NKTX 8-K
Nkarta, Inc. (NKTX)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
(Exact name of Registrant as Specified in Its Charter)
(State or Other Jurisdiction of Incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
|
|
|
|
||
(Address of Principal Executive Offices) |
|
(Zip Code) |
Registrant’s Telephone Number, Including Area Code: (
Not Applicable
(Former Name or Former Address, if Changed Since Last Report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
|
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
|
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
|
Trading Symbol(s) |
|
Name of each exchange on which registered |
|
|
|
(Nasdaq Global Select Market) |
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 May 11, 2023, Nkarta, Inc. (the “Company”) issued a press release announcing the Company’s financial results for the first quarter ended March 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 |
|
Description |
|
|
|
99.1 |
|
|
104 |
|
Cover Page Interactive Data File (embedded within the Inline XBRL document). |
1
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.
|
|
Nkarta, Inc. |
|
|
|
|
|
Date: May 11, 2023 |
|
By: |
/s/ Nadir Mahmood |
|
|
|
Nadir Mahmood |
|
|
|
Chief Financial and Business Officer |
2
Exhibit 99.1
Nkarta Reports First Quarter 2023 Financial Results and Corporate Highlights
SOUTH SAN FRANCISCO, Calif., May 11, 2023 -- Nkarta, Inc. (Nasdaq: NKTX),
a clinical-stage biopharmaceutical company developing engineered natural killer (NK) cell therapies, today reported financial results for the first quarter ended March 31, 2023.
“Nkarta remains focused on the potential of donor-derived CAR NK cell products to broaden access to the transformative power of cell therapy for patients,” said Paul J. Hastings, CEO and President of Nkarta. “We look forward to announcing clinical updates for our two lead programs, NKX101 and NKX019, in 2023.”
Hastings continued, “Our update on NKX101 is expected to include responses from multiple new patients with r/r AML at the 1.5 billion cell dose level. This will include patients from an expansion cohort where cytarabine is substituted for cyclophosphamide and combined with fludarabine as a modified lymphodepletion regimen. Based on our early, encouraging safety data, we see the possibility to combine with other standard of care agents as a potential advantage that NK cell therapy may have over other available treatments. For NKX019, we continue to plan for a full update on non-Hodgkin lymphoma in the second half of the year.”
Clinical Program Updates
NKX101
NKX019
AACR 2023
Other Corporate Highlights
2
First Quarter 2023 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 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. By combining its cell expansion and cryopreservation platform with proprietary cell engineering technologies and CRISPR-based genome engineering
3
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, but are not limited to, 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.
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 clinical 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 Annual Report on Form 10-K for the quarter and year ended December 31, 2022, filed with the SEC on March 16, 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.
4
Nkarta, Inc.
Condensed Statements of Operations
(in thousands, except share and per share data)
(Unaudited)
|
|
Three Months Ended March 31, |
|
|||||
|
|
2023 |
|
|
2022 |
|
||
Operating expenses |
|
|
|
|
|
|
||
Research and development |
|
$ |
26,135 |
|
|
$ |
19,568 |
|
General and administrative |
|
|
8,178 |
|
|
|
6,530 |
|
Total operating expenses |
|
|
34,313 |
|
|
|
26,098 |
|
Loss from operations |
|
|
(34,313 |
) |
|
|
(26,098 |
) |
Other income (expense), net: |
|
|
|
|
|
|
||
Interest income |
|
|
3,465 |
|
|
|
112 |
|
Other income (expense), net |
|
|
33 |
|
|
|
(1 |
) |
Total other income, net |
|
|
3,498 |
|
|
|
111 |
|
Net loss |
|
$ |
(30,815 |
) |
|
$ |
(25,987 |
) |
|
|
|
|
|
|
|
||
Net loss per share, basic and diluted |
|
$ |
(0.63 |
) |
|
$ |
(0.79 |
) |
Weighted average shares used to compute |
|
|
48,921,326 |
|
|
|
32,992,582 |
|
Nkarta, Inc.
Condensed Balance Sheets
(in thousands)
(Unaudited)
|
|
March 31, |
|
|
December 31, |
|
||
Assets |
|
|
|
|
|
|
||
Cash, cash equivalents, restricted cash and investments |
|
$ |
332,100 |
|
|
$ |
354,886 |
|
Property and equipment, net |
|
|
69,777 |
|
|
|
61,908 |
|
Operating lease right-of-use assets |
|
|
45,575 |
|
|
|
45,749 |
|
Other assets |
|
|
10,717 |
|
|
|
10,395 |
|
Total assets |
|
$ |
458,169 |
|
|
$ |
472,938 |
|
Liabilities and stockholders' equity |
|
|
|
|
|
|
||
Accounts payable, accrued and other liabilities |
|
$ |
20,229 |
|
|
$ |
17,797 |
|
Operating lease liabilities |
|
|
91,294 |
|
|
|
82,934 |
|
Total liabilities |
|
|
111,523 |
|
|
|
100,731 |
|
Stockholders’ equity |
|
|
346,646 |
|
|
|
372,207 |
|
Total liabilities and stockholders’ equity |
|
$ |
458,169 |
|
|
$ |
472,938 |
|
Nkarta Media/Investor Contact:
Greg Mann
Nkarta, Inc.
5