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

IND clearance and initiation of global basket trial exploring AlloNK$(R)$ + 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 $166.0 million as of March 31, 2025

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(R) 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(R) (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 

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(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. 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,     December 31, 
                                                 2025           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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May 08, 2025 08:00 ET (12:00 GMT)