Prometheus Biosciences Achieves Milestone Payment from Dr. Falk Pharma GmbH

-Prometheus receives $10 million payment triggered by selection of clinical candidate for PR600

-IND for PR600 expected in 3Q 2022

SAN DIEGO, June 21, 2021 (GLOBE NEWSWIRE) — Prometheus Biosciences, a clinical-stage biotechnology company pioneering a precision medicine approach for the discovery, development, and commercialization of novel therapeutic and companion diagnostic products for the treatment of immune-mediated diseases, starting first with inflammatory bowel disease , today announced it has received a $10 million milestone payment from Dr. Falk Pharma GmbH under its collaboration agreement to develop and commercialize Prometheus’ second program, PR600. Prometheus has selected a clinical candidate for PR600, targeting an undisclosed member of the tumor-necrosis factor superfamily for the treatment of IBD and is initiating IND-enabling studies.

“Partnering with Dr. Falk on PR600 has enabled us to accelerate the PR600 program by sharing costs, resources, and drug development know-how, which has resulted in the achievement of this important milestone within the first year of our collaboration,” said Mark McKenna, President and CEO of Prometheus. “We expect to file an Investigational New Drug Application for PR600 in the third quarter of 2022 and plan to explore its utility in other immune-mediated indications beyond IBD.”

Under the collaboration agreement, which was executed in July 2020, Prometheus and Dr. Falk will share responsibility for the global development of PR600, with Dr. Falk contributing a certain portion of the external development costs associated with PR600 and its companion diagnostic. Dr. Falk acquired exclusive rights to commercialize PR600 in Europe, Australia and New Zealand, and Prometheus retains exclusive rights to commercialize PR600 in the United Stated and rest of world.

About Dr. Falk Pharma GmbH

Dr. Falk Pharma GmbH specializes in the development and marketing of pharmaceuticals used in hepatology and gastroenterology. Falk is one of the leading European companies in the field marketing its products by means of subsidiaries in selected countries and a network of sales partners. Further, the Falk Foundation, an independent organization associated with Dr. Falk Pharma, is well-known for its international symposia, forums and educational literature supporting medical doctors, patients and their families.

About Prometheus Biosciences

Prometheus Biosciences, Inc. is a clinical-stage biotechnology company pioneering a precision medicine approach for the discovery, development, and commercialization of novel therapeutic and companion diagnostic products for the treatment and diagnosis of immune-mediated diseases, starting first with IBD. The Company’s precision medicine platform, Prometheus360TM, combines proprietary bioinformatics discovery methods with one of the world’s largest gastrointestinal bioinformatics databases to identify novel therapeutic targets and develop therapeutic candidates to engage those targets. Prometheus is headquartered in San Diego, CA.

Investors:
Noel Kurdi
VP Investor Relations and Communications
(646) 241-4400
nkurdi@prometheusbiosciences.com

Media:
Juniper Point
Amy Conrad
(858) 914-1962
media@prometheusbiosciences.com