On February 25, 2021 Jounce Therapeutics, Inc. (NASDAQ: JNCE), a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, reported financial results for the fourth quarter and year ended December 31, 2020 and provided a corporate update (Press release, Jounce Therapeutics, FEB 25, 2021, View Source [SID1234575592]).
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"2020 proved to be a year of important pipeline execution and corporate development at Jounce despite the challenges presented by the COVID-19 pandemic. As we enter 2021, we are strongly positioned to execute on our two proof of concept studies, INNATE and SELECT, and continue to advance our sustainable discovery pipeline. Our potential first-in-class programs and biomarker approaches are aimed at bringing meaningful clinical benefit to the growing population of PD-(L)1 inhibitor naïve and experienced patients," said Richard Murray, Ph.D., chief executive officer and president of Jounce Therapeutics. "The need for novel approaches targeting different immune cells in the tumor microenvironment highlights the importance of our translational science platform and our productive discovery engine. This approach has allowed us to generate multiple targets beyond T-cells, most notably our highest priority program, JTX-8064, targeting LILRB2, also known as ILT4. As we enter 2021, Jounce is poised to further our goal of bringing the right immunotherapies to the right patients."
Pipeline Update and Highlights:
JTX-8064 (LILRB2 / ILT4)
Initiated Phase 1 INNATE trial of JTX-8064: In January 2021, Jounce enrolled the first dose cohort in INNATE, a Phase 1 clinical trial of JTX-8064 alone and in combination with its PD-1 inhibitor, JTX-4014, or pembrolizumab. The trial is designed to progress quickly through dose escalation and demonstrate proof of concept in tumor specific expansion cohorts.
Presented JTX-8064 preclinical data at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 35th Annual Meeting: In November 2020 at SITC (Free SITC Whitepaper), Jounce presented preclinical data for JTX-8064 that informed the indication selection and biomarker strategies for JTX-8064 to maximize potential therapeutic benefit for patients with solid tumor malignancies.
Vopratelimab (ICOS) and JTX-4014 (PD-1)
Initiated enrollment in the Phase 2 SELECT trial of vopratelimab: In October 2020, Jounce initiated enrollment in the randomized Phase 2 SELECT trial to evaluate vopratelimab in combination with JTX-4014 versus JTX-4014 alone in immunotherapy naïve TISvopra biomarker-selected, second line non-small cell lung cancer patients. COVID-19 related delays are currently impacting patient enrollment, and Jounce now anticipates reporting data from the SELECT trial in 2022.
Continued to advance JTX-4014 as a combination agent: JTX-4014 is a PD-1 inhibitor intended for combination with Jounce’s broad pipeline beginning with its two ongoing proof of concept studies, the INNATE trial and the SELECT trial. The SELECT trial will also provide additional important single agent data for JTX-4014 in a new biomarker selection paradigm..
JTX-1811 (CCR8)
Established exclusive license agreement with Gilead for the development and commercialization of JTX-1811: In October 2020, Jounce licensed to Gilead Sciences, Inc. ("Gilead") the worldwide rights to JTX-1811, a potential first-in-class antibody designed to bind to CCR8 and selectively deplete immunosuppressive tumor-infiltrating T regulatory cells. Upon clearance of an investigational new drug application ("IND"), JTX-1811 will transition to Gilead for clinical development and potential commercialization. In addition to an $85.0 million upfront and a $35.0 million equity investment, Jounce has the potential to earn up to $685.0 million in milestones as well as royalties on worldwide sales. Jounce continues to progress JTX-1811 to IND clearance and remains on track for an IND filing in the first half of 2021.
Discovery Pipeline
Productive discovery engine with IND every 12 to 18 months: Jounce continues to invest in and advance its growing immuno-oncology pipeline. Its discovery engine is built upon the capability to thoroughly investigate different cell types in the tumor microenvironment, including T cells, myeloid cells and stromal cells.
Fourth Quarter and Full Year 2020 Financial Results:
Cash position: As of December 31, 2020, cash, cash equivalents and investments were $213.2 million, compared to $170.4 million as of December 31, 2019. The increase in cash, cash equivalents and investments was primarily due to receipt of $120.0 million in proceeds from the license and stock purchase agreements with Gilead and $14.5 million received during 2020 under Jounce’s at-the-market offering program ("ATM"), offset by operating expenses incurred during the year. In January 2021, the Company completed the sale of all available amounts under the existing ATM with the sale of 3,156,200 shares for net proceeds of $30.2 million.
License and collaboration revenue: $62.3 million of license and collaboration revenue was recognized during the fourth quarter of 2020. Jounce did not recognize any license and collaboration revenue for the same period in 2019. License and collaboration revenue was $62.3 million for the full year 2020, compared to $147.9 million for the full year 2019. Revenue recognized during 2020 was related to Jounce’s license agreement with Gilead. Revenue recognized during 2019 was comprised of $50.0 million of cash revenue related to Jounce’s JTX-8064 license agreement with Celgene and $97.9 million of non-cash revenue recognition related to the $225.0 million upfront payment received in July 2016 under the Celgene collaboration agreement.
Research and development expenses: Research and development expenses were $20.0 million for the fourth quarter of 2020, compared to $16.6 million for the same period in 2019. Research and development expenses were $78.7 million for the full year 2020, compared to $67.1 million for the full year 2019. The increase in research and development expenses for the full year 2020 was primarily due to $7.9 million of increased clinical and regulatory expense primarily attributable to the SELECT clinical trial, $3.2 million of increased manufacturing and IND-enabling expenses and $2.9 million of increased employee compensation costs. These increases were partially offset by $0.9 million and $0.8 million of decreased other research costs, primarily related to reduced travel, and lab consumable costs, respectively.
General and administrative expenses: General and administrative expenses were $6.9 million for both the fourth quarter of 2020 and 2019. General and administrative expenses were $28.8 million for the full year 2020, compared to $27.9 million for the full year 2019. The increase in general and administrative expenses for full year 2020 was primarily attributable to $1.5 million of increased employee compensation costs.
Net income (loss): Net income was $35.5 million for the fourth quarter of 2020, resulting in basic net income per share of $0.90 and diluted net income per share of $0.86. Net loss was $22.7 million for the same period in 2019, resulting in basic and diluted net loss per share of $0.68. Net loss was $43.8 million for the full year 2020, resulting in basic and diluted net loss per share of $1.24. Net income was $56.8 million for the full year 2019, resulting in basic net income per share of $1.72 and diluted net income per share of $1.66. Net loss for the full year 2020 was attributable to increased operating expenses, offset by $62.3 million of license revenue recognized under Jounce’s agreement with Gilead. Net income for the full year 2019 was primarily attributable to $147.9 million of revenue recognized under the Celgene license and collaboration agreements in the year.
Financial Guidance:
Based on its current operating and development plans, Jounce reiterates its financial guidance for 2021. Gross cash burn on operating expenses and capital expenditures for the full year 2021 is expected to be approximately $95.0 million to $110.0 million. 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 through the second quarter of 2023.
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 4698355. The live webcast can be accessed under "Events & Presentations" in the Investors and Media section of Jounce’s website at www.jouncetx.com. The webcast will be archived and made available for replay on Jounce’s website approximately two hours after the call and will be available for 30 days.