news release
View printer-friendly version |
<< Back |
Announced
Completed an Initial Public Offering;
Advances towards FUROSCIX™ PDUFA date
Recent Business Highlights
- Initial Public Offering in
November 2017 . scPharmaceuticals Inc. completed its initial public offering of its common stock raising net proceeds of approximately$92.7 million . The Company expects the proceeds to fund its operations through the commercial introduction of FUROSCIX, if approved, and to allow the Company to continue to develop its pipeline.
- FUROSCIX PDUFA date
June 23, 2018 . InNovember 2017 , theU.S. Food and Drug Administration (FDA ) accepted the 505(b)(2) New Drug Application (NDA) for FUROSCIX and under the Prescription Drug User Fee Act (PDUFA), set an action date ofJune 23, 2018 . The FUROSCIX NDA included data from two pivotal and four exploratory clinical studies as well as eight formative and four summative human factor studies.
- Continuing FUROSCIX clinical initiatives with multiple investigator- and Company-sponsored studies. scPharmaceuticals will continue to build upon the FUROSCIX clinical data through conducting and supporting additional studies to evaluate the efficacy, safety, patient acceptance, and economic value of FUROSCIX.
scPharmaceuticals-sponsored studies. The Company expects to begin enrollment in the second quarter of 2018 for its FREEDOM-HF (FUROSCIX Real-World Evaluation for Decreasing Hospital Admissions in Heart Failure) study, which will evaluate the economic impact of FUROSCIX administered in an outpatient setting, as compared to intravenous furosemide administered in the hospital. | |||||||||||||||
Investigator-sponsored studies. A study sponsored by Steward Healthcare is targeted to begin enrollment in the first quarter of 2018 and is designed to evaluate the number of FUROSCIX doses necessary to achieve a patient’s target weight. Data from this trial is expected by the end of 2018. | |||||||||||||||
A second investigator-sponsored clinical study for FUROSCIX, SUB-Q-HF (Subcutaneous Furosemide in Acute Decompensated Heart Failure), by the NHLBI (National Heart, Lung and Blood Institute) is currently ongoing. |
“We are very proud of our 2017 achievements – including our NDA submission and successful IPO, which is part of our ongoing transition from research and development to a commercial organization,” said
Fourth Quarter and Full Year 2017 Financial Results and Financial Guidance
scPharmaceuticals reported a net loss of
Research and development expenses were
General and administrative expenses were
scPharmaceuticals ended 2017 with
Based on its current operating plan, scPharmaceuticals expects that its existing cash resources will enable it to fund operating expenses through 2019.
About scPharmaceuticals
scPharmaceuticals is a clinical-stage pharmaceutical company focused on developing and commercializing products that have the potential to transform infused therapies, advance patient care and reduce healthcare costs. Our proprietary platform is designed to enable the subcutaneous administration of therapies that have previously been limited to intravenous delivery. scPharmaceuticals’ corporate headquarters are in
About FUROSCIX
FUROSCIX is a drug-device combination product consisting of a proprietary furosemide solution formulated to a neutral pH to allow for subcutaneous infusion via our patented Infusor, a wearable, pre-programed drug delivery system that is applied to the abdomen for subcutaneous drug administration. FUROSCIX is under review at the
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 product candidates, including the potential timing of regulatory filings and approvals regarding our product candidates; potential timing and advancement of our ongoing or planned clinical trials and investigator-sponsored studies; the announcement of data from these trials and studies; and the Company’s financial condition and cash runway through 2019. Any forward-looking statements in this press release are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that any one or more of our product candidates will not receive regulatory approval or be successfully developed and commercialized, the risk of cessation or delay of any of the ongoing or planned clinical trials and/or our development of our product candidates, and the risk that the results of previously conducted studies will not be repeated or observed in ongoing or future studies involving our product candidates. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in the final prospectus related to the Company’s initial public offering filed with the
Contacts:
scPharmaceuticals Inc., 781-301-6706
ktaudvin@scpharma.com
Westwicke Partners, 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 DECEMBER 31, | YEAR ENDED DECEMBER 31, |
|||||||||||||
2016 | 2017 | 2016 | 2017 | ||||||||||||
Operating expenses: | |||||||||||||||
Research and development | $ | 3,017 | $ | 3,716 | $ | 11,856 | $ | 14,331 | |||||||
General and administrative | 943 | 2,992 | 6,054 | 9,105 | |||||||||||
Total operating expenses | 3,960 | 6,708 | 17,910 | 23,436 | |||||||||||
Loss from operations | (3,960 | ) | (6,708 | ) | (17,910 | ) | (23,436 | ) | |||||||
Other income (expense) | 27 | (7 | ) | 38 | 75 | ||||||||||
Interest income | 4 | 171 | 7 | 341 | |||||||||||
Interest expense | (1,389 | ) | (336 | ) | (6,512 | ) | (797 | ) | |||||||
Net loss and comprehensive loss | $ | (5,318 | ) | $ | (6,880 | ) | $ | (24,377 | ) | $ | (23,817 | ) | |||
Net loss per share, basic and diluted | $ | (4.98 | ) | $ | (0.80 | ) | $ | (25.01 | ) | $ | (8.04 | ) | |||
Weighted—average common shares outstanding, basic and diluted | 1,067,457 | 8,565,779 | 974,660 | 2,962,859 | |||||||||||
scPharmaceuticals, Inc. | |||||||||
Unaudited Balance Sheet Data | |||||||||
(in thousands) | AS OF DECEMBER 31, | ||||||||
2016 | 2017 | ||||||||
Cash and restricted cash | $ | 39,282 | $ | 118,480 | |||||
Working capital | 36,004 | 114,913 | |||||||
Total assets | 39,772 | 120,275 | |||||||
Term loan | — | 9,419 | |||||||
Convertible preferred stock | 73,103 | — | |||||||
Accumulated deficit | (43,199 | ) | (67,016 | ) | |||||
Total stockholders’ (deficit) equity | (37,074 | ) | 105,997 |