Current Report Filing (8-k)
September 22 2020 - 9:11AM
Edgar (US Regulatory)
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): September 22, 2020
PULMATRIX,
INC.
(Exact
name of registrant as specified in its charter)
Delaware
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001-36199
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46-1821392
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(State
or other jurisdiction
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(Commission
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(IRS
Employer
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of
incorporation)
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File Number)
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Identification
No.)
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99
Hayden Avenue, Suite 390
Lexington,
MA 02421
(Address
of principal executive offices) (Zip Code)
(781)
357-2333
(Registrant’s
telephone number, including area code)
N/A
(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:
[ ]
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Written communications pursuant to Rule 425 under the
Securities Act (17 CFR 230.425)
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[ ]
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Soliciting material pursuant to Rule 14a-12 under the
Exchange Act (17 CFR 240.14a-12)
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[ ]
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Pre-commencement communications pursuant to Rule 14d-2(b)
under the Exchange Act (17 CFR 240.14d-2(b))
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[ ]
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Pre-commencement communications pursuant to Rule 13e-4
(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class
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Trading
Symbol(s)
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Name
of exchange on which registered
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Common
Stock, par value $0.0001 per share
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PULM
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The
NASDAQ Stock Market LLC
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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
7.01. Regulation FD Disclosure.
We
intend, from time to time, to present and/or distribute to the investment community and utilize at various industry and other
conferences a slide presentation, which is attached hereto as Exhibit 99.1. We undertake no obligation to update, supplement or
amend the materials attached hereto as Exhibit 99.1.
In
accordance with General Instruction B.2 of Form 8-K, the information in this Item 7.01 of this Current Report on Form 8-K, including
Exhibit 99.1, shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as
amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated
by reference in any filing under the Exchange Act or the Securities Act of 1933, as amended, except as shall be expressly set
forth by reference in such a filing. Furthermore, the furnishing of information under Item 7.01 of this Current Report on Form
8-K is not intended to constitute a determination by us that the information contained herein, including the exhibits hereto,
is material or that the dissemination of such information is required by Regulation FD.
Item 8.01. Other Events.
On
July 9, 2020, we announced that together with our partner Cipla Technologies, LLC (“Cipla”) (with whom we entered
into a development and commercialization agreement on April 15, 2019, for the development and commercialization of Pulmazole)
we decided to end our Phase 2 clinical study of Pulmazole and replace it with a new larger Phase 2b study designed with a longer
treatment duration and key phase 3 enabling efficacy endpoints. Also being considered are clinical studies in India, South Africa
and other regional markets where Cipla has strong clinical development and business capabilities and the potential assignment
to Cipla of exclusive rights to develop and commercialize Pulmazole in these territories is currently under consideration. We
plan to have a Type-C meeting with the FDA in Q1 2021 to inform our final clinical design and timelines. We plan to commence the
new Phase 2b study when the risk of insufficient patient enrollment presented by the ongoing COVID-19 pandemic is reduced to an
acceptable level.
As
we also previously reported in July 2020, we were considering certain proposed amendments to our development and commercialization
agreement with Cipla for the continued development for Pulmazole. We have not agreed to any amendments to the agreement as of
the date of this Current Report. However, we expect that discussions regarding amendments to the agreement will continue. No assurance
can be given that we will be able to reach a mutually acceptable arrangement with Cipla for the conduct of any proposed Phase
2b clinical study in the future. Accordingly, if we are unable to agree with Cipla on such matters such as cost sharing for the
new study, we may be forced to suspend further development of Pulmazole.
On
September 22, 2020, we issued a press release providing a product pipeline update, including with respect to Pulmazole. A copy
of the press release is attached hereto as Exhibit 99.2 and is incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
(d)
Exhibits
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed
on its behalf by the undersigned hereunto duly authorized.
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PULMATRIX,
INC.
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Date:
September 22, 2020
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By:
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/s/
Teofilo Raad
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Teofilo
Raad
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Chief
Executive Officer
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