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Request for Type A meeting was granted by the
Balance sheet remains strong with over
“Since receiving the Complete Response Letter for FUROSCIX® from the
- Granted Type A Post-Action Meeting with the FDA. On
June 13, 2018, scPharmaceuticals announced the Company received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration( FDA) regarding the 505(b)(2) application for FUROSCIX, a treatment candidate for edema, or fluid overload, in patients with heart failure. The Company submitted a request to the FDAand was granted a Type A Post-Action Meeting, scheduled for September 24, 2018. scPharmaceuticals believes the upcoming meeting will provide an opportunity to define the pathway and timing to re-submit the NDA.
- Organizational restructuring in place to ensure financial flexibility. Since receiving the CRL, scPharmaceuticals has implemented a companywide restructuring to align the workforce with the upcoming needs of the business and focus on activities essential to addressing the CRL and FUROSCIX development. Following the restructuring, the company has 24 full time employees.
- Appointed three directors with deep financial, industry and regulatory experience.
Frederick Hudson, 37 years at KPMG and lead partner of KPMG’s Mid-Atlantic region healthcare audit practice; Minnie Baylor-Henry, 20 years regulatory affairs with Johnson & Johnsonand with the FDA; and Dr. Mason Freeman, 5AMVentures and Massachusetts General Hospital, all joined the scPharmaceuticals Board. Each of the three new directors brings to the Company a deep understanding of the biopharmaceutical industry in key areas including audit, clinical, and regulatory strategy that will contribute to scPharmaceuticals’ efforts as it works with the FDAand moves toward the re-submission and potential approval of FUROSCIX.
Second Quarter 2018 Financial Results and Financial Guidance
scPharmaceuticals reported a net loss of
Research and development expenses were
General and administrative expenses were
scPharmaceuticals ended the second quarter of 2018 with
Based on its current operating plan, scPharmaceuticals expects year end 2018 cash and cash equivalents and investment securities to be approximately
FUROSCIX is a proprietary furosemide solution formulated to a neutral pH to allow for subcutaneous infusion via the patented Infusor, a wearable, pre-programed drug delivery system that is applied to the abdomen for subcutaneous drug administration. FUROSCIX is under review by the
scPharmaceuticals is a clinical-stage pharmaceutical company focused on developing and commercializing products that reduce healthcare costs and improve health outcomes. The Company develops products for the subcutaneous, self-administration of IV-strength treatments in heart failure and infectious disease. scPharmaceuticals is headquartered in
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements regarding the Company’s new drug application for FUROSCIX; the Company’s planned actions in response to the FDA’s Complete Response Letter, including the timing of any future public announcement; the outcome of the Company's Type A Post-Action Meeting with the
|Unaudited Statements of Operations and Comprehensive Loss|
|(in thousands, except share and per share data)|
|THREE MONTHS ENDED JUNE 30,||SIX MONTHS ENDED JUNE 30,|
|Research and development||$||4,145||$||4,855||$||7,030||$||8,903|
|General and administrative||2,374||5,049||4,448||9,700|
|Total operating expenses||6,519||9,904||11,478||18,603|
|Loss from operations||(6,519||)||(9,904||)||(11,478||)||(18,603||)|
|Other income (expense)||57||(11||)||67||(53||)|
|Net loss and comprehensive loss||$||(6,536||)||$||(9,850||)||$||(11,448||)||$||(18,582||)|
|Net loss per share, basic and diluted||$||(6.09||)||$||(0.53||)||$||(10.68||)||$||(1.00||)|
|Weighted—average common shares outstanding, basic and diluted||1,072,940||18,549,978||1,071,822||18,542,745|
|Unaudited Balance Sheet Data|
|DECEMBER 31, 2017||JUNE 30, 2018|
|Cash and restricted cash||$||118,480||$||100,950|
|Total stockholders’ equity||105,997||88,592|