TLC - TLC STOCK NEWS

TLC BioSciences has announced a major commercialization agreement with Endo International for TLC599, an injectable for osteoarthritis pain. TLC will receive an upfront payment of $30 million and can earn up to $110 million based on milestones. TLC599 aims to address a significant medical need with more than 32.5 million affected in the U.S. Approval is anticipated in 2025.

TLC BioSciences announced results from its Phase 2 trial of TLC599 for treating knee osteoarthritis, published in Arthritis Research & Therapy. TLC599 showed significantly reduced pain and improved function for up to 24 weeks, with lower oral medication use compared to placebo. Conducted with 75 patients, the study highlighted that TLC599 outperformed in pain reduction metrics. Additionally, results from the ongoing EXCELLENCE Phase 3 study are anticipated this year, reinforcing TLC599’s potential as a nonopioid therapy amidst changing pain management guidelines.

Taiwan Liposome Company (TLC) has announced its intention to voluntarily delist its American depositary shares from Nasdaq following shareholder approval of a stock swap transaction. This swap will make TLC a wholly owned subsidiary of Woods Investment Company, allowing shareholders to choose between cash or Woods Investment securities. The final trading days are set for September 28 and 29, 2021, with the delisting expected to be effective shortly after. The company will also file a Form 25 with the SEC, with deregistration anticipated 90 days post the Form 15F filing.

TLC, a clinical-stage specialty pharmaceutical company, reported Q2 2021 financial results, highlighting a significant revenue increase of 1,260.2% to NT$160.2 million (US$5.7 million) compared to NT$11.8 million (US$0.4 million) in Q2 2020. The net loss decreased to NT$75.5 million (US$2.7 million) from NT$242.4 million (US$8.2 million) year-over-year. Key developments include the approval of their liposomal amphotericin B in India and partnerships for commercialization. The company is advancing its clinical trials, including Phase III trials for TLC599 and planning for TLC590.

Taiwan Liposome Company (TLC) announced a board-approved stock swap with Woods Investment Company, involving the exchange of common shares for Series B preferred shares at NT$100 each. The transaction aims to facilitate the company's long-term development and privatization strategy, which includes plans for delisting from TPEx and Nasdaq by October 8, 2021. Major shareholders, including PAG, will invest ~$90 million in the swap. Post-privatization, Woods will manage TLC as a wholly owned subsidiary, seeking additional funding and pursuing global growth opportunities.

TLC (NASDAQ: TLC, TWO: 4152) has announced a license supply and commercialization agreement with Zydus Healthcare to market AmphoTLC™ in India. AmphoTLC™, a complex generic drug, is bioequivalent to Gilead’s AmBisome® and aims to address the severe shortage of liposomal amphotericin B in India amidst rising COVID-19 associated mucormycosis cases. TLC received necessary regulatory approvals from India's CDSCO on May 25, 2021, enabling immediate distribution to combat this life-threatening infection.

TLC (Nasdaq: TLC, TWO: 4152) has received approval from India's CDSCO for its New Drug Application (NDA) for AmphoTLC™, a liposomal amphotericin B injection. This approval addresses a critical shortage caused by increasing COVID-19 associated mucormycosis cases. TLC's product, proven to be bioequivalent to Gilead’s AmBisome, aims to provide timely treatment to patients, potentially reducing high fatality rates. AmphoTLC™ has been successfully marketed in Taiwan and is under review for authorization in China.

On May 23, 2021, InspirMed, a subsidiary of TLC, presented promising data at the ISAM Congress regarding two inhalable liposome formulations of antiviral drugs for COVID-19: ISPM21 (GS-441524) and ISPM19 (hydroxychloroquine). Both formulations showed significantly enhanced drug delivery to the lungs, with ISPM21 achieving over 200-fold lung concentration compared to intravenous GS-441524. ISPM19 demonstrated a 30-fold lung exposure at only 1% of the oral dose required for effectiveness. The results indicate potential for reduced systemic side effects and effective treatment of COVID-19.