Current Report Filing (8-k)
August 10 2017 - 4:11PM
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): August 4, 2017
Chiasma, Inc.
(Exact
name of registrant as specified in its charter)
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DELAWARE
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001-37500
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76-0722250
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(State or other jurisdiction
of incorporation)
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(Commission
File Number)
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(I.R.S. Employer
Identification No.)
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275 Wyman Street, Suite 250
Waltham, MA
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02451
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(Address of principal executive offices)
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(Zip Code)
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Registrants telephone number, including area code (617)
928-5300
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:
☐
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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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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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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 2.02
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Results of Operations and Financial Condition.
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On August 10, 2017, Chiasma, Inc.
(the Company) issued a press release announcing its financial results for the quarter ended June 30, 2017 and providing a business update. The full text of the press release is furnished as Exhibit 99.1 hereto and incorporated
herein by reference.
On August 10, 2017, the Company issued a press release announcing its receipt of a Special Protocol Assessment
(SPA) agreement with the U.S. Food and Drug Administration (FDA). In this press release, the Company reported its cash and investments balance as of June 30, 2017 (the Financial Information). The Financial Information included in
Exhibit 99.2 attached hereto is incorporated under this Item 2.02 by reference.
The information under this Item 2.02 is intended to
be furnished and shall not be deemed filed for 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 Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 7.01
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Regulation FD Disclosure
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On August 10, 2017, the Company conducted a conference
call concerning its receipt of a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA). As part of this conference call, the Company delivered the slide presentation furnished as Exhibit 99.3 and incorporated
herein by reference herein.
The information under this Item 7.01 is intended to be furnished and shall not be deemed
filed for 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 Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.
On August 4, 2017, the Company received notice of a Special Protocol
Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA) with respect to a Phase 3 clinical trial for oral octreotide capsules for the maintenance therapy of adult patients with acromegaly. On August 10, 2017, the Company
issued a press release announcing its receipt of the SPA agreement with the FDA. A copy of this press release is attached hereto as Exhibit 99.2 and, other than the Financial Information, which is furnished as set forth in Item 2.02 of this
Current Report on Form
8-K,
is incorporated herein by reference
Item 9.01
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Financial Statements and Exhibits.
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(d) Exhibits
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Exhibit
No.
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Description
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99.1
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Press Release of Chiasma, Inc. (concerning financial results) dated August 10, 2017
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99.2
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Press Release of Chiasma, Inc. (concerning the SPA agreement) dated August 10, 2017
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99.3
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Slide Presentation of Chiasma, Inc. dated August 10, 2017
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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.
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Date: August 10, 2017
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Chiasma, Inc.
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By:
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/s/ Mark J. Fitzpatrick
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Mark J. Fitzpatrick
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President, Chief Executive Officer, and Director
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