On November 7, 2023 Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a clinical-stage biopharmaceutical company developing a broad pipeline of novel immunotherapies by applying its proprietary technology to its Tumor Activated T Cell Engager (TRACTr) and Tumor Activated Immunomodulator (TRACIr) platforms, reported financial results for the third quarter ended September 30, 2023, and provided a business update (Press release, Janux Therapeutics, NOV 7, 2023, View Source [SID1234637145]).

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"We are pleased with the enrollment in the two clinical studies for our PSMA-TRACTr JANX007 and our EGFR-TRACTr JANX008," said David Campbell, Ph.D., President and CEO of Janux. "As we enter 2024, equipped with a strong financial foundation, we are committed to advancing these clinical programs and expanding our pipeline so that we can rapidly bring forward new meaningful therapies for cancer patients."

RECENT BUSINESS HIGHLIGHTS AND FUTURE MILESTONES:

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PSMA-TRACTr (JANX007) continues to enroll in the first-in-human Phase 1 clinical trial in mCRPC (NCT05519449).

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EGFR-TRACTr (JANX008) continues to enroll in the first-in-human Phase 1 clinical trial in advanced or metastatic solid tumors (NCT05783622).

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PD-L1xCD28 TRACIr (JANX009) IND-enabling studies completed.

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TROP2-TRACTr development candidate identification completed.

Janux anticipates providing an update on its clinical programs in 2024.

THIRD QUARTER 2023 FINANCIAL HIGHLIGHTS:

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Cash and cash equivalents and short-term investments: As of September 30, 2023, Janux reported cash and cash equivalents and short-term investments of $349.7 million compared to $327.0 million at December 31, 2022, which we project will be sufficient to fund our current operating plan through 2027 to generate Phase 1b data for our PSMA and EGFR-TRACTr programs.

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Research and development expenses: For the quarter ended September 30, 2023, Janux reported research and development expenses of $11.9 million compared to $13.7 million for the comparable period in 2022.

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General and administrative expenses: For the quarter ended September 30, 2023, Janux reported general and administrative expenses of $6.4 million compared to $6.1 million for the comparable period in 2022.

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Net loss: For the quarter ended September 30, 2023, Janux reported a net loss of $11.6 million compared to $16.7 million for the comparable period in 2022.

Janux’s TRACTr and TRACIr Pipeline

Janux’s first clinical candidate, JANX007, is a TRACTr that targets PSMA and is being investigated in a Phase 1 clinical trial in adult subjects with metastatic castration-resistant prostate cancer (mCRPC). Janux’s second clinical candidate, JANX008, is a TRACTr that targets EGFR and is being studied in a Phase 1 clinical trial for the treatment of multiple solid cancers including colorectal cancer, squamous cell carcinoma of the head and neck, non-small cell lung cancer, and renal cell carcinoma. Janux is also applying its proprietary technology to develop a TRACTr designed to target TROP2, a clinically validated anti-tumor target that is overexpressed in various cancer types, such as breast, lung, urothelial, endometrial, ovarian, prostate, pancreatic, gastric, colon, head and neck, and glioma. Janux’s TRACIr drug candidate, JANX009, is designed for targeting both the programmed death-ligand 1 (PD-L1) receptor as well as the costimulatory CD28 receptor on T cells for the treatment of solid tumors. In addition to named programs, Janux is generating a number of unnamed TRACTr and TRACIr programs for potential future development.