On May 8, 2025 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 first quarter ended March 31, 2025, and provided a business update (Press release, Janux Therapeutics, MAY 8, 2025, View Source [SID1234652749]).

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"We are proud to advance into the next phase of our clinical journey for JANX007 and begin treating patients in our Phase 1b expansion studies," said David Campbell, Ph.D., President and CEO of Janux. "We also look forward to our first R&D Day where we will unveil previously undisclosed preclinical programs that utilize our expertise and platform technologies to address significant unmet medical needs."

RECENT BUSINESS HIGHLIGHTS AND FUTURE MILESTONES:

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Initiated first Phase 1b expansion study with JANX007 in taxane-naïve mCRPC patients.
In December 2024, Janux reported positive interim clinical data from the Phase 1a dose escalation portion of the trial in 16 metastatic castration-resistant prostate cancer (mCRPC) patients with a median of four prior lines of therapy. At that time, the median radiographic progression-free survival (rPFS) reported was 7.4 months for all 16 patients.* As of April 21, 2025, updated results** have been achieved in the same 16 patients supporting the initiation of the Phase 1b expansion studies:

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Median rPFS of 7.5 months (n=16)
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Median rPFS of 7.9 months for patients treated at 6mg and 9mg target doses (n=9)
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6-month rPFS of 65% (n=16)
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6-month rPFS of 78% for patients treated at 6mg and 9mg target doses (n=9)
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Safety data remained consistent with the December 2024 data disclosure (n=16)
*8/16 patients were noted as in-progress in the December 2024 reported results.

**rPFS results based upon Kaplan-Meier estimate.

Janux selected 0.3/2/6mg and 0.3/2/9mg with dosing administered once weekly or once every two weeks as the two dose regimens for the Phase 1b expansion studies. In addition, Janux has selected a CRS-mitigation strategy to support the initiation of the Phase 1b expansion studies that is designed to reduce the risk of overuse of steroids while maintaining the early cycle grades 1 and 2 CRS profile reported in December.

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Janux plans to initiate three additional Phase 1b expansion studies with JANX007, evaluating:

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JANX007 in combination with an androgen receptor inhibitor (ARi) in taxane-experienced, ARi-naïve mCRPC patients
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JANX007 monotherapy in PARP inhibitor-resistant mCRPC patients
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JANX007 monotherapy in NHT- and taxane-experienced mCRPC patients designed to support OPTIMUS dose selection for registrational studies

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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).

Additional data from JANX007 and JANX008 will be presented at future Janux events in the second half of 2025. Separately, Janux will host an R&D Day in mid-2025 highlighting product candidates identified from its preclinical pipeline to move into clinical trials.

FIRST QUARTER 2025 FINANCIAL RESULTS:

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Cash and cash equivalents and short-term investments: As of March 31, 2025, Janux reported cash and cash equivalents and short-term investments of $1.01 billion compared to $1.03 billion at December 31, 2024.

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Research and development expenses: Research and development expenses for the quarter ended March 31, 2025, were $25.1 million compared to $14.1 million for the comparable period in 2024.

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General and administrative expenses: General and administrative expenses for the quarter ended March 31, 2025, were $9.8 million compared to $7.3 million for the comparable period in 2024.

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Net loss: For the quarter ended March 31, 2025, Janux reported a net loss of $23.5 million compared to a net loss of $14.8 million for the comparable period in 2024.

Janux’s TRACTr and TRACIr Pipeline

Janux’s first clinical candidate, JANX007, is a TRACTr that targets prostate-specific membrane antigen (PSMA) and is being investigated in a Phase 1 clinical trial in adult patients with mCRPC. Janux’s second clinical candidate, JANX008, is a TRACTr that targets epidermal growth factor receptor (EGFR) and is being studied in a Phase 1 clinical trial for the treatment of multiple solid cancers including colorectal carcinoma, squamous cell carcinoma of the head and neck, non-small cell lung cancer, renal cell carcinoma, small cell lung cancer, pancreatic ductal adenocarcinoma and triple-negative breast cancer. 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.