{"id":744406,"date":"2023-03-31T17:38:36","date_gmt":"2023-03-31T21:38:36","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/timber-pharmaceuticals-provides-business-update-and-announces-fourth-quarter-and-year-end-2022-financial-results\/"},"modified":"2023-03-31T17:38:36","modified_gmt":"2023-03-31T21:38:36","slug":"timber-pharmaceuticals-provides-business-update-and-announces-fourth-quarter-and-year-end-2022-financial-results","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/timber-pharmaceuticals-provides-business-update-and-announces-fourth-quarter-and-year-end-2022-financial-results\/","title":{"rendered":"Timber Pharmaceuticals Provides Business Update and Announces Fourth Quarter and Year End 2022 Financial Results"},"content":{"rendered":"
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\n Lead asset TMB-001 is only compound to receive official orphan drug designation from European Commission for two severe subtypes of congenital ichthyosis, ARCI and XLRI –<\/i>\n <\/p>\n

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\n Timber has enrolled 50% of patients for pivotal TMB-001 Phase 3 ASCEND clinical trial –<\/i>\n <\/p>\n

WARREN, NJ, March 31, 2023 (GLOBE NEWSWIRE) — via NewMediaWire \u2013<\/u><\/a> Timber Pharmaceuticals, Inc. (“Timber” or the \u201cCompany\u201d) (NYSE American: TMBR), a clinical-stage biopharmaceutical company focused on the development and commercialization of treatments for rare and orphan dermatologic diseases, today provided a business update and announced financial results for the fourth quarter and year ended December 31, 2022.<\/p>\n

John Koconis, Chairman and Chief Executive Officer of Timber, commented, \u201cTimber had an exciting year in 2022 and achieved several significant milestones. These include launching the pivotal Phase 3 ASCEND trial for our lead asset, TMB-001, in June 2022, after a successful planning meeting with the U.S. Food and Drug Administration (FDA) earlier in the year. \u00a0In the meeting, the FDA also reviewed the positive results of the Phase 2b CONTROL study that demonstrated clinically meaningful efficacy with a favorable safety profile, which we believe resulted in our receipt of Breakthrough Therapy designation and Fast Track status for TMB-001 from the FDA in Spring 2022. These designations, combined with the positive Phase 2b results, are assisting in our Phase 3 ASCEND clinical trial recruitment, which has now reached 50%. We\u2019re gratified with the pace of enrollment as we continue to work hard to advance the study and potentially bring relief to the many patients that suffer from chronic congenital ichthyosis (CI). <\/p>\n

\u201cDuring the year we also received official orphan drug designation for TMB-001 from the European Commission (EC) for two severe subtypes of CI, autosomal recessive CI (ARCI), and more recently, X-linked recessive ichthyosis (XLRI). These new designations are in addition to the orphan designation and associated potential for market exclusivity that TMB-001 was previously awarded by the FDA for the U.S. market. We have also expanded our Intellectual Property with approvals in South Korea, Japan, and Australia, with additional applications pending in several other countries. Concurrent with all the achievements in TMB-001\u2019s development program, we are exploring ways to efficiently fund the company including entering into non-dilutive partnerships or licensing agreements,\u201d concluded Mr. Koconis.<\/p>\n

\n 2022 Highlights<\/b>\n <\/p>\n