LEO Pharma to Acquire Gene Therapy Platform Replay for $50 Million Upfront, Advancing HSV-Based Treatments for Rare Genetic Skin Disorders

April 30,Denmark, LEO Pharma, a global leader in medical dermatology providing innovative solutions for skin health, announced that it has reached a definitive agreement to acquire Replay, a gene therapy company focused on developing transformative treatments for rare genetic skin diseases. This acquisition adds deep expertise and a next-generation gene therapy platform to LEO Pharma's pipeline through Replay's high-payload herpes simplex virus (HSV) delivery vector.

LEO Pharma to Drive Ongoing Innovation and Project Progress with Replay’s World-Class HSV Design and Manufacturing Expert Team as It Joins Its Dermatology Portfolio. Replay Equity Holders to Receive $50 Million Upfront Payment, Plus Milestone Payments and Tiered Single-Digit Royalties.

Replay's genomic medicine toolkit includes several synergistic technology platforms, including:

synHSV™- A high payload capacity HSV vector capable of delivering up to 30 times the AAV payload, reaching approximately 150kb of genetic material. synHSV™ facilitates the delivery of large genes, genomic genes, multigenes, as well as various transcriptional activators and repressors, thereby expanding the scope of genomic medicine and opening up possibilities for multigene therapy.

Viral gene therapy uses engineered viruses to deliver therapeutic genetic material into cells, treating diseases at their source. Replay's gene therapy platform leverages the unique ability of HSV to deliver large genes, making it particularly suitable for treating rare, gene-driven skin conditions. The transgenic HSV therapy is formulated as a topical gel, which, when applied directly to the skin, can target defective genes.HSV can provide up to 30 times the AAV payload.83% of genes are too large for AAV.

LEO Pharma CEO Christophe Bourdon said:"Replay's HSV gene therapy platform brings tremendous hope to patients with rare hereditary skin diseases. To fully realize its potential, expertise in medical dermatology is required, and LEO Pharma has decades of leadership, scale, and proven execution in this field. Leveraging our unique AI scouting platform, Innoviewer™, we identified Replay as an opportunity with significant potential. This acquisition aligns with our strategy to invest in the most impactful opportunities in dermatology and positions LEO Pharma at the forefront of the next generation of gene therapy."

Replay CEO Lachlan MacKinnon stated:"Replay has developed an HSV gene therapy platform focused on hereditary skin diseases. The natural orientation of skin cells and the ability to redo patients make HSV particularly suitable for treating rare genetic skin conditions. Combined with LEO Pharma's decades of leadership in dermatology and its global infrastructure specifically designed for dermatological conditions, we can deliver treatments to patients who need them most and establish a lasting franchise in the field of rare genetic dermatology."

Replay's main candidate drug in development is currently undergoing preclinical research for the treatment of a rare genetic disorder called dystrophic epidermolysis bullosa (DEB). This condition causes fragile skin that blisters easily, leading to painful chronic wounds that heal slowly and poorly, often resulting in scar tissue and skin cancer.

Martin Steiner, Managing Director of DEBRA Research, a non-profit organization dedicated to advancing effective treatments and cures for DEB, stated:"Dystrophic Epidermolysis Bullosa remains one of the most devastating inherited skin diseases, with unmet needs. Combining Replay's HSV gene therapy platform with LEO Pharma's dermatology expertise and global infrastructure is exactly what the DEB community needs. We welcome LEO Pharma's commitment to rare diseases and look forward to seeing the progress of this platform. DEBRA Research has previously collaborated with Replay, connecting the two companies and helping LEO Pharma better understand the needs and treatment opportunities for DEB patients."”

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