Airway Therapeutics

What Airway Therapeutics does

Airway Therapeutics, Inc. is a privately held, clinical-stage biopharmaceutical company developing zelpultide alfa, a first-in-class recombinant human surfactant protein D (rhSP-D) biologic, for the prevention and treatment of respiratory, inflammatory, and infectious diseases. The lead program targets bronchopulmonary dysplasia (BPD) in very preterm neonates (22 to less than 29 weeks gestational age), where approximately 600,000 infants are at risk annually and no approved preventive therapies exist. The company pursues a "pipeline-in-a-product" platform strategy, with the same molecule being advanced into Acute Respiratory Distress Syndrome, pulmonary fibrosis (including IPF), and exploratory programs in COPD, Influenza A, asthma, RSV, and osteoarthritis.

Zelpultide alfa is engineered to replicate the full quaternary structure and biological function of native SP-D through proprietary cell line technology and optimized glycosylation. The mechanism combines three actions: immunomodulation via TLR4 signaling regulation and LPS-binding inhibition, antimicrobial defense through PAMP recognition and opsonization of bacteria, viruses, and fungi, and surfactant homeostasis through recycling of alveolar lipids to maintain lung compliance. The drug is administered intratracheally during mechanical ventilation as replacement therapy for deficient endogenous SP-D. Manufacturing is protected by proprietary analytics, proprietary human cell lines, and trade secrets, with issued patents extending through 2039 covering sequence variants, formulation technologies, and methods of use across neonatal, pediatric, and adult indications.

The company is pre-revenue with no commercial product. Its business model is biopharmaceutical drug development with planned future revenue from hospital-channel specialty sales of zelpultide alfa into NICUs and neonatology centers across the US, Europe, Argentina, and Australia. The global BPD prevention market is estimated at over $5 billion annually, with peak global sales for the BPD indication estimated at $6 billion. The pivotal Phase 2b/3 trial is enrolling approximately 366 preterm neonates across 80+ hospitals in North America and Europe, supported by an FDA and EMA Orphan Drug Designation and an EMA PDCO-approved Pediatric Investigation Plan (August 2025). The company is led by founder/CEO/CMO Marc Salzberg, MD and CFO/COO Alan Wolk, with operations headquartered in Marietta, Georgia, an Airway Labs facility in Cincinnati, Ohio, and a wholly-owned European subsidiary in Madrid (Airway Therapeutics Spain S.L.).

Name

Airway Therapeutics

Legal name

Airway Therapeutics, Inc.

Website

http://www.airwaytherapeutics.com

Company type

Private

Founded year

2011

Operating status

Operating

Headcount range

1–10 employees

Short description

Airway Therapeutics is a clinical-stage biopharmaceutical company developing zelpultide alfa, a first-in-class recombinant human surfactant protein D biologic, currently in a pivotal Phase 2b/3 trial for bronchopulmonary dysplasia prevention in very preterm neonates, with pipeline expansion into ARDS, pulmonary fibrosis, and other respiratory indications.

Ownership category

akta.pro rank

Product category

Pulmonary Biologics / Neonatal Respiratory Therapeutics

NAICS

Biological Product (except Diagnostic) Manufacturing (325414)

SIC

Pharmaceutical Preparations (2834)

akta.pro primary industry

Pulmonology & Allergy Specialty Pharmaceuticals (HLAIACAF)

akta.pro secondary industries

COPD & Chronic Bronchitis Management (HLAKANAE), Post-Approval Clinical Development (Phase IV & Lifecycle Management) (HLAIALAJ)

Keywords

• Biologic drug development
• Respiratory therapeutics
• Neonatal lung disease
• Clinical-stage biopharmaceuticals
• Pulmonary pharmaceuticals

Headquarters

HQ city

Marietta

HQ country

United States

HQ region

North America

Offices3 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales, Others

Revenue model

1. Future biologic drug sales (zelpultide alfa): Clinical-stage company; not yet revenue-generating. Plans future revenue through commercialization of zelpultide alfa, beginning with hospital-channel sales of the lead BPD prevention indication, with projected peak global sales estimated at $6 billion. Global market for preventing BPD estimated in excess of $5 billion annually.

Go-to-market motion2 records

Distribution channels2 records

Marketing channels7 records

Core offering

Airway Therapeutics is a clinical-stage biopharmaceutical company developing zelpultide alfa (also known as AT-100 or rhSP-D), a first-in-class recombinant human surfactant protein D (SP-D) replacement therapy. It is being advanced via a "pipeline-in-a-product" strategy across multiple respiratory, inflammatory, and infectious disease indications, with the lead program focused on prevention of bronchopulmonary dysplasia (BPD) in very preterm infants and is currently in a pivotal Phase 2b/3 clinical trial.

Product overview

Airway Therapeutics is a clinical-stage biopharmaceutical company developing a single first-in-class platform biologic, zelpultide alfa (also known as AT-100 or rhSP-D), across multiple indications rather than a portfolio of separate products. Its lead program is zelpultide alfa for prevention of bronchopulmonary dysplasia (BPD) in very preterm infants, currently in a pivotal Phase 2b/3 trial. The same molecule is being advanced through a pipeline-in-a-product strategy into related indications — ARDS, Pulmonary Fibrosis, COPD, pneumonia, Influenza A, asthma, RSV, and osteoarthritis — using the drug's three core mechanisms: immunomodulation, antimicrobial defense via PAMPs/​opsonization, and surfactant homeostasis. Subsidiary Airway Therapeutics Spain S.L. leads EU clinical operations to support the multinational development of zelpultide alfa.

Differentiator

Problem solved

Functional benefit

Brands

• Zelpultide Alfa: First-in-class recombinant protein product replicating native surfactant protein D (SP-D), designed to modulate inflammation and enhance infection clearance; the company's lead therapeutic candidate.
• AT-100

Products and services

• Zelpultide Alfa (AT-100, rhSP-D) First-in-class recombinant human protein that precisely replicates the structural and functional biology of native surfactant protein D (SP-D). Engineered to modulate immune responses (TLR4 signaling regulation, LPS-binding inhibition, cytokine release control), enhance antimicrobial defense against bacteria, viruses, and fungi via PAMP recognition and opsonization, and recycle alveolar lipids to maintain surfactant homeostasis and lung compliance. Administered intratracheally during mechanical ventilation as replacement therapy for deficient endogenous SP-D, and is being developed across multiple indications including BPD (lead), ARDS, pulmonary fibrosis, COPD, pneumonia, Influenza A, asthma, RSV, and osteoarthritis under a "pipeline-in-a-product" strategy.
• Zelpultide Alfa — Bronchopulmonary Dysplasia (BPD) Prevention Program Lead clinical program of zelpultide alfa for prevention of bronchopulmonary dysplasia (BPD) in very preterm infants born 22 to less than 29 weeks gestational age, administered intratracheally during mechanical ventilation as replacement therapy for deficient surfactant protein D. Phase 1b results showed 30% relative risk reduction in grade 2 or grade 3 BPD or death, 55% risk reduction among infants surviving more than 14 days, 8 fewer days (31% reduction) on mechanical ventilation at 36 weeks PMA, and an average of 96 hospital days in the first year versus 127 for controls. The program addresses a market of approximately 600,000 at-risk neonates annually (<28 weeks GA) with peak global sales potential of $6 billion against a $5+ billion annual global BPD prevention market.
• Zelpultide Alfa — Acute Respiratory Distress Syndrome (ARDS) Program Investigational development of zelpultide alfa as a potential disease-modifying therapy for acute respiratory distress syndrome (ARDS), a life-threatening non-cardiogenic respiratory failure affecting approximately 10% of all ICU patients worldwide (~3 million cases annually) with 30-45% mortality rising above 50% in severe cases. Positioned to restore alveolar function, reduce mortality, and shorten mechanical ventilation duration in settings where no disease-modifying therapies currently exist.
• Zelpultide Alfa — Pulmonary Fibrosis Program Investigational development of zelpultide alfa as a novel therapeutic candidate for pulmonary fibrosis (PF), including idiopathic pulmonary fibrosis (IPF), targeting key disease pathways to improve clinical outcomes and survival. Addresses approximately 5 million people globally with median survival of 3-5 years post-diagnosis and average annual care cost exceeding $20,000, in a market where current antifibrotic agents (nintedanib, pirfenidone) only slow progression and lung transplant remains the only definitive treatment.
• Zelpultide Alfa — Pipeline Expansion Indications Exploratory development of the zelpultide alfa platform across additional respiratory, inflammatory, and infectious indications including chronic obstructive pulmonary disease (COPD), pneumonia, Influenza A, asthma, respiratory syncytial virus (RSV), and osteoarthritis, applying the same recombinant SP-D mechanism across age groups and disease settings under a pipeline-in-a-product strategy.

Quantifiable outcome

• 30% relative risk reduction in grade 2 or grade 3 BPD or death (Phase 1b)
• +5 more outcomes

Named customers3 records

Segments5 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

Seven partnerships are on record, tiered minor and core.

• Russo Partners, LLCminorGTM or Marketing PartnerRusso Partners, LLC serves as the external media relations and communications partner for Airway Therapeutics, with Tony Russo, Ph.D. listed as media contact on corporate press releases including the August 2025 EMA PDCO approval announcement. Provides public relations and communications support for clinical and corporate milestones.
• Cincinnati Children's Hospital Medical CentercoreStrategic or Co-development PartnerCincinnati Children's Hospital Medical Center (CCHMC) hosts Scientific Advisory Board member Dr. Jeff Whitsett (the namesake of the Whitsett Award Airway won from ATS); underlying SP-D science originates from CCHMC's neonatology and pulmonary biology research. Multiple SAB members (Whitsett) and the company's clinical work are tied to CCHMC's neonatology research community.
• A. Béclère Medical Center / University of Paris-SaclaycoreStrategic or Co-development PartnerDr. Daniele De Luca serves as Principal Investigator of the multinational zelpultide alfa Phase 2b/3 trial and is Professor of Pediatrics (Neonatology) at Paris Saclay University and A. Béclère Medical Center. He is also a member of Airway's Scientific Advisory Board. He co-authored key publications on zelpultide alfa mechanism and clinical trial design.
• Hackensack University Medical CenterminorStrategic or Co-development PartnerDr. Judy Aschner, a member of Airway Therapeutics' Scientific Advisory Board, is affiliated with Hackensack University Medical Center, supporting scientific exchange on neonatology and BPD prevention research.
• Brigham & Women's Hospital / Harvard UniversityminorStrategic or Co-development PartnerDr. Richard Parad, MD, MPH, serves on Airway's Scientific Advisory Board and is affiliated with Brigham & Women's Hospital and Harvard University, providing clinical and scientific guidance on BPD prevention in preterm infants.
• Stanford Medicine Children's HealthminorStrategic or Co-development PartnerDr. Erik Jensen, MD, MCSE, serves on Airway's Scientific Advisory Board from Stanford Medicine Children's Health, contributing clinical expertise on neonatal outcomes and BPD.
• Instituto de Investigación Sanitaria La Fe (Health Research Institute La Fe)coreStrategic or Co-development PartnerDr. Maximo Vento, MD, PhD, serves on Airway's Scientific Advisory Board from Instituto de Investigación Sanitaria La Fe, Spain, and is a Principal Investigator of the multinational zelpultide alfa Phase 2b/3 trial. The institute supports clinical trial execution in Spain.

Scale indicators12 records

Recent moves7 records

Expansion highlights5 records

Broad incumbents

• Chiesi Farmaceutici: Global specialty pharmaceutical company with an established NICU surfactant franchise (Curosurf / poractant alfa) used in neonatal respiratory distress. Most direct existing competitor in the NICU surfactant channel and the standard-of-care benchmark zelpultide alfa would have to displace or complement.
• United Therapeutics: Established biopharmaceutical company with a portfolio of approved pulmonary hypertension therapies (Tyvaso, Remodulin) and a growing pipeline in pulmonary fibrosis and other respiratory indications. Comparable as a US-based specialty respiratory biotech with hospital-channel commercialization and orphan-drug regulatory strategy.
• Galapagos NV: European biopharmaceutical company with a historical IPF program (GLPG1690/ziritaxestat) and a broader pipeline in inflammation and fibrosis. Comparable as a European-listed specialty biotech with a late-stage pulmonary fibrosis focus intersecting with Airway's named pipeline indication.
• Roche / Genentech: Global biopharmaceutical leader with pirfenidone (Esbriet) in idiopathic pulmonary fibrosis, plus an extensive respiratory biologic franchise and global NICU/pulmonology KOL relationships (and the historical employer of Airway CEO Marc Salzberg). Comparable as a broad incumbent whose IPF franchise and hospital infrastructure would compete with future zelpultide alfa pulmonary fibrosis commercialization.
• Boehringer Ingelheim: Major global pharmaceutical company and the established leader in idiopathic pulmonary fibrosis via nintedanib (Ofev), with deep hospital/specialty pulmonology infrastructure. Comparable as a broad incumbent in pulmonary fibrosis whose commercial reach and guideline position would compete with any zelpultide alfa IPF launch.

Emerging players

• Insmed Incorporated: Late-stage respiratory biotech with brensocatib, an innovative small-molecule DPP1 inhibitor for bronchiectasis and other neutrophil-mediated lung diseases. Comparable as a single-platform respiratory biotech with a hospital/specialty launch model and several billion-dollar peak-sales indications in development.
• Pliant Therapeutics: Clinical-stage biotech developing integrin-targeting therapies for idiopathic pulmonary fibrosis (bexotegrast) and primary sclerosing cholangitis. Comparable as a small-cap respiratory/fibrotic-disease platform biotech where the lead IPF program is a $B+ peak-sales opportunity, similar in stage and structure to Airway's zelpultide alfa franchise.
• FibroGen: Late-stage biopharmaceutical company with pamrevlumab in development for idiopathic pulmonary fibrosis and other fibrotic diseases. Comparable as a clinical-stage platform biotech pursuing disease-modifying therapies in pulmonary fibrosis, one of zelpultide alfa's named pipeline indications.

Direct peers

• ONY Biotech: Specialty biotech commercializing Infasurf (calfactant), an animal-derived lung surfactant used in neonatal respiratory distress and related NICU indications. Direct competitor in the neonatal pulmonary surfactant category and another hospital-channel specialty model comparable to Airway's planned launch.

Others

• CorMedix Inc. Late-stage specialty biopharmaceutical company focused on hospital-channel products, led by Chairman and CEO Joe Todisco who was concurrently appointed to Airway's Board of Directors. Comparable as a recently commercial-stage hospital specialty pharma and a real-world proxy for the type of company Airway aspires to become via Joe Todisco's guidance.

Market position

Strengths5 records

Weaknesses2 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/airway-therapeutics
• Facebookfacebook.com/229696873846635

Compliance4 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles7 records

Subsidiaries1 record

Funding overview

Funding rounds8 records

Investors6 records

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M&A

Investments

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Frequently asked questions about Airway Therapeutics