Jounce Therapeutics Reports Third Quarter 2017 Financial Results
November 13 2017 - 6:30AM
- Remain on track to announce preliminary
efficacy data for the Phase 1/2 ICONIC study in 1H 2018 -
Jounce Therapeutics, Inc. (NASDAQ:JNCE), a clinical stage company
focused on the discovery and development of novel cancer
immunotherapies and predictive biomarkers for patient enrichment,
today reported financial results and provided a corporate update
for the quarter ended September 30, 2017.
“During the third quarter, Jounce continued to progress on the
ongoing Phase 2 portion of the ICONIC study. We are pleased with
the ICONIC study enrollment and remain on track to deliver
preliminary efficacy data in the first half of 2018, together with
updated safety and biomarker data. We also made key appointments to
our Board of Directors and leadership team,” said Richard Murray,
Ph.D., chief executive officer and president of Jounce
Therapeutics. “We continue to emphasize and build our earlier stage
research efforts to expand our innovative pipeline and maximize the
value of our Translational Science Platform, with the goal of
delivering novel immunotherapies to provide long-lasting benefits
to cancer patients.”
Corporate and Clinical Highlights:
- Reiterate Timing of Preliminary Efficacy Data:
The Phase 1/2 ICONIC study remains on track and Jounce expects to
share preliminary efficacy data in the first half of 2018.
- Senior Appointments: During the third quarter,
Jounce announced the addition of Hugh Cole to its leadership team
as Chief Business Officer and Head of Corporate Development and the
promotion of Emma Lees, Ph.D., from Vice President to Senior Vice
President of Research. In October, Jounce announced the appointment
of Luis A. Diaz, Jr., M.D., Head of the Division of Solid Tumor
Oncology at Memorial Sloan Kettering Cancer Center, to its Board of
Directors.
- Presentation and Poster at the Annual Society for
Immunotherapy of Cancer (SITC): At the 2017 SITC meeting,
the November 8th oral presentation, during the pre-conference
program, described preclinical data regarding Jounce’s
biomarker-driven strategy to guide the clinical development program
of JTX-2011. The November 10th poster presentation showed the
establishment of an ex vivo tumor histoculture system, which can
facilitate a functional and biomarker analysis of therapies using
intact human tumor tissue.
Third Quarter 2017 Financial Results:
- Cash Position: As of September 30, 2017,
cash, cash equivalents and investments were $283.4 million,
compared to $257.4 million as of December 31, 2016. This increase
was primarily due to the $106.4 million in net proceeds from
Jounce’s initial public offering (IPO), offset by operating costs
during the year.
- Collaboration Revenue: Collaboration revenue
was $18.1 million for the third quarter of 2017, compared to $16.9
million for the same period in 2016. Collaboration revenue
represents the amortization of the $225.0 million upfront payment
received in July 2016 upon the execution of Jounce’s global
strategic collaboration with Celgene.
- Research and Development (R&D) Expenses:
R&D expenses were $17.1 million for the third quarter of 2017,
compared to $9.5 million for the same period in 2016. The increase
in R&D expenses was primarily due to $2.8 million in increased
clinical costs related to the Phase 1/2 ICONIC study of JTX-2011,
$1.9 million in increased external research and development costs,
primarily attributable to the manufacture of pre-commercial
clinical trial materials and related activities for JTX-2011, $2.0
million in increased lab consumable costs attributable to increased
headcount and general research and development activities and $0.8
million in increased facilities costs.
- General and Administrative (G&A) Expenses:
G&A expenses were $5.4 million for the third quarter of 2017,
compared to $3.6 million for the same period in 2016. The increase
in G&A expenses was primarily due to $0.7 million in increased
employee compensation costs related to increased headcount as well
as increased recruiting costs, $0.7 million in increased facilities
costs and $0.4 million in increased other costs attributable to
operating as a public company.
- Net Loss: Net loss was $4.1 million for the
third quarter of 2017, or a basic and diluted net loss per share
attributable to common stockholders of $0.13. Net income was $4.1
million for the same period in 2016, or basic net income per share
attributable to common stockholders of $0.07 and diluted net income
per share attributable to common stockholders of $0.03. The change
is primarily attributable to the increase in operating expenses
from the third quarter of 2016 to the third quarter of 2017 as a
result of increased headcount, research and development activities
and costs attributable to operating as a public company, offset by
increased collaboration revenues.
Financial Guidance:
Jounce has narrowed its financial guidance previously provided
for the full year 2017. Jounce previously announced that it
expected to use approximately $100.0 million to $120.0 million in
cash for the full year 2017. Based on its current operating plan
for the remainder of the year, Jounce now expects to use
approximately $100.0 million to $110.0 million in cash for the full
year 2017, including the projected expense of operating activities,
build out and capital costs associated with the relocation of its
lab and office space in Cambridge, Massachusetts and payment of
federal and state income taxes related to the receipt of the
Celgene upfront payment of $225.0 million in 2016.
Additionally, Jounce previously announced that it expected
collaboration revenue, from the non-cash amortization of the
Celgene upfront payment, for the full year 2017 to be approximately
$80.0 million. Jounce now expects its collaboration revenue for the
full year 2017 to be between $70.0 million and $75.0 million,
representing the amortization of the Celgene upfront payment of
$225.0 million received in 2016. The update from the prior guidance
is due to a change in the estimated performance period for certain
units of accounting under Jounce’s global strategic collaboration
with Celgene.
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
(833) 584-0037 (domestic) or (409) 350-3605 (international) and
refer to conference ID 9279009. The live webcast can be accessed
under "Events & Presentations" in the Investors and Media
section of the company's website at www.jouncetx.com. The webcast
will be archived and made available for replay on the company’s
website approximately two hours after the call and will be
available for 30 days.
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 operating expenses, collaboration
revenue and other financial results and the timing, progress and
results of preclinical studies and clinical trials for Jounce’s
product candidates 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 “anticipate,” “estimate,” “expect,” “intend,”
“may,” “on track,” “plan,” “predict,” “target,” “potential” or
similar terms, variations of such terms or the negative of those
terms. Although the Company believes that the expectations
reflected in the forward-looking statements are reasonable, the
Company 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,
the development plans of its product candidates, actions of
regulatory agencies, which may affect the initiation, timing and
progress of pre-clinical studies and clinical trials of its product
candidates, Jounce’s anticipated milestones, Jounce’s ability to
obtain, maintain and protect its intellectual property, Jounce’s
ability to enforce its patents against infringers and defend its
patent portfolio against challenges from third parties, the timing,
cost or other aspects of a potential commercial launch of Jounce’s
product candidates and potential future sales of our current
product candidates or any other potential products if any are
approved for marketing, competition from others developing products
for similar uses, Jounce’s ability to manage operating expenses,
Jounce’s ability to maintain its collaboration with Celgene and
establish or maintain future collaborations, Jounce’s dependence on
third parties for development, manufacture, marketing, sales and
distribution of product candidates, the outcome of litigation, and
unexpected expenditures, as well as those risks more fully
discussed in the section entitled “Risk Factors” in Jounce’s most
recent Quarterly Report on Form 10-Q 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 the Company
undertakes no obligation to update or revise publicly any
forward-looking statements, whether as a result of new information,
future events or otherwise.
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 the use of
its Translational Science Platform, Jounce first focuses on
specific cell types within tumors to prioritize targets, and then
identifies related biomarkers designed to match the right
immunotherapy to the right patient. Jounce’s lead product
candidate, JTX-2011, is a monoclonal antibody that binds to and
activates ICOS and is currently in the Phase 2 portion of the Phase
1/2 ICONIC trial. For more information, please visit
www.jouncetx.com.
|
|
|
|
Jounce Therapeutics, Inc. |
Condensed Consolidated Statements of
Operations (unaudited) |
(amounts in thousands, except per share
data) |
|
|
|
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
|
2017 |
|
2016 |
|
2017 |
|
2016 |
Revenue: |
|
|
|
|
|
|
|
Collaboration revenue—related party |
$ |
18,077 |
|
|
$ |
16,908 |
|
|
$ |
58,655 |
|
|
$ |
16,908 |
|
Operating
expenses: |
|
|
|
|
|
|
|
Research
and development |
17,094 |
|
|
9,505 |
|
|
49,241 |
|
|
24,250 |
|
General
and administrative |
5,371 |
|
|
3,588 |
|
|
17,077 |
|
|
12,106 |
|
Total
operating expenses |
22,465 |
|
|
13,093 |
|
|
66,318 |
|
|
36,356 |
|
Operating (loss)
income |
(4,388 |
) |
|
3,815 |
|
|
(7,663 |
) |
|
(19,448 |
) |
Other income, net: |
|
|
|
|
|
|
|
Other
income, net |
721 |
|
|
255 |
|
|
2,105 |
|
|
279 |
|
Total
other income, net |
721 |
|
|
255 |
|
|
2,105 |
|
|
279 |
|
(Loss) income before
provision for income taxes |
(3,667 |
) |
|
4,070 |
|
|
(5,558 |
) |
|
(19,169 |
) |
Provision for income
taxes |
417 |
|
|
— |
|
|
1,521 |
|
|
— |
|
Net (loss) income |
$ |
(4,084 |
) |
|
$ |
4,070 |
|
|
$ |
(7,079 |
) |
|
$ |
(19,169 |
) |
|
|
|
|
|
|
|
|
Reconciliation of net
(loss) income to net (loss) income attributable to common
stockholders: |
|
|
|
|
|
|
|
Net (loss) income |
$ |
(4,084 |
) |
|
$ |
4,070 |
|
|
$ |
(7,079 |
) |
|
$ |
(19,169 |
) |
Accrued dividends on
Series A convertible preferred stock |
— |
|
|
(945 |
) |
|
(268 |
) |
|
(2,815 |
) |
Accrued dividends on
Series B convertible preferred stock |
— |
|
|
(1,121 |
) |
|
(318 |
) |
|
(3,339 |
) |
Accrued dividends on
Series B-1 convertible preferred stock |
— |
|
|
(480 |
) |
|
(208 |
) |
|
(480 |
) |
Net income attributable
to preferred stockholders |
— |
|
|
(1,385 |
) |
|
— |
|
|
— |
|
Net (loss) income
attributable to common stockholders |
$ |
(4,084 |
) |
|
$ |
139 |
|
|
$ |
(7,873 |
) |
|
$ |
(25,803 |
) |
Net (loss) income per
share attributable to common stockholders, basic |
$ |
(0.13 |
) |
|
$ |
0.07 |
|
|
$ |
(0.27 |
) |
|
$ |
(12.86 |
) |
Net (loss) income per
share attributable to common stockholders, diluted |
$ |
(0.13 |
) |
|
$ |
0.03 |
|
|
$ |
(0.27 |
) |
|
$ |
(12.86 |
) |
Weighted-average common
shares outstanding, basic |
32,182 |
|
|
2,131 |
|
|
29,321 |
|
|
2,007 |
|
Weighted-average common
shares outstanding, diluted |
32,182 |
|
|
4,751 |
|
|
29,321 |
|
|
2,007 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Jounce Therapeutics, Inc.
Selected Condensed Consolidated Balance Sheet Data
(unaudited)(amounts in thousands) |
|
|
|
|
|
September 30, |
|
December 31, |
|
2017 |
|
2016 |
Cash, cash equivalents
and investments |
$ |
283,396 |
|
|
$ |
257,374 |
|
Working capital |
$ |
196,969 |
|
|
$ |
61,114 |
|
Total assets |
$ |
317,041 |
|
|
$ |
271,312 |
|
Total deferred
revenue—related party |
$ |
129,149 |
|
|
$ |
187,804 |
|
Convertible preferred
stock |
$ |
— |
|
|
$ |
139,038 |
|
Total stockholders’
equity (deficit) |
$ |
175,062 |
|
|
$ |
(69,088 |
) |
|
|
|
|
|
|
|
|
Investor Contact:Komal JoshiJounce
Therapeutics, Inc.(857) 320-2523kjoshi@jouncetx.com
Media Contact:Katie EnglemanPure
Communications, Inc.(919)
333-7722katie@purecommunicationsinc.com
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