Item 2.02 Results of Operations and Financial Condition.
On January 10, 2020, Chiasma, Inc. (the "Company") issued a press release (the
"Press Release") providing a year-end corporate update and preliminary 2020
outlook, which Press Release included the Company's preliminary approximate
cash, cash equivalents and marketable securities as of December 31, 2019 (the
"Financial Information"). The Financial Information is unaudited and does not
present all information necessary for an understanding of the Company's
financial condition as of December 31, 2019 and its results of operations for
the twelve months ended December 31, 2019. A copy of the Press Release is
furnished herewith as Exhibit 99.1.
The Financial Information set forth in Item 2.01 and Exhibit 99.1 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 a
filing.
Item 7.01 Regulation FD.
A copy of the slide presentation that will be used by representatives of the
Company in connection with investor meetings and presentations from time to time
(the "Corporate Presentation") is attached to this Current
Report on Form 8-K as Exhibit 99.1. The Corporate Presentation is current as of
January 10, 2020, and the Company disclaims any obligation to correct or update
this material in the future.
The information set forth in Item 7.01 and Exhibit 99.1 is intended to be
furnished and shall not be deemed "filed" for purposes of Section 18 of 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 a filing.
Item 8.01 Other Events.
On January 10, 2020, the Company issued the Press Release, which announced,
among other things, the Company's resubmission of its new drug application
("NDA") to the United States Food and Drug Administration ("FDA") seeking
marketing approval for its investigational octreotide capsules product
candidate, conditionally trade-named MYCAPSSA®, for the maintenance treatment of
adults with acromegaly. Following the anticipated approval of the NDA by the
FDA, the Company expects to submit two manufacturing supplements to the NDA to
provide for an additional active pharmaceutical ingredient ("API") manufacturer
and an additional commercial-scale manufacturing site affiliated with the API
manufacturer currently referenced in the NDA. These manufacturing sources were
not included in the NDA resubmission in order to allow for further time for the
additional API manufacturer not referenced in the NDA to resolve observations
from a recent regulatory inspection and to allow the Company to seek the FDA's
designation of the resubmission of the NDA as a Class 2 resubmission, which
typically entails a six-month review period. The Company is currently procuring
API from both sources in anticipation of an NDA approval and, subject to FDA's
timely approval of the NDA and either of the manufacturing supplements, expects
to have oral octreotide product available to support its planned commercial
launch in the fourth quarter of 2020.
A copy of the Press Release is attached hereto as Exhibit 99.1 and is
incorporated herein by reference.
Cautionary note on forward-looking statements
This Current Report on Form 8-K contains forward-looking statements, including,
but not limited to, statements regarding the Company's intent to submit
manufacturing supplements to its NDA to provide for an additional API
manufacturer and for an additional commercial-scale manufacturing site of the
API manufacturer currently referenced in the NDA following a potential NDA
approval by the FDA and statements concerning the Company's expectations
regarding the availability of oral octreotide product supply. These
forward-looking statements are not promises or guarantees and involve
substantial risks and uncertainties that can cause actual results to differ
materially from those in such forward-looking statements. Such statements are
subject to numerous important factors, risks and uncertainties, many of which
are beyond the Company's control, that may cause actual events or results to
differ materially from the Company's current expectations. For example, the
review of any manufacturing supplement to the NDA to provide for an additional
API manufacturer and an additional API manufacturing site will require FDA
review and approval of the manufacturing process, facility, equipment and
procedures in place at each manufacturer in accordance with the FDA's current
good manufacturing practice requirements and may require additional regulatory
inspections of each manufacturer, which could prevent or delay approval of any
such manufacturing supplement to the NDA and prevent or delay commercial launch.
In addition, even if the Company is able to obtain approval of the additional
API manufacturer or additional API manufacturing site, there can be no guarantee
that the Company will be able to secure API or commercial octreotide capsules in
sufficient quantities, in a timely manner or at all and initiate the planned
commercial launch of octreotide capsules. Management's expectations and,
therefore, any forward-looking statements in this Current Report on Form 8-K
could be affected by risks and uncertainties relating to a number of factors,
including the following: the content and timing of decisions made by the FDA,
including with respect to the NDA and any manufacturing supplements to the NDA
we may submit to the FDA, the results of any inspections of the Company's
third-party manufacturers, the Company's reliance on third parties to
manufacture API and commercial octreotide capsules, and the Company's ability to
obtain and retain requisite regulatory approvals for the commercial sale of
octreotide capsules in the United States. For a discussion of these and other
risks and uncertainties, and other important factors, any of which could cause
the Company's actual results to differ from those contained in the
forward-looking statements, see the section entitled "Risk Factors" in the
Company's Annual Report on Form 10-K for the year ended December 31, 2018, and
in subsequent filings with the Securities and Exchange Commission. All
information in this Current Report on Form 8-K is as of the date hereof, and the
Company undertakes no duty to update this information unless required by law.
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Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
Exhibit
No. Description
99.1 Press release dated January 10, 2020.
99.2 Corporate presentation current as of January 10, 2020.
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