Nkarta Reports Second Quarter 2021 Financial Results and Business Progress
12 Agosto 2021 - 3:02PM
Nkarta, Inc. (Nasdaq: NKTX), a biopharmaceutical company developing
engineered natural killer (NK) cell therapies to treat cancer,
today reported financial results for the second quarter ended June
30, 2021.
“Nkarta continues to set the pace for NK cell therapy as we
build on the strengths of our next generation platform and advance
our two co-lead clinical programs,” said Paul J. Hastings,
President and Chief Executive Officer of Nkarta. “During the
period, we initiated collaboration activities with CRISPR
Therapeutics, added new platform capabilities for rapid innovation,
and expanded our manufacturing footprint – all designed to stay
ahead of the technology curve and transform the scientific insights
of cell therapy into meaningful medicines for cancer patients.
Nkarta remains on track to report initial clinical data from our
Phase 1 study of NKX101 by the end of this year.”
RECENT ACCOMPLISHMENTS AND FUTURE
MILESTONES
NKX101
- Nkarta aims to present initial clinical data from its ongoing
clinical trial of NKX101 by year end 2021. In the Phase 1 study,
patients receive multiple doses of NKX101 during a 28-day treatment
cycle and are eligible to receive subsequent cycles of treatment
upon evidence of tolerability and disease response.
NKX019
- Nkarta expects patient dosing in a Phase 1 clinical trial of
NKX019 to initiate in the second half of 2021 and has begun
manufacturing of clinical supply of NKX019 at its in-house cGMP
clinical manufacturing facility in South San Francisco,
California.
Manufacturing
- Nkarta entered a lease agreement to establish a combined
manufacturing facility and company headquarters. The manufacturing
facility will produce materials for potential pivotal trials and
commercial launch of multiple engineered NK cell therapy products.
The expanded manufacturing footprint, centered in South San
Francisco, California, builds upon Nkarta’s existing 2,700 square
foot cGMP clinical manufacturing facility.
Pipeline and Platform
- In May 2021, Nkarta and CRISPR Therapeutics announced a
research and development collaboration to co-develop and
co-commercialize two chimeric antigen receptor (CAR) NK cell
product candidates, one targeting CD70, and one combining NK and T
cells (NK+T), each enhanced with genome engineering. The
collaboration also gives Nkarta a license to CRISPR/Cas9 gene
editing technology for use in its own engineered NK cell therapy
products.
- Nkarta continues to integrate important scientific insights,
processes and breakthroughs into its next generation platform.
Platform capabilities include:
- Multiplexed CRISPR/Cas9 genome engineering
- “Armored” cells with membrane-bound IL-15 for persistence
- Enhanced expansion, persistence and activity against tumor
microenvironment inhibition via CISH deletion
- Cytokine activation using IL-12, -15 and -18 to enhance
anti-tumor activity persistence and memory-like properties
- No requirement for cytokine support
- Multi-dose and multi-cycle clinical trial designs
SECOND QUARTER 2021 FINANCIAL HIGHLIGHTS
- Cash and Cash Equivalents: As of June 30,
2021, Nkarta had cash, cash equivalents, restricted cash and
short-term investments of $280.3 million.
- R&D Expenses: Research and development
expenses were $16.0 million for the second quarter of 2021.
Non-cash stock-based compensation expense included in R&D
expense was $1.7 million for the second quarter of 2021.
- G&A Expenses: General and administrative
expenses were $5.7 million for the second quarter of 2021. Non-cash
stock-based compensation expense included in G&A expense was
$1.9 million for the second quarter of 2021.
- Net Loss. Net loss was $21.5 million, or $0.66
per basic and diluted share, for the second quarter of 2021.
FINANCIAL GUIDANCE
- Nkarta expects its current cash and cash equivalents will be
sufficient to fund its current operating plan into at least the
second half of 2023.
About NKX101 NKX101 is an investigational,
off-the-shelf cancer immunotherapy that uses natural killer (NK)
cells derived from the peripheral blood of healthy donors and
engineered with membrane-bound IL15 and 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. By engineering
NKX101 with the proprietary NKG2D-based CAR, the ability of NK
cells to recognize and kill tumor cells in pre-clinical models is
increased significantly compared to non-engineered NK cells. The
addition of membrane-bound IL15, a proprietary version of a
cytokine for activating NK cell growth, has been shown in
pre-clinical models to enhance the proliferation, persistence and
sustained activity of NK cells. A multi-center Phase 1 clinical
trial of NKX101 in patients with relapsed/refractory acute myeloid
leukemia (AML) or higher risk myelodysplastic syndromes (MDS) is
currently enrolling. Additional information about the clinical
trial is available on ClinicalTrials.gov, identifier
NCT04623944.
About NKX019NKX019 is an investigational,
off-the-shelf cancer immunotherapy that uses natural killer (NK)
cells derived from the peripheral blood of healthy donors and
engineered with a CD19-directed chimeric antigen receptor (CAR) and
a proprietary, membrane-bound form of interleukin 15 (IL-15). CD19
is a biomarker for normal and malignant B cells, and it is a
validated target for B cell cancer therapies. Via its CAR, NKX019
targets and binds to CD19 and eliminates CD19-expressing cells via
a robust immune response in preclinical studies. Preclinical models
also demonstrate enhanced proliferation, persistence and activity
of NK cells with the membrane-bound IL-15, an important cytokine
for NK cell survival. Initiation of a Phase 1 clinical trial of
NKX019 in patients with relapsed/refractory B cell malignancies in
multiple centers in the United States and Australia is planned for
the second half of 2021.
About Nkarta’s Platform and Natural Starting
MaterialsNkarta’s engineering platform utilizes healthy
adult donors as the source for NK cells. By enlisting this natural
source of NK cells, Nkarta starts with bona fide NK cells endowed
with inherent tumor-recognizing ability and potent cytotoxic
function. Healthy donor-derived NK cells are also available in
abundance, providing a large quantity of cells with which to begin
the efficient two-week manufacturing process. Finally, healthy
donor-derived adult cells consist of a diverse repertoire of NK
cells, providing Nkarta with the potential to capitalize on the
inherent diversity of the innate immune system in selecting donors
or NK cell populations with optimal characteristics.
About Nkarta’s NK Cell TechnologiesNkarta has
pioneered a novel discovery and development platform for the
engineering and efficient production of allogeneic, off-the-shelf
natural killer (NK) cell therapy candidates. The approach harnesses
the innate ability of NK cells to recognize and kill tumor cells.
To enhance the inherent biological activity of NK cells, Nkarta
genetically engineers the cells with a targeting receptor designed
to recognize and bind to specific proteins on the surface of
cancerous cells. This receptor is fused to co-stimulatory and
signaling domains to amplify cell signaling and NK cell
cytotoxicity. Upon binding the target, NK cells become activated
and release cytokines that enhance the immune response and
cytotoxic granules that lead to killing of the target cell. All of
Nkarta’s NK current cell therapy candidates are also engineered
with a membrane-bound IL15, a proprietary version of a cytokine
known for activating NK cell growth, to enhance the persistence and
activity of the NK cells.
Nkarta’s manufacturing process generates an abundant supply of
NK cells that, at commercial scale, is expected to be significantly
lower in cost than other current allogeneic and autologous cell
therapies. Key to this efficiency is the rapid expansion of
donor-derived NK cells using a proprietary NKSTIM cell line,
leading to the production of hundreds of individual doses from a
single manufacturing run. The platform also features the ability to
freeze and store CAR NK cells for an extended period of time and is
designed to enable immediate, off-the-shelf administration to
patients at the point of care.
About NkartaNkarta 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, Nkarta is
building a pipeline of cell therapy candidates generated by
efficient manufacturing processes, which are engineered to enhance
tumor targeting and improve persistence for sustained activity in
the body. 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
successfully and rapidly develop NK cell therapies, including
advancing its two lead clinical programs and building a pipeline of
product candidates; the benefits of Nkarta’s technology platform;
the timing of NKX019 clinical trial initiation and patient dosing
and NKX101 clinical trial data; Nkarta’s future manufacturing
facility and headquarters and production at the facility; the
programs planned under Nkarta’s collaboration with CRISPR
Therapeutics; Nkarta’s ability to capitalize on the inherent
diversity of the innate immune system; the ability of Nkarta’s
technology to enhance the proliferation, persistence and anti-tumor
activity of NK cells and enable off-the-shelf, point-of-care
administration; the efficiency and cost of Nkarta’s manufacturing
processes; the number of doses generated from a manufacturing run;
Nkarta’s ability to continue manufacturing clinical supply of
NKX019 in house; the proprietary nature of Nkarta’s technology; and
Nkarta’s expected cash runway. 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; 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 our 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 Quarterly Report on Form 10-Q for the quarter ended March
31, 2021, filed with the SEC on May 13, 2021, and our 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, |
|
|
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
|
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
15,957 |
|
|
$ |
7,862 |
|
|
$ |
29,496 |
|
|
$ |
15,122 |
|
General and administrative |
|
|
5,677 |
|
|
|
2,493 |
|
|
|
11,618 |
|
|
|
4,642 |
|
Total operating expenses |
|
|
21,634 |
|
|
|
10,355 |
|
|
|
41,114 |
|
|
|
19,764 |
|
Loss from operations |
|
|
(21,634 |
) |
|
|
(10,355 |
) |
|
|
(41,114 |
) |
|
|
(19,764 |
) |
Other income (expense), net: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change in fair value of preferred stock
purchase right liability |
|
|
— |
|
|
|
(40,741 |
) |
|
|
— |
|
|
|
(40,163 |
) |
Interest income |
|
|
104 |
|
|
|
27 |
|
|
|
214 |
|
|
|
152 |
|
Other income (expense), net |
|
|
(5 |
) |
|
|
4 |
|
|
|
(8 |
) |
|
|
4 |
|
Total other income (expense),
net |
|
|
99 |
|
|
|
(40,710 |
) |
|
|
206 |
|
|
|
(40,007 |
) |
Net loss |
|
$ |
(21,535 |
) |
|
$ |
(51,065 |
) |
|
$ |
(40,908 |
) |
|
$ |
(59,771 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share, basic and
diluted |
|
$ |
(0.66 |
) |
|
$ |
(30.06 |
) |
|
$ |
(1.25 |
) |
|
$ |
(36.13 |
) |
Weighted average shares used
to compute net loss per share, basic and diluted |
|
|
32,827,365 |
|
|
|
1,698,560 |
|
|
|
32,783,730 |
|
|
|
1,654,304 |
|
Nkarta, Inc.Condensed
Balance Sheets(in
thousands)(Unaudited)
|
|
June 30,2021 |
|
December 31,2020 |
Assets |
|
|
|
|
Cash, cash equivalents, restricted cash and short-term
investments |
|
$ |
280,255 |
|
$ |
315,326 |
Property and equipment, net |
|
|
11,350 |
|
|
9,350 |
Operating lease right-of-use
assets |
|
|
12,050 |
|
|
8,505 |
Other assets |
|
|
5,456 |
|
|
4,469 |
Total assets |
|
$ |
309,111 |
|
$ |
337,650 |
Liabilities and
stockholders' equity |
|
|
|
|
Accounts payable, accrued and
other liabilities |
|
$ |
8,034 |
|
$ |
7,511 |
Operating lease liabilities |
|
|
12,695 |
|
|
8,919 |
Total liabilities |
|
|
20,729 |
|
|
16,430 |
Stockholders’ equity |
|
|
288,382 |
|
|
321,220 |
Total liabilities and stockholders’ equity |
|
$ |
309,111 |
|
$ |
337,650 |
Nkarta Media/Investor Contact:Greg MannNkarta,
Inc.gmann@nkartatx.com
Nkarta (NASDAQ:NKTX)
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