Jounce Therapeutics Reports First Quarter 2019 Financial Results
May 08 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 and provided a corporate update
for the first quarter ended March 31, 2019.
“We have made significant progress in recent months by applying
our Translational Science Platform and reverse translational
approach to advance both our ongoing clinical and preclinical
programs. Most importantly, at AACR, we presented promising new
progression free and overall survival data from the ICONIC trial
for patients stratified by our vopratelimab pharmacodynamic
biomarker, ICOS hi CD4 T cells in the blood. Additionally, we
presented validating preclinical data from our lead
tumor-associated macrophage program, JTX-8064,” said Richard
Murray, Ph.D., chief executive officer and president of Jounce
Therapeutics. “With these key accomplishments in hand, we look
forward to advancing our broader pipeline with the goal of three
immunotherapies in the clinic in 2019. We remain focused on the
underlying mechanistic science of our immunotherapies and
understanding of the characteristics of responding patients in our
mission to bring meaningful and long-lasting benefit to cancer
patients with unmet needs.”
Pipeline Highlights:
Vopratelimab (JTX-2011)
- 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 progression free survival (PFS) and
overall survival (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.
- On track for planned initiation of Phase 2 clinical
studies: Based on the recently-presented AACR data, Jounce
plans to initiate additional Phase 2 clinical studies focusing on
settings in which ICOS hi CD4 T effector cells exist or emerge and
are primed to respond to vopratelimab, potentially leading to
clinical benefit. The first of these studies will be a clinical
trial of vopratelimab in combination with ipilimumab in PD-1
inhibitor experienced patients in two tumor types, non-small cell
lung cancer and bladder cancer. Additionally, Jounce expects to
initiate a clinical trial of vopratelimab in combination with
ipilimumab in PD-1 inhibitor naive patients with bladder cancer and
a separate predictive biomarker study. Jounce expects to report
preliminary efficacy data in 2020.
JTX-4014
- On track to complete enrollment of Phase 1
study: Jounce remains on track to assess safety and select
the recommended Phase 2 dose for JTX-4014, its PD-1 inhibitor, in
2019.
JTX-8064
- New validating preclinical data presented at AACR
2019: In April 2019, Jounce presented new preclinical data
demonstrating the properties of JTX-8064, Jounce’s lead tumor
associated macrophage candidate. JTX-8064 is an inhibitor of LILRB2
(leukocyte immunoglobulin like receptor B2; ILT4) and is believed
to reprogram tumor-associated macrophages within the tumor
microenvironment. Highlights from the poster presentation include:
- When LILRB2 binds to its ligands, it maintains macrophages in
the M2 or immuno-suppressive state.
- When JTX-8064 blocks ligand binding to LILRB2, it induces an
immune activating state in macrophages that may lead to the
enhancement of the anti-tumor immune response.
- Inhibiting LILRB2 induces pro-inflammatory cytokine secretion
and a unique transcriptional profile suggestive of an M1-like shift
in human macrophages to an immune stimulatory state.
- On track to file IND and initiate Phase 1 clinical
trial: Jounce expects to file an investigational new drug
(IND) application and initiate a Phase 1 clinical trial of JTX-8064
in 2019.
First Quarter 2019 Financial Results:
- Cash Position: As of March 31, 2019,
cash, cash equivalents and investments were $173.2 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.
- Collaboration Revenue: Collaboration revenue
was $11.0 million for the first quarter of 2019, compared to $11.2
million for the same period in 2018. Collaboration revenue
represents non-cash revenue recognition relating to the $225.0
million upfront payment received in July 2016 upon the execution of
Jounce’s global strategic collaboration with Celgene.
- Research and Development Expenses: Research
and development (R&D) expenses were $17.3 million for the first
quarter of 2019, compared to $18.2 million for the same period in
2018. The decrease in R&D expenses was primarily due to $1.5
million of decreased external research and development costs
attributable to JTX-4014 IND-enabling expenses incurred during the
first quarter of 2018, partially offset by $0.5 million of
increased employee compensation costs.
- General and Administrative Expenses: General
and administrative (G&A) expenses were $7.2 million for the
first quarter of 2019, compared to $6.8 million for the same period
in 2018. The increase in G&A expenses was primarily due to $0.7
million of increased employee compensation costs, including $0.3
million of increased stock-based compensation expense.
- Net Loss: Net loss was $12.4 million for the
first quarter of 2019, or a basic and diluted net loss per share of
$0.38. Net loss was $13.0 million for the same period in 2018, or a
basic and diluted net loss per share of $0.40. The decrease in net
loss and net loss per share was primarily attributable to the
decrease in operating expenses from the first quarter of 2018 to
the first quarter of 2019.
Financial Guidance:
Jounce reiterates its expectation that cash burn on operating
expenses and capital expenditures for the full year 2019 will be
approximately $80.0 million to $95.0 million. Jounce expects to
record approximately $50.0 million to $60.0 million in non-cash
collaboration revenue in 2019 from the recognition of the Celgene
upfront payment received in 2016.
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 5789371. 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-4014; the filing of an IND and initiation of a
Phase 1 trial of JTX-8064 and 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,” “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; Jounce’s ability to maintain its
collaboration with Celgene 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 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 has
three development-stage programs: its two clinical product
candidates, vopratelimab, a monoclonal antibody that binds to and
activates ICOS, and JTX-4014, a monoclonal antibody that binds to
PD-1 and for potential use in combination with Jounce’s pipeline of
future product candidates, and JTX-8064, a monoclonal antibody that
binds to Leukocyte Immunoglobulin Like Receptor B2 (LILRB2) that is
currently in the IND-enabling phase. 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 March 31, |
|
2019 |
|
2018 |
Revenue: |
|
|
|
Collaboration revenue—related party |
$ |
10,981 |
|
|
$ |
11,195 |
|
Operating expenses: |
|
|
|
Research and development |
17,280 |
|
|
18,162 |
|
General and administrative |
7,192 |
|
|
6,802 |
|
Total operating expenses |
24,472 |
|
|
24,964 |
|
Operating loss |
(13,491 |
) |
|
(13,769 |
) |
Other income, net |
1,126 |
|
|
741 |
|
Loss before provision for
income taxes |
(12,365 |
) |
|
(13,028 |
) |
Provision for income
taxes |
12 |
|
|
— |
|
Net loss |
$ |
(12,377 |
) |
|
$ |
(13,028 |
) |
Net loss per share, basic and
diluted |
$ |
(0.38 |
) |
|
$ |
(0.40 |
) |
Weighted-average common shares
outstanding, basic and diluted |
32,959 |
|
|
32,373 |
|
|
|
|
|
Jounce Therapeutics, Inc. Selected
Condensed Consolidated Balance Sheet Data
(unaudited)(amounts in thousands) |
|
|
|
|
|
March 31, |
|
December 31, |
|
2019 |
|
2018 |
Cash, cash equivalents and
investments |
$ |
173,244 |
|
|
$ |
195,864 |
|
Working capital |
$ |
94,165 |
|
|
$ |
126,663 |
|
Total assets |
$ |
213,209 |
|
|
$ |
214,452 |
|
Total deferred revenue—related
party |
$ |
86,891 |
|
|
$ |
97,872 |
|
Total stockholders’
equity |
$ |
94,424 |
|
|
$ |
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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