Aerami Therapeutics to Present Pharmacokinetic Data Supporting AER-901 (Inhaled Imatinib) for Pulmonary Hypertension at the 2023 American Thoracic Society (ATS) International Conference

DURHAM, N.C., May 11, 2023 (GLOBE NEWSWIRE) — Aerami Therapeutics (“Aerami”), a clinical stage biopharmaceutical company dedicated to breathing life into the treatment of serious and rare cardiopulmonary conditions, today announced that non-clinical pharmacokinetic data and details of the completed AER-901 Phase 1 trial in healthy volunteers will be presented at the 2023 American Thoracic Society (ATS) International Conference, being held at the Walter E. Washington Convention Center in Washington, D.C. from May 19-24, 2023. These results, presented by Aerami Chief Medical Officer Gary Burgess, MD, demonstrate the potential to achieve therapeutic lung levels with low inhaled doses of AER-901.

AER-901 is entering Phase 2 clinical development for two serious and rare forms of pulmonary hypertension – pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). By targeting low doses of imatinib to the lung with a high- performance handheld nebulizer, AER-901 has the potential to achieve similar efficacy to oral imatinib as demonstrated in the Phase 3 IMPRES trial, but with a greatly improved safety profile.

Poster Presentation: Pharmacokinetic Profile of Imatinib Mesylate Formulation (AER-901) Demonstrates Potential for Therapeutic Exposure Levels at Low Doses After Pulmonary Administration
Poster Number: 6642
Presenters: Gary Burgess, Dawn Edgerton, Viktoria McDonald and Michelle Widmann of Aerami Therapeutics, Inc; Susan Lee and Nicholas Farinola of CMAX, Adelaide, Australia; Ramandeep Sharma of Novotech CRO, Sydney, Australia
Session Date & Time: May 24, 2023, from 8:00 – 10:00am EST
Session Location: Room 151 B (Street Level)

Aerami will also be featured as a presenting company at the ATS Respiratory Innovation Summit (RIS) being held at the Marriott Marquis Washington from May 19-20, 2023, in Washington, D.C. The presentation will take place during the “Showcase Four: Inflammation, Infectious Disease and Other Innovators” session at 2pm EST on May 20.

For more information about the ATS International Conference, please visit https://conference.thoracic.org/. For more information about the ATS RIS, please visit https://conference.thoracic.org/program/ris/.

About AER-901
AER-901 is a drug-device combination that is designed to deliver potentially reverse-remodeling imatinib therapy deeply and efficiently throughout the diseased tissue of the lung. AER-901 is delivered via a high-performance, handheld, smart nebulizer that controls flow rate and provides patients with real-time feedback to help optimize lung deposition of imatinib. AER-901 is being developed for patients with PH and PH-ILD, two areas with high unmet medical need for improved treatment options.

About Pulmonary Arterial Hypertension (PAH) 
PAH (World Health Organization [WHO] Group 1 PH) is a rare and progressive form of pulmonary hypertension characterized by high blood pressure in the arteries of the lungs due to their narrowing or a blockage. PAH, which disproportionately impacts women and frequently during the middle part of their lives, affects approximately 70,000 patients in the United States and Europe. Pulmonary vascular remodeling leads to narrowing and obstruction of small pulmonary arteries resulting in increased pulmonary arterial pressure, which requires the heart to work harder as it pumps blood through the lungs, eventually leading to right heart failure and, ultimately, death. Currently approved therapies primarily mediate vasodilation, and despite advances in therapy, median survival remains approximately five to seven years.

About Pulmonary Hypertension Associated with Interstitial Lung Disease (PH-ILD) 
Interstitial lung disease (ILD) is an umbrella term for a number of conditions that cause inflammation and scarring (fibrosis) of the lung tissue. Pulmonary hypertension is a serious complication of ILD for more than 80,000 individuals in the U.S. and Europe. Like PAH, PH-ILD is characterized by high blood pressure in the arteries of the lungs. Similarly, pulmonary vascular remodeling, associated with proliferation, fibrosis, and inflammation, is believed to play an important role in PH-ILD development and progression. Currently there is only one approved treatment for PH-ILD, and estimated survival is less than five years.

About Aerami Therapeutics
Aerami is a clinical stage biopharmaceutical company dedicated to breathing life into the treatment of serious and rare cardiopulmonary conditions. Aerami’s mission-driven approach to product development seeks to help patients live longer and live better by combining precision medicines and advanced administration platforms to support ease-of-use and quality-of-life.

This press release contains “forward-looking statements” concerning the development and commercialization of Aerami’s product candidates, timing of clinical trials, the company’s business development efforts and its expectations regarding its prospects, including, but not limited to, the timing and outcome of current and planned clinical trials. 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, but not limited to, uncertainties associated with the clinical development process, including, among other things, the timing, expense, and results of clinical trials and regulatory processes, the company’s ability to financially support its drug-device product candidate clinical development programs, and the timing and outcome of the company’s anticipated interactions with regulatory authorities. 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.

Aerami Media Contact:
Joshua Ziel, PhD
VP, Chief of Staff
jziel@aerami.com

Aerami Investor Contact:
Jeremy Feffer
LifeSci Advisors
212-915-2568
jfeffer@lifesciadvisors.com