Jounce Therapeutics Reports Second Quarter 2020 Financial Results
August 07 2020 - 06:30AM
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 second quarter ended June 30, 2020 and
provided a corporate update.
“We made great strides in the second quarter and this year as a
whole has proven to be a time of execution and important
foundational work in advance of important future milestones. Of
note, we completed EMERGE enrollment to support the interim
analysis despite the challenges of the COVID-19 pandemic, and are
on track for the interim analysis of efficacy and biomarker data in
early 2021. We also expect to initiate enrollment this year of the
Phase 1 trial for JTX-8064, an inhibitor of the LILRB2 receptor (or
ILT4) on macrophages,” said Richard Murray, Ph.D., chief executive
officer and president of Jounce Therapeutics. “We continue to build
a leading immuno-oncology company, focusing on the importance of
deeply rooted science, translational analyses and well-informed
clinical trial design. We look forward to continuing to execute on
our milestones as we progress our broad pipeline of clinical and
preclinical programs to bring the right immunotherapies to the
right patients.”
Pipeline Update:
Clinical Programs: Vopratelimab and
JTX-4014
- Completed enrollment to support interim analysis of
Phase 2 EMERGE trial: Enrollment of patients with
non-small cell lung cancer (NSCLC) who have progressed on or after
both a platinum-based regimen and a PD-1 or PD-L1 inhibitor to
support the interim analysis of the Phase 2 EMERGE trial is
complete. Jounce is on track to complete this analysis of
preliminary efficacy and biomarker data on more than 40 evaluable
patients at different doses in early 2021.
- Phase 2 SELECT trial initiation on track:
Jounce remains on track to initiate the randomized Phase 2 SELECT
trial to evaluate vopratelimab in combination with JTX-4014, a PD-1
inhibitor, versus JTX-4014 alone in immunotherapy naïve TISvopra
biomarker selected, second line NSCLC patients. Jounce expects to
enroll approximately 75 patients outside the U.S. and expects to
report clinical data in 2021.
- Presented vopratelimab translational data at the
American Association for Cancer Research (AACR): In June
2020, Jounce presented new translational data on vopratelimab at
the AACR Virtual Annual Meeting detailing important characteristics
of ICOS hi CD4 T cells associated with vopratelimab treatment that
may contribute to durable clinical responses in monotherapy and
combination. The ICOS hi CD4 T cell population within peripheral
blood of ICONIC responders is comprised of Th1, T central memory
(Tcm) and T follicular helper (Tfh) subsets, which may contribute
to direct anti-tumor effects as well as durability of clinical
responses. Jounce has found that the generation of these
functionally specialized subsets of CD4 cells does not occur with
PD-1 inhibitors. The T cell central memory cells are consistent
with a role for vopratelimab in durable clinical benefit.
Preclinical Development Programs: JTX-8064 and
JTX-1811
- Regained worldwide rights to JTX-8064 and on track to
initiate Phase 1 clinical trial: In June 2020, Jounce
announced that it regained the worldwide rights to JTX-8064 from
Bristol Myers Squibb. JTX-8064 is a highly-selective, potential
first-in-class antibody that targets the Leukocyte Immunoglobulin
Like Receptor B2 (LILRB2 or ILT4) on macrophages, and was
previously licensed to Celgene in July 2019. As part of its Celgene
integration process, Bristol Myers Squibb has streamlined its
pipeline and addressed areas of overlap. As a result, Bristol Myers
Squibb notified Jounce that the JTX-8064 License Agreement was
being terminated. JTX-8064 is the first tumor-associated macrophage
candidate to emerge from Jounce’s Translational Science Platform.
When LILRB2 (ILT4) binds to HLA molecules, including HLA-G, on
cancer cells and macrophages, it induces an immunosuppressive state
in the macrophages. JTX-8064 inhibits this immunosuppressive
interaction, reprogramming the macrophages to a more
immuno-stimulatory state. Jounce expects to begin enrollment in the
Phase 1 dose escalation trial of JTX-8064 in 2020.
- Presented new JTX-1811 preclinical data at
AACR: In June 2020, Jounce introduced its JTX-1811 program
at the AACR Virtual Annual Meeting with preclinical data
demonstrating that by selectively eliminating tumor infiltrating T
regulatory cells (T regs), Jounce believes it can eliminate the
immunosuppressive effect of these cells. Importantly, this biology
may be independent of PD-1. In mouse tumor models, targeting and
eliminating CCR8 positive T regs in the tumor showed single agent
activity for JTX-1811 where PD-1 inhibitors did not, and showed an
ability to restore PD-1 inhibitor responsiveness. Evaluation of T
regs in human tumors versus blood showed the enriched expression of
CCR8, allowing the establishment of an optimal window for depletion
of T regs in the tumor. Jounce plans to continue IND-enabling
activities for JTX-1811 and remains on track to file an
Investigational New Drug, or IND, in the first half of 2021.
Second Quarter 2020 Financial Results:
- Cash position: As of June 30, 2020, cash,
cash equivalents and investments were $127.2 million, compared to
$170.4 million as of December 31, 2019. The decrease in cash,
cash equivalents and investments was primarily due to operating
expenses incurred during the period.
- License and collaboration revenue: Jounce did
not recognize any revenue in the second quarter of 2020. License
and collaboration revenue recognized during the second quarter of
2019 was comprised solely of non-cash revenue recognition related
to the original strategic collaboration with Celgene which ended in
July 2019.
- Research and development expenses: Research
and development expenses were $21.0 million for the second quarter
of 2020, compared to $18.1 million for the same period in 2019. The
increase in research and development expenses was primarily due to
increased external clinical and regulatory costs associated with
the EMERGE and SELECT clinical trials and increased employee
compensation costs, partially offset by decreased IND-enabling
expenses.
- General and administrative expenses: General
and administrative expenses were $7.2 million for the second
quarter of 2020, compared to $7.3 million for the same period in
2019. The decrease in general and administrative expenses was
primarily due to decreased professional service fees.
- Net loss: Net loss was $28.0 million for the
second quarter of 2020, resulting in basic and diluted net loss per
share of $0.82. Net loss was $7.0 million for the same period in
2019, resulting in a basic and diluted net loss per share of $0.21.
The increase in net loss and net loss per share was primarily
attributable to a decrease in license and collaboration revenue and
an increase in operating expenses.
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 2020 to be approximately
$80.0 million to $95.0 million.
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 end of
2021.
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 3898328. 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 four
development-stage programs, two of which are clinical-stage:
vopratelimab, a monoclonal antibody that binds to and activates
ICOS, and JTX-4014, a PD-1 inhibitor intended for combination use
with Jounce’s broader pipeline. Vopratelimab is currently being
assessed in a Phase 2 clinical trial, EMERGE, and Jounce plans to
initiate an additional Phase 2 biomarker trial using TISvopra for
patient selection, SELECT, to assess vopratelimab in combination
with JTX-4014. Jounce’s IND-enabling preclinical programs include
JTX-8064, a LILRB2 (ILT4) receptor antagonist and JTX-1811, a
monoclonal antibody designed to selectively deplete T regulatory
cells in the tumor microenvironment. 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, initiation,
progress, results of and release of data for clinical trials of
Jounce’s product candidates, including vopratelimab, JTX-4014 and
JTX-8064; identification, selection and enrollment of patients for
Jounce’s clinical trials; the timing of IND filings; and the
timing, progress and results of preclinical studies for 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 “goal,” “expect,” “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, 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 further delaying
enrollment and completion of Jounce’s ongoing clinical trials, or
delaying timelines or data disclosures and regulatory submissions
for its product candidates; 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; 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 Ended June 30, |
|
Six Months Ended June 30, |
|
2020 |
|
2019 |
|
2020 |
|
2019 |
Revenue: |
|
|
|
|
|
|
|
License and collaboration revenue—related party |
$ |
— |
|
|
|
$ |
17,446 |
|
|
|
$ |
— |
|
|
|
$ |
28,427 |
|
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
21,023 |
|
|
|
18,130 |
|
|
|
40,669 |
|
|
|
35,410 |
|
|
General and administrative |
7,226 |
|
|
|
7,323 |
|
|
|
14,765 |
|
|
|
14,515 |
|
|
Total operating expenses |
28,249 |
|
|
|
25,453 |
|
|
|
55,434 |
|
|
|
49,925 |
|
|
Operating loss |
(28,249 |
) |
|
|
(8,007 |
) |
|
|
(55,434 |
) |
|
|
(21,498 |
) |
|
Other income, net |
285 |
|
|
|
1,026 |
|
|
|
1,035 |
|
|
|
2,152 |
|
|
Loss before provision for
income taxes |
(27,964 |
) |
|
|
(6,981 |
) |
|
|
(54,399 |
) |
|
|
(19,346 |
) |
|
Provision for income
taxes |
4 |
|
|
|
12 |
|
|
|
12 |
|
|
|
24 |
|
|
Net loss |
$ |
(27,968 |
) |
|
|
$ |
(6,993 |
) |
|
|
$ |
(54,411 |
) |
|
|
$ |
(19,370 |
) |
|
Net loss per share, basic and
diluted |
$ |
(0.82 |
) |
|
|
$ |
(0.21 |
) |
|
|
$ |
(1.60 |
) |
|
|
$ |
(0.59 |
) |
|
Weighted-average common shares
outstanding, basic and diluted |
34,053 |
|
|
|
32,973 |
|
|
|
34,041 |
|
|
|
32,966 |
|
|
|
|
|
|
|
|
|
|
Jounce Therapeutics, Inc.Selected
Condensed Consolidated Balance Sheet Data
(unaudited)(amounts in thousands) |
|
|
|
|
|
June 30, |
|
December 31, |
|
2020 |
|
2019 |
Cash, cash equivalents and
investments |
$ |
127,205 |
|
|
|
$ |
170,444 |
|
|
Working capital |
$ |
114,975 |
|
|
|
$ |
159,297 |
|
|
Total assets |
$ |
158,901 |
|
|
|
$ |
205,882 |
|
|
Total stockholders’
equity |
$ |
127,269 |
|
|
|
$ |
174,593 |
|
|
Investor and Media Contact:Komal JoshiJounce
Therapeutics, Inc.(857) 320-2523kjoshi@jouncetx.com
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