[PART I. FINANCIAL INFORMATION](index=3&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) This section presents Janux Therapeutics' unaudited condensed financial statements and management's discussion and analysis for Q1 2025 [Item 1. Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) This section presents Janux Therapeutics' unaudited condensed financial statements for Q1 2025 and 2024, including balance sheets, statements of operations, stockholders' equity, and cash flows, with detailed notes [Condensed Balance Sheets](index=3&type=section&id=Condensed%20Balance%20Sheets) This section provides a snapshot of the company's financial position at March 31, 2025, and December 31, 2024 | Metric (in thousands) | March 31, 2025 | December 31, 2024 | | :-------------------- | :------------- | :---------------- | | Cash and cash equivalents | $73,743 | $430,605 | | Short-term investments | $940,403 | $594,568 | | Total current assets | $1,023,339 | $1,033,666 | | Total assets | $1,050,772 | $1,061,516 | | Total current liabilities | $17,502 | $17,459 | | Total liabilities | $38,303 | $38,735 | | Total stockholders' equity | $1,012,469 | $1,022,781 | | Accumulated deficit | $(261,265) | $(237,757) | [Unaudited Condensed Statements of Operations and Comprehensive Loss](index=4&type=section&id=Unaudited%20Condensed%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) This section details the company's financial performance, including revenue, expenses, and net loss, for the three months ended March 31, 2025, and 2024 | Metric (in thousands) | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :-------------------- | :-------------------------------- | :-------------------------------- | | Collaboration revenue | $— | $1,252 | | Research and development | $25,055 | $14,070 | | General and administrative | $9,842 | $7,343 | | Total operating expenses | $34,897 | $21,413 | | Loss from operations | $(34,897) | $(20,161) | | Interest income | $11,389 | $5,401 | | Net loss | $(23,508) | $(14,760) | | Net loss per common share, basic and diluted | $(0.38) | $(0.30) | [Unaudited Condensed Statements of Stockholders' Equity](index=5&type=section&id=Unaudited%20Condensed%20Statements%20of%20Stockholders%27%20Equity) This section outlines changes in stockholders' equity, including stock-based compensation and accumulated deficit, for the three months ended March 31, 2025, and 2024 - Stock-based compensation significantly increased from **$5.6 million in Q1 2024** to **$10.7 million in Q1 2025**, reflecting increased equity awards[15](index=15&type=chunk) - Additional paid-in capital increased by **$11.6 million** from December 31, 2024, to March 31, 2025, primarily due to stock-based compensation and option exercises[15](index=15&type=chunk) - The accumulated deficit grew from **$237.8 million** at December 31, 2024, to **$261.3 million** at March 31, 2025, due to the net loss incurred during the quarter[15](index=15&type=chunk) [Unaudited Condensed Statements of Cash Flows](index=6&type=section&id=Unaudited%20Condensed%20Statements%20of%20Cash%20Flows) This section presents the cash inflows and outflows from operating, investing, and financing activities for the three months ended March 31, 2025, and 2024 | Cash Flow Activity (in thousands) | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :-------------------------------- | :-------------------------------- | :-------------------------------- | | Net cash used in operating activities | $(17,024) | $(14,837) | | Net cash used in investing activities | $(340,392) | $(113,736) | | Net cash provided by financing activities | $554 | $322,171 | | Net increase (decrease) in cash, cash equivalents and restricted cash | $(356,862) | $193,598 | | Cash, cash equivalents and restricted cash – end of period | $74,559 | $213,619 | [Notes to Unaudited Condensed Financial Statements](index=7&type=section&id=Notes%20to%20Unaudited%20Condensed%20Financial%20Statements) This section provides detailed explanations and disclosures supporting the unaudited condensed financial statements [1. Organization and Summary of Significant Accounting Policies](index=7&type=section&id=1.%20Organization%20and%20Summary%20of%20Significant%20Accounting%20Policies) This section describes the company's business, its financial condition, and the key accounting principles applied in preparing the financial statements - Janux Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing novel immunotherapies for cancer using its proprietary TRACTr and TRACIr platforms[21](index=21&type=chunk) - The Company has incurred net losses and negative cash flows from operations since inception, with an accumulated deficit of **$261.3 million** as of March 31, 2025. Management believes existing capital is sufficient for at least 12 months[22](index=22&type=chunk) Fair Value Measurements at March 31, 2025 (in thousands) | Asset Category | Total | Level 1 | Level 2 | Level 3 | | :------------- | :---- | :------ | :------ | :------ | | Money market funds | $37,868 | $37,868 | $— | $— | | Commercial paper | $28,399 | $— | $28,399 | $— | | U.S. Treasury securities | $77,750 | $77,750 | $— | $— | | U.S. agency bonds | $332,666 | $— | $332,666 | $— | | Corporate debt securities | $299,372 | $— | $299,372 | $— | | Restricted cash (money market) | $816 | $816 | $— | $— | | **Total assets measured at fair value** | **$1,007,486** | **$116,434** | **$891,052** | **$—** | - Short-term investments, classified as available-for-sale, include U.S. Treasury securities, U.S. agency bonds, corporate debt securities, and commercial paper, all highly rated[33](index=33&type=chunk) - Revenue recognition follows a five-step approach, identifying contracts, performance obligations, transaction price, allocation, and recognition upon transfer of control. Variable consideration for milestones is included if a significant revenue reversal is improbable[44](index=44&type=chunk)[49](index=49&type=chunk)[50](index=50&type=chunk) - Research and development costs are expensed as incurred, with accruals based on the progress of activities and contracted costs[57](index=57&type=chunk) - The Company operates as a single operating segment focused on novel immunotherapies research and development, with all assets held in the United States and revenue derived from the Merck collaboration[62](index=62&type=chunk) Potentially Dilutive Securities Not Included in Diluted Net Loss Per Share (common stock equivalent shares) | Security Type | As of March 31, 2025 | As of March 31, 2024 | | :------------ | :------------------- | :------------------- | | Common stock options outstanding | 9,995,064 | 9,850,776 | | Restricted stock units outstanding | 603,132 | — | | Employee stock purchase plan shares | 78,772 | 55,251 | | **Total potentially dilutive shares** | **10,676,968** | **9,911,798** | [2. Balance Sheet Details](index=20&type=section&id=2.%20Balance%20Sheet%20Details) This section provides a detailed breakdown of specific balance sheet accounts, including prepaid expenses, property and equipment, and accrued expenses Prepaid Expenses and Other Current Assets (in thousands) | Item | March 31, 2025 | December 31, 2024 | | :--- | :------------- | :---------------- | | Interest receivable | $5,585 | $5,381 | | Prepaid research and development | $2,876 | $2,354 | | Other prepaid expenses | $732 | $758 | | **Total** | **$9,193** | **$8,493** | Property and Equipment, Net (in thousands) | Item | March 31, 2025 | December 31, 2024 | | :--- | :------------- | :---------------- | | Laboratory equipment | $8,731 | $8,360 | | Furniture and fixtures | $792 | $792 | | Computer equipment and software | $658 | $658 | | Assets not placed in service | $237 | $6 | | Total property and equipment | $10,418 | $9,816 | | Less: accumulated depreciation | $(5,471) | $(4,952) | | **Property and equipment, net** | **$4,947** | **$4,864** | Accrued Expenses (in thousands) | Item | March 31, 2025 | December 31, 2024 | | :--- | :------------- | :---------------- | | Accrued research and development | $10,564 | $6,200 | | Accrued compensation | $1,851 | $4,566 | | Other accrued expenses | $925 | $918 | | **Total** | **$13,340** | **$11,684** | [3. Commitments and Contingencies](index=21&type=section&id=3.%20Commitments%20and%20Contingencies) This section outlines the company's contractual obligations, including license agreements and operating leases, and potential contingent liabilities - The Company has a Cell Line License Agreement with WuXi Biologics, requiring low single-digit royalty payments on net sales if a third-party manufacturer is used, with a buyout option ranging up to **$15.0 million**[72](index=72&type=chunk)[73](index=73&type=chunk) - The Torrey Plaza operating lease for office and laboratory space commenced on April 1, 2022, with a term of 130 months and future minimum noncancelable operating lease payments totaling **$30.7 million**[75](index=75&type=chunk)[80](index=80&type=chunk) Future Minimum Noncancelable Operating Lease Payments (in thousands) as of March 31, 2025 | Year | Amount | | :--- | :----- | | 2025 (remaining) | $2,640 | | 2026 | $3,611 | | 2027 | $3,719 | | 2028 | $3,830 | | 2029 | $3,945 | | Thereafter | $12,927 | | **Total minimum lease payments** | **$30,672** | [4. Stockholders' Equity](index=23&type=section&id=4.%20Stockholders%27%20Equity) This section details changes in the company's equity, including stock offerings, stock option activity, and restricted stock units - The Company has an ATM Equity Offering Sales Agreement for up to **$150.0 million** of common stock, with the full amount remaining available as of March 31, 2025[82](index=82&type=chunk) - In March 2024, the Company closed an underwritten offering, issuing 5,397,301 shares of common stock and pre-funded warrants, generating net proceeds of **$320.1 million**[84](index=84&type=chunk)[86](index=86&type=chunk) - In December 2024, another underwritten offering of 6,150,793 shares and pre-funded warrants generated net proceeds of **$377.9 million**[88](index=88&type=chunk) Stock Option Activity Summary (in thousands, except share, per share data and years) | Metric | Outstanding at Dec 31, 2024 | Granted | Exercised | Forfeited or cancelled | Outstanding at Mar 31, 2025 | | :----- | :-------------------------- | :------ | :-------- | :--------------------- | :-------------------------- | | Number of Options | 8,873,071 | 1,329,425 | (103,884) | (103,548) | 9,995,064 | | Weighted Average Exercise Price | $12.81 | $52.74 | $8.68 | $42.87 | $17.85 | | Weighted Average Remaining Contractual Term (years) | 7.2 | | | | 7.3 | | Aggregate Intrinsic Value | $361,595 | | | | $131,168 | - Total unrecognized stock-based compensation cost for options was **$79.6 million** as of March 31, 2025, to be recognized over approximately **2.6 years**[94](index=94&type=chunk) Restricted Stock Unit (RSU) Activity Summary | Metric | Outstanding at Dec 31, 2024 | Granted | Vested | Forfeited or cancelled | Outstanding at Mar 31, 2025 | | :----- | :-------------------------- | :------ | :----- | :--------------------- | :-------------------------- | | Number of Restricted Stock Units | 341,847 | 301,080 | — | (39,795) | 603,132 | | Weighted Average Grant Date Fair Value per Share | $59.09 | $51.95 | $— | $48.72 | $56.21 | - Total unrecognized stock-based compensation cost for RSUs was **$30.9 million** as of March 31, 2025, to be recognized over approximately **3.6 years**[100](index=100&type=chunk) Stock-Based Compensation Expense (in thousands) | Expense Category | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--------------- | :-------------------------------- | :-------------------------------- | | Research and development | $5,199 | $2,184 | | General and administrative | $5,503 | $3,441 | | **Total** | **$10,702** | **$5,625** | [5. Research Collaboration and Exclusive License Agreement](index=28&type=section&id=5.%20Research%20Collaboration%20and%20Exclusive%20License%20Agreement) This section details the company's collaboration with Merck for T cell engager immunotherapies, including potential milestone payments and royalties - The Company has a research collaboration and exclusive license agreement with Merck for up to two collaboration targets related to T cell engager immunotherapies for cancer[105](index=105&type=chunk) - Under the Merck Agreement, the Company is eligible to receive up to an aggregate of **$285.0 million** in development and regulatory milestones and up to **$350.0 million** per licensed product in commercial milestones, plus tiered royalties on net sales[105](index=105&type=chunk) Collaboration Revenue (in thousands) | Period | Amount | | :----- | :----- | | Three months ended March 31, 2025 | $0 | | Three months ended March 31, 2024 | $1,252 | - The Company's performance obligations related to the Collaboration Targets under the Merck Agreement were completed as of March 31, 2025[107](index=107&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=29&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's financial condition, operational results, clinical-stage biopharmaceutical focus, Merck collaboration, and future funding needs [Overview](index=29&type=section&id=Overview) This section introduces Janux Therapeutics as a clinical-stage biopharmaceutical company, its lead product candidates, and its financial outlook - Janux Therapeutics is a clinical-stage biopharmaceutical company developing tumor-activated immunotherapies (TRACTr and TRACIr platforms) for cancer, aiming to overcome liabilities of prior T cell engagers[109](index=109&type=chunk) - Lead clinical candidates are JANX007 (PSMA-TRACTr for mCRPC) and JANX008 (EGFR-TRACTr for multiple solid cancers), both showing encouraging early clinical data[109](index=109&type=chunk) Net Losses (in millions) | Period | Net Loss | | :----- | :------- | | Three months ended March 31, 2025 | $23.5 | | Three months ended March 31, 2024 | $14.8 | - The Company expects substantial increases in expenses and operating losses as it advances product candidates through clinical development and operates as a public company[112](index=112&type=chunk)[113](index=113&type=chunk) - Existing cash, cash equivalents, and short-term investments of **$1.01 billion** as of March 31, 2025, are believed to be sufficient to fund operations for at least the next 12 months[114](index=114&type=chunk)[131](index=131&type=chunk) [Our Research Collaboration with Merck](index=31&type=section&id=Our%20Research%20Collaboration%20with%20Merck) This section details the company's research collaboration with Merck, focusing on TRACTr product candidates and potential milestone payments - The collaboration with Merck, initiated in December 2020, focuses on developing TRACTr product candidates for two collaboration targets, with Merck receiving exclusive worldwide licenses[115](index=115&type=chunk) - The Company is eligible for up to **$500.5 million** per target in upfront and milestone payments, plus royalties on sales, with research services for both targets completed in August 2024[115](index=115&type=chunk) [Risks and Uncertainties](index=31&type=section&id=Risks%20and%20Uncertainties) This section addresses the widespread geopolitical and macroeconomic uncertainties impacting the company's business and financial condition - The Company faces widespread geopolitical and macroeconomic uncertainties, including public health crises, bank failures, inflation, and geopolitical conflicts, which could impact its business and financial condition[116](index=116&type=chunk) [Financial Operations Overview](index=31&type=section&id=Financial%20Operations%20Overview) This section provides an overview of the company's revenue, research and development, general and administrative expenses, and other income [Revenues](index=31&type=section&id=Revenues) This section discusses the company's collaboration revenue and the absence of product sales revenue to date - The Company has not generated any product sales revenue to date and does not expect to in the foreseeable future[117](index=117&type=chunk) Collaboration Revenue (in millions) | Period | Revenue | | :----- | :------ | | Three months ended March 31, 2025 | $0 | | Three months ended March 31, 2024 | $1.3 | [Research and Development](index=31&type=section&id=Research%20and%20Development) This section outlines the recognition and components of R&D expenses, and anticipated increases due to ongoing development activities - R&D expenses are recognized as incurred and primarily relate to the development of TRACTr and TRACIr platforms, discovery efforts, and preclinical/clinical development of product candidates[118](index=118&type=chunk) - Direct R&D expenses include external CROs and consultants, while indirect costs cover salaries, facilities, and equipment[119](index=119&type=chunk)[125](index=125&type=chunk) - R&D expenses are anticipated to increase substantially due to ongoing development, preclinical studies, clinical trials, and personnel expansion[120](index=120&type=chunk) [General and Administrative](index=33&type=section&id=General%20and%20Administrative) This section describes the components of G&A expenses and the expected increases due to headcount growth and public company operations - G&A expenses consist mainly of salaries, stock-based compensation, facility costs, legal fees, and professional services[122](index=122&type=chunk) - G&A expenses are expected to increase due to headcount growth, support for R&D, and costs associated with operating as a public company[122](index=122&type=chunk) [Other Income](index=33&type=section&id=Other%20Income) This section explains that other income is primarily derived from interest earned on cash, cash equivalents, and short-term investments - Other income is primarily derived from interest earned on cash, cash equivalents, and short-term investments[123](index=123&type=chunk) [Results of Operations](index=33&type=section&id=Results%20of%20Operations) This section provides a comparative analysis of the company's financial performance for the three months ended March 31, 2025, and 2024 [Collaboration Revenue](index=33&type=section&id=Collaboration%20Revenue) This section details the collaboration revenue trends, noting a decrease due to the completion of research activities under the Merck Agreement Collaboration Revenue (in thousands) | Period | Revenue | | :----- | :------ | | Three months ended March 31, 2025 | $0 | | Three months ended March 31, 2024 | $1,252 | - The **$1.3 million** decrease in collaboration revenue was primarily due to the completion of research activities under the Merck Agreement in August 2024[126](index=126&type=chunk) [Research and Development Expense](index=34&type=section&id=Research%20and%20Development%20Expense) This section analyzes the increase in R&D expenses, driven by direct costs for product candidates and indirect costs Research and Development Expenses (in thousands) | Category | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | Change | | :------- | :-------------------------------- | :-------------------------------- | :----- | | JANX007 | $4,443 | $2,820 | $1,623 | | JANX008 | $1,476 | $1,256 | $220 | | Preclinical stage programs and other direct unallocated costs | $7,046 | $2,430 | $4,616 | | Total direct costs | $12,965 | $6,506 | $6,459 | | Indirect costs | $12,090 | $7,564 | $4,526 | | **Total R&D expenses** | **$25,055** | **$14,070** | **$10,985** | - Total R&D expenses increased by **$11.0 million**, driven by increases in direct costs for JANX007 (**$1.6M**), JANX008 (**$0.2M**), other preclinical programs (**$4.6M**), and indirect costs (**$4.6M**)[128](index=128&type=chunk) [General and Administrative Expense](index=34&type=section&id=General%20and%20Administrative%20Expense) This section examines the increase in G&A expenses, primarily attributed to higher stock-based compensation General and Administrative Expenses (in thousands) | Period | Amount | | :----- | :----- | | Three months ended March 31, 2025 | $9,842 | | Three months ended March 31, 2024 | $7,343 | - G&A expenses increased by **$2.5 million**, primarily due to a **$2.1 million** increase in stock-based compensation[129](index=129&type=chunk) [Other Income](index=34&type=section&id=Other%20Income) This section discusses the increase in other income, driven by higher interest earnings from increased cash and investments Other Income (in thousands) | Period | Amount | | :----- | :----- | | Three months ended March 31, 2025 | $11,389 | | Three months ended March 31, 2024 | $5,401 | - Other income increased by **$6.0 million**, driven by higher interest income from increased cash, cash equivalents, and short-term investments[130](index=130&type=chunk) [Liquidity and Capital Resources](index=34&type=section&id=Liquidity%20and%20Capital%20Resources) This section assesses the company's financial liquidity, capital resources, and cash flow activities for the three months ended March 31, 2025, and 2024 - As of March 31, 2025, the Company had **$1.01 billion** in cash, cash equivalents, restricted cash, and short-term investments, including **$0.8 million** in restricted cash[131](index=131&type=chunk) - The Company has an 'at the market offering' program with BofA Securities for up to **$150.0 million** of common stock, all of which remained available as of March 31, 2025[132](index=132&type=chunk) - Significant capital was raised through underwritten offerings: **$56.5 million** net proceeds in July 2023, **$320.1 million** net proceeds in March 2024, and **$377.9 million** net proceeds in December 2024[133](index=133&type=chunk)[134](index=134&type=chunk)[136](index=136&type=chunk) Cash Flows Summary (in thousands) | Activity | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :------- | :-------------------------------- | :-------------------------------- | | Operating activities | $(17,024) | $(14,837) | | Investing activities | $(340,392) | $(113,736) | | Financing activities | $554 | $322,171 | - Net cash used in operating activities increased to **$17.0 million** in Q1 2025 from **$14.8 million** in Q1 2024, primarily due to increased net loss and changes in operating assets/liabilities[138](index=138&type=chunk) - Net cash used in investing activities significantly increased to **$340.4 million** in Q1 2025 from **$113.7 million** in Q1 2024, mainly due to higher net purchases of short-term investments[139](index=139&type=chunk) - Net cash provided by financing activities decreased substantially to **$0.6 million** in Q1 2025 from **$322.2 million** in Q1 2024, reflecting lower proceeds from equity offerings[140](index=140&type=chunk) [Funding Requirements](index=36&type=section&id=Funding%20Requirements) This section discusses the company's need for substantial additional funding to complete product development and commercialization, and potential financing methods - The Company believes existing capital is sufficient for at least the next 12 months but will require substantial additional funding to complete product candidate development through regulatory approval[141](index=141&type=chunk) - Future capital requirements depend on factors such as clinical trial progress, regulatory approvals, manufacturing costs, personnel hiring, commercialization activities, and intellectual property protection[142](index=142&type=chunk)[144](index=144&type=chunk) - Financing is expected through equity offerings, debt financings, or collaborations, which may lead to stockholder dilution or relinquishing rights to technologies[142](index=142&type=chunk) [Contractual Obligations and Commitments](index=38&type=section&id=Contractual%20Obligations%20and%20Commitments) This section outlines the company's significant contractual obligations, including license agreements and operating lease payments - The Company has a Cell Line License Agreement with WuXi Biologics, potentially requiring royalty payments on net sales if a third-party manufacturer is used, with a buyout option up to **$15.0 million**[143](index=143&type=chunk) - A noncancelable operating lease for office and laboratory space (Torrey Plaza Lease) involves aggregate payments of approximately **$38.0 million** over a 126-month term[146](index=146&type=chunk) [Critical Accounting Policies and Estimates](index=40&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) This section highlights key accounting estimates and judgments, including revenue recognition, R&D accruals, and equity award valuation - Key accounting estimates and judgments include collaboration revenue recognition, accruals for R&D expenses, and valuation of equity awards for stock-based compensation[148](index=148&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=40&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section assesses the company's exposure to market risks, including interest rate, foreign currency, and inflation, and their potential financial impact [Interest rate risk](index=40&type=section&id=Interest%20rate%20risk) This section discusses the company's exposure to interest rate fluctuations on its financial instruments - The Company's financial instruments, including cash, cash equivalents, and short-term investments, are subject to interest rate fluctuations[150](index=150&type=chunk) - A **10.0%** change in interest rates as of March 31, 2025, would not have had a material effect on the fair value of the investment portfolio[150](index=150&type=chunk) [Foreign currency exchange risk](index=40&type=section&id=Foreign%20currency%20exchange%20risk) This section addresses the company's exposure to foreign currency exchange rate risk, noting it is not currently significant - The Company is not currently exposed to significant foreign currency exchange rate risk, despite contracting with some international vendors[151](index=151&type=chunk) - A **10.0%** change in foreign currency exchange rates as of March 31, 2025, would not have had a material effect on the financial statements[151](index=151&type=chunk) [Inflation](index=42&type=section&id=Inflation) This section discusses the impact of inflation on the company's costs and its material effect on financial results - Inflation generally increases labor and preclinical/clinical development costs[153](index=153&type=chunk) - Inflation did not have a material effect on the Company's business, financial condition, or results of operations during the three months ended March 31, 2025[153](index=153&type=chunk) [Item 4. Controls and Procedures](index=42&type=section&id=Item%204.%20Controls%20and%20Procedures) This section details the evaluation of disclosure controls and procedures and reports on changes in internal control over financial reporting [Evaluation of Disclosure Controls and Procedures](index=42&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) This section confirms the effectiveness of the company's disclosure controls and procedures as of March 31, 2025 - As of March 31, 2025, the Chief Executive Officer concluded that the Company's disclosure controls and procedures were effective at the reasonable assurance level[154](index=154&type=chunk) [Changes in Internal Control over Financial Reporting](index=42&type=section&id=Changes%20in%20Internal%20Control%20over%20Financial%20Reporting) This section reports no material changes in internal control over financial reporting during the most recent quarter - There were no changes in internal control over financial reporting during the most recent quarter that materially affected, or are reasonably likely to materially affect, the Company's internal control over financial reporting[155](index=155&type=chunk) [PART II. OTHER INFORMATION](index=43&type=section&id=PART%20II.%20OTHER%20INFORMATION) This section provides additional information not included in the financial statements, covering legal proceedings, risk factors, equity sales, and exhibits [Item 1. Legal Proceedings](index=43&type=section&id=Item%201.%20Legal%20Proceedings) This section states the company is not currently involved in any material legal proceedings - The Company is not currently a party to any material legal proceedings[158](index=158&type=chunk) [Item 1A. Risk Factors](index=43&type=section&id=Item%201A.%20Risk%20Factors) This section outlines significant risks related to the company's limited operating history, financial position, product development, manufacturing, collaborations, industry operations, government regulation, intellectual property, and market factors [Summary of Risks Associated with Our Business](index=43&type=section&id=Summary%20of%20Risks%20Associated%20with%20Our%20Business) This section provides an overview of key risks, including limited operating history, continuous net losses, capital needs, early development stage, reliance on third parties, and intellectual property challenges - Key risks include a limited operating history, continuous net losses, the need for additional capital, early development stage of product candidates (except JANX007 and JANX008), reliance on third parties, and challenges in intellectual property protection[160](index=160&type=chunk)[162](index=162&type=chunk) [Risks Related to Our Limited Operating History, Financial Position and Capital Requirements](index=45&type=section&id=Risks%20Related%20to%20Our%20Limited%20Operating%20History%2C%20Financial%20Position%20and%20Capital%20Requirements) This section details risks stemming from the company's limited operating history, ongoing net losses, and substantial future capital requirements - The Company has incurred net losses since inception (**$23.5M** in Q1 2025, **$14.8M** in Q1 2024) and expects significant future losses, with an accumulated deficit of **$261.3 million** as of March 31, 2025[162](index=162&type=chunk) - Substantial additional funding will be required to complete product development and commercialization, which may lead to stockholder dilution or relinquishing rights to technologies[164](index=164&type=chunk)[168](index=168&type=chunk) - Future capital requirements are highly dependent on the timing and costs of preclinical studies, clinical trials (especially JANX007 and JANX008), regulatory approvals, manufacturing, and commercialization activities[167](index=167&type=chunk)[170](index=170&type=chunk) [Risks Related to the Discovery, Development and Regulatory Approval of Our Product Candidates](index=48&type=section&id=Risks%20Related%20to%20the%20Discovery%2C%20Development%20and%20Regulatory%20Approval%20of%20Our%20Product%20Candidates) This section outlines risks associated with the lengthy, expensive, and uncertain process of discovering, developing, and obtaining regulatory approval for product candidates - Most product candidates are in preclinical or discovery stages, and the Company has limited experience conducting clinical trials, making success in development and commercialization uncertain[172](index=172&type=chunk) - Preclinical and clinical development is lengthy, expensive, and unpredictable; early positive results do not guarantee success in later trials, and product candidates may fail to achieve favorable safety and efficacy[175](index=175&type=chunk) - Delays in clinical trials can occur due to regulatory disagreements, patient enrollment issues, safety concerns, or manufacturing challenges, impacting development timelines and costs[176](index=176&type=chunk)[180](index=180&type=chunk)[191](index=191&type=chunk) - Product candidates based on novel technologies face difficulties in predicting development timing, results, and costs, and adverse developments in one program could impact others[183](index=183&type=chunk) - Serious adverse events or undesirable side effects identified during development or after approval could lead to discontinuation of programs, refusal of regulatory approval, or revocation of marketing authorizations[192](index=192&type=chunk)[195](index=195&type=chunk) - Interim or preliminary clinical data are subject to change and audit, and differences from final data could harm business prospects[196](index=196&type=chunk)[197](index=197&type=chunk) - The regulatory approval process is lengthy, expensive, and uncertain, with potential for delays, limited indications, or post-market requirements[198](index=198&type=chunk)[199](index=199&type=chunk)[204](index=204&type=chunk) - Disruptions at regulatory authorities (e.g., FDA, EMA) due to funding shortages or global health concerns could delay product review and approval[215](index=215&type=chunk)[216](index=216&type=chunk) - Limited resources necessitate prioritizing product candidates, potentially foregoing more profitable opportunities, and there is no guarantee of identifying additional successful candidates[217](index=217&type=chunk)[218](index=218&type=chunk) [Risks Related to Manufacturing, Commercialization and Reliance on Third Parties](index=62&type=section&id=Risks%20Related%20to%20Manufacturing%2C%20Commercialization%20and%20Reliance%20on%20Third%20Parties) This section covers risks associated with manufacturing, commercialization, and heavy reliance on third parties for preclinical testing, clinical trials, and product manufacturing - The Company relies heavily on third parties for preclinical testing, clinical trials, and manufacturing of product candidates, increasing risks of delays, increased costs, or substandard performance[219](index=219&type=chunk)[220](index=220&type=chunk)[224](index=224&type=chunk)[225](index=225&type=chunk) - Manufacturing is complex and relies on single-source suppliers for Bulk Drug Substance (BDS), posing risks of supply limitations, interruptions, or quality issues[225](index=225&type=chunk) - Compliance with cGMP regulations by third-party manufacturers is critical, and any failure could lead to delays, regulatory issues, or inability to meet commercial demand[226](index=226&type=chunk)[229](index=229&type=chunk) - Geopolitical factors, such as trade restrictions or sanctions involving Chinese biotechnology companies like WuXi Biologics, could disrupt the supply chain[229](index=229&type=chunk) - Approved products may fail to achieve market acceptance due to competition, pricing, convenience, or lack of reimbursement, limiting commercial success[236](index=236&type=chunk)[238](index=238&type=chunk) - Unfavorable pricing regulations or third-party coverage and reimbursement policies could make it difficult to sell product candidates profitably, impacting demand and revenue[237](index=237&type=chunk)[240](index=240&type=chunk)[241](index=241&type=chunk) - Product candidates approved as biologics may face biosimilar competition sooner than anticipated, leading to significant pricing pressure[248](index=248&type=chunk)[250](index=250&type=chunk) - The market opportunity may be limited to patients who have failed prior treatments, and estimates of target patient populations may be inaccurate[252](index=252&type=chunk)[254](index=254&type=chunk) - Reliance on third parties requires sharing trade secrets, increasing the risk of discovery or misappropriation by competitors[255](index=255&type=chunk) - The Company lacks internal sales and marketing capabilities and faces risks in establishing its own or outsourcing these functions, potentially hindering commercialization[258](index=258&type=chunk)[259](index=259&type=chunk)[261](index=261&type=chunk) - Failure to obtain regulatory approval or commercialize products outside the United States would limit market potential due to varying international regulatory requirements[262](index=262&type=chunk) [Risks Related to Our Collaborations and Other Strategic Agreements](index=76&type=section&id=Risks%20Related%20to%20Our%20Collaborations%20and%20Other%20Strategic%20Agreements) This section addresses risks associated with collaborations, including potential termination, disputes, and the inability to form new strategic alliances - The existing collaboration with Merck is crucial, and its termination or Merck's de-prioritization of programs could result in reduced or no milestone payments and royalties[264](index=264&type=chunk)[265](index=265&type=chunk) - Disputes with collaborators could delay development, create intellectual property uncertainties, and incur substantial expenses[265](index=265&type=chunk) - Inability to form additional collaborations or realize benefits from strategic alliances could alter or delay development and commercialization plans[269](index=269&type=chunk)[271](index=271&type=chunk) [Risks Related to Our Industry and Business Operations](index=78&type=section&id=Risks%20Related%20to%20Our%20Industry%20and%20Business%20Operations) This section covers risks inherent to the biopharmaceutical industry and business operations, including misconduct, product liability, competition, and macroeconomic factors - The Company is exposed to risks of misconduct by employees, investigators, consultants, and partners, including non-compliance with regulatory standards and healthcare fraud laws[273](index=273&type=chunk) - Product liability claims, even if meritless, could result in substantial costs, reputational harm, and delays in regulatory approvals or commercialization[274](index=274&type=chunk)[277](index=277&type=chunk) - High dependence on key personnel and intense competition for skilled labor in the San Diego area pose risks to business strategy implementation and growth management[278](index=278&type=chunk)[279](index=279&type=chunk)[280](index=280&type=chunk) - The Company faces substantial competition in the immunotherapy market, with competitors having greater resources and more advanced products, potentially rendering its technologies obsolete[285](index=285&type=chunk)[288](index=288&type=chunk) - The ability to use net operating loss (NOL) carryforwards may be limited by ownership changes (Section 382) or state-level restrictions, potentially increasing future tax liability[292](index=292&type=chunk)[294](index=294&type=chunk) - Epidemic diseases could significantly disrupt operations, clinical trials, supply chains, and access to capital, exacerbating other business risks[295](index=295&type=chunk)[297](index=297&type=chunk)[298](index=298&type=chunk)[300](index=300&type=chunk) [Risks Related to Government Regulation](index=87&type=section&id=Risks%20Related%20to%20Government%20Regulation) This section details risks arising from extensive government regulations, including healthcare fraud laws, pricing legislation, data privacy, and international trade policies - Business operations are subject to extensive U.S. federal and state, EU, and foreign healthcare fraud and abuse laws, transparency laws, and other regulations, with potential for substantial penalties for non-compliance[301](index=301&type=chunk)[302](index=302&type=chunk)[303](index=303&type=chunk) - Enacted and future legislation, such as the Affordable Care Act and Inflation Reduction Act (IRA), may increase the difficulty and cost of obtaining marketing approval and commercializing products, and affect pricing[304](index=304&type=chunk)[305](index=305&type=chunk)[307](index=307&type=chunk) - The IRA directs Medicare drug price negotiations and imposes rebates for price increases exceeding inflation, potentially impacting future revenues[307](index=307&type=chunk) - Changes in EU regulatory frameworks, including the Clinical Trials Regulation (CTR) and Health Technology Assessment (HTA) processes, could impact clinical trial authorization and product pricing/reimbursement[310](index=310&type=chunk) - Brexit has changed the UK's regulatory relationship with the EU, requiring compliance with separate UK regulatory frameworks for clinical trials and marketing authorizations[314](index=314&type=chunk)[315](index=315&type=chunk)[316](index=316&type=chunk) - The Company processes sensitive information, including health-related data, and is subject to stringent and evolving data privacy and security laws (e.g., HIPAA, CCPA, GDPR), with non-compliance risking investigations, litigation, and penalties[320](index=320&type=chunk)[321](index=321&type=chunk)[322](index=322&type=chunk)[323](index=323&type=chunk)[328](index=328&type=chunk) - Limitations on cross-border data transfers, particularly from Europe to the U.S., could disrupt operations and lead to significant expenses or regulatory actions[329](index=329&type=chunk)[331](index=331&type=chunk) - International trade policies, including tariffs and sanctions, may adversely affect business by increasing R&D expenses, disrupting supply chains (e.g., WuXi Biologics in China), and creating legal/operational risks[334](index=334&type=chunk)[335](index=335&type=chunk)[336](index=336&type=chunk)[337](index=337&type=chunk) [Risks Related to Our Intellectual Property](index=99&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) This section addresses risks concerning the company's intellectual property, including patent protection, trade secrets, inventorship claims, and trademark protection - Failure to obtain and maintain sufficient patent protection for platform technologies and product candidates could allow competitors to commercialize similar products, adversely affecting the Company's competitive position[339](index=339&type=chunk)[341](index=341&type=chunk) - The patent application process is expensive, time-consuming, and uncertain; issued patents may be challenged, invalidated, or circumvented, limiting protection[342](index=342&type=chunk)[347](index=347&type=chunk) - Reliance on trade secret protection carries risks of disclosure or independent development by competitors, harming competitive position[348](index=348&type=chunk)[383](index=383&type=chunk)[384](index=384&type=chunk) - The Company may be subject to claims challenging inventorship or ownership of patents, potentially leading to loss of valuable intellectual property rights[385](index=385&type=chunk)[386](index=386&type=chunk) - Patent terms may be inadequate to protect product candidates for a sufficient period, leading to biosimilar or generic competition upon expiration[389](index=389&type=chunk) - Inadequate protection of trademarks and trade names could hinder brand recognition and competitive effectiveness[390](index=390&type=chunk) [Risks Related to the Securities Market and Ownership of Our Common Stock](index=119&type=section&id=Risks%20Related%20to%20the%20Securities%20Market%20and%20Ownership%20of%20Our%20Common%20Stock) This section discusses risks related to the volatility of the company's common stock price, stockholder control, future stock issuances, and corporate governance provisions - The price of the Company's common stock is subject to significant volatility due to factors like clinical trial results, regulatory developments, market conditions, and analyst recommendations[392](index=392&type=chunk)[394](index=394&type=chunk) - Principal stockholders and management own a significant percentage of stock, allowing them to exert substantial control over stockholder approval matters[395](index=395&type=chunk) - Future sales and issuances of common stock, including through equity incentive plans, could dilute existing stockholders' ownership and cause the stock price to fall[397](index=397&type=chunk)[398](index=398&type=chunk) - The Company does not intend to pay dividends, limiting stockholder returns to stock appreciation[399](index=399&type=chunk) - Delaware law and corporate provisions could make mergers, tender offers, or proxy contests difficult, potentially depressing the stock price[400](index=400&type=chunk)[404](index=404&type=chunk) - Exclusive forum provisions in corporate documents may limit stockholders' ability to choose a favorable judicial forum for disputes, potentially increasing costs[405](index=405&type=chunk)[407](index=407&type=chunk) [General Risk Factors](index=124&type=section&id=General%20Risk%20Factors) This section covers broad risks including public company operating costs, control failures, accounting changes, market instability, inflation, cybersecurity, natural disasters, and compliance with various laws - Operating as a public company incurs significantly increased legal, accounting, and compliance costs, diverting management time and potentially impacting financial performance[408](index=408&type=chunk)[409](index=409&type=chunk) - Failure to maintain effective disclosure controls and internal control over financial reporting could impair timely and accurate financial statements, harm business, and lead to investor loss of confidence[410](index=410&type=chunk)[413](index=413&type=chunk) - Future changes in financial accounting standards or tax laws could cause adverse revenue fluctuations, increase costs, or impact financial results[416](index=416&type=chunk)[417](index=417&type=chunk) - Unstable market and economic conditions, including health epidemics, bank failures, and geopolitical conflicts, may adversely affect business, financial condition, and stock price[418](index=418&type=chunk)[419](index=419&type=chunk) - Inflation increases operating costs, potentially accelerating cash burn and requiring additional capital sooner than expected[420](index=420&type=chunk) - Compromises of internal IT systems or sensitive information, or those of third parties, could lead to disruptions, regulatory actions, litigation, and reputational harm[422](index=422&type=chunk)[424](index=424&type=chunk)[427](index=427&type=chunk)[431](index=431&type=chunk) - Natural disasters (e.g., earthquakes, fires) could disrupt operations, especially given the concentration of facilities in San Diego, and the lack of comprehensive disaster recovery plans[433](index=433&type=chunk) - Violations of U.S. and foreign anti-corruption, anti-money laundering, export control, and sanctions laws could result in substantial penalties and reputational damage[434](index=434&type=chunk) - Failure to comply with environmental, health, and safety laws could lead to fines, penalties, or substantial costs[435](index=435&type=chunk)[437](index=437&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=135&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section details the company's June 2021 IPO, including gross and net proceeds, and confirms the use of proceeds aligns with planned allocation - The Company's IPO in June 2021 generated gross proceeds of **$222.9 million** and net proceeds of approximately **$204.2 million**[444](index=444&type=chunk) - As of March 31, 2025, **$38.7 million** of the IPO proceeds have been used, with no material change in the planned use, and the balance invested in high-quality marketable securities[445](index=445&type=chunk) [Item 5. Other Information](index=135&type=section&id=Item%205.%20Other%20Information) This section reports no directors or officers adopted or terminated Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during the quarter - No director or officer adopted or terminated any Rule 10b5-1 or non-Rule 10b5-1 trading arrangement during the three months ended March 31, 2025[446](index=446&type=chunk) [Item 6. Exhibits](index=136&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed as part of the Form 10-Q, including corporate governance documents, stock certificates, investor agreements, and certifications - The exhibits include Amended and Restated Certificate of Incorporation, Bylaws, Form of Common Stock Certificate, Amended and Restated Investors' Rights Agreement, Forms of Pre-Funded Warrant, Amended and Restated Non-Employee Director Compensation Policy, and various certifications[448](index=448&type=chunk) [SIGNATURES](index=137&type=section&id=SIGNATURES) This section contains the authorized signature for the Quarterly Report on Form 10-Q - The report is signed by David Campbell, Ph.D., President and Chief Executive Officer (Principal Executive and Financial Officer) of Janux Therapeutics, Inc. on May 8, 2025[453](index=453&type=chunk)

[Executive Summary](index=1&type=section&id=Executive%20Summary) 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](index=1&type=chunk) - The company initiated the first Phase 1b expansion study with JANX007 in taxane-naïve mCRPC patients[2](index=2&type=chunk) - Janux plans to host an R&D Day to unveil previously undisclosed preclinical programs[2](index=2&type=chunk) [Recent Business Highlights and Future Milestones](index=1&type=section&id=RECENT%20BUSINESS%20HIGHLIGHTS%20AND%20FUTURE%20MILESTONES) 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](index=1&type=section&id=JANX007%20Clinical%20Development) 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](index=2&type=chunk)[6](index=6&type=chunk) - Updated JANX007 data from Phase 1a dose escalation (as of April 21, 2025) supported the initiation of Phase 1b expansion studies[2](index=2&type=chunk)[6](index=6&type=chunk) 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](index=4&type=chunk) - Janux plans to initiate three additional Phase 1b expansion studies with JANX007, evaluating combinations and monotherapy in different mCRPC patient populations[5](index=5&type=chunk)[12](index=12&type=chunk) [JANX008 Clinical Development](index=2&type=section&id=JANX008%20Clinical%20Development) 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](index=6&type=chunk)[12](index=12&type=chunk) [Pipeline and R&D Day](index=1&type=section&id=Pipeline%20and%20R%26D%20Day) 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](index=2&type=chunk)[8](index=8&type=chunk) - Updates on JANX007 and JANX008 are expected in the second half of 2025[6](index=6&type=chunk)[8](index=8&type=chunk) [Financial Position Snapshot](index=1&type=section&id=Financial%20Position%20Snapshot) 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](index=6&type=chunk)[12](index=12&type=chunk) [First Quarter 2025 Financial Results](index=2&type=section&id=First%20Quarter%202025%20Financial%20Results) This section provides a detailed overview of Janux's financial performance for Q1 2025, including balance sheet and income statement highlights [Condensed Balance Sheets](index=4&type=section&id=Condensed%20Balance%20Sheets) 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](index=5&type=section&id=Unaudited%20Condensed%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) 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](index=12&type=chunk)[18](index=18&type=chunk) - General and administrative expenses increased by **$2.499 million (34%)** year-over-year[12](index=12&type=chunk)[18](index=18&type=chunk) [About Janux Therapeutics](index=2&type=section&id=About%20Janux%20Therapeutics) This section provides an overview of Janux Therapeutics, its proprietary platforms, and its clinical pipeline of tumor-activated immunotherapies [Company Overview and Platforms](index=2&type=section&id=Company%20Overview%20and%20Platforms) 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](index=1&type=chunk)[11](index=11&type=chunk) - Utilizes proprietary TRACTr and TRACIr bispecific platforms to develop therapeutics[1](index=1&type=chunk)[11](index=11&type=chunk) - 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](index=11&type=chunk) [Clinical Pipeline](index=2&type=section&id=Clinical%20Pipeline) 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](index=10&type=chunk)[13](index=13&type=chunk) - 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](index=10&type=chunk)[13](index=13&type=chunk) - 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](index=10&type=chunk) [Forward-Looking Statements](index=3&type=section&id=Forward-Looking%20Statements) 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](index=14&type=chunk) - 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](index=14&type=chunk) [Contacts](index=5&type=section&id=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](index=19&type=chunk) - Media Contact: Jessica Yingling, Ph.D., Little Dog Communications Inc., jessica@litldog.com, (858) 344-8091[19](index=19&type=chunk)

Group 1 - Janux Therapeutics (JANX) is identified as an early-stage biotech company with a strong pipeline focused on innovative cancer treatments that enhance the immune system's ability to identify and eliminate cancer cells [1] - The company is currently developing a new type of cancer therapy, which is positioned to potentially transform cancer treatment approaches [1] Group 2 - The article does not provide specific financial metrics or performance data related to Janux Therapeutics [2] - There are no detailed insights into the competitive landscape or market positioning of Janux Therapeutics within the biotech industry [2]

Immunotherapy Development - Janux Therapeutics is developing tumor-activated immunotherapies through two bispecific platforms: TRACTr and TRACIr, targeting solid tumors and aiming to minimize safety concerns [24]. - The company is generating additional unnamed TRACTr and TRACIr programs for future development, with some already at the development candidate stage [31]. - Janux's strategy focuses on leveraging its proprietary technology to transform cancer treatment and overcome the limitations of current immunotherapies [38]. - The TRACTr and TRACIr platforms are designed to limit activity to tumor sites, reducing the risk of on-target, healthy tissue toxicity and potentially extending half-lives in serum [44][53]. - The TRACTr platform technology allows for the development of new candidates against a variety of targets, with the first three programs achieving antibody identification and masked tumor-binding domain development in less than six months [40]. - The company is developing multiple TRACTr programs targeting solid tumors with high prevalence, including mCRPC, CRC, and NSCLC [77]. - The company believes that the TRACTr platform technology can improve pharmacokinetics and reduce CRS toxicity compared to existing therapies [88]. Clinical Trials and Results - The first clinical candidate, JANX007, is in a Phase 1 trial for metastatic castration-resistant prostate cancer (mCRPC) and has shown meaningful PSA level drops and a favorable safety profile [24]. - The second clinical candidate, JANX008, targets EGFR and is being studied in a Phase 1 trial for multiple solid cancers, with early data indicating anti-tumor activity and low-grade treatment-related adverse events [24]. - The first patient for the JANX008 trial was dosed in April 2023, with positive early data announced in February 2024 [34]. - The company announced updated interim clinical data for JANX007, showing meaningful and prolonged PSA drops and a favorable safety profile, with CRS and TRAEs primarily limited to Cycle 1 and lower grades [40]. - The first patient was dosed with EGFR-TRACTr JANX008 in April 2023, and positive early data indicated anti-tumor activity in multiple tumor types with low-grade CRS and predominantly low-grade TRAEs [40]. - The first patient was dosed with PSMA-TRACTr in a Phase 1 clinical trial for mCRPC in October 2022, with updated interim data showing meaningful PSA drops and a favorable safety profile [97]. - In the early cohorts, Grade 1 CRS was observed in only two subjects out of 11, with no Grade 2 or higher CRS reported, indicating a favorable safety profile [140]. Collaboration and Financials - Janux has a strategic collaboration with Merck, which includes potential payments of up to $500.5 million per target, plus royalties on sales from the collaboration [36]. - The Merck Agreement includes a one-time upfront payment of $8.0 million for each of the two Collaboration Targets, with potential milestone payments totaling up to $285.0 million collectively [159]. - Tiered royalty payments from Merck range from low single-digit to low teens percentage on annual net sales for licensed products, starting upon the first sale in each country [160]. - The Cell Line License Agreement with WuXi Biologics includes a non-refundable, one-time license fee of $0.2 million and potential royalty payments based on net sales of licensed products [163]. Manufacturing and Cost Efficiency - The TRACTr and TRACIr platforms are expected to offer a lower cost of goods due to their manufacturability resembling that of monoclonal antibodies [30]. - The manufacturing process for TRACTr and TRACIr molecules allows for lower cost-per-dose compared to monoclonal antibodies, with high solubility and good stability [142]. - The TRACTr and TRACIr platforms are designed to be manufacturable at a relatively lower cost, closely resembling the development processes used for monoclonal antibodies [53]. Safety and Efficacy - The TRACTr and TRACIr platforms are designed to reduce cytokine release syndrome (CRS) and on-target healthy tissue toxicity, which are significant limitations of existing TCEs [26]. - The proprietary albumin-binding domain in TRACTrs and TRACIrs is intended to increase serum half-life, with the EGFR-TRACTr demonstrating a half-life of over 100 hours compared to approximately one hour for the corresponding EGFR-TCE [67]. - The EGFR-TRACTr product candidate demonstrated an 8,500-fold shift in activating T cell killing of EGFR-expressing tumor cells when masked compared to unmasked conditions [131]. - Dosing of the EGFR-TRACTr at 100µg/kg resulted in minimal inflammatory cytokine release, compared to a greater than 20-fold increase in IL-6 with the unmasked EGFR-TCE [134]. Patent and Regulatory Landscape - As of February 14, 2025, the company owns 29 pending U.S. provisional and non-provisional patent applications, three U.S. patents, nine pending patent applications filed under the Patent Cooperation Treaty (PCT), and 94 foreign patent applications [168]. - The company has two U.S. non-provisional patent applications and five foreign patent applications directed to compositions of its TRACTr and TRACIr platform technologies applicable across product candidates for PSMA-TRACTr (JANX007) and EGFR-TRACTr (JANX008) programs [168]. - The company intends to pursue patent protection directed to compositions, methods of use, methods of making, dosing, and formulations for its product candidates and processes [169]. - The FDA review process for a biologic includes submission of a Biologics License Application (BLA) after extensive preclinical studies and clinical trials [175]. - The FDA requires two adequate and well-controlled Phase 3 clinical trials to demonstrate the efficacy of a biologic before approval [31]. - The FDA may impose conditions on approval that restrict distribution or use of the product based on post-marketing findings [208].

Financial Performance - Janux reported $1.03 billion in cash, cash equivalents, and short-term investments as of December 31, 2024, compared to $344.0 million at the end of 2023, representing a 200% increase[10]. - The net loss for Q4 2024 was $20.2 million, compared to $11.8 million in Q4 2023, and the total net loss for the year was $69.0 million, up from $58.3 million in 2023, marking an 18.5% increase[10]. - Janux's total assets increased to $1.06 billion as of December 31, 2024, compared to $380.4 million at the end of 2023, reflecting a significant growth in the company's financial position[14]. Research and Development - Research and development expenses for Q4 2024 were $20.8 million, up from $12.2 million in Q4 2023, and total R&D expenses for the year were $68.4 million, compared to $54.9 million in 2023, reflecting a 24.5% year-over-year increase[10]. - Janux plans to provide updates on JANX007 and JANX008 data in 2025, with ongoing enrollment in both Phase 1 clinical trials[4]. - The company anticipates hosting an R&D Day in 2025 to disclose new programs moving toward the clinic[4]. Clinical Trials - Positive Phase 1 clinical trial data for PSMA-TRACTr JANX007 showed a 100% best PSA50 response rate and 63% best PSA90 declines among 16 patients as of November 15, 2024[5]. Management Changes - Zachariah McIver, D.O., Ph.D. was promoted to Chief Medical Officer, bringing over 15 years of clinical research experience to lead Janux's clinical programs[6]. Capital Raising - The company raised approximately $402.5 million in gross proceeds from an underwritten offering of common stock and pre-funded warrants in December 2024[5]. General and Administrative Expenses - General and administrative expenses for Q4 2024 were $8.2 million, compared to $6.4 million in Q4 2023, and total G&A expenses for the year were $41.0 million, up from $26.1 million in 2023, indicating a 56.9% increase year-over-year[10].

Core Viewpoint - Janux Therapeutics' stock surged nearly 12% following an analyst's price-target hike and a new capital-raising initiative, indicating positive market sentiment despite the analyst maintaining a hold recommendation [1][2]. Group 1: Analyst Insights - Scotiabank analyst George Farmer raised his price target for Janux by nearly 50% to $62 per share, while still recommending a sector perform rating [2]. - Farmer noted that the ongoing phase 1 trial of Janux's JANX007 prostate cancer treatment shows promise, but the company lacks a competitive edge and is not yet an attractive acquisition target for larger pharmaceutical firms [3]. Group 2: Capital Raising and Future Plans - Janux announced a $300 million secondary common stock offering, with an option for underwriters to purchase an additional $45 million worth of shares within 30 days [4]. - The company plans to use the proceeds from the share issue to advance the clinical development of its product pipeline and for general corporate purposes, focusing on cancer treatments, a growing area in the biotech sector [5].

Core Viewpoint - Shares of Janux Therapeutics surged 49% following the release of updated interim results from a phase Ib study evaluating JANX007 for advanced or metastatic prostate cancer [1][7]. Group 1: Study Results - The phase Ib study enrolled patients with metastatic castration-resistant prostate cancer (mCRPC) who had a median of four prior therapies [2]. - All 16 treated patients achieved a 50% decline in prostate-specific antigen (PSA) levels after 12 weeks of treatment with JANX007 [3]. - Among the patients, 10 achieved a 90% reduction in PSA levels, with five experiencing a 99% decline [4]. Group 2: Treatment Efficacy - 75% of patients with a 50% PSA decline maintained this reduction for at least 12 weeks, while 50% of those with a 90% decline sustained it for the same duration [4]. - Based on these results, two once-weekly step-dose regimens of JANX007 have been selected for phase Ib expansion studies targeting previously treated mCRPC patients who have not received Pluvicto [5]. Group 3: Stock Performance - Following the announcement, Janux's shares reached an all-time high of $71.25, reflecting strong investor interest due to the impressive clinical performance of JANX007 [6]. - Year to date, Janux Therapeutics' shares have increased by 457.9%, contrasting with a 7.0% decline in the industry [8]. Group 4: Market Reaction - The positive update on JANX007 also led to a 13% rise in shares of Vir Biotechnology, which is developing a similar drug, VIR-5500 [11].

Core Insights - Janux Therapeutics, Inc. announced updated interim clinical data for its JANX007 program, demonstrating substantial activity in patients with 5L metastatic castration-resistant prostate cancer [1][6] - The results indicate strong efficacy and safety profiles for JANX007, supporting its potential as a leading treatment option in heavily pretreated patients [7] Clinical Data Summary - The trial involved patients with a median of four prior lines of therapy, showing high prostate-specific antigen (PSA) response rates: 100% achieved PSA50 declines, 63% achieved PSA90 declines, and 31% achieved PSA99 declines [3] - Durability of PSA declines was noted, with 75% of patients maintaining PSA50 declines for at least 12 weeks and 50% maintaining PSA90 declines for the same duration [4] - Anti-tumor activity was confirmed in 50% of patients, with JANX007 being well-tolerated and adverse events primarily limited to the first treatment cycle [5] Market Outlook - Analysts from William Blair increased the peak sales estimate for JANX007 in the U.S. from $1.7 billion to $3 billion, citing the drug's improving clinical profile [6] - Despite significant share appreciation year-to-date, Janux shares are considered to have meaningful upside potential [6][8]

Company Overview - Janux Therapeutics (NASDAQ: JANX) focuses on developing cancer therapies utilizing its proprietary Tumor Activated T Cell Engager (TRACTr) and Tumor Activated Immunomodulator (TRACIr) platforms [1] Financial Data - The financial data presented shows significant percentage changes over the years, with a cumulative growth of 1212% from 2018 to 2023, despite a decline of 19% in 2022 [2][4] Investment Tools - The company offers a suite of tools for DIY investors through its Android app and website, which includes a software for entering any ticker to access extensive curated research material [3]

Financial Performance - The company reported net losses of $48.8 million and $46.5 million for the nine months ended September 30, 2024 and 2023, respectively, with an accumulated deficit of $217.5 million as of September 30, 2024[89]. - Net loss for the nine months ended September 30, 2024, was $48.8 million, compared to a net loss of $46.5 million in 2023, an increase of $2.3 million[111]. - Total operating expenses rose to $80.4 million for the nine months ended September 30, 2024, compared to $62.5 million in 2023, an increase of $17.9 million[106]. Revenue and Collaboration - Collaboration revenue under the Merck Agreement was $10.6 million for the nine months ended September 30, 2024, compared to $5.6 million for the same period in 2023, reflecting a significant increase[94]. - Collaboration revenue increased to $10.6 million for the nine months ended September 30, 2024, up from $5.6 million in 2023, a change of $5.0 million[107]. - The collaboration with Merck could yield up to $500.5 million per target in upfront and milestone payments, plus royalties on sales[92]. - The company has not generated any revenue from product sales and does not expect to do so for the foreseeable future[91]. Research and Development - Research and development expenses increased to $18.6 million for the three months ended September 30, 2024, up from $11.9 million in 2023, marking a rise of $6.7 million[104]. - Research and development expenses were $47.6 million for the nine months ended September 30, 2024, up from $42.7 million in 2023, reflecting an increase of $4.9 million[109]. - The company anticipates substantial increases in research and development expenses as it continues to develop its TRACTr and TRACIr platforms[97]. - The first clinical candidate, JANX007, is in a Phase 1 trial for metastatic castration-resistant prostate cancer, with interim data showing meaningful PSA drops and a favorable safety profile[87]. - The second clinical candidate, JANX008, is being studied in a Phase 1 trial for multiple solid tumors, with early data indicating antitumor activity and low-grade adverse events[87]. Cash Flow and Financial Position - Cash, cash equivalents, restricted cash, and short-term investments totaled $658.8 million as of September 30, 2024[112]. - Net cash used in operating activities was $27.1 million for the nine months ended September 30, 2024, an improvement from $40.7 million in 2023[116]. - Net cash used in investing activities was $291.9 million for the nine months ended September 30, 2024, compared to $52.3 million in 2023[118]. - Net cash provided by financing activities was $326.6 million for the nine months ended September 30, 2024, significantly higher than $58.7 million in 2023[119]. - The company anticipates that existing cash and short-term investments will be sufficient to meet operating expenses for at least the next 12 months[120]. Corporate Governance and Compliance - The company is classified as an "emerging growth company" and a "smaller reporting company," maintaining this status until December 31, 2024[126]. - The company will reassess its status as a large accelerated filer as of June 30, 2025, and annually thereafter[126]. - There have been no material changes to the critical accounting policies during the nine months ended September 30, 2024[127]. - The company's disclosure controls and procedures were deemed effective as of the end of the reporting period, ensuring timely and accurate information disclosure[128]. - Tighe Reardon resigned as Acting Chief Financial Officer during Q3 2024, leading to modifications in internal controls[129]. - The company is not currently involved in any material legal proceedings, although it may face claims in the ordinary course of business[130]. Expenses - General and administrative expenses rose to $17.7 million for the three months ended September 30, 2024, compared to $6.4 million in 2023, an increase of $11.3 million primarily due to stock-based compensation[105]. - General and administrative expenses increased to $32.8 million for the nine months ended September 30, 2024, compared to $19.8 million in 2023, a rise of $13.0 million[110].