Fate Therapeutics Reports Second Quarter 2023 Financial Results and Business Updates
08 Agosto 2023 - 3:01PM
Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage
biopharmaceutical company dedicated to bringing a first-in-class
pipeline of induced pluripotent stem cell (iPSC)-derived cellular
immunotherapies to patients with cancer and autoimmune disorders,
today reported business highlights and financial results for the
second quarter ended June 30, 2023.
“We have shown great resilience in advancing our most innovative
and differentiated programs while reducing expenses during the
first six months of 2023, creating an operating runway into the
second half of 2025 that enables us to achieve key milestones
across our pipeline,” said Scott Wolchko, President and Chief
Executive Officer of Fate Therapeutics. “We have commenced Phase 1
study start-up activities for our FT522 ADR-armed, CD19-targeted
CAR NK cell program for B-cell lymphoma, where we intend to assess
FT522 with and without administration of conditioning chemotherapy
to patients. We have also initiated GMP manufacturing of
FT825/ONO-8250 under our solid tumor collaboration with ONO
Pharmaceutical, and plan to submit an IND application in the second
half of 2023 for this multiplexed-engineered, HER2-targeted CAR
T-cell program. Finally, we continue to preclinically assess the
potential of our off-the-shelf, iPSC-derived cellular
immunotherapies to selectively target and durably deplete
pathogenic immune cells, and are evaluating opportunities for
clinical expansion into autoimmunity.”
NK Cell Programs
- Phase 1 Start-up Ongoing for
FT522 ADR-armed, CD19-targeted CAR NK Cell Program. FT522
is the Company’s off-the-shelf, multiplexed-engineered, induced
pluripotent stem cell (iPSC)-derived natural killer (NK) cell
product candidate that incorporates five synthetic controls of cell
function. It is the Company’s first product candidate armed with
its proprietary alloimmune defense receptor (ADR) technology, which
is comprised of a synthetic engineered receptor targeting 4-1BB and
is designed to promote anti-tumor activity without requiring
administration of intensive conditioning chemotherapy to patients.
In May, the U.S. Food and Drug Administration (FDA) allowed the
Company’s Investigational New Drug (IND) application for the
clinical investigation of FT522 in combination with CD20-targeted
monoclonal antibody (mAb) therapy in patients with relapsed /
refractory B-cell lymphoma. The dose-escalation stage of the study
is designed to assess the safety and activity of FT522 with and
without administration of intensive conditioning chemotherapy to
patients. The Company is conducting Phase 1 study start-up
activities at multiple sites, and plans to initiate patient
enrollment with a three-dose treatment schedule at 300 million
cells per dose. The Company is also currently evaluating in
preclinical studies the potential of FT522 to induce an immunologic
reset in patients with autoimmune disorders by selectively
targeting and durably depleting pathogenic immune cells, including
disease-causing B cells, plasma cells, and auto-reactive T
cells.
- FT576 BCMA-targeted CAR NK Cell
Program Accruing Patients in Three-dose Treatment Cohorts.
The Company’s Phase 1 study of FT576, its multiplexed-engineered,
BCMA-targeted chimeric antigen receptor (CAR) NK cell product
candidate for relapsed / refractory multiple myeloma, is currently
enrolling patients in two, three-dose treatment cohorts at 1
billion cells per dose. The Company has treated the first patient
as monotherapy, and has also treated the first patient in
combination with CD38-targeted mAb to assess the therapeutic
potential of dual-antigen targeting of myeloma cells. Patient
enrollment in each of the three-dose treatment cohorts is
proceeding independently.
T-cell Programs
- First-of-kind FT819 Program
Advancing in Single-dose Escalation Cohorts for B-cell
Malignancies. The Company’s landmark Phase 1 clinical
trial of FT819 is the first-ever clinical investigation of a T-cell
product candidate manufactured from a clonal master iPSC line.
FT819 incorporates several novel synthetic controls of cell
function, including the integration of a novel CD19-targeted 1XX
CAR construct into the T-cell receptor alpha constant (TRAC) locus,
which is intended to promote uniform CAR expression, enhance T-cell
potency, and prevent graft-versus-host disease. The Company is
currently enrolling patients in single-dose treatment cohorts at
540 million cells in B-cell lymphoma and at 360 million cells in
chronic lymphocytic leukemia.
- 2H23 IND Submission Planned for
HER2-targeted CAR T-cell Program for Solid Tumors. Under
the Company’s collaboration with ONO Pharmaceutical Co., Ltd.
(ONO), the companies are co-developing FT825/ONO-8250, an
iPSC-derived CAR T-cell product candidate that incorporates seven
novel synthetic controls designed to enhance effector cell function
and overcome unique challenges in treating solid tumors. The
Company is currently conducting IND-enabling activities and GMP
manufacturing of FT825/ONO-8250, and plans to submit an IND
application to the FDA in the second half of 2023 to jointly
conduct a Phase 1 study for the treatment of patients with
HER2-positive solid tumors. The multiplexed-engineered,
iPSC-derived CAR T-cell product candidate incorporates a novel
HER2-targeted binding domain with a differentiated activity
profile, a synthetic CXCR2 receptor to promote cell trafficking, a
synthetic TGFβ receptor to redirect immunosuppressive signals in
the tumor microenvironment, and a synthetic interleukin-7 receptor
fusion protein to enhance T-cell function.
Second Quarter 2023 Financial Results
- Cash & Investment
Position: Cash, cash equivalents and investments as of
June 30, 2023 were $385.2 million. In addition, as of June 30,
2023, cash receivables from the Company’s collaboration with ONO
were $2.8 million.
- Total Revenue: Revenue
was $0.9 million for the second quarter of 2023, which was derived
from the Company’s conduct of preclinical development activities
for a second collaboration candidate targeting an undisclosed solid
tumor antigen under its collaboration with ONO.
- Total Operating
Expenses: For the second quarter of 2023, GAAP operating
expenses were $63.5 million, including research and development
expenses of $40.9 million and general and administrative expenses
of $22.6 million. Such amounts included $12.9 million of non-cash
stock-based compensation expense.
- Shares Outstanding:
Common shares outstanding were 98.5 million, and preferred shares
outstanding were 2.8 million, as of June 30, 2023. Each preferred
share is convertible into five common shares.
Today's Conference Call and WebcastThe Company
will conduct a conference call today, Tuesday, August 8, 2023 at
5:00 p.m. ET to review financial and operating results for the
quarter ended June 30, 2023. In order to participate in the
conference call, please register using the conference link
here. The live webcast can be accessed under
"Events & Presentations" in the Investors section of the
Company's website at www.fatetherapeutics.com. The archived webcast
will be available on the Company's website beginning approximately
two hours after the event.
About Fate Therapeutics’ iPSC Product
PlatformThe Company’s proprietary induced pluripotent stem
cell (iPSC) product platform enables mass production of
off-the-shelf, multiplexed-engineered cell products that are
selectively designed, incorporate novel synthetic controls of cell
function, and are intended to deliver multiple mechanisms of
therapeutic importance to patients. Human iPSCs possess the unique
dual properties of unlimited self-renewal and differentiation
potential into all cell types of the body. The Company’s platform
combines multiplexed engineering and single-cell selection of human
iPSCs to create clonal master iPSC lines. Analogous to master cell
lines used to mass produce biopharmaceutical drug products such as
monoclonal antibodies, the Company utilizes its clonal master iPSC
lines as a renewable cell source to manufacture
multiplexed-engineered cell products which are well-defined and
uniform in composition, can be stored in inventory for
off-the-shelf availability, can be combined and administered with
other therapies, and can potentially reach a broad patient
population. As a result, the Company’s platform is uniquely
designed to overcome numerous limitations associated with the
manufacture of cell therapies using patient- or donor-sourced
cells. Fate Therapeutics’ iPSC product platform is supported by an
intellectual property portfolio of over 400 issued patents and 450
pending patent applications.
About Fate Therapeutics, Inc.Fate Therapeutics
is a clinical-stage biopharmaceutical company dedicated to bringing
a first-in-class pipeline of induced pluripotent stem cell
(iPSC)-derived cellular immunotherapies to patients with cancer and
autoimmune disorders. Using its proprietary iPSC product platform,
the Company has established a leadership position in creating
multiplexed-engineered iPSC lines and in the manufacture and
clinical development of off-the-shelf, iPSC-derived cell products.
The Company’s effector cell pipeline includes
multiplexed-engineered, iPSC-derived natural killer (NK) cell and
T-cell product candidates, which incorporate novel synthetic
controls of cell function, such as chimeric antigen receptors
(CARs) to target tumor-associated antigens, and are intended to
deliver multiple mechanisms of therapeutic importance to patients
including in combination with well-established cancer therapies.
Fate Therapeutics is headquartered in San Diego, CA. For more
information, please visit www.fatetherapeutics.com.
Forward-Looking StatementsThis release contains
"forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995 including statements
regarding the progress of and plans related to the Company's
product candidates, clinical studies and preclinical research and
development programs, the therapeutic and market potential of the
Company’s product candidates, the Company’s clinical and product
development strategy, the Company’s plans to submit an IND
application for its FT825/ONO-8250 HER2-targeted CAR T-cell solid
tumor program under its collaboration with ONO, and the impact of
the Company’s expense reduction and projected cash runway. These
and any other forward-looking statements in this release are based
on management's current expectations of future events and are
subject to a number of risks and uncertainties that could cause
actual results to differ materially and adversely from those set
forth in or implied by such forward-looking statements. These risks
and uncertainties include, but are not limited to, the risk that
the Company’s product candidates may not demonstrate the requisite
safety or efficacy to warrant further development or to achieve
regulatory approval, the risk that results observed in prior
studies of the Company’s product candidates, including preclinical
studies and clinical trials, will not be observed in ongoing or
future studies involving these product candidates, the risk of a
delay or difficulties in the manufacturing of the Company’s product
candidates or in the initiation and conduct of, or enrollment of
patients in, any clinical trials, the risk that the Company may
cease or delay preclinical or clinical development of any of its
product candidates for a variety of reasons (including requirements
that may be imposed by regulatory authorities on the initiation or
conduct of clinical trials, changes in the therapeutic, regulatory,
or competitive landscape for which the Company’s product candidates
are being developed, the amount and type of data to be generated or
otherwise to support regulatory approval, difficulties or delays in
patient enrollment and continuation in the Company’s ongoing and
planned clinical trials, difficulties in manufacturing or supplying
the Company’s product candidates for clinical testing, and any
adverse events or other negative results that may be observed
during preclinical or clinical development), the risk that its
product candidates may not produce therapeutic benefits or may
cause other unanticipated adverse effects, the risk that the
Company may not comply with its obligations under and otherwise
maintain its collaboration agreement with ONO Pharmaceutical, Ltd.
or other parties with which the Company may enter into future
collaborations on the agreed upon terms, the risk that research
funding and milestone payments received by the Company under its
collaboration may be less than expected, and the risk that the
Company may incur operating expenses in amounts greater than
anticipated. For a discussion of other risks and uncertainties, and
other important factors, any of which could cause the Company’s
actual results to differ from those contained in the
forward-looking statements, see the risks and uncertainties
detailed in the Company’s periodic filings with the Securities and
Exchange Commission, including but not limited to the Company’s
most recently filed periodic report, and from time to time in the
Company’s press releases and other investor communications. Fate
Therapeutics is providing the information in this release as of
this date and does not undertake any obligation to update any
forward-looking statements contained in this release as a result of
new information, future events or otherwise.
Condensed Consolidated Statements of
Operations and Comprehensive Loss(in thousands,
except share and per share
data)(unaudited)
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
|
|
|
|
|
|
|
Collaboration revenue |
|
$ |
933 |
|
|
$ |
18,549 |
|
|
$ |
59,913 |
|
|
$ |
36,963 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
40,876 |
|
|
|
81,307 |
|
|
|
106,505 |
|
|
|
153,446 |
|
General and administrative |
|
|
22,622 |
|
|
|
20,351 |
|
|
|
44,565 |
|
|
|
41,093 |
|
Total
operating expenses |
|
|
63,498 |
|
|
|
101,658 |
|
|
|
151,070 |
|
|
|
194,539 |
|
Loss
from operations |
|
|
(62,565 |
) |
|
|
(83,109 |
) |
|
|
(91,157 |
) |
|
|
(157,576 |
) |
Other
income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
4,381 |
|
|
|
757 |
|
|
|
8,075 |
|
|
|
1,175 |
|
Change in fair value of stock price appreciation milestones |
|
|
393 |
|
|
|
5,881 |
|
|
|
2,111 |
|
|
|
14,240 |
|
Other Income |
|
|
5,036 |
|
|
|
366 |
|
|
|
9,335 |
|
|
|
366 |
|
Total
other income (expense), net |
|
|
9,810 |
|
|
|
7,004 |
|
|
|
19,521 |
|
|
|
15,781 |
|
Net
loss |
|
$ |
(52,755 |
) |
|
$ |
(76,105 |
) |
|
$ |
(71,636 |
) |
|
$ |
(141,795 |
) |
Other
comprehensive income (loss): |
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gain (loss) on available-for-sale securities, net |
|
|
59 |
|
|
|
(531 |
) |
|
|
1,267 |
|
|
|
(2,619 |
) |
Comprehensive loss |
|
$ |
(52,696 |
) |
|
$ |
(76,636 |
) |
|
$ |
(70,369 |
) |
|
$ |
(144,414 |
) |
Net
loss per common share, basic and diluted |
|
$ |
(0.54 |
) |
|
$ |
(0.79 |
) |
|
$ |
(0.73 |
) |
|
$ |
(1.47 |
) |
Weighted–average common shares used to compute basic and diluted
net loss per share |
|
|
98,400,355 |
|
|
|
96,704,413 |
|
|
|
98,228,476 |
|
|
|
96,524,968 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Condensed Consolidated Balance
Sheets(in
thousands)(unaudited)
|
|
June 30, |
|
|
December 31, |
|
|
|
2023 |
|
|
2022 |
|
|
|
|
|
|
|
|
Assets |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
46,802 |
|
|
$ |
61,333 |
|
Accounts receivable |
|
|
2,833 |
|
|
|
38,480 |
|
Short-term investments |
|
|
331,133 |
|
|
|
374,894 |
|
Prepaid expenses and other current assets |
|
|
11,414 |
|
|
|
27,367 |
|
Total
current assets |
|
|
392,182 |
|
|
|
502,074 |
|
Long-term investments |
|
|
7,291 |
|
|
|
4,942 |
|
Operating lease right-of-use asset |
|
|
63,743 |
|
|
|
66,069 |
|
Other
long-term assets |
|
|
121,541 |
|
|
|
132,476 |
|
Total
assets |
|
$ |
584,757 |
|
|
$ |
705,561 |
|
|
|
|
|
|
|
|
Liabilities and stockholders’ equity |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable and accrued expenses |
|
$ |
36,975 |
|
|
$ |
62,197 |
|
Deferred revenue, current portion |
|
|
1,929 |
|
|
|
42,226 |
|
CIRM award liability, current portion |
|
|
— |
|
|
|
4,000 |
|
Operating lease liability, current portion |
|
|
5,786 |
|
|
|
5,628 |
|
Total
current liabilities |
|
|
44,690 |
|
|
|
114,051 |
|
Operating lease liability, net of current portion |
|
|
100,562 |
|
|
|
103,710 |
|
Stock
price appreciation milestones, net of current portion |
|
|
1,750 |
|
|
|
3,861 |
|
Stockholders’ equity |
|
|
437,755 |
|
|
|
483,939 |
|
Total
liabilities and stockholders’ equity |
|
$ |
584,757 |
|
|
$ |
705,561 |
|
|
|
|
|
|
|
|
Contact:Christina TartagliaStern Investor
Relations, Inc.212.362.1200christina.tartaglia@sternir.com
Fate Therapeutics (NASDAQ:FATE)
Gráfica de Acción Histórica
De May 2024 a Jun 2024
Fate Therapeutics (NASDAQ:FATE)
Gráfica de Acción Histórica
De Jun 2023 a Jun 2024