On January 27, 2023, Sol-Gel Technologies Ltd. (the “Company”) issued a press release announcing the entry into an asset purchase agreement among the Company and PellePharm, Inc. (“PellePharm”),
pursuant to which the Company has agreed to purchase, and PellePharm has agreed to sell, all of the assets related to the topically-applied patidegib, a hedgehog signaling pathway blocker, for the treatment of Gorlin syndrome (such compound
designated as investigational compound SGT-610). Sol-Gel expects the transaction to close on or about January 30, 2023, subject to the satisfaction of customary closing conditions.
Upon closing of the transaction, Sol-Gel will pay an upfront payment of $4.7 million to PellePharm. In addition, based on the anticipated market potential Sol-Gel will be required to pay total
development and NDA acceptance milestones of up to $6.0 million, and up to $64.0 million in commercial milestones as well as single digit royalties.
Gorlin syndrome affects approximately 1 in 31,000 people in the U.S. and is an autosomal dominant genetic disorder, mostly caused by inheritance of one defective copy of the tumor suppressor gene
PTCH1. Gorlin syndrome is also called nevoid basal cell carcinoma (“BCC”) syndrome because approximately 90% of individuals with this syndrome develop multiple BCCs by age 35, ranging from a few to many thousands of lesions during a patient’s
lifetime. Painful surgical excision is the treatment of choice for BCCs. However, as multiple BCCs continue to evolve, repeated surgical intervention becomes impractical, and therefore, an important consideration in the treatment of Gorlin
syndrome is preventing the development of new BCCs. SGT-610 is intended to prevent new BCC formation in adults with Gorlin syndrome without the accompanying systemic adverse events observed with oral BCC therapies.
Patidegib has been granted Orphan Drug Designation by the FDA and the EMA as well as Breakthrough Therapy Designation by the FDA. Both FDA and EMA have stated that approval may be supported by a
single pivotal Phase 3 study. The Company’s planned Phase 3 study of SGT-610 will include well-defined modifications to an earlier Phase 3 study in which the patidegib arm was found to be as tolerable as the vehicle and the significant adverse
events associated with oral hedgehog inhibitors were not observed. These modifications will include selecting patients positive for the PTCH1 mutation (in contrast to the previous study which included symptomatic patients without testing them for
the mutation), as well as a requirement for a higher minimum number of BCCs at baseline. Sol-Gel’s Phase 3 study is expected to begin in the second half of 2023 with results expected by the end of 2025.
Other than as indicated below, the information in this Form 6-K is hereby incorporated by reference into the Company's Registration Statement on Form S-8 (Registration No. 333-223915) and its
Registration Statement on Form F-3 (Registration No. 333-264190).
Attached hereto is the following exhibit which shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject
to the liabilities of that Section, nor shall it be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act:
