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 November 9, 2022, Nkarta, Inc. (the “Company”) issued a press release announcing the Company’s financial results for the third quarter ended September 30, 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.
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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: November 9, 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 Third Quarter 2022 Financial Results and Corporate Highlights
SOUTH SAN FRANCISCO, Calif., November 9, 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 third quarter ended September 30, 2022.
“The third quarter marked significant progress as we continue to treat patients across our two lead clinical programs,” said Paul J. Hastings, President and CEO of Nkarta. “We recently completed the first cycle of treatment for patients in the NKX019 monotherapy dose escalation cohort and look forward to announcing new clinical data by year-end, including data from responding patients reported in the last update. We’ve also opened enrollment in multiple dose expansion cohorts, where we intend to build on our prior experience with NKX019 in patients with autologous CAR T naïve, relapsed/refractory (r/r) LBCL, while simultaneously investigating activity in patients with LBCL who have previously received autologous CAR T. We will also explore NKX019 in combination with rituximab, regardless of prior CAR T treatment. NKX101 continues to enroll patients in monotherapy dose escalation, and we have updated the timing of NKX101 data in r/r AML to the first half of next year. We are continuing our mission to bring our allogeneic, off-the-shelf cell therapies to patients in outpatient and community oncology settings, enabling convenient multi-cycle treatment and broad access."
Anticipated Clinical Milestones
NKX019 Dose Expansion Cohorts
NKX101 Clinical Data – April 2022
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NKX019 Clinical Data – April 2022
SITC 2022
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Other Corporate Highlights
Third Quarter 2022 and Recent Financial Highlights
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
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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 therapies for cancer patients. By combining its cell expansion and cryopreservation platform with proprietary cell engineering technologies and CRISPR-based genome engineering capabilities, Nkarta is building a pipeline of future cell therapies engineered for deep anti-tumor activity and intended for broad access in the outpatient treatment setting. For more information, please visit the company’s website at www.nkartatx.com.
Cautionary Note on Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Words such as "anticipates," "believes," "expects," "intends," “plans,” “potential,” "projects,” “would,” and "future" or similar expressions are intended to identify forward-looking statements. Examples of these forward-looking statements include statements concerning Nkarta’s expectations regarding any or all of the following: Nkarta’s ability to advance its NKX101 and NKX019 clinical programs as planned; the anti-tumor activity, tolerability, and accessibility of 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; the anti-tumor activity and safety profile of NKX019 and NKX101; and Nkarta’s expected cash runway. Interim clinical data reported in this press release were reported on April 25, 2022, 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
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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 June 30, 2022, filed with the SEC on August 11, 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 September 30, |
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Nine Months Ended September 30, |
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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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$ |
23,435 |
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$ |
16,616 |
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$ |
64,053 |
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$ |
46,111 |
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General and administrative |
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6,827 |
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5,812 |
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19,919 |
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17,431 |
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Total operating expenses |
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30,262 |
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22,428 |
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83,972 |
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63,542 |
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Loss from operations |
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(30,262 |
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(22,428 |
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(83,972 |
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(63,542 |
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Other income (expense), net: |
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Interest income |
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1,900 |
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81 |
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2,698 |
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295 |
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Other income (expense), net |
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17 |
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(6 |
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19 |
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(14 |
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Total other income, net |
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1,917 |
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75 |
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2,717 |
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281 |
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Net loss |
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$ |
(28,345 |
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$ |
(22,353 |
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$ |
(81,255 |
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$ |
(63,261 |
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Net loss per share, basic and diluted |
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$ |
(0.58 |
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$ |
(0.68 |
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$ |
(1.94 |
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$ |
(1.93 |
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Weighted average shares used to compute |
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48,630,328 |
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32,902,723 |
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41,878,716 |
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32,823,829 |
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Nkarta, Inc.
Condensed Balance Sheets
(in thousands)
(Unaudited)
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September 30, |
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December 31, |
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Assets |
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Cash, cash equivalents, restricted cash and short-term investments |
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$ |
395,099 |
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$ |
240,186 |
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Property and equipment, net |
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30,248 |
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12,856 |
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Operating lease right-of-use assets |
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67,971 |
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11,678 |
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Other assets |
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10,481 |
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9,183 |
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Total assets |
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$ |
503,799 |
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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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$ |
21,068 |
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$ |
10,477 |
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Operating lease liabilities |
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83,467 |
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12,459 |
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Total liabilities |
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104,535 |
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22,936 |
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Stockholders’ equity |
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399,264 |
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250,967 |
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Total liabilities and stockholders’ equity |
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$ |
503,799 |
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$ |
273,903 |
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Nkarta Media/Investor Contact:
Greg Mann
Nkarta, Inc.
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gmann@nkartatx.com
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