Pulmatrix Stock Price, News & Analysis

Pulmatrix, Inc. (Nasdaq: PULM) is a clinical-stage biopharmaceutical company that has focused on the development of novel inhaled therapeutic products intended to prevent and treat central nervous system (CNS), respiratory and other diseases with important unmet medical needs using its patented iSPERSE™ dry powder inhalation technology. According to the company, its proprietary product pipeline includes treatments for CNS disorders such as acute migraine and serious lung diseases such as Chronic Obstructive Pulmonary Disease (COPD) and allergic bronchopulmonary aspergillosis (ABPA).

Core technology: iSPERSE™ dry powder platform

The foundation of Pulmatrix’s approach is its engineered dry powder delivery platform, iSPERSE™. Company disclosures describe iSPERSE™ as a particle engineering technology that creates dry powder designed to solve limitations of conventional inhaled technologies and expand the universe of inhalable drug therapies. iSPERSE™ allows a broad range of drugs to be formulated as small, dense and dispersible particles for highly efficient drug delivery and deep penetration into the lungs.

Pulmatrix states that iSPERSE™ particles are engineered with a small, dense and dispersible profile and have the dispersibility advantages of porous engineered particles. The company believes this can result in superior drug delivery compared to traditional oral and injectable forms of treatment for certain diseases by optimizing pharmacokinetics and reducing systemic side effects. Company materials indicate that iSPERSE™ can efficiently deliver small molecules, drug combinations, peptides, proteins and nucleic acids via the respiratory system for the treatment of both respiratory and non-respiratory diseases.

As reported in Pulmatrix’s updates, its patent portfolio related to iSPERSE™ includes a substantial number of granted patents, including U.S. patents, along with additional pending patent applications in the U.S. and other jurisdictions. These patents cover aspects of the iSPERSE™ technology and support its use across multiple therapeutic areas.

Key clinical programs and product candidates

Pulmatrix’s disclosed pipeline centers on three main product candidates that apply the iSPERSE™ platform to different disease areas:

• PUR3100 (acute migraine) – PUR3100 is described as an orally inhaled formulation of dihydroergotamine (DHE) engineered with iSPERSE™ for the treatment of acute migraine. Company press releases state that the U.S. Food and Drug Administration accepted an Investigational New Drug (IND) application for PUR3100 and issued a “study may proceed” letter for a Phase 2 study, positioning PUR3100 as a Phase 2–ready asset. The IND includes a Phase 2 clinical protocol in which safety and preliminary efficacy of PUR3100 would be investigated in patients with acute migraine.
• Pulmatrix has reported results from a Phase 1 randomized, double-blind study comparing orally inhaled PUR3100 to intravenous DHE. According to the published data summarized by the company, PUR3100 achieved peak exposures in the targeted therapeutic range with a mean time to maximum concentration of about five minutes after dosing at all tested levels, and the PUR3100 dose groups showed a lower incidence of nausea and no vomiting compared to observations in the intravenously administered DHE group.
• PUR1800 (AECOPD and inflammatory respiratory diseases) – PUR1800 is described as a Narrow Spectrum Kinase Inhibitor (NSKI) engineered with iSPERSE™ for the treatment of acute exacerbations in chronic obstructive pulmonary disease (AECOPD). Pulmatrix reports that it presented complete results from a Phase 1b study of PUR1800 for AECOPD, indicating that PUR1800 was safe and well tolerated with no observed safety signals. The company states that topline data, together with chronic toxicology studies, support continued development of PUR1800 for AECOPD and other inflammatory respiratory diseases.
• PUR1900 (inhaled itraconazole) – PUR1900 is Pulmatrix’s inhaled iSPERSE™ formulation of the antifungal drug itraconazole, intended for indications where an orally inhaled antifungal may provide a therapeutic benefit or address an unmet medical need. Pulmatrix has reported that a Phase 2b trial it was operating was wound down, and that its partner Cipla has continued clinical development of PUR1900 outside the United States. According to Pulmatrix, Cipla completed a Phase 2 study in India and received approval from India’s Central Drug Standard Control Organization to proceed with a Phase 3 clinical trial.

Under its agreement with Cipla, Pulmatrix states that it will receive a 2% royalty on any potential future net sales by Cipla outside the United States should Cipla successfully market PUR1900 in those territories. Within the United States, Pulmatrix and Cipla intend to seek ways to monetize PUR1900 for indications where an orally inhaled antifungal may provide a therapeutic benefit or fulfill an unmet medical need.

Strategic transactions and collaborations

Pulmatrix has described several strategic steps involving its technology and assets. In a cross-license agreement with MannKind Corporation, the company granted MannKind exclusive and non-exclusive licenses to formulate iSPERSE™ with certain drugs and for specific respiratory indications, while receiving licenses to use MannKind’s Cricket® inhalation device for PUR3100 and other neurological dry powder formulations. As part of that transaction, MannKind agreed to assume the lease of Pulmatrix’s research and development facility along with related laboratory equipment and personal property, and Pulmatrix indicated that MannKind planned to hire some members of its R&D staff. Pulmatrix has characterized these actions as part of repositioning itself as a virtual company while continuing to focus on strategic alternatives for PUR3100 and iSPERSE™.

The company has also reported a series of steps related to a proposed merger with Cullgen Inc., a privately held clinical-stage biopharmaceutical company focused on targeted protein degradation. According to Pulmatrix, the parties entered into an agreement and plan of merger in November 2024, later amended, and Pulmatrix stockholders approved the merger and related proposals at a special meeting in June 2025. Company disclosures state that closing of the merger remains subject to conditions including Nasdaq approval of the listing of shares to be issued in the merger and approval from the China Securities Regulatory Commission (CSRC). Pulmatrix has also reported entering into a mutual waiver agreement with Cullgen to allow both parties to explore alternative transactions while continuing to pursue merger approval.

In connection with the proposed merger, Pulmatrix has repeatedly stated that it intends to divest its existing assets, including its iSPERSE™ patent portfolio and related clinical programs such as PUR3100, PUR1800 and PUR1900. The company has described processes to potentially divest these clinical assets and technology as part of its broader strategic review.

Business focus and sector classification

Based on its public statements, Pulmatrix operates in the pharmaceutical preparation manufacturing space within the broader manufacturing and biopharmaceutical sector. Its activities are centered on clinical-stage research and development rather than commercial product sales. The company emphasizes unmet medical needs in CNS and respiratory diseases, including acute migraine, COPD and ABPA, and positions its iSPERSE™ platform as a way to improve therapeutic delivery to the lungs and potentially enhance treatment outcomes.

Company communications highlight that Pulmatrix’s product candidates are based on its proprietary engineered dry powder delivery platform, with the goal of maximizing local drug concentrations in the lungs while reducing systemic side effects. Through partnerships, licensing arrangements and potential corporate transactions, Pulmatrix seeks to advance its inhaled product candidates and realize value from its intellectual property portfolio.

Regulatory and clinical development context

Pulmatrix’s disclosures reference multiple regulatory interactions and clinical milestones. For PUR3100, the company notes FDA acceptance of an IND and a “study may proceed” letter for a Phase 2 trial, as well as publication of Phase 1 clinical results in a peer-reviewed journal. For PUR1800, Pulmatrix cites completion of a Phase 1b study in AECOPD with no observed safety signals and supporting toxicology data. For PUR1900, company statements describe the wind down of a Phase 2b trial under Pulmatrix’s responsibility and continued development by Cipla, including progression to a planned Phase 3 trial in India.

These disclosures illustrate Pulmatrix’s role as a clinical-stage developer, with programs at different stages of clinical evaluation and with varying degrees of partnership involvement. Investors and observers typically follow such milestones through company press releases and SEC filings, which provide updates on trial status, regulatory interactions and strategic decisions affecting the pipeline.

Capital position and operating model

Pulmatrix’s financial updates describe efforts to reduce operating expenses, wind down certain trials and transition to a more virtual operating model, including the transfer of its laboratory and facility lease to MannKind. The company has reported cash and cash equivalents balances and has stated in multiple periods that, based on operational efficiencies and prioritization of spending, it expects its cash position to fund operations for an extended period, including into at least the fourth quarter of 2026 in certain disclosures. These statements reflect management’s view of its cash runway in light of ongoing strategic transactions and reduced internal R&D activity.

Status of proposed merger with Cullgen

As of the most recent information provided, Pulmatrix continues to work toward completion of its proposed merger with Cullgen while also exploring alternative transactions under a mutual waiver agreement. The company has not reported completion of the merger or a change in its Nasdaq listing status in the materials provided. If the proposed merger is completed, Pulmatrix has stated that the business of Cullgen will continue as the business of the combined company, and that Pulmatrix’s existing assets, including iSPERSE™-based programs, are intended to be divested.

Summary

In summary, Pulmatrix, Inc. is a Nasdaq-listed, clinical-stage biopharmaceutical company focused on inhaled therapeutics built on its patented iSPERSE™ dry powder technology. Its disclosed pipeline includes PUR3100 for acute migraine, PUR1800 for AECOPD and other inflammatory respiratory diseases, and PUR1900, an inhaled itraconazole formulation being advanced with a partner outside the United States. The company has entered into licensing and facility transfer agreements with MannKind Corporation and has pursued a proposed merger with Cullgen Inc., while indicating plans to divest its existing inhalation assets and technology portfolio as part of its strategic evolution.