SAN DIEGO, May 27, 2025 (GLOBE NEWSWIRE) -- AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics, will host an investor call and live webcast to review updated data from the global Phase 2b RENOIR clinical trial of investigational rosnilimab, a depleter and agonist targeting PD-1+ T cells, for moderate-to-severe rheumatoid arthritis on Tuesday, June 3, 2025, at 4:15pm ET / 1:15pm PT. During the webcast, members of Anaptys management ...

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, 2025 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 ...

PORTFOLIO UPDATES Rosnilimab (PD-1 depleter and agonist) Anaptys Announces First Quarter 2025 Financial Results and Provides Business Update SAN DIEGO, May 5, 2025 — AnaptysBio, Inc. (Nasdaq: ANAB), a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics, today reported financial results for the first quarter ended March 31, 2025, and provided a business update. "Our lead program, rosnilimab, delivered impressive three-month Phase 2b efficacy, safety and tolerability ...

Core Insights - AnaptysBio reported strong Phase 2b efficacy data for its lead program, rosnilimab, in rheumatoid arthritis, with plans to present updated data in June 2025 and initial ulcerative colitis data in Q4 2025 [2][7][8] - The company is advancing its autoimmune portfolio with multiple catalysts expected in the coming years, including ongoing Phase 1 trials for ANB033 and ANB101 [2][4][5] - AnaptysBio remains well-capitalized with a cash runway extending through the end of 2027, supported by a $75 million stock repurchase program and anticipated royalties from collaborations [2][11][12] Financial Updates - For Q1 2025, AnaptysBio reported collaboration revenue of $27.8 million, a significant increase from $7.2 million in Q1 2024, driven by royalties from Jemperli and revenue from the Vanda license agreement [11][19] - Research and development expenses rose to $41.2 million in Q1 2025 from $37.0 million in Q1 2024, primarily due to costs associated with Phase 2 trials for rosnilimab and Phase 1 trials for ANB033 and ANB101 [11][19] - The net loss for Q1 2025 was $39.3 million, or $1.28 per share, compared to a net loss of $43.9 million, or $1.64 per share, in the same period of 2024 [11][16][19] Portfolio Updates - Rosnilimab is in a Phase 2b trial for rheumatoid arthritis and a Phase 2 trial for ulcerative colitis, with positive results reported in a 424-patient Phase 2b RA trial [3][8][14] - ANB033, a CD122 antagonist, and ANB101, a BDCA2 modulator, are both in Phase 1 trials, with enrollment ongoing for healthy volunteers [4][5][7] - The company has a collaboration with GSK, which includes anticipated milestone payments and royalties from the sales of Jemperli [9][12][14]

Core Insights - Bright Peak Therapeutics has appointed John Schmid to its Board of Directors, bringing extensive experience in the biotechnology sector [1][2] - Schmid has over 35 years of financial and senior management experience, having raised over $900 million through various financing methods [2][4] - The company is focused on developing multifunctional immunotherapies for cancer, with its lead program BPT567 currently in Phase 1/2a clinical trials [5] Company Overview - Bright Peak Therapeutics is a clinical-stage biotechnology company specializing in multifunctional immunotherapies for cancer [5] - The company utilizes innovative protein engineering and a proprietary chemical conjugation platform to develop its pipeline [5] - Bright Peak operates from dual locations in San Diego, California, and Basel, Switzerland [5] Leadership and Experience - John Schmid has a proven track record, having guided two companies through successful IPOs and participated in six additional IPOs as an independent board member [2][4] - His previous roles include CFO of Auspex Pharmaceuticals, which went public in 2014 and was sold to Teva for $3.5 billion, and co-founder of Trius Therapeutics, acquired for over $700 million [4] - Schmid currently serves on the boards of several biotechnology companies and acts as Audit Chair for each [3]

Company Overview - AnaptysBio, Inc. (ANAB) shares increased by 9.5% to close at $18.71, following a stock repurchase plan authorization for up to $75 million [1] - The stock had previously experienced an 8.1% decline over the past four weeks [1] Financial Performance Expectations - AnaptysBio is projected to report a quarterly loss of $1.30 per share, reflecting a year-over-year increase of 20.7% [2] - Expected revenues for the upcoming quarter are $18.23 million, which is a significant increase of 153.9% compared to the same quarter last year [2] Earnings Estimate Revisions - The consensus EPS estimate for AnaptysBio has been revised 2.2% higher in the last 30 days, indicating a positive trend that may lead to price appreciation [3] - Trends in earnings estimate revisions are strongly correlated with near-term stock price movements, suggesting potential strength in the stock [2][3] Industry Context - AnaptysBio operates within the Zacks Medical - Biomedical and Genetics industry, which includes other companies like MeiraGTx Holdings PLC (MGTX) [3] - MGTX's consensus EPS estimate has increased by 26.9% over the past month, indicating a change of 50.7% from the previous year [4]

Core Viewpoint - AnaptysBio, Inc. has authorized a Stock Repurchase Plan allowing the company to repurchase up to $75 million of its outstanding common stock, indicating confidence in its financial position and future growth potential [1]. Financial Position - As of December 31, 2024, AnaptysBio reported cash, cash equivalents, and investments exceeding $420 million [2]. - The company expects to receive a $75 million commercial sales milestone payment from GSK in 2025 or 2026, which will further bolster its financial resources [2]. - Despite the Stock Repurchase Plan, AnaptysBio maintains its cash runway guidance through year-end 2027 to support its research and development initiatives [2]. Stock Repurchase Plan Details - The shares may be repurchased through open market transactions or other means in accordance with relevant securities regulations [3]. - The execution of the Stock Repurchase Plan will depend on various factors including market conditions and prevailing stock prices [3]. - The plan is set to expire on December 31, 2025, and can be suspended or discontinued at any time without obligation to repurchase any specific amount of stock [3]. Company Overview - AnaptysBio is a clinical-stage biotechnology company focused on innovative immunology therapeutics for autoimmune and inflammatory diseases [4]. - The lead program, rosnilimab, is currently in Phase 2b trials for rheumatoid arthritis and Phase 2 trials for ulcerative colitis [4]. - The company has additional antibodies in its portfolio, including ANB033 and ANB101, which are in various stages of clinical trials [4]. - AnaptysBio has also collaborated with GSK on multiple therapeutic antibodies for immuno-oncology, including a PD-1 antagonist and a TIM-3 antagonist [4].

Clinical Development and Regulatory Challenges - The company is currently in Phase 2 clinical development of rosnilimab, with interim positive results reported for its Phase 2b clinical trial in rheumatoid arthritis as of February 2025[132]. - Regulatory approvals are critical for the company to commercialize its product candidates, and delays or failures in obtaining these approvals could materially impair revenue generation[143]. - Adverse events or side effects observed in clinical trials could inhibit regulatory approval or market acceptance of the company's product candidates[138]. - The complexity of biologics manufacturing may lead to difficulties with third-party manufacturers, potentially delaying clinical trials or market supply[133]. - The company currently lacks a marketing and sales force, which may hinder its ability to effectively sell or market its product candidates if approved[133]. - The company is currently in Phase 2 clinical development of rosnilimab, with no prior experience in commercializing biotechnology products, which may complicate future viability assessments[155]. - Significant post-marketing regulatory requirements will be imposed on any product candidates that receive approval, including safety monitoring and compliance with cGMPs[148]. - The company faces uncertainty regarding insurance coverage and reimbursement for newly approved products, which is essential for commercialization[201]. Financial Condition 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 to date[143]. - The company has limited operating revenue and a history of operational losses, requiring additional capital to finance operations, which may not be available on acceptable terms[133]. - The company expects to continue incurring significant expenses and increasing operating losses for the foreseeable future[178]. - The company may not have sufficient financial resources to continue development or collaborations if regulatory approval is delayed or denied[156]. - The company has financed operations primarily through public offerings and collaboration agreements, indicating a dependency on external funding sources[178]. - The macroeconomic and geopolitical environment, including inflation and global health crises, may adversely impact the company's financial condition and ability to raise capital[175]. - The company may need to raise additional funds or obtain funding through collaboration agreements to continue the development of its product candidates[182]. - The company may need to seek additional financing if development costs increase significantly due to delays or other issues[191]. Competition and Market Risks - The company faces significant competition, and if competitors develop more effective or safer products, it could negatively impact commercial opportunities[133]. - The company faces competition from major pharmaceutical and biotechnology firms with greater resources, which may hinder its ability to commercialize products effectively[159]. - Competitors in the PD-1 agonist antibody program include Gilead's GS-0151 and Boehringer Ingelheim's PD-1 agonist antibody, both in early development stages[160]. - The biotechnology industry is subject to rapid technological changes, and competitors may develop more effective or safer products, impacting the company's market opportunities[163]. - Pricing pressures are expected due to efforts by governmental and third-party payors to cap healthcare costs, impacting coverage and reimbursement levels for new products[204]. Intellectual Property and Legal Risks - The company has filed numerous patent applications in the U.S. and foreign jurisdictions, but the patent prosecution process is expensive and time-consuming, with no guarantee of success[224]. - The patent position of biotechnology companies is highly uncertain, and pending patent applications may not result in patents that effectively protect the company's technology[226]. - Changes in patent law, such as the transition to a "first-to-file" system, could increase uncertainties and costs surrounding patent applications and enforcement[235]. - The potential for third parties to challenge patent validity in the USPTO could increase the risk of losing patent claims[236]. - The company may face claims regarding the misappropriation of intellectual property by former employees, leading to potential litigation[253]. - The potential for litigation over intellectual property rights could divert management resources and incur substantial costs[244]. Compliance and Regulatory Environment - Compliance with healthcare laws and regulations is critical, as violations could lead to criminal sanctions, civil penalties, and reputational harm[214]. - The company is subject to strict privacy and data security laws, including GDPR, which impose significant compliance obligations and potential fines for noncompliance[218]. - Legislative changes may continue to impact the healthcare landscape, creating uncertainty regarding future pricing and reimbursement policies[211]. - The evolving compliance and operational requirements related to data privacy and security could materially affect the company's business and financial condition[222]. Operational and Management Challenges - The company must attract and retain highly skilled employees to succeed in its development and commercialization efforts[133]. - Employee misconduct poses risks, including noncompliance with FDA regulations and potential fraud, which could result in significant fines or sanctions[223]. - The company expects to expand its development and regulatory capabilities, which may lead to difficulties in managing growth and could disrupt operations[260]. - The company is increasingly dependent on information technology systems, and any failure or security breach could materially disrupt drug discovery and development programs[261]. Stock and Market Considerations - The market price of the company's stock has been volatile, influenced by various factors including competitive products and regulatory actions[265]. - The company may face securities litigation due to stock price volatility, which could divert management's attention and resources[268]. - The requirements of being a public company may strain resources and affect the ability to attract and retain qualified personnel[269]. - The company does not intend to pay dividends on its common stock, limiting returns to stock appreciation[275].

Financial Performance - The net loss for Q4 2024 was $21.8 million, or $0.72 per share, a decrease from a net loss of $42.2 million, or $1.59 per share, in Q4 2023[12]. - The comprehensive loss for the year ended December 31, 2024, was $144.129 million, down from $159.170 million in 2023, indicating a 9.5% improvement[18]. - Basic and diluted net loss per common share for Q4 2024 was $0.72, compared to $1.59 in Q4 2023, representing a 54.8% decrease[18]. - Loss from operations improved to $9.670 million in Q4 2024, compared to a loss of $42.135 million in Q4 2023, reflecting a 77% reduction[18]. Revenue and Collaboration - Collaboration revenue increased to $43.1 million for Q4 2024, compared to $9.0 million in Q4 2023, driven by commercial milestones from Jemperli sales exceeding $250 million[12]. - Collaboration revenue for Q4 2024 reached $43.113 million, a significant increase from $9.005 million in Q4 2023, representing a growth of 378%[18]. - GSK reported $598 million in sales for Jemperli in 2024, representing over 200% year-over-year growth from $175.6 million in 2023[12]. Research and Development - Research and development expenses for Q4 2024 were $42.6 million, up from $33.5 million in Q4 2023, primarily due to costs associated with rosnilimab and other candidates[12]. - Research and development expenses rose to $42.589 million in Q4 2024, compared to $33.525 million in Q4 2023, reflecting a 27% increase[18]. - The company anticipates full clinical data for rosnilimab in rheumatoid arthritis in Q2 2025 and top-line data for ulcerative colitis in Q4 2025[5]. - Rosnilimab achieved a 69% low disease activity (CDAI LDA) response at Week 14 in a Phase 2b trial for rheumatoid arthritis, with significant results on primary and secondary endpoints[6]. Assets and Financial Position - AnaptysBio reported cash and investments of approximately $420 million as of December 31, 2024, with a cash runway extending through year-end 2027[9]. - Total assets increased to $483.8 million as of December 31, 2024, compared to $452.4 million at the end of 2023[16]. - The company’s accumulated deficit reached $759.3 million as of December 31, 2024, compared to $614.1 million at the end of 2023[16]. Operating Expenses - Total operating expenses for Q4 2024 were $52.783 million, slightly up from $51.140 million in Q4 2023, indicating a 3.2% increase[18]. - Total other (expense) income, net for Q4 2024 was $(12.120) million, compared to $(80) thousand in Q4 2023, indicating a significant increase in expenses[18]. Shareholder Information - The weighted-average number of shares outstanding for basic and diluted shares increased to 30.448 million in Q4 2024 from 26.586 million in Q4 2023, a growth of 14%[18]. - Interest income increased to $5.263 million in Q4 2024 from $4.880 million in Q4 2023, marking an 8% rise[18]. Licensing and Agreements - AnaptysBio has an exclusive global license agreement with Vanda Pharmaceuticals for the development of imsidolimab, receiving $15 million upfront and potential future milestones[8].

Company Overview - AnaptysBio, Inc. is a clinical-stage biotechnology company focused on innovative immunology therapeutics for autoimmune and inflammatory diseases [2] - The lead program, rosnilimab, targets PD-1+ T cells and is currently in Phase 2b trials for rheumatoid arthritis and Phase 2 trials for ulcerative colitis [2] - Other antibodies in the portfolio include ANB033, a CD122 antagonist in Phase 1 trials, and ANB101, a BDCA2 modulator entering Phase 1 trials [2] - Anaptys has licensed multiple therapeutic antibodies to GSK for immuno-oncology, including a PD-1 antagonist (Jemperli) and a TIM-3 antagonist (cobolimab) [2] Upcoming Events - Daniel Faga, CEO of Anaptys, and other executive team members will participate in several investor conferences [1] - Conferences include TD Cowen 45th Annual Healthcare Conference in Boston, Leerink Partners 2025 Global Healthcare Conference in Miami, and Barclays 27th Annual Global Healthcare Conference in Miami [1] - Live webcasts of the events will be available on the Anaptys investor website, with replays accessible for at least 30 days [1] Event Schedule - Fireside chat and one-on-one investor meetings on March 4, 2025, at 1:10 PM ET / 10:10 AM PT [3] - Fireside chat and one-on-one investor meetings on March 11, 2025, at 10:40 AM ET / 7:40 AM PT [3] - Presentation and one-on-one investor meetings on March 12, 2025, at 8:30 AM ET / 5:30 AM PT [3]