Five Prime Therapeutics, Inc. (Nasdaq:FPRX), a clinical-stage
biotechnology company focused on discovering and developing
innovative immuno-oncology protein therapeutics, today provided a
corporate update and reported financial results for the fourth
quarter and full year ending December 31, 2016.
"2016 was a year of tremendous progress in Five
Prime’s clinical and preclinical pipeline,” said Lewis T. "Rusty"
Williams, M.D., Ph.D., president and chief executive officer of
Five Prime. "We advanced our three clinical-stage programs and look
forward to announcing data from each of these programs this year.
With a concerted focus on building out our pipeline, we also
unveiled three preclinical programs that we advanced into
IND-enabling activities. We are on track to meet our goal of filing
at least one IND application for a new molecule each year for the
foreseeable future, beginning this year.”
2016 Business Highlights and Recent
Developments
Clinical Pipeline:
- Cabiralizumab (FPA008): an investigational
antibody that inhibits CSF1R and has been shown to block the
activation and survival of monocytes and macrophages. In the
setting of advanced cancer, tumor-associated macrophages can
inhibit the immune system’s ability to eradicate the disease. In
pigmented villonodular synovitis (PVNS), a CSF-1-driven tumor, the
bulk of the tumor mass in joints is formed by the macrophages
themselves. Five Prime and Bristol-Myers Squibb (BMS) have an
exclusive worldwide collaboration agreement for the development and
commercialization of cabiralizumab for these and potentially
additional indications.
- Initiated Phase 1b portion of
cabiralizumab/OPDIVO trial. In October 2016, Five
Prime initiated the Phase 1b portion of the clinical trial
evaluating the immunotherapy combination of cabiralizumab with the
PD- 1 immune checkpoint inhibitor OPDIVO® (nivolumab) in multiple
tumor types. Five Prime and BMS are evaluating the safety,
tolerability and preliminary efficacy of the combination in
advanced solid tumors, including non-small cell lung cancer,
squamous cell carcinoma of the head and neck, pancreatic cancer,
glioblastoma, renal cell carcinoma and ovarian cancer. Five Prime
expects to complete enrollment in the current Phase 1b trial
cohorts in the second half of 2017.
- Advanced the Phase 2 trial of
cabiralizumab in patients with tenosynovial giant cell
tumor (TGCT), also known as pigmented villonodular synovitis
(PVNS). Five Prime expects to complete enrollment of the
Phase 2 trial of cabiralizumab in PVNS in the first half of 2017.
Five Prime is evaluating clinical measures, including response
rate, pain and range of motion in approximately 30 PVNS
patients.
- Five Prime plans to seek regulatory
guidance on a pivotal trial in diffuse PVNS.
- Five Prime plans to disclose clinical
data from the cabiralizumab PVNS trial at the
American Society of Clinical Oncology (ASCO) 2017 Annual
Meeting and from the cabiralizumab immuno-oncology trial in the
second half of 2017.
- FPA144: an isoform-selective antibody in
development as a targeted immuno-therapy for tumors that
overexpress FGFR2b, a splice variant of a receptor for some members
of the fibroblast growth factor (FGF) family. FPA144 has been
engineered for enhanced antibody-dependent cell-mediated
cytotoxicity (ADCC) to increase direct tumor cell killing by
recruiting natural killer (NK) cells. Five Prime retains global
development and commercialization rights to FPA144.
- Opened new gastric cancer cohorts and
added a bladder cancer cohort in Phase 1 monotherapy trial of
FPA144. Enrollment continues in the expansion portion of
the trial, evaluating the safety, PK and efficacy of biweekly 15
mg/kg infusions of FPA144 in patients with gastric cancer whose
tumors highly overexpress FGFR2b. During the third quarter of 2016,
Five Prime added cohorts to evaluate FPA144 in patients with
bladder cancer whose tumors overexpress FGFR2b and in patients with
gastric cancer whose tumors express moderate or low levels of
FGFR2b. Five Prime reported initial single-agent efficacy and
safety data at the ASCO 2016 Annual Meeting and at the ASCO 2016
Gastrointestinal Cancers Symposium.
- Five Prime plans to seek regulatory
guidance on a registrational path for FPA144 in combination with
chemotherapy as an early-line gastric cancer therapy.
- Five Prime plans to disclose updated
clinical data from the FPA144 program at the ASCO 2017 Annual
Meeting.
- FP-1039: a protein drug designed to block FGF
signaling. As a ligand trap, FP-1039 binds to and neutralizes a
subset of FGF ligands (such as FGF2), preventing these
growth-promoting and angiogenic proteins from reaching FGFR1 on the
surface of tumor cells.
- Five Prime plans to make decisions on potential
future development of FP-1039 in mesothelioma after data on
objective response rate, disease control rate and progression-free
survival are mature. Five Prime regained full rights to
FP-1039 from GlaxoSmithKline (GSK) in September 2016. GSK is
completing the ongoing Phase 1b trial combining FP-1039 with
1st-line pemetrexed and cisplatin in untreated, unresectable
mesothelioma. GSK concluded trial recruitment with 25 patients
enrolled at the 15 mg/kg dose in June 2016, and continues to dose
and follow patients.
- Five Prime plans to disclose clinical data from
this program at the European Society for Medical Oncology (ESMO)
2017 Congress.
Preclinical Research and Development:
- Five Prime unveiled three preclinical development
candidates in IND-enabling studies at its R&D Day in New York
City in December 2016.
- FPA150 (anti-B7-H4)
-- An antibody designed for two
mechanisms of action: to block an inhibitory T cell checkpoint
pathway and to enhance killing of B7-H4-expressing tumors by
ADCC. -- Investigational New Drug (IND)
application planned for the fourth quarter of 2017.
- FPA154 (GITR agonist antibody)
-- A tetravalent agonist antibody
designed for greater GITR activation versus conventional
antibodies. Conventional GITR agonist antibodies have two GITR
binding sites while FPA154 has four. --
IND application planned for the fourth quarter of 2017.
- FPT155 (CD80)
-- A natural, multi-targeting immune
modulator that stimulates T cell responses through three critical
pathways: CTLA4 blockade, CD28 agonism (without superagonism) and
PD-L1 blockade that removes a potent inhibitory checkpoint.
-- IND planned in 2018.
- Progress in pre-clinical and research programs is on track for
the company to achieve the goal of filing at least one IND
application for a new molecule each year for the foreseeable
future, beginning this year.
- Completed multiple immuno-oncology research screens to
identify new targets and drug candidates. Five Prime’s
research team completed functional screens on CD8 T cells and
regulatory T cells, as well as a comprehensive screen of all
extracellular binding interactions in the “immunome,” a defined
subset of 700 extracellular proteins enriched for potential immune
cell modulators. Five Prime conducted the screens to identify new
immuno-oncology targets, which the company is prioritizing for
further development as targets for new drug candidates or drug
candidates themselves, either as monotherapies or as part of
rational combination regimens.
- Five Prime will feature three preclinical research
poster presentations during the 2017 American Association for
Cancer Research (AACR) Annual Meeting, April 1 - 5, 2017, in
Washington, D.C.
Summary of Financial Results and Guidance:
- Cash Position. Cash, cash equivalents and
marketable securities totaled $421.7 million on December 31, 2016
compared to $517.5 million on December 31, 2015. The decrease in
year-end cash in 2016 was primarily attributable to net cash used
in operations to advance the company’s clinical and preclinical
pipeline.
- Revenue. Collaboration and license revenue for
the fourth quarter of 2016 was $8.3 million compared to $363.3
million for the fourth quarter of 2015. During the fourth quarter
of 2015, the company recognized the entire upfront payment of $350
million as revenue under the cabiralizumab license and
collaboration agreement with BMS. Collaboration and license
revenue for the full year 2016 was $30.7 million compared to $379.8
million for the full year 2015.
- R&D Expenses. Research and development
expenses for the fourth quarter of 2016 increased by $8.2 million,
or 39%, to $29.1 million from $21.0 million in the fourth quarter
of 2015. Full year 2016 research and development expenses increased
by $23.9 million, or 34%, to $94.1 million in 2016 from $70.2
million in 2015. These increases were primarily related to
advancing the FPA144 program in a phase 1 clinical trial, advancing
the cabiralizumab program in immuno-oncology and PVNS, and
advancing our internal immuno-oncology preclinical and research
activities.
- G&A Expenses. General and administrative
expenses for the fourth quarter of 2016 increased by $1.9 million,
or 22%, to $10.5 million from $8.6 million in the fourth quarter of
2015. Full year 2016 general and administrative expenses were $35.8
million, an increase of $13.2 million, or 58%, from $22.6 million
in 2015. This increase was primarily due to increases in personnel
related expenses, including stock-based compensation.
- Net Income (Loss). Net loss for the fourth
quarter of 2016 was $20.1 million, or $0.73 per basic share and
diluted share, compared to net income of $296.1 million, or $11.37
per basic share and $10.63 per diluted share, for the fourth
quarter of 2015. Full year 2016 net loss was $65.7 million, or
$2.44 per basic share and diluted share, compared to net income of
$249.6 million, or $9.73 per basic share and $9.23 per diluted
share. These decreases in net income were primarily related to
recognizing the 2015 upfront payment of $350 million as revenue
under the cabiralizumab license and collaboration agreement with
BMS.
Cash Guidance. Five Prime expects full-year
2017 net cash used in operating activities to be less than $120
million. The company estimates ending 2017 with approximately $300
million in cash, cash equivalents and marketable securities.
Conference Call Information
Five Prime will host a conference call and live audio webcast
today at 4:30 p.m. (ET) / 1:30 p.m. (PT) to discuss its financial
results and provide a corporate update. To participate in the
conference call, please dial (877) 878-2269 (domestic) or (253)
237-1188 (international) and refer to conference ID 60580589. To
access the live webcast please visit the "Events &
Presentations" page under the "Investors" tab on Five Prime's
website at www.fiveprime.com. An archived copy of the webcast will
be available on Five Prime's website beginning approximately two
hours after the conference call. Five Prime will maintain an
archived replay of the webcast on its website for at least 30 days
after the conference call.
About Five PrimeFive Prime Therapeutics, Inc.
discovers and develops innovative therapeutics to improve the lives
of patients with serious diseases. Five Prime's comprehensive
discovery platform, which encompasses virtually every medically
relevant extracellular protein, positions it to explore pathways in
cancer, inflammation and their intersection in immuno-oncology, an
area with significant therapeutic potential and a growing focus of
the company's R&D activities. Five Prime has entered into
strategic collaborations with leading global pharmaceutical
companies and has promising product candidates in clinical and late
preclinical development. For more information, please visit
www.fiveprime.com.
Cautionary Note on Forward-looking
StatementsThis press release contains forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. Words such as "may," "will," "expect," "plan,"
"anticipate," "estimate," "intend" and similar expressions (as well
as other words or expressions referencing future events, conditions
or circumstances) are intended to identify forward-looking
statements. These forward-looking statements are based on Five
Prime's expectations and assumptions as of the date of this press
release. Each of these forward-looking statements involves risks
and uncertainties. Actual results may differ materially from these
forward-looking statements. Forward-looking statements contained in
this press release include statements about (i) the timing of IND
filings; (ii) the timing of initiation, progress and scope of
clinical trials for Five Prime's product candidates, including
regarding the completion of enrollment in such trials; (iii) Five
Prime's full-year 2017 net cash used in operating activities; and
(iv) the estimated amount of Five Prime's cash, cash equivalents
and marketable securities at the end of 2017. Many factors may
cause differences between current expectations and actual results
including unexpected safety or efficacy data observed during
preclinical or clinical studies, clinical trial site activation or
enrollment rates that are lower than expected, changes in expected
or existing competition, changes in the regulatory environment,
failure of Five Prime's collaborators to support or advance
collaborations or product candidates, and unexpected litigation or
other disputes. Other factors that may cause Five Prime's actual
results to differ from those expressed or implied in the
forward-looking statements in this press release are discussed in
Five Prime's filings with the U.S. Securities and Exchange
Commission, including the "Risk Factors" sections contained
therein. Except as required by law, Five Prime assumes no
obligation to update any forward-looking statements contained
herein to reflect any change in expectations, even as new
information becomes available.
|
|
Five Prime Therapeutics, Inc. |
|
Selected Balance Sheets Data |
|
(in thousands) |
|
|
|
|
|
|
|
|
|
December 31, |
|
December 31, |
|
|
|
|
2016 |
|
|
2015 |
|
Balance Sheet Data: |
|
|
|
|
|
Cash,
cash equivalents and marketable securities |
|
$ |
421,748 |
|
$ |
517,466 |
|
Total
assets |
|
|
448,281 |
|
|
548,285 |
|
Total current
liabilities (excluding deferred revenue) |
|
|
24,591 |
|
|
61,859 |
|
Deferred
revenue (in total, including short term portion) |
|
32,006 |
|
|
48,777 |
|
Total
stockholders’ equity |
|
|
391,575 |
|
|
433,206 |
|
|
|
|
|
|
|
Five Prime Therapeutics, Inc. |
|
|
Condensed Statements of
Operations |
|
|
(in thousands, except per share
amounts) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For The Three Months Ended
December 31, |
|
For The Year
Ended December 31, |
|
|
|
|
2016 |
|
|
|
2015 |
|
|
|
2016 |
|
|
|
2015 |
|
|
|
Collaboration and
license revenue |
$ |
8,262 |
|
|
$ |
363,341 |
|
|
$ |
30,691 |
|
|
$ |
379,801 |
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
Research
and development |
|
29,149 |
|
|
|
20,956 |
|
|
|
94,072 |
|
|
|
70,197 |
|
|
|
General
and administrative |
|
10,522 |
|
|
|
8,602 |
|
|
|
35,831 |
|
|
|
22,631 |
|
|
|
Total operating
expenses |
|
39,671 |
|
|
|
29,558 |
|
|
|
129,903 |
|
|
|
92,828 |
|
|
|
Operating income
(loss) |
|
(31,409 |
) |
|
|
333,783 |
|
|
|
(99,212 |
) |
|
|
286,973 |
|
|
|
Interest income |
|
646 |
|
|
|
155 |
|
|
|
2,467 |
|
|
|
484 |
|
|
|
Income (loss) before
income tax |
|
(30,763 |
) |
|
|
333,938 |
|
|
|
(96,745 |
) |
|
|
287,457 |
|
|
|
Income tax benefit
(provision) |
|
10,657 |
|
|
|
(37,810 |
) |
|
|
31,048 |
|
|
|
(37,810 |
) |
|
|
Net income (loss) |
$ |
(20,106 |
) |
|
$ |
296,128 |
|
|
$ |
(65,697 |
) |
|
$ |
249,647 |
|
|
|
Basic net income (loss)
per common share |
$ |
(0.73 |
) |
|
$ |
11.37 |
|
|
$ |
(2.44 |
) |
|
$ |
9.73 |
|
|
|
Diluted net income
(loss) per common share |
$ |
(0.73 |
) |
|
$ |
10.63 |
|
|
$ |
(2.44 |
) |
|
$ |
9.23 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used to compute
basic net income (loss) per common share |
|
27,436 |
|
|
|
26,043 |
|
|
|
26,955 |
|
|
|
25,661 |
|
|
|
Shares used to compute
diluted net income (loss) per common share |
|
27,436 |
|
|
|
27,850 |
|
|
|
26,955 |
|
|
|
27,035 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Heather Rowe
Investor Relations
415-365-5737
heather.rowe@fiveprime.com
Amy Kendall
Corporate Communications
415-365-5776
amy.kendall@fiveprime.com
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