Part I Business 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 cancers18 - 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-T2232 - 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 Diego3332 Our Pipeline 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 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, 20243873 - 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 diseases7138 - 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 2024262883 - 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 dosing12379 Manufacturing and Collaborations 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 patients147 - 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 payments171173 - 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 studies129197 Government Regulation 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 marketing201 - 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 approval27434 - 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 GDPR236265278 Risk Factors 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 commercialization305307311 - 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, AlloNK316326 - 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 facility384388 - 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 resources481400 - 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 violated413447 Unresolved Staff Comments The company reports no unresolved staff comments from the SEC - None590 Cybersecurity 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 risk597 - 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 plan591598 - 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 risks598600 Properties 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 2029602 Legal Proceedings 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 business603 Mine Safety Disclosures This item is not applicable to the company - Not applicable604 Part II Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 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, 2024607 - 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 million614615 - The company has never paid cash dividends and intends to retain future earnings to fund business development609 Reserved This item is reserved Management's Discussion and Analysis of Financial Condition and Results of Operations 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 2023653671 - 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 focus674 - 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 2026678 Quantitative and Qualitative Disclosures About Market Risk 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 item719 Financial Statements and Supplementary Data 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-K720 Changes in and Disagreements With Accountants on Accounting and Financial Disclosure The company reports no changes or disagreements with its accountants on financial disclosure - None722 Controls and Procedures 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 level723 - No material changes were made to the internal control over financial reporting during the quarter ended December 31, 2024724 Other Information 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 2024726 Disclosure Regarding Foreign Jurisdictions that Prevent Inspections This item is not applicable to the company - Not applicable727 Part III Directors, Executive Officers and Corporate Governance 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 shareholders731 Executive Compensation 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 shareholders732 Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 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 shareholders733 Certain Relationships and Related Transactions, and Director Independence 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 shareholders734 Principal Accounting Fees and Services 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 shareholders735 Part IV Exhibits, Financial Statement Schedules 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 report738 - 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 agreements740743 Form 10-K Summary The company reports that there is no Form 10-K summary - None746 Financial Statements Balance Sheets 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 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 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 |
Artiva Biotherapeutics, Inc.(ARTV) - 2024 Q4 - Annual Report