SOUTH SAN FRANCISCO, Calif., Oct. 22, 2025 (GLOBE NEWSWIRE) -- Nkarta, Inc. (Nasdaq: NKTX), a clinical-stage biopharmaceutical company developing engineered natural killer (NK) cell therapies to treat autoimmune disease, today announced it will be presenting a poster this Sunday in Chicago at the American College of Rheumatology (ACR) Convergence 2025 meeting. Nkarta will present clinical data showing that the company’s investigational therapy, NKX019, achieved robust pathogenic B-cell depletion followed by ...

Summary of Nkarta's Conference Call Company Overview - **Company**: Nkarta - **Focus**: Development of CARN-K allogeneic cell therapy platform targeting autoimmune diseases, specifically B-cell malignancies and autoimmune-mediated diseases [2][3] Core Points and Arguments - **CARN-K Platform**: The CARN-K platform is designed for CD19-directed therapies, which have shown significant growth and potential in treating autoimmune diseases, particularly lupus nephritis and other B-cell related conditions [2][4] - **LEAP Program**: The LEAP program includes NK-019, a CD19-directed CARN-K cell therapy, which utilizes a chimeric antigen receptor and a membrane-bound form of IL-15 to enhance activity and persistence [3][4] - **Clinical Trials**: Nkarta is conducting two IND trials: NTRUST-1 (focused on lupus nephritis and primary membranous nephropathy) and NTRUST-2 (a basket trial for systemic sclerosis, myositis, and oncoassociated vasculitis) [4][10] - **Safety Profile**: CARN-K cells are considered safer than CAR-T therapies due to the absence of serious side effects like cytokine release syndrome and neurotoxicity, as NK cells do not expand in the same way [7][8] - **Dosing Regimen**: The company has standardized its dosing regimen to three doses over one week, which is more patient-friendly and aims to achieve deep B-cell depletion [16][20] Important Data and Insights - **Durability of Response**: There is potential for durable responses in autoimmune diseases, with some patients showing remission lasting up to three years. The ability to re-dose patients is a significant advantage over traditional CAR-T therapies [20][21] - **Translational Research**: Nkarta is focusing on five pillars in its translational research, including B-cell depletion, cytokine and chemokine analysis, autoantibody production, immune reset markers, and disease-specific biomarkers [9][10] - **NTRUST-1 Trial Design**: Key markers in the NTRUST-1 trial include serum creatinine, protein levels in urine, and GFR, which are indicators of kidney function and long-term outcomes in renal diseases [11][12] Industry Context - **Competitive Landscape**: The interest in cell therapy for autoimmune diseases has been spurred by positive data from other companies and academic centers, particularly regarding CD19 as a target [5][17] - **Regulatory Environment**: There is a growing recognition from health authorities regarding the potential of cell therapies, which may facilitate faster development timelines [28][29] Financial Position - **Cash Runway**: Nkarta has a cash runway extending into 2029, providing flexibility to advance its programs without immediate concerns about raising additional funds [31] Upcoming Milestones - **Data Updates**: Nkarta plans to provide updates on its trials in the second half of 2025, which will include initial data from the autoimmune space across multiple indications [31][26] Conclusion - Nkarta is positioned to leverage its CARN-K platform in the growing field of cell therapies for autoimmune diseases, with a focus on safety, accessibility, and the potential for durable responses. The company is well-funded and has a clear strategy for advancing its clinical programs.

Group 1 - Nkarta, Inc. is participating in the H.C. Wainwright 27th Annual Global Investment Conference on September 9, 2025, at 8:30 a.m. ET, featuring a fireside chat [1] - A simultaneous webcast of the event will be available on Nkarta's website, with a replay archived for approximately 90 days [1] - Nkarta is a clinical-stage biotechnology company focused on developing allogeneic, off-the-shelf natural killer (NK) cell therapies for autoimmune diseases [2] Group 2 - The company utilizes a cell expansion and cryopreservation platform combined with proprietary cell engineering technologies and CRISPR-based genome engineering capabilities [2] - Nkarta aims to build a pipeline of future cell therapies designed for deep therapeutic activity and broad access in outpatient treatment settings [2]

[Risk Factor Summary](index=4&type=section&id=RISK%20FACTOR%20SUMMARY) [Risk Factor Summary](index=4&type=section&id=RISK%20FACTOR%20SUMMARY) This section provides a high-level overview of the material factors that make an investment in Nkarta's common stock speculative or risky, highlighting key challenges including a limited operating history, significant financial losses, and dependence on its CAR NK-cell technology platform - The company has a limited operating history, has incurred significant losses since inception, and has no products approved for sale[13](index=13&type=chunk) - Business success is highly dependent on the clinical success of its CAR NK-cell technology platform, particularly the NKX019 product candidate[13](index=13&type=chunk) - The manufacturing process is novel and complex, with reliance on third parties and sole suppliers for certain materials, posing risks of production difficulties and delays[13](index=13&type=chunk) - The company faces risks related to intellectual property, including the potential loss of key licenses and insufficient patent protection, which could allow competitors to develop similar products[14](index=14&type=chunk) [PART I. FINANCIAL INFORMATION](index=7&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Financial Statements](index=7&type=section&id=Item%201.%20Financial%20Statements) The unaudited condensed financial statements for the period ended June 30, 2025, show a decrease in total assets and an increase in accumulated deficit, with ongoing net losses driven by research and development expenses [Condensed Balance Sheets](index=7&type=section&id=Condensed%20Balance%20Sheets) As of June 30, 2025, total assets decreased to $448.3 million from $501.2 million, while the accumulated deficit grew to $599.2 million, reflecting ongoing net losses Condensed Balance Sheet Highlights (in thousands) | Metric | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $53,414 | $27,873 | | Total current assets | $296,571 | $273,338 | | Total assets | $448,312 | $501,203 | | Total liabilities | $90,644 | $93,227 | | Accumulated deficit | $(599,184) | $(544,224) | | Total stockholders' equity | $357,668 | $407,976 | [Condensed Statements of Operations and Comprehensive Loss](index=8&type=section&id=Condensed%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) For Q2 2025, the net loss was $23.0 million, and for H1 2025, it was $55.0 million, with changes driven by fluctuations in operating expenses, particularly R&D costs Statement of Operations Highlights (in thousands) | Metric | Q2 2025 | Q2 2024 | H1 2025 | H1 2024 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $20,778 | $23,130 | $44,950 | $48,367 | | General and administrative | $6,408 | $7,585 | $18,800 | $15,110 | | Loss from operations | $(27,186) | $(30,715) | $(63,750) | $(63,477) | | Net loss | $(22,977) | $(24,993) | $(54,960) | $(54,511) | | Net loss per share | $(0.31) | $(0.34) | $(0.74) | $(0.88) | [Condensed Statements of Cash Flows](index=11&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) For H1 2025, net cash used in operating activities was $48.4 million, offset by $73.8 million from investing activities, resulting in a $25.5 million net increase in cash Cash Flow Summary for Six Months Ended June 30 (in thousands) | Cash Flow Category | 2025 | 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(48,365) | $(50,400) | | Net cash provided by (used in) investing activities | $73,829 | $(86,140) | | Net cash provided by financing activities | $77 | $225,898 | | Net increase in cash and cash equivalents | $25,541 | $89,358 | [Notes to Unaudited Condensed Financial Statements](index=12&type=section&id=Notes%20to%20Unaudited%20Condensed%20Financial%20Statements) The notes detail the company's business, liquidity, accounting policies, and specific financial items, including a workforce reduction and deprioritized programs - The company is a biopharmaceutical firm developing engineered natural killer (NK) cell therapies for autoimmune diseases and believes its current cash of **$334.0 million** is sufficient to meet obligations for at least twelve months from the report's filing date[29](index=29&type=chunk)[30](index=30&type=chunk)[31](index=31&type=chunk) - In March 2025, the company initiated a reduction in force, cutting **53 positions (34% of its workforce)** to decrease costs, resulting in severance and benefit costs of approximately **$5.4 million**[79](index=79&type=chunk)[80](index=80&type=chunk) - The collaboration with CRISPR Therapeutics to co-develop NKX070 and NK+T product candidates has been deprioritized[61](index=61&type=chunk) - In March 2024, the company raised **$240.1 million** in gross proceeds through an underwritten public offering of common stock and pre-funded warrants[71](index=71&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=25&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's focus on developing NKX019 for autoimmune diseases, recent clinical trial updates, and the financial impact of a March 2025 workforce reduction, noting strong liquidity [Overview](index=25&type=section&id=Overview) Nkarta is a clinical-stage biopharmaceutical company focused on developing allogeneic, off-the-shelf engineered NK cell therapies, with its lead program NKX019 targeting autoimmune diseases, alongside recent trial modifications and a workforce reduction - The company's lead program is **NKX019**, a CAR NK product candidate for treating autoimmune diseases like lupus nephritis (LN) and primary membranous nephropathy (pMN)[83](index=83&type=chunk)[86](index=86&type=chunk) - In May 2025, the company modified the lymphodepleting conditioning (LD) for its Ntrust-1 and Ntrust-2 trials to use a combination of fludarabine (Flu) and cyclophosphamide (Cy)[86](index=86&type=chunk) - A reduction in workforce was approved in March 2025 to decrease costs and streamline the organization to support its reprioritized product pipeline[85](index=85&type=chunk) [Results of Operations](index=29&type=section&id=Results%20of%20Operations) R&D expenses decreased for Q2 and H1 2025 due to lower personnel costs, while G&A expenses increased for H1 2025 primarily due to **$5.1 million** in severance costs from the workforce reduction Comparison of Operating Expenses (in thousands) | Expense Category | Q2 2025 | Q2 2024 | Change | H1 2025 | H1 2024 | Change | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | Research and development | $20,778 | $23,130 | $(2,352) | $44,950 | $48,367 | $(3,417) | | General and administrative | $6,408 | $7,585 | $(1,177) | $18,800 | $15,110 | $3,690 | - The decrease in R&D expenses for Q2 2025 was primarily due to a **$3.1 million** reduction in personnel costs resulting from lower headcount after the March 2025 reduction in force[102](index=102&type=chunk)[104](index=104&type=chunk) - The increase in G&A expenses for H1 2025 was primarily due to **$5.1 million** in severance expenses from the reduction in force, partially offset by a **$2.0 million** decrease in other personnel and facilities expenses[102](index=102&type=chunk) [Liquidity and Capital Resources](index=31&type=section&id=Liquidity%20and%20Capital%20Resources) As of June 30, 2025, the company had **$334.0 million** in cash and investments, with management believing this capital is sufficient for at least the next 12 months, though substantial additional funding will be required long-term - The company had cash, cash equivalents, restricted cash and investments of **$334.0 million** as of June 30, 2025[105](index=105&type=chunk) - In March 2024, the company raised **$225.1 million** in net proceeds from an underwritten public offering of common stock and pre-funded warrants[105](index=105&type=chunk)[107](index=107&type=chunk) - Management believes that current cash and investments are sufficient to meet cash needs for at least 12 months following the date of this report[110](index=110&type=chunk)[117](index=117&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=38&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a "smaller reporting company," Nkarta is not required to provide the information for this item - The company is not required to provide this information as it qualifies as a "smaller reporting company"[129](index=129&type=chunk) [Controls and Procedures](index=38&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were effective as of June 30, 2025, with no material changes to internal control over financial reporting during the quarter - Management concluded that the company's disclosure controls and procedures were effective at a reasonable assurance level as of June 30, 2025[130](index=130&type=chunk) - No material changes to the internal control over financial reporting were identified during the quarter ended June 30, 2025[131](index=131&type=chunk) [PART II. OTHER INFORMATION](index=39&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Legal Proceedings](index=39&type=section&id=Item%201.%20Legal%20Proceedings) The company reports no pending claims or actions likely to have a material adverse effect on its business, financial condition, or growth prospects - As of the report date, there are no material legal proceedings pending against the company[134](index=134&type=chunk) [Risk Factors](index=39&type=section&id=Item%201A.%20Risk%20Factors) This section details numerous risks associated with an investment in Nkarta, categorized into financial position, business and industry, manufacturing, intellectual property, commercialization, and common stock [Risks Related to our Financial Position](index=39&type=section&id=Risks%20Related%20to%20our%20Financial%20Position) The company faces significant financial risks due to its limited operating history, lack of approved products, and a history of substantial net losses, with an accumulated deficit of **$599.2 million** as of June 30, 2025 - The company has incurred significant operating losses since its 2015 inception, with an accumulated deficit of **$599.2 million** as of June 30, 2025, and expects losses to continue for the foreseeable future[138](index=138&type=chunk) - Nkarta will require substantial additional capital to advance its product candidates, particularly NKX019, into pivotal trials, and failure to raise capital may cause dilution or force curtailment of operations[145](index=145&type=chunk) [Risks Related to Our Business and Industry](index=43&type=section&id=Risks%20Related%20to%20Our%20Business%20and%20Industry) The company's success is highly dependent on its novel CAR NK-cell technology platform and lead candidate NKX019, facing significant development, regulatory, and competitive challenges due to the newness of the approach - The business is highly dependent on the success of its CAR NK-cell platform and its lead candidate, **NKX019**, for autoimmune diseases, having deprioritized its hematologic malignancy programs[149](index=149&type=chunk)[156](index=156&type=chunk) - Utilizing CAR NK cells for autoimmune diseases is a novel approach with limited clinical data, and regulatory agencies may lack precedents for evaluation, potentially causing delays and additional costs[150](index=150&type=chunk)[172](index=172&type=chunk) - The company has experienced and may continue to face significant challenges in enrolling patients for its Ntrust-1 and Ntrust-2 clinical trials due to competition and the novelty of the therapy in autoimmune indications[174](index=174&type=chunk)[177](index=177&type=chunk) [Risks Related to Manufacturing](index=76&type=section&id=Risks%20Related%20to%20Manufacturing) Nkarta's novel and complex manufacturing process is susceptible to product loss and contamination, with reliance on third parties and sole suppliers for critical materials, posing risks of delays and disruptions - The manufacturing process for genetically engineered human cells is complex, highly regulated, and subject to risks of product loss, failure, and contamination, which could delay clinical trials[252](index=252&type=chunk)[254](index=254&type=chunk) - The company is reliant on Miltenyi as a sole supplier for the CliniMACS® Plus system and related reagents, creating a significant supply chain risk[266](index=266&type=chunk) - Delays in commissioning and receiving regulatory approvals for its new commercial-scale manufacturing facility could limit the ability to develop product candidates and generate revenue[269](index=269&type=chunk) [Risks Related to Our Intellectual Property](index=82&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) The company's intellectual property position is critical but uncertain, relying on a potentially terminable exclusive license and facing risks that its patents may not be robust or could be challenged, allowing competitors to enter the market - The company's rights to key NK-cell engineering technology depend on a license agreement with the National University of Singapore and St. Jude Children's Research Hospital; termination of this agreement would severely impact its product candidates, including **NKX019**[276](index=276&type=chunk) - The patent position of biotechnology companies is uncertain, and the company's pending applications may not result in issued patents that provide meaningful protection against competitors[278](index=278&type=chunk)[279](index=279&type=chunk) - The company may face costly litigation if accused of infringing on third-party intellectual property rights, which could delay or prevent the commercialization of its product candidates[282](index=282&type=chunk) [Risks Related to Commercialization](index=94&type=section&id=Risks%20Related%20to%20Commercialization) Commercial success is not guaranteed even if products are approved, as the company lacks sales capabilities, market acceptance is uncertain, and securing adequate reimbursement from third-party payors will be critical and challenging - The company has limited sales, marketing, or distribution expertise and will need to build these capabilities or partner with third parties to commercialize any approved products[325](index=325&type=chunk) - Commercial success depends on market acceptance by physicians, patients, and payors, which is uncertain and relies on factors like perceived efficacy, safety, cost-effectiveness, and advantages over alternative treatments[332](index=332&type=chunk) - Failure to obtain and maintain adequate coverage and reimbursement from government and private payors for potentially high-cost cell therapies could significantly limit the ability to market products and generate revenue[335](index=335&type=chunk) [Risks Related to Our Common Stock](index=107&type=section&id=Risks%20Related%20to%20Our%20Common%20Stock) The market price of Nkarta's common stock is likely to be highly volatile, with significant ownership concentration among insiders, and the company's status as an "emerging growth company" may affect investor attractiveness - The trading price of the company's common stock is likely to be highly volatile due to factors such as clinical trial results, regulatory decisions, and broader market conditions[363](index=363&type=chunk) - As of August 8, 2025, directors, executive officers, and principal stockholders beneficially own **58%** of the common stock, enabling them to control or significantly influence all matters requiring stockholder approval[367](index=367&type=chunk) - The company qualifies as an "emerging growth company" and a "smaller reporting company," allowing it to rely on exemptions from certain disclosure and governance requirements, which may result in less information available to investors[371](index=371&type=chunk)[373](index=373&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=120&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities during the period covered by this report - There were no unregistered sales of equity securities during the quarter[408](index=408&type=chunk) [Other Information](index=120&type=section&id=Item%205.%20Other%20Information) During the quarter ended June 30, 2025, no directors or officers adopted, modified, or terminated a Rule 10b5-1 trading arrangement - No directors or officers adopted, modified, or terminated a Rule 10b5-1 trading arrangement during the quarter[412](index=412&type=chunk)

[Nkarta Q2 2025 Earnings Release Overview](index=1&type=section&id=Nkarta%20Reports%20Second%20Quarter%202025%20Financial%20Results%20and%20Corporate%20Highlights) [Executive Summary](index=1&type=section&id=Executive%20Summary) Nkarta reported Q2 2025 results, highlighting **$334.0 million** cash, NKX019 clinical progress, and a new CMO appointment - The company is focused on executing clinical trials for NK cell therapy to treat autoimmune diseases[3](index=3&type=chunk) - Dr. Shawn Rose, an experienced rheumatologist and immunologist, was appointed Chief Medical Officer and Head of R&D in **June 2025**[4](index=4&type=chunk) - Initial data updates for the NKX019 program in multiple autoimmune indications are expected in the **second half of 2025**[6](index=6&type=chunk) - The company's cash balance of **$334.0 million** as of June 30, 2025, is projected to fund operations **into 2029**[6](index=6&type=chunk) [NKX019 Clinical Program](index=1&type=section&id=NKX019%20Clinical%20Program%20Progress%20and%20Upcoming%20Milestones) [Program Progress and Milestones](index=1&type=section&id=Program%20Progress%20and%20Milestones) NKX019 autoimmune clinical programs are enrolling, with Ntrust-1 and Ntrust-2 preliminary data expected in H2 2025 - Patient enrollment is ongoing for the Ntrust-1, Ntrust-2, and two investigator-sponsored clinical trials for NKX019 in autoimmune diseases[7](index=7&type=chunk) - Preliminary data from the Ntrust-1 and Ntrust-2 clinical trials are planned for release in the **second half of 2025**[7](index=7&type=chunk) [Ntrust℠ Clinical Trials (Ntrust-1 & Ntrust-2)](index=2&type=section&id=About%20the%20Ntrust%E2%84%A0%20Clinical%20Trials%20in%20Autoimmune%20Disease) Ntrust-1 and Ntrust-2 trials evaluate NKX019 safety and efficacy in autoimmune diseases like lupus nephritis and systemic sclerosis - Ntrust-1 (NCT06557265) is enrolling **up to 24 patients** with lupus nephritis or primary membranous nephropathy[9](index=9&type=chunk)[10](index=10&type=chunk) - Ntrust-2 (NCT06733935) is enrolling **up to 36 patients** with systemic sclerosis, idiopathic inflammatory myopathy, or ANCA-associated vasculitis[9](index=9&type=chunk)[10](index=10&type=chunk) - The trial protocol includes a **three-dose cycle** of NKX019 following lymphodepletion, with no supplemental cytokines, to evaluate the single-agent activity of the therapy[11](index=11&type=chunk) [Investigator-Sponsored Clinical Trials](index=2&type=section&id=About%20the%20Investigator-Sponsored%20Clinical%20Trials) Nkarta supports two **Phase 1** investigator-sponsored trials for NKX019 in myasthenia gravis and systemic lupus erythematosus - A **Phase 1** investigator-sponsored trial is enrolling patients with generalized myasthenia gravis to evaluate the safety and clinical outcomes of NKX019[12](index=12&type=chunk) - A separate **Phase 1** investigator-sponsored trial (NCT06518668) is enrolling **up to 6 patients** with systemic lupus erythematosus to evaluate NKX019[14](index=14&type=chunk) [Financial Performance and Position](index=1&type=section&id=Second%20Quarter%202025%20and%20Recent%20Financial%20Highlights) [Financial Highlights and Guidance](index=1&type=section&id=Financial%20Highlights%20and%20Guidance) Nkarta held **$334.0 million** cash as of June 30, 2025, expected to fund operations into 2029, with a Q2 2025 net loss of **$23.0 million** Q2 2025 Financial Summary | Metric | Amount (in millions) | | :--- | :--- | | Cash, Cash Equivalents, and Investments | $334.0 | | Research & Development (R&D) Expenses | $20.8 | | General & Administrative (G&A) Expenses | $6.4 | | Net Loss | $23.0 | | Net Loss per Share | $0.31 | - The company's current cash and cash equivalents are expected to be sufficient to fund its operating plan **into 2029**[8](index=8&type=chunk) [Condensed Statements of Operations](index=5&type=section&id=Condensed%20Statements%20of%20Operations) Nkarta's Q2 2025 total operating expenses decreased to **$27.2 million**, resulting in a net loss of **$23.0 million** Condensed Statements of Operations (in thousands) | Line Item | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $20,778 | $23,130 | $44,950 | $48,367 | | General and administrative | $6,408 | $7,585 | $18,800 | $15,110 | | **Total operating expenses** | **$27,186** | **$30,715** | **$63,750** | **$63,477** | | Loss from operations | ($27,186) | ($30,715) | ($63,750) | ($63,477) | | Interest income | $3,970 | $5,724 | $8,346 | $8,970 | | **Net loss** | **($22,977)** | **($24,993)** | **($54,960)** | **($54,511)** | | Net loss per share, basic and diluted | ($0.31) | ($0.34) | ($0.74) | ($0.88) | [Condensed Balance Sheets](index=5&type=section&id=Condensed%20Balance%20Sheets) As of June 30, 2025, Nkarta's total assets were **$448.3 million**, with **$334.0 million** in cash and investments Condensed Balance Sheet Highlights (in thousands) | Account | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash, cash equivalents, restricted cash and investments | $334,041 | $380,489 | | Total assets | $448,312 | $501,203 | | Total liabilities | $90,644 | $93,227 | | Total stockholders' equity | $357,668 | $407,976 | [Company and Product Information](index=3&type=section&id=About%20Nkarta) [About NKX019](index=3&type=section&id=About%20NKX019) NKX019 is an **allogeneic, off-the-shelf** immunotherapy using engineered NK cells with a **CD19-directed CAR** and **membrane-bound IL-15** - NKX019 is an **allogeneic**, cryopreserved, **off-the-shelf** immunotherapy candidate using NK cells from healthy donors[15](index=15&type=chunk) - It is engineered with a humanized **CD19-directed CAR** and a **membrane-bound form of IL-15** to improve persistence and activity without exogenous cytokine support[15](index=15&type=chunk) [About Nkarta](index=3&type=section&id=About%20Nkarta%20Company) Nkarta is a **clinical-stage** biotechnology company developing **allogeneic, off-the-shelf** NK cell therapies for autoimmune diseases - Nkarta is a **clinical-stage** biotechnology company developing **allogeneic, off-the-shelf** NK cell therapies for autoimmune diseases[16](index=16&type=chunk) - The company's goal is to build a pipeline of cell therapies for broad access in an **outpatient treatment setting**[16](index=16&type=chunk) [Forward-Looking Statements and Risk Factors](index=3&type=section&id=Cautionary%20Note%20on%20Forward-Looking%20Statements) [Forward-Looking Statements](index=3&type=section&id=Forward-Looking%20Statements) This press release contains forward-looking statements regarding Nkarta's clinical development timelines, data, regulatory pathways, and cash runway - Forward-looking statements include expectations for clinical development timelines, availability of clinical data, regulatory pathways for NKX019, and the company's cash runway[17](index=17&type=chunk) [Risk Factors](index=4&type=section&id=Risk%20Factors) Key risks include limited operating history, lack of approved products, clinical trial unpredictability, funding needs, and NKX019 dependence - Identified risks include limited operating history, lack of approved products, potential for clinical trial failures, need for additional funding, and competition[18](index=18&type=chunk) - The company is dependent on the clinical success of its lead candidate, NKX019, and faces risks related to manufacturing complexity and third-party reliance[18](index=18&type=chunk) - More detailed risk factors are described in Nkarta's SEC filings, including its Quarterly Report on **Form 10-Q**[19](index=19&type=chunk)

Core Insights - Nkarta, Inc. is focused on developing engineered natural killer (NK) cell therapies for autoimmune diseases, with a strong emphasis on clinical trial execution and the potential of NK cell therapy to meet unmet medical needs [2][3]. Financial Highlights - For the second quarter of 2025, Nkarta reported a net loss of $23.0 million, or $0.31 per share, with research and development expenses amounting to $20.8 million and general and administrative expenses of $6.4 million [10][20]. - The company had a cash balance of $334.0 million as of June 30, 2025, which is expected to fund operations into 2029 [5][8]. Clinical Program Updates - The NKX019 clinical program is progressing with ongoing patient enrollment in the Ntrust-1 and Ntrust-2 trials, which focus on safety and long-term remission in autoimmune diseases [6][9]. - Initial updates for NKX019 in multiple autoimmune indications are anticipated in the second half of 2025 [8][9]. Leadership and Expertise - Dr. Shawn Rose was appointed as Chief Medical Officer and Head of Research and Development in June 2025, bringing extensive experience in rheumatology and drug development for autoimmune conditions [3][4]. Clinical Trials Overview - Ntrust-1 and Ntrust-2 are multi-center, open-label, dose escalation trials assessing NKX019's safety and efficacy in patients with various autoimmune diseases, including lupus nephritis and systemic sclerosis [6][7][11]. - The trials involve a three-dose cycle of NKX019, designed to evaluate its single-agent activity without supplemental cytokines or antibody-based therapeutics [11][12].

Summary of Nkarta (NKTX) Conference Call - July 30, 2025 Company Overview - Nkarta is focused on developing allogeneic CAR NK cell therapies for autoimmune diseases, particularly targeting B cell mediated immune diseases, having pivoted from oncology to autoimmune indications due to the potential of cell therapy in these areas [2][3][4] Key Points and Arguments Industry and Market Context - The cell therapy landscape is evolving, with significant interest in CAR NK therapies for autoimmune diseases, inspired by successful CAR T cell data [3][20] - The safety profile of NK cells is favorable compared to CAR T cells, with no high-grade cytokine release syndrome (CRS) or neurotoxicity observed in trials [4][21][56] Product Pipeline - Nkarta's lead program, NKX019, targets CD19 and is currently in IND studies for lupus nephritis, primary membranous nephropathy, systemic sclerosis, myositis, and onc-associated vasculitis [6][25] - The company is conducting a phase one trial for NKX019, focusing on dose escalation and early safety and pharmacology [24][51] Clinical Efficacy and Safety - Early readouts from the NKX019 trial will focus on clinical markers such as creatinine levels, protein in urine, and glomerular filtration rate (GFR), which are critical for assessing kidney function in autoimmune renal diseases [25][26] - The updated lymphodepletion regimen now includes fludarabine, aligning with standard practices in cell therapy to enhance B cell depletion [27][28] Competitive Advantages - CAR NK cells are designed to be off-the-shelf, scalable, and do not require leukapheresis, making them more accessible for patients compared to CAR T therapies [4][14][21] - The potential for outpatient administration of CAR NK therapies could significantly broaden access and reduce the burden on healthcare facilities [67][70] Future Outlook - Initial data from NKX019 is expected in the second half of 2025, with ongoing enrollment in the trial [51][72] - The company has a strong cash position of approximately $350 million, providing a runway into 2029 to support ongoing trials without immediate capital raising pressures [71][72] Additional Important Insights - The shift from oncology to autoimmune diseases is seen as a strategic move, with the need for accessible therapies in the rheumatology and nephrology fields being emphasized [20][66] - The potential for durable responses and immune reset in treatment-refractory autoimmune conditions represents a significant advancement in the field [37][39] - Nkarta is exploring additional indications beyond lupus nephritis, including myositis and systemic sclerosis, indicating a broadening of their therapeutic focus [46][48] Conclusion - Nkarta is positioned to leverage its CAR NK cell therapy platform to address significant unmet needs in autoimmune diseases, with a focus on safety, accessibility, and clinical efficacy. The upcoming data readouts and ongoing trials will be critical in determining the future trajectory of the company's product offerings and market positioning [76]

Group 1 - Nkarta, Inc. is a clinical-stage biopharmaceutical company focused on developing engineered natural killer (NK) cell therapies [1][3] - The company is participating in the H.C. Wainwright "HCW@Home" Series, with a fireside chat scheduled for July 30, 2025 [2] - Nkarta is advancing allogeneic, off-the-shelf NK cell therapies aimed at treating autoimmune diseases, utilizing a combination of cell expansion, cryopreservation, and CRISPR-based genome engineering [3] Group 2 - The event will be available via a simultaneous webcast on Nkarta's website, with a replay accessible for approximately 90 days [2] - Nkarta's approach is designed for deep therapeutic activity and broad access in outpatient treatment settings [3] - For further information, Nkarta's media and investor contact is Nadir Mahmood [4]

Core Insights - Nkarta, Inc. (NASDAQ: NKTX) has shown a relatively flat performance since the last analysis in March, indicating a stable but cautious outlook for the investment thesis [1] Company Overview - Nkarta, Inc. specializes in allogeneic cell therapies, which are a significant area of interest in the biotech sector [1] Analyst Background - The analysis is conducted by an individual with a PhD in biochemistry and extensive experience in analyzing clinical trials and biotech companies, emphasizing the importance of understanding the science behind investments [1]

Core Insights - Nkarta, Inc. has appointed Dr. Shawn Rose as the new Chief Medical Officer and Head of Research and Development, effective June 23, 2025, succeeding Dr. David R. Shook who is leaving to pursue opportunities in oncology [1][4]. Company Overview - Nkarta is a clinical-stage biopharmaceutical company focused on developing engineered natural killer (NK) cell therapies for autoimmune diseases [7]. - The company is advancing its NKX019 candidate, an allogeneic, cryopreserved immunotherapy that utilizes NK cells from healthy donors, engineered for enhanced targeting and persistence [6]. Leadership Transition - Dr. Rose has extensive experience in immunology and has successfully led multiple programs from discovery to clinical development, including the development of approved medicines like Sotyktu, Stelara, and Tremfya [2][3]. - During the transition, Dr. Rose will collaborate with Dr. Shook, who will serve as a consultant until July 11, 2025 [4]. Strategic Direction - The appointment of Dr. Rose is seen as critical for maximizing the potential of Nkarta's NK cell platform in treating autoimmune diseases [3]. - The company aims to leverage Dr. Rose's expertise in rheumatology and immunology to enhance its clinical development efforts [3][4].