Jounce Therapeutics Reports Second Quarter 2019 Financial Results
August 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 for patient enrichment,
today reported financial results for the second quarter ended
June 30, 2019 and provided a corporate update.
“2019 has been a time of clinical progress and important
strategic business development activity for Jounce, with the
initiation of our Phase 2 EMERGE trial for vopratelimab, the
completion of enrollment in our Phase 1 clinical trial of JTX-4014
and the recently announced renegotiation of our Celgene
collaboration. These important developments demonstrate the value
and utilization of our novel scientific platform and reverse
translational analyses to further advance our immuno-oncology
pipeline with an aim to match the right therapies to the right
patients,” said Richard Murray, Ph.D., chief executive officer and
president of Jounce Therapeutics. “Our translational science
platform has been further validated by the establishment of our new
licensing agreement with Celgene for the worldwide rights to
JTX-8064. Now that we have retained full worldwide rights to
vopratelimab, JTX-4014 and all of our discovery programs, we look
forward to advancing our broad pipeline of potential
next-generation immuno-oncology therapies.”
Wholly-owned Programs:Vopratelimab
(JTX-2011)
- Initiated Phase 2 EMERGE trial: In June 2019,
Jounce announced the initiation of dosing in the Phase 2 EMERGE
clinical trial of its lead product candidate, vopratelimab, in
combination with ipilimumab in patients with non-small cell lung
cancer or urothelial cancer who have progressed on or after
PD-1/PD-L1 inhibitor therapies.
- The primary endpoint of EMERGE is overall response rate and
secondary endpoints include safety, duration of response,
progression free survival (PFS) and overall survival (OS).
Additional important assessments will include close monitoring of
ICOS hi CD4 T cell emergence, and a range of other biomarkers,
including exploratory assessment of potential predictive
biomarkers. Jounce expects to report preliminary efficacy and
biomarker relationships to clinical outcomes for up to 80 patients
in 2020.
- Key data presented at AACR 2019: In April
2019, Jounce presented two posters on vopratelimab at the American
Association for Cancer Research (AACR) Annual Meeting. Highlights
from the poster presentations include:
- Patients in the ICONIC trial with the emergence of ICOS hi CD4
T cells demonstrated improved PFS and OS compared to patients with
ICOS lo CD4 T cells, based on an analysis of a subgroup of patients
with multiple solid tumor types including PD-1 inhibitor naive and
PD-1 inhibitor experienced patients.
- The characteristics of ICOS hi CD4 T cells associated with
vopratelimab treatment via translational analyses demonstrated that
vopratelimab stimulates only primed CD4 T cells with high levels of
ICOS. The translational data shows that vopratelimab, unlike PD-1
inhibitors, leads to expansion and activation of peripheral CD4 T
effector cells, and that these are observed in patients with
clinical benefit.
JTX-4014
- Completed enrollment of Phase 1 trial: Jounce
is pleased to announce the completion of enrollment in the Phase 1
clinical trial of JTX-4014, its PD-1 inhibitor, and determination
of the recommended Phase 2 dose. Jounce plans to report data from
the trial in the second half of this year.
Discovery Pipeline
- On track to announce next discovery 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 later this year.
Licensed Program:
JTX-8064
- Licensed JTX-8064: In July 2019, Jounce
announced a new agreement in which Celgene exclusively licensed the
worldwide rights to JTX-8064, a highly-selective, potential
first-in-class antibody that targets the LILRB2 receptor on
macrophages. Under this license agreement, Jounce received a $50.0
million non-refundable license fee and is eligible to receive up to
$480.0 million in development, regulatory and commercial milestone
payments, as well as potential royalties on worldwide sales.
Celgene will be responsible for all development and
commercialization of JTX-8064.Jounce and Celgene also entered into
a mutual agreement to terminate the original strategic
collaboration agreement, established in July 2016. Jounce now
retains full worldwide rights to its pipeline beyond JTX-8064,
including vopratelimab, JTX-4014 and all discovery programs.
Second Quarter 2019 Financial Results:
- Cash Position: As of June 30, 2019, cash,
cash equivalents and investments were $152.0 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. In July 2019, Jounce received a
$50.0 million license fee pursuant to its new license agreement
with Celgene.
- Collaboration Revenue: Collaboration revenue
was $17.4 million for the second quarter of 2019, compared to $19.4
million for the same period in 2018. Collaboration revenue during
both periods represents 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 expects that the remaining deferred
revenue relating to the Celgene agreement will be fully recognized
in the third quarter of 2019.
- Research and Development Expenses: Research
and development (R&D) expenses were $18.1 million for the
second quarter of 2019, compared to $18.5 million for the same
period in 2018. The decrease in R&D expenses was primarily due
to $0.5 million of decreased external research and development
costs attributable to vopratelimab manufacturing expenses incurred
during the second quarter of 2018, $0.4 million of decreased
external clinical and regulatory costs and $0.3 million of
decreased lab consumables expenses. These decreases were partially
offset by $0.7 million of increased employee compensation
costs.
- General and Administrative Expenses: General
and administrative (G&A) expenses were $7.3 million for the
second quarter of 2019, compared to $6.5 million for the same
period in 2018. The increase in G&A expenses was primarily due
to $0.5 million of increased employee compensation costs, including
$0.3 million of increased stock-based compensation expense, and
$0.3 million of increased other G&A costs to support Jounce’s
operations.
- Net Loss: Net loss was $7.0 million for the
second quarter of 2019, or a basic and diluted net loss per share
of $0.21. Net loss was $4.7 million for the same period in 2018, or
a basic and diluted net loss per share of $0.14. The increase in
net loss and net loss per share was primarily attributable to the
decrease in non-cash collaboration revenue from the second quarter
of 2018 to the second quarter of 2019.
Financial Guidance:
Jounce reiterates its updated revenue guidance and expects to
record $50.0 million in cash revenue in 2019 related to the license
of JTX-8064 and approximately $98.0 million in non-cash revenue in
2019 representing the remaining recognition of the Celgene upfront
payment received in July 2016.
Based on its operating and development plans, Jounce continues
to expect gross cash burn on operating expenses and capital
expenditures for the full year 2019 to be approximately $80.0
million to $95.0 million.
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 4484315. The live webcast can be accessed
under "Events & Presentations" in the Investors and Media
section of the company's website at www.jouncetx.com. The webcast
will be archived and made available for replay on the company’s
website approximately two hours after the call and will be
available for 30 days.
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 operating expenses, capital
expenditures, collaboration revenue and other financial results;
the timing, progress and release of data for Phase 2 clinical
studies of vopratelimab; the timing, progress and results of the
Phase 1 trial of JTX-4014and the timing, progress and results of
preclinical studies and clinical trials 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 “anticipate,” “believe,” “continue,”
“estimate,” “expect,” “intend,” “may,” “on track,” “plan,”
“predict,” “target,” “potential” or similar terms, variations of
such terms or the negative of those terms. Although the Company
believes that the expectations reflected in the forward-looking
statements are reasonable, the Company 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 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 the Company
undertakes no obligation to update or revise publicly any
forward-looking statements, whether as a result of new information,
future events or otherwise.
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 use in combination with
future pipeline products, and Jounce has completed enrollment in
the JTX-4014 Phase 1 clinical trial. 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.
Jounce Therapeutics, Inc.
Condensed Consolidated Statements of Operations
(unaudited)(amounts in thousands, except per share
data)
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
2019 |
|
2018 |
|
2019 |
|
2018 |
Revenue: |
|
|
|
|
|
|
|
Collaboration revenue—related party |
$ |
17,446 |
|
|
$ |
19,378 |
|
|
$ |
28,427 |
|
|
$ |
30,573 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
18,130 |
|
|
18,495 |
|
|
35,410 |
|
|
36,657 |
|
General and administrative |
7,323 |
|
|
6,523 |
|
|
14,515 |
|
|
13,325 |
|
Total operating expenses |
25,453 |
|
|
25,018 |
|
|
49,925 |
|
|
49,982 |
|
Operating loss |
(8,007 |
) |
|
(5,640 |
) |
|
(21,498 |
) |
|
(19,409 |
) |
Other income, net |
1,026 |
|
|
966 |
|
|
2,152 |
|
|
1,707 |
|
Loss before provision for
income taxes |
(6,981 |
) |
|
(4,674 |
) |
|
(19,346 |
) |
|
(17,702 |
) |
Provision for income
taxes |
12 |
|
|
— |
|
|
24 |
|
|
— |
|
Net loss |
$ |
(6,993 |
) |
|
$ |
(4,674 |
) |
|
$ |
(19,370 |
) |
|
$ |
(17,702 |
) |
Net loss per share, basic and
diluted |
$ |
(0.21 |
) |
|
$ |
(0.14 |
) |
|
$ |
(0.59 |
) |
|
$ |
(0.55 |
) |
Weighted-average common shares
outstanding, basic and diluted |
32,973 |
|
|
32,497 |
|
|
32,966 |
|
|
32,435 |
|
Jounce Therapeutics, Inc. Selected
Condensed Consolidated Balance Sheet Data
(unaudited)(amounts in thousands) |
|
|
|
|
|
June 30, |
|
December 31, |
|
2019 |
|
2018 |
Cash, cash equivalents and
investments |
$ |
152,020 |
|
|
$ |
195,864 |
|
Working capital |
$ |
79,753 |
|
|
$ |
126,663 |
|
Total assets |
$ |
190,604 |
|
|
$ |
214,452 |
|
Total deferred revenue—related
party |
$ |
69,445 |
|
|
$ |
97,872 |
|
Total stockholders’
equity |
$ |
90,064 |
|
|
$ |
104,129 |
|
Investor Contact:Komal JoshiJounce
Therapeutics, Inc.(857) 320-2523kjoshi@jouncetx.com
Media Contact:Gina NugentThe Yates Network(617)
460-3579gina@theyatesnetwork.com
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