On July 30, 2019 TLC (Nasdaq: TLC, TWO: 4152), a clinical-stage specialty pharmaceutical company dedicated to the development and commercialization of novel nanomedicines designed to target areas of unmet medical need in osteoarthritis, pain management, ophthalmology and oncology, reported financial results for the second quarter ended June 30, 2019, and provided a business update (Press release, Taiwan Liposome Company, JUL 30, 2019, View Source [SID1234537903]).

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"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 U.S. Food and Drug Administration that indicated a single pivotal Phase III trial for TLC599, our lead product candidate, in knee osteoarthritis would be sufficient for a potential submission of a new drug application. On the corporate front, we partnered with 3SBio and Birdie Biopharmaceuticals, which further strengthened and validated the value and versatility of our NanoX technology platform," said TLC President George Yeh. "The second half of 2019 will continue to be an exciting year filled with pivotal moments, with the anticipated commencement of TLC599’s Phase III clinical trial and the determination of the maximum tolerated dose for TLC178 in adults."

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) (Free ESMO Whitepaper) 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 ESMO (Free ESMO Whitepaper) 2019 World Congress in Barcelona, SpainSeptember 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.
Corporate Highlights

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 NT$20.6 million (US$0.7 million), a 32.2% increase compared to NT$15.6 million in the second quarter of fiscal 2018. Operating expenses for the second quarter of fiscal 2019 was NT$262.3 million (US$8.5 million), a 5.1% increase compared to NT$249.6 million in the second quarter of fiscal 2018. Net loss for the second quarter of fiscal 2019 was NT$241.5 million (US$7.8 million), compared to a loss of NT$232.6 million in the second quarter of 2018, or a net loss of NT$3.79(US$0.12) per share for the second quarter of fiscal 2019, compared to a net loss of NT$4.18 per share for the second quarter of fiscal 2018.

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 NT$685.1 million (US$22.1 million) as of June 30, 2019, compared to NT$1,114.6 million as of December 31, 2018.