Cisplatin/Vinblastine/SHAO

Late-stage clinical studies advancing in soft tissue sarcoma and presurgical triple-negative breast cancer Over 200 patients enrolled in completed INT230-6 studies with a peer-reviewed paper published Active strategic partnering initiatives supported by maturing INT230-6 clinical and regulatory profile Strengthened balance sheet supporting disciplined clinical development strategy SHELTON, Conn., July 1, 2026 /PRNewswire/ -- Intensity Therapeutics, Inc. ("Intensity" or "the Company") (Nasdaq: INTS), a late-stage clinical biotechnology company focused on the discovery and development of novel intratumoral cancer therapies that are designed to kill tumors and increase immune system recognition of cancers using its proprietary non-covalent conjugation technology, today provides a mid-year update highlighting the Company's late-stage development programs and growing strategic partnering focus for INT230-6. During the first half of 2026, Intensity advanced key clinical and regulatory priorities, strengthened its balance sheet, expanded business development engagement with potential pharmaceutical collaborators and continued building the clinical and scientific foundation for INT230-6 as a differentiated oncology product. "Intensity's human clinical data, peer-reviewed publications, late-stage clinical programs and active regulatory engagement in both the U.S. and Europe have progressed nicely in the past 12 months. Our priority now is to execute and advance our clinical programs, generate meaningful data, publish results, preserve financial flexibility and evaluate partnering opportunities to accelerate development, increase stockholder value and ultimately increase the potential impact of INT230-6 for cancer patients and their caregivers," said Lewis H. Bender, Intensity Therapeutics President and Chief Executive Officer. "We also believe INT230-6 is increasingly positioned as a partnerable oncology platform with potential relevance across difficult-to-treat solid tumors, therapeutic combination-treatment settings, and broader platform-based collaborations." Clinical Progress Across INT230-6 Programs During the first half of 2026, Intensity continued to advance its clinical development priorities across both breast cancer and soft tissue sarcoma. In the Company's Phase 2 INVINCIBLE-4 study in presurgical triple-negative breast cancer ("TNBC"), Intensity reported favorable preliminary observations from a small patient sample evaluating INT230-6 prior to standard-of-care immunochemotherapy compared with standard-of-care therapy alone. The Company previously reported that five of seven patients receiving INT230-6 prior to standard of care achieved a pathological complete response, compared with two of six evaluable patients in the standard-of-care arm, with one patient still to be evaluated. The Company also reported 44% fewer grade 3 or higher adverse events in the INT230-6 cohort compared with the standard-of-care arm. While these observations remain preliminary and from a limited patient population, management believes these observations are important because they support the central clinical thesis of INT230-6: the potential to enhance anti-tumor activity while preserving or potentially improving tolerability when used in combination with existing treatment regimens. In March 2026, a protocol amendment was submitted to Swissmedic and the Swiss Ethics Committee. Full approval to resume enrollment in the INVINCIBLE-4 study was granted on March 26, 2026, and we plan to resume enrollment in the third quarter of 2026 in Switzerland and France as part of its Phase 2/3 development strategy for presurgical TNBC. In soft tissue sarcoma, the Company paused new site activations and patient enrollments in the Phase 3 INVINCIBLE-3 study in March 2025 due to funding constraints. In April 2026, the Company announced it will resume enrollment of the INVINCIBLE-3 study in a limited number of U.S. sites. The INVINCIBLE-3 study is designed to evaluate INT230-6 as monotherapy compared with standard-of-care drugs in second- and third-line treatment for specific soft tissue sarcoma subtypes, with overall survival as the primary endpoint. The decision to resume enrollment in the INVINCIBLE-3 and INVINCIBLE-4 studies reflects management's continued conviction in the scientific rationale and clinical potential of INT230-6 in difficult-to-treat tumors where available treatment options remain limited, and patient outcomes remain poor. Peer-Reviewed Publications Validate Scientific Foundation and Platform Intensity's progress is supported by a clinical foundation that now includes more than 200 patients enrolled across completed INT230-6 studies, including a Phase 1/2 dose escalation study in metastatic cancers and a randomized Phase 2 study in locally advanced breast cancer. The Company previously announced a peer-reviewed publication in eBioMedicine, a Lancet Discovery Science journal, which represented an important validation point for the INT230-6 drug product. The publication reported clinical observations in advanced solid tumors, including evidence of disease control, survival outcomes in certain patient subsets and signs of systemic immune engagement, including observations consistent with abscopal effects in patients receiving higher levels of tumor burden treatment. Management believes this growing body of evidence distinguishes INT230-6 from conventional intratumoral approaches. Rather than relying solely on localized injection effects, Intensity's strategy is designed around the ability to saturate tumors, kill cancer cells, release neoantigens and potentially activate systemic anti-tumor immunity. The Company is seeking to further report clinical data from two completed studies in the second half of 2026 in other peer-reviewed publications. Partnering and Collaborations Initiatives Intensity's recent business development activity reflects growing awareness of INT230-6 among potential pharmaceutical collaborators. At the 2026 BIO International Convention ("BIO") in San Diego, the Company participated in more than 20 partnering discussions, primarily with regionally focused pharmaceutical companies, as well as several global pharmaceutical companies. Management also engaged with companies prior to the BIO conference. Many of these meetings were requested by potential partners, which management believes underscores the strategic relevance of INT230-6 as a differentiated oncology product. While the process is in the early stages, the Company intends to continue actively exploring and evaluating potential partnering and collaboration opportunities that may support the advancement of INT230-6 across priority indications, new indications, geographies, stages of disease and treatment settings, while maintaining disciplined execution and continued data generation with a goal of accelerating long-term stockholder value creation. Strengthened Balance Sheet and Capital Flexibility The Company entered 2026 with cash and cash equivalents of $11.9 million as of December 31, 2025. In March 2026, the Company established a $60 million at-the-market facility and has effectively and opportunistically raised capital during the first half of 2026 to fund operations. As of March 31, 2026, the Company had cash and cash equivalents of $10.2 million. This strengthened financial position is expected to support Intensity's near-term development priorities while providing flexibility as the Company evaluates potential strategic collaborations. Management believes maintaining capital discipline is important to preserving optionality and negotiating from a position of greater strength. About INT230-6 INT230-6, Intensity's lead proprietary investigational product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity's proprietary DfuseRx℠ technology platform. The drug consists of two proven, potent anti-cancer agents, cisplatin and vinblastine sulfate, and a diffusion and cell penetration enhancer molecule ("SHAO") that non-covalently conjugates to the two payload drugs, facilitating the dispersion of potent cytotoxic drugs throughout tumors and allowing the active agents to diffuse into cancer cells. These agents remain in the tumor, resulting in a favorable safety profile. In addition to local disease control and direct tumor killing, INT230-6 causes a release of a bolus of neoantigens specific to the malignancy, leading to immune system engagement and systemic anti-tumor effects. Importantly, these effects are mediated without immunosuppression, which often occurs with systemic chemotherapy. About Intensity Therapeutics Intensity is a late-stage clinical biotechnology company whose novel engineered chemistry enables aqueous cytotoxic-containing drug formulations to mix and saturate a tumor's dense, high-fat, pressurized environment following direct intratumoral injection. As a result of the saturation, Intensity's clinical trials have demonstrated the ability of INT230-6 to kill tumors and elicit an adaptive immune response within days of injection, representing a new approach to cancer cell death that holds the potential to shift the treatment paradigm and turn many deadly cancers into chronic diseases even for malignancies that do not respond to conventional immunotherapy. Intensity has completed two clinical studies that enrolled over 200 patients using INT230-6: a Phase 1/2 dose escalation study in metastatic cancers including sarcomas (NCT03058289), and a Phase 2 randomized control clinical trial in locally advanced breast cancer (the "INVINCIBLE-2 Study") (NCT04781725) in women without undergoing chemotherapy prior to their surgery. The Company initiated a Phase 3 trial in soft tissue sarcoma (the "INVINCIBLE-3 Study") (NCT06263231), testing INT230-6 as second or third-line monotherapy compared to the SOC with overall survival as an endpoint. Intensity also initiated a Phase 2 study in collaboration with the Swiss Cancer Institute (the "INVINCIBLE-4 Study") (NCT06358573) as part of a Phase 2/3 program evaluating INT230-6 followed by the SOC immunochemotherapy and the SOC alone for patients with presurgical triple-negative breast cancer. pCR is the endpoint. For more information about Intensity, including publications, papers, and posters about its novel approach to cancer therapeutics, visit or review our SEC filings. Forward-Looking Statements Certain statements in this press release may constitute "forward-looking statements" within the meaning of the United States Private Securities Litigation Reform Act of 1995, as amended to date. These statements include, but are not limited to, statements relating to the Company's expected future plans, cash runway, development activities, projected milestones, business activities or results. When or if used in this communication, the words "may," "could," "should," "anticipate," "believe," "estimate," "expect," "intend," "plan," "predict" and similar expressions and their variants, as they relate to the Company or its management, may identify forward-looking statements. The forward-looking statements contained in this press release are based on management's current expectations and projections about future events. Nevertheless, actual results or events could differ materially from the plans, intentions, and expectations disclosed in, or implied by, the forward-looking statements. These risks and uncertainties, many of which are beyond our control, include: the initiation, timing, progress and results of future preclinical studies and clinical trials and research and development programs; the need to raise additional funding before the Company can expect to generate any revenues from product sales; plans to develop and commercialize product candidates; the timing or likelihood of regulatory filings and approvals; the ability of the Company's research to generate and advance additional product candidates; the risk that product candidates that appear promising in early research and clinical trials do not demonstrate safety and/or efficacy in larger-scale or later clinical trials; the implementation of the Company's business model, strategic plans for the Company's business, product candidates and technology; commercialization, marketing and manufacturing capabilities and strategy; the rate and degree of market acceptance and clinical utility of the Company's system; the Company's competitive position; the Company's intellectual property position; developments and projections relating to the Company's competitors and its industry; the Company's ability to maintain and establish collaborations or obtain additional funding; expectations related to the use of cash and cash equivalents and investments; our potential inability to satisfy the Nasdaq Capital Market's requirements for continued listing and be subject to delisting; estimates regarding expenses, future revenue, capital requirements and needs for additional financing; and other risks described in the section entitled "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended December 31, 2025 and in the Company's subsequent SEC filings, which can be obtained on the SEC website at . Readers are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date on which they are made and reflect management's current estimates, projections, expectations and beliefs. The Company does not plan to update any such forward-looking statements and expressly disclaims any duty to update the information contained in this press release except as required by law. Investor Relations Contact: Justin Kulik CORE IR [email protected] (516) 222-2560 Media Contact: Matt Cossel CORE IR [email protected] SOURCE Intensity Therapeutics Inc. 21% more press release views with Request a Demo