Inhibitor Therapeutics, Inc.

Current report

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.

Current report

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 endpoint, and accepting our analyses of the completed HP2001 study, read against that endpoint, as adequate to support a marketing application under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act. In written responses provided on May 5, 2026, the FDA did not agree that the per-lesion response rate we had previously proposed was an appropriate primary efficacy endpoint and recommended that we conduct a prospective, randomized, placebo-controlled trial. We submitted a further meeting request on July 10, 2026 proposing the surgically eligible endpoint and our proposed pathway, which the FDA has classified as a Type C meeting and to which it has elected to respond in writing rather than by meeting, with a stated goal date of the end of September 2026. The FDA is not obligated to agree with our position, and its prior comments indicate that it may not.

Current report

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 adequate and well controlled, it may treat the evidence as uncontrolled or partially controlled; applicable regulations provide that such evidence may not serve as the sole basis for an effectiveness claim. The FDA may also conclude that our data are insufficient, that the endpoint is not adequately validated or clinically meaningful, or that additional clinical, nonclinical, pharmacokinetic, or chemistry, manufacturing and controls data are necessary. We may then be required to conduct one or more additional clinical trials before a marketing application could be submitted or approved. We do not currently have the capital required to conduct such a trial, and as described in Note 2 to our condensed financial statements there is substantial doubt about our ability to continue as a going concern. Any such requirement would materially delay, and could prevent, commercialization of our product candidate, and could require us to curtail, suspend or discontinue the program.