Fate Therapeutics Reports Third Quarter 2023 Financial Results and Business Updates
09 November 2023 - 8:01AM
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
third quarter ended September 30, 2023.
“We achieved several key milestones for our iPSC product
platform in oncology and autoimmunity, creating additional
opportunities to generate new clinical data across multiple
programs during 2024,” said Scott Wolchko, President and Chief
Executive Officer of Fate Therapeutics. “We have initiated patient
enrollment in our Phase 1 study of FT522, our ADR-armed,
CD19-targeted CAR NK cell program, where we intend to assess FT522
with and without conditioning chemotherapy in patients with B-cell
lymphoma. In addition, our IND application was cleared by the FDA
for FT825/ONO-8250 in solid tumors under our collaboration with ONO
Pharmaceutical, which multiplexed-engineered CAR T-cell program
incorporates seven synthetic controls of cell function including a
novel cancer-specific binding domain targeting HER2. Finally, I am
pleased to announce the expansion of our iPSC product platform into
autoimmunity with the clearance by the FDA of our IND application
for FT819, our off-the-shelf, CD19-targeted CAR T-cell program, in
systemic lupus erythematosus.”
FT522 iPSC-derived CAR NK Cell Program in B-cell
Lymphoma
- Phase 1 Study of ADR-armed,
CD19-targeted CAR NK Cell Program Open for Enrollment.
FT522 is the Company’s off-the-shelf, multiplexed-engineered
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 expressed on alloreactive
immune cells. In preclinical studies, engagement of ADR-armed CAR
NK cells with alloreactive immune cells mitigated rejection,
promoted cellular proliferation, and increased anti-tumor activity,
indicating that ADR-armed CAR NK cells may be effective without
requiring administration of intensive conditioning chemotherapy to
patients. The Phase 1 study of FT522 in combination with rituximab
for relapsed / refractory B-cell lymphoma (BCL) is designed to
assess safety, pharmacokinetics, and activity with and without
administration of a standard three-day preconditioning regimen to
patients. Enrollment into the first three-dose cohort at 300
million cells per dose has been initiated. The Company is also
assessing in preclinical studies the potential of FT522 to induce
benefit across a range of autoimmune diseases.
FT825/ONO-8250 iPSC-derived CAR T-cell Program in Solid
Tumors
- IND Application Cleared by FDA
for Multiplexed-engineered, CAR T-cell Program Incorporating Seven
Novel Synthetic Controls of Cell Function. 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 a novel cancer-specific
H2CasMab-2 CAR targeting HER2 and is designed to overcome unique
challenges in treating solid tumors. The Company’s Investigational
New Drug (IND) application for FT825/ONO-8250 was cleared by the
U.S. Food and Drug Administration (FDA) in October for conduct of a
Phase 1 study in patients with advanced solid tumors. The
dose-escalation schema includes two treatment regimens: single-dose
FT825/ONO-8250 as monotherapy; and FT825/ONO-8250 in combination
with cetuximab. Novel synthetic controls incorporated into the
multiplexed-engineered CAR T-cell product candidate include a CXCR2
receptor to promote cell trafficking, a chimeric TGFβ receptor to
redirect immunosuppressive signals in the tumor microenvironment,
and a high-affinity, non-cleavable CD16a receptor to promote
antibody-dependent cellular cytotoxicity. Preclinical data of
FT825/ONO-8250, which was presented at the 2023 Society for
Immunotherapy of Cancer (SITC) Annual Meeting, demonstrated that
the antigen binding profile of H2CasMab-2 is unique and
differentiated from that of trastuzumab, exhibiting similar potency
with greater specificity for malignant HER2-expressing cells.
FT819 iPSC-derived CAR T-cell Program in Systemic Lupus
Erythematosus and B-cell Malignancies
- Expansion into Autoimmunity
with Phase 1 Study Start-up Ongoing in SLE. In July, the
Company’s IND application was cleared by the FDA for clinical
investigation of FT819 in patients with systemic lupus
erythematosus (SLE), including those with active lupus nephritis
(LN) or active SLE without renal involvement. FT819 is the
Company’s off-the-shelf, iPSC-derived CAR T-cell product candidate
that 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 clinical trial
is designed to evaluate the safety, pharmacokinetics, anti-B-cell
activity of a single dose of FT819 administered following a
standard three-day preconditioning regimen. The FT819 Phase 1
protocol received a favorable review by clinical experts of the
Protocol Design Committee of Lupus Therapeutics, an affiliate of
the Lupus Research Alliance.
- Phase 1 Study 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. The Company is
currently enrolling patients in single-dose treatment cohorts at
540 million cells in BCL and at 360 million cells in chronic
lymphocytic leukemia using a standard three-day preconditioning
regimen. Clinical data previously presented by the Company from the
first 11 patients with relapsed / refractory BCL 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
immune effector-cell associated neurotoxicity syndrome (ICANS) and
mild cytokine release syndrome (CRS).
FT576 iPSC-derived CAR NK Cell Program in Multiple
Myeloma
- Phase 1 Study Accruing Patients
in Three-dose Treatment Cohorts. The Company’s Phase 1
study of FT576, its multiplexed-engineered BCMA-targeted 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 three
patients as monotherapy as well as two patients in combination with
CD38-targeted monoclonal antibody therapy to assess the therapeutic
potential of dual-antigen targeting of myeloma cells, with no
dose-limiting toxicities reported by investigators in either
cohort.
Third Quarter 2023 Financial Results
- Cash & Investment
Position: Cash, cash equivalents and investments as of
September 30, 2023 were $349.7 million. In addition, as of
September 30, 2023, cash receivables from the Company’s
collaboration with ONO were $1.5 million.
- Total Revenue: Revenue
was $1.9 million for the third 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 third quarter of 2023, GAAP operating
expenses were $53.2 million, including research and development
expenses of $34.3 million and general and administrative expenses
of $18.9 million. Such amounts included $10.1 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 September 30, 2023. Each
preferred share is convertible into five common shares.
Today's Conference Call and WebcastThe Company
will conduct a conference call today, Wednesday, November 8, 2023
at 5:00 p.m. ET to review financial and operating results for the
quarter ended September 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 research and development programs and product candidates,
the Company’s clinical and product development strategy, the
Company’s expectations regarding progress and timelines, and the
objectives, plans and goals of 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 research and development programs and
product candidates 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, 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 |
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
|
|
|
|
|
|
|
Collaboration revenue |
|
$ |
1,944 |
|
|
$ |
14,981 |
|
|
$ |
61,857 |
|
|
$ |
51,944 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
34,275 |
|
|
|
79,817 |
|
|
|
140,780 |
|
|
|
233,263 |
|
General and administrative |
|
|
18,948 |
|
|
|
21,555 |
|
|
|
63,513 |
|
|
|
62,648 |
|
Total operating expenses |
|
|
53,223 |
|
|
|
101,372 |
|
|
|
204,293 |
|
|
|
295,911 |
|
Loss from operations |
|
|
(51,279 |
) |
|
|
(86,391 |
) |
|
|
(142,436 |
) |
|
|
(243,967 |
) |
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
4,697 |
|
|
|
1,787 |
|
|
|
12,772 |
|
|
|
2,962 |
|
Change in fair value of stock price appreciation milestones |
|
|
1,049 |
|
|
|
891 |
|
|
|
3,160 |
|
|
|
15,131 |
|
Other Income |
|
|
363 |
|
|
|
150 |
|
|
|
9,698 |
|
|
|
516 |
|
Total other income (expense),
net |
|
|
6,109 |
|
|
|
2,828 |
|
|
|
25,630 |
|
|
|
18,609 |
|
Net loss |
|
$ |
(45,170 |
) |
|
$ |
(83,563 |
) |
|
$ |
(116,806 |
) |
|
$ |
(225,358 |
) |
Other comprehensive income
(loss): |
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gain (loss) on available-for-sale securities, net |
|
|
88 |
|
|
|
128 |
|
|
|
1,355 |
|
|
|
(2,491 |
) |
Comprehensive loss |
|
$ |
(45,082 |
) |
|
$ |
(83,435 |
) |
|
$ |
(115,451 |
) |
|
$ |
(227,849 |
) |
Net loss per common share,
basic and diluted |
|
$ |
(0.46 |
) |
|
$ |
(0.86 |
) |
|
$ |
(1.19 |
) |
|
$ |
(2.33 |
) |
Weighted–average common shares
used to compute basic and diluted net loss per share |
|
|
98,568,012 |
|
|
|
97,023,506 |
|
|
|
98,342,898 |
|
|
|
96,692,974 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Condensed Consolidated Balance Sheets(in
thousands)(unaudited) |
|
|
|
|
|
|
|
|
|
September 30, |
|
|
December 31, |
|
|
|
2023 |
|
|
2022 |
|
|
|
|
|
|
|
|
Assets |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
33,334 |
|
|
$ |
61,333 |
|
Accounts receivable |
|
|
1,538 |
|
|
|
38,480 |
|
Short-term investments |
|
|
316,400 |
|
|
|
374,894 |
|
Prepaid expenses and other current assets |
|
|
12,902 |
|
|
|
27,367 |
|
Total current assets |
|
|
364,174 |
|
|
|
502,074 |
|
Long-term investments |
|
|
— |
|
|
|
4,942 |
|
Operating lease right-of-use
asset |
|
|
62,721 |
|
|
|
66,069 |
|
Other long-term assets |
|
|
116,893 |
|
|
|
132,476 |
|
Total assets |
|
$ |
543,788 |
|
|
$ |
705,561 |
|
|
|
|
|
|
|
|
Liabilities and
stockholders’ equity |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable and accrued expenses |
|
$ |
34,246 |
|
|
$ |
62,197 |
|
Deferred revenue, current portion |
|
|
1,110 |
|
|
|
42,226 |
|
CIRM award liability, current portion |
|
|
— |
|
|
|
4,000 |
|
Operating lease liability, current portion |
|
|
5,977 |
|
|
|
5,628 |
|
Total current liabilities |
|
|
41,333 |
|
|
|
114,051 |
|
Operating lease liability, net
of current portion |
|
|
98,977 |
|
|
|
103,710 |
|
Stock price appreciation
milestones, net of current portion |
|
|
701 |
|
|
|
3,861 |
|
Stockholders’ equity |
|
|
402,777 |
|
|
|
483,939 |
|
Total liabilities and
stockholders’ equity |
|
$ |
543,788 |
|
|
$ |
705,561 |
|
|
|
|
|
|
|
|
Contact:Christina TartagliaStern Investor
Relations, Inc.212.362.1200christina.tartaglia@sternir.com
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