Group 1 - Janux Therapeutics (NASDAQ: JANX) has garnered significant interest from investors, alongside various buy-out rumors [1] - The company specializes in the research and development of novel Cell & Gene Therapies (CGT) aimed at addressing multiple clinical needs [1] - The analysis will focus on biotechnology, pharmaceutical, Medtech, and healthcare stocks, leveraging expertise in life sciences to evaluate the potential of new treatments [1]

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, 2025 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 | ...

Exhibit 99.1 Janux Therapeutics Reports First Quarter 2025 Financial Results and Business Highlights SAN DIEGO, May 8, 2025 – Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a clinical-stage biopharmaceutical company developing a broad pipeline of novel immunotherapies by applying its proprietary technology to its Tumor Activated T Cell Engager (TRACTr) and Tumor Activated Immunomodulator (TRACIr) platforms, today reported financial results for the first quarter ended March 31, 2025, and provided a busines ...

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]