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Company Spotlight: Pulmatrix

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Shares of Pulmatrix Inc. (PULM) have gained nearly 130% in the last 5 trading days.

Pulmatrix, a clinical stage biopharmaceutical company, is focused on developing innovative inhaled therapies to address serious pulmonary diseases like chronic obstructive pulmonary disease, asthma and cystic fibrosis.

The most advanced product candidate in the company's pipeline is PUR0200, a novel dry powder formulation of a currently marketed once daily LAMA bronchodilator Spiriva HandiHaler, for the treatment of chronic obstructive pulmonary disease, or COPD.

Long acting muscarinic antagonist, or LAMA in short, is the mainstay of treatment for COPD. An estimated 65 million people have moderate to severe chronic obstructive pulmonary disease, according to the World Health Organization.

Spiriva HandiHaler, developed by German pharmaceutical company Boehringer Ingelheim Pharmaceuticals, recorded sales of 1.46 billion euros in the first half of 2016, despite its patent expiring in some markets.

The current clinical development of PUR0200 is focused on pharmacokinetic bioequivalence in Europe.

Pulmatrix has an agreement with Mylan N.V. (MYL) for the development of PUR0200 outside the U.S. that was signed in June 2015. Financial terms of the agreement are confidential.

Last July, Pulmatrix reported positive topline data from a phase I pilot pharmacokinetic bioavailability trial of PUR0200, and the key criteria to demonstrating pharmacokinetic bioequivalence was established.

The pilot trial involved 42 subjects who were randomized to receive a single dose of one of five PUR0200 formulations or the reference product.

Because nearly the entire dose reaches the site of action in the lung and is not swallowed or otherwise lost, PUR0200 can achieve the same effect as Spiriva at 20% of the dose administered, according to the company.

Road ahead for PUR0200...

EU PK Bioequivalence Path

• Actively negotiating partnership rights
• Preferred development path identified with target of next clinical trial FPI Q2 2017.
• PK Bioequivalent product anticipated to be registered in EU by 2019

US 505(b)2 Path

• Pulmatrix actively talking to potential partners about the US rights
• Goal is to partner the program and initiate 505(b)2 development
• Pre-IND meeting will be sought to gain FDA opinion of lower effective dose profile and additional required clinical data for approval
• Based on precedents, Pulmatrix expects at least one Phase 2 and one 12-week Phase 3 safety trial will be required; will evaluate alternate streamlined approach
• Anticipated NDA submission in 2021

Source: Investor presentation in Oct.2016.

Also in the pipeline are:

-- PUR1900 to treat pulmonary fungal infections in patients with cystic fibrosis and severe asthma, under non clinical development.

A 7-day phase I/IA trial of PUR1900, to evaluate safety and tolerability in healthy normal volunteers and patients, is expected to be initiated in the second half of 2017.

If all goes well as planned, a phase II, 28-day Proof-of-Concept study of PUR1900 in cystic fibrosis patients is planned for the second half of 2018.

On January 17, 2017, PUR1900 was designated as a "Qualified Infectious Disease Product" by the FDA. PUR1900 was bestowed the FDA's orphan drug status tag last August. The two designations entitle PUR1900 for a full 12 years of market exclusivity.

-- PUR1500, an inhaled antifibrotic for idiopathic pulmonary fibrosis, which is under preclinical testing.

Key Financial Data:

- Total shares outstanding: 16.85 million
- Cash on hand at September 30, 2016: $7.3 million

On January 30, 2017, the company agreed to sell an aggregate of about 2 million shares of common stock, at a price of $2.50 each in a registered direct offering. The estimated net proceeds to the company from the offering are expected to be approximately $4.5 million.

PULM touched a 52-week high of $6.98 on Thursday, before closing the day's trading at $5.10, up 36.73%.

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