Exhibit 99.1
Nkarta Reports Third Quarter 2023 Financial Results and Corporate Highlights
SOUTH SAN FRANCISCO, Calif., November 9, 2023 -- Nkarta, Inc. (Nasdaq: NKTX), a clinical-stage biopharmaceutical company developing engineered natural killer (NK) cell therapies, today reported financial results for the third quarter ended September 30, 2023.
“Earlier this month, we announced bold plans for the future of Nkarta. This includes the expansion of our NK cell therapy pipeline into autoimmune disease, key anticipated updates in 2024, and the extension of our projected cash runway into 2026,” said Paul J. Hastings, President and CEO of Nkarta. “Our pipeline now has three clinical-stage NK cell therapy programs, each increasing our opportunity for success. Our strategy for advancing these programs centers on stringent capital allocation, rapid execution, and business prioritization.”
Hastings continued, “As we maintain our commitment to developing novel cell therapies for patients with cancer, we are also strongly encouraged by the prospect of NK cell-based therapies for patients with autoimmune disease. Early outcomes have been profound for patients treated with CD19-directed cell therapy in recent academic studies. Our aim is to replicate these remarkable, potentially disease-modifying benefits using NKX019, while still
leveraging the advantages of NK cells. In addition to offering superior off-the-shelf accessibility, we aim to build on the safety profile of NK cell biology, the potential advantages of NK cell kinetics, and reduced need for lymphodepletion. Patients with severe autoimmune diseases need safe and novel therapies, and we look forward to initiating dosing in the clinical trial of NKX019 in patients with refractory lupus nephritis in the first half of 2024.”
NKX019 in autoimmune disease
NKX101 in acute myeloid leukemia (AML)
2
NKX019 in non-Hodgkin lymphoma (NHL)
Other Corporate Highlights
Third Quarter 2023 Financial Highlights
3
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 a membrane-bound form of interleukin-15 (IL15) for greater persistence and activity without exogenous cytokine support.
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 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 NK cell therapies, including NKX101 and NKX019; the therapeutic potential, accessibility, tolerability and safety profile of NK cell therapies, including NKX101 for the treatment of AML and NKX019 for the treatment of NHL and autoimmune diseases, such as LN; plans and timelines for the future availability and disclosure of NKX101 and NKX019 clinical data or other clinical updates; potential opportunities and strategies for NKX101 and NKX019, and Nkarta’s ability to evaluate and exploit such opportunities and strategies; and
4
Nkarta’s expected cash runway. Interim clinical data for NKX101 and NKX019 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.
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 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 our business of the COVID-19 pandemic or similar public health crises.
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 June 30, 2023, filed with the SEC on August 10, 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.
5
Nkarta, Inc.
Condensed Statements of Operations
(in thousands, except share and per share data)
(Unaudited)
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
||||||||||
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
||||
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Research and development |
|
$ |
22,194 |
|
|
$ |
23,435 |
|
|
$ |
73,451 |
|
|
$ |
64,053 |
|
General and administrative |
|
|
7,100 |
|
|
|
6,827 |
|
|
|
27,014 |
|
|
|
19,919 |
|
Total operating expenses |
|
|
29,294 |
|
|
|
30,262 |
|
|
|
100,465 |
|
|
|
83,972 |
|
Loss from operations |
|
|
(29,294 |
) |
|
|
(30,262 |
) |
|
|
(100,465 |
) |
|
|
(83,972 |
) |
Other income, net: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Interest income |
|
|
3,616 |
|
|
|
1,900 |
|
|
|
10,651 |
|
|
|
2,698 |
|
Other income, net |
|
|
33 |
|
|
|
17 |
|
|
|
67 |
|
|
|
19 |
|
Total other income, net |
|
|
3,649 |
|
|
|
1,917 |
|
|
|
10,718 |
|
|
|
2,717 |
|
Net loss |
|
$ |
(25,645 |
) |
|
$ |
(28,345 |
) |
|
$ |
(89,747 |
) |
|
$ |
(81,255 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Net loss per share, basic and diluted |
|
$ |
(0.52 |
) |
|
$ |
(0.58 |
) |
|
$ |
(1.83 |
) |
|
$ |
(1.94 |
) |
Weighted average shares used to compute |
|
|
49,062,799 |
|
|
|
48,630,328 |
|
|
|
48,985,373 |
|
|
|
41,878,716 |
|
Nkarta, Inc.
Condensed Balance Sheets
(in thousands)
(Unaudited)
|
|
September 30, |
|
|
December 31, |
|
||
Assets |
|
|
|
|
|
|
||
Cash, cash equivalents, restricted cash and investments |
|
$ |
278,356 |
|
|
$ |
354,886 |
|
Property and equipment, net |
|
|
77,687 |
|
|
|
61,908 |
|
Operating lease right-of-use assets |
|
|
40,519 |
|
|
|
45,749 |
|
Other assets |
|
|
9,302 |
|
|
|
10,395 |
|
Total assets |
|
$ |
405,864 |
|
|
$ |
472,938 |
|
Liabilities and stockholders' equity |
|
|
|
|
|
|
||
Accounts payable, accrued and other liabilities |
|
$ |
19,583 |
|
|
$ |
17,797 |
|
Operating lease liabilities |
|
|
89,465 |
|
|
|
82,934 |
|
Total liabilities |
|
|
109,048 |
|
|
|
100,731 |
|
Stockholders’ equity |
|
|
296,816 |
|
|
|
372,207 |
|
Total liabilities and stockholders’ equity |
|
$ |
405,864 |
|
|
$ |
472,938 |
|
Nkarta Media/Investor Contact:
Greg Mann
Nkarta, Inc.
gmann@nkartatx.com
6