On August 5, 2020 TLC (Nasdaq: TLC, TWO: 4152), a clinical-stage specialty pharmaceutical company developing novel nanomedicines to target areas of unmet medical need, reported financial results for the second quarter ending June 30, 2020, and provided a business update (Press release, Taiwan Liposome Company, AUG 5, 2020, View Source [SID1234562933]).
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"I am happy to report that we have recently reached the halfway mark in patient enrollment in our EXCELLENCE trial and are on schedule to complete enrollment by the end of this year," commented George Yeh, President of TLC. "Other key highlights in the second quarter include positive topline results from the TLC590 trial in bunionectomy, introduction of our inhalable liposomal hydroxychloroquine to potentially treat COVID-19, and a successful round of financing in Taiwan. As TLC is a member of the healthcare industry and based in Taiwan, where there has been fewer than 500 confirmed cases of COVID-19, we are committed to alleviating the global crisis while maintaining focus on the development of our key programs, and we will continue to work closely with relevant parties to ensure their most efficacious advancement."
Clinical Pipeline Update and Upcoming Milestones
50% enrollment complete in EXCELLENCE for TLC599. The Phase III, multi-center, randomized, double-blind, placebo- and active comparator- controlled pivotal study evaluating the efficacy and safety of both a single and a repeated dose of TLC599 for symptomatic knee osteoarthritis has enrolled half of all 500 patients. Some patients have proceeded to receive a second injection at week 24. EXCELLENCE remains on-track to complete enrollment before the end of 2020, with topline data expected in late 2021.
Subgroup analyses of TLC599 Phase II data confirm robustness of response through 24 weeks. The pattern of responsiveness seen in the overall population, with greater reductions in pain by TLC599 than with placebo, sustaining from Week 1 to Week 24, was remarkably consistent between the subgroups, which were categorized based on gender, age, Kellgren-Lawrence grade, unilateral or bilateral knee pain, baseline Visual Analog scale pain scores and baseline Western Ontario and McMaster Universities Index (WOMAC) pain scores. These findings were accepted as an abstract at Osteoarthritis Research Society International (OARSI) 2020 and published in the Osteoarthritis and Cartilage journal (#722).
Positive results for TLC590 Phase II trial for postsurgical pain following bunionectomy. In this randomized, double-blind, placebo- and comparator-controlled study of 150 patients, TLC590 demonstrated greater reductions in pain than both placebo and bupivacaine through 168 hours. TLC590 achieved statistically significant pain relief over placebo and bupivacaine from 0-12, 0-24, 0-36 and 0-48 hours as measured by area under the curve on the numerical pain rating scale. TLC590 significantly delayed the time to first opioid use; total opioid consumption of TLC590 was less than placebo and bupivacaine at every time point through 168 hours. TLC590 was well-tolerated, with a safety profile comparable to bupivacaine and placebo.
Introduction of inhalable liposomal hydroxychloroquine (HCQ) to potentially treat COVID-19. A manuscript pre-print that has been made publicly available found that TLC’s sustained release, liposomal formulation of HCQ, with targeted delivery of a tiny but therapeutic dose directly to the lung, can dramatically reduce systemic and cardiac adverse events, which was cause for termination in several global clinical trials involving orally administered – and extremely high doses – of HCQ.
Corporate Highlights
Completed US$23 million financing along with a US$12 million venture financing from Cathay Bank, which, along with existing cash and equivalents, we expect will provide sufficient funding for operations into EXCELLENCE’s data readout.
Scheduled to present at several conferences in September. TLC will be virtually attending and presenting at Baird’s 2020 Virtual Global Healthcare Conference (September 9-10), HC Wainwright 22nd Annual Global Investment Conference (September 14-16), Cantor Virtual Global Healthcare Conference (September 15-17) and Oppenheimer Fall Healthcare Life Sciences & MedTech Summit (September 21-23). Details on presentations times will follow closer to the dates.
Ampholipad receives approval for scale-up production. Production of TLC’s AmBisome generic can now exceed a million vials a year, a capacity capable of meeting global demands.
Expanded global intellectual property protection to 234 patents spanning 41 countries/territories, with 149 patents granted and 85 applications worldwide as of June 30, 2020.
Financial Results
Operating revenue for the second quarter of fiscal 2020 was NT$11.8 million (US$0.4 million), a 42.7% decrease compared to NT$20.6 million (US$0.7 million) in the second quarter of fiscal 2019. Operating expenses for the second quarter of fiscal 2020 was NT$268.4 million (US$9.1 million), a 2.3% increase compared to NT$262.3 million (US$8.5 million) in the second quarter of fiscal 2019. Net loss for the second quarter of fiscal 2020 was NT$242.4 million (US$8.2 million), compared to net loss of NT$241.5 million (US$7.8 million) in the second quarter of fiscal 2019, or a net loss of NT$3.28 (US$0.11) per share for the second quarter of fiscal 2020, compared to a net loss of NT$3.79 (US$0.12) per share for the second quarter of fiscal 2019.
The Company’s cash and cash equivalents were NT$1,234.8 million (US$41.9 million) as of June 30, 2020, compared to NT$1,023.9 million (US$34.2 million) as of December 31, 2019.