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Corporate Restructuring
Under the restructuring program, staff will be reduced by 40%, from 43 to 26 active employees, with immediate effect. The company will discontinue its discovery research activities to focus on clinical development and seek a partner for further development of its preclinical STING agonist program. Further cost savings will be achieved through operational efficiencies.
These savings are expected to reduce cash outlay from approximately CDN$10 million per quarter in the first half of 2019 to approximately CDN$4-7 million per quarter in 2020. The company currently expects to have cash and cash equivalents of approximately CDN$36 million at the end of the third quarter of 2019.
CD47 Program Update
The ongoing dose escalation trial of intravenously administered TTI-621 is on track and remains the key strategic priority going forward. The 0.7 mg/kg dose cohort in this study has been completed and no dose-limiting toxicities have been identified. Enrollment in the 1.0 mg/kg cohort is beginning. The goal of this trial is to identify a recommended phase 2 dose to enable additional studies in both cutaneous T-cell lymphoma (CTCL) and other hematologic malignancy indications with high unmet medical need.
In September, the company met with the U.S. Food and Drug Administration (FDA) which provided guidance on the intratumoral use of TTI-621 for the treatment of early-stage CTCL, including aspects of a potential registration study. The company is evaluating this guidance and considering options going forward, given current resource constraints. The ongoing phase 1b intratumoral trial, which provided the data set for the FDA interaction and informed the guidance, will now be closed.
