ARTV 8-K
Artiva Biotherapeutics, Inc. (ARTV)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
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(Address of principal executive offices)
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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) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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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:
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Indicate by check mark whether the registrant is an emerging growth company as defined in 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 August 6, 2026, Artiva Biotherapeutics, Inc. (“Artiva”) issued a press release announcing its financial results for the quarter ended June 30, 2026. A copy of the press release is attached hereto as Exhibit 99.1.
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 Artiva expressly sets forth in such filing that such information is to be considered “filed” or incorporated by reference therein.
Item 9.01 |
Financial Statements and Exhibits. |
(d) Exhibits.
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Exhibit No. |
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Description |
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99.1 |
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104 |
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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.
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Artiva Biotherapeutics, Inc. |
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By: |
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/s/ Fred Aslan |
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Fred Aslan, M.D. |
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Chief Executive Officer |
Dated: August 6, 2026
Exhibit 99.1
Artiva Biotherapeutics Reports Second Quarter 2026 Financial Results and Recent Business Highlights
Clinical, safety and translational data presented at EULAR 2026 reinforced AlloNK®’s potential to drive deep B-cell depletion and meaningful clinical activity, with a tolerability profile supportive of outpatient administration
U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to AlloNK plus rituximab for refractory rheumatoid arthritis (RA)
Initiating Phase 3 registrational randomized controlled trial evaluating AlloNK plus rituximab versus rituximab alone in approximately 150 refractory RA patients in the second half of 2026
Strong balance sheet with cash, cash equivalents and investments of $349.4 million as of June 30, 2026, expected to fund operations into 2029
SAN DIEGO, August 6, 2026 -- 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 debilitating autoimmune diseases, today announced financial results for the second quarter ended June 30, 2026, and highlighted recent progress.
“The second quarter was transformative for Artiva. The clinical and translational data presented at EULAR reinforced AlloNK’s potential to drive deep B-cell depletion and meaningful clinical responses, with a tolerability profile supportive of outpatient administration. RMAT designation for refractory rheumatoid arthritis, together with FDA alignment on our Phase 3 design, further supports our advancement of AlloNK into registrational development,” said Fred Aslan, M.D., chief executive officer of Artiva Biotherapeutics. “Having raised approximately $300 million in an underwritten offering, we are well capitalized to initiate and execute our planned Phase 3 trial in refractory RA and continue advancing AlloNK across B-cell-driven autoimmune diseases.”
Recent Business Highlights
Presented clinical, safety and translational data for AlloNK at EULAR 2026
Received FDA RMAT designation for AlloNK plus rituximab in refractory RA
Published first peer-reviewed manuscript supporting AlloNK’s potential in B-cell-driven autoimmune disease
Completed an approximately $300 million underwritten offering
Strengthened the executive leadership team
Upcoming Milestone
Initiate Phase 3 registrational trial in refractory RA
Second Quarter 2026 Financial Results
About Artiva Biotherapeutics
Artiva is a clinical-stage biotechnology company whose mission is to develop effective, safe and accessible cell therapies for patients with debilitating autoimmune diseases. Artiva is initiating a Phase 3 registrational trial of its lead program, AlloNK® (also known as AB-101), in refractory rheumatoid arthritis (RA) in the second half of 2026. Initial clinical data evaluating AlloNK in combination with anti-CD20 antibodies have demonstrated encouraging activity across multiple B-cell-driven autoimmune diseases, together with a tolerability profile supportive of outpatient administration. AlloNK is an allogeneic, off-the-shelf, non-genetically modified, cryopreserved natural killer (NK) cell therapy candidate designed to enhance the antibody-dependent cellular cytotoxicity of anti-CD20 antibodies and drive deep B-cell depletion. Artiva is developing AlloNK to drive deep B-cell depletion through a scalable, outpatient-administered treatment regimen compatible with community rheumatology settings. In addition to refractory RA, AlloNK is being evaluated in Sjögren disease, systemic sclerosis and myositis.
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 regarding the potential benefits, accessibility, effectiveness and safety of AlloNK®, including based on interim pooled data across clinical trials; Artiva's registrational strategy, including trial design, the registrational Phase 3 trial for AlloNK® and generate sufficient trial and pooled safety data to support a BLA submission; Artiva's expectations on the timing to initiate and report data for the Phase 3 trial; Artiva's expectations with respect to ACR50 responses in the Phase 3 trial for both AlloNK® and the control arm; Artiva's ability to realize the potential benefits associated with FDA RMAT designation for AlloNK; and Artiva's future results of operations and financial position, including cash runway. 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, risks inherent in developing product candidates; Artiva's ability to obtain adequate financing to fund its planned clinical trials and other expenses; risks that future clinical trial results may not be consistent with interim, initial, preliminary, or topline results or results from prior preclinical studies or clinical trials; the risk that Artiva's registrational strategy is based in part on recent interactions with the FDA and later feedback from the FDA may be inconsistent with past interactions; the risk that differences exist between trial designs, patient characteristics and other factors for the Artiva-sponsored Phase 2a basket trial and an investigator-initiated basket trial, and caution should be exercised in drawing any conclusions from such data across separate trials as such pooling and comparative data is inherently limited and such data may not be directly comparable; and risks related to the legal and regulatory framework for the industry. 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 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.
Artiva Biotherapeutics, Inc.
Condensed Balance Sheets
(Unaudited)
(in thousands)
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June 30, |
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December 31, |
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Assets |
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Cash, cash equivalents and investments |
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$ |
349,394 |
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$ |
108,008 |
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Property and equipment, net |
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5,671 |
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6,618 |
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Operating and financing lease right-of-use assets |
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9,416 |
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10,737 |
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Other assets |
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4,152 |
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5,577 |
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Total assets |
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$ |
368,633 |
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$ |
130,940 |
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Liabilities and stockholders' equity |
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Accounts payable and accrued expenses |
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$ |
11,282 |
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$ |
9,955 |
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Operating and financing lease liabilities |
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9,849 |
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10,942 |
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Other liabilities |
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— |
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73 |
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Total liabilities |
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21,131 |
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20,970 |
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Stockholders' equity |
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347,502 |
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109,970 |
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Total liabilities and stockholders' equity |
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$ |
368,633 |
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$ |
130,940 |
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Artiva Biotherapeutics, Inc.
Condensed Statements of Operations and Comprehensive Loss
(Unaudited)
(in thousands, except share and per share data)
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Three Months Ended |
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Six Months Ended |
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2026 |
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2025 |
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2026 |
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2025 |
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Operating expenses: |
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Research and development |
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21,925 |
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17,861 |
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41,237 |
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34,914 |
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General and administrative |
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4,965 |
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4,949 |
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10,083 |
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10,068 |
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Total operating expenses |
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26,890 |
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22,810 |
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51,320 |
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44,982 |
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Loss from operations |
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(26,890 |
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(22,810 |
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(51,320 |
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(44,982 |
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Other income, net: |
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Interest income |
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1,886 |
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1,561 |
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2,798 |
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3,425 |
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Other (expense) income, net |
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(1 |
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(5 |
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1 |
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(8 |
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Total other income, net |
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1,885 |
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1,556 |
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2,799 |
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3,417 |
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Net loss |
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$ |
(25,005 |
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$ |
(21,254 |
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$ |
(48,521 |
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$ |
(41,565 |
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Net loss per share, basic and diluted |
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$ |
(0.63 |
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$ |
(0.87 |
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$ |
(1.51 |
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$ |
(1.71 |
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Weighted-average common shares outstanding, basic and diluted |
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39,413,236 |
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24,378,823 |
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32,086,532 |
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24,360,502 |
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Comprehensive loss: |
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Net loss |
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$ |
(25,005 |
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$ |
(21,254 |
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$ |
(48,521 |
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$ |
(41,565 |
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Other comprehensive (loss) income, net |
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(3 |
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2 |
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(124 |
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131 |
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Comprehensive loss |
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$ |
(25,008 |
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$ |
(21,252 |
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$ |
(48,645 |
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$ |
(41,434 |
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Contacts
Investors & Media: Noopur Batsha Liffick, MPH, NBL LifeSci Advisory LLC, [email protected]
Source: Artiva Biotherapeutics, Inc.