NKTX Nkarta Inc.

17.12
+0.01  (+0%)
Previous Close 17.11
Open 16.98
52 Week Low 16.73
52 Week High 76.5026
Market Cap $563,360,136
Shares 32,906,550
Float 23,915,158
Enterprise Value $292,303,350
Volume 240,904
Av. Daily Volume 246,152
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Upcoming Catalysts

Drug Stage Catalyst Date
NKX101
Acute myeloid leukemia / myelodysplastic syndromes
Phase 1
Phase 1
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NKX019
B-cell malignancies
Phase 1
Phase 1
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Latest News

    • First patients dosed in Phase 1 clinical trial evaluating NKX019 in CD19+ advanced B cell malignancies
    • Initial data from the NKX019 clinical trial expected in 2022
    • Initial data from Phase 1 clinical trial evaluating NKX101 in AML and MDS expected in 1H 2022

    SOUTH SAN FRANCISCO, Calif., Oct. 07, 2021 (GLOBE NEWSWIRE) -- Nkarta, Inc. (NASDAQ:NKTX), a biopharmaceutical company developing engineered natural killer (NK) cell therapies to treat cancer, today announced NKX019 and NKX101 clinical development program updates.

    Patients have been dosed in the international Phase 1 clinical trial of NKX019 in advanced B-cell malignancies. NKX019 is an NK cell immunotherapy that is engineered to eradicate tumors expressing CD19, a validated B-cell cancer…

    • First patients dosed in Phase 1 clinical trial evaluating NKX019 in CD19+ advanced B cell malignancies
    • Initial data from the NKX019 clinical trial expected in 2022
    • Initial data from Phase 1 clinical trial evaluating NKX101 in AML and MDS expected in 1H 2022

    SOUTH SAN FRANCISCO, Calif., Oct. 07, 2021 (GLOBE NEWSWIRE) -- Nkarta, Inc. (NASDAQ:NKTX), a biopharmaceutical company developing engineered natural killer (NK) cell therapies to treat cancer, today announced NKX019 and NKX101 clinical development program updates.

    Patients have been dosed in the international Phase 1 clinical trial of NKX019 in advanced B-cell malignancies. NKX019 is an NK cell immunotherapy that is engineered to eradicate tumors expressing CD19, a validated B-cell cancer target.

    "We are excited to explore the potential of NKX019, our second clinical-stage, engineered chimeric antigen receptor (CAR) NK cell therapy candidate, to become a leading treatment of B-cell malignances for eventual use in a broadly accessible outpatient setting," said Paul J. Hastings, President and Chief Executive Officer of Nkarta. "NKX019 builds upon the potent innate anti-tumor biology and promising safety profile of natural killer cells. This trial moves us one step closer to bringing game-changing, off-the-shelf cell therapies to cancer patients. We anticipate reporting initial data from the NKX019 study in 2022."

    Nkarta is producing the clinical supply of NKX019 at its in-house cGMP clinical manufacturing facility in South San Francisco, California.

    Nkarta is also updating guidance on when it expects to announce initial data from the first-in-human Phase 1 clinical trial of NKX101, an engineered CAR NK cell therapy candidate targeting the NKG2D ligand, in patients with relapsed or refractory acute myeloid leukemia (AML) or higher-risk myelodysplastic syndromes (MDS) to the first half of 2022.

    Multiple factors have affected the cadence of the NKX101 Phase 1 study, including the use of haplomatched donor derived cells in the original study design, requirement for a staggered enrollment of patients that was longer than originally expected, and COVID-19 related disruptions. As previously announced, the clinical trial protocol was later amended in consultation with the U.S. Food and Drug Administration to be able to dose patients with either off-the-shelf or haplomatched cells, shorten the stagger between certain patients, and introduce a second parallel dosing regimen. The new timing is intended to allow Nkarta to report a robust data set from the study, which is currently enrolling patients at several locations in the United States.

    About the NKX019-101 Clinical Trial

    The NKX019-101 clinical trial is a Phase 1, multi-center, open-label, dose-finding and dose-expansion study to evaluate the safety and anti-tumor activity of NKX019 as a multi-dose, multi-cycle monotherapy. Patients with CAR T naïve relapsed/refractory non-Hodgkin lymphoma (NHL), chronic lymphocytic leukemia (CLL) or B-cell acute lymphoblastic leukemia (B-ALL) will be enrolled in the dose-finding portion of the study. Following the selection of a recommended Phase 2 dose, patients with r/r B-ALL, CLL, or other subtypes of NHL, including patients who did not achieve a durable response after treatment with a CD19 CAR T cell therapy, will be enrolled in the dose-expansion portion of the trial. To learn more about the clinical trial of NKX019 in advanced B cell malignancies, please visit ClinicalTrials.gov.

    About NKX019

    NKX019 is an investigational, allogeneic, off-the-shelf cancer immunotherapy that uses natural killer (NK) cells derived from the peripheral blood of healthy adult donors. It is engineered with a humanized CD19-directed CAR for enhanced tumor cell targeting and a proprietary, membrane-bound form of interleukin-15 (IL-15) for greater persistence and activity without exogenous cytokine support. CD19 is a biomarker for normal and malignant B cells, and it is a validated target for B cell cancer therapies.

    About NKX101

    NKX101 is an investigational, off-the-shelf cancer immunotherapy that uses natural killer (NK) cells derived from the peripheral blood of healthy donors and engineered with membrane-bound IL-15 and a chimeric antigen receptor (CAR) targeting NKG2D ligands on tumor cells. NKG2D, a key activating receptor found on naturally occurring NK cells, induces a cell-killing immune response through the detection of stress ligands that are widely expressed on cancer cells. By engineering NKX101 with the proprietary NKG2D-based CAR, the ability of NK cells to recognize and kill tumor cells in pre-clinical models is increased significantly compared to non-engineered NK cells. The addition of membrane-bound IL15, a proprietary version of a cytokine for activating NK cell growth, has been shown in pre-clinical models to enhance the proliferation, persistence and sustained activity of NK cells. To learn more about the NKX101 clinical trial in adults with AML or MDS, please visit ClinicalTrials.gov.

    About B-Cell Cancers

    B-cell lineage cancers are a worldwide healthcare burden. Over 500,000 new cases of non-Hodgkin lymphoma (NHL) and 50,000 new cases of acute lymphoblastic leukemia (ALL) are diagnosed world-wide each year (seer.cancer.gov, Smith 2015, Solomon 2017). Despite progress in treatment, many patients diagnosed with this heterogeneous group of cancers still succumb to their diseases. Autologous chimeric antigen receptor (CAR) T cells specific for CD19 have altered the treatment landscape for some patients with relapsed or refractory B-cell malignancies, though significant toxicities associated with T-cell expansion and the necessity for bespoke manufacturing have limited their use.

    About AML and MDS

    Acute Myeloid Leukemia (AML) is a rapidly progressing blood cancer caused by abnormalities of myeloid cells, a cell type in the bone marrow that would normally develop into different types of blood cells. AML usually worsens rapidly and can lead to death if not treated. Over 120,000 new cases of AML are diagnosed world-wide each year.* Despite recent advancements, an unmet need for novel treatment options remains high. After treatment with approved therapies for AML, many patients either do not achieve complete response (CR) or relapse after CR. There is no approved therapy and limited treatment options for patients with relapsed or refractory (r/r) AML. CR rates of 12% to 18% with repeated cycles of chemotherapy are reported in this patient population.**

    Myelodysplastic Syndromes (MDS) are a group of bone marrow disorders in which the blood-forming cells in the bone marrow do not produce enough healthy blood cells. Some patients with MDS have too many young, immature blood-making cells in the bone marrow. The median overall survival rate of higher risk MDS patients is 0.8 to 3.0 years. There is currently no curative treatment for patients who relapse after front-line therapy or do not respond to front-line therapy. MDS can progress to AML in about one-third of patients.

    *Ming Yi et al, J Hematol Oncol. 2020; 13: 72.

    **Roboz et al, JCO 2014; 32: 18. Faderl et al, JCO 2012; 30: 20. Ravandi et al, Lancet 2015; 16: 9.

    About Nkarta

    Nkarta is a clinical-stage biotechnology company advancing the development of allogeneic, off-the-shelf natural killer (NK) cell therapies for cancer patients. By combining its cell expansion and cryopreservation platform with proprietary cell engineering technologies and CRISPR-based genome engineering capabilities, Nkarta is building a pipeline of future cell therapies engineered for deep anti-tumor activity and intended for broad access in the outpatient treatment setting. For more information, please visit the company's website at www.nkartatx.com.

    Cautionary Note on Forward-Looking Statements

    Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Words such as "anticipates," "believes," "expects," "intends," "plans," "potential," "projects," "would" and "future" or similar expressions are intended to identify forward-looking statements. Examples of these forward-looking statements include, but are not limited to, statements concerning Nkarta's expectations regarding any or all of the following: the safety, anti-tumor activity, success, and accessibility of Nkarta's NK cell therapy candidates, including NKX019 for the treatment of B-cell malignancies; the timing of the initial NKX019 and NKX101 clinical trial data, and the nature of those data; Nkarta's ability to build and advance a pipeline of cell therapies; and Nkarta's ability to produce clinical supply of NKX019. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, among others: Nkarta's limited operating history and historical losses; Nkarta's lack of any products approved for sale and its ability to achieve profitability; Nkarta's ability to raise additional funding to complete the development and any commercialization of its product candidates; Nkarta's dependence on the success of its co-lead product candidates, NKX101 and NKX019; that Nkarta may be delayed in initiating, enrolling or completing any clinical trials; competition from third parties that are developing products for similar uses; Nkarta's ability to obtain, maintain and protect its intellectual property; Nkarta's dependence on third parties in connection with manufacturing, clinical trials and pre-clinical studies; the complexity of the manufacturing process for CAR NK cell therapies; and risks relating to the impact on our business of the COVID-19 pandemic or similar public health crises.

    These and other risks are described more fully in Nkarta's filings with the Securities and Exchange Commission ("SEC"), including the "Risk Factors" section of Nkarta's Quarterly Report on Form 10-Q for the quarter ended June 30, 2021, filed with the SEC on August 12, 2021, and Nkarta's other documents subsequently filed with or furnished to the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, Nkarta undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    Nkarta Media/Investor Contact:

    Greg Mann

    Nkarta, Inc.

    415-317-3675

    gmann@nkartatx.com



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    • Data support potential clinical applications of CRISPR/Cas9 genome engineering, CD70 chimeric antigen receptor (CAR) targeting, and donor selection algorithms in next generation NK cell development programs
    • Update also highlights novel methods for scaling the expansion of engineered NK cells to potentially supply a life cycle's worth of commercial product from a single donor

    SOUTH SAN FRANCISCO, Calif., Oct. 01, 2021 (GLOBE NEWSWIRE) -- Nkarta, Inc. (NASDAQ:NKTX), a biopharmaceutical company developing engineered natural killer (NK) cell therapies to treat cancer, today announced four presentations at the upcoming Society for Immunotherapy of Cancer (SITC) 36th Annual Meeting and Pre-Conference Programs to be held November 10-14, 2021.

    The…

    • Data support potential clinical applications of CRISPR/Cas9 genome engineering, CD70 chimeric antigen receptor (CAR) targeting, and donor selection algorithms in next generation NK cell development programs
    • Update also highlights novel methods for scaling the expansion of engineered NK cells to potentially supply a life cycle's worth of commercial product from a single donor

    SOUTH SAN FRANCISCO, Calif., Oct. 01, 2021 (GLOBE NEWSWIRE) -- Nkarta, Inc. (NASDAQ:NKTX), a biopharmaceutical company developing engineered natural killer (NK) cell therapies to treat cancer, today announced four presentations at the upcoming Society for Immunotherapy of Cancer (SITC) 36th Annual Meeting and Pre-Conference Programs to be held November 10-14, 2021.

    The full abstracts are scheduled to be available on the SITC website on November 9, 2021.

    Presented jointly with CRISPR Therapeutics:

    Title: A Combined Strategy of CD70 CAR Co-expression with Membrane-bound IL-15 and CISH Knockout Results in Enhanced NK Cytotoxicity and Persistence

    Abstract Number and Type: 16439, oral*

    Poster Presentation Date and Time: November 10, 2021, 2:40 p.m. ET

    Title: CISH Gene-knockout Anti-CD70-CAR NK Cells Demonstrate Potent Anti-tumor Activity Against Solid Tumor Cell Lines and Provide Partial Resistance to Tumor Microenvironment Inhibition

    Abstract Number and Type: 113, poster

    Poster Presentation Date and Time: November 12, 2021, 7:00 am – 8:30 pm ET

    Nkarta presentations:

    Title: Potentiating the Large-Scale Expansion and Engineering of Peripheral Blood-Derived CAR NK Cells for Off-the-Shelf Application

    Abstract Number and Type: 151, poster

    Poster Presentation Date and Time: November 12, 2021, 7:00 am – 8:30 pm ET

    Title: KIR Haplotype Can Inform Donor Selection in the Production of Allogeneic Memory-Like CAR NK Cells for Clinical Application

    Abstract Number and Type: 128, poster

    Poster Presentation Date and Time: November 13, 2021, 7:00 am – 8:30 pm ET

    * https://www.sitcancer.org/2021/program/pre-conference-programs/industryprogram; a pre-conference program; additional registration is required.

    About Nkarta

    Nkarta is a clinical-stage biotechnology company advancing the development of allogeneic, off-the-shelf natural killer (NK) cell therapies for cancer patients. By combining its cell expansion and cryopreservation platform with proprietary cell engineering technologies, Nkarta is building a pipeline of cell therapy candidates generated by efficient manufacturing processes, which are engineered to enhance tumor targeting and improve persistence for sustained activity in the body. For more information, please visit the company's website at www.nkartatx.com.

    Cautionary Note on Forward-Looking Statements

    Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Words such as "anticipates," "believes," "expects," "intends," "plans," "potential," "projects," "would" and "future" or similar expressions are intended to identify forward-looking statements. Examples of these forward-looking statements include, but are not limited to, statements concerning Nkarta's expectations regarding any or all of the following: the efficiency and scalability of Nkarta's manufacturing processes; Nkarta's ability to develop manufacturing methods that produce a life cycle's worth of commercial product from a single donor; Nkarta's ability to build a pipeline of cell therapies; and the benefits of Nkarta's cell engineering and other technologies. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, among others: Nkarta's limited operating history and historical losses; Nkarta's lack of any products approved for sale and its ability to achieve profitability; Nkarta's ability to raise additional funding to complete the development and any commercialization of its product candidates; Nkarta's dependence on the success of its co-lead product candidates, NKX101 and NKX019; that Nkarta may be delayed in initiating, enrolling or completing any clinical trials; competition from third parties that are developing products for similar uses; Nkarta's ability to obtain, maintain and protect its intellectual property; Nkarta's dependence on third parties in connection with manufacturing, clinical trials and pre-clinical studies; the complexity of the manufacturing process for CAR NK cell therapies; and risks relating to the impact on our business of the COVID-19 pandemic or similar public health crises.

    These and other risks are described more fully in Nkarta's filings with the Securities and Exchange Commission ("SEC"), including the "Risk Factors" section of Nkarta's Quarterly Report on Form 10-Q for the quarter ended June 30, 2021, filed with the SEC on August 12, 2021, and Nkarta's other documents subsequently filed with or furnished to the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, Nkarta undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    Nkarta Media/Investor Contact:

    Greg Mann

    Nkarta, Inc.

    415-317-3675

    gmann@nkartatx.com



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  1. SOUTH SAN FRANCISCO, Calif., Sept. 14, 2021 (GLOBE NEWSWIRE) -- Nkarta, Inc. (NASDAQ:NKTX), a biopharmaceutical company developing engineered natural killer (NK) cell therapies to treat cancer, today announced its participation at this upcoming investor conference:

    Cantor Virtual Global Healthcare Conference
    Tuesday, September 28, 2021
    4:00 p.m. ET - fireside chat presentation

    A simultaneous webcast of the presentation will be available on the Investors section of Nkarta's website, www.nkartatx.com, and a replay will be archived on the website for approximately four weeks.

    About Nkarta
    Nkarta is a clinical-stage biotechnology company advancing the development of allogeneic, off-the-shelf natural killer (NK) cell therapies for cancer patients…

    SOUTH SAN FRANCISCO, Calif., Sept. 14, 2021 (GLOBE NEWSWIRE) -- Nkarta, Inc. (NASDAQ:NKTX), a biopharmaceutical company developing engineered natural killer (NK) cell therapies to treat cancer, today announced its participation at this upcoming investor conference:

    Cantor Virtual Global Healthcare Conference

    Tuesday, September 28, 2021

    4:00 p.m. ET - fireside chat presentation

    A simultaneous webcast of the presentation will be available on the Investors section of Nkarta's website, www.nkartatx.com, and a replay will be archived on the website for approximately four weeks.

    About Nkarta

    Nkarta is a clinical-stage biotechnology company advancing the development of allogeneic, off-the-shelf natural killer (NK) cell therapies for cancer patients. By combining its cell expansion and cryopreservation platform with proprietary cell engineering technologies, Nkarta is building a pipeline of cell therapy candidates generated by efficient manufacturing processes, which are engineered to enhance tumor targeting and improve persistence for sustained activity in the body. For more information, please visit the company's website at www.nkartatx.com.

    Nkarta Media/Investor Contact:

    Greg Mann

    Nkarta, Inc.

    gmann@nkartatx.com

     



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    • Initial data from NKX101 clinical trial expected by end of 2021
    • NKX019 patient dosing expected to start in 2H 2021
    • Collaboration with CRISPR Therapeutics to develop gene-edited cell therapies
    • New lease for commercial manufacturing center / headquarters to support rapid innovation and scaled production of NK cell therapies

    SOUTH SAN FRANCISCO, Calif., Aug. 12, 2021 (GLOBE NEWSWIRE) -- Nkarta, Inc. (NASDAQ:NKTX), a biopharmaceutical company developing engineered natural killer (NK) cell therapies to treat cancer, today reported financial results for the second quarter ended June 30, 2021.

    "Nkarta continues to set the pace for NK cell therapy as we build on the strengths of our next generation platform and advance our two co-lead clinical programs…

    • Initial data from NKX101 clinical trial expected by end of 2021
    • NKX019 patient dosing expected to start in 2H 2021
    • Collaboration with CRISPR Therapeutics to develop gene-edited cell therapies
    • New lease for commercial manufacturing center / headquarters to support rapid innovation and scaled production of NK cell therapies

    SOUTH SAN FRANCISCO, Calif., Aug. 12, 2021 (GLOBE NEWSWIRE) -- Nkarta, Inc. (NASDAQ:NKTX), a biopharmaceutical company developing engineered natural killer (NK) cell therapies to treat cancer, today reported financial results for the second quarter ended June 30, 2021.

    "Nkarta continues to set the pace for NK cell therapy as we build on the strengths of our next generation platform and advance our two co-lead clinical programs," said Paul J. Hastings, President and Chief Executive Officer of Nkarta. "During the period, we initiated collaboration activities with CRISPR Therapeutics, added new platform capabilities for rapid innovation, and expanded our manufacturing footprint – all designed to stay ahead of the technology curve and transform the scientific insights of cell therapy into meaningful medicines for cancer patients. Nkarta remains on track to report initial clinical data from our Phase 1 study of NKX101 by the end of this year."

    RECENT ACCOMPLISHMENTS AND FUTURE MILESTONES

    NKX101

    • Nkarta aims to present initial clinical data from its ongoing clinical trial of NKX101 by year end 2021. In the Phase 1 study, patients receive multiple doses of NKX101 during a 28-day treatment cycle and are eligible to receive subsequent cycles of treatment upon evidence of tolerability and disease response.

    NKX019

    • Nkarta expects patient dosing in a Phase 1 clinical trial of NKX019 to initiate in the second half of 2021 and has begun manufacturing of clinical supply of NKX019 at its in-house cGMP clinical manufacturing facility in South San Francisco, California.

    Manufacturing

    • Nkarta entered a lease agreement to establish a combined manufacturing facility and company headquarters. The manufacturing facility will produce materials for potential pivotal trials and commercial launch of multiple engineered NK cell therapy products. The expanded manufacturing footprint, centered in South San Francisco, California, builds upon Nkarta's existing 2,700 square foot cGMP clinical manufacturing facility.

    Pipeline and Platform

    • In May 2021, Nkarta and CRISPR Therapeutics announced a research and development collaboration to co-develop and co-commercialize two chimeric antigen receptor (CAR) NK cell product candidates, one targeting CD70, and one combining NK and T cells (NK+T), each enhanced with genome engineering. The collaboration also gives Nkarta a license to CRISPR/Cas9 gene editing technology for use in its own engineered NK cell therapy products.



    • Nkarta continues to integrate important scientific insights, processes and breakthroughs into its next generation platform. Platform capabilities include:



      • Multiplexed CRISPR/Cas9 genome engineering
      • "Armored" cells with membrane-bound IL-15 for persistence
      • Enhanced expansion, persistence and activity against tumor microenvironment inhibition via CISH deletion
      • Cytokine activation using IL-12, -15 and -18 to enhance anti-tumor activity persistence and memory-like properties
      • No requirement for cytokine support
      • Multi-dose and multi-cycle clinical trial designs

    SECOND QUARTER 2021 FINANCIAL HIGHLIGHTS

    • Cash and Cash Equivalents: As of June 30, 2021, Nkarta had cash, cash equivalents, restricted cash and short-term investments of $280.3 million.



    • R&D Expenses: Research and development expenses were $16.0 million for the second quarter of 2021. Non-cash stock-based compensation expense included in R&D expense was $1.7 million for the second quarter of 2021.



    • G&A Expenses: General and administrative expenses were $5.7 million for the second quarter of 2021. Non-cash stock-based compensation expense included in G&A expense was $1.9 million for the second quarter of 2021.



    • Net Loss. Net loss was $21.5 million, or $0.66 per basic and diluted share, for the second quarter of 2021.

    FINANCIAL GUIDANCE

    • Nkarta expects its current cash and cash equivalents will be sufficient to fund its current operating plan into at least the second half of 2023.

    About NKX101

    NKX101 is an investigational, off-the-shelf cancer immunotherapy that uses natural killer (NK) cells derived from the peripheral blood of healthy donors and engineered with membrane-bound IL15 and a chimeric antigen receptor (CAR) targeting NKG2D ligands on tumor cells. NKG2D, a key activating receptor found on naturally occurring NK cells, induces a cell-killing immune response through the detection of stress ligands that are widely expressed on cancer cells. By engineering NKX101 with the proprietary NKG2D-based CAR, the ability of NK cells to recognize and kill tumor cells in pre-clinical models is increased significantly compared to non-engineered NK cells. The addition of membrane-bound IL15, a proprietary version of a cytokine for activating NK cell growth, has been shown in pre-clinical models to enhance the proliferation, persistence and sustained activity of NK cells. A multi-center Phase 1 clinical trial of NKX101 in patients with relapsed/refractory acute myeloid leukemia (AML) or higher risk myelodysplastic syndromes (MDS) is currently enrolling. Additional information about the clinical trial is available on ClinicalTrials.gov, identifier NCT04623944.

    About NKX019

    NKX019 is an investigational, off-the-shelf cancer immunotherapy that uses natural killer (NK) cells derived from the peripheral blood of healthy donors and engineered with a CD19-directed chimeric antigen receptor (CAR) and a proprietary, membrane-bound form of interleukin 15 (IL-15). CD19 is a biomarker for normal and malignant B cells, and it is a validated target for B cell cancer therapies. Via its CAR, NKX019 targets and binds to CD19 and eliminates CD19-expressing cells via a robust immune response in preclinical studies. Preclinical models also demonstrate enhanced proliferation, persistence and activity of NK cells with the membrane-bound IL-15, an important cytokine for NK cell survival. Initiation of a Phase 1 clinical trial of NKX019 in patients with relapsed/refractory B cell malignancies in multiple centers in the United States and Australia is planned for the second half of 2021.

    About Nkarta's Platform and Natural Starting Materials

    Nkarta's engineering platform utilizes healthy adult donors as the source for NK cells. By enlisting this natural source of NK cells, Nkarta starts with bona fide NK cells endowed with inherent tumor-recognizing ability and potent cytotoxic function. Healthy donor-derived NK cells are also available in abundance, providing a large quantity of cells with which to begin the efficient two-week manufacturing process. Finally, healthy donor-derived adult cells consist of a diverse repertoire of NK cells, providing Nkarta with the potential to capitalize on the inherent diversity of the innate immune system in selecting donors or NK cell populations with optimal characteristics.

    About Nkarta's NK Cell Technologies

    Nkarta has pioneered a novel discovery and development platform for the engineering and efficient production of allogeneic, off-the-shelf natural killer (NK) cell therapy candidates. The approach harnesses the innate ability of NK cells to recognize and kill tumor cells. To enhance the inherent biological activity of NK cells, Nkarta genetically engineers the cells with a targeting receptor designed to recognize and bind to specific proteins on the surface of cancerous cells. This receptor is fused to co-stimulatory and signaling domains to amplify cell signaling and NK cell cytotoxicity. Upon binding the target, NK cells become activated and release cytokines that enhance the immune response and cytotoxic granules that lead to killing of the target cell. All of Nkarta's NK current cell therapy candidates are also engineered with a membrane-bound IL15, a proprietary version of a cytokine known for activating NK cell growth, to enhance the persistence and activity of the NK cells.

    Nkarta's manufacturing process generates an abundant supply of NK cells that, at commercial scale, is expected to be significantly lower in cost than other current allogeneic and autologous cell therapies. Key to this efficiency is the rapid expansion of donor-derived NK cells using a proprietary NKSTIM cell line, leading to the production of hundreds of individual doses from a single manufacturing run. The platform also features the ability to freeze and store CAR NK cells for an extended period of time and is designed to enable immediate, off-the-shelf administration to patients at the point of care.

    About Nkarta

    Nkarta is a clinical-stage biotechnology company advancing the development of allogeneic, off-the-shelf natural killer (NK) cell therapies for cancer patients. By combining its cell expansion and cryopreservation platform with proprietary cell engineering technologies, Nkarta is building a pipeline of cell therapy candidates generated by efficient manufacturing processes, which are engineered to enhance tumor targeting and improve persistence for sustained activity in the body. For more information, please visit the company's website at www.nkartatx.com.

    Cautionary Note on Forward-Looking Statements

    Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Words such as "anticipates," "believes," "expects," "intends," "plans," "potential," "projects," "would" and "future" or similar expressions are intended to identify forward-looking statements. Examples of these forward-looking statements include statements concerning Nkarta's expectations regarding any or all of the following: Nkarta's ability to successfully and rapidly develop NK cell therapies, including advancing its two lead clinical programs and building a pipeline of product candidates; the benefits of Nkarta's technology platform; the timing of NKX019 clinical trial initiation and patient dosing and NKX101 clinical trial data; Nkarta's future manufacturing facility and headquarters and production at the facility; the programs planned under Nkarta's collaboration with CRISPR Therapeutics; Nkarta's ability to capitalize on the inherent diversity of the innate immune system; the ability of Nkarta's technology to enhance the proliferation, persistence and anti-tumor activity of NK cells and enable off-the-shelf, point-of-care administration; the efficiency and cost of Nkarta's manufacturing processes; the number of doses generated from a manufacturing run; Nkarta's ability to continue manufacturing clinical supply of NKX019 in house; the proprietary nature of Nkarta's technology; and Nkarta's expected cash runway. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, among others: Nkarta's limited operating history and historical losses; Nkarta's lack of any products approved for sale and its ability to achieve profitability; Nkarta's ability to raise additional funding to complete the development and any commercialization of its product candidates; Nkarta's dependence on the success of its co-lead product candidates, NKX101 and NKX019; that Nkarta may be delayed in initiating, enrolling or completing any clinical trials; competition from third parties that are developing products for similar uses; Nkarta's ability to obtain, maintain and protect its intellectual property; Nkarta's dependence on third parties in connection with manufacturing, clinical trials and pre-clinical studies; the complexity of the manufacturing process for CAR NK cell therapies; and risks relating to the impact on our business of the COVID-19 pandemic or similar public health crises.

    These and other risks are described more fully in Nkarta's filings with the Securities and Exchange Commission ("SEC"), including the "Risk Factors" section of Nkarta's Quarterly Report on Form 10-Q for the quarter ended March 31, 2021, filed with the SEC on May 13, 2021, and our other documents subsequently filed with or furnished to the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, Nkarta undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    Nkarta, Inc.

    Condensed Statements of Operations

    (in thousands, except share and per share data)

    (Unaudited)

      Three Months Ended

    June 30,
      Six Months Ended

    June 30,
     
      2021  2020  2021  2020 
    Operating expenses                
    Research and development $15,957  $7,862  $29,496  $15,122 
    General and administrative  5,677   2,493   11,618   4,642 
    Total operating expenses  21,634   10,355   41,114   19,764 
    Loss from operations  (21,634)  (10,355)  (41,114)  (19,764)
    Other income (expense), net:                
    Change in fair value of preferred stock

               purchase right liability
         (40,741)     (40,163)
    Interest income  104   27   214   152 
    Other income (expense), net  (5)  4   (8)  4 
    Total other income (expense), net  99   (40,710)  206   (40,007)
    Net loss $(21,535) $(51,065) $(40,908) $(59,771)
                     
    Net loss per share, basic and diluted $(0.66) $(30.06) $(1.25) $(36.13)
    Weighted average shares used to compute

    net loss per share, basic and diluted
      32,827,365   1,698,560   32,783,730   1,654,304 



    Nkarta, Inc.


    Condensed Balance Sheets

    (in thousands)

    (Unaudited)

      June 30,

    2021
     December 31,

    2020
    Assets     
    Cash, cash equivalents, restricted cash and short-term investments $280,255 $315,326
    Property and equipment, net  11,350  9,350
    Operating lease right-of-use assets  12,050  8,505
    Other assets                   5,456  4,469
    Total assets $309,111 $337,650
    Liabilities and stockholders' equity     
    Accounts payable, accrued and other liabilities $8,034 $7,511
    Operating lease liabilities  12,695  8,919
    Total liabilities               20,729  16,430
    Stockholders' equity                 288,382  321,220
    Total liabilities and stockholders' equity $309,111 $337,650



    Nkarta Media/Investor Contact:


    Greg Mann

    Nkarta, Inc.

    gmann@nkartatx.com



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    • 88,000 square foot facility in South San Francisco will support scaled manufacturing of Nkarta's engineered NK cell therapy candidates, and be home to company headquarters
    • Planned production expansion builds upon Nkarta's foundational manufacturing, operational and process development expertise
    • All operations remain closely integrated in South San Francisco, the international hub of biotechnology innovation, with its substantial talent pool and industry resources

    SOUTH SAN FRANCISCO, Calif., July 14, 2021 (GLOBE NEWSWIRE) -- Nkarta, Inc. (NASDAQ:NKTX), a biopharmaceutical company developing engineered natural killer (NK) cell therapies to treat cancer, today announced that it has signed a lease agreement for a facility to support research…

    • 88,000 square foot facility in South San Francisco will support scaled manufacturing of Nkarta's engineered NK cell therapy candidates, and be home to company headquarters
    • Planned production expansion builds upon Nkarta's foundational manufacturing, operational and process development expertise
    • All operations remain closely integrated in South San Francisco, the international hub of biotechnology innovation, with its substantial talent pool and industry resources

    SOUTH SAN FRANCISCO, Calif., July 14, 2021 (GLOBE NEWSWIRE) -- Nkarta, Inc. (NASDAQ:NKTX), a biopharmaceutical company developing engineered natural killer (NK) cell therapies to treat cancer, today announced that it has signed a lease agreement for a facility to support research and development and future commercial manufacturing of Nkarta's cell therapy pipeline. The new facility will also serve as the company's headquarters with office space and research facilities. The manufacturing center will be custom designed to complement Nkarta's state-of-the-art technology platform and optimize the production of its multiple off-the-shelf NK cell therapy investigational products. Nkarta plans to produce materials for potential pivotal clinical trials and commercial launch at the new center.

    "Our goal is to ensure that cost-effective, commercial-scale production of cell therapies can be made available widely and rapidly to the cancer patients who need them, and we expect this new facility will enable us to do just that," said Paul J. Hastings, President and CEO of Nkarta. "As we advance our NKX101 and NKX019 clinical programs and enhance our proprietary platform with exciting new capabilities like CRISPR Cas9 genome engineering, we believe our expanded footprint will drive continued operational excellence and accelerate the development of transformative NK cell therapies for a broad range of cancers."

    Earlier this year, Nkarta completed the construction and qualification of a 2,700 square foot cGMP facility at its primary location in South San Francisco, California. This current clinical manufacturing facility was designed to integrate with Nkarta's internal process development expertise and meet the production needs of Nkarta's research activities and early stage clinical trials. Nkarta is currently manufacturing clinical supply for its planned Phase 1 study of NKX019, expected to start in the second half of 2021, and plans to transfer the production of NKX101 and other proprietary platform materials to the clinical manufacturing facility in the future.

    The newly leased facility in South San Francisco will be built-out as a multi-product facility and is expected to be operational by the end of 2023. At full capacity, the manufacturing center is expected to have the flexibility to produce commercial supply of multiple cell therapy products. Nkarta will also consolidate administrative offices and research and development laboratories at the new site.

    About NKX101

    NKX101 is an investigational, off-the-shelf cancer immunotherapy that uses natural killer (NK) cells derived from the peripheral blood of healthy donors and engineered with membrane-bound IL15 and a chimeric antigen receptor (CAR) targeting NKG2D ligands on tumor cells. NKG2D, a key activating receptor found on naturally occurring NK cells, induces a cell-killing immune response through the detection of stress ligands that are widely expressed on cancer cells. By engineering NKX101 with the proprietary NKG2D-based CAR, the ability of NK cells to recognize and kill tumor cells in pre-clinical models is increased significantly compared to non-engineered NK cells. The addition of membrane-bound IL15, a proprietary version of a cytokine for activating NK cell growth, has been shown in pre-clinical models to enhance the proliferation, persistence and sustained activity of NK cells. A multi-center Phase 1 clinical trial of NKX101 in patients with relapsed/refractory acute myeloid leukemia (AML) or higher risk myelodysplastic syndromes (MDS) is currently enrolling. Additional information about the clinical trial is available on ClinicalTrials.gov, identifier NCT04623944.

    About NKX019

    NKX019 is an investigational, off-the-shelf cancer immunotherapy that uses natural killer (NK) cells derived from the peripheral blood of healthy donors and engineered with a CD19-directed chimeric antigen receptor (CAR) and a proprietary, membrane-bound form of interleukin 15 (IL-15). CD19 is a biomarker for normal and malignant B cells, and it is a validated target for B cell cancer therapies. Via its CAR, NKX019 targets and binds to CD19 and eliminates CD19-expressing cells via a robust immune response in preclinical studies. Preclinical models also demonstrate enhanced proliferation, persistence and activity of NK cells with the membrane-bound IL-15, an important cytokine for NK cell survival. Initiation of a Phase 1 clinical trial of NKX019 in patients with relapsed/refractory B cell malignancies in multiple centers in the United States and Australia is planned for the second half of 2021.

    About Nkarta's Platform and Natural Starting Materials

    Nkarta's engineering platform utilizes healthy adult donors as the source for NK cells. By enlisting this natural source of NK cells, Nkarta starts with bona fide NK cells endowed with inherent tumor-recognizing ability and potent cytotoxic function. Healthy donor-derived NK cells are also available in abundance, providing a large quantity of cells with which to begin the efficient two-week manufacturing process. Finally, healthy donor-derived adult cells consist of a diverse repertoire of NK cells, providing Nkarta with the potential to capitalize on the inherent diversity of the innate immune system in selecting donors or NK cell populations with optimal characteristics.

    About Nkarta's NK Cell Technologies

    Nkarta has pioneered a novel discovery and development platform for the engineering and efficient production of allogeneic, off-the-shelf natural killer (NK) cell therapy candidates. The approach harnesses the innate ability of NK cells to recognize and kill tumor cells. To enhance the inherent biological activity of NK cells, Nkarta genetically engineers the cells with a targeting receptor designed to recognize and bind to specific proteins on the surface of cancerous cells. This receptor is fused to co-stimulatory and signaling domains to amplify cell signaling and NK cell cytotoxicity. Upon binding the target, NK cells become activated and release cytokines that enhance the immune response and cytotoxic granules that lead to killing of the target cell. All of Nkarta's NK current cell therapy candidates are also engineered with a membrane-bound IL15, a proprietary version of a cytokine known for activating NK cell growth, to enhance the persistence and activity of the NK cells.

    Nkarta's manufacturing process generates an abundant supply of NK cells that, at commercial scale, is expected to be significantly lower in cost than other current allogeneic and autologous cell therapies. Key to this efficiency is the rapid expansion of donor-derived NK cells using a proprietary NKSTIM cell line, leading to the production of hundreds of individual doses from a single manufacturing run. The platform also features the ability to freeze and store CAR NK cells for an extended period of time and is designed to enable immediate, off-the-shelf administration to patients at the point of care.

    About Nkarta

    Nkarta is a clinical-stage biotechnology company advancing the development of allogeneic, off-the-shelf natural killer (NK) cell therapies for cancer patients. By combining its cell expansion and cryopreservation platform with proprietary cell engineering technologies, Nkarta is building a pipeline of cell therapy candidates generated by efficient manufacturing processes, which are engineered to enhance tumor targeting and improve persistence for sustained activity in the body. For more information, please visit the company's website at www.nkartatx.com.

    Cautionary Note on Forward-Looking Statements

    Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Words such as "anticipates," "believes," "expects," "intends," "plans," "potential," "projects," "would" and "future" or similar expressions are intended to identify forward-looking statements. Examples of these forward-looking statements include statements concerning: Nkarta's expectations regarding the future benefits and impact of the new facility; Nkarta's plans for the use of the facility; the efficiency and cost of Nkarta's manufacturing processes and operations, including for commercial-scale manufacturing; the capacity of the future manufacturing facility and the timeline for it to be operational; the expected timing of the NKX019 trial initiation; Nkarta's ability to manufacture clinical supply of NKX019 in house and transfer production of NKX101 in house; Nkarta's ability to capitalize on the inherent diversity of the innate immune system; the ability of Nkarta's technology to enhance the proliferation, persistence and anti-tumor activity of NK cells and enable off-the-shelf, point-of-care administration; the number of doses generated from a manufacturing run; and the proprietary nature of Nkarta's technology. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, among others: Nkarta's limited operating history and historical losses; Nkarta's ability to raise additional funding to complete the development and any commercialization of its product candidates; Nkarta's dependence on the success of its co-lead product candidates, NKX101 and NKX019; that Nkarta may be delayed in initiating, enrolling or completing any clinical trials; competition from third parties that are developing products for similar uses; Nkarta's ability to obtain, maintain and protect its intellectual property; Nkarta's dependence on third parties in connection with manufacturing, clinical trials and pre-clinical studies; the complexity of the manufacturing process for CAR NK cell therapies; and risks relating to the impact on our business of the COVID-19 pandemic or similar public health crises.

    These and other risks are described more fully in Nkarta's filings with the Securities and Exchange Commission ("SEC"), including the "Risk Factors" section of Nkarta's Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2021, filed with the SEC on May 13, 2021, and our other documents subsequently filed with or furnished to the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, Nkarta undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    Nkarta Media/Investor Contact:

    Greg Mann

    Nkarta, Inc.

    gmann@nkartatx.com



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