Airway Therapeutics Awarded $1.9 Million NIH Grant to Advance Phase 2b/3 Study of Zelpultide Alfa for Prevention of Bronchopulmonary Dysplasia

• NIH funding provides non-dilutive capital to advance late-stage U.S. clinical development of zelpultide alfa
• Program builds on favorable safety and tolerability results from a Phase 1b study and a strong start of the trial in Europe, Argentina, and Israel

ATLANTA, Sept. 29, 2026 /PRNewswire/ -- Airway Therapeutics, Inc., a late-stage clinical biopharmaceutical company developing novel biologic therapies for respiratory, inflammatory, and infectious diseases, today announced that it has been awarded a $1.9 million grant (R44HL186892) from the National Institutes of Health (NIH) to support its U.S. Phase 2b clinical study evaluating zelpultide alfa for the prevention of bronchopulmonary dysplasia (BPD) in very preterm infants.

The award was made through the National Heart, Lung, and Blood Institute (NHLBI) of the NIH under the Small Business Innovation Research (SBIR) program and provides $1.9 million in non-dilutive funding. The funding will support Airway Therapeutics' late-stage clinical development program in BPD, a condition for which there are currently no approved preventive therapies.

"This NIH award is an important recognition of the scientific rationale behind our program and the need for new preventive approaches in BPD," said Marc Salzberg, MD, Chairman and Chief Executive Officer of Airway Therapeutics. "It strengthens our ability to execute our late-stage development strategy and advance a differentiated biologic in an area of significant unmet need. We remain focused on advancing the clinical development of zelpultide alfa and evaluating its ability to improve outcomes for very preterm infants at risk of BPD."

BPD is a serious chronic lung disease of prematurity associated with inflammation and injury to the developing lungs of very preterm infants. These infants are particularly vulnerable because important pulmonary defense mechanisms, including those mediated by surfactant protein D (SP-D), are not fully developed. SP-D plays an important role in regulating pulmonary inflammation, supporting innate immune defense and maintaining surfactant homeostasis. Zelpultide alfa is being developed as a recombinant human SP-D therapy designed to restore these protective functions in very preterm infants after birth, when the immature lung is particularly susceptible to inflammation, infection and injury that can contribute to BPD.

The ongoing Phase 2b program in the U.S. builds on favorable safety and tolerability results from a Phase 1b study of zelpultide alfa, as well as a strong start to the trial in Europe, Argentina, and Israel. The late-stage study is designed to further evaluate the efficacy and safety of zelpultide alfa compared with standard of care in high-risk preterm neonates and to assess its potential to reduce the incidence and severity of BPD.

About Zelpultide Alfa
Zelpultide alfa is a recombinant human surfactant protein D (rhSP-D) precisely engineered to replicate the native protein's full quaternary structure and biological function, incorporating optimized glycosylation through advanced cell line technology. Its therapeutic activity is driven by three key mechanisms: modulation of immune responses to mitigate excessive inflammation, enhancement of pathogen recognition and clearance, and maintenance of surfactant homeostasis to support pulmonary function. As a versatile biologic platform, zelpultide alfa is being developed for patients across all age groups—from preventing bronchopulmonary dysplasia (BPD) in very preterm infants to treating acute and chronic respiratory, inflammatory and infectious conditions in adults.

Zelpultide alfa's lead indication, BPD prevention, is currently progressing through a Phase 2b/3 clinical trial, following a Phase 1b study that demonstrated a favorable safety and tolerability profile.

About Airway Therapeutics
Airway Therapeutics is a late-stage clinical biopharmaceutical company developing a new class of biologic therapies to redefine the prevention and treatment of respiratory, inflammatory, and infectious diseases. Its lead candidate, zelpultide alfa, is currently in late-stage clinical development for the prevention of bronchopulmonary dysplasia (BPD) in very preterm infants, a condition with no approved preventive therapies. As a platform biologic, zelpultide alfa is also being advanced for broader application across age groups and disease settings, with the goal of improving outcomes for vulnerable patient populations.

For more information, please visit https://www.airwaytherapeutics.com

NIH Funding Acknowledgment
The clinical development program described in this press release is supported by the National Heart, Lung, and Blood Institute of the National Institutes of Health under Award Number R44HL186892. 4.3% of the total project costs, or $1,906,253, are financed with federal funds, and 95.7% of the total project costs, or $42,000,100, are financed by nongovernmental sources. The content is solely the responsibility of Airway Therapeutics and does not necessarily represent the official views of the National Institutes of Health.

Company Contact:
Libba Muzi
Airway Therapeutics
muzi@airwaytherapeutics.com
513-770-9630