Arcturus Therapeutics and Cystic Fibrosis Foundation Extend Agreement to Advance ARCT-032, an Investigational Messenger RNA (mRNA) Therapeutic to Treat Cystic Fibrosis

Arcturus Therapeutics Holdings Inc., a global late-stage clinical messenger RNA medicines company focused on the development of infectious disease vaccines and opportunities within liver and respiratory rare diseases, announced that Arcturus and the Cystic Fibrosis Foundation (CF Foundation) have extended their ongoing agreement. The CF Foundation agreed to increase its financial commitment to ~$25 million to advance ARCT-032, a novel messenger RNA (mRNA) therapeutic candidate formulated with Arcturus’ LUNAR delivery technology. This agreement extends a prior research program, initiated in 2017, which has resulted in the advancement of ARCT-032 into ongoing clinical studies.

“We are thrilled to extend our productive relationship with the Cystic Fibrosis Foundation, and we are grateful for their meaningful financial support,” said Pad Chivukula, Ph.D., Chief Scientific Officer of Arcturus. “ARCT-032 has the potential to express fully functional CFTR protein in the lung, thereby addressing the root cause of cystic fibrosis. The resources and valuable expertise provided by the CF Foundation will support the continued clinical development of ARCT-032, including the completion of a Phase 1b study that we plan to initiate imminently in adults living with cystic fibrosis.”

ARCT-032 is made up of mRNA that codes for CFTR, encapsulated by lipid nanoparticles utilizing LUNAR delivery technology that has been optimized for inhaled lung delivery. ARCT-032 is agnostic to the underlying mutations associated with the disease and has the potential to provide clinical benefits across a wide range of those living with CF, including those not served by currently approved CFTR modulators. The program has completed dosing in a Phase 1 study in healthy volunteers.