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 |

Core Insights - Artiva Biotherapeutics has received IND clearance and initiated a global basket trial for AlloNK® combined with rituximab targeting refractory rheumatoid arthritis, Sjögren's disease, idiopathic inflammatory myopathies, and systemic sclerosis, marking the first trial of its kind in the U.S. [1][3] - Initial safety and translational data are expected to be presented by the end of 2025, with clinical response data anticipated in the first half of 2026 [1][2][10] - The company reported a cash runway extending into Q2 2027, with cash, cash equivalents, and investments totaling $166.0 million as of March 31, 2025 [1][10] Company Developments - Artiva has transformed its development team to enhance expertise in autoimmune diseases and refine clinical trial strategies for AlloNK [2][3] - The company is conducting a Phase 2a basket clinical trial for AlloNK + rituximab, with continuous enrollment and no hospitalization requirement for patients [3][9] - A new Chief Medical Officer, Subhashis Banerjee, M.D., was appointed to strengthen the company's leadership in autoimmune disease and cell therapy [6] Financial Performance - For Q1 2025, research and development expenses were $17.1 million, up from $11.2 million in Q1 2024, while general and administrative expenses increased to $5.1 million from $3.6 million [10][14] - The net loss for Q1 2025 was $20.3 million, compared to a net loss of $14.0 million in the same period of 2024 [14][16] - The company reported total operating expenses of $22.2 million for Q1 2025, compared to $14.7 million for Q1 2024 [16] Upcoming Milestones - By the end of 2025, Artiva plans to share initial safety and translational data for AlloNK across multiple autoimmune indications and disclose the lead indication for further development [10] - Initial clinical response data in the lead autoimmune indication is expected in the first half of 2026, which will inform the registrational strategy [10]

Core Insights - Artiva Biotherapeutics announced promising long-term Phase 1/2 data for AlloNK® in treating relapsed/refractory B-cell non-Hodgkin lymphoma, highlighting prolonged duration of response, deep B-cell depletion, and a well-tolerated safety profile when combined with rituximab [1][4] - The company will present additional data on the scalability and consistency of the AlloNK manufacturing process at the upcoming ASGCT 28th Annual Meeting [2][3] Company Overview - Artiva Biotherapeutics is a clinical-stage biotechnology company focused on developing effective, safe, and accessible cell therapies for autoimmune diseases and cancers [4] - The lead program, AlloNK, is an allogeneic, off-the-shelf, non-genetically modified, cryopreserved NK cell therapy designed to enhance the antibody-dependent cellular cytotoxicity effect of monoclonal antibodies [4] - Artiva's pipeline includes CAR-NK candidates targeting both solid and hematologic cancers, with ongoing clinical trials for systemic lupus erythematosus and other autoimmune indications [4] Presentation Details - The company will present two abstracts at the ASGCT 28th Annual Meeting: - Abstract 858 on AlloNK Cell Therapy ± Rituximab on May 13, 2025 [3] - Abstract 1765 on the scalability and consistency of AlloNK on May 15, 2025 [3]

Core Insights - Artiva Biotherapeutics has appointed Dr. Subhashis Banerjee as Chief Medical Officer, enhancing its development team focused on autoimmune diseases and cell therapy [1][2] - Dr. Banerjee has over 20 years of clinical development experience, previously holding significant roles at Bristol Myers Squibb and VYNE Therapeutics [1][2] - The company aims to advance its AlloNK® program for treating B-cell driven autoimmune diseases, leveraging Dr. Banerjee's expertise in regulatory approval of major therapies [2][5] Company Overview - Artiva Biotherapeutics is a clinical-stage biotechnology company dedicated to developing safe and effective cell therapies for autoimmune diseases and cancers [5][6] - The lead program, AlloNK®, is a non-genetically modified NK cell therapy designed to enhance the efficacy of monoclonal antibodies for B-cell depletion [5] - Artiva was founded in 2019 as a spin-out from GC Cell, holding exclusive rights to NK cell manufacturing technology outside of Asia, Australia, and New Zealand [5] Recent Appointments - Dr. David Moriarty has been appointed as SVP of Clinical Operations, bringing nearly 25 years of experience in clinical research related to cell therapy and autoimmune diseases [3][4] - Benjamin Dewees has joined as SVP of Regulatory Affairs, with over 25 years of experience in regulatory affairs across various therapeutic areas [9] - Feng Xu has been appointed as SVP of Biometrics, contributing over 20 years of clinical development experience, including successful global regulatory filings [9]

Core Viewpoint - Artiva Biotherapeutics, Inc. is set to present at the 24th Annual Needham Virtual Healthcare Conference on April 7, 2025, highlighting its focus on developing cell therapies for autoimmune diseases and cancers [1][2]. Company Overview - Artiva Biotherapeutics is a clinical-stage biotechnology company founded in 2019, specializing in cell therapies for autoimmune diseases and cancers [3]. - The company's lead program, AlloNK, is an allogeneic, off-the-shelf, non-genetically modified, cryopreserved NK cell therapy candidate aimed at enhancing the efficacy of monoclonal antibodies for B-cell depletion [3]. - AlloNK is currently undergoing clinical trials for systemic lupus erythematosus and is involved in an investigator-initiated basket trial for multiple autoimmune indications [3]. - Artiva's pipeline also includes CAR-NK candidates targeting both solid and hematologic cancers [3]. - The company has exclusive worldwide rights (excluding Asia, Australia, and New Zealand) to GC Cell's NK cell manufacturing technology and programs, following a strategic partnership [3]. Event Participation - Members of the Artiva management team will engage in investor meetings during the conference, and a live webcast of the presentation will be available for the public [2]. - A replay of the webcast will be accessible for 90 days post-event [2]. Contact Information - For investor inquiries, Neha Krishnamohan can be contacted at ir@artivabio.com, and for media inquiries, Jessica Yingling, Ph.D., can be reached at jessica@litldog.com or +1.858.344.8091 [6].

[Part I](index=7&type=section&id=PART%20I) [Business](index=7&type=section&id=Item%201.%20Business) Artiva Biotherapeutics develops allogeneic, off-the-shelf NK cell therapies for autoimmune diseases and cancers, leveraging a manufacturing-first approach - The company's lead product candidate, AlloNK, is a non-genetically modified, cryopreserved NK cell therapy being evaluated in combination with B-cell targeted monoclonal antibodies (mAbs) for autoimmune diseases and cancers[18](index=18&type=chunk) - Artiva believes its approach offers advantages over autologous CAR-T therapies in scalability, safety, and cost, with an estimated cost of goods sold (COGS) for an AlloNK treatment regimen being approximately an order of magnitude below that of auto-CAR-T[22](index=22&type=chunk)[32](index=32&type=chunk) - The company has a strategic partnership with GC Cell, granting it exclusive ex-APAC rights to GC Cell's NK cell manufacturing technology and programs. Artiva has also established its own 9,000 square foot cGMP manufacturing facility in San Diego[33](index=33&type=chunk)[32](index=32&type=chunk) [Our Pipeline](index=9&type=section&id=Our%20Pipeline) Artiva's pipeline features AlloNK (AB-101) in clinical trials for autoimmune diseases and B-NHL, plus preclinical CAR-NK programs Artiva Biotherapeutics Pipeline | Product Candidate | Target | Indication | Preclinical | Phase 1 | Phase 2 | Rights | |---|---|---|---|---|---|---| | **AlloNK (AB-101) + mAb** | | | | | | | | AlloNK + anti-CD20 | B-cell | SLE with/without LN | | ► | | Artiva (ex-APAC) | | AlloNK + anti-CD20 | B-cell | Autoimmune Basket (IIT) (1) | | ► | | Artiva (ex-APAC) | | AlloNK + anti-CD20 | B-cell | B-NHL | | ► | | Artiva (ex-APAC) | | **Collaborator-Funded Trials** | | | | | | | | AlloNK + Acimtamig | CD30 | Hodgkin Lymphoma | | | ► | Affimed/Artiva | | **CAR-NK Programs** | | | | | | | | AB-201 | HER2+ | Solid Tumors | ► | | | Artiva (ex-APAC) | | AB-205 | CD5+ | T-Cell Malignancies | ► | | | Artiva (ex-APAC) | [AlloNK Development](index=20&type=section&id=AlloNK%20Development) AlloNK development targets autoimmune diseases and cancer, showing promising B-NHL efficacy and a favorable safety profile - In a Phase 1/2 trial for relapsed/refractory B-NHL, AlloNK in combination with rituximab demonstrated a **71% ORR** and a **57% CR rate** in 14 CAR-T naïve patients as of April 30, 2024[38](index=38&type=chunk)[73](index=73&type=chunk) - All 29 B-NHL patients with samples analyzed achieved non-quantifiable peripheral B-cell levels by Day 8 or 15, supporting the B-cell depleting mechanism of action proposed for autoimmune diseases[71](index=71&type=chunk)[38](index=38&type=chunk) - A Phase 1/1b trial is enrolling patients with SLE with or without LN. Additionally, an investigator-initiated basket trial is assessing AlloNK in RA, PV, GPA/MPA, and SLE, with the first patient dosed in August 2024[26](index=26&type=chunk)[28](index=28&type=chunk)[83](index=83&type=chunk) - The therapy has shown a favorable safety profile, with only **9% of 45 B-NHL patients** experiencing CRS (no Grade 3 or higher) and no ICANS observed as of April 8, 2024. **69% of patients** were not hospitalized within 30 days of dosing[123](index=123&type=chunk)[79](index=79&type=chunk) [Manufacturing and Collaborations](index=33&type=section&id=Manufacturing%20and%20Collaborations) Artiva's manufacturing-first strategy leverages GC Cell's technology for scalable NK cell production and includes key collaborations - Artiva's manufacturing process can generate over **4,000 one-billion-cell vials** from a single cord blood unit, sufficient to treat over **250 to 1,000 autoimmune patients**[147](index=147&type=chunk) - The company has a Core Agreement with GC Cell for an exclusive, ex-APAC license to its NK cell technology. Artiva has licensed specific products like AlloNK (AB-101), AB-201, and AB-205, with obligations for milestone and royalty payments[171](index=171&type=chunk)[173](index=173&type=chunk) - Artiva has a collaboration with Affimed to jointly develop AlloNK with acimtamig. If accelerated approval is obtained, revenues will be shared **67% to Affimed** and **33% to Artiva**, with shared costs for confirmatory studies[129](index=129&type=chunk)[197](index=197&type=chunk) [Government Regulation](index=44&type=section&id=Government%20Regulation) Artiva's biologics face extensive FDA and international regulation, requiring rigorous testing and compliance with evolving healthcare laws - Artiva's products are regulated as biologics and considered 'more than minimally manipulated,' requiring submission and approval of a BLA to the FDA before marketing[201](index=201&type=chunk) - The company has received Fast Track designation for AlloNK in both LN and B-NHL, which may expedite the review process but does not guarantee approval[27](index=27&type=chunk)[434](index=434&type=chunk) - The company is subject to complex U.S. and international regulations, including the EU's Clinical Trials Regulation (CTR) and rules for Advanced Therapy Medicinal Products (ATMPs), as well as healthcare laws like the Anti-Kickback Statute and data privacy laws like GDPR[236](index=236&type=chunk)[265](index=265&type=chunk)[278](index=278&type=chunk) [Risk Factors](index=64&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant risks from limited operating history, funding needs, unproven therapy, complex manufacturing, and regulatory hurdles - The company has a limited operating history, has incurred significant losses (**$65.4M in 2024**, **$28.7M in 2023**), and will require substantial additional funding to complete development and commercialization[305](index=305&type=chunk)[307](index=307&type=chunk)[311](index=311&type=chunk) - The company's NK cell-based therapy approach is unproven, especially for autoimmune diseases, and it is substantially dependent on the success of its lead product candidate, AlloNK[316](index=316&type=chunk)[326](index=326&type=chunk) - Manufacturing cell therapies is complex and novel. The company relies on its partner GC Cell for manufacturing certain candidates and faces risks related to supply chain, quality control, and scaling its own new facility[384](index=384&type=chunk)[388](index=388&type=chunk) - The company depends on intellectual property licensed from GC Cell and faces risks of patent challenges, infringement claims, and competition from other biotechnology companies with greater resources[481](index=481&type=chunk)[400](index=400&type=chunk) - The regulatory pathway for cell therapies is lengthy, complex, and uncertain. The company is also subject to stringent healthcare laws, including fraud and abuse, data privacy (HIPAA, GDPR), and pricing regulations, which could result in substantial penalties if violated[413](index=413&type=chunk)[447](index=447&type=chunk) [Unresolved Staff Comments](index=132&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) The company reports no unresolved staff comments from the SEC - None[590](index=590&type=chunk) [Cybersecurity](index=132&type=section&id=Item%201C.%20Cybersecurity) Artiva's cybersecurity program, overseen by the audit committee, manages risks through policies, training, and incident response - The audit committee of the board of directors is responsible for overseeing the company's cybersecurity risk[597](index=597&type=chunk) - The company's cybersecurity risk management program is guided by the National Institute of Standards and Technology Cybersecurity Framework (NIST CSF) and includes policies, monitoring tools, employee training, and an incident response plan[591](index=591&type=chunk)[598](index=598&type=chunk) - Management, including the head of information technology and the legal function, implements the cybersecurity program and reports periodically to the audit committee on significant threats and risks[598](index=598&type=chunk)[600](index=600&type=chunk) [Properties](index=134&type=section&id=Item%202.%20Properties) The company leases its principal office, labs, and cGMP manufacturing facility in San Diego, totaling over 51,000 square feet - The company leases **51,621 square feet** in San Diego, CA, which houses its principal office, research and development labs, and a cGMP manufacturing center. This lease expires in 2029[602](index=602&type=chunk) [Legal Proceedings](index=134&type=section&id=Item%203.%20Legal%20Proceedings) The company is not currently involved in any legal proceedings expected to materially affect 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[603](index=603&type=chunk) [Mine Safety Disclosures](index=134&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[604](index=604&type=chunk) [Part II](index=135&type=section&id=PART%20II) [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=135&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) Artiva's common stock began trading on Nasdaq in July 2024, raising **$162.3 million** from its IPO, with no dividends paid - The company's common stock has been listed on the Nasdaq Global Market under the symbol "ARTV" since July 19, 2024[607](index=607&type=chunk) - The company completed its IPO on July 22, 2024, and with the partial exercise of the underwriters' option, received net proceeds of approximately **$162.3 million**[614](index=614&type=chunk)[615](index=615&type=chunk) - The company has never paid cash dividends and intends to retain future earnings to fund business development[609](index=609&type=chunk) [Reserved](index=136&type=section&id=Item%206.%20%5BReserved%5D) This item is reserved [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=137&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Artiva reported a net loss of **$65.4 million** in 2024 due to reduced revenue, with **$185.4 million** cash expected to fund operations through 2026 Results of Operations Comparison (in thousands) | | YEAR ENDED DECEMBER 31, | | CHANGE | |---|---|---|---| | | **2024** | **2023** | **$** | | **Total revenue** | $ 251 | $ 33,492 | $ (33,241) | | **Research and development** | 50,328 | 50,251 | 77 | | **General and administrative** | 17,205 | 13,912 | 3,293 | | **Loss from operations** | (67,282) | (30,671) | (36,611) | | **Net loss** | **$ (65,373)** | **$ (28,720)** | **$ (36,653)** | - The decrease in total revenue is due to the termination of the Merck Collaboration Agreement in October 2023, which resulted in the recognition of the remaining deferred revenue in 2023[653](index=653&type=chunk)[671](index=671&type=chunk) - R&D expenses remained flat, with a **$5.9 million** increase in AB-101 clinical trial costs offset by a **$3.5 million** decrease in spending on other programs as the company narrowed its focus[674](index=674&type=chunk) - As of December 31, 2024, the company had cash, cash equivalents, and investments of **$185.4 million** and believes these funds are sufficient to support operations at least through the end of 2026[678](index=678&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=154&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Artiva is not required to provide this market risk information - The company is a smaller reporting company and is not required to provide the information otherwise required under this item[719](index=719&type=chunk) [Financial Statements and Supplementary Data](index=154&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) The company's financial statements are incorporated by reference from Item 15 of this Annual Report - The financial statements required for this item are incorporated by reference from Item 15(a)(1) and (2) of the Annual Report on Form 10-K[720](index=720&type=chunk) [Changes in and Disagreements With Accountants on Accounting and Financial Disclosure](index=155&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20With%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) The company reports no changes or disagreements with its accountants on financial disclosure - None[722](index=722&type=chunk) [Controls and Procedures](index=155&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management concluded disclosure controls were effective as of December 31, 2024, with no material changes to internal controls - Management concluded that as of December 31, 2024, the company's disclosure controls and procedures were effective at a reasonable assurance level[723](index=723&type=chunk) - No material changes were made to the internal control over financial reporting during the quarter ended December 31, 2024[724](index=724&type=chunk) [Other Information](index=155&type=section&id=Item%209B.%20Other%20Information) No director or officer adopted or terminated any Rule 10b5-1 or non-Rule 10b5-1 trading arrangement in Q4 2024 - No director or officer adopted or terminated any Rule 10b5-1 or non-Rule 10b5-1 trading arrangement during the fourth quarter of 2024[726](index=726&type=chunk) [Disclosure Regarding Foreign Jurisdictions that Prevent Inspections](index=155&type=section&id=Item%209C.%20Disclosure%20Regarding%20Foreign%20Jurisdictions%20that%20Prevent%20Inspections) This item is not applicable to the company - Not applicable[727](index=727&type=chunk) [Part III](index=156&type=section&id=PART%20III) [Directors, Executive Officers and Corporate Governance](index=156&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) Information on directors, executive officers, and corporate governance will be incorporated by reference from the 2025 proxy statement - The required information will be incorporated by reference from the company's definitive proxy statement for its 2025 annual meeting of shareholders[731](index=731&type=chunk) [Executive Compensation](index=156&type=section&id=Item%2011.%20Executive%20Compensation) Executive compensation information will be incorporated by reference from the 2025 proxy statement - The required information will be incorporated by reference from the company's definitive proxy statement for its 2025 annual meeting of shareholders[732](index=732&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=156&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) Security ownership information will be incorporated by reference from the 2025 proxy statement - The required information will be incorporated by reference from the company's definitive proxy statement for its 2025 annual meeting of shareholders[733](index=733&type=chunk) [Certain Relationships and Related Transactions, and Director Independence](index=156&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) Related party transactions and director independence information will be incorporated by reference from the 2025 proxy statement - The required information will be incorporated by reference from the company's definitive proxy statement for its 2025 annual meeting of shareholders[734](index=734&type=chunk) [Principal Accounting Fees and Services](index=156&type=section&id=Item%2014.%20Principal%20Accounting%20Fees%20and%20Services) Principal accounting fees and services information will be incorporated by reference from the 2025 proxy statement - The required information will be incorporated by reference from the company's definitive proxy statement for its 2025 annual meeting of shareholders[735](index=735&type=chunk) [Part IV](index=157&type=section&id=PART%20IV) [Exhibits, Financial Statement Schedules](index=157&type=section&id=Item%2015.%20Exhibits%2C%20Financial%20Statement%20Schedules) This section details financial statements, schedules, and a comprehensive list of exhibits filed with the Annual Report on Form 10-K - The financial statements of Artiva Biotherapeutics, Inc., along with the report from KPMG LLP, are included in the report[738](index=738&type=chunk) - A list of exhibits filed with the report is provided, including the Amended and Restated Certificate of Incorporation, Bylaws, forms of equity plans, material collaboration agreements, and executive employment agreements[740](index=740&type=chunk)[743](index=743&type=chunk) [Form 10-K Summary](index=160&type=section&id=Item%2016.%20Form%2010-K%20Summary) The company reports that there is no Form 10-K summary - None[746](index=746&type=chunk) [Financial Statements](index=164&type=section&id=Financial%20Statements) [Balance Sheets](index=164&type=section&id=Balance%20Sheets) Total assets increased to **$209.6 million** in 2024, driven by IPO proceeds, shifting equity from deficit to positive **$186.6 million** Balance Sheet Summary (in thousands) | | Dec 31, 2024 | Dec 31, 2023 | |---|---|---| | **Total Current Assets** | $188,631 | $79,821 | | Cash and cash equivalents | $40,235 | $53,504 | | Short-term investments | $145,193 | $23,467 | | **Total Assets** | **$209,581** | **$105,114** | | **Total Liabilities** | $22,940 | $50,716 | | Convertible preferred stock | $0 | $216,413 | | **Total Stockholders' Equity (Deficit)** | $186,641 | $(162,015) | | **Total Liabilities & Equity** | **$209,581** | **$105,114** | [Statements of Operations and Comprehensive Loss](index=165&type=section&id=Statements%20of%20Operations%20and%20Comprehensive%20Loss) Net loss increased to **$65.4 million** in 2024 due to reduced revenue from collaboration termination, despite stable operating expenses Statement of Operations Summary (in thousands) | | Year Ended Dec 31, 2024 | Year Ended Dec 31, 2023 | |---|---|---| | **Total Revenue** | $251 | $33,492 | | **Total Operating Expenses** | $67,533 | $64,163 | | *Research and development* | $50,328 | $50,251 | | *General and administrative* | $17,205 | $13,912 | | **Loss from Operations** | $(67,282) | $(30,671) | | **Net Loss** | **$(65,373)** | **$(28,720)** | | **Net Loss Per Share** | $(5.81) | $(35.78) | [Statements of Cash Flows](index=167&type=section&id=Statements%20of%20Cash%20Flows) Net cash used in operations was **$55.0 million**, offset by **$162.2 million** from IPO financing, resulting in a **$13.3 million** cash decrease Cash Flow Summary (in thousands) | | Year Ended Dec 31, 2024 | Year Ended Dec 31, 2023 | |---|---|---| | **Net cash used in operating activities** | $(55,032) | $(47,430) | | **Net cash used in investing activities** | $(120,463) | $(25,975) | | **Net cash provided by financing activities** | $162,226 | $24,391 | | **Net decrease in cash** | $(13,269) | $(49,014) | | **Cash at end of period** | $40,493 | $53,762 |

Exhibit 99.1 Corporate and Financial Updates Artiva Biotherapeutics Reports Full Year 2024 Financial Results and Recent Business Highlights Initial data for AlloNK® from autoimmune program expected H1 2025 Updated clinical data from Phase 1/2 trial exploring AlloNK + rituximab in NHL showing continued durability of response to be presented at a medical conference in 2025 Strengthened key leadership with cell therapy and autoimmune expertise across organization Robust balance sheet with cash, cash equivalent ...

Initial data for AlloNK® from autoimmune program expected H1 2025 Updated clinical data from Phase 1/2 trial exploring AlloNK + rituximab in NHL showing continued durability of response to be presented at a medical conference in 2025 Strengthened key leadership with cell therapy and autoimmune expertise across organization Robust balance sheet with cash, cash equivalents and investments of $185.4 million as of December 31, 2024, is expected to fund operations at least through end of 2026 SAN DIEGO, March 24 ...

SAN DIEGO, Feb. 20, 2025 (GLOBE NEWSWIRE) -- Artiva Biotherapeutics, Inc. (Nasdaq: ARTV), a clinical-stage biotechnology company whose mission is to develop effective, safe, and accessible cell therapies for patients with devastating autoimmune diseases and cancers, today announced that management will present at the TD Cowen 45th Annual Health Care Conference on Wednesday, March 5, 2025, at 2:30 p.m. EST, in Boston, MA. Members of the Artiva management team will also be available to participate in in-perso ...