Jounce Therapeutics Reports First Quarter 2022 Financial Results
05 May 2022 - 9:00PM
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 first quarter ended March 31, 2022 and provided a
corporate update.
“Jounce made significant progress this quarter
as we focused on the continued advancement of our two proof of
concept studies, INNATE and SELECT, in addition to advancing
candidates from our discovery engine, such as JTX-1484, our LILRB4
(or ILT3) inhibitor. With our cash runway extending beyond our key
inflection points, we are poised for an important second half of
this year,” said Richard Murray, Ph.D., chief executive officer and
president of Jounce Therapeutics. “I’m very pleased to share that
we recently met the prespecified response criteria in two
combination cohorts to continue the Phase 2 expansion in the INNATE
trial, and, in our SELECT trial, we have achieved target
enrollment. These achievements represent significant progress in
building our pipeline of diverse immunotherapy candidates. We
continue to focus on our mission of delivering meaningful and
long-lasting benefit to cancer patients through the discovery and
pursuit of therapies that target new mechanisms of immune
suppression across different types of immune cells, and bringing
the right immunotherapies to the right patients.”
Pipeline Update &
Highlights:JTX-8064 (LILRB2/ILT4)
- Expanded two of seven combination cohorts in INNATE
Phase 2 trial. Jounce is evaluating JTX-8064 in the
ongoing Phase 2 portion of the INNATE clinical trial, which is
comprised of indication specific expansion cohorts, including one
monotherapy cohort and seven combination therapy cohorts. Each
cohort is a Simon 2-stage design, in which we enroll 10 patients,
wait for initial response data, and then further expand to a total
of 29 patients if prespecified response criteria are met. Today,
Jounce is announcing that the first two combination cohorts have
met their response criteria for expansion within INNATE and are now
continuing enrollment to 29 patients each. Jounce has seen an
acceptable safety profile for both the monotherapy and combination
therapy to date.
- On track to report preliminary clinical data in the
second half of 2022. The INNATE clinical trial is studying
three distinct patient populations across the 7 indications: (1)
PD-1 inhibitor naïve patients with tumors for which there are
approved PD-1 or PD-L1 inhibitors, (2) PD-(L)1 inhibitor naïve
patients who have tumors for which there are no PD-1 or PD-L1
inhibitors approved and (3) patients who were previously treated
with a PD-1 inhibitor and are PD-1 inhibitor resistant. Jounce
remains on track to report preliminary clinical data, including all
31 dose escalation patients and at least 60 Phase 2 patients from
INNATE, in the second half of 2022.
Vopratelimab (ICOS) and Pimivalimab (PD-1)
- Patient screening finished in the Phase 2 SELECT trial
of vopratelimab. Patient screening is complete with the
target enrollment of at least 60 evaluable patients having been met
in SELECT, a randomized Phase 2 trial evaluating vopratelimab in
combination with pimivalimab versus pimivalimab alone in
immunotherapy naïve, TISvopra biomarker-selected, second line
non-small cell lung cancer (NSCLC) patients. Jounce is on track to
report data from the SELECT trial in the second half of 2022,
including additional single agent data for pimivalimab.
JTX-1484 (LILRB4/ILT3)
- JTX-1484 is the most recent product candidate to emerge
from our Translational Science Platform. JTX-1484 is a
monoclonal antibody designed to block human LILRB4 expressed on
myeloid cells in the tumor microenvironment with the potential to
reduce immune suppression and enhance T cell functionality.
JTX-1484 is currently in IND-enabling activities, with the goal of
filing an investigational new drug application (“IND”) in
2023.
Discovery Pipeline
- Productive discovery engine
with the goal of an IND every 12 to 18 months: Jounce
continues to invest in and advance its growing immuno-oncology
pipeline. Its discovery engine is built upon the capability to
thoroughly interrogate different cell types in the tumor
microenvironment, including T cells and myeloid cells. This
approach has resulted in four clinical stage programs, with a fifth
in IND enabling studies, over the last 6 years.
First Quarter 2022 Financial Results:
- Cash position: As of March 31, 2022, cash,
cash equivalents and investments decreased to $186.4 million,
compared to $220.2 million as of December 31, 2021. The decrease
was due to operating expenses incurred during the period.
- License and collaboration revenue: Jounce did
not recognize any revenue during the first quarter of 2022. License
and collaboration revenue of $1.5 million was recognized during the
first quarter of 2021 and was comprised solely of non-cash revenue
related to the performance of research and transition services
under the Gilead License Agreement.
- Research and development expenses: Research
and development expenses were $30.1 million for the first quarter
of 2022, compared to $20.5 million for the same period in 2021. The
increase in research and development expenses was primarily due to
increased manufacturing activities performed for Jounce’s
development programs, increased clinical and regulatory costs for
INNATE, and increased payroll and stock-based compensation
expense.
- General and administrative expenses: General
and administrative expenses were $7.3 million for the first quarter
of 2022, compared to $7.6 million for the same period in 2021. The
decrease in general and administrative expenses was primarily due
to decreased external consulting and stock-based compensation
expense.
- Net loss: Net loss was $37.4 million for the
first quarter of 2022, resulting in basic and diluted net loss per
share of $0.72. Net loss was $26.5 million for the same period in
2021, resulting in a basic and diluted net loss per share of $0.58.
The increase in net loss was primarily attributable to increased
operating expenses incurred during the first quarter of 2022.
Financial Guidance:Based on its current
operating and development plans, Jounce reiterates its financial
guidance for 2022. Gross cash burn on operating expenses and
capital expenditures for the full year 2022 is expected to be
approximately $115.0 million to $130.0 million. 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 third quarter of 2023.
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 9072989. 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. Jounce currently has multiple
development stage programs ongoing while simultaneously advancing
additional early-stage assets from its robust discovery engine
based on its Translational Science Platform. Jounce’s highest
priority program, JTX-8064, is a LILRB2 (ILT4) receptor antagonist
shown to reprogram immune-suppressive tumor associated macrophages
to an anti-tumor state in preclinical studies. JTX-8064 is
currently being investigated alone and in combination with
pimivalimab (formerly JTX-4014), Jounce’s internal PD-1 inhibitor,
in one monotherapy and seven indication-specific combination
therapy cohorts in the Phase 1/2 INNATE trial and is currently
enrolling patients with advanced solid tumors in the Phase 2
portion of the study. Jounce’s most advanced product candidate,
vopratelimab, is a monoclonal antibody that binds to and activates
ICOS, and is currently being studied in the SELECT Phase 2 trial.
Pimivalimab is a PD-1 inhibitor intended for combination use in the
INNATE and SELECT trials and with Jounce’s broader pipeline.
Additionally, Jounce exclusively licensed worldwide rights to
GS-1811 (formerly JTX-1811), a monoclonal antibody targeting CCR8
and designed to selectively deplete T regulatory cells in the tumor
microenvironment, to Gilead Sciences, Inc. 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, gross cash
burn, operating expenses, capital expenditures and funding
requirements; the timing, initiation or expansion, progress,
results of and release of data for clinical trials of Jounce’s
product candidates, including JTX-8064, vopratelimab and
pimivalimab; the timing of an IND filing for JTX-1484 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,” “goal,” “intend,” “on track,” 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; risks that the
COVID-19 pandemic may disrupt Jounce’s business and/or the global
healthcare system more severely than anticipated, which may have
the effect of delaying enrollment and completion of Jounce’s
ongoing clinical trials, or delaying timelines or data disclosures
and regulatory submissions for its product candidates; risks that
invasion of Ukraine and political unrest in the surrounding region
may disrupt clinical trial activities, which may adversely affect
the completion of Jounce’s ongoing clinical trials, or delay
timelines or data disclosures; 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;
management of Jounce’s supply chain for the delivery of drug
product and materials for use in clinical trials and research and
development activities; 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 EndedMarch 31, |
|
|
2022 |
|
|
|
2021 |
|
Revenue: |
|
|
|
License and collaboration revenue—related party |
$ |
— |
|
|
$ |
1,539 |
|
Operating expenses: |
|
|
|
Research and development |
|
30,115 |
|
|
|
20,507 |
|
General and administrative |
|
7,347 |
|
|
|
7,615 |
|
Total operating expenses |
|
37,462 |
|
|
|
28,122 |
|
Operating loss |
|
(37,462 |
) |
|
|
(26,583 |
) |
Other income,
net |
|
96 |
|
|
|
49 |
|
Loss before provision for
income taxes |
|
(37,366 |
) |
|
|
(26,534 |
) |
Provision for income
taxes |
|
1 |
|
|
|
1 |
|
Net loss |
$ |
(37,367 |
) |
|
$ |
(26,535 |
) |
Net loss per share, basic and
diluted |
$ |
(0.72 |
) |
|
$ |
(0.58 |
) |
Weighted-average common shares
outstanding, basic and diluted |
|
51,638 |
|
|
|
45,962 |
|
|
|
|
|
Jounce Therapeutics, Inc.Selected
Condensed Consolidated Balance Sheet Data
(unaudited)(amounts in thousands) |
|
|
|
March 31, |
|
December 31, |
|
|
2022 |
|
|
|
2021 |
|
Cash, cash equivalents and
investments |
$ |
186,395 |
|
|
$ |
220,223 |
|
Working capital |
$ |
148,134 |
|
|
$ |
171,929 |
|
Total assets |
$ |
214,671 |
|
|
$ |
252,696 |
|
Total stockholders’
equity |
$ |
188,963 |
|
|
$ |
223,805 |
|
|
|
|
|
|
|
|
|
Investor and Media Contacts:Eric LaubJounce
Therapeutics, Inc.+1-857-259-3853elaub@jouncetx.com
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