Inhibitor Therapeutics reports clinical, regulatory, formulation and legal progress

Inhibitor Therapeutics (OTCQB:
INTI) announced on September 8, 2026 that it is advancing itraconazole for basal cell carcinoma nevus syndrome (BCCNS), also known as Gorlin syndrome.

The company reported descriptive Phase IIb HP2001 results:
among 258 baseline surgically eligible tumors, 52.7% showed an objective response, 87.2% were controlled, and the mean reduction in longest diameter was 40.4%. Treatment discontinuation because of adverse events was 13.2% over a median seven-month period.

Inhibitor said it is pursuing a revised regulatory strategy centered on surgically eligible basal-cell carcinomas and continues discussions with the FDA. The FDA classified the company’s requested meeting as a Type C meeting and is expected to provide written responses by the end of September 2026.

The company reported that its proposed ITZ101 75 mg formulation produced itraconazole exposure broadly comparable to TOLSURA 65 mg, supporting further commercial-formulation development.

Inhibitor filed a U.S. provisional patent application covering an oral amorphous nano/microparticle itraconazole formulation and related pharmaceutical uses. It also highlighted FDA orphan-drug designation for itraconazole in BCCNS.

The company said an internal model estimates potential peak U.S. annual revenue of approximately $178 million to $222 million at about 3,700 treated patients; this is a company estimate, not a forecast or guarantee.

A Delaware Court of Chancery entered a default judgment in Inhibitor’s favor for $3.0 million, plus applicable attorneys’ fees and interest, relating to an investor’s failure to fund a previously announced registered direct offering.

The 2026 Annual Meeting of Stockholders is scheduled virtually for September 15, 2026, at 10:00 a.m. Eastern Time. Stockholders were encouraged to vote in advance; online and telephone voting was available through 11:
59 p.m. Eastern Time on September 14.