Expanded Access Policy

Vasomune Therapeutics’ goal is to create new medicines for patients with unmet medical needs in
therapeutic areas associated with vascular endothelial dysfunction. Vasomune’s lead technology,
AV-001, is currently in a clinical trial for Pneumonia Due To COVID-19 or Other Respiratory
Infections, (NCT05123755), with pathogen-induced Acute Respiratory Distress Syndrome
(ARDS) as our initial indication, described in the Lead Technology section of our website.
Vasomune aims to efficiently bring safe and effective medicines to all appropriate patients by
conducting rigorous clinical trials and obtaining marketing approval by regulatory authorities,
including the U.S. Food and Drug Administration (FDA).


Prior to such approval, participation in one of our clinical trials is the optimal way for patients to
gain access to our investigational medicines. However, we understand that some patients may not
be able to participate in a clinical trial and may seek access to investigational treatments before
they are approved.


If early data from clinical trials suggest that an investigational treatment can offer benefits for
patients facing serious or life-threatening conditions, Vasomune may consider requests to provide
access outside of a clinical trial. In reviewing any request, we will consider if:

  • The patient to be treated has a serious or immediately life-threatening illness and there are
    no comparable or satisfactory alternative therapy options available;
  • The patient is ineligible to participate in the ongoing clinical trial of the investigational
    product, including lack of access due to geographic limitations;
  • There is preliminary clinical evidence of effectiveness and acceptable safety of the
    investigational treatment for that patient’s condition;
  • The potential benefit of the investigational medicine to the patient is greater than the
    potential risk;
  • There is an adequate supply of the investigational medicine;
  • Providing the investigational medicine will not impede the timely completion of clinical
    trials necessary for marketing approval, which could otherwise delay its availability to
    other patients.

Patients interested in obtaining access to a Vasomune investigational therapy must do so via their
physician. Physicians should contact Dr. Brian Jahns at 1-905-334-1079 or
bjahns@vasomune.com. All requests will be carefully considered on a case-by-case basis in a fair
and equitable manner by Vasomune whose decisions are final. Vasomune may request more
detailed information, including patient history, to fully evaluate the request. The requesting
physician should be qualified to administer the investigational product. The physician must agree
in writing to comply with applicable country-specific regulatory and ethical requirements related
to providing investigational product under expanded access as well as to any of Vasomune’s
requirements in terms of medical criteria, safety reporting, monitoring treatment outcomes, and
drug supply/use. We will use our best efforts to acknowledge each submitted request within 48
hours of receiving the expanded access request.