On March 10, 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 fourth quarter and full year ended December 31, 2022, and provided a business update (Press release, Janux Therapeutics, MAR 10, 2023, View Source [SID1234628523]).

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"Janux made great strides in 2022 as we transitioned to a clinical-stage company by dosing the first patient with our PSMA-TRACTr and advancing our pipeline utilizing our novel TRACTr and TRACIr platforms. We recently received IND clearance from the FDA for our EGFR-TRACTr, keeping us on track to enter a second program into the clinic. Importantly, this milestone underscores our ability to reproducibly bring novel immunotherapies through development and deliver them to patients. Two of our core values at Janux are ‘collaboration’ and ‘urgency,’ and both were on display in connection with hitting these milestones," said David Campbell, Ph.D., President and CEO of Janux.

RECENT BUSINESS HIGHLIGHTS AND FUTURE MILESTONES:

Janux has prioritized its programs to enable sufficient funding to provide key clinical data assessments for its lead programs. Janux is aware of recent media reports related to the closure of Silicon Valley Bank ("SVB"). Janux considers its exposure to any liquidity concern at SVB as immaterial and will have no impact on its short- or long-term objectives. In addition, none of Janux’s investment portfolio contains direct exposure to SVB.

Lead program PSMA-TRACTr (JANX007) continues to enroll in first-in-human Phase 1 clinical trial in prostate cancer patients.
Janux received U.S. Food and Drug Administration (FDA) clearance for an IND application for EGFR-TRACTr (JANX008).
PD-L1xCD28 TRACIr (JANX009) on-track for an IND submission in 2023.
TROP2-TRACTr evaluations to support development candidate selection are ongoing.
Janux anticipates providing an interim clinical update from the PSMA-TRACTr (JANX007) trial in the second half of 2023. In addition, Janux expects to select a development candidate for its TROP2-TRACTr in 2023.

FOURTH QUARTER AND FULL YEAR 2022 FINANCIAL RESULTS:

Cash and cash equivalents and short-term investments: As of December 31, 2022, Janux reported cash and cash equivalents and short-term investments of $327.0 million, compared to $375.0 million at December 31, 2021.
Research and development expenses: Research and development expenses were $15.4 million for the quarter and $53.4 million for the year ended December 31, 2022, compared to $11.2 million and $26.2 million for the same quarter and year in 2021.
General and administrative expenses: General and administrative expenses were $5.7 million for the quarter and $22.3 million for the year ended December 31, 2022, compared to $3.9 million and $10.3 million for the same quarter and year in 2021.
Net loss: Net loss was $16.1 million for the quarter and $63.1 million for the year ended December 31, 2022, compared to $13.4 million and $32.7 million for the same quarter and year in 2021.
Janux’s TRACTr and TRACIr Pipeline

Janux’s lead candidate, JANX007, is being investigated in a phase 1 clinical trial in adult subjects with metastatic castration-resistant prostate cancer (mCRPC). JANX007 is a TRACTr that targets PSMA, a protein expressed in prostate cancer tumors and the vasculature of tumors, and a validated target for treating mCRPC. Similarly, JANX008 is a TRACTr that targets EGFR and is being studied in a phase 1 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’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 and is being investigated in preclinical studies for the treatment of solid tumors. 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. In addition to named programs, Janux is generating a number of unnamed TRACTr and TRACIr programs for potential future development.