In March 2026, the Company reported the following: The Company expects presentation of more detailed results for the seven (7) Cohort A patients at a future oncology conference. INVINCIBLE-3 Study: Phase 3 open-label, randomized study testing INT230-6 as monotherapy compared to the SOC drugs in second- and third-line treatment for specific soft tissue sarcoma subtypes. In March 2025, the Company paused new site activations and patient enrollments due to funding constraints. Before this pause, the trial had ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K x ANNUAL REPORT PURSUANT TO SECTION 13 or 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2025 or o TRANSITION REPORT PURSUANT TO SECTION 13 or 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 INTENSITY THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) | Delaware | 46-1488089 | | --- | --- | | (State or other jurisdiction of incorporation or organization ...

Intensity Therapeutics Strengthens IP Portfolio with Issuance of New Patent in the US Accessibility StatementSkip NavigationNew US patent 12,496,345 strengthens the existing portfolioPatents now granted in 41 countries protect the Company's novel intratumoral technology, including lead compound INT230-6SHELTON, Conn., March 24, 2026 /PRNewswire/ -- Intensity Therapeutics, Inc., (Nasdaq: INTS) ("Intensity" or the "Company"), a late-stage clinical biotechnology company focused on the discovery and development ...

Core Insights - Intensity Therapeutics Inc. provided an update on the INVINCIBLE-4 Study, a Phase 2 study analyzing the clinical activity, safety, and tolerability of INT230-6 in early-stage, operable triple-negative breast cancer patients [1] Enrollment and Preliminary Data - A total of 14 patients have been treated so far, with an expected total enrollment of 61 patients [2] - Preliminary results indicate that 5 out of 7 patients (71.4%) receiving INT230-6 before standard of care (SOC) achieved a pathological complete response (pCR), compared to 2 out of 6 patients (33%) in the SOC arm alone [2] Safety Observations - Safety data for patients receiving INT230-6 plus SOC remain favorable compared to SOC alone [3] Enrollment Status - Enrollment was paused in September 2025 due to skin irritations observed in the INT230-6 group before SOC [4] - A protocol amendment was submitted in March 2026 to resume enrollment with a lower drug volume per tumor volume ratio and a single injection of INT230-6 [4] Management Commentary - The company highlighted a 44% reduction in the total number of grade 3 or higher adverse events, particularly immune-related adverse events, and the potential for a higher pCR rate with INT230-6 prior to SOC [5] Stock Activity - Intensity Therapeutics announced a 1-for-25 reverse stock split to increase the per-share trading price and comply with Nasdaq listing requirements [6] - The company's shares were down 6.70% at $7.50 at the time of publication [8] Market Performance - The Benzinga Edge scorecard indicates that the company's momentum is weak, with a score of 6.98, suggesting underperformance compared to the broader market [7]

Core Insights - Intensity Therapeutics, Inc. provided an update on the Phase 2 INVINCIBLE-4 Study for presurgical treatment of triple-negative breast cancer, highlighting promising preliminary data on pathological complete response (pCR) rates and safety profile [1][2] Group 1: Study Overview - The INVINCIBLE-4 Study is a Phase 2 non-comparative, randomized open-label study analyzing the clinical activity, safety, and tolerability of INT230-6 combined with standard of care (SOC) immunochemotherapy in early-stage, operable triple-negative breast cancer [2] - Enrollment was paused in September 2025 due to skin irritations, but a protocol amendment was submitted in March 2026 to resume enrollment with adjusted dosing [1][2] - The expected total enrollment for the study is up to sixty-one (61) patients [1][2] Group 2: Efficacy Data - Preliminary results show that 71.4% (5 out of 7) of patients in Cohort A (receiving INT230-6 prior to SOC) achieved a pCR, compared to 33% (2 out of 6) in Cohort B (SOC alone) [1][2] - The pCR analysis is ongoing, and results are considered preliminary [1][2] Group 3: Safety Data - Cohort A experienced 14 grade 3 or higher adverse events (AEs), with only one being a common immune-related side effect, while Cohort B had 25 grade 3 AEs, including three grade 3 and one grade 4 [1][2] - There was a 44% reduction in grade 3 or higher AEs in Cohort A compared to Cohort B, indicating a favorable safety profile for INT230-6 combined with SOC [1][2] Group 4: Background on Triple-Negative Breast Cancer - Triple-negative breast cancer (TNBC) is an aggressive subtype with limited treatment options, accounting for approximately 11 to 17% of breast cancer cases [2] - The standard neoadjuvant treatment for TNBC includes systemic chemotherapy and pembrolizumab, with pCR rates ranging from 50% to 65% depending on tumor size [2] Group 5: INT230-6 Product Information - INT230-6 is designed for direct intratumoral injection and combines cisplatin and vinblastine sulfate with a diffusion enhancer, facilitating effective tumor penetration and immune engagement without immunosuppression [2] - The drug aims to improve local disease control and elicit systemic anti-tumor effects, representing a potential shift in the treatment paradigm for aggressive cancers [2]

Financial Updates - Intensity Therapeutics, Inc. updated its Financial Highlights Slide through December 31, 2025, which is available on its Investor Relations website[4] - All figures in the Slide are unaudited and preliminary, subject to completion of financial closing procedures[5] Company Classification - The Company is classified as an emerging growth company under the Securities Act of 1933[3]

Core Viewpoint - Intensity Therapeutics, Inc. announced a 1-for-25 reverse stock split to increase the per share trading price and regain compliance with Nasdaq's minimum bid price requirement [1] Company Overview - Intensity Therapeutics is a late-stage clinical biotechnology company focused on developing novel intratumoral cancer therapies using proprietary non-covalent conjugation technology [1] - The company’s lead product candidate, INT230-6, is designed for direct intratumoral injection and combines two potent anti-cancer agents, cisplatin and vinblastine sulfate, with a diffusion enhancer [1] Reverse Stock Split Details - The reverse stock split will take effect on February 18, 2026, with trading on a split-adjusted basis starting February 19, 2026 [1] - The number of outstanding shares will decrease from approximately 63,346,579 to about 2,533,863 shares [1] - No fractional shares will be issued; stockholders will receive cash payments for any fractional shares [1] Clinical Trials and Product Development - INT230-6 has shown the ability to kill tumors and elicit an immune response within days of injection, representing a potential shift in cancer treatment paradigms [1] - The company has completed two clinical studies with over 200 patients, including a Phase 1/2 study in metastatic cancers and a Phase 2 randomized control trial in locally advanced breast cancer [1] - A Phase 3 trial in soft tissue sarcoma and a Phase 2 study in collaboration with the Swiss Cancer Group are also underway [1]

Core Insights - Intensity Therapeutics, Inc. is positioned for growth in 2026 following key milestones achieved in 2025, including clinical validations and a strengthened balance sheet [1][3][4] Clinical Developments - The INVINCIBLE-4 Study, a Phase 2 trial, showed a pathological complete response in the first patient and favorable safety results, with 50% fewer grade 3 or higher adverse events compared to standard care [2] - The INVINCIBLE-3 Study, a Phase 3 trial, paused new patient enrollments due to funding constraints but continues to treat existing patients and plans to reinitiate enrollment in 2026 once funding is secured [2] - A potential new Phase 3 breast cancer study may be initiated, contingent on funding and positive trends from the INVINCIBLE-4 Study [2] Financial Position - The company raised over $20 million in gross proceeds during 2025, strengthening its balance sheet and extending its operational runway into the second quarter of 2027 [3][7] - The company aims to maintain a disciplined operating approach and may seek additional capital in 2026 to support ongoing and new studies [7] Research and Publications - A peer-reviewed publication in the Lancet journal eBioMedicine reported a 75% disease control rate and median overall survival of 11.9 months for patients with advanced solid tumors, reinforcing the clinical potential of INT230-6 [2][4] - The company plans to pursue an aggressive publication strategy for its completed studies throughout 2026 [2] Product Information - INT230-6 is designed for direct intratumoral injection and combines two potent anti-cancer agents, cisplatin and vinblastine sulfate, with a diffusion enhancer, leading to localized tumor control and systemic immune engagement [5][6]

Core Viewpoint - Intensity Therapeutics Inc. (INTS) has been upgraded to a Zacks Rank 2 (Buy), indicating a positive outlook based on rising earnings estimates, which significantly influence stock prices [1][3]. Earnings Estimates and Stock Price Impact - The Zacks rating system is based on changes in earnings estimates, which are closely correlated with near-term stock price movements, particularly due to institutional investors adjusting their valuations based on these estimates [4][6]. - An increase in earnings estimates typically leads to higher fair value for a stock, prompting institutional investors to buy or sell, which in turn affects stock prices [4]. Company Performance and Outlook - The upgrade for Intensity Therapeutics Inc. reflects an improvement in the company's underlying business, suggesting that investor sentiment regarding this trend could drive the stock price higher [5]. - The Zacks Consensus Estimate for Intensity Therapeutics Inc. has increased by 7.9% over the past three months, with expectations of earnings at -$0.35 per share for the fiscal year ending December 2025, indicating no year-over-year change [8]. Zacks Rank System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with a strong historical performance, particularly for Zacks Rank 1 stocks, which have generated an average annual return of +25% since 1988 [7]. - Intensity Therapeutics Inc.'s upgrade to Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, suggesting a strong potential for market-beating returns in the near term [10].

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]