Pulmatrix Halts PUR1900 Phase 2B Enrollment with Cipla to Focus on Strategic Options and Cash Preservation

Pulmatrix, a biopharmaceutical firm specializing in inhaled therapies for pulmonary and CNS diseases, has made significant changes to its development strategy for PUR1900, a treatment for Allergic Bronchopulmonary Aspergillosis (ABPA). The company has entered into a revised agreement with Cipla Ltd., transferring full development responsibility to Cipla. This move is aimed at targeting markets with the most urgent needs and the quickest route to market approval. In return, Pulmatrix will receive a 2% royalty on net sales of PUR1900.
As part of the strategic shift, Pulmatrix will cease patient recruitment for the Phase 2b study of PUR1900 and close the study. This decision is expected to extend the company's financial runway into the first quarter of 2026, as it currently holds approximately $19 million in cash reserves. The company's new focus will be on exploring strategic options that capitalize on its robust pipeline and proprietary iSPERSE™ technology.
The iSPERSE™ platform is a groundbreaking particle engineering innovation that produces dry powder formulations, overcoming the limitations of traditional inhalation therapies. This technology enables a wide array of drugs to be delivered efficiently and deeply into the lungs, treating both respiratory and non-respiratory conditions. Pulmatrix's pipeline includes treatments for conditions such as ABPA, Chronic Obstructive Pulmonary Disease (COPD), and acute migraines.
Two of the company's key products are PUR3100 and PUR1800. PUR3100 is an inhaled dihydroergotamine (DHE) formulation for acute migraines, with Phase 1 results presented at a major headache society meeting in June 2023. The IND for its Phase 2 trial received FDA acceptance in September 2023. PUR1800, an inhaled RV1162 formulation, targets acute exacerbations in COPD and has also undergone Phase 1 trials.
Cipla will now hold exclusive rights to develop and market PUR1900 outside the United States, while Pulmatrix will no longer bear financial responsibility for its development post-study closure. The company has engaged MTS Health Partners, L.P. as a financial advisor to assist in evaluating and implementing strategic alternatives to maximize shareholder value.
Pulmatrix remains committed to advancing its innovative therapies and improving patient outcomes through its engineered dry powder delivery platform, which aims to enhance therapeutic delivery to the lungs by increasing local concentrations and minimizing systemic side effects.