Nkarta Reports Second Quarter 2024 Financial Results and Corporate Highlights
13 Agosto 2024 - 3:01PM
Nkarta, Inc. (Nasdaq: NKTX), a clinical-stage biopharmaceutical
company developing engineered natural killer (NK) cell therapies,
today reported financial results for the second quarter ended June
30, 2024.
“Patients remain our focus, and early execution on our clinical
trials across disease areas is a testament to that commitment,”
said Paul J. Hastings, CEO of Nkarta. “NKX019 has the potential to
reach people living with a wide range of autoimmune diseases, and
we will continue to evaluate ways to maximize our impact in this
field. Our cellular engineering enables us to evaluate a reduced
toxicity lymphodepletion regimen, to limit hospitalization and
patient burden, and spare the complications of other agents.”
Continued execution in clinical development of NKX019
for autoimmune diseases
- Received clearance from FDA of second Investigational New Drug
(IND) application for NKX019 in autoimmune disease, supporting the
planned initiation of Ntrust-2, a clinical trial of NKX019 for the
treatment of systemic sclerosis, myositis and vasculitis. Patients
enrolled in Ntrust-2 will receive three doses of NKX019 on Days 0,
3, and 7 following lymphodepletion (LD) with single-agent
cyclophosphamide (cy).
- Initiation of an investigator-sponsored trial (IST) of NKX019
in systemic lupus erythematosus (SLE) with or without LN by
researchers at Columbia University Irving Medical Center. Patients
enrolled in the IST will receive three doses of NKX019 on Days 0,
3, and 7 following LD with single-agent cy.
Autoimmune milestones 2024-2025
- Initiation of patient enrollment in Ntrust-2 clinical trial
expected by year-end 2024.
- Preliminary clinical data from Ntrust-1 and Ntrust-2 clinical
trials planned for 2025.
Mid-year update for NKX019 in non-Hodgkin lymphoma
(NHL)
- Nkarta presented follow-up data from its Phase 1 clinical trial
of NKX019 in relapsed/refractory NHL at the Pan Pacific Lymphoma
Conference in July 2024, including follow-up on 4 patients who were
retreated and re-entered complete response (CR), demonstrating the
safety and encouraging effectiveness (4/4 CR) of retreatment.
- Nkarta previously opened a cohort with a compressed (7-day)
dosing schedule, where patients with large B-cell lymphoma (LBCL)
who have progressed following CAR T therapy receive NKX019 on Days
0, 3, and 7 following LD with fludarabine (flu) and cy.
- Nkarta has completed enrollment of patients into the 7-day
dosing cohort in LBCL following CAR T and expects to announce data
from this cohort in late-2024.
- Future development of NKX019 in NHL will be contingent on
favorable outcomes from the seven patients that have been treated
in the new cohort.
Leadership Updates
- In July 2024, Nadir Mahmood, Ph.D., joined Nkarta as President,
and David R. Shook, M.D., was promoted to Chief Medical Officer,
Head of Research & Development, with both executives reporting
to Paul J. Hastings, Chief Executive Officer.
- In June 2024, George Vratsanos, M.D., FACR, an accomplished
biopharmaceutical executive with scientific and clinical expertise
in immunology and autoimmunity, joined Nkarta’s Board of
Directors.
Second Quarter 2024 and Recent Financial
Highlights
- Nkarta had cash, cash equivalents, restricted cash, and
investments in marketable securities of $426.7 million as of June
30, 2024.
- Research and development (R&D) expenses were $23.1 million
for the second quarter of 2024. Non-cash stock-based compensation
expense included in R&D expense was $2.2 million for the second
quarter of 2024.
- General and administrative (G&A) expenses were $7.6 million
for the second quarter of 2024. Non-cash stock-based compensation
expense included in G&A expense was $2.2 million for the second
quarter of 2024.
- Net loss was $25.0 million, or $0.34 per basic and diluted
share, for the second quarter of 2024. This net loss includes
non-cash charges of $6.7 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 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, patients with refractory lupus nephritis
receive NKX019 on Days 0, 7 and 14. 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 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 (including initiation of further clinical trials) for
the continued and future clinical development and commercial
potential of its product candidates, including NKX019 for the
treatment of autoimmune disease, including lupus, systemic
sclerosis, myositis, and vasculitis; the therapeutic potential,
accessibility, tolerability, advantages, and safety profile of NK
cell therapies, including NKX019 for the treatment of autoimmune
diseases, including lupus, systemic sclerosis, myositis, and
vasculitis, and NHL; Nkarta’s plans and timelines for the future
availability and disclosure of clinical data from Ntrust-1 and
Ntrust-2 or other updates regarding Nkarta’s clinical trials; 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 March 31, 2024, filed
with the SEC on May 9, 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 June 30, |
|
Six Months Ended June 30, |
|
|
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
Operating expenses |
|
|
|
|
|
|
|
|
Research and development |
|
$ |
23,130 |
|
|
$ |
25,122 |
|
|
$ |
48,367 |
|
|
$ |
51,257 |
|
General and administrative |
|
|
7,585 |
|
|
|
11,736 |
|
|
|
15,110 |
|
|
|
19,914 |
|
Total
operating expenses |
|
|
30,715 |
|
|
|
36,858 |
|
|
|
63,477 |
|
|
|
71,171 |
|
Loss
from operations |
|
|
(30,715 |
) |
|
|
(36,858 |
) |
|
|
(63,477 |
) |
|
|
(71,171 |
) |
Other
income, net: |
|
|
|
|
|
|
|
|
Interest income |
|
|
5,724 |
|
|
|
3,570 |
|
|
|
8,970 |
|
|
|
7,035 |
|
Other (expense) income, net |
|
|
(2 |
) |
|
|
1 |
|
|
|
(4 |
) |
|
|
34 |
|
Total
other income, net |
|
|
5,722 |
|
|
|
3,571 |
|
|
|
8,966 |
|
|
|
7,069 |
|
Net
loss |
|
$ |
(24,993 |
) |
|
$ |
(33,287 |
) |
|
$ |
(54,511 |
) |
|
$ |
(64,102 |
) |
|
|
|
|
|
|
|
|
|
Net loss per share, basic and
diluted |
|
$ |
(0.34 |
) |
|
$ |
(0.68 |
) |
|
$ |
(0.88 |
) |
|
$ |
(1.31 |
) |
Weighted average shares used to compute net loss per share, basic
and diluted |
|
|
73,494,523 |
|
|
|
48,970,391 |
|
|
|
62,088,495 |
|
|
|
48,946,018 |
|
Nkarta, Inc.Condensed Balance
Sheets(in
thousands)(Unaudited) |
|
|
|
|
June 30, 2024 |
|
December 31, 2023 |
Assets |
|
|
|
|
|
Cash, cash equivalents, restricted cash and investments |
|
|
$ |
426,650 |
|
|
$ |
250,932 |
Property
and equipment, net |
|
|
|
77,551 |
|
|
|
79,326 |
Operating lease right-of-use assets |
|
|
|
39,374 |
|
|
|
39,949 |
Other
assets |
|
|
|
10,511 |
|
|
|
8,678 |
Total assets |
|
|
$ |
554,086 |
|
|
$ |
378,885 |
Liabilities and stockholders' equity |
|
|
|
|
|
|
Accounts
payable, accrued and other liabilities |
|
|
$ |
15,329 |
|
|
$ |
17,261 |
Operating lease liabilities |
|
|
|
85,573 |
|
|
|
88,339 |
Total liabilities |
|
|
|
100,902 |
|
|
|
105,600 |
Stockholders’ equity |
|
|
|
453,184 |
|
|
|
273,285 |
Total liabilities and stockholders’ equity |
|
|
$ |
554,086 |
|
|
$ |
378,885 |
|
Nkarta Media/Investor Contact:Greg MannNkarta,
Inc.gmann@nkartatx.com
Nkarta (NASDAQ:NKTX)
Gráfica de Acción Histórica
De Jul 2024 a Ago 2024
Nkarta (NASDAQ:NKTX)
Gráfica de Acción Histórica
De Ago 2023 a Ago 2024