Expanded Access Policy

Our mission is simple: impact patient’s lives. We are developing disease-modifying drugs and making them available to the people that need them. We are currently striving to impact the lives of patients heavily burdened by peripheral neuropathy with the development of WST-057, our lead drug. WST-057 is currently in Phase 2 clinical trials to treat diabetic peripheral neuropathy and soon in other indications. The goal is to seek approval in the next few years.

Our primary focus is getting our drug approved. Thus, we recommend that patients first try to participate in one of our clinical trials. Please visit our website or www.clinicaltrials.gov for more information.

However, our clinical study or alternative clinical studies may not be viable options, or for others, approval may not be soon enough. In line with our mission, we are actively exploring any and all options to help patients suffering from peripheral neuropathy, including ways to make drugs available to patients as soon as possible.

Today, we are unable to accommodate these individuals. We have been channeling all of our resources to ensure the success of clinical studies that may result in an approvable drug for a global population. Due to the complex nature of manufacturing and distributing a supply of an investigational drug, we are unable to immediately offer our medication, WST-057, through the Expanded Access Program. But we are working on solving this.

While we are currently not able to offer our investigational medication via Expanded Access, we hope to be able to do so in the near future. At that time, we will consider providing a requesting physician with pre-approval access to WST-057 for the treatment of an individual patient outside of a clinical trial under the FDA’s Expanded Access Policy when certain conditions are met.

The conditions include the following:

• The patient has a serious or life-threatening illness or condition and is either no longer responsive to or no longer able
to tolerate any available treatment option;
• The investigational drug is in active clinical development with sufficient data available to determine an appropriate
dose and schedule for the patient’s specific condition;
• A benefit-risk analysis, based on both the available clinical data as well as the requesting physician’s assessment of the
individual patient’s condition and history, supports making the investigational drug available;
• Making the investigational drug available will not negatively impact or delay the conduct of clinical trials or regulatory
review or approval of the investigational drug for broader patient access;
• Adequate supply of the investigational drug is available.

Please return to our website often for updated information. If, in the future, we are able to offer expanded access, we will evaluate and respond to each request on a case-by-case basis.

If you or your physician would like additional information or have any questions, please have your physician contact us at patients@winsantor.com. We will make every effort to respond to each request within 5 business days.