- Presented Phase 1 data from ICONIC study of
JTX-2011 at the 2017 American Society of Clinical Oncology (ASCO)
Annual Meeting -
Jounce Therapeutics, Inc. (NASDAQ:JNCE), a clinical stage company
focused on the discovery and development of novel cancer
immunotherapies coupled with predictive biomarkers for patient
enrichment, today reported financial results and provided a
corporate update for the second quarter ended June 30, 2017.
“The second quarter was marked by significant progress as we
reported our first set of clinical data from the Phase 1 arms of
our ICONIC study, showing JTX-2011 to be well-tolerated in both the
monotherapy setting and in combination with nivolumab. I am pleased
to announce today that the combination portion of our Phase 2 study
is now underway. Both monotherapy and combination will evaluate
preliminary efficacy in patient populations enriched for
ICOS-positive immune cells in at least six solid tumor types,” said
Richard Murray, Ph.D., chief executive officer of Jounce
Therapeutics. “With our Celgene collaboration, which just marked
its one year anniversary, and a commitment to our Translational
Science Platform, we are poised to continue to progress our
pipeline in cancer immunotherapy.”
Clinical Highlights:
Presented Phase 1 data from ICONIC study at the 2017 American
Society of Clinical Oncology (ASCO) Annual Meeting:
- In June 2017, Jounce presented the Phase 1 portion of the Phase
1/2 ICONIC (ICOS AgONist Antibody
for Immunotherapy in Cancer
Patients) dose-escalation study to assess safety and tolerability
of JTX-2011 and to determine the recommended Phase 2 dose (RP2D) of
JTX-2011 as a monotherapy and in combination with nivolumab.
- The preliminary data showed JTX-2011 to be well-tolerated at
doses up to 0.3 mg/kg as a monotherapy and in combination with
nivolumab in patients with advanced solid tumors. Immune-related
dose limiting toxicities were identified at the highest dose tested
of 1 mg/kg in monotherapy.
- The Phase 2 dose was established for monotherapy based on the
safety profile and pre-specified PK/PD criteria.
Initiated the biomarker-driven Phase 2 portion of the ICONIC
study in at least six solid tumor types:
- In April 2017, the Phase 2 Part C monotherapy portion of the
ICONIC study of JTX-2011 was initiated and enrollment is ongoing.
The monotherapy portion of the study evaluates JTX-2011 in at least
three tumor-specific cohorts, including head and neck squamous cell
cancer (HNSCC), non-small cell lung cancer (NSCLC) and
non-indication specific solid tumors.
- In July 2017, after determining the recommended Phase 2 dose of
JTX-2011 in combination with a fixed dose of nivolumab, enrollment
began in the Phase 2 Part D combination study and enrollment is
ongoing. The combination portion evaluates JTX-2011 plus nivolumab
in at least six tumor types, including HNSCC, NSCLC, triple
negative breast cancer, melanoma, gastric cancer and additional
tumor types based on emerging science.
- Each of the Phase 2 tumor types was selected using Jounce’s
Translational Science Platform based on high relative prevalence of
ICOS-expressing infiltrating immune cells, the target of JTX-2011.
In addition to the choice of tumor types, we are further enriching
at the individual patient level to ensure that at least 50 percent
of each cohort has high ICOS biomarker scores. Based on our
preclinical science, these patients may be more likely to respond,
and may enable a correlation between biomarker scores and
preliminary efficacy.
Updated timing of preliminary efficacy data:
- Preliminary efficacy evaluation is expected in the first half
of 2018.
Corporate Highlights:
- Expanded Corporate Facility: In May 2017,
Jounce moved to expanded facilities in Cambridge, Mass. The
expansion enables Jounce to advance JTX-2011, our immunotherapy
pipeline and continue to build a strong team with a focus on
corporate culture.
- Received 2016 NEVY Award for Deal of the Year:
In May 2017, Jounce was the recipient of the New England Venture
Capital Association’s Deal of the Year Award for its Celgene
collaboration entered into in July 2016.
- Added to Loncar Cancer Immunotherapy Index: In
June 2017, Jounce was added to the Loncar Cancer Immunotherapy
Index as a result of the semi-annual rebalance and reconstitution
of the index holdings, which includes a group of 30 companies
developing cancer immunotherapy.
Second Quarter 2017 Financial Results:
- Cash Position: As of June 30, 2017, cash,
cash equivalents and investments were $309.9 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 the initial public
offering (IPO), offset by operating costs during the year.
- Collaboration Revenue: Collaboration revenues
were $20.3 million for the second quarter of 2017. Jounce did not
record any collaboration revenue during the same period in 2016.
The increase in revenue was due to the Company’s global strategic
collaboration with Celgene, which it
- entered into in July 2016. Collaboration revenue in the second
quarter of 2017 reflected the amortization of the upfront payment
of $225.0 million received from Celgene in 2016.
- R&D Expenses: Research and development
expenses were $17.2 million for the second quarter of 2017,
compared to $6.5 million for the same period in 2016. The increase
in R&D expenses was primarily due to $3.7 million in increased
clinical costs related to the Phase 1/2 ICONIC study of JTX-2011,
$3.0 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, $1.8
million in increased employee compensation costs related to
increased headcount and $1.2 million of increased facilities
costs.
- G&A Expenses: General and administrative
expenses were $6.1 million for the second quarter of 2017, compared
to $5.9 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, $1.2 million in increased facilities
costs and $1.0 million in increased other costs attributable to
operating as a public company as well as increased headcount. These
increases were offset by $2.0 million of legal and accounting costs
written off in the second quarter of 2016 as a result of the
postponement of the IPO. The IPO was originally postponed for a
period significantly in excess of 90 days, and as a result, the
previously-capitalized costs were written off to general and
administrative expenses.
- Net Loss: Net loss was $3.4 million for the
second quarter of 2017, or a basic and diluted net loss per share
attributable to common shareholders of $0.11, as compared to a net
loss of $12.3 million for the same period in 2016, or a basic and
diluted net loss per share attributable to common stockholders of
$7.23. The decrease in net loss per share attributable to common
shareholders is primarily due to the completion of the IPO in
February 2017, which resulted in the sale of 7,319,750 shares of
common stock and the automatic conversion of 22,283,690 shares of
convertible preferred stock into shares of common stock.
Financial Guidance:
Jounce reiterates the financial guidance previously provided for
the full year 2017. Based on its current operating plan, Jounce
expects to use approximately $100.0 to $120.0 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 within Cambridge, Mass. and
payment of federal and state income taxes related to the receipt of
the Celgene upfront payment of $225.0 million in 2016.
Jounce expects collaboration revenue for the full year 2017 of
approximately $80.0 million, representing the amortization of the
Celgene upfront payment of $225.0 million received in 2016.
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 61078435. 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 the timing, progress and results of
preclinical studies and clinical trials for Jounce’s product
candidates and any future product candidates; the timing, scope or
likelihood of regulatory filings and approvals; and Jounce’s
ability to identify new targets for additional product candidates,
to develop future product candidates and combination therapies, and
to successfully commercialize and market products 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 pre-clinical 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 therapy
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 a Phase 2 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 June 30, |
|
Six Months Ended June 30, |
|
2017 |
|
2016 |
|
2017 |
|
2016 |
Revenue: |
|
|
|
|
|
|
|
Collaboration revenue—related party |
$ |
20,289 |
|
|
$ |
— |
|
|
$ |
40,578 |
|
|
$ |
— |
|
Operating
expenses: |
|
|
|
|
|
|
|
Research
and development |
17,188 |
|
|
6,490 |
|
|
32,147 |
|
|
14,745 |
|
General
and administrative |
6,129 |
|
|
5,872 |
|
|
11,706 |
|
|
8,518 |
|
Total
operating expenses |
23,317 |
|
|
12,362 |
|
|
43,853 |
|
|
23,263 |
|
Operating loss |
(3,028 |
) |
|
(12,362 |
) |
|
(3,275 |
) |
|
(23,263 |
) |
Other income, net: |
|
|
|
|
|
|
|
Other
income, net |
752 |
|
|
13 |
|
|
1,384 |
|
|
24 |
|
Total
other income, net |
752 |
|
|
13 |
|
|
1,384 |
|
|
24 |
|
Loss before provision
for income taxes |
(2,276 |
) |
|
(12,349 |
) |
|
(1,891 |
) |
|
(23,239 |
) |
Provision for income
taxes |
1,104 |
|
|
— |
|
|
1,104 |
|
|
— |
|
Net loss |
$ |
(3,380 |
) |
|
$ |
(12,349 |
) |
|
$ |
(2,995 |
) |
|
$ |
(23,239 |
) |
|
|
|
|
|
|
|
|
Reconciliation of net
loss to net loss attributable to common stockholders: |
|
|
|
|
|
|
|
Net loss |
$ |
(3,380 |
) |
|
$ |
(12,349 |
) |
|
$ |
(2,995 |
) |
|
$ |
(23,239 |
) |
Accrued dividends on
Series A convertible preferred stock |
— |
|
|
(935 |
) |
|
(268 |
) |
|
(1,870 |
) |
Accrued dividends on
Series B convertible preferred stock |
— |
|
|
(1,109 |
) |
|
(318 |
) |
|
(2,218 |
) |
Accrued dividends on
Series B-1 convertible preferred stock |
— |
|
|
— |
|
|
(208 |
) |
|
— |
|
Net loss attributable
to common stockholders |
$ |
(3,380 |
) |
|
$ |
(14,393 |
) |
|
$ |
(3,789 |
) |
|
$ |
(27,327 |
) |
Net loss per share
attributable to common stockholders, basic and diluted |
$ |
(0.11 |
) |
|
$ |
(7.23 |
) |
|
$ |
(0.14 |
) |
|
$ |
(14.05 |
) |
Weighted-average common
shares outstanding, basic and diluted |
32,144 |
|
|
1,991 |
|
|
27,867 |
|
|
1,945 |
|
Jounce Therapeutics, Inc.
Selected Condensed Consolidated Balance Sheet Data
(unaudited)(amounts in
thousands) |
|
|
June 30, |
|
December 31, |
|
2017 |
|
2016 |
Cash, cash equivalents
and investments |
$ |
309,889 |
|
|
$ |
257,374 |
|
Working capital |
$ |
200,456 |
|
|
$ |
61,114 |
|
Total assets |
$ |
336,444 |
|
|
$ |
271,312 |
|
Total deferred
revenue—related party |
$ |
147,225 |
|
|
$ |
187,804 |
|
Convertible preferred
stock |
$ |
— |
|
|
$ |
139,038 |
|
Total stockholders’
equity (deficit) |
$ |
175,508 |
|
|
$ |
(69,088 |
) |
Media Contact:
Katie Engleman
Pure Communications, Inc.
(919) 333-7722
katie@purecommunicationsinc.com
Investor Contact:
Beth DelGiacco
Stern Investor Relations, Inc.
(212) 362-1200
beth@sternir.com
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