Janux Therapeutics(JANX) - 2025 Q1 - Quarterly Results

Executive Summary Janux Therapeutics announced Q1 2025 financial results and business updates, including the initiation of a Phase 1b expansion study for JANX007 and plans for an R&D Day - Janux Therapeutics announced financial results for the first quarter ended March 31, 2025, and provided a business update[1] - The company initiated the first Phase 1b expansion study with JANX007 in taxane-naïve mCRPC patients[2] - Janux plans to host an R&D Day to unveil previously undisclosed preclinical programs[2] Recent Business Highlights and Future Milestones This section details recent clinical advancements for JANX007 and JANX008, upcoming R&D Day plans, and the company's financial position snapshot JANX007 Clinical Development JANX007 advanced to Phase 1b expansion studies in mCRPC patients, supported by Phase 1a data showing a median rPFS of 7.5 months - Initiated first Phase 1b expansion study with JANX007 in taxane-naïve mCRPC patients[2][6] - Updated JANX007 data from Phase 1a dose escalation (as of April 21, 2025) supported the initiation of Phase 1b expansion studies[2][6] JANX007 Phase 1a Updated rPFS Results (n=16) | Metric | All Patients (n=16) | 6mg and 9mg Target Doses (n=9) | | :----- | :------------------ | :------------------------------- | | Median rPFS | 7.5 months | 7.9 months | | 6-month rPFS | 65% | 78% | | Safety data | Consistent with Dec 2024 | Consistent with Dec 2024 | - Selected 0.3/2/6mg and 0.3/2/9mg as two dose regimens for Phase 1b expansion studies, along with a CRS-mitigation strategy[4] - Janux plans to initiate three additional Phase 1b expansion studies with JANX007, evaluating combinations and monotherapy in different mCRPC patient populations[5][12] JANX008 Clinical Development Enrollment is ongoing for JANX008 in its first-in-human Phase 1 clinical trial for advanced or metastatic solid tumors - Enrollment is ongoing for JANX008 in the first-in-human Phase 1 clinical trial in advanced or metastatic solid tumors (NCT05783622)[6][12] Pipeline and R&D Day Janux plans to host an R&D Day in mid-2025 to unveil new preclinical programs and expects further updates on JANX007 and JANX008 in the second half of 2025 - Janux will host an R&D Day in mid-2025 highlighting product candidates from its preclinical pipeline to move into clinical trials[2][8] - Updates on JANX007 and JANX008 are expected in the second half of 2025[6][8] Financial Position Snapshot Janux reported $1.01 billion in cash, cash equivalents, and short-term investments as of March 31, 2025 - Cash, cash equivalents, and short-term investments totaled $1.01 billion at the end of the first quarter 2025[6][12] First Quarter 2025 Financial Results This section provides a detailed overview of Janux's financial performance for Q1 2025, including balance sheet and income statement highlights Condensed Balance Sheets As of March 31, 2025, Janux reported total assets of $1.05 billion, total liabilities of $38.3 million, and total stockholders' equity of $1.01 billion Condensed Balance Sheet Highlights (in thousands) | Item | March 31, 2025 | December 31, 2024 | Change (QoQ) | | :-------------------------------- | :------------- | :---------------- | :----------- | | Cash and cash equivalents | $73,743 | $430,605 | -$356,862 | | Short-term investments | $940,403 | $594,568 | +$345,835 | | Total current assets | $1,023,339 | $1,033,666 | -$10,327 | | Total assets | $1,050,772 | $1,061,516 | -$10,744 | | Total liabilities | $38,303 | $38,735 | -$432 | | Total stockholders' equity | $1,012,469 | $1,022,781 | -$10,312 | Unaudited Condensed Statements of Operations and Comprehensive Loss Janux reported a Q1 2025 net loss of $23.5 million, an increase from Q1 2024, primarily due to higher R&D and G&A expenses and zero collaboration revenue Condensed Statements of Operations Highlights (in thousands) | Item | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | Change (YoY) | | :-------------------------------- | :-------------------------------- | :-------------------------------- | :----------- | | Collaboration revenue | $0 | $1,252 | -$1,252 | | Research and development expenses | $25,055 | $14,070 | +$10,985 | | General and administrative expenses | $9,842 | $7,343 | +$2,499 | | Total operating expenses | $34,897 | $21,413 | +$13,484 | | Net loss | $(23,508) | $(14,760) | -$8,748 | | Net loss per common share, basic and diluted | $(0.38) | $(0.30) | -$0.08 | - Research and development expenses increased by $10.985 million (78%) year-over-year[12][18] - General and administrative expenses increased by $2.499 million (34%) year-over-year[12][18] About Janux Therapeutics This section provides an overview of Janux Therapeutics, its proprietary platforms, and its clinical pipeline of tumor-activated immunotherapies Company Overview and Platforms Janux is a clinical-stage biopharmaceutical company developing tumor-activated immunotherapies for cancer through its proprietary TRACTr and TRACIr platforms, designed to direct the immune system to tumors while minimizing safety concerns - Janux is a clinical-stage biopharmaceutical company developing tumor-activated immunotherapies for cancer[1][11] - Utilizes proprietary TRACTr and TRACIr bispecific platforms to develop therapeutics[1][11] - The goal of both platforms is to provide safe and effective therapeutics that direct and guide the immune system to eradicate tumors while minimizing safety concerns[11] Clinical Pipeline Janux has two TRACTr therapeutic candidates in Phase 1 clinical trials: JANX007, targeting PSMA for mCRPC, and JANX008, targeting EGFR for multiple solid cancers - JANX007 (TRACTr) targets prostate-specific membrane antigen (PSMA) and is being investigated in a Phase 1 clinical trial in adult patients with mCRPC[10][13] - JANX008 (TRACTr) 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[10][13] - Janux is generating a number of additional TRACTr and TRACIr programs for potential future development, some at development candidate stage or later, and is currently assessing priorities in its preclinical pipeline[10] Forward-Looking Statements This section highlights that the news release contains forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially - This news release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied[14] - Factors that may cause actual results to differ materially include risks related to preclinical/clinical trial efficacy, regulatory approval, reliance on third parties, financing, and the general process of drug discovery, development, and commercialization[14] Contacts This section provides contact information for investor relations and media inquiries - Investor Contact: Andy Meyer, Janux Therapeutics, ameyer@januxrx.com, (202) 215-2579[19] - Media Contact: Jessica Yingling, Ph.D., Little Dog Communications Inc., jessica@litldog.com, (858) 344-8091[19]