8-K
Pulmatrix, Inc. (PULM)
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
Dateof Report (Date of earliest event reported): May 28, 2024
PULMATRIX,
INC.
(Exactname of registrant as specified in its charter)
| Delaware | 001-36199 | 46-1821392 |
|---|---|---|
| (State or other jurisdiction<br><br> <br>of incorporation) | (Commission<br><br> <br>File Number) | (IRS Employer<br><br> <br>Identification No.) |
36Crosby Drive, Suite 100
Bedford,MA 01730
(Addressof principal executive offices) (Zip Code)
(781)357-2333
(Registrant’stelephone number, including area code)
N/A
(Formername 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:
| ☐ | Written<br> communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|---|---|
| ☐ | Soliciting<br> material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement<br> communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | Pre-commencement<br> communications pursuant to Rule 13e-4 (c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
|---|---|---|
| Common Stock, par value $0.0001 per share | PULM | The NASDAQ Stock Market LLC |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item1.01 Entry into a Material Definitive Agreement.
On May 28, 2024, Pulmatrix, Inc. (the “Company”) and MannKind Corporation, a Delaware Corporation (“MannKind”) entered into a Bill of Sale and Assignment Agreement (the “BSA”) with respect to the transfer of the Company’s Bedford, Massachusetts, R&D facility (the “R&DFacility”) to MannKind along with all leasehold improvements, laboratory equipment and other related personal property. In connection with the transfer of the R&D Facility, the Company, MannKind and Cobalt Propco 2020, LLC, a Delaware limited liability company (the “Landlord”) will enter into an Amendment to Lease and Consent to Assignment of Lease (the “Lease Assignment Agreement”) in connection with the premises (the “Premises”) that the Company leases at 36 Crosby Drive, Bedford, Massachusetts, pursuant to that certain Lease Agreement, dated as of January 7, 2022 (the “Lease Agreement”), by and between the Company and the Landlord (collectively, the “MannKind Transactions”). Pursuant to the Lease Assignment Agreement, MannKind will assume all of the Company’s obligations under the Lease Agreement, including all rent and other payments pursuant to the Lease Agreement. The transfer of the R&D Facility to MannKind is expected to close during July 2024.
In connection with the transactions contemplated by the BSA and Lease Assignment, the Company and MannKind entered into an Intellectual Property Cross License Agreement (the “IPA”). The effectiveness of the IPA and the licenses granted therein is subject to closing of the transactions contemplated by the BSA and the Lease Assignment Agreement. Pursuant to the IPA, the Company will grant to MannKind (i) an exclusive license to develop, use, manufacture, market, offer and sell its inhaled Small Particles Easily Respirable and Emitted (“iSPERSE”) formulations of Clofazimine, (ii) an exclusive license to develop, use, manufacture, market, offer and sell formulations of iSPERSE with one more active pharmaceutical ingredients for the treatment of nontuberculous mycobacteria lung disease in humans, (iii) an exclusive license to develop, use, manufacture, market, offer and sell iSPERSE formulations of insulin, (iv) a non-exclusive license to develop, use, manufacture, market, offer and sell formulations of iSPERSE with one more active pharmaceutical ingredients for the treatment of endocrine disease in humans, and (v) a non-exclusive license to develop, use, manufacture, market, offer and sell formulations of iSPERSE with one more active pharmaceutical ingredients for the treatment of interstitial lung diseases (including IPF, PPF and other related lung diseases) in humans. Additionally, pursuant to the IPA, MannKind will grant to the Company (i) the exclusive right to develop, use, manufacture, market, offer and sell its “Cricket” single-use disposable dry powder inhaler (including all modifications or improvement thereto made by or on behalf of the Company, the “Cricket Device”) for the inhaled delivery of dihydroergotamine in any formulation whatsoever, including the Company’s PUR3100 treatment of acute migraine and (ii) a non-exclusive license to develop, use, manufacture, market, offer and sell the Cricket Device for the inhaled delivery of one more active pharmaceutical ingredients formulated with iSPERSE for the treatment of neurological disease in humans.
Additionally, pursuant to the Master Services Agreement, by and between the Company and MannKind, MannKind shall provide certain development services to the Company, including but not limited to, activities to develop a dry powder formulation of the active pharmaceutical ingredient that the Company provides to MannKind for oral inhalation using iSPERSE.
The BSA, the IPA, the MSA and the Lease Assignment Agreement contain customary representation, warranties and indemnification provisions, as applicable, and as related to transactions of this type.
Item8.01 Other Events
On May 29, 2024, the Company issued a press release announcing the MannKind Transactions, which is attached hereto as Exhibit 99.1 and incorporated herein by reference.
Item9.01 Financial Statements and Exhibits.
(d) Exhibits
| Exhibit No. | Description |
|---|---|
| 99.1 | Press Release, dated May 29, 2024 |
| 104 | Cover<br> Page Interactive Data File (embedded within the Inline XBRL document) |
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:<br> May 29, 2024 | By: | /s/ Teofilo Raad |
| Teofilo<br> Raad | ||
| Chief<br> Executive Officer |
Exhibit 99.1
Pulmatrix Announces Cross License Agreement and Transfer of Laboratory to MannKind Corporation
Crosslicense involves Pulmatrix iSPERSE^TM^ technology and MannKind’s Cricket^®^ inhalation device.
Pulmatrixtransferring leased building, all leasehold improvements, laboratory equipment and other related personal property in exchange for MannKindassumption of lease.
Masterservice agreement in place for MannKind to provide future iSPERSE^TM^ dry powder drug formulation development services to Pulmatrix.
Bedford, Mass., May 29, 2024 – Pulmatrix, Inc. (“Pulmatrix” or the “Company”) (Nasdaq: PULM), a clinical-stage biopharmaceutical company developing innovative inhaled therapies to address serious central nervous system and pulmonary diseases using its patented dry powder inhalation iSPERSE™ technology, today announced a series of transactions with MannKind Corporation (Nasdaq: MNKD).
Ted Raad, Chief Executive Officer of Pulmatrix, commented, “MannKind’s interest in iSPERSE^TM^ 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 1^st^ 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^TM^, 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^TM^ 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^TM^ 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 Bedford, Mass., R&D facility along with all leasehold improvements, laboratory equipment and other related personal property used in the laboratory. To maintain continuity of iSPERSE^TM^ platform knowledge, MannKind plans to hire some members of the Pulmatrix R&D staff.
The agreements are anticipated to close in July 2024.
AboutPulmatrix, 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.
AboutPUR3100
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 the United States and there is currently no orally inhaled DHE treatment option for patients.
AboutiSPERSE™ 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^TM^ 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^TM^ 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-LookingStatements
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.
InvestorContact:
Timothy McCarthy, CFA
917-679-9282
tim@lifesciadvisors.com