Jounce Therapeutics Reports First Quarter 2021 Financial Results
May 04 2021 - 5:30AM
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 first quarter ended March 31, 2021 and
provided a corporate update.
“Jounce made meaningful progress this quarter as we continue to
advance our two proof of concept studies, grow our discovery and
development IO pipeline, and add to our strong balance sheet. We
also welcomed a new Chief Scientific Officer, Dr. Dmitri
Wiederschain, who brings more than 15 years of pharmaceutical
industry experience and a broad knowledge of contemporary
immuno-oncology approaches,” said Richard Murray, Ph.D., chief
executive officer and president of Jounce Therapeutics. “We are at
an exciting point in Jounce’s development, with the leadership,
capital and resources, and scientific and clinical development
acumen needed to move beyond our next set of inflection points. We
remain committed to our core strategy of translational science,
biomarker approaches, and targeting new immune mechanisms in our
goal of bringing the right immunotherapies to the right
patients.”
Pipeline Update & Highlights:
JTX-8064 (LILRB2 / ILT4)
- Initiated enrollment in the
Phase 1 INNATE trial of JTX-8064: In January 2021, Jounce
initiated enrollment in INNATE, a Phase 1 clinical trial of
JTX-8064 alone and in combination with its PD-1 inhibitor,
JTX-4014, now known as pimivalimab, or an approved PD-1 inhibitor.
INNATE remains on track for the opening of eight expansion cohorts
in the second half of the year, one with JTX-8064 monotherapy, and
seven in combination with a PD-1 inhibitor.
- Presented JTX-8064
preclinical data at the American Association for Cancer Research
(AACR) Annual Meeting: In April 2021 at AACR, Jounce
presented data describing how expression profiles of LILRB2 mRNA,
the proprietary Tumor Associated Macrophage (“TAM”) signature, and
an interferon gamma signature were used to identify tumor types
that may benefit most from JTX-8064 treatment, alone or in
combination with a PD-1 inhibitor. This data was used to inform the
tumor types in the expansion cohorts of the INNATE trial.
- Trial in progress posters to
be presented at the American Society of Clinical Oncology (ASCO)
2021 Annual Meeting: On June 4, 2021 Jounce will present a
trial in progress poster at the ASCO Annual Meeting on INNATE. The
poster will include the study design and the rationale for
indications chosen for the expansion cohorts. Eight expansion
cohorts will be opening for enrollment in the second half of 2021,
one with JTX-8064 and seven with JTX-8064 plus a PD-1
inhibitor.
Vopratelimab (ICOS) and Pimivalimab (PD-1)
- Continued enrollment in the
Phase 2 SELECT trial of vopratelimab: Enrollment continues
in SELECT, a randomized Phase 2 trial to evaluate vopratelimab in
combination with pimivalimab versus pimivalimab alone in
immunotherapy naïve, TISvopra biomarker-selected, second line
non-small cell lung cancer patients. Jounce is on track to report
data from the SELECT trial in 2022. The SELECT trial will also
provide additional important single agent data for pimivalimab in a
new biomarker selection paradigm.
- Trial in progress poster to
be presented at the ASCO 2021 Annual Meeting: On June 4,
2021 Jounce will present a trial in progress poster at the ASCO
Annual Meeting on SELECT. The poster will describe the study
design, TISvopra biomarker, and patient selection strategy of the
SELECT trial.
JTX-1811 (CCR8)
- Progressed JTX-1811 toward IND: Jounce
continues to progress JTX-1811, a potential first-in-class antibody
designed to bind to CCR8 and selectively deplete immunosuppressive
tumor-infiltrating T regulatory cells. JTX-1811 remains on track
for an investigational new drug application (“IND”) clearance in
2021 at which point Gilead Sciences, Inc. will take over clinical
development and potential commercialization.
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. The broad discovery
pipeline includes multiple programs targeting diverse immune cell
types and PD-(L)1 inhibitor resistance mechanisms.
First Quarter 2021 Financial Results:
- Cash position: As
of March 31, 2021, cash, cash equivalents and investments
increased to $271.3 million, compared to $213.2 million as of
December 31, 2020. The increase was primarily due to receipt
of $60.6 million in net proceeds from the follow-on public offering
completed in March 2021 and receipt of $30.2 million in net
proceeds from sales under Jounce’s at-the-market offering program
(“ATM”), offset by operating expenses incurred during the
period.
- License and collaboration
revenue: License revenue of $1.5 million was recognized
during the first quarter of 2021 and was comprised solely of
non-cash revenue related to research and transition services
performed under the Gilead License Agreement. Jounce did not
recognize any license or collaboration revenue in the first quarter
of 2020.
- Research and development
expenses: Research and development expenses were $20.5
million for the first quarter of 2021, compared to $19.6 million
for the same period in 2020. The increase in research and
development expenses was primarily due to increased manufacturing
and IND-enabling activities performed for our development programs,
offset by decreased clinical and regulatory costs attributable to
reduced spend on vopratelimab.
- General and administrative
expenses: General and administrative expenses were $7.6
million for the first quarter of 2021, compared to $7.5 million for
the same period in 2020. The increase in general and administrative
expenses was primarily due to increased stock-based compensation
expense.
- Net loss: Net loss was $26.5 million for the
first quarter of 2021, resulting in basic and diluted net loss per
share of $0.58. Net loss was $26.4 million for the same period in
2020, resulting in a basic and diluted net loss per share of $0.78.
The increase in net loss was primarily attributable to increased
operating expenses, offset by revenue recognized in the first
quarter of 2021.
Financial Guidance:
Based on its current operating and development plans, Jounce
continues to expect gross cash burn on operating expenses and
capital expenditures for the full year 2021 to be approximately
$95.0 million to $110.0 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 second 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 1389694. 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. A Phase 1 clinical
trial, named INNATE, of JTX-8064 as a monotherapy and in
combination with pimivalimab (formerly JTX-4014), Jounce’s internal
PD-1 inhibitor, or an approved PD-1 inhibitor is currently
enrolling patients with advanced solid tumors. 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 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, operating
expenses and capital expenditures; the timing, progress, results
and release of data for clinical trials of vopratelimab,
pimivalimab and JTX-8064; identification, selection and enrollment
of patients for Jounce’s clinical trials; the use of pimivalimab in
combination with Jounce’s other product candidates; and the timing,
progress and results of preclinical studies and development of
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,” “goal,” “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.Condensed
Consolidated Statements of Operations
(unaudited)(amounts in thousands, except per share
data) |
|
|
Three Months EndedMarch 31, |
|
2021 |
|
2020 |
Revenue: |
|
|
|
License and collaboration revenue—related party |
$ |
1,539 |
|
|
$ |
— |
|
Operating expenses: |
|
|
|
Research and development |
20,507 |
|
|
19,646 |
|
General and administrative |
7,615 |
|
|
7,539 |
|
Total operating expenses |
28,122 |
|
|
27,185 |
|
Operating loss |
(26,583 |
) |
|
(27,185 |
) |
Other income, net |
49 |
|
|
750 |
|
Loss before provision for
income taxes |
(26,534 |
) |
|
(26,435 |
) |
Provision for income
taxes |
1 |
|
|
8 |
|
Net loss |
$ |
(26,535 |
) |
|
$ |
(26,443 |
) |
Net loss per share, basic and
diluted |
$ |
(0.58 |
) |
|
$ |
(0.78 |
) |
Weighted-average common shares
outstanding, basic and diluted |
45,962 |
|
|
34,029 |
|
|
|
|
|
Jounce Therapeutics, Inc.Selected
Condensed Consolidated Balance Sheet Data
(unaudited)(amounts in thousands) |
|
|
|
March 31, |
|
December 31, |
|
2021 |
|
2020 |
Cash, cash equivalents and
investments |
$ |
271,286 |
|
|
$ |
213,188 |
|
Working capital |
$ |
254,088 |
|
|
$ |
192,067 |
|
Total assets |
$ |
305,153 |
|
|
$ |
244,236 |
|
Total stockholders’
equity |
$ |
279,454 |
|
|
$ |
211,294 |
|
|
|
|
|
|
|
|
|
Investor and Media Contacts:Malin DeonJounce
Therapeutics, Inc.+1-857-259-3843mdeon@jouncetx.com
Mark YoreJounce Therapeutics,
Inc.+1-857-200-1255myore@jouncetx.com
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