Nkarta, Inc 8-K, filed Mar 21, 2024
Nkarta, Inc. (NKTX)
About this 8-K
Nkarta, Inc filed this 8-K on March 21, 2024.
Items reported
- Item 2.02: Financial results
- Item 9.01: Financial statements and exhibits
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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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 21, 2024, Nkarta, Inc. (the “Company”) issued a press release announcing the Company’s financial results for the fourth quarter and year ended December 31, 2023. 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 21, 2024 |
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By: |
/s/ Alyssa Levin |
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Alyssa Levin |
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Chief Financial and Business Officer |
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Exhibit 99.1
Nkarta Reports Fourth Quarter and Full Year 2023 Financial Results and Corporate Highlights
SOUTH SAN FRANCISCO, Calif., March 21, 2024 -- Nkarta, Inc. (Nasdaq: NKTX), a clinical-stage biopharmaceutical company developing engineered natural killer (NK) cell therapies, today reported financial results for the fourth quarter and year ended December 31, 2023.
“Patients with severe autoimmune diseases deserve novel, effective treatments,” noted Paul J. Hastings, President and CEO of Nkarta. “Recent academic studies have shown that CD19-directed cell therapy has the promise to be truly transformative, and we believe that NKX019 may replicate these early results with superior safety and accessibility. Our approach leverages the potential advantages of NK cells, including fludarabine-free lymphodepletion, deep and rapid B-cell depletion, and the added utility of on-demand dosing. Work with investigators, sites and patients is advancing rapidly, and we remain on track to initiate dosing in our clinical trial of NKX019 in refractory lupus nephritis in the first half of 2024.”
Hastings continued, “The potential of NKX019 to transform the treatment landscape in autoimmune disease demands our focus. To support our early-mover advantage and advance this program, Nkarta has deprioritized the development of NKX101. This follows a planned interim evaluation of Phase 1 data from NKX101 that included 14 new patients with AML. While the safety profile remained encouraging, the response rate was meaningfully lower than that from the first 6 previously reported patients. We see promise in NKX101, but before pursuing further development or significant investment, we will evaluate options for optimizing future
study design, dosing schedule and manufacturing. We are grateful for the support of the NKX101 investigators as well as their patients for their commitment and trust.”
NKX019 in autoimmune disease
NKX019 in non-Hodgkin lymphoma (NHL)
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NKX101 in acute myeloid leukemia (AML)
Fourth Quarter and Full Year 2023 Financial Highlights
Financial Guidance
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About NKX019
NKX019 is an allogeneic, cryopreserved, off-the-shelf 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 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 B cells as well as those implicated in autoimmune disease and B cell-derived malignancies.
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 a membrane-bound form of interleukin-15 (IL-15) for greater persistence and activity without exogenous cytokine support.
About Nkarta
Nkarta is a clinical-stage biotechnology company advancing the development of allogeneic, off-the-shelf natural killer (NK) cell therapies. 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 therapeutic activity and intended for broad access in the outpatient treatment setting. For more information, please visit the company’s website at www.nkartatx.com.
Cautionary Note on Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Words such as "anticipates," "believes," "expects," "intends," “plans,” “potential,” "projects,” “would” and "future" or similar expressions are intended to identify forward-looking statements. Examples of these forward-looking statements include, but are not limited to, statements concerning Nkarta’s expectations regarding any or all of the following: Nkarta’s position, plans, strategies, and timelines for the continued and future clinical development and commercial potential of its product candidates, including NKX019 and NKX101, and for the outcomes of realignment of Nkarta’s pipeline; the therapeutic potential, accessibility, tolerability, advantages, and safety profile of NK cell therapies, including NKX019 for the treatment of autoimmune diseases, such as LN, and NHL, and NKX101 for the treatment of AML; plans and timelines for the future availability and disclosure of NKX019 clinical data or other clinical updates; and Nkarta’s expected cash runway. Interim clinical data for NKX019 and NKX101 included in this press release 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.
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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; 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 clinical success of NKX019; that Nkarta may be delayed in initiating, enrolling or completing its 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 the complexity of the manufacturing process for CAR NK cell therapies.
These and other risks and uncertainties 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, 2023, filed with the SEC on November 9, 2023, 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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2023 |
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2022 |
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2023 |
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2022 |
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Operating expenses |
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Research and development |
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23,322 |
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26,845 |
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96,773 |
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90,897 |
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General and administrative |
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7,863 |
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8,138 |
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34,877 |
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28,058 |
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Total operating expenses |
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31,185 |
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34,983 |
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131,650 |
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118,955 |
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Loss from operations |
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(31,185 |
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(34,983 |
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(131,650 |
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(118,955 |
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Other income, net: |
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Interest income |
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3,456 |
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2,890 |
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14,107 |
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5,588 |
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Other income (expense), net |
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(25 |
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(489 |
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42 |
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(470 |
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Total other income, net |
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3,431 |
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2,401 |
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14,149 |
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5,118 |
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Net loss |
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$ |
(27,754 |
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$ |
(32,582 |
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$ |
(117,501 |
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$ |
(113,837 |
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Net loss per share, basic and diluted |
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$ |
(0.57 |
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$ |
(0.67 |
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$ |
(2.40 |
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$ |
(2.61 |
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Weighted average shares used to compute |
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49,100,140 |
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48,833,577 |
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49,014,300 |
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43,631,722 |
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Nkarta, Inc.
Condensed Balance Sheets
(in thousands)
(Unaudited)
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December 31, |
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2023 |
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2022 |
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Assets |
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Cash, cash equivalents, restricted cash and short-term investments |
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$ |
250,932 |
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$ |
354,886 |
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Property and equipment, net |
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79,326 |
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61,908 |
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Operating lease right-of-use assets |
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39,949 |
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45,749 |
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Other assets |
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8,678 |
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10,395 |
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Total assets |
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$ |
378,885 |
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$ |
472,938 |
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Liabilities and stockholders' equity |
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Accounts payable, accrued and other liabilities |
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$ |
17,261 |
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$ |
17,797 |
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Operating lease liabilities |
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88,339 |
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82,934 |
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Total liabilities |
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105,600 |
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100,731 |
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Stockholders’ equity |
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273,285 |
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372,207 |
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Total liabilities and stockholders' equity |
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$ |
378,885 |
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$ |
472,938 |
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Nkarta Media/Investor Contact:
Greg Mann
Nkarta, Inc.
gmann@nkartatx.com
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