[Janux Therapeutics First Quarter 2024 Report](index=1&type=section&id=Janux%20Therapeutics%20First%20Quarter%202024%20Report) [Business Highlights and Future Milestones](index=1&type=section&id=Business%20Highlights%20and%20Future%20Milestones) Janux Therapeutics is advancing its clinical programs, with continued enrollment in Phase 1 trials for its key drug candidates, JANX007 for prostate cancer and JANX008 for various solid tumors, anticipating data updates in 2024 and 2025 while expanding its preclinical pipeline - Enrollment is ongoing for the Phase 1 clinical trial of **JANX007 (PSMA-TRACTr)** in patients with metastatic castration-resistant prostate cancer (**mCRPC**)[5](index=5&type=chunk)[6](index=6&type=chunk) - Enrollment continues for the Phase 1 clinical trial of **JANX008 (EGFR-TRACTr)** in patients with advanced or metastatic **solid tumors**[5](index=5&type=chunk)[6](index=6&type=chunk) - Key data updates are planned, with **JANX007** data and expansion cohort dose selection expected in the **second half of 2024**, and an update on **JANX008** data anticipated in **2025**[3](index=3&type=chunk)[5](index=5&type=chunk) [First Quarter 2024 Financial Results](index=1&type=section&id=First%20Quarter%202024%20Financial%20Results) In the first quarter of 2024, Janux significantly strengthened its financial position, with cash, cash equivalents, and short-term investments increasing to $651.8 million, reporting a reduced net loss of $14.8 million compared to $17.5 million in the prior-year period, primarily due to lower research and development expenses Cash Position Comparison (in millions) | Metric | March 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | Cash, cash equivalents and short-term investments | $651.8 | $344.0 | Q1 2024 vs Q1 2023 Operating Results (in millions) | Metric | Q1 2024 | Q1 2023 | Change | | :--- | :--- | :--- | :--- | | Research and development expenses | $14.1 | $15.9 | Decreased | | General and administrative expenses | $7.3 | $6.5 | Increased | | Net loss | $14.8 | $17.5 | Decreased | [Janux's TRACTr and TRACIr Pipeline](index=2&type=section&id=Janux%27s%20TRACTr%20and%20TRACIr%20Pipeline) Janux's pipeline is built on its proprietary TRACTr and TRACIr platforms, designed to create safer and more effective tumor-activated immunotherapies, with lead clinical candidates JANX007 for prostate cancer and JANX008 for various solid tumors, alongside active preclinical programs - The company's core technology consists of two platforms: Tumor Activated T Cell Engagers (**TRACTr**) and Tumor Activated Immunomodulators (**TRACIr**), aimed at minimizing safety concerns while eradicating tumors[8](index=8&type=chunk) - **JANX007**, the first clinical candidate, is a **TRACTr** targeting **PSMA** for the treatment of metastatic castration-resistant prostate cancer (**mCRPC**)[7](index=7&type=chunk) - **JANX008**, the second clinical candidate, is a **TRACTr** targeting **EGFR** for solid cancers including colorectal, head and neck, non-small cell lung, and renal cell carcinoma[7](index=7&type=chunk) [Financial Statements](index=3&type=section&id=Financial%20Statements) The financial statements for the period ending March 31, 2024, reflect a significant increase in assets and stockholders' equity, alongside a reduction in net loss compared to the same period in 2023 [Condensed Balance Sheets](index=3&type=section&id=Condensed%20Balance%20Sheets) As of March 31, 2024, Janux's balance sheet showed a substantial increase in total assets to $689.0 million from $380.4 million at year-end 2023, driven by a significant rise in cash, cash equivalents, and short-term investments, resulting in a strengthened stockholders' equity position of $655.8 million Balance Sheet Summary (in thousands) | Account | March 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | **Total current assets** | **$658,666** | **$349,241** | | Total assets | $688,984 | $380,407 | | Total liabilities | $33,221 | $36,058 | | **Total stockholders' equity** | **$655,763** | **$344,349** | [Unaudited Condensed Statements of Operations and Comprehensive Loss](index=4&type=section&id=Unaudited%20Condensed%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) For the three months ended March 31, 2024, Janux reported collaboration revenue of $1.3 million and a net loss of $14.8 million, or ($0.30) per share, representing an improvement from the prior-year period's net loss of $17.5 million, or ($0.42) per share, driven by lower R&D expenses and higher other income Q1 Statement of Operations Summary (in thousands, except per share data) | Metric | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | Collaboration revenue | $1,252 | $2,048 | | Research and development | $14,070 | $15,865 | | Total operating expenses | $21,413 | $22,329 | | **Net loss** | **$(14,760)** | **$(17,459)** | | **Net loss per common share** | **$(0.30)** | **$(0.42)** |

Investors looking for a white-knuckle ride can easily find one by buying biotech stocks. There is a certain thrill in investing in a company making actual life-or-death decisions with drugs. And they offer the potential for creating fabulous wealth for investors willing to get in early enough.Yet, biotechs can also plunge to new depths when their drug trials go awry. It’s definitely not a sector to invest in for the faint of heart. Finding the right horse to back is a key consideration. Below are three biot ...

Shares of cancer-biotech Janux Therapeutics, Inc. (JANX) have surged close to 50% in the past week, following a report issued by Bloomberg. The report stated that the company is considering a potential sale after big pharmaceutical companies showed takeover interest.Per the report, JANX is currently evaluating its alternative for the buyout with a financial adviser. Apparently, Janux’s innovative pipeline of cancer candidates is attracting buyout offers from big pharma companies.Shares of Janux have rallied ...

While "the trend is your friend" when it comes to short-term investing or trading, timing entries into the trend is a key determinant of success. And increasing the odds of success by making sure the sustainability of a trend isn't easy.The trend often reverses before exiting the trade, leading to a short-term capital loss for investors. So, for a profitable trade, one should confirm factors such as sound fundamentals, positive earnings estimate revisions, etc. that could keep the momentum in the stock aliv ...

Janux's silence about a potential acquisition deal could be golden.Janux Therapeutics (JANX 12.06%) stock is crushing it. The stock was up 42.4% for the week as of market close on Thursday, according to data from S&P Global Market Intelligence.The big gain came after Bloomberg reported on Wednesday that Janux was exploring a potential sale. Big drugmakers have expressed interest in acquiring Janux, according to anonymous sources interviewed by Bloomberg.Silence is golden?Janux hasn't publicly commented on t ...

Shares of Janux Therapeutics, Inc. (JANX) have gained 11.8% over the past four weeks to close the last trading session at $44.62, but there could still be a solid upside left in the stock if short-term price targets of Wall Street analysts are any indication. Going by the price targets, the mean estimate of $62.60 indicates a potential upside of 40.3%.The mean estimate comprises five short-term price targets with a standard deviation of $21.58. While the lowest estimate of $48 indicates a 7.6% increase from ...

One of the hotter biotech companies on the scene might be changing owners before long.Clinical-stage biotech Janux Therapeutics (JANX 11.47%) was a standout title on a gloomy Wednesday stock market. As investors fretted about an unfavorable inflation report from the federal government, bulls piled into the company's shares on a report that it might be for sale. As a result, it closed the day almost 12% higher in price, contrasting very sharply with the nearly 1% decline of the bellwether S&P 500 index.Hangi ...

PART I [Item 1. Business](index=7&type=section&id=Item%201.%20Business) Janux Therapeutics is a clinical-stage biopharmaceutical company developing tumor-activated immunotherapies for cancer using its proprietary TRACTr and TRACIr platforms, with lead candidates JANX007 and JANX008 in Phase 1 clinical trials demonstrating promising early anti-tumor activity and favorable safety profiles [Overview](index=7&type=section&id=Overview) Janux is a clinical-stage biopharmaceutical company developing tumor-activated immunotherapies using its proprietary **TRACTr** (Tumor Activated T Cell Engagers) and **TRACIr** (Tumor Activated Immunomodulators) platforms[20](index=20&type=chunk) The company's technology aims to overcome key limitations of previous T cell engagers (TCEs), such as cytokine release syndrome (CRS), on-target healthy tissue toxicity, and short half-life[20](index=20&type=chunk) Lead candidate **JANX007**, a PSMA-TRACTr for metastatic castration-resistant prostate cancer (mCRPC), has shown meaningful PSA drops and a favorable safety profile in a **Phase 1** trial[20](index=20&type=chunk) Second clinical candidate **JANX008**, an EGFR-TRACTr for multiple solid cancers, has shown anti-tumor activity with low-grade CRS in early **Phase 1** data[20](index=20&type=chunk) [Our TRACTr and TRACIr Platforms](index=8&type=section&id=Our%20TRACTr%20and%20TRACIr%20Platforms) The platforms are designed to be selectively activated by proteases in the tumor microenvironment, which unmasks the T-cell and tumor-binding domains, thereby localizing immune activation to the tumor site[23](index=23&type=chunk)[43](index=43&type=chunk) An albumin-binding domain is incorporated into the masked, inactive form of the therapeutic to extend its serum half-life, allowing for less frequent dosing compared to first-generation TCEs[23](index=23&type=chunk)[45](index=45&type=chunk) Once activated in the tumor, the therapeutic is designed to have a short half-life if it escapes back into circulation, minimizing systemic toxicity like CRS and on-target, off-tumor effects[41](index=41&type=chunk)[46](index=46&type=chunk) In a proof-of-concept study in non-human primates (NHPs), an EGFR-TRACTr demonstrated a half-life of **over 100 hours** (vs. **~1 hour** for a standard TCE) and significantly reduced inflammatory cytokine release, a marker for CRS[59](index=59&type=chunk)[61](index=61&type=chunk) [Our Lead Programs](index=22&type=section&id=Our%20Lead%20Programs) Janux Therapeutics Wholly-Owned Pipeline | Program | Target(s) | Initial Indication(s) | Stage of Development | | :--- | :--- | :--- | :--- | | **TRACTr Programs** | | | | | PSMA-TRACTr JANX007 | PSMAxCD3 | mCRPC | Phase 1 | | EGFR-TRACTr JANX008 | EGFRxCD3 | CRC, SCCHN, NSCLC, RCC | Phase 1 | | Unnamed TRACTr Programs | TxCD3 | Undisclosed | Discovery | | **Unnamed TRACIr Programs** | | | | | TRACIr | TxCD28 | Undisclosed | Discovery | JANX007 (PSMA-TRACTr) Interim Phase 1 Efficacy Data (as of Feb 12, 2024) | Metric | Starting Dose ≥ 0.1 mg | Starting Step Dose ≥ 0.2 mg | | :--- | :--- | :--- | | **PSA30 Declines** | 78% (14 of 18) | 100% (6 of 6) | | **PSA50 Declines** | 56% (10 of 18) | 83% (5 of 6) | For JANX007, Cytokine Release Syndrome (CRS) was temporary and mild (**Grade 1 or 2**), mainly occurring in the first cycle, with no **Grade 4 or 5** treatment-related adverse events (TRAEs) observed[87](index=87&type=chunk) For JANX008 (EGFR-TRACTr), early data from 11 patients showed encouraging clinical activity, including a confirmed partial response in an NSCLC patient, with a favorable safety profile and only **Grade 1** CRS in two subjects and no dose-limiting toxicities[114](index=114&type=chunk)[116](index=116&type=chunk) [Manufacturing](index=36&type=section&id=Manufacturing) The company does not own or operate cGMP manufacturing facilities and relies on third-party manufacturers for raw materials and production of its TRACTr and TRACIr molecules[121](index=121&type=chunk) The manufacturing process for TRACTr and TRACIr molecules is similar to that of standard monoclonal antibodies, utilizing common Chinese hamster ovary (CHO) cells and standard purification techniques like Protein A affinity chromatography[120](index=120&type=chunk) The company has or intends to have a master cell bank for each product candidate, stored in two independent locations to mitigate risk of loss[122](index=122&type=chunk) [Competition](index=37&type=section&id=Competition) The company faces intense competition from large pharmaceutical and biotechnology companies, including AbbVie, Amgen, AstraZeneca, Bristol Myers Squibb, Johnson & Johnson, Merck & Co., Pfizer, and Roche/Genentech[124](index=124&type=chunk)[125](index=125&type=chunk) For its lead PSMA-TRACTr program, competitors include Amgen, Johnson & Johnson, Regeneron, Novartis, and Bayer, who are developing T-cell engagers, ADCs, CAR-T therapies, and radiopharmaceuticals targeting PSMA[128](index=128&type=chunk) For its EGFR-TRACTr program, competition comes from approved therapies like cetuximab and panitumumab, as well as clinical-stage immunotherapies from companies like Amgen/CytomX, AstraZeneca, and Regeneron[129](index=129&type=chunk) The company also competes with other biologic prodrug developers such as CytomX Therapeutics, BioAtla, and Xilio Therapeutics[131](index=131&type=chunk) [Collaborations and License Agreements](index=38&type=section&id=Collaborations%20and%20License%20Agreements) Janux has a research collaboration and exclusive license agreement with Merck Sharp & Dohme Corp. (Merck) to develop TRACTr candidates against two cancer targets selected by Merck[134](index=134&type=chunk) Under the Merck agreement, Janux is eligible to receive up to **$500.5 million** per target in upfront and milestone payments, plus tiered royalties on sales, with Merck providing research funding[134](index=134&type=chunk)[136](index=136&type=chunk) The company has a cell line license agreement with WuXi Biologics for technology used to manufacture components of its PSMA-TRACTr and EGFR-TRACTr candidates, including a one-time license fee, potential future royalties, and a buyout option[139](index=139&type=chunk)[140](index=140&type=chunk) [Intellectual Property](index=40&type=section&id=Intellectual%20Property) The company's intellectual property strategy relies on a combination of patents, trade secrets, and know-how to protect its TRACTr and TRACIr platform technologies and product candidates[142](index=142&type=chunk) As of February 16, 2024, the company's patent portfolio includes **2 U.S. patents**, **24 pending U.S. applications**, **7 pending PCT applications**, and **72 foreign patent applications** covering its platform technologies, specific product candidates like JANX007 and JANX008, and their components[143](index=143&type=chunk) Patents expected to issue from these pending applications are projected to expire between **2038 and 2044**, excluding any potential patent term adjustments or extensions[143](index=143&type=chunk) [Government Regulation](index=41&type=section&id=Government%20Regulation) The company's products are subject to extensive regulation by the FDA in the United States and comparable authorities in other countries, covering research, development, testing, manufacturing, approval, and marketing[148](index=148&type=chunk) The U.S. drug approval process involves preclinical studies, submitting an Investigational New Drug (IND) application, and conducting Phase 1, 2, and 3 clinical trials before submitting a Biologics License Application (BLA) for marketing approval[150](index=150&type=chunk)[151](index=151&type=chunk)[155](index=155&type=chunk) In the European Union, clinical trials are governed by the Clinical Trials Regulation (CTR), and marketing authorization for biologics typically follows the centralized procedure administered by the European Medicines Agency (EMA)[185](index=185&type=chunk)[189](index=189&type=chunk) The company is also subject to healthcare fraud and abuse laws (e.g., Anti-Kickback Statute, False Claims Act), data privacy laws (e.g., GDPR, CCPA), and regulations concerning pricing and reimbursement, which are critical for commercial success[208](index=208&type=chunk)[216](index=216&type=chunk)[232](index=232&type=chunk) [Employees and Human Capital Resources](index=59&type=section&id=Employees%20and%20Human%20Capital%20Resources) As of December 31, 2023, Janux had **64 full-time employees**, with **47** in research and development and **17** in general and administrative roles[242](index=242&type=chunk) The company's human capital objectives include recruiting, retaining, and incentivizing employees through competitive pay, benefits, and equity incentive plans[243](index=243&type=chunk)[244](index=244&type=chunk) [Item 1A. Risk Factors](index=60&type=section&id=Item%201A.%20Risk%20Factors) The company faces numerous risks, including a limited operating history with significant net losses, reliance on raising additional capital, and the inherent uncertainties of early-stage drug development - Financial Risks: The company has a limited operating history, has incurred net losses since inception (**$58.3 million** in 2023), and will require substantial additional capital to fund development, which may not be available on favorable terms[248](index=248&type=chunk)[250](index=250&type=chunk) - Development Risks: The company's product candidates are based on novel technologies, making it difficult to predict development costs and timelines, and preclinical and early clinical results are not always predictive of future success, with candidates potentially failing in later-stage trials[258](index=258&type=chunk)[264](index=264&type=chunk) - Operational Risks: Janux relies on third parties for manufacturing and conducting clinical trials, and any failure by these third parties to perform adequately could delay or impair development programs[295](index=295&type=chunk)[299](index=299&type=chunk) - Commercial Risks: The company faces substantial competition from larger, more established companies, and even if approved, products may not achieve market acceptance or favorable pricing and reimbursement, which is critical for commercial success[308](index=308&type=chunk)[310](index=310&type=chunk)[352](index=352&type=chunk) - Regulatory and Legal Risks: The business is subject to extensive government regulation, healthcare fraud and abuse laws, and data privacy laws, with failure to comply potentially resulting in significant penalties, and the company also faces risks related to obtaining and defending its intellectual property[365](index=365&type=chunk)[382](index=382&type=chunk)[393](index=393&type=chunk) [Item 1B. Unresolved Staff Comments](index=116&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) Not applicable - The company reports that there are no unresolved staff comments[501](index=501&type=chunk) [Item 1C. Cybersecurity](index=116&type=section&id=Item%201C.%20Cybersecurity) The company has implemented information security processes to manage cybersecurity risks, overseen by its IT department and the audit committee of the board of directors, integrating cybersecurity into its overall enterprise risk management program and managing associated vendor risks - The company's IT department, IT Director, legal department, and CFO are responsible for identifying, assessing, and managing cybersecurity threats[503](index=503&type=chunk) - Cybersecurity risk management is integrated into the company's overall enterprise risk management program, with oversight provided by the audit committee of the board of directors[505](index=505&type=chunk)[510](index=510&type=chunk) - The company employs various measures to mitigate risks, including an incident response policy, vulnerability management, disaster recovery plans, encryption, and employee training[504](index=504&type=chunk) - Processes are in place to manage cybersecurity risks associated with the use of third-party service providers, such as CROs and CMOs[507](index=507&type=chunk) [Item 2. Properties](index=117&type=section&id=Item%202.%20Properties) The company's corporate headquarters, including office and laboratory space, is located in San Diego, California, under a lease agreement that commenced in July 2022 and expires in January 2033 - The company leases its corporate headquarters, which includes office and laboratory space, in San Diego, California[515](index=515&type=chunk) - The current lease agreement commenced in July 2022 and is set to expire in January 2033[515](index=515&type=chunk) [Item 3. Legal Proceedings](index=117&type=section&id=Item%203.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings and may become involved in claims arising in the ordinary course of business from time to time - As of the filing date, the company is not a party to any material legal proceedings[516](index=516&type=chunk) [Item 4. Mine Safety Disclosures](index=118&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) Not applicable - This item is not applicable to the company[517](index=517&type=chunk) PART II [Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=119&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) The company's common stock trades on the Nasdaq Global Market under the symbol "JANX" since its IPO on June 11, 2021, with approximately 24 stockholders of record as of February 29, 2024, and no cash dividends paid or intended to be paid, while net IPO proceeds of approximately $204.2 million remain unused and held in cash, cash equivalents, and marketable securities - The company's common stock has been publicly traded on the Nasdaq Global Market under the symbol "JANX" since its IPO on June 11, 2021[520](index=520&type=chunk) - The company has never declared or paid cash dividends and intends to retain all future earnings to support operations and business growth[523](index=523&type=chunk) - The IPO in June 2021 generated gross proceeds of **$222.9 million**, with net proceeds of approximately **$204.2 million** after deducting underwriting discounts and offering costs[526](index=526&type=chunk) - As of **December 31, 2023**, the company has not used any of the proceeds from its IPO, which are held in cash, cash equivalents, and marketable securities[527](index=527&type=chunk) [Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=120&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) For the year ended December 31, 2023, Janux reported a net loss of $58.3 million, primarily due to a $10.7 million increase in interest income offsetting a $5.4 million increase in total operating expenses, with research and development expenses rising to $54.9 million and general and administrative expenses to $26.1 million, funded by cash on hand, Merck collaboration proceeds, and a July 2023 offering that raised $56.5 million, resulting in $344.8 million in cash, cash equivalents, restricted cash, and short-term investments, believed to be sufficient for at least the next 12 months [Results of Operations](index=123&type=section&id=Results%20of%20Operations) Comparison of the Years Ended December 31, 2023 and 2022 (in thousands) | | 2023 | 2022 | Change | | :--- | :--- | :--- | :--- | | **Collaboration revenue** | $8,083 | $8,612 | $(529) | | **Research and development** | $54,922 | $53,441 | $1,481 | | **General and administrative** | $26,140 | $22,262 | $3,878 | | **Total operating expenses** | $81,062 | $75,703 | $5,359 | | **Loss from operations** | $(72,979) | $(67,091) | $(5,888) | | **Other income** | $14,686 | $4,032 | $10,654 | | **Net loss** | $(58,293) | $(63,059) | $4,766 | Research and development expenses increased by **$1.5 million** in 2023, primarily due to higher indirect costs (personnel, facilities) and increased spending on the JANX007 program, offset by decreased spending on JANX008 and other preclinical programs[551](index=551&type=chunk) General and administrative expenses increased by **$3.8 million** in 2023, mainly driven by higher stock-based compensation (**$2.2 million**) and increased personnel and facilities costs (**$2.0 million**)[552](index=552&type=chunk) Other income increased by **$10.7 million**, primarily due to higher interest income earned on the company's investments as a result of rising interest rates[553](index=553&type=chunk) [Liquidity and Capital Resources](index=124&type=section&id=Liquidity%20and%20Capital%20Resources) As of December 31, 2023, the company had **$344.8 million** in cash, cash equivalents, restricted cash, and short-term investments[554](index=554&type=chunk) In July 2023, the company raised net proceeds of **$56.5 million** from an underwritten offering of common stock and pre-funded warrants[558](index=558&type=chunk) In March 2024, subsequent to the reporting period, the company closed another underwritten offering, raising estimated net proceeds of **$320.2 million**[559](index=559&type=chunk) Summary of Cash Flows (in thousands) | | Year Ended Dec 31, 2023 | Year Ended Dec 31, 2022 | | :--- | :--- | :--- | | **Net cash used in Operating activities** | $(50,575) | $(42,922) | | **Net cash (used in) provided by Investing activities** | $(41,194) | $58,266 | | **Net cash provided by Financing activities** | $59,548 | $500 | Management believes existing cash, cash equivalents, and short-term investments are sufficient to fund operations and capital expenditures for **at least the next 12 months** from the report's filing date[565](index=565&type=chunk) [Critical Accounting Policies and Estimates](index=127&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) Collaboration Revenue: Revenue from the Merck agreement is recognized over time based on the progress of research services, measured by the proportion of actual Full-Time Equivalent (FTE) employees utilized against the total estimated FTEs for the project[574](index=574&type=chunk)[581](index=581&type=chunk) Variable consideration, such as development and regulatory milestone payments, is constrained and not included in the transaction price until achievement is probable and a significant revenue reversal would not occur[578](index=578&type=chunk) Accrued Research and Development Expenses: The company estimates accrued R&D expenses based on services received and efforts expended, which involves reviewing contracts and communicating with personnel and vendors to determine the level of service performed[584](index=584&type=chunk)[585](index=585&type=chunk) Stock-Based Compensation: Expense is calculated using the Black-Scholes option-pricing model, which requires subjective assumptions for inputs like expected volatility and expected term[587](index=587&type=chunk)[588](index=588&type=chunk) [Item 7A. Quantitative and Qualitative Disclosures About Market Risk](index=130&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) Not applicable as the company is a smaller reporting company - This item is not applicable as the company qualifies as a smaller reporting company[593](index=593&type=chunk) [Item 8. Financial Statements and Supplementary Data](index=130&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) This section contains the company's audited financial statements for the years ended December 31, 2023 and 2022, including the Balance Sheets, Statements of Operations and Comprehensive Loss, Statements of Stockholders' Equity, and Statements of Cash Flows, along with the accompanying notes and the report from the independent registered public accounting firm, Ernst & Young LLP [Financial Statements](index=131&type=section&id=Financial%20Statements) Balance Sheet Highlights (in thousands) | | Dec 31, 2023 | Dec 31, 2022 | | :--- | :--- | :--- | | **Cash, cash equivalents, and short-term investments** | $344,028 | $327,016 | | **Total Assets** | $380,407 | $364,010 | | **Total Liabilities** | $36,058 | $43,270 | | **Total Stockholders' Equity** | $344,349 | $320,740 | | **Accumulated Deficit** | $(168,763) | $(110,470) | Statement of Operations Highlights (in thousands) | | Year Ended Dec 31, 2023 | Year Ended Dec 31, 2022 | | :--- | :--- | :--- | | **Collaboration revenue** | $8,083 | $8,612 | | **Total operating expenses** | $81,062 | $75,703 | | **Net loss** | $(58,293) | $(63,059) | | **Net loss per share, basic and diluted** | $(1.32) | $(1.52) | [Notes to Financial Statements](index=136&type=section&id=Notes%20to%20Financial%20Statements) The company has incurred net losses since inception, with an accumulated deficit of **$168.8 million** as of December 31, 2023, but management has concluded that there is sufficient capital to fund operations for **at least 12 months** from the issuance date of the financial statements[612](index=612&type=chunk)[613](index=613&type=chunk) As of December 31, 2023, the company held **$324.8 million** in short-term investments, primarily in U.S. Treasury securities, U.S. agency bonds, and commercial paper[619](index=619&type=chunk)[628](index=628&type=chunk) The company has a noncancelable operating lease for its San Diego office and lab space, with total future minimum lease payments of **$34.9 million** as of December 31, 2023[676](index=676&type=chunk)[678](index=678&type=chunk) As of December 31, 2023, the company had federal and state net operating loss (NOL) carryforwards of **$49.9 million** and **$117.6 million**, respectively, and maintains a full valuation allowance against its deferred tax assets[722](index=722&type=chunk)[723](index=723&type=chunk) [Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure](index=167&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20with%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) Not applicable - The company reports no changes in or disagreements with its accountants on accounting and financial disclosure[732](index=732&type=chunk) [Item 9A. Controls and Procedures](index=167&type=section&id=Item%209A.%20Controls%20and%20Procedures) Management, including the CEO and Acting CFO, evaluated the company's disclosure controls and procedures and concluded they were effective as of December 31, 2023, also assessing and concluding on the effectiveness of internal control over financial reporting, with no material changes made during the fourth quarter of 2023, and an attestation report from the independent registered public accounting firm is not included as the company is an emerging growth company - Management concluded that the company's disclosure controls and procedures were effective at a reasonable assurance level as of December 31, 2023[733](index=733&type=chunk) - Based on an assessment using the COSO framework, management concluded that the company's internal control over financial reporting was effective as of December 31, 2023[734](index=734&type=chunk) - The company is exempt from providing an auditor's attestation report on internal control over financial reporting because it qualifies as an "emerging growth company" under the JOBS Act[735](index=735&type=chunk) [Item 9B. Other Information](index=167&type=section&id=Item%209B.%20Other%20Information) During the fourth quarter of 2023, no director or officer of the company adopted or terminated any Rule 10b5-1 trading arrangement or any non-Rule 10b5-1 trading arrangement - No director or officer adopted or terminated any Rule 10b5-1 or non-Rule 10b5-1 trading arrangement during the three months ended December 31, 2023[736](index=736&type=chunk) [Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections](index=167&type=section&id=Item%209C.%20Disclosure%20Regarding%20Foreign%20Jurisdictions%20that%20Prevent%20Inspections) Not applicable - This item is not applicable to the company[737](index=737&type=chunk) PART III [Item 10. Directors, Executive Officers and Corporate Governance](index=169&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) Information required by this item will be incorporated by reference from the company's definitive Proxy Statement for its 2024 Annual Meeting of Stockholders - The required information regarding directors, executive officers, and corporate governance is incorporated by reference from the company's forthcoming 2024 Proxy Statement[739](index=739&type=chunk) [Item 11. Executive Compensation](index=169&type=section&id=Item%2011.%20Executive%20Compensation) Information required by this item will be incorporated by reference from the company's definitive Proxy Statement for its 2024 Annual Meeting of Stockholders - The required information regarding executive compensation is incorporated by reference from the company's forthcoming 2024 Proxy Statement[741](index=741&type=chunk) [Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=169&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) Information required by this item will be incorporated by reference from the company's definitive Proxy Statement for its 2024 Annual Meeting of Stockholders - The required information regarding security ownership is incorporated by reference from the company's forthcoming 2024 Proxy Statement[742](index=742&type=chunk) [Item 13. Certain Relationships and Related Transactions, and Director Independence](index=169&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) Information required by this item will be incorporated by reference from the company's definitive Proxy Statement for its 2024 Annual Meeting of Stockholders - The required information regarding related transactions and director independence is incorporated by reference from the company's forthcoming 2024 Proxy Statement[743](index=743&type=chunk) [Item 14. Principal Accounting Fees and Services](index=169&type=section&id=Item%2014.%20Principal%20Accounting%20Fees%20and%20Services) Information required by this item will be incorporated by reference from the company's definitive Proxy Statement for its 2024 Annual Meeting of Stockholders - The required information regarding principal accounting fees and services is incorporated by reference from the company's forthcoming 2024 Proxy Statement[744](index=744&type=chunk) PART IV [Item 15. Exhibits and Financial Statement Schedules](index=170&type=section&id=Item%2015.%20Exhibits%20and%20Financial%20Statement%20Schedules) This section lists the financial statements filed as part of the report and provides a list of all exhibits filed with the Form 10-K, including corporate governance documents, material contracts, and certifications - This item includes the list of financial statements and the report of the independent registered public accounting firm[746](index=746&type=chunk) - A list of exhibits filed with the report is provided, including the company's certificate of incorporation, bylaws, material contracts (such as the Merck collaboration and WuXi Biologics license), and executive employment agreements[748](index=748&type=chunk)[749](index=749&type=chunk) [Item 16. Form 10-K Summary](index=174&type=section&id=Item%2016.%20Form%2010-K%20Summary) Not applicable - This item is not applicable to the company[751](index=751&type=chunk)

[Janux Therapeutics Q4 and Full Year 2023 Earnings Release](index=1&type=section&id=Janux%20Therapeutics%20Reports%20Fourth%20Quarter%20and%20Full%20Year%202023%20Financial%20Results%20and%20Business%20Highlights) The company reported positive clinical trial data, key corporate updates, and detailed financial results for Q4 and the full year 2023 [Business Highlights and Future Milestones](index=1&type=section&id=Business%20Highlights%20and%20Future%20Milestones) The company reported positive interim Phase 1 data for its key drug candidates and significantly strengthened its financial position - Presented positive interim Phase 1 clinical data for PSMA-TRACTr JANX007 in mCRPC, demonstrating a **favorable safety profile** and **promising efficacy signals** at higher doses[6](index=6&type=chunk) - Key efficacy data for JANX007 showed that **83% (5/6) of subjects achieved PSA50 declines** with a first step dose ≥ 0.2mg, and **no Cytokine Release Syndrome (CRS) greater than Grade 2** was observed[6](index=6&type=chunk) - Presented positive interim Phase 1 data for EGFR-TRACTr JANX008 in solid tumors, highlighted by a subject with NSCLC achieving a **complete target lesion reduction**[6](index=6&type=chunk) - The company's balance sheet was significantly strengthened by an underwritten offering in March 2024, raising approximately **$320.2 million in net proceeds**[5](index=5&type=chunk)[6](index=6&type=chunk) - A future milestone is anticipated in the **second half of 2024**, with an update on JANX007 data and the selection of doses for expansion cohorts[5](index=5&type=chunk)[7](index=7&type=chunk) [Fourth Quarter and Full Year 2023 Financial Results](index=2&type=section&id=Fourth%20Quarter%20and%20Full%20Year%202023%20Financial%20Results) The company reported a reduced net loss for 2023 alongside increased operating expenses and a strong year-end cash position [Key Financial Metrics](index=2&type=section&id=Key%20Financial%20Metrics) The company's 2023 financials show a slight rise in R&D costs, a notable increase in G&A expenses, and an improved net loss Full Year 2023 vs 2022 Financial Summary | Metric | Full Year 2023 | Full Year 2022 | | :--- | :--- | :--- | | Research and Development Expenses | $54.9 million | $53.4 million | | General and Administrative Expenses | $26.1 million | $22.3 million | | Net Loss | $58.3 million | $63.1 million | | Cash, Cash Equivalents & Short-term Investments (Year-End) | $344.0 million | $327.0 million | Q4 2023 vs Q4 2022 Financial Summary | Metric | Q4 2023 | Q4 2022 | | :--- | :--- | :--- | | Research and Development Expenses | $12.2 million | $15.4 million | | General and Administrative Expenses | $6.4 million | $5.7 million | | Net Loss | $11.8 million | $16.1 million | [Condensed Balance Sheets](index=4&type=section&id=Condensed%20Balance%20Sheets) Total assets and stockholders' equity increased as of year-end 2023, while total liabilities decreased Balance Sheet Summary (in thousands) | Account | Dec 31, 2023 | Dec 31, 2022 | | :--- | :--- | :--- | | **Total Current Assets** | **$349,241** | **$332,439** | | Cash and cash equivalents | $19,205 | $51,426 | | Short-term investments | $324,823 | $275,590 | | **Total Assets** | **$380,407** | **$364,010** | | **Total Liabilities** | **$36,058** | **$43,270** | | **Total Stockholders' Equity** | **$344,349** | **$320,740** | [Condensed Statements of Operations and Comprehensive Loss](index=5&type=section&id=Condensed%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The company's 2023 operating statement reflects a lower net loss per share compared to 2022 despite a slight dip in revenue Statement of Operations Summary (in thousands, except per share data) | Metric | Year Ended 2023 | Year Ended 2022 | Q4 2023 | Q4 2022 | | :--- | :--- | :--- | :--- | :--- | | Collaboration Revenue | $8,083 | $8,612 | $2,461 | $2,845 | | Total Operating Expenses | $81,062 | $75,703 | $18,598 | $21,111 | | Loss from Operations | ($72,979) | ($67,091) | ($16,137) | ($18,266) | | Net Loss | ($58,293) | ($63,059) | ($11,758) | ($16,065) | | Net Loss Per Share | ($1.32) | ($1.52) | ($0.25) | ($0.39) | [Corporate and Pipeline Overview](index=2&type=section&id=Corporate%20and%20Pipeline%20Overview) The company is advancing its clinical pipeline, led by JANX007 and JANX008, based on its proprietary TRACTr platform - The company's pipeline is built on two proprietary platforms: Tumor Activated T Cell Engagers (**TRACTr**) and Tumor Activated Immunomodulators (**TRACIr**)[2](index=2&type=chunk)[9](index=9&type=chunk)[11](index=11&type=chunk) - Lead clinical candidate **JANX007** is a PSMA-TRACTr in a Phase 1 trial for **metastatic castration-resistant prostate cancer (mCRPC)**[9](index=9&type=chunk)[10](index=10&type=chunk) - Second clinical candidate **JANX008** is an EGFR-TRACTr in a Phase 1 trial for **multiple solid cancers**, including colorectal, lung, head and neck, and renal cancers[9](index=9&type=chunk)[10](index=10&type=chunk) - Co-founder **Dr. Tommy DiRaimondo was promoted to Chief Scientific Officer**, recognizing his role in advancing the company's lead programs into the clinic[10](index=10&type=chunk)

PART I. FINANCIAL INFORMATION [Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) Unaudited condensed financial statements for Q3 2023 reflect increased assets, a net loss of $46.5 million, and $58.7 million in financing cash flow [Condensed Balance Sheets](index=3&type=section&id=Condensed%20Balance%20Sheets) As of September 30, 2023, total assets increased to $386.9 million, driven by short-term investments, with equity rising to $348.9 million Condensed Balance Sheet Summary (in thousands) | Account | September 30, 2023 (unaudited) | December 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $17,152 | $51,426 | | Short-term investments | $332,560 | $275,590 | | Total current assets | $355,195 | $332,439 | | **Total assets** | **$386,850** | **$364,010** | | **Liabilities & Equity** | | | | Total current liabilities | $14,471 | $16,507 | | **Total liabilities** | **$37,902** | **$43,270** | | **Total stockholders' equity** | **$348,948** | **$320,740** | | Accumulated deficit | ($157,005) | ($110,470) | [Unaudited Condensed Statements of Operations and Comprehensive Loss](index=4&type=section&id=Unaudited%20Condensed%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) For Q3 2023, net loss improved to $11.6 million; for nine months, net loss was $46.5 million, comparable to prior year due to increased interest income Statement of Operations Summary (in thousands, except per share data) | Metric | Q3 2023 | Q3 2022 | 9 Months 2023 | 9 Months 2022 | | :--- | :--- | :--- | :--- | :--- | | Collaboration revenue | $2,517 | $1,813 | $5,622 | $5,767 | | Research and development | $11,892 | $13,737 | $42,681 | $38,007 | | General and administrative | $6,438 | $6,098 | $19,783 | $16,585 | | Loss from operations | ($15,813) | ($18,022) | ($56,842) | ($48,825) | | Interest income | $4,245 | $1,326 | $10,307 | $1,831 | | **Net loss** | **($11,568)** | **($16,696)** | **($46,535)** | **($46,994)** | | Net loss per share | ($0.25) | ($0.40) | ($1.08) | ($1.13) | [Unaudited Condensed Statements of Cash Flows](index=7&type=section&id=Unaudited%20Condensed%20Statements%20of%20Cash%20Flows) For nine months ended Sep 30, 2023, net cash used in operations was $40.7 million, investing $52.3 million, with financing providing $58.7 million from a stock offering Cash Flow Summary (Nine Months Ended September 30, in thousands) | Activity | 2023 | 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | ($40,674) | ($31,009) | | Net cash provided by (used in) investing activities | ($52,317) | $59,870 | | Net cash provided by financing activities | $58,717 | $309 | | **Net decrease (increase) in cash** | **($34,274)** | **$29,170** | - Financing activities in 2023 were primarily driven by **$56.5 million** in net proceeds from the issuance of common stock and pre-funded common stock warrants[19](index=19&type=chunk) [Notes to Unaudited Condensed Financial Statements](index=8&type=section&id=Notes%20to%20Unaudited%20Condensed%20Financial%20Statements) Notes detail accounting policies, liquidity, an accumulated deficit of $157.0 million, sufficient capital for 12 months, and $56.5 million net proceeds from a July 2023 offering - The company is a clinical-stage biopharmaceutical firm developing immunotherapies using its TRACTr and TRACIr platforms, having incurred net losses since inception, with an accumulated deficit of **$157.0 million** as of September 30, 2023[22](index=22&type=chunk)[23](index=23&type=chunk) - Management believes the company has sufficient capital to fund operations for **at least 12 months** from the financial statement issuance date[23](index=23&type=chunk) - In July 2023, the company closed an underwritten offering of common stock and pre-funded warrants, resulting in net proceeds of **$56.5 million**[79](index=79&type=chunk) - Revenue of **$5.6 million** was recognized under the Merck Agreement for the nine months ended September 30, 2023, with remaining performance obligations for the Second Collaboration Target expected to be completed over the next **0.9 years**[99](index=99&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=23&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses clinical-stage platforms, increased R&D and G&A expenses for nine months ended Sep 30, 2023, and strengthened liquidity with **$350.5 million** sufficient through **2027** - The company is a clinical-stage biopharmaceutical company focused on its TRACTr and TRACIr platforms, with lead candidates **JANX007 (PSMA-TRACTr)** for prostate cancer and **JANX008 (EGFR-TRACTr)** for multiple solid cancers, both in **Phase 1 clinical trials**[101](index=101&type=chunk) Comparison of Operating Results (Nine Months Ended September 30, in thousands) | Metric | 2023 | 2022 | Change | | :--- | :--- | :--- | :--- | | Collaboration Revenue | $5,622 | $5,767 | ($145) | | Research and Development | $42,681 | $38,007 | $4,674 | | General and Administrative | $19,783 | $16,585 | $3,198 | | Loss from Operations | ($56,842) | ($48,825) | ($8,017) | | Other Income | $10,307 | $1,831 | $8,476 | | **Net Loss** | **($46,535)** | **($46,994)** | **$459** | - The increase in R&D expenses for the nine months ended Sep 30, 2023 was primarily due to a **$5.0 million** increase in indirect costs (personnel, facilities) and a **$1.8 million** increase in direct costs for JANX007, offset by a decrease in costs for JANX008[127](index=127&type=chunk) - As of September 30, 2023, the company had cash, cash equivalents, restricted cash, and short-term investments of **$350.5 million**, which management believes are sufficient to meet operating expenses and capital requirements through **2027**[131](index=131&type=chunk)[141](index=141&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=30&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) This section is not applicable as Janux Therapeutics qualifies as a smaller reporting company - The company has indicated that quantitative and qualitative disclosures about market risk are not applicable as it is a smaller reporting company[149](index=149&type=chunk) [Controls and Procedures](index=31&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls and procedures were effective as of September 30, 2023, with no material changes in internal control over financial reporting - Management concluded that as of the end of the period, the company's disclosure controls and procedures were **effective**[150](index=150&type=chunk) - No changes in internal control over financial reporting occurred during the quarter that have materially affected, or are reasonably likely to materially affect, internal controls[151](index=151&type=chunk) PART II. OTHER INFORMATION [Legal Proceedings](index=32&type=section&id=Item%201.%20Legal%20Proceedings) The company reports that it is not currently a party to any material legal proceedings - As of the filing date, the company is not involved in any material legal proceedings[154](index=154&type=chunk) [Risk Factors](index=32&type=section&id=Item%201A.%20Risk%20Factors) Key risks include limited operating history with net losses, need for additional capital, early-stage product candidates, reliance on third parties, and challenges in regulatory approval and intellectual property - The company has a limited operating history, has incurred net losses since inception (net loss of **$46.5 million** for the nine months ended Sep 30, 2023), and anticipates continued significant losses[157](index=157&type=chunk)[159](index=159&type=chunk) - The company is in the **early stages of development**, with its product candidates based on **novel technologies**, making it difficult to predict the timing, cost, and likelihood of success in clinical trials and regulatory approval[157](index=157&type=chunk)[177](index=177&type=chunk) - The company relies on **third parties** for conducting clinical trials and manufacturing, which introduces risks related to performance, quality, and supply chain continuity[157](index=157&type=chunk)[208](index=208&type=chunk)[212](index=212&type=chunk) - The company's ability to obtain and maintain sufficient **intellectual property protection** for its platform and product candidates is critical and uncertain, facing risks from competitors and complex patent laws[157](index=157&type=chunk)[306](index=306&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=80&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section addresses the use of proceeds from the June 2021 IPO, with no net proceeds used as of September 30, 2023, and funds held in marketable securities - The company's IPO in June 2021 generated gross proceeds of **$222.9 million**[415](index=415&type=chunk) - As of September 30, 2023, the company has not used any of the proceeds from its IPO, and there has been no material change in the planned use of these funds[416](index=416&type=chunk) [Other Information](index=80&type=section&id=Item%205.%20Other%20Information) During Q3 2023, no director or officer adopted or terminated any Rule 10b5-1 or other non-Rule 10b5-1 trading arrangements - **No director or officer** adopted or terminated any Rule 10b5-1 trading arrangement during the three months ended September 30, 2023[417](index=417&type=chunk) [Exhibits](index=81&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Quarterly Report on Form 10-Q, including corporate documents, stock forms, underwriting agreements, and officer certifications - This section provides a list of all exhibits filed as part of the Form 10-Q[419](index=419&type=chunk)