Jounce Therapeutics Reports Third Quarter 2020 Financial Results
-On track to begin enrollment in the Phase 1 trial for JTX-8064 by year-end 2020-
-Established exclusive license agreement with Gilead for JTX-1811-
-Initiated the Phase 2 SELECT biomarker selection trial of vopratelimab in combination with JTX-4014-
-Company to host conference call and webcast today at
“Jounce made continued progress this quarter and I am very proud of the work our team has done to initiate our next clinical study, SELECT, and move our lead macrophage program, JTX-8064, an inhibitor of the LILRB2 (or ILT4) receptor, towards the clinic. Notably, we also entered into a license agreement with Gilead for our anti-CCR8 program JTX-1811,” said
Clinical Programs: Vopratelimab and JTX-4014
- Initiated Phase 2 SELECT trial of vopratelimab: Jounce initiated the randomized Phase 2 SELECT trial to evaluate vopratelimab in combination with JTX-4014, a PD-1 inhibitor, versus JTX-4014 alone in immunotherapy naïve TISvopra biomarker-selected, second line NSCLC patients. Jounce expects to enroll approximately 75 patients outside the
U.S.and expects to report clinical data in late 2021.
- Reported interim analysis data from Phase 2 EMERGE trial and announced no expansion of enrollment: The interim analysis of the EMERGE Phase 2 clinical trial of the ipilimumab and vopratelimab combination did not meet its pre-specified criteria for expansion of the study. Overall survival and biomarkers will continue to be evaluated.
Preclinical Development Programs: JTX-8064 and JTX-1811
- On track to initiate Phase 1 clinical trial of JTX-8064 by year-end 2020: Enrollment in the Phase 1 dose escalation trial of JTX-8064, a highly-selective, potential first in class antibody that targets the Leukocyte Immunoglobulin Like Receptor B2 (LILRB2 or ILT4) on macrophages, is expected to begin by year-end 2020.
- New JTX-8064 preclinical data to be presented at the
Society for Immunotherapyof Cancer’s (SITC) 2020 Annual Meeting: On November 11, 2020Jounce will present additional preclinical data for JTX-8064 at the SITC Annual Meeting. The poster will include data informing the indication selection and biomarker strategies for JTX-8064 to maximize potential therapeutic benefit for patients with solid tumor malignancies.
- Established exclusive license agreement with Gilead for the development and commercialization of JTX-1811: In
September 2020, Jounce announced an exclusive license agreement providing Gilead with the worldwide rights to JTX-1811, Jounce’s highly selective, potential first-in-class antibody designed to selectively deplete immunosuppressive tumor-infiltrating T regulatory cells. The transaction closed in October 2020and Jounce received $120 millionin cash, including a $35 millionequity investment. Under the terms of the agreement, Jounce continues to progress JTX-1811 to IND clearance and is on track for an IND filing in the first half 2021.
Third Quarter 2020 Financial Results:
- Cash position: As of
September 30, 2020, cash, cash equivalents and investments were $105.3 million, compared to $170.4 millionas of December 31, 2019. The decrease in cash, cash equivalents and investments was primarily due to operating expenses incurred during the period. Not included in the September 30, 2020cash balance is the $120.0 millionwe received upon the closing of the Gilead agreements in October 2020.
- License and collaboration revenue: Jounce did not recognize any revenue in the third quarter of 2020. License and collaboration revenue recognized during the third quarter of 2019 was comprised of
$50.0 millionof cash revenue related to Jounce’s license agreement with Celgene and $69.4 millionof non-cash revenue recognition related to Jounce’s first strategic collaboration with Celgene, which ended in July 2019.
- Research and development expenses: Research and development expenses were
$18.0 millionfor the third quarter of 2020, compared to $15.1 millionfor the same period in 2019. The increase in research and development expenses was primarily due to increased IND-enabling expenses for JTX-1811, external clinical and regulatory costs associated with the SELECT clinical trial and increased employee compensation costs.
- General and administrative expenses: General and administrative expenses were
$7.1 millionfor the third quarter of 2020, compared to $6.5 millionfor the same period in 2019. The increase in general and administrative expenses was primarily due to increased employee compensation costs.
- Net (loss) income: Net loss was
$24.9 millionfor the third quarter of 2020, resulting in basic and diluted net loss per share of $0.73. Net income was $98.9 millionfor the same period in 2019, resulting in a basic net income per share of $2.99and diluted net income per share of $2.90. The increase in net loss was primarily attributable to no license and collaboration revenue in the third quarter of 2020 and an increase in operating expenses.
Based on its current operating and development plans, Jounce continues to expect gross cash burn on operating expenses and capital expenditures for the full year 2020 to be approximately
Jounce expects its existing cash, cash equivalents and investments as of
Conference Call and Webcast Information:
Cautionary Note Regarding Forward-Looking Statements:
Various statements in this release concerning Jounce’s future expectations and plans, including without limitation, Jounce’s expectations regarding the timing, initiation, progress, results of and release of data for clinical trials of Jounce’s product candidates, including vopratelimab, JTX-4014 and JTX-8064, 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,” “look forward” 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, risks that the COVID-19 pandemic may disrupt Jounce’s business and/or the global healthcare system more severely than anticipated, which may have the effect of delaying enrollment and completion of Jounce’s clinical trials, or delaying timelines or data disclosures and regulatory submissions for its product candidates; Jounce’s ability to successfully demonstrate the efficacy and safety of its product candidates; Jounce’s ability to successfully manage its clinical trials; the development plans of its product candidates and any companion or complementary diagnostics; management of Jounce’s supply chain for the delivery of drug product and materials for use in clinical trials; actions of regulatory agencies, which may affect the initiation, timing and progress of preclinical studies and clinical trials of Jounce’s product candidates; 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
|Jounce Therapeutics, Inc.|
|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||$||—||$||119,445||$||—||$||147,872|
|Research and development||18,002||15,115||58,671||50,525|
|General and administrative||7,102||6,483||21,867||20,998|
|Total operating expenses||25,104||21,598||80,538||71,523|
|Operating (loss) income||(25,104||)||97,847||(80,538||)||76,349|
|Other income, net||203||1,025||1,238||3,177|
|(Loss) income before provision for income taxes||(24,901||)||98,872||(79,300||)||79,526|
|Provision for income taxes||2||12||14||36|
|Net (loss) income||$||(24,903||)||$||98,860||$||(79,314||)||$||79,490|
|Net (loss) income per share, basic||$||(0.73||)||$||2.99||$||(2.33||)||$||2.41|
|Net (loss) income per share, diluted||$||(0.73||)||$||2.90||$||(2.33||)||$||2.33|
|Weighted-average common shares outstanding, basic||34,159||33,112||34,081||33,015|
|Weighted-average common shares outstanding, diluted||34,159||34,141||34,081||34,160|
|Jounce Therapeutics, Inc.|
|Selected Condensed Consolidated Balance Sheet Data (unaudited)|
|(amounts in thousands)|
|Cash, cash equivalents and investments||$||105,281||$||170,444|
|Total stockholders’ equity||$||105,087||$||174,593|
Investor and Media Contacts:
Source: Jounce Therapeutics, Inc.