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TLC Reports Third Quarter 2020 Financial Results and Provides Business Update

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 Iclinicaltrial ofinhalableanti-COVID-19program. Following approval from Australia’s Human Research Ethics Committee (HREC) and Taiwan’s Food 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 TLC’s 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 TLC’s MAA for Ampholipad™, TLC’s complex generic of Gilead’s 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.
  • Presentedat severalglobalconferences. The management team of TLC presented the latest company updates at Baird’s 2020 Virtual Global Healthcare Conference, HC Wainwright 22 nd 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 Company’s 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 and cash equivalents and time deposit $ 1,023,874 $ 34,232 $ 1,015,093 $ 35,064
Total current assets 1,095,614 36,631 1,158,516 40,018
Total assets 1,385,978 46,339 1,486,068 51,332
Total current liabilities 556,697 18,612 285,411 9,859
Long-term borrowings 55,508 1,856 401,710 13,876
Total liabilities 664,068 22,202 763,627 26,377
Total equity 721,910 24,137 722,441 24,955

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 revenue $ 18,837 $ 607 $ 66,095 $ 2,283 $ 197,194 $ 6,351 $ 89,845 $ 3,104
Operating expenses
General and administrative expenses (40,226 ) (1,296 ) (38,166 ) (1,318 ) (119,129 ) (3,837 ) (110,533 ) (3,818 )
Research and development expenses (157,901 ) (5,085 ) (271,541 ) (9,380 ) (611,273 ) (19,687 ) (692,200 ) (23,910 )
Total operating expenses (198,127 ) (6,381 ) (309,707 ) (10,698 ) (730,402 ) (23,524 ) (802,733 ) (27,728 )
Loss before income tax (178,301 ) (5,742 ) (233,576 ) (8,068 ) (530,331 ) (17,080 ) (689,829 ) (23,828 )
Income tax expense (124 ) (4 ) (117 ) (4 ) (1,255 ) (40 ) (886 ) (31 )
Net loss $ (178,425 ) $ (5,746 ) $ (233,693 ) $ (8,072 ) $ (531,586 ) $ (17,120 ) $ (690,715 ) $ (23,859 )
Total other comprehensive loss $ (1,675 ) $ (54 ) $ (183 ) $ (6 ) $ (759 ) $ (25 ) $ (1,991 ) $ (69 )
Total comprehensive loss $ (180,100 ) $ (5,800 ) $ (233,876 ) $ (8,078 ) $ (532,345 ) $ (17,145 ) $ (692,706 ) $ (23,928 )
Loss per share of common stock
Basic and diluted loss per share (in dollars) $ (2.80 ) $ (0.09 ) $ (2.78 ) $ (0.10 ) $ (8.35 ) $ (0.27 ) $ (8.93 ) $ (0.31 )

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 Taiwan’s Corporate Governance Evaluations.

Cautionary Note on Forward-Looking Statements

SOUTH SAN FRANCISCO, Calif. and TAIPEI, Taiwan, Oct. 28, 2020 (GLOBE NEWSWIRE) — TLC (Nasdaq: TLC, TWO: 4152), a clinical-stage specialty pharmaceutical…

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