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Timber Pharma's Robust Pipeline: Uniquely Focused on Orphan Dermatology Conditions 

Timber Pharmaceuticals is a client of PCG Advisory, Inc., an investor relations and communications firm. Please see our disclosures on our website www.pcgadvisory.com.

 © PCG Advisory, 2020. All Rights Reserved. 

Timber Pharmaceuticals, Inc. is a biopharmaceutical company focused on the development and commercialization of treatments for orphan dermatologic diseases. The Company's investigational therapies have proven mechanisms-of-action backed by decades of clinical experience and well-established CMC (chemistry, manufacturing and control) and safety profiles. The Company is initially focused on developing non-systemic treatments for rare dermatologic diseases including congenital ichthyosis (CI), facial angiofibromas (FAs) in tuberous sclerosis complex (TSC), and localized scleroderma.

Building Bridges in Medical Dermatology

A Fortified Balance Sheet Can Push Trials Forward

As of May 18, 2020, there were 11,867,923 outstanding shares. Timber also raised a total of $25 million in equity to fund the company through its clinical development milestones. Strategic allies include advisors from UCSF, Yale, and Stanford, plus relationships with AFT Pharmaceuticals, the Foundation for Ichthyosis, and the Tuberous Sclerosis Alliance.


Phase 2 studies bring two new treatments closer to market.

Timber Pharmaceuticals (NYSE American: TMBR) is creating shareholder value by specializing in drug development for orphan dermatological conditions with no current FDA approved treatments. Timber currently has three treatments in progress for orphan dermatologic diseases:  a Phase 2b congenital ichthyosis (CI) program, a Phase 2b program for facial angiofibromas in tuberous sclerosis complex (TSC), and a preclinical localized scleroderma program. 

Most recently, the TMB-001 CONTROL study initiated all of its 11 sites in both the U.S. and Australia and has patients actively enrolling. Its target enrollment is 45 patients who are nine years or older. TMB-002’s Phase 2B clinical trial is now open and enrolling patients in 70 percent of sites. Its target enrollment is 120 patients in 16 sites across the world.

Orphan drugs get special treatment from the FDA

The FDA offers multiple incentives for pharmaceutical companies developing treatments for orphan diseases. Clinical trial requirements are smaller and less expensive to improve cost efficiencies. There’s also the potential to receive valuable priority review vouchers from the FDA, which significantly shorten the agency’s review timeline from 10 months to just six months.

Timber employs the FDA’s 505(b)(2) pathway for orphan drugs to move straight to Phase 2 studies. Because the safety and efficacy of certain aspects of treatments are already established, there are fewer upfront FDA requirements. Timber’s portfolio is potentially de-risked from a clinical perspective because of existing clinical proof-of-concept, proven mechanism of action, and well-known chemistry and safety profiles.

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Timber Pharmaceuticals is a client of PCG Advisory, Inc., an investor relations and communications firm. Please see our disclosures on our website www.pcgadvisory.com.

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