Synthetic RoyaltyTM FinancingUp to $100 Million
Rhythm’s lead commercial asset, IMCIVREE (setmelanotide) is a once daily injectable peptide drug that acts as an agonist on the melanocortin-4 receptor (MC4R), an important component of the pathway that drives satiety signaling and helps to promote energy homeostasis by balancing intake with expenditure. In November 2020, IMCIVREE received FDA approval for chronic weight management in adult and pediatric patients (6 years+) with obesity due to three ultra-rare diseases: proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), and leptin receptor (LEPR) deficiency. Subsequently in July 2021, IMCIVREE received EMA approval for the same indications. In June 2021, the FDA approved IMCIVREE’s sNDA for patients with Bardet-Biedl syndrome (“BBS”).
As Rhythm was preparing for the launch of IMCIVREE, the company was seeking non-dilutive financing to support commercial and clinical development activities. In June 2022, HealthCare Royalty and Rhythm announced a Synthetic RoyaltyTM Financing for up to $100 Million. Under the terms of the agreement, Rhythm received $37.5 million at closing, and will receive $37.5M upon EMA approval in BBS and $25M contingent upon Rhythm’s achievement of certain agreed sales milestones in 2023.