Jounce Therapeutics Reports Third Quarter 2019 Financial Results
- New safety and preliminary efficacy data from JTX-4014 to be presented at the
- JTX-4014 data supports use as a combination agent for future studies -
- 2019 cash burn guidance reduced -
- Company to host conference call and webcast today at
“We have continued to work diligently on advancing our pipeline and further executing on our clinical development plans through our Translational Science Platform and reverse translational analysis. Both of our clinical-stage programs, vopratelimab and JTX-4014, continue to progress well. We are pleased to be presenting both new data from JTX-4014, as well as the dosing and sequencing strategy for vopratelimab in our ongoing EMERGE Phase 2 trial, at the
- Two development paths established for vopratelimab program: The reverse translational analysis from the ICONIC trial established the correlation between
ICOShi CD4 T cells, which emerged due to vopratelimab, and clinical benefit. The first development path focuses on the biology of optimizing the induction of ICOShi CD4 T cells prior to vopratelimab administration. The second path focuses on the use of a predictive biomarker to identify and select patients who may be more likely to benefit from a combination of vopratelimab and a PD-1 inhibitor. The first of the induction studies, EMERGE, is underway.
- Dosing and sequencing strategy for EMERGE Phase 2 trial to be presented at the
Society for Immunotherapy of Cancer( SITC): On November 9, 2019, Jounce will present a Trials in Progressposter on the EMERGE trial, which will include the combination dosing and sequencing strategy based on its understanding of the kinetics of induction of ICOShi CD4 T effector cells by ipilimumab and their expansion and sustained activation by vopratelimab. The EMERGE Phase 2 clinical trial began enrollment in mid-June 2019. Jounce expects to report EMERGE data including preliminary efficacy and biomarker relationships to clinical outcomes for up to 80 patients in 2020.
- Predictive biomarker approach: In the second development path, Jounce will focus on the use of a predictive biomarker. In the analysis of ICONIC patients, Jounce was able to identify a biomarker from baseline samples that correlated with the emergence of
ICOShi CD4 T cells, ORR, PFS and OS, in patients treated with vopratelimab alone or in combination with nivolumab. Jounce plans to use this potential predictive biomarker to select patients in a new trial with vopratelimab and JTX-4014. Jounce will provide more details in the next few months on this clinical trial.
- New safety and preliminary efficacy data from JTX-4014 Phase 1 trial to be presented at
SITC: On November 8, 2019, Jounce will present new safety and preliminary efficacy data from the Phase 1 trial of JTX-4014 during a poster session at the SITC2019 Annual Meeting.
- JTX-4014 identified as combination agent: Based on the encouraging safety and preliminary efficacy data, Jounce plans to use JTX-4014 as the PD-1 inhibitor in combination with its other product candidates, including in the new predictive biomarker trial with vopratelimab.
- On track to announce next development 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 by the end of the year.
- Senior appointments: During the third quarter of 2019, Jounce announced the addition of
Jacqui Fahey Sandellto its management team as Chief Legal Officer and Corporate Secretary. In October, Haley Laken, Ph.D., VP of Program and Portfolio Strategy, who has been with Jounce since early 2018, also joined the management team.
Third Quarter 2019 Financial Results:
- Cash position: As of September 30, 2019, cash, cash equivalents and investments were
$185.1 million, compared to $195.9 millionas of December 31, 2018. The decrease in cash, cash equivalents and investments was primarily due to operating costs incurred during the period, offset by the $50.0 millionlicense fee received in July 2019pursuant to Jounce’s new license agreement with Celgene.
- License and collaboration revenue: License and collaboration revenue was
$119.4 millionfor the third quarter of 2019, compared to $14.5 millionfor the same period in 2018. License and collaboration revenue recognized during the third quarter of 2019 was comprised of $50.0 millionof cash revenue related to Jounce’s new license agreement with Celgeneand $69.4 millionof non-cash revenue recognition relating to the $225.0 millionupfront payment received in July 2016upon the execution of Jounce’s original strategic collaboration with Celgene. In connection with the termination of the original strategic collaboration, Jounce recognized the remaining deferred revenue relating to this agreement in the third quarter of 2019. License and collaboration revenue recognized during the third quarter of 2018 was comprised solely of non-cash revenue recognition related to the $225.0 millionupfront payment.
- Research and development expenses: Research and development expenses were
$15.1 millionfor the third quarter of 2019, compared to $16.8 millionfor the same period in 2018. The decrease in research and development expenses was primarily due to $2.2 millionof decreased external research and development costs attributable to vopratelimab manufacturing expenses and JTX-4014 IND-enabling expenses incurred during the third quarter of 2018. This decrease was partially offset by $0.9 millionof increased employee compensation costs.
- General and administrative expenses: General and administrative expenses were
$6.5 millionfor both the third quarter of 2019 and the same period in 2018.
- Net income (loss): Net income was
$98.9 millionfor the third quarter of 2019, resulting in basic net income per share of $2.99and diluted net income per share of $2.90. This increase in net income was primarily attributable to $119.4 millionof license and collaboration revenue recognized under Jounce’s agreements with Celgene. Net loss was $7.6 millionfor the same period in 2018, or a basic and diluted net loss per share of $0.23.
Based on its operating and development plans for the remainder of 2019, Jounce now expects 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 financial guidance, operating expenses and capital expenditures; the timing, progress, results and release of data for clinical studies of vopratelimab and JTX-4014; identification and selection of patients for Jounce’s clinical studies; the use of JTX-4014 in combination with Jounce’s other product candidates; and the timing, progress and results of preclinical studies 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 “expect,” “plan,” “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, 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 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
Condensed Consolidated Statements of Operations (unaudited)
(amounts in thousands, except per share data)
|Three Months Ended
|Nine Months Ended
|License and collaboration revenue—related party||$||119,445||$||14,528||$||147,872||$||45,101|
|Research and development||15,115||16,751||50,525||53,408|
|General and administrative||6,483||6,517||20,998||19,842|
|Total operating expenses||21,598||23,268||71,523||73,250|
|Operating income (loss)||97,847||(8,740||)||76,349||(28,149||)|
|Other income, net||1,025||1,103||3,177||2,810|
|Income (loss) before provision for income taxes||98,872||(7,637||)||79,526||(25,339||)|
|Provision for income taxes||12||—||36||—|
|Net income (loss)||$||98,860||$||(7,637||)||$||79,490||$||(25,339||)|
|Net income (loss) per share, basic||$||2.99||$||(0.23||)||$||2.41||$||(0.78||)|
|Net income (loss) per share, diluted||$||2.90||$||(0.23||)||$||2.33||$||(0.78||)|
|Weighted-average common shares outstanding, basic||33,112||32,641||33,015||32,462|
|Weighted-average common shares outstanding, diluted||34,141||32,641||34,160||32,462|
|Jounce Therapeutics, Inc.
Selected Condensed Consolidated Balance Sheet Data (unaudited)
(amounts in thousands)
|September 30,||December 31,|
|Cash, cash equivalents and investments||$||185,097||$||195,864|
|Total deferred revenue—related party||$||—||$||97,872|
|Total stockholders’ equity||$||191,409||$||104,129|
The Yates Network
Source: Jounce Therapeutics, Inc.