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 ...

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 fires ...

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].