TFF Pharmaceuticals, Inc.

Single-Patient EA Policies/Criteria Voriconazole Inhalation Powder for Pulmonary Aspergillosis and other voriconazole-sensitive pulmonary fungal infections Available Therapies via Single-Patient EA TFF Pharmaceuticals is developing its two lead drug candidates, Voriconazole Inhalation Powder and Tacrolimus Inhalation Powder, through the conduct of clinical trials. We understand that in some cases, patients may have exhausted other therapeutic options and/or may not qualify for participation in clinical trials. In such cases, treating physicians may request the use of an investigational drug on an expanded access or compassionate use basis. It is important to remember that the potential risks of an investigational drug are not yet established and therefore the treating physician must weigh the potential risks of an investigational drug against its potential benefits before considering the use of an investigational drug. At this point, TFF Pharmaceuticals will consider providing a requesting physician with access to a specific TFF Pharmaceuticals investigational drug on an expanded access/compassionate use basis when certain conditions are met. TFF Pharmaceuticals will consider requests for expanded access to Voriconazole Inhalation Powder: • The patient is deemed by the patient’s physician to have a serious or life-threatening condition, with no satisfactory alternative therapies available, or has had an unfavorable response to adequate standard of care therapy. • The patient’s physician believes that the use of Voriconazole Inhalation Powder is in the patient’s best interest. • If provided, the investigational drug will be used in accordance with applicable laws and regulatory requirements of the country where the patient is treated. • The patient is ineligible for or otherwise unable to participate in a clinical trial. • Making the investigational drug available to a patient will not negatively impact or delay the conduct of ongoing clinical trials or regulatory review or approval of the investigational drug for broader patient access. The treating physician must submit a formal request for expanded access to TFF Pharmaceuticals at expandedaccess@tffpharma.com . The treating physician is responsible for obtaining local regulatory and/or ethics/IRB approval for the investigational use. The request for expanded access must include at a minimum the requesting physician’s name and contact information, the indication, and rationale for request. Product specific eligibility criteria may apply and the treating physician will be requested to provide additional information. The medical reviewers at TFF Pharmaceuticals will evaluate each request based on the criteria above, and the overall assessment of potential benefits and risks in the given patient. TFF Pharmaceuticals may require more detailed information in order to fully evaluate a request. Every effort will be made to provide a response to an expanded access request within 3 business days of the formal request, with approval, non-approval or a request for additional information. Additional information on Expanded Access for Voriconazole Inhalation Powder

Indications: Invasive Pulmonary Aspergillosis Chronic Pulmonary Aspergillosis Allergic Bronchopulmonary Aspergillosis Aspergillus Tracheobronchitis Aspergillus bronchial anastomotic infection Other voriconazole-sensitive pulmonary fungal infections

Eligibility Criteria: Inclusion Criteria:

Exclusion Criteria: