regulatory approvals, which may involve additional testing and could delay product introductions[140] Competition and Market Dynamics - The company faces significant competition, and if competitors develop more effective or less expensive products, commercial opportunities may be negatively impacted[93] - Company faces competition from major multinational pharmaceutical and biotechnology companies with greater resources and experience in clinical testing and regulatory approvals[108] - Competitors for GPP include therapies such as secukinumab (Cosentyx) and ustekinumab (Stelara), while acne treatments include retinoids and antibiotics[109] - The biotechnology industry is characterized by rapid technological change, and failure to keep pace may hinder competitive effectiveness[111] - The company’s product candidates may not achieve adequate market acceptance, which is crucial for commercial success[112] - Market acceptance will depend on factors such as efficacy, safety profile, and cost of treatment compared to alternatives[112] Operational Risks and Dependencies - The company relies on third-party manufacturers for production, and any difficulties they encounter could delay clinical trials or product supply[93] - The company relies on third parties for manufacturing and supply of product candidates, making it vulnerable to disruptions that could adversely affect business operations[133] - The company depends on a small number of suppliers for key raw materials, and any loss or failure of these suppliers could materially impact its business[135] - The company has limited data regarding the safety profile of its product candidates when dosed in humans, which may affect regulatory approval[93] - The company must attract and retain highly skilled employees to succeed in its operations[93] - The company faces significant competition for qualified personnel, which is critical for the success of its product development efforts[122] Intellectual Property and Legal Risks - The company has filed numerous patent applications to protect its intellectual property rights, which are crucial for competitive advantage[152] - The company is involved in numerous legal proceedings regarding intellectual property rights, which can be expensive and time-consuming, potentially harming business and financial results[161] - The company may face claims from third parties alleging infringement of their intellectual property rights, which could block the development and commercialization of product candidates[164] - The company relies on trade secrets and proprietary information to maintain its competitive position, but breaches of confidentiality agreements could lead to significant risks[167] - The patent prosecution process is expensive and time-consuming, with potential failure to identify patentable aspects of inventions[153] - The company may not be able to protect its intellectual property rights globally, as enforcement varies by country[154] Compliance and Regulatory Environment - The company must comply with extensive regulatory requirements for manufacturing, labeling, and distribution post-approval, which could impose operational burdens[138] - Compliance with healthcare laws and regulations may expose the company to criminal sanctions, civil penalties, and reputational harm[148] - The company is subject to the federal Anti-Kickback Statute and other healthcare fraud laws, which could impact its marketing and sales arrangements[149] - The company may need to conduct expensive pharmaco-economic studies to demonstrate the cost-effectiveness of its products to obtain reimbursement[144] - Legislative reforms in healthcare could increase the difficulty and costs associated with obtaining marketing approvals and affect pricing strategies[145] - The company anticipates that compliance with evolving laws and regulations will increase general and administrative expenses[175] Market and Stock Performance - The market price of the company's stock has been volatile, influenced by various factors including regulatory actions and competitive product success[170] - The company has broad discretion in the use of net proceeds from public offerings, which may not necessarily enhance stockholder value[173] - The company is currently subject to securities litigation, which could result in substantial costs and divert management's attention[174] - The company is classified as a "smaller reporting company," which may result in reduced disclosure obligations and potentially make its stock less attractive to investors[185]