- New data from two programs to be presented at
AACR -
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 fourth quarter and year ended December 31, 2018.
“2018 was an important year of learnings and significant
progress for Jounce. We accomplished several milestones, most
notably data readouts and analyses from the Phase 1/2 ICONIC trial
for vopratelimab, formerly called JTX-2011, at ASCO and SITC, which
provided important insights into vopratelimab’s mechanism of action
and a strong scientific rationale for the next stage of clinical
development. We also continued to advance our pipeline of
immunotherapies including JTX-4014, our PD-1 inhibitor, which began
a Phase 1 clinical trial and completed enrollment in the first
cohort in late 2018,” said Richard Murray, Ph.D., chief executive
officer and president of Jounce Therapeutics.
“In 2019, we plan to advance our first-in-class highly selective
antibody JTX-8064, which targets the LILRB2 receptor on
macrophages, by filing an IND and initiating a Phase 1 trial,
supporting our goal of three immunotherapies in the clinic this
year, while we continue to progress novel discovery programs toward
development. We remain committed to advancing our pipeline through
our unique translational approach and are convinced, more than
ever, that the potential for durable survival benefit in the next
generation of immunotherapies will require investment in
understanding translational mechanistic science and biomarkers from
the clinic,” Dr. Murray continued.
Pipeline Highlights:
Vopratelimab (JTX-2011)
- Combination safety data supports new Phase 2
studies: Dose escalation combination cohorts with
ipilimumab and with pembrolizumab began enrollment in June 2018.
Safety was acceptable with ipilimumab and with pembrolizumab, and
these data support the next stage of clinical development.
- Key data readouts presented at ASCO and SITC
2018: Jounce presented Phase 1/2 ICONIC data at the
American Society for Clinical Oncology (ASCO) Annual Meeting in
June 2018 and the Society for Immunotherapy of Cancer’s (SITC)
Annual Meeting in November 2018.
Tumor reductions were associated with an ICOS pharmacodynamic
biomarker, specifically, emergence in the peripheral blood of a
population of ICOS hi CD4 T cells, which have the characteristics
of activated CD4 T effector cells. In a separate study, these cells
were not identified in patients treated with PD-1 inhibitor
monotherapy, including responders. This pharmacodynamic biomarker
has been critical in the interpretation of Jounce’s clinical data
and in informing the planned Phase 2 clinical studies.
Additionally, in a separate analysis, vopratelimab was
demonstrated to activate CD4 T cells only if they express high
levels of ICOS per T cell. The association of the emergence of ICOS
hi CD4 T cells, clinical benefit and the requirement for these
cells to be present for vopratelimab activity has led to two new
development paths: first, vopratelimab in combination with
ipilimumab and, second, patient selection with potential new
predictive biomarkers that may enrich for patients whose CD4 T
cells are primed to respond to vopratelimab and, therefore, may be
more likely to benefit from treatment.
- Planned initiation of Phase 2 clinical
studies: Based on reverse translational work to date,
Jounce plans to initiate additional Phase 2 clinical studies,
including one or more new dosing schedules and combination
sequences, in 2019 and expects to report preliminary efficacy data
from these additional clinical studies in 2020.
- Upcoming presentations of new data at AACR
2019: In April 2019, Jounce will present two posters on
vopratelimab at the American Association for Cancer Research (AACR)
Annual Meeting. One poster will contain clinical data showing
improved progression free survival and overall survival in ICONIC
patients who have emergence of these ICOS hi CD4 T cells and the
other will provide more details about the characteristics of these
cells.
JTX-4014
- Initiated Phase 1 clinical trial and completed
enrollment of first cohort: In late 2018, Jounce advanced
JTX-4014, its PD-1 inhibitor, into a Phase 1 clinical trial and
completed enrollment in the first cohort. Jounce remains on track
to identify the recommended Phase 2 dose in 2019.
JTX-8064
- Initiated IND-enabling studies: In early 2018,
Jounce announced the advancement of its first tumor-associated
macrophage candidate, JTX-8064, into IND-enabling studies. JTX-8064
targets LILRB2, a macrophage target which Jounce believes may act
as a macrophage checkpoint. It is the first tumor-associated
macrophage candidate to emerge from Jounce’s Translational Science
Platform. Jounce expects to file an Investigational New Drug (IND)
application and initiate a Phase 1 clinical trial of JTX-8064 later
this year.
- Upcoming presentation of new data at AACR
2019: In April 2019, Jounce will present a poster on the
preclinical evaluation of JTX-8064 and its role in reprogramming
tumor-associated macrophages within the tumor
microenvironment.
Fourth Quarter and Full Year 2018 Financial
Results:
- Cash Position: As of December 31, 2018,
cash, cash equivalents and investments were $195.9 million,
compared to $257.9 million as of December 31, 2017. Cash was
utilized for operating costs incurred during the year, offset by
the receipt of state and federal income tax refunds. This is in
line with the 2018 cash guidance previously provided of ending cash
of $185.0 million to $195.0 million.
- Collaboration Revenue: Collaboration revenue
was $20.1 million for the fourth quarter of 2018, compared to $13.0
million for the same period in 2017 and $65.2 million for the full
year 2018, compared to $71.6 million for the same period in 2017.
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 (R&D) Expenses:
R&D expenses were $16.6 million for the fourth quarter of 2018,
compared to $18.6 million for the same period in 2017. The decrease
in R&D expenses for the fourth quarter of 2018 was primarily
due to $2.8 million of decreased external research and development
costs, offset by $1.7 million of increased external clinical and
regulatory costs associated with vopratelimab as well as the
initiation of the JTX-4014 Phase 1 clinical trial during the fourth
quarter of 2018.
R&D expenses were $70.1 million for the full year 2018,
compared to $67.8 million for the same period in 2017. The increase
in R&D expenses for the full year 2018 was due to $3.1 million
of increased employee compensation costs, including $1.7 million of
increased stock-based compensation expense, and $3.0 million of
increased external clinical and regulatory costs associated with
vopratelimab as well as the initiation of the JTX-4014 Phase 1
clinical trial, offset by $2.1 million of decreased external
research and development costs and $2.0 million of decreased lab
consumables purchases.
- General and Administrative (G&A) Expenses:
G&A expenses were $6.6 million for the fourth quarter of 2018,
compared to $6.0 million for the same period in 2017 and $26.4
million for the full year 2018, compared to $23.1 million for the
same period in 2017. The increase in G&A expenses for both the
fourth quarter of 2018 and the full year 2018 was primarily due to
increased employee compensation costs.
- Net Loss: Net loss was $2.0 million for the
fourth quarter of 2018, or a basic and diluted net loss per share
attributable to common stockholders of $0.06. Net loss was $9.4
million for the same period in 2017, or a basic and diluted net
loss per share attributable to common stockholders of $0.29. The
decrease in net loss and net loss per share attributable to common
stockholders is primarily attributable to the increase in
collaboration revenue and the decrease in operating expenses from
the fourth quarter of 2017 to the fourth quarter of 2018. Net
loss was $27.4 million for the full year 2018, or a basic and
diluted net loss per share attributable to common stockholders of
$0.84 compared to $16.4 million for same period in 2017, or a basic
and diluted net loss per share attributable to common stockholders
of $0.57. The increase in net loss and net loss per share
attributable to common stockholders is primarily due to the
decrease in collaboration revenue and the increase in operating
expenses from 2017 to 2018.
Financial Guidance:
Based on its current operating and development plans, Jounce
expects cash burn on operating expenses and capital expenditures
for the full year 2019 to 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
continued recognition of the Celgene upfront payment received in
2016.
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 for at least the next 24 months.
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 8678456. 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.
Consolidated Statements of Operations
(unaudited)(amounts in thousands, except per share
data)
|
Three Months Ended December 31, |
|
Year Ended December 31, |
|
2018 |
|
2017 |
|
2018 |
|
2017 |
Revenue: |
|
|
|
|
|
|
|
Collaboration revenue—related party |
$ |
20,100 |
|
|
$ |
12,989 |
|
|
$ |
65,201 |
|
|
$ |
71,644 |
|
Operating
expenses: |
|
|
|
|
|
|
|
Research
and development |
16,644 |
|
|
18,557 |
|
|
70,052 |
|
|
67,798 |
|
General
and administrative |
6,601 |
|
|
5,984 |
|
|
26,443 |
|
|
23,061 |
|
Total
operating expenses |
23,245 |
|
|
24,541 |
|
|
96,495 |
|
|
90,859 |
|
Operating loss |
(3,145 |
) |
|
(11,552 |
) |
|
(31,294 |
) |
|
(19,215 |
) |
Other income, net |
1,151 |
|
|
703 |
|
|
3,961 |
|
|
2,808 |
|
Loss before provision
for (benefit from) income taxes |
(1,994 |
) |
|
(10,849 |
) |
|
(27,333 |
) |
|
(16,407 |
) |
Provision for (benefit
from) income taxes |
46 |
|
|
(1,485 |
) |
|
46 |
|
|
36 |
|
Net loss |
$ |
(2,040 |
) |
|
$ |
(9,364 |
) |
|
$ |
(27,379 |
) |
|
$ |
(16,443 |
) |
|
|
|
|
|
|
|
|
Reconciliation of net
loss to net loss attributable to common stockholders: |
|
|
|
|
|
|
|
Net loss |
$ |
(2,040 |
) |
|
$ |
(9,364 |
) |
|
$ |
(27,379 |
) |
|
$ |
(16,443 |
) |
Accrued dividends on
Series A convertible preferred stock |
— |
|
|
— |
|
|
— |
|
|
(268 |
) |
Accrued dividends on
Series B convertible preferred stock |
— |
|
|
— |
|
|
— |
|
|
(318 |
) |
Accrued dividends on
Series B-1 convertible preferred stock |
— |
|
|
— |
|
|
— |
|
|
(208 |
) |
Net loss attributable
to common stockholders |
$ |
(2,040 |
) |
|
$ |
(9,364 |
) |
|
$ |
(27,379 |
) |
|
$ |
(17,237 |
) |
Net loss per share
attributable to common stockholders, basic and diluted |
$ |
(0.06 |
) |
|
$ |
(0.29 |
) |
|
$ |
(0.84 |
) |
|
$ |
(0.57 |
) |
Weighted-average common
shares outstanding, basic and diluted |
32,750 |
|
|
32,234 |
|
|
32,567 |
|
|
30,055 |
|
|
|
|
|
|
|
|
|
Jounce Therapeutics, Inc.
Selected Consolidated Balance Sheet Data
(unaudited)(amounts in thousands) |
|
|
|
|
|
December 31, |
|
2018 |
|
2017 |
Cash, cash equivalents
and investments |
$ |
195,864 |
|
|
$ |
257,851 |
|
Working capital |
$ |
126,663 |
|
|
$ |
193,046 |
|
Total assets |
$ |
214,452 |
|
|
$ |
296,660 |
|
Total deferred
revenue—related party |
$ |
97,872 |
|
|
$ |
116,160 |
|
Total stockholders’
equity |
$ |
104,129 |
|
|
$ |
167,109 |
|
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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