Fate Therapeutics Reports Fourth Quarter 2016 Financial Results
March 16 2017 - 4:01PM
First Subject Treated with ProTmune™ for GvHD
Prevention
Fate Therapeutics, Inc. (NASDAQ:FATE), a clinical-stage
biopharmaceutical company dedicated to the development of
programmed cellular immunotherapies for cancer and immune
disorders, today reported business highlights and financial results
for the fourth quarter and year ended December 31, 2016.
“The past twelve months has been a period of significant
progress for Fate Therapeutics, including advancing two
first-in-class product candidates to clinical development and
launching our revolutionary induced pluripotent cell platform to
enable our ‘one cell, many patients’ approach to cancer
immunotherapy. We have recently treated the first subject in our
PROTECT study with ProTmune, our next-generation mobilized
peripheral blood graft with the potential to change the field of
allogeneic hematopoietic cell transplantation, and FDA clearance
was granted for clinical investigation of FATE-NK100, our
first-in-class adaptive memory natural killer cell product
candidate. Additionally, we established collaborations with Dr.
Jeffrey S. Miller at the University of Minnesota and Dr. Michel
Sadelain at Memorial Sloan Kettering Cancer Center to build our
off-the-shelf cancer immunotherapy pipeline using master
pluripotent cell lines,” said Scott Wolchko, President and Chief
Executive Officer of Fate Therapeutics. “Looking ahead to a
data-rich 2017, having recently raised approximately $70 million
from a leading investor syndicate, we are in a position of
financial strength and are poised to be the first company to
advance a cancer immunotherapy created from a master pluripotent
cell line toward clinical development.”
Recent Highlights & Program
Updates
- First Subject Treated with ProTmune™ for GvHD
Prevention. The Company’s Phase 1/2 PROTECT study of
ProTmune for the prevention of acute graft-versus-host disease
(GvHD) has treated its first subject and is open across ten U.S.
centers. The Phase 1 stage of the clinical study is expected to
enroll up to ten adult subjects with hematologic malignancies
undergoing allogeneic mobilized peripheral blood hematopoietic cell
transplantation. ProTmune has been granted Fast Track and Orphan
Drug Designations by the U.S. Food and Drug Administration (FDA)
and Orphan Medicinal Product Designation by the European Medicines
Agency.
- IND Cleared by FDA for FATE-NK100 in AML.
Enrollment of a first-in-human clinical trial of FATE-NK100 under
an investigator-initiated clinical trial is poised to commence at
the Masonic Cancer Center, University of Minnesota (UMN). In
February 2017, the FDA cleared the Investigational New Drug (IND)
application of FATE-NK100 for the treatment of refractory or
relapsed acute myelogenous leukemia (AML). An oral presentation at
the 58th American Society of Hematology Annual Meeting and
Exposition in December 2016 featured FATE-NK100 preclinical data.
The natural killer (NK) cell product candidate demonstrated
enhanced anti-tumor activity across a broad range of liquid and
solid tumors, improved persistence and increased resistance to
immune checkpoint pathways as compared to current conventional NK
cell therapies.
- Expanded Collaboration with UMN to Advance hnCD16-iNK
Cell Product Candidate. In February 2017, Fate
Therapeutics and UMN expanded their collaboration, initiating the
clinical translation of a first-of-kind product candidate, an
off-the-shelf cellular immunotherapy created from an induced
pluripotent stem cell (iPSC) line for the treatment of cancer.
Similar to the manufacture of therapeutic antibodies using master
cell lines, the Company’s targeted NK cell product candidate is
created from a master iPSC line engineered to express a proprietary
high-affinity, non-cleavable CD16 (hnCD16) receptor. Preclinical
data, which the Company plans to present at the upcoming 2017
Annual Meeting of the American Association for Cancer Research,
demonstrates the potential of its hnCD16-iNK cell product candidate
to complement standard-of-care monoclonal antibody therapy for the
treatment of breast, head and neck, colorectal and certain blood
cancers by binding to and selectively killing antibody-coated tumor
cells.
- Launched iPSC-derived NK Cell Research Collaboration
with Oslo University Hospital. In February 2017, Fate
Therapeutics formed a two-year research collaboration with Oslo
University Hospital to develop NK cell product candidates
expressing certain activating and targeting receptors using master
pluripotent cell lines. The collaboration is being led by
Karl-Johan Malmberg, M.D., Ph.D., Group Leader of Natural Killer
Cell Biology and Cell Therapy, Department of Immunology, who has
extensively studied the human NK cell repertoire, including the
influence of killer cell immunoglobulin-like receptors, in
regulating anti-tumor activity.
- Bolstered NK Cell Product and iPSC Platform
Intellectual Property. In December 2016, the Company
exclusively licensed intellectual property from UMN covering
compositions of a modified CD16, as well as certain chimeric
antigen, receptors and immune cells expressing such receptors. In
addition, in March 2017, the U.S. Patent and Trademark Office
issued U.S. Patent No. 9,593,311, which is owned by the Whitehead
Institute for Biomedical Research and licensed exclusively to the
Company for all therapeutic purposes, protecting cellular
compositions comprising an iPSC and a WNT pathway activator.
Publications in the pluripotent cell biology field have shown that
WNT pathway activation is required to enable single cell isolation
and clonal expansion of iPSCs, which are critical steps in
generating, engineering and maintaining master pluripotent cell
lines.
- Completed $56.7M Common and Preferred Stock Private
Placement. In November 2016, Fate Therapeutics issued 2.82
million shares of non-voting Class A Preferred Stock at $13.30 per
share, each of which is convertible into five shares of common
stock upon certain conditions, and 7.24 million shares of common
stock at $2.66 per share. The sale and issuance was pursuant to a
securities purchase agreement with certain institutional and
accredited investors including Redmile Group LLC, BVF Partners
L.P., EcoR1 Capital LLC, Franklin Advisers, Inc. and certain
members of the Company’s Board of Directors and management.
Fourth Quarter 2016 Financial
Results
- Cash & Short-term Investment Position:
Cash, cash equivalents and short-term investments as of December
31, 2016 were $92.1 million compared to $64.8 million as of
December 31, 2015. The increase was primarily driven by net
proceeds from the sale of the Company’s securities in two private
issuances, a $56.7 million sale and issuance of preferred and
common stock in November 2016 and a $10.2 million sale and issuance
of common stock in August 2016. These proceeds were offset by the
Company’s use of cash to fund operating activities and to service
principal and interest obligations under its loan agreement with
Silicon Valley Bank.
- Total Revenue: Revenue was $1.0 million for
the fourth quarter of 2016 compared to $1.1 million for the
comparable period in 2015. All revenue was derived from the
Company’s research collaboration and license agreement with Juno
Therapeutics.
- Total Operating Expenses: Total operating
expenses were $8.7 million for the fourth quarter of 2016 compared
to $8.0 million for the comparable period in 2015. Operating
expenses for the fourth quarter of 2016 included $0.8 million of
stock compensation expense, compared to $0.5 million for the
comparable period in 2015.
- R&D Expenses: Research and development
expenses were $6.2 million for the fourth quarter of 2016 compared
to $5.4 million for the comparable period in 2015. The increase in
R&D expenses was primarily related to an increase in
third-party service provider fees to support the Company’s clinical
development of ProTmune and the preclinical development of its NK
cell programs.
- G&A Expenses: General and administrative
expenses were $2.5 million for the fourth quarter of 2016 compared
to $2.6 million for the comparable period in 2015. The decrease in
G&A expenses was primarily related to a decrease in
intellectual property-related expenses.
- Common Shares Outstanding: Common shares
outstanding as of December 31, 2016 were 41.4 million compared to
28.7 million as of December 31, 2015. Common shares outstanding
increased primarily as a result of the Company’s sale and issuance
of its securities in two private issuances in November and August
2016, respectively.
- Preferred Shares Outstanding: Preferred shares
outstanding as of December 31, 2016 were 2.82 million. Preferred
shares outstanding increased as a result of the Company’s sale and
issuance of 2.82 million shares of non-voting Class A convertible
preferred stock to Redmile Group, LLC in November 2016.
Today's Conference Call and Webcast
The Company will conduct a conference call today,
Thursday, March 16, 2017 at 5:00 p.m. ET to review financial and
operating results for the quarter ended December 31, 2016. In order
to participate in the conference call, please dial 1-877-303-6235
(domestic) or 1-631-291-4837 (international) and refer to
conference ID 85799370. The live webcast can be accessed under
"Events & Presentations" in the Investors & Media 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, Inc.
Fate Therapeutics is a clinical-stage
biopharmaceutical company dedicated to the development of
programmed cellular immunotherapies for cancer and immune
disorders. The Company’s hematopoietic cell therapy pipeline is
comprised of NK- and T-cell immuno-oncology programs, including
off-the-shelf product candidates derived from engineered induced
pluripotent cells, and immuno-regulatory programs, including
product candidates to prevent life-threatening complications in
patients undergoing hematopoietic cell transplantation and to
promote immune tolerance in patients with autoimmune disease. Its
adoptive cell therapy programs are based on the Company’s novel ex
vivo cell programming approach, which it applies to modulate the
therapeutic function and direct the fate of immune cells. Fate
Therapeutics is headquartered in San Diego, CA. For more
information, please visit www.fatetherapeutics.com.
Forward-Looking Statements
This release contains "forward-looking statements"
within the meaning of the Private Securities Litigation Reform Act
of 1995, including statements regarding the Company’s advancement
of and plans related to the Company’s product candidates, clinical
studies, research and development programs, and partnerships, the
Company’s progress and plans for its clinical investigation of
ProTmune™ and of FATE-NK100, the Company’s expected product
registration strategy for ProTmune, including its ability to pursue
accelerated registration, the ability of ProTmune to prevent, or
reduce the incidence or severity of life-threatening complications,
including acute graft-versus-host disease and severe viral
infections, the scope of the Company’s intellectual property, and
the Company’s projected cash expenditures. 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
results observed in prior studies, including preclinical studies of
ProTmune and the Company’s other product candidates, will not be
observed in ongoing or future studies involving these product
candidates, the risk that the Company may cease or delay
preclinical or clinical development activities for any of its
existing or future product candidates for a variety of reasons
(including requirements that may be imposed by regulatory
authorities and requirements for regulatory approval, difficulties
or delays in patient enrollment in current and planned clinical
trials, and any adverse events or other negative results that may
be observed during preclinical or clinical development), the risk
that the Company’s research collaborations may not be successful or
may be terminated, and the risk that the Company’s expenditures may
exceed current expectations for a variety of reasons. For a
discussion of other risks and uncertainties, and other important
factors, any of which could cause our 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 the Company’s 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.
Availability of Other Information about Fate
Therapeutics, Inc.
Investors and others should note that the Company
routinely communicates with investors and the public using its
website (www.fatetherapeutics.com) and its investor relations
website (ir.fatetherapeutics.com), including without limitation,
through the posting of investor presentations, SEC filings, press
releases, public conference calls and webcasts on these websites.
The information posted on these websites could be deemed to be
material information. As a result, investors, the media, and others
interested in Fate Therapeutics are encouraged to review this
information on a regular basis. The contents of the Company’s
website, or any other website that may be accessed from the
Company’s website, shall not be deemed incorporated by reference in
any filing under the Securities Act of 1933, as amended.
|
|
Condensed Consolidated Statements of
Operations and Comprehensive Loss |
|
(in thousands, except share and per share
data) |
|
|
|
|
|
Three Months EndedDecember
31, |
|
|
Years EndedDecember
31, |
|
|
|
2016 |
|
|
2015 |
|
|
2016 |
|
|
2015 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(unaudited) |
|
Collaboration revenue |
|
$ |
1,027 |
|
|
$ |
1,076 |
|
|
$ |
4,402 |
|
|
$ |
2,431 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development |
|
|
6,230 |
|
|
|
5,433 |
|
|
|
26,452 |
|
|
|
19,861 |
|
General
and administrative |
|
|
2,451 |
|
|
|
2,555 |
|
|
|
9,913 |
|
|
|
10,352 |
|
Total
operating expenses |
|
|
8,681 |
|
|
|
7,988 |
|
|
|
36,365 |
|
|
|
30,212 |
|
Loss
from operations |
|
|
(7,654 |
) |
|
|
(6,912 |
) |
|
|
(31,963 |
) |
|
|
(27,782 |
) |
Other
income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
income |
|
|
43 |
|
|
|
3 |
|
|
|
138 |
|
|
|
10 |
|
Interest
expense |
|
|
(329 |
) |
|
|
(537 |
) |
|
|
(1,637 |
) |
|
|
(2,220 |
) |
Total
other expense, net |
|
|
(286 |
) |
|
|
(534 |
) |
|
|
(1,499 |
) |
|
|
(2,210 |
) |
Net
loss |
|
$ |
(7,940 |
) |
|
$ |
(7,446 |
) |
|
$ |
(33,462 |
) |
|
$ |
(29,992 |
) |
Other
comprehensive loss: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized loss on available-for-sale securities, net |
|
|
(4 |
) |
|
|
— |
|
|
|
(1 |
) |
|
|
— |
|
Comprehensive loss |
|
$ |
(7,944 |
) |
|
$ |
(7,446 |
) |
|
$ |
(33,463 |
) |
|
$ |
(29,992 |
) |
Net loss
per common share, basic and diluted |
|
$ |
(0.21 |
) |
|
$ |
(0.26 |
) |
|
$ |
(1.05 |
) |
|
$ |
(1.18 |
) |
Weighted-average common shares used to compute basic and diluted
net loss per share |
|
|
37,216,488 |
|
|
|
28,687,797 |
|
|
|
31,754,140 |
|
|
|
25,484,262 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Condensed Consolidated Balance
Sheets |
|
(in thousands) |
|
|
|
|
|
December
31, |
|
|
December
31, |
|
|
|
2016 |
|
|
2015 |
|
|
|
|
(unaudited) |
|
|
|
|
|
Assets |
|
|
|
|
|
|
|
|
Current
assets: |
|
|
|
|
|
|
|
|
Cash and
cash equivalents |
|
$ |
88,609 |
|
|
$ |
64,809 |
|
Short-term investments |
|
|
3,503 |
|
|
|
— |
|
Prepaid
expenses and other current assets |
|
|
1,211 |
|
|
|
843 |
|
Total
current assets |
|
|
93,323 |
|
|
|
65,652 |
|
Long-term assets |
|
|
1,725 |
|
|
|
2,306 |
|
Total
assets |
|
$ |
95,048 |
|
|
$ |
67,958 |
|
|
|
|
|
|
|
|
|
|
Liabilities and stockholders’ equity |
|
|
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
|
|
Accounts
payable and accrued expenses |
|
$ |
4,891 |
|
|
$ |
3,435 |
|
Long-term
debt, current portion |
|
|
8,187 |
|
|
|
7,550 |
|
Current
portion of deferred revenue |
|
|
2,105 |
|
|
|
2,401 |
|
Other
current liabilities |
|
|
4 |
|
|
|
55 |
|
Total
current liabilities |
|
|
15,187 |
|
|
|
13,441 |
|
Long-term debt, net of current portion |
|
|
2,501 |
|
|
|
10,688 |
|
Deferred
revenue |
|
|
2,829 |
|
|
|
4,934 |
|
Other
long-term liabilities |
|
|
1,377 |
|
|
|
857 |
|
Stockholders’ equity |
|
|
73,154 |
|
|
|
38,038 |
|
Total
liabilities and stockholders’ equity |
|
$ |
95,048 |
|
|
$ |
67,958 |
|
|
|
|
|
|
|
|
|
|
Contact:
Christina Tartaglia
Stern Investor Relations, Inc.
212.362.1200
christina@sternir.com
Fate Therapeutics (NASDAQ:FATE)
Historical Stock Chart
From Mar 2024 to Apr 2024
Fate Therapeutics (NASDAQ:FATE)
Historical Stock Chart
From Apr 2023 to Apr 2024