Exhibit 99.1
TLC Reports Fiscal Year End 2019 Financial Results
and Provides Business Update
SOUTH SAN FRANCISCO, CA and TAIPEI, Taiwan– February 11, 2020 –TLC (Nasdaq: TLC, TWO: 4152), a clinical-stage specialty pharmaceutical company developing novel nanomedicines to target areas of unmet medical need in pain management, ophthalmology and oncology, today announced financial results for the fiscal year ended December 31, 2019, and provided a business update.
“We saw a monumental year for TLC in 2019, marked not only by tremendous clinical and manufacturing advancements in both our programs in pain management – TLC599 and TLC590, but also by new business development agreements, addition of internationally experienced personnel to the management team, and presentation and publication of impressive data at numerous investor conferences as well as prestigious scientific conventions,” said George Yeh, President of TLC. “With this continual momentum, we look forward to achieving more milestones in 2020, including the completion of patient enrollment in the EXCELLENCE trial and data readout from the TLC590 Phase II trial, both of which will bring us closer to the goal of mitigating the proliferation of highly addictive opioids with the availability of ournon-opioid alternatives.”
Clinical Pipeline Update and Upcoming Milestones
| • | | Commencement of patient enrollment in EXCELLENCE trial evaluating single and repeated administrations ofTLC599 for knee osteoarthritis pain.The Phase III pivotal study, which enrolled its first patient in November 2019, will dose about 500 patients at a 2:1:1 ratio with TLC599, dexamethasone or placebo across 45 sites in the United States and Australia. At Week 24, patients can receive a second blinded injection of TLC599 or placebo. Primary endpoint is the magnitude of pain relief by WOMAC Pain score versus placebo at Week 16 and Week 40. Patient enrollment is expected to take about one year, and all patients will be followed for 52 weeks. |
| • | | Commencement of patient dosing in Part 2 of Phase II trial evaluating the analgesic efficacy ofTLC590 following bunionectomy.With the first batch of patients dosed in January 2020, a total of about 150 patients will receive TLC590, bupivacaine or normal saline placebo at a ratio of 1:1:1 at the end of their bunion removal surgery. Primary endpoint is area under the curve (AUC) from 0 to 72 hours on the numerical pain rating scale. |
Corporate Highlights
| • | | Completed US$27.3 million financing. The Company completed a cash capital offering of ordinary (common) shares in Taiwan in October 2019. The offering consisted of 10,200,000 new common shares issued at a price of NT$82 per common share for gross proceeds of NT$836.4 million (~US$27.3 million). |