TLC Reports Second Quarter 2019 Financial Results and Provides Business Update
“In the first half of 2019, we made significant progress in our clinical pipeline with encouraging data from Part 1 of a Phase II study of TLC590 for post-surgical pain management following bunionectomy and receiving positive feedback and guidance from the
Clinical Pipeline Update and Upcoming Milestones
- Presented new data on possibility forrepeat dosing of TLC599 for knee osteoarthritis pain at EULAR
European Congress of Rheumatology2019. Pharmacokinetic and toxicokinetic data showed TLC599 to have a long-lasting release profile in dog joints up to 120 days. The lack of dexamethasone phosphate accumulation in dog plasma supports the possibility of repeat dosing in humans. System exposure following TLC599 injection was minimal and generally dose proportional.
- Established dose linearity and relative bioavailability of TLC590 in Part 1 of TLC590 Phase II clinical trial for postsurgical pain management following bunionectomy. Part 1, which randomized 50 patients in a ratio of 1:1:1:1 to receive 152, 190, 228mg TLC590 or 50mg ropivacaine, found that all three doses of TLC590 were well tolerated, with a safety profile comparable to ropivacaine. Most treatment-emergent adverse events (AEs) were mild to moderate, with no treatment-related or serious AEs or AEs leading to withdrawal. TLC590 228mg was chosen to move forward based on maximum feasible volume for bunionectomy. In Part 2, safety and efficacy of TLC590 will be analyzed against bupivacaine as a relevant active comparator as well as placebo.
- Abstracts accepted for presentation at the
American Society of Anesthesiologists(ASA) Annual Meeting and European Society for Medical Oncology (ESMO) Congress. An abstract on the safety, pharmacokinetics, and efficacy of TLC590 for postsurgical pain management following inguinal hernia repair has been accepted and will be presented at ASA Anesthesiology 2019 Annual Meeting in Orlando, FL, October 19-23, 2019. An abstract on the in vivo efficacy and enhanced tumor accumulation of TLC178 (liposomal vinorelbine) has been accepted and will be presented at ESMO2019 World Congressin Barcelona, Spain September 27-October 1, 2019.
- Imminent initiation of TLC599’s Phase III pivotal trial, which will evaluate not only a single injection, but also the safety and efficacy of repeated doses of TLC590 in approximately 500 patients with knee osteoarthritis.
- Advancement towards maximum tolerated dose (MTD) in TLC178 in adults. The 3+3 dose escalation study of TLC178 in adults, with dosing regimen of every four weeks, is approaching MTD. Once the MTD for a dosing regimen of every two weeks is determined, sufficient data will be available to commence clinical trials in the pediatric setting.
- Formed exclusive partnership with 3SBio to commercialize two NanoX products in
China. TLC will utilize its commercial-scale manufacturing capabilities to supply the two liposome products for 3SBio to commercialize in mainland China. TLC has received an upfront payment and is eligible to receive subsequent regulatory and sales milestone payments totaling US$25 million, plus a share of the potential profits from product sales.
- Further extended the application of NanoX by developing an immunotherapy product in collaboration with
Birdie Biopharmaceuticals Inc.(“Birdie”), where Birdie engaged TLC in the development and manufacturing of a liposomal formulated dual agonist product against toll-like receptors 7 and 8 (TLR7/8). TLC has received an upfront payment and is eligible to receive potential milestone payments totaling US$49 million, plus royalties based on net sales.
- Grew global intellectual property protection, with 59 granted patents and 75 applications worldwide as of
June 30, 2019.
Second Quarter 2019 Financial Results
Operating revenue for the second quarter of fiscal 2019 was
The Company's cash and cash equivalents and time deposits with maturity over three months (which are classified as “current financial assets at amortized cost” in the Company’s consolidated financial statements) were
Selected Consolidated Balance Sheet Data
|December 31, 2018||June 30, 2019|
|Cash and cash equivalents and time deposit||$||1,114,634||$||685,108||$||22,093|
|Total current assets||1,188,695||767,133||24,738|
|Total current liabilities||344,288||606,616||19,562|
Selected Consolidated Statements of Operations Data
|Three-month periods ended June 30,||Six-month periods ended June 30,|
|General and administrative expenses||(33,853||)||(38,126||)||(1,230||)||(67,762||)||(78,903||)||(2,544||)|
|Research and development expenses||(215,737||)||(224,217||)||(7,230||)||(366,842||)||(453,372||)||(14,620||)|
|Loss before income tax||(232,327||)||(240,622||)||(7,759||)||(398,461||)||(352,030||)||(11,352||)|
|Income tax expense||(242||)||(854||)||(28||)||(411||)||(1,131||)||(36||)|
|Total other comprehensive income||$||2,051||$||374||$||12||$||417||$||916||$||29|
|Total comprehensive loss||$||(230,518||)||$||(241,102||)||$||(7,775||)||$||(398,455||)||$||(352,245||)||$||(11,359||)|
|Loss per share of common stock|
|Basic and diluted loss per share (in dollars)||$||(4.18||)||$||(3.79||)||$||(0.12||)||$||(7.16||)||$||(5.55||)||$||(0.18||)|
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 annual report on Form 20-F for the year ended
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