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 and…

    • 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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  2. SOUTH SAN FRANCISCO, Calif., June 16, 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:

    Raymond James Human Health Innovation Conference
    June 21, 2021
    3:20 p.m. ET - fireside chat presentation

    The live webcast of the presentation will be available on the Investors section of Nkarta's website, www.nkartatx.com. A replay of the webcast 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. By combining…

    SOUTH SAN FRANCISCO, Calif., June 16, 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:

    Raymond James Human Health Innovation Conference

    June 21, 2021

    3:20 p.m. ET - fireside chat presentation

    The live webcast of the presentation will be available on the Investors section of Nkarta's website, www.nkartatx.com. A replay of the webcast 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. 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 www.nkartatx.com.

    Nkarta Media/Investor Contact:

    Greg Mann

    Nkarta, Inc.

    gmann@nkartatx.com

     



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  3. SOUTH SAN FRANCISCO, Calif., June 14, 2021 (GLOBE NEWSWIRE) -- Nkarta, Inc. (NASDAQ:NKTX), a biopharmaceutical company developing engineered natural killer (NK) cell therapies to treat cancer, today announced that Chief Executive Officer Paul Hastings has been elected as the Chair of the Biotechnology Innovation Organization (BIO) Board of Directors for the 2021-2022 term.

    "Paul is a true biotech pioneer with an incredible journey first as a patient, then as a patient advocate, a biotech innovator, CEO, a BIO committee organizer and now as the new Chair of BIO's Board of Directors," said Ali Behbahani, MD, co-founder and Chair of Nkarta's Board of Directors. "We applaud Paul's election. We have witnessed firsthand the power of Paul's vision…

    SOUTH SAN FRANCISCO, Calif., June 14, 2021 (GLOBE NEWSWIRE) -- Nkarta, Inc. (NASDAQ:NKTX), a biopharmaceutical company developing engineered natural killer (NK) cell therapies to treat cancer, today announced that Chief Executive Officer Paul Hastings has been elected as the Chair of the Biotechnology Innovation Organization (BIO) Board of Directors for the 2021-2022 term.

    "Paul is a true biotech pioneer with an incredible journey first as a patient, then as a patient advocate, a biotech innovator, CEO, a BIO committee organizer and now as the new Chair of BIO's Board of Directors," said Ali Behbahani, MD, co-founder and Chair of Nkarta's Board of Directors. "We applaud Paul's election. We have witnessed firsthand the power of Paul's vision at Nkarta and look forward to seeing him help support the broader biotech industry as it continues to foster innovation and equity for patients."

    BIO is the world's largest advocacy organization representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products. Paul Hastings has spent a long career in biotech and brings a wealth of experience both as a leader and as an advocate. He will serve as BIO chair through June 2022, when he will be eligible for re-election for another one-year term.

    "I look forward to working closely with Paul as our new Board Chair," said BIO President and CEO Dr. Michelle McMurry-Heath. "Paul has been an active and highly engaged leader of BIO for more than two decades. His steadfast commitment to innovation, collaboration, education and patient advocacy will be critical to the continued success and future of our industry."

    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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  4. SOUTH SAN FRANCISCO, Calif., May 25, 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:

    Jefferies Virtual Healthcare Conference
    June 2, 2021
    Fireside chat presentation: 3:30 p.m. ET

    The live webcast of the presentation will be available on the Investors section of Nkarta's website, www.nkartatx.com. A replay of the webcast 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. By combining its cell…

    SOUTH SAN FRANCISCO, Calif., May 25, 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:

    Jefferies Virtual Healthcare Conference

    June 2, 2021

    Fireside chat presentation: 3:30 p.m. ET

    The live webcast of the presentation will be available on the Investors section of Nkarta's website, www.nkartatx.com. A replay of the webcast 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. 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 www.nkartatx.com.

    Nkarta Media/Investor Contact:

    Greg Mann

    Nkarta, Inc.

    gmann@nkartatx.com

     



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    • NKX019 IND received FDA clearance; NKX019 patient dosing expected to start in 2H 2021
    • Protocol amendment to ongoing NKX101 clinical trial adds a second multi-dosing regimen and a shorter waiting period between enrollment of patients
    • Initial data from NKX101 clinical trial expected by end of 2021
    • CRISPR Therapeutics collaboration supports early stage cell therapy pipeline with up to three joint programs and enables Nkarta to build gene edits into its own product pipeline
    • Cash and cash equivalents of $299.7 million as of March 31, 2021

    SOUTH SAN FRANCISCO, Calif., May 13, 2021 (GLOBE NEWSWIRE) -- Nkarta, Inc. (NASDAQ:NKTX), a biopharmaceutical company developing engineered natural killer (NK) cell therapies to treat cancer, today reported financial…

    • NKX019 IND received FDA clearance; NKX019 patient dosing expected to start in 2H 2021
    • Protocol amendment to ongoing NKX101 clinical trial adds a second multi-dosing regimen and a shorter waiting period between enrollment of patients
    • Initial data from NKX101 clinical trial expected by end of 2021
    • CRISPR Therapeutics collaboration supports early stage cell therapy pipeline with up to three joint programs and enables Nkarta to build gene edits into its own product pipeline
    • Cash and cash equivalents of $299.7 million as of March 31, 2021

    SOUTH SAN FRANCISCO, Calif., May 13, 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 first quarter ended March 31, 2021.

    "As Nkarta prepares NKX019, our second co-lead CAR NK program, to enter clinical trials later this year, we look forward to the evolution of broad proof of concept for our healthy donor derived engineered CAR NK product candidates as mono and combination therapies across multiple targets and indications," said Paul J. Hastings, President and Chief Executive Officer of Nkarta. "We expect to report initial clinical data from NKX101, our first co-lead program, by the end of 2021, with additional data announcements from both programs in 2022."

    Hastings continued, "As previously announced, we're excited and proud to be working with CRISPR Therapeutics to enhance the potential of our NK cell therapy platform using their best in class genome engineering technology and expertise in allogeneic CAR T cell therapy. This collaboration brings together the complementary strengths of two leaders in cell therapy with the aim of accelerating our research and development efforts to advance important cell therapies that can be made broadly accessible to cancer patients."

    RECENT ACCOMPLISHMENTS AND FUTURE MILESTONES

    NKX019

    • In April 2021, the U.S. Food & Drug Administration cleared the Investigational New Drug (IND) application for NKX019, a chimeric antigen receptor (CAR) NK cell therapy candidate engineered to target tumors expressing CD19, for the treatment of relapsed/refractory B cell malignancies. Nkarta expects patient dosing in a Phase 1 clinical trial of NKX019 to initiate in the second half of 2021.     

    NKX101

    • In April 2021, the FDA approved a protocol amendment to the clinical trial of NKX101 for patients with relapsed/refractory acute myeloid leukemia (AML) or higher risk myelodysplastic syndromes (MDS). The amendment includes an overall shorter waiting period between enrollment of patients, an additional two-dose regimen to increase patient convenience and to deliver more CAR NK cells earlier in each treatment cycle, and the earlier introduction of non haplo-related, off-the-shelf NKX101 in the ongoing dose finding cohort.

       
    • 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.       

    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 a product candidate 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.

    Manufacturing

    • Nkarta expects to manufacture NKX019 clinical supply for the Phase 1 clinical trial at its in-house cGMP clinical manufacturing facility located in South San Francisco, California.

       
    • Nkarta has started early planning for a commercial-scale cell therapy manufacturing facility in the United States.

    FIRST QUARTER 2021 FINANCIAL HIGHLIGHTS

    • Cash and Cash Equivalents: As of March 31, 2021, Nkarta had cash, cash equivalents, restricted cash and short-term investments of $299.7 million.

       
    • R&D Expenses: Research and development expenses were $13.5 million for the first quarter of 2021. Non-cash stock-based compensation expense included in R&D expense was $1.6 million for the first quarter of 2021.

       
    • G&A Expenses: General and administrative expenses were $5.9 million for the first quarter of 2021. Non-cash stock-based compensation expense included in G&A expense was $1.8 million for the first quarter of 2021.

       
    • Net Loss. Net loss was $19.4 million, or $0.59 per basic and diluted share, for the first 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 proof of concept of its CAR NK product candidates; the timing of the NKX019 trial initiation and patient dosing on its clinical trials; Nkarta's plans regarding the reporting of clinical data; the expected benefits of Nkarta's collaboration with CRISPR; 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 manufacture 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 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 Annual Report on Form 10-K for the year ended December 31, 2020, filed with the SEC on March 25, 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 March 31,
       2021   2020 
    Operating expenses    
    Research and development $13,539  $7,260 
    General and administrative  5,942   2,148 
    Total operating expenses  19,481   9,408 
    Loss from operations  (19,481)  (9,408)
    Other income (expense), net:    
    Change in fair value of preferred stock purchase right liability     578 
    Interest income  110   124 
    Other income (expense), net  (2)   
    Total other income (expense), net  108   702 
    Net loss $(19,373) $(8,706)
         
    Net loss per share, basic and diluted $(0.59) $(5.41)
    Weighted average shares used to compute net loss per share, basic and diluted  32,739,610   1,609,184 



    Nkarta, Inc.


    Condensed Balance Sheets

    (in thousands)

    (Unaudited)

      March 31,

    2021
     December 31,

    2020
    Assets     
    Cash, cash equivalents, restricted cash and short-term investments $            299,676 $           315,326
    Property and equipment, net      10,498                   9,350
    Operating lease right-of-use assets                 11,873  8,505
    Other assets                  3,645                    4,469
    Total assets $            325,692 $            337,650
    Liabilities and stockholders' equity     
    Accounts payable, accrued and other liabilities $                7,277 $                7,511
    Operating lease liabilities                12,425                    8,919
    Total liabilities              19,702                  16,430
    Stockholders' equity                305,990               321,220
    Total liabilities and stockholders' equity $            325,692 $            337,650



    Nkarta Media/Investor Contact:


    Greg Mann

    Nkarta, Inc.

    gmann@nkartatx.com

     



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  5. -Collaboration brings together breakthrough gene editing technology and leading natural killer (NK) cell and T cell discovery, development, and manufacturing capabilities-

    -Companies to co-develop and co-commercialize two chimeric antigen receptor (CAR) NK cell product candidates, one targeting CD70, and a product candidate combining NK and T cells (NK+T)-

    -Nkarta obtains a license to CRISPR gene editing technology for use in its own engineered NK cell therapy products-

    -Nkarta to host conference call today at 4:30 p.m. ET-

    ZUG, Switzerland, CAMBRIDGE, Mass., and SOUTH SAN FRANCISCO, Calif., May 06, 2021 (GLOBE NEWSWIRE) -- CRISPR Therapeutics (NASDAQ:CRSP), a biopharmaceutical company focused on developing transformative gene-based medicines…

    -Collaboration brings together breakthrough gene editing technology and leading natural killer (NK) cell and T cell discovery, development, and manufacturing capabilities-

    -Companies to co-develop and co-commercialize two chimeric antigen receptor (CAR) NK cell product candidates, one targeting CD70, and a product candidate combining NK and T cells (NK+T)-

    -Nkarta obtains a license to CRISPR gene editing technology for use in its own engineered NK cell therapy products-

    -Nkarta to host conference call today at 4:30 p.m. ET-

    ZUG, Switzerland, CAMBRIDGE, Mass., and SOUTH SAN FRANCISCO, Calif., May 06, 2021 (GLOBE NEWSWIRE) -- CRISPR Therapeutics (NASDAQ:CRSP), a biopharmaceutical company focused on developing transformative gene-based medicines for serious diseases, and Nkarta, Inc. (NASDAQ:NKTX), a biopharmaceutical company developing engineered NK cell therapies to treat cancer, today announced a strategic partnership to research, develop, and commercialize CRISPR/Cas9 gene-edited cell therapies for cancer.

    Under the agreement, the companies will co-develop and co-commercialize two CAR NK cell product candidates, one targeting the CD70 tumor antigen and the other target to be determined. In addition, the companies will bring together their complementary cell therapy engineering and manufacturing capabilities to advance the development of a novel NK+T product candidate harnessing the synergies of the adaptive and innate immune systems. Finally, Nkarta obtains a license to CRISPR gene editing technology to edit five gene targets in an unlimited number of its own NK cell therapy products.

    CRISPR Therapeutics and Nkarta will equally share all research and development costs and profits worldwide related to the collaboration products. For each non-collaboration product candidate incorporating a gene editing target licensed from CRISPR Therapeutics, Nkarta will retain worldwide rights and pay CRISPR Therapeutics milestones and royalties on net sales. The agreement includes a three-year exclusivity period between CRISPR Therapeutics and Nkarta covering the research, development, and commercialization of allogeneic, gene-edited, donor-derived NK cells and NK+T cells.

    "By bringing together CRISPR Therapeutics' and Nkarta's highly complementary expertise and proprietary platforms we plan to accelerate the development of potentially groundbreaking genome engineered NK cell therapies," said Samarth Kulkarni, Ph.D., Chief Executive Officer at CRISPR Therapeutics. "This collaboration broadens the scope of our efforts in oncology cell therapy, and expands our efforts to discover and develop novel cancer therapies for patients."

    "Uniting the best-in-class gene editing solution and allogeneic T cell therapy expertise of CRISPR with Nkarta's best-in-class CAR NK cell therapy platform will be a major advantage to advancing the next wave of transformative cancer cell therapies," said Paul J. Hastings, President and Chief Executive Officer of Nkarta. "With this partnership, Nkarta can systematically apply world-class gene editing across our entire pre-clinical pipeline going forward. CRISPR's deep understanding of CD70 biology and experience in allogeneic T cell clinical development can accelerate the development of early-stage Nkarta programs, to deliver innovative treatments to patients that much faster."

    Nkarta Conference Call Details

    Nkarta management will host a conference call to discuss the collaboration today at 4:30 p.m. Eastern Time (ET). The event will be simultaneously webcast and available for replay from the Nkarta website at www.nkartatx.com, under the Investors section. Investors may also participate in the conference call by calling 877-876-9174 (domestic) or +1-785-424-1669 (international). The conference ID is NKARTA.

    About CRISPR Therapeutics

    CRISPR Therapeutics is a leading gene editing company focused on developing transformative gene-based medicines for serious diseases using its proprietary CRISPR/Cas9 platform. CRISPR/Cas9 is a revolutionary gene editing technology that allows for precise, directed changes to genomic DNA. CRISPR Therapeutics has established a portfolio of therapeutic programs across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine and rare diseases. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic collaborations with leading companies including Bayer, Vertex Pharmaceuticals and ViaCyte, Inc. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Cambridge, Massachusetts, and business offices in San Francisco, California and London, United Kingdom. For more information, please visit www.crisprtx.com.

    CRISPR THERAPEUTICS® word mark and design logo are registered trademarks of CRISPR Therapeutics AG. All other trademarks and registered trademarks are the property of their respective owners.

    CRISPR Therapeutics Forward-Looking Statement

    This press release may contain a number of "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements made by Dr. Kulkarni and Mr. Hastings in this press release, as well as statements regarding CRISPR Therapeutics' expectations about any or all of the following: (i) the future activities of the parties pursuant to the collaboration and the expected benefits of CRISPR Therapeutics' collaboration with Nkarta; and (ii) the therapeutic value, development, and commercial potential of CRISPR/Cas9 gene editing technologies and therapies. Without limiting the foregoing, the words "believes," "anticipates," "plans," "expects" and similar expressions are intended to identify forward-looking statements. You are cautioned that forward-looking statements are inherently uncertain. Although CRISPR Therapeutics believes that such statements are based on reasonable assumptions within the bounds of its knowledge of its business and operations, forward-looking statements are neither promises nor guarantees and they are necessarily subject to a high degree of uncertainty and risk. Actual performance and results may differ materially from those projected or suggested in the forward-looking statements due to various risks and uncertainties. These risks and uncertainties include, among others: CRISPR Therapeutics may not realize the potential benefits of the collaboration, uncertainties inherent in the initiation and completion of preclinical studies; availability and timing of results from preclinical studies; whether results from a preclinical study will be favorable and predictive of future results of future studies or clinical trials; uncertainties about regulatory approvals and that future competitive or other market factors may adversely affect the commercial potential for product candidates; potential impacts due to the coronavirus pandemic, such as the timing and progress of preclinical studies; uncertainties regarding the intellectual property protection for CRISPR Therapeutics' technology and intellectual property belonging to third parties, and the outcome of proceedings (such as an interference, an opposition or a similar proceeding) involving all or any portion of such intellectual property; and those risks and uncertainties described under the heading "Risk Factors" in CRISPR Therapeutics' most recent annual report on Form 10-K, quarterly report on Form 10-Q, and in any other subsequent filings made by CRISPR Therapeutics with the U.S. Securities and Exchange Commission, which are available on the SEC's website at www.sec.gov. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date they are made. CRISPR Therapeutics disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release, other than to the extent required by law.

    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. 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 www.nkartatx.com.

    Nkarta, Inc. 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 its ability to advance the development and commercialization of two gene-edited CAR-NK cell therapies and an NK+T cell therapy under the collaboration with CRISPR Therapeutics, and the ability of Nkarta and CRISPR Therapeutics to leverage the combination of their respective expertise and platforms to accelerate that development; Nkarta's application of gene-editing across its preclinical pipeline; the ability of Nkarta's technology to enhance the 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; 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 Nkarta's 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 Annual Report on Form 10-K for the year ended December 31, 2020, filed with the SEC on March 25, 20201, 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.

    CRISPR Therapeutics Investor Contact:

    Susan Kim

    +1-617-307-7503

    susan.kim@crisprtx.com

    CRISPR Therapeutics Media Contact:

    Jennifer Paganelli

    Real Chemistry on behalf of CRISPR

    +1-347-658-8290

    jpaganelli@realchemistry.com

    Nkarta Media/Investor Contact:

    Greg Mann

    Nkarta, Inc.

    +1-415-317-3675

    gmann@nkartatx.com



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    • NKX019 to be Nkarta's second CAR NK pipeline program to enter clinical trial

    SOUTH SAN FRANCISCO, Calif., April 28, 2021 (GLOBE NEWSWIRE) -- Nkarta, Inc. (NASDAQ:NKTX), a biopharmaceutical company developing engineered natural killer (NK) cell therapies to treat cancer, today announced that the U.S. Food & Drug Administration (FDA) has cleared an Investigational New Drug (IND) application to study NKX019 in patients with relapsed or refractory B cell malignancies.

    NKX019 is an off-the-shelf cancer immunotherapy candidate that uses NK cells engineered with a CD19-directed chimeric antigen receptor (CAR). The CAR is designed to target cancer cells expressing CD19, a clinically validated target, and to enhance the innate anti-tumor activity of…

    • NKX019 to be Nkarta's second CAR NK pipeline program to enter clinical trial

    SOUTH SAN FRANCISCO, Calif., April 28, 2021 (GLOBE NEWSWIRE) -- Nkarta, Inc. (NASDAQ:NKTX), a biopharmaceutical company developing engineered natural killer (NK) cell therapies to treat cancer, today announced that the U.S. Food & Drug Administration (FDA) has cleared an Investigational New Drug (IND) application to study NKX019 in patients with relapsed or refractory B cell malignancies.

    NKX019 is an off-the-shelf cancer immunotherapy candidate that uses NK cells engineered with a CD19-directed chimeric antigen receptor (CAR). The CAR is designed to target cancer cells expressing CD19, a clinically validated target, and to enhance the innate anti-tumor activity of NK cells. In addition, NKX019 is engineered with a membrane-bound form of IL-15, an important cytokine for NK cell survival, which has been shown in preclinical models to enhance NK cell proliferation, persistence and activity.

    Initiation of a Phase 1 clinical trial of NKX019 in patients with relapsed/refractory B cell malignancies, including non-Hodgkin lymphoma, chronic lymphocytic leukemia and acute lymphoblastic leukemia, is planned for the second half of 2021.

    "Academic studies have highlighted the ability of donor-derived NK cells, when collected from healthy donors, to effectively target and kill cancer cells without some of the safety risks commonly associated with T cell therapies," noted Kanya Rajangam, MD, PhD, Chief Medical Officer of Nkarta. "We look forward to evaluating NKX019 in our trial as a planned multi-dose, multi-cycle treatment regimen to determine its potential for enhanced anti-tumor activity with a beneficial safety profile."

    "This IND clearance, our second in less than 10-months time, builds on the strong track record of the Nkarta team to deliver on challenging goals," said Paul J. Hastings, President and Chief Executive Officer of Nkarta. "Thanks to their outstanding efforts, Nkarta will soon have two differentiated co-lead programs, NKX101 and NKX019, in clinical trials as we look forward to the continued progress of our best-in-class, healthy donor-derived NK cell platform and pipeline of novel cell therapy candidates for cancer patients."

    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 identify and kill tumor cells. To enhance the inherent anti-tumor activity of NK cells, Nkarta genetically engineers the cells with a targeting receptor designed to recognize and bind to cancer cells through recognition of specific surface proteins. This receptor is fused to co-stimulatory and signaling domains, which amplify cell signaling and NK cell cytotoxicity. Upon target binding, NK cells activate and release cytotoxic granules for target cell killing as well as cytokines that enhance the cumulative immune response. All of Nkarta's current NK cell therapy candidates are also engineered with a membrane-bound IL-15, a proprietary version of an activating cytokine important for NK cell growth and enhancement of NK cell persistence.

    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 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 extended periods 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 progress of its NK cell platform and pipeline; the timing of the initiation of the NKX019 clinical trial; the anti-tumor activity and safety profile of NKX019; the treatment regimen under which NKX019 will be studied; the location of the NKX019 clinical trial sites; Nkarta's ability to capitalize on the inherent diversity of the innate immune system and select donors or NK cells with optimal characteristics; the ability of Nkarta's technology to enhance the proliferation, persistence and anti-tumor activity of NK cells and enable off-the-shelf administration; the efficiency and cost of Nkarta's manufacturing processes; 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 Annual Report on Form 10-K for the year ended December 31, 2020, filed with the SEC on March 25, 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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    • Continued progress in dosing of patients in clinical trial of NKX101, investigational CAR NK cell therapy engineered with NKG2D receptor, in acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS)
    • Interim top-line data from NKX101 clinical trial expected by end of 2021
    • On track to file IND application for NKX019 in 1Q 2021
    • IND filings for two solid tumor programs planned for 2022
    • In-house manufacturing of off-the-shelf NKX019 clinical trial supply expected to start in 1H 2021
    • Commercial-scale cell therapy manufacturing planning activities underway
    • Cash and cash equivalents of $315.3 million as of December 31, 2020

    SOUTH SAN FRANCISCO, Calif., March 25, 2021 (GLOBE NEWSWIRE) -- Nkarta, Inc. (NASDAQ:NKTX), a clinical-stage biopharmaceutical…

    • Continued progress in dosing of patients in clinical trial of NKX101, investigational CAR NK cell therapy engineered with NKG2D receptor, in acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS)

    • Interim top-line data from NKX101 clinical trial expected by end of 2021
    • On track to file IND application for NKX019 in 1Q 2021
    • IND filings for two solid tumor programs planned for 2022
    • In-house manufacturing of off-the-shelf NKX019 clinical trial supply expected to start in 1H 2021
    • Commercial-scale cell therapy manufacturing planning activities underway
    • Cash and cash equivalents of $315.3 million as of December 31, 2020

    SOUTH SAN FRANCISCO, Calif., March 25, 2021 (GLOBE NEWSWIRE) -- Nkarta, Inc. (NASDAQ:NKTX), a clinical-stage biopharmaceutical company developing engineered natural killer (NK) cell therapies to treat cancer, today reported financial results for the fourth quarter and year ended December 31, 2020.

    "We continue our work to supercharge the distinctive tumor-killing power of healthy donor-derived natural killer cells and advance our co-lead development programs in allogeneic, off-the-shelf, engineered cell therapy," said Paul J. Hastings, President and Chief Executive Officer of Nkarta. "Our goal remains to report early clinical data from the dose finding portion of our ongoing clinical trial of NKX101 by the end of this year. In addition, we are on track to file the IND application for NKX019 this month and begin patient dosing in a multi-center clinical trial for patients with B cell malignancies in the second half of 2021. Nkarta remains committed to the transformative potential of CAR NK cell therapy for cancer patients and we strive to keep patients at the center of all that we do."

    Anticipated Clinical Milestones

    • In the first quarter of 2021, Nkarta plans to file an Investigational New Drug (IND) application for NKX019, a CAR (chimeric antigen receptor) NK cell therapy candidate engineered to target tumors expressing CD19 antigen for the treatment of B-cell malignancies. Following the regulatory clearance of the IND, Nkarta expects patient dosing in a Phase 1 clinical trial of NKX019 to initiate in the second half of 2021.
    • Nkarta expects to manufacture NKX019 clinical supply for the Phase 1 clinical trial at its in-house cGMP clinical manufacturing facility located in South San Francisco, California.
    • Nkarta aims to present initial clinical data from its ongoing clinical trial of NKX101 in patients with r/r AML and MDS by year end. In the Phase 1 study, patients receive multiple doses of NKX101 during a 28-day treatment cycle and are eligible to receive a second cycle of treatment upon evidence of tolerability and disease response.
    • 2022 milestones are expected to include an IND amendment for NKX101 for the treatment of solid tumors and an IND application for Nkarta's third engineered CAR NK cell product candidate that is designed to target solid tumors and hematologic malignancies.

    Fourth Quarter and Full Year 2020 Financial Highlights

    • Cash and Cash Equivalents: As of December 31, 2020, Nkarta had cash, cash equivalents, restricted cash and short-term investments of $315.3 million, which includes proceeds from the Company's July 2020 IPO of $265.1 million, net of underwriting discounts and commissions and other offering costs.



    • R&D Expenses: Research and development expenses were $36.2 million for the full year 2020 and $11.3 million for the fourth quarter of 2020. Non-cash stock-based compensation expense included in R&D expense was $1.9 million for the full year 2020 and $0.8 million for the fourth quarter of 2020.



    • G&A Expenses: General and administrative expenses were $15.3 million for the full year 2020 and $6.7 million for the fourth quarter of 2020. Non-cash stock-based compensation expense included in G&A expense was $4.9 million for the full year 2020 and $3.3 million for the fourth quarter of 2020.



    • Net Loss. Net loss was $91.4 million, or $5.44 per basic and diluted share, for the full year 2020. This net loss includes a non-recurring $40.2 million non-cash change in fair value of preferred stock purchase liability. Net loss was $17.9 million, or $0.55 per basic and diluted share, for the quarter ended December 31, 2020.

    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 chimeric antigen receptor (CAR) targeting the CD19 antigen and membrane-bound IL15. CD19 antigen is a B-cell marker and validated target for B-cell cancer therapies. NKX019 uses the CAR to target and bind to CD19, leading to an immune response that eliminates CD19-expressing cells in preclinical studies. The addition of membrane-bound IL15, a proprietary version of a cytokine for activating NK cell growth, has been shown in preclinical models to enhance the proliferation, persistence and activity of NK cells. Nkarta plans to file an IND application with the FDA in the first quarter of 2021. Initiation of a Phase 1 clinical trial of NKX019 in patients with advanced relapsed/refractory B cell malignancies 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 already endowed with inherent tumor-recognizing and cytotoxic potencies, as compared to other more complex cell sources where these basic therapeutic features must be painstakingly designed and synthetically added to the cells. 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. By utilizing a cell source that contains the broad and naturally occurring gamut of NK cells, Nkarta has the potential to capitalize on the inherent diversity of the innate immune system and select for different NK cell sub-populations with desired 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. 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 timing of the NKX019 IND filing, trial initiation and patient dosing; Nkarta's ability to enroll in and advance its development programs, including the NKX101 program; Nkarta's plans for its two IND filings in 2022; Nkarta's plans to present clinical data by year end; the mechanism of action and anti-tumor activity of Nkarta's product candidates and CAR NK cell therapy; the efficiency and cost of Nkarta's manufacturing processes; the number of doses generated from a manufacturing run; Nkarta's progress towards in-house cGMP capability, including its ability to provide clinical supply of NKX019 in 1H 2021; Nkarta's progress towards commercial-scale manufacturing; the potential advantages of donor-derived NK cells; Nkarta's ability to enable off-the-shelf NK cell therapy; 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 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 final prospectus for its initial public offering, filed with the SEC on July 13, 2020, Nkarta's Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2020, filed with the SEC on August 20, 2020, Nkarta's Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2020, filed with the SEC on November 12, 2020, 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

    December 31,
      Year Ended

    December 31,
     
      2020  2019  2020  2019 
    Collaboration revenue $  $  $  $115 
    Operating expenses                
    Research and development  11,270   6,682   36,220   17,217 
    General and administrative  6,728   1,966   15,288   5,247 
    Total operating expenses  17,998   8,648   51,508   22,464 
    Loss from operations  (17,998)  (8,648)  (51,508)  (22,349)
    Other income (expense), net:                
    Change in fair value of preferred stock purchase right liability     (2,065)  (40,163)  1,318 
    Change in fair value of derivative liability           858 
    Loss from extinguishment of debt           (752)
    Interest income  99   244   313   304 
    Interest expense           (473)
    Other income (expense), net  2   (18)  (3)  18 
    Total other income (expense), net  101   (1,839)  (39,853)  1,273 
    Net loss $(17,897) $(10,487) $(91,361) $(21,076)
                     
    Net loss per share, basic and diluted $(0.55) $(6.62) $(5.44) $(14.41)
    Weighted average shares used to compute net loss per share, basic and diluted  32,611,697   1,583,102   16,806,262   1,462,511 
                     



     
    Nkarta, Inc.

    Condensed Balance Sheets

    (in thousands)

    (Unaudited)
     
      December 31, 
      2020 2019 
    Assets       
    Cash, cash equivalents, restricted cash and short-term investments $315,326 $37,259 
    Property and equipment, net  9,350  3,080 
    Operating lease right-of-use assets  8,505  7,144 
    Other assets  4,469  929 
    Total assets $337,650 $48,412 
    Liabilities, convertible preferred stock and stockholders' equity (deficit)       
    Accounts payable, accrued and other liabilities $7,511 $5,305 
    Preferred stock purchase right liability    1,478 
    Operating lease liabilities  8,919  7,296 
    Total liabilities  16,430  14,079 
    Convertible preferred stock    59,815 
    Stockholders' equity (deficit)  321,220  (25,482)
    Total liabilities, convertible preferred stock and stockholders' equity (deficit) $337,650 $48,412 
            

    Nkarta Media/Investor Contact:

    Greg Mann

    Nkarta, Inc.

    gmann@nkartatx.com



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  6. SOUTH SAN FRANCISCO, Calif., Feb. 17, 2021 (GLOBE NEWSWIRE) -- Nkarta, Inc. (NASDAQ:NKTX), a clinical-stage biopharmaceutical company developing engineered natural killer (NK) cell therapies to treat cancer, today announced its participation at these upcoming investor conferences:

    SVB Leerink 10th Annual Global Healthcare Conference
    February 26, 2021
    Fireside chat presentation: 1:40 p.m. ET

    Cowen 41st Annual Health Care Conference
    March 3-4, 2021
    No presentation

    Barclays Global Healthcare Conference
    March 11, 2021
    Fireside chat presentation: 10:20 a.m. ET

    Live audio webcasts of the presentations will be available on the Investors section of Nkarta's website, www.nkartatx.com. Replays of the webcasts will be archived on the website for approximately…

    SOUTH SAN FRANCISCO, Calif., Feb. 17, 2021 (GLOBE NEWSWIRE) -- Nkarta, Inc. (NASDAQ:NKTX), a clinical-stage biopharmaceutical company developing engineered natural killer (NK) cell therapies to treat cancer, today announced its participation at these upcoming investor conferences:

    SVB Leerink 10th Annual Global Healthcare Conference

    February 26, 2021

    Fireside chat presentation: 1:40 p.m. ET



    Cowen 41st Annual Health Care Conference

    March 3-4, 2021

    No presentation



    Barclays Global Healthcare Conference

    March 11, 2021

    Fireside chat presentation: 10:20 a.m. ET

    Live audio webcasts of the presentations will be available on the Investors section of Nkarta's website, www.nkartatx.com. Replays of the webcasts 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. 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



    Primary Logo

    View Full Article Hide Full Article
    • First patient dosed in clinical trial of NKX101, investigational NK cell therapy engineered with NKG2D-targeted CAR, in acute myeloid leukemia and myelodysplastic syndromes
    • IND application for NKX019 expected to be filed in 1Q 2021
    • Ended third quarter 2020 with $330.2 million of cash and cash equivalents, believed to be sufficient to fund operations into at least the second half of 2023

    SOUTH SAN FRANCISCO, Calif., Nov. 12, 2020 (GLOBE NEWSWIRE) -- Nkarta, Inc. (NASDAQ:NKTX), a clinical-stage biopharmaceutical company developing engineered natural killer (NK) cell therapies to treat cancer, today reported financial results for the third quarter ended September 30, 2020, and highlighted recent corporate accomplishments.

    "We're excited by the…

    • First patient dosed in clinical trial of NKX101, investigational NK cell therapy engineered with NKG2D-targeted CAR, in acute myeloid leukemia and myelodysplastic syndromes

    • IND application for NKX019 expected to be filed in 1Q 2021
    • Ended third quarter 2020 with $330.2 million of cash and cash equivalents, believed to be sufficient to fund operations into at least the second half of 2023

    SOUTH SAN FRANCISCO, Calif., Nov. 12, 2020 (GLOBE NEWSWIRE) -- Nkarta, Inc. (NASDAQ:NKTX), a clinical-stage biopharmaceutical company developing engineered natural killer (NK) cell therapies to treat cancer, today reported financial results for the third quarter ended September 30, 2020, and highlighted recent corporate accomplishments.

    "We're excited by the continued progress made at Nkarta this quarter and the ability of our teams to advance Nkarta's allogeneic, off-the-shelf cell therapy programs," said Paul J. Hastings, President and Chief Executive Officer of Nkarta. "We have dosed the first patient in our first clinical trial of NKX101, continue to prepare our in-house clinical GMP capabilities for the production of NKX019, and remain on track to file Nkarta's second IND in the first quarter of 2021 for NKX019. With patients always foremost in mind, we remain focused on advancing Nkarta's NK cell platform as the next foundation in anti-cancer cell therapy."

    Recent Developments

    • First patient dosed in the Phase 1 clinical trial of NKX101, a first-in-class investigational NK cell cancer immunotherapy engineered to express a chimeric antigen receptor (CAR) targeting NKG2D ligand, for the treatment of relapsed/refractory acute myeloid leukemia (AML) and higher risk myelodysplastic syndromes (MDS).
    • Nadir Mahmood, Ph.D. appointed to the expanded role of Chief Financial and Business Officer, having previously served as Nkarta's Chief Business Officer. He succeeded Matthew Plunkett, Ph.D., who stepped down as Chief Financial Officer in October 2020.
    • Alicia J. Hager, J.D., Ph.D. joined Nkarta as its Chief Legal Officer.

    Anticipated Near-term Clinical Milestones

    • In 1Q 2021, Nkarta expects to file an Investigational New Drug (IND) Application for NKX019, an investigational NK cell therapy engineered to target tumors expressing CD19 antigen for the treatment of B-cell malignancies.

    Third Quarter 2020 Financial Highlights

    • Cash and Cash Equivalents: As of September 30, 2020, Nkarta had cash, cash equivalents, restricted cash and short-term investments of $330.2 million, which includes proceeds from the Company's July 2020 IPO of $265.1 million, net of underwriting discounts and commissions and other offering costs.



    • R&D Expenses: Research & development expenses were $9.8 million for the third quarter of 2020, which includes $0.7 million of non-cash stock-based compensation expense.



    • G&A Expenses: General and administrative expenses were $3.9 million for the third quarter of 2020, which includes $0.9 million of non-cash stock-based compensation expense.



    • Net Loss. Net loss was $13.7 million, or $0.44 per basic and diluted share, for the quarter ended September 30, 2020.

    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. The company expects cash and cash equivalents at December 31, 2020 to be in the range of $300 million to $310 million.

    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 chimeric antigen receptor (CAR) targeting the CD19 antigen and membrane-bound IL15. CD19 antigen is a B-cell marker and validated target for B cell cancer therapies. NKX019 uses the CAR to target and bind to CD19, leading to an immune response that eliminates CD19-expressing cells in preclinical studies. The addition of membrane-bound IL15, a proprietary version of a cytokine for activating NK cell growth, has been shown in preclinical models to enhance the proliferation, persistence and activity of NK cells. Nkarta plans to file an IND application with the FDA in the first quarter of 2021. A Phase 1 clinical trial of NKX019 in patients with advanced relapsed/refractory B cell malignancies is planned to initiate in 2021.

    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, and builds upon the important advances in cellular immunotherapy and chimeric antigen receptor (CAR) biology. To enhance the intrinsic activity of NK cells, Nkarta genetically engineers the cells with a CAR that consists of 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 cell therapy candidates are 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. 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 its growth, strategy, progress and timing of its preclinical studies and clinical trials for NKX101 and NKX019, including its regulatory plans and the timing of the NKX019 IND and trial initiation; the mechanism of action and activity of Nkarta's product candidates; the efficiency and cost of Nkarta's manufacturing processes; the number of doses generated from a manufacturing run; Nkarta's progress towards in-house clinical GMP capability; the proprietary nature of Nkarta's technology; and Nkarta's expected cash burn for 2020 and 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 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; 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 final prospectus for its initial public offering, filed with the SEC on July 13, 2020, Nkarta's Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2020, filed with the SEC on August 20, 2020, Nkarta's Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2020, filed with the SEC on November 12, 2020, 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 September 30, Nine Months Ended September 30, 
       2020   2019   2020   2019  
    Collaboration revenue $  $  $  $115  
    Operating expenses         
    Research and development  9,828   4,620   24,950   10,535  
    General and administrative  3,918   1,289   8,560   3,281  
    Total operating expenses  13,746   5,909   33,510   13,816  
    Loss from operations  (13,746)  (5,909)  (33,510)  (13,701) 
    Other income (expense), net:         
    Change in fair value of preferred stock purchase right liability     3,383   (40,163)  3,383  
    Other income (expense), net  53   (142)  209   (271) 
    Total other income (expense), net  53   3,241   (39,954)  3,112  
    Net loss $(13,693) $(2,668) $(73,464) $(10,589) 
              
    Net loss per share, basic and diluted $(0.44) $(1.75) $(6.39) $(7.45) 
    Weighted average shares used to compute net loss per share, basic and diluted  30,981,441   1,528,510   11,499,327   1,421,882  
              

    Nkarta, Inc.

    Condensed Balance Sheets

    (in thousands)

    (Unaudited)

      September 30, 2020 December 31, 2019 
    Assets      
    Cash, cash equivalents, restricted cash and short-term investments $330,172 $37,259  
    Property and equipment, net  9,180  3,080  
    Operating lease right-of-use assets  8,763  7,144  
    Other assets  4,180  929  
    Total assets $352,295 $48,412  
    Liabilities and stockholders' equity (deficit)     
    Preferred stock purchase right liability $ $1,478  
    Operating lease liabilities  9,135  7,296  
    Other liabilities  8,179  5,305  
    Total liabilities  17,314  14,079  
    Convertible preferred stock    59,815  
    Stockholders' equity (deficit)  334,981  (25,482) 
    Total liabilities and stockholders' equity (deficit) $352,295 $48,412  
          

    Nkarta Media/Investor Contact:

    Greg Mann

    Nkarta, Inc.

    gmann@nkartatx.com

    Primary Logo

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  7. SOUTH SAN FRANCISCO, Calif., Nov. 12, 2020 (GLOBE NEWSWIRE) -- Nkarta, Inc. (NASDAQ:NKTX), a clinical-stage biopharmaceutical company developing engineered natural killer (NK) cell therapies to treat cancer, today announced that the first patient has been treated in the first-in-human Phase 1 clinical trial of NKX101 for the treatment of relapsed/refractory acute myeloid leukemia (AML) or higher risk myelodysplastic syndromes (MDS). The multi-center clinical trial is designed to evaluate safety, pharmacokinetics, and preliminary anti-tumor activity of NKX101.

    NKX101 is the first investigational NK cell cancer immunotherapy engineered to express a chimeric activating receptor (CAR) targeting NKG2D. NKG2D, a key activating receptor found…

    SOUTH SAN FRANCISCO, Calif., Nov. 12, 2020 (GLOBE NEWSWIRE) -- Nkarta, Inc. (NASDAQ:NKTX), a clinical-stage biopharmaceutical company developing engineered natural killer (NK) cell therapies to treat cancer, today announced that the first patient has been treated in the first-in-human Phase 1 clinical trial of NKX101 for the treatment of relapsed/refractory acute myeloid leukemia (AML) or higher risk myelodysplastic syndromes (MDS). The multi-center clinical trial is designed to evaluate safety, pharmacokinetics, and preliminary anti-tumor activity of NKX101.

    NKX101 is the first investigational NK cell cancer immunotherapy engineered to express a chimeric activating receptor (CAR) targeting NKG2D. 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 and specifically expressed on cancer cells. With NKX101, NKG2D expression is increased by 10-fold and cytotoxic activity increased by 4-fold compared to non-engineered NK cells in preclinical models. NKX101 is also designed to express membrane-bound IL-15, which in preclinical models enhances the activity and persistence of the engineered NK cells. Nkarta's proprietary manufacturing processes enable the evaluation of cryopreserved NKX101, expanding trial access across multiple clinical centers.

    "Despite recent treatment breakthroughs, AML patients who relapse after front-line therapy still have poor outcomes, underscoring the need for new treatment options for this aggressive and lethal blood cancer," said Carlos Bachier, M.D., Director of Cellular Therapy Research, Sarah Cannon Research Institute and Program Director for Sarah Cannon Center for Blood Cancer at TriStar Centennial Medical Center in Nashville, Tennessee, where the first patient has been treated. "To date, the significant clinical benefit achieved with CAR T cell therapies in the treatment of B cell lymphomas and acute lymphocytic leukemia has not extended to AML or other myeloid malignant disorders. The investigation of NKG2D-targeting and the tumor-killing potential of an engineered innate immune cell type is a promising new approach."

    "An extensive body of academic research has already shown increased expression of NKG2D targets in AML and other cancers, and demonstrated clinical responses in relapsed/refractory AML patients who received non-engineered allogeneic NK cells in single center academic studies as treatment," said Kanya Rajangam, M.D., Ph.D., Chief Medical Officer of Nkarta. "With its amplified NKG2D targeting and enhanced NK cell engineering, NKX101 has the potential to improve upon this earlier clinical experience with non-engineered NK cells and to activate a deep and robust immune response in AML patients."

    A poster on the design of the NKX101 clinical trial in progress has been accepted for presentation at the 2020 American Society of Hematology Annual Meeting and Exhibition, Abstract 1040, "A Phase 1 Study of NKX101, an Allogeneic CAR Natural Killer (NK) Cell Therapy, in Subjects with Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML) or Higher-Risk Myelodysplastic Syndrome (MDS)," Session 616, December 5, 2020. 

    About the Phase 1 Clinical Trial of NKX101 in Participants with Relapsed/Refractory Acute Myeloid Leukemia (AML) or Higher Risk Myelodysplastic Syndromes (MDS)

    This First-in-Human Phase 1 study evaluates the safety, pharmacokinetics, and preliminary anti-tumor activity of NKX101, administered in a cycle of three weekly infusions following lymphodepletion, in adult patients living with relapsed/refractory AML or higher risk MDS. This single-arm, open-label, multi-center study consists of sequential dose-finding and dose-expansion. The safety of participants will be monitored by assessment of vital signs, physical examinations and laboratory tests. The clinical trial is designed to identify a recommended Phase 2 dose, and will evaluate cellular kinetics, pharmacodynamics, and preliminary anti-tumor activity using standard response criteria. Additional information is available on ClinicalTrials.gov, identifier NCT04623944.

    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. Despite recent advancements, an unmet need for novel treatment options remains high. Only approximately one in four patients with AML survive longer than five years. Patients with AML have a high rate of disease relapse after a treatment response. Due to age and comorbidities, not all patients are eligible to receive intensive chemotherapy, leaving them with limited treatment options. Once relapsed or refractory to front-line therapy, patients have limited treatment options. The worldwide incidence of AML was estimated to be more than 119,500 cases in 2017.* In the United States, there will be an estimated 19,940 new cases of AML in 2020, with an estimated 11,180 deaths resulting from the disease.**

    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; **National Institutes of Health, Cancer Stat Facts, accessed 11 Nov 2020.

    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 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, and builds upon the important advances in cellular immunotherapy and chimeric antigen receptor (CAR) biology. To enhance the intrinsic activity of NK cells, Nkarta genetically engineers the cells with a CAR that consists of 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 cell therapy candidates are 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. 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: Nkarta's growth, strategy, progress and timing of its preclinical studies and clinical trials for NKX101; the mechanism of action and activity of Nkarta's product candidates, including the activity of NKX101 in AML patients; NKX101's potential as a treatment for AML; the size of the AML market; the efficiency and cost of Nkarta's manufacturing processes; 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; 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 final prospectus for its initial public offering, filed with the SEC on July 13, 2020, Nkarta's Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2020, filed with the SEC on August 20, 2020, 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

     

    Primary Logo

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  8. SOUTH SAN FRANCISCO, Calif., Nov. 09, 2020 (GLOBE NEWSWIRE) -- Nkarta, Inc. (NASDAQ:NKTX), a clinical-stage biopharmaceutical company developing engineered natural killer (NK) cell therapies to treat cancer, today announced a preclinical update on NKX019, its investigational allogeneic cancer immunotherapy that uses donor-derived natural killer (NK) cells engineered with a membrane-bound form of IL15 and a chimeric antigen receptor (CAR) targeting the CD19 antigen.

    The data were presented today in a poster at the Society for Immunotherapy of Cancer (SITC) 35th Anniversary Annual Meeting entitled "Preclinical evaluation of NKX019, a CD19-targeting CAR NK Cell". Poster # 127.

    Highlights of the preclinical findings include:

    Cryopreserved NKX019…

    SOUTH SAN FRANCISCO, Calif., Nov. 09, 2020 (GLOBE NEWSWIRE) -- Nkarta, Inc. (NASDAQ:NKTX), a clinical-stage biopharmaceutical company developing engineered natural killer (NK) cell therapies to treat cancer, today announced a preclinical update on NKX019, its investigational allogeneic cancer immunotherapy that uses donor-derived natural killer (NK) cells engineered with a membrane-bound form of IL15 and a chimeric antigen receptor (CAR) targeting the CD19 antigen.

    The data were presented today in a poster at the Society for Immunotherapy of Cancer (SITC) 35th Anniversary Annual Meeting entitled "Preclinical evaluation of NKX019, a CD19-targeting CAR NK Cell". Poster # 127.



    Highlights of the preclinical findings include:

    Cryopreserved NKX019 demonstrated potent, targeted anti-tumor activity in vitro and in vivo across different CD19-expressing cancer models for B cell lymphoma and acute lymphoblastic leukemia.

    Compared to non-engineered NK cell controls, the dosing of NKX019 resulted in increased treatment exposure and superior anti-tumor activity.   

    Compared to T cells transduced to express a CD19 CAR, NKX019 demonstrated several advantages. NKX019 was more potent on a per cell basis than CD19 CAR T cells, with a more rapid onset of activity. Moreover, when exposed to tumor cells side-by-side with CAR19+ T cells, NKX019 produced significantly lower quantities of factors associated with cytokine release syndrome (CRS), a type of adverse event associated with approved CAR T cell therapies.

    The preclinical data support the potency, safety and tolerability profile of NKX019. In addition to the limited cytokine response of NKX019 in the presence of tumor cells, NKX019 cell killing was highly specific, confined to CD19+ cells when tested in bulk peripheral blood.

    James Trager, Ph.D., Nkarta's Chief Scientific Officer, noted, "Unprecedented outcomes have been seen in patients with B cell malignancies who received CD19-directed autologous CAR T cells. Despite the remarkable medical advance of these therapies, a significant need remains for treating these patients, and we've designed NKX019 with those needs in mind. The potential potency, safety and scalability of CD19-targeted NK cells create an opportunity to advance a new treatment paradigm. A recent publication by researchers at M.D. Anderson Cancer Center of a cohort of patients treated with a CD19 CAR-NK therapy achieved a complete remission in seven of 11 patients. We believe the anti-tumor activity and favorable cytokine profile demonstrated by our preclinical findings support the development of NKX019. We look forward to filing our IND for NKX019 in the first quarter of 2021."

    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 chimeric antigen receptor (CAR) targeting the CD19 antigen and a membrane-bound form of IL15. CD19 antigen is a B cell marker and validated target for B cell cancer therapies. NKX019 uses the CAR to target and bind to CD19, leading to an immune response that eliminates CD19-expressing cells in preclinical studies. 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 activity of NK cells. Nkarta plans to file an IND application with the FDA in the first quarter of 2021. A Phase 1 clinical trial of NKX019 in patients with advanced relapsed/refractory B cell malignancies is planned to initiate in 2021.

    About Nkarta's NK Cell Technologies

    Nkarta has pioneered a novel 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, and builds upon the important advances in cellular immunotherapy and chimeric antigen receptor (CAR) biology. To enhance the intrinsic activity of NK cells, Nkarta genetically engineers the cells with a CAR that consists of 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 can become activated and release cytokines that can enhance the immune response and cytotoxic granules that lead to killing of the target cell. All of Nkarta's NK cell therapy candidates are 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. 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 timing of Nkarta's NKX019 IND filing; the timing of initiation of the NKX019 Phase 1 clinical trial; NKX019's potential as a treatment for B cell malignancies; the activity and persistence of Nkarta's engineered NK cells, including NKX019; the potential potency, safety and scalability of CD19-targeted NK cells; the efficiency and cost of Nkarta's manufacturing processes; 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; 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 final prospectus for its initial public offering, filed with the SEC on July 13, 2020, Nkarta's Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2020, filed with the SEC on August 20, 2020, 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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  9. SOUTH SAN FRANCISCO, Calif., Nov. 05, 2020 (GLOBE NEWSWIRE) -- Nkarta, Inc. (NASDAQ:NKTX), a clinical-stage biopharmaceutical company developing engineered natural killer (NK) cell therapies to treat cancer, today announced its participation at these upcoming investor conferences:

    Cowen 2020 IO Next Summit
    Date: Friday, November 13, 2020
    Fireside chat presentation: 11:45 a.m. ET

    Stifel 2020 Virtual Healthcare Conference
    Date: Tuesday, November 17, 2020
    Fireside chat presentation: 2:00 p.m. ET

    Evercore ISI 3rd Annual HealthCONx Conference
    Date: Tuesday, December 1, 2020
    Fireside chat presentation: 9:40 a.m. ET

    A live audio webcast of the event will be available on the Investors section of Nkarta's website, www.nkartatx.com. A replay of the webcast…

    SOUTH SAN FRANCISCO, Calif., Nov. 05, 2020 (GLOBE NEWSWIRE) -- Nkarta, Inc. (NASDAQ:NKTX), a clinical-stage biopharmaceutical company developing engineered natural killer (NK) cell therapies to treat cancer, today announced its participation at these upcoming investor conferences:

    Cowen 2020 IO Next Summit

    Date: Friday, November 13, 2020

    Fireside chat presentation: 11:45 a.m. ET

    Stifel 2020 Virtual Healthcare Conference

    Date: Tuesday, November 17, 2020

    Fireside chat presentation: 2:00 p.m. ET

    Evercore ISI 3rd Annual HealthCONx Conference

    Date: Tuesday, December 1, 2020

    Fireside chat presentation: 9:40 a.m. ET

    A live audio webcast of the event will be available on the Investors section of Nkarta's website, www.nkartatx.com. A replay of the webcast will be archived on the website for approximately four weeks.

    About Nkarta

    Nkarta is a clinical-stage biotechnology company advancing the development of allogeneic natural killer (NK) cell therapies for cancer. 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, and 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

    Primary Logo

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  10. Nadir Mahmood, Ph.D. Named to Expanded Role as Chief Financial and Business Officer
    Alicia J. Hager, J.D., Ph.D. to Join as Chief Legal Officer

    SOUTH SAN FRANCISCO, Calif., Oct. 05, 2020 (GLOBE NEWSWIRE) -- Nkarta, Inc. (NASDAQ:NKTX), a clinical-stage biopharmaceutical company developing engineered natural killer (NK) cell therapies to treat cancer, today announced that Nadir Mahmood, Ph.D., Chief Business Officer of Nkarta, is assuming the expanded role of Chief Financial and Business Officer effective immediately. He replaces Matthew Plunkett, Ph.D. who has stepped down as Chief Financial Officer to pursue other opportunities. In addition, Alicia J. Hager, J.D., Ph.D. is expected to join Nkarta as Chief Legal Officer later this month.

    "We…

    Nadir Mahmood, Ph.D. Named to Expanded Role as Chief Financial and Business Officer

    Alicia J. Hager, J.D., Ph.D. to Join as Chief Legal Officer

    SOUTH SAN FRANCISCO, Calif., Oct. 05, 2020 (GLOBE NEWSWIRE) -- Nkarta, Inc. (NASDAQ:NKTX), a clinical-stage biopharmaceutical company developing engineered natural killer (NK) cell therapies to treat cancer, today announced that Nadir Mahmood, Ph.D., Chief Business Officer of Nkarta, is assuming the expanded role of Chief Financial and Business Officer effective immediately. He replaces Matthew Plunkett, Ph.D. who has stepped down as Chief Financial Officer to pursue other opportunities. In addition, Alicia J. Hager, J.D., Ph.D. is expected to join Nkarta as Chief Legal Officer later this month.

    "We are delighted to welcome Nadir to his newly expanded role at Nkarta," said Paul J. Hastings, Chief Executive Officer of Nkarta. "Since joining the company in 2018, Nadir has played a direct role in shaping Nkarta's strategy and operations, provided exceptional cross-functional leadership and demonstrated a deep understanding of the many facets of our business. These achievements, in addition to his experience in corporate development and equity research, make him particularly well suited for Nkarta at this stage in our growth. He will be supported by a seasoned finance organization as we look forward to his continued contributions."

    Mahmood said, "I look forward to working with our investors, collaborators and the Nkarta team as we continue the important pursuit of advancing the next potential wave of transformative cell therapy that can bring new hope to cancer patients. Building on the strong foundation Matt helped to create, we remain focused on expanding platform innovation, advancing our manufacturing capabilities, and preparing for clinical trials of our potentially disruptive co-lead NK cell therapy candidates."

    Hastings continued, "We would like to thank Matt for his many valuable contributions to Nkarta. His unique skill set of advanced scientific training and financial market experience helped us rapidly build our financial foundation and take Nkarta to where we are today. I know I speak for everyone at the company when I say we wish Matt well as he embarks on the next leg of his successful career."

    Plunkett added, "I appreciate the opportunity from Paul and the Board to contribute to Nkarta's financing and operations over the last two years, and I am delighted to leave the company with a solid financial foundation for future success."

    "We're also pleased to welcome Alicia to Nkarta as we broaden the expertise and capabilities of our outstanding leadership team," Hastings added. "As an experienced chief counsel and biopharma executive, she will provide critical legal expertise and leadership to support our goal of accelerating the development of groundbreaking therapies."

    About Nadir Mahmood, Ph.D.

    Prior to joining Nkarta in 2018, Dr. Mahmood headed corporate development at Second Genome where he was responsible for establishing strategy and partnerships across the company's portfolio of programs. Earlier in his career, he was staff scientist at Kythera Biopharmaceuticals (acquired by Allergan), overseeing preclinical research for the company's lead molecule, Kybella®. Dr. Mahmood has also worked in equity research at Goldman Sachs and consulted for early stage companies in the life sciences and clean energy sectors. He earned a B.S. in Biochemistry from the University of Texas at Austin and a Ph.D. in Cell Regulation from the University of Texas Southwestern Medical Center, and completed postdoctoral research at the Scripps Research Institute in La Jolla, CA.

    About Alicia J. Hager, J.D., Ph.D.

    Dr. Hager brings to Nkarta a deep scientific background and nearly 20 years of broad legal experience in the life sciences. She previously served as Senior Vice President and General Counsel of OncoMed Pharmaceuticals, where she held multiple roles of increasing responsibility and leadership over the years. Prior to joining OncoMed, Dr. Hager was an attorney at the law firm of Morrison & Foerster LLP, where she served as intellectual property counsel for biotech and pharmaceutical clients. Earlier in her career, Dr. Hager was a patent agent at the law firm of Heller Ehrman White & McAuliffe LLP. Dr. Hager received an A.B. in Chemistry from Occidental College, an A.M. and Ph.D. in Chemistry from Harvard University and a J.D. from Stanford Law School.

    About Nkarta

    Nkarta is a clinical-stage biotechnology company advancing the development of allogeneic natural killer (NK) cell therapies for cancer. 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, and 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 its growth and financial position, the progress of its platform innovation and manufacturing capabilities, and the expertise of its executives. 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 are described more fully in Nkarta's filings with the Securities and Exchange Commission ("SEC"), including the "Risk Factors" section of the Company's Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2020, filed with the SEC on August 20, 2020, 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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  11. SOUTH SAN FRANCISCO, Calif., Sept. 29, 2020 (GLOBE NEWSWIRE) -- Nkarta, Inc. (NASDAQ:NKTX), a clinical-stage biopharmaceutical company developing engineered natural killer (NK) cell therapies to treat cancer, today announced that it will participate at the following virtual investor conference:

    Jefferies Virtual Cell Therapy Summit
    Date: Tuesday, October 6, 2020
    Fireside chat presentation: 4:30 p.m. ET

    A live audio webcast of the event will be available on the Investors section of Nkarta's website, www.nkartatx.com. A replay of the webcast will be archived on the website for approximately four weeks.

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

    SOUTH SAN FRANCISCO, Calif., Sept. 29, 2020 (GLOBE NEWSWIRE) -- Nkarta, Inc. (NASDAQ:NKTX), a clinical-stage biopharmaceutical company developing engineered natural killer (NK) cell therapies to treat cancer, today announced that it will participate at the following virtual investor conference:

    Jefferies Virtual Cell Therapy Summit

    Date: Tuesday, October 6, 2020

    Fireside chat presentation: 4:30 p.m. ET

    A live audio webcast of the event will be available on the Investors section of Nkarta's website, www.nkartatx.com. A replay of the webcast will be archived on the website for approximately four weeks.

    About Nkarta

    Nkarta is a clinical-stage biotechnology company advancing the development of allogeneic natural killer (NK) cell therapies for cancer. 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, and 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

    Primary Logo

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  12. SOUTH SAN FRANCISCO, Calif., Sept. 08, 2020 (GLOBE NEWSWIRE) -- Nkarta, Inc. (NASDAQ:NKTX), a clinical-stage biopharmaceutical company developing engineered natural killer (NK) cell therapies to treat cancer, today announced that it will participate at the following virtual investor conference:

    Cantor Virtual Global Healthcare Conference
    Date: Tuesday, September 15, 2020
    Fireside chat presentation: 2:00 p.m. ET

    A live audio webcast of the event will be available on the Investors section of Nkarta's website, www.nkartatx.com. A replay of the webcast will be archived on the website for approximately four weeks.

    About Nkarta
    Nkarta is a clinical-stage biotechnology company advancing the development of allogeneic natural killer (NK) cell therapies…

    SOUTH SAN FRANCISCO, Calif., Sept. 08, 2020 (GLOBE NEWSWIRE) -- Nkarta, Inc. (NASDAQ:NKTX), a clinical-stage biopharmaceutical company developing engineered natural killer (NK) cell therapies to treat cancer, today announced that it will participate at the following virtual investor conference:

    Cantor Virtual Global Healthcare Conference

    Date: Tuesday, September 15, 2020

    Fireside chat presentation: 2:00 p.m. ET

    A live audio webcast of the event will be available on the Investors section of Nkarta's website, www.nkartatx.com. A replay of the webcast will be archived on the website for approximately four weeks.

    About Nkarta

    Nkarta is a clinical-stage biotechnology company advancing the development of allogeneic natural killer (NK) cell therapies for cancer. 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, and 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

    Primary Logo

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    • Co-Lead programs on track: NKX101 expected to begin Phase 1 dosing in 4Q 2020 and IND for NKX019 expected to be filed in 1Q 2021
    • Completed construction of cGMP clinical manufacturing facility
    • Completed initial public offering of common stock on July 14, 2020, raising $289.8 million in gross proceeds
    • Cash and cash equivalents of $341.8 million (pro forma) as of June 30, 2020, believed to be sufficient to fund operations into at least the second half of 2023

    SOUTH SAN FRANCISCO, Calif., Aug. 20, 2020 (GLOBE NEWSWIRE) -- Nkarta, Inc. (NASDAQ:NKTX), a clinical-stage biopharmaceutical company developing engineered natural killer (NK) cell therapies to treat cancer, today reported financial results for the second quarter ended June 30, 2020, and highlighted…

    • Co-Lead programs on track: NKX101 expected to begin Phase 1 dosing in 4Q 2020 and IND for NKX019 expected to be filed in 1Q 2021

    • Completed construction of cGMP clinical manufacturing facility
    • Completed initial public offering of common stock on July 14, 2020, raising $289.8 million in gross proceeds
    • Cash and cash equivalents of $341.8 million (pro forma) as of June 30, 2020, believed to be sufficient to fund operations into at least the second half of 2023

    SOUTH SAN FRANCISCO, Calif., Aug. 20, 2020 (GLOBE NEWSWIRE) -- Nkarta, Inc. (NASDAQ:NKTX), a clinical-stage biopharmaceutical company developing engineered natural killer (NK) cell therapies to treat cancer, today reported financial results for the second quarter ended June 30, 2020, and highlighted recent corporate accomplishments.

    "Nkarta made outstanding progress in the second quarter of 2020 as we pursue our goal of advancing engineered natural killer cells as the next foundation in anti-cancer cell therapy," said Paul J. Hastings, President and Chief Executive Officer of Nkarta. "With the success of our recently completed initial public offering and the resultant strengthening of our balance sheet, acceptance of our first IND by the FDA for NKX101, construction of our clinical manufacturing facility, and meaningful strides in our pipeline of allogeneic NK cell therapy candidates, we are off to a momentous start as a public company. We are grateful to our employees and collaborators who have supported this high level of execution in the midst of the difficult challenges posed by the COVID-19 pandemic."

    Recent Developments

    • In March and April 2020, Nkarta appointed two new independent directors to its Board of Directors, Laura K. Shawver, Ph.D., President, Chief Executive Officer and Director of Silverback Therapeutics, and Leone Patterson, President of Adverum Biotechnologies.

       
    • Nkarta recently completed the construction of its cGMP manufacturing facility in South San Francisco, California, that is designed to enable Nkarta to supply clinical product for its early-stage clinical trials. Qualification of the facility is in process and Nkarta expects to manufacture NKX019 at this cGMP facility. In a second, final phase of this buildout, Nkarta expects to expand the capabilities of the facility to include the production of retroviral vector, stimulatory cell line and clinical manufacturing of NKX101.

       
    • In July 2020, the U.S. Food and Drug Administration cleared Nkarta's Investigational New Drug Application (IND) for NKX101, an investigational NK cell therapy engineered to target NKG2D ligands.

       
    • In July 2020, Nkarta closed the second tranche of its Series B preferred stock financing, with gross proceeds of $64.4 million.

       
    • In July 2020, Nkarta completed an initial public offering (IPO) in which it issued and sold 16,100,000 shares of common stock, including full exercise of the underwriters' over-allotment option, resulting in gross proceeds of $289.8 million, before deducting underwriting discounts and commissions and other offering expenses.

    Anticipated Near-term Clinical Milestones

    • In 4Q 2020, Nkarta plans to begin dosing in a Phase 1 clinical trial of NKX101 for the treatment of relapsed or refractory (r/r) acute myeloid leukemia (AML) and r/r higher risk myelodysplastic syndrome (MDS).

       
    • In 1Q 2021, Nkarta expects to file an Investigational New Drug Application (IND) for NKX019, an investigational NK cell therapy engineered to target tumors expressing CD19 antigen for the treatment of B cell malignancies.

    Second Quarter 2020 Financial Highlights

    • Cash and Cash Equivalents: As of June 30, 2020, Nkarta had cash, cash equivalents, restricted cash and short-term investments of $22.1 million, which excludes $54.2 million of the proceeds from the Company's Series B Second Tranche Financing of $64.4 million which closed on July 1, 2020, as well as the net proceeds from the Company's July 2020 IPO of $265.5 million.

       
    • R&D Expenses: Research & development expenses were $7.9 million for the second quarter of 2020, which includes $0.2 of non-cash stock-based compensation expense.

       
    • G&A Expenses: General and administrative expenses were $2.5 million for the second quarter of 2020, which includes $0.3 million of non-cash stock-based compensation expense.

       
    • Net Loss. Net loss was $51.1 million, or $30.06 per basic and diluted share, for the quarter ended June 30, 2020. This net loss includes a non-recurring $40.7 million non-cash change in fair value of preferred stock purchase liability.

    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. The company expects cash and cash equivalents at December 31, 2020 to be in the range of $300 million to $310 million.

    Upcoming Events

    • Executive management plans to participate in a fireside chat at the Cantor Virtual Healthcare Conference on Tuesday, September 15, 2020 at 2:00 PM ET. A webcast of the event will be available on the Investors section of the Nkarta website. http://bit.ly/Nkarta_Events

    About Nkarta

    Nkarta is a clinical-stage biotechnology company advancing the development of allogeneic natural killer (NK) cell therapies for cancer. 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, and 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 its growth, strategy, progress and timing of its preclinical studies and clinical trials for NKX101 and NKX019, including its regulatory plans; the potential impact of COVID-19 on Nkarta's ongoing and planned preclinical studies, clinical trials, business and operations; Nkarta's plans to participate at upcoming conferences; 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 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; 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 the Company's Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2020, filed with the SEC on August 20, 2020, 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,
     
      2020  2019  2020  2019 
    Collaboration revenue $  $2  $  $115 
    Operating expenses                
    Research and development  7,862   3,621   15,122   5,915 
    General and administrative  2,494   1,052   4,642   1,992 
    Total operating expenses  10,356   4,673   19,764   7,907 
    Loss from operations  (10,356)  (4,671)  (19,764)  (7,792)
    Other expense, net:                
    Change in fair value of preferred stock

      purchase right liability
      (40,741)     (40,163)   
    Interest and income (expense), net  31   (167)  156   (129)
    Total other expense, net  (40,710)  (167)  (40,007)  (129)
    Net loss $(51,066) $(4,838) $(59,771) $(7,921)
                     
    Net loss per share, basic and diluted $(30.06) $(3.39) $(36.13) $(5.79)
    Weighted average shares used to compute net loss

      per share, basic and diluted
      1,698,560   1,426,984   1,654,304   1,367,686 
                     



    Nkarta, Inc.

    Condensed Balance Sheets

    (in thousands)

    (Unaudited)
     
      June 30,

    2020
      December 31,

    2019
     
     Assets        
    Cash, cash equivalents and short-term investments $21,646  $36,991 
    Property and equipment, net  7,751   3,080 
    Operating lease right-of-use assets  9,017   7,144 
    Other assets  5,202   1,197 
    Total assets $43,616  $48,412 
    Liabilities and stockholders' deficit        
    Preferred stock purchase right liability $41,641  $1,478 
    Liability to related parties  10,245    
    Operating lease liabilities  9,348   7,296 
    Other liabilities  6,456   5,306 
    Total liabilities  67,690   14,080 
    Convertible preferred stock  59,815   59,815 
    Stockholders' deficit  (83,889)  (25,483)
    Total liabilities and stockholders' deficit $43,616  $48,412 
             

    Nkarta Media/Investor Contact:

    Greg Mann

    Nkarta, Inc.

    gmann@nkartatx.com 

    Primary Logo

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  13. SOUTH SAN FRANCISCO, Calif., July 14, 2020 (GLOBE NEWSWIRE) -- Nkarta, Inc. (NASDAQ:NKTX), a clinical-stage biopharmaceutical company developing engineered natural killer (NK) cell therapies to treat cancer, today announced the closing of its initial public offering of 16,100,000 shares of common stock, including the exercise in full by the underwriters of their option to purchase up to 2,100,000 additional shares of common stock, at a public offering price of $18.00 per share. The aggregate gross proceeds from the offering were $289.8 million, before deducting underwriting discounts and commissions and other offering expenses payable by Nkarta.  All shares in the offering were offered by Nkarta. Nkarta's common stock began trading on The…

    SOUTH SAN FRANCISCO, Calif., July 14, 2020 (GLOBE NEWSWIRE) -- Nkarta, Inc. (NASDAQ:NKTX), a clinical-stage biopharmaceutical company developing engineered natural killer (NK) cell therapies to treat cancer, today announced the closing of its initial public offering of 16,100,000 shares of common stock, including the exercise in full by the underwriters of their option to purchase up to 2,100,000 additional shares of common stock, at a public offering price of $18.00 per share. The aggregate gross proceeds from the offering were $289.8 million, before deducting underwriting discounts and commissions and other offering expenses payable by Nkarta.  All shares in the offering were offered by Nkarta. Nkarta's common stock began trading on The Nasdaq Global Select Market on July 10, 2020 under the ticker symbol "NKTX."

    Cowen, Evercore ISI, Stifel and Mizuho Securities acted as joint book-running managers for the offering.

    A registration statement relating to these securities was filed with the Securities and Exchange Commission and became effective on July 9, 2020. The offering was made only by means of a prospectus, copies of which may be obtained from Cowen and Company, LLC, Attn: Prospectus Department, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attn: Prospectus Department, by email at PostSaleManualRequests@broadridge.com, or by telephone at (833) 297-2926; Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 36th Floor, New York, New York 10055, by telephone at 888-474-0200, or by email at ecm.prospectus@evercore.com; Stifel, Nicolaus & Company, Incorporated, Attention: Prospectus Department, One Montgomery Street, Suite 3700, San Francisco, CA 94104 or by telephone at (415) 364-2720 or by email at syndprospectus@stifel.com; Mizuho Securities USA LLC, Attention: Equity Capital Markets, 1271 Avenue of the Americas, 3rd Floor, New York, NY 10020, or by email at US-ECM@us.mizuho-sc.com, or by telephone at (212) 205-7600.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About Nkarta

    Nkarta, Inc. focuses on combining its natural killer (NK) cell expansion and cryopreservation platform with proprietary cell engineering technologies to generate an abundant supply of NK cells, engineer enhanced NK cell recognition of tumor targets, and improve persistence for sustained activity in the body for the treatment of cancer. Nkarta's mission is to discover, develop and deliver novel off-the-shelf NK cell therapy product candidates that have a profound impact on patients. For more information, please visit the company's website at www.nkartatx.com.

    Contact:

    Greg Mann

    Nkarta, Inc.

    gmann@nkartatx.com

    Primary Logo

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  14. SOUTH SAN FRANCISCO, July 10, 2020 (GLOBE NEWSWIRE) -- Nkarta, Inc. (NASDAQ:NKTX), a clinical-stage biopharmaceutical company developing engineered natural killer (NK) cell therapies to treat cancer, today announced the pricing of its initial public offering of 14,000,000 shares of common stock at a public offering price of $18.00 per share. Nkarta anticipates total gross proceeds of approximately $252.0 million, before deducting underwriting discounts and commissions and other offering expenses. The shares are expected to begin trading on The Nasdaq Global Select Market on July 10, 2020 under the ticker symbol "NKTX." All shares of common stock are being offered by Nkarta. The offering is expected to close on or about July 14, 2020, subject…

    SOUTH SAN FRANCISCO, July 10, 2020 (GLOBE NEWSWIRE) -- Nkarta, Inc. (NASDAQ:NKTX), a clinical-stage biopharmaceutical company developing engineered natural killer (NK) cell therapies to treat cancer, today announced the pricing of its initial public offering of 14,000,000 shares of common stock at a public offering price of $18.00 per share. Nkarta anticipates total gross proceeds of approximately $252.0 million, before deducting underwriting discounts and commissions and other offering expenses. The shares are expected to begin trading on The Nasdaq Global Select Market on July 10, 2020 under the ticker symbol "NKTX." All shares of common stock are being offered by Nkarta. The offering is expected to close on or about July 14, 2020, subject to customary closing conditions. In addition, Nkarta has granted the underwriters a 30-day option to purchase up to an additional 2,100,000 shares of common stock at the initial public offering price.

    Cowen, Evercore ISI, Stifel and Mizuho Securities are acting as joint book-running managers for the offering.

    A registration statement relating to these securities has been filed with the Securities and Exchange Commission and became effective on July 9, 2020. The offering is being made only by means of a prospectus. Copies of the final prospectus relating to the offering, when available, may be obtained from Cowen and Company, LLC, Attn: Prospectus Department, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attn: Prospectus Department, by email at PostSaleManualRequests@broadridge.com, or by telephone at (833) 297-2926; Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 36th Floor, New York, New York 10055, by telephone at 888-474-0200, or by email at ecm.prospectus@evercore.com; Stifel, Nicolaus & Company, Incorporated, Attention: Prospectus Department, One Montgomery Street, Suite 3700, San Francisco, CA 94104 or by telephone at (415) 364-2720 or by email at syndprospectus@stifel.com; Mizuho Securities USA LLC, Attention: Equity Capital Markets, 1271 Avenue of the Americas, 3rd Floor, New York, NY 10020, or by email at US-ECM@us.mizuho-sc.com, or by telephone at (212) 205-7600.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About Nkarta

    Nkarta, Inc. focuses on combining its natural killer (NK) cell expansion and cryopreservation platform with proprietary cell engineering technologies to generate an abundant supply of NK cells, engineer enhanced NK cell recognition of tumor targets, and improve persistence for sustained activity in the body for the treatment of cancer. Nkarta's mission is to discover, develop and deliver novel off-the-shelf NK cell therapy product candidates that have a profound impact on patients. For more information, please visit the company's website at www.nkartatx.com.

    Contact:

    Greg Mann

    Nkarta, Inc.

    gmann@nkartatx.com

     

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