On August 31, 2018, scPharmaceuticals Inc. (the “Company”) was informed by the National Heart and Lung Institute (the “NHLBI”) of its decision to close the investigator-sponsored Subcutaneous Furosemide in Acute Decompensated Heart Failure(SUB-Q-HF) study. The NHLBI’s decision to discontinue the trial was based on slower than expected enrollment, in part due to the current study design, and was not related to any concerns regarding safety or device performance.SUB-Q-HF is a multi-centered study sponsored by Adrian Hernandez, MD at Duke Clinical Research, conducted at hospitals within the Heart Failure Network and funded through a research grant awarded by the NHLBI. After completion of the pilot phase, the data was reviewed by a Data Safety and Monitoring Board, which recommended proceeding to the full study.
TheSUB-Q-HF study was not a component of the Furoscix NDA submission and the decision by the NHLBI will not impact the initiation of future company-sponsored studies.
By filing this information, the Company makes no admission as to the materiality of any information in this report. The information contained in this report is intended to be considered in the context of the Company’s filings with the U.S. Securities and Exchange Commission (the “Commission”) and other public announcements that the Company makes, by press release or otherwise, from time to time. The Company undertakes no duty or obligation to publicly update or revise the information contained in this report, although it may do so from time to time as its management believes is appropriate. Any such updating may be made through the filing of other reports or documents with the Commission, through press releases or through other public disclosure.
This report contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Any statements contained herein which do not describe historical facts, including but not limited to statements regarding the Company’s expectations with regard to its NDA for Furoscix and the initiation of future company-sponsored studies are forward-looking statements which involve risks and uncertainties that could cause actual results to differ materially from those discussed in such forward-looking statements. Such risks and uncertainties include, without limitation, risks associated with the receipt of regulatory approval for Furoscix, as well as other risks set forth under the caption “Risk Factors” in the Company’s Annual Report on Form10-K for the year ended December 31, 2017 and its subsequent public filings with the Commission. The Company cautions investors not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. Except as required by law, the Company disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.
