Verrica Licenses LTX-315 for Dermatologic Oncology Indications

Verrica Pharmaceuticals has entered into an exclusive worldwide license agreement with Lytix Biopharma AS to develop and commercialize LTX-315 for dermatologic oncology indications. Verrica intends to focus initially on basal cell and squamous cell carcinomas as the lead indications for development. LTX-315 is a first-in-class oncolytic peptide that is injected directly into a tumor to induce immunogenic cell death. The compound has demonstrated positive tumor-specific immune cell responses in multi-indication Phase I/II oncology trials.

“This is an important milestone in the broadening of Verrica’s strategy to bring breakthrough treatments for skin diseases to patients and physicians, as dermatologic cancers are highly prevalent and many patients suffer from them,” said Dr. Gary Goldenberg, Verrica’s Chief Medical Officer. “Innovation in dermatology is one of the primary drivers that prompted me to recently join Verrica, and LTX-315’s unique mechanism of action is clearly an innovative approach to potentially provide significant improvement over invasive surgery. LTX-315 has the potential to revolutionize one of the most common disease states in dermatology – non-melanoma skin cancers. We look forward to leveraging Verrica’s depth of clinical development experience to develop this innovative asset for the potential benefit of patients. We intend to submit an IND in the United States for LTX-315 during the first half of 2021 and commence clinical development thereafter.”

“Skin cancer is the most common cancer in the U.S., with 5 million diagnoses of basal and squamous cell carcinomas each year,” said Darrell Rigel, MD, Clinical Professor of Dermatology at NYU. “Patients are typically treated with surgery, which can result in damage to healthy tissue, pain, and permanent scarring. LTX-315 is a clinical-stage, non-surgical immunotherapy product candidate that directly targets cancerous skin cells, with the potential to transform the treatment of skin cancer by offering a therapeutic alternative to surgery."

“We are pleased to enter into this collaboration with Verrica, which has significant expertise within the field of dermatology,” said Øystein Rekdal, Lytix`s CEO. “Our lead drug candidate, LTX-315, has shown very promising efficacy and safety signals in cancer patients during Phase I/II studies and we are excited that this partnership with Verrica will expand the applications for LTX-315.”

Under the terms of the agreement, Lytix will be entitled to receive an upfront payment, contingent regulatory milestones based on achievement of specified development goals, and sales milestones, with aggregate payments of up to $113.5 million, in addition to tiered royalties based on worldwide annual sales. The agreed upon royalty rates start in the low double digits and increase to the mid-teens based on net sales achieved.

Verrica is solely responsible for the development, regulatory filings, and commercialization of LTX-315 in dermatology, while Lytix is responsible for manufacturing the active pharmaceutical ingredient. The license includes worldwide rights for Verrica to develop and commercialize LTX-315 for all malignant and pre-malignant dermatological indications, except for metastatic melanoma and metastatic Merkel cell carcinoma.

The Company reaffirms its belief that its existing cash, cash equivalents, and marketable securities will be sufficient to support planned operations, inclusive of this agreement with Lytix and LTX-315 development activities, at least through the fourth quarter of 2021.