Form 8-K
8-K — Artiva Biotherapeutics, Inc.
Accession: 0001193125-26-432806
Filed: 2026-10-27
Period: 2026-10-22
CIK: 0001817241
SIC: 2836 (BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES))
Item: Results of Operations and Financial Condition
Item: Cost Associated with Exit or Disposal Activities
Item: Financial Statements and Exhibits
Documents
8-K — d102135d8k.htm (Primary)
EX-99.1 (d102135dex991.htm)
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8-K
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): October 22, 2026
Artiva Biotherapeutics, Inc.
(Exact name of registrant as specified in its charter)
Delaware
001-42179
83-3614316
(State or other jurisdiction
of incorporation)
(Commission
File Number)
(IRS Employer
Identification No.)
5505 Morehouse Drive, Suite 100
San Diego, California 92121
(Address of principal executive offices)
Registrant’s telephone number, including area code: (858) 267-4467
N/A
(Former name or former address, if changed since last report.)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
☐
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
Trading
symbol(s)
Name of each exchange
on which registered
Common Stock, $0.0001 par value per share
ARTV
Nasdaq Global Market
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 2.02
Results of Operations and Financial Condition.
On October 27, 2026, Artiva Biotherapeutics, Inc. (the “Company”) issued a press release announcing that it is halting all further development of AlloNK® (AB-101) and initiating a process to explore strategic alternatives to maximize stockholder value. In the press release, the Company also announced that it had preliminary cash, cash equivalents and investments of approximately $319.1 million as of September 30, 2026. A copy of the press release is attached as Exhibit 99.1 hereto.
The cash, cash equivalents and investments amount as of September 30, 2026 is preliminary and may change, is based on information available to management as of the date of this Current Report and is subject to completion by management of the financial statements as of and for the quarter ended September 30, 2026. There can be no assurance that the Company’s cash, cash equivalents and investments as of September 30, 2026 will not differ from these preliminary amounts. The preliminary financial data included in this Current Report has been prepared by and is the responsibility of the Company’s management. The Company’s independent registered public accounting firm has not audited, reviewed, compiled, or applied agreed-upon procedures with respect to the preliminary financial data, and does not express an opinion or any other form of assurance with respect thereto. Complete quarterly results will be included in the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2026.
The information contained under this Item 2.02, including Exhibit 99.1 attached hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or under the Exchange Act, regardless of any general incorporation language in any such filing, unless the Company expressly sets forth in such filing that such information is to be considered “filed” or incorporated by reference therein.
Item 2.05
Costs Associated with Exit or Disposal Activities.
On October 22, 2026, the board of directors of the Company approved the discontinuation of the Company’s development of AlloNK® (AB-101), its non-genetically modified, allogeneic natural killer (NK) cell therapy candidate, as the Company conducts a process to explore strategic alternatives to maximize stockholder value, which includes a plan to implement a reduction of the Company’s workforce by approximately 94% of the Company’s current employee base (the “Wind Down”). At this time, the Company cannot reasonably estimate the total costs and charges in connection with the Wind Down. These costs and charges will relate primarily to contract termination and other costs related to the discontinuation of its clinical trials, costs related to leases, other existing liabilities and operational closing activities, and costs related to the workforce reduction. The Company expects to complete the workforce reduction in the first quarter of 2027 and to incur a significant majority of the costs related to the Wind Down in the fourth quarter of 2026. The Company may also incur other charges or cash expenditures not currently contemplated due to events that may occur as a result of, or associated with, the Wind Down. The estimated timing of the Wind Down as well as the estimated timing of the related costs, are subject to a number of assumptions and actual results may differ.
Forward-Looking Statements
This Current Report on Form 8-K contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical fact contained in this Current Report on Form 8-K are forward-looking statements. The words “aim,” “anticipate,” “believe,” “can,” “continue,” “could,” “design,” “enable,” “expect,” “initiate,” “intend,” “may,” “estimate,” “on-track,” “ongoing,” “plan,” “potential,” “should,” “target,” “update,” “will,” “would,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements in this Current Report on Form 8-K include, but are not limited to, the Company’s statements regarding its workforce reduction and the expected timing of its completion, wind-down of clinical activities and exploration of strategic alternatives, including the timing and outcome of that process and its ability to maximize stockholder value, the scope and the timing of the Wind Down and the timing of the expected costs associated with the Wind Down, and other statements that are not historical fact. The Company may not actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements, and undue reliance should not be placed on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including, without limitation, market conditions and availability of acceptable strategic alternatives, the Company’s ability to complete the Wind Down in a timely and cost-effective manner, the Company’s ability to retain the personnel needed to complete the Wind Down and conduct the strategic alternatives process; the Company’s ability to identify,
negotiate and complete a strategic transaction on acceptable terms, or at all, and the risk that any such transaction does not deliver the anticipated value to stockholders. The estimated timing of the Wind Down as well as the estimated timing of the related costs, are subject to a number of assumptions and actual results may differ. These and other risks are described in greater detail under the caption “Risk Factors” included in the Company’s most recent annual or quarterly report and in other reports it has filed or may file with the Securities and Exchange Commission. Any forward-looking statements contained in this Current Report on Form 8-K speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statements, whether because of new information, future events or otherwise, except as may be required by law.
Item 9.01
Financial Statements and Exhibits
(d) Exhibits
Exhibit
Number
Description
99.1
Press Release, dated October 27, 2026
104
Cover Page Interactive Data File (embedded within the Inline XBRL document)
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Artiva Biotherapeutics, Inc.
By:
/s/ Fred Aslan
Fred Aslan, M.D.
Chief Executive Officer
Dated: October 27, 2026
EX-99.1
EX-99.1
Filename: d102135dex991.htm · Sequence: 2
EX-99.1
Exhibit 99.1
Artiva Biotherapeutics Announces Strategic Update and Discontinues Development of
AlloNK®
•
Company halting further development of
AlloNK® (AB-101), including the planned phase 3 pivotal trial
•
Updated deep B cell depletion and clinical response data is consistent with previously reported findings;
however, updated longer-term data showed that durability of clinical response did not meet the threshold the Company required to support continued development
•
Company shares details of two recent Grade 5 events, consisting of a case of leukoencephalopathy assessed as
likely fludarabine toxicity, and a second event assessed as unrelated to any component of the study treatment
•
Company reducing its workforce by approximately 94% and evaluating strategic alternatives; Leerink Partners
engaged as financial advisor
•
Cash, cash equivalents and investments of approximately $319.1 million (preliminary and
unaudited) as of September 30, 2026
SAN DIEGO, October 27, 2026 — Artiva Biotherapeutics, Inc.
(Nasdaq: ARTV) (Artiva or the Company), a clinical-stage biotechnology company whose mission is to develop effective, safe and accessible cell therapies for patients with debilitating autoimmune diseases, today announced that it will discontinue
further development of AlloNK® (AB-101), its non-genetically modified, allogeneic NK cell therapy candidate
being evaluated in combination with rituximab in rheumatoid arthritis (RA) and other B-cell-driven autoimmune diseases. The decision follows the Company’s review of the overall risk-benefit in the
context of updated clinical data, including longer-term follow-up, and recent Grade 5 safety events. The Company also announced that it is implementing a reduction in workforce and evaluating strategic
alternatives to maximize stockholder value that may include a merger, business combination, sale or licensing of assets, or dissolution and liquidation.
“After careful consideration, we have made the difficult decision to discontinue development of AlloNK and to pursue strategic alternatives,” said
Fred Aslan, M.D., chief executive officer of Artiva Biotherapeutics. “Throughout the development of AlloNK, the safety and well-being of patients have remained our highest priority. We are deeply saddened by the deaths of two patients who
participated in our clinical studies and extend our sincere condolences to their families. We plan to provide findings from the first case, which was assessed as likely related to fludarabine toxicity, given its widespread use in cell therapy
conditioning regimens.”
“I am incredibly proud of the Artiva team and grateful for their dedication, professionalism and deep commitment to
patients. We also thank the patients, families and investigators who have contributed to advancing our understanding of AlloNK and its potential role in the treatment of autoimmune diseases,” Dr. Aslan added.
Grade 5 Fludarabine Associated Neurotoxicity
A participant in the Company’s Phase 2a basket trial experienced a fatal neurological event (leukoencephalopathy) following study treatment, which
included protocol-specified lymphodepletion with cyclophosphamide and fludarabine. The investigator and an independent safety review assessed the event as likely related to fludarabine-associated neurotoxicity. Artiva reported the event to the FDA,
investigators and the Data Safety Monitoring Board. Following notification, the FDA asked Artiva to pause enrollment and dosing in the Phase 2a study. The Company also paused the planned Phase 3 trial enrollment and dosing.
Given the widespread use of fludarabine-containing lymphodepletion regimens in cell therapy development, Artiva intends to share additional details of this
case in a scientific publication.
Additional Grade 5 Safety Event
A second participant in the trial experienced sudden death approximately two months after initiating study treatment. The investigator assessed this event as
unrelated to AlloNK or any other component of the study treatment regimen, and the cause of death has not been determined. Artiva promptly reported this event to the FDA, investigators and the Data Safety Monitoring Board.
Clinical Development Discontinuation and Patient Follow-Up
Updated clinical response data from patients receiving AlloNK in combination with rituximab continued to demonstrate deep B cell depletion and clinical
activity consistent with the Company’s previously reported findings. However, longer-term follow-up did not reflect the level of durability of clinical response the Company believes is needed to support
continued development. Following an assessment of the risk-benefit of the therapy, likely enrollment delays and the overall development and potential commercial outlook, Artiva has decided to halt further development of AlloNK. No additional
patients will be dosed in any ongoing AlloNK clinical study and the planned Phase 3 pivotal trial will not be initiated. The Company will work closely with the FDA, investigators and institutional review boards to ensure an appropriate and orderly close-out of its clinical development program, including continued safety monitoring and reporting as required.
In
light of the decision to discontinue AlloNK development, Artiva no longer plans to present its previously announced clinical data at ACR Convergence 2026 and will cancel its investor webcast scheduled for November 9, 2026. Updated clinical data
may be presented at future scientific meetings depending on the outcome of the strategic alternatives process.
Strategic Alternatives and Corporate
Restructuring
Artiva’s Board of Directors is evaluating internal options and potential strategic alternatives intended to maximize stockholder
value. Leerink Partners has been engaged as the Company’s financial advisor to assist in the strategic evaluation process. These alternatives may include a merger, business combination, sale or licensing of assets, dissolution and liquidation.
There can be no assurance that the evaluation will result in any transaction or particular outcome.
In connection with the discontinuation of AlloNK
development and to preserve capital while evaluating strategic alternatives, Artiva is reducing its workforce by approximately 94%.
As of September 30, 2026, Artiva had approximately $319.1 million in cash, cash equivalents and
investments (preliminary and unaudited). The preliminary cash, cash equivalents and investments as of September 30, 2026 are unaudited and subject to adjustment. Complete quarterly results will be included in Artiva’s Quarterly Report on
Form 10-Q for the quarter ended September 30, 2026. There can be no assurance that Artiva’s cash, cash equivalents and investments as of September 30, 2026 will not differ from these
preliminary amounts.
The Company does not intend to provide further updates on its strategic alternatives process unless and until the Board of Directors
has approved a specific course of action, the process has concluded, or the Company determines that further disclosure is appropriate or required by law.
About Artiva Biotherapeutics
Artiva is a clinical-stage
biotechnology company that has focused on developing allogeneic natural killer (NK) cell therapies for autoimmune diseases. AlloNK® (AB-101), the
Company’s lead development candidate, is a non-genetically modified, allogeneic, cryopreserved NK cell therapy that was evaluated in combination with
B-cell-targeted monoclonal antibodies. On October 27, 2026, Artiva announced the discontinuation of further clinical development of AlloNK and the initiation of an evaluation of strategic alternatives.
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: the discontinuation of AlloNK development; the
close-out of the Company’s clinical studies and continued patient safety follow-up; the Company’s intention to publish clinical data in a future scientific
publication or to present such clinical data at a future scientific meeting; the evaluation of strategic alternatives and the ability to consummate any transaction related to such strategic alternative; the timing and size of the workforce reduction
and related activities; the Company’s preliminary cash, cash equivalents and investments as of September 30, 2026 and the Company’s future financial position and plans. These forward-looking statements are based on the beliefs of
the management of Artiva as well as assumptions made by and information currently available to Artiva. Such statements reflect the current views of Artiva with respect to future events and are subject to known and unknown risks and uncertainties,
including, without limitation, the Company’s ability and timing to complete study close-out and continued patient follow-up; whether clinical data will be
published or presented as anticipated; whether the strategic review process will result in a transaction or enhance stockholder value; the costs and operational impacts of the workforce reduction and related activities. These and other factors that
may cause Artiva’s actual results to differ from current expectations are discussed in Artiva’s filings with the Securities and Exchange Commission (the “SEC”), including the section titled “Risk Factors” in
Artiva’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2026. 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, Artiva undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.
Contacts
Investors & Media
Noopur Batsha Liffick, MPH
NBL LifeSci Advisory LLC
ir@artivabio.com
Source: Artiva Biotherapeutics, Inc.
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