PRESS RELEASES

Aerami Therapeutics Signs a Global License Agreement with Vectura Group, Adding an Inhaled Therapy for Patients with Pulmonary Arterial Hypertension to Their Pipeline

DURHAM, N.C., June 08, 2020 (GLOBE NEWSWIRE) — Aerami Therapeutics, Inc. (“Aerami” or the “Company”) a clinical stage biopharmaceutical company developing inhaled therapies to treat severe respiratory and chronic diseases today announces the signing of a global license and development agreement with Vectura Group plc (LSE: VEC) (“Vectura”) to develop and commercialize inhaled imatinib for the treatment of Pulmonary Arterial Hypertension (“PAH”).

Aerami will be responsible for the overall development and commercialization of inhaled imatinib, with Vectura providing a combination of its development services expertise and a license to its FOX® mesh nebulizer technology. The drug device combination product is targeted to go into a Phase 1 trial in the second half of 2020. Aerami plans to pursue orphan disease designation for PAH. In return for the license, the Company will be obligated to pay Vectura certain regulatory and net sales-based milestones, a mid-single digit royalty on global net sales and will purchase FOX® devices from Vectura.

Timm Crowder, Chief Operating Officer of Aerami, commented, “Despite multiple products being available to treat the symptoms of PAH patients, it remains a fatal disease with substantial unmet needs. We believe that inhaled imatinib has the potential to improve PAH patients’ lives based on the significant efficacy demonstrated in a proof of concept Phase 3 trial completed with oral imatinib.  We look forward to working with Vectura, the PAH patient and clinician community to initiate clinical development this year.”

Clinical Needs
PAH is a devastating disease for which there is no cure. The disease causes blood vessels in the lungs to become narrowed, blocked or destroyed. The damage slows blood flow through the lungs, and blood pressure in the lung arteries rises. Over time, the heart must work harder to pump blood through the lungs, eventually causing the heart muscle to become weak and fail.

The Inhaled Advantage
Although oral imatinib demonstrated statistically significant improvement in pulmonary hemodynamics and physical capacity in PAH patients in a Phase 3 trial, the indication was not pursued because of the substantial adverse events seen in the clinical trial. By delivering an inhaled imatinib directly to the site of the disease, we believe that we will be able to significantly reduce the dose necessary to achieve therapeutic benefit and avoid the significant adverse events seen with oral imatinib.

About Aerami Therapeutics – More information can be found at www.aerami.com  

This press release contains “forward-looking statements” concerning the development and commercialization of Aerami’s products, timing of clinical trials, the company’s business development efforts and its expectations regarding its prospects. Forward-looking statements are subject to risks, assumptions and uncertainties that could cause actual future events or results to differ materially from such statements, including the ability to obtain funding to support planned clinical activities. These statements are made as of the date of this press release. Actual results may vary. Aerami undertakes no obligation to update any forward-looking statements for any reason.

Contact: Michael Kaseta – Chief Financial Officer   +1 (732) 690-9545