Janux Therapeutics(JANX) - 2025 Q2 - Quarterly Results

Executive Summary Janux Therapeutics reported Q2 2025 financial results, highlighting strategic expansion of its TRACTr, TRACIr, and ARM platforms and anticipated clinical data releases Introduction and CEO Commentary Janux Therapeutics reported Q2 2025 results, highlighting strategic expansion of its TRACTr, TRACIr, and ARM programs and anticipated clinical data for JANX007 and JANX008 - Janux Therapeutics is a clinical-stage biopharmaceutical company developing novel immunotherapies using its proprietary TRACTr, TRACIr, and ARM platforms[2] - CEO David Campbell emphasized the strategy to maximize current clinical programs, including JANX007, while advancing other differentiated candidates in oncology and autoimmune disease[3] - Additional clinical data from JANX007 and JANX008 is expected in the second half of 2025[3][7] Business Highlights and Pipeline Updates This section details Janux's pipeline advancements, ongoing clinical trials for lead candidates, strategic collaborations, and platform overview R&D Day and Platform Progress Janux's R&D Day in July 2025 showcased significant pipeline progress and the best-in-class potential of its novel bispecific ARM platform for autoimmune diseases, identifying multiple preclinical candidates for future clinical trials - R&D Day in July 2025 highlighted pipeline progress and the best-in-class potential of the novel bispecific ARM platform for autoimmune diseases[4][5] - Multiple product candidates from the preclinical pipeline were identified to move towards clinical trials[4] - New candidates include a PSMA-TRACIr for combination with JANX007, a TROP2-TRACTr for solid tumors, and a CD19-ARM for rapid, deep, and durable B-cell depletion in autoimmune diseases[6] Clinical Development Status Enrollment is actively ongoing for Janux's lead clinical candidates, JANX007 and JANX008, in their respective Phase 1 clinical trials, with further data presentations anticipated in the latter half of 2025 - Enrollment is ongoing for JANX007 in its first-in-human Phase 1 clinical trial for mCRPC (NCT05519449)[5][6] - Enrollment is ongoing for JANX008 in its first-in-human Phase 1 clinical trial for advanced or metastatic solid tumors (NCT05783622)[5][6] - Updates on JANX007 and JANX008 are expected in the second half of 2025[5][7] Strategic Collaborations Janux received a $10 million milestone payment from Merck, triggered by the dosing of the first patient in their lead collaboration program under the existing 2020 Research Collaboration and Exclusive License Agreement - A clinical milestone payment of $10 million from Merck was triggered by the first patient dosed in the lead collaboration program[5][6] - This payment is part of the companies' 2020 Research Collaboration and Exclusive License Agreement[6] Company Overview: Platforms and Pipeline Janux Therapeutics is a clinical-stage biopharmaceutical company focused on developing novel immunotherapies through its proprietary TRACTr, TRACIr, and ARM platforms, with two TRACTr candidates in Phase 1 clinical trials and several preclinical programs - Janux develops novel immunotherapies using its proprietary TRACTr, TRACIr, and ARM platforms[9][10] - JANX007, a PSMA-targeting TRACTr, is in a Phase 1 clinical trial for mCRPC[9][10] - JANX008, an EGFR-targeting TRACTr, is in a Phase 1 clinical trial for multiple solid cancers including colorectal carcinoma, NSCLC, and triple-negative breast cancer[9][10] - Additional programs include a PSMA-TRACIr for combination with JANX007, a TROP2-TRACTr for TROP2+ solid tumors, and a CD19-ARM for autoimmune diseases, all advancing towards clinical trials[9] Second Quarter 2025 Financial Performance Janux Therapeutics reported its Q2 2025 financial results, detailing increased net loss, higher R&D expenses, and a strong cash position Financial Summary Janux reported a net loss of $33.9 million for Q2 2025, a significant increase from the $6.0 million net loss in Q2 2024, primarily driven by higher research and development expenses and the absence of collaboration revenue, while maintaining a strong cash position Key Financial Highlights (Q2 2025 vs. Q2 2024) | Metric | Q2 2025 (in thousands) | Q2 2024 (in thousands) | Change (YoY) | | :-------------------------------- | :--------------------- | :--------------------- | :----------- | | Collaboration Revenue | $0 | $8,897 | -$8,897 | | Research and Development Expenses | $34,664 | $14,898 | +$19,766 | | General and Administrative Expenses | $10,454 | $7,821 | +$2,633 | | Net Loss | $(33,858) | $(5,959) | -$(27,899) | - Cash, cash equivalents, and short-term investments totaled $996.0 million as of June 30, 2025, compared to $1.03 billion at December 31, 2024[5][11][14] Condensed Balance Sheets As of June 30, 2025, Janux's total assets decreased to $1,032.2 million from $1,061.5 million at December 31, 2024, primarily due to a decrease in cash and cash equivalents, partially offset by an increase in short-term investments, with total stockholders' equity also declining Condensed Balance Sheets (as of June 30, 2025 vs. December 31, 2024) | Asset/Liability/Equity | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | Change | | :-------------------------------- | :----------------------------- | :------------------------------- | :----- | | Cash and cash equivalents | $52,446 | $430,605 | $(378,159) | | Short-term investments | $943,565 | $594,568 | $348,997 | | Total current assets | $1,005,553 | $1,033,666 | $(28,113) | | Total assets | $1,032,212 | $1,061,516 | $(29,304) | | Total current liabilities | $21,379 | $17,459 | $3,920 | | Total liabilities | $41,696 | $38,735 | $2,961 | | Total stockholders' equity | $990,516 | $1,022,781 | $(32,265) | Unaudited Condensed Statements of Operations and Comprehensive Loss For the three months ended June 30, 2025, Janux reported no collaboration revenue, a significant increase in R&D and G&A expenses, leading to a wider net loss of $33.9 million or $(0.55) per common share Unaudited Condensed Statements of Operations and Comprehensive Loss (Three Months Ended June 30) | Metric | Q2 2025 (in thousands) | Q2 2024 (in thousands) | Change (YoY) | | :-------------------------------- | :--------------------- | :--------------------- | :----------- | | Collaboration revenue | $0 | $8,897 | -$8,897 | | Research and development | $34,664 | $14,898 | +$19,766 | | General and administrative | $10,454 | $7,821 | +$2,633 | | Total operating expenses | $45,118 | $22,719 | +$22,399 | | Loss from operations | $(45,118) | $(13,822) | -$(31,296) | | Total other income | $11,260 | $7,863 | +$3,397 | | Net loss | $(33,858) | $(5,959) | -$(27,899) | | Comprehensive loss | $(33,867) | $(7,051) | -$(26,816) | | Net loss per common share, basic and diluted | $(0.55) | $(0.11) | -$(0.44) | | Weighted-average shares outstanding | 61,902,411 | 54,451,666 | +7,450,745 | Unaudited Condensed Statements of Operations and Comprehensive Loss (Six Months Ended June 30) | Metric | H1 2025 (in thousands) | H1 2024 (in thousands) | Change (YoY) | | :-------------------------------- | :--------------------- | :--------------------- | :----------- | | Collaboration revenue | $0 | $10,149 | -$10,149 | | Research and development | $59,719 | $28,968 | +$30,751 | | General and administrative | $20,296 | $15,164 | +$5,132 | | Total operating expenses | $80,015 | $44,132 | +$35,883 | | Loss from operations | $(80,015) | $(33,983) | -$(46,032) | | Total other income | $22,649 | $13,264 | +$9,385 | | Net loss | $(57,366) | $(20,719) | -$(36,647) | | Comprehensive loss | $(55,782) | $(23,000) | -$(32,782) | | Net loss per common share, basic and diluted | $(0.93) | $(0.40) | -$(0.53) | | Weighted-average shares outstanding | 61,847,372 | 51,750,690 | +10,096,682 | Forward-Looking Statements This section outlines inherent risks and uncertainties associated with forward-looking statements, which could impact actual results Forward-Looking Statements Disclaimer This section details inherent risks and uncertainties in forward-looking statements, including clinical trial outcomes, regulatory approvals, and reliance on third parties - The news release contains forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially[11][12] - Risks include interim clinical trial results not being indicative of final results, compounds failing in later preclinical or clinical trials, inability to obtain marketing approval, and reliance on third parties and outside financing[12] - Janux assumes no obligation to update any forward-looking statements, which are qualified by the safe harbor provisions of the Private Securities Litigation Reform Act of 1995[12] Contacts This section provides essential contact information for investor and media relations inquiries Investor and Media Relations This section provides contact information for investor and media inquiries regarding Janux Therapeutics - Investor contact: Andy Meyer, ameyer@januxrx.com, (202) 215-2579[17] - Media contact: Jessica Yingling, Ph.D., jessica@litldog.com, (858) 344-8091[17]