Five Prime Therapeutics, Inc. (NASDAQ: FPRX), a clinical-stage
biotechnology company focused on developing immune modulators and
precision therapies for solid tumor cancers, today announced its
results for the third quarter and provided an update on the
company’s recent activities.
“We have advanced all of our wholly-owned programs according to
our plan for 2019,” said William Ringo, Chairman and interim Chief
Executive Officer of Five Prime Therapeutics. “As we approach 2020,
we have repositioned Five Prime with a focus on prioritizing our
pipeline based on upcoming data readouts, while also extending our
cash runway, in order to maximize the long-term potential of the
company.”
Third Quarter 2019 Business Highlights and Milestones
Clinical Pipeline:
Bemarituzumab (anti-FGFR2b)
is a first-in-class isoform-selective antibody with enhanced
antibody-dependent cell-mediated cytotoxicity (ADCC) in development
as a targeted immunotherapy for tumors that overexpress FGFR2b.
Bemarituzumab is being evaluated in combination with mFOLFOX6 in
the Phase 3 FIGHT (FGFR2b
Inhibition in Gastric and Gastroesophageal Junction Cancer Treatment) trial.
- The company has enrolled approximately 140 patients with newly
diagnosed advanced stage gastric cancer into the FIGHT trial,
representing approximately 25% of projected total trial enrollment,
and has paused pre-screening of patients for enrollment in the
trial.
- The prevalence of FGFR2b overexpression in this patient
population is approximately 30% based on global pre-screening
data.
- The company expects to conduct a planned futility analysis for
the FIGHT trial in mid-2020. The purpose of the futility analysis
is to ensure the trial is adequately powered to detect an overall
survival benefit at full enrollment.
FPA150 (anti-B7-H4) is a
first-in-class B7-H4 antibody designed to target tumor cells by
enhancing killing of B7-H4 overexpressing tumors through ADCC and
by blocking B7-H4 from sending an inhibitory signal to CD8 T cells.
B7-H4 is frequently overexpressed in breast, ovarian and
endometrial cancers.
- The company presented a poster at the European Society for
Medical Oncology (ESMO) Congress with preliminary FPA150 efficacy
results from the monotherapy Phase 1b expansion cohorts at the
20mg/kg dose in patients with breast, ovarian or endometrial
cancers that overexpress B7-H4.
- As of the August 9, 2019 data cut-off date, one patient in the
ovarian cohort had a confirmed response; 11 patients had stable
disease and remained on therapy. As of the data cut-off date, 31
patients across the ovarian, endometrial and breast cohorts were
evaluable for response.
- The company also presented safety data for four patients in the
combination arm of FPA150 with Keytruda® (pembrolizumab) suggesting
that FPA150 could be combined at a full dose of 20 mg/kg every
three weeks with the standard dose of pembrolizumab.
FPT155 (CD80-Fc) is a
first-in-class CD80-Fc fusion protein that uses the binding
interactions of soluble CD80 to directly engage CD28 to enhance its
co-stimulatory T cell activity without inducing super agonism and
to block CTLA-4 from competing for endogenous CD80, allowing CD28
signaling to prevail in T cell activation in the tumor
microenvironment.
- On November 9, the company will present initial safety data
from the Phase 1 clinical trial of FPT155 in patients with advanced
solid tumors in a poster presentation at the Society for
Immunotherapy of Cancer (SITC) 34th Annual Meeting in National
Harbor, Maryland.
- FPT155 data presented at SITC will include initial safety
results from the Phase 1a dose escalation portion of the trial,
which is designed to characterize the safety and pharmacokinetic
(PK)/pharmacodynamic (PD) profile of FPT155 and identify a
recommended dose for the Phase 1b portion of the trial.
Cabiralizumab (anti-CSF1R)
is an antibody that inhibits CSF1R and has been shown to block the
activation and survival of tumor-associated macrophages. Pursuant
to a worldwide collaboration agreement, Bristol-Myers Squibb (BMS)
has an exclusive worldwide license for the development and
commercialization of cabiralizumab, and Five Prime retains the
rights to a U.S. co-promotion option.
- Bristol-Myers Squibb has completed enrollment in the randomized
Phase 2 trial testing the combination of cabiralizumab with Opdivo®
(nivolumab) with and without chemotherapy in approximately 160
patients with locally advanced or metastatic pancreatic cancer that
has progressed during or after one line of chemotherapy.
- The next anticipated event from the Phase 2 trial is the
announcement of actionable data from BMS in 2020.
BMS-986258 (anti-TIM-3) is a
fully-human monoclonal antibody targeting TIM-3 (T cell
immunoglobulin and mucin domain-3), an immune checkpoint receptor
that may limit the duration and magnitude of T cell responses. This
is the first clinical candidate from the discovery collaboration
between Five Prime and BMS that includes targets in three immune
checkpoint pathways.
- The Phase 1/2 clinical trial continues to progress, with the
expected size of the trial increased to 383 patients in July
2019.
Corporate Highlights
- In October, the company announced a corporate restructuring to
extend its cash runway without impacting or delaying the data
timelines of its clinical programs. The company will retain a small
research group focused on advancing three wholly-owned, late-stage
research programs.
- In September, the company’s board of directors appointed
William Ringo as interim Chief Executive Officer in addition to his
position as Chairman of the Board of Directors.
Summary of Financial Results and Guidance:
Cash Position: Cash, cash equivalents and marketable
securities totaled $186.0 million as of September 30, 2019,
compared to $214.1 million as of June 30, 2019. The decrease in
cash, cash equivalents and marketable securities was primarily
attributable to quarterly operating expenses that exceeded
quarterly revenues.
Revenue: Collaboration and license revenue for the third
quarter of 2019 decreased by $2.8 million, or 48.3%, to $3.0
million from $5.8 million for the third quarter of 2018. This
decrease was primarily related to the completion of the research
term under the immuno-oncology research collaboration with BMS in
March 2019 and from progress made towards the company’s performance
obligation under the original collaboration agreement.
R&D Expenses: Research and development expenses for
the third quarter of 2019 decreased by $17.8 million, or 39.8%, to
$26.9 million from $44.7 million for the third quarter of 2018.
This decrease was primarily due a one-time milestone payment
triggered by the dosing of the first patient in the Phase 3 FIGHT
trial in the third quarter of 2018. Lower compensation costs,
pre-clinical and research activities, manufacturing and diagnostic
expenses and the reduction in the use of temporary resources
contributed to the decrease and were partially offset by increased
clinical trial expense to advance the company’s bemarituzumab,
FPA150, and FPT155 clinical programs.
G&A Expenses: General and administrative expenses for
the third quarter of 2019 increased by $3.4 million, or 34.7%, to
$13.2 million from $9.8 million for the third quarter of 2018. The
increase was primarily due to increased compensation costs offset
by a reduction in the use of temporary resources.
Net Loss: Net loss for the third quarter of 2019 was
$36.1 million, or $1.03 per basic and diluted share, compared to a
net loss of $47.2 million, or $1.37 per basic and diluted share,
for the third quarter of 2018.
Shares Outstanding: Weighted average shares outstanding
for the third quarter of 2019 was 34,996,298 as of September 30,
2019.
Cash Guidance: Five Prime expects full-year 2019 net cash
used in operating activities to be between $117 and $122 million
and estimates ending 2019 with cash, cash equivalents and
marketable securities between $148 and $153 million.
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 5769473. 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 Prime Therapeutics
Five Prime Therapeutics, Inc. develops innovative protein
therapeutics to improve the lives of patients with cancer. The
company focuses on developing immune modulators and precision
therapies for solid tumor cancers paired with companion diagnostics
to identify patients who are most likely to benefit from treatment
with Five Prime’s product candidates. The company’s product
candidates have innovative mechanisms of action and address patient
populations in need of better therapies. Five Prime has entered
into strategic collaborations with leading global pharmaceutical
companies and has promising product candidates in clinical and
preclinical development. For more information, please visit
www.fiveprime.com.
Cautionary Note on Forward-looking Statements
This 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. Forward-looking statements contained in this press
release include statements regarding (i) the timing of progress and
scope of clinical trials for Five Prime’s product candidates; (ii)
the potential use of Five Prime’s product candidates, including in
combination with other products, to treat certain patients; (iii)
the extent of protein overexpression in certain patient
populations; (iv) the timing of the presentation of data for Five
Prime’s product candidates; (v) the impact of the restructuring on
the data timelines of Five Prime’s clinical trials; (vi) Five
Prime’s full-year 2019 net cash used in operating activities; and
(vii) the amount of Five Prime’s cash, cash equivalents and
marketable securities at the end of 2019. Actual results may differ
materially from these forward-looking statements. Factors that may
cause 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” 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.
Source: Five Prime Therapeutics, Inc.
Five Prime Therapeutics, Inc. Selected Balance Sheets
Data (in thousands) September 30 December
31,
2019
2018
Balance Sheet Data: Cash, cash equivalents and marketable
securities
$
185,987
$
270,138
Total assets
258,540
321,534
Total current liabilities (excluding deferred revenue)
26,356
26,059
Deferred revenue (in total, including short term portion)
7,176
11,893
Total stockholders' equity
178,434
265,139
Five Prime Therapeutics, Inc Condensed Statement
of Operations (in thousands, except per share data)
For The Three Months Ended For The Six Months Ended
September 30 September 30
2019
2018
2019
2018
Collaboration and license revenue
$
2,984
$
5,771
$
11,664
$
45,837
Operating expenses: Research and development
26,948
44,687
88,126
121,619
General and administrative
13,206
9,832
33,377
30,092
Total operating expenses
40,154
54,519
121,503
151,711
Loss from operations
(37,170
)
(48,748
)
(109,839
)
(105,874
)
Interest income and other loss, net
1,100
1,531
3,996
4,212
Other (lss)/gain), net
1
(27
)
(2
)
(32
)
Loss before income tax
(36,069
)
(47,244
)
(105,845
)
(101,694
)
Income tax provision
-
-
-
-
Net loss
$
(36,069
)
$
(47,244
)
$
(105,845
)
$
(101,694
)
Basic and diluted net loss per common share
$
(1.03
)
$
(1.37
)
$
(3.03
)
$
(3.01
)
Weighted-average shares used to compute basic and diluted net loss
per common share
34,996
34,482
34,901
33,740
Five Prime Therapeutics, Inc. Shares outstanding
9/30/2019
Total shares outstanding as of: September 30,
2019
35,099,100
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version on businesswire.com: https://www.businesswire.com/news/home/20191106005979/en/
Media and Investor Contact Martin Forrest VP, Investor
Relations & Corporate Communications Five Prime Therapeutics,
Inc. 415-365-5625 martin.forrest@fiveprime.com
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