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Artiva Biotherapeutics, Inc.(ARTV) - 2025 Q2 - Quarterly Report
2025-08-06 20:13
☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) (State or other jurisdiction of incorporation or organization) Delaware 83-3614316 (I.R.S. Employer Identification No.) 5505 Morehouse Drive, Suite 100 San Diego CA 92121 (858) 267-4467 For the quarterly period ended June 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For ...
Artiva Biotherapeutics, Inc.(ARTV) - 2025 Q2 - Quarterly Results
2025-08-06 20:11
Exhibit 99.1 Artiva Biotherapeutics Reports Second Quarter 2025 Financial Results, Recent Business Highlights First patient treated in company-sponsored global basket trial exploring AlloNK® + rituximab in refractory rheumatoid arthritis, Sjögren's disease, idiopathic inflammatory myopathies, and systemic sclerosis Continued execution and enrollment progress with over a dozen patients treated with AlloNK + mAb across over a dozen sites in company-sponsored and investigator-initiated clinical trials in autoi ...
Artiva Biotherapeutics Reports Second Quarter 2025 Financial Results, Recent Business Highlights
Globenewswire· 2025-08-06 20:05
First patient treated in company-sponsored global basket trial exploring AlloNK® + rituximab in refractory rheumatoid arthritis, Sjögren’s disease, idiopathic inflammatory myopathies, and systemic sclerosis Continued execution and enrollment progress with over a dozen patients treated with AlloNK + mAb across over a dozen sites in company-sponsored and investigator-initiated clinical trials in autoimmune diseases Initial safety, translational data, and lead indication selection for AlloNK in autoimmune dise ...
Artiva Biotherapeutics (ARTV) 2025 Conference Transcript
2025-06-04 14:20
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.
Artiva Biotherapeutics to Participate in the Jefferies Global Healthcare Conference
Globenewswire· 2025-05-28 20:05
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]
Artiva Biotherapeutics Announces Longer-term Phase 1/2 Data Demonstrating Prolonged Durability for AlloNK® in Combination with Rituximab in Patients with B-cell-Non-Hodgkin Lymphoma at the ASGCT 28th Annual Meeting
Globenewswire· 2025-05-13 20:05
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]
Artiva Biotherapeutics, Inc.(ARTV) - 2025 Q1 - Quarterly Report
2025-05-08 12:06
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)
Artiva Biotherapeutics, Inc.(ARTV) - 2025 Q1 - Quarterly Results
2025-05-08 12:03
[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 |
Artiva Biotherapeutics Reports First Quarter 2025 Financial Results, Recent Business Highlights
GlobeNewswire News Room· 2025-05-08 12:00
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]
Artiva Biotherapeutics to Present Longer-term Phase 1/2 Data for AlloNK® in Combination with Rituximab in Patients with B-cell-Non-Hodgkin Lymphoma at the ASGCT 28th Annual Meeting
Globenewswire· 2025-04-28 20:35
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]