Frontera Therapeutics Secures $160M Series B Financing and Advances FT-001 Gene Therapy with FDA Clearance and CDE IND Acceptance

On July 19, 2022, Frontera Therapeutics (hereinafter referred to as "Frontera") announced the completion of a $160 million Series B financing round. The Series B round was led by Boyu Capital and HongShan, with participation from Loyal Valley Capital, Starr Investment, and other investment institutions. Existing shareholders OrbiMed and Hongyuan Capital continued their support. Established in 2019, Frontera is committed to developing innovative gene therapy drugs, providing high-quality and affordable gene therapy products for patients with rare diseases and chronic conditions worldwide. Frontera has raised a total of $195 million in financing.

Currently, Frontera Therapeutics' first innovative product, FT-001, has received clinical trial approval from the U.S. Food and Drug Administration (FDA) and has been accepted by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration for clinical trial application. FT-001 is a recombinant adeno-associated virus (AAV) gene therapy drug targeting inherited retinal diseases caused by RPE65 gene mutations. This disease manifests as early onset in childhood, progressive vision loss, and even blindness, with no effective treatment currently available in China. Meanwhile, several other gene therapy drugs developed by Frontera Therapeutics have also begun preparations for clinical research applications.

Dr. Dai Yong, Founder and CEO of Frontera Therapeutics

Regarding the company's completion of this round of financing,Dr. Dai Yong, Founder and CEO of Frontera Therapeutics"We are greatly honored to continuously receive trust and strong support from many well-known international investment institutions as we strive to create value for patients and shareholders. Frontera Therapeutics’ vision is to become a gene therapy drug research, development, and production enterprise that is trusted by patients, respected by the industry, and recognized by society. The FT-001 project took less than two years from initiation to obtaining FDA clinical trial approval, showcasing our team's excellent execution capabilities. In the future, our team will remain committed to the research and production of gene therapy drugs. We believe that with the power of capital, we will be one step closer to realizing the company’s vision and serving patients worldwide!"

Dr. Carl Gordon, Managing Partner of OrbiMed and Board Member of Frontera Therapeutics"We are very excited to be able to support Frontera Therapeutics in expanding gene therapy to the global market and meeting the needs of potential patient populations."

Dr. Li Wei, Founding Partner and Chairman of Hongyuan Capital"The FDA's approval of the clinical trial application for FT-001 marks an encouraging achievement for Frontera Therapeutics in project development and team management. It also signifies the company’s entry into the clinical stage, representing a crucial step in further validating its industry-leading technology in scalable production. By building an efficient and expandable AAV gene therapy drug development platform, Frontera Therapeutics is poised to shorten the development cycle from product research, clinical trials, to final market approval."

Frontera Therapeutics is an international innovative gene therapy drug research and development and production company. Its R&D center is located in Boston, USA, with clinical operations and GMP production bases in Shanghai and Suzhou, China. The company has established an innovative recombinant adeno-associated virus (AAV) gene expression system platform aimed at optimizing innovative, clinically validated AAV vectors to enhance the safety and efficacy of gene therapy products. The company has also built a 500L scaled GMP production system with the capacity to meet the medication needs of patients across different clinical indications. Frontera's R&D pipeline covers disease areas such as rare ophthalmic diseases, chronic diseases, blood disorders, neuromuscular conditions, and metabolic diseases, offering significant market potential. Frontera Therapeutics is committed to providing high-quality, affordable gene therapy drugs for patients with rare diseases and chronic illnesses worldwide.