Expanded Access Policy

KATMAI is a clinical-stage biopharmaceutical company singularly focused on developing targeted, brain penetrant therapies for aggressive primary brain cancers. Our lead drug candidate, KTM-101, is undergoing multiple Phase 1 clinical studies in high grade glioma (GBM). Regulatory authorities require that we conduct adequately designed and controlled human clinical trials to investigate the safety, activity and other important pharmaceutical properties of our investigational lead drug. Pharmaceutical regulators review this study data when making determinations regarding further clinical studies and potential commercial approval.

Presently KATMAI's research and development resources are focused on performing non-clinical and clinical studies designed to determine the safety and effectiveness of our lead investigational drug, both as a monotherapy and when used in combination with other treatment therapies. Qualifying patients can potentially participate in ongoing clinical trials involving our lead drug candidate, subject to inclusion criteria required by trial sites' institutional review boards and regulatory authorities such as the U.S. FDA. Information on these clinical trials is available at www.clinicaltrials.gov where the KATMAI lead drug candidate is named ERAS-801.

In the U.S. and under select circumstances when a patient with a serious or immediate life-threatening illness is unable to qualify for a clinical trial and there are no remaining comparable or satisfactory treatment options, patients may gain access to experimental therapies prior to regulatory approval under an Expanded Access provision. Among several criteria that may permit patients to gain Expanded Access to an investigational therapy, patients must be unable to participate in a relevant clinical trial, potential treatment benefits justify the potential risks to the patient, and providing an investigational therapy to patients would not impede its current or planned development.

Due to KATMAI's need to focus its limited resources on drug research and development, and the potential for Expanded Access to impede expeditious and effective clinical development of its lead drug candidate, the company does not provide Expanded Access at this time and does not anticipate providing Expanded Access for the foreseeable future.