Theratechnologies Inc. announced that it will phase down its preclinical oncology research activities. The Company will continue to prioritize its ongoing Phase 1 clinical trial of sudocetaxel zendusortide (TH1902), a novel peptide-drug conjugate, in patients with advanced ovarian cancer. All figures below are in U.S. dollars.

The Company will continue to share accumulated preclinical data, including the presentation of two separate posters at the American Association for Cancer Research (AACR) annual meeting, to be held April 5-9 in San Diego, Calif., one of which features data from new PDCs. Theratechnologies recently announced the initiation of the next cohort of patients in Part 3 of its Phase 1 trial of sudocetaxel zendusortide, in which the first patient has already received treatment at a higher dose. Recruitment has been ramped up at the six trial sites across North America.

To date, more than 40 individuals with various types of cancer have been treated with sudocetaxel zendusortide. The phasing down of research activities is aligned with the Company?s focus on its commercial business and will further optimize organizational cost structure, pursuant to goal of generating positive Adjusted EBITDAi. These changes are expected to result in a restructuring charge of approximately $625,000 in cash charges related to severance and other expenses and approximately $770,000 in non-cash charges.

The company anticipates all charges to be fully taken during 2024. Sudocetaxel zendusortide is a first-of-its-kind sortilin receptor (SORT1)-targeting PDC, and the first compound to emerge from the Company?s broader licensed oncology platform. A new chemical entity, sudocetaxel zendusortide employs a cleavable linker to conjugate (attach) a proprietary peptide to docetaxel, a well-established cytotoxic chemotherapeutic agent used to treat many cancers.

The FDA granted Fast Track designation to sudocetaxel zendusortide as a single agent for the treatment of all sortilin-positive recurrent advanced solid tumors that are refractory to standard therapy. Sudocetaxel zendusortide is currently being evaluated in a Phase 1 clinical trial. Theratechnologies has established the SORT1+ TechnologyTM platform as an engine for the development of PDCs that target SORT1, which is expressed in multiple tumor types.

SORT1 is a ?scavenger? receptor that plays a significant role in protein internalization, sorting, and trafficking. Expression of SORT1 is associated with aggressive disease, poor prognosis, and decreased survival.

It is estimated that SORT1 is expressed in 40% to 90% of endometrial, ovarian, colorectal, triple-negative breast (TNBC), and pancreatic cancers, making this receptor an attractive target for anticancer drug development.