Pulmatrix Reports Q2 2024 Financial Results and Corporate Update

16 August 2024

Pulmatrix, Inc., a clinical-stage biopharmaceutical firm recognized for its innovative treatments for central nervous system and pulmonary diseases, has disclosed its financial outcomes for the second quarter of 2024 and provided updates on its clinical assets. Utilizing its proprietary iSPERSE™ technology, Pulmatrix specializes in developing inhaled therapeutic products aiming to improve patient care and treatment efficacy.

Peter Ludlum, the Interim CEO, highlighted the company's efforts to minimize costs, finalize transactions with MannKind Corporation, and wrap up the Phase 2b study for PUR1900. These steps have positioned Pulmatrix as a more agile entity, equipped to explore strategic alternatives that can leverage their PUR3100 and iSPERSE™ technologies.

Program Highlights

PUR3100: This orally inhaled dihydroergotamine (DHE) for acute migraine treatment is developed using the iSPERSE™ technology. Pulmatrix is currently looking for financing or partnerships to initiate a Phase 2 clinical study. The FDA has accepted an IND application for PUR3100, allowing the company to proceed with the Phase 2 study, which will assess the drug's safety and preliminary efficacy in acute migraine patients. The Phase 1 trial results, published in 2023, showed promising outcomes, including peak therapeutic exposure and reduced nausea and vomiting compared to intravenous DHE.

PUR1800: Developed for treating acute exacerbations in chronic obstructive pulmonary disease (AECOPD), PUR1800 employs iSPERSE™ technology as well. Results from a Phase 1b study in 2023 demonstrated that PUR1800 is safe and well-tolerated, with no observed safety issues. These results support the continued development of PUR1800 for AECOPD and other respiratory diseases. Pulmatrix is exploring partnership opportunities to further the development of this asset.

PUR1900: This is an inhaled formulation of the antifungal drug itraconazole, designed for conditions where inhalation could provide therapeutic benefits. In collaboration with its partner Cipla, Pulmatrix stopped patient enrollment for the Phase 2b study of PUR1900 due to non-safety-related reasons. The company aims to complete all wind-down activities by the third quarter of 2024. Post-wind-down, Pulmatrix will bear no further financial responsibility for PUR1900 but will receive 2% royalties on future global sales by Cipla. Pulmatrix and Cipla are currently seeking to monetize PUR1900 in the U.S.

Financial Overview

For the second quarter ending June 30, 2024, Pulmatrix reported a revenue drop to $1.6 million from $1.8 million in the same period last year. This decline is attributed to the ongoing winding down of the PUR1900 Phase 2b trial, leading to fewer reimbursable expenses. Research and development expenses also saw a decrease to $2.8 million from $4.2 million, primarily due to the winding down of the same trial. However, general and administrative expenses rose to $2.0 million from $1.7 million, largely due to increased legal costs.

The company recorded a $2.6 million loss on the disposal of assets held for sale as of June 30, 2024. Pulmatrix had $12.4 million in cash and cash equivalents and $1.4 million in short-term restricted cash, which became unrestricted in August 2024. This financial position is expected to sustain the company's operations into the fourth quarter of 2026.

About Pulmatrix

Pulmatrix is dedicated to developing novel inhaled therapeutic products for central nervous system disorders, respiratory conditions, and other diseases with unmet medical needs. Their proprietary iSPERSE™ technology aims to optimize drug delivery to the lungs, enhancing local concentration while minimizing systemic side effects. Their pipeline includes treatments for conditions like acute migraine, Chronic Obstructive Pulmonary Disease (COPD), and allergic bronchopulmonary aspergillosis (ABPA).

By focusing on strategic partnerships and optimizing their proprietary technologies, Pulmatrix aims to advance their therapeutic candidates and improve patient outcomes in critical disease areas.

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