SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–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 | ||||||
Contacts
Media and Investor Contact
Martin Forrest
VP, Investor
Relations & Corporate Communications
Five Prime Therapeutics,
Inc.
415-365-5625
martin.forrest@fiveprime.com