Overview

Business

Pulmatrix is a biopharmaceutical company that has focused on the development of novel inhaled therapeutic products intended to prevent and treat migraine and respiratory diseases using its patented iSPERSE™ technology. The company’s proprietary product pipeline includes treatments for central nervous system (CNS) disorders such as acute migraine and serious lung diseases such as Chronic Obstructive Pulmonary Disease (COPD) and allergic bronchopulmonary aspergillosis (ABPA).

Pulmatrix’s iSPERSE™ technology enables the delivery of small or large molecule drugs to the lungs by inhalation for local or systemic applications. The iSPERSE™ powders are engineered to be small, dense particles with highly efficient dispersibility and delivery to airways. The company believes the iSPERSE™ dry powder technology offers enhanced drug loading and delivery efficiency compared to traditional lactose-blend inhaled dry powder therapies.

After a strategic review, Pulmatrix entered into a merger agreement with Cullgen Inc. in November 2024. The company is currently seeking opportunities to monetize its existing clinical assets, including PUR3100 for acute migraine, PUR1800 for AECOPD, and PUR1900 for ABPA. Continued development of these candidates would be contingent on securing additional funding.

Therapeutic Candidates

PUR3100 Pulmatrix developed PUR3100, an iSPERSE™ formulation of dihydroergotamine (DHE), for the treatment of acute migraine. A Phase 1 study showed that PUR3100 achieved peak exposures in the targeted therapeutic range with a faster time to maximum concentration compared to IV DHE, and had a lower incidence of gastrointestinal side effects. Pulmatrix received FDA acceptance of an IND for a Phase 2 study to further evaluate the safety and efficacy of PUR3100 in acute migraine patients.

PUR1800 PUR1800 is a Narrow Spectrum Kinase Inhibitor, engineered with Pulmatrix’s iSPERSE™ technology, being developed for the treatment of acute exacerbations in chronic obstructive pulmonary disease (AECOPD). A Phase 1b study showed that PUR1800 was well tolerated with no safety signals and had low systemic exposure, supporting continued development for AECOPD and other inflammatory respiratory diseases.

PUR1900 PUR1900 is an iSPERSE™ formulation of the antifungal drug itraconazole, being developed for the treatment of allergic bronchopulmonary aspergillosis (ABPA) in patients with asthma. Pulmatrix has an agreement with Cipla for the co-development and commercialization of PUR1900, with Cipla responsible for development and commercialization outside the United States.

Financial Overview

Pulmatrix has not generated any product sales to date. Research and development expenses have decreased due to the winding down of the PUR1900 program and reduced costs following the MannKind transaction. General and administrative expenses have increased primarily due to costs related to the Merger with Cullgen.

As of March 31, 2025, Pulmatrix had $7.7 million in cash and cash equivalents, which the company believes will enable it to fund operations for at least the next 12 months. Continued development of the company’s product candidates would require significant additional funding.

In summary, Pulmatrix is focused on exploring strategic alternatives, including the pending merger with Cullgen, while seeking opportunities to monetize its existing clinical assets. The company’s future operations are highly dependent on the success of the Merger.