Efficacy of Zelpultide Alfa in Preterm Neonates at High Risk of Developing Bronchopulmonary Dysplasia (BPD)

Inclusion Criteria:

1. Born between gestational age (GA) 23 0/7 to 27 6/7 weeks, inclusive.

2. Received at least 1 dose of SOC-indicated animal-derived pulmonary surfactanttreatment after birth.

3. Intubated and on invasive mechanical ventilation per SOC.

4. Able to receive the first dose of zelpultide alfa or air-sham at least 15 min afterthe surfactant administration but within 96 h of birth and within 48 h from thestart of invasive mechanical ventilation. Subjects extubated and re-intubated aftertheir pulmonary surfactant dose(s) are eligible as long as the inclusion criteriaare met.

5. Informed consent and personal information authorization form signed by the subject'sparent(s) or legal guardian(s).

Exclusion Criteria:

1. Birth weight < 400 g or > 1,500 g.

2. Major apparent congenital abnormalities impacting cardio and pulmonary functionidentified before randomization, such as, but not limited to:

• Clinically relevant Potter-like syndrome and any pulmonary congenitalanomalies,

• Clinically relevant congenital diaphragmatic hernia,

• Omphalocele or gastroschisis, esophageal atresia,

• Known or suspected cyanotic congenital heart disease (ie, tetralogy of fallot,transposition of the great arteries, etc).

3. Active do no resuscitate (DNR) order in place.

4. History of allergy or sensitivity to any surfactant or any component of zelpultidealfa.

5. Concurrent enrollment in any clinical study that utilizes treatments (investigational medical products or devices) outside of SOC or participation instudies within the last 30 days (or 5 half-lives of an IMP) prior to birth (for themother) or up to week 36 PMA.

6. Any condition or situation that, in the Investigator's judgement, puts the neonateat significant risk, could confound the study results, or may interferesignificantly with the neonate's participation in the study.