Jounce Therapeutics, Inc. (NASDAQ:JNCE) is a clinical-stage immunotherapy company dedicated to developing novel therapies that enable the immune system to attack tumors and provide long-lasting benefits to patients. The company's biomarker-driven approach from discovery through clinical development has positioned it at the forefront of the rapidly evolving cancer immunotherapy landscape.
Business Overview
Jounce's strategy is to leverage its Translational Science Platform to comprehensively interrogate the cellular and molecular composition of tumors, enabling the company to prioritize targets and identify related biomarkers. This approach allows Jounce to match the right therapy to the right patient, a critical factor in the success of cancer immunotherapies.
The company's pipeline is focused on product candidates to address PD-(L)1 inhibitor resistant and PD-(L)1 inhibitor sensitive tumors, representing significant opportunities that require different biological approaches. Jounce's highest priority program, JTX-8064, is being developed for patients with either PD-(L)1 inhibitor resistant or PD-(L)1 inhibitor sensitive tumors.
JTX-8064 is a monoclonal antibody that binds to Leukocyte Immunoglobulin Like Receptor B2 (LILRB2), a cell surface receptor expressed on macrophages and other myeloid cells. The INNATE clinical trial is a Phase 1/2 study evaluating JTX-8064 as a monotherapy and in combination with Jounce's PD-1 inhibitor, pimivalimab, in patients with solid tumors. The company has selected a 700 mg recommended Phase 2 dose for further evaluation, and the trial is designed to demonstrate proof-of-concept, with plans to move JTX-8064 into randomized trials on a cohort-by-cohort basis once proof-of-concept is established.
Vopratelimab, Jounce's clinical-stage monoclonal antibody that binds to and activates the Inducible T cell CO-Stimulator (ICOS), is being evaluated in the SELECT trial, a randomized Phase 2 proof-of-concept trial outside the United States. Although the trial did not meet its primary endpoint, the company believes the results for the low dose cohort are encouraging and plans to reevaluate the vopratelimab program in the context of its broader pipeline.
Pimivalimab, Jounce's clinical-stage anti-PD-1 monoclonal antibody, is being developed primarily for use in combination with the company's product candidates, as combination therapy is believed to be a mainstay of cancer immunotherapy.
GS-1811, formerly JTX-1811, is Jounce's fourth internally developed program to enter the clinic, and the company has transitioned the program to Gilead Sciences, Inc. under an exclusive license agreement. GS-1811 is a monoclonal antibody designed to selectively deplete T regulatory cells in the tumor microenvironment by targeting the CCR8 receptor.
Jounce's most recent product candidate, JTX-1484, is a monoclonal antibody designed to block human Leukocyte Immunoglobulin Like Receptor B4 (LILRB4), which the company believes may lead to reduced immune suppression and enhancement of T cell functionality. Jounce is currently conducting IND-enabling activities for JTX-1484, with the goal of submitting an IND in 2023.
Financials
For the full year 2022, Jounce reported annual net loss of $101,878,000 and annual revenue of $0.
In the third quarter of 2022, the company reported revenue of $0, compared to $0 in the prior-year quarter. Research and development expenses were $23,752,000, up from $23,288,000 in the same period of 2021, while general and administrative expenses increased to $7,653,000 from $6,854,000 a year earlier. The company's net loss for the quarter was $30,998,000, compared to a net loss of $30,093,000 in the third quarter of 2021.
For the first nine months of 2022, Jounce reported revenue of $0, compared to $26,907,000 in the same period of 2021. Research and development expenses increased to $80,070,000 from $65,895,000, and general and administrative expenses rose to $22,511,000 from $21,786,000. The company's net loss for the first nine months of 2022 was $101,878,000, compared to a net loss of $60,639,000 in the prior-year period.
Liquidity
As of September 30, 2022, Jounce had cash, cash equivalents, and investments of $130,300,000. The company expects its existing cash, cash equivalents, and investments will enable it to fund its expected operating expenses and capital expenditure requirements for at least 12 months from November 10, 2022.
Jounce has funded its operations primarily through proceeds from public offerings and private placements of its stock, as well as payments from collaboration and license agreements. The company continues to actively monitor the COVID-19 pandemic and its impact on its business, but has not experienced a significant financial impact directly related to the pandemic as of November 10, 2022.
Risks and Challenges
Jounce, like other clinical-stage companies, faces a number of risks and challenges, including dependence on key individuals, the need to develop commercially viable products, competition from larger and better-capitalized companies, and the need to obtain adequate additional financing to fund the development of its products.
The company's ability to generate future revenue and its results of operations and financial position could be materially adversely affected if it or third parties fail to complete the development of its product candidates in a timely manner or obtain regulatory approval for them.
Outlook
Jounce continues to actively advance its pipeline of immunotherapy programs, with a focus on its lead candidate, JTX-8064. The company plans to report clinical data on all Phase 1 dose escalation patients for JTX-8064 at the ESMO Immuno-Oncology Annual Congress in December 2022 and expects to share preliminary clinical data for Phase 2 patients in the first half of 2023.
Additionally, the company plans to reevaluate the vopratelimab program in the context of its broader pipeline as the progression-free survival and overall survival data continue to mature.
Jounce remains committed to its biomarker-driven approach and continues to enhance its Translational Science Platform to identify and advance novel immuno-oncology targets. The company believes this sustainable approach will enable it to continue developing innovative cancer immunotherapies that have the potential to provide greater benefit to patients.
Conclusion
Jounce Therapeutics is at the forefront of the rapidly evolving cancer immunotherapy landscape, leveraging its Translational Science Platform to develop novel therapies that address the unmet medical needs of patients with PD-(L)1 inhibitor resistant and PD-(L)1 inhibitor sensitive tumors. With a robust pipeline, including its lead candidate JTX-8064, and a strong focus on biomarker-driven development, Jounce is well-positioned to transform the treatment of cancer and deliver long-lasting benefits to patients.