On July 1, 2026 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, reported 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.
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"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.
(Press release, Intensity Therapeutics, JUL 1, 2026, View Source [SID1234669041])