Pulmatrix Provides 2017 Company Year-to-Date Highlights and Q2 2017 Updated Financials
Strengthened Board of Directors and Completed In-License Agreement
"During the second quarter, we further strengthened our board of directors with the appointment of Amit Munshi and added to our pipeline via the completion of the in-license agreement with RespiVert Ltd., a wholly owned subsidiary of Janssen Biotech, Inc. Through the in-license agreement, we gained access to a portfolio of novel drug candidates that we believe are well suited for formulation with our iSPERSE technology and offer an innovative approach for treating lung inflammation in diseases like chronic obstructive pulmonary disease (COPD), asthma, and idiopathic pulmonary fibrosis (IPF)," said Robert W. Clarke, Ph.D., chief executive officer of Pulmatrix. "We believe that adding the Janssen compounds to our pipeline along with our lead inhaled antifungal program and our once-daily bronchodilator gives Pulmatrix a robust group of assets in development for unmet needs in major pulmonary diseases," Dr. Clarke added.
2017 Company Year-to-Date Highlights
Completed In-License of Narrow Spectrum Kinase Inhibitors (NSKI) from RespiVert Ltd. ("RespiVert"), a Wholly Owned Subsidiary of Janssen Biotech, Inc.
In June, 2017, Pulmatrix announced completion of an in license deal with RespiVert Ltd. for three anti-inflammatory molecules targeted for the major pulmonary diseases COPD, asthma, and idiopathic pulmonary fibrosis. We believe these molecules represent a potentially highly valuable class of therapeutic agents that act to reduce inflammation by inhibiting multiple targets within the inflammatory cascade.
The most advanced compound, PUR1800, will be developed as an anti-inflammatory for the treatment of acute exacerbations of COPD (AECOPD). As a treatment of AECOPD, PUR1800 is expected to be used in an acute, episodic paradigm to treat exacerbations, with significantly reduced development costs and risk compared to chronic therapies for COPD based on anticipated study size and duration. PUR1800 has already been successfully tested in a multi dose proof-of-principle trial in COPD patients (completed by RespiVert) which showed inhibition of molecular targets and reduced markers of inflammation. As part of a previous paid feasibility program with RespiVert, Pulmatrix scientists successfully formulated PUR1800 and identified lead development formulations. Developing the molecule in Pulmatrix's iSPERSE technology will more effectively deliver the active molecule to the site of inflammation in the airways. PUR1800 is targeted for a 14-28 day Phase II proof of principle trial in COPD patients expected to complete in Q4 2018.
PUR5700 is an earlier stage compound that has demonstrated efficacy in preclinical models of asthma and COPD, and has activity against key targets relevant to idiopathic pulmonary fibrosis (IPF). Pulmatrix intends to evaluate iSPERSE formulations of the active molecule in appropriate pre-clinical models of IPF to identify lead formulations for consideration for future clinical development.
Completed Scientific Advice Meetings in Sweden and the United Kingdom for PUR0200 Program
Members of the Pulmatrix team along with consultants for the company in CMC, Pharmacokinetics, and Regulatory met with officials from the Swedish MPA and UK MHRA to review the status of PUR0200 as a pharmacokinetic bioequivalent alternative to Spiriva Handihaler. Pulmatrix shared its clinical data on pharmacokinetics in healthy normal volunteers and pharmacodynamics in COPD patients following dosing of PUR0200. Based on the Regulatory feedback from both agencies, the company is moving PUR0200 into pivotal testing for pharmacokinetic bioequivalence to support an EU product registration. Pulmatrix is progressing PUR0200 according to plan and is on target to partner the program in 2017.
Received Notice of Grant of Key Patents for Pulmatrix iSPERSE Platform Technology and PUR0200 Program
In 2017, Pulmatrix received notice of grants of additional patents around our platform technology and PUR0200 that expand on a broad base of patent protection which lasts well into the 2030s. A new EU patent (EP 2410981 B1) provides broad coverage for the iSPERSE platform technology and follows on similar patents that Pulmatrix has been granted in the United States and Japan.
Another new patent, US 9642798, follows both an earlier patent granted in Japan in 2016 (JP 5877204) for the composition of PUR0200 and several broader patents (such as US 9061352, 9119778, 9233158, 9238005 and 9433576) provide protection for Pulmatrix's technology platform and its use to treat a wide variety of diseases. The new patent covers PUR0200, an inhaled drug made by combining Pulmatrix's technology platform with tiotropium bromide. Tiotropium bromide is the active ingredient in Spiriva, a blockbuster inhaled drug with annual global sales of approximately €3 billion in 2016.
Received Qualified Infectious Disease Product (QIDP) Status for PUR1900 Inhaled Antifungal to treat Fungal Infections in the Airways of Cystic Fibrosis (CF) Patients
Earlier in 2017, the company received notification of a grant of QIDP status for PUR1900 for CF. PUR1900 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. When combined with the 2016 grant of Orphan Drug Designation for PUR1900 for CF, the product has twelve (12) years of market exclusivity. Pulmatrix is seeking similar QIDP status for PUR1900 to treat allergic bronchopulmonary aspergillosis (ABPA) in severe asthma patients, a second population with high unmet need. PUR1900 is expected to enter into a Phase IB clinical trial in early Q1 2018 with data readout in Q2 2018. This study will enroll 30 Healthy Normal Volunteers in a two part single ascending dose/multi ascending dose (SAD/MAD) safety and tolerability trial. A third arm of the study will include 12-16 asthma patients who will be treated with PUR1900 or oral itraconazole (Sporanox). Pharmacokinetic levels of the drug will be measured in lung sputum and blood to directly compare the lung versus systemic exposure of itraconazole following oral or inhaled dosing.
As of June 30, 2017, Pulmatrix had $11.0 million in cash and cash equivalents, compared to $4.2 million as of December 31, 2016.
Pulmatrix generated no revenues in the second quarter of 2017, compared to $0.3 million for the second quarter of 2016. The decreased revenue was directly related to the conclusion of the clinical study funded under our collaboration agreement to develop PUR0200 for COPD.
Research and development expenses for the second quarter of 2017 were $3.4 million, compared to $2.4 million for the same period last year. The increase was primarily due to a $1.0 million up-front license fee to RespiVert Ltd. General and administrative expenses for the second quarter of 2017 were $2.1 million, compared to $2.2 million for the same period in 2016. The decrease was primarily due to a decrease in stock-based compensation expense, partially offset by an increase in salaries, legal and professional consultant costs.
Net loss for the second quarter of 2017 was $5.6 million compared to a net loss of $9.2 million in the same period last year. The decrease in net loss was primarily attributable to the non-recurrence of the 2016 write-off of the in-process research and development and the related deferred tax liability acquired as part of Pulmatrix's merger with Ruthigen, net of the noted changes in operating expenses.
Financial Tables to Follow
SOURCE Pulmatrix, Inc.