Post by icemandios on Mar 14, 2018 0:00:58 GMT
Pulmatrix Reports 2017 Financial Results; Provides 2018 Outlook on Pulmonary Disease Pipeline
LEXINGTON, Mass., March 13, 2018 /PRNewswire/ -- Pulmatrix, Inc. (NASDAQ: PULM) today announces 2017 financial results, reviews the Company's recent progress, and provides an outlook for its pulmonary disease development pipeline.
"The Company continues to advance its iSPERSE-based product candidates," said Robert W. Clarke, Ph.D., chief executive officer of Pulmatrix. "We expect Phase 1b data in mid-2018 on Pulmazole targeting fungal infections for severe asthma and cystic fibrosis patients. We also expect non-clinical safety data on PUR1800 in the second half of 2018."
Projected 2018 Milestones
Pulmazole
Single dose escalation phase of the first-in-human study for Pulmazole commenced in February 2018.
Phase 1/1b study results expected mid-2018.
Phase 2a study expected to begin in Q4-2018.
PUR1800
Complete CMC development work and 28-day GLP inhalation toxicology studies in preparation for Phase 2a anti-inflammatory efficacy study in 2019.
PUR0200
Pulmatrix expects that pre-agreed pharmaceutical development criteria will be achieved, which will trigger a technology access fee of $1 million payable by Vectura to Pulmatrix in the second half of 2018.
2018 YTD and 2017 Progress
Pulmatrix achieved several research, clinical and business milestones which reflect the Company's progress. These milestones include the following:
2018
Dosed first patient in Phase 1b clinical study of Pulmazole.
Received authorization of its Clinical Trial Application from the UK Medicines and Healthcare Products Regulatory Agency to initiate its first-in-human study for Pulmazole.
2017
Received a second QIDP status for Pulmazole to treat fungal infections in the airways of allergic bronchopulmonary aspergillosis patients.
Received award from Cystic Fibrosis Foundation Therapeutics to support the development of its lead inhaled anti-fungal product candidate Pulmazole.
Partnered with Vectura Group plc to develop Pulmatrix's drug candidate, PUR0200, for chronic obstructive pulmonary disease for the U.S. market.
Received qualified infectious disease product (QIDP) status for Pulmazole inhaled antifungal to treat fungal infections in the airways of cystic fibrosis patients.
Completed an agreement to in-license narrow spectrum kinase inhibitors from RespiVert Ltd., a wholly owned subsidiary of Janssen Biotech, Inc.
Financials
Pulmatrix ended 2017 with $3.6 million in cash and cash equivalents compared to $6.4 million as of September 30, 2017.
Revenue for 2017 was $0.3 million, compared to $0.8 million for 2016. The decrease was the result of the conclusion of the clinical study funded under our collaboration agreement with Mylan in 2016, partially offset by the revenue from the CFFT award in 2017.
Research and development expense was $10.2 million in both 2017 and 2016. General and administrative expense was $7.6 million for 2017, compared to $8.0 million for 2016. The decrease was primarily due to a decrease of $1.1 million in stock-based compensation expense, net of increases of $0.4 million in salary related expense and $0.3 million in patent and legal expense.
In 2016, the Company recorded a full write-off of the IPR&D acquired from our 2015 merger with Pulmatrix Operating Company, Inc. These non-cash charges did not have comparable charges in 2017.
There was no goodwill impairment charge in 2017 compared to $5.0 million in 2016.
Net loss for 2017 was $18.1 million compared to a net loss of $27.8 million in 2016. The decrease in net loss was primarily attributable to non-reoccurrence of the 2016 write-off of IPR&D and 2016 goodwill impairment.
About Pulmatrix
Pulmatrix is a clinical stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary disease using its patented iSPERSE™ technology. The Company's proprietary product pipeline is focused on advancing treatments for serious lung diseases, including Pulmazole (PUR1900), an inhaled anti-fungal for patients with ABPA, and PUR1800, a narrow spectrum kinase inhibitor for patients with obstructive lung diseases including asthma and COPD. In addition, Pulmatrix has partnered with Vectura Group plc to develop Pulmatrix's drug candidate, PUR0200, for COPD for the U.S. market. Pulmatrix's product candidates are based on iSPERSE™, its proprietary engineered dry powder delivery platform, which seeks to improve therapeutic delivery to the lungs by maximizing local concentrations and reducing systemic side effects to improve patient outcomes.
10-K
LEXINGTON, Mass., March 13, 2018 /PRNewswire/ -- Pulmatrix, Inc. (NASDAQ: PULM) today announces 2017 financial results, reviews the Company's recent progress, and provides an outlook for its pulmonary disease development pipeline.
"The Company continues to advance its iSPERSE-based product candidates," said Robert W. Clarke, Ph.D., chief executive officer of Pulmatrix. "We expect Phase 1b data in mid-2018 on Pulmazole targeting fungal infections for severe asthma and cystic fibrosis patients. We also expect non-clinical safety data on PUR1800 in the second half of 2018."
Projected 2018 Milestones
Pulmazole
Single dose escalation phase of the first-in-human study for Pulmazole commenced in February 2018.
Phase 1/1b study results expected mid-2018.
Phase 2a study expected to begin in Q4-2018.
PUR1800
Complete CMC development work and 28-day GLP inhalation toxicology studies in preparation for Phase 2a anti-inflammatory efficacy study in 2019.
PUR0200
Pulmatrix expects that pre-agreed pharmaceutical development criteria will be achieved, which will trigger a technology access fee of $1 million payable by Vectura to Pulmatrix in the second half of 2018.
2018 YTD and 2017 Progress
Pulmatrix achieved several research, clinical and business milestones which reflect the Company's progress. These milestones include the following:
2018
Dosed first patient in Phase 1b clinical study of Pulmazole.
Received authorization of its Clinical Trial Application from the UK Medicines and Healthcare Products Regulatory Agency to initiate its first-in-human study for Pulmazole.
2017
Received a second QIDP status for Pulmazole to treat fungal infections in the airways of allergic bronchopulmonary aspergillosis patients.
Received award from Cystic Fibrosis Foundation Therapeutics to support the development of its lead inhaled anti-fungal product candidate Pulmazole.
Partnered with Vectura Group plc to develop Pulmatrix's drug candidate, PUR0200, for chronic obstructive pulmonary disease for the U.S. market.
Received qualified infectious disease product (QIDP) status for Pulmazole inhaled antifungal to treat fungal infections in the airways of cystic fibrosis patients.
Completed an agreement to in-license narrow spectrum kinase inhibitors from RespiVert Ltd., a wholly owned subsidiary of Janssen Biotech, Inc.
Financials
Pulmatrix ended 2017 with $3.6 million in cash and cash equivalents compared to $6.4 million as of September 30, 2017.
Revenue for 2017 was $0.3 million, compared to $0.8 million for 2016. The decrease was the result of the conclusion of the clinical study funded under our collaboration agreement with Mylan in 2016, partially offset by the revenue from the CFFT award in 2017.
Research and development expense was $10.2 million in both 2017 and 2016. General and administrative expense was $7.6 million for 2017, compared to $8.0 million for 2016. The decrease was primarily due to a decrease of $1.1 million in stock-based compensation expense, net of increases of $0.4 million in salary related expense and $0.3 million in patent and legal expense.
In 2016, the Company recorded a full write-off of the IPR&D acquired from our 2015 merger with Pulmatrix Operating Company, Inc. These non-cash charges did not have comparable charges in 2017.
There was no goodwill impairment charge in 2017 compared to $5.0 million in 2016.
Net loss for 2017 was $18.1 million compared to a net loss of $27.8 million in 2016. The decrease in net loss was primarily attributable to non-reoccurrence of the 2016 write-off of IPR&D and 2016 goodwill impairment.
About Pulmatrix
Pulmatrix is a clinical stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary disease using its patented iSPERSE™ technology. The Company's proprietary product pipeline is focused on advancing treatments for serious lung diseases, including Pulmazole (PUR1900), an inhaled anti-fungal for patients with ABPA, and PUR1800, a narrow spectrum kinase inhibitor for patients with obstructive lung diseases including asthma and COPD. In addition, Pulmatrix has partnered with Vectura Group plc to develop Pulmatrix's drug candidate, PUR0200, for COPD for the U.S. market. Pulmatrix's product candidates are based on iSPERSE™, its proprietary engineered dry powder delivery platform, which seeks to improve therapeutic delivery to the lungs by maximizing local concentrations and reducing systemic side effects to improve patient outcomes.
10-K