Artiva Biotherapeutics Reports Second Quarter 2025 Financial Results, Recent Business Highlights
Artiva Biotherapeutics (NASDAQ:ARTV) has reported significant progress in its clinical trials for AlloNK® therapy in autoimmune diseases during Q2 2025. The company has treated over a dozen patients across multiple sites, with the first patient receiving AlloNK + rituximab in their global Phase 2a basket trial for various autoimmune conditions.
The company ended Q2 2025 with $142.4 million in cash and investments, providing runway into Q2 2027. Financial results showed R&D expenses of $17.9 million and a net loss of $21.3 million. Artiva plans to present initial safety and translational data by year-end 2025, along with announcing their lead indication, followed by clinical response data in 1H2026.
Artiva Biotherapeutics (NASDAQ:ARTV) ha riportato progressi significativi nei suoi studi clinici per la terapia AlloNK® nelle malattie autoimmuni durante il secondo trimestre del 2025. L'azienda ha trattato più di una dozzina di pazienti in diversi centri, con il primo paziente che ha ricevuto AlloNK + rituximab nel loro trial globale di Fase 2a a basket per varie condizioni autoimmuni.
La società ha chiuso il secondo trimestre del 2025 con 142,4 milioni di dollari in liquidità e investimenti, garantendo risorse fino al secondo trimestre del 2027. I risultati finanziari hanno mostrato spese di R&S pari a 17,9 milioni di dollari e una perdita netta di 21,3 milioni di dollari. Artiva prevede di presentare i primi dati di sicurezza e traslazionali entro la fine del 2025, annunciando anche la loro indicazione principale, seguiti dai dati di risposta clinica nella prima metà del 2026.
Artiva Biotherapeutics (NASDAQ:ARTV) ha informado avances significativos en sus ensayos clínicos para la terapia AlloNK® en enfermedades autoinmunes durante el segundo trimestre de 2025. La compañía ha tratado a más de una docena de pacientes en múltiples sitios, con el primer paciente recibiendo AlloNK + rituximab en su ensayo global de fase 2a tipo cesta para diversas condiciones autoinmunes.
La empresa finalizó el segundo trimestre de 2025 con 142,4 millones de dólares en efectivo e inversiones, lo que le proporciona recursos hasta el segundo trimestre de 2027. Los resultados financieros mostraron gastos de I+D por 17,9 millones de dólares y una pérdida neta de 21,3 millones de dólares. Artiva planea presentar datos iniciales de seguridad y traslacionales para finales de 2025, junto con el anuncio de su indicación principal, seguido de datos de respuesta clínica en la primera mitad de 2026.
아티바 바이오테라퓨틱스 (NASDAQ:ARTV)는 2025년 2분기 동안 자가면역 질환에 대한 AlloNK® 치료 임상시험에서 상당한 진전을 보고했습니다. 회사는 여러 기관에서 12명 이상의 환자를 치료했으며, 첫 번째 환자는 다양한 자가면역 질환을 대상으로 한 글로벌 2a상 바스켓 임상시험에서 AlloNK와 리툭시맙 병용 치료를 받았습니다.
회사는 2025년 2분기 말에 1억 4,240만 달러의 현금 및 투자 자산을 보유하여 2027년 2분기까지 운영 자금을 확보했습니다. 재무 결과는 연구개발비가 1,790만 달러, 순손실이 2,130만 달러임을 보여주었습니다. 아티바는 2025년 말까지 초기 안전성 및 전임상 데이터 발표와 함께 주요 적응증을 발표할 계획이며, 2026년 상반기에는 임상 반응 데이터를 공개할 예정입니다.
Artiva Biotherapeutics (NASDAQ:ARTV) a annoncé des progrès significatifs dans ses essais cliniques de la thérapie AlloNK® pour les maladies auto-immunes au cours du deuxième trimestre 2025. L'entreprise a traité plus d'une douzaine de patients sur plusieurs sites, le premier patient ayant reçu AlloNK + rituximab dans leur essai mondial de phase 2a en panier pour diverses affections auto-immunes.
L'entreprise a terminé le deuxième trimestre 2025 avec 142,4 millions de dollars en liquidités et investissements, assurant une autonomie financière jusqu'au deuxième trimestre 2027. Les résultats financiers ont montré des dépenses de R&D de 17,9 millions de dollars et une perte nette de 21,3 millions de dollars. Artiva prévoit de présenter les premières données de sécurité et translationnelles d'ici la fin 2025, ainsi que d'annoncer leur indication principale, suivies des données de réponse clinique au premier semestre 2026.
Artiva Biotherapeutics (NASDAQ:ARTV) hat im zweiten Quartal 2025 bedeutende Fortschritte bei seinen klinischen Studien zur AlloNK®-Therapie bei Autoimmunerkrankungen gemeldet. Das Unternehmen hat an mehreren Standorten über ein Dutzend Patienten behandelt, wobei der erste Patient AlloNK plus Rituximab in der globalen Phase-2a-Basket-Studie für verschiedene Autoimmunerkrankungen erhielt.
Das Unternehmen schloss das zweite Quartal 2025 mit 142,4 Millionen US-Dollar an liquiden Mitteln und Investitionen ab, was eine Finanzierung bis ins zweite Quartal 2027 sichert. Die Finanzergebnisse zeigten Forschungs- und Entwicklungskosten von 17,9 Millionen US-Dollar sowie einen Nettoverlust von 21,3 Millionen US-Dollar. Artiva plant, bis Ende 2025 erste Sicherheits- und Translationale Daten sowie die Bekanntgabe der wichtigsten Indikation zu präsentieren, gefolgt von klinischen Reaktionsdaten im ersten Halbjahr 2026.
- Strong cash position of $142.4 million providing extended runway into Q2 2027
- Clinical trial expansion with over a dozen active sites and patients treated across multiple autoimmune conditions
- First patient treated in Phase 2a basket trial with AlloNK + rituximab
- Increased net loss to $21.3 million compared to $17.8 million in Q2 2024
- Higher R&D expenses at $17.9 million vs $12.3 million year-over-year
- G&A expenses increased to $4.9 million from $3.9 million year-over-year
Insights
Artiva advancing AlloNK trials in autoimmune diseases with $142.4M cash runway into Q2 2027; clinical data expected within 6-12 months.
Artiva Biotherapeutics is making significant clinical progress with its AlloNK® (AB-101) cell therapy program for autoimmune diseases. The company has now treated over a dozen patients across multiple conditions including rheumatoid arthritis, SLE, lupus nephritis, Sjögren's disease, and systemic sclerosis. This indicates accelerating enrollment and execution across their clinical trial program.
The company's $142.4 million cash position as of June 30, 2025, provides runway into Q2 2027, giving them approximately 22 months of operational capability at current burn rates. This financial cushion allows them to reach multiple data readouts without immediate financing pressure. Their quarterly net loss increased to $21.3 million from $17.8 million year-over-year, primarily driven by higher R&D expenses of $17.9 million (up from $12.3 million), reflecting intensified clinical activity.
Two critical upcoming catalysts will shape Artiva's future trajectory: (1) By year-end 2025, they'll present initial safety and translational data across multiple autoimmune indications and announce their lead indication for further development; (2) In 1H 2026, they'll share initial clinical response data in that lead indication. These readouts will provide critical validation for their platform.
A key differentiator is Artiva's focus on developing an outpatient cell therapy for autoimmune conditions despite using cyclophosphamide and fludarabine conditioning, which typically require hospital stays. The company's emphasis on community rheumatology sites suggests they're positioning AlloNK as more accessible than traditional cell therapies, which could expand their addressable market significantly if efficacy is demonstrated.
Artiva's AlloNK trials expand across autoimmune diseases with promising outpatient potential; critical efficacy data coming 2025-2026.
Artiva's AlloNK® platform represents an intriguing approach to treating severe autoimmune diseases through allogeneic NK cell therapy combined with monoclonal antibodies. The company's global basket trial design is scientifically sound, targeting mechanistically related conditions including rheumatoid arthritis, Sjögren's disease, inflammatory myopathies, and systemic sclerosis - all characterized by pathogenic autoantibodies that could potentially be cleared through NK-mediated antibody-dependent cellular cytotoxicity (ADCC).
Their parallel trial in systemic lupus erythematosus with/without lupus nephritis addresses another high-unmet need autoimmune condition where current therapies often fail to induce durable remissions. The company's strategy of testing across multiple indications before selecting a lead indication is pragmatic, as it allows them to identify where the risk-benefit profile appears most favorable.
The planned release of translational data by year-end 2025 will be crucial for validating the mechanistic rationale behind AlloNK therapy in autoimmune conditions. This data should reveal whether the therapy effectively depletes pathogenic B cells and plasma cells, reduces autoantibody levels, and modulates inflammatory cytokines - all essential for clinical benefit.
Perhaps most significant is Artiva's focus on developing an outpatient administration protocol despite using cyclophosphamide and fludarabine conditioning. If successful, this would represent a major advance over current cell therapies that require lengthy hospitalization. The accessibility in community rheumatology settings could dramatically expand patient access beyond academic centers, though the safety profile of this approach requires careful scrutiny in the upcoming data releases.
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 diseases to be presented by year-end 2025; initial clinical response data in the lead indication to be presented in 1H2026
Cash runway into Q2 2027, with cash, cash equivalents, and investments of
June 30, 2025
SAN DIEGO, Aug. 06, 2025 (GLOBE NEWSWIRE) -- Artiva Biotherapeutics, Inc. (Nasdaq: ARTV) (Artiva), 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 financial results for the second quarter ended June 30, 2025, and highlighted recent progress.
“We are making meaningful progress across our ongoing clinical trials exploring AlloNK® in autoimmune disease. We now have over a dozen sites enrolling across our trials in the US and have already treated over a dozen patients with AlloNK in combination with monoclonal antibodies across rheumatoid arthritis, SLE, lupus nephritis, Sjögren’s disease, and systemic sclerosis,” said Fred Aslan, M.D., Chief Executive Officer of Artiva. “By the end of 2025, we look forward to sharing initial translational data, supporting AlloNK’s mechanism of action, and safety data, supporting the potential of our therapy, which includes the use of cyclophosphamide and fludarabine, to be administered and managed in an outpatient setting across multiple autoimmune indications. We also look forward to announcing our lead indication by the end of 2025, setting the stage to share initial clinical response data in that indication in the first half of next year.”
Recent Business Highlights
AlloNK® (also known as AB-101) Updates
- Over a dozen clinical sites active and enrolling across two company-sponsored trials in autoimmune diseases: the Phase 2a basket clinical trial and the Phase 1/1b clinical trial in systemic lupus erythematosus (SLE) with or without lupus nephritis (LN)
- First patient treated with AlloNK + rituximab in recently initiated global Phase 2a company-sponsored basket clinical trial for refractory rheumatoid arthritis (RA), Sjögren’s disease (SjD), idiopathic inflammatory myopathies (myositis, or IIM), and systemic sclerosis (scleroderma, or SSc)
- Over a dozen patients treated with AlloNK + monoclonal antibody (mAb) across refractory RA, SLE, LN, SjD, and SSc in the company-sponsored trials and an investigator-initiated basket trial
Upcoming Milestones
- By Year-End 2025: Initial safety and translational data for AlloNK + mAb across multiple autoimmune diseases from ongoing clinical trials and disclosure of lead indication for further development
- Mechanistic and translational data for AlloNK in autoimmune diseases
- Insights into tolerability of AlloNK + mAb, and the patient journey in community rheumatology sites, including the potential ease of use of conditioning regimens with cyclophosphamide and fludarabine
- Disclosure of lead indication for AlloNK development in autoimmune diseases
- 1H 2026: Initial clinical response data in the lead autoimmune indication from ongoing clinical trials with longer follow-up to inform registrational strategy
Second Quarter 2025 Financial Results
- Cash, Cash Equivalents and Investments. As of June 30, 2025, Artiva had cash, cash equivalents, and investments of
$142.4 million , which is expected to fund operations into Q2 2027 - Research and Development Expenses. Research and development expenses were
$17.9 million for the three months ended June 30, 2025, compared to$12.3 million for the three months ended June 30, 2024 - General and Administrative Expenses. General and administrative expenses were
$4.9 million for the three months ended June 30, 2025, compared to$3.9 million for the three months ended June 30, 2024 - Other Income (expense), net. Other income, net, was
$1.6 million for the three months ended June 30, 2025, compared to other expense, net, of$1.7 million for the three months ended June 30, 2024 - Net Loss. Net loss totaled
$21.3 million for the three months ended June 30, 2025, as compared to net loss of$17.8 million for the three months ended June 30, 2024, with non-cash stock-based compensation expense of$1.5 million for the three months ended June 30, 2025, and June 30, 2024
About Artiva Biotherapeutics
Artiva is a clinical-stage biotechnology company whose mission is to develop effective, safe and accessible cell therapies for patients with devastating autoimmune diseases and cancers. Artiva’s lead program, AlloNK® (also known as AB-101), is an allogeneic, off-the-shelf, non-genetically modified, cryopreserved NK cell therapy candidate designed to enhance the antibody-dependent cellular cytotoxicity effect of monoclonal antibodies to drive B-cell depletion. AlloNK is currently being evaluated in three ongoing clinical trials for the treatment of B-cell driven autoimmune diseases. This includes two company-sponsored trials, one in systemic lupus erythematosus for patients with or without lupus nephritis, and a basket trial across autoimmune diseases including rheumatoid arthritis and Sjögren’s disease, as well as an investigator-initiated basket trial in B-cell driven autoimmune diseases. Artiva’s pipeline also includes CAR-NK candidates targeting both solid and hematologic cancers. Artiva was founded in 2019 as a spin out of GC Cell, formerly GC Lab Cell Corporation, a leading healthcare company in the Republic of Korea, pursuant to a strategic partnership granting Artiva exclusive worldwide rights (excluding Asia, Australia and New Zealand) to GC Cell’s NK cell manufacturing technology and programs.
Artiva is headquartered in San Diego, California. For more information, please visit www.artivabio.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements in this press release that are not statements of historical fact are forward-looking statements. Such forward-looking statements include, without limitation, statements regarding: expectations of Artiva Biotherapeutics, Inc. (the “Company”) regarding the potential benefits, accessibility, ease of use, effectiveness, safety and mechanism of action of AlloNK; the Company’s ability to advance AlloNK in autoimmune disease; the Company’s ability to demonstrate progress and clinical validation of its approach; the Company’s expectations regarding timing and availability of data from the Company’s clinical trials or the basket IIT; the timing related to the selection of a lead autoimmune indication; the timing, likelihood or success of the Company's business strategy, as well as plans and objectives of management for future operations; and the Company’s future results of operations and financial position, including cash runway. These forward-looking statements are based on the beliefs of the management of the Company as well as assumptions made by and information currently available to the Company. Such statements reflect the current views of the Company with respect to future events and are subject to known and unknown risks and uncertainties. In light of these risks and uncertainties, the events or circumstances referred to in the forward-looking statements may not occur. These and other factors that may cause the Company’s actual results to differ from current expectations are discussed in the Company’s filings with the Securities and Exchange Commission (the “SEC”), including the section titled “Risk Factors” in the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2025. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date this press release is given. Except as required by law, the Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.
| Artiva Biotherapeutics, Inc. Condensed Balance Sheets (Unaudited) (in thousands) | ||||||||
| June 30, 2025 | December 31, 2024 | |||||||
| Assets | ||||||||
| Cash, cash equivalents and investments | $ | 142,365 | $ | 185,428 | ||||
| Property and equipment, net | 6,886 | 6,370 | ||||||
| Operating and financing lease right-of-use assets | 12,940 | 14,055 | ||||||
| Other assets | 7,200 | 3,728 | ||||||
| Total assets | $ | 169,391 | $ | 209,581 | ||||
| Liabilities and stockholders' equity | ||||||||
| Accounts payable and accrued expenses | $ | 7,053 | $ | 8,513 | ||||
| Operating and financing lease liabilities | 13,224 | 14,354 | ||||||
| Other liabilities | 73 | 73 | ||||||
| Total liabilities | 20,350 | 22,940 | ||||||
| Stockholders' equity | 149,041 | 186,641 | ||||||
| Total liabilities and stockholders' equity | $ | 169,391 | $ | 209,581 | ||||
| Artiva Biotherapeutics, Inc. Condensed Statements of Operations and Comprehensive Loss (Unaudited) (in thousands, except share and per share data) | ||||||||||||||||
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| License and development support revenue | $ | - | $ | - | $ | - | $ | 251 | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 17,861 | 12,333 | 34,914 | 23,488 | ||||||||||||
| General and administrative | 4,949 | 3,857 | 10,068 | 7,444 | ||||||||||||
| Total operating expenses | 22,810 | 16,190 | 44,982 | 30,932 | ||||||||||||
| Loss from operations | (22,810 | ) | (16,190 | ) | (44,982 | ) | (30,681 | ) | ||||||||
| Other income (expense), net | ||||||||||||||||
| Interest income | 1,561 | 676 | 3,425 | 1,326 | ||||||||||||
| Change in fair value of SAFEs | — | (2,352 | ) | — | (2,620 | ) | ||||||||||
| Other (expense) income, net | (5 | ) | 23 | (8 | ) | 169 | ||||||||||
| Total other income (expense), net | 1,556 | (1,653 | ) | 3,417 | (1,125 | ) | ||||||||||
| Net loss | $ | (21,254 | ) | $ | (17,843 | ) | $ | (41,565 | ) | $ | (31,806 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.87 | ) | $ | (22.00 | ) | $ | (1.71 | ) | $ | (39.24 | ) | ||||
| Weighted-average common shares outstanding, basic and diluted | 24,378,823 | 811,210 | 24,360,502 | 810,484 | ||||||||||||
| Comprehensive loss: | ||||||||||||||||
| Net loss | $ | (21,254 | ) | $ | (17,843 | ) | $ | (41,565 | ) | $ | (31,806 | ) | ||||
| Other comprehensive income (loss), net | 2 | (86 | ) | 131 | (187 | ) | ||||||||||
| Comprehensive loss | $ | (21,252 | ) | $ | (17,929 | ) | $ | (41,434 | ) | $ | (31,993 | ) | ||||
Contacts
Investors: Neha Krishnamohan, Artiva Biotherapeutics, ir@artivabio.com
Media: Jessica Yingling, Ph.D., Little Dog Communications Inc., jessica@litldog.com
Source: Artiva Biotherapeutics, Inc.
FAQ
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