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Resubmission of FURSOCIX® with the
Balance sheet remains strong with over
“After receiving the minutes from our Type A Post-Action Meeting for FUROSCIX, we have directed our attention to the activities required to re-file our New Drug Application (NDA),” said
- Provided regulatory update on FUROSCIX. On
October 18, 2018, scPharmaceuticals announced it received minutes from the Type A Post-Action Meeting held on September 24, 2018between the Company and the FDAto discuss the Company’s NDA for FUROSCIX. As an outcome of the meeting, the FDAhas asked the Company to conduct additional human factors studies and a dose delivery validation study, with the recently modified FUROSCIX Infusor. The FDAhas not requested additional clinical trials at this time.
FDAgranted Type C Meeting. In response to the October 18, 2018minutes from the Type A Post-Action Meeting and the FDA’s request for a dose delivery validation study, the Company requested, and was granted by the FDA, a Type C Meeting to be held on January 9, 2019to discuss the dose delivery validation protocol.
- Anticipate FUROSCIX NDA to be re-filed with the
FDAby year-end 2019. Based on the requirements from the FDAminutes, and pending the feedback from the Type C Meeting, the Company anticipates completing human factors and dose delivery validation studies in time to re-file the FUROSCIX NDA by year-end 2019.
Third 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 third 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 being developed for treatment of edema, or fluid overload, in patients with heart failure. FUROSCIX has the potential to provide an outpatient alternative for the treatment of worsening heart failure due to edema.
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 timing of the Company’s resubmission of its NDA for FUROSCIX; the Company’s plans to meet with the
|Unaudited Statements of Operations and Comprehensive Loss|
|(in thousands, except share and per share data)|
|THREE MONTHS ENDED SEPTEMBER 30,||NINE MONTHS ENDED SEPTEMBER 30,|
|Research and development||$||3,585||$||3,896||$||10,615||$||12,799|
|General and administrative||1,665||1,945||6,113||11,645|
|Total operating expenses||5,250||5,841||16,728||24,444|
|Loss from operations||(5,250||)||(5,841||)||(16,728||)||(24,444||)|
|Other income (expense)||15||(5||)||82||(58||)|
|Net loss and comprehensive loss||$||(5,489||)||$||(5,761||)||$||(16,937||)||$||(24,343||)|
|Net loss per share, basic and diluted||$||(5.08||)||$||(0.31||)||$||(15.76||)||$||(1.31||)|
|Weighted—average common shares outstanding, basic and diluted||1,080,351||18,569,289||1,074,702||18,551,690|
|Unaudited Balance Sheet Data|
|DECEMBER 31, 2017||SEPTEMBER 30, 2018|
|Cash, cash equivalents and restricted cash||$||118,480||$||95,481|
|Total stockholders’ equity||105,997||83,390|