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].

Financial Performance - As of September 30, 2024, Janux reported cash and cash equivalents and short-term investments of $658.0 million, up from $344.0 million at December 31, 2023, representing a 91.5% increase[3] - For Q3 2024, Janux reported a net loss of $28.1 million, compared to a net loss of $11.6 million for the same period in 2023, indicating a 142.3% increase in losses[5] - Total operating expenses for Q3 2024 were $36.3 million, compared to $18.3 million for the same period in 2023, representing a 98.1% increase[11] Research and Development - Research and development expenses for Q3 2024 were $18.6 million, compared to $11.9 million for the same period in 2023, reflecting a 56.4% increase[3] - Janux is developing a broad pipeline of TRACTr and TRACIr therapeutics targeting various solid tumors, with ongoing assessments of preclinical pipeline priorities[8] - The company is currently enrolling participants in the Phase 1 clinical trials for JANX007 and JANX008, with updates on JANX007 data expected by year-end 2024[2] - An update on JANX008 data is anticipated in 2025, as the company continues to progress in its clinical trials[2] Administrative Expenses - General and administrative expenses for Q3 2024 were $17.7 million, significantly higher than $6.4 million for the comparable period in 2023, marking a 176.6% increase[4] - The company incurred $9.5 million in stock-based compensation expense in Q3 2024, contributing to the rise in general and administrative expenses[4] Shareholder Information - The weighted-average shares of common stock outstanding for Q3 2024 were 54,628,670, compared to 45,708,649 for the same period in 2023, reflecting a 19.5% increase[11]

Company Overview - Janux Therapeutics, Inc. (JANX) shares increased by 6.5% to $46.53 in the last trading session, with a notable trading volume that exceeded the average [1] - The stock has gained 8.8% over the past four weeks, indicating positive momentum [1] Pipeline and Clinical Studies - The rise in stock price is linked to positive investor expectations regarding Janux's pipeline, particularly candidates JANX007 and JANX008, which are in early-stage clinical studies for prostate cancer and solid tumors, respectively [2] - An update on JANX007 data and doses for expansion cohorts is expected by the end of 2024, while data for JANX008 is anticipated in 2025 [2] Financial Performance Expectations - The company is projected to report a quarterly loss of $0.37 per share, reflecting a year-over-year decline of 48% [3] - Expected revenues are $1 million, down 60.3% from the same quarter last year [3] - The consensus EPS estimate has been revised 5.3% lower over the last 30 days, indicating a negative trend in earnings estimate revisions [4] Industry Context - Janux Therapeutics operates within the Zacks Medical - Biomedical and Genetics industry, where another company, Krystal Biotech, Inc. (KRYS), has shown a different performance with a 1.6% decline in its last trading session [4] - Krystal Biotech's consensus EPS estimate remains unchanged at $0.77, representing a significant year-over-year increase of 214.9% [5]

Group 1 - Janux Therapeutics reported a quarterly loss of $0.11 per share, significantly better than the Zacks Consensus Estimate of a loss of $0.32, and an improvement from a loss of $0.42 per share a year ago, resulting in an earnings surprise of 65.63% [1] - The company achieved revenues of $8.9 million for the quarter ended June 2024, exceeding the Zacks Consensus Estimate by 1,078.41%, compared to revenues of $1.06 million in the same quarter last year [2] - Janux Therapeutics has surpassed consensus EPS estimates for four consecutive quarters, indicating strong performance [2] Group 2 - The stock of Janux Therapeutics has increased approximately 243.9% since the beginning of the year, outperforming the S&P 500's gain of 9.9% [3] - The company's earnings outlook is crucial for investors, as it includes current consensus earnings expectations for upcoming quarters and any recent changes to these expectations [4] - The current consensus EPS estimate for the upcoming quarter is -$0.32 on revenues of $1.06 million, and for the current fiscal year, it is -$1.34 on revenues of $2.11 million [7] Group 3 - The Medical - Biomedical and Genetics industry, to which Janux Therapeutics belongs, is currently ranked in the top 37% of over 250 Zacks industries, suggesting a favorable outlook for the sector [8] - Empirical research indicates a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can be tracked by investors [5] - The estimate revisions trend for Janux Therapeutics is currently mixed, resulting in a Zacks Rank 3 (Hold) for the stock, indicating expected performance in line with the market [6]

Financial Performance - Net losses for the six months ended June 30, 2024 were $20.7 million, compared to $35.0 million for the same period in 2023, with an accumulated deficit of $189.5 million as of June 30, 2024[82] - Net loss improved by $14.2 million to $20.7 million for the six months ended June 30, 2024, compared to the same period in 2023[96] - Other income increased by $4.7 million to $7.9 million for the three months ended June 30, 2024, driven by higher cash balances and interest rate impacts[96] - Cash, cash equivalents, restricted cash, and short-term investments totaled $647.1 million as of June 30, 2024[102] - Net cash provided by financing activities was $324.9 million for the six months ended June 30, 2024, primarily from equity offerings[108] - Net cash used in investing activities was $304.6 million for the six months ended June 30, 2024, mainly due to short-term investment purchases[107] - The company has $150.0 million remaining available for sale under its ATM Equity Offering program as of June 30, 2024[103] Collaboration and Revenue - Collaboration revenue under the Merck Agreement was $10.1 million for the six months ended June 30, 2024, up from $3.1 million in the same period in 2023[86] - Collaboration revenue increased by $7.0 million to $10.1 million for the six months ended June 30, 2024, due to a developmental milestone under the Merck Agreement[97] - The company's collaboration with Merck could yield up to $500.5 million per target in upfront and milestone payments, plus royalties on sales of products derived from the collaboration[84] Research and Development - Research and development expenses for the three months ended June 30, 2024 were $14.9 million, consistent with the same period in 2023, with fluctuations in costs related to JANX007 and JANX008 development[93][94] - Research and development expenses decreased by $1.8 million to $29.0 million for the six months ended June 30, 2024, primarily due to reduced preclinical program costs[99] - JANX007, a prostate-specific membrane antigen TRACTr, showed meaningful PSA drops and a favorable safety profile in Phase 1 clinical trials for metastatic castration-resistant prostate cancer[80] - JANX008, an EGFR-TRACTr, demonstrated anti-tumor activity in multiple solid cancers with low-grade cytokine release syndrome and treatment-related adverse events in Phase 1 trials[80] - The company's TRACTr and TRACIr platforms aim to develop tumor-activated immunotherapies for cancer, with a focus on overcoming limitations of prior T cell engager technologies[80] General and Administrative Expenses - General and administrative expenses increased to $7.8 million for the three months ended June 30, 2024, up from $6.9 million in the same period in 2023, primarily due to stock-based compensation and personnel costs[95] - General and administrative expenses increased by $1.9 million to $15.2 million for the six months ended June 30, 2024, driven by higher stock-based compensation and personnel costs[100] Future Outlook and Financial Position - The company expects to continue incurring significant losses for the foreseeable future as it advances its research and development activities, with no product revenue expected for many years[83] - The company believes its existing cash, cash equivalents, and short-term investments will be sufficient to meet operating expenses and capital expenditure requirements for at least the next 12 months[83] - The company believes its current cash reserves will support operations for at least the next 12 months[109] Regulatory and Legal Matters - The company qualifies as an "emerging growth company" and "smaller reporting company" until December 31, 2024, after which it will reassess its status as a large accelerated filer[114] - Financial statements are prepared under U.S. GAAP, requiring estimates and judgments for assets, liabilities, revenues, and expenses, with actual results potentially differing from estimates[115] - No material changes to critical accounting policies during the six months ended June 30, 2024[116] - Disclosure controls and procedures were effective as of the end of the reporting period, ensuring timely and accurate reporting under SEC rules[118] - No changes in internal control over financial reporting during the most recent quarter that materially affected or are likely to affect financial reporting[119] - The company is not currently involved in any material legal proceedings, but such proceedings could have adverse impacts regardless of outcome[120]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-40475 Janux Therapeutics, Inc. (Exact Name of Registrant as Specified in its Charter) | Delaware | 82-2289112 | ...