GlobeNewswire Inc | Oct 28, 2020 04:51AM EDT

October 28, 2020

SOUTH SAN FRANCISCO, Calif. and TAIPEI, Taiwan, Oct. 28, 2020 (GLOBE NEWSWIRE) -- TLC (Nasdaq: TLC, TWO: 4152), a clinical-stage specialty pharmaceutical company developing novel nanomedicines to target areas of unmet medical need, today announced financial results for the third quarter ending September 30, 2020, and provided a business update.

As we journey toward the end of 2020, we are excited about the imminent enrollment completion in our EXCELLENCE trial of TLC599 for osteoarthritis pain, commented George Yeh, President of TLC. Moreover, we have made tremendous progress in the advancement of our anti-COVID-19 program, TLC19, which has evolved from an incubated idea to being tested in humans in an extremely short amount of time. I would also like to extend a very warm welcome back to Mr. Tom Bliss, who will serve as our new CBO and lead TLC in its commercialization and licensing efforts.

Clinical Pipeline Update and Upcoming Milestones

-- First patient enrollment in Phase I clinical trial of inhalable anti-COVID-19 program. Following approval from Australias Human Research Ethics Committee (HREC)and TaiwansFood and Drug Administration (TFDA), TLC has promptly enrolled the first patient in the Phase I randomized, vehicle-controlled, blinded study, which will evaluate the safety, tolerability, and pharmacokinetics of single ascending doses of inhaled TLC19 (inhalable liposomal hydroxychloroquine) in healthy volunteers. Data from this trial will serve as a basis for subsequent clinical trials in patients with COVID-19. -- ~80% enrollment complete inEXCELLENCE, 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.EXCELLENCE remains on-track to complete enrollment of all 500 patients before the end of 2020, with topline data expected in late 2021.

Corporate Highlights

-- Appointment of Thomas H. Bliss, Jr., MBA, as Chief Business Officer. Mr. Bliss brings with him ample experience in licensing and business development functions from Amgen, Baxter and Johnson & Johnson, and will take the lead in TLCs global corporate and business development efforts, with a key focus on the United States. -- Acceptance of Marketing Authorization Application (MAA) for Ampholipad in China. The Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted TLCs MAA for Ampholipad, TLCs complex generic of Gileads AmBisome (amphotericin B liposome for injection) for the treatment of systemic fungal infections. AmBisome is currently not available in mainland China, creating a rare opportunity for Ampholipad to become available before the brand drug. -- Presented at several global conferences. The management team of TLC presented the latest company updates at Bairds 2020 Virtual Global Healthcare Conference, HC Wainwright 22nd Annual Global Investment Conference, Cantor Virtual Global Healthcare Conference and Oppenheimer Fall Healthcare Life Sciences & MedTech Summit. -- Expanded global intellectual property protection to 243 patents, with 156 patents granted and 87 applications worldwide as of September 30, 2020.

Financial Results

Operating revenue for the third quarter of fiscal 2020 was NT$66.1 million (US$2.3 million), a 250.9% increase compared to NT$18.8 million (US$0.6 million) in the third quarter of fiscal 2019. Operating expenses for the third quarter of fiscal 2020 was NT$309.7 million (US$10.7 million), a 56.3% increase compared to NT$198.1 million (US$6.4 million) in the third quarter of fiscal 2019. Net loss for the third quarter of fiscal 2020 was NT$233.7 million (US$8.1 million), compared to a loss of NT$178.4 million (US$5.7 million) in the third quarter of 2019, or a net loss of NT$2.78 (US$0.10) per share for the third quarter of fiscal 2020, compared to a net loss of NT$2.80 (US$0.09) per share for the third quarter of fiscal 2019.

The Companys cash and cash equivalents were NT$1,015.1 million (US$35.1 million) as of September 30, 2020, compared to NT$1,023.9 million (US$34.2 million) as of December 31, 2019.

Financial Summary

Selected Consolidated Balance Sheet Data

December 31, 2019 September 30, 2020 NT$000 US$000 NT$000 US$000 Cash andcashequivalents $ 1,023,874 $ 34,232 $ 1,015,093 $ 35,064 and timedepositTotalcurrent 1,095,614 36,631 1,158,516 40,018 assetsTotal 1,385,978 46,339 1,486,068 51,332 assetsTotalcurrent 556,697 18,612 285,411 9,859 liabilitiesLong-term 55,508 1,856 401,710 13,876 borrowingsTotal 664,068 22,202 763,627 26,377 liabilitiesTotal 721,910 24,137 722,441 24,955 equity

Selected Consolidated Statements of Operations Data

Three-month periods ended September 30, Nine-month periods ended September 30, 2019 2020 2019 2020 NT$000 US$000 NT$000 US$000 NT$000 US$000 NT$000 US$000 Operating $ 18,837 $ 607 $ 66,095 $ 2,283 $ 197,194 $ 6,351 $ 89,845 $ 3,104 revenueOperating expensesGeneral andadministrative (40,226 ) (1,296 ) (38,166 ) (1,318 ) (119,129 ) (3,837 ) (110,533 ) (3,818 )expensesResearch anddevelopment (157,901 ) (5,085 ) (271,541 ) (9,380 ) (611,273 ) (19,687 ) (692,200 ) (23,910 )expensesTotal operating (198,127 ) (6,381 ) (309,707 ) (10,698 ) (730,402 ) (23,524 ) (802,733 ) (27,728 )expensesLoss before (178,301 ) (5,742 ) (233,576 ) (8,068 ) (530,331 ) (17,080 ) (689,829 ) (23,828 )income taxIncome tax (124 ) (4 ) (117 ) (4 ) (1,255 ) (40 ) (886 ) (31 )expenseNet loss $ (178,425 ) $ (5,746 ) $ (233,693 ) $ (8,072 ) $ (531,586 ) $ (17,120 ) $ (690,715 ) $ (23,859 )Total othercomprehensive $ (1,675 ) $ (54 ) $ (183 ) $ (6 ) $ (759 ) $ (25 ) $ (1,991 ) $ (69 )lossTotalcomprehensive $ (180,100 ) $ (5,800 ) $ (233,876 ) $ (8,078 ) $ (532,345 ) $ (17,145 ) $ (692,706 ) $ (23,928 )lossLoss per share of common stockBasic anddiluted loss per $ (2.80 ) $ (0.09 ) $ (2.78 ) $ (0.10 ) $ (8.35 ) $ (0.27 ) $ (8.93 ) $ (0.31 )share (indollars)

About TLC

TLC (NASDAQ: TLC, TWO: 4152) is a clinical-stage, specialty pharmaceutical company dedicated to the research and development of novel nanomedicines that maximize the potential of its proprietary lipid-assembled drug delivery platform (LipAD), including BioSeizer sustained release technology and NanoX active drug loading technology, which are versatile in the choice of active pharmaceutical ingredients and scalable in manufacturing. TLC has a diverse, wholly owned portfolio of therapeutics targeting areas of unmet medical need in pain management, ophthalmology, oncology and infectious diseases. TLC is consistently ranked top 5% among all listed companies in Taiwans Corporate Governance Evaluations.

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 TLCs expectations regarding the clinical development of TLCs product candidates, including TLC599 and TLC19, the clinical benefits of TLCs product candidates, the timing, scope, progress and outcome of TLCs clinical trials, including TLC599 and TLC19, how sufficient cash and equivalents will be to fund operations, the anticipated timelines for the release of clinical data and progress of TLCs 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 TLC's annual report on Form 20-F for the year ended December 31, 2019 filed with the U.S. Securities and Exchange Commission (the SEC) as well as subsequent filings with the SEC. All forward-looking statements are based on TLC's expectations and assumptions as of the date of this press release. Actual results may differ materially from these forward-looking statements. Except as required by law, TLC expressly disclaims any responsibility to update any forward-looking statement contained herein, whether as a result of new information, future events or otherwise.

TLC Contact:Dawn ChiCorporate Communicationsdawn@tlcbio.com