Jounce Therapeutics Reports Second Quarter 2021 Financial Results
August 05 2021 - 7:00AM
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, 2021 and
provided a corporate update.
“I am very pleased with the progress Jounce has made this
quarter as we continued to advance our two proof of concept
studies, INNATE and SELECT, achieved IND clearance on our fourth
internally discovered program and expanded our discovery programs
to include additional LILRB family members. Our team has made
important and rapid progress in our INNATE study with the
announcement today of monotherapy dose escalation enrollment
completion and target dose selection. We look forward to beginning
the next stages of the trial in third quarter of this year,” said
Richard Murray, Ph.D., chief executive officer and president of
Jounce Therapeutics. “We remain steadfast in our commitment to
discover and develop novel IO therapies to meet the growing unmet
medical need experienced in cancer patients, particularly in the
area of PD-(L)1 inhibitor resistance. We believe our focus on
translational science, biomarker approaches, and targeting new
immune mechanisms leads us closer to bringing the right
immunotherapies to the right patients.”
Pipeline Update:
JTX-8064 (LILRB2 / ILT4)
- Completed enrollment in
monotherapy dose escalation portion of INNATE: Jounce
announces today that the monotherapy dose escalation portion of the
Phase 1 trial of JTX-8064 is complete. The monotherapy dose
escalation included seven doses ranging from 50 mg to the highest
planned dose of 1200 mg. To date, JTX-8064 has been well-tolerated
with no dose limiting toxicities.
- Identified target dose for next stages of
INNATE: Jounce announces today the selection of its target
dose of 700 mg. The selected target dose was based on a combination
of safety, pharmacokinetic, and receptor occupancy data in the
first three-week cycle. During the third quarter of 2021, Jounce
expects to open eight expansion cohorts for enrollment, one with
JTX-8064 monotherapy at its target dose and seven with JTX-8064 in
combination with pimivalimab.
- Presented trial in progress
posters at the American Society of Clinical Oncology (ASCO) 2021
Annual Meeting: In June 2021, Jounce presented a trial in
progress poster at the ASCO Annual Meeting on INNATE. The poster
included the study design and the rationale for indications chosen
for the expansion cohorts.
Vopratelimab (ICOS) and Pimivalimab (PD-1)
- Continued enrollment in
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 (NSCLC) patients. The SELECT trial also
aims to provide additional important single agent data for
pimivalimab in a new biomarker selection paradigm. Jounce is on
track to report data from the SELECT trial in 2022.
- Presented trial in progress
poster at the ASCO 2021 Annual Meeting: In
June 2021, Jounce presented a trial in progress poster at the ASCO
Annual Meeting on SELECT. The poster described the study design,
TISvopra biomarker, and patient selection strategy of the SELECT
trial.
JTX-1811 (CCR8)
- Clearance of IND triggering first milestone under
Gilead license agreement: In June 2021, Jounce received
clearance from the U.S. Food and Drug Administration (FDA) of an
investigational new drug (IND) application for JTX-1811, a
potential first-in-class antibody designed to bind to CCR8 and
selectively deplete immunosuppressive tumor-infiltrating T
regulatory cells. The IND clearance triggered a $25.0 million
milestone payment to Jounce which was received in July 2021. Gilead
now has sole rights to develop and commercialize the JTX-1811
program, which will be referred to as GS-1811 in their
pipeline.
Discovery Pipeline
- Announced new discovery program targets:
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. Jounce is rapidly advancing two
additional LILRB family programs through discovery, one targeting
LILRB1 and the other targeting LILRB4. With the goal of submitting
a new IND every 12 to 18 months, Jounce expects at least one of its
next development candidates to target the LILRB family of
receptors.
Second Quarter 2021 Financial Results:
- Cash position: As
of June 30, 2021, cash, cash equivalents and investments were
$246.1 million, compared to $213.2 million as of December 31,
2020. The increase was primarily due to receipt of $90.9 million in
net proceeds from the follow-on public offering and sales under
Jounce’s at-the-market offering program completed during the
period, offset by operating expenses incurred. This amount excludes
the $25.0 million milestone Jounce received from Gilead in July
2021.
- License and collaboration
revenue: Jounce recognized $25.4 million of license and
collaboration revenue during the second quarter of 2021. License
and collaboration revenue recognized during the period was related
to milestone achievement and research and transition services
performed under the license agreement with Gilead. No revenue was
recognized for the same period in 2020.
- Research and development
expenses: Research and development expenses were $22.1
million for the second quarter of 2021, compared to $21.0 million
for the same period in 2020. The increase in research and
development expenses was primarily due to increased manufacturing
activities performed for Jounce’s development programs and
increased clinical and regulatory spend on JTX-8064 offset by
decreased spend on vopratelimab.
- General and administrative
expenses: General and administrative expenses were $7.3
million for the second quarter of 2021, compared to $7.2 million
for the same period in 2020. The increase in general and
administrative expenses was primarily due to increased insurance
expense.
- Net loss: Net loss was $4.0 million for the
second quarter of 2021, resulting in basic and diluted net loss per
share of $0.08. Net loss was $28.0 million for the same period in
2020, resulting in a basic and diluted net loss per share of $0.82.
The decrease in net loss and net loss per share was attributable to
revenue recognized in the second 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 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 4291658. 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, 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 obtained IND clearance for and 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, initiation,
progress, results of and release of data for clinical trials of
Jounce’s product candidates, including JTX-8064, vopratelimab and
pimivalimab; 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 “aim,” “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 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.
|
Three Months EndedJune 30, |
|
Six Months EndedJune 30, |
|
2021 |
|
2020 |
|
2021 |
|
2020 |
Revenue: |
|
|
|
|
|
|
|
License and collaboration revenue—related party |
$ |
25,368 |
|
|
$ |
— |
|
|
$ |
26,907 |
|
|
$ |
— |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
22,100 |
|
|
21,023 |
|
|
42,607 |
|
|
40,669 |
|
General and administrative |
7,317 |
|
|
7,226 |
|
|
14,932 |
|
|
14,765 |
|
Total operating expenses |
29,417 |
|
|
28,249 |
|
|
57,539 |
|
|
55,434 |
|
Operating loss |
(4,049 |
) |
|
(28,249 |
) |
|
(30,632 |
) |
|
(55,434 |
) |
Other income, net |
40 |
|
|
285 |
|
|
89 |
|
|
1,035 |
|
Loss before provision for
income taxes |
(4,009 |
) |
|
(27,964 |
) |
|
(30,543 |
) |
|
(54,399 |
) |
Provision for income
taxes |
2 |
|
|
4 |
|
|
3 |
|
|
12 |
|
Net loss |
$ |
(4,011 |
) |
|
$ |
(27,968 |
) |
|
$ |
(30,546 |
) |
|
$ |
(54,411 |
) |
Net loss per share, basic and
diluted |
$ |
(0.08 |
) |
|
$ |
(0.82 |
) |
|
$ |
(0.63 |
) |
|
$ |
(1.60 |
) |
Weighted-average common shares
outstanding, basic and diluted |
51,212 |
|
|
34,053 |
|
|
48,601 |
|
|
34,041 |
|
|
|
|
Jounce Therapeutics, Inc.Selected
Condensed Consolidated Balance Sheet Data
(unaudited)(amounts in thousands) |
|
|
|
|
|
June 30, |
|
December 31, |
|
2021 |
|
2020 |
Cash, cash equivalents and
investments |
$ |
246,148 |
|
|
$ |
213,188 |
|
Working capital |
$ |
241,278 |
|
|
$ |
192,067 |
|
Total assets |
$ |
306,160 |
|
|
$ |
244,236 |
|
Total stockholders’
equity |
$ |
278,462 |
|
|
$ |
211,294 |
|
Investor and Media Contact:Mark YoreJounce
Therapeutics, Inc.+1-857-200-1255 myore@jouncetx.com
Julie SeidelStern Investor
Relations+1-212-362-1200Julie.Seidel@sternir.com
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