Jounce Therapeutics Reports Fourth Quarter and Full Year 2019 Financial Results
February 27 2020 - 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 fourth quarter and year ended December 31,
2019 and provided a corporate update.
“On the heels of a year of significant clinical progress in
2019, we have set the pace for a robust 2020 with the advancement
of our vopratelimab Phase 2 studies, the ongoing EMERGE trial and
the upcoming SELECT trial. The recent announcement of the TISvopra
biomarker for patient selection in SELECT is a testament to our
Translational Science Platform and further emphasizes our vision of
bringing the right immunotherapy to the right patients,” said
Richard Murray, Ph.D., chief executive officer and president of
Jounce Therapeutics. “With two of our programs, vopratelimab and
JTX-4014, in clinical trials, along with the advancement of our
potential first-in-class monoclonal antibody, JTX-1811, into IND
enabling activities, we are continuing to establish our
differentiated approach to immunotherapy and clinical trial design.
We look forward to executing on several key milestones in 2020
across our growing pipeline.”
Pipeline Update and
Highlights:Vopratelimab
- Established two development paths for vopratelimab
program: In early 2019, Jounce announced two development
paths for vopratelimab, which are now represented by two distinct
and independent Phase 2 clinical trials, EMERGE and SELECT. Both
trials are based on the biology related to the pharmacodynamic
biomarker, ICOS hi CD4 T cells, which emerge in the blood of
patients due to vopratelimab and not PD-1 inhibitors and are
associated with clinical benefit.
-- Enrollment on track in Phase 2 EMERGE
trial: EMERGE trial enrollment in non-small cell lung
cancer (NSCLC) remains on track, and Jounce expects to report
preliminary efficacy and related biomarker data in the second half
of 2020. -- Identified
the baseline TISvopra biomarker: In February 2020, Jounce
presented new data announcing the identification of the predictive
biomarker associated with vopratelimab patient selection, known as
TISvopra, which will be used in the upcoming SELECT trial to select
patients more likely to develop ICOS hi CD4 T cells and experience
clinical benefit in the presence of vopratelimab. The TISvopra
biomarker is a baseline RNA signature with a threshold optimized
for the prediction of the emergence of ICOS hi CD4 T cells and is
expected to predict for both vopratelimab and PD-1 activity.
-- Announced trial design for upcoming Phase 2
SELECT trial: In January 2020, Jounce announced the trial
design for SELECT, a randomized, ex-U.S. trial that will evaluate
vopratelimab and JTX-4014, a PD-1 inhibitor, in patients with
second line, PD-1 inhibitor naive NSCLC. Jounce expects to enroll
approximately 75 patients, who will be selected using the TISvopra
biomarker. Jounce expects to initiate the Phase 2 SELECT trial in
mid-2020 and report interim clinical data in 2021.
JTX-4014
- Established JTX-4014 as combination agent for Phase 2
SELECT trial: Based on the results of the Phase 1 JTX-4014
trial announced in November 2019, Jounce plans to use JTX-4014 as
the PD-1 inhibitor in combination with its other product candidates
beginning with the upcoming Phase 2 SELECT trial.
- Presented safety and preliminary efficacy data from
Phase 1 trial at the Society for Immunotherapy of Cancer’s (SITC)
34th Annual Meeting: In November 2019, Jounce presented
safety and preliminary efficacy data from the Phase 1 trial of
JTX-4014 at SITC demonstrating anti-tumor activity with an overall
RECIST 1.1 response rate of 16.7% (3/18), one complete response,
two partial responses and a disease control rate of 44.4% (8/18) in
patients with advanced refractory solid tumor malignancies and an
average of over four lines of prior therapies. JTX-4014 was found
to have an acceptable safety profile in this trial.
JTX-1811
- Named JTX-1811 as next development candidate from
Translational Science Platform: In December 2019, JTX-1811
was selected as the next development candidate to emerge from
Jounce's Translational Science Platform. JTX-1811 is a monoclonal
antibody designed to selectively deplete immuno-suppressive T
regulatory cells. Jounce will present additional preclinical data
at the 2020 American Association for Cancer Research (AACR) annual
meeting and expects to file an Investigational New Drug (IND)
application in the first half of 2021.
Research Collaborations and Partnerships:
- Established research collaboration with NanoString
Technologies to support the application of TISvopra in Phase 2
SELECT trial: In January 2020, Jounce entered into a new
research collaboration with NanoString Technologies for the
application of the TISvopra biomarker, including the optimized
selection threshold in the SELECT trial. The TISvopra clinical
trial assay will be implemented on the nCounter® Dx Analysis
System.
- Updated strategic collaboration with Celgene
Corporation: In July 2019, Jounce and Celgene entered into
a mutual agreement to terminate their broad strategic collaboration
established in 2016. As a result, Jounce owns all global rights to
its current pipeline, including vopratelimab, JTX-4014, JTX-1811
and all discovery-stage assets. Separately, Celgene obtained
exclusive worldwide licensing rights to JTX-8064, a potential
first-in-class antibody that targets the LILRB2 receptor on
macrophages. Under the terms of the new license agreement, Jounce
received a $50.0 million non-refundable license fee and is eligible
to receive up to $480.0 million from Celgene in development,
regulatory and commercial milestone payments, as well as royalties
from potential worldwide sales.
Fourth Quarter and Full Year 2019 Financial
Results:
- Cash position: As of December 31, 2019,
cash, cash equivalents and investments were $170.4 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 year, offset by the
$50.0 million license fee received in July 2019 pursuant to
Jounce’s JTX-8064 license agreement with Celgene.
- License and collaboration revenue: No
license and collaboration revenue was recognized during the fourth
quarter of 2019, compared to $20.1 million for the same period in
2018. License and collaboration revenue was $147.9 million for the
full year 2019, compared to $65.2 million for the full year 2018.
License and collaboration revenue recognized during 2019 was
comprised of $50.0 million of cash revenue related to Jounce’s
JTX-8064 license agreement with Celgene and $97.9 million of
non-cash revenue recognition relating to the $225.0 million upfront
payment received from Celgene in July 2016. License and
collaboration revenue recognized during 2018 was comprised solely
of non-cash revenue recognition related to the July 2016 upfront
payment.
- Research and development expenses: Research
and development expenses were $16.6 million for both the fourth
quarter of 2019 and 2018. Research and development expenses were
$67.1 million for the full year 2019, compared to $70.1 million for
the full year 2018. The decrease in research and development
expenses for the full year 2019 was primarily due to $6.0 million
of decreased manufacturing and IND-enabling expenses as well as
$0.9 million of decreased lab consumable costs. These decreases
were partially offset by $3.1 million of increased employee
compensation costs.
- General and administrative expenses: General
and administrative expenses were $6.9 million for the fourth
quarter of 2019, compared to $6.6 million for the same period in
2018 and $27.9 million for the full year 2019, compared to $26.4
million for the full year 2018. The increase in general and
administrative expenses for both the fourth quarter of 2019 and the
full year 2019 was primarily attributable to increased employee
compensation costs.
- Net (loss) income: Net loss was $22.7 million
for the fourth quarter of 2019, or a basic and diluted net loss per
share of $0.68. Net loss was $2.0 million for the same period in
2018, or a basic and diluted net loss per share of $0.06. Net
income was $56.8 million for the full year 2019, resulting in basic
net income per share of $1.72 and diluted net income per share of
$1.66. Net loss was $27.4 million for the full year 2018, or a
basic and diluted net loss per share of $0.84. Net income
recognized for the full year 2019 was primarily attributable to
$147.9 million of license and collaboration revenue recognized
under Jounce’s agreements with Celgene.
Financial Guidance:Based on its current
operating and development plans, Jounce expects gross cash burn on
operating expenses and capital expenditures for the full year 2020
to be approximately $80.0 million to $95.0 million. Jounce will no
longer provide license and collaboration revenue guidance as
potential future payments under the JTX-8064 license agreement with
Celgene are royalty- and milestone-based.
Given the strength of its balance sheet, Jounce expects its
existing cash, cash equivalents and investments to be sufficient to
enable the funding of its operating expenses and capital
expenditure requirements through the end of 2021.
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 7889239. 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 TherapeuticsJounce 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. Jounce
has three development-stage programs, two of which are
clinical-stage, vopratelimab, a monoclonal antibody that binds to
and activates ICOS, and JTX-4014, a PD-1 inhibitor intended for
combination use with Jounce’s broader pipeline. Vopratelimab is
currently being assessed in a Phase 2 clinical trial, EMERGE, and a
biomarker trial using TISvopra for patient selection, SELECT, to
assess vopratelimab in combination with JTX-4014 will be initiated
mid-year 2020. The next development candidate to emerge from
Jounce’s Translational Science Platform is JTX-1811, a monoclonal
antibody designed to selectively deplete T regulatory cells in the
tumor microenvironment. JTX-1811 is currently in IND-enabling
activities. In addition, Jounce has exclusively licensed worldwide
rights to JTX-8064, a LILRB2 receptor antagonist, to Celgene
Corporation, a wholly-owned subsidiary of Bristol-Myers Squibb
Company. For more information, please visit www.jouncetx.com.
nCounter® is a registered trademark of NanoString Technologies,
Inc.
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 trials of
vopratelimab and JTX-4014; identification, selection and enrollment
of patients for Jounce’s clinical trials; 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, including JTX-1811, 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,” “on track,”
“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;
Jounce’s ability to successfully manage its clinical trials; 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. |
Consolidated Statements of Operations
(unaudited) |
(amounts in thousands, except per share data) |
|
|
Three Months Ended December
31, |
|
Year Ended December 31, |
|
2019 |
|
2018 |
|
2019 |
|
2018 |
Revenue: |
|
|
|
|
|
|
|
License and collaboration revenue—related party |
$ |
— |
|
|
|
$ |
20,100 |
|
|
|
$ |
147,872 |
|
|
$ |
65,201 |
|
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
16,610 |
|
|
|
16,644 |
|
|
|
67,135 |
|
|
70,052 |
|
|
General and administrative |
6,922 |
|
|
|
6,601 |
|
|
|
27,920 |
|
|
26,443 |
|
|
Total operating expenses |
23,532 |
|
|
|
23,245 |
|
|
|
95,055 |
|
|
96,495 |
|
|
Operating loss (income) |
(23,532 |
) |
|
|
(3,145 |
) |
|
|
52,817 |
|
|
(31,294 |
) |
|
Other income, net |
875 |
|
|
|
1,151 |
|
|
|
4,052 |
|
|
3,961 |
|
|
(Loss) income before provision
for income taxes |
(22,657 |
) |
|
|
(1,994 |
) |
|
|
56,869 |
|
|
(27,333 |
) |
|
Provision for income
taxes |
10 |
|
|
|
46 |
|
|
|
46 |
|
|
46 |
|
|
Net (loss) income |
$ |
(22,667 |
) |
|
|
$ |
(2,040 |
) |
|
|
$ |
56,823 |
|
|
$ |
(27,379 |
) |
|
Net (loss) income per share,
basic |
$ |
(0.68 |
) |
|
|
$ |
(0.06 |
) |
|
|
$ |
1.72 |
|
|
$ |
(0.84 |
) |
|
Net (loss) income per
share, diluted |
$ |
(0.68 |
) |
|
|
$ |
(0.06 |
) |
|
|
$ |
1.66 |
|
|
$ |
(0.84 |
) |
|
Weighted-average common shares
outstanding, basic |
33,272 |
|
|
|
32,750 |
|
|
|
33,080 |
|
|
32,567 |
|
|
Weighted-average common shares
outstanding, diluted |
33,272 |
|
|
|
32,750 |
|
|
|
34,294 |
|
|
32,567 |
|
|
|
|
|
|
|
|
|
|
|
Jounce Therapeutics, Inc. |
Selected Consolidated Balance Sheet Data
(unaudited) |
(amounts in thousands) |
|
|
|
|
|
December 31, |
|
2019 |
|
2018 |
Cash, cash equivalents and
investments |
$ |
170,444 |
|
|
|
$ |
195,864 |
|
|
Working capital |
$ |
159,297 |
|
|
|
$ |
126,663 |
|
|
Total assets |
$ |
205,882 |
|
|
|
$ |
214,452 |
|
|
Total deferred revenue—related
party |
$ |
— |
|
|
|
$ |
97,872 |
|
|
Total stockholders’
equity |
$ |
174,593 |
|
|
|
$ |
104,129 |
|
|
|
|
|
|
|
|
|
|
|
|
Investor and Media Contact:Komal JoshiJounce
Therapeutics, Inc.(857) 320-2523kjoshi@jouncetx.com
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