·        Option to exclusively license the rights to develop, manufacture and commercialize “RGRN-305” for all human indications, incl. oral treatment of Hidradenitis Suppurativa (“HS”)

·        RGRN-305 is a new chemical entity having a novel mode of action targeting HS

·        Clinical data from a double-blinded placebo-controlled Ph2a trial in HS patients conducted at Aarhus University Hospital, Denmark will be presented in a late-breaking session on October 11th during the upcoming European Academy of Dermatology and Venereology Congress in Berlin

MC2 Therapeutics announced today that it has acquired option rights from Regranion, LLC to exclusively license Regranion’s RGRN-305 for the treatment of all human diseases, incl, oral treatment of HS globally, excluding the greater China region. RGRN-305 is an orally administered new chemical entity in preparation for clinical phase 2b.

Under the agreement, Regranion will receive an upfront option payment with additional development and sales milestones as well as royalties, once MC2 Therapeutics exercises its option.

“This agreement is part of our strategy to leverage our scientific know-how to develop novel treatment paradigms within immune-mediated and inflammatory diseases where patients have no or limited treatment options. RGRN-305 adds a third phase 2 stage project to our pipeline and holds the potential to become a leading oral drug for multiple large immune-mediated inflammatory diseases.” said Jesper J. Lange, CEO of MC2. “Regranion has demonstrated an outstanding can-do attitude in the development of RGRN-305 – a mindset that we embrace at MC2. We look forward to building on the value already created.”

“During my time as Chair Professor of Dermatology at Aarhus University Hospital I had the chance to work with RGRN-305 and I was encouraged by the positive biological effects that RGRN-305 demonstrated both in cell cultures and in clinical trials in humans. The project is a perfect match to the MC2 pipeline, and I am very pleased to be able to further explore the major potential of this compound.” said Lars Iversen, CMO of MC2 Therapeutics.

“We are excited to partner RGRN-305 with MC2 Therapeutics which has a strong scientific and clinical expertise and a proven track record in clinical and regulatory development.” said Gautam Ghatnekar, CEO of Regranion. “We believe the compelling mode of action and the placebo controlled clinical trial data support the potential for RGRN-305 to become a leading oral drug for HS and other indications.”

About RGRN-305

RGRN-305 is a new chemical entity small molecule, Heat Shock Protein 90 (HSP90) inhibitor with a proven capability to clinically attenuate skin inflammation through a novel mode of action enabled by exceptional pharmacological properties. RGRN-305 has been tested successfully in a small double-blinded, placebo-controlled, proof-of-concept trial in Hidradenitis Suppurativa and Plaque Psoriasis.

HSP90 is a group of chaperone molecules involved in several cellular processes, incl. cellular signaling and recent evidence has demonstrated that HSP90 inhibition has strong anti-inflammatory properties. RGRN-305 selectively inhibits the two HSP90 isoforms, HSP90α and HSP90β and causes inhibition of several pro-inflammatory pathways involved in the pathogenesis of Hidradenitis Suppurativa.

About Hidradenitis Suppurativa (“HS”)

HS is an immune-mediated debilitating, life long, recurring, inflammatory skin disorder with a high, unmet medical need. It is characterized by chronic, painful nodules, abscesses, and suppurating sinus tracts that in the most severe form cause significant scarring. Commonly affected body locations include the armpits, below the breasts, the groin, the genitals, perineal and gluteal regions.

The pathogenesis of HS is complex and implicates activation of cells of both the innate and adaptive immune systems and involves several proinflammatory pathways. Broad immune modulation can therefore be a preferred strategy.

About MC2 Therapeutics

MC2 Therapeutics is a commercial stage biotech company focused on developing novel treatment paradigms within immune-mediated and inflammatory conditions initially focusing on manifestations in the skin.

Its innovative approach in immunology is anchored in a deep understanding of skin biology, clinical expertise and cross-silo thinking. Fuelled by an entrepreneurial mindset and creativity, MC2 Therapeutics aims to set new standards in treatment satisfaction for people with immune-mediated and inflammatory conditions.