A Safety Study of PC945 (Opelconazole) Prophylaxis or Pre-emptive Therapy Against Pulmonary Aspergillosis in Lung Transplant Recipients (OPERA-S Study)

Key Inclusion Criteria:

2. Participant has received either a single or double lung transplant but did notreceive any other organ transplant (e.g., heart, kidney, etc.) at the time of thelung transplantation. History of prior transplant (>1 year) is acceptable

6a. (De novo prophylaxis immediately post transplant): participant must be ready to be randomized and start anti-mold prophylaxis within 72 hours of returning to the intensive care unit (ICU) after the transplant surgery or

6b. (Pre-emptive therapy): participant must meet all of the following:

• Aspergillus spp. colonization of the respiratory tract confirmed within 91 days (13weeks) after a lung transplant. Colonization is defined according to the 2010International Society for Heart Lung Transplantation (ISHLT) Consensus Statementdefinition criteria for colonization

• Without evidence of pulmonary fungal disease

• Must be ready to start anti-mold medication within 96 hours after the positiveculture(s), galactomannan or polymerase chain reaction (PCR) result(s) were reported

Key Exclusion Criteria:

1. Participant would normally receive nebulized amphotericin B as the only mold activeantifungal agent as initial SoC prophylaxis or pre-emptive therapy

2. Fungal disease requiring systemic antifungal treatment at the time of transplant

3. Has received a mold active antifungal agent post-transplant (Note: a participant whoreceives a mold active antifungal agent within 24 hours before, during, or after thetransplant procedure will not be excluded if the mold active medication was stoppedwithin 72 hours of returning to the ICU after the transplant surgery, or prior torandomization (whichever happens first)

4. Has previously received opelconazole

5. Is receiving, or who is due to receive at any time during the study, aninvestigational medicinal agent

6. Is participating, or who is due to participate at any time during the study, in atherapeutic clinical trial. For any other trials (e.g. observational or usingapproved medication), consultation with Pulmocide and the medical monitor isrequired.

7. Has an endobronchial stent in situ

8. Known history of allergy, hypersensitivity, or any previous serious reaction to anycomponent of the opelconazole formulation, azoles, echinocandins, or amphotericin B

9. Elevated alanine transaminase (ALT) or, aspartate transaminase (AST) > 5 x the upperlimit of normal (ULN)

10. Any known history or current evidence of alcohol or drug abuse that, in theInvestigator's opinion, would exclude the participant from participation in thestudy

11. Life expectancy is not expected to be sustained for the duration of the trial (16weeks), in the opinion of the investigator

Note: Other protocol defined Inclusion/Exclusion criteria may apply.