TLC Reports First Quarter of 2019 Financial Results and Provides Business Update
“We started 2019 with strong continued momentum with our clinical programs highlighted by positive end of Phase II meeting with the
Clinical Pipeline Update and Upcoming Milestones
- Positive End-of-Phase II Meeting with
FDAfor TLC599 for knee osteoarthritis. In agreement with the U.S. Food and Drug Administration( FDA), TLC believes its proposed overall design of a single global pivotal Phase III trial would be sufficient to support a New Drug Application submission. Initiation of this trial is expected in mid-2019.
- Presented new data on TLC599 at OARSI 2019. Numerous preclinical studies found TLC599 to have no marked cartilage damage after either single or repeated dosing of TLC599; in contrast, proteoglycan loss in cartilage was observed in current steroid treatments. Further Phase II clinical trial data found TLC599 to have significantly greater reductions in both WOMAC and VAS pain at every scheduled visit through 24 weeks. Rescue pain medication use in the TLC599 group was numerically less at every time point and only 1/5 of the placebo group after 12 weeks.
- Presented high-scoring abstracts on TLC590 for postsurgical pain at ASRA Spring 2019. Preclinical data demonstrated local tolerance of TLC590 in clinically relevant models. The half-life of TLC590 was about 22 times longer than ropivacaine; the maximum serum concentration of TLC590 was only 1/9 of ropivacaine, demonstrating TLC590’s improved tolerance with its BioSeizer® formulation. TLC590 had faster onset and longer duration of analgesic effect than an approved extended release bupivacaine product.
- Reached full enrollment in Part 1 of Phase II trial of TLC590 for postsurgical pain management following bunionectomy. Interim analysis will review the safety, efficacy and pharmacokinetics of three doses of TLC590 and ropivacaine; results are expected in mid-2019.
- Strengthened the management team. Appointed Dr.
George Spencer-Greenas Chief Medical Officer.
- Earned the highest ranking in corporate governance among all 1,554
Taiwan-listed companies. TLC is the only biotech company to have remained in the top 5% of evaluations every year since its Taiwan IPO; this year marks the fifth consecutive year.
- Growing global intellectual property protection with 56 granted patents and 73 applications worldwide as of
March 31, 2019.
First Quarter of 2019 Financial Results
Operating revenue for the first quarter of fiscal 2019 was
The Company's cash and cash equivalents and time deposits with maturity over three months (which are classified as “current financial assets at amortized cost” in the Company’s consolidated financial statements) were
Selected Consolidated Balance Sheet Data
|March 31, 2019|
|Cash and cash equivalents and time deposit||$||1,114,634||$||988,284||$||32,025|
|Total current assets||1,188,695||1,083,621||35,114|
|Total current liabilities||344,288||403,509||13,075|
Selected Consolidated Statements of Operations Data
|Three-month periods ended March 31,|
|General and administrative expenses||(33,909||)||(40,777||)||(1,321||)|
|Research and development expenses||(151,105||)||(229,155||)||(7,426||)|
|Loss before income tax||(166,134||)||(111,408||)||(3,610||)|
|Income tax expense||(169||)||(277||)||(9||)|
|Total other comprehensive income (loss)||$||(1,634||)||$||542||$||17|
|Total comprehensive loss||$||(167,937||)||$||(111,143||)||$||(3,602||)|
|Loss per share of common stock|
|Basic and diluted loss per share (in dollars)||$||(2.99||)||$||(1.76||)||$||(0.06||)|
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. Other risks are described in the Risk Factors section of TLC's prospectus dated
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