Post by icemandios on Mar 10, 2016 14:25:41 GMT
Pulmatrix Reports 2015 Financial Results; Provides 2016 Outlook on Pulmonary Disease Pipeline
2015 was a transformational year - lead assets for COPD and cystic fibrosis continue to progress in clinical development.
LEXINGTON, Mass., March 10, 2016 /PRNewswire/ -- Pulmatrix, Inc. (NASDAQ: PULM) today announces 2015 financial results, reviews the Company's recent progress, and provides an outlook for 2016 for its pulmonary disease development pipeline.
"2015 was a transformational year for Pulmatrix. We positioned the Company to have two iSPERSE-based product candidates in clinical trials during 2016, strengthened our balance sheet, and became publicly listed on NASDAQ," said Robert W. Clarke, Ph.D., chief executive officer of Pulmatrix. "We expect clinical data in the first half of 2016 on PUR0200 targeting the large market of COPD, and the second program, PUR1900, will enter the clinic this year targeting fungal infections in cystic fibrosis patients. As our product pipeline and iSPERSE technology continue to advance, we feel the Company is well positioned for clinical success in 2016 and beyond."
In a March 10th letter to shareholders, Dr. Clarke added that the Company aims to keep up its aggressive pace in 2016 "thanks to the dedication of our scientists and management to developing products that can make a real difference in the lives of patients, and to the much-appreciated support of our shareholders."
Planned 2016 Milestones
Pulmatrix has two major priorities for 2016: Pulmatrix intends to continue to advance PUR0200, a branded generic bronchodilator for COPD, through clinical development and intends to initiate clinical testing for PUR1900, an inhaled anti-fungal initially targeted for patients with cystic fibrosis.
PUR0200
Report data from European pilot pharmacokinetic bioequivalence clinical study of PUR0200, funded as part of a previously disclosed research collaboration agreement, in the first half of 2016
Initiate development work in the second half of 2016 to support a future European pivotal pharmacokinetic bioequivalence approval study
Expand current research collaboration focused on US development to form a more expansive development and commercialization partnership in the second half of 2016
PUR1900
Initiate Phase 1/1b trial in fungal infections in cystic fibrosis patients in the second half of 2016
Expand PUR1900 program to indication(s) outside of cystic fibrosis
PUR1500
Identify the active pharmaceutical ingredient for an IPF candidate(s), which could include a small molecule kinase inhibitor and/or a biologic in the first half of 2016
2015 and 2016 YTD Progress
In 2015 and early 2016, Pulmatrix achieved several research, clinical and business milestones, reflective of the Company's progress. These milestones include the following:
Reported Phase 1b clinical data on PUR0200 demonstrating it was well tolerated and achieved significant lung function improvement over a 24 hour period relative to placebo and comparable effects to the marketed reference product using a fraction of the active pharmaceutical ingredient
Completed manufacture of clinical candidates for PUR0200 in the second half of 2015
Initiated a European pilot pharmacokinetic bioequivalence study of PUR0200 in the first quarter of 2016
Reported that PUR1900 was active and potent in in vitro preclinical models against Aspergillus fumigatus and other fungal species that commonly infect cystic fibrosis patients, while achieving high lung concentrations and low systemic exposure in in vivo preclinical models
Announced that a collaboration with Celdara, Inc. to develop an iSPERSE™ formulation of a novel biologic, CM-YJH01, was awarded a three-year, $1.7 million NIH Research grant to fund development of an inhaled treatment for idiopathic pulmonary fibrosis (IPF)
Further strengthened the Company's patent portfolio through the receipt of a composition of matter patent related to the iSPERSE™ technology
Entered into a strategic manufacturing agreement with Capsugel to fulfill manufacturing needs for our planned clinical trial activities in cystic fibrosis and, longer term, enable us to manufacture iSPERSE-based products at commercial scale
Financials
"In 2015, we achieved a considerable amount of progress by advancing our proprietary programs and partnered products through an efficient deployment of capital," said William Duke, Jr., chief financial officer of Pulmatrix. "We expect to continue maintaining our fiscal discipline and based on our current operating plan, we believe that we have sufficient capital to fund our pipeline and business activities into mid-2017, when we anticipate to be beyond multiple data readouts and other corporate milestones."
Pulmatrix ended 2015 with $18.9 million in cash and cash equivalents compared to $22.0 million as of September 30, 2015.
Revenues for 2015 were $1.2 million, which were primarily comprised of reimbursed formulation and clinical development expenses related to our research collaboration to develop PUR0200 for COPD. There was $0.4 million of comparable revenues for 2014.
Research and development expense for 2015 was $7.2 million, compared to $6.6 million for 2014. The increase was primarily due to increases in clinical development costs and external service costs on the PUR0200 and PUR1900 projects. General and administrative expense was $17.0 million for 2015, compared to $2.8 million in 2014. The increase was primarily due to increases of $7.5 million in advisory, legal and accounting costs incurred in connection with the merger that resulted in our public listing on Nasdaq (the "Merger") and $5.0 million in stock-based compensation expense.
Net loss for 2015 was $26.2 million compared to a net loss of $24.1 million for 2014. The increase in net loss was primarily attributable to costs incurred in connection with the Merger.
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 rare diseases, including PUR1900, an inhaled anti-fungal for patients with cystic fibrosis (CF). In addition, Pulmatrix is pursuing opportunities in major pulmonary diseases through collaborations, including PUR0200, a branded generic in clinical development for chronic obstructive pulmonary disease (COPD). Pulmatrix's product candidates are based on iSPERSE™, its proprietary 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.
2015 was a transformational year - lead assets for COPD and cystic fibrosis continue to progress in clinical development.
LEXINGTON, Mass., March 10, 2016 /PRNewswire/ -- Pulmatrix, Inc. (NASDAQ: PULM) today announces 2015 financial results, reviews the Company's recent progress, and provides an outlook for 2016 for its pulmonary disease development pipeline.
"2015 was a transformational year for Pulmatrix. We positioned the Company to have two iSPERSE-based product candidates in clinical trials during 2016, strengthened our balance sheet, and became publicly listed on NASDAQ," said Robert W. Clarke, Ph.D., chief executive officer of Pulmatrix. "We expect clinical data in the first half of 2016 on PUR0200 targeting the large market of COPD, and the second program, PUR1900, will enter the clinic this year targeting fungal infections in cystic fibrosis patients. As our product pipeline and iSPERSE technology continue to advance, we feel the Company is well positioned for clinical success in 2016 and beyond."
In a March 10th letter to shareholders, Dr. Clarke added that the Company aims to keep up its aggressive pace in 2016 "thanks to the dedication of our scientists and management to developing products that can make a real difference in the lives of patients, and to the much-appreciated support of our shareholders."
Planned 2016 Milestones
Pulmatrix has two major priorities for 2016: Pulmatrix intends to continue to advance PUR0200, a branded generic bronchodilator for COPD, through clinical development and intends to initiate clinical testing for PUR1900, an inhaled anti-fungal initially targeted for patients with cystic fibrosis.
PUR0200
Report data from European pilot pharmacokinetic bioequivalence clinical study of PUR0200, funded as part of a previously disclosed research collaboration agreement, in the first half of 2016
Initiate development work in the second half of 2016 to support a future European pivotal pharmacokinetic bioequivalence approval study
Expand current research collaboration focused on US development to form a more expansive development and commercialization partnership in the second half of 2016
PUR1900
Initiate Phase 1/1b trial in fungal infections in cystic fibrosis patients in the second half of 2016
Expand PUR1900 program to indication(s) outside of cystic fibrosis
PUR1500
Identify the active pharmaceutical ingredient for an IPF candidate(s), which could include a small molecule kinase inhibitor and/or a biologic in the first half of 2016
2015 and 2016 YTD Progress
In 2015 and early 2016, Pulmatrix achieved several research, clinical and business milestones, reflective of the Company's progress. These milestones include the following:
Reported Phase 1b clinical data on PUR0200 demonstrating it was well tolerated and achieved significant lung function improvement over a 24 hour period relative to placebo and comparable effects to the marketed reference product using a fraction of the active pharmaceutical ingredient
Completed manufacture of clinical candidates for PUR0200 in the second half of 2015
Initiated a European pilot pharmacokinetic bioequivalence study of PUR0200 in the first quarter of 2016
Reported that PUR1900 was active and potent in in vitro preclinical models against Aspergillus fumigatus and other fungal species that commonly infect cystic fibrosis patients, while achieving high lung concentrations and low systemic exposure in in vivo preclinical models
Announced that a collaboration with Celdara, Inc. to develop an iSPERSE™ formulation of a novel biologic, CM-YJH01, was awarded a three-year, $1.7 million NIH Research grant to fund development of an inhaled treatment for idiopathic pulmonary fibrosis (IPF)
Further strengthened the Company's patent portfolio through the receipt of a composition of matter patent related to the iSPERSE™ technology
Entered into a strategic manufacturing agreement with Capsugel to fulfill manufacturing needs for our planned clinical trial activities in cystic fibrosis and, longer term, enable us to manufacture iSPERSE-based products at commercial scale
Financials
"In 2015, we achieved a considerable amount of progress by advancing our proprietary programs and partnered products through an efficient deployment of capital," said William Duke, Jr., chief financial officer of Pulmatrix. "We expect to continue maintaining our fiscal discipline and based on our current operating plan, we believe that we have sufficient capital to fund our pipeline and business activities into mid-2017, when we anticipate to be beyond multiple data readouts and other corporate milestones."
Pulmatrix ended 2015 with $18.9 million in cash and cash equivalents compared to $22.0 million as of September 30, 2015.
Revenues for 2015 were $1.2 million, which were primarily comprised of reimbursed formulation and clinical development expenses related to our research collaboration to develop PUR0200 for COPD. There was $0.4 million of comparable revenues for 2014.
Research and development expense for 2015 was $7.2 million, compared to $6.6 million for 2014. The increase was primarily due to increases in clinical development costs and external service costs on the PUR0200 and PUR1900 projects. General and administrative expense was $17.0 million for 2015, compared to $2.8 million in 2014. The increase was primarily due to increases of $7.5 million in advisory, legal and accounting costs incurred in connection with the merger that resulted in our public listing on Nasdaq (the "Merger") and $5.0 million in stock-based compensation expense.
Net loss for 2015 was $26.2 million compared to a net loss of $24.1 million for 2014. The increase in net loss was primarily attributable to costs incurred in connection with the Merger.
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 rare diseases, including PUR1900, an inhaled anti-fungal for patients with cystic fibrosis (CF). In addition, Pulmatrix is pursuing opportunities in major pulmonary diseases through collaborations, including PUR0200, a branded generic in clinical development for chronic obstructive pulmonary disease (COPD). Pulmatrix's product candidates are based on iSPERSE™, its proprietary 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.