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
DATE OF REPORT (DATE OF EARLIEST EVENT REPORTED): June 9, 2017
PULMATRIX, INC.
(Exact name of registrant as specified in its charter)
Delaware | 001-36199 | 46-1821392 | ||
(State of incorporation) | (Commission File No.) |
(IRS Employer Identification No.) |
99 Hayden Avenue, Suite 390
Lexington, MA 02421
(Address of principal executive offices) (Zip Code)
Registrants telephone number, including area code: (781) 357-2333
Not Applicable
(Former name 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 (see General Instruction A.2. below):
☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
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. ☐
Item 1.01. | Entry Into a Material Definitive Agreement. |
On June 9, 2017, Pulmatrix, Inc. (the Company) entered into a License, Development and Commercialization Agreement (the License Agreement) with RespiVert Ltd. (RespiVert), a wholly owned subsidiary of Janssen Biotech, Inc., pursuant to which RespiVert granted the Company an exclusive, royalty-bearing license in its intellectual property portfolio of materials and technology related to narrow spectrum kinase inhibitor compounds (the Licensed IP), to develop and commercialize products worldwide that incorporate the Licensed IP. The development, application, design and marketing of the Licensed IP and any licensed products will be managed exclusively by the Company.
The Company will pay RespiVert an up-front, non-refundable license fee of $1,000,000 in partial consideration for the rights granted by RespiVert to the Company, and will pay RespiVert designated amounts when any licensed product achieves certain developmental milestones. Following the commencement of commercial sales of the licensed products, the Company will pay RespiVert designated amounts when certain milestone events occur. The development milestones and commercial milestones range from $1,000,000 to $80,000,000 depending upon the significance of the particular milestone. We are also required to pay RespiVert royalties on all sales of licensed products, with such royalties ranging from 6% - 10% of sales.
The License Agreement terminates upon the expiration of the Companys obligation to pay royalties for all licensed products, unless earlier terminated. In addition, the License Agreement may be terminated (i) by the Company for any reason upon 120 days advance notice to RespiVert; (ii) by RespiVert upon receipt of notice from the Company of either voluntary or involuntary insolvency proceedings of the Company; and (iii) by either party for a material breach which remains uncured following the cure period.
The License Agreement also contains mutual confidentiality and indemnification obligations of the Company and RespiVert.
Item 8.01. | Other Events. |
On June 13, 2017, the Company issued a press release announcing the License Agreement. A copy of that press release is filed as Exhibit 99.1 to this Current Report on Form 8-K.
Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits.
Exhibit No. |
Description | |
99.1 | Press Release, issued on June 13, 2017. |
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: June 13, 2017 | By: | /s/ William Duke, Jr. | ||||
William Duke, Jr. | ||||||
Chief Financial Officer |
Exhibit 99.1
Pulmatrix Licenses Novel Drug Candidates from RespiVert Ltd., a wholly owned subsidiary of Janssen Biotech, Inc.
The novel compounds target an enzyme involved in both inflammation and cancer, and may offer a new approach for treating respiratory diseases
LEXINGTON, MA Pulmatrix, Inc. (NASDAQ: PULM), a clinical stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary diseases, today announced that it has entered into an exclusive, worldwide license agreement with RespiVert Ltd., a wholly owned subsidiary of Janssen Biotech, Inc. Through the agreement, Pulmatrix gains access to a portfolio of novel drug candidates in a class called kinase inhibitors that the company plans to develop.
Kinase inhibitors are chemical entities that block so-called kinase enzymes, which are involved in inflammation or cancer.
We believe these innovative compounds licensed from RespiVert Ltd. will offer a new approach for treating lung inflammation in diseases like chronic obstructive pulmonary disease (COPD), asthma, and idiopathic pulmonary fibrosis (IPF), said Pulmatrix CEO Robert Clarke, PhD. They are also perfectly suited for formulation with our iSPERSE technology.
Professor Peter J. Barnes, Margaret Turner-Warwick Professor of Medicine and the Head of Respiratory Medicine at Imperial College, London, stated Kinase inhibitors could be a very promising step forward for treating COPD and severe asthma. Coupled with the innovative iSPERSE technology to facilitate delivery to the site of disease within the lung, Pulmatrix is poised to improve the available therapeutic landscape for these patients in need.
The key advance in the iSPERSETM approach is a dry powder that flies easily into the lungs and can work with virtually any drug class ranging from small molecules to biologics. Drugs attached to the particles are thus delivered to the lungs with very high efficiency including small molecules like the RespiVert kinase inhibitors.
Pulmatrix is already developing inhaled drugs for COPD and fungal infections. These new compounds will significantly expand what we believe is already an impressive pipeline of drug candidates, said Clarke. Because these compounds have already been explored in a Phase I program, we envision that we will be able to quickly move to clinical proof-of-concept studies.
Under the terms of the agreement, which covers both respiratory and oncology uses of the drug candidates, Pulmatrix will assume all development and commercialization activities worldwide.
About Pulmatrix
Pulmatrix is a clinical stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary disease using its patented iSPERSE technology. The Companys proprietary product pipeline is focused on advancing treatments for lung diseases, including opportunities in major pulmonary diseases through collaborations, like PUR0200, a branded generic in clinical development for chronic obstructive pulmonary disease (COPD) and PUR1900, an inhaled antifungal that could benefit severe asthmatics and patients with rare diseases like cystic fibrosis. Pulmatrixs product candidates are based on iSPERSE, its proprietary dry powder delivery platform, which seeks to improve therapeutic delivery to the lungs by maximizing local concentrations and reducing systemic side effects to improve patient outcomes.
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 safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements concerning the amount and use of proceeds the Company expects to receive from the sale of the shares of common stock in the registered direct offering, the closing of the transaction described in this press release, which is subject to customary conditions, and other statements that are not 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. The Company cautions that such statements involve risks and uncertainties that may materially affect the Companys results of operations. 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, market and other conditions, the satisfaction of customary closing conditions related to the registered direct offering of common stock, 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 Companys 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; and the ability to secure and enforce legal rights related to the Companys 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 Companys filings with the Securities and Exchange Commission, including its annual report on Form 10-K filed with the Securities and Exchange Commission on March 10, 2017, as may be supplemented or amended by the Companys Quarterly Reports on Form 10-Q. 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
Robert Clarke, CEO
(781) 357-2333
rclarke@pulmatrix.com
William Duke, CFO
(781) 357-2333
wduke@pulmatrix.com
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