Jounce Therapeutics Reports First Quarter 2020 Financial Results
06 May 2020 - 8:30PM
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, 2020 and
provided a corporate update.
“The start to 2020 has been marked by unprecedented times as the
impact of the ongoing COVID-19 pandemic has been felt globally.
Through this challenging environment, Jounce remains committed to
driving our novel science forward as we work hard to bring
long-lasting benefit to cancer patients with critical unmet needs
and I am proud of our team’s strength and commitment during this
time,” said Richard Murray, Ph.D., chief executive officer and
president of Jounce Therapeutics. “Though both the enrollment of
the EMERGE Phase 2 trial and initiation of the SELECT Phase 2 trial
have been modestly impacted by COVID-19, we are dedicated to the
continued advancement of vopratelimab while simultaneously keeping
the safety of our patients, employees and clinical collaborators at
the forefront of our work. We look forward to executing on our
milestones as we work diligently to progress our pipeline of
clinical and preclinical programs.”
Pipeline Update:Clinical Programs:
Vopratelimab and JTX-4014Jounce currently expects a modest
delay of approximately 2 to 3 months to both EMERGE interim
analysis and initiation of the SELECT clinical trial due to
COVID-19.
- Phase 2 EMERGE trial interim analysis data:
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 is expected to be complete
mid-year 2020, and per protocol, will include at least 18 weeks of
clinical plus biomarker data from all evaluable patients. The
interim analysis will be conducted approximately 6 months after the
last patient is enrolled and as such has shifted into early
2021.
- Phase 2 SELECT trial initiation: Preparations
continue for the initiation of the randomized SELECT trial to
evaluate vopratelimab in combination with JTX-4014, a PD-1
inhibitor, versus JTX-4014 alone, in PD-1 inhibitor naive TISvopra
biomarker selected patients in second line NSCLC. Jounce expects to
enroll approximately 75 patients, outside the U.S. Despite the
approximate 2 to 3 month delay to initiate the trial due to
COVID-19, Jounce still expects to report clinical data in
2021.
- Identified TISvopra predictive biomarker for Phase 2
SELECT trial: In February 2020, Jounce presented new data
identifying the predictive biomarker associated with vopratelimab
patient selection, known as TISvopra, a baseline RNA signature with
a threshold optimized for the prediction of the emergence of ICOS
hi CD4 T cells which is expected to predict for both vopratelimab
and PD-1 activity.
Pre-Clinical Program: JTX-1811
- Announced CCR8 as the JTX-1811 target: CCR8 is
a chemokine receptor enriched on intra-tumoral T regulatory cells.
CCR8 was one of Jounce’s top choices of T regulatory targets
stemming from its systematic interrogation of the tumor
microenvironment using its discovery engine. JTX-1811, the next
potential first-in-class development program, is a monoclonal
antibody designed to selectively deplete immuno-suppressive T
regulatory cells. When JTX-1811 binds to CCR8, it targets the T
regulatory cells for depletion by enhanced antibody-dependent
cellular cytotoxicity. Jounce will present new preclinical data at
the second portion of the virtual 2020 American Association for
Cancer Research (AACR) annual meeting being held June 22-24 and
expects to file an Investigational New Drug (IND) application in
the first half of 2021.
Corporate Update:
- COVID-19 and Jounce operations: Amid the
ongoing COVID-19 pandemic, Jounce has taken key precautions in line
with guidance from public health officials to ensure the health and
safety of its employees, patients enrolled in clinical trials,
investigators and clinical collaborators. Critical research lab
work continues on site, while non-laboratory employees are working
remotely.
First Quarter 2020 Financial Results:
- Cash position: As of March 31, 2020,
cash, cash equivalents and investments were $148.6 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: We did not
recognize any license and collaboration revenue in the first
quarter of 2020. License and collaboration revenue recognized
during the first 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 $19.6 million for the first quarter
of 2020, compared to $17.3 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 $7.5 million for the first quarter
of 2020, compared to $7.2 million for the same period in 2019. The
increase in general and administrative expenses was primarily due
to increased professional service fees.
- Net loss: Net loss was $26.4 million for the
first quarter of 2020, resulting in basic and diluted net loss per
share of $0.78. Net loss was $12.4 million for the same period in
2019, resulting in a basic and diluted net loss per share of $0.38.
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.
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 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 4044098. 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
has three 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 a
biomarker trial using TISvopra for patient selection, SELECT, to
assess vopratelimab in combination with JTX-4014. The next
development candidate to emerge from Jounce’s Translational Science
Platform is JTX-1811, a monoclonal antibody designed to selectively
deplete T regulatory cells in the tumor microenvironment. JTX-1811
is currently in IND-enabling activities. In addition, Jounce has
exclusively licensed worldwide rights to JTX-8064, a LILRB2
receptor antagonist, to Celgene Corporation, a wholly-owned
subsidiary of Bristol-Myers Squibb Company. 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 and JTX-4014; identification, selection and enrollment
of patients for Jounce’s clinical trials; the timing and release of
JTX-1811 data; 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, 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 March 31, |
|
2020 |
|
2019 |
Revenue: |
|
|
|
License and collaboration revenue—related party |
$ |
— |
|
|
$ |
10,981 |
|
Operating expenses: |
|
|
|
Research and development |
19,646 |
|
|
17,280 |
|
General and administrative |
7,539 |
|
|
7,192 |
|
Total operating expenses |
27,185 |
|
|
24,472 |
|
Operating loss |
(27,185 |
) |
|
(13,491 |
) |
Other income, net |
750 |
|
|
1,126 |
|
Loss before provision for
income taxes |
(26,435 |
) |
|
(12,365 |
) |
Provision for income
taxes |
8 |
|
|
12 |
|
Net loss |
$ |
(26,443 |
) |
|
$ |
(12,377 |
) |
Net loss per share, basic and
diluted |
$ |
(0.78 |
) |
|
$ |
(0.38 |
) |
Weighted-average common shares
outstanding, basic and diluted |
34,029 |
|
|
32,959 |
|
|
|
|
|
Jounce Therapeutics, Inc.Selected
Condensed Consolidated Balance Sheet Data
(unaudited)(amounts in thousands) |
|
|
|
March 31, |
|
December 31, |
|
2020 |
|
2019 |
Cash, cash equivalents and
investments |
$ |
148,574 |
|
|
$ |
170,444 |
|
Working capital |
$ |
138,064 |
|
|
$ |
159,297 |
|
Total assets |
$ |
182,950 |
|
|
$ |
205,882 |
|
Total stockholders’
equity |
$ |
152,544 |
|
|
$ |
174,593 |
|
Investor and Media Contact:Komal JoshiJounce
Therapeutics, Inc.(857) 320-2523kjoshi@jouncetx.com
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