UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item 2.02 Results of Operations and Financial Condition.
On March 17, 2022, Nkarta, Inc. (the “Company”) issued a press release announcing the Company’s financial results for the fourth quarter and year ended December 31, 2021. A copy of the Company’s press release is attached hereto as Exhibit 99.1.
The information in Item 2.02 of this Current Report on Form 8-K (including Exhibit 99.1) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be, or be deemed, incorporated by reference in any filings under the Securities Act of 1933, as amended (the “Securities Act”), unless the Company specifically states that the information is to be considered “filed” under the Exchange Act or incorporates it by reference into a filing under the Securities Act or the Exchange Act.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
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Description |
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99.1 |
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104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document). |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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Nkarta, Inc. |
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Date: March 17, 2022 |
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By: |
/s/ Nadir Mahmood |
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Nadir Mahmood |
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Chief Financial and Business Officer |
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Exhibit 99.1
Nkarta Reports Fourth Quarter and Full Year 2021 Financial Results and Corporate Highlights
– 1H 2022 - NKX101, a CAR NK cell therapy candidate engineered with NKG2D receptor, in relapsed/refractory acute myeloid leukemia (AML) and higher-risk myelodysplastic syndrome (MDS)
– FY 2022 - NKX019, a CAR NK cell therapy candidate engineered with CD19 receptor, in relapsed/refractory B cell malignancies
SOUTH SAN FRANCISCO, Calif., March 17, 2022 -- 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, 2021.
“2021 was a year of solid execution for Nkarta across our two clinical development programs, unique NK cell engineering platform and efficient manufacturing processes,” said Paul J. Hastings, President and CEO of Nkarta. “2022 is set to be a catalyst rich year with clinical data milestones that include initial results from our single-agent NKX101 Phase 1 clinical trial in the first half of 2022 as well as initial results from our single-agent NKX019 Phase 1 clinical trial in 2022. Nkarta continues to make excellent progress in advancing our pipeline of groundbreaking therapies for cancer patients with limited treatment options.”
Anticipated Clinical Milestones
2021 and Recent Operational Highlights
NKX101
NKX019
Pipeline and Platform
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Manufacturing
Fourth Quarter and Full Year 2021 Financial Highlights
Financial Guidance
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About NKX101
NKX101 is an allogeneic and off-the-shelf natural killer (NK) cell immunotherapy candidate that builds on the innate anti-cancer biology of NK cells and their positive safety profile. Using NK cells selected from healthy donors, NKX101 is engineered to express a chimeric antigen receptor (CAR) targeting NKG2D ligands on tumor cells and a proprietary membrane-bound form of interleukin 15 (IL-15) to augment the activity of the NK 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. To learn more about the NKX101 clinical trial in adults with acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS), please visit ClinicalTrials.gov, identifier NCT04623944.
About the NKX101-101 Clinical Trial
The NKX101-101 clinical trial is a Phase 1, multi-center, open-label, sequential dose-finding and dose-expansion study to evaluate the safety and anti-tumor activity of NKX101 as a multi-dose, multi-cycle therapy. Patients with relapsed or refractory acute myeloid leukemia (AML) or higher-risk myelodysplastic syndromes (MDS) will be enrolled in the dose-finding portion of the study followed by disease specific expansion cohorts including a combination cohort. Additional information is available on ClinicalTrials.gov, identifier NCT04623944.
About NKX019
NKX019 is an allogeneic and off-the-shelf natural killer (NK) cell immunotherapy candidate that builds on the innate anti-cancer biology of NK cells and their positive safety profile. Using NK cells selected from healthy donors, NKX019 is engineered to express a chimeric antigen receptor (CAR) targeting the B-cell antigen CD19 and a proprietary membrane-bound form of interleukin 15 (IL-15) to augment the activity of the NK cells. CD19 is a biomarker for normal and malignant B cells, and it is a validated target for B cell cancer therapies. To learn more about the clinical trial of NKX019 in advanced B cell malignancies, please visit ClinicalTrials.gov, identifier NCT05020678.
About the NKX019-101 Clinical Trial
The NKX019-101 clinical trial is a Phase 1, multi-center, open-label, sequential dose-finding and dose-expansion study to evaluate the safety and anti-tumor activity of NKX019 as a multi-dose, multi-cycle therapy. Patients with CAR T naïve relapsed/refractory non-Hodgkin lymphoma (NHL), chronic lymphocytic leukemia (CLL) or B-cell acute lymphoblastic leukemia (B-ALL) will be enrolled in the dose-finding portion of the study, followed by disease specific expansion cohorts that also include CAR T exposed patients. To learn more about the clinical trial of NKX019 in advanced B cell malignancies, please visit ClinicalTrials.gov, identifier NCT05020678.
About Nkarta
Nkarta is a clinical-stage biotechnology company advancing the development of allogeneic, off-the-shelf natural killer (NK) cell immunotherapies for cancer patients. By combining its cell expansion and cryopreservation platform with proprietary cell engineering technologies and CRISPR-based genome engineering capabilities, Nkarta is building a pipeline of future cell
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therapies engineered for deep anti-tumor activity and intended for broad access in the outpatient treatment setting. For more information, please visit the company’s website at www.nkartatx.com.
Cautionary Note on Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Words such as "anticipates," "believes," "expects," "intends," “plans,” “potential,” "projects,” “would,” and "future" or similar expressions are intended to identify forward-looking statements. Examples of these forward-looking statements include statements concerning Nkarta’s expectations regarding any or all of the following: Nkarta’s ability to continue to build and advance its pipeline of clinical and preclinical product candidates; the timing of release of initial NKX019 and NKX101 clinical trial data; the safety profile of NKX019 and NKX101; the timing of the dose expansion cohorts in the NKX101 clinical trial; Nkarta’s future manufacturing capabilities; the ability of Nkarta’s technology to augment the anti-tumor activity of NK cells and enable broad access; the potential development incentives due to receiving ODD for NKX101 in AML; the benefits and flexibility of the amended study designs for the NKX101 and NKX019 clinical trials; 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 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 Quarterly Report on Form 10-Q for the quarter ended September 30, 2021, filed with the SEC on November 10, 2021, and Nkarta’s other documents subsequently filed with or furnished to the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, Nkarta undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
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Nkarta, Inc.
Condensed Statements of Operations
(in thousands, except share and per share data)
(Unaudited)
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Three Months Ended |
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Year Ended |
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2021 |
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2020 |
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2021 |
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2020 |
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Operating expenses |
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Research and development |
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17,301 |
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11,270 |
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63,412 |
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36,220 |
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General and administrative |
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5,586 |
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6,728 |
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23,017 |
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15,288 |
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Total operating expenses |
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22,887 |
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17,998 |
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86,429 |
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51,508 |
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Loss from operations |
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(22,887 |
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(17,998 |
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(86,429 |
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(51,508 |
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Other income (expense), net: |
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Change in fair value of preferred stock |
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— |
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— |
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— |
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(40,163 |
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Interest income |
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74 |
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99 |
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370 |
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313 |
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Other income (expense), net |
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(1 |
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2 |
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(16 |
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(3 |
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Total other income (expense), net |
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73 |
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101 |
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354 |
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(39,853 |
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Net loss |
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$ |
(22,814 |
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$ |
(17,897 |
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$ |
(86,075 |
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$ |
(91,361 |
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Net loss per share, basic and diluted |
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$ |
(0.69 |
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$ |
(0.55 |
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$ |
(2.62 |
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$ |
(5.44 |
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Weighted average shares used to compute |
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32,954,965 |
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32,611,697 |
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32,856,883 |
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16,806,262 |
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Nkarta, Inc.
Condensed Balance Sheets
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(Unaudited)
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December 31, |
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2021 |
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2020 |
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Assets |
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Cash, cash equivalents, restricted cash and short-term investments |
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$ |
240,186 |
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$ |
315,326 |
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Property and equipment, net |
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12,856 |
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9,350 |
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Operating lease right-of-use assets |
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11,678 |
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8,505 |
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Other assets |
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9,183 |
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4,469 |
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Total assets |
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$ |
273,903 |
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$ |
337,650 |
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Liabilities and stockholders' equity |
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Accounts payable, accrued and other liabilities |
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$ |
10,477 |
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$ |
7,511 |
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Operating lease liabilities |
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12,459 |
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8,919 |
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Total liabilities |
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22,936 |
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16,430 |
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Stockholders’ equity |
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250,967 |
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321,220 |
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Total liabilities and stockholders' equity |
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$ |
273,903 |
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$ |
337,650 |
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Nkarta Media/Investor Contact:
Greg Mann
Nkarta, Inc.
gmann@nkartatx.com
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