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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
Business Highlights
- Granted Type A Post-Action Meeting with the FDA. On
June 13, 2018 , scPharmaceuticals announced the Company received a Complete Response Letter (CRL) from theU.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 theFDA and was granted a Type A Post-Action Meeting, scheduled forSeptember 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 withJohnson & Johnson and with theFDA ; and Dr.Mason Freeman ,5AM Ventures andMassachusetts 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 theFDA and 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
About FUROSCIX
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
About scPharmaceuticals
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
Forward-Looking Statement
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
Contacts:
781-301-7216
tignelzi@scpharma.com
339-970-2843
chris.brinzey@westwicke.com
scPharmaceuticals, Inc. | |||||||||||||||
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, | ||||||||||||||
2017 | 2018 | 2017 | 2018 | ||||||||||||
Operating expenses: | |||||||||||||||
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 | ) | |||||||||
Interest income | 58 | 424 | 95 | 775 | |||||||||||
Interest expense | (132 | ) | (359 | ) | (132 | ) | (701 | ) | |||||||
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 | |||||||||||
scPharmaceuticals, Inc. | |||||||||||||||
Unaudited Balance Sheet Data | |||||||||||||||
(in thousands) | |||||||||||||||
DECEMBER 31, 2017 | JUNE 30, 2018 | ||||||||||||||
Cash and restricted cash | $ | 118,480 | $ | 100,950 | |||||||||||
Working capital | 114,672 | 95,502 | |||||||||||||
Total assets | 122,048 | 105,009 | |||||||||||||
Term loan | 9,419 | 9,562 | |||||||||||||
Accumulated deficit | (67,016 | ) | (85,599 | ) | |||||||||||
Total stockholders’ equity | 105,997 | 88,592 |