Over 100 patients treated with AlloNK across autoimmune and oncology indications
Refractory rheumatoid arthritis $(RA)$ prioritized as lead indication following FDA Fast Track Designation for AlloNK$(R)$, the first known therapy within the emerging deep B-cell depletion category to receive this designation in RA
Company to host webcast later this morning to discuss initial safety and translational data from clinical trials evaluating AlloNK in combination with anti-CD20 monoclonal antibodies across autoimmune diseases; presentation to also include outpatient feasibility and tolerability observations
Initial clinical response data in refractory RA expected in the first half of 2026, with FDA discussions planned to align on potential pivotal trial design in refractory RA
Cash runway into Q2 2027, with cash, cash equivalents, and investments of $123.0 million as of September 30, 2025
SAN DIEGO, Nov. 12, 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 third quarter ended September 30, 2025, and provided recent business updates.
"During the third quarter, we continued to execute on our mission to deliver accessible, scalable immunotherapies for autoimmune disease. We have now treated over a hundred patients with AlloNK across oncology and autoimmune disease, a significant milestone for the company," said Fred Aslan, M.D., President and Chief Executive Officer of Artiva. "With refractory rheumatoid arthritis now established as our lead indication and Fast Track designation granted by the FDA, we have taken an important step forward in the development of AlloNK. We look forward to sharing the emerging translational and safety data later today, supporting AlloNK's profile as an outpatient-ready therapy capable of achieving deep B-cell depletion, followed by clinical response data in the first half of 2026 from more than 15 refractory RA patients, several of whom will have six or more months of follow-up. In addition, we are planning FDA interactions in the first half of 2026 that could enable AlloNK to become the first deep B-cell depleting therapy to advance to a pivotal trial in patients with RA."
Recent Business Highlights
AlloNK(R) (also known as AB-101) Updates:
-- Lead indication and Fast Track Designation: In October 2025, Artiva
announced that the U.S. Food and Drug Administration (FDA) granted Fast
Track Designation to AlloNK for the treatment of refractory rheumatoid
arthritis (RA) in combination with rituximab. This represents the first
known therapy within the emerging deep B-cell depletion category to
receive this designation in RA. Artiva has prioritized refractory
rheumatoid arthritis as its lead indication, with the potential to
address a large, underserved patient population that continues to
experience inadequate disease control despite existing treatment options
-- Upcoming webcast and initial data disclosure: Artiva will host a virtual
event today, at 8:00 a.m. ET to discuss initial safety and translational
data from its ongoing clinical trials evaluating AlloNK in combination
with anti-CD20 antibodies for the treatment of autoimmune diseases
-- Upcoming 1H 2026 Milestones:
-- Initial clinical response data from ongoing clinical trials for
more than 15 refractory RA patients, including several with >=6
months of follow-up, remain on track for 1H 2026
-- Artiva plans to engage with the FDA in 1H 2026 to align on the
potential pivotal trial design for AlloNK in refractory RA
Corporate Update
-- Announced Chief Financial Officer transition. Neha Krishnamohan will
continue to serve as Chief Financial Officer and EVP, Corporate
Development until the end of December and then transition to an advisory
role. The company plans to conduct a search for her replacement
Third Quarter 2025 Financial Results
-- Cash, Cash Equivalents and Investments. As of September 30, 2025, Artiva
had cash, cash equivalents, and investments of $123.0 million, which is
expected to fund operations into Q2 2027
-- Research and Development Expenses. Research and development expenses were
$17.6 million for the three months ended September 30, 2025, compared to
$13.5 million for the three months ended September 30, 2024
-- General and Administrative Expenses. General and administrative expenses
were $5.3 million for the three months ended September 30, 2025, compared
to $4.8 million for the three months ended September 30, 2024
-- Other Income (Expense), Net. Other income, net, was $1.4 million for the
three months ended September 30, 2025, compared to $0.9 million for the
three months ended September 30, 2024
-- Net Loss. Net loss totaled $21.5 million for the three months ended
September 30, 2025, as compared to $17.5 million for the three months
ended September 30, 2024, with non-cash stock-based compensation expense
of $1.6 million for the three months ended September 30, 2025, and $1.9
million for the three months ended September 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(R) (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, including a company-sponsored basket trial across autoimmune diseases that includes rheumatoid arthritis and Sjögren's disease and 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 RA or any other 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 clinical trials; the timing and outcome of regulatory interactions; the Company's ability to realize any benefit from Fast Track or other regulatory designations; the timing, likelihood or success of the Company's business strategy, as well as plans and objectives of management for future operations; Ms. Krishnamohan's transition and the planned search for her replacement; 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 September 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)
September 30, 2025 December 31, 2024
-------------------- ---------------------
Assets
Cash, cash equivalents
and investments $ 122,968 $ 185,428
Property and equipment,
net 6,981 6,370
Operating and financing
lease right-of-use
assets 11,478 14,055
Other assets 7,435 3,728
Total assets $ 148,862 $ 209,581
=== =============== === ==============
Liabilities and stockholders'
equity
Accounts payable and
accrued expenses $ 7,874 $ 8,513
Operating and financing
lease liabilities 11,691 14,354
Other liabilities 73 73
Total liabilities 19,638 22,940
--- --------------- --- --------------
Stockholders' equity 129,224 186,641
Total liabilities and
stockholders' equity $ 148,862 $ 209,581
=== =============== === ==============
Artiva Biotherapeutics, Inc.
Condensed Statements of Operations and Comprehensive
Loss
(Unaudited)
(in thousands, except share and per share data)
Three Months Ended Nine Months Ended September
September 30, 30,
-------------------------- ---------------------------
2025 2024 2025 2024
---------- ---------- ---------- ---------
License and
development
support revenue $ - $ - $ - $ 251
Operating
expenses:
Research and
development 17,633 13,524 52,546 37,011
General and
administrative 5,264 4,811 15,332 12,255
---------- ---------- ---------- ---------
Total
operating
expenses 22,897 18,335 67,878 49,266
Loss from
operations (22,897) (18,335) (67,878) (49,015)
Other income
(expense), net:
Interest income 1,372 1,846 4,797 3,172
Change in fair
value of
SAFEs -- (977) -- (3,597)
Other (expense)
income, net (3) (6) (12) 162
Total other
income
(expense),
net 1,369 863 4,785 (263)
---------- ---------- ---------- ---------
Net loss $ (21,528) $ (17,472) $ (63,093) $ (49,278)
========== ========== ========== =========
Net loss per
share, basic and
diluted $ (0.88) $ (0.92) $ (2.59) $ (7.16)
========== ========== ========== =========
Weighted-average
common shares
outstanding,
basic and
diluted 24,481,722 18,896,829 24,401,353 6,883,271
========== ========== ========== =========
Comprehensive
loss:
Net loss $ (21,528) $ (17,472) $ (63,093) $ (49,278)
Other
comprehensive
income, net 85 217 216 30
Comprehensive loss $ (21,443) $ (17,255) $ (62,877) $ (49,248)
========== ========== ========== =========
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.
(END) Dow Jones Newswires
November 12, 2025 07:00 ET (12:00 GMT)