At the forefront of the Inhibitor Therapeutics, Inc. announced that itraconazole to treat basal cell carcinomas in Basal Cell Carcinoma Nevus Syndrome (BCCNS) a Gorlin Syndrome. This rare hereditary cancer syndrome is characterized by patients with hundreds to thousands of basal cell carcinomas. BCCNS is an orphan disease with approximately 11,000 patients in the USA.

Inhibitor believes that itraconazole has clinically meaningful effects on the BCCs, which led to recruit a team of five experienced Mohs surgeons to form a Scientific Advisory Board (SAB) to critically review the outcomes of Inhibitor's phase 2b trial in BCCNS. They are academically affiliated, well-respected leaders in the practice of treating basal cell carcinomas and other skin cancers The purpose of the SAB is to assess the clinical benefits of adding itraconazole to the therapeutic options for the basal cell carcinomas in these patients. The initial focus of the SAB is a review of the final clinical outcomes of INTI's phase 2b study of itraconazole in BCCNS.

Due to a recently resolved dispute with the former supply partner, the trial results are now available but have not been publicly released, nor shared with the trial investigators, or filed with the FDA for guidance. The Phase 2b SCORING Trial completed during 2018 assessed 477 pre-existing surgically eligible target lesions across 38 patients. Unlike virtually all other disseminated cancers that have a single primary with metastatic lesions, the standard measure of response is RECIST (Response Criteria in Solid Tumors) which are size criteria based upon an analysis of response by patient.

Patients with BCCNS are predominantly concerned with the high number of surgical interventions required during their lifetime and the disfigurement that results from these procedures, particularly on areas of the body such as the face that are exposed to the public. Therefore, a therapy without significant toxicity that can reduce the number of lesions that require a scar producing intervention will fulfill an unmet need for these patients. The review of the Phase 2b Clinical Study Report by Scientific Advisory Board will focus on whether the SCORING trial is sufficiently clinically meaningful to warrant filing itraconazole for a New Drug Application ("NDA") as the first and only drug to be approved to treat BCCNS.

The Gorlin Syndrome Alliance (a non-for-profit independent patient advocacy organization) (GSA) conducted an EL-PFDD (ex externally led patient focused drug development) meeting on October 8, 2021. This was conducted to help advance the GSA's mission to thoughtfully support, comprehensively educate, and aggressively seek the best treatments and a cure for those affected by Gorlin Syndrome. She received her undergraduate degree from Cornell University and her medical degree from Penn State University College of Medicine.

She is a Mohs micrographic surgeon with more than 30 years' experience in Mohs Surgery and skin cancer management. She also has performed numerous clinical trials related to skin cancer. Dr. Billingsley is a past president of the American College of Mohs Surgery.

She is affiliated with the Gorlin Syndrome Alliance and is a member of their Medical and Scientific Advisory Committee. Additionally, Dr. Christensen focuses on complex skin cancer issues such as field characterization, preventative strategies in high-risk patients and management of advanced or aggressive skin cancer. Dr. Christensen has published extensively on skin cancer pathogenesis and treatment and has experience in clinical trials for organizations such as the American Academy of Dermatology and the American College of Mohs surgery, and currently serves as the Treasurer for the International Transplant Skin Cancer Collaborative.