Pulmatrix, Inc., a clinical stage biotechnology company, discovers and develops inhaled therapies to prevent and treat respiratory and other diseases with unmet medical needs in the United States. The company focuses on developing products based on its inhaled small particles easily respirable and emitted (iSPERSE) technology, which enables delivery of small or large molecule drugs to the lungs by inhalation for local or systemic applications. It engages in developing Pulmazole, an inhaled anti-fungal drug for the treatment of allergic bronchopulmonary aspergillosis in patients with asthma, and in patients with cystic fibrosis; PUR1800, a narrow spectrum kinase inhibitor that is in Phase 1b clinical trials for patients with stable moderate-severe chronic obstructive pulmonary disease; and PUR3100, an iSPERSE formulation of dihydroergotamine for the treatment of acute migraine. The company has a license agreement with RespiVert Ltd. for access to a portfolio of kinase inhibitor drug candidates; a development and commercialization agreement with Cipla Technologies LLC for the development and commercialization of Pulmazole; and a collaboration and license agreement with Sensory Cloud, Inc. Pulmatrix, Inc. was founded in 2003 and is headquartered in Lexington, Massachusetts.
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Here are 1-2 brief analogies to describe Pulmatrix (PULM):
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A Moderna (MRNA) focused on using a unique dry powder platform to develop inhaled drugs for respiratory conditions.
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An early-stage Vertex Pharmaceuticals (VRTX), developing novel inhaled treatments for a range of severe respiratory diseases like cystic fibrosis and asthma.
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- PUR1900: An inhaled antifungal candidate designed to treat allergic bronchopulmonary aspergillosis (ABPA) in patients with asthma and cystic fibrosis.
- PUR1800: An inhaled kinase inhibitor candidate being developed for the treatment of severe asthma and other inflammatory lung diseases.
- iSPERSE Technology Platform: A proprietary dry powder drug delivery platform utilized to create highly dispersible, small particles for efficient lung delivery of therapeutic compounds.
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Pulmatrix (PULM) is a clinical-stage biopharmaceutical company focused on the development of novel inhaled therapeutic products. As such, it does not sell products directly to individuals. Its business model primarily involves researching, developing, and licensing its drug candidates to other pharmaceutical companies for further clinical development, manufacturing, and commercialization.
Pulmatrix sells primarily to other companies. Its major customer and strategic partner is:
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Chiesi Farmaceutici S.p.A. (a private global pharmaceutical company)
Pulmatrix entered into a global licensing and development agreement with Chiesi Farmaceutici S.p.A. for its drug candidate PUR1900, an inhaled antifungal for cystic fibrosis patients. Under this agreement, Chiesi is responsible for the clinical development, manufacturing, and commercialization of PUR1900 worldwide.
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Peter Ludlum Interim Chief Executive Officer and Interim Chief Financial Officer
Mr. Ludlum is an experienced financial executive with over 23 years of experience working with early-stage and high-growth companies in the life science sector. He is currently a Senior Director at Danforth Advisors, LLC, a financial consultancy specializing in life sciences companies. Mr. Ludlum has served as the Interim Chief Executive Officer for Pulmatrix since July 20, 2024. He has also served as the company's Interim CFO, principal accounting officer, and principal financial officer since April 2022. Previously, Mr. Ludlum held roles such as Co-President, Chief Business Officer, Chief Financial Officer, Financial Compliance Officer, and Group Controller at pharmaceutical, medical device, diagnostic products, and reference laboratory companies. He holds a B.S. in Business and Economics with an accounting major from Lehigh University and an MBA with a concentration in Finance from California State University, Fullerton.
Steven Kramer Vice President Quality
Mr. Kramer is responsible for the Quality function at Pulmatrix, in addition to overseeing safety and facilities. He joined the company in 2009 and has progressed through numerous roles of increasing responsibility. Prior to joining Pulmatrix, Mr. Kramer held positions at Alkermes and AMAG Pharmaceutical, bringing over 15 years of experience in Quality Assurance and Quality Control within the pharmaceutical industry. Mr. Kramer holds a Bachelor of Science degree in Forensic Toxicology from John Jay College of Criminal Justice and a Master of Science degree in Pharmaceutical Biotechnology from Northeastern University.
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The public company Pulmatrix (PULM) faces several significant risks to its business, primarily centered around its proposed merger and ongoing financial challenges.
- Uncertainty of Cullgen Merger and Significant Financial Distress: Pulmatrix's future operations are heavily dependent on the successful completion of its merger with Cullgen Inc.. The merger is currently pending various regulatory approvals, including those from NASDAQ and the China Security Regulatory Commission; a failure to finalize this transaction could lead to restructuring or liquidation. The company has reported no revenue in recent quarters (Q2 and Q3 2025), raising concerns about its ability to generate sales. Pulmatrix also has an accumulated deficit exceeding $300 million and continues to experience negative cash flows, with limited cash reserves of $4.8 million as of September 30, 2025, indicating a constrained cash runway if the merger is not concluded.
- Divestment of Core iSPERSE™ Technology and Clinical Assets: As part of the planned merger, Pulmatrix intends to divest its proprietary iSPERSE™ dry powder delivery technology and its related clinical programs, which include PUR3100, PUR1800, and PUR1900. This strategic shift is significant, as iSPERSE™ technology has been foundational to Pulmatrix's development of inhaled therapeutic products. The ability to divest these assets on favorable terms, or at all, poses a considerable risk. All development activities for existing clinical assets are currently paused pending the merger, which limits the potential for near-term value creation.
- Inherent Risks of Biopharmaceutical Product Development and Regulatory Approval: As a biopharmaceutical company, Pulmatrix is subject to inherent risks associated with drug development. These include potential delays in clinical trials, the challenge of proving product efficacy and safety, obtaining necessary governmental approvals for marketing, and securing and defending intellectual property rights. Currently, Pulmatrix's therapeutic candidates, such as Pulmazole, PUR1800, and PUR3100, are investigational drugs and have not yet received FDA or other regulatory approvals for commercialization. Additionally, there is an ongoing contractual dispute with Cipla Technologies, LLC, concerning the development of Pulmazole, which could result in further delays or require arbitration to regain sole ownership of the program.
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A clear emerging threat to Pulmatrix (PULM) is the rapid development and potential market penetration of **oral small molecule immunomodulators for severe asthma.**
Pulmatrix's lead product candidate, PUR1800, is an inhaled tyrosine kinase inhibitor aimed at treating severe asthma. While it offers a novel mechanism and delivery method, larger pharmaceutical companies are increasingly investing in and advancing oral small molecules, such as JAK inhibitors and other targeted immunomodulators, through clinical trials for severe asthma and other inflammatory airway diseases. These oral therapies, if proven effective and safe, could offer a significant advantage in patient convenience (a pill versus an inhaler or injection for biologics), potentially capturing a substantial market share and reducing the need for alternative therapies, including novel inhaled small molecules like PUR1800. This trend represents a direct competitive challenge to Pulmatrix's pipeline, as these emerging oral drugs target the same severe asthma patient population with a potentially more preferred administration route.
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Pulmatrix (PULM) is a clinical-stage biopharmaceutical company developing innovative inhaled therapies. The addressable markets for their main product candidates are:
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PUR1900 (Allergic Bronchopulmonary Aspergillosis - ABPA): The global allergic bronchopulmonary aspergillosis treatment market size was valued at approximately USD 1.14 billion in 2024 and is projected to reach USD 3.30 billion by 2032. Approximately 4.8 million people worldwide are estimated to be affected by ABPA.
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PUR1800 (Acute Exacerbations of Chronic Obstructive Pulmonary Disease - AECOPD): The global chronic obstructive pulmonary disease (COPD) treatment market, which includes treatments for exacerbations, is calculated at USD 23.55 billion in 2025 and is expected to reach around USD 34.76 billion by 2034. North America is a dominant region, estimated to hold 43.2% of the market share in 2025.
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PUR3100 (Acute Migraine): The global acute migraine treatment market size was valued at USD 3.46 billion in 2024, is calculated at USD 3.85 billion in 2025, and is expected to reach approximately USD 10.08 billion by 2034. North America dominated the acute migraine treatment market in 2024, holding a 42% market share. The U.S. acute migraine treatment market size was estimated at USD 1.02 billion in 2024 and is projected to surpass around USD 3.02 billion by 2034.
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The future revenue growth for Pulmatrix (PULM) over the next 2-3 years is primarily expected to be driven by the strategic shift resulting from its proposed merger with Cullgen, a privately held, clinical-stage biopharmaceutical company. Upon the anticipated closing of the merger in the first half of 2025, Pulmatrix plans to divest its current clinical assets and iSPERSE™ technology, with the combined entity focusing on Cullgen's pipeline of targeted protein degrader therapies.
The expected drivers of future revenue growth include:
- Advancement and Commercialization of Cullgen's Oncology Pipeline: The merged company will focus on Cullgen's targeted protein degradation technology, which includes two degrader programs in Phase 1 clinical trials for the treatment of cancer. Successful progression through clinical trials and eventual commercialization of these oncology candidates would be a significant revenue driver.
- Development and Commercialization of Cullgen's Pain Program: Cullgen has a targeted protein degrader program in Phase 1 clinical trials for the treatment of acute and chronic pain, which recently completed enrollment. Future revenue growth would be contingent on the successful development and market entry of this therapy.
- Expansion of the Targeted Protein Degradation Platform: The proposed merger aims to create a Nasdaq-listed company centered on targeted protein degradation technology. This platform has the potential to generate additional product candidates beyond the current pipeline, leading to future revenue streams through new drug development and potential commercialization.
- Strategic Partnerships and Licensing Agreements: As the combined entity advances its pipeline of targeted protein degrader therapies, forming strategic collaborations or licensing agreements with larger pharmaceutical companies could provide non-dilutive funding, accelerate development, and expand market access, thereby contributing to revenue growth.
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Share Repurchases
- Pulmatrix reported no share repurchase activity in the fourth quarter of 2024.
- The company also reported no share repurchase activity in the fourth quarter of 2023.
Share Issuance
- Pulmatrix has historically raised capital through public offerings and private placements of stock.
- A 1-for-20 reverse stock split was executed, effective March 1, 2022, to increase the per-share trading price and maintain Nasdaq listing compliance. This action reduced the number of outstanding shares from approximately 65.97 million to 3.30 million.
Inbound Investments
- A proposed merger with Cullgen Inc. was announced on November 13, 2024, and is anticipated to close in the first half of 2025. As part of this merger, Pulmatrix plans to divest its current assets, including its Phase 2-ready acute migraine candidate PUR3100 and iSPERSE™ technology. [cite: 15 (previous search result), 6]
- The company has a collaboration and license agreement with Cipla for the development of PUR1900 (Pulmazole). Revenues increased in 2023 due to higher activity under this agreement. A contract modification in the first quarter of 2024 resulted in a $5.2 million increase in net income through a cumulative catch-up adjustment in non-cash revenue.
Capital Expenditures
- Pulmatrix reported negligible or zero capital expenditures, with compliance for environmental requirements having no material effect on capital expenditures for the years ended December 31, 2024, 2023, 2021, and 2020.
- The company's total capital expenditures were $0. [cite: 2 (previous search result)]
- A decrease in research and development expenses in 2024 was partly attributed to the disposal of the company's lab and facilities lease, indicating a reduction in physical assets. [cite: 15 (previous search result)]