- New entity poised to accelerate the development of Aerami's diverse pipeline of next-generation inhaled therapies
- AER-901, Aerami's proprietary inhaled, nebulized formulation of imatinib, targeted to advance in 2022 into a Phase 2/3 clinical trial for PAH
- Aerami expected to file in 2022 a 510(k) for its proprietary AFINA inhaler platform
Aerami Therapeutics Holdings, Inc. (“Aerami” or the “Company”), a biopharmaceutical company focused on developing inhaled therapies to treat severe respiratory and chronic diseases, and FoxWayne Enterprises Acquisition Corp. (NASDAQ: FOXWU) (“FoxWayne”), a special purpose acquisition company (“SPAC”), today announced they have entered into a definitive business combination agreement. Upon closing of the transaction, which is currently anticipated to occur in the first quarter of 2022, the combined company will be named “Aerami Therapeutics Holdings, Inc.” and will be led by Steve Thornton, chief executive officer of Aerami, and the rest of the Company’s current management. The combined company’s common stock is expected to continue to be listed on the Nasdaq Capital Market.
Proceeds from the transaction will be applied toward advancing AER-901, Aerami’s proprietary inhaled, nebulized formulation of imatinib, into a planned Phase 2/3 clinical trial in 2022. Aerami believes AER-901 has the potential to be a disease modifying therapy for pulmonary arterial hypertension (PAH) in an estimated $5 billion market. In addition, Aerami anticipates filing in 2022 for 510(k) clearance in the U.S. for its proprietary, proprietary AFINA inhaler technology platform to capitalize on the rapidly growing global smart inhaler market. Aerami plans to pursue internal development and partnering of AFINA-based pipeline opportunities for inhaled therapies targeted at addressing large markets with significant unmet needs.
“We are deeply committed to advancing inhaled therapies which address severe respiratory and chronic diseases. This transaction is expected to provide significant capital and a platform to accelerate the development of our drug product candidates including taking our lead product, inhaled imatinib for the treatment of pulmonary arterial hypertension, into a planned Phase 2/3 trial in 2022,” said Mr. Thornton.
Robb Knie, chief executive officer of FoxWayne, added, “We see immense opportunities in Aerami’s approach to delivering inhaled therapies for targeted indications that present large unmet medical needs, including pulmonary arterial hypertension, a debilitating disease for which there currently are no available disease modifying therapies.”
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Source: Biospace