Intensity Therapeutics, Inc. Q2 FY2026 earnings call

Clinical Program Updates

• Invincible III (Phase III, INT230-6 for soft tissue sarcoma): Enrollment was paused in March 2025 due to funding constraints, with 21 patients already enrolled who remained on treatment/monitoring during the pause. Protocol amendments based on investigator feedback were approved by the FDA, and new patient enrollment at a limited number of U.S. sites is expected to begin in Q3 2026. Prior to the pause, over 60 qualified sites across 8 countries were contracted or in late-stage negotiations, and many sites remain interested in participating given high unmet need for treatments in this indication. The company plans to prepare documentation to activate sites in five European countries (France, Germany, Italy, Poland, Spain) as additional capital is raised.
• Invincible IV (Phase 2, INT230-6 for early-stage triple negative breast cancer (TNBC)): Enrollment was paused after some patients experienced localized skin reactions. An amended protocol with a single reduced-volume injection was approved by Swissmedic, the EMA, and the relevant ethics committees, and patient treatment has resumed in Switzerland with a new site opened in France. 14 patients were enrolled under the original protocol, and 2 additional patients have been treated under the amended protocol to date. Preliminary data from the original 14 patients showed 71% pathological complete response (pCR) in the INT230-6 arm (vs 42% in the standard of care alone arm) among patients with a median tumor size of over 2.4 cm, plus a trend toward fewer grade 3 adverse events including immune-related events. The company targets full enrollment completion by the end of 2027, requiring approximately 45 additional patients. 7 new patients will be added to the INT230-6 arm to replace those dosed under the original protocol.

Publication and Business Development

• In November 2025, safety and efficacy data from the Phase 1-2 IT01 study of INT230-6 was published in eBiomedicine, a top-quartile oncology journal with an impact factor of 11. The published data showed a 75% disease control rate and 12-month median overall survival in refractory metastatic cancer patients, with 18.7-month median overall survival for patients treated to >40% of their tumor burden, which management notes is well above typical outcomes for this patient population.
• At the June 2026 BIO International Conference, management held over 20 meetings with potential strategic partners, many requested by the partnering companies, driven by interest in the company's published clinical data. Discussions will continue in the second half of 2026, and management is open to all partnership structures from global rights to regional rights.

Financial Position

• Since pausing the Invincible III study in Q2 2025, the company has raised over $23 million in capital, improving its balance sheet and operating flexibility. A $60 million at-the-market (ATM) equity facility was established in March 2026; the company raised $1.6 million in net proceeds in Q2 2026 and an additional $1.3 million in net proceeds after quarter-end, and will continue to use the facility opportunistically.

Intensity Therapeutics is a clinical-stage biotech company with a single lead product candidate, INT230-6, being tested in two clinical trials. For Q2 2026, research and development expenses totaled $1.8 million, compared to $1.5 million in Q2 2025, a 19% increase. Clinical trial expenses (the majority of R&D spending, covering the Invincible III and Invincible IV studies) were $1.2 million in Q2 2026, up from $936,000 year-over-year. General and administrative expenses were $155,000 higher than the prior year period, partially offset by $144,000 lower stock-based compensation. Overall net loss for Q2 2026 was $3 million, compared to a $2.5 million net loss in Q2 2025, a 19% increase in net loss. As of June 30, 2026, the company held $9.5 million in cash and cash equivalents. Cash burn from operating activities for the first half of 2026 was $4.2 million.

• The company projects average monthly operating cash burn of approximately $1 million for the second half of 2026.
• Full completion of the Invincible III study is expected to require an incremental $30 million in total capital over the next several years. Current cash on hand, plus planned ATM proceeds, will only support ongoing limited enrollment at U.S. sites; full global site activation requires additional incremental capital.
• Full enrollment for the Invincible IV study is targeted for completion by the end of 2027, subject to site opening and funding availability.

• The company currently lacks sufficient capital to complete full activation and enrollment of the global Invincible III Phase III trial, and must raise additional incremental capital through its ATM facility, other equity offerings, or strategic partnerships to fully advance the program. Delays or failure to raise additional capital will slow or halt trial progress.
• Early preliminary efficacy and safety signals from the Invincible IV study are from a very small patient population, and final data may not confirm the observed trends. It is too early to conclude whether the amended dosing protocol will resolve the prior skin irritation issue while preserving the efficacy signal.
• All forward-looking statements regarding trial timelines, partnership discussions, and capital raising are subject to inherent risks and uncertainties that could cause actual outcomes to differ materially, as detailed in the company's SEC filings.

Q: What capital is needed to fully restart Invincible III enrollment, and what milestones can the current cash balance support without additional ATM proceeds?

A: An incremental $30 million in total capital is required over the next several years to complete the full Invincible III study. Current cash on hand plus planned opportunistic ATM draws only support maintaining limited enrollment at the initial U.S. sites; additional capital is required before all global sites can be activated. The company will accelerate enrollment if additional capital is secured via the ATM, other offerings, or partnerships.

Q: What is the status of the 21 patients enrolled prior to the Invincible III pause, and how has the pause affected trial timing?

A: Protocol changes include updated inclusion criteria and progression definitions. The company is still working with statisticians to evaluate whether the 21 pre-pause patients will be included in the final intent-to-treat analysis, and no final decision has been made yet.

Q: What partnership structures is Intensity open to following the BIO International meetings?

A: Management is evaluating all options, from multinational companies seeking global rights to regional players seeking rights to one or more markets. The company's core goal is to advance INT230-6 to patients as quickly as possible globally. Discussions are still at a very early stage, with some companies moving faster than others, and no timeline for a potential deal can be given.

Q: What key changes were made to the Invincible III protocol based on investigator feedback during the enrollment pause?

A: The two largest changes are adding an exclusion criterion for tumors larger than 15 centimeters (to exclude patients with extremely large, untreatable tumors that were previously allowed), and switching to a central independent radiology review for tumor progression assessments, to improve consistency across trial sites.