Pulmatrix Reports 3rd Quarter Results; Provides Update On Business & Development Pipeline

LEXINGTON, Mass., Nov. 12, 2015 /PRNewswire/ -- Pulmatrix, Inc. (NASDAQ: PULM) reports third quarter financial results and provides an update on the progress year to date on the business and its drug development pipeline. Since the beginning of the third quarter, the Company has achieved the following milestones:

  • Completed formulation of clinical candidates for a planned European pharmacokinetic bioequivalence study of PUR0200, in chronic obstructive pulmonary disease;
  • 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;
  • Reported that PUR1900 was active and potent in in vitro preclinical models against Aspergillus fumigatus, a common fungal infection in Cystic Fibrosis, while achieving high lung concentrations and low systemic exposure in in vivo preclinical models;
  • Announced that the 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); and
  • Further strengthened the Company’s patent portfolio through the receipt of a composition of matter patent related to the iSPERSE technology.

“During the third quarter, we made progress across our development pipeline of inhaled therapeutics,” said Robert W. Clarke, Ph.D., chief executive officer of Pulmatrix. “In 2016, we expect to report data from the European bioequivalence study of our branded generic for COPD and begin clinical testing for what could become the first inhaled treatment for fungal infections in patients with Cystic Fibrosis. Lastly, as part of our efforts in IPF, we have selected our internal candidate for IND-enabling studies and, through our collaboration with Celdara, continued preclinical formulation studies for a novel biologic aimed at preventing epithelial cell death.”

Financials
Revenues for the third quarter of 2015 were $0.7 million, which were comprised of reimbursed formulation and clinical development expenses related to our research collaboration to develop PUR0200 for COPD. There was $30,000 of comparable revenues for the same period in 2014.

Research and development expenses for the third quarter of 2015 were $2.2 million, compared to $1.9 million for the same period last year. General and administrative expenses for the third quarter of 2015 were $3.1 million, including $2.3 million in non-cash stock based compensation resulting from the stock option grants issued in June 2015, compared to $0.7 million for the same period in 2014. Total operating expenses for the third quarter of 2015 were $5.3 million compared to $2.6 million for the same period in 2014.

Net loss for the third quarter of 2015 was $4.9 million compared to a net loss of $11.1 million in the same period last year. The decrease in net loss is attributable mostly to a $7.9 million interest expense related to the accretion of the debt discount on the notes payable to stockholders in the third quarter of 2014 as compared to interest expense of $0.2 million in the third quarter of 2015.

As of September 30, 2015, Pulmatrix had $22.0 million in cash and cash equivalents, compared to $25.5 million as of June 30, 2015.

“We continued to maintain fiscal discipline, while advancing our proprietary programs and working with our partner on implementing our COPD bioequivalence study,” said William Duke, Jr., chief financial officer of Pulmatrix. “Based on our current operating plan, we believe that we have sufficient capital to fund our pipeline and business activities into mid-2017, which we anticipate to be beyond multiple data readouts and other corporate milestones.”

About Pulmatrix
Pulmatrix is a clinical stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary disease using its patented iSPERSE technology.

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