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, 2024.
"We’re encouraged by the early progress that we’ve made in the
clinical investigation of NKX019 for autoimmune disease,” said Paul
J. Hastings, CEO of Nkarta. “Having dosed a first patient in both
Ntrust-1 and the Columbia University Irving Medical Center IST, our
learnings can help us optimize the execution of our current and
future clinical trials. This includes our Ntrust-2 trial, which is
on track to initiate enrollment later this year. Safety and
accessibility are paramount in autoimmune disease, and we believe
that an off-the-shelf, engineered NK cell therapy has the greatest
potential to help patients.”
Hastings continued, “We have decided to forgo future development
of NKX019 in non-Hodgkin lymphoma. In reviewing the clinical data
from the latest cohort of patients with large B-cell lymphoma and
the evolving treatment landscape, Nkarta will focus its efforts on
autoimmune diseases, where we believe NKX019 has potential to
transform patient care.”
Clinical development of NKX019 for autoimmune diseases
advances
- Dosing of the first patient in Ntrust-1, a clinical trial of
NKX019 for the treatment of lupus nephritis. As previously
announced, the first Ntrust-1 patient entered screening in June
2024.
- Dosing of the first patient in the IST of NKX019 in systemic
lupus erythematosus at Columbia University Irving Medical Center
(CUIMC). As previously announced, the CUIMC IST was initiated in
July 2024.
- Both studies continue to enroll participants.
Anticipated autoimmune milestones 2024-2025
- Initiation of patient enrollment expected by year-end 2024 in
Ntrust-2, a clinical trial of NKX019 for the treatment of systemic
sclerosis, myositis and vasculitis. As previously announced, the
Investigational New Drug (IND) Application for Ntrust-2 cleared in
June 2024.
- Preliminary clinical data from Ntrust-1 and Ntrust-2 clinical
trials planned for 2025.
Update for NKX019 in non-Hodgkin lymphoma
(NHL)
- A cohort of seven patients with heavily pretreated large B-cell
lymphoma (LBCL) whose disease progressed following treatment with a
CD19 CAR T-cell therapy received NKX019 on Days 0, 3, and 7
following lymphodepletion.
- There were no cases of Grade >2 cytokine release syndrome
(CRS) and no cases of immune effector cell-associated neurotoxicity
(ICANS).
- Five patients achieved a partial response after a first cycle
of treatment. One of these five patients achieved a complete
response with >6 months durability after receiving a second
cycle of treatment.
- Nkarta aims to report final data from the LBCL cohort at a
future medical conference.
- Nkarta will forgo further development in NHL and prioritize
development efforts on autoimmune diseases.
Third Quarter 2024 and Recent Financial
Highlights
- Nkarta had cash, cash equivalents, restricted cash, and
investments in marketable securities of $405.3 million as of
September 30, 2024.
- Research and development (R&D) expenses were $25.3 million
for the third quarter of 2024. Non-cash stock-based compensation
expense included in R&D expense was $1.8 million for the third
quarter of 2024.
- General and administrative (G&A) expenses were $8.5 million
for the third quarter of 2024. Non-cash stock-based compensation
expense included in G&A expense was $2.3 million for the third
quarter of 2024.
- Net loss was $28.3 million, or $0.39 per basic and diluted
share, for the third quarter of 2024. This net loss includes
non-cash charges of $5.8 million that consisted primarily of
share-based compensation and depreciation expenses.
Financial Guidance
- Nkarta expects its current cash and cash equivalents will be
sufficient to fund its current operating plan into late 2027.
About NKX019NKX019 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 chimeric antigen receptor (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 Ntrust™ Clinical Trials in Autoimmune
DiseaseNtrust-1 and Ntrust-2 are multi-center, open label,
dose escalation clinical trials that build on academic studies of
durable, drug-free remissions in patients with autoimmune disease
after CD19-targeted cell therapy. Both trials will assess the
safety of NKX019 in people living with autoimmune diseases as well
as its ability to enable long-term remissions via a “reset” of the
immune system through the elimination of pathogenic B cells. Per
the trial protocols, patients receive three-dose cycles of NKX019
at 1 billion or 1.5 billion cells per dose following single-agent
lymphodepletion with cyclophosphamide, an agent with an established
safety profile across autoimmune diseases. Leveraging the
engineering of NKX019, no patients in either trial will receive
supplemental cytokines or antibody-based therapeutics. This
approach is designed to evaluate the single-agent activity of
NKX019 and facilitate a more rapid path to regulatory approval.
In the Ntrust-1 study (NCT06557265), patients with refractory
lupus nephritis receive three-dose cycles of NKX019 following
lymphodepletion. Patients in Ntrust-1 may also receive additional
cycles to restore response.
Once initiated, Ntrust-2 will enroll patients with systemic
sclerosis (scleroderma), idiopathic inflammatory myopathy
(myositis), and ANCA-associated vasculitis into parallel cohorts,
and NKX019 will be dosed on Days 0, 3, and 7, a regimen that may be
advantageous across all Nkarta clinical trials. Each trial is
designed to initially enroll up to 12 patients.
About the Investigator-Sponsored Clinical Trial of
NKX019 for Systemic Lupus NephritisThe single-center,
single-arm, open-label Phase 1 investigator-sponsored clinical
trial is designed to enroll up to 6 patients with systemic lupus
erythematosus, regardless of renal involvement, and will evaluate
safety and clinical outcomes in a potentially different population
than Ntrust-1. Translational and biomarker studies, including
autoantibodies, cytokine profiles and pharmacokinetics are also
planned. Patients receive NKX019 following single-agent
lymphodepletion with cyclophosphamide. The clinical trial is being
led by Anca D. Askanase, M.D., M.P.H., Director, Lupus Center at
Columbia University Irving Medical Center and the Director of
Rheumatology Clinical Trials.
About NkartaNkarta 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
StatementsStatements 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 NKX019 (including initiation of further
clinical trials such as Ntrust-2 and the future availability and
disclosure of clinical data and other updates from Nkarta’s
clinical trials); the therapeutic potential, accessibility,
tolerability, advantages, and safety profile of NK cell therapies,
including NKX019 for the treatment of autoimmune diseases, lupus,
systemic sclerosis, myositis, and vasculitis, and NHL; and Nkarta’s
expected cash runway. Interim clinical data for 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 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 June 30, 2024, filed with
the SEC on August 13, 2024, 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.
|
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, |
|
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
| Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
$ |
25,250 |
|
|
$ |
22,194 |
|
|
$ |
73,617 |
|
|
$ |
73,451 |
|
|
General and administrative |
|
8,544 |
|
|
|
7,100 |
|
|
|
23,654 |
|
|
|
27,014 |
|
| Total operating expenses |
|
33,794 |
|
|
|
29,294 |
|
|
|
97,271 |
|
|
|
100,465 |
|
| Loss from operations |
|
(33,794 |
) |
|
|
(29,294 |
) |
|
|
(97,271 |
) |
|
|
(100,465 |
) |
| Other income, net: |
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
5,453 |
|
|
|
3,616 |
|
|
|
14,423 |
|
|
|
10,651 |
|
|
Other (expense) income, net |
|
(3 |
) |
|
|
33 |
|
|
|
(7 |
) |
|
|
67 |
|
| Total other income, net |
|
5,450 |
|
|
|
3,649 |
|
|
|
14,416 |
|
|
|
10,718 |
|
| Net loss |
$ |
(28,344 |
) |
|
$ |
(25,645 |
) |
|
$ |
(82,855 |
) |
|
$ |
(89,747 |
) |
| |
|
|
|
|
|
|
|
|
|
|
|
| Net loss per share, basic and
diluted |
$ |
(0.39 |
) |
|
$ |
(0.52 |
) |
|
$ |
(1.26 |
) |
|
$ |
(1.83 |
) |
| Weighted average shares used
to compute net loss per share, basic and diluted |
|
73,563,316 |
|
|
|
49,062,799 |
|
|
|
65,941,355 |
|
|
|
48,985,373 |
|
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nkarta, Inc.Condensed Balance
Sheets(in
thousands)(Unaudited) |
|
|
September 30,2024 |
|
|
December 31,2023 |
|
| Assets |
|
|
|
|
|
|
Cash, cash equivalents, restricted cash and investments |
$ |
405,265 |
|
|
$ |
250,932 |
|
| Property and equipment,
net |
|
76,231 |
|
|
|
79,326 |
|
| Operating lease right-of-use
assets |
|
38,804 |
|
|
|
39,949 |
|
| Other assets |
|
11,734 |
|
|
|
8,678 |
|
|
Total assets |
$ |
532,034 |
|
|
$ |
378,885 |
|
| Liabilities and
stockholders' equity |
|
|
|
|
|
| Accounts payable, accrued and
other liabilities |
$ |
15,712 |
|
|
$ |
17,261 |
|
| Operating lease
liabilities |
|
85,449 |
|
|
|
88,339 |
|
|
Total liabilities |
|
101,161 |
|
|
|
105,600 |
|
| Stockholders’ equity |
|
430,873 |
|
|
|
273,285 |
|
|
Total liabilities and stockholders’ equity |
$ |
532,034 |
|
|
$ |
378,885 |
|
|
|
|
|
|
|
|
|
|
Nkarta Media/Investor Contact:Greg MannNkarta,
Inc.gmann@nkartatx.com
Nkarta (NASDAQ:NKTX)
過去 株価チャート
から 11 2024 まで 12 2024
Nkarta (NASDAQ:NKTX)
過去 株価チャート
から 12 2023 まで 12 2024
