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 16, 2023, Nkarta, Inc. (the “Company”) issued a press release announcing the Company’s financial results for the fourth quarter and year ended December 31, 2022. 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.
Exhibit Number |
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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 16, 2023 |
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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 2022 Financial Results and Corporate Highlights
SOUTH SAN FRANCISCO, Calif., March 16, 2023 -- 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, 2022.
“Clinical data from our co-lead pipeline candidates have highlighted the promise of our allogeneic NK cell therapy technology to lead the next wave of cell therapy,” said Paul J. Hastings, President and CEO of Nkarta. “We believe that the future of cell therapy is improved accessibility, and NK cells may be uniquely equipped to overcome access barriers owing to their intrinsic tumor killing ability and relative ease of administration. We have shown early proof of concept that engineered NK cells derived from healthy donors have the potential to induce deep and meaningful responses in patients without the safety challenges inherent to T-cell based approaches. Nkarta continues to make excellent progress and we look forward to announcing clinical updates for our two programs in 2023.”
2022 Pipeline Updates
NKX101
NKX019
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2022 Platform Updates
2022 Corporate Updates
Fourth Quarter and Full Year 2022 Financial Highlights
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Financial Guidance
About NKX101
NKX101 is an allogeneic, cryopreserved, off-the-shelf cancer immunotherapy candidate that uses natural killer (NK) cells derived from the peripheral blood of healthy donors. It is engineered with 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. NKX101 is also engineered with membrane-bound form of interleukin-15 (IL15) for greater persistence and activity without exogenous cytokine support. To learn more about the NKX101 clinical trial in adults with AML or MDS, please visit ClinicalTrials.gov.
About NKX019
NKX019 is an allogeneic, cryopreserved, off-the-shelf cancer immunotherapy candidate that uses natural killer (NK) cells derived from the peripheral blood of healthy adult donors. It is engineered with a humanized CD19-directed CAR for enhanced tumor cell targeting and a proprietary, membrane-bound form of interleukin-15 (IL-15) for greater persistence and activity without exogenous cytokine support. CD19 is a biomarker for normal and malignant B cells, and it is a validated target for B cell cancer therapies. To learn more about the NKX019 clinical trial in adults with advanced B cell malignancies, please visit ClinicalTrials.gov.
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 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
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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 advance its pipeline as planned, including its NKX101 and NKX019 clinical programs; the promise, anti-tumor activity, tolerability, and accessibility of allogeneic NK cell therapy and Nkarta’s product candidates, including NKX101 and NKX019; the timing of release of additional NKX019 and NKX101 clinical trial data and the nature of the data to be released; and Nkarta’s expected cash runway. Interim clinical data reported in this press release were reported on April 25, 2022 (for NKX101) and December 5, 2022 (for NKX019) and are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and more data on existing patients become available.
Because forward-looking 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; the risk that the results of preclinical studies and early-stage clinical trials may not be predictive of future results; 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 two 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; the availability of components and supplies necessary for the conduct of our clinical trials; 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, 2022, filed with the SEC on November 9, 2022, 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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2022 |
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2021 |
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2022 |
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2021 |
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Operating expenses |
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Research and development |
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26,845 |
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17,301 |
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90,897 |
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63,412 |
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General and administrative |
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8,138 |
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5,586 |
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28,058 |
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23,017 |
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Total operating expenses |
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34,983 |
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22,887 |
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118,955 |
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86,429 |
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Loss from operations |
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(34,983 |
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(22,887 |
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(118,955 |
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(86,429 |
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Other income (expense), net: |
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Interest income |
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2,890 |
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74 |
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5,588 |
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370 |
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Other expense, net |
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(489 |
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(1 |
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(470 |
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(16 |
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Total other income (expense), net |
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2,401 |
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73 |
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5,118 |
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354 |
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Net loss |
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$ |
(32,582 |
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$ |
(22,814 |
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$ |
(113,837 |
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$ |
(86,075 |
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Net loss per share, basic and diluted |
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$ |
(0.67 |
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$ |
(0.69 |
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$ |
(2.61 |
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$ |
(2.62 |
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Weighted average shares used to compute |
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48,833,577 |
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32,954,965 |
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43,631,722 |
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32,856,883 |
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Nkarta, Inc.
Condensed Balance Sheets
(in thousands)
(Unaudited)
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December 31, |
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2022 |
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2021 |
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Assets |
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Cash, cash equivalents, restricted cash and short-term investments |
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$ |
354,886 |
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$ |
240,186 |
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Property and equipment, net |
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61,908 |
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12,856 |
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Operating lease right-of-use assets |
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45,749 |
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11,678 |
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Other assets |
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10,395 |
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9,183 |
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Total assets |
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$ |
472,938 |
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$ |
273,903 |
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Liabilities and stockholders' equity |
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Accounts payable, accrued and other liabilities |
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$ |
17,797 |
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$ |
10,477 |
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Operating lease liabilities |
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82,934 |
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12,459 |
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Total liabilities |
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100,731 |
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22,936 |
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Stockholders’ equity |
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372,207 |
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250,967 |
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Total liabilities and stockholders' equity |
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$ |
472,938 |
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$ |
273,903 |
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Nkarta Media/Investor Contact:
Greg Mann
Nkarta, Inc.
gmann@nkartatx.com
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