Single-Patient Expanded Access Policy

OnCusp Therapeutics, Inc. (OnCusp) is a biopharmaceutical company committed to bringing new, innovative medicines for patients battling cancer by conducting rigorous clinical trials and obtaining marketing approval by the U.S. Food and Drug Administration (FDA) and other regulatory authorities. Our investigational agent, CUSP06, is in clinical trials to evaluate its efficacy and safety. A full complement of evidence from these trials will be submitted to regulatory authorities, who will make the final decision to approve the treatment or not. Until a regulatory authority has made this decision, the treatment remains experimental and is not yet available to patients.

CUSP06 is currently in early development and OnCusp has not yet established a recommended dose and schedule for the treatment of patients outside of its clinical trial. Additionally, in order to assure an adequate supply of investigational medicine for its clinical studies, OnCusp will retain the ability to manufacture and supply investigational medicines in a fair and equitable manner and in a volume that provides a suitable supply for ongoing clinical trials and development programs. Hence, currently, OnCusp is unable to provide its investigational medicines on an expanded access or Right to Try basis.

At this time, OnCusp believes participation in a clinical trial is the optimal way to access CUSP06 to enable thorough evaluation and to support regulatory approvals. For patients seeking access to our investigational medicines before they are approved by a regulatory authority, information is available on clinical trials for CUSP06 at https://www.oncusptx.com, or visit https://clinicaltrials.gov and search by company, disease or medicine.

If you have additional questions, please speak with your physician or contact OnCusp at [email protected].

Consistent with the 21st Century Cures Act, OnCusp may revise this policy at any time.