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 first quarter and provided an update
on the company’s recent activities.
The company also provided an update on the Phase 3 FIGHT trial
testing bemarituzumab in combination with mFOLFOX6 in patients with
gastric (GC) or gastroesophageal junction (GEJ) cancer that
overexpresses FGFR2b.
“We and our partners have made steady progress advancing all
five clinical programs in our pipeline, and we are swiftly
responding to new information from the Phase 3 FIGHT trial,” said
Aron Knickerbocker, Chief Executive Officer of Five Prime
Therapeutics. “In light of biomarker screening results from the
FIGHT trial, we have made the decision to conduct an early futility
analysis, which we expect to occur in the first half of 2020. We
believe this is both clinically and fiscally responsible.”
First Quarter 2019 Business Highlights and Milestones
Clinical Pipeline:
Bemarituzumab (FPA144) 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.
- Based on the FIGHT trial design,
patients are being selected for enrollment by: (a) tissue IHC
testing (FGFR2b protein overexpression), (b) blood ctDNA testing
(FGFR2 gene amplification), or (c) both IHC and ctDNA testing, as
data support that patients with tumors meeting criteria in any of
the three biomarker categories may benefit from the addition of
bemarituzumab to front-line chemotherapy.
- The FIGHT trial marks the first time
that FGFR2b protein overexpression has been measured on a large
scale in front-line patients with advanced gastric and GEJ
cancers. Greater than 30% of patients screened have tested
positive for FGFR2b overexpression by IHC alone, which is
significantly higher than expected. The company expected 10% of
patients to test positive by either IHC and/or ctDNA tests in the
FIGHT trial. Also, the company expected that patients who tested
positive for FGFR2b overexpression by IHC alone would represent a
minority of the patients enrolled in the FIGHT trial, but these
patients represent the vast majority of biomarker positive patients
in the FIGHT trial.
- Because the composition of the enrolled
patient population differs from the company’s expectations, Five
Prime plans to conduct an early futility analysis.
FPA150 (anti-B7-H4)
is a first-in-class anti-B7-H4 antibody designed to target tumor
cells by blocking B7-H4 from sending an inhibitory signal to CD8 T
cells and by enhancing killing of B7-H4 overexpressing tumors
through ADCC. B7-H4 is frequently overexpressed in breast, ovarian
and endometrial cancers.
- The company initiated dosing in the
Phase 1b monotherapy expansion portion of the Phase 1a/1b trial in
February 2019. The company expects to initiate dosing in May 2019
in a safety lead-in evaluating FPA150 in combination with Keytruda®
(pembrolizumab) in patients with advanced ovarian cancer that
overexpresses B7-H4.
- The abstract titled “Phase 1a/1b study
of first-in-class B7-H4 antibody, FPA150, as monotherapy in
patients with advanced solid tumors” was accepted for a poster
presentation at the 2019 American Society of Clinical Oncology
(ASCO) Annual Meeting. Preliminary safety data from the Phase 1a/1b
trial will be presented.
- Additional safety data along with
preliminary efficacy data from the Phase 1b monotherapy expansion
cohorts are expected to be presented at the European Society for
Medical Oncology (ESMO) 2019 Annual Congress.
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.
- The company presented preclinical data
regarding FPT155 during the New Drugs on the
Horizon Oral Session at the 2019 American Association for
Cancer Research (AACR) Annual Meeting.
- The company expects to present data
from the Phase 1a dose escalation portion of the ongoing Phase
1a/1b trial at the 34th Annual Meeting of the Society for
Immunotherapy of Cancer (SITC) in November 2019.
Cabiralizumab
(FPA008) is an antibody that inhibits CSF1R and has
been shown to block the activation and survival of tumor-associated
macrophages.
- A 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 is ongoing at sites in the U.S., Canada,
Europe, Japan, Korea and Taiwan.
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.
Corporate Highlights
- In January 2019, the company announced
a corporate restructuring to focus resources on clinical
development and late-stage research programs, primarily eliminating
positions in research, pathology and manufacturing.
Summary of Financial Results and Guidance:
Cash Position: Cash, cash equivalents and marketable
securities totaled $237.0 million as of March 31, 2019, compared to
$270.1 million as of December 31, 2018. The decrease in cash, cash
equivalents and marketable securities was primarily attributed to
quarterly operating expenses that exceeded quarterly revenues.
Revenue: Collaboration and license revenue for the
first quarter of 2019 decreased by $27.1 million, or 84%, to $5.3
million from $32.5 million for the first quarter of 2018. This
decrease was primarily related to the $25.0 million milestone
earned in the first quarter of 2018 relating to the dosing of the
first patient in the BMS Phase 2 clinical trial of cabiralizumab in
combination with Opdivo with and without chemotherapy.
R&D Expenses: Research and development expenses
for the first quarter of 2019 decreased by $11.8 million, or 27%,
to $31.8 million from $43.6 million for first quarter of 2018. This
decrease was primarily related to companion diagnostic expense
incurred in the first quarter of 2018, with no corresponding
expense in the first quarter of 2019 and lower compensation costs,
and lower clinical trial expenses that were partially offset by
higher manufacturing costs related to the FPA150 program.
G&A Expenses: General and administrative
expenses for both the first quarters of 2019 and 2018 were $10.5
million.
Net Loss: Net loss for the first quarter of 2019 was
$35.4 million, or ($1.02) per basic and diluted share, compared to
a net loss of $20.4 million, or ($0.63) per basic and diluted
share, for the first quarter of 2018.
Shares Outstanding: Total shares outstanding were
34,838,684 as of March 31, 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 9689855. 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 the FIGHT Trial
The Phase 3 FIGHT (FGFR2b Inhibition
in Gastric and Gastroesophageal Junction
Cancer Treatment) trial is a double-blind randomized
and controlled study evaluating 15 mg/kg of bemarituzumab or
placebo given every two weeks combined with modified FOLFOX6
(mFOLFOX6) chemotherapy in patients with GC or GEJ cancer whose
tumors overexpress FGFR2b. The primary endpoint is overall survival
(OS), with key secondary endpoints being progression-free survival
(PFS), objective response rate (ORR), safety and pharmacokinetic
(PK) parameters.
The Phase 3 FIGHT trial is the first prospective FGFR2b-specific
front-line gastric study that is evaluating bemarituzumab and
mFOLFOX6 in advanced GC and GEJ cancer across clinical trial sites
in Asia, the US, and Europe. Zai Lab and Five Prime have a
strategic development collaboration under which Zai
Lab will manage the Phase 3 portion of the FIGHT trial
in China.
Unmet Need in Gastric Cancer (GC) and Gastroesophageal
Junction (GEJ) cancer
Gastric cancer, including GEJ cancer, is the fifth most common
cancer worldwide and third leading cause of cancer death. Gastric
cancer is the second most common cancer in China.
Current first-line chemotherapy treatment delays progression by
approximately six months compared to best supportive care, but
median OS remains poor with literature-reported ranges of
approximately 10 to 11 months and PFS of approximately six months.
The presence of FGFR2b overexpression is present in patients with
GC/GEJ and is associated with a worse prognosis. Few treatment
options following progression are available after first-line
chemotherapy, and a significant unmet need remains in the treatment
of GC/GEJ worldwide.
Five Prime has partnered with two companion diagnostics
companies to identify FGFR2b overexpression using an
immunohistochemistry (IHC) test and FGFR2 gene
amplification using circulating tumor DNA (ctDNA) analysis. Five
Prime is using both assays to select patients for the FIGHT
trial.
About Bemarituzumab
Bemarituzumab is a first-in-class, isoform-selective, humanized
monoclonal antibody in clinical development as a targeted
immunotherapy for tumors that overexpress FGFR2b, a splice variant
of a receptor for some members of the fibroblast growth factor
(FGF) family. Bemarituzumab blocks FGFs 7, 10 and 22 from binding
to FGFR2b, and has been engineered for enhanced antibody-dependent
cell-mediated cytotoxicity (ADCC) to increase direct tumor cell
killing by recruiting natural killer (NK) cells. Clinical results
to date suggest that the specificity of bemarituzumab avoids the
dose-limiting toxicities that have been seen with less selective
pan-FGFR tyrosine kinase inhibitors that act on multiple FGFRs,
including FGFR2.
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 and
gene amplification 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.
Five Prime Therapeutics, Inc. Selected Balance
Sheet Data (in thousands) March
31, December 31, 2019 2018 Balance
Sheet Data: Cash, cash equivalents and marketable securities $
236,957 $ 270,138 Total assets 315,764 321,534 Total current
liabilities (excluding deferred revenue) 24,072 26,059 Deferred
revenue (in total, including short term portion) 8,764 11,893 Total
stockholders' equity 234,326 265,139
Five Prime
Therapeutics, Inc. Condensed Statements of Operations
(in thousands, except per share amounts)
For The Three For The Three Months
Ended Months Ended March 31, March 31,
2019 2018 Collaboration and license revenue $ 5,347 $
32,486 Operating expenses: Research and development 31,753 43,552
General and administrative 10,510 10,478
Total operating expenses 42,263 54,030
Loss from operations (36,916 ) (21,544 ) Interest income and
other loss, net 1,531 1,154 Loss before
income tax (35,385 ) (20,390 ) Income tax provision -
- Net loss $ (35,385 ) $ (20,390 ) Basic and diluted
net loss per common share $ (1.02 ) $ (0.63 ) Weighted-average
shares used to compute basic and diluted net loss per common share
34,794 32,314
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Media and Investor ContactMartin ForrestVP, Investor
Relations & Corporate CommunicationsFive Prime Therapeutics,
Inc.415-365-5625martin.forrest@fiveprime.com
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