The deal represents a total transaction value of up to $36 million with (i) an initial upfront consideration of $14 million, and (ii) up to an additional $22.0 million in contingent value rights (CVRs) payable upon achievement of certain milestones.

Timber Pharmaceuticals’ lead investigational product candidate, TMB-001, is a topical reformulation of the active ingredient, isotretinoin, which is aimed at treating congenital ichthyosis – a rare skin disease with significant unmet need and no approved prescription therapies available.

Isotretinoin is an API that today only exists in an oral formulation in the U.S. The reformulation, TMB-001, has received an orphan and breakthrough designation by the FDA, and is on track with an action date as early as mid-2025. TMB-001 has shown positive results in Phase 2, with Phase 3 recruitment currently on-going in the US and in Europe.

Christophe Bourdon, CEO of LEO Pharma commented:

“Signing an agreement to acquire Timber Pharmaceuticals and TMB-001, which is still subject to certain closing conditions, is an additional step in delivering on our strategy. We will add an attractive late-stage asset to our medical dermatology pipeline and strengthen our team in the US. And most importantly, we will add an asset with promising outlook to be able to help patients suffering from a debilitating disease that today have no proper treatment options.”

John Koconis, Chairman and Chief Executive Officer of Timber Pharmaceuticals, said:

“We are very pleased to deliver a transaction that will maximize long term value for Timber Pharmaceuticals’ shareholders. LEO Pharma is a leader in global dermatology with a mission that matches our own - a relentless pursuit to help patients suffering from skin diseases. LEO’s expertise and global footprint make it the best choice to advance and achieve the full potential of Timber Pharmaceuticals’ portfolio of product candidates. We believe that LEO has the potential to establish TMB-001 as the standard of care in the treatment of congenital ichthyosis, a devastating, rare disease.”

The transaction is pending final Timber Pharmaceuticals’ shareholder approval and certain other closing conditions before the transaction can be closed, which is expected to happen in the 4^th quarter of 2023.

Timber Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of treatments for rare and orphan dermatologic diseases. Timber is focused on developing non-systemic treatments for rare dermatologic diseases including congenital ichthyosis (CI) and sclerotic skin diseases. For more information, visit www.timberpharma.com.