2020 data milestones remain on track for
proprietary programs
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
results for the fourth quarter and year ended December 31, 2019, in
addition to providing an update on the company’s recent
activities.
“Our 2020 focus is on generating clinical data from three
proprietary programs that will allow us to prioritize future
pipeline investments,” said William Ringo, interim Chief Executive
Officer and Chairman of the Board. “Additionally, we are advancing
our novel late-stage research programs and plan to bring one new
program into preclinical development later this year. We are also
looking to acquire early-stage clinical assets that we can develop
to generate actionable data in the near- to medium-term by
utilizing our clinical development and translational
expertise.”
2020 Milestones and Review of 2019 Business
Highlights
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 paused enrollment in the FIGHT trial pending
the occurrence of a sufficient number of events to trigger a
futility analysis that is expected to occur in mid-2020.
- Approximately 150 patients with newly diagnosed advanced stage
gastric cancer were enrolled into the FIGHT trial before the
company paused enrollment in the fourth quarter of 2019.
- The company expects that it will only resume enrollment in the
FIGHT trial if the trial passes the futility analysis and the
company will look to enter into a collaboration or license
agreement that will pay for all or substantially all of any future
development and commercialization costs for bemarituzumab.
- In the event that the company is unable to secure a partner, it
will consider alternatives that would allow for the advancement of
the bemarituzumab program, including converting the FIGHT trial to
a Phase 2 or Phase 2/3 clinical trial.
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 remains on track to generate data by mid-2020 from
the Phase 1 combination of FPA150 plus pembrolizumab in a cohort of
ovarian cancer patients with B7-H4 overexpression.
- The company presented safety and preliminary FPA150 efficacy
results from the Phase 1a/1b clinical trial at the 2019 American
Society of Clinical Oncology (ASCO) Annual Meeting and the 2019
European Society for Medical Oncology (ESMO) Congress.
- Data from the Phase 1a/1b trial of FPA150 showed that the drug
was well tolerated in monotherapy and in combination at a
recommended dose of 20mg/kg every three weeks. While an efficacy
signal for FPA150 as monotherapy was observed, the response was not
sufficient for the company to move forward in developing the
compound as a single agent.
- The company continues to evaluate FPA150 in combination with
Keytruda in a Phase 1b cohort of patients with ovarian cancer that
overexpresses B7-H4, but does not plan to advance the clinical
development of the combination independently in the near term given
the cost of advancing this combination in clinical development when
compared to current resources and priorities.
- The company believes B7-H4 may be a potential target to treat
tumors that overexpress B7-H4 using antibody drug candidates
(ADCs), bi-specific antibodies, or CAR-T therapies that incorporate
FPA150 or one of the company’s other B7-H4 antibodies.
FPT155 (CD80-Fc) is a first-in-class CD80-Fc fusion
protein that directly engages CD28 without superagonism and binds
to CTLA-4, promoting T cell activation in the tumor
microenvironment.
- The company remains on track to generate early monotherapy
efficacy data in 2020.
- The company has completed nine monotherapy dose escalation
cohorts and is currently dosing patients in the 280mg dose level in
the Phase 1a portion of the study. The company has not observed
evidence of superagonism in the trial. Dose escalation continues
and the company has initiated screening of patients for enrollment
in an exploratory cohort evaluating FPT155 in patients with tumors
more likely to have T cell infiltration.
- The company has observed pharmacodynamic (PD) biomarker data in
the Phase 1a dose escalation portion of the trial that show
expansion of central memory T cells in blood. This expansion of
central memory T cells is consistent with the mechanism of action
of FPT155 observed in preclinical studies.
- Based on this early clinical PD data and the safety data to
date, the company plans to add a cohort to the ongoing Phase 1a/1b
trial to test the combination of escalating doses of FPT155 and an
anti-PD(L)-1 therapy in patients with non-small cell lung cancer
followed by an expansion in this same patient population at a
selected dose of FPT155 in combination with an anti-PD(L)-1
therapy.
- The company presented initial safety results from dose
escalation in the FPT155 Phase 1 study at the 2019 Society for
Immunotherapy of Cancer (SITC) Annual Meeting. This study is
designed to characterize the safety and pharmacokinetic
(PK)/pharmacodynamic (PD) profile of FPT155 and identify a
recommended dose for ongoing clinical development.
Cabiralizumab (FPA008) is an antibody that
inhibits CSF1R and has been shown to block the activation and
survival of tumor-associated macrophages.
- In February 2020, the company announced that the Phase 2 trial
of cabiralizumab plus Opdivo® (nivolumab) with and without
chemotherapy in advanced pancreatic cancer being conducted by
Bristol-Myers Squibb Company (BMS) did not meet its primary
endpoint.
- BMS informed the company that while BMS has no near-term plans
for additional sponsored development of cabiralizumab, it will
continue to support the evaluation of cabiralizumab in select,
ongoing investigator-sponsored trials and may continue to assess
future development opportunities for the investigational asset. In
addition, BMS informed the company that no new safety signals were
observed in the Phase 2 clinical trial.
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.
- BMS continues to conduct the Phase 1/2 clinical trial testing
the combination of BMS-986258 with Opdivo or hyaluronidase, with
the objective of evaluating the safety and tolerability of the
combination.
- The next anticipated event from this trial is BMS’s potential
transition of the trial from the Phase 1 portion of the trial to
the Phase 2 portion of the trial.
2020 and 2019 Corporate Highlights
- In February 2020, the company announced a global license
agreement with Seattle Genetics, Inc. to develop and commercialize
novel ADC therapies using monoclonal antibodies developed by Five
Prime that are directed to a single target. Under the terms of the
agreement, the company received a $5 million upfront payment and is
eligible to receive progress-dependent development and regulatory
milestone payments as well as cumulative commercial milestone
payments. Cumulative milestone payments may reach up to $525
million for the first two ADC product candidates.
- In October 2019, the company announced a corporate
restructuring to extend its cash runway without impacting or
delaying the data timelines of its clinical programs while still
advancing its three wholly-owned, late-stage research programs.
This followed a restructuring in January 2019 to focus on clinical
development and later-stage research priorities.
- In September 2019, the company announced a management
transition and the appointment of William Ringo as interim Chief
Executive Officer in addition to his position as Chairman of the
Board of Directors.
- During 2019, the company announced the appointment of Lori
Lyons-Williams and Carol Schafer to its board of directors and the
resignation of Dr. Lewis T. “Rusty” Williams and Dr. Sheila
Gujrathi from the Board.
Summary of Fourth Quarter and Full Year 2019 Financial
Results and 2020 Guidance:
Cash Position: Cash, cash equivalents and marketable
securities totaled $157.9 million as of December 31, 2019, compared
to $271.7 million as of December 31, 2018. The decrease was
attributable to cash used in operating activities throughout the
year.
Revenue: Collaboration and license revenue for the fourth
quarter of 2019 decreased by $0.8 million, or 20%, to $3.2 million
from $4.0 million for the fourth quarter of 2018. The decrease was
primarily due to the completion of the research term of the
company’s immuno-oncology research collaboration with BMS in March
2019.
Collaboration and license revenue for the year ended December
31, 2019 decreased by $35 million, or 70.1%, to $14.9 million from
$49.9 million for the year ended December 31, 2018. Lower revenue
was the result of a decrease in revenue recognized under several
partner collaboration agreements, including the company’s October
2015 cabiralizumab collaboration agreement, November 2014
collaboration agreement, and immuno-oncology research collaboration
agreement with BMS as well as lower collaboration revenues from the
company’s partnerships with Zai Lab and UCB.
R&D Expenses: Research and development expenses for
the fourth quarter of 2019 decreased by $8.8 million, or 25.4%, to
$25.9 million from $34.7 million primarily due to lower
compensation costs resulting from the January 2019 corporate
restructuring, decreased clinical trial expenses related to the
cabiralizumab trial, lower preclinical costs, reduced use of
temporary resources, clinical services, specialty laboratory
services, lower manufacturing costs for bemarituzumab and FPA150,
and lower miscellaneous research and development costs. These
decreases were partially offset by increased impairment charges for
lab equipment and higher companion diagnostic expenses relating to
bemarituzumab.
Research and development expenses for the year ended December
31, 2019 decreased by $42.3 million, or 27.0%, to $114.1 million
from $156.4 million for the year ended December 31, 2018. The
decrease was attributable principally to lower compensation costs
resulting from the January 2019 corporate restructuring, lower
preclinical program and clinical service expenses, decreased
companion diagnostic clinical trial expense, the use of fewer
temporary resources, lower allocated costs resulting from the
restructurings, and milestone payments resulting from the dosing of
the first patient in two clinical trials. These savings were
partially offset by higher bioanalytic and specialty laboratory,
and clinical trial expenses that were required to advance the
bemarituzumab and FPA150 programs as well as an impairment charge
for lab equipment.
G&A Expenses: General and administrative expenses for
the fourth quarter of 2019 decreased by $0.2 million, or 2.1%, to
$9.4 million from $9.6 million.
General and administrative expenses for the year ended December
31, 2019 increased by $3.0 million, or 7.8%, to $42.7 million from
$39.7 million. The increase was primarily the result of higher
allocated costs related to the corporate restructurings, higher
compensation costs, and higher professional services fees that were
partially offset by a reduction in the use of temporary
resources.
Net Loss: Net loss for the fourth quarter of 2019 was
$31.4 million, or $0.89 per basic and diluted share, compared to a
net loss of $38.8 million, or $1.12 per basic and diluted share for
the fourth quarter of 2018.
Net loss for the full year 2019 was $137.2 million, or $3.92 per
basic and diluted share, compared to a net loss of $140.4 million,
or $4.13 per basic and diluted share, for the full year 2019.
Shares Outstanding: Weighted average shares outstanding
for the fourth quarter of 2019 was 35,175,624 as of December 31,
2019.
Cash Guidance: Five Prime expects full-year 2020 net cash
used in operating activities to be between $77 and $82 million and
estimates ending 2020 with cash, cash equivalents and marketable
securities between $77 and $82 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 3872638. 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. 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,
including the timing of the planned futility analysis for the FIGHT
trial; (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 potential
receipt of upfront and milestone payments and royalties under the
license agreement with Seattle Genetics; (vi) the impact of the
October 2019 restructuring on Five Prime’s cash runway and the data
timelines of Five Prime’s clinical trials; (vii) Five Prime’s
estimated full-year 2020 net cash used in operating activities; and
(viii) Five Prime’s estimated cash, cash equivalents and marketable
securities at the end of 2020. 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) December 31,
December 31,
2019
2018
Balance Sheet Data: Cash, cash equivalents and marketable
securities
$
157,923
$
271,681
Total assets
223,873
321,534
Total current liabilities (excluding deferred revenue)
21,727
26,059
Deferred revenue (in total, including short term portion)
6,141
11,893
Total stockholders' equity
150,473
265,139
Five Prime Therapeutics, Inc Condensed Statement of
Operations (in thousands, except per share data)
For The Three Months Ended For The Year Ended
December 31 December 31
2019
2018
2019
2018
Collaboration and license revenue
$
3,210
$
4,031
$
14,874
$
49,868
Operating expenses: Research and development
25,937
34,733
114,063
156,352
General and administrative
9,372
9,579
42,749
39,671
Total operating expenses
35,309
44,312
156,812
196,023
Loss from operations
(32,099
)
(40,281
)
(141,938
)
(146,155
)
Interest income and other loss, net
744
1,528
4,740
5,792
Other (lss)/gain), net
(2
)
-
(4
)
(84
)
Loss before income tax
(31,357
)
(38,753
)
(137,202
)
(140,447
)
Income tax provision
-
-
-
-
Net loss
$
(31,357
)
$
(38,753
)
$
(137,202
)
$
(140,447
)
Basic and diluted net loss per common share
$
(0.89
)
$
(1.12
)
$
(3.92
)
$
(4.13
)
Weighted-average shares used to compute basic and diluted net loss
per common share
35,175
34,675
34,967
33,976
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version on businesswire.com: https://www.businesswire.com/news/home/20200227005890/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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