INTI — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-08-14

• Itraconazole has demonstrated multiple antitumor mechanisms that provide a scientific rationale for its development in basal cell carcinoma (“BCC”). Investigators at Johns Hopkins University (“JHU”) identified itraconazole as an inhibitor of angiogenesis, demonstrating that it inhibits endothelial c…

• Itraconazole also exhibits substantial distribution into human skin. In a human pharmacokinetic study, skin tissue concentrations in the beard region and back were consistently higher than corresponding plasma concentrations after seven days of oral administration, while concentrations in sebum reac…

• In HP2001, no correlation was observed between serial trough plasma itraconazole concentrations and objective therapeutic response, and reductions in tumor measurements were not correlated with plasma itraconazole levels. Published human pharmacokinetic studies have shown that itraconazole distribut…

• The primary efficacy endpoint we propose for this program is the rate and response of surgically eligible BCCs, meaning those tumors that have reached the anatomic site-referenced size at which surgical excision is warranted. This endpoint, which was the endpoint of the only randomized, placebo-cont…

• On December 12, 2023, we entered into an Exclusive License Agreement (the “Agreement”) with JHU pursuant to which, JHU granted to our Company the exclusive worldwide patent rights to a Granted US Patent, No. 8,980,930 entitled “New Angiogenesis Inhibitors” (the “JHU Patent”). The JHU Patent relates …

Text removed vs the prior filing · source: 10-Q · 2026-05-15

• On December 12, 2023, we entered into an Exclusive License Agreement (the “Agreement”) with Johns Hopkins University (“JHU”) pursuant to which, JHU granted to our Company the exclusive worldwide patent rights to a Granted US Patent, No. 8,980,930 entitled “New Angiogenesis Inhibitors” (the “Patent”)…

• We have engaged Avior Bio, Inc. (“Avior”), to develop a novel formulation of itraconazole. Avior has completed the formulation development process, and upon finalization, will conduct a pharmacokinetic (“PK”) crossover study of the generic formulation and the formulation that was used within the HP2…

• In October 2025, we entered into a performance-based master services agreement with Frameshift Management, Inc. (“Frameshift”) to provide regulatory, biostatistical and strategic consulting services supporting our lead development program targeting basal cell carcinomas associated with Gorlin Syndro…

• We have incurred losses and negative cash flows from operations and expect to incur additional losses until such time that we can generate significant revenue from the licensing of a product once we receive approval by the FDA, which will allow for commercialization of the product candidate. During …

• In response to these conditions, management is currently evaluating the scope of our 2026 operations, including potential financing strategies that include, but are not limited to, the public or private sale of equity or debt securities or from loans or through other strategic collaboration and/or f…

Text added vs the prior filing · source: 10-Q · 2026-08-14

• The FDA has not agreed with our previously proposed efficacy endpoint, and if it does not accept the surgically eligible endpoint we now propose we may be required to conduct additional clinical trials that we are not currently able to fund.

• Our development strategy for itraconazole in BCCNS depends on the FDA accepting the rate and response of surgically eligible basal cell carcinomas, meaning those tumors that have reached the anatomic site-referenced size at which surgical excision is warranted, as an appropriate primary efficacy end…

• HP2001 was an open-label, single-arm study completed a number of years ago and did not include a concurrent control. We are proposing to evaluate its new-tumor data against the placebo arm of the randomized Tang trial as a historical external control. If the FDA does not accept that construction as …