Jounce Therapeutics Reports Third Quarter 2018 Financial Results
- Dose escalation cohorts of JTX-2011 Phase 1/2 ICONIC trial, in combination with ipilimumab and in combination with pembrolizumab, on track -
- IND filed and clearance to proceed received for JTX-4014 PD-1 program -
- On track for IND filing for JTX-8064, first tumor-associated macrophage program -
- Ended third quarter 2018 with
- Company to host conference call and webcast today at
“We are pleased to announce continued advancement across our development programs including JTX-2011, JTX-4014 and JTX-8064. While we complete our biomarker and clinical data analysis on JTX-2011, safety dose escalation cohorts are proceeding as planned to enable us to pursue new combination trials. Additionally, we filed an IND for our internal PD-1 program, JTX-4014, and recently received clearance from the
Corporate and Development Highlights:
- JTX-2011 Dose Escalation Cohorts Progressing: As previously announced, in
June 2018, Jounce began the enrollment of dose escalation cohorts evaluating the safety of JTX-2011 in combination with ipilimumab and in combination with pembrolizumab, and these studies are progressing as planned.
- Newly Reported Data Confirms Mechanism of Action of JTX-2011: At the
Society for Immunotherapyof Cancer’s ( SITC) 33rd annual meeting in November, Jounce presented new data from ICONIC patients demonstrating the agonistic properties of JTX-2011. These data are in addition to the subset analysis data presented at the 2018 American Society of Clinical Oncology( ASCO) annual meeting in June demonstrating the emergence of ICOShi CD4 T cells in the blood of all patients with ≥30% target lesion tumor reductions, both in patients treated with JTX-2011 monotherapy and in combination with nivolumab. The ICOShi CD4 T cells were not observed in patients with primary progressive disease.
Through additional reverse translational studies, presented at
SITC, Jounce established two key insights that provide the scientific foundation for the next stage of development of JTX-2011.
• First, the emergence of these
ICOShi CD4 T cells was related to JTX-2011, as it has not been detected in a separate study Jounce conducted of responding and non-responding patients that received PD-1/L1 inhibitor monotherapy treatment; and
• Second, in vitro experimental data showed that JTX-2011 only activates CD4 T cells if they already express high levels of
Additionally, new preclinical tumor model data presented in a separate poster at
SITC, strengthens Jounce’s belief that agents that induce ICOShi CD4 T cells detectable in the bloodstream, such as anti-CTLA-4, may be attractive combination partners for JTX-2011.
- JTX-4014 IND Filed and Cleared: Jounce filed an Investigational New Drug (IND) application for JTX-4014, its PD-1 inhibitor, in
September 2018. In October 2018, the U.S. Food and Drug Administration( FDA) concluded that Jounce may proceed with a Phase 1 dose escalation trial. Jounce will initiate this trial as the next key step for this program.
- JTX-8064 IND Filing on Track: Jounce continues to advance its first tumor-associated macrophage candidate targeting Leukocyte Immunoglobulin Like Receptor B2 (LILRB2) from its Translational Science Platform through IND-enabling studies. JTX-8064 is a selective antagonist antibody that demonstrates preclinical characteristics of reprogramming immune suppressive macrophages in the tumor microenvironment.
- Jounce Founders Awarded 2018 Nobel Prize and Coley Award: In
October 2018, Jounce founder Dr. James P. Allisonwas jointly awarded the 2018 Nobel Prize in Physiology or Medicine for the discovery of cancer therapy by inhibition of negative immune regulation. Also in October 2018, Jounce founder Dr. Padmanee Sharma was awarded the William B. ColeyAward for Distinguished Researchin Tumor Immunology for her innovative work understanding factors that enhance and hinder cancer immunotherapy.
Third Quarter 2018 Financial Results:
- Cash Position: As of September 30, 2018, cash, cash equivalents and investments were
$214.7 million, compared to $257.9 millionas of December 31, 2017. Cash was utilized for operating costs incurred during the period, offset by the receipt of state and federal income tax refunds.
- Collaboration Revenue: Collaboration revenue was
$14.5 millionfor the third quarter of 2018, compared to $18.1 millionfor the same period in 2017. Collaboration revenue represents revenue recognition relating to the $225.0 millionupfront payment received in July 2016upon the execution of Jounce’s global strategic collaboration with Celgene.
- Research and Development (R&D) Expenses: R&D expenses were
$16.8 millionfor the third quarter of 2018, compared to $17.1 millionfor the same period in 2017. The decrease in R&D expenses was due to $1.5 millionof decreased lab consumables offset primarily by $0.5 millionof increased stock-based compensation expense, $0.3 millionof increased external clinical and regulatory expenses related to the Phase 1/2 ICONIC trial and $0.4 millionof increased other research expenses primarily due to license and milestone payments associated with preclinical programs.
- General and Administrative (G&A) Expenses: G&A expenses were
$6.5 millionfor the third quarter of 2018, compared to $5.4 millionfor the same period in 2017. The increase in G&A expenses was primarily due to $1.2 millionof increased employee compensation costs, including $0.8 millionof increased stock-based compensation expense.
- Net Loss: Net loss was
$7.6 millionfor the third quarter of 2018, or a basic and diluted net loss per share attributable to common stockholders of $0.23. Net loss was $4.1 millionfor the same period in 2017, or a basic and diluted net loss per share attributable to common stockholders of $0.13. The increase in net loss and net loss per share attributable to common stockholders is primarily attributable to the decrease in non-cash collaboration revenue and the increase in operating expenses from the third quarter of 2017 to the third quarter of 2018.
Jounce continues to expect to end the year with approximately
Jounce is reiterating its 2018 collaboration revenue guidance of approximately
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 4689666. 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, cash burn and other financial results, the timing and progress of the Phase 1/2 ICONIC trial, the clinical development of JTX-4014, the preclinical development 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, actions of regulatory agencies, which may affect the initiation, timing and progress of preclinical studies and clinical trials of its 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
|Jounce Therapeutics, Inc.
Condensed Consolidated Statements of Operations (unaudited)
(amounts in thousands, except per share data)
|Three Months Ended
|Nine Months Ended
|Collaboration revenue—related party||$||14,528||$||18,077||$||45,101||$||58,655|
|Research and development||16,751||17,094||53,408||49,241|
|General and administrative||6,517||5,371||19,842||17,077|
|Total operating expenses||23,268||22,465||73,250||66,318|
|Other income, net||1,103||721||2,810||2,105|
|Loss before provision for income taxes||(7,637||)||(3,667||)||(25,339||)||(5,558||)|
|Provision for income taxes||—||417||—||1,521|
|Reconciliation of net loss to net loss attributable to common stockholders:|
|Accrued dividends on Series A convertible preferred stock||—||—||—||(268||)|
|Accrued dividends on Series B convertible preferred stock||—||—||—||(318||)|
|Accrued dividends on Series B-1 convertible preferred stock||—||—||—||(208||)|
|Net loss attributable to common stockholders||$||(7,637||)||$||(4,084||)||$||(25,339||)||$||(7,873||)|
|Net loss per share attributable to common stockholders, basic and diluted||$||(0.23||)||$||(0.13||)||$||(0.78||)||$||(0.27||)|
|Weighted-average common shares outstanding, basic and diluted||32,641||32,182||32,462||29,321|
|Jounce Therapeutics, Inc.
Selected Condensed Consolidated Balance Sheet Data (unaudited)
(amounts in thousands)
|September 30,||December 31,|
|Cash, cash equivalents and investments||$||214,728||$||257,851|
|Total deferred revenue—related party||$||117,972||$||116,160|
|Total stockholders’ equity||$||103,410||$||167,109|
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