EX-99.1 2 artv-ex99_1.htm EX-99.1 EX-99.1

 

Exhibit 99.1

Artiva Biotherapeutics Reports Second Quarter 2025 Financial Results, Recent Business Highlights

 

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 $142.4 million as of June 30, 2025

 

SAN DIEGO, August 6, 2025 -- 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
o
Mechanistic and translational data for AlloNK in autoimmune diseases
o
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
o
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.