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Taiwan Liposome Company, Ltd. (TLC)

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Previous Close5.3800
Open5.5200
Bid0.0000 x 900
Ask0.0000 x 1200
Day's Range4.9700 - 5.5200
52 Week Range4.0700 - 12.6500
Volume6,746
Avg. Volume17,952
Market Cap214.821M
Beta (5Y Monthly)N/A
PE Ratio (TTM)N/A
EPS (TTM)-0.8480
Earnings DateN/A
Forward Dividend & YieldN/A (N/A)
Ex-Dividend DateN/A
1y Target Est12.00
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  • TLC Reports First Quarter 2021 Financial Results  and Provides Business Update
    GlobeNewswire

    TLC Reports First Quarter 2021 Financial Results and Provides Business Update

    SOUTH SAN FRANCISCO, Calif. and TAIPEI, Taiwan, May 14, 2021 (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 first quarter ended March 31, 2021 and provided a business update. “The first quarter of 2021 is marked by continual progress in our lead programs, TLC599 and TLC590, as well as the global commercialization of Ampholipad, for which we look forward to announcing the details when they are finalized,” commented George Yeh, President of TLC. “We are happy to announce that we have once again made the top 5% ranking in Taiwan’s corporate governance evaluation. Being the only biotech company to have achieved this honor seven years in a row, we think this is an incredible feat and a representation of the company’s dedication to the principles of transparency, accountability, and security.” Clinical Pipeline Update and Upcoming Milestones Continuous excellent progress in EXCELLENCE, the Phase III pivotal clinical trial of TLC599 in ~500 patients with symptomatic knee osteoarthritis. Over 440 patients have reached the 24-week timepoint, of whom a majority have received the second injection of either TLC599 or placebo. There has been 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, as well as a repeat, dose of TLC599 in patients with knee OA across 46 sites in the United States and Australia.Imminent End-of-Phase 2 meeting with the FDA on TLC590 for postsurgical pain. The United States Food and Drug Administration (FDA) has scheduled an End-of-Phase 2 meeting with TLC in June to discuss the development plan for TLC590. With the meeting, TLC hopes to obtain FDA’s input and reach an agreement on the design parameters of the proposed pivotal clinical studies that will be used to support the TLC590 NDA application.Subsidiary InspirMed to present potential advantages of ISPM21 and ISPM19 in treating COVID-19 at 23rd International Society for Aerosols in Medicine (ISAM) Congress, in a poster titled “A Strategy to Treat COVID-19 with Targeted Delivery of Inhalable Liposomal Antiviral Drugs”, which will be posted both on the website (www.isam.org) and printed for display at the Boise Conference Center for live presentation in Boise, Idaho, USA, on May 22-26, 2021. Corporate Highlights Once again ranked Top 5% in Corporate Governance Evaluation amongst all Taiwan Stock Exchange Corporation (TWSE) and Taipei Exchange (TPEx) listed companies, marking the seventh consecutive year TLC has won the prestigious status. TLC was also ranked in the Top 5% in the newly added, non-industry-specific, Small and Medium-Sized Enterprises (SMEs) category (TWD 5-10 billion market value), winning praise from TWSE and TPEx for being a benchmark for all SMEs.Partnership discussions for Ampholipad™ advancing swimmingly. Strategic partnerships for the complex generic drug in several territories are nearing conclusion. Details of the partnerships are expected to be finalized and announced shortly.US$20 million additional financing. Cathay Bank has issued a term sheet and agrees to provide additional financing amounting to US$20 million if conditions are fulfilled.Presented the latest updates at investor conferences, including HC Wainwright & Co Global Life Sciences Conference (March 9-10, 2021) and Oppenheimer 31st Annual Healthcare Conference (March 16-17, 2021).Expanded global intellectual property protection to 299 patents, with 162 patents granted and 137 applications worldwide as of March 31, 2021. First Quarter 2021 Financial Results Operating revenue for the first quarter 2021 was NT$37.6 million (US$1.3 million), a 214.2% increase compared to NT$12.0 million (US$0.4 million) in the first quarter 2020. Operating expenses for the first quarter 2021 was NT$253.8 million (US$8.9 million), an 13.0% increase compared to NT$224.7 million (US$7.4 million) in the first quarter 2020. Net loss for the first quarter 2021 was NT$218.2 million (US$7.7 million), compared to a loss of NT$214.6 million (US$7.1 million) in the first quarter 2020, or a net loss of NT$2.39 (US$0.08) per share for the first quarter 2021, compared to a net loss of NT$2.90 (US$0.10) per share for the first quarter 2020. The Company’s cash and cash equivalents were NT$1,080.0 million (US$37.9 million) as of March 31, 2021, compared to NT$1,342.7 million (US$47.8 million) as of December 31, 2020. Financial Summary Selected Consolidated Balance Sheet Data December 31, 2020 March 31, 2021 NT$000 US$000 NT$000 US$000 Cash and cash equivalents $1,342,667 $47,816 $1,080,009 $37,922 Total current assets 1,431,977 50,997 1,173,607 41,208 Total assets 1,749,461 62,303 1,509,396 52,998 Total current liabilities 348,127 12,398 378,463 13,289 Long-term borrowings 469,076 16,705 421,589 14,803 Total liabilities 886,134 31,557 868,762 30,504 Total equity 863,327 30,746 640,634 22,494 Selected Consolidated Statements of Operations Data Three-month periods ended March 31, 2020 2021 NT$000 US$000 NT$000 US$000 Operating revenue $11,974 $396 $37,618 $1,321 Operating expenses General and administrative expenses (32,880) (1,087) (31,047) (1,090)Research and development expenses (191,778) (6,340) (222,774) (7,822)Total operating expenses (224,658) (7,427) (253,821) (8,912)Loss before income tax (214,164) (7,080) (217,998) (7,655)Income tax expense (421) (14) (239) (8)Net loss $(214,585) $(7,094) $(218,237) $(7,663)Total other comprehensive loss $(3,506) $(116) $(8,195) $(288)Total comprehensive loss $(218,091) $(7,210) $(226,432) $(7,951)Loss per share of common stock Basic and diluted loss per share (in dollars) $(2.90) $(0.10) $(2.39) $(0.08) 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 in the top 5% among all listed companies in Taiwan’s 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 TLC’s expectations regarding the clinical development of TLC’s product and product candidates, including Ampholipad, TLC599, TLC590 and TLC19, the clinical benefits of TLC’s products and product candidates, the timing, scope, progress and outcome of TLC’s clinical trials and regulatory communications, the timing, scope, progress and outcome of TLC’s collaborations and partnerships, the commercialization of Ampholipad, how sufficient cash and equivalents will be to fund operations, 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, 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. CONTACT: TLC Contact Dawn Chi Corporate Communications dawn@tlcbio.com

  • TLC Earns Highest Ranking in Corporate Governance Evaluation Seven Years Running
    GlobeNewswire

    TLC Earns Highest Ranking in Corporate Governance Evaluation Seven Years Running

    Praised as benchmark for small and medium-sized enterprisesSOUTH SAN FRANCISCO, Calif. and TAIPEI, Taiwan, May 03, 2021 (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 that it once again ranks in the Top 5% in Corporate Governance Evaluation amongst all Taiwan Stock Exchange Corporation (TWSE) and Taipei Exchange (TPEx) listed companies. This marks the seventh consecutive year TLC has won the prestigious status since the establishment of the evaluation system in 2015, and TLC remains the only biotech company to have gained such an honor. In addition, TLC also ranks in the Top 5% in the newly added, non-industry-specific, Small and Medium-Sized Enterprises (SMEs) category (TWD 5-10 billion market value) with 5 other TPEx-listed companies. The 7th Corporate Governance Evaluation indicators and evaluation results can be found on the website of Corporate Governance Center at https://cgc.twse.com.tw/evaluationCorp/listEn and the Securities and Futures Institute website (https://www.sfi.org.tw/cga/cga1), with links to the Market Observation Post System (https://mops.twse.com.tw/mops/web/index) for convenient access by investors. As customary, TWSE and TPEx will hold an award ceremony in early June to honor the Top 5% companies. This year, in accordance with the “Corporate Governance 3.0 - Sustainable Development Roadmap” and to encourage corporate governance among SMEs, the exchanges will also publicly praise the Top 5% companies with market value of TWD 5 to 10 billion, of which there are 7 from TWSE and 6 from TPEx, including TLC. According TWSE and TPEx, these 13 companies serve as a benchmark for all SMEs, and they strongly recommend that all companies strive for the same level of achievement in corporate governance. The 7th Corporate Governance Evaluation included 905 TWSE- and 712 TPEx-listed companies. According to the evaluation scores, the companies are divided into seven groups of the top 5%, 6% to 20%, 21% to 35%, 36% to 50%, 51% to 65%, 66% to 80%, and 81% to 100%, respectively. The evaluation results for the TWSE- and TPEx-listed companies are announced separately. Among the 1,617 companies, TLC is the only biotech company to have remained in the Top 5% since the establishment of the evaluation system, once again solidifying its status as a benchmark in its sector. 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 in the top 5% among all listed companies in Taiwan’s Corporate Governance Evaluations. CONTACT: TLC Contact: Dawn Chi Corporate Communications dawn@tlcbio.com

  • InspirMed to Present at the 23rd International Society for Aerosols in Medicine (ISAM) Congress
    GlobeNewswire

    InspirMed to Present at the 23rd International Society for Aerosols in Medicine (ISAM) Congress

    SOUTH SAN FRANCISCO, Calif. and TAIPEI, Taiwan, April 26, 2021 (GLOBE NEWSWIRE) -- InspirMed Inc., a subsidiary of TLC (Nasdaq: TLC, TWO: 4152) that specializes in the development of inhalable liposome formulation programs, announced today that a late-breaking abstract describing the potential advantages of ISPM21 and ISPM19 has been accepted by the scientific committee for poster presentation at the 23rd International Society for Aerosols in Medicine (ISAM) Congress. The poster, titled “A Strategy to Treat COVID-19 with Targeted Delivery of Inhalable Liposomal Antiviral Drugs”, has a poster number of 072 (New Devices and Emerging Therapies) and will be posted both on the website (www.isam.org) with an opportunity for a short oral presentation and printed for display at the Boise Conference Center for live presentation in Boise, Idaho, USA, on May 22-26, 2021. ISAM Congress will gather hundreds of attendees including clinicians, respiratory health care professionals, critical care professionals, aerosol scientists and engineers, formulations scientists, and product development and regulatory experts at one of the world’s largest pulmonary drug delivery and respiratory health conferences. The objective of the Congress is to foster scientific discussions around the current state-of-the-art for aerosols in medicine. TLC previously presented an inhalable liposomal nintedanib for enhanced treatment of pulmonary diseases at the 22nd ISAM Congress in Switzerland. The link to the abstract (N-003) for the poster presentation can be found on page A-13 under the New Devices and Emerging Therapies section of the Journal of Aerosol Medicine and Pulmonary Drug Delivery (https://www.liebertpub.com/doi/pdf/10.1089/jamp.2019.ab02.abstracts). About ISPM21 ISPM21 is a proprietary inhalable liposome formulation of GS-441524, the active ingredient that reaches the lungs following administration of remdesivir. Originally indicated for the treatment of hepatitis, remdesivir has shown efficacy in inhibiting viral replication of the SARS-CoV-2 virus that causes COVID-19 and is approved by the US Food & Drug Administration (FDA) for the treatment of COVID-19 requiring hospitalization. GS-441524’s favorable chemical properties – low molecular weight, greater hydrophilicity, greater localization to AT1/2 cells and ability to cross the blood-brain-barrier – make it a promising candidate as a therapeutic or prophylactic agent for COVID-19. However, the low oral bioavailability of GS-441524 means an extremely high oral dose would be required to achieve therapeutic levels. By encapsulating GS-441524 in an inhalable liposome formulation (ISPM21), there is no need for the complex excipient cyclodextrin, thus potentially eliminating nephrotoxicity, and targeted delivery by inhalation of liposomes enables increased availability and prolonged exposure of the active drug in the lungs. About ISPM19 ISPM19, formerly known as TLC19, is a proprietary inhalable liposome formulation of hydroxychloroquine (HCQ). HCQ has shown potential in prophylaxis and/or treatment for COVID-19 in in vitro and preliminary clinical trial studies, but orally administered HCQ cannot reach therapeutic levels due to its dose-limiting toxicities. ISPM19 utilizes ~1% of the highest oral HCQ dose tested and delivers the drug directly to the airways and lungs, potentially avoiding systemic toxicities associated with oral HCQ while providing a sustained effective concentration at the primary site of infection. ISPM19 is designed to be cost-effective, easily accessible and can be self-administered with a portable nebulizer. A Phase 1 randomized, vehicle-controlled, blinded study to assess the safety, tolerability, and pharmacokinetics of ascending doses of inhaled ISPM19 in healthy volunteer subjects is ongoing. About InspirMed InspirMed is a newly established subsidiary of TLC specializing in the development of inhalable liposome formulation programs for severe acute and chronic pulmonary diseases. 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. CONTACT: Contact Dawn Chi Corporate Communications dawn@tlcbio.com