On August 8, 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 second quarter ended June 30, 2023, and provided a business update (Press release, Janux Therapeutics, AUG 8, 2023, View Source [SID1234633978]).

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"The combination of our positive proof of principle interim clinical data from JANX007 and our ability to secure additional capital gives us confidence to drive forward the next wave of assets from our TRACTr and TRACIr portfolios," said David Campbell, Ph.D., President and CEO of Janux. "We continue to believe we can leverage our technology to rapidly identify exciting targets, develop differentiated molecules against those targets, and advance those programs into the clinic, creating value for Janux, and more importantly new meaningful therapies for cancer patients."

RECENT BUSINESS HIGHLIGHTS AND FUTURE MILESTONES:

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Presented positive interim Phase 1 clinical trial data for PSMA-TRACTr JANX007 in prostate cancer in July 2023.
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PSMA-TRACTr clinical data consistent with TRACTr mechanism-of-action
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Meaningful PSA drops coupled with manageable safety and cytokine release syndrome (CRS) profile
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PK exposure demonstrated TRACTr activation with lack of T cell engager (TCE) accumulation
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No significant treatment-emergent anti-drug antibody (ADA) titers observed

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Gross proceeds of approximately $60 million (before deducting underwriting discounts, commissions and other offering expenses) raised in an underwritten offering of common stock and pre-funded warrants in July 2023.
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Janux plans to deploy these funds to advance another program into clinical trials and advance additional preclinical programs

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Strengthened management team with the appointment of Dr. Zachariah ("Zach") McIver as Vice President, Clinical Development. Zach is a physician-scientist that brings more than 15 years of experience in clinical research and a breadth of experience with bispecific T-cell engagers. Dr. McIver joins Janux after serving as Amgen’s Executive Medical Director, where he led cross-functional teams in the design, implementation, and execution of clinical and correlative study strategies.

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EGFR-TRACTr (JANX008) continues to enroll in first-in-human Phase 1 clinical trial in solid tumors.

SECOND QUARTER 2023 FINANCIAL HIGHLIGHTS:

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Cash and cash equivalents and short-term investments: As of June 30, 2023, Janux reported cash and cash equivalents and short-term investments of $303.3 million compared to $327.0 million at December 31, 2022.

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Research and development expenses: Research and development expenses for the quarter ended June 30, 2023, were $14.9 million compared to $14.1 million for the comparable period in 2022.

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General and administrative expenses: General and administrative expenses for the quarter ended June 30, 2023, were $6.9 million compared to $5.5 million for the comparable period in 2022.

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Net loss: For the quarter ended June 30, 2023, Janux reported a net loss of $17.5 million compared to a net loss of $16.9 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 and is being investigated in preclinical studies 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.