TAMPA, Fla., Sept. 08, 2026 (GLOBE NEWSWIRE) -- Inhibitor Therapeutics, Inc. (OTCQB: INTI) ("Inhibitor" or the "Company") today highlighted several important developments disclosed in its Quarterly Report on Form 10-Q filed August 14, 2026, and encouraged stockholders and other interested parties to review the filing for a more complete discussion of the Company's progress.
Recent progress includes a revised regulatory strategy for itraconazole in Basal Cell Carcinoma Nevus Syndrome ("BCCNS" or "Gorlin Syndrome"), descriptive characterization of prospectively collected measurements from the completed Phase IIb HP2001 study, continued FDA engagement, development of a proposed commercial formulation, a new provisional patent filing, outside scientific support and a favorable Delaware Court of Chancery judgment.
INTI is proposing surgically eligible basal cell carcinomas as the primary efficacy endpoint for the program. The endpoint focuses on tumors that have reached a size at which surgical removal would ordinarily be warranted. It was used in the randomized, placebo-controlled Tang study of vismodegib in Gorlin Syndrome(1) , where treatment reduced both the development of new surgically eligible tumors and the number of performed patient surgeries. Separately, vismodegib was approved by FDA for advanced basal cell carcinoma based on single-arm response data in an advanced-disease population. INTI believes these two distinct precedents provide important clinical and regulatory context for the Company's questions now before FDA.
Applying the same site-based surgical thresholds used in the Tang study to prospectively collected HP2001 lesion measurements identified 258 surgically eligible baseline tumors. A descriptive characterization of those tumors showed that 52.7% achieved an objective response, 87.2% were controlled, and the mean best reduction in longest diameter was 40.4%. HP2001 enrolled 38 patients and followed 477 target basal cell carcinomas in total. These descriptive readings characterize observed therapeutic activity in the small, operable tumors that drive the repeated surgical burden of Gorlin Syndrome.
Applying the same surgical thresholds to prospectively collected measurements of tumors arising during HP2001 identified 10 new surgically eligible tumors across seven patients during 37.77 patient-years of on-treatment exposure, corresponding to a descriptive rate of 0.265 per patient-year - well below one new surgically eligible tumor per patient-year. For context, the separate randomized Tang study reported approximately 2 new surgically eligible tumors per patient-year with vismodegib and approximately 29 per patient-year with placebo. The markedly low on-treatment rate observed in HP2001 is particularly notable in a lifelong disease characterized by the continual development of new BCCs and forms part of the Company's request for FDA guidance on the use of the Tang placebo experience as an external control for the HP2001 new-lesion endpoint.
These findings align closely with outcomes identified as important by the Gorlin Syndrome patient community. In the Gorlin Syndrome Alliance Voice of the Patient report, 70% of respondents selected preventing BCCs from developing as one of their top three desired treatment outcomes, and 94% said that a preventive treatment reducing new basal cell carcinomas by 30% without challenging side effects would represent an improvement over current options(3) . Against that patient-defined benchmark, the descriptive HP2001 rate of 0.265 new surgically eligible BCCs per patient-year is an encouraging finding. The numerical separation between the HP2001 rate and the rates reported in Tang is considerably greater than the 30% threshold patients identified, although the cross-trial comparison is descriptive and is not an adjusted treatment-effect estimate. Taken together, the results support further evaluation of itraconazole as a potential preventive therapy aimed at reducing the development of new BCCs to surgical eligibility. The observation is also biologically plausible given itraconazole's demonstrated antitumor activity in human BCC and preferential distribution into cutaneous tissue(2) .
The patient-defined prevention benchmark also emphasized the importance of avoiding challenging side effects, making tolerability and treatment persistence particularly relevant in a condition that may require long-term management. In HP2001, 13.2% of patients discontinued itraconazole because of adverse events over a median of approximately 7.0 months on treatment. In the randomized Tang Gorlin study, 27% of patients had discontinued vismodegib because of adverse events at a mean observation time of approximately 8 months, rising to 54% at the later study cutoff. Although these are separate studies rather than a head-to-head safety comparison, the observed itraconazole tolerability and treatment persistence align strongly with the treatment profile patients said they wanted: fewer new tumors together with a therapy suitable for sustained use.
Measure HP2001 Tang Tang
itraconazole vismodegib placebo
----------------------- ----------------------- ------------- -------------
Mean reduction in 40.4% Approx. 65% Approx. 11%
existing surgically
eligible tumors
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New surgically 0.265 Approx. 2 Approx. 29
eligible BCCs per
patient-year
----------------------- ----------------------- ------------- -------------
Adverse-event-related 13.2% (median 27% at --
discontinuation approximately 7 approx. 8
months) months; 54%
at later
cutoff
----------------------- ----------------------- ------------- -------------
Selected descriptive cross-trial context from INTI's Type C Meeting Information Package and Tang et al. (2012). Each figure describes its respective study; the comparison is not an adjusted between-study treatment-effect estimate.
1 Tang JY, Mackay-Wiggan JM, Aszterbaum M, et al. N Engl J Med. 2012;366(23):2180-2188. doi:10.1056/NEJMoa1113538.
2 Kim DJ et al. J Clin Oncol. 2014;32(8):745-751. doi:10.1200/JCO.2013.49.9525; Cauwenbergh G et al. J Am Acad Dermatol. 1988;18(2 Pt 1):263-268. doi:10.1016/S0190-9622(88)70037-7.3 Gorlin Syndrome Alliance. Voice of the Patient Report: Living with Gorlin Syndrome. Externally Led Patient-Focused Drug Development Meeting, October 8, 2021; published 2022, p. 45.
On July 10, 2026, INTI submitted a meeting request and associated briefing package to FDA. The Company is seeking FDA guidance on the proposed surgically eligible tumor endpoint for the non-advanced Gorlin population, the use of the existing clinical evidence within a potential marketing application under Section 505(b)(2), and the path forward for the program. The briefing package specifically asks FDA to consider the HP2001 readings, whether expressed at the surgically eligible threshold or per lesion, as descriptive characterizations of prospectively collected measurements rather than inferential post-hoc tests of a treatment effect. FDA subsequently classified the meeting as Type C, elected to provide written responses and has stated a goal date by the end of September 2026.
The Company's regulatory position is also supported by outside scientific and clinical input, including a letter submitted to FDA from Professor D. Gareth Evans, an internationally recognized expert in inherited cancer-predisposition syndromes and Gorlin Syndrome, addressing the disease biology, the independent nature of the tumors and the clinical importance of reducing surgical burden.
Formulation work also advanced during the period. The completed ITZ101 pilot comparative-bioavailability study showed that the Company's 75 mg formulation produced systemic exposure most comparable to TOLSURA(R) 65 mg, with geometric mean ratios of 105.36% for AUC0-t and 102.19% for Cmax. Based on those results, the Company intends to advance an approximate 75 mg formulation.
On August 14, 2026, the Company filed a U.S. provisional patent application covering its novel oral itraconazole formulation, including its amorphous nano/microparticle composition and related pharmaceutical uses. The filing is intended to support formulation-specific and related-use intellectual-property protection extending beyond the February 2029 expiration of the licensed Johns Hopkins University patent. Itraconazole also has FDA Orphan Drug Designation for BCCNS, which may provide a separate period of U.S. regulatory exclusivity following approval for the designated indication, subject to applicable requirements.
The program also carries meaningful commercial potential. An internal illustrative model assumes an estimated U.S. BCCNS population of approximately 11,000 patients, approximately one-third market penetration and illustrative pricing of $4,000 to $5,000 per patient per month. Under those assumptions, approximately 3,700 treated patients would correspond to potential peak annual U.S. revenue of approximately $178 million to $222 million. The analysis is for internal strategic planning, is highly sensitive to its assumptions and is not Company financial guidance or a revenue forecast.
Separately, on August 3, 2026, the Delaware Court of Chancery entered a default judgment in favor of the Company against the institutional investor that failed to fund a previously announced $3.0 million registered direct offering. The judgment awarded the Company $3.0 million plus attorneys' fees and applicable interest, and the Company is pursuing enforcement and collection.