Artiva Biotherapeutics Reports First Quarter 2025 Financial Results, Recent Business Highlights
Artiva Biotherapeutics (NASDAQ: ARTV) reported its Q1 2025 financial results and business updates. The company announced IND clearance and initiation of a global basket trial exploring AlloNK® + rituximab in multiple autoimmune conditions, marking the first allogeneic cell therapy trial for rheumatoid arthritis and Sjögren's disease in the U.S. The company ended Q1 2025 with $166.0 million in cash, extending runway into Q2 2027.
Key financial metrics include R&D expenses of $17.1 million (up from $11.2M in Q1 2024), G&A expenses of $5.1 million (up from $3.6M), and a net loss of $20.3 million (increased from $14.0M). The company's B-NHL trial data showed promising results comparable to approved auto-CAR-T therapies. Initial safety and translational data are expected by year-end 2025, with clinical response data in the lead indication planned for 1H2026.
Artiva Biotherapeutics (NASDAQ: ARTV) ha comunicato i risultati finanziari del primo trimestre 2025 e aggiornamenti aziendali. La società ha annunciato l'approvazione IND e l'avvio di uno studio globale a cesto che esplora AlloNK® + rituximab in diverse malattie autoimmuni, segnando il primo trial di terapia cellulare allogenica per artrite reumatoide e sindrome di Sjögren negli Stati Uniti. Al termine del primo trimestre 2025, la società disponeva di 166,0 milioni di dollari in liquidità, garantendo la continuità operativa fino al secondo trimestre 2027.
I principali indicatori finanziari includono spese in R&S di 17,1 milioni di dollari (in aumento rispetto agli 11,2 milioni del primo trimestre 2024), spese generali e amministrative di 5,1 milioni di dollari (in aumento rispetto a 3,6 milioni) e una perdita netta di 20,3 milioni di dollari (in crescita rispetto ai 14,0 milioni). I dati del trial B-NHL hanno mostrato risultati promettenti, comparabili a quelli delle terapie auto-CAR-T approvate. I dati iniziali sulla sicurezza e traslazionali sono attesi entro la fine del 2025, mentre i dati di risposta clinica per l'indicazione principale sono previsti per la prima metà del 2026.
Artiva Biotherapeutics (NASDAQ: ARTV) informó sus resultados financieros del primer trimestre de 2025 y actualizaciones comerciales. La compañía anunció la aprobación IND y el inicio de un ensayo global tipo cesta que explora AlloNK® + rituximab en múltiples enfermedades autoinmunes, marcando el primer ensayo de terapia celular alogénica para artritis reumatoide y enfermedad de Sjögren en EE.UU. Al finalizar el primer trimestre de 2025, la empresa contaba con 166,0 millones de dólares en efectivo, extendiendo su financiación hasta el segundo trimestre de 2027.
Las métricas financieras clave incluyen gastos en I+D de 17,1 millones de dólares (aumentando desde 11,2M en el primer trimestre de 2024), gastos G&A de 5,1 millones de dólares (subiendo desde 3,6M) y una pérdida neta de 20,3 millones de dólares (incrementada desde 14,0M). Los datos del ensayo B-NHL mostraron resultados prometedores comparables a terapias auto-CAR-T aprobadas. Se esperan datos iniciales de seguridad y traslacionales para finales de 2025, con datos de respuesta clínica en la indicación principal planeados para el primer semestre de 2026.
Artiva Biotherapeutics (NASDAQ: ARTV)는 2025년 1분기 재무 실적 및 사업 업데이트를 발표했습니다. 회사는 IND 승인 및 전 세계 바스켓 임상시험 개시를 발표했으며, 이는 여러 자가면역 질환에서 AlloNK® + 리툭시맙을 탐구하는 시험으로, 미국에서 류마티스 관절염과 쇼그렌 증후군에 대한 최초의 동종 세포 치료 임상시험입니다. 2025년 1분기 말 기준 회사는 1억 6600만 달러의 현금을 보유하여 2027년 2분기까지 운영 자금을 확보했습니다.
주요 재무 지표로는 연구개발비 1710만 달러 (2024년 1분기 1120만 달러에서 증가), 일반관리비 510만 달러 (360만 달러에서 증가), 순손실 2030만 달러 (1400만 달러에서 증가)가 포함됩니다. B-NHL 임상시험 데이터는 승인된 자가 CAR-T 치료제와 비교할 만한 유망한 결과를 보여주었습니다. 초기 안전성 및 전임상 데이터는 2025년 말까지, 주요 적응증의 임상 반응 데이터는 2026년 상반기에 발표될 예정입니다.
Artiva Biotherapeutics (NASDAQ : ARTV) a publié ses résultats financiers du premier trimestre 2025 ainsi que des mises à jour commerciales. La société a annoncé l'autorisation IND et le lancement d'un essai basket mondial explorant AlloNK® + rituximab dans plusieurs maladies auto-immunes, marquant le premier essai de thérapie cellulaire allogénique pour la polyarthrite rhumatoïde et la maladie de Sjögren aux États-Unis. À la fin du premier trimestre 2025, la société disposait de 166,0 millions de dollars en liquidités, garantissant une autonomie financière jusqu'au deuxième trimestre 2027.
Les indicateurs financiers clés comprennent des dépenses de R&D de 17,1 millions de dollars (en hausse par rapport à 11,2 M$ au T1 2024), des frais G&A de 5,1 millions de dollars (en hausse par rapport à 3,6 M$) et une perte nette de 20,3 millions de dollars (en augmentation par rapport à 14,0 M$). Les données de l'essai B-NHL ont montré des résultats prometteurs comparables aux thérapies auto-CAR-T approuvées. Les premières données de sécurité et translationnelles sont attendues d'ici la fin 2025, avec des données de réponse clinique pour l'indication principale prévues au premier semestre 2026.
Artiva Biotherapeutics (NASDAQ: ARTV) meldete seine Finanzergebnisse für das erste Quartal 2025 sowie geschäftliche Updates. Das Unternehmen gab die IND-Freigabe und den Start einer globalen Basket-Studie bekannt, die AlloNK® + Rituximab bei verschiedenen Autoimmunerkrankungen untersucht und die erste allogene Zelltherapie-Studie für rheumatoide Arthritis und Sjögren-Syndrom in den USA darstellt. Zum Ende des ersten Quartals 2025 verfügte das Unternehmen über 166,0 Millionen US-Dollar in bar, was die Finanzierung bis zum zweiten Quartal 2027 sichert.
Wichtige finanzielle Kennzahlen umfassen F&E-Ausgaben von 17,1 Millionen US-Dollar (gestiegen von 11,2 Mio. im Q1 2024), Verwaltungs- und Gemeinkosten von 5,1 Millionen US-Dollar (gestiegen von 3,6 Mio.) sowie einen Nettoverlust von 20,3 Millionen US-Dollar (gestiegen von 14,0 Mio.). Die B-NHL-Studienergebnisse zeigten vielversprechende Resultate, die mit zugelassenen Auto-CAR-T-Therapien vergleichbar sind. Erste Sicherheits- und translationale Daten werden bis Ende 2025 erwartet, klinische Ansprechdaten für die Hauptindikation sind für das erste Halbjahr 2026 geplant.
- None.
- Increased net loss to $20.3M in Q1 2025 from $14.0M in Q1 2024
- Higher R&D expenses at $17.1M, up from $11.2M year-over-year
- Increased G&A expenses to $5.1M from $3.6M year-over-year
Insights
Artiva advances AlloNK® therapy in autoimmune diseases with FDA clearance and promising oncology data, demonstrating potential for off-the-shelf cell therapy in community settings.
Artiva has achieved a significant regulatory milestone with FDA clearance for their global basket trial of AlloNK® + rituximab across four autoimmune conditions - rheumatoid arthritis, Sjögren's disease, idiopathic inflammatory myopathies, and systemic sclerosis. Most notably, this represents the first company-sponsored allogeneic cell therapy trial in refractory RA and Sjögren's disease in the U.S., positioning Artiva at the forefront of cell therapy applications in autoimmunity.
The trial design includes several patient-friendly elements that differentiate it from typical cell therapy protocols: no hospitalization requirement and continuous enrollment without staggered dosing. This approach reflects AlloNK's apparent favorable safety profile and could dramatically expand accessibility compared to autologous cell therapies that require specialized centers.
In oncology, the company will present longer-term B-NHL data at ASGCT showing complete response rates and median duration of response reportedly in line with approved autologous CAR-T therapies in heavily pretreated patients. This data, while still to be presented formally, provides important validation of AlloNK's B-cell depleting capability – the same mechanism potentially driving efficacy in autoimmune conditions.
The company has established a clear development timeline with safety and translational data expected by year-end 2025, lead indication selection by year-end 2025, and initial clinical response data in the first half of 2026. The recently appointed Chief Medical Officer with autoimmune expertise further strengthens their development capabilities in this therapeutic area.
Artiva reports solid $166M cash position extending runway into Q2 2027, supporting expanded clinical initiatives despite increased R&D investment to $17.1M.
Artiva's financial position remains robust with
Research and development expenses increased to
The net loss of
The company's appointment of a new Chief Medical Officer with autoimmune expertise completes their strategic shift toward building a development team focused on this therapeutic area. This balanced approach to resource allocation – maintaining a two-year runway while advancing multiple programs – positions Artiva to potentially capitalize on near-term clinical readouts while managing financial resources prudently.
IND clearance and initiation of global basket trial exploring AlloNK® + rituximab in refractory rheumatoid arthritis, Sjögren’s disease, idiopathic inflammatory myopathies and systemic sclerosis
First trial to explore an allogeneic cell therapy in refractory rheumatoid arthritis and Sjögren’s disease in the U.S.
Initial safety, translational data, and lead indication selection to be presented by year-end 2025; initial clinical response data in the lead indication to be presented in 1H2026
Longer-term clinical data from Phase 1/2 trial exploring AlloNK + rituximab in B-NHL in heavily pretreated CAR-T naïve patients to be presented at ASGCT, demonstrating complete response rates and median duration of responses in line with approved auto-CAR-T therapies, support deep B-cell depletion
Cash runway extension into Q2 2027, with cash, cash equivalents and investments of
SAN DIEGO, May 08, 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 first quarter ended March 31, 2025, and highlighted recent progress.
“We are encouraged by our early experience with AlloNK® in autoimmune disease. We have initiated regulatory submissions globally for our company-sponsored basket trial in refractory rheumatoid arthritis, Sjögren’s disease, myositis and scleroderma. Notably, we are first to announce a company-sponsored allogeneic cell therapy trial in rheumatoid arthritis and Sjögren’s disease in the U.S.; two sizeable indications that could benefit from AlloNK’s potential ease of use and well-tolerated safety profile in the community setting,” said Fred Aslan, M.D., Chief Executive Officer of Artiva. “Since the IPO last July, we have transformed our development team and now have a deep bench of autoimmune expertise to expand and refine the clinical trial infrastructure and development strategy for AlloNK in autoimmune disease. By the end of 2025, we plan on sharing initial safety and translational data supporting AlloNK’s mechanism of action and tolerability profile across multiple autoimmune diseases, as well as announcing our lead indication. In the first half of 2026, we expect to share clinical response data in our lead indication with longer follow-up to substantiate AlloNK’s emerging target product profile, and to have initial insights on registrational approaches.”
Dr. Aslan continued, “Our longer-term aggressive B-NHL data is maturing into a leading data set, in line with approved auto-CAR-T therapies, providing proof of concept of AlloNK’s ability to deplete B-cells deeply and durably. We remain well capitalized to generate meaningful data sets and to differentiate ourselves over time from other therapeutic approaches in areas of significant unmet need in the community setting.”
Recent Business Highlights
AlloNK® (also known as AB-101) Updates
Autoimmune clinical program updates:
Company-sponsored clinical trials:
- Phase 2a company-sponsored basket clinical trial:
- Following Investigational New Drug application clearance by the U.S. Food and Drug Administration, initiating global Phase 2a company-sponsored basket clinical trial for AlloNK + rituximab for refractory rheumatoid arthritis (RA), Sjögren’s disease, idiopathic inflammatory myopathies (myositis, or IIM) and systemic sclerosis (scleroderma, or SSc), with site initiation underway
- First company-sponsored trial exploring an allogeneic cell therapy in refractory RA and Sjögren’s disease in the U.S.
- Protocol allows for continuous enrollment with no stagger within dose levels and no hospitalization/inpatient requirement for patients dosed with AlloNK
- Initiation of regulatory submissions across multiple geographic regions
- Phase 1/1b company-sponsored trial in systemic lupus erythematosus (SLE) with or without lupus nephritis (LN):
- Treatment of patients in combination cohort with AlloNK + monoclonal antibodies (mAb) initiated in late 2024
- Prioritization of patient enrollment in AlloNK + obinutuzumab cohort
- Currently exploring 1 billion cells per AlloNK dose x 3 weekly doses in company-sponsored trials with plan to escalate to 4 billion cells per AlloNK dose x 3 weekly doses across both trials
Investigator-initiated trial (IIT):
- Ongoing IIT Basket Trial: IIT assessing the safety, tolerability, and clinical activity of AlloNK + rituximab in patients with RA, pemphigus vulgaris, granulomatosis with polyangiitis/microscopic polyangiitis, and SLE. The trial is being conducted by Integral Rheumatology & Immunology Specialists (IRIS), in an outpatient setting at a community rheumatology clinic.
- Initial tolerability supports prioritization of community sites for clinical development of AlloNK
AlloNK + rituximab in B-cell non-Hodgkin lymphoma (B-NHL) updates:
- Longer-term clinical data from Phase 1/2 trial exploring AlloNK + rituximab in patients with relapsed/refractory B-NHL to be presented at The American Society of Gene & Cell Therapy (ASGCT) 28th annual meeting on May 13, 2025. Abstracts are currently available on the ASGCT website
- Updated clinical data in heavily pre-treated, CAR-T naïve patients with B-NHL shows prolonged duration of response, with complete response rates and median duration of response in line with approved auto-CAR-T therapies in aggressive B-NHL patients with multiple prior lines of treatment
Other program updates:
- Preclinical data on the ablation of SLE donor B-cells with AlloNK in combination with either an anti-CD19 or anti-CD20 monoclonal antibody presented at the 2025 Pan-American League of Rheumatology Congress (PANLAR) and to be presented at the 16th International Congress on Systemic Lupus Erythematosus (LUPUS 2025), being held May 21-24, 2025, in Toronto, Canada
- Poster presentation featuring the scalability and consistency of the manufacturing process for AlloNK to be presented at the ASGCT 28th annual meeting on May 15, 2025
- Data highlights consistent and high expression of CD16, uniform expansion across greater than 40 manufacturing lots, and high viability and cytotoxicity after 4 years of shelf life for AlloNK
- Data highlights consistent and high expression of CD16, uniform expansion across greater than 40 manufacturing lots, and high viability and cytotoxicity after 4 years of shelf life for AlloNK
Corporate Updates
- Appointment of Subhashis Banerjee, M.D., as Chief Medical Officer announced on April 8, 2025, culminating Artiva’s efforts to build a seasoned development team with strong expertise in autoimmune disease and cell therapy
Upcoming Milestones
- By Year-End 2025: Initial safety and translational data for AlloNK + mAb across multiple autoimmune indications from ongoing clinical trials and disclosure of lead autoimmune indication for further development
- Mechanistic and translational data for AlloNK in autoimmune indications
- 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
First Quarter 2025 Financial Results
- Cash, Cash Equivalents and Investments. As of March 31, 2025, Artiva had cash, cash equivalents, and investments of
$166.0 million which is expected to fund operations into Q2 2027. - Research and Development Expenses. Research and development expenses were
$17.1 million for the three months ended March 31, 2025, compared to$11.2 million for the three months ended March 31, 2024. - General and Administrative Expenses. General and administrative expenses were
$5.1 million for the three months ended March 31, 2025, compared to$3.6 million for the three months ended March 31, 2024. - Other Income, net. Other income, net, was
$1.9 million for the three months ended March 31, 2025, compared to other income, net, of$0.5 million for the three months ended March 31, 2024. - Net Loss. Net loss totaled
$20.3 million for the three months ending March 31, 2025, as compared to net loss of$14.0 million for the three months ending March 31, 2024, with non-cash stock-based compensation expense of$2.1 million and$1.4 million for the three months ended March 31, 2025 and 2024, respectively.
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 and safety 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 belief that of Phase 1/2 trial data in B-NHL provides support for B-cell depletion as a MoA and its comparison to approved auto-CAR-T therapies; the Company’s expectations regarding design, 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 March 31, 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) | |||||||
| March 31, 2025 | December 31, 2024 | ||||||
| Assets | |||||||
| Cash, cash equivalents and investments | $ | 165,963 | $ | 185,428 | |||
| Property and equipment, net | 7,057 | 6,370 | |||||
| Operating and financing lease right-of-use assets | 13,728 | 14,055 | |||||
| Other assets | 4,515 | 3,728 | |||||
| Total assets | $ | 191,263 | $ | 209,581 | |||
| Liabilities and stockholders' equity | |||||||
| Accounts payable and accrued expenses | $ | 8,411 | $ | 8,513 | |||
| Operating and financing lease liabilities | 13,996 | 14,354 | |||||
| Other liabilities | 73 | 73 | |||||
| Total liabilities | 22,480 | 22,940 | |||||
| Stockholders' equity | 168,783 | 186,641 | |||||
| Total liabilities and stockholders' equity | $ | 191,263 | $ | 209,581 | |||
| Artiva Biotherapeutics, Inc. Condensed Statements of Operation and Comprehensive Loss (Unaudited) (in thousands, except share and per share data) | |||||||
| Three Months Ended March 31, | |||||||
| 2025 | 2024 | ||||||
| License and development support revenue | $ | - | $ | 251 | |||
| Operating expenses: | |||||||
| Research and development | 17,052 | 11,156 | |||||
| General and administrative | 5,119 | 3,587 | |||||
| Total operating expenses | 22,171 | 14,743 | |||||
| Loss from operations | (22,171 | ) | (14,492 | ) | |||
| Other income, net | |||||||
| Interest income | 1,864 | 650 | |||||
| Change in fair value of SAFEs | — | (268 | ) | ||||
| Other income (expense) | (4 | ) | 147 | ||||
| Total other income, net | 1,860 | 529 | |||||
| Net loss | $ | (20,311 | ) | $ | (13,963 | ) | |
| Net loss per share, basic and diluted | $ | (0.83 | ) | $ | (17.24 | ) | |
| Weighted-average common shares outstanding, basic and diluted | 24,341,978 | 809,758 | |||||
| Comprehensive loss: | |||||||
| Net loss | $ | (20,311 | ) | $ | (13,963 | ) | |
| Other comprehensive income (loss) | 129 | (101 | ) | ||||
| Comprehensive loss | $ | (20,182 | ) | $ | (14,064 | ) | |
Contacts
Investors: Neha Krishnamohan, Artiva Biotherapeutics, ir@artivabio.com
Media: Jessica Yingling, Ph.D., Little Dog Communications Inc., jessica@litldog.com, +1.858.344.8091
Source: Artiva Biotherapeutics, Inc.
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