Jounce Therapeutics Reports Third Quarter 2019 Financial Results
November 07 2019 - 6:30AM
Jounce Therapeutics, Inc. (NASDAQ: JNCE), a clinical-stage company
focused on the discovery and development of novel cancer
immunotherapies and predictive biomarkers, today reported financial
results for the third quarter ended September 30, 2019 and
provided a corporate update.
“We have continued to work diligently on advancing our pipeline
and further executing on our clinical development plans through our
Translational Science Platform and reverse translational analysis.
Both of our clinical-stage programs, vopratelimab and JTX-4014,
continue to progress well. We are pleased to be presenting both new
data from JTX-4014, as well as the dosing and sequencing strategy
for vopratelimab in our ongoing EMERGE Phase 2 trial, at the SITC
2019 Annual Meeting this weekend,” said Richard Murray, Ph.D.,
chief executive officer and president of Jounce Therapeutics. “We
continue to focus on the underlying mechanistic science of our
immunotherapies as we work towards bringing meaningful and
long-lasting benefits to cancer patients. We look forward to
executing on several key milestones in 2020 across our robust
pipeline.”
Clinical
Programs:Vopratelimab
- Two development paths established for vopratelimab
program: The reverse translational analysis from the
ICONIC trial established the correlation between ICOS hi CD4 T
cells, which emerged due to vopratelimab, and clinical benefit. The
first development path focuses on the biology of optimizing the
induction of ICOS hi CD4 T cells prior to vopratelimab
administration. The second path focuses on the use of a predictive
biomarker to identify and select patients who may be more likely to
benefit from a combination of vopratelimab and a PD-1 inhibitor.
The first of the induction studies, EMERGE, is underway.
- Dosing and sequencing strategy for EMERGE Phase 2 trial
to be presented at the Society for Immunotherapy of Cancer
(SITC): On November 9, 2019, Jounce will present a Trials
in Progress poster on the EMERGE trial, which will include the
combination dosing and sequencing strategy based on its
understanding of the kinetics of induction of ICOS hi CD4 T
effector cells by ipilimumab and their expansion and sustained
activation by vopratelimab. The EMERGE Phase 2 clinical trial began
enrollment in mid-June 2019. Jounce expects to report EMERGE data
including preliminary efficacy and biomarker relationships to
clinical outcomes for up to 80 patients in 2020.
- Predictive biomarker approach: In the second
development path, Jounce will focus on the use of a predictive
biomarker. In the analysis of ICONIC patients, Jounce was able to
identify a biomarker from baseline samples that correlated with the
emergence of ICOS hi CD4 T cells, ORR, PFS and OS, in patients
treated with vopratelimab alone or in combination with nivolumab.
Jounce plans to use this potential predictive biomarker to select
patients in a new trial with vopratelimab and JTX-4014. Jounce will
provide more details in the next few months on this clinical
trial.
JTX-4014
- New safety and preliminary efficacy data from JTX-4014
Phase 1 trial to be presented at SITC: On November 8,
2019, Jounce will present new safety and preliminary efficacy data
from the Phase 1 trial of JTX-4014 during a poster session at the
SITC 2019 Annual Meeting.
- JTX-4014 identified as combination agent:
Based on the encouraging safety and preliminary efficacy data,
Jounce plans to use JTX-4014 as the PD-1 inhibitor in combination
with its other product candidates, including in the new predictive
biomarker trial with vopratelimab.
Discovery Pipeline:
- On track to announce next development
candidate: Jounce continues to advance and develop its
broad discovery pipeline, which includes multiple programs
targeting T-regulatory cells, macrophages and stromal cells. Jounce
expects to move its next novel program into IND-enabling studies by
the end of the year.
Corporate Highlights:
- Senior appointments: During the third quarter
of 2019, Jounce announced the addition of Jacqui Fahey Sandell to
its management team as Chief Legal Officer and Corporate Secretary.
In October, Haley Laken, Ph.D., VP of Program and Portfolio
Strategy, who has been with Jounce since early 2018, also joined
the management team.
Third Quarter 2019 Financial Results:
- Cash position: As of September 30, 2019,
cash, cash equivalents and investments were $185.1 million,
compared to $195.9 million as of December 31, 2018. The
decrease in cash, cash equivalents and investments was primarily
due to operating costs incurred during the period, offset by the
$50.0 million license fee received in July 2019 pursuant to
Jounce’s new license agreement with Celgene.
- License and collaboration revenue: License and
collaboration revenue was $119.4 million for the third quarter of
2019, compared to $14.5 million for the same period in 2018.
License and collaboration revenue recognized during the third
quarter of 2019 was comprised of $50.0 million of cash revenue
related to Jounce’s new license agreement with Celgene and $69.4
million of non-cash revenue recognition relating to the $225.0
million upfront payment received in July 2016 upon the execution of
Jounce’s original strategic collaboration with Celgene. In
connection with the termination of the original strategic
collaboration, Jounce recognized the remaining deferred revenue
relating to this agreement in the third quarter of 2019. License
and collaboration revenue recognized during the third quarter of
2018 was comprised solely of non-cash revenue recognition related
to the $225.0 million upfront payment.
- Research and development expenses: Research
and development expenses were $15.1 million for the third quarter
of 2019, compared to $16.8 million for the same period in 2018. The
decrease in research and development expenses was primarily due to
$2.2 million of decreased external research and development costs
attributable to vopratelimab manufacturing expenses and JTX-4014
IND-enabling expenses incurred during the third quarter of 2018.
This decrease was partially offset by $0.9 million of increased
employee compensation costs.
- General and administrative expenses: General
and administrative expenses were $6.5 million for both the third
quarter of 2019 and the same period in 2018.
- Net income (loss): Net income was $98.9
million for the third quarter of 2019, resulting in basic net
income per share of $2.99 and diluted net income per share of
$2.90. This increase in net income was primarily attributable to
$119.4 million of license and collaboration revenue recognized
under Jounce’s agreements with Celgene. Net loss was $7.6 million
for the same period in 2018, or a basic and diluted net loss per
share of $0.23.
Financial Guidance:
Based on its operating and development plans for the remainder
of 2019, Jounce now expects gross cash burn on operating expenses
and capital expenditures for the full year 2019 to be approximately
$75.0 million to $85.0 million, a decrease from its previously
announced guidance of approximately $80.0 million to $95.0 million
for the full year 2019.
Conference Call and Webcast Information:
Jounce Therapeutics will host a live conference call and webcast
today at 8:00 a.m. ET. To access the conference call, please dial
(866) 916-3380 (domestic) or (210) 874-7772 (international) and
refer to conference ID 3379867. The live webcast can be accessed
under "Events & Presentations" in the Investors and Media
section of Jounce's website at www.jouncetx.com. The webcast will
be archived and made available for replay on Jounce’s website
approximately two hours after the call and will be available for 30
days.
About Jounce Therapeutics
Jounce Therapeutics, Inc. is a clinical-stage immunotherapy
company dedicated to transforming the treatment of cancer by
developing therapies that enable the immune system to attack tumors
and provide long-lasting benefits to patients through a
biomarker-driven approach. Through the use of its Translational
Science Platform, Jounce first focuses on specific cell types
within the human tumor microenvironment to prioritize targets, and
then identifies related biomarkers designed to match the right
immunotherapy to the right patient. Jounce is developing two
clinical-stage programs as well as advancing and building out its
broad and wholly-owned discovery pipeline of immuno-oncology
targets, including those expressed on T-regulatory cells,
macrophages and stromal cells. Jounce’s lead product candidate,
vopratelimab, is a monoclonal antibody that binds to and activates
ICOS and is currently being assessed in a Phase 2 clinical trial.
JTX-4014 is a PD-1 inhibitor intended for potential use in
combination with its pipeline of future product candidates. Jounce
completed enrollment in the Phase 1 clinical trial of JTX-4014 and
additional studies with JTX-4014 are planned. In addition, Jounce
has exclusively licensed worldwide rights to JTX-8064, a LILRB2
receptor antagonist, to Celgene. For more information, please visit
www.jouncetx.com.
Cautionary Note Regarding Forward-Looking
Statements:
Various statements in this release concerning Jounce’s future
expectations, plans and prospects, including without limitation,
Jounce’s expectations regarding financial guidance, operating
expenses and capital expenditures; the timing, progress, results
and release of data for clinical studies of vopratelimab and
JTX-4014; identification and selection of patients for Jounce’s
clinical studies; the use of JTX-4014 in combination with Jounce’s
other product candidates; and the timing, progress and results of
preclinical studies for Jounce’s product candidates and any future
product candidates may constitute forward-looking statements for
the purposes of the safe harbor provisions under The Private
Securities Litigation Reform Act of 1995 and other federal
securities laws and are subject to substantial risks, uncertainties
and assumptions. You should not place reliance on these
forward-looking statements, which often include words such as
“expect,” “plan,” “will” or similar terms, variations of such terms
or the negative of those terms. Although Jounce believes that the
expectations reflected in the forward-looking statements are
reasonable, Jounce cannot guarantee such outcomes. Actual results
may differ materially from those indicated by these forward-looking
statements as a result of various important factors, including,
without limitation, Jounce’s ability to successfully demonstrate
the efficacy and safety of its product candidates and future
product candidates; the preclinical and clinical results for its
product candidates, which may not support further development and
marketing approval; the potential advantages of Jounce’s product
candidates; the development plans of its product candidates and any
companion or complementary diagnostics; actions of regulatory
agencies, which may affect the initiation, timing and progress of
preclinical studies and clinical trials of Jounce’s product
candidates; Jounce’s ability to obtain, maintain and protect its
intellectual property; Jounce’s ability to manage operating
expenses and capital expenditures; and those risks more fully
discussed in the section entitled “Risk Factors” in Jounce’s most
recent Annual Report on Form 10-K filed with the Securities and
Exchange Commission as well as discussions of potential risks,
uncertainties, and other important factors in Jounce’s subsequent
filings with the Securities and Exchange Commission. All such
statements speak only as of the date made, and Jounce undertakes no
obligation to update or revise publicly any forward-looking
statements, whether as a result of new information, future events
or otherwise.
Jounce Therapeutics, Inc.
Condensed Consolidated Statements of Operations
(unaudited)(amounts in thousands, except per share
data)
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
|
2019 |
|
2018 |
|
2019 |
|
2018 |
Revenue: |
|
|
|
|
|
|
|
License and collaboration revenue—related party |
$ |
119,445 |
|
|
$ |
14,528 |
|
|
$ |
147,872 |
|
|
$ |
45,101 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
15,115 |
|
|
16,751 |
|
|
50,525 |
|
|
53,408 |
|
General and administrative |
6,483 |
|
|
6,517 |
|
|
20,998 |
|
|
19,842 |
|
Total operating expenses |
21,598 |
|
|
23,268 |
|
|
71,523 |
|
|
73,250 |
|
Operating income (loss) |
97,847 |
|
|
(8,740 |
) |
|
76,349 |
|
|
(28,149 |
) |
Other income, net |
1,025 |
|
|
1,103 |
|
|
3,177 |
|
|
2,810 |
|
Income (loss) before provision
for income taxes |
98,872 |
|
|
(7,637 |
) |
|
79,526 |
|
|
(25,339 |
) |
Provision for income
taxes |
12 |
|
|
— |
|
|
36 |
|
|
— |
|
Net income (loss) |
$ |
98,860 |
|
|
$ |
(7,637 |
) |
|
$ |
79,490 |
|
|
$ |
(25,339 |
) |
Net income (loss) per share,
basic |
$ |
2.99 |
|
|
$ |
(0.23 |
) |
|
$ |
2.41 |
|
|
$ |
(0.78 |
) |
Net income (loss) per share,
diluted |
$ |
2.90 |
|
|
$ |
(0.23 |
) |
|
$ |
2.33 |
|
|
$ |
(0.78 |
) |
Weighted-average common shares
outstanding, basic |
33,112 |
|
|
32,641 |
|
|
33,015 |
|
|
32,462 |
|
Weighted-average common shares
outstanding, diluted |
34,141 |
|
|
32,641 |
|
|
34,160 |
|
|
32,462 |
|
|
|
|
|
|
|
|
|
Jounce Therapeutics, Inc. Selected
Condensed Consolidated Balance Sheet Data
(unaudited)(amounts in thousands) |
|
|
|
|
|
September 30, |
|
December 31, |
|
2019 |
|
2018 |
Cash, cash equivalents and
investments |
$ |
185,097 |
|
|
$ |
195,864 |
|
Working capital |
$ |
167,745 |
|
|
$ |
126,663 |
|
Total assets |
$ |
222,358 |
|
|
$ |
214,452 |
|
Total deferred revenue—related
party |
$ |
— |
|
|
$ |
97,872 |
|
Total stockholders’
equity |
$ |
191,409 |
|
|
$ |
104,129 |
|
|
|
|
|
|
|
|
|
Investor Contact:Komal JoshiJounce
Therapeutics, Inc.(857) 320-2523kjoshi@jouncetx.com
Media Contact:Kathryn MorrisThe Yates
Network914-204-6412kathryn@theyatesnetwork.com
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