On March 8, 2024 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, 2023, and provided a business update (Press release, Janux Therapeutics, MAR 8, 2024, View Source [SID1234640966]).

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"2023 was a critical year for Janux as we tested the potential power of our TRACTr platform in the clinic. We believe the data recently presented from both of our clinical programs displays the profound impact we can have on patients through our tumor-activated approach. We are excited to be helping cancer patients who need novel therapies and with our substantial cash runway we feel well-positioned to execute on our clinical plan," said David Campbell, Ph.D., President and CEO of Janux.

RECENT BUSINESS HIGHLIGHTS AND FUTURE MILESTONES:

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Presented positive updated interim Phase 1 clinical trial data for PSMA-TRACTr JANX007 in prostate cancer in February 2024. As of February 12, 2024:
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Increasing depth of PSA declines and RECIST responses at higher doses were observed, while a favorable safety profile was maintained.
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83% (5/6) of subjects achieved PSA50 declines with first step dose ≥ 0.2mg.
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56% (10/18) of subjects achieved PSA50 declines with first dose ≥ 0.1mg.
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No CRS > Grade 2 observed in heavily pre-treated late stage mCRPC population.
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Majority of non-CRS treatment-related adverse events (TRAEs) were Grade 1 or 2.
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Low incidence of Grade 3 TRAEs, and no Grade 4 or 5 events were observed.
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JANX007 has been administered at doses up to 3mg, significantly exceeding the anticipated maximum tolerable dose for the parental T cell engager, while the maximum tolerable dose for the TRACTr has not yet been established.

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Also presented positive interim Phase 1 clinical trial data for EGFR-TRACTr JANX008 in solid tumors. As of February 12, 2024:
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A subject with NSCLC achieved a RECIST PR maintained through 18-weeks with 100% target lung lesion reduction and elimination of liver metastasis with no CRS or TRAEs.
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No CRS greater than Grade 1 observed in any cohort.
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Majority of non-CRS TRAEs were Grade 1 or 2.
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No treatment related SAEs or DLTs have been observed.
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Net proceeds of approximately $320.2 million (after deducting underwriting discounts, commissions and other estimated offering expenses) raised in an underwritten offering of common stock and pre-funded warrants in March 2024.

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Janux plans to deploy these funds to expand development of clinical programs, advance additional preclinical programs and extend corporate runway.

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

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

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Co-founder Dr. Tommy DiRaimondo promoted to Chief Scientific Officer. Tommy was instrumental in successfully transitioning Janux’s PSMA-TRACTr and EGFR-TRACTr programs from research into clinical trials. Tommy continues to manage the internal and external research operations and plays an integral role in managing the IP, discovery, creation, optimization and expansion of Janux’s preclinical pipeline.

An update on JANX007 data and doses selected for expansion cohorts is anticipated in the second half of 2024.

FOURTH QUARTER AND FULL YEAR 2023 FINANCIAL RESULTS:

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Cash and cash equivalents and short-term investments: As of December 31, 2023, Janux reported cash and cash equivalents and short-term investments of $344.0 million compared to $327.0 million at December 31, 2022.

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Research and development expenses: Research and development expenses were $12.2 million for the quarter and $54.9 million for the year ended December 31, 2023, compared to $15.4 million and $53.4 million for the same quarter and year in 2022.

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General and administrative expenses: General and administrative expenses were $6.4 million for the quarter and $26.1 million for the year ended December 31, 2023, compared to $5.7 million and $22.3 million for the same quarter and year in 2022.

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Net loss: Net loss was $11.8 million for the quarter and $58.3 million for the year ended December 31, 2023, compared to $16.1 million and $63.1 million for the same quarter and year 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. We are also generating a number of additional TRACTr and TRACIr programs for potential future development, some of which are at development candidate stage or later. We are currently assessing priorities in our preclinical pipeline.