BoB@JPM: Marc Salzberg, M.D., Airway Therapeutics

What It Covers

Marc Salzberg, CEO and CMO of Airway Therapeutics, discusses building a privately funded clinical-stage biotech developing zelpultide alfa, a recombinant surfactant protein D targeting bronchopulmonary dysplasia in preterm infants born at 22–28 weeks, now entering a multinational phase 2b/3 pivotal trial across Europe, the US, and Israel.

Key Questions Answered

• •BPD Incidence by Gestational Age: Bronchopulmonary dysplasia affects over 90% of infants born at 22–23 weeks, dropping to 30–50% near 28 weeks. Airway Therapeutics targets the 22–27 week and six day population for its pivotal trial, with plans to expand the addressable market to include babies born at 29–30 weeks post-approval.
• •Private Funding Strategy for Clinical-Stage Biotechs: Airway Therapeutics raised nearly $100 million without institutional investors, relying on family offices, high-net-worth individuals, and a private equity arm of an insurance company. Salzberg now identifies institutional capital as essential for completing the pivotal trial and scaling manufacturing, making JPM a deliberate fundraising target.
• •Regulatory Incentives for Rare Pediatric Indications: Zelpultide alfa holds orphan designation in both the US and Europe and qualifies for the FDA pediatric priority review voucher program. Salzberg used this designation to justify moving directly from phase 1b into a combined phase 2b/3 pivotal trial, compressing the development timeline and reducing capital requirements.
• •Manufacturing Process Development as the Core IP Barrier: The difficulty with zelpultide alfa was not the manufacturing itself but developing the upstream process, purification workflow, and accompanying analytics. Once that process was established, a limited number of capable CDMOs in the US and internationally were identified. Securing financing, not technical readiness, is now the bottleneck to scaling.
• •Bridging Academia and Industry in Drug Development: Salzberg's founding of PharmaBrains addressed a structural gap: academia lacks regulatory expertise and commercial focus, while industry lacks clinical feasibility knowledge. His model brought all three stakeholders — academic, industry, and regulatory — onto a shared platform to run studies that were both scientifically rigorous and commercially viable.