0001193125-16-499212.txt : 20160310 0001193125-16-499212.hdr.sgml : 20160310 20160310080034 ACCESSION NUMBER: 0001193125-16-499212 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 5 CONFORMED PERIOD OF REPORT: 20160310 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20160310 DATE AS OF CHANGE: 20160310 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Pulmatrix, Inc. CENTRAL INDEX KEY: 0001574235 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 461821392 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-36199 FILM NUMBER: 161496182 BUSINESS ADDRESS: STREET 1: 99 HAYDEN AVENUE STREET 2: SUITE 390 CITY: LEXINGTON STATE: MA ZIP: 02421 BUSINESS PHONE: (781) 357-2333 MAIL ADDRESS: STREET 1: 99 HAYDEN AVENUE STREET 2: SUITE 390 CITY: LEXINGTON STATE: MA ZIP: 02421 FORMER COMPANY: FORMER CONFORMED NAME: Ruthigen, Inc. DATE OF NAME CHANGE: 20130411 8-K 1 d24686d8k.htm FORM 8-K Form 8-K

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

PURSUANT TO SECTION 13 OR 15(d) OF THE

SECURITIES EXCHANGE ACT OF 1934

DATE OF REPORT (DATE OF EARLIEST EVENT REPORTED): March 10, 2016

 

 

PULMATRIX, INC.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   001-36199   46-1821392
(State of incorporation)   (Commission File No.)   (IRS Employer Identification No.)

99 Hayden Avenue, Suite 390

Lexington, MA 02421

(Address of principal executive offices) (Zip Code)

Registrant’s telephone number, including area code: (781) 357-2333

Not Applicable

(Former name or former address, if changed since last report.)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

  ¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

  ¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

  ¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

  ¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 


Item 2.02. Results of Operations and Financial Condition.

On March 10, 2016, Pulmatrix, Inc. (the “Company”) issued a press release announcing its financial results for the fiscal year ended December 31, 2015. A copy of the press release is furnished as Exhibit 99.1 hereto and is incorporated herein by reference.

 

Item 7.01. Regulation FD Disclosure.

On March 10, 2016, the Company posted a letter to shareholders on the Company’s website. A copy of the letter is furnished as Exhibit 99.2 hereto and is incorporated herein by reference.

In accordance with General Instruction B.2 of Form 8-K, the information in this Current Report on Form 8-K, including Exhibits 99.1 and 99.2, is being furnished pursuant to Items 2.02 and 7.01, respectively, and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Exchange Act or the Securities Act of 1933, as amended, except as shall be expressly set forth by reference in such a filing. Furthermore, the furnishing of information under Item 7.01 of this Current Report on Form 8-K is not intended to constitute a determination by the Company that the information contained herein, including the exhibits hereto, is material or that the dissemination of such information is required by Regulation FD.

 

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

 

Exhibit No.

  

Description

99.1    Press Release, issued on March 10, 2016 (furnished herewith pursuant to Item 2.02).
99.2    Shareholder letter (furnished herewith pursuant to Item 7.01).


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

    PULMATRIX, INC.
Date: March 10, 2016     By:  

/s/ William Duke, Jr.

      William Duke, Jr.
      Chief Financial Officer
EX-99.1 2 d24686dex991.htm EX-99.1 EX-99.1

Exhibit 99.1

 

LOGO

March 10, 2016

Pulmatrix Reports 2015 Financial Results; Provides 2016 Outlook on Pulmonary Disease Pipeline

2015 was a transformational year – lead assets for COPD and cystic fibrosis continue to progress in clinical development.

LEXINGTON, MA — Pulmatrix, Inc. (NASDAQ: PULM) today announces 2015 financial results, reviews the Company’s recent progress, and provides an outlook for 2016 for its pulmonary disease development pipeline.

“2015 was a transformational year for Pulmatrix. We positioned the Company to have two iSPERSE-based product candidates in clinical trials during 2016, strengthened our balance sheet, and became publicly listed on NASDAQ,” said Robert W. Clarke, Ph.D., chief executive officer of Pulmatrix. “We expect clinical data in the first half of 2016 on PUR0200 targeting the large market of COPD, and the second program, PUR1900, will enter the clinic this year targeting fungal infections in cystic fibrosis patients. As our product pipeline and iSPERSE technology continue to advance, we feel the Company is well positioned for clinical success in 2016 and beyond.”

In a March 10th letter to shareholders, Dr. Clarke added that the Company aims to keep up its aggressive pace in 2016 “thanks to the dedication of our scientists and management to developing products that can make a real difference in the lives of patients, and to the much-appreciated support of our shareholders.”

Planned 2016 Milestones

Pulmatrix has two major priorities for 2016: Pulmatrix intends to continue to advance PUR0200, a branded generic bronchodilator for COPD, through clinical development and intends to initiate clinical testing for PUR1900, an inhaled anti-fungal initially targeted for patients with cystic fibrosis.

PUR0200

 

    Report data from European pilot pharmacokinetic bioequivalence clinical study of PUR0200, funded as part of a previously disclosed research collaboration agreement, in the first half of 2016

 

    Initiate development work in the second half of 2016 to support a future European pivotal pharmacokinetic bioequivalence approval study

 

    Expand current research collaboration focused on US development to form a more expansive development and commercialization partnership in the second half of 2016

PUR1900

 

    Initiate Phase 1/1b trial in fungal infections in cystic fibrosis patients in the second half of 2016

 

    Expand PUR1900 program to indication(s) outside of cystic fibrosis

PUR1500

 

    Identify the active pharmaceutical ingredient for an IPF candidate(s), which could include a small molecule kinase inhibitor and/or a biologic in the first half of 2016


LOGO

 

2015 and 2016 YTD Progress

In 2015 and early 2016, Pulmatrix achieved several research, clinical and business milestones, reflective of the Company’s progress. These milestones include the following:

 

  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

 

  Completed manufacture of clinical candidates for PUR0200 in the second half of 2015

 

  Initiated a European pilot pharmacokinetic bioequivalence study of PUR0200 in the first quarter of 2016

 

  Reported that PUR1900 was active and potent in in vitro preclinical models against Aspergillus fumigatus and other fungal species that commonly infect cystic fibrosis patients, while achieving high lung concentrations and low systemic exposure in in vivo preclinical models

 

  Announced that a 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)

 

  Further strengthened the Company’s patent portfolio through the receipt of a composition of matter patent related to the iSPERSE™ technology

 

  Entered into a strategic manufacturing agreement with Capsugel to fulfill manufacturing needs for our planned clinical trial activities in cystic fibrosis and, longer term, enable us to manufacture iSPERSE-based products at commercial scale

Financials

“In 2015, we achieved a considerable amount of progress by advancing our proprietary programs and partnered products through an efficient deployment of capital,” said William Duke, Jr., chief financial officer of Pulmatrix. “We expect to continue maintaining our fiscal discipline and based on our current operating plan, we believe that we have sufficient capital to fund our pipeline and business activities into mid-2017, when we anticipate to be beyond multiple data readouts and other corporate milestones.”

Pulmatrix ended 2015 with $18.9 million in cash and cash equivalents compared to $22.0 million as of September 30, 2015.

Revenues for 2015 were $1.2 million, which were primarily comprised of reimbursed formulation and clinical development expenses related to our research collaboration to develop PUR0200 for COPD. There was $0.4 million of comparable revenues for 2014.


LOGO

 

Research and development expense for 2015 was $7.2 million, compared to $6.6 million for 2014. The increase was primarily due to increases in clinical development costs and external service costs on the PUR0200 and PUR1900 projects. General and administrative expense was $17.0 million for 2015, compared to $2.8 million in 2014. The increase was primarily due to increases of $7.5 million in advisory, legal and accounting costs incurred in connection with the merger that resulted in our public listing on Nasdaq (the “Merger”) and $5.0 million in stock-based compensation expense.

Net loss for 2015 was $26.2 million compared to a net loss of $24.1 million for 2014. The increase in net loss was primarily attributable to costs incurred in connection with the Merger.

About Pulmatrix

Pulmatrix is a clinical stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary disease using its patented iSPERSE™ technology. The Company’s proprietary product pipeline is focused on advancing treatments for rare diseases, including PUR1900, an inhaled anti-fungal for patients with cystic fibrosis (CF). In addition, Pulmatrix is pursuing opportunities in major pulmonary diseases through collaborations, including PUR0200, a branded generic in clinical development for chronic obstructive pulmonary disease (COPD). Pulmatrix’s product candidates are based on iSPERSE™, its proprietary dry powder delivery platform, which seeks to improve therapeutic delivery to the lungs by maximizing local concentrations and reducing systemic side effects to improve patient outcomes.

FORWARD-LOOKING STATEMENTS

Certain statements in this press release that are forward-looking and not statements of historical fact are forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The Company cautions that such statements involve risks and uncertainties that may materially affect the Company’s results of operations. Such forward-looking statements are based on the beliefs of management as well as assumptions made by and information currently available to management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including but not limited to the ability to establish that potential products are efficacious or safe in preclinical or clinical trials; the ability to establish or maintain collaborations on the development of therapeutic candidates; the ability to obtain appropriate or necessary governmental approvals to market potential products; the ability to obtain future funding for developmental products and working capital and to obtain such funding on commercially reasonable terms; the Company’s ability to manufacture product candidates on a commercial scale or in collaborations with third parties; changes in the size and nature of competitors; the ability to retain key executives and scientists; and the ability to secure and enforce legal rights related to the Company’s products, including patent protection. A discussion of these and other factors, including risks and uncertainties with respect to the Company, is set forth in the Company’s annual report on Form 10-K filed by the Company with the Securities and Exchange Commission on March 10, 2016. The Company disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

###

Financial Tables to Follow


LOGO

 

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands, except share and per share data)

 

     December 31,  
     2015     2014  

Assets

    

Current assets:

    

Cash and cash equivalents

   $ 18,902      $ 451   

Prepaid expenses and other current assets

     1,560        380   
  

 

 

   

 

 

 

Total current assets

     20,462        831   

Property and equipment, net

     685        470   

Long-term restricted cash

     250        250   

Intangible assets

     7,534        —    

Goodwill

     15,942        —    
  

 

 

   

 

 

 

Total assets

   $ 44,873      $ 1,551   
  

 

 

   

 

 

 

Liabilities and stockholders’ equity (deficit)

    

Current liabilities:

    

Convertible notes payable to stockholders, net of discount

   $ —       $ 39,703   

     1,029        —    

Accounts payable

     1,090        216   

Accrued expenses

     1,486        3,544   
  

 

 

   

 

 

 

Total current liabilities

     3,605        43,463   

Loan payable, net of current portion, debt discount and issuance costs

     5,692        —    

Derivative liability

     11        —    

Preferred stock warrant liability

     —         1,309   

Deferred tax liability

     2,959        —    
  

 

 

   

 

 

 

Total liabilities

     12,267        44,772   
  

 

 

   

 

 

 

Redeemable convertible preferred stock, $0.0001 par value—authorized 500,000 shares and 209,297,265 shares at December 31, 2015 and December 31, 2014, respectively

    

Series B redeemable convertible preferred stock, $0.01 par value — 0 shares and 180,980,200 shares designated at December 31, 2015 and December 31, 2014; 0 shares and 41,788,790 shares issued and outstanding at December 31, 2015 and December 31, 2014, respectively (liquidation preference of $0 and $20,894 at December 31, 2015 and December 31, 2014)

     —         20,894   

Seed Redeemable Convertible Preferred Stock, $0.01 par value — 0 shares and 1,219,508 shares designated at December 31, 2015; 0 shares and 1,219,508 shares issued and outstanding at December 31, 2015 and December 31, 2014, respectively (liquidation preference of $0 and $1,331 at December 31, 2015 and December 31, 2014)

     —         1,331   

Series A-4 Redeemable Convertible Preferred Stock, $0.01 par value — 0 shares and 1,307,190 shares designated; 0 shares and 1,307,190 shares issued and outstanding at December 31, 2015 and December 31, 2014, respectively; (liquidation preference of $0 and $4,000 at December 31, 2015 and December 31, 2014)

     —         4,000   

Series B-1 Redeemable Convertible Preferred Stock, $0.01 par value — 0 shares and 18,687,554 shares designated; 0 shares and 18,687,554 shares issued and outstanding at December 31, 2015 and December 31, 2014, respectively; (liquidation preference of $0 and $9,344 at December 31, 2015 and December 31, 2014)

     —         9,344   

Junior Seed Convertible Preferred Stock, $0.01 par value — 0 shares and 410,000 shares designated; 0 shares and 410,000 shares issued and outstanding at December 31, 2015 and December 31, 2014, respectively; (liquidation preference of $0 and $820 at December 31, 2015 and December 31, 2014)

     —         4   

Stockholders’ Equity (Deficit):

    

Common stock, $0.0001 par value — 100,000,000 shares and 233,500,000 shares authorized at December 31, 2015 and December 31, 2014; 14,745,754 shares and 188,625 shares issued and outstanding, including vested restricted stock units of 229,744 and 0, at December 31, 2015 and December 31, 2014, respectively

     1        —    

Additional paid-in capital

     160,708        23,142   

Accumulated deficit

     (128,103     (101,936
  

 

 

   

 

 

 

Total stockholders’ equity (deficit)

     32,606        (78,794
  

 

 

   

 

 

 

Total liabilities, redeemable convertible preferred stock and stockholders’ equity (deficit)

   $ 44,873      $ 1,551   
  

 

 

   

 

 

 


LOGO

 

CONDENSED CONSOLIDATED RESULTS OF OPERATIONS

(in thousands, except share and per share data)

 

     Years ended
December 31,
 
     2015     2014  

Revenues

   $ 1,201      $ 352   

Operating expenses

    

Research and development

     7,187        6,590   

General and administrative

     17,032        2,838   
  

 

 

   

 

 

 

Total operating expenses

     24,219        9,428   
  

 

 

   

 

 

 

Loss from operations

     (23,018     (9,076

Interest expense

     (953     (15,276

Loss on the conversion of convertible notes

     (1,170     —    

Fair value adjustment of preferred stock warrant liability

     1,309        211   

Fair value adjustment of derivative liability

     (2,291     —    

Other expense, net

     (44     (3
  

 

 

   

 

 

 

Net loss

   $ (26,167   $ (24,144
  

 

 

   

 

 

 

Net loss attributable to common stockholders (Note 16)

   $ (26,167   $ (6,453
  

 

 

   

 

 

 

Net loss per share attributable to common stockholders, basic and diluted

   $ (3.23   $ (34.52
  

 

 

   

 

 

 

Weighted average shares used to compute basic and diluted net loss per share attributable to common stockholders

     8,089,925        186,955   
  

 

 

   

 

 

 

###

 

  Investor Contact        
  Robert Clarke, CEO      William Duke, CFO   
  (781) 357-2333      (781) 357-2333   
  rclarke@pulmatrix.com      wduke@pulmatrix.com   
EX-99.2 3 d24686dex992.htm EX-99.2 EX-99.2

Exhibit 99.2

 

LOGO

March 10, 2016

Dear Fellow Shareholders,

Continuing our Momentum

As Pulmatrix moves into 2016, we wanted to describe to our shareholders the significant progress the Company is making—and how our momentum is expected to continue throughout the upcoming year. Our goal at Pulmatrix is to become a leading developer of innovative, differentiated inhaled therapies for patients suffering from serious pulmonary diseases like cystic fibrosis and chronic obstructive pulmonary disease building around our expertise in Respiratory drug development and our novel iSPERSE inhaled dry powder technology. We are rapidly moving towards that goal, as shown by our results in 2015.

Last year was a transformative one for the Company. We went public on the NASDAQ. We delivered on the promise of our patented iSPERSE technology with a strong pipeline of product candidates and clinical trial results. We announced our PUR1900 drug candidate, the first inhaled antifungal to treat infections in the airways of cystic fibrosis patients. We reported clinical data on lung function improvement in COPD patients with PUR0200, an iSPERSE version of a marketed once daily inhaled bronchodilator; PUR0200 delivered at less than 20% of the reference product dose provided matching lung function improvement. Even with uncertain market conditions and volatile public markets, we have built a strong fundamental story and have maintained the pace of our business activities.

We intend to continue to keep up that pace in 2016, thanks to the dedication of our scientists and management to developing products that can make a real difference in the lives of patients, and to the much-appreciated support of our shareholders.

Advancing our Pipeline

In 2016, management will relentlessly focus on making progress with our two lead clinical development programs: PUR1900, the anti-fungal for cystic fibrosis patients, and PUR0200, a bronchodilator for chronic obstructive pulmonary disease (COPD). At the same time, we are pushing forward quickly on earlier stage work on candidate(s) for idiopathic pulmonary fibrosis (IPF), a fatal rare pulmonary disease.

The markets we are aiming for are significant. We project that the global market for our inhaled antifungal, PUR1900, for cystic fibrosis exceeds $250 million per year at peak sales. The annual worldwide sales for all daily long acting muscarinic antagonist (LAMA) bronchodilators for chronic obstructive pulmonary disease (COPD), such as PUR0200, continue to grow year over year, and is forecasted to top $10 billion by 2020.

Here are some of the milestones we expect to achieve in 2016 with our pipeline of products as we move forward to capture those markets:

For PUR1900:

We are planning to file our Clinical Trial Application (CTA) early in the third quarter of 2016 in the European Union (EU). We have already begun making sufficient quantities of the product for the clinical trial through our recently announced alliance with Capsugel/BEND Research.

 

99 Hayden Avenue, Suite 390 Lexington, MA 02421   t. 781.357.2333   f. 781.357.2399             www.pulmatrix.com


LOGO

 

In addition, Pulmatrix intends to begin a Phase 1/1b trial in healthy normal volunteers and cystic fibrosis patients in the second half of 2016. This multi-site trial is planned for the EU. The Company anticipates favorable safety and tolerability data as well as pharmacokinetic (PK) information from the Phase 1 healthy volunteer portion by end of year 2016. The Phase 1b portion of the trial in CF patients is expected to provide similar data by the first quarter of 2017.

Pulmatrix plans to expand the PUR1900 program outside of cystic fibrosis by the first quarter of 2017, targeting other rare diseases and exploring the use of antifungals to prevent disease as well as to treat existing disease. Pulmatrix expects to move into parallel clinical development of this program in 2017. We estimate the addressable market for prophylactic use of PUR1900 to peak at over $700 million in annual sales. Together with the $250 million annual peak sales for cystic fibrosis, the total potential value of PUR1900 approaches $1 billion annually, with even further opportunities in severe asthma.

For PUR0200:

We started enrollment of a European pilot pharmacokinetic (PK) bioequivalence trial for PUR0200, a once daily bronchodilator for COPD, in January 2016 and completed dosing this past week. We expect clinical pharmacokinetic (PK) data in the first half of 2016.

The PK data sets from the PUR0200 trial are expected to lead into additional development work in the second half of 2016 to support a future European pivotal PK Bioequivalence trial.

We are also expanding an ongoing research collaboration, which is developing a multi-dose dry powder version of PUR0200, into a larger development and commercialization partnership targeting the US market in the second half of 2016.

For PUR1500:

Pulmatrix expects to complete preclinical PK and pharmacodynamic (PD) evaluation of PUR1500, a treatment for idiopathic pulmonary fibrosis (IPF) by the second quarter of 2016. The goal is to select a lead active pharmaceutical ingredient that can slow down the progression of this rare and generally fatal disease. The candidates include small molecule kinase inhibitors and/or novel small molecules focused on an undisclosed target. The market for effective treatments for IPF is projected to be more than $3 billion dollars per year within the next few years.

For CM-YJHO1:

Supported by a Small Business Innovation Research (SBIR) award from the National Institutes of Health, Pulmatrix is collaborating with Celdara Medical to develop a new therapeutic for an additional (though still undisclosed) biological target for IPF. Ongoing preclinical PK/PD studies are expected to enable us to identify a lead product candidate for further advancement.

Maintaining Strong Fundamentals

Pulmatrix is backed by a strong syndicate of U.S. healthcare investors and maintains a strong balance sheet. At the end of 2015, we had approximately $18.9 million in cash.

Pulmatrix Research and Development (R&D) has been reaching our fundamental goals on time and on budget. In addition, our investor relations program is working intensively to increase investor awareness, provide corporate transparency, and offer shareholders an open conduit for communication.

 

99 Hayden Avenue, Suite 390 Lexington, MA 02421   t. 781.357.2333   f. 781.357.2399             www.pulmatrix.com


LOGO

 

In parallel to our R&D efforts, Pulmatrix has initiated extensive business development activities in order to advance our programs. Starting with a previously announced research collaboration around PUR0200, we are actively negotiating with other potential partners to increase the pace of commercial development for additional products in our pipeline.

2016 will be an important year for Pulmatrix. Our smart and experienced team is committed and motivated to bring our products to market as quickly as possible—and those markets are expected to be large because of the many advantages of our iSPERSE technology.

As a result, we believe Pulmatrix is poised to stand out as a technology driven specialty pharma company delivering great value to both patients and investors.

In the coming weeks, we look forward to providing updates and news related to our advancing development pipeline.

Thank you for your interest in Pulmatrix and your continued support.

Respectfully,

Robert W Clarke, PhD

CEO

Pulmatrix Inc.

About iSPERSE™

At the core of our drug development pipeline lies our patented iSPERSE™ technology, which stands for inhaled Small Particles Easily Respirable and Emitted. The iSPERSE™ dry powder technology was developed, patented and validated by our team of scientists and engineers and importantly, we believe solves the significant limitations of other inhaled technologies available today, such as nebulizers, metered dose inhalers, and conventional lactose blend dry powder inhalers.

In short, iSPERSE™ particles are engineered to be small, dense, and easily dispersible. This ensures the powders fly easily upon inhalation, thereby making drugs more efficiently delivered to the airways improving dosing characteristics. This targeted airway delivery of drugs also reduces systemic exposure and potential side effects. Importantly, unlike other traditional inhalation technologies, iSPERSE™ is also flow rate independent, which should provide reliable dose delivery across patient populations regardless of the status of their lung function.

We are well positioned to efficiently apply our technology across several types of pulmonary diseases and therapeutic modalities to build out a deep pipeline of proprietary therapeutic products. Using our internal engineering expertise and an outsourced model of commercial manufacture, Pulmatrix intends to scale its technology to support clinical development and eventual commercial launch of iSPERSE™ products, reducing risk to timelines and burn rate.

 

99 Hayden Avenue, Suite 390 Lexington, MA 02421   t. 781.357.2333   f. 781.357.2399             www.pulmatrix.com


LOGO

 

In addition, we have a robust portfolio of patents relating to our iSPERSE™ technology with more than 100 patents granted or pending in 19 patent families. As our iSPERSE™ platform technology continues to advance through our pipeline, we intend to expand our patent portfolio to capture improvements.

About Pulmatrix

Pulmatrix is a clinical stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary disease using its patented iSPERSE™ technology. The Company’s proprietary product pipeline is focused on advancing treatments for rare diseases, including PUR1900, an inhaled anti-fungal for patients with cystic fibrosis (CF). In addition, Pulmatrix is pursuing opportunities in major pulmonary diseases through collaborations, including PUR0200, a branded generic in clinical development for chronic obstructive pulmonary disease (COPD). Pulmatrix’s product candidates are based on iSPERSE™, its proprietary dry powder delivery platform, which seeks to improve therapeutic delivery to the lungs by maximizing local concentrations and reducing systemic side effects to improve patient outcomes.

FORWARD-LOOKING STATEMENTS

Certain statements in this press release that are forward-looking and not statements of historical fact are forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The Company cautions that such statements involve risks and uncertainties that may materially affect the Company’s results of operations. Such forward-looking statements are based on the beliefs of management as well as assumptions made by and information currently available to management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including but not limited to the ability to establish that potential products are efficacious or safe in preclinical or clinical trials; the ability to establish or maintain collaborations on the development of therapeutic candidates; the ability to obtain appropriate or necessary governmental approvals to market potential products; the ability to obtain future funding for developmental products and working capital and to obtain such funding on commercially reasonable terms; the Company’s ability to manufacture product candidates on a commercial scale or in collaborations with third parties; changes in the size and nature of competitors; the ability to retain key executives and scientists; and the ability to secure and enforce legal rights related to the Company’s products, including patent protection. A discussion of these and other factors, including risks and uncertainties with respect to the Company, is set forth in the Company’s annual report on Form 10-K filed by the Company with the Securities and Exchange Commission on March 10, 2016. The Company disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

###

 

  Investor Contact        
  Robert Clarke, CEO      William Duke, CFO   
  (781) 357-2333      (781) 357-2333   
  rclarke@pulmatrix.com      wduke@pulmatrix.com   

 

99 Hayden Avenue, Suite 390 Lexington, MA 02421   t. 781.357.2333   f. 781.357.2399             www.pulmatrix.com

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