MAT2203 Expanded Access Policy

One of the Company’s lead candidates is MAT2203, which is currently being developed for the treatment of cryptococcal meningitis. This development program is being conducted through clinical trials. If successful, these may provide the basis for submissions for drug approval to regulatory authorities, including the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA).

Matinas Biopharma believes that participation in clinical trials at this point in time is the most adequate way of treating patients with invasive fungal infections, which are conducted according to current standards of clinical care and compliance with applicable regulations.

Details about our clinical trials, including eligibility requirements for participating in ongoing or planned studies, are published in public databases such as clinicaltrials.gov

We recognize that there may be patients with invasive fungal infections or a related condition for whom participation in a clinical trial may not be an option. Where allowed, such patients may be interested in seeking access to investigational drugs before the regulatory approval of a drug via compassionate use or expanded access. Providing access outside of controlled clinical trials at this time could jeopardize the conduct of these trials and thus even prevent or delay access to MAT2203 for other patients in need. Also, in consideration of the currently available data on the safety and efficacy of MAT2203, we came to the conclusion that it is not appropriate to provide access to MAT2203 outside of our clinical trials at this point in time.

This policy may be reviewed and amended in the future. For additional information about this policy, please contact us at info@matinasbiopharma.com. We aim to provide responses within one week.