Nkarta Reports Third Quarter 2023 Financial Results and Corporate Highlights
09 Novembre 2023 - 10:02PM
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
- In October 2023, Nkarta announced the expansion of its pipeline
to include autoimmune disease following the FDA clearance of its
IND application for NKX019 in lupus nephritis (LN).
- The expansion of NKX019 into an additional disease category is
based on academic studies reporting durable complete responses to
CD19-directed cell therapy in patients with severe, refractory
autoimmune disease.
- The multi-center, open label, dose escalation clinical trial
will assess the safety and clinical activity of NKX019 in up to 12
patients with refractory LN. Patients will receive a three-dose
cycle of NKX019 at 1 billion or 1.5 billion cells per dose on Days
0, 7 and 14 following lymphodepletion (LD) with single agent
cyclophosphamide (cy), an agent with an established safety profile
in systemic lupus erythematosus (SLE) and LN.
- Nkarta has partnered with Lupus Therapeutics, the clinical
research affiliate of the Lupus Research Alliance, to accelerate
development of NKX019 through select sites of the Lupus Clinical
Investigators Network (LuCIN).
- Nkarta plans to dose the first patient in the LN study in the
first half of 2024.
- Additional autoimmune diseases are being evaluated for
potential clinical investigation with NKX019.
NKX101 in acute myeloid leukemia (AML)
- In June 2023, Nkarta reported updated clinical data from its
Phase 1 clinical trial evaluating NKX101 in patients with relapsed
or refractory (r/r) AML. In patients that received NKX101 after LD
comprising fludarabine and cytarabine (Flu/Ara-C), 4 of 6 achieved
CR/CRi. Flu/Ara-C LD is expected to be the basis of NKX101
development moving forward.
- Nkarta plans to present a poster at the American Society of
Hematology annual meeting in December 2023 with follow-up data on
the six patients from the June 2023 report that received NKX101
after Flu/Ara-C LD.
- As previously announced, Nkarta successfully filed a
manufacturing process change amendment with the FDA as part of
ongoing scale-up and preparation for potential commercial
manufacturing. After pausing for inventory buildup, patient
enrollment resumed with material generated with the optimized
manufacturing process.
- As previously announced, Nkarta plans to present an update in
the first half of 2024 that includes preliminary safety and
response data from 12 to 20 additional patients that received
NKX101 after Flu/Ara-C LD.
NKX019 in non-Hodgkin lymphoma (NHL)
- In October 2023, Nkarta announced the opening of a new cohort
in its Phase 1 study of NKX019 in r/r NHL. The new cohort
introduces a compressed dosing schedule, where patients receive
NKX019 doses on Days 0, 3 and 7 following LD with Flu/cy. In
previous cohorts, NKX019 has been administered on Days 0, 7 and 14
following LD. The new dosing schedule is designed to intensify
exposure to NKX019 in the first week after LD, when internal data
suggest that NKX019 exposure is highest. The new cohort will target
patients (n=6) with large B-cell lymphoma (LBCL), including those
who have received prior CD19-directed CAR-T cell therapy.
- Nkarta expects to announce preliminary data from the dose
compression cohort in mid-2024.
- In December 2022, Nkarta announced opening dose-expansion
cohorts evaluating NKX019 monotherapy and NKX019 in combination
with rituximab in patients with LBCL. Based on the preliminary
results of NKX019 in the dose finding portion of the study, Nkarta
is prioritizing the previously mentioned compressed dosing cohort
and no longer enrolling patients in these cohorts.
Other Corporate Highlights
- In October 2023, Nkarta announced cost containment measures,
which included a reduction in force of approximately 10% of its
workforce, a stringent cap on future headcount, planned
centralization of operations to a single location, and early
success in the optimization of Nkarta’s manufacturing
platform.
Third Quarter 2023 Financial Highlights
- As of September 30, 2023, Nkarta had cash, cash equivalents,
restricted cash, and investments of $278.4 million.
- Research and development (R&D) expenses were $22.2 million
for the third quarter of 2023. Non-cash stock-based compensation
expense included in R&D expense was $2.1 million for the third
quarter of 2023.
- General and administrative (G&A) expenses were $7.1 million
for the third quarter of 2023. Non-cash stock-based compensation
expense included in G&A expense was $2.2 million for the third
quarter of 2023.
- Net loss was $25.6 million, or $0.52 per basic and diluted
share, for the third quarter of 2023. This net loss includes
non-cash charges of $5.8 million that consisted primarily of
share-based compensation and depreciation.
Financial Guidance
- Nkarta expects its current cash and cash equivalents will be
sufficient to fund its current operating plan into 2026.
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 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 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 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 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 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.
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 computenet loss per share, basic and diluted |
|
|
49,062,799 |
|
|
|
48,630,328 |
|
|
|
48,985,373 |
|
|
|
41,878,716 |
|
Nkarta, Inc.Condensed Balance Sheets(in
thousands)(Unaudited) |
|
|
|
|
|
September 30,2023 |
|
|
December 31,2022 |
|
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 MannNkarta,
Inc.gmann@nkartatx.com
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