Summary of Artiva Biotherapeutics Conference Call Company Overview - **Company**: Artiva Biotherapeutics - **Founded**: 2019 - **Focus**: NK cell therapies, specifically non-genetically modified NK cells combined with monoclonal antibodies for enhanced B cell killing [2][3] Core Points and Arguments NK Cell Therapy Advantages - **Non-Genetically Modified NK Cells**: Artiva's NK cells are sourced from umbilical cord units, allowing for the production of thousands of vials with a billion cryopreserved NK cells each, with a shelf life of 3-4 years [2] - **Safety Profile**: NK cells are reported to have a safer profile compared to T cell modalities, reducing the risk of cytokine release syndrome [3][10] - **Efficacy**: The combination of NK cells with monoclonal antibodies enhances the potency of B cell killing, which has been demonstrated in clinical trials [6][7] Current Trials and Indications - **Autoimmunity Trials**: Artiva is currently running trials in the autoimmunity space, exploring various indications [4] - **CYFLU Regimen**: The use of cyclophosphamide (CY) and fludarabine (FLU) is intended to enhance NK cell survival and reduce B cell burden, with low doses deemed safe [10][12][13] Competitive Landscape - **Efficacy vs. Safety**: Artiva aims to demonstrate that their allo-NK therapy can achieve high efficacy while maintaining a favorable safety profile, making it suitable for community administration [6][7][19] - **Comparison with Other Therapies**: The company acknowledges the need to show superiority over existing therapies, including rituximab and other B cell depleting modalities [37][38] Enrollment and Data Generation - **Enrollment Update**: Over a dozen patients have been enrolled across more than a dozen sites, with a focus on generating robust safety and efficacy data [26][30] - **Data Sharing Plans**: Artiva plans to share pooled data on B cell depletion and safety by year-end, with a focus on demonstrating the therapy's effectiveness compared to standard care [30][32] Future Directions - **Lead Indication Announcement**: The company intends to announce its lead indication by year-end, aiming to differentiate itself in the competitive landscape [31][32] - **Pivotal Trials**: Artiva is optimistic about moving towards pivotal trials based on the data generated from ongoing studies [46] Other Important Content - **Prophylactic Measures**: The use of prophylactic antibiotics, antivirals, and antifungals is discussed to mitigate infection risks associated with lymphodepletion [19][22] - **Community Setting Compatibility**: The therapy is designed to be manageable in a community setting, allowing for outpatient treatment and reducing the need for hospitalization [23][24] - **Immune Reset Concept**: The concept of immune reset is introduced, where deep B cell depletion leads to a more naive phenotype of reconstituted B cells, potentially reducing autoantibodies [34][35] This summary encapsulates the key points discussed during the conference call, highlighting Artiva Biotherapeutics' innovative approach to NK cell therapies and its strategic positioning within the competitive landscape of autoimmune treatments.

Core Insights - Artiva Biotherapeutics, Inc. is a clinical-stage biotechnology company focused on developing cell therapies for autoimmune diseases and cancers [3] - The company will participate in the Cantor Global Healthcare Conference 2025 on September 3, 2025, at 9:45 a.m. EDT [1] - Artiva's lead program, AlloNK®, is an allogeneic NK cell therapy currently evaluated in three clinical trials targeting B-cell driven autoimmune diseases [3] Company Overview - Artiva Biotherapeutics was founded in 2019 as a spin-out from GC Cell, gaining exclusive worldwide rights to NK cell manufacturing technology [3] - The company is headquartered in San Diego, California [4] - Artiva's pipeline includes CAR-NK candidates aimed at treating both solid and hematologic cancers [3] Conference Participation - Members of Artiva's management team will be available for investor meetings during the conference [2] - A live webcast of the presentation will be accessible through the "Investors" section on Artiva's website, with a replay available for 90 days post-event [2]

Part I - Financial Information [Item 1. Financial Statements (Unaudited)](index=7&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) The unaudited statements show decreased assets, an increased net loss to $41.6 million, and a growing accumulated deficit for the first half of 2025 [Condensed Balance Sheets](index=7&type=section&id=Condensed%20Balance%20Sheets) Total assets decreased to $169.4 million as of June 30, 2025, driven by a reduction in cash and investments, while the accumulated deficit grew to $288.2 million Condensed Balance Sheet Highlights (in thousands) | Account | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $28,468 | $40,235 | | Short-term investments | $113,897 | $145,193 | | **Total current assets** | **$149,066** | **$188,631** | | **Total assets** | **$169,391** | **$209,581** | | Total current liabilities | $10,768 | $12,253 | | **Total liabilities** | **$20,350** | **$22,940** | | Accumulated deficit | ($288,249) | ($246,684) | | **Total stockholders' equity** | **$149,041** | **$186,641** | [Condensed Statements of Operations and Comprehensive Loss](index=8&type=section&id=Condensed%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The net loss for the first six months of 2025 increased to $41.6 million from $31.8 million year-over-year, primarily due to higher R&D expenses Statement of Operations Highlights (in thousands) | Metric | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | License and development support revenue | $0 | $251 | | Research and development expenses | $34,914 | $23,488 | | General and administrative expenses | $10,068 | $7,444 | | **Loss from operations** | **($44,982)** | **($30,681)** | | **Net loss** | **($41,565)** | **($31,806)** | | Net loss per share, basic and diluted | ($1.71) | ($39.24) | [Condensed Statements of Cash Flows](index=11&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) Net cash used in operations increased to $42.8 million for the first half of 2025, while cash, cash equivalents, and restricted cash decreased by $11.6 million Cash Flow Summary - Six Months Ended June 30 (in thousands) | Activity | 2025 | 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($42,824) | ($28,771) | | Net cash provided by investing activities | $31,093 | $11,131 | | Net cash provided by (used in) financing activities | $167 | ($1,616) | | **Net decrease in cash, cash equivalents and restricted cash** | **($11,564)** | **($19,256)** | | Cash, cash equivalents and restricted cash at end of period | $28,929 | $34,506 | [Notes to Condensed Financial Statements](index=12&type=section&id=Notes%20to%20Condensed%20Financial%20Statements) The notes detail the company's liquidity, accounting policies, recent IPO, and collaboration agreements, confirming sufficient cash for at least one year of operations - The company completed its IPO on July 22, 2024, raising aggregate net proceeds of **$162.3 million**[29](index=29&type=chunk) - As of June 30, 2025, the company had **$142.4 million** in cash, cash equivalents, and investments and believes this is sufficient to fund planned operations for at least one year[30](index=30&type=chunk) - Immediately upon completion of the IPO, all **6,160,385 outstanding shares** of convertible preferred stock converted into common stock[84](index=84&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=36&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the focus on allogeneic NK cell therapies, the increased net loss driven by R&D expenses, and the sufficiency of cash to fund operations into Q2 2027 - The company is a clinical-stage biotech focused on allogeneic NK cell therapies, with its lead candidate, AlloNK, being evaluated in trials for autoimmune diseases[120](index=120&type=chunk)[121](index=121&type=chunk) - The increase in R&D expenses for the six months ended June 30, 2025, was primarily due to an **$8.4 million increase** in external costs related to AlloNK product development and clinical trials[151](index=151&type=chunk) - Based on current operating plans, the company expects its existing cash, cash equivalents, and investments of **$142.4 million** to be sufficient to fund operations into the second quarter of 2027[155](index=155&type=chunk) Comparison of Results of Operations (in thousands) | Metric | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Research and development | $34,914 | $23,488 | | General and administrative | $10,068 | $7,444 | | **Loss from operations** | **($44,982)** | **($30,681)** | | **Net loss** | **($41,565)** | **($31,806)** | [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=53&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, this section is not required and has been omitted - As a smaller reporting company, Artiva Biotherapeutics is not required to provide quantitative and qualitative disclosures about market risk[182](index=182&type=chunk) [Item 4. Controls and Procedures](index=53&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of June 30, 2025, with no material changes to internal controls - Management concluded that the company's disclosure controls and procedures were **effective as of June 30, 2025**[183](index=183&type=chunk) - No changes in internal control over financial reporting occurred during the quarter ended June 30, 2025, that have materially affected, or are reasonably likely to materially affect, internal controls[184](index=184&type=chunk) Part II - Other Information [Item 1. Legal Proceedings](index=54&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings - The company reports that it is not currently involved in any litigation or legal proceedings that management believes are likely to have a material adverse effect on the business[186](index=186&type=chunk) [Item 1A. Risk Factors](index=54&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks related to its limited operating history, unproven therapies, reliance on third parties, and intense competition - The company has a **limited operating history**, no approved products, and a history of significant net losses, making it difficult to evaluate its future success[189](index=189&type=chunk) - The development of NK cell-based product candidates is an **unproven approach**, and the company may not be able to develop any products of commercial value[199](index=199&type=chunk) - The manufacture of cell therapy products is novel and complex; the company **relies on GC Cell for manufacturing** certain candidates and faces risks of delays or quality issues[279](index=279&type=chunk)[283](index=283&type=chunk) - The company faces **significant competition** from other biotechnology and pharmaceutical companies, many of which have greater financial and technical resources[294](index=294&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=159&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company details the use of its $162.3 million in net IPO proceeds and reports no unregistered sales of equity securities - The company completed its IPO on July 22, 2024, and received net proceeds of approximately **$162.3 million**[490](index=490&type=chunk)[491](index=491&type=chunk) - There has been **no material change** in the planned use of proceeds from the IPO as described in the final prospectus[492](index=492&type=chunk) [Item 3. Defaults Upon Senior Securities](index=161&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This item is not applicable to the company - The company reports no defaults upon senior securities[494](index=494&type=chunk) [Item 4. Mine Safety Disclosures](index=161&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - The company reports that mine safety disclosures are not applicable[495](index=495&type=chunk) [Item 5. Other Information](index=161&type=section&id=Item%205.%20Other%20Information) No directors or officers adopted or terminated Rule 10b5-1 trading arrangements during the quarter - No director or officer adopted or terminated any Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during the quarter[496](index=496&type=chunk) [Item 6. Exhibits](index=162&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the report, including required officer certifications - The report includes certifications from the Principal Executive Officer and Principal Financial Officer pursuant to Sarbanes-Oxley Act Sections 302 and 906[498](index=498&type=chunk)

[Business and Clinical Highlights](index=1&type=section&id=Business%20and%20Clinical%20Highlights) Artiva advanced AlloNK® in autoimmune diseases, initiating a global basket trial and expanding US enrollment - The **first patient** has been treated in a global basket trial exploring **AlloNK®** combined with **rituximab** for refractory rheumatoid arthritis (RA), Sjögren's disease (SjD), idiopathic inflammatory myopathies (IIM), and systemic sclerosis (SSc)[1](index=1&type=chunk)[6](index=6&type=chunk) - **Over a dozen patients** have been treated with **AlloNK®** plus a **monoclonal antibody (mAb)** across various autoimmune diseases in both company-sponsored and investigator-initiated trials[1](index=1&type=chunk)[2](index=2&type=chunk)[6](index=6&type=chunk) - **More than a dozen clinical sites** are actively enrolling patients across **two company-sponsored trials** in the US for autoimmune diseases, including a Phase 2a basket trial and a Phase 1/1b trial in systemic lupus erythematosus (SLE)[2](index=2&type=chunk)[6](index=6&type=chunk) - The company anticipates that its therapy, including the use of cyclophosphamide and fludarabine, can be administered and managed in an **outpatient setting**[2](index=2&type=chunk) [Upcoming Milestones](index=1&type=section&id=Upcoming%20Milestones) Artiva expects initial AlloNK® safety data by year-end 2025, with lead indication and clinical response data in 1H 2026 - By **Year-End 2025**: The company plans to present **initial safety and translational data** for AlloNK® + mAb, provide insights into its tolerability in community rheumatology sites, and disclose the **lead indication** for further development[1](index=1&type=chunk)[2](index=2&type=chunk)[6](index=6&type=chunk) - **1H 2026**: Artiva expects to present **initial clinical response data** in the selected **lead autoimmune indication**, which will inform the registrational strategy[1](index=1&type=chunk)[6](index=6&type=chunk) [Second Quarter 2025 Financial Results](index=1&type=section&id=Second%20Quarter%202025%20Financial%20Results) Artiva reported a **$21.3 million net loss** in Q2 2025, with **$142.4 million cash** providing runway into Q2 2027 [Financial Performance Summary](index=2&type=section&id=Financial%20Performance%20Summary) Artiva's Q2 2025 showed **$142.4 million cash**, increased operating expenses, and a **$21.3 million net loss** - As of June 30, 2025, the company had cash, cash equivalents, and investments of **$142.4 million**, which is expected to fund operations into **Q2 2027**[1](index=1&type=chunk)[10](index=10&type=chunk) Q2 2025 Financial Highlights (vs. Q2 2024) | Financial Metric | Q2 2025 | Q2 2024 | | :--- | :--- | :--- | | Research and Development Expenses | $17.9 million | $12.3 million | | General and Administrative Expenses | $4.9 million | $3.9 million | | Other Income (expense), net | $1.6 million | ($1.7 million) | | Net Loss | ($21.3 million) | ($17.8 million) | [Condensed Balance Sheets](index=3&type=section&id=Condensed%20Balance%20Sheets) Total assets decreased to **$169.4 million** by June 30, 2025, from **$209.6 million** at year-end 2024, due to reduced cash Condensed Balance Sheet Data (in thousands) | Account | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash, cash equivalents and investments | $142,365 | $185,428 | | Total assets | $169,391 | $209,581 | | **Liabilities & Equity** | | | | Total liabilities | $20,350 | $22,940 | | Stockholders' equity | $149,041 | $186,641 | | Total liabilities and stockholders' equity | $169,391 | $209,581 | [Condensed Statements of Operations](index=4&type=section&id=Condensed%20Statements%20of%20Operations) Artiva reported a **net loss of $21.3 million** (or **($0.87) per share**) for Q2 2025, due to higher R&D expenses Statement of Operations Highlights (in thousands, except per share data) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | | :--- | :--- | :--- | | Research and development | $17,861 | $12,333 | | Total operating expenses | $22,810 | $16,190 | | Loss from operations | ($22,810) | ($16,190) | | Net loss | ($21,254) | ($17,843) | | Net loss per share | ($0.87) | ($22.00) | [About Artiva Biotherapeutics](index=2&type=section&id=About%20Artiva%20Biotherapeutics) Artiva Biotherapeutics is a clinical-stage biotech developing accessible cell therapies for autoimmune diseases and cancers, with AlloNK® as its lead - Artiva's mission is to develop **effective, safe, and accessible cell therapies** for patients with devastating autoimmune diseases and cancers[7](index=7&type=chunk) - The lead program, **AlloNK® (AB-101)**, is an **allogeneic, off-the-shelf, non-genetically modified NK cell therapy** candidate currently being evaluated in **three clinical trials** for B-cell driven autoimmune diseases[7](index=7&type=chunk)

Core Insights - Artiva Biotherapeutics is advancing its AlloNK therapy in clinical trials for autoimmune diseases, with over a dozen patients treated and multiple sites enrolling [1][2][6] - Initial safety and translational data for AlloNK are expected to be presented by the end of 2025, with initial clinical response data anticipated in the first half of 2026 [1][6] Company Overview - Artiva Biotherapeutics is a clinical-stage biotechnology company focused on developing cell therapies for autoimmune diseases and cancers, with its lead program being AlloNK (AB-101) [7] - AlloNK is designed to enhance the efficacy of monoclonal antibodies in treating B-cell driven autoimmune diseases [7] Clinical Trials Progress - The company has initiated a global Phase 2a basket trial for refractory rheumatoid arthritis, Sjögren's disease, idiopathic inflammatory myopathies, and systemic sclerosis, with the first patient treated [1][6] - Over a dozen patients have been treated with AlloNK in combination with monoclonal antibodies across various autoimmune diseases [2][6] Financial Highlights - As of June 30, 2025, Artiva reported cash, cash equivalents, and investments totaling $142.4 million, which is projected to fund operations into Q2 2027 [5][11] - Research and development expenses for Q2 2025 were $17.9 million, an increase from $12.3 million in Q2 2024 [11][13] Upcoming Milestones - By the end of 2025, the company plans to disclose initial safety and translational data for AlloNK, as well as its lead indication for further development [6] - Initial clinical response data in the lead indication is expected to be shared in the first half of 2026 [6]

Summary of Ativa Biotherapeutics Conference Call Company Overview - **Company**: Ativa Biotherapeutics - **Industry**: Biotech, specifically focusing on cell therapies for autoimmune diseases and oncology Key Points and Arguments Oncology Programs - Ativa Biotherapeutics was founded as a spin-off from GC Cell, focusing on a scalable process for generating NK cells [3] - The company has conducted two oncology trials: one for Non-Hodgkin Lymphoma (NHL) using RNK cells with Rituximab, and another for Hodgkin's lymphoma with Affimed using a CD30 targeted biologic [4] - The lead asset, AlloNK, is a non-genetically modified NK cell that combines with targeted therapies, showing enhanced efficacy and a safer profile compared to other cell therapies [5] Autoimmune Programs - Initial data for the autoimmune program (L1K) has been postponed to the first half of 2026 to ensure more interpretable results [6] - The decision to delay was influenced by the need for a larger patient pool to derive meaningful efficacy signals, as patient heterogeneity can skew results [8] - Ativa plans to present data sets by year-end that will pool across indications, focusing on safety and translational markers [9] Patient Selection and Trial Management - Patient selection is crucial; younger patients with less organ damage tend to respond better to therapies [11] - The company acknowledges that real-world patients often have more severe disease than those in academic studies, leading to a need for stricter inclusion criteria over time [15] - The goal is to identify patients with significant disease activity who can benefit from inflammation resolution [15] Efficacy Benchmarks - Evidence of B cell depletion is necessary but not sufficient for efficacy; safety profiles are also critical [17] - Efficacy benchmarks will vary by indication, with comparisons to the best available therapies [20] - For lupus nephritis, efficacy will be benchmarked against obinutuzumab, while for rheumatoid arthritis (RA), comparisons will be made against patients refractory to multiple therapies [21] Clinical Trial Enrollment - Ativa has learned that expanding beyond CAR T centers to non-CAR T centers can enhance patient enrollment due to a favorable safety profile [23] - The company emphasizes the importance of having multiple trial sites to ensure adequate patient recruitment [25] Community Settings - The company is conducting investigator-initiated trials in community settings, which have shown promise in managing patients as outpatients [27] Dosing and Lymphodepletion - The dosing schedule for L1K aims to achieve deeper B cell depletion by administering monoclonal antibodies alongside NK cells [28] - Lymphodepletion is viewed as manageable and not a major limitation, with ongoing education about its short-term effects [32] Regulatory Path - Ativa is closely monitoring FDA conversations regarding regulatory pathways for autoimmune therapies, noting that smaller indications may have more flexibility for accelerated approval [40] - The company anticipates that larger indications will require more robust data to demonstrate safety and efficacy compared to standard care [41] Additional Important Insights - The company is exploring various monoclonal antibodies for combination therapies, starting with those already approved to minimize regulatory friction [36] - There is ongoing speculation about the efficacy of different B cell targets (CD19 vs. CD20) in various indications, with plans to announce further developments [39] This summary encapsulates the key discussions and insights from the Ativa Biotherapeutics conference call, highlighting the company's strategic focus on both oncology and autoimmune therapies, as well as its approach to clinical trials and regulatory considerations.

Core Insights - Artiva Biotherapeutics, Inc. is a clinical-stage biotechnology company focused on developing cell therapies for autoimmune diseases and cancers [3] - The company will participate in the Jefferies Global Healthcare Conference on June 4, 2025, at 9:20 a.m. EDT [1] - Artiva's lead program, AlloNK®, is an allogeneic NK cell therapy candidate currently evaluated in three clinical trials targeting B-cell driven autoimmune diseases [3] Company Overview - Artiva Biotherapeutics was founded in 2019 as a spin-out from GC Cell, gaining exclusive worldwide rights to NK cell manufacturing technology [3] - The company is headquartered in San Diego, California [4] - Artiva's pipeline includes CAR-NK candidates aimed at treating both solid and hematologic cancers [3] Upcoming Events - Management will be available for investor meetings during the Jefferies Global Healthcare Conference [2] - A live webcast of the presentation will be accessible through the company's website, with a replay available for 90 days post-event [2]

Core Insights - Artiva Biotherapeutics announced promising long-term Phase 1/2 data for AlloNK® in combination with rituximab for patients with relapsed/refractory B-cell non-Hodgkin lymphoma, showing a 64% complete response rate and a median duration of response of at least 19.4 months [1][2][3] Group 1: Clinical Data - AlloNK + rituximab demonstrated a 64% complete response rate (9 out of 14 patients) in heavily pretreated patients who were naïve to prior CAR-T cell therapy [1][3] - The median duration of response is at least 19.4 months, indicating durability comparable to approved auto-CAR-T therapies [1][3] - The safety profile of AlloNK + rituximab was well-tolerated among 45 patients, with no reports of immune effector cell associated neurotoxicity syndrome (ICANS) or graft-versus-host disease [7] Group 2: Comparison with CAR-T Therapies - The complete response rate of AlloNK + rituximab is comparable to outcomes from approved auto-CAR-T therapies, which reported 58% for Yescarta, 53% for Breyanzi, and 40% for Kymriah [3] - The median duration of response for AlloNK + rituximab is competitive with auto-CAR-T therapies, which showed 11.1 months for Yescarta, 23.1 months for Breyanzi, and not reached for Kymriah at 40.3 months follow-up [3] Group 3: Mechanism and Future Implications - AlloNK has shown the potential to enhance the activity of monoclonal antibodies, driving deep and durable responses in both aggressive B-NHL and potentially in autoimmune diseases [2][7] - The tolerability profile of AlloNK supports its use in outpatient community settings, making it a viable option for patients with refractory autoimmune diseases [7]

Part I [Part I - Financial Information](index=5&type=section&id=Part%20I%20-%20Financial%20Information) [Financial Statements (Unaudited)](index=5&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) Unaudited Q1 2025 financial statements reflect decreased assets to $191.3 million and an increased net loss of $20.3 million, driven by higher R&D expenses [Condensed Balance Sheets](index=5&type=section&id=Condensed%20Balance%20Sheets) As of March 31, 2025, total assets decreased to $191.3 million from $209.6 million, primarily due to reduced cash and investments, while stockholders' equity also declined Condensed Balance Sheet Data (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $30,401 | $40,235 | | Short-term investments | $135,562 | $145,193 | | Total current assets | $170,004 | $188,631 | | Total assets | $191,263 | $209,581 | | **Liabilities & Stockholders' Equity** | | | | Total current liabilities | $12,204 | $12,253 | | Total liabilities | $22,480 | $22,940 | | Total stockholders' equity | $168,783 | $186,641 | | Total liabilities and stockholders' equity | $191,263 | $209,581 | [Condensed Statements of Operations and Comprehensive Loss](index=6&type=section&id=Condensed%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) For Q1 2025, net loss increased to $20.3 million from $14.0 million in Q1 2024, mainly due to higher research and development expenses Condensed Statement of Operations Data (in thousands, except per share data) | Account | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | License and development support revenue | $0 | $251 | | Research and development expenses | $17,052 | $11,156 | | General and administrative expenses | $5,119 | $3,587 | | Loss from operations | $(22,171) | $(14,492) | | Net loss | $(20,311) | $(13,963) | | Net loss per share, basic and diluted | $(0.83) | $(17.24) | [Condensed Statements of Cash Flows](index=8&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) Net cash used in operating activities increased to $19.8 million in Q1 2025, leading to a $9.6 million decrease in total cash and equivalents Condensed Statement of Cash Flows Data (in thousands) | Activity | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(19,841) | $(15,086) | | Net cash provided by investing activities | $9,971 | $9,782 | | Net cash provided by financing activities | $239 | $0 | | Net decrease in cash, cash equivalents and restricted cash | $(9,631) | $(5,304) | | Cash, cash equivalents and restricted cash at end of period | $30,862 | $48,458 | [Notes to Condensed Financial Statements](index=9&type=section&id=Notes%20to%20Condensed%20Financial%20Statements) The notes detail the company's accumulated deficit of $267.0 million, its IPO proceeds, and key collaboration agreements with GC Cell - The company has an accumulated deficit of **$267.0 million** as of March 31, 2025, and expects to continue incurring net losses. Existing cash, cash equivalents, and investments of **$166.0 million** are believed to be sufficient to fund planned operations for at least one year[30](index=30&type=chunk) - In July 2024, the company completed its IPO, raising aggregate net proceeds of **$162.3 million**. Immediately upon the IPO, all outstanding convertible preferred stock converted into common stock[29](index=29&type=chunk)[84](index=84&type=chunk) - The company has multiple license and service agreements with related party GC Cell for its core NK cell therapy platform, including for product candidates AB-101, AB-201, and AB-205. These agreements involve potential milestone payments up to **$22.0 million** for AB-101, **$25.0 million** for AB-201, and **$29.5 million** for AB-205, plus sales-based milestones and royalties[64](index=64&type=chunk)[66](index=66&type=chunk)[70](index=70&type=chunk) - Stock-based compensation expense was **$2.1 million** for Q1 2025, up from **$1.4 million** in Q1 2024, primarily recorded under R&D and G&A expenses[101](index=101&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=25&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's focus on developing NK cell-based therapies, particularly AlloNK, with increased R&D expenses and sufficient liquidity into Q2 2027 [Overview](index=25&type=section&id=MD&A%20Overview) Artiva is a clinical-stage biotechnology company developing off-the-shelf, allogeneic NK cell therapies, with lead candidate AlloNK in trials for autoimmune diseases - The company's lead product candidate, AlloNK, is being evaluated in a Phase 1/1b trial for systemic lupus erythematosus (SLE) and a Phase 2a basket trial for rheumatoid arthritis (RA) and other autoimmune diseases[119](index=119&type=chunk)[120](index=120&type=chunk) - Artiva expects to report initial safety and translational data for AlloNK in autoimmune indications by the end of 2025, and initial clinical response data in the first half of 2026[120](index=120&type=chunk) [Results of Operations](index=27&type=section&id=MD&A%20Results%20of%20Operations) Total operating expenses increased by $7.4 million in Q1 2025, driven by a $5.9 million rise in R&D expenses for the AlloNK program Research and Development Expenses (in thousands) | Expense Category | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | **External R&D** | | | | AB-101 | $7,545 | $3,289 | | Other programs | $14 | $47 | | **Internal R&D** | | | | Personnel-related | $6,243 | $4,740 | | Other | $3,250 | $3,080 | | **Total R&D Expense** | **$17,052** | **$11,156** | - The **$5.9 million** increase in R&D expenses was primarily due to a **$4.2 million** increase in AB-101 costs related to product development and clinical trials for B-NHL and the commencement of the AlloNK for SLE/LN program[142](index=142&type=chunk) - General and administrative expenses increased by **$1.5 million**, mainly due to a **$1.2 million** rise in personnel-related costs, including a **$0.5 million** increase in non-cash stock-based compensation[143](index=143&type=chunk) [Liquidity and Capital Resources](index=28&type=section&id=MD&A%20Liquidity%20and%20Capital%20Resources) The company has an accumulated deficit of $267.0 million but holds $166.0 million in cash and investments, sufficient to fund operations into Q2 2027 - As of March 31, 2025, the company had cash, cash equivalents and investments of **$166.0 million** and an accumulated deficit of **$267.0 million**[146](index=146&type=chunk) - Based on current operating plans, the company expects its existing cash, cash equivalents and investments will be sufficient to fund planned operating expenses and capital expenditure requirements into the second quarter of 2027[146](index=146&type=chunk)[187](index=187&type=chunk) Summary of Net Cash Flow (in thousands) | Activity | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(19,841) | $(15,086) | | Net cash provided by investing activities | $9,971 | $9,782 | | Net cash provided by financing activities | $239 | $0 | [Quantitative and Qualitative Disclosures About Market Risk](index=34&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Artiva is not required to provide quantitative and qualitative disclosures about market risk - As a smaller reporting company, Artiva is not required to provide quantitative and qualitative disclosures about market risk[173](index=173&type=chunk) [Controls and Procedures](index=34&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were effective as of March 31, 2025, with no material changes in internal control over financial reporting - Management concluded that as of March 31, 2025, the company's disclosure controls and procedures were effective at a reasonable assurance level[174](index=174&type=chunk) - There were no changes in internal control over financial reporting during the quarter ended March 31, 2025, that have materially affected, or are reasonably likely to materially affect, internal controls[175](index=175&type=chunk) Part II [Part II - Other Information](index=35&type=section&id=Part%20II%20-%20Other%20Information) [Legal Proceedings](index=35&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any legal proceedings expected to have a material adverse effect on its business - The company is not currently a party to any litigation or legal proceedings that management believes are likely to have a material adverse effect on the business[177](index=177&type=chunk) [Risk Factors](index=35&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant financial, clinical, manufacturing, intellectual property, regulatory, and commercialization risks inherent to its early-stage biopharmaceutical operations - **Financial Risks:** The company has a limited operating history, a significant accumulated deficit (**$267.0 million** as of March 31, 2025), and will need substantial additional funding to continue operations[180](index=180&type=chunk)[182](index=182&type=chunk)[186](index=186&type=chunk) - **Clinical & Development Risks:** The company's NK cell-based approach is unproven, especially for autoimmune diseases where clinical data is limited. The business is substantially dependent on the success of its lead product candidate, AlloNK[190](index=190&type=chunk)[202](index=202&type=chunk)[206](index=206&type=chunk) - **Manufacturing & Supply Risks:** Manufacturing cell therapies is complex and novel. The company relies on GC Cell for manufacturing certain candidates and on third-party suppliers for critical materials like cord blood and viral vectors, some of which are single-source[268](index=268&type=chunk)[272](index=272&type=chunk)[278](index=278&type=chunk) - **Intellectual Property Risks:** The company depends substantially on intellectual property licensed from GC Cell. Loss of these licenses could halt the development of its product candidates[365](index=365&type=chunk) - **Regulatory Risks:** The regulatory approval process for novel cell therapies is lengthy, complex, and uncertain. The regulatory landscape is still developing, which could result in delays or unexpected costs[295](index=295&type=chunk)[304](index=304&type=chunk) - **Commercialization Risks:** The company faces significant competition from other biopharmaceutical companies, has no marketing or sales organization, and faces uncertainty regarding market acceptance and reimbursement for its potential products[282](index=282&type=chunk)[286](index=286&type=chunk)[287](index=287&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=93&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities occurred during the quarter, and the planned use of $162.3 million IPO proceeds remains unchanged - The company completed its IPO on July 22, 2024, receiving net proceeds of approximately **$162.3 million** after deducting underwriting discounts and offering expenses[473](index=473&type=chunk)[474](index=474&type=chunk) - There has been no material change in the planned use of proceeds from the IPO as described in the final prospectus[475](index=475&type=chunk) [Defaults Upon Senior Securities](index=93&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This item is not applicable [Mine Safety Disclosures](index=93&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable [Other Information](index=93&type=section&id=Item%205.%20Other%20Information) No director or officer adopted or terminated any Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during Q1 2025 - No director or officer adopted or terminated any Rule 10b5-1 or non-Rule 10b5-1 trading arrangement during the first quarter of 2025[479](index=479&type=chunk) [Exhibits](index=94&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including corporate documents and officer certifications [Signatures](index=95&type=section&id=Signatures)

[Business Highlights and Outlook](index=1&type=section&id=Business%20Highlights%20and%20Outlook) Artiva advanced AlloNK® clinical programs with FDA IND clearance, strengthened leadership, and extended cash runway - Received Investigational New Drug (IND) clearance and initiated a global basket trial for AlloNK® plus rituximab in several autoimmune diseases, including refractory rheumatoid arthritis and Sjögren's disease[1](index=1&type=chunk) - Cash runway extended into Q2 2027, with cash, cash equivalents, and investments of **$166.0 million** as of March 31, 2025[2](index=2&type=chunk) [CEO's Remarks](index=1&type=section&id=CEO%27s%20Remarks) CEO highlighted AlloNK®'s global autoimmune trial initiation and anticipated key data readouts by H1 2026 - Announced the initiation of a company-sponsored allogeneic cell therapy trial for rheumatoid arthritis and Sjögren's disease in the U.S., two indications that could benefit from AlloNK's potential ease of use and safety profile[3](index=3&type=chunk) - Plans to share initial safety and translational data by the end of 2025, announce a lead indication, and present clinical response data for that indication in the first half of 2026[3](index=3&type=chunk) - Longer-term data in aggressive B-NHL is maturing to a level comparable with approved auto-CAR-T therapies, providing proof of concept for AlloNK's ability to achieve deep and durable B-cell depletion[3](index=3&type=chunk) [AlloNK® (AB-101) Program Updates](index=1&type=section&id=AlloNK%C2%AE%20(AB-101)%20Program%20Updates) AlloNK® advanced with a global Phase 2a autoimmune trial, strong B-NHL data, and demonstrated manufacturing scalability - Following FDA IND clearance, the company is initiating a global Phase 2a basket clinical trial of AlloNK + rituximab for refractory rheumatoid arthritis (RA), Sjögren's disease, myositis (IIM), and systemic sclerosis (SSc)[4](index=4&type=chunk) - Longer-term clinical data from the Phase 1/2 trial in B-NHL shows complete response rates and median duration of response in line with approved auto-CAR-T therapies[10](index=10&type=chunk) - Manufacturing process data demonstrates consistency across over 40 lots and high viability and cytotoxicity after 4 years of shelf life[10](index=10&type=chunk) [Corporate Updates](index=2&type=section&id=Corporate%20Updates) Artiva strengthened its leadership by appointing Dr. Subhashis Banerjee as Chief Medical Officer, enhancing development expertise - Appointed Subhashis Banerjee, M.D., as Chief Medical Officer on April 8, 2025, to build a seasoned development team with strong expertise in autoimmune disease and cell therapy[7](index=7&type=chunk) [Upcoming Milestones](index=2&type=section&id=Upcoming%20Milestones) Artiva outlined key AlloNK® autoimmune milestones: initial safety data by year-end 2025 and clinical response data in H1 2026 - **By Year-End 2025:** Release initial safety and translational data for AlloNK® + mAb across multiple autoimmune indications and disclose the lead autoimmune indication for further development[10](index=10&type=chunk) - **1H 2026:** Present initial clinical response data in the lead autoimmune indication, with longer follow-up, to inform the company's registrational strategy[10](index=10&type=chunk) [First Quarter 2025 Financial Results](index=2&type=section&id=First%20Quarter%202025%20Financial%20Results) Artiva reported a net loss of $20.3 million in Q1 2025 due to increased expenses, maintaining a strong cash position of $166.0 million Q1 2025 Financial Highlights (vs. Q1 2024) | Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Research and Development Expenses | $17.1 million | $11.2 million | | General and Administrative Expenses | $5.1 million | $3.6 million | | Other Income, net | $1.9 million | $0.5 million | | Net Loss | $20.3 million | $14.0 million | - As of March 31, 2025, the company had cash, cash equivalents, and investments of **$166.0 million**, which is expected to fund operations into Q2 2027[14](index=14&type=chunk) [Financial Statements](index=4&type=section&id=Financial%20Statements) Unaudited condensed financial statements for Q1 2025 detail the company's financial position and operational results, including a $20.3 million net loss [Condensed Balance Sheets](index=4&type=section&id=Condensed%20Balance%20Sheets) Artiva's total assets were $191.3 million as of March 31, 2025, with total liabilities at $22.5 million and stockholders' equity at $168.8 million Condensed Balance Sheet Data (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash, cash equivalents and investments | $165,963 | $185,428 | | Total assets | $191,263 | $209,581 | | Total liabilities | $22,480 | $22,940 | | Stockholders' equity | $168,783 | $186,641 | [Condensed Statements of Operation and Comprehensive Loss](index=5&type=section&id=Condensed%20Statements%20of%20Operation%20and%20Comprehensive%20Loss) For Q1 2025, Artiva reported a net loss of $20.3 million, or ($0.83) per share, primarily due to increased R&D expenses Statement of Operations Data (in thousands, except per share data) | Metric | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Research and development | $17,052 | $11,156 | | General and administrative | $5,119 | $3,587 | | Loss from operations | $(22,171) | $(14,492) | | Net loss | $(20,311) | $(13,963) | | Net loss per share, basic and diluted | $(0.83) | $(17.24) | | Weighted-average common shares outstanding | 24,341,978 | 809,758 |