Pulmatrix Announces Licensing Deal and Lab Transfer to MannKind

Pulmatrix Inc., a clinical-stage biopharmaceutical company focusing on inhaled therapies for serious CNS and pulmonary diseases, has announced a series of strategic transactions with MannKind Corporation. These transactions are expected to extend Pulmatrix's cash runway and foster the development of innovative therapies.

Pulmatrix and MannKind have entered into a cross-license agreement. Pulmatrix will gain a perpetual, royalty-free, exclusive license to use MannKind's Cricket® inhalation device for their proprietary formulation, PUR3100, a dihydroergotamine (DHE) treatment for acute migraines. Additionally, they will have a non-exclusive license for the Cricket® device to deliver any dry powder formulation aimed at treating or preventing neurological diseases. Meanwhile, MannKind will receive a perpetual, royalty-free, exclusive license to use Pulmatrix's iSPERSE™ technology with clofazimine for treating infections and non-tuberculous mycobacteria lung diseases. Moreover, MannKind will have a non-exclusive license to use iSPERSE™ for treating endocrine and interstitial lung diseases, including idiopathic pulmonary fibrosis (IPF) and other related conditions.

As part of these transactions, MannKind will assume the lease of Pulmatrix's R&D facility in Bedford, Massachusetts. This includes all associated leasehold improvements, laboratory equipment, and related personal property. To ensure continuity in the knowledge and application of iSPERSE™ technology, MannKind plans to hire some of Pulmatrix's R&D staff. These agreements are expected to be finalized by July 2024.

Ted Raad, CEO of Pulmatrix, emphasized that MannKind's interest in iSPERSE™ technology underscores its potential in enhancing particle engineering for dry powder formulations. The assumption of the lease by MannKind will allow Pulmatrix to extend its financial resources until 2026. This agreement also sets the stage for potential collaborations in developing orally inhaled treatments for acute migraines with the Cricket® device.

Pulmatrix is advancing a range of inhaled therapeutic products through its patented iSPERSE™ technology, which aims to improve drug delivery to the lungs by optimizing local concentrations and minimizing systemic side effects. The company is developing treatments for CNS disorders, severe pulmonary diseases such as Chronic Obstructive Pulmonary Disease (COPD), and allergic bronchopulmonary aspergillosis (ABPA).

PUR3100, a prominent product in Pulmatrix's pipeline, is an orally inhaled DHE formulation designed for acute migraine treatment. It leverages the iSPERSE™ technology to enhance the delivery and efficacy of DHE. The promising results from Phase 1 clinical trials were presented at the American Headache Society's 65th Annual Meeting in June 2023. This formulation could potentially fill a significant gap for the 38 million migraine sufferers in the U.S. who currently lack an orally inhaled DHE treatment option.

The iSPERSE™ technology represents a significant innovation in drug delivery, allowing a wide range of drugs to be formulated into small, dense, and dispersible particles for effective lung delivery. This technology can efficiently deliver small molecules, drug combinations, peptides, proteins, and nucleic acids, broadening the scope of inhalable therapies for both respiratory and non-respiratory conditions.

These strategic transactions and the ongoing development of innovative inhaled therapies highlight Pulmatrix's commitment to addressing unmet medical needs in CNS and pulmonary diseases through its advanced drug delivery platforms. The collaboration with MannKind is expected to accelerate the development of new treatments and extend Pulmatrix's operational viability well into the future.