AlloNK data moves Artiva (NASDAQ: ARTV) toward Phase 3 RA trial
Rhea-AI Filing Summary
Artiva Biotherapeutics reported a first-quarter 2026 net loss of $23.5 million as it advances its AlloNK cell therapy program for autoimmune diseases. Cash, cash equivalents and investments were $86.8 million as of March 31, 2026, down from $108.0 million at year-end 2025.
Initial refractory rheumatoid arthritis data from AlloNK plus rituximab showed a 71% ACR50 response rate at six months in a company-sponsored Phase 2a basket trial, with no patients relapsing or needing new immunomodulatory drugs. Across 55 autoimmune patients, no cytokine release syndrome or ICANS and a 2% rate of grade 3 or higher infections were reported.
The company has alignment with the FDA on conducting a single Phase 3 registrational randomized controlled trial in approximately 150 refractory RA patients, comparing AlloNK plus rituximab to rituximab alone, with ACR50 at six months as the primary endpoint. Trial initiation is planned for the second half of 2026 and a potential BLA submission is targeted for 2029.
Positive
- AlloNK efficacy signal in refractory RA: In the company-sponsored Phase 2a basket trial, 71% of refractory rheumatoid arthritis patients with at least six months of follow-up achieved an ACR50 response on AlloNK plus rituximab, with no relapses or need for new immunomodulatory agents reported at the data cutoff.
- Favorable safety and outpatient profile: Among 55 autoimmune patients treated with AlloNK plus rituximab, no cytokine release syndrome or ICANS was observed and grade 3 or higher infections occurred in 2% of patients, supporting administration in community rheumatology settings.
- Regulatory alignment on Phase 3 path: The FDA agreed with a single Phase 3 registrational randomized controlled trial of approximately 150 refractory RA patients, using ACR50 at six months as the primary endpoint and supporting Artiva’s plan for a potential BLA submission in 2029.
Negative
- Rising losses and shrinking cash balance: Net loss increased to $23.5 million for Q1 2026 from $20.3 million a year earlier, while cash, cash equivalents and investments declined to $86.8 million from $108.0 million at December 31, 2025, highlighting ongoing funding needs for late-stage trials.
Insights
Strong early AlloNK data and FDA alignment support Artiva’s RA strategy, despite ongoing cash burn.
Artiva Biotherapeutics reported Q1 2026 net loss of $23.5M on operating expenses of $24.4M, reflecting continued investment in AlloNK development. Cash, cash equivalents and investments of $86.8M as of March 31, 2026 provide a finite but meaningful runway for clinical execution.
Clinically, AlloNK plus rituximab generated a 71% ACR50 response at six months in refractory RA patients within the company-sponsored Phase 2a basket trial, alongside no CRS or ICANS and a 2% rate of grade 3+ infections across 55 autoimmune patients. This combination of efficacy signal and outpatient-suitable safety is notable in a difficult-to-treat population.
The company obtained FDA alignment on a single Phase 3 registrational randomized controlled trial in approximately 150 refractory RA patients, with ACR50 at six months as the primary endpoint and potential BLA submission in 2029. While timelines and outcomes remain contingent on future data and funding, these disclosures outline a clear regulatory path in a large unmet-need segment of the RA market.
8-K Event Classification
Key Figures
Key Terms
ACR50 response medical
b/tsDMARDs medical
B-cell depletion medical
registrational randomized controlled trial regulatory
biologics license application (BLA) regulatory
cytokine release syndrome (CRS) medical
Earnings Snapshot
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
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FORM
CURRENT REPORT
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| Item 2.02 | Results of Operations and Financial Condition. |
On May 8, 2026, Artiva Biotherapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended March 31, 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 (the “Securities Act”), 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 7.01 | Regulation FD Disclosure. |
On May 8, 2026, the Company issued a press release announcing positive initial clinical data from ongoing clinical trials evaluating AlloNK® (also known as AB-101) in combination with rituximab. A copy of the press release is furnished as Exhibit 99.2 to this Current Report on Form 8-K.
On May 8, 2026, the Company made available an updated corporate presentation, which can be found on the Company’s website (the “Corporate Presentation”). The Corporate Presentation is furnished as Exhibit 99.3 and is incorporated herein by reference.
The information set forth in this Item 7.01 and the accompanying Exhibits 99.2 and 99.3 are deemed to be “furnished” under “Item 7.01 Regulation FD Disclosure” and shall not be deemed to be “filed” for purposes of Section 18 of the Exchange Act, or otherwise subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act. The information set forth in this Item 7.01, including Exhibits 99.2 and 99.3, shall not be deemed incorporated by reference into any filing with the Securities and Exchange Commission (the “SEC”) made by us, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
| Item 8.01 | Other Events. |
ATM Suspension
On May 8, 2026, the Company delivered written notice to Leerink Partners LLC (“Leerink”) that the Company has suspended and is not offering any shares of its common stock pursuant to the prospectus filed with the SEC on August 6, 2025, relating to the Sales Agreement, dated August 6, 2025 (the “Sales Agreement”), by and between the Company and Leerink. The Company will not make any sales of common stock pursuant to the Sales Agreement unless and until a new prospectus supplement is filed with the SEC; however, the Sales Agreement remains in full force and effect.
Company Update
As of the April 3, 2026 data cutoff, the initial clinical dataset includes 21 refractory rheumatoid arthritis (“RA”) patients with at least 12 weeks of follow-up, including 13 patients with six months of follow-up, from the Company’s company-sponsored Phase 2a basket trial and an investigator-initiated basket trial evaluating AlloNK in B-cell driven autoimmune diseases. The broader autoimmune dataset also includes 11 Sjogren disease (“SjD”) patients and five systemic sclerosis (“SSc”) patients, including seven SjD patients and four SSc patients with at least six months of follow-up.
The Company also announced alignment with the U.S. Food and Drug Administration (“FDA”) on a single registrational randomized controlled trial design for AlloNK in refractory RA expected to enroll approximately 150 RA patients who have had an inadequate response to two or more biologic or targeted synthetic disease modifying anti-rheumatic drugs (“b/tsDMARDs”) of distinct classes. Patients are expected to be randomized 2:1 to receive AlloNK plus rituximab or rituximab alone, with ACR50 response at six months as the primary efficacy endpoint.
As of April 30, 2026, more than 70 autoimmune patients had initiated treatment with AlloNK across ongoing clinical trials, with more than 40 clinical sites activated globally. All patients have been treated in the outpatient setting, with the majority treated in community rheumatology clinics, providing a strong foundation to support the Company’s planned Phase 3 registrational trial in refractory RA.
Summary of Efficacy Data in Refractory RA
Patients had longstanding and highly active disease, with mean disease duration of 14.8 years. All patients had high disease activity at baseline and 81% had failed two or more prior b/tsDMARD classes. More than 50% of patients with six months of follow-up achieved an ACR50 response. Patients with only 12 weeks of follow-up demonstrated early improvements across disease activity measures consistent with those observed in patients with six or more months of follow-up. No patient started a new b/tsDMARD following treatment with AlloNK plus rituximab as of the data cutoff.
Nineteen of 21 patients demonstrated clinically meaningful reductions from baseline in both CDAI (defined as reductions of at least 12 points) and DAS28-ESR (defined as reductions of at least 1.2 points). Clinically meaningful reductions in CDAI and DAS28-ESR were observed by three months and deepened at six months, with mean reductions from baseline at six months of 37 points in CDAI and 2.8 points in DAS28-ESR.
Summary of Safety Data
No cytokine release syndrome (“CRS”) or immune effector cell-associated neurotoxicity syndrome (“ICANS”) was reported. Additionally, no treatment discontinuations due to adverse events and no serious adverse events related to AlloNK were reported.
The most common treatment-emergent adverse events were consistent with those associated with rituximab or cyclophosphamide/fludarabine conditioning. The Grade 3 or higher infection rate was 2% (n=1), which is comparable to serious infection rates reported for approved RA therapies, including rituximab and other biologic or targeted therapies.
During the initial 28-day post-treatment period, no patients were hospitalized for infection. Two of 55 autoimmune patients treated with AlloNK plus rituximab were hospitalized for treatment-emergent adverse events during this period: one admission for dehydration in a SjD patient with diarrhea and one admission for diabetic ketoacidosis in a RA patient with insulin-dependent Type 2 diabetes. Neither hospitalization was deemed related to AlloNK.
Summary of B-cell depletion and B-cell reconstitution profile
Uniform and consistent B-cell depletion in peripheral blood was observed by Day 13 in all 51 patients treated with cyclophosphamide/fludarabine, AlloNK and rituximab who had available samples as of the April 3, 2026 data cutoff. Complete B-cell depletion was observed using a high-sensitivity assay in all 28 RA patients evaluated as of the data cutoff. B-cell reconstitution in all patients treated with AlloNK plus rituximab demonstrated a predominance of naïve/transitional B cells, consistent with the hypothesized B-cell “reset” mechanism.
Summary of Efficacy Data in SjD and SSc
As of the April 3, 2026 data cutoff, initial clinical data included 11 patients with moderate-to-severe SjD and five patients with moderate-to-severe SSc. Clinical responses observed in these patient populations were consistent with the RA data and support the potential of AlloNK across B-cell driven autoimmune diseases. In SjD, patients demonstrated mean improvements at six months (n=7) of 8.6 points in ClinESSDAI, 6.6 points in ESSDAI and 3.0 points in ESSPRI, with a mean increase of 0.76 mL/min in stimulated salivary flow. All patients were off steroids as of the April 3, 2026 data cutoff. In SSc, patients demonstrated a mean improvement in mRSS of 9.5 points at six months (n=4), with 100% achieving rCRISS25 and 50% achieving rCRISS50 responses among patients with six months of follow-up. No patients were on steroids as of the April 3, 2026 data cutoff.
FDA Alignment and Registrational Strategy in Refractory RA
Following a recent FDA interaction, the Company plans to initiate a Phase 3 randomized controlled trial evaluating AlloNK in approximately 150 RA patients who have had an inadequate response to two or more b/tsDMARDs of distinct classes. The Company has alignment with the FDA on the Company’s plans to conduct a single registrational trial design. Patients are expected to be randomized 2:1 to receive AlloNK plus rituximab or rituximab alone, with ACR50 response at six months as the primary efficacy endpoint. Rituximab was selected as the active comparator because it is a component of the proposed AlloNK treatment regimen, is approved for the treatment of RA and has demonstrated ACR50 responses at six months in line with other approved RA therapies. Patients randomized to the rituximab-alone control arm who do not respond are expected to have the opportunity to cross over to the AlloNK plus rituximab arm at six months.
The proposed AlloNK dosing regimen is expected to include two doses of 4 billion AlloNK cells administered on Days 6 and 20 together with rituximab, following conditioning with low-dose cyclophosphamide and fludarabine on Days 1, 2 and 3.
Assuming a favorable risk-benefit profile, the Company believes its ongoing and planned autoimmune clinical trials, including the planned Phase 3 registrational trial in refractory RA, will generate a safety database of more than 250 patients treated with AlloNK plus rituximab, consisting primarily of RA patients and including patients with other autoimmune diseases, to support a potential biologics license application (BLA) submission for RA. Based on FDA feedback, the Company believes pooled safety data across autoimmune indications may supplement RA-specific safety data.
Subject to final protocol and regulatory considerations, the trial is expected to be conducted globally across more than 80 sites, including approximately 40 sites already active in the Company’s ongoing autoimmune clinical program. The Company expects to initiate the registrational trial in the second half of 2026 and report primary efficacy data in the second half of 2028, with a potential BLA submission in 2029.
Significant opportunity and unmet need in refractory RA
RA remains a large and underserved autoimmune disease, particularly among patients who have had an inadequate response to two or more b/tsDMARD classes, also known as difficult-to-treat RA under EULAR guidelines. The Company estimates that between 150,000 to 200,000 patients in the U.S. have failed two or more b/tsDMARDs, representing approximately 25% of the U.S. b/tsDMARD-treated RA population. Real-world registry analyses and published data suggest that patients in this setting only have an 11% to 19% likelihood of achieving an ACR50 response with currently available therapies. The Company estimates that within the U.S. RA market (valued at approximately $20 billion per year), about $5 billion annually is spent on patients with an 80–90% chance of not achieving an ACR50 response.
The Company’s objective is to develop AlloNK as a deep B-cell depleting therapy in combination with rituximab with the potential to deliver ACR50 responses in at least 50% of refractory RA patients at six months, provide durable clinical benefit, and offer an outpatient treatment profile that can be administered and managed in community rheumatology settings. The Company expects patients in the rituximab-alone control arm to achieve ACR50 responses of approximately 20% to 25% at six months.
Forward Looking Statements
This Current Report on Form 8-K (this “Report”) contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements in this Report that are not statements of historical fact are forward-looking statements. Such forward-looking statements include, without limitation, statements regarding: expectations of the Company regarding the potential benefits, accessibility, effectiveness and safety of AlloNK, including based on interim pooled data across clinical trials; the Company’s registrational strategy, including trial design, plans to conduct a single registrational Phase 3 trial for AlloNK and generate sufficient trial and pooled safety data to support a BLA submission, and the Company’s expectations on timing and FDA alignment with such strategy; the Company’s expectations on the timing to initiate and report data for the Phase 3 trial; the Company’s expectations with respect to ACR50 responses in the Phase 3 trial for both AlloNK and the control arm; estimates regarding the size of patient populations and response rates to existing therapies; and the potential market opportunity for AlloNK. 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, including, without limitation, risks inherent in developing product candidates; the Company’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 the Company’s registrational strategy is based in part on its views following its recent meeting with the FDA and later feedback from the FDA may be inconsistent with such meeting or its views from such meeting, including the risk that the official FDA minutes which the Company expects to receive in the coming weeks may include interpretations, requests for additional data, or conclusions that differ from the Company’s understanding of prior discussions; the risk that differences exist between trial designs, patient characteristics and other factors for the Company-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 the Company’s actual results to differ from current expectations are described in further detail under the section titled “Risk Factors” contained in the Company’s filings with the Securities and Exchange Commission (the “SEC”), including the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, and its subsequent Quarterly Reports on Form 10-Q, each as filed or to be filed with the SEC. 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.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits.
| Exhibit No. |
Description | |
| 99.1 | Press Release, dated May 8, 2026. | |
| 99.2 | Press Release, dated May 8, 2026. | |
| 99.3 | Corporate Presentation, dated May 8, 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. | ||
| President and Chief Executive Officer | ||
Dated: May 8, 2026
Exhibit 99.1
Artiva Biotherapeutics Reports First Quarter 2026 Financial Results and Recent Business Highlights
Initial AlloNK® (AB-101) clinical data demonstrated 71% ACR50 response in refractory rheumatoid
arthritis (RA) patients with at least six months of follow-up in the company-sponsored Phase 2a basket
trial, with no patients relapsing or requiring new immunomodulatory agents
AlloNK treatment regimen demonstrated a consistent pattern of deep B-cell depletion and tolerability
results supportive of outpatient administration in community rheumatology settings
U.S. Food and Drug Administration (FDA) alignment on a single Phase 3 registrational randomized
controlled trial evaluating AlloNK plus rituximab versus rituximab alone in approximately 150 refractory
RA patients, with ACR50 at six months as the primary endpoint; trial initiation planned for H2 2026
Multiple oral and poster presentations at EULAR 2026, including a late-breaking oral presentation on
AlloNK clinical efficacy in refractory RA, Sjögren disease (SjD) and systemic sclerosis (SSc)
SAN DIEGO, May 8, 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 first quarter ended March 31, 2026, and highlighted recent progress.
“Artiva has reached an important inflection point, with positive initial clinical data across multiple autoimmune diseases and FDA alignment on a single Phase 3 registrational trial design in refractory RA,” said Fred Aslan, M.D., president and chief executive officer of Artiva Biotherapeutics. “The initial RA data demonstrated meaningful responses in highly refractory patients, alongside a tolerability profile supportive of outpatient administration in community rheumatology settings. Together, these data support AlloNK’s potential to become the first deep B-cell depleting therapy to advance into a Phase 3 trial in refractory RA, the autoimmune indication with the largest number of refractory patients.”
Dr. Aslan continued, “By combining deep B-cell depletion, meaningful clinical responses and an outpatient profile suited to community rheumatology practices, AlloNK has the potential to redefine the treatment paradigm for patients with refractory autoimmune disease.”
Recent Business Highlights
Reported positive initial clinical data from ongoing clinical trials evaluating AlloNK in combination with rituximab across multiple autoimmune diseases
| • | As of the April 3, 2026 data cutoff, the initial clinical dataset included 21 refractory RA patients with at least 12 weeks of follow-up, including 13 patients with at least six months of follow-up from Artiva’s company-sponsored Phase 2a basket trial and an investigator-initiated basket trial evaluating AlloNK in B-cell driven autoimmune disease. The broader autoimmune dataset also included 11 SjD patients and five SSc patients, including seven SjD patients and four SSc patients with at least six months of follow-up. |
| • | In refractory RA, clinically meaningful improvements were observed across multiple measures of disease activity, including ACR responses, CDAI and DAS28-ESR. Five of seven patients (71%) with six months of follow-up in the company-sponsored Phase 2a basket trial achieved an ACR50 response. Nineteen of 21 RA patients demonstrated clinically meaningful reductions from baseline in both CDAI and DAS28-ESR. |
| • | The AlloNK treatment regimen demonstrated tolerability results supportive of outpatient administration in community rheumatology settings, with no CRS, ICANS or treatment discontinuations related to AlloNK reported as of the data cutoff. |
| • | Deep B-cell depletion was observed across evaluable patients, including complete B-cell depletion using a high-sensitivity assay in all 28 RA patients evaluated as of the data cutoff, supporting AlloNK’s proposed mechanism of action. |
| • | Clinical responses in SjD and SSc were consistent with the RA data and support the potential of AlloNK across B-cell-driven autoimmune diseases. |
| • | More than 70 autoimmune patients have been treated with AlloNK across more than 40 active clinical sites, mostly in community rheumatology settings, providing a strong foundation for planned registrational trial initiation. |
Achieved FDA alignment on Phase 3 registrational trial design in refractory RA
| • | Artiva announced alignment with the FDA on a single Phase 3 registrational randomized controlled trial evaluating AlloNK plus rituximab versus rituximab alone in approximately 150 refractory RA patients, with ACR50 response at six months as the primary endpoint. |
Upcoming Milestones
Present AlloNK clinical data at EULAR 2026
| • | Multiple abstracts accepted for presentation at EULAR 2026, expected to further characterize AlloNK’s mechanism of action, clinical activity and outpatient feasibility, including: |
| • | Late Breaking Oral Abstract Presentation - LB0003: AB-101, an Outpatient-Administered Allogeneic NK Cell Therapy Combined with Rituximab, Generates Robust Clinical Efficacy Responses Comparable with Autologous CAR T in 31 Patients with Rheumatologic Diseases |
| • | Oral Abstract Presentation - OP0129: AB-101, an Allogeneic NK Cell Therapy, Combined with Rituximab was Highly Effective in Severe Sjögren Disease: Experience in First Patient Treated |
| • | Poster View Presentation - POS1177: Robust and Durable Clinical Responses Observed Following Treatment with AB-101, an Allogeneic NK Cell Therapy, Combined with Rituximab in Patients with Severe Rheumatoid Arthritis and Inadequate Response to Multiple Prior Targeted Therapies |
| • | Poster Tour - POS0355: AB-101, an Allogeneic NK Cell Therapy, in Combination with Anti-CD20 Monoclonal Antibodies, Consistently Achieves Deep B-cell Depletion Comparable with CAR T Cell Therapies in Patients with Rheumatologic Diseases |
Initiate Phase 3 registrational trial in refractory RA
| • | In the second half of 2026, Artiva plans to initiate a Phase 3 randomized controlled trial evaluating AlloNK plus rituximab versus rituximab alone in approximately 150 RA patients who have had an inadequate response to two or more biologic or targeted synthetic disease-modifying anti-rheumatic drugs (b/tsDMARDs) of distinct classes, with ACR50 response at six months as the primary efficacy endpoint. |
First Quarter 2026 Financial Results
| • | Cash, Cash Equivalents and Investments. As of March 31, 2026, Artiva had cash, cash equivalents and investments of $86.8 million, which is expected to fund operations into Q2 2027. |
| • | Research and Development Expenses. Research and development expenses were $19.3 million for the three months ended March 31, 2026, compared to $17.1 million for the three months ended March 31, 2025. |
| • | General and Administrative Expenses. General and administrative expenses were $5.1 million for each of the three months ended March 31, 2026 and 2025. |
| • | Other Income, net. Other income, net, was $0.9 million for the three months ended March 31, 2026, compared to other income, net, of $1.9 million for the three months ended March 31, 2025. |
| • | Net Loss. Net loss totaled $23.5 million for the three months ended March 31, 2026, as compared to net loss of $20.3 million for the three months ended March 31, 2025, with non-cash stock-based compensation expense of $1.6 million and $2.1 million for the three months ended March 31, 2026 and 2025, 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 debilitating autoimmune diseases. 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, 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 plans to initiate a Phase 3 registrational trial evaluating AlloNK in refractory RA in 2026. 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 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, plans to conduct a single registrational Phase 3 trial for AlloNK® and generate sufficient trial and pooled safety data to support a BLA submission, and Artiva’s expectations on timing and FDA alignment with such strategy; 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; estimates regarding the size of patient populations and response rates to existing therapies; the potential market opportunity for AlloNK®; Artiva’s future results of operations and financial position, including cash runway; and Artiva’s presentation 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, 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 its views following its recent meeting with the FDA and later feedback from the FDA may be inconsistent with such meeting or its views from such meeting, including the risk that the official FDA minutes which Artiva expects to receive in the coming weeks may include interpretations, requests for additional data, or conclusions that differ from Artiva’s understanding of prior discussions; 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 March 31, 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)
| March 31, 2026 |
December 31, 2025 |
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| Assets |
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| Cash, cash equivalents and investments |
$ | 86,782 | $ | 108,008 | ||||
| Property and equipment, net |
6,216 | 6,618 | ||||||
| Operating and financing lease right-of-use assets |
10,080 | 10,737 | ||||||
| Other assets |
2,877 | 5,577 | ||||||
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| Total assets |
$ | 105,955 | $ | 130,940 | ||||
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| Liabilities and stockholders’ equity |
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| Accounts payable and accrued expenses |
$ | 7,845 | $ | 9,955 | ||||
| Operating and financing lease liabilities |
10,263 | 10,942 | ||||||
| Other liabilities |
— | 73 | ||||||
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| Total liabilities |
18,108 | 20,970 | ||||||
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| Stockholders’ equity |
87,847 | 109,970 | ||||||
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| Total liabilities and stockholders’ equity |
$ | 105,955 | $ | 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)
| Three Months Ended March 31, |
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| 2026 | 2025 | |||||||
| Operating expenses: |
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| Research and development |
19,312 | 17,052 | ||||||
| General and administrative |
5,118 | 5,119 | ||||||
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| Total operating expenses |
24,430 | 22,171 | ||||||
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| Loss from operations |
(24,430 | ) | (22,171 | ) | ||||
| Other income, net: |
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| Interest income |
912 | 1,864 | ||||||
| Other income (expense), net |
2 | (4 | ) | |||||
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| Total other income, net |
914 | 1,860 | ||||||
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Contacts
Investors
Noopur Batsha Liffick, MPH
NBL LifeSci Advisory LLC
ir@artivabio.com
Media
Jessica Yingling, Ph.D.
Little Dog Communications Inc.
jessica@litldog.com
Source: Artiva Biotherapeutics, Inc.
Exhibit 99.2
Artiva Announces Positive Initial Clinical Data with AlloNK® Across Multiple Autoimmune Diseases and FDA Alignment to Initiate Phase 3 Registrational Trial in Rheumatoid Arthritis in 2026
Initial clinical data demonstrated in the company-sponsored Phase 2a basket trial 71% ACR50 response in refractory rheumatoid arthritis (RA) patients with at least six months of follow-up, with no patients relapsing or requiring new immunomodulatory agents
AlloNK treatment regimen demonstrated tolerability results supportive of outpatient administration in community rheumatology settings, with no CRS, ICANS, or treatment discontinuations observed in autoimmune patients treated with AlloNK
More than 70 autoimmune patients treated with AlloNK across more than 40 active clinical sites, mostly in community settings, providing a strong foundation for planned registrational trial initiation in H2 2026
U.S. Food and Drug Administration (FDA) alignment on a single registrational randomized controlled trial evaluating AlloNK plus rituximab versus rituximab alone in approximately 150 refractory RA patients, with ACR50 at six months as the primary endpoint
Multiple oral and poster presentations at EULAR 2026, including a late-breaking oral presentation on AlloNK clinical efficacy in refractory RA, Sjögren disease (SjD) and systemic sclerosis (SSc)
SAN DIEGO, May 8, 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 positive initial clinical data from ongoing clinical trials evaluating AlloNK® (also known as AB-101) in combination with rituximab. As of the April 3, 2026 data cutoff, the initial clinical dataset includes 21 refractory RA patients with at least 12 weeks of follow-up, including 13 patients with six months of follow-up, from Artiva’s company-sponsored Phase 2a basket trial and an investigator-initiated basket trial evaluating AlloNK in B-cell driven autoimmune diseases. The broader autoimmune dataset also includes 11 SjD patients and five SSc patients, including seven SjD patients and four SSc patients with at least six months of follow-up.
Artiva also announced alignment with the FDA on a single registrational randomized controlled trial design for AlloNK in refractory RA expected to enroll approximately 150 RA patients who have had an inadequate response to two or more biologic or targeted synthetic disease modifying anti-rheumatic drugs (b/tsDMARDs) of distinct classes. Patients are expected to be randomized 2:1 to receive AlloNK plus rituximab or rituximab alone, with ACR50 response at six months as the primary efficacy endpoint.
“A new chapter begins for Artiva as we advance the first deep B-cell depleting therapy into a registrational trial in RA and share clinical data demonstrating AlloNK’s potential to drive auto-CAR-T-like activity across indications through an off-the-shelf, more scalable and cost-effective therapeutic approach that could address refractory patients in the community setting,” said Fred Aslan, M.D., president and chief executive officer of Artiva Biotherapeutics. “I am very proud of the Artiva team. In less than four years since the seminal deep B-cell depletion work was published by Schett et al., we rapidly initiated and supported trials in autoimmune diseases, activated more than 40 sites globally, treated more than 70 autoimmune patients and built a robust clinical trial network, mostly in the community setting, to support our efforts to conduct an efficient randomized controlled trial in RA, one of the largest refractory autoimmune patient populations.”
“After reviewing AlloNK’s initial clinical data in refractory RA, I am encouraged by the magnitude and consistency of improvements across multiple measures of disease activity, including swollen and tender joint counts, CDAI, DAS28 and ACR responses,” said Stanley Cohen, M.D., adjunct professor of internal medicine at University of Texas Southwestern Medical School and program director of rheumatology at THR Presbyterian Dallas. “Patients who have had an inadequate response to multiple distinct b/tsDMARDs remain difficult to treat, and there is a significant need for new therapeutic approaches that can deliver meaningful clinical benefit. I am pleased to be advising Artiva on their planned Phase 3 registrational trial of AlloNK in refractory RA.”
“Since the inception of Artiva’s clinical trials in autoimmune diseases, I have treated more than 20 patients with AlloNK in my community practice and have observed meaningful improvements in many refractory patients across indications,” said Guillermo J. Valenzuela, M.D., F.A.C.R., medical director of Integral Rheumatology & Immunology Specialists (IRIS). “Importantly, these clinical responses have been observed alongside a favorable tolerability profile that supports administration and management in the community setting. I am enthusiastic to see AlloNK advance into a Phase 3 trial for refractory RA.”
As of April 30, 2026, more than 70 autoimmune patients had initiated treatment with AlloNK across ongoing clinical trials, with more than 40 clinical sites activated globally. All patients have been treated in the outpatient setting, with the majority treated in community rheumatology clinics, providing a strong foundation to support Artiva’s planned Phase 3 registrational trial in refractory RA.
Key Data Highlights
Initial clinical activity observed in refractory RA patients
| • | As of the April 3, 2026 data cutoff, pooled data included 21 refractory RA patients with at least 12 weeks of follow-up, including 13 patients with six months of follow-up, from Artiva’s company-sponsored Phase 2a basket trial and an investigator-initiated basket trial. |
| • | Patients had longstanding and highly active disease, with mean disease duration of 14.8 years. All patients had high disease activity at baseline and 81% had failed two or more prior b/tsDMARD classes. |
| • | Five of seven patients (71%) with six months of follow-up in the company-sponsored Phase 2a basket trial achieved an ACR50 response. In the investigator-initiated basket trial, five of six patients (83%) with six months of follow-up demonstrated greater than 50% improvement on at least four of five measured components; HAQ-DI and Pain scores were not collected in the IIT, and therefore ACR50 could not be adequately assessed. Patients with only 12 weeks of follow-up demonstrated early improvements across disease activity measures consistent with those observed in patients with six or more months of follow-up. As of the data cutoff, no patients started a new b/tsDMARD following treatment with AlloNK plus rituximab. |
| • | Nineteen of 21 patients demonstrated clinically meaningful reductions from baseline in both CDAI (defined as reductions of at least 12 points) and DAS28-ESR (defined as reductions of at least 1.2 points). Clinically meaningful reductions in CDAI and DAS28-ESR were observed by three months and deepened at six months, with mean reductions from baseline at six months of 37 points in CDAI and 2.8 points in DAS28-ESR. |
Tolerability profile of AlloNK plus rituximab continues to support outpatient administration in community rheumatology settings
| • | All patients have been treated in the outpatient setting, with the majority treated in community rheumatology clinics. |
| • | No cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) was reported. |
| • | No treatment discontinuations due to adverse events and no serious adverse events related to AlloNK were reported. |
| • | The most common treatment-emergent adverse events were consistent with those associated with rituximab or cyclophosphamide/fludarabine conditioning. The Grade 3 or higher infection rate was 2% (n=1), which is comparable to serious infection rates reported for approved RA therapies, including rituximab and other biologic or targeted therapies. |
| • | During the initial 28-day post-treatment period, no patients were hospitalized for infection. Two of 55 autoimmune patients treated with AlloNK plus rituximab were hospitalized for treatment-emergent adverse events during this period: one admission for dehydration in a SjD patient with diarrhea and one admission for diabetic ketoacidosis in a RA patient with insulin-dependent Type 2 diabetes. Neither hospitalization was deemed related to AlloNK. |
Deep B-cell depletion and B-cell reconstitution profile support proposed mechanism of action
| • | Uniform and consistent B-cell depletion in peripheral blood was observed by Day 13 in all 51 patients treated with cyclophosphamide/fludarabine, AlloNK and rituximab who had available samples as of the April 3, 2026 data cutoff. |
| • | Complete B-cell depletion was observed using a high-sensitivity assay in all 28 RA patients evaluated as of the data cutoff. |
| • | B-cell reconstitution in all patients treated with AlloNK plus rituximab demonstrated a predominance of naïve/transitional B cells, consistent with the hypothesized B-cell “reset” mechanism. |
Initial clinical responses in Sjögren disease and systemic sclerosis support broader potential across B-cell-driven autoimmune diseases
| • | As of the April 3, 2026 data cutoff, initial clinical data included 11 patients with moderate-to-severe SjD and five patients with moderate-to-severe SSc. Clinical responses observed in these patient populations were consistent with the RA data and support the potential of AlloNK across B-cell driven autoimmune diseases. |
| • | In SjD, patients demonstrated mean improvements at six months (n=7) of 8.6 points in ClinESSDAI, 6.6 points in ESSDAI and 3.0 points in ESSPRI, with a mean increase of 0.76 mL/min in stimulated salivary flow. All patients were off steroids as of the April 3, 2026 data cutoff. |
| • | In SSc, patients demonstrated a mean improvement in mRSS of 9.5 points at six months (n=4), with 100% achieving rCRISS25 and 50% achieving rCRISS50 responses among patients with six months of follow-up. No patients were on steroids as of the April 3, 2026 data cutoff. |
FDA Alignment and Registrational Strategy in Refractory RA
Following a recent FDA interaction, Artiva plans to initiate a Phase 3 randomized controlled trial evaluating AlloNK in approximately 150 RA patients who have had an inadequate response to two or more b/tsDMARDs of distinct classes. Artiva has alignment with the FDA on its plans to conduct a single registrational trial design. Patients are expected to be randomized 2:1 to receive AlloNK plus rituximab or rituximab alone, with ACR50 response at six months as the primary efficacy endpoint. Rituximab was selected as the active comparator because it is a component of the proposed AlloNK treatment regimen, is approved for the treatment of RA and has demonstrated ACR50 responses at six months in line with other approved RA therapies. Patients randomized to the rituximab-alone control arm who do not respond are expected to have the opportunity to cross over to the AlloNK plus rituximab arm at six months.
The proposed AlloNK dosing regimen is expected to include two doses of 4 billion AlloNK cells administered on Days 6 and 20 together with rituximab, following conditioning with low-dose cyclophosphamide and fludarabine on Days 1, 2 and 3.
Assuming a favorable risk-benefit profile, Artiva believes its ongoing and planned autoimmune clinical trials, including the planned Phase 3 registrational trial in refractory RA, will generate a safety database of more than 250 patients treated with AlloNK plus rituximab, consisting primarily of RA patients and including patients with other autoimmune diseases, to support a potential biologics license application (BLA) submission for RA. Based on FDA feedback, Artiva believes pooled safety data across multiple autoimmune indications may supplement RA-specific safety data.
Subject to final protocol and regulatory considerations, the trial is expected to be conducted globally across more than 80 sites, including approximately 40 sites already active in Artiva’s ongoing autoimmune clinical program. Artiva expects to initiate the registrational trial in the second half of 2026 and report primary efficacy data in the second half of 2028, with a potential BLA submission in 2029.
Significant opportunity and unmet need in refractory RA
RA remains a large and underserved autoimmune disease, particularly among patients who have had an inadequate response to two or more b/tsDMARD classes, also known as difficult-to-treat RA under EULAR guidelines. Artiva estimates that between 150,000 to 200,000 patients in the U.S. have failed two or more b/tsDMARDs, representing approximately 25% of the U.S. b/tsDMARD-treated RA population. Real-world registry analyses and published data suggest that patients in this setting only have an 11% to 19% likelihood of achieving an ACR50 response with currently available therapies.
Artiva’s objective is to develop AlloNK as a deep B-cell depleting therapy in combination with rituximab with the potential to deliver ACR50 responses in at least 50% of refractory RA patients at six months, provide durable clinical benefit and offer an outpatient treatment profile that can be administered and managed in community rheumatology settings. Artiva expects patients in the rituximab-alone control arm to achieve ACR50 responses of approximately 20% to 25% at six months.
Multiple abstracts accepted for presentation at EULAR 2026
| • | Late Breaking Oral Abstract Presentation - LB0003: AB-101, an Outpatient-Administered Allogeneic NK Cell Therapy Combined with Rituximab, Generates Robust Clinical Efficacy Responses Comparable with Autologous CAR T in 31 Patients with Rheumatologic Diseases |
| • | Oral Abstract Presentation - OP0129: AB-101, an Allogeneic NK Cell Therapy, Combined with Rituximab was Highly Effective in Severe Sjögren Disease: Experience in First Patient Treated |
| • | Poster View Presentation - POS1177: Robust and Durable Clinical Responses Observed Following Treatment with AB-101, an Allogeneic NK Cell Therapy, Combined with Rituximab in Patients with Severe Rheumatoid Arthritis and Inadequate Response to Multiple Prior Targeted Therapies |
| • | Poster Tour - POS0355: AB-101, an Allogeneic NK Cell Therapy, in Combination with Anti-CD20 Monoclonal Antibodies, Consistently Achieves Deep B-cell Depletion Comparable with CAR T Cell Therapies in Patients with Rheumatologic Diseases |
About AlloNK®
AlloNK® (also known as AB-101) is an allogeneic, off-the-shelf, non-genetically modified, cryopreserved natural killer (NK) cell therapy candidate designed to enhance the antibody-dependent cellular cytotoxicity effect of monoclonal antibodies to drive B-cell depletion. In rheumatoid arthritis (RA) and other autoimmune diseases, AlloNK is being evaluated in combination with anti-CD20 monoclonal antibodies following a standard conditioning regimen of low-dose cyclophosphamide and fludarabine. AlloNK is currently being evaluated across multiple ongoing clinical trials in B-cell driven autoimmune diseases, including refractory RA, Sjögren disease, systemic sclerosis and idiopathic inflammatory myopathies (myositis).
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’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, including a company-sponsored basket trial across autoimmune diseases that includes rheumatoid arthritis and Sjögren disease and an investigator-initiated basket trial in B-cell driven autoimmune diseases. Artiva plans to initiate a Phase 3 registrational trial evaluating AlloNK in refractory RA in 2026. 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 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, plans to conduct a single registrational Phase 3 trial for AlloNK and generate sufficient trial and pooled safety data to support a BLA submission, and Artiva’s expectations on timing and FDA alignment with such strategy; 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; estimates regarding the size of patient populations and response rates to existing therapies; and the potential market opportunity for AlloNK. These forward-looking statements are based on the beliefs of the management of Artiva as well as assumptions made by and information currently available 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 its views following its recent meeting with the FDA and later feedback from the FDA may be inconsistent with such meeting or its views from such meeting, including the risk that the official FDA minutes which Artiva expects to receive in the coming weeks may include interpretations, requests for additional data, or conclusions that differ from Artiva’s understanding of prior discussions; 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 described in further detail under the section titled “Risk Factors” contained in Artiva’s filings with the Securities and Exchange Commission (the “SEC”), including Artiva’s Annual Report on Form 10-K for the year ended December 31, 2025, and its subsequent Quarterly Reports on Form 10-Q, each as filed or to be filed with the SEC. 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
Noopur Batsha Liffick, MPH
NBL LifeSci Advisory LLC
ir@artivabio.com
Media
Jessica Yingling, Ph.D.
Little Dog Communications Inc.
jessica@litldog.com
Source: Artiva Biotherapeutics, Inc.
Artiva Biotherapeutics May 2026 Exhibit 99.3
Disclaimers and Forward-looking Statements This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements in this presentation 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 AlloNK and its potential benefits, mechanism of action, activity, potency, differentiation, safety, tolerability, effectiveness, depth and duration of response, comparability to other products/candidates or modalities, scalability, outpatient administrability, potential for adoption in a community setting, potential to help patients get off immunomodulatory drugs and/or steroids, market opportunity, competitive landscape, ability to address an unmet need, potential timing and outcome of regulatory interactions, registrational strategy (including potential and timing to advance into a registrational trial and design of a potential registrational trial), potential and timing of additional clinical data, potential to move into follow-on indications, and potential to be approved for marketing or be first-in-class; the Company’s plans and expectations regarding its research and development programs, including the design, timing, and results of preclinical and clinical study designs and results, and the timing or likelihood of regulatory filings and approvals; and the Company’s business strategy, IP protection, ability to deliver value creation, future results of operations, and financial position, including cash runway. Words such as “opportunity,” “potential,” “estimate,” “emerging,” “near-term,” “next,” “focus,” “can,” “design,” “TBD,” “target,” “initial,” “future,” “path,” “runway,” references to specific future dates or periods, and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements necessarily contain these identifying words. 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, including business, regulatory, economic and competitive risks and uncertainties about the Company, including, without limitation, risks inherent in developing product candidates, the fact that initial, preliminary, and interim data from the Company’s clinical trials may change as more patient data become available and remain subject to audit and verification procedures that could result in material differences from the financial data, future results from the Company’s ongoing and planned clinical trials, the Company’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, trends in the industry, the Company’s relationships with its existing and future collaboration partners, the legal and regulatory framework for the industry, and future expenditures. In light of these risks and uncertainties, the events or circumstances referred to in the forward-looking statements may not occur. The actual results may vary from the anticipated results, and the variations may be material. Other factors that may cause the Company’s actual results to differ from current expectations are discussed in the Company’s filings with the U.S. Securities and Exchange Commission, including the section titled “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date this presentation 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. This presentation discusses product candidates that are under clinical study and have not yet been approved for marketing by the U.S. Food and Drug Administration. No representation is made as to the safety or effectiveness of these product candidates for the use for which such product candidates are being studied. The clinical data for AlloNK in this presentation are based on separate studies and include pooled data from the Phase 2a company-sponsored basket trial (NCT06991114) and investigator-initiated basket trial (NCT06581562), and cross-study comparative data. No head-to-head trial has been conducted evaluating AlloNK against any other products or product candidates included herein. Differences exist between clinical trial design, patient populations, and the product candidates themselves, and caution should be exercised when pooling and/or comparing data across trials as pooled data and cross-study comparisons are inherently limited and such data may not be directly comparable. The trademarks included herein are the property of the owners thereof and are used for reference purposes only. Such use should not be construed as an endorsement of such products. Artiva Biotherapeutics
Management Team with Deep Expertise in Cell & Gene Therapy and Autoimmune Disease Fred Aslan Subhashis Banerjee Jennifer Bush Chris Horan Thad Huston Heather Raymon Nicholas Veomett CEO CMO COO CTOO SVP Research & Early Development VP, Corp Dev CFO Development Experience Across Multiple Notable Blockbuster Approvals Artiva Biotherapeutics Note: Chief Executive Officer (CEO); Chief Medical Officer (CMO); Chief Technical Operations Officer (CTOO); Chief Financial Officer (CFO); Chief Operating Officer (COO)
Opportunity Summary Deep B-cell depletion – potent mechanism vis-à-vis other novel approaches Artiva Biotherapeutics 1 6 2 Strategic interest across modalities (auto-CAR-T, TCE, in vivo, allo) 3 Refractory RA – approx. $5B* being spent on patients unlikely to respond after failed 2+ b/tsDMARDs 4 AlloNK activity and tolerability – potentially high impact if first-in-class in RA; other indications 5 CY/FLU tolerability in community setting Favorable competitive landscape – supports potential multi billion dollar opportunity Potential scalable, outpatient IV therapy with biologics-like gross margin b/tsDMARDs: biologic or targeted disease-modifying antirheumatic drugs; RA: Rheumatoid Arthritis; CY: cyclophosphamide; FLU: fludarabine *U.S. RA market: $20B per year (Emergen Research est. $16.5B; Ken Research est. $19B; Precedence Research est. $26B; Research & Markets est. $27B); 150k failed 2+ b/tsDMARDs out of 575k total treated with any b/tsDMARD ~25%
Consistent Activity Observed Across Indications N=14 aNHL, N=24 r/rHL, Over 70 Autoimmunity Patients Initiated Treatment as of end of April 2026 Artiva Biotherapeutics mDoR (mo) ≥19.4 (N.R.) 23.1 No discontinuations due to AEs, no patient started a new b/tsDMARD CRR % imab Auto-CAR-T benchmark* aNHL: aggressive non-Hodgkin lymphoma; r/rHL: relapsed/refractory Hodgkin lymphoma; SjD: Sjögren’s Disease; SSc: Systemic Sclerosis; IIT: investigator-initiated trial; CRR: complete response rate; mDoR: median duration of response; CDAI: Clinical Disease Activity Index; ClinESSDAI: Clinical European League Against Rheumatism Sjögren's Syndrome Disease Activity Index; mRSS: modified Rodnan skin score; SEM: standard error of the mean * Benchmarks: NHL: Breyanzi (Abramson et al Blood 2024; 143(5): 404-16);HL: CD30 CAR T (Ahmen Blood (2022) 140 (Supplement 1): 7496–7497.) Artiva data: NHL: Farooq ASGCT 2025;HL: Maakaron ASCO 2025 Abstr 7008Artiva autoimmune: Preliminary data from ongoing autoimmune clinical trials as of April 03, 2026, data cutoff: Phase 2a company-sponsored basket trial (NCT06991114) and investigator-initiated basket trial (NCT06581562). CRR % CDAI (change) Mean +/- SEM (mean 50.7 baseline) Month ClinESSDAI (change) Mean +/- SEM (mean 16.1 baseline) Month mRSS (change) Mean +/- SEM (mean 19.8 baseline) Month N = 14 aNHL N = 24 r/rHL N = 21 RA N = 11 SjD N = 5 SSc Includes all patients with 3 or more months of follow-up in IIT and Basket Study Clinically meaningful response Clinically meaningful response Clinically meaningful response
B-Cell Depletion and “Reset” Hypothesis Artiva Biotherapeutics Autoantibody production / tissue damage Cytokine secretion / inflammation Antigen presentation / T cell amplification Role of B cells in autoimmune disease: 1 2 3 “Reset” with naive / transitional B cell phenotype Rituximab “Dimming” Durable benefit Transient benefit
Supportive CY/FLU conditioning CD8/CD4 rejection NK rejection (missing self) HLA ab (ADCP- macrophage, ADCC- NK, neutrophils) AlloNK: CD16 is a strong cell activating receptor, driving ADCC against B cells AlloNK (NK cell) Pathogenic B-cell CD16 B-cell Antigen X 1 2 3 Rejection D1 D2 D3 D6 D20 CY/FLU conditioning AlloNK Dose: 4B cells x 2 Monoclonal Antibody B-cell targeting mAb CY/FLU Artiva Biotherapeutics
AlloNK + RTX Showed Consistent Complete B-Cell Depletion in Autoimmune Diseases Opportunity to see B-cell reconstitution within 6 to 12 months following treatment B-cell Reconstitution in Patients Treated with AlloNK + RTX Consistent with Auto-CAR T Academic Study Uniform and consistent B-cell depletion observed by Day 13 in all 51 patients with autoimmune diseases treated with Cy / Flu + AlloNK + RTX Uniform and consistent B-cell depletion observed by Day 13 in all 51 patients with autoimmune diseases B-cell reconstitution after AlloNK + RTX demonstrated increase in naïve B cells (N=13) Studies with RTX showed correlation between higher proportion of naïve/transitional cells with a good response in RA patients2 Note: Preliminary data from ongoing autoimmune clinical trials as of April 03, 2026 data cutoff: Phase 2a basket trial, Phase 1/1b trial in SLE/LN, investigator-initiated basket trial Right panel reflects patients who have seen B-cell reconstitution since treatment from AlloNK + RTX treated patients. (n=13) 1Adapted from Mackensen et al 2022. Nature Medicine volume 28, 2124–2132, 2Adlowitz et al 2015 Cy: cyclophosphamide; Flu: fludarabine; mAbs: monoclonal antibodies; anti-CD20 mAbs: RTX: rituximab; OBI: obinutuzumab; BL: Baseline, EaR: Early reconstitution Artiva Biotherapeutics
AlloNK + RTX Showed Complete B-Cell Depletion Using High Sensitivity Assay Note: No head-to-head trial has been conducted evaluating AlloNK against other data included herein. Differences exist between clinical trial design, patient populations and the product candidates/products themselves, and caution should be exercised when pooling and/or comparing data across trials as pooled data and cross-study comparisons are inherently limited and such data may not be directly comparable Preliminary data as of April 3, 2026 data cutoff; Reflects patients with respective follow up as noted on chart for whom samples were analyzed as of the data cutoff. Preliminary AlloNK data from ongoing autoimmune clinical trials: Phase 2a basket trial, investigator-initiated basket trial. Lower limit of quantitation (LLOQ)= 0.2 cells /µl. Note: RTX: Rituximab, RA: Rheumatoid Arthritis; BSL: Baseline, LOQ: Limit of quantitation, LOD: Limit of detection Adapted from Dass et al., Arthritis & Rheumatology (2008) 58(10):2993–99, DOI:10.1002/art.23902. Day 28 Synovial Biopsy H&E CD19/CD20 IF RTX-only resulted in incomplete depletion using high sensitivity assay N=60 RA patients with RTX only Median level of B-cells (cells/µl) at 2 weeks using high sensitivity assay1 RTX-only B-cells (cells/µl) at nadir using high sensitivity assay AlloNK + RTX No CD19+ B cells in single tissue biopsy case study in RA patient Note: Synovial intima was not captured in baseline biopsy AlloNK + RTX achieved complete B-cell depletion in all RA patients N=28 RA patients with AlloNK + RTX LOQ Artiva Biotherapeutics
Incomplete Depletion Likely Leads to Relapse Blinatumomab (CD19 TCE) B-cell depletion in 6 patients with RA1 Bucci et al Nat Med 2024(2) Grieshaber-Bouyer et al 2026 Accelerating Bio-Innovation (ABI) Conference 9 of 15 relapsed by 3 mos 13 of 15 relapsed by 6 mos 2 Artiva Biotherapeutics
The Unmet Need in RA: Poor Responses in Patients who Failed 2+ b/tsDMARDs % of RA patients achieving ACR50 Response 1st 2nd TNF 3rd and later b/tsDMARD line (1) SELECT-COMPARE. Fleischmann et al 2019 DOI 10.1002/art.41032; wk12(2) Humira USPI, Study RA-III, 6mo(3) SELECT-BEYOND. Genovese et al 2018 DOI: 10.1016/S0140-6736(18)31116-4; 12wk (4) REFLEX. Cohen et al 2006 DOI: 10.1002/art.22025(5) Orencia USPI, Study IV, 6mo(6) Rendas-Baum et al. Arthritis Research & Therapy 2011, 13:R25 (7) Unpublished internal analysis; CorEvitas registry, patients trt Aug 2015 - Aug 2025; Including only subjects with moderate-severe RA (CDAI >10) and ≥ 6 SJC and TJC at baseline; % subjects reaching ACR50 at 6mo Artiva Biotherapeutics AlloNK’s goal: ACR50 in ≥50% of refractory RA patients The RA “Ceiling Effect” 2nd
~$5B Spent on US RA Patients Who Failed 2+ b/tsDMARDs Artiva Biotherapeutics 820k treated w/ csDMARD (e.g. MTX) 1.5M Total Diagnosed U.S. Prevalence [1] Mild: 45%[1] Moderate/Severe: 55% [1] 150-200k Failed 2+ b/tsDMARDs [2] US RA market: ~$20B/yr[3-6] ~575k treated with b/tsDMARDs [2] ~$5B/yr (25%*) spent on patients with 80-90% chance of not achieving an ACR50 response [1] Black, et al. Lancet Rheumatol. 2023 Sep 25;5(10):e594-e610. From Supplement (Fig. 3), adjusted for population growth [2] Multiple publications based on real-world registry data, including: Paudel et al 2024 Rheumatology; Watanabe et al 2024 Rheumatology; Roodenrijs et al 2021 Rheumatology; Jung et al 2023 Arthritis Res Ther.; Failed 2+ b/tsDMARDs population represents ~10-15% of all RA patients [3] Emergen Research est. $16.5B;[4] Ken Research est. $19B; [5] Precedence Research est. $26B; [6] Research & Markets est. $27B* 150k failed 2+ b/tsDMARDs out of 575k total treated with any b/tsDMARD ~25%
AlloNK+RTX Initial Clinical Data in RA: Patient Demographics Artiva Biotherapeutics Mean (range) Demographics Age (yrs) 52.5 (31-76) Female (%) 100% Disease Duration (yrs) 14.8 (1.6-41) Disease Activity CDAI 50.7 (24.9-75.6) DAS28-ESR 7.3 (5.5-8.9) * n=6 from IIT (NCT06581562); n=15 from company-sponsored basket study (NCT06991114) POOLED INITIAL DATA AS OF 03APR2026 21 RA Patients* with 12+ Week Follow-Up # Prior Classes b/tsDMARDs 81% failed 2+ b/tsDMARDs
CDAI & DAS28-ESR Reduction Observed at 3 or 6 Months Artiva Biotherapeutics Subject RA-2 RA-5 RA-6 RA-3 RA-1 RA-4 RA-11 RA-10* RA-13 RA-8* RA-12 RA-7 RA-9 RA-19 RA-20 RA-21 RA-17 RA-15* RA-18* RA-14 RA-16 Change in CDAI Change in DAS28-ESR MCII* (≥ 12 for CDAI; ≥ 1.2 for DAS28) Baseline CDAI 36 34 54.5 52.5 57 71 44.6 44.6 44.7 66.6 45 60.1 64.9 31.7 24.9 40.7 45.5 45.5 63.6 75.6 63.6 23 18 28 Baseline DAS28-ESR 5.9 5.5 7.1 7.6 7.8 8.9 6.8 8.2 6.3 7.7 6.8 7.2 7.9 7 6.1 7.4 7.4 8 7 8.9 7.7 5.8 5.6 6.0 6.2 * Subjects who failed 1 prior class of b/tsDMARDPOOLED PRELIMINARY DATA AS OF 03APR2026; Month 3 = 12wks; Month 6 = 22 or 24 wks [1] Subj 1-3: Li et al Cell Res 2025 & Chen et al EULAR 2025 Abstract OP0291;[2] Subj 4: Charite University, Berlin; 2025 DGRh (German Society for Rheum). DAS28-ESR data points estimated from published graphs; 6mo = 24wk for Li et al; 180d for Charite IIT Basket Study 19 / 21 with clinically meaningful CDAI and DAS28-ESR reductions Auto CAR-T in RA [1,2] External
CDAI & DAS28 Change from Baseline Artiva Biotherapeutics CDAI (mean 50.7 baseline) Month N= 21 13 Month DAS28-ESR (mean 7.3 baseline) * Minimal Clinically Important Improvement ϕ CRP collected in basket study only POOLED INITIAL DATA AS OF 03APR2026; Month 3 = 12wks; Month 6 = 22 or 24 wks [1] Subj 1-3: Li et al Cell Res 2025 & Chen et al EULAR 2025 Abstract OP0291; [2] Subj 4: Charite University, Berlin; 2025 DGRh (German Society for Rheum) DAS28-ESR data points estimated from published graphs; 6mo = 24wk for Li et al; 180d for Charite MCII* (≥ 12 for CDAI; ≥ 1.2 for DAS28) AlloNK + Ritux: Mean Change from Baseline (+/- SEM) Rapid improvement in clinical scores, with further reduction from 3 to 6mo Newer subjects (n=8 w/ only 12wk f/u) responded similarly to first 13 subjects DAS28-CRP (basketϕ) (mean 6.7 baseline) Month N= 21 13 N= 15 7
ACR50 Scoring Using Currently Available ACR Components as Proxy Artiva Biotherapeutics PhGA PtGA SJC TJC HAQ-DI ESR or CRP Pain 3 of 5 ACR50 mACR50 ACR Components 2 of 3 ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓
ACR Component Scores Artiva Biotherapeutics Swollen Joints (SJC) Month Clinical response (>50% reduction) POOLED INITIAL DATA AS OF 03APR2026; Month 3 = 12wks; Month 6 = 22 or 24 wks N= 21 13 Tender Joints (TJC) Month N= 21 13 Required for ACR50 Response: ≥ 50% improvement in both SJC and TJC Newer subjects (n=8 w/ only 12wk f/u) responded similarly to first 13 subjects AlloNK + Ritux: Mean Change from Baseline (+/- SEM) -70
High Initial ACR Response Rate Observed at 6 Months Artiva Biotherapeutics mACR50 calculated only for the IIT, where HAQ-DI and Pain were not collected: TJC&SJC >50% and 2 other components >50% POOLED INITIAL DATA AS OF 03APR2026; Month 6 = 22 or 24 wks; Last Visit Carried Forward for missing data 83% ACR50/mACR50 in IIT 71% ACR50 in Basket Study ACR Heat-Map at 6 Months: % Change from Baseline ≥50% improvement Majority of Component Scores Showed ≥ 70% Improvement
High ACR Response Rate Observed in Refractory RA Patients at 6 Months 19 Artiva Biotherapeutics ACR Responses Among RA Patients in Company-Sponsored Basket Study INITIAL DATA AS OF 03APR2026; Month 6 = 22 wks; Last Visit Carried Forward for missing data Deep responses, supporting TPP of ≥50% ACR50 at 6 months RCT with more uniform parameters Patients remain on background meds, up to 10mg of steroids Dosing regimen: doses of 4B AlloNK cells
“Swimmer’s plot” for RA patients Artiva Biotherapeutics AlloNK treatment cycle On-study; no steroids beyond “soft rescue”; no new b/tsDMARDs Loss of response* or study discontinuation û ϕ Noted at 3mo only if subject achieved ACR50 at 6mo (Subject RA-2 had ACR50 at 3mo but not 6mo; all others maintained ACR50 from 3 to 6mo) * Loss of response = rescue steroids beyond protocol allowance, and/or started new b/tsDMARD mACR50 calculated only for the IIT, where HAQ-DI and Pain were not collected: TJC&SJC >50% and 2 other components >50% POOLED INITIAL DATA AS OF 03APR2026; Month 6 = 22 or 24 wks; Last Visit Carried Forward for missing data 0 3 6 9 12 15 18 21 Months RA-1 ü RA-2 RA-3 ü RA-4 ü RA-5 ü RA-6 ü RA-7 ü RA-8 ü RA-9 ü RA-10 RA-11 RA-12 ü RA-13 ü RA-14 RA-15 RA-16 RA-17 RA-18 RA-19 RA-20 RA-21 ACR50/mACR50 at 6 months ACR50/mACR50 achieved prior to 6 monthsϕ
Tolerability Profile of AlloNK + RTX Observed Compared Favorably to Autologous CAR-T and BCMA Targeted T-Cell Engagers AlloNK + ritux Auto CAR-T Schett / CASTLE1 T-Cell Engager teclistamab2 No. of Patients 55 24 10 CRS (any/Gr 3+) - / - 75% / - 80% / - Tocilizumab for CRS - 58% 80% Infections (any/Gr3+) 29% / 2% N.R. / 13% 70% / 30% IVIG for Hypogamm. - N.R. 100% Deep B-cell Depletion Datasets Note: FOR ILLUSTRATIVE PURPOSES ONLY; no head-to-head trial has been conducted evaluating AlloNK against other data included herein. Differences exist between clinical trial design, patient populations and the product candidates/products themselves, and caution should be exercised when pooling and/or comparing data across unrelated trials as pooled data and cross-study comparisons are inherently limited and such data may not be directly comparable. Pooled preliminary data as 03Apr, 2026 data cutoff for CY/FLU + AlloNK + rituximab from ongoing autoimmune clinical trials: Phase 2a basket trial NCT06991114, investigator-initiated basket trial NCT06581562. N.R.: Not ReportedCRS: cytokine release syndrome; ICANS: immune effector cell-associated neurotoxicity syndrome; mAbs: monoclonal antibodies; RA: rheumatoid arthritis; IVIG: intravenous immunoglobulin (1) Hagen et al ACR 2025. Abstract #0641(2) Bucci et al ACR 2025. Abstract #0236(3) Initial AlloNK + ritux Grade 3+ infection rate and serious infection rate both 2%; Infection rates in USPI for Humira, Rinvoq, Orencia and Rituxan Artiva Biotherapeutics Comparable to Serious Infection Rates for Approved RA therapies3: AlloNK + RTX: 2% Rituxan: 2% Orencia: 3% TNF – Humira: 4.3 / 100 patient years JAK – Rinvoq: 4.6 / 100 patient years Most common TEAEs consistent with those associated with rituximab or CY/FLU Any TEAE ≥ 20%: Nausea (53%), headache (36%), leukopenia (22%), neutropenia (22%), alopecia (20%), lymphopenia (20%) Any Grade 3+ TEAE ≥ 5%: Lymphopenia (5.5%), neutropenia (5.5%) Most common infections: UTI (15%), URTI (13%); no patients hospitalized in first 28d for infection No discontinuations from any TEAEs; no SAEs related to AlloNK
Experience in First 55 Autoimmune Patients Treated with AlloNK + RTX Hospitalization Rates Consistent with mAb Alone Showing Ability to Manage Patients as Outpatient Pooled initial data as 03Apr, 2026 data cutoff for CY/FLU + AlloNK + rituximab from ongoing autoimmune clinical trials: Phase 2a basket trial NCT06991114, investigator-initiated basket trial NCT06581562 * Protocol variances: AlloNK on d5 vs d6; first mAb dose on d1 vs d2; second mAb dose on d13 in company sponsored trial vs d15 in IIT, second dose of AlloNK in both at D13 ** Protocol and practice variations: some patients had >6 infusion days due to separation of AlloNK and mAb dosing IIT Company-Sponsored No hospitalizations for TEAEs related to AlloNK Only 2 of these 55 patients hospitalized for a TEAE during first 28 days SjD subject: Dehydration from diarrhea (Days 27-29; 2 nights) RA subject: Diabetic ketoacidosis in patient with diabetes (Days 8-12; 4 nights) Artiva Biotherapeutics Outpatient Treatment Day Hospitalization for AE
Neutrophil Counts Returned to Normal by Day 28 in Most RA Subjects Artiva Biotherapeutics Data cut as of April 3, 2026 Absolute Neutrophil Counts in N=30 RA subjects from AB-101-05 and IRIS-RD-01 studies
Illustrative Rethinking of Cell Therapy-like Activity with Biologics-like Ease-of-Use Artiva Biotherapeutics AlloNK AlloNK AlloNK AlloNK AlloNK Potential for long-term control on AlloNK – off other chronic meds 18-24+ months 30d “acute” Phase Off immunomodulatory drugs Low doses of CY/FLU 4 3 Scalability, $8K COGS 1 Outpatient treatment 2 40 activated sites AlloNK® 1B cell vial Cumulative (mg/m2)
Registrational Strategy Single registrational RCT; N = ~150 RA pts with inadequate response to 2+ b/tsDMARDs Randomized 2:1 to AlloNK + RTX vs. RTX-only Primary efficacy end point: ACR50 at 6 months AlloNK dosing: 4B cells x 2 doses (Days 6 and 20) RTX-only non-responders may cross-over into AlloNK + RTX arm at 6 months Global trial with 80+ sites; 40 sites already active in 05 study Proposed safety database (patients treated with AlloNK + RTX): N=100+ RA patients from RCT alone N=250+ total, mostly RA patients, including patients with other autoimmune diseases Targeted ACR50 at 6 months: AlloNK+RTX: 50%+; RTX-only: 20-25% Expected RCT primary efficacy read-out in H2'28; expected BLA filing in 2029 Expected clinical updates in 30-50+ RA patients in ACR'26, EULAR'27 and ACR’27 Expected read-outs: ACR50%, mDoR, safety Artiva Biotherapeutics
Artiva Biotherapeutics To be the first FDA-approved deep B-cell depleting therapy for refractory RA patients who have failed 2+ b/tsDMARDs To be a one-time treatment (“reset”) lasting more than 18 months with several patients still benefiting 3 years later; patients off other immunomodulatory drugs To have greater than 50% of patients experience an ACR50 response at 6 months; higher than any approved product in RA To be a cell therapy rheumatologists can “own”, and provide in their infusion chair Program Commercial Objectives “Enough! Time for cell therapy”
Illustrative Market Reach in US alone Reimbursement framework expected to be in line with other IV therapies Artiva Biotherapeutics 250 clinics 1-2 patients per month 50 clinics in RCT in US …out of >2,000 rheum community clinics with infusion chairs [1,2] …where top HCPs see estimated 20-30 2+b/tsDMARD-IR patients per month [3,4] x [1] Remicade treatment centers (2infuse database), accessed Dec 2025[2] CMS data, claims year 2017 [3] Trella database analysis, Apr 2026[4] Average across n=20 calls with US-based community rheumatologist HCPs
Clinical Responses Observed in SjD Artiva Biotherapeutics N= 11 7 ESSPRI (change) (Mean +/- SEM) N= 11 7 ESSDAI (change) (Mean +/- SEM) SSF at 6mo (change) (Mean +/- SEM) Months Months INITIAL DATA AS OF 03APR2026; Month 3 = 12wks; Month 6 = 22 or 24 wks Mean 13.1 baseline Mean 8.0 baseline Mean 0.65 baseline Min. Point Change for Response N= 11 7 ClinESSDAI (change) (Mean +/- SEM) Months Mean 16.1 baseline +0.76 N=7 All patients off steroids
Clinical Responses Observed in SjD Artiva Biotherapeutics INITIAL DATA AS OF 03APR2026; No head-to-head trial has been conducted evaluating AlloNK against other data included herein. Differences exist between clinical trial design, patient populations and the product candidates/products themselves, and caution should be exercised when pooling and/or comparing data across trials as pooled data and cross-study comparisons are inherently limited and such data may not be directly comparable; Month 3 = 12wks; Month 6 = 22 or 24 wks; - denotes no data reported [1] Grader-Beck et al EULAR 2025 LB24. Two trials (NEPTUNUS-1 and NEPTUNUS-2; QM arm, range shown represents both studies) [2] Bowman et al Lancet 2022; 399: 161–71 [3] Noaiseh et al Lancet 2025; 406: 2435–48 [4] St. Clair et al Nat Med 2024; 30: 1583-92. “Population 1” [5] Xu et al ACR 2025 Abstr LB11; Vor Bio corporate presentation Min. Point Change for Response Disease Duration Clin ESSDAI ESSDAI ESSPRI SSF FACIT-F PtGA AlloNK + rtx, 6mo Mean 12.2yr -8.6 -6.6 -3.0 +0.76 +13.0 -44% Ianalumab Ph2 + Ph3, 24wk[1,2] Max 7.5yr - -5.1 to -5.9[1] -1.8[2] +0.1[1] +8.6[2] -34%[2] Nipocalimab Ph 2, 24wk[3] Mean 6.2yr -6.4 -4.6 -2.3 - - - Dazodalibep Ph2, 169d[4] - - -6.3 -1.8 +0.39 +8.1 - Telitacicept Ph3 (CN), 24wk[5] Mean <2yr - -4.4 -1.9 - - - Benchmarking Against Other Emerging Rx in SjD
Clinical Responses Observed in Systemic Sclerosis (SSc) Artiva Biotherapeutics * rCRISS25: ≥25% probability (score ≥0.25) that a patient has improved overall. rCRISS50: ≥50% probability (score ≥0.50) of overall improvement, a stricter threshold. Initial data as of 03Apr2026 mRSS (change) (Mean +/- SEM) N= 5 4 Months Mean age 54yrs, 60% male Mean 4.1yr disease duration Mean baseline mRSS = 19.8 Resistant to prior immunomodulators (incl. 3/5 with prior rituximab) Assessed ΔmRSS (score of skin thickness) and rCRISS* (0–1 composite score estimating overall improvement using skin, lung, and function measures) All patients off steroids Min. Point Change for Response rCRISS response (%) 6 months (n=4)
Expected Data and Trial Maturation in RA H2’26 Artiva Biotherapeutics H1’27 H2’27 H1’28 H2’28 30+ total pts 15+ pts w/ ACR50@6m RA open-label update: 50+ total pts 40+ pts w/ ACR50@6m 20+ pts w/ 12-18+ mos f/u 50+ total pts w/ 18-36 mos f/u RCT read-out RA RCT Enrollment complete Trial initiation Plans for second indication TBD Other basket indications: SjD, SSc, IIM IIM: idiopathic inflammatory myopathies
Road Map to Becoming Potential First-in-Class Artiva Biotherapeutics Deep B-cell depletion MoA (low sensitivity + high sensitivity B-cell assay, B-cell reconstitution) Initial safety profile consistent with desired TPP in community (rheumatologists can “own”) Efficacy/initial durability signal >>> SOC; potential success of ACR50 >50% in RCT FDA alignment on potential registrational trial for AlloNK + RTX First deep B-cell depleting agent to potentially get approval in RA ✓ ✓ Unmet need in 2+ b/tsDMARD failure in RA (25% of $20B+ b/tsDMARD market) ✓ ✓ ✓
Opportunity Summary Deep B cell depletion - potent mechanism vis-à-vis other novel approaches Artiva Biotherapeutics 1 6 2 Strategic interest across modalities (auto-CAR-T, TCE, in vivo, allo) 3 Refractory RA – approx. $5B* being spent on patients unlikely to respond after failed 2+ b/tsDMARDs 4 AlloNK activity and tolerability – potentially high impact if first-in-class in RA; other indications 5 CY/FLU tolerability in community setting Favorable competitive landscape – supports potential multi billion-dollar opportunity b/tsDMARDs: biologic or targeted disease-modifying antirheumatic drugs; RA: Rheumatoid Arthritis; CY: cyclophosphamide; FLU: fludarabine *U.S. RA market: $20B per year (Emergen Research est. $16.5B; Ken Research est. $19B; Precedence Research est. $26B; Research & Markets est. $27B); 150k failed 2+ b/tsDMARDs out of 575k total treated with any b/tsDMARD ~25%