Expanded Access Policy Numab Therapeutics AG (Numab) is committed to developing multi-specific antibody-based therapeutics for patients with serious cancers. Numab aims to provide access to our investigational therapies primarily through ongoing clinical trials. “Expanded Access” refers to the use of an investigational therapy for potential treatment of a serious condition in a patient, where such use is not within a clinical trial setting. The US Food and Drug Administration has set forth guidelines when considering expanded access. They include:

• The disease or condition must be serious or immediately life-threatening with no adequate alternative therapy options available;
• There must be sufficient evidence that, based on available safety and efficacy information, the potential benefit to the patient would likely outweigh any potential risks; and
• Provision of the investigational drug for expanded access use will not interfere with, or delay, ongoing or planned clinical development programs, completion of which would enable therapy access for many more patients.

Certain therapies, like those developed by Numab, are made through complex manufacturing processes. Numab seeks to retain the ability to make and supply product in a fair and equitable manner and in a volume that assures adequate manufacturing capacity for our clinical trial development programs. Numab believes that participation in clinical trials is the most appropriate way to access these investigational therapies. At this time, Numab is not currently making its unapproved therapies available on an expanded access basis. In the event Numab decides to consider expanded access in the future, Numab will evaluate and respond to each request that it receives on a case-by-case basis. In the meantime, you can find current information about our ongoing clinical trials at https://clinicaltrials.gov. If you have additional questions, please speak with your physician or contact clinicaltrials@numab.com. Consistent with the 21st Century Cures Act, Numab may revise this policy at any time.