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- New data from two programs to be presented at AACR -
- New Phase 2 studies to be initiated in 2019 supported by established safety from dose escalation cohorts of vopratelimab (JTX-2011), with ipilimumab and with pembrolizumab -
- Ended 2018 with $195.9 million in cash, cash equivalents and investments -
- Company to host conference call and webcast today at 8:00 AM ET -
CAMBRIDGE, Mass., March 06, 2019 (GLOBE NEWSWIRE) -- 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 fourth quarter and year ended December 31, 2018.
“2018 was an important year of learnings and significant progress for Jounce. We accomplished several milestones, most notably data readouts and analyses from the Phase 1/2 ICONIC trial for vopratelimab, formerly called JTX-2011, at ASCO and SITC, which provided important insights into vopratelimab’s mechanism of action and a strong scientific rationale for the next stage of clinical development. We also continued to advance our pipeline of immunotherapies including JTX-4014, our PD-1 inhibitor, which began a Phase 1 clinical trial and completed enrollment in the first cohort in late 2018,” said Richard Murray, Ph.D., chief executive officer and president of Jounce Therapeutics.
“In 2019, we plan to advance our first-in-class highly selective antibody JTX-8064, which targets the LILRB2 receptor on macrophages, by filing an IND and initiating a Phase 1 trial, supporting our goal of three immunotherapies in the clinic this year, while we continue to progress novel discovery programs toward development. We remain committed to advancing our pipeline through our unique translational approach and are convinced, more than ever, that the potential for durable survival benefit in the next generation of immunotherapies will require investment in understanding translational mechanistic science and biomarkers from the clinic,” Dr. Murray continued.
Tumor reductions were associated with an ICOS pharmacodynamic biomarker, specifically, emergence in the peripheral blood of a population of ICOS hi CD4 T cells, which have the characteristics of activated CD4 T effector cells. In a separate study, these cells were not identified in patients treated with PD-1 inhibitor monotherapy, including responders. This pharmacodynamic biomarker has been critical in the interpretation of Jounce’s clinical data and in informing the planned Phase 2 clinical studies.
Additionally, in a separate analysis, vopratelimab was demonstrated to activate CD4 T cells only if they express high levels of ICOS per T cell. The association of the emergence of ICOS hi CD4 T cells, clinical benefit and the requirement for these cells to be present for vopratelimab activity has led to two new development paths: first, vopratelimab in combination with ipilimumab and, second, patient selection with potential new predictive biomarkers that may enrich for patients whose CD4 T cells are primed to respond to vopratelimab and, therefore, may be more likely to benefit from treatment.
Fourth Quarter and Full Year 2018 Financial Results:
R&D expenses were $70.1 million for the full year 2018, compared to $67.8 million for the same period in 2017. The increase in R&D expenses for the full year 2018 was due to $3.1 million of increased employee compensation costs, including $1.7 million of increased stock-based compensation expense, and $3.0 million of increased external clinical and regulatory costs associated with vopratelimab as well as the initiation of the JTX-4014 Phase 1 clinical trial, offset by $2.1 million of decreased external research and development costs and $2.0 million of decreased lab consumables purchases.
Based on its current operating and development plans, Jounce expects cash burn on operating expenses and capital expenditures for the full year 2019 to be approximately $80.0 million to $95.0 million. Jounce expects to record approximately $50.0 million to $60.0 million in non-cash collaboration revenue in 2019 from the continued recognition of the Celgene upfront payment received in 2016.
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 for at least the next 24 months.
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 8678456. 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, 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-4014; the filing of an IND and initiation of a Phase 1 trial of JTX-8064 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,” “believe,” “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; Jounce’s ability to maintain its collaboration with Celgene 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 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 the human tumor microenvironment to prioritize targets, and then identifies related biomarkers designed to match the right immunotherapy to the right patient. Jounce has three development-stage programs: its two clinical product candidates, vopratelimab, a monoclonal antibody that binds to and activates ICOS, and JTX-4014, a monoclonal antibody that binds to PD-1 and for potential use in combination with Jounce’s pipeline of future product candidates, and JTX-8064, a monoclonal antibody that binds to Leukocyte Immunoglobulin Like Receptor B2 (LILRB2) that is currently in the IND-enabling phase. For more information, please visit www.jouncetx.com.
Jounce Therapeutics, Inc.
Consolidated Statements of Operations (unaudited)
(amounts in thousands, except per share data)
Three Months Ended
|Collaboration revenue—related party||$||20,100||$||12,989||$||65,201||$||71,644|
|Research and development||16,644||18,557||70,052||67,798|
|General and administrative||6,601||5,984||26,443||23,061|
|Total operating expenses||23,245||24,541||96,495||90,859|
|Other income, net||1,151||703||3,961||2,808|
|Loss before provision for (benefit from) income taxes||(1,994||)||(10,849||)||(27,333||)||(16,407||)|
|Provision for (benefit from) income taxes||46||(1,485||)||46||36|
|Reconciliation of net loss to net loss attributable to common stockholders:|
|Accrued dividends on Series A convertible preferred stock||—||—||—||(268||)|
|Accrued dividends on Series B convertible preferred stock||—||—||—||(318||)|
|Accrued dividends on Series B-1 convertible preferred stock||—||—||—||(208||)|
|Net loss attributable to common stockholders||$||(2,040||)||$||(9,364||)||$||(27,379||)||$||(17,237||)|
|Net loss per share attributable to common stockholders, basic and diluted||$||(0.06||)||$||(0.29||)||$||(0.84||)||$||(0.57||)|
|Weighted-average common shares outstanding, basic and diluted||32,750||32,234||32,567||30,055|
Jounce Therapeutics, Inc.
Selected Consolidated Balance Sheet Data (unaudited)
(amounts in thousands)
|Cash, cash equivalents and investments||$||195,864||$||257,851|
|Total deferred revenue—related party||$||97,872||$||116,160|
|Total stockholders’ equity||$||104,129||$||167,109|
Jounce Therapeutics, Inc.
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