Fate Therapeutics Reports Second Quarter 2024 Financial Results and Business Updates
August 13 2024 - 4:05PM
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 diseases,
today reported business highlights and financial results for the
second quarter ended June 30, 2024.
“We are pleased with the initial clinical and translational
observations from our three ongoing Phase 1 studies and look
forward to sharing data from each program in the second half of
2024,” said Scott Wolchko, President and Chief Executive Officer of
Fate Therapeutics. “We remain keenly focused on achieving
therapeutic differentiation in autoimmunity with our off-the-shelf
FT819 CAR T-cell and FT522 CAR NK cell product candidates. Our
ongoing FT819 study for systemic lupus erythematosus now includes
single-agent cyclophosphamide as an alternative conditioning
regimen for patients, and we are working to expand clinical
investigation of FT819 to treat additional B cell-mediated
diseases. We are also finalizing our FT522 IND submission for the
treatment of a basket of autoimmune diseases without administration
of conditioning chemotherapy to patients, having now treated the
first patient without conditioning chemotherapy in our ongoing
FT522 study for B cell lymphoma. In addition, under our solid tumor
collaboration with Ono Pharmaceutical, we have now treated the
first three patients as monotherapy with our multiplexed-engineered
FT825 CAR T-cell collaboration candidate, and we are poised to
initiate dosing in combination with monoclonal antibody therapy to
explore the potential of dual-antigen targeting in advanced solid
tumors.”
FT819 iPSC-derived 1XX CAR T-cell Program
- Enrollment Ongoing in FT819 Phase 1 Autoimmunity
Study. The multi-center, Phase 1 clinical trial for
patients with systemic lupus erythematosus (SLE) is designed to
evaluate the safety, pharmacokinetics, and anti-B cell activity of
FT819, the Company’s off-the-shelf CD8αβ+ T-cell product candidate
that incorporates a CD19-targeted chimeric antigen receptor (CAR)
with a novel 1XX costimulatory domain into the T-cell receptor
alpha constant (TRAC) locus (NCT06308978). The first patient
treated in the study, a 27 year-old woman diagnosed with lupus
nephritis over ten years ago who has refractory disease despite
having been treated with multiple standard-of-care therapies,
received conditioning chemotherapy followed by a single dose of
FT819 at 360 million cells. The patient remains on-study, and there
have been no Grade ≥3 adverse events and no events of any grade of
cytokine release syndrome (CRS), immune effector-cell associated
neurotoxicity syndrome (ICANS), or graft-versus-host disease
(GvHD). The Company plans to present clinical and translational
data from the Phase 1 study at a medical conference in the second
half of 2024.
- Single-agent Cyclophosphamide Included as Alternative
Conditioning Regimen. In addition to conditioning of
patients with either cyclophosphamide and fludarabine (Cy / Flu) or
bendamustine, the Company amended the clinical protocol of its
FT819 Phase 1 autoimmunity study to include single-agent
cyclophosphamide (Cy) as a third conditioning regimen. Cy is a
commonly-used agent with an established safety profile for the
treatment of patients with B cell-mediated autoimmune
diseases.
- Favorable Safety Profile and Proof-of-Concept for
Autoimmune Disease Established in FT819 Phase 1 BCM
Study. At the American Society of Gene and Cell
Therapy (ASGCT) 27th Annual Meeting in May, the Company presented
clinical and translational data from its FT819 Phase 1 study in
relapsed / refractory B cell malignancies (BCM) (NCT04629729). 43
heavily pre-treated patients were treated with conditioning
chemotherapy and a single dose of FT819 across five dose levels.
The safety and tolerability profile of FT819 was favorable, with no
dose-limiting toxicities, no events of any grade of ICANS or GvHD,
and low incidence (14%) of low-grade CRS. In addition, a single
dose of FT819 exhibited multiple mechanisms implicated in
generating an immune reset in patients with B cell-mediated
autoimmune diseases, including rapid, deep, and sustained CD19+
B-cell depletion in the periphery throughout the one-month
treatment cycle as well as primary, secondary, and tertiary tissue
trafficking, infiltration, and activity with CD19+ B cell
elimination in tissue. The Company successfully completed dose
escalation in its FT819 Phase 1 BCM study, and has focused further
clinical development of FT819 exclusively in autoimmunity.
FT825 / ONO-8250 iPSC-derived CAR T-cell
Program
- Enrollment Ongoing in Phase 1 Study with
HER2-targeted CAR T-cell for Advanced Solid
Tumors. Under its collaboration with Ono
Pharmaceutical Co., Ltd. (Ono), the Company is conducting a
multi-center, Phase 1 study to assess the safety, pharmacokinetics,
and activity of FT825 / ONO-8250 as monotherapy and in combination
with monoclonal antibody therapy in patients with advanced solid
tumors (NCT06241456). 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,
which has exhibited similar potency with greater specificity for
cancer cells expressing HER2 compared to trastuzumab in preclinical
studies. Three patients have been treated in the Phase 1 study with
a single dose of FT825 / ONO-8250 as monotherapy at the first dose
level of 100 million cells and, during the third quarter of 2024,
the Company plans to initiate enrollment as monotherapy at the
second dose level of 300 million cells and in combination with
epidermal growth factor receptor (EGFR)-targeted monoclonal
antibody therapy at the first dose level of 100 million cells. The
Company plans to present clinical and translational data from the
Phase 1 study at a medical conference in the second half of
2024.
FT522 iPSC-derived CAR NK Cell Program
- First Patient Treated without Conditioning in Phase 1
BCL Study. FT522 is the Company’s off-the-shelf,
CD19-targeted CAR NK cell product candidate and its first to
incorporate Alloimmune Defense Receptor (ADR) technology, which is
designed to reduce or eliminate the need for administration of
conditioning chemotherapy to patients receiving cell therapies. In
its ongoing multi-center, Phase 1 clinical trial of FT522 in
patients with relapsed / refractory B-cell lymphoma (BCL)
(NCT05950334), the first patient has now been treated in the first
three-dose cohort at 300 million cells per dose without
conditioning chemotherapy (Regimen B). In addition, the first
patient has now been treated in the second three-dose cohort at 900
million cells per dose with conditioning chemotherapy (Regimen A).
No dose-limiting toxicities and no events of any grade of CRS,
ICANS, or GvHD, have been reported in the Phase 1 study. The
Company plans to present clinical and translational data from the
Phase 1 study at a medical conference in the second half of
2024.
- IND Application for Phase 1 Basket Study in
Autoimmunity to be Submitted in 3Q24. The Company
intends to submit an Investigational New Drug (IND) application to
the U.S. Food and Drug Administration (FDA) in the third quarter of
2024 for the treatment of a basket of B cell-mediated autoimmune
diseases with FT522, including without administration of
conditioning chemotherapy to patients. At the ASGCT conference, the
Company presented preclinical data from a novel re-challenge assay
using peripheral blood mononuclear cells (PBMCs) from unmatched SLE
donors, showing that FT522 uniquely drove rapid and deep CD19+ B
cell depletion, eliminated alloreactive T cells, and maintained
functional persistence, indicating that FT522 can function
effectively in the presence of an unmatched host immune system. The
Company also shared initial clinical observations from the first
two patients treated with FT522 at 100 million cells per dose in
Regimen A of its ongoing Phase 1 BCL study, which showed rapid,
deep, and sustained B-cell depletion in the periphery throughout
the one-month treatment cycle. In addition, both patients showed
enhanced persistence of FT522 in the periphery compared to clinical
data observed with FT596, a prior-generation CD19-targeted CAR NK
cell without ADR technology.
Second Quarter 2024 Financial Results
- Cash & Investment Position: Cash, cash
equivalents and investments as of June 30, 2024 were $352.0
million.
- Total Revenue: Revenue was $6.8 million for
the second quarter of 2024, which was derived from the achievement
of a $5 million milestone in connection with the clinical
development of FT825 / ONO-8250 and the 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 2024, GAAP operating expenses were $51.9 million,
including research and development expenses of $34.6 million and
general and administrative expenses of $17.3 million. Such amounts
included $9.6 million of non-cash stock-based compensation
expense.
- Shares Outstanding: Common shares outstanding
were 113.8 million, pre-funded warrants outstanding were 3.9
million, and preferred shares outstanding were 2.8 million, as of
June 30, 2024. Each preferred share is convertible into five common
shares.
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 diseases. 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 Company’s plans to
submit additional IND applications for its product candidates and
the timing thereof, 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, 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, |
|
| |
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
| |
|
|
|
|
|
| Collaboration
revenue |
$ |
6,772 |
|
|
$ |
933 |
|
|
$ |
8,697 |
|
|
$ |
59,913 |
|
| Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
34,604 |
|
|
|
40,876 |
|
|
|
66,742 |
|
|
|
106,505 |
|
|
General and administrative |
|
17,251 |
|
|
|
22,622 |
|
|
|
38,106 |
|
|
|
44,565 |
|
| Total operating expenses |
|
51,855 |
|
|
|
63,498 |
|
|
|
104,848 |
|
|
|
151,070 |
|
| Loss from operations |
|
(45,083 |
) |
|
|
(62,565 |
) |
|
|
(96,151 |
) |
|
|
(91,157 |
) |
| Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
4,827 |
|
|
|
4,381 |
|
|
|
8,976 |
|
|
|
8,075 |
|
|
Change in fair value of stock price appreciation milestones |
|
1,556 |
|
|
|
393 |
|
|
|
162 |
|
|
|
2,111 |
|
|
Other Income |
|
273 |
|
|
|
5,036 |
|
|
|
582 |
|
|
|
9,335 |
|
| Total other income (expense), net |
|
6,656 |
|
|
|
9,810 |
|
|
|
9,720 |
|
|
|
19,521 |
|
| Net loss |
$ |
(38,427 |
) |
|
$ |
(52,755 |
) |
|
$ |
(86,431 |
) |
|
$ |
(71,636 |
) |
| Other comprehensive income (loss): |
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized (loss) gain on available-for-sale securities, net |
|
(228 |
) |
|
|
59 |
|
|
|
(437 |
) |
|
|
1,267 |
|
| Comprehensive loss |
$ |
(38,655 |
) |
|
$ |
(52,696 |
) |
|
$ |
(86,868 |
) |
|
$ |
(70,369 |
) |
| Net loss per common share, basic and diluted |
$ |
(0.33 |
) |
|
$ |
(0.54 |
) |
|
$ |
(0.79 |
) |
|
$ |
(0.73 |
) |
| Weighted–average common shares used to compute basic and
diluted net loss per share |
|
117,468,124 |
|
|
|
98,400,355 |
|
|
|
109,286,235 |
|
|
|
98,228,476 |
|
|
Condensed Consolidated Balance Sheets |
|
(in thousands) |
|
(unaudited) |
| |
| |
June
30, |
|
|
December 31, |
|
| |
2024 |
|
|
2023 |
|
| |
|
|
|
|
|
| Assets |
|
|
|
|
|
| Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
$ |
36,917 |
|
|
$ |
41,870 |
|
|
Accounts receivable |
|
1,048 |
|
|
|
1,826 |
|
|
Short-term investments |
|
267,962 |
|
|
|
273,305 |
|
|
Prepaid expenses and other current assets |
|
13,461 |
|
|
|
14,539 |
|
| Total current assets |
|
319,388 |
|
|
|
331,540 |
|
| Long-term investments |
|
47,162 |
|
|
|
980 |
|
| Operating lease right-of-use asset |
|
59,547 |
|
|
|
61,675 |
|
| Other long-term assets |
|
102,720 |
|
|
|
112,022 |
|
| Total assets |
$ |
528,817 |
|
|
$ |
506,217 |
|
| |
|
|
|
|
|
| Liabilities and stockholders’ equity |
|
|
|
|
|
| Current liabilities: |
|
|
|
|
|
|
Accounts payable and accrued expenses |
$ |
28,149 |
|
|
$ |
32,233 |
|
|
Deferred revenue |
|
--- |
|
|
|
685 |
|
|
Operating lease liability, current portion |
|
6,644 |
|
|
|
6,176 |
|
| Total current liabilities |
|
34,793 |
|
|
|
39,094 |
|
| CIRM award liability |
|
1,940 |
|
|
|
--- |
|
| Operating lease liability, net of current portion |
|
93,918 |
|
|
|
97,360 |
|
| Stock price appreciation milestones |
|
1,184 |
|
|
|
1,346 |
|
| Stockholders’ equity |
|
396,982 |
|
|
|
368,417 |
|
| Total liabilities and stockholders’ equity |
$ |
528,817 |
|
|
$ |
506,217 |
|
| |
|
|
|
|
|
Contact:Christina Tartaglia Precision AQ
212.362.1200 christina.tartaglia@precisionaq.com
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