Expanded Access Policy RMC-035

Expanded Access Policy RMC-035

Guard’s vision is to develop innovative medicines based on world-leading medical, technical and operational excellence.

We are a biotech company that identifies and develops new therapies for diseases with great unmet medical need for more effective treatments. The company has chosen to focus the development of RMC-035 on acute kidney injuries, but additional indications and therapeutic areas are relevant to the GTI platform.

We understand the interest of patients in accessing RMC-035 outside of clinical trials and prior to regulatory approval. However, participation in one of our clinical trials is currently the most appropriate way to gain access to treatment with RMC-035. Guard has decided not to offer Expanded Access (EA; also known as Compassionate Use) to RMC-035 at this time and will not approve EA requests.

We recognize the need for EA programs, and we will re-evaluate the status of our policy based on data from ongoing and future clinical trials.

If you have additional questions, please consult your physician or contact medical@guardtherapeutics.com. We anticipate acknowledging receipt of requests sent to this email within five business days.