PULM: Pulmatrix Analysis and Research Report

2018-02-15 - by Asif , Contributing Analyst - 465 views

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Business

The Company is a clinical stage biotechnology company focused on the discovery and development of a novel class of inhaled therapeutic products. The Company's proprietary dry powder delivery platform, iSPERSE (inhaled Small Particles Easily Respirable and Emitted), is engineered to deliver small, dense particles with highly efficient dispersibility and delivery to the airways, which can be used with an array of dry powder inhaler technologies and can be formulated with a variety of drug substances. The Company is developing a pipeline of iSPERSE-based therapeutic candidates targeted at prevention and treatment of a range of respiratory diseases and infections with significant unmet medical needs. Since its inception in 2003, Pulmatrix has devoted substantially all of its efforts to product research and development. The company do not have any products approved for sale and have not generated any revenue from product sales. Pulmatrix has funded its operations to date through proceeds from issuances of common and convertible preferred stock, issuances of convertible debt, collaborations with third parties and non-dilutive grants received from government agencies.

The company expect to continue to incur significant expenses and increasing operating losses for at least the next several years based on its drug development plans. The company expect its expenses and capital requirements will increase substantially in connection with its ongoing activities, as the company:

initiate and expand clinical trials for PUR1900 for patients with severe lung disease; seek regulatory approval for its product candidates; hire personnel to support its product development, commercialization and administrative efforts; and advance the research and development related activities for inhaled therapeutic products in its pipeline.

The company will not generate product sales unless and until the company successfully complete clinical developments and obtain regulatory approvals for its product candidates. Additionally, the company currently utilize third-party contract research organizations, or CROs, to carry out its clinical development activities, and the company do not yet have a commercial organization. If the company obtain regulatory approval for any of its product candidates, the company expect to incur significant expenses related to developing its internal commercialization capability to support product sales, marketing and distribution. Accordingly, the company anticipate that the company will seek to fund its operations through public or private equity or debt financings or other sources, potentially including collaborative commercial arrangements. Likewise, the company intend to seek to limit its commercialization costs by partnering with other companies with complementary capabilities or larger infrastructure including sales and marketing.

On June 9, 2017, the Company entered into a License, Development and Commercialization Agreement (the License Agreement) with RespiVert Ltd. (RespiVert), a wholly owned subsidiary of Janssen Biotech, Inc., pursuant to which RespiVert granted the Company an exclusive, royalty-bearing license in its intellectual property portfolio of materials and technology related to narrow spectrum kinase inhibitor compounds (the Licensed IP), to develop and commercialize products worldwide that incorporate the Licensed IP. The development, application, design and marketing of the Licensed IP and any licensed products will be managed exclusively by the Company.

Under the terms of the License Agreement, the Company paid RespiVert an up-front, non-refundable license fee of $1,000,000 in partial consideration for the rights granted by RespiVert to the Company, and will pay RespiVert designated amounts when any licensed product achieves certain developmental milestones. Following the commencement of commercial sales of the licensed products, the Company will pay RespiVert designated amounts when certain milestone events occur. The development milestones and commercial milestones range from $1,000,000 to $80,000,000 depending upon the significance of the particular milestone. The Company is also required to pay RespiVert royalties on all sales of licensed products, with such royalties ranging from 6%—10% of sales.

On September 5, 2017, the Company entered into a Feasibility and Development Agreement to develop Pulmatrix's drug candidate, PUR0200, for chronic obstructive pulmonary disease (COPD) for the U.S. market with Vectura Limited (“Vectura”). 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 commence development immediately and 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.

Because of the numerous risks and uncertainties associated with product development, Pulmatrix is unable to predict the timing or amount of increased expenses or when or if the company will be able to achieve or maintain profitability. Even if Pulmatrix is able to generate product sales, the company may not become profitable. If the company fail to become profitable or are unable to sustain profitability on a continuing basis, then the company may be unable to continue its operations at planned levels and be forced to reduce or terminate its operations.

Pipeline

Pulmatrix is advancing a pipeline of product candidates to treat serious pulmonary diseases. The company's first-in-class anti-fungal product candidate for treating allergic bronchopulmonary aspergillosis (ABPA) in severe asthma and cystic fibrosis (CF) will enter Phase 1 in 2018. PUR1800 is the most advanced program in its proprietary pipeline, having completed a Phase 2a study in COPD patients, with continued development of an iSPERSE formulation focused on treatment of acute exacerbations in COPD. PUR5700 is a preclinical program focused on assessment of the compound for use in IPF and development activities focused on supporting Phase 1.

The company's branded generic of Spiriva HandiHaler, PUR0200 has completed two clinical trials in support of establishing bioequivalence to the reference product in Europe and is poised to enter pivotal studies to support registration.

PUR1900 is an iSPERSE™ formulation incorporating a large, complex anti-fungal compound that can be administered at high therapeutic dose to the lung while minimizing systemic side effects. Patients with severe asthma and CF are afflicted with ABPA, a complex hypersensitivity reaction that occurs in response to colonization of the airways with Aspergillus fumigatus. It is estimated that 2.5% of asthmatics and nearly 15% of patients with cystic fibrosis CF suffer from ABPA, which is associated with severe exacerbations and poor long term outcomes. PUR1900 is the first inhaled anti-fungal product candidate for severe asthma and CF.

PUR1800 is a narrow-spectrum kinase inhibitor (NSKI) recently in-licensed from Respivert, a subsidiary of Janssen Pharmaceuticals. NSKIs inhibit steroid resistant inflammatory processes induced by a variety of stimuli including cytokines, pathogens and free radical stressors such as cigarette smoke. PUR1800 has completed a Phase 2a clinical trial in COPD patients and will be reformulated into an iSPERSE formulation that can be used as a treatment for acute exacerbations of COPD (AECOPD). Acute exacerbations cause significant morbidity and mortality in COPD and are currently poorly managed with existing therapies.

PUR5700 is a second NSKI in preclinical development. Preclinical data demonstrate the potential of PUR5700 to be used broadly in COPD to prevent or treat AECOPD, to treat severe asthma and as a therapy for IPF.

PUR0200 is a once-daily, inhalable iSPERSE™ reformulation of tiotropium bromide for COPD patients. PUR0200 is under development as a substitutable product for Spiriva® HandiHaler® in the European Union (EU) and as a branded alternative to Spiriva HandiHaler in the US.

Recent development

Feb. 12, 2018 Pulmatrix, Inc. a clinical stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary diseases announced today that the single dose escalation phase of the first-in-human study for Pulmazole (PUR1900) - an inhaled iSPERSE™ formulation of the anti-fungal drug itraconazole for the treatment of allergic bronchopulmonary aspergillosis (ABPA) in patients with asthma - has commenced.

ABPA is a disease that occurs most often in patients with underlying asthma or cystic fibrosis, and it is characterized by an exaggerated allergic hypersensitivity response of the immune system to the fungus Aspergillus growing in the airways. Oral itraconazole (Sporanox®) is currently used as an adjunctive treatment to corticosteroids in ABPA patients. However, its use is limited by poor bioavailability, variable pharmacokinetics, and toxicity concerns related primarily to the risk of gastrointestinal and cardiac side effects, as well as extensive drug-drug interactions. The Pulmatrix Pulmazole program is the first inhaled dry powder version of itraconazole known to the company to be advanced into clinical development, with the goal of improving upon the known safety and efficacy profile associated with oral Sporanox by delivering the drug directly to the lung.

This phase 1/1b study is being conducted in healthy subjects and patients with mild to moderate stable asthma. The study will include single ascending dose (SAD) and multiple ascending dose (MAD) arms in normal healthy volunteers (NHV) to assess safety, tolerability, and pharmacokinetics (PK). A third study arm will evaluate safety and tolerability in patients with mild to moderate stable asthma and will also include PK analysis of itraconazole levels in the blood and sputum following administration of a single dose of oral itraconazole (Sporanox; 200 mg itraconazole) or Pulmazole (20 mg itraconazole) in a crossover study design.

"Dosing its first subject with Pulmazole and entering the clinic represents a major milestone for this program commented Jim Roach, M.D., Chief Medical Officer of Pulmatrix. In addition to generating the requisite safety and tolerability data from this study to advance dosing of Pulmazole into asthmatic patients with ABPA, the company anticipate that the collective pharmacokinetic data obtained in Phase 1 will further corroborate the key PK preclinical findings reported last week at the 8th Advances Against Aspergillosis Conference in Lisbon, Portugal - namely, that Pulmazole can provide higher lung exposure and lower systemic exposure than oral Sporanox."

The study is planned to include up to 42 subjects in the SAD/MAD evaluation in NHV and 16 asthmatics in the crossover study. The company expects that top line results will be available in mid-2018.

Robert Clarke, Ph.D., Chief Executive Officer of Pulmatrix, added "The initiation of its Pulmazole clinical trial is important validation of its iSPERSE dry powder technology as the second program to advance into the clinic along with PUR0200. The company look forward to advancing Pulmazole and its iSPERSE pipeline to improve the treatment approaches for patients with unmet medical needs."


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