news release
View printer-friendly version |
<< Back |
Remain on track to resubmit FUROSCIX® NDA with the FDA by mid-year 2020
Strong balance sheet with over
Projected annual loss for 2020 narrows to
Business Update
-
Remain on track to resubmit the FUROSCIX New Drug Application (NDA) under the current 505(b)(2) approval pathway with the
U.S. Food and Drug Administration (FDA) by mid-year 2020. FUROSCIX is the Company’s lead program for the treatment of congestion in patients with heart failure.
- Device validation and drug stability testing remain on track to be completed prior to the resubmission of the FUROSCIX NDA. All designated drug stability timepoints to date have been successfully completed with one final timepoint remaining prior to submission. The Company also continues to make progress on all key aspects of the device validation program and has recently accomplished critical function reliability testing. Final testing for both device validation and drug stability remains on schedule to be completed to enable the resubmission of the FUROSCIX NDA by mid-year 2020.
- Completed a third-party market research study as part of pre-commercialization preparation. The research study surveyed one hundred heart failure specialists and nurse practitioners regarding current outpatient diuresis treatment. Key findings included 100 percent of those surveyed agree/strongly agree that decreased oral diuretic bioavailability is an impediment to the effective treatment of heart failure (HF). Additionally, study respondents agreed that decreasing hospital readmissions/financial penalties was the primary driver of health systems establishing HF clinics. Overall, the research supports the opportunity for FUROSCIX to provide IV-level diuresis in outpatient settings. The Company will continue to turn its attention to pre-commercialization efforts taking a staged approach that efficiently follows FUROSCIX’s regulatory progress.
“We continue to make excellent progress as we drive towards our planned mid-year resubmission of the FUROSCIX NDA with the FDA,” said
First Quarter 2020 Financial Results and Financial Guidance
scPharmaceuticals reported a net loss of
scPharmaceuticals ended the first quarter with
Based on the Company’s current operating plan and variation of quarterly expenses, scPharmaceuticals is adjusting its prior forecasted 2020 loss of
About FUROSCIX
FUROSCIX is a proprietary furosemide solution formulated to a neutral pH to allow for subcutaneous infusion via a wearable, pre-programmed on-body drug delivery system, for outpatient self-administration. FUROSCIX is being developed for treatment of congestion, 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 congestion.
About scPharmaceuticals
scPharmaceuticals is a pharmaceutical company focused on developing and commercializing products that are designed to reduce healthcare costs and improve health outcomes. The Company develops, internally and through strategic partnerships, innovative products and solutions that aim to expand and advance the outpatient care of select acute conditions. The Company’s lead programs focus on 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 planned resubmission of the FUROSCIX NDA, including potential timing of, and the Company’s expected progress towards, the resubmission and the advancement of the Company’s device verification, research and validation studies, the Company’s planned efforts to prepare for commercialization of FUROSCIX, and the Company’s 2020 financial guidance, including projected annual loss. 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 the Company will not resubmit the FUROSCIX NDA in the expected timeframe or at all, the ability of the FUROSCIX On-Body Infusor to appropriately deliver therapy, the receipt of regulatory approval for the FUROSCIX On-Body Infusor or any of our other product candidates or, if approved, the successful commercialization of such products, the risk of cessation or delay of any of the ongoing or planned clinical trials and/or our development of our product candidates, the risk that the results of previously conducted studies will not be repeated or observed in ongoing or future studies involving our product candidates, and the risk that the current COVID-19 pandemic will impact the Company’s device validation, drug stability testing, the timing of the FDA’s review of the Company’s FUROSCIX NDA and other operations. 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 its Annual Report on Form 10-K for the year ended
scPharmaceuticals Inc. | |||||||
Unaudited Consolidated Statements of Operations and Comprehensive Loss | |||||||
(in thousands, except share and per share data) | |||||||
THREE MONTHS ENDED |
|||||||
2019 |
2020 |
||||||
Operating expenses: | |||||||
Research and development |
$ |
6,524 |
|
$ |
4,146 |
|
|
General and administrative |
|
2,323 |
|
|
2,503 |
|
|
Total operating expenses |
|
8,847 |
|
|
6,649 |
|
|
Loss from operations |
|
(8,847 |
) |
|
(6,649 |
) |
|
Other expense |
|
(8 |
) |
|
(31 |
) |
|
Interest income |
|
490 |
|
|
224 |
|
|
Interest expense |
|
(354 |
) |
|
(636 |
) |
|
Net loss and comprehensive loss |
$ |
(8,719 |
) |
$ |
(7,092 |
) |
|
Net loss per share, basic and diluted |
$ |
(0.47 |
) |
$ |
(0.35 |
) |
|
Weighted—average common shares outstanding, basic and diluted |
|
18,575,726 |
|
|
20,218,473 |
|
|
scPharmaceuticals Inc. | |||||||
Unaudited Consolidated Balance Sheet Data | |||||||
(in thousands) |
|
|
|||||
2019 |
2020 |
||||||
Cash, cash equivalents and restricted cash |
$ |
72,806 |
|
$ |
75,521 |
|
|
Working capital |
|
70,410 |
|
|
74,410 |
|
|
Total assets |
|
77,283 |
|
|
80,488 |
|
|
Term loan |
|
18,915 |
|
|
18,996 |
|
|
Accumulated deficit |
|
(129,455 |
) |
|
(136,547 |
) |
|
Total stockholders’ equity |
|
51,365 |
|
|
55,104 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20200512005080/en/
781-301-6706
ktaudvin@scpharma.com
339-970-2843
chris.brinzey@westwicke.com
Source: scPharmaceuticals Inc.