Welcome to our dedicated page for Timber Pharmaceuticals news (Ticker: TMBR), a resource for investors and traders seeking the latest updates and insights on Timber Pharmaceuticals stock.
Timber Pharmaceuticals, Inc. (NYSE American: TMBR) is a clinical-stage biopharmaceutical company dedicated to the development and commercialization of treatments for rare and orphan dermatologic diseases. Founded in 2019 and headquartered in Woodcliff Lake, New Jersey, Timber specializes in non-systemic therapies aimed at conditions like congenital ichthyosis (CI) and sclerotic skin diseases. The company leverages proven mechanisms-of-action, backed by extensive clinical experience and well-established chemistry, manufacturing, and control (CMC) and safety profiles.
Timber has been actively engaged in several high-impact projects. The company recently entered into a definitive agreement to be acquired by LEO US Holding, Inc., a subsidiary of LEO Pharma A/S, in a transaction valued at up to $36 million. This deal includes an initial upfront consideration of $14 million and potential additional payments of up to $22 million, contingent upon achieving specific milestones for TMB-001, Timber's lead candidate for the treatment of congenital ichthyosis. The merger, which is expected to close in the fourth quarter of 2023, will convert all outstanding shares of Timber into the right to receive the initial consideration, subject to certain deductions.
In addition to the merger, Timber is navigating through a Chapter 11 reorganization process, having filed voluntary petitions on November 17, 2023. The U.S. Bankruptcy Court for the District of Delaware approved all initial motions, including $3 million in interim funding via a debtor-in-possession (DIP) financing facility provided by LEO US Holding, Inc. This funding aims to support the company's ongoing operations, particularly the Phase 3 ASCEND study for TMB-001.
Timber's innovative approach and strategic partnerships, including the recent acquisition deal with LEO Pharma, position the company to make significant advancements in the field of dermatology. For more detailed information, investors can visit Timber Pharmaceuticals' official website.
Timber Pharmaceuticals (NYSE American: TMBR) announced that the European Commission granted orphan drug designation for TMB-001, targeting X-linked recessive ichthyosis (XLRI). This follows a similar designation for autosomal recessive congenital ichthyosis (ARCI). TMB-001 is a topical isotretinoin formulated with the IPEG™ delivery system, currently assessed in a Phase 3 ASCEND clinical trial across multiple countries including the U.S., Canada, Italy, France, and Germany. The trial aims to enroll approximately 142 patients ages six and older. Orphan drug designation offers financial incentives and market exclusivity for therapies addressing rare diseases.
BASKING RIDGE, NJ, Dec. 14, 2022 – Timber Pharmaceuticals (NYSE American: TMBR) announced a virtual investor Business Briefing set for December 20, 2022, at 10:30 am ET. CEO John Koconis will highlight 2022 achievements, including FDA Fast Track and Breakthrough Therapy designations for their lead product, TMB-001, aimed at treating congenital ichthyosis. TMB-001 has received orphan designation from the European Commission, granting potential 10-year market exclusivity in the EU. The company is progressing in its Phase 3 ASCEND trial and exploring partnerships across Europe.
Timber Pharmaceuticals has announced that it has regained compliance with the NYSE American's continued listing standards as of December 8, 2022. The notice confirms that the company resolved a previous deficiency concerning its low selling price. Timber Pharmaceuticals specializes in developing treatments for rare dermatologic diseases, focusing on therapies that are non-systemic and targeting conditions like congenital ichthyosis. This compliance is a significant milestone for the company, ensuring its ability to continue trading on the NYSE American.
Timber Pharmaceuticals announced receiving orphan designation from the European Commission for its lead asset, TMB-001, aimed at treating congenital ichthyosis. The pivotal Phase 3 ASCEND clinical trial is progressing, with expectations to enroll over 140 patients. The company reported no revenue for Q3 2022, down from $225,128 in Q3 2021, ending the quarter with approximately $11.2 million in cash. A reverse stock split was executed to maintain listing on NYSE American. Timber is also exploring partnerships in Europe while expanding its intellectual property for TMB-001.
Timber Pharmaceuticals, Inc. (TMBR) has announced a 1-for-50 reverse stock split to address low share pricing, following a halt in trading since November 1, 2022. The NYSE American is reviewing the split, with trading expected to resume on November 9, 2022, based on NYSE approval. Post-split, outstanding shares will decrease from approximately 145.5 million to 2.9 million. This split was approved by shareholders and aims to help the company meet listing requirements. No fractional shares will be issued; instead, cash payments will be provided for any fractional shares.
Timber Pharmaceuticals (NYSE American: TMBR) announced a trading halt by the NYSE due to its low stock price as of November 1, 2022. This halt will continue until the Special Meeting of Stockholders on November 7, 2022, where shareholders will vote on a proposed reverse stock split to regain compliance with the NYSE. The company is optimistic about TMB-001, its lead asset for treating congenital ichthyosis, which has received Breakthrough and Fast Track designations from the FDA. Compliance with NYSE standards post-split remains uncertain.
Timber Pharmaceuticals has received orphan designation from the European Commission for TMB-001, targeting autosomal recessive congenital ichthyosis (ARCI). The positive comments from the EMA Pediatric Committee pave the way for a Marketing Authorization Application (MAA). The company is also set to apply for orphan designation for TMB-001 for X-linked recessive ichthyosis (XLRI) by October 26. The ongoing Phase 3 ASCEND clinical trial will enroll approximately 142 patients across the U.S. and Europe, further establishing Timber's commitment to addressing rare dermatologic diseases.
Timber Pharmaceuticals has received a positive opinion from the European Medicines Agency's COMP for orphan designation of TMB-001, intended for treating autosomal recessive congenital ichthyosis (ARCI). The European Commission is expected to decide on this designation within 30 days. TMB-001 is currently undergoing a pivotal Phase 3 clinical trial, aiming to treat moderate to severe congenital ichthyosis, with an enrollment target of approximately 142 patients. If granted orphan designation, the drug will qualify for various incentives, including 10 years of marketing exclusivity in the EU.
Timber Pharmaceuticals (TMBR) received a deficiency letter from NYSE American due to its stock trading below the required price for continued listing. The company has until February 23, 2023, to demonstrate sustained price improvement or consider a reverse stock split. Despite this, the letter does not immediately affect the trading status of TMBR shares, which will continue to be listed. Timber is actively seeking ways to regain compliance with NYSE standards while maintaining its business operations unaffected.
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