Chiasma, Inc. (NASDAQ:CHMA) Files An 8-K Results of Operations and Financial ConditionItem 2.02
On August10, 2017, Chiasma, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended June30, 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 August10, 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 June30, 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 Section18 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 2.02 | Regulation FD Disclosure |
On August10, 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 2.02 is intended to be furnished and shall not be deemed “filed” for purposes of Section18 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 August4, 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 August10, 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 2.02 | Financial Statements and Exhibits. |
(d)Exhibits
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Exhibit No. |
Description |
| 99.1 | Press Release of Chiasma, Inc. (concerning financial results) dated August10, 2017 |
| 99.2 | Press Release of Chiasma, Inc. (concerning the SPA agreement) dated August10, 2017 |
| 99.3 | Slide Presentation of Chiasma, Inc. dated August10, 2017 |
CHIASMA, INC ExhibitEX-99.1 2 d438713dex991.htm EX-99.1 EX-99.1 Exhibit 99.1 Chiasma Reports Second Quarter 2017 Results Anticipated release of top-line data from new OPTIMAL trial by end of 2019 WALTHAM,…To view the full exhibit click here
About Chiasma, Inc. (NASDAQ:CHMA)
Chiasma, Inc. is a biopharmaceutical company. The Company is engaged in developing and commercializing oral forms of therapies that are available only by injection. Using its Transient Permeability Enhancer (TPE) technology platform, the Company is developing oral therapies. The Company has completed a Phase III clinical trial of its TPE platform-based product candidate, oral octreotide capsules (trade named as MYCAPSSA) for the treatment of acromegaly, a condition that results in the body’s production of excess growth hormone. Octreotide is an analog of somatostatin, a natural inhibitor of growth hormone secretion. The Company is developing octreotide capsules as a liquid-filled solid gelatin capsule formulation, which is intended to be taken over twice a day. The Company’s TPE technology enhances the absorption through the intestinal wall of drugs. The Company also focuses on developing CH2 for Orphan indication.
