GlobeNewswire Inc | Aug 12, 2021 05:45AM EDT

August 12, 2021

SOUTH SAN FRANCISCO, Calif. and TAIPEI, Taiwan, Aug. 12, 2021 (GLOBE NEWSWIRE) -- TLC, a clinical-stage specialty pharmaceutical company developing novel nanomedicines to target areas of unmet medical need, today announced financial results for the second quarter ended June 30, 2021 and provided a business update.

The second quarter of 2021 was marked mainly by the timely approval of our liposomal amphotericin B product in India and the immediate partnerships for their commercialization and sales in the territory, commented George Yeh, President of TLC. We are grateful to have the ability to be of assistance in this humanitarian crisis brought about by the COVID-19 pandemic by fulfilling an unmet need, and will continue our quest to provide best-in-class treatments in pain management, ophthalmology, oncology, as well as infectious diseases.

Clinical Pipeline Update and Upcoming Milestones

-- All subjects have reached the 24-week timepoint in EXCELLENCE. The Phase III pivotal clinical trial of TLC599 in ~500 subjects is progressing smoothly, with all subject having reached the 24-week timepoint and the majority of whom having received the second injection of either TLC599 or placebo. There remains no safety concerns or serious adverse events related to treatment. The multi-center, randomized, double-blind, active comparator- and placebo-controlled pivotal study is evaluating the efficacy and safety of a single and a repeat dose of TLC599 in patients with knee osteoarthritis across 46 sites in the United States and Australia. -- Pivotal clinical trial of TLC590to kick off soon. Following a fruitful End-of-Phase 2 meeting with the United States Food and Drug Administration (FDA), TLC has accrued additional guidelines on the design parameters for the pivotal clinical trials of TLC590 for post-operative pain and will be kicking off the next trial soon. -- Liposomal amphotericin B receives approval in India. The Central Drugs Standard Control Organization (CDSCO) of India approved the New Drug Application (NDA) of Amphotericin B Liposome for Injection 50mg (known as Ampholipad in Taiwan and AmphoTLC in India). The registration allows for immediate importation per approved usage and indication to aid in the countrys acute shortage of treatments for COVID-19 associated mucormycosis. -- Presented data on advantages of inhalable liposome formulations of antiviral drugs for lung diseases at ISAM. At the 23rd International Society for Aerosols in Medicine (ISAM) Congress, TLCs subsidiary, InspirMed, presented data from pharmacokinetic studies on ISPM21 (inhalable liposomal GS-441524, main plasma metabolite of remdesivir), and ISPM19 (inhalable liposomal hydroxychloroquine) that showed significantly higher concentrations in the lungs than their conventional counterparts, suggesting feasibility of higher dosing without hepatotoxicity or nephrotoxicity as an improvement upon current treatments.

Corporate Highlights

-- Commercialization of liposomal amphotericin B in India. Following the new drug registration, TLC entered non-exclusive partnerships with Zydus Healthcare Limited and Strides Pharma Science Limited to begin immediate distribution of its liposomal amphotericin B product in India. -- Partnership with Endo International plc for the commercialization of a liposomal product. TLC is eligible to receive upfront and subsequent milestone payments as well as a double-digit share of the net profits from product sales in the United States. -- Stock swap and restructuring. Details of the share swap transactions and restructuring with Woods Investment Company, along with a list of frequently asked questions, can be found on the company website (www.tlcbio.com) under Investors/Shareholder Resources/Share Swap. -- Expanded global intellectual property protection to 314 patents, with 165 patents granted and 149 applications worldwide as of June 30, 2021.

Financial Results

Operating revenue for the second quarter of fiscal 2021 was NT$160.2 million (US$5.7 million), a 1,260.2% increase compared to NT$11.8million (US$0.4 million) in the second quarter of fiscal 2020. Operating expenses for the second quarter of fiscal 2021 was NT$251.7million (US$9.0 million), a 6.2% decrease compared to NT$268.4million (US$9.1 million) in the second quarter of fiscal 2020. Net loss for the second quarter of fiscal 2021 was NT$75.5million (US$2.7 million), compared to a loss of NT$242.4million (US$8.2 million) in the second quarter of 2020, or a net loss of NT$0.66 (US$0.02) per share for the second quarter of fiscal 2021, compared to a net loss of NT$3.28 (US$0.11) per share for the second quarter of fiscal 2020.

The Companys cash and cash equivalents were NT$696.7million (US$25.0 million) as of June30, 2021, compared to NT$1,342.7million (US$47.8 million) as of December31, 2020.

Financial Summary

Selected Consolidated Balance Sheet Data

December 31, 2020 June 30, 2021 NT$000 US$000 NT$000 US$000 Cash andcashequivalents $ 1,342,667 $ 47,816 $ 696,737 $ 24,964 and timedepositTotalcurrent 1,431,977 50,997 986,874 35,359 assetsTotal 1,749,461 62,303 1,330,969 47,688 assetsTotalcurrent 348,127 12,398 327,849 11,747 liabilitiesLong-term 469,076 16,705 372,809 13,357 borrowingsTotal 886,134 31,557 775,191 27,775 liabilitiesTotal 863,327 30,746 555,778 19,913 equity

Selected Consolidated Statements of Operations Data

Three-month periods ended June 30, Six-month periods ended June 30, 2020 2021 2020 2021 NT$000 US$000 NT$000 US$000 NT$000 US$000 NT$000 US$000 Operating $ 11,776 $ 400 $ 160,176 $ 5,739 $ 23,750 $ 807 $ 197,794 $ 7,087 revenueOperating expensesGeneral andadministrative (39,487 ) (1,341 ) (31,622 ) (1,133 ) (72,367 ) (2,458 ) (62,669 ) (2,245 )expensesResearch anddevelopment (228,881 ) (7,774 ) (220,087 ) (7,886 ) (420,659 ) (14,289 ) (442,861 ) (15,868 )expensesTotal operating (268,368 ) (9,115 ) (251,709 ) (9,019 ) (493,026 ) (16,747 ) (505,530 ) (18,113 )expensesLoss before (242,089 ) (8,223 ) (75,144 ) (2,692 ) (456,253 ) (15,498 ) (293,142 ) (10,503 )income taxIncome tax (348 ) (12 ) (363 ) (13 ) (769 ) (26 ) (602 ) (22 )expenseNet loss $ (242,437 ) $ (8,235 ) $ (75,507 ) $ (2,705 ) $ (457,022 ) $ (15,524 ) $ (293,744 ) $ (10,525 )Total othercomprehensive $ 1,698 $ 58 $ (13,090 ) $ (469 ) $ (1,808 ) $ (61 ) $ (21,285 ) $ (762 )lossTotalcomprehensive $ (240,739 ) $ (8,177 ) $ (88,597 ) $ (3,174 ) $ (458,830 ) $ (15,585 ) $ (315,029 ) $ (11,287 )lossLoss per share of common stockBasic anddiluted loss per $ (3.28 ) $ (0.11 ) $ (0.66 ) $ (0.02 ) $ (6.18 ) $ (0.21 ) $ (3.05 ) $ (0.11 )share (indollars)

About TLC

TLC 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.

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 and product candidates, including Ampholipad, TLC599, TLC590, ISPM21 and ISPM19, the clinical benefits of TLCs products and product candidates, the timing, scope, progress and outcome of TLCs clinical trials and regulatory communications, the timing, scope, progress and outcome of TLCs collaborations and partnerships, the commercialization of TLCs products, 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, 2020 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