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TLC, a clinical-stage specialty pharmaceutical company focusing on novel nanomedicines, announced that George Yeh, its President, will present at Baird’s 2020 Global Healthcare Conference on September 9, 2020, at 8:30 am ET. The 30-minute session will cover a company overview and include a Q&A segment. The conference runs from September 9-10, 2020, and TLC will also engage in one-on-one discussions. Registered clients can access the fireside chat, while a comprehensive corporate presentation will be available on TLC's website in the Investors section.
TLC (NASDAQ: TLC, TWO: 4152) announced the acceptance of its Marketing Authorization Application for Ampholipad™, a complex generic of AmBisome® in China. This antifungal medication, effective against systemic fungal infections, is currently unavailable in mainland China. Ampholipad™ will be marketed by TLC's partner, 3SBio, which boasts a robust sales team and significant market presence. The product has demonstrated bioequivalence to AmBisome® and has recently scaled production to over a million vials annually. This development opens a substantial commercial opportunity in the Chinese market.
TLC has submitted an Investigational New Drug (IND) Application to the Taiwan FDA for TLC19 Hydroxychloroquine Liposome Inhalation Suspension, aimed at treating COVID-19. This innovative formulation uses proprietary liposome technology, allowing for a 30-fold increase in lung exposure compared to oral doses, while minimizing cardiotoxicity. Collaborating with MicroBase Technology, TLC aims to expedite clinical trials. The firm anticipates starting Phase I trials in Taiwan soon, with subsequent Phase II/III trials planned in the U.S. and other heavily impacted countries.
TLC (Nasdaq: TLC, TWO: 4152), a clinical-stage specialty pharmaceutical company, reported its Q2 2020 financial results with operating revenue of NT$11.8 million (US$0.4 million), reflecting a 42.7% decline year-over-year. The net loss was NT$242.4 million (US$8.2 million), slightly higher than the previous year's loss. Notably, TLC achieved 50% patient enrollment in the EXCELLENCE trial and reported positive results from the TLC590 trial for postsurgical pain relief. The company also introduced an inhalable liposomal hydroxychloroquine to potentially treat COVID-19 and completed US$23 million in financing.
TLC, a clinical-stage specialty pharmaceutical company, has released a pre-print manuscript detailing its strategy for treating COVID-19 using inhalable liposomal hydroxychloroquine. This formulation aims to deliver higher drug concentrations directly to the lungs while minimizing systemic exposure. Nonclinical studies indicate inhalable liposomal HCQ achieves about 30-fold increased lung exposure compared to traditional oral HCQ. TLC's President emphasized the urgency of developing effective treatments during the pandemic, and the manuscript is currently under peer review for publication.
TLC, a clinical-stage specialty pharmaceutical company, has successfully closed a cash capital offering of 10 million new ordinary shares in Taiwan, raising approximately NT$680 million (US$23 million). This financing aims to support its ongoing clinical programs, particularly the Phase III trial for TLC599 targeting osteoarthritis pain, which is expected to complete patient enrollment by the end of 2020. Topline data is anticipated in late 2021, with plans to submit a New Drug Application (NDA) to the FDA should results be positive.
TLC (Nasdaq: TLC, TWO: 4152) announced positive subgroup analysis results from a Phase II clinical trial for TLC599, demonstrating sustained pain relief in osteoarthritis patients. Efficacy was consistent across various demographics, with significant reductions in pain sustained from Week 1 to Week 24. TLC599, a BioSeizer® formulation of dexamethasone sodium phosphate, showed promising results, making it a potential effective treatment for over 300 million adults affected by osteoarthritis. Ongoing Phase III trials will further evaluate its efficacy and safety.
TLC (Nasdaq: TLC, TWO: 4152), a clinical-stage specialty pharmaceutical company, reported a significant 92.4% decline in operating revenue for Q1 2020, totaling NT$12.0 million (US$0.4 million), down from NT$157.8 million (US$5.1 million) in Q1 2019. Operating expenses decreased by 16.8% to NT$224.7 million (US$7.4 million). The net loss increased to NT$214.6 million (US$7.1 million), or NT$2.90 (US$0.10) per share. Despite these challenges, TLC is progressing in its clinical trials, with confident enrollment timelines and notable governance recognition in Taiwan.
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