PULMATRIX, INC. (NASDAQ:PULM) Files An 8-K Other Events
Item 8.01. Other Events.
On July 10, 2020, the joint steering committee established by Pulmatrix, Inc. (the “Company”) and Cipla Technologies, LLC (“Cipla”), with whom the Company entered into a development and commercialization agreement on April 15, 2019 for the development and commercialization of Pulmazole, determined to terminate the Company’s Phase 2a clinical study of Pulmazole. Upon renegotiation of the Company’s development and commercialization agreement with Cipla, the Company expects to initiate a new Phase 2b clinical study, which, based upon a recently completed 6-month inhalation toxicology study in dogs, would be of longer duration and include efficacy primary endpoints, whereas the current Phase 2a study is of 28-day duration with safety and tolerability as its primary endpoint. There can be no assurance that the Company will be able to renegotiate its development and commercialization agreement with Cipla on favorable terms, or at all. If Cipla does not agree to initiate a new Phase 2b study or the Company and Cipla cannot agree on how the costs of such new Phase 2b study should be allocated among the Company and Cipla, the Company may be forced to suspend the continued development of Pulmazole.
About PULMATRIX, INC. (NASDAQ:PULM)
Pulmatrix, Inc. is a clinical stage biopharmaceutical company developing inhaled therapies to address serious pulmonary disease. The Company’s product pipeline is focused on advancing treatments for rare diseases, including PUR1900, an inhaled anti-fungal for patients with lung disease, including cystic fibrosis. In addition, the Company focuses on pulmonary diseases through collaboration with partners, including PUR0200, a generic in clinical development for chronic obstructive pulmonary disease.