TLC Reports Fiscal Year End 2020 Financial Results and Provides Business Update
“In the tumultuous year that was 2020, we were fortunate enough to have achieved early patient enrollment in the Phase II clinical trial of our postsurgical pain program before COVID-19 began its spread to the United States,” commented
Clinical Pipeline Update and Upcoming Milestones
- Following the completion of patient enrollment, 500 patients have received their first injection of TLC599, dexamethasone sodium phosphate or normal saline in EXCELLENCE, the Phase III pivotal clinical trial of TLC599 for symptomatic knee osteoarthritis. Majority of the patients who are due for Week 24 have received a second injection of either TLC599 or placebo. 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 41 sites in
the United Statesand five sites in Australia.
- Preparations for pivotal studies of TLC590 for postsurgical pain management are underway, with planned End-of-Phase-2 meetings to occur in 2021 with the
United States Food and Drug Administration(FDA) on the design of the clinical trials and production preparations.
- Published peer-reviewed manuscript in
Clinical and Translational Science Journal, presenting the feasibility of applying TLC’s inhalable liposome technology to drugs for direct delivery to – and extended release in – the lungs, as endorsed by key opinion leaders in respiratory therapies. A Phase I randomized, vehicle-controlled, blinded study evaluating the safety, tolerability, and pharmacokinetics of TLC19 (inhalable liposomal hydroxychloroquine) in healthy volunteers is ongoing.
US$15 millionfinancing for InspirMed™ Inc., a newly established subsidiary that specializes in the development of inhalable liposome formulation programs, such as TLC19, for severe acute and chronic pulmonary diseases. The strategic move to partition lung disease programs from TLCwill allow TLCto maintain focus on its current pipeline of liposomal injectable formulation programs, including TLC599 and TLC590.
- Commercialization of Ampholipad™ advancing smoothly, with a non-binding term sheet for commercialization in a specified territory in
Latin Americarecently signed and review of the formal agreement underway. In Asia, China’s National Medical Products Administrationis reviewing the Marketing Authorization Application of the generic liposomal amphotericin B drug. Worldwide discussions for partnership opportunities are ongoing.
- Held investor conference and attended
JP Morgan Healthcare Conference. The management team of TLCpresented the latest company updates during the virtual investor conference hosted by KGI Securities, as well as at JP Morgan Healthcare Conference, the largest annual biotech event in the world, which was also conducted virtually due to the COVID-19 pandemic.
- Expanded global intellectual property protection to 257 patents, with 160 patents granted and 97 applications worldwide as of
December 31, 2020.
Fiscal Year End 2020 Financial Results
Operating revenue for the fiscal year 2020 was
The Company’s cash and cash equivalents were
Selected Consolidated Balance Sheet Data
|Cash and cash equivalents and time deposit||$||1,023,874||$||34,232||$||1,342,667||$||47,816|
|Total current assets||1,095,614||36,631||1,431,977||50,997|
|Total current liabilities||556,697||18,612||348,127||12,398|
Selected Consolidated Statements of Operations Data
|General and administrative expenses||(166,377||)||(5,562||)||(145,769||)||(5,191||)|
|Research and development expenses||(860,419||)||(28,767||)||(967,503||)||(34,455||)|
|Total operating expenses||(1,026,796||)||(34,329||)||(1,113,272||)||(39,646||)|
|Loss before income tax||(803,402||)||(26,861||)||(982,177||)||(34,978||)|
|Income tax expense||(4,120||)||(138||)||(1,132||)||(40||)|
|Total other comprehensive loss||$||(2,782||)||$||(93||)||$||262||$||9|
|Total comprehensive loss||$||(810,304||)||$||(27,092||)||$||(983,047||)||$||(35,009||)|
|Loss per share of common stock|
|Basic and diluted loss per share (in dollars)||$||(12.32||)||$||(0.41||)||$||(12.42||)||$||(0.44||)|
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
Dawn ChiCorporate Communications email@example.com