Catabasis Pharmaceuticals,Inc. (NASDAQ:CATB) Files An 8-K Other Events

ME Staff 8-k
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Catabasis Pharmaceuticals,Inc. (NASDAQ:CATB) Files An 8-K Other Events
Item 8.01. Other Events.

On February13, 2018, Catabasis Pharmaceuticals,Inc. (the “Company”) issued a press release announcing data from the open-label extension of the Company’s MoveDMD®clinical trial. The press release is filed as Exhibit99.1 to this Current Report on Form8-K, and the information contained therein is incorporated herein by reference.

Item 9.01. Financial Statements and Exhibits.

(d)Exhibits

The Exhibitto this Current Report on Form8-K is listed in the ExhibitIndex below.

Cautionary Note Regarding Forward-Looking Statements

This Current Report on Form8-K, including the press release filed as Exhibit99.1, contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, contained in this Current Report on Form8-K, including statements regarding the Company’s plans to commence a single global Phase 3 trial in Duchenne muscular dystrophy, or DMD, in the first half of 2018 to evaluate the efficacy and safety of edasalonexent for registration purposes and the Company’s plans to report top-line results from this trial in 2020, are forward-looking statements. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The Company may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of important risks and uncertainties, including uncertainties inherent in the initiation and completion of preclinical studies and clinical trials and clinical development of the Company’s product candidates, including the final trial design of the Company’s planned Phase 3 clinical trial in DMD; availability and timing of results from preclinical studies and clinical trials, including the availability of top-line results from the Company’s planned Phase 3 clinical trial in DMD in 2020; whether interim results from a clinical trial will be predictive of the final results of the trial or the results of future trials; expectations for regulatory approvals to conduct trials or to market products, including the Company’s expected target product profile for edasalonexent in DMD; the Company’s ability to obtain financing on acceptable terms and in a timely manner to fund the Company’s planned Phase 3 clinical trial in DMD to evaluate the efficacy and safety of edasalonexent for registration purposes; availability of funding sufficient for the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements; other matters that could affect the availability or commercial potential of the Company’s product candidates; and general economic and market conditions and other factors discussed in the Company’s most recent Quarterly Report on Form10-Q for the period ended September 30, 2017, particularly in the “Risk Factors” section, which is on file with the Securities and Exchange Commission. Except as otherwise required by law, the Company disclaims any intention or obligation to update any forward-looking statements as a result of developments occurring after the date of this Current Report on Form8-K.


CATABASIS PHARMACEUTICALS INC Exhibit
EX-99.1 2 a18-5914_1ex99d1.htm EX-99.1 Exhibit 99.1     Catabasis Pharmaceuticals Reports Edasalonexent Preserved Muscle Function and Substantially Slowed Duchenne Muscular Dystrophy Disease Progression Through More Than One Year of Treatment   — Consistent Improvements Sustained Across All Assessments of Muscle Function Through 48 and 60 Weeks of Edasalonexent Treatment in MoveDMD® Trial —   — Single Global Phase 3 Trial Expected to Begin in First Half of 2018 —     CAMBRIDGE,…
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About Catabasis Pharmaceuticals,Inc. (NASDAQ:CATB)

Catabasis Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company. The Company is focused on the discovery, development and commercialization of therapeutics based on its Safely Metabolized And Rationally Targeted (SMART), a linker drug discovery platform. The SMART linker drug discovery platform enables to engineer product candidates that can modulate multiple targets in a disease. The Company’s primary focus is on treatments for rare diseases. The Company is also developing other product candidates for the treatment of lipid disorders. The Company’s CAT-1004 is a SMART linker conjugate of salicylate, a non-steroidal anti-inflammatory drug, and the omega-3 fatty acid docosahexaenoic acid (DHA), a naturally occurring unsaturated fatty acid with anti-inflammatory properties. Its CAT-2000 series product candidates inhibit the Sterol Regulatory Element Binding Protein (SREBP) pathway. The Company’s CAT-4001 is a SMART linker conjugate of monomethyl fumarate and DHA.