TLC Reports First Quarter 2020 Financial Results and Provides Business Update
“The beginning of 2020 saw a pandemic that threatened public health globally and devastated the world economy. At our headquarters in
Clinical Pipeline Update and Upcoming Milestones
- Early completion of patient enrollment in TLC590 Phase II trial for on-track delivery of results mid-2020. The randomized, double-blind, comparator- and placebo-controlled study, which took place across four sites in
the United States, will evaluate the analgesic efficacy and safety of TLC590 for postsurgical pain management following bunionectomy. Enrollment of all 150 patients was well ahead of schedule – before COVID-19 was declared a pandemic – which has allowed for delivery of topline results as scheduled, in mid-2020.
- Patient enrollment continues in EXCELLENCE for TLC599. Despite a slight slowdown in enrollment across 45 sites in
the United Statesand Australiadue to the COVID-19 pandemic, TLCremains confident that all 500 patients will be enrolled within the originally anticipated one-year timeframe. The Phase III, multi-center, randomized, double-blind, placebo- and active comparator- controlled pivotal study will evaluate the efficacy and safety of both a single and a repeated dose of TLC599 for symptomatic knee osteoarthritis. Following the first injection, all patients will be monitored for a total of 52 weeks.
- Upcoming milestones:
• TLC590 Phase II topline data: mid-2020
• EXCELLENCE for TLC599 last patient enrollment: end-2020
• TLC178 clinical update: 3Q 2020
TLCearns highest ranking of Top 5% in Corporate Governance Evaluation amongst all 1,600 Taiwan Stock Exchange Corporationand Taipei Exchange listed companies in the sixth annual evaluation, becoming the only biotech company to have received the elite status since the establishment of the evaluation system.
TLCwas slated to present at HC Wainwright Healthcare Conferencein London, Oppenheimer Healthcare Conferencein New York, and Osteoarthritis Research Society International(OARSI 2020) in Vienna; unfortunately, these events were forced to cancel due to the COVID-19 pandemic. A selected abstract on subgroup analyses of TLC599’s Phase II trial, which was scheduled for presentation at OARSI, has been published in Osteoarthritis and Cartilage (#722).
- Expanded global intellectual property protection to 229 patents spanning 41 countries/territories, with 147 patents granted and 82 applications worldwide as of
March 31, 2020.
Operating revenue for the first quarter of fiscal 2020 was
The Company's cash and cash equivalents were
Selected Consolidated Balance Sheet Data
|Cash and cash equivalents||$||1,023,874||$||34,232||$||680,643||$||22,501|
|Total current assets||1,095,614||36,631||842,395||27,848|
|Total current liabilities||556,697||18,612||517,156||17,096|
Selected Consolidated Statements of Operations Data
|Three-month periods ended
|General and administrative expenses||(40,777||)||(1,321||)||(32,880||)||(1,087||)|
|Research and development expenses||(229,155||)||(7,426||)||(191,778||)||(6,340||)|
|Total operating expenses||(269,932||)||(8,747||)||(224,658||)||(7,427||)|
|Loss before income tax||(111,408||)||(3,610||)||(214,164||)||(7,080||)|
|Income tax expense||(277||)||(9||)||(421||)||(14||)|
|Total other comprehensive income (loss)||$||542||$||17||$||(3,506||)||$||(116||)|
|Total comprehensive loss||$||(111,143||)||$||(3,602||)||$||(218,091||)||$||(7,210||)|
|Loss per share of common stock|
|Basic and diluted loss per share (in dollars)||$||(1.76||)||$||(0.06||)||$||(2.90||)||$||(0.10||)|
Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements contained in this press release include, without limitation, statements regarding TLC’s expectations regarding the clinical development of TLC’s product candidates, including TLC599, TLC590 and TLC178, the clinical benefits of TLC’s product candidates, the timing, scope, progress and outcome of TLC’s clinical trials, the anticipated timelines for the release of clinical data and progress of TLC’s manufacturing capabilities. Words such as "may," "believe," "will," "expect," "plan," "anticipate," "estimate," "intend" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are not guarantees of future performance and involve a number of risks, assumptions, uncertainties and factors, including risks that the outcome of any clinical trial is inherently uncertain and product candidates may prove to be unsafe or ineffective, or may not achieve commercial approval, and delays or disruptions on our business or clinical trials due to the COVID-19 pandemic. Other risks are described in the Risk Factors section of
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