Pulmatrix Announces Cross License Agreement and Transfer of Laboratory to MannKind Corporation
Pulmatrix announced a series of transactions with MannKind involving a cross-license agreement and transfer of laboratory assets. Pulmatrix's iSPERSE™ technology will be licensed to MannKind, while Pulmatrix gains access to MannKind's Cricket® inhalation device for its PUR3100 formulation, aimed at treating acute migraine. Additionally, MannKind will assume Pulmatrix's lease for its Bedford, Mass. R&D facility, extending Pulmatrix's cash runway into 2026. The agreement, expected to close in July 2024, also includes a master service arrangement for MannKind to provide future dry powder drug formulation services to Pulmatrix.
- Cross-license agreement validates Pulmatrix's iSPERSE™ technology.
- Pulmatrix gains exclusive license for MannKind's Cricket® inhalation device for PUR3100.
- Lease assumption by MannKind extends Pulmatrix's cash runway into 2026.
- Master service agreement ensures future formulation services by MannKind.
- Potential to develop the first orally inhaled DHE treatment for acute migraines.
- Transfer of leased R&D facility and assets to MannKind could impact Pulmatrix's internal R&D capabilities.
- Dependency on MannKind for future iSPERSE™ dry powder drug formulation services.
The cross-licensing agreement between Pulmatrix and MannKind Corporation is a strategic move that has significant financial implications for both companies. For Pulmatrix, transferring the leased building and related assets to MannKind will substantially reduce its overhead costs. This move is expected to extend Pulmatrix's cash runway further into 2026, providing more financial stability and flexibility. Moreover, the master service agreement allowing MannKind to provide future iSPERSE™ dry powder drug formulation development services to Pulmatrix will reduce R&D costs for Pulmatrix.
For MannKind, the acquisition of Pulmatrix’s laboratory and equipment can enhance its research capabilities without the need for a significant capital investment. Additionally, the exclusive and non-exclusive licenses for using each other’s technologies potentially pave the way for new revenue streams and collaborative product development, especially in the fields of neurological and pulmonary diseases.
This agreement aligns well with industry trends where companies are increasingly forming strategic alliances to leverage each other’s technological capabilities while optimizing operational costs. From an investor’s perspective, this should be seen as a positive move that strengthens both companies’ financial positions and enhances their future growth prospects.
From a pharmaceutical standpoint, the cross-licensing deal is pivotal for both Pulmatrix and MannKind. The iSPERSE™ technology, which is a proprietary dry powder inhalation technology developed by Pulmatrix, has been recognized for its potential in delivering therapies for serious diseases. MannKind's Cricket® inhalation device, already established in the market, complements this technology well.
This partnership will allow Pulmatrix to leverage MannKind's expertise and established device for delivering PUR3100, an innovative treatment targeting acute migraines using dihydroergotamine (DHE). Additionally, MannKind’s license to use iSPERSE™ with clofazimine and insulin opens new therapeutic avenues, particularly in treating nontuberculous mycobacteria lung disease and diabetes. These are areas with significant unmet medical needs, suggesting that these developments could lead to breakthrough therapies.
This agreement is reflective of a growing trend in the pharmaceutical industry where collaborations are becoming important for innovation. This could potentially lead to faster development times and increased efficacy of new treatments, benefiting patients and enhancing the companies' competitive positioning in the market.
The strategic collaboration between Pulmatrix and MannKind Corporation is likely to have a notable impact on the market dynamics for both companies. By combining Pulmatrix’s iSPERSE™ technology with MannKind’s Cricket® device, the two companies are positioning themselves to address significant market needs in the treatment of neurological and pulmonary diseases.
The partnership is particularly interesting in the context of the pharmaceutical market because it highlights a trend towards specialization and co-development. For instance, the focus on delivering the first orally inhaled treatment for acute migraine represents a unique market proposition, potentially tapping into a large patient population that requires more effective and rapid treatments.
Furthermore, MannKind's assumption of the lease and laboratory assets will likely result in operational synergies, reducing costs and allowing for better resource allocation. The prospect of MannKind hiring members of the Pulmatrix R&D staff is also positive for maintaining continuity and leveraging existing expertise.
Investors should view this collaboration as a strategic alignment that not only targets immediate operational efficiencies but also holds long-term growth potential through the development of innovative therapies and entry into new market segments.
Cross license involves Pulmatrix iSPERSE™ technology and MannKind's Cricket® inhalation device.
Pulmatrix transferring leased building, all leasehold improvements, laboratory equipment and other related personal property in exchange for MannKind assumption of lease.
Master service agreement in place for MannKind to provide future iSPERSE™ dry powder drug formulation development services to Pulmatrix.
Ted Raad, Chief Executive Officer of Pulmatrix, commented, "MannKind's interest in iSPERSE™ validates the enablement potential of our innovative particle engineering dry powder technology. In addition, the assumption of our lease and laboratory by MannKind helps extend our cash runway further into 2026. We are able to build upon this agreement to further support development of PUR3100 and its potential application with MannKind's Cricket® device to develop the 1st orally inhaled DHE treatment for acute migraine."
The Company entered into a cross license with MannKind pursuant to which MannKind will grant Pulmatrix a perpetual, royalty free, exclusive license to use MannKind's Cricket inhalation device for the inhaled delivery of PUR3100, our proprietary formulation of dihydroergotamine (DHE) with iSPERSE™, and a perpetual, royalty free, non-exclusive license to use MannKind's Cricket inhalation device for the inhaled delivery of any dry powder formulation formulated for the treatment or prevention of neurological disease. As part of the cross-license, the Company will grant MannKind a perpetual, royalty free, exclusive license to formulate iSPERSE™ with clofazimine for inhalation by humans for the treatment or prevention of infection, for the treatment or prevention of nontuberculous mycobacteria lung disease in humans, and with insulin for inhalation by humans for the treatment or prevention of diabetes. We will also grant MannKind a perpetual, royalty free, non-exclusive license to formulate iSPERSE™ for inhalation for the treatment or prevention of endocrine disease and for inhalation for the treatment or prevention of interstitial lung diseases (including IPF, PPF and other related lung diseases) in humans ("ILD").
As part of the transaction, MannKind will assume the lease of our
The agreements are anticipated to close in July 2024.
About Pulmatrix, Inc.
Pulmatrix is a clinical-stage biopharmaceutical company 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™ technology. The Company's 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"). Pulmatrix's product candidates are based on its proprietary engineered dry powder delivery platform, iSPERSE™, which seeks to improve therapeutic delivery to the lungs by maximizing local concentrations and reducing systemic side effects to improve patient outcomes.
For more on the Company's inhaled product candidates please visit:
https://www.pulmatrix.com/pipeline.html.
About PUR3100
PUR3100 is an orally inhaled formulation of dihydroergotamine (DHE) engineered with iSPERSE™ for the treatment of acute migraine. The Phase 1 PUR3100 trial results were presented at the 65th Annual Meeting of the American Headache society in June 2023. Over 38 million patients suffer from migraine in
About iSPERSE™ Technology
Our innovative particle engineering technology creates dry powder, which solves limitations of conventional inhaled technologies and expands the universe of inhalable drug therapies. iSPERSE™ is a proprietary technology that 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. 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.
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 federal securities laws. Such forward-looking statements include, but are not limited to, statements of historical fact and may be identified by words such as "anticipates," "assumes," "believes," "can," "could," "estimates," "expects," "forecasts," "guides," "intends," "is confident that", "may," "plans," "seeks," "projects," "targets," and "would," and their opposites and similar expressions are intended to identify forward-looking statements. 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 Company's ability to conduct its business and raise capital in the future when needed; delays in planned clinical trials; 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; 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 filings with the Securities and Exchange Commission, including its most recent Annual Report on Form 10-K, as may be supplemented or amended by the Company's Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. 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:
Timothy McCarthy, CFA
917-679-9282
tim@lifesciadvisors.com
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SOURCE Pulmatrix Inc.
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