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See Important Disclosures and Disclaimers at the end of this report. 1 12/15/15 Laura S Engel, CPA Laura S Engel, CPA [email protected] 2149874121 COMPANY DESCRIPTION Pulmatrix, Inc., is a clinical stage biopharma company developing inhaled therapies to address certain pulmonary diseases with its proprietary technology, iSPERSE™. The basis of the iSPERSE technology involves engineered spray-dried particles that enable the efficient delivery of inhaled therapeutics to the lungs. The iSPERSE technology platform can be utilized to create inhaled formulations for a wide range of therapeutics, including biologics. The company currently has an R&D collaboration with Mylan on its chronic obstructive pulmonary disease (COPD) candidate, PUR0200, a branded generic that has completed a Phase 1 trial in COPD patients. Pulmatrix also has two programs underway targeting rare diseases – an anti-fungal for the treatment of cystic fibrosis (CF) and an anti-fibrotic targeting idiopathic pulmonary fibrosis (IPF). The company is headquartered in Lexington, MA. SUMMARY While the company is in the earlier stages of clinical development with its three drug candidates, Pulmatrix offers an opportunity for investors looking to participate in the development of pulmonary therapeutics targeting significant markets with a unique drug delivery platform: PUR0200 is Pulmatrix’s lead product candidate, having completed a Phase 1b for patients with moderate to severe COPD. Results showed a significantly reduced effective dose compared to the reference product. In Europe, the company has partnered with Mylan to develop PUR0200, with additional trials to begin 1H16. PUR0200 could be the first branded generic of an estimated $5 billion worldwide market. Pulmatrix is developing PUR1900, which could become the first inhaled anti- fungal for CF representing a potential $300 MM opportunity. Specifically, PUR1900 is an iSPERSE formulation of Itraconazole targeting pulmonary aspergillus infections, estimated to affect over 60% of US adolescents and adults with CF. Additionally, PUR1900 could be developed for several other rare indications, where aspergillus arises. PUR1500 is a novel inhaled anti-fibrotic targeting IPF, advancing to clinical studies in the near-term with attractive market potential. The company’s novel iSPERSE technology delivers therapeutics in an inhaled dry powder that supports increased drug loading and solves many formulation issues; thus, this platform is capable of delivering a wide range of APIs – small molecules, combinations, peptides, proteins, and biologics, including antibodies. In addition to its partnership with Mylan, Pulmatrix actively considers both in- licensing and out-licensing development prospects; the company recently announced a $1.7M NIH research grant to work with Celdara, Inc., on an inhaled anti-fibrotic labeled CM-YJH01. The company has a solid patent portfolio, with extensive protection surrounding its proprietary iSPERSE technology; to date, Pulmatrix reports 37 issued patents worldwide covering its IP through 2030. As most recently reported, the Company has approximately $22 million in cash on hand, which is expected to support continued development into mid-2017. Pulmatrix is well-positioned to leverage its novel iSPERSE technology in combination with the three drug candidates currently progressing within its pipeline. The Company has a current market capitalization of $56M and enterprise value of $40.7M versus comparable companies’ median market capitalization of $175.1M and median enterprise value of $68.3M. CONDENSED BALANCE SHEET ($mm, except per sh data) Balance Sheet Date: 9/30/2015 Cash & Cash Equivalent: $22.03 Cash/Share: $1.50 Debt: $6.73 Equity (Book Value): $35.91 Equity/Share: $2.45 MARKET STATISTICS Exchange / Symbol Nasdaq:PULM Price: $3.82 Market Cap ($mm): $55.98 Enterprise Value: $40.68 Shares Outstanding: 14.65M Insider Ownership: 57% Volume (3 month avg): 12,000 52 Week Range: $3.30-$14.55 Industry: Biotechnology CONDENSED INCOME STATEMENTS ($mm, except per sh data) FY - 12/31 Revenue Net Loss EPS FY13 $0.65 ($13.31) ($78.78) FY14 $0.35 ($24.14) ($34.51) FY15E $1.23 ($26.73) ($3.31) Fy16E $0.51 ($21.82) ($1.45) LARGEST SHAREHOLDERS Polaris Venture Mgmt. Co., LLC 5,200,000 Arch Venture Partners, LP 2,287,000 5AM Venture Management, LLC 1,361,000 Altitude Life Sciences Ventures 436,000 The Vanguard Group, Inc. 20,000 Goldman Sachs Group 19,000 Morgan Stanley 9,000 Blackrock, Inc. 2,000 STOCK CHART $0.00 $3.00 $6.00 $9.00 $12.00 $15.00

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Page 1: PULM DEC 2015 - Stonegate Capitalstonegateinc.com/reports/PULM_DEC_2015.pdf · treatment of pulmonary fungal infections for cystic fibrosis • PUR1500 – a proprietary inhaled anti-fibrotic

See Important Disclosures and Disclaimers at the end of this report.

1

12/15/15

Laura S Engel, CPA

Laura S Engel, CPA [email protected]

214-­‐987-­‐4121  

COMPANY DESCRIPTION

Pulmatrix, Inc., is a clinical stage biopharma company developing inhaled therapies to address certain pulmonary diseases with its proprietary technology, iSPERSE™. The basis of the iSPERSE technology involves engineered spray-dried particles that enable the efficient delivery of inhaled therapeutics to the lungs. The iSPERSE technology platform can be utilized to create inhaled formulations for a wide range of therapeutics, including biologics. The company currently has an R&D collaboration with Mylan on its chronic obstructive pulmonary disease (COPD) candidate, PUR0200, a branded generic that has completed a Phase 1 trial in COPD patients. Pulmatrix also has two programs underway targeting rare diseases – an anti-fungal for the treatment of cystic fibrosis (CF) and an anti-fibrotic targeting idiopathic pulmonary fibrosis (IPF). The company is headquartered in Lexington, MA.

SUMMARY

While the company is in the earlier stages of clinical development with its three drug candidates, Pulmatrix offers an opportunity for investors looking to participate in the development of pulmonary therapeutics targeting significant markets with a unique drug delivery platform:

• PUR0200 is Pulmatrix’s lead product candidate, having completed a Phase 1b for patients with moderate to severe COPD. Results showed a significantly reduced effective dose compared to the reference product. In Europe, the company has partnered with Mylan to develop PUR0200, with additional trials to begin 1H16. PUR0200 could be the first branded generic of an estimated $5 billion worldwide market.

• Pulmatrix is developing PUR1900, which could become the first inhaled anti-fungal for CF representing a potential $300 MM opportunity. Specifically, PUR1900 is an iSPERSE formulation of Itraconazole targeting pulmonary aspergillus infections, estimated to affect over 60% of US adolescents and adults with CF. Additionally, PUR1900 could be developed for several other rare indications, where aspergillus arises.

• PUR1500 is a novel inhaled anti-fibrotic targeting IPF, advancing to clinical studies in the near-term with attractive market potential.

• The company’s novel iSPERSE technology delivers therapeutics in an inhaled dry powder that supports increased drug loading and solves many formulation issues; thus, this platform is capable of delivering a wide range of APIs – small molecules, combinations, peptides, proteins, and biologics, including antibodies.

• In addition to its partnership with Mylan, Pulmatrix actively considers both in-licensing and out-licensing development prospects; the company recently announced a $1.7M NIH research grant to work with Celdara, Inc., on an inhaled anti-fibrotic labeled CM-YJH01.

• The company has a solid patent portfolio, with extensive protection surrounding its proprietary iSPERSE technology; to date, Pulmatrix reports 37 issued patents worldwide covering its IP through 2030.

• As most recently reported, the Company has approximately $22 million in cash on hand, which is expected to support continued development into mid-2017.

• Pulmatrix is well-positioned to leverage its novel iSPERSE technology in combination with the three drug candidates currently progressing within its pipeline. The Company has a current market capitalization of $56M and enterprise value of $40.7M versus comparable companies’ median market capitalization of $175.1M and median enterprise value of $68.3M.

CONDENSED BALANCE SHEET

($mm,  except  per  sh  data)  

Balance  Sheet  Date:   9/30/2015  Cash  &  Cash  Equivalent:   $22.03  Cash/Share:   $1.50  

       

Debt:   $6.73  Equity  (Book  Value):   $35.91  Equity/Share:   $2.45      

MARKET STATISTICS

Exchange  /  Symbol     Nasdaq:PULM  Price:   $3.82  Market  Cap  ($mm):   $55.98  Enterprise  Value:   $40.68  Shares  Outstanding:   14.65M  Insider  Ownership:   57%  Volume  (3  month  avg):   12,000  52  Week  Range:   $3.30-$14.55  Industry:                                                                                                          Biotechnology  

CONDENSED INCOME STATEMENTS ($mm,  except  per  sh  data)  

FY - 12/31 Revenue Net Loss EPS

FY13   $0.65   ($13.31)   ($78.78)  

FY14   $0.35   ($24.14)   ($34.51)  

FY15E   $1.23   ($26.73)   ($3.31)  

Fy16E   $0.51   ($21.82)   ($1.45)  

LARGEST SHAREHOLDERS  Polaris  Venture  Mgmt.  Co.,  LLC                                          5,200,000        Arch  Venture  Partners,  LP                                                            2,287,000  

5AM  Venture  Management,  LLC                                      1,361,000  

Altitude  Life  Sciences  Ventures                                                436,000  

The  Vanguard  Group,  Inc.                                                                          20,000  

Goldman  Sachs  Group                                                                                        19,000    

 Morgan  Stanley                                                                                                                    9,000  

Blackrock,  Inc.                                                                                                                          2,000  

 

 

 

 

 

 

 

 

STOCK CHART

$0.00

$3.00

$6.00

$9.00

$12.00

$15.00

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BUSINESS OVERVIEW

Pulmatrix is a clinical stage biopharmaceutical company, which owns a novel, patented technology – iSPERSE. This drug delivery platform enables the company’s therapeutics to be inhaled, and initially the company is targeting the treatment of serious pulmonary diseases with iSPERSE. Three principal product candidates populate the company’s internal drug development pipeline:

• PUR0200 – a branded generic bronchodilator for COPD that currently has no generic competition

• PUR1900 – a proprietary inhaled anti-fungal for the treatment of pulmonary fungal infections for cystic fibrosis

• PUR1500 – a proprietary inhaled anti-fibrotic with therapeutic potential to treat idiopathic pulmonary fibrosis

For its lead candidate PUR0200, the company has already completed a Phase 1b study for patients suffering from COPD. Pulmatrix has partnered EU development with Mylan. Additionally, the company’s pipeline focuses on advancing treatment for two rare diseases – PUR1900 as an anti-fungal therapy for CF and PUR1500 as an anti-fibrotic for IPF. Both conditions have significant unmet medical needs. Furthermore, the company has recently disclosed a $1.7M NIH research grant to work in collaboration with Celdara, Inc., to develop an inhaled anti-fibrotic biologic know as CM-YJH01. And Pulmatrix management continues to entertain discussions both for in-license and out-license opportunities with the goal that its technology and therapeutics may be applied more broadly. To date, the company has not generated any product sales but does recognize development revenues from an R&D collaboration with Mylan; additionally, Pulmatrix recognizes some grant revenue from government agencies. Moving forward with the iSPERSE technology (inhaled Small Particles Easily Respirable and Emitted), Pulmatrix envisions many more applications for this novel drug delivery technology than conventional pulmonary delivery approaches. The basis for iSPERSE is an inhaled dry powder technology. These are small, dense and dispersible dry powders made up of proprietary combinations of cationic salts and excipients proven to deliver their payloads with great efficiency. While there are other inhalation technologies available such as nebulizers, metered dose inhalers, and conventional lactose blend dry powder inhalers, the engineering around the design of the iSPERSE particles, making them very small, dense, and easily dispersible, results in a superior delivery to the airways. And notably, iSPERSE is flow rate independent, meaning that it delivers a predictable dosage across all patient populations, regardless of the patient’s lung function status. The company has experience in scaling manufacturing (Kg quantities) under GMP conditions. This one-step, flexible to scale process utilizes standard production and filling equipment. Pulmatrix has also been able to achieve variegated formulation concepts for particle production to add certain advantages to the product, such as varying particles size and formulation.

The company’s IP portfolio covers its iSPERSE technology and protects this novel drug platform relating to the efficient delivery of inhaled therapeutics. As most recently reported, Pulmatrix had 37 issued patents worldwide covering iSPERSE technology through at least 2030. In addition to numerous pending patent applications, this patent portfolio safeguards the company’s technology with multiple layers of protection for its formulation concepts for small dense dry powders that encompass a wide array of pharmaceutical agents that can be efficiently delivered to the lungs.

Exhibit 1: Small, Dense Inhalable iSPERSE Particles

Source: Company Reports Prior to June 15, 2015, Pulmatrix acquired Ruthigen, Inc., via a reverse merger. PULM assumed certain rights to RUT58-60, a product designed to reduce infections related to post-operative invasive procedures. However, this is no longer a primary focus of Pulmatrix. PULM is actively working on a partnership for RUT58-60 to monetize the asset as it is not part of the company’s core focus on pulmonary disease.

CLINICAL TRIALS PROGRESS

The company has outlined the progress below for its drug development programs: Exhibit 2: Pulmatrix Pipeline

Source: Company Reports

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Pulmatrix’s iSPERSE formulation of a currently marketed once daily bronchodilator, PUR0200, has completed a Phase 1 PK bioequivalence study in Europe in moderate to severe COPD patients; results show a substantially reduced dose (possibly up to 80% reduction) compared to the reference product with similar effects. The drug was well tolerated and had significantly improved lung function relative to placebo. The company has completed formulation of clinical candidates for its next European study with the aim of achieving a bioequivalence match (i.e. Cmax & AUC). Pulmatrix has partnered with Mylan on this product to fund development of the next trial in Europe. This PK bioequivalence trial could begin as early as 1H16. In the US, PUR0200 would follow a 505(b)2 regulatory pathway.

PUR1900 is also seeking 505(b)2 approval in the US as an orphan drug product. Pulmatrix anticipates starting a Phase 1/1b in the 2H16 with PUR1900 as an inhaled anti-fungal for cystic fibrosis patients with pulmonary infections. If successful, as compared to current oral therapies, PUR1900 has the potential to:

• Deliver high concentration of the drug directly to the site of infection

• Reduce the required therapeutic dose and required duration of treatment

• Improve efficacy and tolerability • Limit systemic exposure to the anti-fungal drug and drug

to drug interactions

Management estimates that this product could launch as early as 2021 and notes several other potential rare indications that could be treated with the same inhaled drug product (for example – immunosuppressed patients at risk for fungal infections such as lung transplant patients). To date, PUR1900 has shown to be active and potent in preclinical models against a common fungal pathogen (asperillus) in CF, while also achieving high lung concentrations and low systemic exposure as a result of the iSPERSE delivery methodology.

PUR1500 has been in the early stages of pre-clinical and formulation development for IPF, a rare and fatal pulmonary disease. The company anticipates that inhaled administration of this drug candidate will have both improved efficacy and tolerability (less side effects) than approved therapies. In addition, in October 2015, Pulmatrix announced that it will be collaborating on product candidate CM-YJH01 as an inhaled anti-fibrotic for the treatment of idiopathic pulmonary fibrosis with Celdara, Inc. The NIH has awarded a three-year, $1.7M research grant for the development of this novel biologic utilizing the iSPERSE platform.

MARKET OVERVIEW

COPD Chronic obstructive pulmonary disease is a somewhat broad term used to describe several progressive lung diseases including:

• Emphysema • Chronic bronchitis • Refractory asthma • Certain forms of bronchiectasis

COPD affects over 24 million Americans, and over 800,000 hospitalizations per year are attributed to the condition. COPD is characterized by increasing breathlessness, frequent coughing, wheezing, and tightness in the chest. Early screening can identify COPD to prevent further loss of lung function. Most of the cases are caused by inhaling pollutants, including smoke, second-hand smoke, fumes, chemicals and dust. Additionally, research shows that there are genetic risk factors as well. Per company reports, for a therapeutic such as PUR0200 once commercialized, potential sales in the EU are estimated at $300 - $500 million and $450 - $650 million in the US. Cystic Fibrosis CF is an inherited life-threatening disorder that damages the lungs and digestive system. There are approximately 30,000 people living with CF in the US, and that number grows to approximately 70,000 worldwide. Over 1,000 new cases are diagnosed annually. Cystic fibrosis patients suffer from a thick, sticky mucus that builds up in their lungs, putting them at greater risk for lung infections caused by bacteria. Those with CF have to be extremely mindful to minimize their contact with germs. The buildup of mucus in the pancreas can stop or limit the absorption of food and nutrients, which can result in malnutrition and stunt growth. Mucus can also build up in the liver, resulting in liver disease.

Because of current courses of therapy and earlier diagnosis, today’s mean predicted survival age is almost 40; in the mid-1900s, a child with CF rarely made it to grade school age. There are no cures, only treatments to address symptoms and reduce complications. While CF patients are routinely threatened by both bacteria and fungal threats, should PUR1900 be commercialized, it could be the first inhaled anti-fungal treatment for CF (as well as for other immunocompromised conditions), estimated as a potential $1 billion opportunity for all indications by Pulmatrix. Exhibit 3: Organs Most Commonly Affected by CF Source: Healthwise, Inc.

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IPF Idiopathic pulmonary fibrosis is a condition actually five times more common than CF, yet the disease is virtually unknown. It is characterized by scarring of the lungs, which thickens the lining of the lungs, and causes irreversible loss of the tissue’s ability to transport oxygen. There is no known cause for IPF, and currently there are no FDA approved treatments. Approximately two-thirds of patients diagnosed pass away within five years. It is estimated that around 128,000 people in the US have IPF, and about 48,000 new cases are diagnosed annually. Similar to breast cancer statistics, approximately 40,000 people die each year to IPF.

The market potential for this anti-fibrotic treatment is significant; previous deals based on pre-clinical and Phase 1 data with large pharma for promising IPF candidates have ranged from approximately $400 million to over $1 billion.

RISKS

As with any investment, there are certain risks associated with Pulmatrix’s operations as well as with the industry dynamic and surrounding economic and regulatory environments.

• Biotechnology companies as a whole tend to be small with only one to a few compounds in development. Many biotech companies operate with losses because the time to develop a compound is lengthy. The biotechnology industry is a very research intensive industry and as a result, the cash burn for many companies is initially high, with offsetting revenues being little to none. Should the company fail to successfully commercialize a product, it may be forced to cease operations.

• It can take several or up to 12 to 15 years for an experimental drug to go from early stage concept to approval following an often long and arduous process. Every stage from production to manufacture, to research and development are highly regulated. In the US, Canada, and Europe, there are regulatory agencies that heavily enforce regulations. Many of these regulations are promulgated by legislation surrounding issues such as licensing, manufacturing, contract research, research and testing, governmental review and approval of clinical results. All must be addressed prior to marketing of the therapeutic, and competitors can be not far behind in the race.

• Pulmatrix works with strategic partners that assist in taking its therapeutics to market. These arrangements defray the enormous costs associated with the successful commercialization of a product. The company faces significant competition for these partners’ resources and could have difficulty attracting the top corporate and academic collaborators in the marketplace. Additionally, negotiating favorable terms can be very intricate and a time-consuming task.

• The Company has 37 patents issued to protect its proprietary rights covering its iSPERSE technology worldwide through at least 2030. Even if patents are issued, they can be challenged by competitors.

Additionally, competitors can develop modified, non-infringing versions of the drug in order to obtain generic approval for sales. Litigation related to IP infringement can be lengthy and very costly to prove.

• Since inception, the company has incurred significant losses. Management expects to incur significant operating losses as it continues product research and development and clinical trials. Therefore, Pulmatrix will likely need additional financing in the future to fund its ongoing R&D programs. If the Company raises money through convertible debt or equity, there is risk of shareholder dilution. Additionally, the company may not find capital under favorable terms depending on the timing and the amount of funds needed.

Exhibit 4: Potential Dilution for PULM Shares

Source: Capital IQ, Stonegate Capital Partners

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INCOME STATEMENTS

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VALUATION

Pulmatrix is a clinical stage biopharmaceutical company with no current products commercialized. While the company does recognize some revenue from feasibility studies done on behalf of other pharmaceutical companies as well as grant revenue from government agencies, it will be several years before Pulmatrix generates any significant top line numbers. The company reports that its current cash balance of $22 million should last into mid-2017 in order to achieve critical milestones within its pipeline. Our income statements for 2015 E and 2016 E are in-line with management’s cash burn guidance and result in a net loss of ($26.73) million, or a loss per share of ($3.31), and a net loss of ($21.82) million, or ($1.45) per share, respectively. We note that 2015 numbers include the costs of the merger on 6/15/15 and new listing for PULM in Q2. Pulmatrix currently has three product candidates in its development pipeline – PUR0200 as a therapeutic for patients suffering from COPD, PUR1900 as an anti-fungal treatment for CF patients, and PUR1500 as an anti-fibrotic for the treatment of IPF. Notably, PUR0200 has the potential to begin generating sales within the next 3 years and has reached a Phase 2 status in clinical trials. Additionally, the worldwide market for PUR0200 is the most significant of the three candidates – with the current leading branded product reporting almost $4 billion in sales in 2014. The company expects to report PUR1900 Phase 1b clinical data in the 2H 2016 and pre-clinical data for PUR1500 in Q1 2016. As these product candidates progress in the pipeline, they will build the PULM share value, but they remain in early stages of development to date. Below we have included a comparative analysis for review. Pulmatrix is uniquely positioned to leverage its novel iSPERSE technology in combination with the three drug candidates currently progressing within its pipeline. The Company has a current market capitalization of $56M and enterprise value of $40.7M versus comparable companies’ median market

capitalization of $175.1M and median enterprise value of $68.3M. Given the novel aspects of its pipeline, the market potential of a successful drug, and the market capitalization afforded by the street to comparable companies, PULM would be well positioned if any one or more of its current three products under development were successfully commercialized. We also note two privately held company purchases to add further insight:

• Acorda Therapeutics, Inc. purchased Civitas Therapeutics for $525 million in September 2014 for a Parkinson’s disease late stage drug candidate that was an inhaled dry powder formulation of the current oral treatment, levodopa

• AstraZeneca paid $560 million for Pearl, with another $450 million possible if regulatory milestones are met, and $140 million if certain sales targets are reached in June 2013; Pearl’s key drug in late stage development was LABA/LAMA, a combination drug that is inhaled to open up COPD patients’ airways.

Finally, we believe that the company could further expand its earnings potential through the acquisition of additional technologies or compounds related to the treatment of pulmonary diseases.

Exhibit 5: Comparative Analysis

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PULMATRIX GOVERNANCE

October 8 2015 The company reports study results for PUR1900, showing high lung retention and potency against fungal infection in cystic fibrosis patients

October 1, 2015 NIH grants $1.7 million for Celdara Medical and Pulmatrix to develop an inhaled biologic treatment for idiopathic pulmonary fibrosis, CM-YJH01

September 29, 2015 Pulmatrix reports clinical data on PUR0200 in patients with chronic obstructive pulmonary disease noting that it was well tolerated and achieved significant lung function improvement at lower dosages than the reference product

September 2, 2015 The company receives an additional patent covering composition of matter for iSPERSE technology

July 23, 2015 PULM issued patents covering iSPERSE technology for the treatment of patients with inhaled dry powders

June 16, 2015 Pulmatrix signs deal with Mylan for ex-US development of drug candidate PUR0200 for the treatment of COPD

June 16, 2015 Company announces first inhaled anti-fungal therapy for cystic fibrosis, drug candidate PUR1900

June 16, 2015 Pulmatrix raises $10 million in private placement and begins trading on Nasdaq under symbol “PULM”

June 15, 2015 As of the time of the merger, the company effected a 1-for-2.5 reverse stock split

June 15, 2015 Merger between Pulmatrix, Inc., and Ruthigen, Inc., with Pulmatrix as the surviving operating entity, and former shareholders owning 81.7% of outstanding shares, while former Ruthigen shareholders retain 18.3%; focus of company redirected to pulmonary therapeutics utilizing iSPERSE technology

   

Robert Clarke, Ph.D., CEO– Dr. Clarke was promoted to Chief Executive Officer of Pulmatrix in 2012 after serving as the Chief Scientific Officer. Joining Pulmatrix in 2004 as the first Ph.D. level scientist, his role evolved to oversight of Research and Development efforts at Pulmatrix focused on developing the Pulmatrix technologies for treatment of respiratory disease. He has helped raise greater than $60 million in venture capital funding for the company as well as secured more than $10 million in non-dilutive funding to support Pulmatrix R&D programs. Previous to Pulmatrix, he was an Associate Director of Life Sciences at Alkermes, Inc., focused mainly on developing inhaled therapeutic products with the AIR® technology platform. Dr. Clarke holds a B.Sc. in Biomedical Engineering from Boston University, has his Ph.D. in Physiology from Johns Hopkins University, and completed his post-doctoral training in Respiratory Biology at Brigham and Women’s Hospital and Harvard University. Dr. Clarke has over a dozen years industry and over 20 years total experience focused on pulmonary drug delivery and the role of inhaled particles in respiratory biology and medicine leading to the co-authorship of over 80 chapters, papers, and abstracts. David Hava, Ph.D., CSO - As CSO, Dr. Hava leads the Research and Development organization in the development of iSPERSE dry powder delivery platform. In addition, Dr. Hava directs and manages the company’s therapeutic strategy to identify and prioritize drug targets and drugs that are enabled by the iSPERSE dry powder delivery platform. Dr. Hava joined Pulmatrix in 2006 as one of the first Senior Scientists and has been involved in the early stage research and development programs that identified and characterized several of the key aspects of the Pulmatrix technology. Dr. Hava earned his Ph.D. in Molecular Biology and Microbiology at Tufts University and completed his post-doctoral training studying immunology and host-pathogen interactions at Harvard Medical School. Dr. Hava has co-authored over 20 papers and abstracts focused on pulmonary infectious disease, immunology and chronic lung diseases. William Duke, Jr., CFO - Mr. Duke previously served as chief financial officer of Valeritas, Inc., a company that manufactures and commercializes an insulin delivery device for adults with Type 2 diabetes. He has more than 20 years of experience in finance leadership roles, with the majority coming at life sciences companies including Valeritas, Genzyme and Haemonetics. Prior to his role as chief financial officer of Valeritas, Mr. Duke held various leadership roles in finance and accounting for public and private companies. Previously, he served as a Senior Director of Finance at Genzyme Corporation and as a Director of Finance/Accounting at Haemonetics Corporation. Mr. Duke holds a Bachelor of Science degree in Accounting from Stonehill College, a Master of Business Administration from Bentley College, and is a Certified Public Accountant. Jean Sung, Ph.D., Vice President of Pharmaceutical Development - Dr. Sung has spent over a decade developing novel particle engineering and formulation technologies to advance respiratory dry powder drug delivery. Dr. Sung joined Pulmatrix in 2008, leading the formulation, process, particle engineering and analytical chemistry development functions. Prior to her graduate studies, Dr. Sung was an early employee at Advanced Inhalation Research (AIR®) Inc., and later Alkermes, Inc., after the acquisition of AIR, where she advanced formulation development of the pulmonary drug delivery platform technology across small molecule and macromolecule therapies. Dr. Sung has numerous scientific publications and patents/applications in drug delivery, primarily focused on particle formulations for inhaled therapeutics. Dr. Sung has a S.B. in Chemical Engineering from Massachusetts Institute of Technology and holds a Ph.D. and M.S. in Engineering Sciences with a focus on Biomedical Engineering from Harvard University.

Board of Directors: Robert Clarke, Ph.D. – Director Michael J. Higgins – Director Steven Gillis, Ph.D. – Director Mark Iwicki - Chairman

Kurt Graves – Director Terrance McGuire - Director Scott Rocklage, Ph.D. - Director

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IMPORTANT DISCLOSURES AND DISCLAIMERS

The following disclosures are related to Stonegate Capital Partners “SCP” research reports. ANALYST DISCLOSURES I, Laura S. Engel, CPA, hereby certify that the view expressed in this research report accurately reflects my personal views about the subject securities and issuers. I also certify that no part of my compensation was, is, or will be, directly or indirectly, related to the recommendations or views expressed in this research report. I believe the information used for the creation of this report has been obtained from sources I considered to be reliable, but I can neither guarantee nor represent the completeness or accuracy of the information herewith. Such information and the opinions expressed are subject to change without notice. INVESTMENT BANKING, REFERRALS, AND FEES FOR SERVICE SCP does not provide nor has it received compensation for investment banking services on the securities covered in this report. SCP does not expect to receive compensation for investment banking services on the securities covered in this report. SCP has a non-exclusive Advisory Services agreement to provide research coverage, retail and institutional awareness, and overall Investor Relations support for which it is compensated $5,000 per month. Stonegate Capital Markets “SCM” (Member FINRA) is an affiliate of SCP and may seek to receive future compensation for investment banking or other business relationships with the covered companies mentioned in this report. In certain instances, SCP has contracted with SCM to produce research reports for its client companies. SCP pays SCM a monthly retainer for said services. POLICY DISCLOSURES SCP Analysts are restricted from holding or trading securities in the issuers that they cover. SCP and SCM do not make a market in any security nor do they act as dealers in securities. Each SCP analyst has full discretion on the content and valuation discussion based on his or her own due diligence. Analysts are paid in part based on the overall profitability of SCP. Such profitability is derived from a variety of sources and includes payments received from issuers of securities covered by SCP for services described above. No part of analyst compensation was, is or will be, directly or indirectly, related to the specific recommendations or views expressed in any report or article. No employee of SCP serves on the Company’s Board of Directors. Research Analyst and/or a member of the Analyst’s household do not own shares of this security. The Research Analyst and/or a member of the Analyst’s household do not serve as an officer, director, or advisory board member of the Company. This security is eligible for sale in one or more states. This security is subject to the Securities and Exchange Commission’s Penny Stock Rules, which may set forth sales practice requirements for certain low-priced securities. SCP or its affiliates do not beneficially own 1% or more of an equity security of the Company. SCP does not have other actual, material conflicts of interest in the securities of the Company. ADDITIONAL INFORMATION Please note that this report was originally prepared and issued by SCP for distribution to their market professional and institutional investor customers. Recipients who are not market professional or institutional investor customers of SCP should seek the advice of their independent financial advisor prior to making any investment decision based on this report or for any necessary explanation of its contents. The information contained herein is based on sources, which we believe to be reliable, but is not necessarily complete and its accuracy cannot be guaranteed. 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The opinions or information expressed are believed to be accurate as of the date of this report; no subsequent publication or distribution of this report shall mean or imply that any such opinions or information remains current at any time after the date of this report. All opinions are subject to change without notice, and we do not undertake to advise you of any such changes. Reproduction or redistribution of this report without the expressed written consent of SCP is prohibited. Additional information on any securities mentioned is available on request. RATING & RECOMMENDATION SCP does not rate the securities covered in its research. SCP does not have, nor has previously had, a rating for any securities of the Company. SCP does not have a price target for any securities of the Company.

CONTACT INFORMATION

Pulmatrix, Inc. Investor Relations Bob Clarke, CEO Thomas Baker 99 Hayden Ave., Ste. 390 [email protected] Lexington, MA 02421 Phone: 617-532-0624 Phone: 781-357-2333 www.pulmatrix.com