Fate Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Business Updates
February 26 2024 - 4:01PM
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
fourth quarter and full year ended December 31, 2023.
“We have started the year with strong momentum across our iPSC
product platform in oncology and autoimmunity, including the award
of a grant by the California Institute of Regenerative Medicine to
support Phase 1 clinical investigation of our off-the-shelf FT819
CAR T-cell program in systemic lupus erythematosus,” said Scott
Wolchko, President and Chief Executive Officer of Fate
Therapeutics. “We have also treated the first patient with FT522,
our off-the-shelf CAR NK cell program targeting CD19+ B cells,
which is our first product candidate to incorporate our proprietary
Alloimmune Defense Receptor technology that is designed to reduce
or eliminate the need for administration of intense chemotherapy
conditioning to patients. In addition, we have initiated the Phase
1 study of our FT825 / ONO-8250 CAR T-cell program in solid tumors,
which incorporates seven synthetic controls of cell function
including a novel cancer-specific binding domain targeting HER2. We
are well positioned to generate initial clinical data across these
off-the-shelf programs during 2024.”
FT819 iPSC-derived CAR T-cell Program
- CLIN2 Grant Awarded by CIRM to Fund FT819 Phase 1
Autoimmunity Study in SLE. In February, the Company was
awarded $7.9 million by the California Institute for Regenerative
Medicine (CIRM) to support clinical investigation of FT819 in
patients with systemic lupus erythematosus (SLE). FT819 is the
Company’s off-the-shelf CAR T-cell product candidate that
incorporates several novel synthetic controls of cell function,
including the integration of a novel CD19-targeted 1XX chimeric
antigen receptor (CAR) construct into the T-cell receptor alpha
constant (TRAC) locus that is intended to promote uniform CAR
expression, enhance T-cell potency, and prevent graft-versus-host
disease (GvHD). The multi-center, Phase 1 clinical trial for SLE is
designed to evaluate the safety, pharmacokinetics, and anti-B-cell
activity of a single dose of FT819 administered following a
standard three-day chemotherapy conditioning regimen. The Company
is currently conducting study start-up activities at multiple U.S.
clinical sites.
- Dose Escalation Ongoing in Phase 1 Study for B-cell
Lymphoma. The Company’s landmark clinical trial of FT819
for the treatment of relapsed / refractory B-cell malignancies is
the first-ever clinical investigation of a T-cell product candidate
manufactured from a clonal master iPSC line. The Company is
currently enrolling patients in single-dose treatment cohorts at
540 million cells and at 1.08 billion cells using a standard
three-day chemotherapy conditioning regimen. Any further clinical
development of FT819 for the treatment of B-cell malignancies will
be determined by the Company based on safety and activity at these
higher dose levels. Clinical data previously presented by the
Company from the first 11 patients with relapsed / refractory
B-cell lymphoma treated with a single dose of FT819 at up to 360
million cells showed anti-tumor activity including three complete
responses and one partial response, CAR T-cell expansion that
peaked in the peripheral blood between Days 8 and 11, and a
favorable safety profile with no dose-limiting toxicities, no
events of any grade of immune effector-cell associated
neurotoxicity syndrome (ICANS) or GvHD, and no events of Grade 3 or
greater cytokine release syndrome (CRS).
FT825 / ONO-8250 iPSC-derived CAR T-cell
Program
- Phase 1 Study Initiated with HER2-targeted CAR T-cell
for Advanced Solid Tumors. In January, the Company
initiated enrollment of a multi-center, Phase 1 clinical trial of
FT825 / ONO-8250 under its collaboration with Ono Pharmaceutical
Co., Ltd. (Ono). Designed using the Company’s iPSC product
platform, FT825 / ONO-8250 incorporates seven synthetic controls of
cell function including a novel cancer-specific H2CasMab-2 CAR
targeting human epidermal growth factor receptor 2 (HER2).
Preclinical data of FT825 / ONO-8250 presented at the 2023 Society
for Immunotherapy of Cancer Annual Meeting demonstrated that the
profile of its novel HER2-targeted antigen binding domain is unique
and differentiated from that of trastuzumab, exhibiting similar
potency with greater specificity for cancer cells expressing HER2.
The Phase 1 study is designed to assess the safety,
pharmacokinetics, and activity of a single dose of FT825 / ONO-8250
as monotherapy and in combination with monoclonal antibody therapy
in patients with advanced solid tumors.
FT522 iPSC-derived CAR NK Cell Program
- First Patient Treated with ADR-armed, CD19-targeted CAR
NK Cell Product Candidate. FT522 is the Company’s first
product candidate incorporating its proprietary Alloimmune Defense
Receptor (ADR) technology, which is designed to reduce or eliminate
the need for administration of intense chemotherapy conditioning to
patients receiving cell therapies. The multi-center, Phase 1
clinical trial of FT522 in patients with relapsed / refractory
B-cell lymphoma is currently enrolling patients in the first
three-dose cohort at 300 million cells per dose of Regimen A, which
includes administration of chemotherapy conditioning. Subject to
clearance of dose-limiting toxicities at this first dose level of
Regimen A, enrollment is expected to commence in the first
three-dose cohort at 300 million cells per dose of Regimen B
without administration of chemotherapy conditioning.
- Preclinical Studies Ongoing to Support Expansion into
Autoimmunity. The Company is conducting a preclinical
assessment of the potential for FT522 to induce CD19+ B-cell
depletion across a range of autoimmune diseases, including without
administration of intense chemotherapy conditioning to patients. In
a disseminated Nalm6 leukemia model comprised of CD19+ target cells
resistant to T-cell killing, ADR-armed, CD19-targeted CAR NK cells
exhibited robust killing in vivo of CD19+ target cells in the
presence of alloreactive T cells, suggesting that FT522 has the
potential to deplete CD19+ B cells without administration of
intense chemotherapy conditioning to patients. Additional
preclinical studies are ongoing with FT522 in combination with
monoclonal antibody therapy to assess the potential depletion of
both CD19+ B-cell and CD38+ plasma-cell autoantibody-producing
lineages.
FT576 iPSC-derived CAR NK Cell Program
- Dose Escalation Ongoing in Phase 1 Multiple Myeloma
Study. The Company’s multi-center, Phase 1 clinical trial
of FT576, its BCMA-targeted CAR NK cell product candidate, is
currently accruing patients with relapsed / refractory multiple
myeloma in three-dose treatment cohorts as monotherapy as well as
in combination with CD38-targeted monoclonal antibody. Using a
standard three-day chemotherapy conditioning regimen, the Company
has treated six patients at 1 billion cells per dose, with no
dose-limiting toxicities and no reports of any grade of CRS, ICANS
or GvHD. The study is currently enrolling patients at 2.5 billion
cells per dose. Any further clinical development of FT576 for the
treatment of multiple myeloma will be determined by the Company
based on safety and activity at these higher dose levels.
Fourth Quarter 2023 Financial Results
- Cash & Investment
Position: Cash, cash equivalents and investments as of
December 31, 2023 were $316.2 million.
- Total Revenue: Revenue
was $1.7 million for the fourth 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 fourth quarter of 2023, GAAP operating
expenses were $49.8 million, including research and development
expenses of $31.8 million and general and administrative expenses
of $17.9 million. Such amounts included $9.5 million of non-cash
stock-based compensation expense.
- Shares Outstanding:
Common shares outstanding were 98.6 million, and preferred shares
outstanding were 2.8 million, as of December 31, 2023. Each
preferred share is convertible into five common shares.
Today's Conference Call and WebcastThe Company
will conduct a conference call today, Monday, February 26, 2024 at
5:00 p.m. ET to review financial and operating results for the
quarter and full year ended December 31, 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
PlatformHuman induced pluripotent stem cells (iPSCs)
possess the unique dual properties of unlimited self-renewal and
differentiation potential into all cell types of the body. The
Company’s proprietary iPSC product platform combines
multiplexed-engineering of human iPSCs with single-cell selection
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 starting cell source to manufacture 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 500 issued patents and 500
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 master iPSC lines and in the manufacture and
clinical development of off-the-shelf, iPSC-derived cell products.
The Company’s pipeline includes iPSC-derived natural killer (NK)
cell and T-cell product candidates, which are selectively designed,
incorporate novel synthetic controls of cell function, and are
intended to deliver multiple therapeutic mechanisms to patients.
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 Company’s results of operations, financial condition,
anticipated operating expenses and cash runway, and sufficiency of
its cash and cash equivalents to fund its operations, as well as
statements regarding the advancement of and plans related to the
Company's product candidates, clinical studies and preclinical
research and development programs, the Company’s progress, plans
and timelines for the clinical investigation of its product
candidates, including the initiation and continuation of enrollment
in the Company’s clinical trials, the initiation of additional
clinical trials and additional dose cohorts in ongoing clinical
trials of the Company’s product candidates, the availability of
data from the Company’s clinical trials, the therapeutic and market
potential of the Company’s research and development programs and
product candidates, the Company’s clinical and product development
strategy, and the Company’s expectations regarding progress and
timelines, and the objectives, plans and goals of its collaboration
with Ono. 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 research and development programs and
product candidates, including those product candidates in clinical
investigation, may not demonstrate the requisite safety, efficacy,
or other attributes 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, failure to
demonstrate that a product candidate has the requisite safety,
efficacy, or other attributes to warrant further development, 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 |
|
Year Ended |
|
December 31, |
|
December 31, |
|
2023 |
|
2022 |
|
2023 |
|
2022 |
|
|
|
|
|
|
Collaboration revenue |
$ |
1,676 |
|
|
$ |
44,356 |
|
|
$ |
63,533 |
|
|
$ |
96,300 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
31,816 |
|
|
|
87,191 |
|
|
|
172,596 |
|
|
|
320,454 |
|
General and administrative |
|
17,935 |
|
|
|
21,584 |
|
|
|
81,448 |
|
|
|
84,232 |
|
Total
operating expenses |
|
49,751 |
|
|
|
108,775 |
|
|
|
254,044 |
|
|
|
404,686 |
|
Loss
from operations |
|
(48,075 |
) |
|
|
(64,419 |
) |
|
|
(190,511 |
) |
|
|
(308,386 |
) |
Other
income (expense): |
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
4,414 |
|
|
|
2,880 |
|
|
|
17,186 |
|
|
|
5,842 |
|
Change in fair value of stock price appreciation milestones |
|
(645 |
) |
|
|
5,176 |
|
|
|
2,515 |
|
|
|
20,307 |
|
Other income |
|
184 |
|
|
|
— |
|
|
|
9,882 |
|
|
|
516 |
|
Total
other income (expense), net |
|
3,953 |
|
|
|
8,056 |
|
|
|
29,583 |
|
|
|
26,665 |
|
Net
loss |
$ |
(44,122 |
) |
|
$ |
(56,363 |
) |
|
$ |
(160,928 |
) |
|
$ |
(281,721 |
) |
Other
comprehensive gain (loss): |
|
|
|
|
|
|
|
|
|
|
|
Unrealized gain (loss) on available-for-sale securities, net |
|
514 |
|
|
|
1,399 |
|
|
|
1,869 |
|
|
|
(1,092 |
) |
Comprehensive loss |
$ |
(43,608 |
) |
|
$ |
(54,964 |
) |
|
$ |
(159,059 |
) |
|
$ |
(282,813 |
) |
Net
loss per common share, basic and diluted |
$ |
(0.45 |
) |
|
$ |
(0.58 |
) |
|
$ |
(1.64 |
) |
|
$ |
(2.91 |
) |
Weighted-average common shares used to compute basic and
diluted net loss per share |
|
98,613,726 |
|
|
|
97,220,972 |
|
|
|
98,411,162 |
|
|
|
96,826,058 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Condensed Consolidated Balance
Sheets(in
thousands)(unaudited)
|
December 31, |
|
December 31, |
|
2023 |
|
2022 |
|
|
|
|
Assets |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
41,870 |
|
|
$ |
61,333 |
|
Accounts receivable |
|
1,826 |
|
|
|
38,480 |
|
Short-term investments |
|
273,305 |
|
|
|
374,894 |
|
Prepaid expenses and other current assets |
|
14,539 |
|
|
|
27,367 |
|
Total
current assets |
|
331,540 |
|
|
|
502,074 |
|
Long-term investments |
|
980 |
|
|
|
4,942 |
|
Operating lease right-of-use asset |
|
61,675 |
|
|
|
66,069 |
|
Other
long-term assets |
|
112,022 |
|
|
|
132,476 |
|
Total
assets |
$ |
506,217 |
|
|
$ |
705,561 |
|
|
|
|
|
Liabilities and stockholders’ equity |
|
|
|
Current liabilities: |
|
|
|
Accounts payable and accrued expenses |
$ |
32,233 |
|
|
$ |
62,197 |
|
Deferred revenue |
|
685 |
|
|
|
42,226 |
|
CIRM award liability |
|
— |
|
|
|
4,000 |
|
Operating lease liability, current portion |
|
6,176 |
|
|
|
5,628 |
|
Total
current liabilities |
|
39,094 |
|
|
|
114,051 |
|
Operating lease liability, net of current portion |
|
97,360 |
|
|
|
103,710 |
|
Stock
price appreciation milestones |
|
1,346 |
|
|
|
3,861 |
|
Stockholders’ equity |
|
368,417 |
|
|
|
483,939 |
|
Total
liabilities and stockholders’ equity |
$ |
506,217 |
|
|
$ |
705,561 |
|
|
|
|
|
Contact:Christina TartagliaStern Investor
Relations, Inc.212.362.1200christina.tartaglia@sternir.com
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