Intensity Therapeutics — Third Quarter 2026 Earnings Summary

Financial Performance:

• Net loss was $3.5 million for the third quarter of 2026, compared to a net loss of $2.7 million for the same period in 2025.
• Research and development expenses were $2.4 million for the third quarter of 2026, an increase from $1.6 million in the third quarter of 2025.
• General and administrative expenses were $1.2 million for the third quarter of 2026, unchanged from $1.2 million in the third quarter of 2025.
• Cash and cash equivalents totaled $8.5 million as of September 30, 2026, down from $11.9 million as of December 31, 2025.
• Total operating expenses were $3.6 million for the three months ended September 30, 2026, compared to $2.7 million in the same period in 2025.
• Loss per share, basic and diluted, was $1.09 for the three months ended September 30, 2026, compared to $1.55 in the same period in 2025.

Guidance and Future Outlook:

• The Company targets complete enrollment in the INVINCIBLE-4 Study by the end of 2027.
• An update regarding the Independent Data Monitoring Board (IDMB) review of safety data for the INVINCIBLE-4 Study is planned for the first quarter of 2027.
• Increased site activation and patient enrollment rates are expected for the INVINCIBLE-3 Study as sufficient incremental funding is obtained.
• Submission of documentation necessary to restart the INVINCIBLE-3 Study in the EU and Canada is in process.
• Management continues to pursue business development opportunities following discussions at ESMO.

Business Segments and Product Lines:

• New patient enrollment activities resumed in a limited number of U.S. sites for the Phase 3 INVINCIBLE-3 Study in the third quarter of 2026.
• New patient enrollment and treatment resumed for the Phase 2 INVINCIBLE-4 Study in the third quarter of 2026.
• Preliminary data from the first 14 patients in the INVINCIBLE-4 Study showed a 71% pathological complete response (pCR) in Cohort A (INT230-6 + SOC) compared to 42% in Cohort B (SOC alone).
• The INVINCIBLE-4 Study observed a 44% reduction in grade 3 adverse events in Cohort A compared to Cohort B.
• In the INVINCIBLE-4 Study, no invasive breast cancer cells were detected in the axillary lymph nodes in 6 of 7 patients in Cohort A after INT230-6 treatment.
• All 7 patients in Cohort A of the INVINCIBLE-4 Study exhibited tumor necrosis after 1 or 2 injections.
• A new INT230-6 manufacturing batch was initiated during the third quarter of 2026.
• The Company opened its first site in France for the INVINCIBLE-4 Study in August 2026.

Market and Competitive Landscape:

• Approximately 56,000 new cases of triple-negative breast cancer (TNBC) are diagnosed annually in the US, with 420,000 worldwide.
• The standard neoadjuvant treatment for TNBC includes systemic chemotherapy and the anti-PD-1 monoclonal antibody pembrolizumab, with pCR rates ranging from 50% to 65%.
• The Keynote-522 regimen has a high toxicity profile, with 77% of patients experiencing grade 3 or higher treatment-related adverse events.
• Approximately 14,400 patients in the US have regional or distal leiomyosarcoma, liposarcoma, and undifferentiated pleomorphic sarcoma.
• INT230-6 is designed to kill tumors and elicit an adaptive immune response without immunosuppression, differing from conventional systemic chemotherapy.

Risks and Challenges:

• The Company paused new site activations and patient enrollment in the INVINCIBLE-3 Study in March 2025 due to funding constraints.
• The Company paused new patient enrollment in the INVINCIBLE-4 Study in September 2025 to revise the dosing regimen due to localized skin irritation in patients.
• Actual results may differ materially from forward-looking statements regarding clinical trial initiation, timing, progress, and results.
• There is a risk that product candidates may not demonstrate safety and/or efficacy in larger-scale or later clinical trials.
• The Company faces the risk of needing to raise additional funding before generating revenues from product sales.
• There is a potential inability to satisfy Nasdaq Capital Market requirements for continued listing.

Management Commentary and Tone:

• Lewis H. Bender, President and CEO, stated the Company is excited that recruitment has been reinitiated in both trials.
• Management noted that protocol adjustments for the INVINCIBLE-3 Study have been well received by investigators.
• European and Canadian investigators for the INVINCIBLE-3 Study have expressed a strong desire to restart patient enrollment.
• Management expressed confidence that the skin issue in the INVINCIBLE-4 Study is resolved if the IDMB report in Q1 2027 is positive.
• Management highlighted good motivation for sites to enroll patients in the INVINCIBLE-4 Study based on overall safety and potential improved efficacy.

Other Key Points:

• In March 2026, the Company established a $60 million at-the-market (ATM) facility.
• During the third quarter of 2026, the Company raised net proceeds of $1.5 million under the ATM facility.
• During the nine months ended September 30, 2026, the Company raised net proceeds of $3.2 million under the ATM facility.
• The INVINCIBLE-4 Study utilizes a lower drug volume per tumor volume ratio and a single injection of INT230-6 in Cohort A following protocol amendments approved by Swissmedic, the Swiss Ethics Committee, and the French National regulatory agency.
• The Swiss Cancer Institute has established an independent data monitoring board (IDMB) to review safety data and images for the INVINCIBLE-4 Study.
• Intensity Therapeutics is a late-stage clinical biotechnology company focused on intratumoral cancer therapies using its proprietary non-covalent conjugation technology.