Timber Pharmaceuticals, Inc. Stock Price, News & Analysis

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.