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Preparations ongoing for
Business Update
-
Announced that the
U.S. Food and Drug Administration (FDA) has accepted for review the Company’s New Drug Application (NDA) resubmission for FUROSCIX and has set a Prescription Drug User-Fee Act (PDUFA) target action date ofDecember 30, 2020 -
Raised gross proceeds of approximately
$53.8 million through an underwritten offering of common stock, bringing the Company’s current cash, cash equivalents, restricted cash, and investments to over$119 million as ofJune 30, 2020 -
Appointed
Sara Bonstein to its Board of Directors, who has 15 years of operational and financial leadership experience in the life sciences industry - Selected for inclusion into the Russell 2000 Index
-
Four abstracts accepted for poster presentation at the upcoming Heart Failure Society of America (HFSA) Virtual Annual
Scientific Meeting 2020,September 30 through October 6, 2020
“The highlight since our last quarterly update has been the FDA’s acceptance of our FUROSCIX NDA resubmission, and the assignment of our PDUFA date, which is scheduled for December 30,” said
Second Quarter 2020 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 with
Based on its current operating plan, the Company expects the net loss for 2020 to be in the range 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 timing of the FDA’s review of the FUROSCIX NDA and the Company’s planned efforts to prepare for commercialization of FUROSCIX, if approved, 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 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 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 planned Phase 4 study of FUROSCIX, 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 |
SIX MONTHS ENDED |
||||||||||||||
|
|
2019 |
|
|
|
2020 |
|
|
|
2019 |
|
|
|
2020 |
|
|
| Operating expenses: | |||||||||||||||
| Research and development |
$ |
5,496 |
|
$ |
5,139 |
|
$ |
12,020 |
|
$ |
9,285 |
|
|||
| General and administrative |
|
1,839 |
|
|
2,537 |
|
|
4,162 |
|
|
5,040 |
|
|||
| Total operating expenses |
|
7,335 |
|
|
7,676 |
|
|
16,182 |
|
|
14,325 |
|
|||
| Loss from operations |
|
(7,335 |
) |
|
(7,676 |
) |
|
(16,182 |
) |
|
(14,325 |
) |
|||
| Other expense |
|
(14 |
) |
|
(1 |
) |
|
(22 |
) |
|
(32 |
) |
|||
| Interest income |
|
463 |
|
|
21 |
|
|
953 |
|
|
245 |
|
|||
| Interest expense |
|
(369 |
) |
|
(639 |
) |
|
(723 |
) |
|
(1,275 |
) |
|||
| Net loss and comprehensive loss |
$ |
(7,255 |
) |
$ |
(8,295 |
) |
$ |
(15,974 |
) |
$ |
(15,387 |
) |
|||
| Net loss per share, basic and diluted |
$ |
(0.39 |
) |
$ |
(0.36 |
) |
$ |
(0.86 |
) |
$ |
(0.71 |
) |
|||
| Weighted—average common shares outstanding, basic and diluted |
|
18,580,430 |
|
|
23,355,418 |
|
|
18,578,091 |
|
|
21,786,946 |
|
|||
| scPharmaceuticals Inc. | ||||||||
| Unaudited Consolidated Balance Sheet Data | ||||||||
| (in thousands) | ||||||||
|
|
2019 |
|
|
2020 |
|
|||
| Cash, cash equivalents, restricted cash and investments |
$ |
72,806 |
|
$ |
119,511 |
|
||
| Working capital |
|
70,410 |
|
|
116,607 |
|
||
| Total assets |
|
77,283 |
|
|
123,919 |
|
||
| Term loan |
|
18,915 |
|
|
19,076 |
|
||
| Accumulated deficit |
|
(129,455 |
) |
|
(144,842 |
) |
||
| Total stockholders’ equity |
|
51,365 |
|
|
98,059 |
|
||
View source version on businesswire.com: https://www.businesswire.com/news/home/20200813005164/en/
scPharmaceuticals Inc., 781-301-6706
ktaudvin@scpharma.com
Investors:
hans@lifesciadvisors.com
Media:
kate.coyle@icrinc.com
Source: scPharmaceuticals Inc.