On May 4, 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 first quarter ended March 31, 2021 and provided a corporate update (Press release, Jounce Therapeutics, MAY 4, 2021, View Source [SID1234579042]).
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"Jounce made meaningful progress this quarter as we continue to advance our two proof of concept studies, grow our discovery and development IO pipeline, and add to our strong balance sheet. We also welcomed a new Chief Scientific Officer, Dr. Dmitri Wiederschain, who brings more than 15 years of pharmaceutical industry experience and a broad knowledge of contemporary immuno-oncology approaches," said Richard Murray, Ph.D., chief executive officer and president of Jounce Therapeutics. "We are at an exciting point in Jounce’s development, with the leadership, capital and resources, and scientific and clinical development acumen needed to move beyond our next set of inflection points. We remain committed to our core strategy of translational science, biomarker approaches, and targeting new immune mechanisms in our goal of bringing the right immunotherapies to the right patients."
Pipeline Update & Highlights:
JTX-8064 (LILRB2 / ILT4)
Initiated enrollment in the Phase 1 INNATE trial of JTX-8064: In January 2021, Jounce initiated enrollment in INNATE, a Phase 1 clinical trial of JTX-8064 alone and in combination with its PD-1 inhibitor, JTX-4014, now known as pimivalimab, or an approved PD-1 inhibitor. INNATE remains on track for the opening of eight expansion cohorts in the second half of the year, one with JTX-8064 monotherapy, and seven in combination with a PD-1 inhibitor.
Presented JTX-8064 preclinical data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting: In April 2021 at AACR (Free AACR Whitepaper), Jounce presented data describing how expression profiles of LILRB2 mRNA, the proprietary Tumor Associated Macrophage ("TAM") signature, and an interferon gamma signature were used to identify tumor types that may benefit most from JTX-8064 treatment, alone or in combination with a PD-1 inhibitor. This data was used to inform the tumor types in the expansion cohorts of the INNATE trial.
Trial in progress posters to be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2021 Annual Meeting: On June 4, 2021 Jounce will present a trial in progress poster at the ASCO (Free ASCO Whitepaper) Annual Meeting on INNATE. The poster will include the study design and the rationale for indications chosen for the expansion cohorts. Eight expansion cohorts will be opening for enrollment in the second half of 2021, one with JTX-8064 and seven with JTX-8064 plus a PD-1 inhibitor.
Vopratelimab (ICOS) and Pimivalimab (PD-1)
Continued enrollment in the Phase 2 SELECT trial of vopratelimab: Enrollment continues in SELECT, a randomized Phase 2 trial to evaluate vopratelimab in combination with pimivalimab versus pimivalimab alone in immunotherapy naïve, TISvopra biomarker-selected, second line non-small cell lung cancer patients. Jounce is on track to report data from the SELECT trial in 2022. The SELECT trial will also provide additional important single agent data for pimivalimab in a new biomarker selection paradigm.
Trial in progress poster to be presented at the ASCO (Free ASCO Whitepaper) 2021 Annual Meeting: On June 4, 2021 Jounce will present a trial in progress poster at the ASCO (Free ASCO Whitepaper) Annual Meeting on SELECT. The poster will describe the study design, TISvopra biomarker, and patient selection strategy of the SELECT trial.
JTX-1811 (CCR8)
Progressed JTX-1811 toward IND: Jounce continues to progress JTX-1811, a potential first-in-class antibody designed to bind to CCR8 and selectively deplete immunosuppressive tumor-infiltrating T regulatory cells. JTX-1811 remains on track for an investigational new drug application ("IND") clearance in 2021 at which point Gilead Sciences, Inc. will take over clinical development and potential commercialization.
Discovery Pipeline
Productive discovery engine with the goal of an IND every 12 to 18 months: Jounce continues to invest in and advance its growing immuno-oncology pipeline. The broad discovery pipeline includes multiple programs targeting diverse immune cell types and PD-(L)1 inhibitor resistance mechanisms.
First Quarter 2021 Financial Results:
Cash position: As of March 31, 2021, cash, cash equivalents and investments increased to $271.3 million, compared to $213.2 million as of December 31, 2020. The increase was primarily due to receipt of $60.6 million in net proceeds from the follow-on public offering completed in March 2021 and receipt of $30.2 million in net proceeds from sales under Jounce’s at-the-market offering program ("ATM"), offset by operating expenses incurred during the period.
License and collaboration revenue: License revenue of $1.5 million was recognized during the first quarter of 2021 and was comprised solely of non-cash revenue related to research and transition services performed under the Gilead License Agreement. Jounce did not recognize any license or collaboration revenue in the first quarter of 2020.
Research and development expenses: Research and development expenses were $20.5 million for the first quarter of 2021, compared to $19.6 million for the same period in 2020. The increase in research and development expenses was primarily due to increased manufacturing and IND-enabling activities performed for our development programs, offset by decreased clinical and regulatory costs attributable to reduced spend on vopratelimab.
General and administrative expenses: General and administrative expenses were $7.6 million for the first quarter of 2021, compared to $7.5 million for the same period in 2020. The increase in general and administrative expenses was primarily due to increased stock-based compensation expense.
Net loss: Net loss was $26.5 million for the first quarter of 2021, resulting in basic and diluted net loss per share of $0.58. Net loss was $26.4 million for the same period in 2020, resulting in a basic and diluted net loss per share of $0.78. The increase in net loss was primarily attributable to increased operating expenses, offset by revenue recognized in the first quarter of 2021.
Financial Guidance:
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 2021 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 1389694. 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.