Pulmatrix Provides Q3 2017 Highlights and Q3 2017 Updated Financials
Completed Out-License Agreement for PUR0200 US Rights and Received Award to Advance Development of Pulmazole
"During the third quarter, we made significant progress with our clinical stage programs. We partnered with Vectura to develop Pulmatrix's drug candidate, PUR0200, for chronic obstructive pulmonary disease (COPD) for the U.S. market. Vectura will be responsible for all future development costs to advance the product for the U.S., thus allowing us to focus on the development of our two lead pipeline programs – Pulmazole, an inhaled anti-fungal for patients with ABPA, and PUR1800," said Robert W. Clarke, Ph.D., chief executive officer of Pulmatrix. "We believe that both Pulmazole (formerly PUR1900) and PUR1800 have blockbuster potential," Dr. Clarke added.
Q3 2017 Highlights
Partnered with Vectura Group plc ("Vectura") to develop Pulmatrix's drug candidate, PUR0200, for chronic obstructive pulmonary disease (COPD) for the U.S. market
Vectura and/or its partners will be responsible for all future development costs to advance the product for the U.S. Pulmatrix will provide the data package for PUR0200 and assist with the transfer of development and manufacturing activities to Vectura. As part of the agreement, a technology access fee of $1 million will be payable to Pulmatrix upon successful achievement of pre-agreed pharmaceutical development criteria. Vectura will pay Pulmatrix a mid-teen percentage share of any future revenues that Vectura receives relating to future development and sale of PUR0200 and PUR0200-related products including future combinations.
Received award from Cystic Fibrosis Foundation Therapeutics (CFFT) to support the development of its lead inhaled anti-fungal product candidate Pulmazole
Pulmazole is targeting the treatment of allergic bronchopulmonary aspergillosis (ABPA) in patients with compromised lung function. The award from CFFT supports advancing Pulmazole toward a Phase 1/1B clinical study in healthy volunteers and asthmatic patients to compare Pulmazole with oral itraconazole dosing in early 2018.
Received notice of grant of two new patents for Pulmatrix iSPERSE™ platform technology and PUR0200 program
Adding to the previously issued intellectual property protection already received on Pulmatrix's iSPERSE drug delivery technology, the new patent makes the technology even more versatile. A drug is typically formulated in the iSPERSE matrix using "excipients"—typically inert ingredients like salts that enhance the drug's utility. The previous patents had provided intellectual property protection for the use of two such excipients. The new patent (US 9744130) adds protection for the use of two more excipients.
The second new patent expands protections for Pulmatrix's PUR0200 drug candidate for COPD. Pulmatrix had previously received several key patents protecting PUR0200. The new patent (US 9737518) broadens the intellectual property protection to include complete protection for the composition of the drug and certain dose ranges.
Additional Recent Highlights
Pulmazole received Qualified Infectious Disease Product (QIDP) designation for a second indication by the U.S. Food & Drug Administration
In October 2017, the company received notification of a grant of QIDP status for Pulmazole for treatment of pulmonary Aspergillus infections in patients with ABPA. Pulmazole is a reformulation of the oral antifungal drug itraconazole for inhaled delivery in iSPERSE. QIDP status conveys five (5) additional years of market exclusivity for the product in this indication. Pulmatrix had previously received QIDP status as well as orphan drug designation from the FDA for Pulmazole (PUR1900) to treat fungal infections in the airways of patients with cystic fibrosis, a rare genetic disease estimated to affect 75,000-100,000 patients worldwide. This new QIDP status expands the eligible ABPA population to include asthmatic patients; 1.5% of adult asthmatics suffer from ABPA. Pulmazole is expected to enter into a Phase IB clinical trial in early Q1 2018 with data readout in mid-2018.
Appointed Dr. James Roach as Chief Medical Officer
In November 2017, Dr. Roach joined Pulmatrix to lead the clinical development of Pulmatrix's innovative inhaled drugs for serious lung diseases, including ABPA and COPD. Dr. Roach was most recently the Chief Medical Officer at Veristat. Prior to joining Veristat, he served as Senior Vice President, Development and Chief Medical Officer of Momenta Pharmaceuticals, Senior Vice President, Medical Affairs at Sepracor Pharmaceuticals, and Head of Medical Affairs at Millennium Pharmaceuticals.
As of September 30, 2017, Pulmatrix had $6.4 million in cash and cash equivalents, compared to $4.2 million as of December 31, 2016.
Pulmatrix generated $0.3 million in revenue in the third quarter of 2017, compared to $0.1 million for the third quarter of 2016. The revenue in 2017 was associated with a grant received from the Cystic Fibrosis Foundation Therapeutics, Inc. and the revenue in 2016 related to the clinical study funded under our collaboration agreement to develop PUR0200 for COPD.
Research and development expenses for the third quarter of 2017 were $2.6 million, compared to $1.5 million for the same period last year. The increase was primarily due to increases in clinical development costs on the Pulmazole project. General and administrative expenses for the second quarter of 2017 were $2.0 million, compared to $1.6 million for the same period in 2016. The increase was primarily due to increases in employment and professional consultant costs.
Net loss for the third quarter of 2017 was $4.5 million compared to a net loss of $3.2 million in the same period last year. The increase in net loss was attributable to the noted operating expense increases, partially offset by the noted increase in revenue.
Financial Tables to Follow
SOURCE Pulmatrix, Inc.