Jounce Therapeutics Reports Fourth Quarter and Full Year 2020 Financial Results
February 25 2021 - 6:30AM
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 fourth quarter and year ended December 31,
2020 and provided a corporate update.
“2020 proved to be a year of important pipeline execution and
corporate development at Jounce despite the challenges presented by
the COVID-19 pandemic. As we enter 2021, we are strongly positioned
to execute on our two proof of concept studies, INNATE and SELECT,
and continue to advance our sustainable discovery pipeline. Our
potential first-in-class programs and biomarker approaches are
aimed at bringing meaningful clinical benefit to the growing
population of PD-(L)1 inhibitor naïve and experienced patients,”
said Richard Murray, Ph.D., chief executive officer and president
of Jounce Therapeutics. “The need for novel approaches targeting
different immune cells in the tumor microenvironment highlights the
importance of our translational science platform and our productive
discovery engine. This approach has allowed us to generate multiple
targets beyond T-cells, most notably our highest priority program,
JTX-8064, targeting LILRB2, also known as ILT4. As we enter 2021,
Jounce is poised to further our goal of bringing the right
immunotherapies to the right patients.”
Pipeline Update and Highlights:
JTX-8064 (LILRB2 / ILT4)
- Initiated Phase 1 INNATE trial of
JTX-8064: In January 2021, Jounce
enrolled the first dose cohort in INNATE, a Phase 1 clinical trial
of JTX-8064 alone and in combination with its PD-1 inhibitor,
JTX-4014, or pembrolizumab. The trial is designed to progress
quickly through dose escalation and demonstrate proof of concept in
tumor specific expansion cohorts.
- Presented JTX-8064 preclinical data at the Society for
Immunotherapy of Cancer’s (SITC) 35th Annual Meeting: In
November 2020 at SITC, Jounce presented preclinical data for
JTX-8064 that informed the indication selection and biomarker
strategies for JTX-8064 to maximize potential therapeutic benefit
for patients with solid tumor malignancies.
Vopratelimab (ICOS) and JTX-4014 (PD-1)
- Initiated enrollment in the Phase 2 SELECT trial of
vopratelimab: In October 2020, Jounce initiated enrollment
in the randomized Phase 2 SELECT trial to evaluate vopratelimab in
combination with JTX-4014 versus JTX-4014 alone in immunotherapy
naïve TISvopra biomarker-selected, second line non-small cell lung
cancer patients. COVID-19 related delays are currently impacting
patient enrollment, and Jounce now anticipates reporting data from
the SELECT trial in 2022.
- Continued to advance JTX-4014 as a combination
agent: JTX-4014 is a PD-1 inhibitor intended for
combination with Jounce’s broad pipeline beginning with its two
ongoing proof of concept studies, the INNATE trial and the SELECT
trial. The SELECT trial will also provide additional important
single agent data for JTX-4014 in a new biomarker selection
paradigm..
JTX-1811 (CCR8)
- Established exclusive license agreement with Gilead for
the development and commercialization of JTX-1811: In
October 2020, Jounce licensed to Gilead Sciences, Inc. (“Gilead”)
the worldwide rights to JTX-1811, a potential first-in-class
antibody designed to bind to CCR8 and selectively deplete
immunosuppressive tumor-infiltrating T regulatory cells. Upon
clearance of an investigational new drug application (“IND”),
JTX-1811 will transition to Gilead for clinical development and
potential commercialization. In addition to an $85.0 million
upfront and a $35.0 million equity investment, Jounce has the
potential to earn up to $685.0 million in milestones as well
as royalties on worldwide sales. Jounce continues to progress
JTX-1811 to IND clearance and remains on track for an IND filing in
the first half of 2021.
Discovery Pipeline
- Productive discovery engine with 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 investigate different cell types
in the tumor microenvironment, including T cells, myeloid cells and
stromal cells.
Fourth Quarter and Full Year 2020 Financial
Results:
- Cash position: As
of December 31, 2020, cash, cash equivalents and investments
were $213.2 million, compared to $170.4 million as of
December 31, 2019. The increase in cash, cash equivalents and
investments was primarily due to receipt of $120.0 million in
proceeds from the license and stock purchase agreements with Gilead
and $14.5 million received during 2020 under Jounce’s
at-the-market offering program (“ATM”), offset by operating
expenses incurred during the year. In January 2021, the Company
completed the sale of all available amounts under the existing ATM
with the sale of 3,156,200 shares for net proceeds of
$30.2 million.
- License and collaboration
revenue: $62.3 million of license and collaboration
revenue was recognized during the fourth quarter of 2020. Jounce
did not recognize any license and collaboration revenue for the
same period in 2019. License and collaboration revenue was $62.3
million for the full year 2020, compared to $147.9 million for the
full year 2019. Revenue recognized during 2020 was related to
Jounce’s license agreement with Gilead. Revenue recognized during
2019 was comprised of $50.0 million of cash revenue related to
Jounce’s JTX-8064 license agreement with Celgene and
$97.9 million of non-cash revenue recognition related to the
$225.0 million upfront payment received in July 2016 under the
Celgene collaboration agreement.
- Research and development
expenses: Research and development expenses were $20.0
million for the fourth quarter of 2020, compared to $16.6 million
for the same period in 2019. Research and development expenses were
$78.7 million for the full year 2020, compared to $67.1 million for
the full year 2019. The increase in research and development
expenses for the full year 2020 was primarily due to $7.9 million
of increased clinical and regulatory expense primarily attributable
to the SELECT clinical trial, $3.2 million of increased
manufacturing and IND-enabling expenses and $2.9 million of
increased employee compensation costs. These increases were
partially offset by $0.9 million and $0.8 million of decreased
other research costs, primarily related to reduced travel, and lab
consumable costs, respectively.
- General and administrative
expenses: General and administrative expenses were $6.9
million for both the fourth quarter of 2020 and 2019. General and
administrative expenses were $28.8 million for the full year 2020,
compared to $27.9 million for the full year 2019. The increase in
general and administrative expenses for full year 2020 was
primarily attributable to $1.5 million of increased employee
compensation costs.
- Net income (loss): Net income was $35.5
million for the fourth quarter of 2020, resulting in basic net
income per share of $0.90 and diluted net income per share of
$0.86. Net loss was $22.7 million for the same period in 2019,
resulting in basic and diluted net loss per share of $0.68. Net
loss was $43.8 million for the full year 2020, resulting in basic
and diluted net loss per share of $1.24. Net income was $56.8
million for the full year 2019, resulting in basic net income per
share of $1.72 and diluted net income per share of $1.66. Net loss
for the full year 2020 was attributable to increased operating
expenses, offset by $62.3 million of license revenue recognized
under Jounce’s agreement with Gilead. Net income for the full year
2019 was primarily attributable to $147.9 million of revenue
recognized under the Celgene license and collaboration agreements
in the year.
Financial Guidance:
Based on its current operating and development plans, Jounce
reiterates its financial guidance for 2021. Gross cash burn on
operating expenses and capital expenditures for the full year 2021
is expected 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 4698355. 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, for JTX-8064 as a monotherapy and in
combination with JTX-4014, Jounce’s internal PD-1 inhibitor, or
pembrolizumab 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. JTX-4014 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, JTX-4014 and JTX-8064; identification, selection and
enrollment of patients for Jounce’s clinical trials; the use of
JTX-4014 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.Consolidated Statements of
Operations (unaudited)(amounts in thousands,
except per share data)
|
Three Months EndedDecember
31, |
|
Year EndedDecember 31, |
|
2020 |
|
2019 |
|
2020 |
|
2019 |
Revenue: |
|
|
|
|
|
|
|
License and collaboration revenue—related party |
$ |
62,339 |
|
|
$ |
— |
|
|
$ |
62,339 |
|
|
$ |
147,872 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
20,019 |
|
|
16,610 |
|
|
78,690 |
|
|
67,135 |
|
General and administrative |
6,899 |
|
|
6,922 |
|
|
28,766 |
|
|
27,920 |
|
Total operating expenses |
26,918 |
|
|
23,532 |
|
|
107,456 |
|
|
95,055 |
|
Operating income (loss) |
35,421 |
|
|
(23,532 |
) |
|
(45,117 |
) |
|
52,817 |
|
Other income, net |
51 |
|
|
875 |
|
|
1,289 |
|
|
4,052 |
|
Income (loss) before provision
for income taxes |
35,472 |
|
|
(22,657 |
) |
|
(43,828 |
) |
|
56,869 |
|
Provision for income
taxes |
— |
|
|
10 |
|
|
14 |
|
|
46 |
|
Net income (loss) |
$ |
35,472 |
|
|
$ |
(22,667 |
) |
|
$ |
(43,842 |
) |
|
$ |
56,823 |
|
Net income (loss) per share,
basic |
$ |
0.90 |
|
|
$ |
(0.68 |
) |
|
$ |
(1.24 |
) |
|
$ |
1.72 |
|
Net income (loss) per share,
diluted |
$ |
0.86 |
|
|
$ |
(0.68 |
) |
|
$ |
(1.24 |
) |
|
$ |
1.66 |
|
Weighted-average common shares
outstanding, basic |
39,434 |
|
|
33,272 |
|
|
35,426 |
|
|
33,080 |
|
Weighted-average common shares
outstanding, diluted |
41,442 |
|
|
33,272 |
|
|
35,426 |
|
|
34,294 |
|
|
|
|
|
|
|
|
|
Jounce Therapeutics, Inc.Selected
Consolidated Balance Sheet Data
(unaudited)(amounts in thousands) |
|
|
|
|
|
December 31, |
|
2020 |
|
2019 |
Cash, cash equivalents and
investments |
$ |
213,188 |
|
|
$ |
170,444 |
|
Working capital |
$ |
192,067 |
|
|
$ |
159,297 |
|
Total assets |
$ |
244,236 |
|
|
$ |
205,882 |
|
Total stockholders’
equity |
$ |
211,294 |
|
|
$ |
174,593 |
|
Investor and Media Contacts:Malin DeonJounce
Therapeutics, Inc.+1-857-259-3843mdeon@jouncetx.com
Mark YoreJounce Therapeutics, Inc.+1-857-200-1255
myore@jouncetx.com
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