Business
Pulmatrix Reports First Quarter 2021 Financial Results and Provides Business Update
PUR1800 Phase 1b data anticipated in Q4 2021 Phase 1/ Phase 2 Study for PUR3100 in acute migraine treatment on-track for study start in Q1 2022 Cash runway
About this update from Pulmatrix, Inc.
[{"type":"text","content":"PUR1800 Phase 1b data anticipated in Q4 2021\n Phase 1/ Phase 2 Study for PUR3100 in acute migraine treatment on-track for study start in Q1 2022\n Cash runway extends beyond anticipated PUR1800 Ph1b and PUR3100 Ph1/Ph2 data milestones\n Pulmatrix seeks reaffirmation of 50/50 partnership from Cipla Technologies\n\n\nLEXINGTON, Mass., May 11, 2021 /PRNewswire/ -- Pulmatrix, Inc. (NASDAQ: PULM), a clinical stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary and non-pulmonary disease using its patented iSPERSE™ technology, today reports its first quarter 2021 financial results and provides a business update.\n\n \n \n \n \n \n \n\n \nQ1 and Recent Highlights:\nPUR1800\nPulmatrix regained full rights to its narrow spectrum kinase inhibitor (NSKI) portfolio, including PUR1800, following Johnsons & Johnson's Enterprise Innovation's (JJEI) decision to terminate the Company's license, development and commercialization agreement. JJEI's termination of the agreement had no material impact on our financial projections. Pulmatrix intends to continue the development of PUR1800, with ongoing clinical and toxicology studies to support programs in acute exacerbations in COPD (AECOPD) and other chronic airway diseases. Initiated the Phase 1b clinical study of PUR1800, dosing 5 of 15 patients to date. Study endpoints include safety, tolerability and exploratory biomarkers to demonstrate target engagement and anti-inflammatory effect. Ph1b top-line data is expected in Q4 2021, shortly after data from 6 and 9-month toxicology studies. With existing 28-day toxicology results, the Company expects that completion of the PUR1800 Phase 1b will enable a Ph2 efficacy trial in AECOPD. The results from 6 and 9-month toxicology studies underway may expand the PUR1800 opportunity to additional indications which require chronic dosing.PUR3100\nPUR3100 development candidate, a dry powder iSPERSE formulation of dihydroergotamine (DHE) for pulmonary delivery in acute migraine. Completed dog PK study of PUR3100, demonstrated similar exposure kinetics to modelled kinetics from published data with MAP0004, the MAP Pharmaceuticals pMDI inhaled formulation of DHE. Pulmazole\nSuccessfully completed a Type C Meeting with the U.S. FDA for the further clinical development of Pulmazole. On May 10, 2021, we sent a letter to C...