Core Viewpoint - AnaptysBio, Inc. plans to separate its business into two independent, publicly traded companies, "Royalty Management Co" and "Biopharma Co," to enhance value and align with different investment strategies [1][14]. Group 1: Business Separation - The separation aims to create two distinct entities, allowing investors to align their portfolios with the strategic opportunities of each company [1][14]. - Royalty Management Co will manage rights to royalties and milestone payments from collaborations, focusing on maximizing shareholder value [3][6]. - Biopharma Co will concentrate on developing innovative therapeutics for autoimmune and inflammatory diseases, including rosnilimab, ANB033, and ANB101 [10][13]. Group 2: Financial Collaborations and Royalties - Anaptys has financial collaborations with GSK and Vanda, which include substantial potential royalties and milestone payments [2][8]. - GSK's Jemperli has shown strong sales performance, with $262 million in Q2 2025 and projected peak sales exceeding $2.7 billion [4][5]. - The royalty structure from GSK includes tiered royalties based on net sales, with rates ranging from 8% to 25% depending on sales thresholds [5][6]. Group 3: Clinical Development Pipeline - Rosnilimab has completed a Phase 2b trial for rheumatoid arthritis and is in a Phase 2 trial for ulcerative colitis, with data expected in late 2025 [11][18]. - ANB033 is in a Phase 1b trial for celiac disease, while ANB101 is in a Phase 1a trial targeting autoimmune diseases [12][13]. - The outcomes of these clinical trials will influence the economic value allocation between the two new companies [11]. Group 4: Future Plans and Leadership - The separation is anticipated to be completed by the end of 2026, with Daniel Faga expected to lead Biopharma Co [14]. - Specific details regarding the transaction, board composition, and financial operations will be disclosed later [14][15].

AnaptysBio Conference Call Summary Company Overview - **Company**: AnaptysBio (NasdaqGS:ANAB) - **Focus**: Development of antibodies targeting disease-driving immune cells, specifically in autoimmune and inflammatory diseases [2][3] Key Programs 1. **Rosnilimab**: - **Type**: Selective depletor of pathogenic T cells - **Phase IIb Trial**: Completed in August 2025 with high impact and durable responses observed over nine months [2][3][4] - **Safety Profile**: Safe and tolerable with less than 2% of patients discontinuing due to adverse events [10] - **Efficacy**: High ACR20 rates, with deepening responses over time [10][12] - **Comparison with Competitors**: Demonstrated superior efficacy compared to Eli Lilly's parasolumab, which showed declining efficacy over time [12][14] 2. **ANB033**: - **Type**: CD122 receptor antagonist - **Phase IA Trial**: Nearing initiation for celiac disease, with an upcoming investor relations event [3][52] 3. **ANB101**: - **Type**: BDCA2 modulator - **Phase IA Trial**: Initiated in healthy volunteers earlier in the year [3] Financial Position - **Capital**: Almost $300 million available as of summer 2025 [3] - **Royalties**: Substantial royalty interest in dostarlimab (Jemperli) from GSK, projected to generate over $1 billion in revenue, triggering a $75 million milestone for AnaptysBio [4] Competitive Landscape - **Eli Lilly's Parasolumab**: Recent phase IIb study revealed safety concerns with malignancies reported, contrasting with AnaptysBio's safety profile [5][11][17] - **Johnson & Johnson and Gilead**: Different programs with less potency and effectiveness compared to AnaptysBio's offerings [24] Upcoming Milestones - **Ulcerative Colitis Trial**: Initial data readout expected in Q4 2025, with a focus on achieving clinical remission [27][32] - **Long-term Data**: Six-month data will be critical for strategic decisions regarding the future of rosnilimab [46][50] Market Opportunity - **Autoimmune Disease Market**: Significant potential for a biologic that can drive deeper remission and stable outcomes over time, addressing the high patient turnover in existing treatments [38][40] Safety and Regulatory Insights - **FDA Communication**: No concerns raised by the FDA regarding the class of drugs being developed [21][23] - **Ongoing Safety Monitoring**: No severe infections or malignancies reported in blinded data from ongoing trials [20] Conclusion AnaptysBio is positioned strongly within the autoimmune disease market with promising clinical data for its lead program, rosnilimab, and a robust pipeline. The company is focused on maintaining a competitive edge through targeted therapies and is preparing for significant upcoming data releases that could influence its strategic direction.

Financial Data and Key Metrics Changes - The company reported a cash balance of just under $300 million entering the second half of the year, which is expected to sustain operations through the end of 2027 [7][75]. - The royalty asset from GSK for the drug Jemperli is projected to generate significant revenue, with estimates suggesting potential royalties of $80 million for every $1 billion in sales [79][82]. Business Line Data and Key Metrics Changes - The lead program, rozanolimab, showed positive results in clinical trials for arthritis, with stable off-drug data through nine months and a second trial for ulcerative colitis fully enrolled [5][10]. - The company has two additional drugs in clinical development: AMB033, a CD122 antagonist, and AMB101, a BCA2 modulator, both in Phase 1a trials [6][71]. Market Data and Key Metrics Changes - The market for ulcerative colitis is seen as a growth opportunity, with a significant number of patients likely to switch classes of drugs, indicating a demand for new mechanisms of action [43][44]. - The competitive landscape in rheumatoid arthritis (RA) is noted to be stagnant, with no new classes launched in over a decade, positioning the company favorably [50]. Company Strategy and Development Direction - The company is considering two primary paths forward: advancing independently in ulcerative colitis or pursuing multiple diseases, including RA and UC [45][48]. - The focus is on maximizing clinical remissions and ensuring patient tolerability to drive long-term engagement with the drug [32][36]. Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming data readouts for ulcerative colitis, emphasizing the importance of demonstrating efficacy at three and six months [19][20]. - The company is optimistic about the potential for rozanolimab to provide a differentiated treatment option in a competitive market, particularly given the observed long-lasting effects in RA [49][51]. Other Important Information - The company highlighted the significance of the royalty from GSK, which is expected to provide a valuation backstop and support future growth initiatives [82]. - There is a strong emphasis on the translational research capabilities of the company's platform, which is seen as a competitive advantage in developing new therapies [87][88]. Q&A Session Summary Question: What are the expectations around the three-month update for ulcerative colitis? - Management indicated that the primary endpoint is the change in MMS versus placebo, with expectations for clinical response and remission rates to be comparable to existing biologic classes [36][40]. Question: How does the company balance resources between ulcerative colitis and rheumatoid arthritis? - The decision-making process will depend on the six-month data from the ulcerative colitis trial, with a focus on patient safety and efficacy [41][42]. Question: What is the competitive landscape for the company's drugs? - Management noted that while there are no new RA classes in development, the company is well-positioned due to the potency and tolerability of its drug compared to competitors [50][51]. Question: What is the potential market opportunity for AMB033 in celiac disease? - The company highlighted the significant unmet need in celiac disease, with over two million patients in the U.S. and no approved treatments, making it an attractive market [61][62]. Question: How does the company view its antibody platform's value? - The platform is seen as a critical asset for developing differentiated therapies, with a focus on translational research and process development to optimize drug candidates [87][88].

Summary of AnaptysBio Conference Call Company Overview - AnaptysBio is focused on developing antibodies that modulate overexpressed or disease-driving immune cells to restore immune homeostasis in patients with autoimmune inflammatory diseases [4][6] - The company has three development-stage antibodies: rosnilimab, ANB033, and ANB101 [4][5] Key Programs and Developments Rosnilimab - Rosnilimab is a selective and potent depleter of pathogenic T cells, with recent Phase IIb arthritis study results showing remission rates surpassing best-in-class medicines [4][5][9] - The drug demonstrated over 90% depletion of specific T cells in both the periphery and synovium, with a tolerability profile showing less than 2% dropout due to adverse events [9][10] - Initial data from an ulcerative colitis trial is expected in Q4 of this year [5][11] ANB033 - ANB033 is a CD122 antagonist targeting celiac disease, with the Phase Ib trial starting imminently [5][39] - The drug is designed to block both IL-15 and IL-2, providing a dual mechanism of action [41][42] ANB101 - ANB101 is a BDCA2 modulator currently in Phase IA trials with healthy volunteers [5] Financial Position - AnaptysBio has over $300 million in capital, sufficient to fund operations through year-end 2027 [6][50] Market Dynamics - The ulcerative colitis market is seen as an attractive opportunity, with a potential $6 billion market size in the U.S. [25][26] - The company anticipates a different market uptake in ulcerative colitis compared to rheumatoid arthritis, which is more mature and competitive [24][25] Competitive Landscape - AnaptysBio believes its rosnilimab has a differentiated mechanism compared to competitors like J&J, which faced challenges in dosing and efficacy [33][34][35] - The company is optimistic about the potential for class cycling in ulcerative colitis, similar to trends seen in rheumatoid arthritis [25][26] Future Expectations - The company is focused on achieving maximum remission rates in ulcerative colitis, with a significant readout expected in six months [27][29] - The royalty stream from Jemperli, a drug discovered by AnaptysBio, is projected to be a significant asset, with potential revenues exceeding the company's current market cap [49][50] Conclusion - AnaptysBio is positioned for growth with multiple promising drug candidates and a strong financial foundation, targeting significant unmet needs in autoimmune diseases [6][50]

[PART I. FINANCIAL INFORMATION](index=3&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Item 1. Consolidated Financial Statements (unaudited)](index=3&type=section&id=Item%201.%20Consolidated%20Financial%20Statements%20(unaudited)) This section presents unaudited consolidated financial statements and detailed notes on business, accounting policies, and agreements [Consolidated Balance Sheets](index=4&type=section&id=Consolidated%20Balance%20Sheets) **Consolidated Balance Sheet Highlights (in thousands):** | Metric | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $44,298 | $123,080 | | Short-term investments | $221,412 | $262,293 | | Total current assets | $291,906 | $431,876 | | Total assets | $335,250 | $483,834 | | Total current liabilities | $35,527 | $45,428 | | Liability related to sale of future royalties | $331,361 | $353,426 | | Total stockholders' (deficit) equity | $(44,733) | $70,868 | | Accumulated deficit | $(837,286) | $(759,327) | [Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) **Consolidated Statements of Operations and Comprehensive Loss Highlights (in thousands):** | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Collaboration revenue | $22,263 | $10,971 | $50,034 | $18,150 | | Research and development expenses | $37,824 | $41,997 | $79,004 | $79,039 | | General and administrative expenses | $10,609 | $9,295 | $24,739 | $21,633 | | Loss from operations | $(26,170) | $(40,321) | $(53,709) | $(82,522) | | Non-cash interest expense for sale of future royalties | $(19,606) | $(10,953) | $(37,667) | $(17,270) | | Net loss | $(38,630) | $(46,660) | $(77,959) | $(90,596) | | Basic and diluted net loss per common share | $(1.34) | $(1.71) | $(2.62) | $(3.35) | [Consolidated Statements of Stockholders' Equity](index=6&type=section&id=Consolidated%20Statements%20of%20Stockholders'%20Equity) **Changes in Stockholders' Equity (in thousands) for Six Months Ended June 30, 2025:** | Metric | Amount | | :--- | :--- | | Balance, December 31, 2024 | $70,868 | | Issuance of common stock from exercises of options and ESPP | $1,713 | | Net share settlement of restricted stock units | $(1,451) | | Repurchases and retirements of common stock | $(55,522) | | Stock-based compensation | $18,409 | | Net loss | $(77,959) | | Balance, June 30, 2025 | $(44,733) | [Consolidated Statements of Cash Flows](index=8&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) **Consolidated Statements of Cash Flows (in thousands) for Six Months Ended June 30:** | Activity | 2025 | 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(50,944) | $(58,575) | | Net cash provided by investing activities | $51,250 | $66,174 | | Net cash (used in) provided by financing activities | $(79,088) | $28,257 | | Net (decrease) increase in cash and cash equivalents | $(78,782) | $35,856 | | Cash and cash equivalents, end of period | $44,298 | $71,821 | [Notes to the Unaudited Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20the%20Unaudited%20Consolidated%20Financial%20Statements) [1. Description of the Business](index=9&type=section&id=1.%20Description%20of%20the%20Business) - AnaptysBio, Inc. is a clinical-stage biotechnology company focused on developing innovative immunology therapeutics for autoimmune and inflammatory diseases[28](index=28&type=chunk) - The company's pipeline includes rosnilimab (Phase 2b for RA, Phase 2 for UC), ANB033 (Phase 1 for CeD), and ANB101 (Phase 1)[28](index=28&type=chunk) - Out-licensed antibodies include Jemperli (PD-1 antagonist) to GSK and imsidolimab (IL-36R antagonist) to Vanda Pharmaceuticals Inc., generating revenue from milestones and royalties[28](index=28&type=chunk) [2. Summary of Significant Accounting Policies](index=9&type=section&id=2.%20Summary%20of%20Significant%20Accounting%20Policies) - The unaudited consolidated financial statements are prepared in accordance with SEC rules and U.S. GAAP, including all known adjustments for fair presentation[30](index=30&type=chunk) - The company operates in one reportable segment, with its wholly-owned Australian subsidiary deregistered as of June 30, 2025, without material impact[31](index=31&type=chunk) - Management makes significant estimates for revenue recognition, accrued R&D expenses, stock-based compensation, and the liability related to future royalty sales[32](index=32&type=chunk)[33](index=33&type=chunk) - Recently issued ASU No. 2023-09 (Income Taxes) and ASU No. 2024-03 (Income Statement Expenses) are being assessed for potential impact, with effective dates after December 15, 2024, and December 15, 2026, respectively[37](index=37&type=chunk)[38](index=38&type=chunk) [3. Balance Sheet Accounts and Supplemental Disclosures](index=11&type=section&id=3.%20Balance%20Sheet%20Accounts%20and%20Supplemental%20Disclosures) **Property and Equipment, Net (in thousands):** | Category | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Laboratory equipment | $6,719 | $6,715 | | Office furniture and equipment | $1,581 | $1,530 | | Leasehold improvements | $203 | $203 | | Less: accumulated depreciation and amortization | $(6,875) | $(6,599) | | **Total property and equipment, net** | **$1,628** | **$1,849** | **Accrued Expenses (in thousands):** | Category | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Accrued compensation and related expenses | $6,400 | $8,449 | | Accrued professional fees and other expenses | $982 | $839 | | Accrued research, development and manufacturing expenses | $22,335 | $30,213 | | Accrued for repurchases of common stock | $480 | $— | | **Total accrued expenses** | **$30,197** | **$39,501** | [4. Collaborative Research and Development Agreements](index=11&type=section&id=4.%20Collaborative%20Research%20and%20Development%20Agreements) - Under the GSK Agreement, the company is eligible for tiered **4-8% royalties** on worldwide net sales of products like Jemperli and cobolimab, with Jemperli royalties increased to **8-25%** under Amendment No. 3[42](index=42&type=chunk) **GSK Collaboration Royalty Revenue (in millions):** | Period | 2025 | 2024 | | :--- | :--- | :--- | | Three Months Ended June 30 | $22.2 | $11.0 | | Six Months Ended June 30 | $40.4 | $18.2 | *All royalty revenue recognized is non-cash due to royalty monetization agreements. **GSK Collaboration Milestones (in millions):** | Program | Recognized through June 30, 2025 | May be recognized in the future | | :--- | :--- | :--- | | PD-1 (Jemperli/Dostarlimab) | $133.0 | $140.0 | | TIM-3 (GSK4069889/Cobolimab) | $13.0 | $260.0 | - The Vanda License Agreement for imsidolimab included an upfront payment of **$10.0 million** for the license and **$5.0 million** for existing drug supply[51](index=51&type=chunk) - Under the Vanda License Agreement, the company recognized **$9.6 million** in license revenue and **$5.4 million** in other income (related to drug supply) for the six months ended June 30, 2025, and is eligible for up to **$35.0 million** in future milestones and a **10% royalty** on net sales[51](index=51&type=chunk)[52](index=52&type=chunk) - The Centessa Agreement for the BDCA2 modulator antibody portfolio (ANB101) involved an upfront cash payment of **$4.0 million** and **$3.0 million** for manufacturing costs, expensed as in-process R&D[54](index=54&type=chunk) [5. Sale of Future Royalties](index=14&type=section&id=5.%20Sale%20of%20Future%20Royalties) - The Jemperli Royalty Monetization Agreement with Sagard provided **$250.0 million** in October 2021 and an additional **$50.0 million** in May 2024, in exchange for future Jemperli royalties and milestones up to a threshold of **$600.0 million** or **$675.0 million**[56](index=56&type=chunk)[57](index=57&type=chunk) - As of June 30, 2025, Sagard has received **$121.5 million** in royalties and milestones, and the company retained rights to a **$75.0 million** sales milestone when Jemperli annual net sales exceed **$1.0 billion**[57](index=57&type=chunk)[58](index=58&type=chunk) - The estimated effective interest rate for the Jemperli Royalty Monetization Agreement was **28.9%** as of June 30, 2025, leading to non-cash interest expense of **$37.2 million** for the six months ended June 30, 2025[60](index=60&type=chunk)[62](index=62&type=chunk) - The Zejula Royalty Monetization Agreement with DRI provided **$35.0 million** in September 2022 for future Zejula royalties, with an additional **$10.0 million** contingent on FDA approval for endometrial cancer by December 31, 2025[65](index=65&type=chunk) - Non-cash interest expense for the Zejula Royalty Monetization Agreement was **$0.5 million** for the six months ended June 30, 2025[68](index=68&type=chunk) [6. Fair Value Measurements and Available for Sale Investments](index=16&type=section&id=6.%20Fair%20Value%20Measurements%20and%20Available%20for%20Sale%20Investments) - The company uses a fair value hierarchy (Level 1 and Level 2 inputs) for recurring fair value measurements of financial instruments[71](index=71&type=chunk)[72](index=72&type=chunk)[73](index=73&type=chunk) **Assets Measured at Fair Value (in thousands) at June 30, 2025:** | Category | Fair Value | Level 1 | Level 2 | | :--- | :--- | :--- | :--- | | Money market funds | $27,276 | $27,276 | $— | | Mutual funds | $11,894 | $11,894 | $— | | U.S. Treasury securities | $225,118 | $225,118 | $— | | Agency securities | $7,602 | $— | $7,602 | | Commercial and corporate obligations | $16,688 | $— | $16,688 | **Total Available for Sale Investments (in thousands) at June 30, 2025:** | Metric | Amount | | :--- | :--- | | Amortized Cost | $249,207 | | Gross Unrealized Gains | $243 | | Gross Unrealized Losses | $(42) | | **Total Fair Value** | **$249,408** | - Unrealized losses on available-for-sale investments were less than **$0.1 million** for both June 30, 2025, and December 31, 2024, with no investments in a continuous loss position for greater than 12 months[76](index=76&type=chunk)[79](index=79&type=chunk) [7. Stockholders' Equity](index=19&type=section&id=7.%20Stockholders'%20Equity) - As of June 30, 2025, there were **27,972,997 shares** of common stock issued and outstanding[80](index=80&type=chunk) - The Board authorized a **$75.0 million** stock repurchase program in March 2025, under which **2,853,836 shares** totaling **$55,522 thousand** were repurchased through June 30, 2025, leaving **$19.5 million** available[81](index=81&type=chunk) - In August 2024, the company issued **2,750,498 shares** of common stock through an underwriting agreement, generating approximately **$93.9 million** in net proceeds[83](index=83&type=chunk) [8. Equity Incentive Plans](index=19&type=section&id=8.%20Equity%20Incentive%20Plans) - The 2017 Equity Incentive Plan was amended in June 2024 and June 2025 to increase available shares by **2,700,000** and **1,650,000** respectively, with **2,504,515 shares** available for future issuance as of June 30, 2025[84](index=84&type=chunk) - For the six months ended June 30, 2025, **1,745,653 stock options** were granted, and **610,428 time-based Restricted Stock Units (RSUs)** were granted[86](index=86&type=chunk)[88](index=88&type=chunk) **Total Stock-Based Compensation Expense (in thousands):** | Category | Three Months Ended June 30, 2025 | Six Months Ended June 30, 2025 | | :--- | :--- | :--- | | Research and development | $4,456 | $8,863 | | General and administrative | $4,783 | $9,546 | | **Total** | **$9,239** | **$18,409** | [9. Commitments and Contingencies](index=22&type=section&id=9.%20Commitments%20and%20Contingencies) - The company leases approximately **45,000 square feet** of space in San Diego, California, under an operating lease agreement for a term of **124 months**, commencing April 5, 2021[93](index=93&type=chunk) - As of June 30, 2025, the weighted-average remaining lease term is approximately **6.2 years**, with a weighted-average discount rate of **4.0%**[94](index=94&type=chunk) **Future Minimum Annual Operating Lease Obligations (in thousands) at June 30, 2025:** | Years Ending December 31, | Amount | | :--- | :--- | | 2025 | $1,278 | | 2026 | $2,607 | | 2027 | $2,685 | | 2028 | $2,766 | | 2029 | $2,849 | | Thereafter | $4,939 | | **Total minimum payments required** | **$17,124** | [10. Segment Reporting](index=23&type=section&id=10.%20Segment%20Reporting) - The company operates as one reportable segment, focusing on research and development activities for immunology therapeutics[97](index=97&type=chunk) - The Chief Executive Officer serves as the Chief Operating Decision Maker (CODM), managing business activities on a consolidated basis[98](index=98&type=chunk) **Segment Financials (in thousands) for Six Months Ended June 30:** | Metric | 2025 | 2024 | | :--- | :--- | :--- | | Collaboration revenue | $50,034 | $18,150 | | Total R&D expenses | $79,004 | $79,039 | | Total G&A expenses | $24,739 | $21,633 | | Segment net loss | $(77,959) | $(90,596) | [11. Subsequent Event](index=24&type=section&id=11.%20Subsequent%20Event) - The One Big Beautiful Bill Act (OBBBA) was signed into law in July 2025, introducing significant changes to U.S. tax laws, including current deduction of domestic research expenses and 100% bonus depreciation[101](index=101&type=chunk)[102](index=102&type=chunk) - The company is evaluating the impact of the OBBBA but does not anticipate a change to its effective income tax rate or net deferred federal income tax assets due to maintaining a full valuation allowance[102](index=102&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=28&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section analyzes the company's financial condition, operating results, and liquidity, detailing changes in revenue, expenses, and cash flows [Overview](index=28&type=section&id=Overview) - AnaptysBio is a clinical-stage biotechnology company focused on developing immunology therapeutics for autoimmune and inflammatory diseases[112](index=112&type=chunk) - The company's pipeline includes rosnilimab (RA, UC), ANB033 (CeD), and ANB101 (BDCA2 modulator), alongside out-licensed assets Jemperli (GSK) and imsidolimab (Vanda)[112](index=112&type=chunk) [Our Wholly Owned Product Candidate Pipeline](index=28&type=section&id=Our%20Wholly%20Owned%20Product%20Candidate%20Pipeline) - Rosnilimab, an IgG1 antibody targeting pathogenic T cells, completed a Phase 2b trial for moderate-to-severe rheumatoid arthritis (RA), achieving its primary endpoint and demonstrating clinically meaningful efficacy and a favorable safety profile[114](index=114&type=chunk)[116](index=116&type=chunk)[119](index=119&type=chunk) - A randomized, placebo-controlled Phase 2 trial for rosnilimab in moderate-to-severe ulcerative colitis (UC) is ongoing, with top-line data through Week 12 anticipated in the **fourth quarter of 2025**[120](index=120&type=chunk)[121](index=121&type=chunk) - ANB033, a CD122 antagonist, initiated a Phase 1 clinical trial in healthy volunteers in October 2024, with a cohort in celiac disease (CeD) planned for the **fourth quarter of 2025**[122](index=122&type=chunk)[123](index=123&type=chunk) - ANB101, a BDCA2 modulator antibody, initiated a Phase 1 clinical trial in healthy volunteers in March 2025, targeting plasmacytoid dendritic cells to inhibit interferon secretion[125](index=125&type=chunk)[126](index=126&type=chunk) [Collaborative Programs](index=30&type=section&id=Collaborative%20Programs) - Jemperli (dostarlimab), a PD-1 antagonist under the GSK collaboration, received multiple FDA and EMA approvals for advanced or recurrent endometrial cancer, including in combination with chemotherapy[130](index=130&type=chunk)[131](index=131&type=chunk) - The Phase 3 COSTAR Lung trial for cobolimab (TIM-3 antibody) in combination with dostarlimab and docetaxel did not meet its primary endpoint of overall survival benefit in July 2025[132](index=132&type=chunk) - Imsidolimab (IL-36R antagonist mAb), licensed to Vanda, completed two registration-enabling global Phase 3 trials for Generalized Pustular Psoriasis (GPP)[133](index=133&type=chunk) [Components of Operating Results](index=31&type=section&id=Components%20of%20Operating%20Results) - Collaboration revenue is derived from upfront license payments, R&D funding, and milestone and royalty payments under collaboration and license agreements[135](index=135&type=chunk) - Research and development expenses include external costs (CROs, CMOs, consultants), employee-related expenses, facilities, and license fees, expensed as incurred[136](index=136&type=chunk)[137](index=137&type=chunk)[138](index=138&type=chunk) - Non-cash interest expense for the sale of future royalties is imputed using the effective interest method, based on forecasted royalty and milestone payments[141](index=141&type=chunk) [Critical Accounting Policies and Use of Estimates](index=32&type=section&id=Critical%20Accounting%20Policies%20and%20Use%20of%20Estimates) - The financial statements are prepared in accordance with U.S. GAAP, requiring management judgments and estimates[143](index=143&type=chunk) - No significant changes in critical accounting policies have occurred since the Annual Report on Form 10-K filed on February 27, 2025[143](index=143&type=chunk) [Results of Operations – Comparison of the Three and Six Months Ended June 30, 2025 and 2024](index=32&type=section&id=Results%20of%20Operations%20%E2%80%93%20Comparison%20of%20the%20Three%20and%20Six%20Months%20Ended%20June%2030,%202025%20and%202024) [Collaboration Revenue](index=32&type=section&id=Collaboration%20Revenue) **Collaboration Revenue (in thousands):** | Period | 2025 | 2024 | Change (YoY) | | :--- | :--- | :--- | :--- | | Three Months Ended June 30 | $22,263 | $11,000 | +102.4% | | Six Months Ended June 30 | $50,034 | $18,200 | +174.9% | - All royalty revenue recognized for both periods is non-cash, pursuant to the Royalty Monetization Agreements[145](index=145&type=chunk) - For the six months ended June 30, 2025, the company recognized **$9.6 million** in license revenue and **$0.1 million** in transition services revenue under the Vanda License Agreement, along with **$5.4 million** in other income from drug supply[146](index=146&type=chunk) [Research and Development Expenses](index=33&type=section&id=Research%20and%20Development%20Expenses) **Total Research and Development Expenses (in thousands):** | Period | 2025 | 2024 | Change (YoY) | | :--- | :--- | :--- | :--- | | Three Months Ended June 30 | $37,824 | $41,997 | -10.0% | | Six Months Ended June 30 | $79,004 | $79,039 | -0.04% | - The decrease in R&D expenses for the three months ended June 30, 2025, was primarily due to a **$2.5 million** decrease in clinical expenses and a **$3.4 million** decrease in manufacturing expenses, partially offset by a **$0.9 million** increase in stock-based compensation[147](index=147&type=chunk) **External R&D Costs by Program (in thousands) for Six Months Ended June 30:** | Program | 2025 | 2024 | Change (YoY) | | :--- | :--- | :--- | :--- | | Rosnilimab | $30,639 | $22,965 | +$7,674 | | ANB033 | $7,729 | $5,645 | +$2,084 | | ANB101 | $3,521 | $944 | +$2,577 | | ANB032 | $3,644 | $12,451 | -$(8,807) | | Imsidolimab | $(1,156) | $6,363 | -$(7,519) | [General and Administrative Expenses](index=33&type=section&id=General%20and%20Administrative%20Expenses) **Total General and Administrative Expenses (in thousands):** | Period | 2025 | 2024 | Change (YoY) | | :--- | :--- | :--- | :--- | | Three Months Ended June 30 | $10,609 | $9,295 | +14.1% | | Six Months Ended June 30 | $24,739 | $21,633 | +14.4% | - The increase in G&A expenses for the six months ended June 30, 2025, was primarily driven by a **$2.5 million** increase in transaction costs related to the Vanda License Agreement and a **$0.9 million** increase in personnel costs[151](index=151&type=chunk) [Non-Cash Interest Expense for the Sale of Future Royalties](index=34&type=section&id=Non-Cash%20Interest%20Expense%20for%20the%20Sale%20of%20Future%20Royalties) **Non-Cash Interest Expense for Sale of Future Royalties (in thousands):** | Period | 2025 | 2024 | Change (YoY) | | :--- | :--- | :--- | :--- | | Three Months Ended June 30 | $19,606 | $10,953 | +79.0% | | Six Months Ended June 30 | $37,667 | $17,270 | +118.1% | - The significant increase in non-cash interest expense was primarily due to the Jemperli Amendment, which increased the threshold amounts of aggregate Jemperli royalties and milestones to be received by Sagard[153](index=153&type=chunk)[154](index=154&type=chunk) [Interest Income](index=34&type=section&id=Interest%20Income) **Interest Income (in thousands):** | Period | 2025 | 2024 | Change (YoY) | | :--- | :--- | :--- | :--- | | Three Months Ended June 30 | $3,654 | $4,623 | -21.0% | | Six Months Ended June 30 | $8,067 | $9,207 | -12.3% | - The decrease in interest income was primarily due to lower investment balances and the timing of sales, maturities, and purchases of investments[155](index=155&type=chunk)[156](index=156&type=chunk) [Other Income (Expense), Net](index=34&type=section&id=Other%20Income%20(Expense),%20Net) **Other Income (Expense), Net (in thousands):** | Period | 2025 | 2024 | | :--- | :--- | :--- | | Three Months Ended June 30 | $3,531 (income) | $0 (expense) | | Six Months Ended June 30 | $5,433 (income) | $(2) (expense) | - The increase in other income was primarily related to **$3.5 million** (Q2 2025) and **$5.4 million** (YTD 2025) recognized from existing drug supply transferred to Vanda under the Vanda License Agreement[157](index=157&type=chunk)[158](index=158&type=chunk) [Liquidity and Capital Resources](index=34&type=section&id=Liquidity%20and%20Capital%20Resources) - From inception through June 30, 2025, the company received **$1.3 billion** to fund operations, including **$739.9 million** from equity sales, **$335.0 million** from royalty sales, and **$249.2 million** from collaboration agreements[159](index=159&type=chunk) **Cash, Cash Equivalents and Investments (in millions):** | Date | Amount | | :--- | :--- | | June 30, 2025 | $293.7 | | December 31, 2024 | $420.8 | - The company believes its existing cash, cash equivalents, and investments will fund its current operating plan for at least the next 12 months[165](index=165&type=chunk) [Funding Requirements](index=35&type=section&id=Funding%20Requirements) - Primary uses of capital include third-party clinical and preclinical R&D services, manufacturing, laboratory supplies, compensation, legal, patent, regulatory, and general overhead costs[164](index=164&type=chunk) - The company may seek additional financing through equity or debt financings or through collaborations or partnerships[163](index=163&type=chunk) [Cash Flows](index=35&type=section&id=Cash%20Flows) **Summary of Cash Flows (in thousands) for Six Months Ended June 30:** | Activity | 2025 | 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(50,944) | $(58,575) | | Net cash provided by investing activities | $51,250 | $66,174 | | Net cash (used in) provided by financing activities | $(79,088) | $28,257 | | **Net (decrease) increase in cash and cash equivalents** | **$(78,782)** | **$35,856** | - Net cash used in financing activities for the six months ended June 30, 2025, was primarily due to **$55.5 million** for common stock repurchases and retirements, and **$23.8 million** for repayments of future royalties liability[170](index=170&type=chunk) [Contractual Obligations](index=36&type=section&id=Contractual%20Obligations) - The company has agreements with vendors for goods and services, including manufacturing and development, which may include purchase obligations and termination obligations[172](index=172&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=37&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section confirms no material changes in market risk exposures, including interest rate, inflation, and foreign currency risks - No material changes in market risk, including interest rate risk, inflation risk, and foreign currency exchange risk, have occurred since the Annual Report on Form 10-K filed on February 27, 2025[174](index=174&type=chunk) [Item 4. Controls and Procedures](index=37&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls and procedures were effective, with no material changes in internal control over financial reporting - The company's disclosure controls and procedures were concluded to be effective at a reasonable assurance level as of June 30, 2025[175](index=175&type=chunk) - No material changes in internal control over financial reporting were identified during the quarter ended June 30, 2025[177](index=177&type=chunk) [PART II. OTHER INFORMATION](index=38&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=38&type=section&id=Item%201.%20Legal%20Proceedings) The company may face legal proceedings, accruing for probable losses, with litigation potentially impacting business - The company may be involved in legal proceedings arising in the ordinary course of business[179](index=179&type=chunk) - Estimates for resolution of legal and other contingencies are accrued when losses are probable and estimable[179](index=179&type=chunk) - Litigation can have an adverse impact due to defense and settlement costs, diversion of management resources, negative publicity, and reputational harm[179](index=179&type=chunk) [Item 1A. Risk Factors](index=38&type=section&id=Item%201A.%20Risk%20Factors) This section outlines significant investment risks, covering product development, financial, third-party, regulatory, IP, and operational factors [Summary of Risk Factors](index=38&type=section&id=Summary%20of%20Risk%20Factors) - Investing in the company's common stock involves a high degree of risk[180](index=180&type=chunk) - Key risks include product candidate development failures or delays, adverse events in clinical trials, difficulties in obtaining regulatory approvals, significant competition, and challenges in achieving market acceptance[181](index=181&type=chunk) - Other risks involve manufacturing complexities, macroeconomic impacts, limited operating revenue, the need for additional capital, dependence on collaborations, intellectual property protection issues, and stock price volatility[181](index=181&type=chunk)[188](index=188&type=chunk) [Risks Related to Discovery and Development of Our Product Candidates](index=39&type=section&id=Risks%20Related%20to%20Discovery%20and%20Development%20of%20Our%20Product%20Candidates) - Product candidates may fail or suffer delays at any stage of preclinical and clinical development due to scientific feasibility, safety, efficacy, or changing standards of medical care[183](index=183&type=chunk)[185](index=185&type=chunk) - Results from preclinical testing or early clinical trials may not predict results in later phase trials, and unexpected adverse events or side effects could inhibit regulatory approval or market acceptance[185](index=185&type=chunk)[191](index=191&type=chunk) - Inability to obtain or delays in obtaining required regulatory approvals in the U.S. or foreign jurisdictions would materially impair the ability to commercialize and generate revenue from product candidates[197](index=197&type=chunk) [Risks Related to Our Financial Position and Capital Needs](index=49&type=section&id=Risks%20Related%20to%20Our%20Financial%20Position%20and%20Capital%20Needs) - The company has a limited operating history, no products approved for commercial sale, and has incurred significant operating losses, with an accumulated deficit of **$837.3 million** as of June 30, 2025[236](index=236&type=chunk)[237](index=237&type=chunk) - Significant additional capital will be required to finance operations, including increased R&D expenses and commercialization costs, which may not be available on acceptable terms or at all[241](index=241&type=chunk)[242](index=242&type=chunk) - Failure to raise additional capital could lead to delays, scaling back, or discontinuing development and commercialization efforts, and future equity sales could result in dilution for existing stockholders[246](index=246&type=chunk)[248](index=248&type=chunk) [Risks Related to Our Dependence on Third Parties](index=52&type=section&id=Risks%20Related%20to%20Our%20Dependence%20on%20Third%20Parties) - The company's business is highly dependent on existing collaborations with GSK and Vanda, and the success of these collaborations is uncertain, with potential for termination or de-prioritization of programs[249](index=249&type=chunk)[250](index=250&type=chunk) - Reliance on third-party clinical investigators, CROs, CMOs, and consultants for discovery, manufacturing, preclinical studies, and clinical trials means less control over timing and quality, and potential for delays or unsuccessful outcomes[252](index=252&type=chunk) - Complete reliance on third parties for manufacturing drug supplies entails risks such as production difficulties, supply chain disruptions (including from macroeconomic conditions or foreign trade policies), and potential breaches or terminations of manufacturing agreements[227](index=227&type=chunk)[231](index=231&type=chunk)[254](index=254&type=chunk)[257](index=257&type=chunk)[258](index=258&type=chunk) [Risks Related to Regulatory Approval of Our Product Candidates and Other Legal Compliance Matters](index=54&type=section&id=Risks%20Related%20to%20Regulatory%20Approval%20of%20Our%20Product%20Candidates%20and%20Other%20Legal%20Compliance%20Matters) - Failure to obtain regulatory approval in international jurisdictions would prevent marketing product candidates outside the U.S., reducing target market and commercial potential[259](index=259&type=chunk)[260](index=260&type=chunk) - Approved drugs may face unfavorable third-party reimbursement practices and pricing regulations, which are essential for market acceptance and profitability, and are subject to significant uncertainty and cost containment initiatives[261](index=261&type=chunk)[262](index=262&type=chunk)[265](index=265&type=chunk) - Healthcare legislative reforms, such as the ACA and IRA, could increase the difficulty and cost of obtaining marketing approval, affect pricing, and impose rebates or other restrictions on drug products[270](index=270&type=chunk)[272](index=272&type=chunk) - The company's relationships with customers and third-party payors are subject to anti-kickback, fraud and abuse, transparency, and other healthcare laws and regulations, with potential for criminal sanctions, civil penalties, and reputational harm for non-compliance[276](index=276&type=chunk)[277](index=277&type=chunk) - Failure to comply with evolving privacy and data security laws (e.g., GDPR, CCPA) could result in significant fines, lawsuits, regulatory investigations, and damage to reputation[279](index=279&type=chunk)[280](index=280&type=chunk)[283](index=283&type=chunk) [Risks Related to Intellectual Property](index=59&type=section&id=Risks%20Related%20to%20Intellectual%20Property) - The company's success depends significantly on its ability to establish, maintain, and protect patents and other intellectual property rights, which is an expensive, time-consuming, and uncertain process[285](index=285&type=chunk)[286](index=286&type=chunk)[287](index=287&type=chunk) - The issuance, scope, validity, enforceability, and commercial value of patent rights are highly uncertain, and patents may be challenged, narrowed, or invalidated by third parties or changes in patent law[287](index=287&type=chunk)[288](index=288&type=chunk)[298](index=298&type=chunk) - Reliance on third parties requires sharing trade secrets, increasing the risk of misappropriation or unauthorized disclosure, which could impair the company's competitive position[300](index=300&type=chunk)[302](index=302&type=chunk) - Involvement in lawsuits to protect or enforce intellectual property, or defending against infringement claims, could be expensive, time-consuming, and unsuccessful, potentially leading to loss of rights or significant damages[303](index=303&type=chunk)[311](index=311&type=chunk)[314](index=314&type=chunk) [Risks Related to Managing Growth, Operations and Macroeconomic Conditions](index=66&type=section&id=Risks%20Related%20to%20Managing%20Growth,%20Operations%20and%20Macroeconomic%20Conditions) - The company must attract and retain highly skilled employees, particularly at the management level, facing significant competition for experienced personnel[319](index=319&type=chunk) - Expected growth in employees and operations, especially in product candidate development and clinical trials, may be difficult to manage effectively with limited financial resources and management experience[321](index=321&type=chunk) - The company is vulnerable to security breaches and cyber-attacks on its internal computer systems or those of third-party collaborators, potentially disrupting development programs, causing data loss, and incurring liability[322](index=322&type=chunk)[324](index=324&type=chunk) - Operations are vulnerable to interruptions from natural disasters, power loss, terrorist activity, health epidemics, and other events beyond control, especially given geographically concentrated supply chains[325](index=325&type=chunk)[326](index=326&type=chunk) [Risks Related to Ownership of Our Common Stock](index=67&type=section&id=Risks%20Related%20to%20Ownership%20of%20Our%20Common%20Stock) - The market price of the company's common stock has been and may continue to be highly volatile, influenced by factors such as clinical trial results, regulatory actions, competitive products, and macroeconomic conditions[327](index=327&type=chunk)[328](index=328&type=chunk)[331](index=331&type=chunk) - Future sales and issuances of common stock or rights to purchase common stock, including under equity incentive plans, could result in additional dilution of stockholders' percentage ownership and cause the stock price to fall[334](index=334&type=chunk) - Provisions in the company's organizational documents and Delaware law might discourage, delay, or prevent a change in control or changes in management, potentially depressing the market price of common stock[340](index=340&type=chunk)[341](index=341&type=chunk) - The company plans to use federal and state net operating loss (NOL) carryforwards to offset taxable income, but their ability to be utilized in future years could be limited by ownership changes under Section 382 of the Code or state-level suspensions[348](index=348&type=chunk)[349](index=349&type=chunk) [Item 2. Unregistered Sales of Equity Securities, Use of Proceeds and Issuer Purchases of Equity Securities](index=69&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities,%20Use%20of%20Proceeds%20and%20Issuer%20Purchases%20of%20Equity%20Securities) This section details the company's stock repurchase activity under the 2025 Repurchase Program - The company's board of directors approved a stock repurchase program on March 24, 2025, authorizing repurchases of up to **$75.0 million** of outstanding common stock[353](index=353&type=chunk) **Stock Repurchase Activity (Three Months Ended June 30, 2025):** | Period | Total Shares Repurchased | Average Price Paid per Share | Maximum Approximate Dollar Value Remaining (in thousands) | | :--- | :--- | :--- | :--- | | April 1, 2025 - April 30, 2025 | 1,007,397 | $18.19 | $51,303 | | May 1, 2025 - May 31, 2025 | 1,456,709 | $20.42 | $21,555 | | June 1, 2025 - June 30, 2025 | 96,832 | $21.45 | $19,478 | | **Total** | **2,560,938** | | | [Item 3. Defaults Upon Senior Securities](index=73&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This item is not applicable to the company for the reporting period - This item is not applicable[355](index=355&type=chunk) [Item 4. Mine Safety Disclosures](index=74&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company for the reporting period - This item is not applicable[356](index=356&type=chunk) [Item 5. Other Information](index=74&type=section&id=Item%205.%20Other%20Information) This section discloses Rule 10b5-1 trading arrangements entered into by key executives, with the CEO's plan terminated - Daniel Faga (CEO) entered a Rule 10b5-1 trading plan on April 11, 2025, which was terminated on July 15, 2025, with no shares sold[357](index=357&type=chunk) - Dennis Mulroy (CFO) entered a Rule 10b5-1 plan on April 11, 2025, for up to **25,725 shares**, scheduled to terminate by December 31, 2025[358](index=358&type=chunk) - Eric Loumeau (Chief Legal Officer) and Paul Lizzul (Chief Medical Officer) also entered Rule 10b5-1 plans in April 2025 for potential sales of common stock[359](index=359&type=chunk)[360](index=360&type=chunk) [Item 6. Exhibits](index=74&type=section&id=Item%206.%20Exhibits) This section provides an index of exhibits filed as part of the Quarterly Report, including certifications and XBRL documents - The exhibit index includes certifications from the Principal Executive Officer and Principal Financial Officer (Exhibits 31.1, 31.2, 32.1, 32.2)[364](index=364&type=chunk) - Inline XBRL documents (Instance Document, Schema, Calculation Linkbase, Label Linkbase, Presentation Linkbase, Definition Linkbase) are also included as exhibits[364](index=364&type=chunk) [Signatures](index=76&type=section&id=Signatures) The report is officially signed by the President and CEO, and the CFO, on behalf of AnaptysBio, Inc - The report was signed by Daniel Faga, President and Chief Executive Officer, and Dennis Mulroy, Chief Financial Officer[369](index=369&type=chunk) - The signing date for the report was August 6, 2025[369](index=369&type=chunk)

[Executive Summary & Q2 2025 Business Update](index=1&type=section&id=executive_summary_q2_2025_business_update) AnaptysBio reported positive Phase 2b data for rosnilimab in RA, completed enrollment for its UC trial, announced celiac disease as the initial indication for ANB033, and anticipates a $75 million milestone from GSK [Q2 2025 Business Highlights](index=1&type=section&id=q2_2025_business_highlights) AnaptysBio reported positive Phase 2b data for rosnilimab in RA, completed enrollment for its UC trial, announced celiac disease as the initial indication for ANB033 with a Phase 1b cohort planned, and anticipates a $75 million milestone from GSK for Jemperli - AnaptysBio, Inc. (Nasdaq: ANAB) is a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics, reporting **Q2 2025** financial results and business update[2](index=2&type=chunk) - Rosnilimab's **Phase 2b** data in rheumatoid arthritis (RA) delivered a compelling safety and tolerability profile and JAK-like efficacy[3](index=3&type=chunk) - Enrollment completed in the **Phase 2** ulcerative colitis (UC) trial, with top-line data through **Week 12** expected in **Q4 2025**[3](index=3&type=chunk)[5](index=5&type=chunk) - Initial indication for CD122 antagonist, ANB033, is celiac disease (CeD), with a **Phase 1b** cohort planned to initiate by **Q4 2025**[3](index=3&type=chunk)[5](index=5&type=chunk) - Anticipate triggering a **$75 million** commercial sales milestone from GSK in 2025 once Jemperli achieves **$1 billion** in worldwide net sales[5](index=5&type=chunk) [Portfolio Updates](index=1&type=section&id=portfolio_updates) Provides updates on clinical programs including rosnilimab for RA and UC, ANB033 for celiac disease, and ANB101, all progressing through clinical trials [Rosnilimab (Pathogenic T Cell Depleter)](index=1&type=section&id=rosnilimab_pathogenic_t_cell_depleter) Rosnilimab's Phase 2b RA trial showed compelling safety and JAK-like efficacy with durable responses, supporting potential for extended maintenance dosing. Enrollment for the Phase 2 UC trial is complete, with top-line data expected in Q4 2025 [Rheumatoid Arthritis (RA) Program](index=1&type=section&id=rosnilimab_ra_program) Positive Phase 2b data for rosnilimab in RA demonstrated compelling efficacy and a favorable safety profile, supporting extended maintenance dosing - Positive data through **Week 38** from **424-patient** **Phase 2b** RA trial, demonstrating best-in-disease profile with JAK-like efficacy and **monthly (Q4W)** dosing[5](index=5&type=chunk)[6](index=6&type=chunk) - Favorable safety and tolerability profile, particularly compared to standard of care biologics or JAK inhibitors[6](index=6&type=chunk) - CDAI LDA responders at **Week 28** showed durable responses for at least **12-14 weeks** off drug through **Week 38**, supporting potential for extended maintenance dosing (e.g., **Q8W or Q12W**)[6](index=6&type=chunk) [Ulcerative Colitis (UC) Program](index=1&type=section&id=rosnilimab_uc_program) Enrollment is complete for the Phase 2 UC trial, assessing rosnilimab's efficacy and safety with top-line data expected in Q4 2025 - Enrollment complete for global **Phase 2** trial in moderate-to-severe UC (**N=136**, **~50% advanced therapy experienced**)[5](index=5&type=chunk)[9](index=9&type=chunk) - Assessing **Q2W and Q4W** dose levels of subcutaneously administered rosnilimab vs. placebo[9](index=9&type=chunk) - Top-line data through **Week 12**, including primary and key secondary endpoints, on track for **Q4 2025**[5](index=5&type=chunk)[9](index=9&type=chunk) - Blinded surveillance data suggests a favorable safety and tolerability profile consistent with prior rosnilimab trials[9](index=9&type=chunk) [ANB033 (CD122 Antagonist)](index=1&type=section&id=anb033_cd122_antagonist) ANB033 is in Phase 1, with celiac disease announced as its initial indication. A Phase 1b cohort is planned for Q4 2025, leveraging its MoA to inhibit IL-2 and IL-15 signaling for CeD - **Phase 1** trial ongoing in healthy volunteers[5](index=5&type=chunk)[7](index=7&type=chunk) - Initial indication for ANB033 is celiac disease (CeD), affecting over **2.1 million** people in the U.S. with no approved therapies[3](index=3&type=chunk)[5](index=5&type=chunk)[9](index=9&type=chunk) - ANB033's MoA, inhibiting both IL-2 and IL-15 signaling, is believed to be well-suited to target multiple pathogenic drivers of CeD[3](index=3&type=chunk) - Plan to initiate a **Phase 1b** cohort for ANB033 in celiac disease by **Q4 2025**[3](index=3&type=chunk)[5](index=5&type=chunk)[9](index=9&type=chunk) [ANB101 (BDCA2 Modulator)](index=1&type=section&id=anb101_bdca2_modulator) ANB101 is currently in an ongoing Phase 1 trial in healthy volunteers - **Phase 1** trial ongoing in healthy volunteers[5](index=5&type=chunk)[7](index=7&type=chunk) [Collaboration Updates](index=2&type=section&id=collaboration_updates) Details updates on collaborations with GSK for Jemperli, anticipating a $75 million milestone, and Vanda for imsidolimab, with an upcoming BLA submission and potential milestones [GSK Immuno-Oncology Financial Collaboration (Jemperli)](index=2&type=section&id=gsk_immuno_oncology_financial_collaboration_jemperli) GSK reported strong Q2 2025 sales for Jemperli, leading Anaptys to anticipate a $75 million milestone payment in 2025 upon Jemperli reaching $1 billion in worldwide net sales. GSK is also advancing Jemperli in multiple pivotal trials for various cancer indications - GSK announced strong commercial performance for Jemperli with **$262 million** in **Q2 2025** sales and **$482 million** in **1H 2025** sales, showing **>19% USD** and **>12% GBP** quarter-over-quarter growth[9](index=9&type=chunk) - Anaptys anticipates triggering a one-time **$75 million** commercial sales milestone from GSK in 2025 once Jemperli achieves **$1 billion** in worldwide net sales in a calendar year[5](index=5&type=chunk)[9](index=9&type=chunk) - GSK is investing in additional indications for Jemperli monotherapy and combinations, including pivotal **Phase 2 and 3** trials for various colorectal and head and neck cancers[9](index=9&type=chunk) [Vanda Imsidolimab Financial Collaboration](index=3&type=section&id=vanda_imsidolimab_financial_collaboration) Vanda anticipates FDA BLA submission for imsidolimab in GPP in 2H 2025. Anaptys is eligible for up to $35 million in regulatory and sales milestones, plus a 10% royalty on net sales - Vanda anticipates FDA BLA submission for generalized pustular psoriasis (GPP) in **2H 2025**[11](index=11&type=chunk) - Anaptys is eligible to receive up to **$35 million** for future regulatory approval (including a **$5 million** milestone upon U.S. FDA approval) and sales milestones, plus a **10% royalty** on net sales[11](index=11&type=chunk) [Financial Performance](index=3&type=section&id=financial_performance) Summarizes Q2 and 1H 2025 financial results, including collaboration revenue, operating expenses, net loss, cash position, and stock repurchase activities [Second Quarter 2025 Financial Results Summary](index=3&type=section&id=second_quarter_2025_financial_results_summary) AnaptysBio reported significant increases in collaboration revenue, managed operating expenses with a slight R&D decrease and G&A increase, and a reduced net loss for Q2 and 1H 2025 compared to the prior year [Collaboration Revenue](index=3&type=section&id=collaboration_revenue) Collaboration revenue significantly increased in Q2 and 1H 2025, driven by higher Jemperli royalties and revenue from the Vanda license agreement | Metric | Q2 2025 (in thousands) | Q2 2024 (in thousands) | YoY Change (Q2) | 1H 2025 (in thousands) | 1H 2024 (in thousands) | YoY Change (1H) | | :------------------- | :--------------------- | :--------------------- | :---------------- | :--------------------- | :--------------------- | :---------------- | | Collaboration Revenue | $22,263 | $10,971 | +102.9% | $50,034 | $18,150 | +175.7% | - Increase primarily due to Jemperli royalties increasing by **$11.0 million (Q2)** and **$22.1 million (1H)**, and **$9.7 million** in revenue recognized for the Vanda license agreement[11](index=11&type=chunk) [Operating Expenses](index=3&type=section&id=operating_expenses) Operating expenses were managed, with a decrease in R&D primarily due to lower development costs, and an increase in G&A due to transaction costs | Metric | Q2 2025 (in thousands) | Q2 2024 (in thousands) | YoY Change (Q2) | 1H 2025 (in thousands) | 1H 2024 (in thousands) | YoY Change (1H) | | :-------------------- | :--------------------- | :--------------------- | :---------------- | :--------------------- | :--------------------- | :---------------- | | Research and development | $37,824 | $41,997 | -10.0% | $79,004 | $79,039 | -0.04% | | General and administrative | $10,609 | $9,295 | +14.1% | $24,739 | $21,633 | +14.4% | - R&D decrease in **Q2 2025** primarily due to lower development costs for ANB032 and imsidolimab, offset by higher costs for rosnilimab RA/UC **Phase 2** trials and ANB033/ANB101 **Phase 1** trials[11](index=11&type=chunk) - G&A increase primarily due to transaction costs associated with the Vanda Pharmaceuticals license agreement[11](index=11&type=chunk) [Net Loss and EPS](index=3&type=section&id=net_loss_and_eps) Net loss and loss per share significantly reduced in Q2 and 1H 2025, reflecting improved financial performance | Metric | Q2 2025 | Q2 2024 | YoY Change (Q2) | 1H 2025 | 1H 2024 | YoY Change (1H) | | :-------------------- | :-------- | :-------- | :---------------- | :-------- | :-------- | :---------------- | | Net Loss (in thousands) | $(38,630)$ | $(46,660)$ | **+17.2% (reduced loss)** | $(77,959)$ | $(90,596)$ | **+14.0% (reduced loss)** | | Net Loss Per Share | $(1.34)$ | $(1.71)$ | **+21.6% (improved)** | $(2.62)$ | $(3.35)$ | **+21.8% (improved)** | [Cash Position and Runway](index=3&type=section&id=cash_position_and_runway) Cash and investments decreased to $293.7 million by June 30, 2025, primarily due to operating activities and share repurchases, but the company maintains a cash runway through year-end 2027 | Metric | June 30, 2025 (in millions) | December 31, 2024 (in millions) | Change (in millions) | | :-------------------- | :-------------------------- | :----------------------------- | :------------------- | | Cash and Investments | $293.7 | $420.8 | $(127.1)$ | - Decrease primarily due to operating activities and **$55.5 million** in shares repurchased, offset by **$15.0 million** received from Vanda Pharmaceuticals[11](index=11&type=chunk) - Reiterating cash runway through **year-end 2027**[11](index=11&type=chunk) [Stock Repurchase Program](index=3&type=section&id=stock_repurchase_program) AnaptysBio has repurchased 9.3% of its outstanding shares for $55.5 million under its $75.0 million program as of June 30, 2025 - Repurchased **2,853,836 shares** (**9.3% shares outstanding**) with **$55.5 million** as of **June 30, 2025**, from its **$75.0 million** Stock Repurchase Program[11](index=11&type=chunk) [About Anaptys](index=4&type=section&id=about_anaptys) Anaptys is a clinical-stage biotechnology company focused on developing innovative immunology therapeutics for autoimmune and inflammatory diseases - Anaptys is a clinical-stage biotechnology company focused on delivering innovative immunology therapeutics for autoimmune and inflammatory diseases[12](index=12&type=chunk) - Lead program rosnilimab is in **Phase 2b** for RA and **Phase 2** for UC. Pipeline also includes ANB033 (celiac disease) and ANB101 (both in **Phase 1** trials)[12](index=12&type=chunk) - Out-licensed therapeutic antibodies include Jemperli (PD-1 antagonist) to GSK and imsidolimab (IL-36R antagonist) to Vanda Pharmaceuticals[12](index=12&type=chunk) [Consolidated Financial Statements](index=5&type=section&id=consolidated_financial_statements) Presents the company's consolidated balance sheets and statements of operations, detailing assets, liabilities, equity, revenue, and expenses for the reported periods [Consolidated Balance Sheets](index=5&type=section&id=consolidated_balance_sheets) The balance sheet shows a significant decrease in total assets and a shift to a stockholders' deficit as of June 30, 2025, compared to December 31, 2024, primarily due to reductions in cash, investments, and receivables | Metric | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | Change (in thousands) | | :-------------------------------- | :-------------------------- | :----------------------------- | :-------------------- | | Total Assets | $335,250 | $483,834 | $(148,584)$ | | Total Current Assets | $291,906 | $431,876 | $(139,970)$ | | Cash and cash equivalents | $44,298 | $123,080 | $(78,782)$ | | Short-term investments | $221,412 | $262,293 | $(40,881)$ | | Total Liabilities | $379,983 | $412,966 | $(32,983)$ | | Total Stockholders' (Deficit) Equity | $(44,733)$ | $70,868 | $(115,601)$ | [Consolidated Statements of Operations and Comprehensive Loss](index=6&type=section&id=consolidated_statements_of_operations_and_comprehensive_loss) The statement details the company's financial performance for Q2 and 1H 2025, highlighting increased collaboration revenue, managed operating expenses, and a reduced net loss, alongside a notable increase in non-cash interest expense | Metric (in thousands) | Q2 2025 | Q2 2024 | 1H 2025 | 1H 2024 | | :------------------------------------------ | :-------- | :-------- | :-------- | :-------- | | Collaboration revenue | $22,263 | $10,971 | $50,034 | $18,150 | | Research and development | $37,824 | $41,997 | $79,004 | $79,039 | | General and administrative | $10,609 | $9,295 | $24,739 | $21,633 | | Loss from operations | $(26,170)$ | $(40,321)$ | $(53,709)$ | $(82,522)$ | | Non-cash interest expense for sale of future royalties | $(19,606)$ | $(10,953)$ | $(37,667)$ | $(17,270)$ | | Net loss | $(38,630)$ | $(46,660)$ | $(77,959)$ | $(90,596)$ | | Basic and diluted net loss per common share | $(1.34)$ | $(1.71)$ | $(2.62)$ | $(3.35)$ | [Legal & Contact Information](index=4&type=section&id=legal_contact_information) Contains important disclosures regarding forward-looking statements and provides contact information for investor relations [Forward-Looking Statements](index=4&type=section&id=forward_looking_statements) This section advises that the press release contains forward-looking statements regarding future events, which are subject to inherent risks and uncertainties that could cause actual results to differ from projections - The press release contains forward-looking statements regarding clinical trial data release timing (rosnilimab UC, ANB033 CeD), potential milestone payments from Vanda and GSK, and projected cash runway[13](index=13&type=chunk) - These statements involve risks and uncertainties, including the ability to advance product candidates, obtain regulatory approval, fund development, and protect intellectual property[13](index=13&type=chunk) [Contact Information](index=4&type=section&id=contact_information) Provides contact details for investor relations inquiries - Contact: Nick Montemarano, Executive Director, Investor Relations, 858.732.0178, investors@anaptysbio.com[14](index=14&type=chunk)

Core Insights - AnaptysBio reported positive Phase 2b data for rosnilimab in rheumatoid arthritis, demonstrating a favorable safety profile and JAK-like efficacy, with durable responses observed for at least 12-14 weeks off-drug [2][5] - The company completed enrollment for a Phase 2 trial of rosnilimab in ulcerative colitis, with top-line data expected in Q4 2025 [4][9] - AnaptysBio plans to initiate a Phase 1b trial for ANB033, a CD122 antagonist targeting celiac disease, by Q4 2025 [2][4] Financial Updates - As of June 30, 2025, AnaptysBio reported cash and investments totaling $293.7 million, down from $420.8 million at the end of 2024, primarily due to operating activities and share repurchases [13] - Collaboration revenue for Q2 2025 was $22.3 million, compared to $11.0 million in Q2 2024, driven by increased royalties from Jemperli [13] - The net loss for Q2 2025 was $38.6 million, an improvement from a net loss of $46.7 million in Q2 2024, with a net loss per share of $1.34 compared to $1.71 in the prior year [13][19] Pipeline Developments - Rosnilimab's Phase 2b trial for rheumatoid arthritis involved 424 patients and showed a best-in-disease profile with monthly dosing [5] - The company is assessing different dosing levels for rosnilimab in the ulcerative colitis trial, with a primary endpoint focused on the modified Mayo score [9] - Ongoing Phase 1 trials for ANB033 and ANB101 are in healthy volunteers, with plans for further updates on ANB033 at a dedicated R&D event later this year [4][6] Collaboration and Milestones - AnaptysBio anticipates a $75 million milestone payment from GSK in 2025 once Jemperli achieves $1 billion in worldwide net sales [4][10] - GSK reported strong sales performance for Jemperli, with Q2 2025 sales of $262 million, reflecting over 19% quarter-over-quarter growth [10]

Rosnilimab (PD-1 depleter and agonist) in Rheumatoid Arthritis (RA) - Rosnilimab is well-positioned for the ~$20 billion U S RA market, which hasn't had a new mechanism approved since 2012[14] - In b/tsDMARD-naïve patients, Rosnilimab shows JAK-like efficacy, with 64% achieving CDAI LDA, 48% achieving ACR50, and 23% achieving ACR70[28] - In b/tsDMARD-experienced patients, Rosnilimab surpassed the 6-month Target Product Profile (TPP) and is comparable at mid/high dose to JAKs in all-active H2H study[30] - 83% of Week 28 CDAI LDA responders were still in response at Week 34, demonstrating durable responses for at least 2-months off-drug[33] - Synovial biopsies show ~90% reduction of PD-1+ T cells in the target issue with 400mg/600mg doses[39, 40] Rosnilimab in Ulcerative Colitis (UC) - Initial Phase 2 data for Rosnilimab in Ulcerative Colitis is expected in Q4 2025[2, 78] - Enrollment is ongoing in the Phase 2 trial for moderate-to-severe UC, with interim 6-month data expected in Q4 2025[60] - The primary endpoint of the UC trial is the change in modified Mayo score (mMS) vs placebo at Week 12[62] ANB033 (CD122 antagonist) - Phase 1 trial of ANB033 in healthy volunteers has been initiated, with an R&D event planned for H2 2025[63, 78] - ANB033 is designed to reduce pathogenic T cells and NK Cells by potently inhibiting IL-15 and IL-2 biology[63, 65, 66] Financial Position - The company has a strong capital position with ~$383 million in cash as of Q1 2025, expected to provide a cash runway through YE 2027[7, 69, 76]

Summary of AnaptysBio (ANAB) FY Conference Call - June 11, 2025 Company Overview - AnaptysBio is focused on developing antibodies targeting overactive immune cells in autoimmune inflammatory diseases, with three clinical stage programs in development [3][5][20]. Key Programs and Data - **Rozanolimab**: Lead program targeting rheumatoid arthritis (RA) with promising Phase 2b data showing 70% of patients achieving low disease activity at three months [3][13]. - **Ozanelimab**: Ongoing trial for ulcerative colitis (UC) with initial data expected by the end of 2025 [4][8]. - **ANB033**: A CD123 antagonist that started Phase 1a in October 2024 [5]. - **AMB101**: A BTCA2 modulator with plans for an R&D event later in 2025 [5]. Financial Position - Company reported $383 million in cash at the end of Q1 2025 and has access to a significant royalty stream from GSK's drug JEMPRIRLY [5][6]. Upcoming Catalysts - Key upcoming catalysts include: - Phase 2b results for rozanolimab in RA [7]. - Initial data readout for ozanelimab in UC [4][8]. - Royalty readout from GSK's lung cancer trial involving cabolumab [8][11]. Market Dynamics - The RA market has not seen a new mechanism of action approved since 2012, indicating a potential opportunity for rozanolimab [12]. - The company believes the RA market is less crowded than perceived, with few competitors in Phase III development [12][20]. Efficacy and Safety Data - Rozanolimab demonstrated significant efficacy with over 80% of patients achieving ACR20 (20% improvement) [16]. - Safety profile appears favorable with no serious infections or malignancies reported in the Phase 2b trial [50][51]. - The drug targets PD-1 high expressing T cells, aiming to restore immune homeostasis without broadly depleting T cells [46][48]. Competitive Landscape - AnaptysBio's rozanolimab is positioned against other treatments like JAK inhibitors and biologics, with a focus on achieving deeper and more durable responses [17][56]. - The company views the discontinuation of competing PD-1 drugs by other firms as a positive indicator of its drug's potential [53][56]. Future Directions - The company is considering partnerships for further development in RA and UC, with a focus on maximizing the drug's potential in various autoimmune diseases [22][33]. - AnaptysBio is exploring additional indications beyond RA and UC, leveraging its PD-1 depleting mechanism [60][62]. Conclusion - AnaptysBio is well-positioned with a strong financial base, promising clinical data, and a strategic focus on autoimmune diseases, particularly RA and UC, with significant upcoming milestones that could enhance its market position [81].

Core Insights - The article emphasizes the importance of understanding the underlying science, fundamentals, and technical analysis in biotech investing, highlighting the risks of speculative investments [2]. Group 1: Investment Strategy - The focus is on innovative companies developing breakthrough therapies and pharmaceuticals, particularly those with catalysts for potential acquisitions [2]. - The article suggests that effective position management around catalysts is crucial for success in biotech investments [2]. Group 2: Analyst Background - The author has a long position in shares of major pharmaceutical companies such as ABBV, PFE, and LLY, indicating a vested interest in the sector [3]. - The author has a background in the medical field, which informs their investment strategy in biotech and life-saving therapies [2].