Core Insights - Intensity Therapeutics, Inc. is presenting two posters at the San Antonio Breast Cancer Symposium, focusing on its investigational drug INT230-6 for treating Triple Negative Breast Cancer (TNBC) [1][2] Study Observations - The INVINCIBLE-4 study, initiated in 2024, has treated 14 patients, with 7 in each cohort, showing favorable safety data [3][6] - Cohort A (INT230-6 plus standard of care) exhibited 50% fewer grade 3 or higher adverse events compared to Cohort B (standard of care alone) [5][6] - Specific adverse events included 9 grade 3 or higher events in Cohort A versus 20 in Cohort B [6] Clinical Trial Details - The ongoing Phase II randomized clinical trial is evaluating INT230-6's safety and efficacy in early-stage TNBC patients [5][11] - A potential Phase 3 study design may include INT230-6 with standard of care, with and without the anthracycline doxorubicin, aiming for improved safety and efficacy [8][9] Drug Mechanism and Composition - INT230-6 is designed for direct intratumoral injection, combining cisplatin and vinblastine sulfate with a diffusion enhancer to improve drug delivery within tumors [13] - The drug aims to elicit an immune response while minimizing systemic toxicity, a common issue with traditional chemotherapy [13][14] Market Context - TNBC represents a significant challenge in breast cancer treatment, with approximately 56,000 new cases diagnosed annually in the U.S. and 420,000 worldwide [11] - Current standard treatments often involve high toxicity, with 80% of patients experiencing severe adverse events [11] Regulatory Pathway - The FDA's Accelerated Approval Program may facilitate INT230-6's approval based on pathological complete response (pCR) as a surrogate endpoint [12] - If successful, this could lead to a safer treatment regimen for TNBC patients, potentially avoiding the use of highly toxic agents like doxorubicin [11][12]

Market Overview - U.S. stocks showed mixed performance, with the Dow Jones index falling over 100 points, down 0.30% to 47,379.27, while NASDAQ rose 0.27% to 23,644.68, and S&P 500 dropped 0.07% to 6,817.76 [1] - Consumer discretionary shares increased by 3.8%, while utilities stocks decreased by 1.2% [1] Company Performance - Amazon.com Inc. reported third-quarter net sales of $180.2 billion, a 13% year-over-year increase, surpassing the consensus estimate of $177.8 billion. The company anticipates fourth-quarter net sales between $206.0 billion and $213.0 billion, reflecting a year-over-year growth of 10% to 13% [2] - AMTD Digital Inc. saw a significant revenue increase of 1,085.9% year-over-year, reaching $73.2 million for the six months ended April 30, leading to a 99% surge in its share price to $3.3600 [8] - Butterfly Network, Inc. shares rose 27% to $2.59 following better-than-expected quarterly results [8] - Illumina, Inc. shares increased by 23% to $121.41 after reporting third-quarter results above estimates and raising its full-year guidance [8] - Luminar Technologies, Inc. shares dropped 49% to $1.0801 after receiving a subpoena from the SEC and suspending its FY25 guidance [8] - Intensity Therapeutics, Inc. shares fell 42% to $0.7612 after announcing a $4 million registered direct offering of common stock [8] - OneSpan Inc. shares decreased by 27% to $11.32 after reporting worse-than-expected third-quarter sales and cutting its FY25 sales guidance, with Rosenblatt reducing its price target from $17 to $15 [8] Commodity Market - Oil prices increased by 0.5% to $60.87, while gold prices decreased by 0.5% to $3,995.20. Silver fell by 0.9% to $48.190, and copper dropped 0.4% to $5.0820 [5] European Market - European shares were lower, with the eurozone's STOXX 600 slipping 0.51%, Spain's IBEX 35 Index down 0.05%, London's FTSE 100 down 0.44%, Germany's DAX 40 down 0.67%, and France's CAC 40 down 0.44% [6] Asian Market - Asian markets closed mostly lower, with Japan's Nikkei 225 gaining 2.12%, while Hong Kong's Hang Seng fell 1.43%, China's Shanghai Composite dipped 0.81%, and India's BSE Sensex declined 0.55% [9]

Market Overview - U.S. stocks traded higher, with the Nasdaq Composite gaining more than 1% on Friday, while the Dow rose 0.09% to 47,563.80, and the S&P 500 increased by 0.58% to 6,862.07 [1] - Consumer discretionary shares saw a significant jump of 4.3% on Friday, indicating strong performance in that sector [1] Company Performance - Apple Inc. reported fiscal fourth-quarter revenue of $102.47 billion, surpassing analyst estimates of $102.17 billion, and earnings of $1.85 per share, exceeding expectations of $1.76 per share [3] - EPWK Holdings Ltd. shares surged 137% to $0.1559, while Getty Images Holdings, Inc. shares rose 45% to $2.93 following a multi-year licensing agreement with Perplexity AI [10] - MSP Recovery, Inc. shares increased by 77% to $0.56 [10] Declines in Company Stocks - Luminar Technologies, Inc. shares dropped 34% to $1.3801 after receiving a subpoena from the SEC and suspending its FY25 guidance [10] - Intensity Therapeutics, Inc. shares fell 28% to $0.95 after announcing a $4 million registered direct offering of common stock [10] - OneSpan Inc. shares decreased by 26% to $11.52 due to worse-than-expected third-quarter sales results and a cut in FY25 sales guidance [10] Commodity Market - Oil prices increased by 0.7% to $61.04, while gold rose by 0.4% to $4,031.90 [6] - Silver prices fell by 0.3% to $48.485, and copper decreased by 0.4% to $5.0860 [6] International Markets - European shares were lower, with the eurozone's STOXX 600 slipping 0.5% and major indices in Spain, London, Germany, and France also experiencing declines [7] - Asian markets closed mostly lower, with Japan's Nikkei 225 gaining 2.12%, while Hong Kong's Hang Seng fell 1.43%, and China's Shanghai Composite dipped 0.81% [8]

Market Overview - U.S. stocks traded higher, with the Nasdaq Composite gaining more than 1% on Friday, while the Dow rose 0.09% to 47,563.80, and the S&P 500 increased by 0.58% to 6,862.07 [1] - Consumer discretionary shares saw a significant jump of 4.3% on Friday, indicating strong performance in that sector [1] Company Performance - Apple Inc. reported fiscal fourth-quarter revenue of $102.47 billion, surpassing analyst estimates of $102.17 billion, and earnings of $1.85 per share, exceeding expectations of $1.76 per share [3] - EPWK Holdings Ltd. shares surged 137% to $0.1559, while Getty Images Holdings, Inc. experienced a 45% increase to $2.93 following a licensing agreement with Perplexity AI [10] - MSP Recovery, Inc. shares rose 77% to $0.56, indicating strong market interest [10] - Luminar Technologies, Inc. shares dropped 34% to $1.3801 after receiving a subpoena from the SEC and suspending its FY25 guidance [10] - Intensity Therapeutics, Inc. shares fell 28% to $0.95 after announcing a $4 million registered direct offering of common stock [10] - OneSpan Inc. shares decreased by 26% to $11.52 after reporting worse-than-expected third-quarter sales and cutting its FY25 sales guidance [10] Commodity Market - Oil prices increased by 0.7% to $61.04, while gold rose by 0.4% to $4,031.90 [6] - Silver prices fell by 0.3% to $48.485, and copper decreased by 0.4% to $5.0860 [6] International Markets - European shares were lower, with the eurozone's STOXX 600 slipping 0.5%, and major indices in Spain, London, Germany, and France also experiencing declines [7] - Asian markets closed mostly lower, with Japan's Nikkei 225 gaining 2.12%, while Hong Kong's Hang Seng fell 1.43%, and China's Shanghai Composite dipped 0.81% [8]

Group 1: Amazon's Financial Performance - Amazon reported third-quarter net sales of $180.2 billion, representing a 13% year-over-year increase, surpassing the Street consensus estimate of $177.8 billion [1] - The company anticipates fourth-quarter net sales to be between $206.0 billion and $213.0 billion, indicating a year-over-year growth of 10% to 13% [1] Group 2: Stock Movements - Amazon shares increased by 12.5% to $250.79 in pre-market trading following the positive financial results [2] - Other notable stock movements included DEFSEC Technologies Inc gaining 74.3%, Beneficient surging 46%, and Medicinova Inc rising 37.7% in pre-market trading [5]

Core Insights - Intensity Therapeutics (INTS.US) experienced a pre-market drop of 37.88% to $0.82 after a significant increase of 394.57% the previous day, recovering losses from over six months [1] - The company announced results from its Phase 1/2 clinical trial for its cancer candidate INT230-6, showing an increase in activated CD4+ and CD8+ T cells in the tumor microenvironment [1] - The trial involved 64 patients across more than 20 cancer types, all of whom had undergone extensive prior treatments, achieving a disease control rate of 75% [1] Company Performance - The closing price on October 30 was $1.32, with a significant trading volume of 1.434 billion shares [1] - The stock reached a high of $1.74 and a low of $0.64 during the trading session, with a previous close of $0.267 [1] - The market capitalization stood at approximately $64.75 million, with a total share count of about 49.06 million [1] Clinical Trial Results - The clinical trial results indicated a promising potential for a new cancer treatment method, resonating positively with the market [1] - CEO Lewis Bender highlighted the early data's significance in the field of solid tumor treatment, expressing hope for broader patient benefits [1]

Core Insights - Intensity Therapeutics (INTS.US) announced significant results from its Phase 1/2 clinical trial for the candidate drug INT230-6, leading to a nearly 395% surge in stock price [1] Group 1: Drug Mechanism and Clinical Data - INT230-6 operates by directly injecting into tumors, facilitating the diffusion of cisplatin and vinblastine sulfate, along with a cell-penetrating enhancer molecule (SHAO) [1] - The trial involved 64 patients across over 20 cancer types, all of whom had undergone extensive prior treatments, achieving a disease control rate of 75% [1] - The median overall survival (mOS) for the entire patient group was 11.9 months, with a notable 21.3 months for the metastatic sarcoma subgroup [1] - No grade 4 or 5 treatment-related adverse events were reported, with only 7 patients experiencing grade 3 adverse events, and no dose-limiting toxicities observed [1] Group 2: Market Reaction and Future Plans - The market reacted positively to the trial data, indicating strong interest in the field of solid tumor treatments [2] - Intensity Therapeutics has partnered with Merck (MRK.US) and Bristol-Myers Squibb (BMY.US) to explore combination therapies with Keytruda and Yervoy [2] - A conference call is scheduled for October 31 to discuss the clinical trial results, which have been published in the journal eBioMedicine [2]

Market Overview - U.S. stocks traded mostly lower, with the Nasdaq Composite falling more than 1% on Thursday [1] - The Dow increased slightly by 0.03% to 47,644.08, while the S&P 500 dropped 0.63% to 6,847.40 [1] Company Financials - Alphabet Inc. reported third-quarter revenue of $102.35 billion, exceeding analyst estimates of $99.64 billion [2] - The company also reported earnings of $2.87 per share, surpassing estimates of $2.33 per share [2] Sector Performance - Financial shares increased by 0.5% on Thursday [1] - Communication services stocks fell by 2.3% [1] Commodity Prices - Oil prices decreased by 1% to $59.89, while gold fell by 0.6% to $3,977.50 [5] - Silver prices increased by 0.1% to $47.915, and copper prices dropped by 3.2% to $5.0955 [5] International Markets - European shares were lower, with the eurozone's STOXX 600 slipping 0.5% [6] - Asian markets closed mostly lower, with Japan's Nikkei 225 gaining slightly by 0.04% [7] Notable Stock Movements - Intensity Therapeutics, Inc. shares surged 175% to $0.7408 following the publication of clinical results [8] - Cambium Networks Corporation shares rose 85% to $5.46 after announcing integration with Starlink [8] - CPI Aerostructures, Inc. shares increased by 90% to $4.4798 after receiving an order from Raytheon [8] - CERo Therapeutics Holdings, Inc. shares dropped 82% to $0.3200 due to a Nasdaq listing denial [8] - Aditxt, Inc. shares fell 44% to $0.0643 after announcing a reverse stock split [8] - FMC Corporation shares decreased by 41% to $17.22 after lowering FY2025 earnings guidance [8]

Core Insights - Intensity Therapeutics, Inc. announced the publication of its phase 1/2 IT-01 clinical study manuscript for the treatment of metastatic or refractory cancers, demonstrating promising efficacy and safety of its investigational product INT230-6 [1][4][5] Study Results - The phase 1/2 trial showed a disease control rate of 75% (48 out of 64 patients) and a median overall survival (mOS) of 11.9 months, which is significantly better than historical mOS of 4 to 7 months for similar patient populations [4][5] - In a subset of metastatic sarcoma patients treated with INT230-6, the mOS was reported at 21.3 months [4] - An exploratory analysis indicated that patients receiving INT230-6 at doses treating more than 40% of their tumor burden had an 83.3% disease control rate and an mOS of 18.7 months, compared to 50% and 3.1 months for those treated with less than 40% [4] Mechanism of Action - INT230-6 utilizes a diffusion process for local treatment, directly injected into tumors, leading to tumor cell death and systemic immune activation [4][6] - The treatment resulted in a qualitative decrease in proliferating cancer cells and an increase in activated T-cells within the tumor microenvironment [4][5] Safety Profile - The trial reported no dose-limiting toxicities among the 64 patients, with only 10.9% experiencing grade 3 adverse events and no grade 4 or 5 treatment-related adverse events [4][5] - Pharmacokinetic data showed over 95% of active cytotoxic agents remained localized within the injected tumors, indicating a favorable safety profile [5] Future Directions - The company plans to initiate randomized controlled studies, including a Phase 3 trial in sarcoma, to further evaluate the efficacy of INT230-6 [5][10]

Accessibility StatementSkip Navigation "While efficacy of INT230-6 is quite promising, and we are excited by the early radiological and pathological results, an essential aspect of any treatment for breast cancer patients is to have a good cosmetic result post- surgery," said Ursina Zürrer, M.D. Chief Physician for Genetic Counseling, Department of Medical Oncology and Hematology, Cantonal Hospital Winterthur, Switzerland, and the Coordinating Investigator for the INVINCIBLE-4 Study. "We believe that the IN ...