Nkarta Reports First Quarter 2022 Financial Results and Corporate Highlights
12 Mayo 2022 - 3:02PM
Nkarta, Inc. (Nasdaq: NKTX), a clinical-stage biopharmaceutical
company developing engineered natural killer (NK) cell therapies to
treat cancer, today reported financial results for the first
quarter ended March 31, 2022.
“Last month marked an exciting new chapter for Nkarta and the
field of cell therapy as we announced positive preliminary data for
our co-lead NK cell therapy candidates, NKX101 and NKX1019,
validating our best-in-class allogeneic NK cell platform,” said
Paul J. Hastings, President and CEO of Nkarta. “Independent
clinical trials showed early evidence of powerful anti-tumor
activity and beneficial safety profiles in patients with two
distinct types of relapsed / refractory hematologic malignancies.
Early signs of durability and deepening of responses with
additional cycles of therapy were observed in both trials,
including MRD negativity in patients with AML who received NKX101.
Enrollment is underway at higher 3-dose monotherapy regimens of 1.5
billion cells per dose in both dose expansion studies, and Nkarta
looks forward to presenting additional data later this year.”
NKX101 Clinical Update
- On April 25, 2022, Nkarta reported preliminary data from its
Phase 1 study evaluating NKX101, an allogeneic, cryopreserved,
off-the-shelf cancer immunotherapy candidate that uses NK cells
engineered to target NKG2D ligands on cancer cells, as a
multi-dose, multi-cycle monotherapy in patients with relapsed /
refractory (r/r) acute myeloid leukemia (AML) and higher-risk
myelodysplastic syndrome (MDS). As of data cut-off on April 21,
2022, 21 patients had been enrolled and dosed.
- Three of five patients with heavily pre-treated AML treated at
the higher dose level in a three-dose regimen achieved a complete
response (60% CR) with hematologic recovery, with two of the three
responses MRD (measurable residual disease) negative.
- NKX101 was generally well tolerated. No dose-limiting
toxicities were observed. No cytokine release syndrome (CRS),
graft-versus-host disease (GvHD), or immune effector
cell-associated neurotoxicity syndrome (ICANS) was observed. The
most common higher-grade adverse events were myelosuppression and
infection, which are common in this patient population following
lymphodepletion.
NKX019 Clinical Update
- On April 25, 2022, Nkarta reported preliminary data from its
Phase 1 study evaluating NKX019, an allogeneic, cryopreserved,
off-the-shelf cancer immunotherapy candidate that uses NK cells
engineered to target the B-cell antigen CD19, as a multi-dose,
multi-cycle monotherapy in patients with r/r B-cell malignancies.
As of data cut-off on April 21, 2022, 13 patients had been enrolled
and dosed.
- Three of six patients treated at the higher dose level in a
three-dose regimen showed a complete response (50% CR), including
one patient with aggressive diffuse large B cell lymphoma (DLBCL)
and one patient with mantle cell lymphoma (MCL).
- NKX019 was generally well tolerated. No dose-limiting
toxicities were observed. No CRS, GvHD, or neurotoxicity (ICANS)
was observed. The most common higher-grade adverse events were
myelosuppression, which is common in this patient population
following lymphodepletion.
Anticipated Clinical Milestones
- As previously announced, Nkarta plans to present additional
clinical data in the second half of 2022 from its ongoing dose
escalation clinical trials of NKX101 and NKX019. These data would
include longer follow-up on previously reported responses as well
as safety and activity data from patients being enrolled in the
3-dose monotherapy regimen of 1.5 billion CAR NK cells per
dose.
Pipeline and Platform
- In April 2022, Nkarta presented preclinical data from its
engineered NK cell platform in four posters at the annual meeting
of the American Association for Cancer Research (AACR). The posters
included data on the use of CRISPR/Cas9 genome editing to enhance
the ability of NK cells to target CD70 antigen (jointly presented
with CRISPR Therapeutics); analytical and translational methods to
better understand patterns of response to CAR NK cells; analysis of
surface antigen expression in preclinical models of multiple
myeloma; and immune masking strategies for extending the
persistence of allogeneic cell therapies.
Other Corporate Highlights
- In April 2022, Nkarta received approximately $215.5
million in net proceeds from a public offering of its common
stock. This amount included the exercise in full by the
underwriters of their option to purchase additional shares of
common stock.
- In March 2022, Nkarta appointed Angela M. Thedinga, MBA, MPH to
its Board of Directors. Ms. Thedinga, an experienced manufacturing
technology executive, brings extensive operational expertise in
supply chain and commercial-scale manufacturing operations.
First Quarter 2022 and Recent Financial
Highlights
- Cash and Cash Equivalents: As of March 31, 2022, Nkarta had
cash, cash equivalents, restricted cash, and short-term investments
of $219.1 million. This amount does not include net proceeds of
approximately $215.5 million from the public offering of common
stock in April 2022.
- R&D Expenses: Research and development (R&D) expenses
were $19.6 million for the first quarter of 2022. Non-cash
stock-based compensation expense included in R&D expense was
$1.9 million for the first quarter of 2022.
- G&A Expenses: General and administrative (G&A) expenses
were $6.5 million for the first quarter of 2022. Non-cash
stock-based compensation expense included in G&A expense was
$2.2 million for the first quarter of 2022.
- Net Loss: Net loss was $26.0 million, or $0.79 per basic and
diluted share, for the first quarter of 2022. This net loss
includes non-cash charges of $6.7 million that consisted primarily
of share-based compensation of $4.1 million.
Financial Guidance
- Nkarta expects its current cash and cash equivalents will be
sufficient to fund its current operating plan into 2025. This
guidance reflects the proceeds received following the April 2022
public offering of common stock.
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 for cancer
patients. 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 statements
concerning Nkarta’s expectations regarding any or all of the
following: Nkarta’s ability to continue to build and advance its
pipeline of clinical and preclinical product candidates; the timing
of release of additional NKX019 and NKX101 clinical trial data; the
anti-tumor activity and safety profile of NKX019 and NKX101; the
ability of Nkarta’s technology to augment the anti-tumor activity
of NK cells and enable broad access; and Nkarta’s expected cash
runway. Interim clinical data reported in this press release were
reported on April 25, 2022, 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 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 success of its co-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; 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 year ended December 31, 2021, filed with the SEC
on March 17, 2022, 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 EndedMarch 31, |
|
|
|
2022 |
|
|
2021 |
|
Operating expenses |
|
|
|
|
|
|
Research and development |
|
$ |
19,568 |
|
|
$ |
13,539 |
|
General and administrative |
|
|
6,530 |
|
|
|
5,942 |
|
Total operating expenses |
|
|
26,098 |
|
|
|
19,481 |
|
Loss from operations |
|
|
(26,098 |
) |
|
|
(19,481 |
) |
Other income (expense),
net: |
|
|
|
|
|
|
Interest income |
|
|
112 |
|
|
|
110 |
|
Other expense, net |
|
|
(1 |
) |
|
|
(2 |
) |
Total other income (expense),
net |
|
|
111 |
|
|
|
108 |
|
Net loss |
|
$ |
(25,987 |
) |
|
$ |
(19,373 |
) |
|
|
|
|
|
|
|
Net loss per share, basic and
diluted |
|
$ |
(0.79 |
) |
|
$ |
(0.59 |
) |
Weighted average shares used
to compute net loss per share, basic and diluted |
|
|
32,992,582 |
|
|
|
32,739,610 |
|
|
|
|
|
|
|
|
|
|
Nkarta, Inc.Condensed
Balance Sheets(in
thousands)(Unaudited)
|
|
March 31,2022 |
|
|
December 31,2021 |
|
|
|
|
|
|
Assets |
|
|
|
|
|
|
Cash, cash equivalents, restricted cash and short-term
investments |
|
$ |
219,055 |
|
|
$ |
240,186 |
|
Property and equipment, net |
|
|
14,053 |
|
|
|
12,856 |
|
Operating lease right-of-use
assets |
|
|
65,469 |
|
|
|
11,678 |
|
Other assets |
|
|
7,722 |
|
|
|
9,183 |
|
Total assets |
|
$ |
306,299 |
|
|
$ |
273,903 |
|
Liabilities and
stockholders' equity |
|
|
|
|
|
|
Accounts payable, accrued and
other liabilities |
|
$ |
8,348 |
|
|
$ |
10,477 |
|
Operating lease liabilities |
|
|
69,245 |
|
|
|
12,459 |
|
Total liabilities |
|
|
77,593 |
|
|
|
22,936 |
|
Stockholders’ equity |
|
|
228,706 |
|
|
|
250,967 |
|
Total liabilities and stockholders' equity |
|
$ |
306,299 |
|
|
$ |
273,903 |
|
|
|
|
|
|
|
|
|
|
Nkarta Media/Investor Contact:Greg MannNkarta,
Inc.gmann@nkartatx.com
Nkarta (NASDAQ:NKTX)
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