Airway Therapeutics Raises $50 Million to Advance Zelpultide Alfa in Bronchopulmonary Dysplasia

Airway Therapeutics has closed a $50 million equity financing to advance zelpultide alfa, its recombinant human surfactant protein D (rhSP-D), through an ongoing Phase 2b/3 trial for the prevention of bronchopulmonary dysplasia (BPD) in very preterm infants. The financing will support the Phase 2b portion of the study, along with CMC and analytical activities needed to prepare the program for potential regulatory filing.

Financing Supports Late-Stage Development

The financing comprises $26 million previously raised through a SAFE and $24 million from the company’s Series E-2 round. Approximately 94% of existing investors participated in the Series E-2 financing, including Cincinnati Children’s and a syndicate of family offices.

The proceeds will primarily fund completion of the Phase 2b portion of the ongoing Phase 2b/3 trial, as well as chemistry, manufacturing and controls (CMC) and analytical work required for late-stage development and BLA readiness. These activities support manufacturing and process development as the program advances toward potential regulatory submission, although the company has not disclosed a specific breakdown of the CMC spending.

BPD is a major complication of extreme prematurity and can lead to prolonged respiratory support, hospitalization and persistent pulmonary morbidity. No approved preventive therapy specifically targets BPD, leaving a significant unmet need in very preterm infants.

Zelpultide Alfa Replaces a Developmentally Limited Lung Protein

Zelpultide alfa is a recombinant form of human surfactant protein D (SP-D), an innate immune protein that contributes to pathogen recognition, inflammatory regulation and pulmonary surfactant homeostasis.

Very preterm infants have developmentally low pulmonary SP-D levels, which increase with gestational age. Reduced SP-D availability may limit innate immune protection during a period when immature lungs are particularly vulnerable to inflammation, infection and injury.

Zelpultide alfa reproduces the native protein’s full quaternary structure and biological function and incorporates optimized glycosylation through cell-line technology. Its proposed activity combines modulation of excessive inflammation, enhancement of pathogen recognition and clearance, and maintenance of surfactant homeostasis to support pulmonary function.

This biological rationale underpins development of rhSP-D as a potential approach to reducing the inflammatory and infectious processes that contribute to BPD.

Phase 2b/3 Trial Heads Toward Interim Analysis

The BPD program advanced into Phase 2b/3 development following a Phase 1b study that demonstrated a favorable safety and tolerability profile.

The ongoing Phase 2b/3 trial is evaluating zelpultide alfa for BPD prevention in very preterm infants. The company has not disclosed interim efficacy data, statistical outcomes, detailed endpoint results or additional safety findings from the ongoing study.

The next major milestone is an interim analysis marking completion of the Phase 2b portion of the trial. Airway expects results by the end of the second quarter of 2027.

Investor Support Extends the Development Runway

Marc Salzberg, MD, chairman and CEO of Airway Therapeutics, said participation by approximately 94% of existing investors reflects continued support for the company and zelpultide alfa as it advances through late-stage development.

CFO and COO Alan S. Wolk said the financing provides capital for the clinical trial and the CMC and analytical work needed to support BLA readiness.

Beyond BPD prevention, the company is developing zelpultide alfa as a broader respiratory biologic for inflammatory, infectious and pulmonary conditions across pediatric and adult populations.

For the lead program, however, the critical catalyst is the Phase 2b interim analysis expected by the end of Q2 2027. The findings should determine whether zelpultide alfa can demonstrate sufficient clinical benefit to support further late-stage development and a potential regulatory pathway for BPD prevention.

Reference

Airway Therapeutics Closes $50 Million Equity Round to Advance Late-Stage Development of Zelpultide Alfa – Airway Therapeutics