CEO Marc Salzberg clarifies that for their recombinant protein, the difficulty was not in the manufacturing itself but in designing the complex upstream process, purification, and analytics. This innovation became a core asset and "claim to fame," allowing them to transfer a well-defined process to a capable CDMO for scaling.
Airway Therapeutics' CEO founded a CRO to resolve the disconnect between academic research's discovery focus and industry's market-driven goals. This "translator" model aligned incentives and regulatory understanding, fostering more efficient drug development by merging clinical feasibility with commercial targets.
Airway selected Bronchopulmonary Dysplasia (BPD) for its lead program due to strong preclinical data, a unique mechanism in infants (arrested lung development), and zero approved treatments. This strategic choice created a clear regulatory path, a strong competitive advantage, and addressed a significant unmet medical need.
CEO Marc Salzberg wears CEO, CMO, and Board Chair hats, acknowledging it's a temporary "big stretch." This demonstrates a practical early-stage strategy where a leader covers multiple critical functions to save capital and ensure continuity, with a clear plan to hire dedicated experts as the company matures.
Airway Therapeutics' CEO sold his first company, a CRO, when he realized he couldn't personally guarantee his core promise of quality engagement on every project. This highlights a critical decision point for founders: sell when growth threatens the very value proposition that made the company successful.
Airway Therapeutics defied convention by raising nearly $100 million from family offices and high-net-worth individuals, not traditional VCs. This strategy funded the company through a pivotal Phase 2B/3 trial, proving that alternative capital sources can successfully fuel late-stage biotech development before institutional rounds.