Nkarta Reports Second Quarter 2023 Financial Results and Corporate Highlights
10 Agosto 2023 - 1:01PM
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, 2023.
“Nkarta remains well positioned to advance allogeneic cell
therapy and lead the development of groundbreaking natural killer
cell therapy candidates,” said Paul J. Hastings, President and CEO
of Nkarta. “We continue to learn, improve and explore potential
opportunities for our best-in-class platform. In our June 2023
update on NKX101, we reported complete responses in unusually
high-risk and heavily pre-treated patients with AML who received a
disease-adapted lymphodepletion regimen. In our other co-lead
program, NKX019, we continue to evaluate multiple strategies to
treat patients with the most aggressive forms of lymphoma. We look
forward to providing further updates as we advance both
candidates.”
Pipeline UpdatesNKX101
- In June 2023, Nkarta reported updated clinical data from its
Phase 1 clinical trial evaluating NKX101 in patients with relapsed
or refractory acute myeloid leukemia (AML).
- As of data cut-off on June 10, 2023, in patients that received
NKX101 after Flu/Ara-C lymphodepletion (LD), 4 of 6 achieved CR/CRi
(67% CR/CRi rate) and 3 of 6 achieved a complete response with
hematologic recovery (50% CR rate). Two of the 4 reported CR/CRi
were MRD (measurable residual disease) negative.
- As of data cut-off on June 10, 2023, in patients that received
the highest doses of NKX101 (3 weekly doses at 1 billion or 1.5
billion cells per dose) after fludarabine/cyclophosphamide (Flu/Cy)
LD, 4 of 18 achieved CR/CRi (22% CR/CRi rate) and 3 of 18 achieved
a complete response with hematologic recovery CR (17% CR rate).
There were no CRs at the lower doses of NKX101.
- NKX101 was well tolerated across dose-levels and LD regimens.
There were no dose-limiting toxicities observed across all
cohorts.
- Flu/Ara-C LD is expected to be the basis of NKX101 development
moving forward.
- As previously announced, Nkarta plans to present an update on
the ongoing clinical trial of NKX101 in the first half of 2024. The
update is expected to include additional patients treated with
NKX101 at 1.5 billion cells/dose x 3 dose regimen following
Flu/Ara-C LD, as well as longer-term follow up of patients who were
in response as of the June 2023 data cut-off.
NKX019
- In June 2023, Nkarta presented preliminary clinical data based
on a November 2022 data cut-off from its Phase 1 dose escalation
clinical trial of NKX019 in patients with relapsed or refractory
non-Hodgkin lymphoma (NHL) at two scientific meetings: an oral
presentation at the annual meeting of the European Hematology
Association (EHA) and an encore poster presentation at the
International Conference on Malignant Lymphoma (17-ICML).
- Nkarta is evaluating the potential for clinical development of
NKX019 in non-malignant, B-cell mediated disease.
- As previously announced, Nkarta plans to present updated
results from its ongoing clinical trial of NKX019 in the second
half of 2023. The update is expected to include patients enrolled
in multiple dose expansion cohorts, as well as longer-term
follow-up of patients who were in response as of the November 2022
data cut-off.
Other Corporate Highlights
- In July 2023, Nkarta announced the appointment of Alyssa Levin,
CPA, CA, as Chief Financial and Business Officer. Ms. Levin will be
responsible for leading Nkarta’s corporate finance, business
development, information technology, and human resources
functions.
Second Quarter 2023 and Recent Financial
Highlights
- As of June 30, 2023, Nkarta had cash, cash equivalents,
restricted cash, and investments of $302.2 million.
- Research and development (R&D) expenses were $25.1 million
for the second quarter of 2023. Non-cash stock-based compensation
expense included in R&D expense was $2.1 million for the second
quarter of 2023.
- General and administrative (G&A) expenses were $11.7
million for the second quarter of 2023. Non-cash stock-based
compensation expense included in G&A expense was $2.5 million
for the second quarter of 2023.
- Net loss was $33.3 million, or $0.68 per basic and diluted
share, for the second quarter of 2023. This net loss includes
non-cash charges of $9.2 million that consisted primarily of
share-based compensation of $4.6 million and an impairment charge
of $4.1 million against right-of-use assets that Nkarta plans to
sublease.
Financial Guidance
- Nkarta expects its current cash and cash equivalents will be
sufficient to fund its current operating plan into 2025.
About NKX101NKX101 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 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 proprietary membrane-bound form of interleukin-15
(IL-15) for greater persistence and activity without exogenous
cytokine support. To learn more about the NKX101 clinical trial in
adults with AML, please visit ClinicalTrials.gov.
About NKX019NKX019 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 chimeric antigen receptor (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 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 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 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, tolerability and safety profile of NK cell therapies,
including NKX101 and NKX019; plans and timelines for the future
availability and presentation of NKX101 and NKX019 clinical data;
potential opportunities and strategies for Nkarta’s platform and
product candidates, including NKX101 and NKX019, and Nkarta’s
ability to evaluate and exploit such opportunities and strategies;
and Nkarta’s expected cash runway. Interim clinical data for NKX101
included in this press release were reported on June 27, 2023 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 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
March 31, 2023, filed with the SEC on May 11, 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.
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, |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
25,122 |
|
|
$ |
21,049 |
|
|
$ |
51,257 |
|
|
$ |
40,617 |
|
General and administrative |
|
|
11,736 |
|
|
|
6,563 |
|
|
|
19,914 |
|
|
|
13,093 |
|
Total operating expenses |
|
|
36,858 |
|
|
|
27,612 |
|
|
|
71,171 |
|
|
|
53,710 |
|
Loss from operations |
|
|
(36,858 |
) |
|
|
(27,612 |
) |
|
|
(71,171 |
) |
|
|
(53,710 |
) |
Other income, net: |
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
3,570 |
|
|
|
686 |
|
|
|
7,035 |
|
|
|
798 |
|
Other income, net |
|
|
1 |
|
|
|
3 |
|
|
|
34 |
|
|
|
2 |
|
Total other income, net |
|
|
3,571 |
|
|
|
689 |
|
|
|
7,069 |
|
|
|
800 |
|
Net loss |
|
$ |
(33,287 |
) |
|
$ |
(26,923 |
) |
|
$ |
(64,102 |
) |
|
$ |
(52,910 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share, basic and
diluted |
|
$ |
(0.68 |
) |
|
$ |
(0.61 |
) |
|
$ |
(1.31 |
) |
|
$ |
(1.38 |
) |
Weighted average shares used
to compute net loss per share, basic and diluted |
|
|
48,970,391 |
|
|
|
43,841,392 |
|
|
|
48,946,018 |
|
|
|
38,446,956 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nkarta, Inc.Condensed Balance Sheets(in
thousands)(Unaudited) |
|
|
June 30,2023 |
|
December 31,2022 |
Assets |
|
|
|
|
Cash, cash equivalents, restricted cash and investments |
|
$ |
302,224 |
|
$ |
354,886 |
Property and equipment,
net |
|
|
76,094 |
|
|
61,908 |
Operating lease right-of-use
assets |
|
|
41,071 |
|
|
45,749 |
Other assets |
|
|
9,649 |
|
|
10,395 |
Total assets |
|
$ |
429,038 |
|
$ |
472,938 |
Liabilities and
stockholders' equity |
|
|
|
|
Accounts payable, accrued and
other liabilities |
|
$ |
20,563 |
|
$ |
17,797 |
Operating lease
liabilities |
|
|
90,497 |
|
|
82,934 |
Total liabilities |
|
|
111,060 |
|
|
100,731 |
Stockholders’ equity |
|
|
317,978 |
|
|
372,207 |
Total liabilities and stockholders’ equity |
|
$ |
429,038 |
|
$ |
472,938 |
|
|
|
|
|
|
|
Nkarta Media/Investor Contact:Greg MannNkarta,
Inc.gmann@nkartatx.com
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