Study to Evaluate ALIS (Amikacin Liposome Inhalation Suspension) in Participants With Nontuberculous Mycobacterial Lung Infection Caused by Mycobacterium Avium Complex

Inclusion Criteria:

• Male or female, ≥ 18 years of age (19 years or older in South Korea, 20 years orolder in Japan).

• Current diagnosis of MAC lung infection. MAC or mixed infection with MAC as thedominant species is allowed, with MAC as the intended organism for treatment.

• A chest computerized tomography (CT) scan, read locally, within 6 months prior toScreening to determine presence and size of pulmonary cavities. Participants who donot have a chest CT scan within 6 months prior to Screening will be required toobtain a chest CT scan, read locally, during Screening.

• Willingness and ability to adhere to prescribed study treatment during the study.

• Women of childbearing potential (WOCBP) (ie, fertile following menarche and untilbecoming postmenopausal unless permanently sterile) and fertile men (ie, all menafter puberty unless permanently sterile by bilateral orchidectomy) agree topractice a highly effective method of birth control from Day 1 to at least 90 daysafter the last dose. Examples of such birth controls are:

• true abstinence (refraining from heterosexual intercourse during the entirestudy),

• copper intrauterine device (IUD),

• hormonal methods (levonorgestrel-releasing intrauterine system, progestogenimplant, combined oral contraceptive pill [combined with barrier method]),

• exclusive homosexual relationship, or

• sole male partner who has undergone surgical sterilization with confirmation ofazoospermia at least 3 months post procedure.

• Provide signed informed consent prior to administration of study drugs or performingany study-related procedure.

• Be able to comply with study drugs use, study visits, and study procedures asdefined by the protocol.

• Men with partners who are WOCBP (pregnant or non-pregnant) agree to use condoms andnon-pregnant partners should practice a highly effective method of birth control

Exclusion Criteria:

• Diagnosis of cystic fibrosis (CF).

• History of more than 3 MAC lung infections (a 4th MAC lung infection is noteligible)

• Received any mycobacterial antibiotic treatment for current MAC lung infection

• Refractory MAC lung infection, defined as having positive MAC cultures while beingtreated with a multidrug mycobacterial antibiotic treatment regimen for a minimum of 6 consecutive months and no documented successful treatment, defined as negativesputum culture for MAC and cessation of treatment

• Relapse of prior MAC lung infection, defined as positive sputum culture for MAC ≤6months of cessation of prior successful treatment

• Evidence of any pulmonary cavity ≥ 2 cm in diameter, as determined by chest CT scan,read locally, during Screening or within 6 months prior to Screening

• Radiographic finding of new lobar consolidation, atelectasis, significant pleuraleffusion, or pneumothorax during routine clinical care within 2 months prior toScreening

• Active pulmonary malignancy (primary or metastatic) or any malignancy requiringchemotherapy or radiation therapy within 1 year prior to Screening or anticipatedduring the study

• Acute pulmonary exacerbation (eg, chronic obstructive pulmonary disease (COPD) orbronchiectasis) requiring treatment with antibiotics, or corticosteroids (intravenous [IV] or oral), within 4 weeks prior to and during Screening

• Current smoker

• History of lung transplantation

• Prior exposure to ALIS (including clinical study)

• Known hypersensitivity or contraindications to use to ALIS, aminoglycosides, or anyof their excipients

• Disseminated MAC infection

• Administration of any investigational drug within 8 weeks prior to Screening

• Known or suspected acquired immunodeficiency syndromes (Human Immunodeficiency Virus (HIV) -positive, regardless of CD4 counts). Other immunodeficiency syndromes thatmay interfere with study participation in the opinion of the Investigator

• Current alcohol, medication, or illicit drug abuse

• Known and active COVID-19 infection

• Known hypersensitivity or contraindications to use of ethambutol, azithromycin (including other macrolides or ketolides), or any of their excipients per locallabeling guidance.