Five Prime Therapeutics, Inc. (NASDAQ: FPRX), a clinical-stage
biotechnology company focused on discovering and developing
innovative immuno-oncology protein therapeutics, today announced
its results for the second quarter and provided an update on the
company’s recent activities.
“We are pleased that enrollment in our Phase 3 FIGHT trial
continues to exceed expectations due to FGFR2b biomarker prevalence
above 30% and continued strong investigator support. We are
enthusiastic about the potential of bemarituzumab to be an
important new medicine for patients with previously untreated,
advanced gastric cancer,” said Aron Knickerbocker, Chief Executive
Officer of Five Prime Therapeutics. “We estimate that the FIGHT
trial will reach sufficient enrollment in the coming months to
support the planned, event-driven futility analysis in the first
half of 2020, allowing us to pause enrollment in the fourth quarter
of this year. This is consistent with our portfolio prioritization,
which is currently focused on conducting the FIGHT trial, advancing
the most promising FPA150 opportunities, as well as assessing
safety and dose finding for FPT155.”
Second 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 and mFOLFOX6 are being evaluated in combination with
mFOLFOX6 in the Phase 3 FIGHT (FGFR2b Inhibition in Gastric and
Gastroesophageal Junction Cancer Treatment) trial.
- Enrollment in the FIGHT trial continues ahead of projections
due to FGFR2b biomarker prevalence that has remained steady at more
than 30%, strong clinical trial execution, and continued support
and enthusiasm from clinical investigators.
- The company plans to conduct an early futility analysis for the
FIGHT trial during the first half of 2020. The purpose of the
futility analysis is to ensure the trial is adequately powered to
detect an overall survival benefit at full enrollment.
- Consistent with its portfolio prioritization and given the
higher than expected enrollment rate, the company will pause
enrollment in the FIGHT trial when sufficient patients have been
enrolled in the trial to support the planned futility analysis. The
company expects the pause in enrollment to occur during the fourth
quarter of 2019.
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.
- Five Prime will present a poster at the European Society for
Medical Oncology (ESMO) Congress that will include preliminary
FPA150 data from the monotherapy Phase 1b expansion cohorts at the
20 mg/kg dose in patients with breast, ovarian or endometrial
cancers that overexpress B7-H4 and early safety data from the Phase
1a lead-in testing FPA150 in combination with Keytruda®.
- The company presented preliminary monotherapy safety data from
the dose escalation and exploration portions of the Phase 1a/1b
trial of FPA150 in patients with advanced solid tumors at the 2019
American Society of Clinical Oncology (ASCO) Annual Meeting.
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.
- Enrollment is proceeding according to plan in the dose
escalation portion of the Phase 1a/1b trial, with six dose level
cohorts enrolled and dose escalation continuing.
- An abstract was submitted for the Society for Immunotherapy of
Cancer (SITC) Annual Meeting, where the company expects to present
safety and pharmacokinetic data from the Phase 1a dose escalation
portion of the ongoing Phase 1a/1b 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.
- The next anticipated event is completion of enrollment in the
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.
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, and, in
July, the expected size of the trial was increased from 308 to 383
patients.
Corporate Highlights
- During the second quarter, the company announced the
appointment of Carol Schafer and Lori Lyons-Williams to its board
of directors. The company also announced the departure of Dr.
Sheila Gujrathi from the board.
Summary of Financial Results and Guidance:
Cash Position: Cash, cash equivalents and marketable
securities totaled $214.1 million as of June 30, 2019, compared to
$237.0 million as of March 31, 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 second
quarter of 2019 decreased by $4.3 million, or 56.6%, to $3.3
million from $7.6 million for the second quarter of 2018. This
decrease was primarily related to lower collaboration revenues from
BMS due to a reduction in activities in the Phase 1a/1b trial of
the combination of cabiralizumab and nivolumab and the completion
of the research term under the immuno-oncology research
collaboration in March 2019.
R&D Expenses: Research and development expenses for
the second quarter of 2019 decreased by $4.0 million, or 12.0%, to
$29.4 million from $33.4 million for the second quarter of 2018.
This decrease was primarily due to lower compensation costs, as
well lower manufacturing costs related to FPT155 drug production
and lower diagnostic costs related to the FIGHT trial. These cost
reductions were partially offset by higher CRO costs that were
related to strong patient enrollment and the opening of new
clinical trial sites.
G&A Expenses: General and administrative expenses for
the second quarter of 2019 decreased by $0.1 million, or 1%, to
$9.7 million from $9.8 million for the second quarter of 2018. The
decrease was primarily due to decreased use of consultants in a
number of functions across the company.
Net Loss: Net loss for the second quarter of 2019 was
$34.4 million, or $0.99 per basic and diluted share, compared to a
net loss of $34.1 million, or $0.99 per basic and diluted share,
for the second quarter of 2018.
Shares Outstanding: Weighted average shares outstanding
for the second quarter of 2019 was 34,909,479 as of June 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 3575436. 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. discovers and develops innovative
protein therapeutics to improve the lives of patients with serious
diseases. Five Prime’s product candidates have innovative
mechanisms of action and address patient populations in need of
better therapies. The company focuses on researching and developing
immuno-oncology and targeted cancer therapies paired with companion
diagnostics to identify patients who are most likely to benefit
from treatment with Five Prime’s product candidates. 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 or follow us
on LinkedIn, Twitter and Facebook.
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. Actual results may differ materially from these
forward-looking statements. Forward-looking statements contained in
this press release include statements regarding (i) the timing of
initiation, 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) Five Prime’s
full-year 2019 net cash used in operating activities; and (vi) the
amount of Five Prime’s cash, cash equivalents and marketable
securities at the end of 2019. Many factors may cause differences
between current expectations and actual results including
unexpected safety or efficacy data observed during research,
preclinical or clinical studies, changes in expected or existing
competition, changes in the regulatory, pricing or reimbursement
environment, and unexpected litigation or other disputes. Other
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)
June 30,
December 31,
2019
2018
Balance Sheet Data: Cash, cash equivalents and marketable
securities
$
214,131
$
270,138
Total assets
292,911
321,534
Total current liabilities (excluding deferred revenue)
30,588
26,059
Deferred revenue (in total, including short term portion)
8,114
11,893
Total stockholders' equity
206,612
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 June
30 June 30
2019
2018
2019
2018
Collaboration and license revenue
$
3,333
$
7,580
$
8,680
$
40,066
Operating expenses: Research and development
29,425
33,380
61,178
76,932
General and administrative
9,661
9,782
20,171
20,260
Total operating expenses
39,086
43,162
81,349
97,192
Loss from operations
(35,753
)
(35,582
)
(72,669
)
(57,126
)
Interest income and other loss, net
1,362
1,522
2,893
2,676
Loss before income tax
(34,391
)
(34,060
)
(69,776
)
(54,450
)
Income tax provision
-
-
-
-
Net loss
$
(34,391
)
$
(34,060
)
$
(69,776
)
$
(54,450
)
Basic and diluted net loss per common share
$
(0.99
)
$
(0.99
)
$
(2.00
)
$
(1.63
)
Weighted-average shares used to compute basic and diluted net loss
per common share
34,909
34,401
34,852
33,363
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version on businesswire.com: https://www.businesswire.com/news/home/20190807005656/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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