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March 10, 2017
Pulmatrix Reports 2016 Financial Results; Provides 2017 Outlook on Pulmonary Disease Pipeline
LEXINGTON, MA Pulmatrix, Inc. (NASDAQ: PULM) today announces 2016 financial results, reviews the Companys recent progress, and provides an outlook for 2017 for its pulmonary disease development pipeline.
The Company continues to advance its two iSPERSE-based product candidates and recently strengthened our balance sheet, with the closing of two registered direct offerings that brought in net proceeds of approximately $7.5 million, said Robert W. Clarke, Ph.D., chief executive officer of Pulmatrix. We expect pre-clinical data in the first half of 2017 on PUR1900 targeting fungal infections for severe asthma and cystic fibrosis patients and seek to secure a strategic partner(s) on PUR0200, a branded generic bronchodilator for COPD. As our product pipeline and iSPERSE technology continue to advance, we feel the Company is positioned for success as a leader in the treatment of Respiratory diseases.
Planned 2017 Milestones
Pulmatrix plans to continue advancement of our active pipeline in 2017: Following on our 2016 successful clinical trial in the EU for PUR0200, a branded generic bronchodilator for COPD, the company is planning meetings with both EU and US Regulators regarding the critical path for clinical development to approval and plans to continue development towards initial clinical testing in patients of PUR1900, an inhaled anti-fungal initially targeted for patients with cystic fibrosis and severe asthma.
|||Following up on our successful pharmacokinetic equivalence pilot trial in 2016, Pulmatrix plans to seek scientific advice from three EU countries to gain a better understanding of the pivotal trial design for PUR0200.|
|||Pulmatrix intends to seek a pre-IND meeting with the FDA to inform the US clinical development path for PUR0200 in the second half of 2017.|
|||Continue CMC development work in the first half of 2017 to support a future European pivotal pharmacokinetic bioequivalence approval study as well as the US development path.|
|||Pulmatrix seeks to secure partnership for the rights to PUR0200 in 2017 for a geography or geographies to be determined.|
|||Complete CMC development work and non-clinical safety testing to support clinical development of PUR1900 for severe asthma and cystic fibrosis.|
|||Plan a Phase I/IB trial in healthy normal volunteers (HNV) and severe asthma patients including safety/tolerability and pharmacokinetic readout following inhalation of PUR1900.|
|||Continue pre-clinical development of PUR1500 moving towards lead selection based on either a 505(b)2 or in license opportunity.|
2016 and 2017 YTD Progress
In 2016 and early 2017, Pulmatrix achieved several research, clinical and business milestones, reflective of the Companys progress. These milestones include the following:
|||Completed the pilot study of PUR0200 for patients with chronic obstructive pulmonary disease (COPD) and announced positive pharmacokinetic bioavailability data that informed our continued development of PUR0200 for European Registration.|
|||The U.S. Food and Drug Administration (FDA) granted orphan drug designation to Pulmatrixs wholly-owned drug candidate PUR1900. PUR1900 combines a previously approved anti-fungal drug with its proprietary dry powder iSPERSETM delivery platform to effectively deliver to the lungs a drug used to treat pulmonary fungal infections in patients with cystic fibrosis (CF).|
The following information was filed by Pulmatrix, Inc. (PULM) on Friday, March 10, 2017 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.
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