- INNATE trial of JTX-8064 +/- pimivalimab Phase 1 Dose Escalation data at ESMO-IO Annual Congress -
- SELECT randomized trial of pimivalimab +/- vopratelimab phase 2 data at ESMO-IO AnnualCongress -
- Two preclinical posters on JTX-1484 and LILRB family at SITC 2022 -
- Ended the quarter with $130.3 million in cash, cash equivalents and investments -
- Company to host conference call and webcast today at 8:00 AM ET -
CAMBRIDGE, Mass., Nov. 10, 2022 (GLOBE NEWSWIRE) -- Jounce Therapeutics, Inc. (NASDAQ: JNCE), a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, today reported financial results for the third quarter ended September 30, 2022 and provided a corporate update.
“We have continued to execute across our pipeline of innovative immunotherapy candidates in the third quarter, especially in the Phase 2 cohorts of the INNATE study. We are proud to be sharing multiple sets of data from our discovery and development programs at two important immuno-oncology conferences this year,” said Richard Murray, Ph.D., chief executive officer and president of Jounce Therapeutics. “Our goal is to strive for a meaningful immunotherapy for patients who have few options. This is at the heart of our approach to developing novel mechanisms guided by biomarkers.”
Pipeline Update & Highlights:
JTX-8064 (LILRB2/ILT4)
Vopratelimab (ICOS) and Pimivalimab (PD-1)
JTX-1484 (LILRB4/ILT3)
Discovery Pipeline
Business Update
Third Quarter 2022 Financial Results:
Financial Guidance:
Based on its current operating and development plans and cost containment efforts, Jounce is reiterating its financial guidance for 2022. Gross cash burn on operating expenses and capital expenditures for the full year 2022 is expected to be at the lower end of the range of $115.0 million to $130.0 million. Jounce expects its existing cash, cash equivalents and investments to be sufficient to enable the funding of its operating expenses and capital expenditure requirements into the first quarter of 2024.
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, participants may register here.1 It is advised to register at least 10 minutes prior to joining the call. 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 thereafter.
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 may provide long-lasting benefits to patients through a biomarker-driven approach. Jounce currently has multiple development stage programs ongoing while simultaneously advancing additional early-stage assets from its robust discovery engine based on its Translational Science Platform. Jounce’s highest priority program, JTX-8064, is a LILRB2 (ILT4) receptor antagonist shown to reprogram immune-suppressive tumor associated macrophages to an anti-tumor state in preclinical studies. JTX-8064 is currently being investigated alone and in combination with pimivalimab (formerly JTX-4014), Jounce’s internal PD-1 inhibitor, in one monotherapy and eight indication-specific combination therapy cohorts in the Phase 1/2 INNATE trial and is currently enrolling patients with advanced solid tumors in the Phase 2 portion of the study. Jounce’s most advanced product candidate, vopratelimab, is a monoclonal antibody that binds to and activates ICOS, and is currently being studied in the SELECT Phase 2 trial. Pimivalimab is a PD-1 inhibitor intended for combination use in the INNATE and SELECT trials and with Jounce’s broader pipeline. Additionally, Jounce exclusively licensed worldwide rights to GS-1811 (formerly JTX-1811), a monoclonal antibody targeting CCR8 and designed to selectively deplete T regulatory cells in the tumor microenvironment, to Gilead Sciences, Inc. For more information, please visit www.jouncetx.com.
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, gross cash burn, operating expenses, capital expenditures and funding requirements; the timing, initiation or expansion, progress, results of and release of data from clinical trials of Jounce’s product candidates, including JTX-8064 and pimivalimab; the timing of an IND filing for JTX-1484; and the presentation of clinical data 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,” “goal,” “plan,” “strive,” 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; 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 ongoing clinical trials, or delaying timelines or data disclosures and regulatory submissions for its 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; 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 and research and development activities; actions of regulatory agencies, which may affect the initiation, timing and progress of preclinical studies and clinical trials of Jounce’s product candidates; abstract submissions and acceptance, or lack thereof, related to Jounce’s clinical and preclinical programs; 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 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 Jounce undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.
Jounce Therapeutics, Inc.
Condensed Consolidated Statements of Operations (unaudited)
(amounts in thousands, except per share data)
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||
2022 | 2021 | 2022 | 2021 | ||||||||||||
Revenue: | |||||||||||||||
License and collaboration revenue—related party | $ | — | $ | — | $ | — | $ | 26,907 | |||||||
Operating expenses: | |||||||||||||||
Research and development | 23,752 | 23,288 | 80,070 | 65,895 | |||||||||||
General and administrative | 7,653 | 6,854 | 22,511 | 21,786 | |||||||||||
Total operating expenses | 31,405 | 30,142 | 102,581 | 87,681 | |||||||||||
Operating loss | (31,405 | ) | (30,142 | ) | (102,581 | ) | (60,774 | ) | |||||||
Other income, net | 412 | 55 | 721 | 144 | |||||||||||
Loss before provision for income taxes | (30,993 | ) | (30,087 | ) | (101,860 | ) | (60,630 | ) | |||||||
Provision for income taxes | 5 | 6 | 18 | 9 | |||||||||||
Net loss | $ | (30,998 | ) | $ | (30,093 | ) | $ | (101,878 | ) | $ | (60,639 | ) | |||
Net loss per share, basic and diluted | $ | (0.60 | ) | $ | (0.59 | ) | $ | (1.97 | ) | $ | (1.23 | ) | |||
Weighted-average common shares outstanding, basic and diluted | 51,694 | 51,232 | 51,670 | 49,488 | |||||||||||
Jounce Therapeutics, Inc. Selected Condensed Consolidated Balance Sheet Data (unaudited) (amounts in thousands) | |||||||||||||||
September 30, | December 31, | ||||||||||||||
2022 | 2021 | ||||||||||||||
Cash, cash equivalents and investments | $ | 130,332 | $ | 220,223 | |||||||||||
Working capital | $ | 118,133 | $ | 171,929 | |||||||||||
Total assets | $ | 158,081 | $ | 252,696 | |||||||||||
Total stockholders’ equity | $ | 129,358 | $ | 223,805 |
Investor and Media Contact:
Eric Laub
Jounce Therapeutics, Inc.
+1-857-259-3853
elaub@jouncetx.com
1 https://register.vevent.com/register/BI36a5d163e9a3449a8a7140a523628dbf