Exhibit 99.1

 

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February 19, 2019

Pulmatrix Reports 2018 Financial Results; Provides 2019 Outlook on Pulmonary Disease Pipeline

LEXINGTON, MA — Pulmatrix, Inc. (NASDAQ: PULM) today announces 2018 financial results, reviews the Company’s recent progress, and provides an outlook for its pulmonary disease development pipeline.

“The funds raised in January and February have extended our cash runway, allowing us to evaluate potential strategic partnership opportunities relating to our pipeline programs. Pulmatrix continues to advance its iSPERSE-based product candidates with a focus on our Pulmazole program that targets fungal infections for severe asthma and cystic fibrosis patients,” said Robert W. Clarke, Ph.D., chief executive officer of Pulmatrix. “With our recently announced IND approval, we are preparing for the Pulmazole Phase 2 trial that we expect to begin in the first half of 2019.”

Projected 2019 Milestones

Pulmazole

 

 

Initiate the planned Phase 2 study in asthmatic patients with allergic bronchopulmonary aspergillosis (ABPA) in the first half of 2019.

 

 

Complete six-month study for GLP inhalation toxicity in animals.

PUR1800

 

 

Initiate CMC development work in preparation for a Phase 2 study in patients with COPD.

2018 Achievements

Pulmatrix achieved several research, clinical and business milestones which reflect the Company’s progress. These achievements include the following:

2018

 

 

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.

 

 

Initiated and completed first patient in Phase 1/1b clinical trial of Pulmazole.

 

 

Pulmazole Ph1/1b study results indicated that Pulmazole was safe and well tolerated when administered as a single-dose of 20 mg inhaled itraconazole in asthmatic subjects. Based on review of the data, the trial successfully achieved all of its objectives.

 

 

Submitted Investigational New Drug (IND) application for Pulmazole to the US Food and Drug Administration.

 

 

Completed CMC development work and 28-day GLP inhalation toxicology studies for PUR1800 in preparation for a future Phase 2 anti-inflammatory efficacy study.

Financials

Pulmatrix ended 2018 with $2.6 million in cash and cash equivalents compared to $3.8 million as of September 30, 2018.

Revenue for 2018 was $0.2 million, compared to $0.3 million for 2017. The decrease was the result of the conclusion of the CFFT award that began in 2017.

Research and development expense was $13.0 million in 2018 compared to $10.2 million in 2017. The increase was primarily due to increased spend of $1.9 million on the Pulmazole project, $0.5 million on the PUR1800 project and $0.3 million in employment costs.

General and administrative expense was consistent for the two years — $7.5 million for 2018 and $7.6 million for 2017.


The following information was filed by Pulmatrix, Inc. (PULM) on Tuesday, February 19, 2019 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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