Company Overview

Company Description

We are building a vertically integrated radiopharmaceutical therapeutics company with our lead program in a Phase 3 clinical trial. We believe we have established a leadership position in the emerging radiopharmaceutical therapeutics modality. We have created a pipeline of multiple drug candidates in therapeutic areas with significant market opportunities. Much like antibody drug conjugates emerged as a new and transformative treatment modality in certain cancers, we see an opportunity for innovative radiopharmaceutical therapeutics to follow a similar path. We believe the strategic investments we are making in our robust product pipeline, development capabilities, and manufacturing infrastructure position us to be an industry-leading pioneer in the broad application of radiopharmaceutical therapeutics in cancer.

We are initially focused on building a market leading somatostatin receptor type 2, or SSTR2, franchise. As multiple diagnostic and therapeutic commercial products targeting SSTR2 are available, it is a clinically validated target that is expressed in multiple solid tumors. Our lead drug candidate, RYZ101, is designed to deliver a highly potent alpha particle radioisotope, Actinium 225, or Ac225, to tumors overexpressing SSTR2. RYZ101 consists of DOTATATE, a peptide binder, and a chelator, bound to Ac225. The U.S. Food and Drug Administration, or FDA, has approved the use of DOTATATE as the peptide binder for SSTR2 diagnostic imaging and therapeutic agents. We believe that a radiopharmaceutical therapeutic, or RPT, utilizing Ac225 has the potential to provide greater efficacy over approved beta particle radioisotope Lutetium 177, or Lu177, therapies. Alpha particles deliver up to 400 times higher energy compared to beta particles leading to double-stranded DNA breaks which are lethal to cancer cells.

We are enrolling in a registrational Phase 3 clinical trial of RYZ101 for the treatment of gasteroenteropancreatic neuroendocrine tumors, or GEP-NETs, in patients who have experienced progression of their cancer following treatment with Lu177 therapy. In addition to our lead indication of refractory GEP-NETs, we have an ongoing Phase 1b clinical trial for patients with extensive stage small cell lung cancer, or ES-SCLC. Complementing RYZ101 is our development program targeting Glypican-3, or GPC3, for hepatocellular carcinoma, or HCC, as well as our ongoing discovery efforts.

We have taken an expansive view on constructing our program portfolio and building a pipeline that provides numerous options to capitalize on the potential of RPT to treat cancer patients. At the foundation of our company is our entrepreneurial team, RPT expertise spanning early discovery through development to manufacturing, and vertically integrated infrastructure inclusive of a fully operational custom-built 28,000 square foot radiopharmaceutical research and development facility and a 63,000 square foot GMP facility, which is expected to be operational by the end of 2023. On top of this foundation is our SSTR2 franchise, in which RYZ101 is in a Phase 3 registrational clinical trial for patients with refractory GEP-NETs, as well as a Phase 1b clinical trial for patients with ES-SCLC. Complementing RYZ101 is our development program targeting GPC3 for HCC as well as our ongoing discovery efforts. Significant investments have been made by others in educating the physician community on the benefits of RPT and expanding the commercial and operational footprint of the RPT supply chain. We plan to leverage the advancements made thus far and be a driving catalyst to unlock the potential for RPT to be a major cancer treatment modality.

We were incorporated in Delaware in January 2020. Our principal executive offices are located at 5505 Morehouse Drive, Suite 300, San Diego, CA 92121, and our telephone number is (619) 937-2754. Our corporate website address is www.rayzebio.com.