Jounce Therapeutics Reports Second Quarter 2019 Financial Results
- Initiated Phase 2 EMERGE trial of vopratelimab -
- Completed enrollment of Phase 1 trial of JTX-4014 -
- Updated strategic collaboration and established new licensing agreement with
received
- Company to host conference call and webcast today at
“2019 has been a time of clinical progress and important strategic business development activity for Jounce, with the initiation of our Phase 2 EMERGE trial for vopratelimab, the completion of enrollment in our Phase 1 clinical trial of JTX-4014 and the recently announced renegotiation of our
Wholly-owned Programs:
Vopratelimab (JTX-2011)
- Initiated Phase 2 EMERGE trial: In
June 2019 , Jounce announced the initiation of dosing in the Phase 2 EMERGE clinical trial of its lead product candidate, vopratelimab, in combination with ipilimumab in patients with non-small cell lung cancer or urothelial cancer who have progressed on or after PD-1/PD-L1 inhibitor therapies.- The primary endpoint of EMERGE is overall response rate and secondary endpoints include safety, duration of response, progression free survival (PFS) and overall survival (OS). Additional important assessments will include close monitoring of
ICOS hi CD4 T cell emergence, and a range of other biomarkers, including exploratory assessment of potential predictive biomarkers. Jounce expects to report preliminary efficacy and biomarker relationships to clinical outcomes for up to 80 patients in 2020.
- The primary endpoint of EMERGE is overall response rate and secondary endpoints include safety, duration of response, progression free survival (PFS) and overall survival (OS). Additional important assessments will include close monitoring of
- Key data presented at AACR 2019: In
April 2019 , Jounce presented two posters on vopratelimab at theAmerican Association for Cancer Research (AACR) Annual Meeting. Highlights from the poster presentations include:- Patients in the ICONIC trial with the emergence of
ICOS hi CD4 T cells demonstrated improved PFS and OS compared to patients withICOS lo CD4 T cells, based on an analysis of a subgroup of patients with multiple solid tumor types including PD-1 inhibitor naive and PD-1 inhibitor experienced patients. - The characteristics of
ICOS hi CD4 T cells associated with vopratelimab treatment via translational analyses demonstrated that vopratelimab stimulates only primed CD4 T cells with high levels ofICOS . The translational data shows that vopratelimab, unlike PD-1 inhibitors, leads to expansion and activation of peripheral CD4 T effector cells, and that these are observed in patients with clinical benefit.
- Patients in the ICONIC trial with the emergence of
JTX-4014
- Completed enrollment of Phase 1 trial: Jounce is pleased to announce the completion of enrollment in the Phase 1 clinical trial of JTX-4014, its PD-1 inhibitor, and determination of the recommended Phase 2 dose. Jounce plans to report data from the trial in the second half of this year.
Discovery Pipeline
- On track to announce next discovery candidate: Jounce continues to advance and develop its broad discovery pipeline, which includes multiple programs targeting T-regulatory cells, macrophages and stromal cells. Jounce expects to move its next novel program into IND-enabling studies later this year.
Licensed Program:
JTX-8064
- Licensed JTX-8064: In
July 2019 , Jounce announced a new agreement in whichCelgene exclusively licensed the worldwide rights to JTX-8064, a highly-selective, potential first-in-class antibody that targets the LILRB2 receptor on macrophages. Under this license agreement, Jounce received a$50.0 million non-refundable license fee and is eligible to receive up to$480.0 million in development, regulatory and commercial milestone payments, as well as potential royalties on worldwide sales.Celgene will be responsible for all development and commercialization of JTX-8064.
Jounce andCelgene also entered into a mutual agreement to terminate the original strategic collaboration agreement, established inJuly 2016 . Jounce now retains full worldwide rights to its pipeline beyond JTX-8064, including vopratelimab, JTX-4014 and all discovery programs.
Second Quarter 2019 Financial Results:
- Cash Position: As of June 30, 2019, cash, cash equivalents and investments were
$152.0 million , compared to$195.9 million as of December 31, 2018. The decrease in cash, cash equivalents and investments was primarily due to operating costs incurred during the period. InJuly 2019 , Jounce received a$50.0 million license fee pursuant to its new license agreement withCelgene . - Collaboration Revenue: Collaboration revenue was
$17.4 million for the second quarter of 2019, compared to$19.4 million for the same period in 2018. Collaboration revenue during both periods represents non-cash revenue recognition relating to the$225.0 million upfront payment received inJuly 2016 upon the execution of Jounce’s original strategic collaboration withCelgene . In connection with the termination of the original strategic collaboration, Jounce expects that the remaining deferred revenue relating to theCelgene agreement will be fully recognized in the third quarter of 2019. - Research and Development Expenses: Research and development (R&D) expenses were
$18.1 million for the second quarter of 2019, compared to$18.5 million for the same period in 2018. The decrease in R&D expenses was primarily due to$0.5 million of decreased external research and development costs attributable to vopratelimab manufacturing expenses incurred during the second quarter of 2018,$0.4 million of decreased external clinical and regulatory costs and$0.3 million of decreased lab consumables expenses. These decreases were partially offset by$0.7 million of increased employee compensation costs. - General and Administrative Expenses: General and administrative (G&A) expenses were
$7.3 million for the second quarter of 2019, compared to$6.5 million for the same period in 2018. The increase in G&A expenses was primarily due to$0.5 million of increased employee compensation costs, including$0.3 million of increased stock-based compensation expense, and$0.3 million of increased other G&A costs to support Jounce’s operations. - Net Loss: Net loss was
$7.0 million for the second quarter of 2019, or a basic and diluted net loss per share of$0.21 . Net loss was$4.7 million for the same period in 2018, or a basic and diluted net loss per share of$0.14 . The increase in net loss and net loss per share was primarily attributable to the decrease in non-cash collaboration revenue from the second quarter of 2018 to the second quarter of 2019.
Financial Guidance:
Jounce reiterates its updated revenue guidance and expects to record
Based on its operating and development plans, Jounce continues to expect gross cash burn on operating expenses and capital expenditures for the full year 2019 to be approximately
Conference Call and Webcast Information:
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, capital expenditures, collaboration revenue and other financial results; the timing, progress and release of data for Phase 2 clinical studies of vopratelimab; the timing, progress and results of the Phase 1 trial of JTX-4014and 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,” “believe,” “continue,” “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 and any companion or complementary diagnostics; 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 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
About
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, |
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2019 | 2018 | 2019 | 2018 | ||||||||||||
Revenue: | |||||||||||||||
Collaboration revenue—related party | $ | 17,446 | $ | 19,378 | $ | 28,427 | $ | 30,573 | |||||||
Operating expenses: | |||||||||||||||
Research and development | 18,130 | 18,495 | 35,410 | 36,657 | |||||||||||
General and administrative | 7,323 | 6,523 | 14,515 | 13,325 | |||||||||||
Total operating expenses | 25,453 | 25,018 | 49,925 | 49,982 | |||||||||||
Operating loss | (8,007 | ) | (5,640 | ) | (21,498 | ) | (19,409 | ) | |||||||
Other income, net | 1,026 | 966 | 2,152 | 1,707 | |||||||||||
Loss before provision for income taxes | (6,981 | ) | (4,674 | ) | (19,346 | ) | (17,702 | ) | |||||||
Provision for income taxes | 12 | — | 24 | — | |||||||||||
Net loss | $ | (6,993 | ) | $ | (4,674 | ) | $ | (19,370 | ) | $ | (17,702 | ) | |||
Net loss per share, basic and diluted | $ | (0.21 | ) | $ | (0.14 | ) | $ | (0.59 | ) | $ | (0.55 | ) | |||
Weighted-average common shares outstanding, basic and diluted | 32,973 | 32,497 | 32,966 | 32,435 | |||||||||||
Jounce Therapeutics, Inc. Selected Condensed Consolidated Balance Sheet Data (unaudited) (amounts in thousands) |
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June 30, | December 31, | ||||||||||||||
2019 | 2018 | ||||||||||||||
Cash, cash equivalents and investments | $ | 152,020 | $ | 195,864 | |||||||||||
Working capital | $ | 79,753 | $ | 126,663 | |||||||||||
Total assets | $ | 190,604 | $ | 214,452 | |||||||||||
Total deferred revenue—related party | $ | 69,445 | $ | 97,872 | |||||||||||
Total stockholders’ equity | $ | 90,064 | $ | 104,129 |
Investor Contact:
(857) 320-2523
kjoshi@jouncetx.com
Media Contact:
The Yates Network
(617) 460-3579
gina@theyatesnetwork.com
Source: Jounce Therapeutics, Inc.